UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
____________________
FORM
10-K
(Mark
One)
|
þ
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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For
the fiscal year ended December 31, 2007
or
o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
|
For
the transition period from
to
Commission
file number: 1-9813
GENENTECH,
INC.
(Exact
name of registrant as specified in its charter)
A
Delaware Corporation
(State
or other jurisdiction of incorporation or organization)
|
94-2347624
(I.R.S.
Employer Identification No.)
|
1
DNA Way, South San Francisco, California
(Address
of principal executive offices)
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94080
(Zip
Code)
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(650) 225-1000
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title of Each
Class
|
Name of Each Exchange
on Which Registered
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Common
Stock, $0.02 par value
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New
York Stock Exchange
|
Securities
registered pursuant to Section 12(g) of the Act:
None
(Title
of class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes þ No o
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes o No þ
Indicate
by check mark whether the registrant (1) has filed all reports required to
be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934
during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days. Yes þ No o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the
best of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. þ
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer and large accelerated filer” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer þ
|
Accelerated
filer o
|
Non-accelerated
filer o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of Act). Yes o No þ
The
aggregate market value of Common Stock held by non-affiliates as of June 30,
2007 was $35,196,069,756.(A) All
executive officers and directors of the registrant and Roche Holdings, Inc. have
been deemed, solely for the purpose of the foregoing calculation, to be
“affiliates” of the registrant.
Number
of shares of Common Stock outstanding as of February 12,
2008: 1,053,124,320
Documents
incorporated by reference:
Portions
of the Definitive Proxy Statement with respect to the 2008 Annual
Meeting of Stockholders to be filed by Genentech, Inc. with the Securities
and Exchange Commission (hereinafter referred to as “Proxy
Statement”)
|
Part III
|
________________________
(A)
|
Excludes
587,250,021 shares of Common Stock held by directors and executive
officers of Genentech and Roche Holdings,
Inc.
|
GENENTECH,
INC.
2007
Form 10-K Annual Report
Table
of Contents
Page
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Item 1
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1
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Item 1A
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11
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Item 1B
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24
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Item 2
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24
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Item 3
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25
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Item 4
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27
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28
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Item 5
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30
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Item 6
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32
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Item 7
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33
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Item 7A
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64
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Item 8
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67
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Item 9
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107
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Item 9A
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107
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Item 9B
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109
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Item 10
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110
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Item 11
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110
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Item 12
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110
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Item 13
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110
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Item 14
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110
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Item 15
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111
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115
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In
this report, “Genentech,” “we,” “us,” and “our” refer to Genentech,
Inc. “Common Stock” refers to Genentech’s Common Stock, par value $0.02 per
share, “Special Common Stock” refers to Genentech’s callable putable common
stock, par value $0.02 per share, all of which was redeemed by Roche Holdings,
Inc. (RHI) on June 30, 1999.
We
own or have rights to various copyrights, trademarks, and trade names used in
our business, including the following: Activase® (alteplase, recombinant)
tissue-plasminogen activator; Avastin® (bevacizumab) anti-VEGF antibody;
Cathflo® Activase® (alteplase for catheter clearance); Genentech®, Herceptin®
(trastuzumab) anti-HER2 antibody; Lucentis® (ranibizumab) anti-VEGF antibody
fragment; Nutropin® (somatropin [rDNA origin] for injection) growth hormone;
Nutropin AQ® and Nutropin AQ Pen® (somatropin [rDNA origin] for injection)
liquid formulation growth hormone; Pulmozyme® (dornase alfa, recombinant)
inhalation solution; Raptiva® (efalizumab) anti-CD11a antibody; and TNKase®
(tenecteplase) single-bolus thrombolytic agent. Rituxan® (rituximab) anti-CD20
antibody is a registered trademark of Biogen Idec Inc.; Tarceva® (erlotinib) is
a registered trademark of OSI Pharmaceuticals, Inc.; and Xolair® (omalizumab)
anti-IgE antibody is a registered trademark of Novartis AG. This report also
includes other trademarks, service marks, and trade names of other
companies.
Overview
Genentech
is a leading biotechnology company that discovers, develops, manufactures, and
commercializes pharmaceutical products to treat patients with significant unmet
medical needs. A number of the currently approved biotechnology products
originated from or are based on Genentech science. We commercialize multiple
biotechnology products and also receive royalties from companies that are
licensed to market products based on our technology. See “Marketed Products” and
“Licensed Products” below. Genentech was organized in 1976 as a California
corporation and was reincorporated in Delaware in 1987.
Marketed
Products
We
commercialize the pharmaceutical products listed below in the United States
(U.S.):
Avastin (bevacizumab) is an
anti-VEGF (vascular endothelial growth factor) humanized antibody approved for
use in combination with intravenous 5-fluorouracil-based chemotherapy as a
treatment for patients with first- or second-line metastatic cancer of the colon
or rectum. It is also approved for use in combination with carboplatin and
paclitaxel chemotherapy for the first-line treatment of unresectable, locally
advanced, recurrent or metastatic non-squamous, non-small cell lung cancer
(NSCLC). On February 22, 2008, we received accelerated approval from the
U.S. Food and Drug Administration (FDA) to market Avastin in combination with
paclitaxel chemotherapy for the treatment of patients who have not received
prior chemotherapy for metastatic HER2-negative breast cancer (BC).
Rituxan (rituximab) is an
anti-CD20 antibody that we commercialize with Biogen Idec Inc. It is approved
for first-line treatment of patients with follicular, CD20-positive, B-cell
non-Hodgkin’s lymphoma (NHL) in combination with cyclophosphamide, vincristine,
and prednisone (CVP) chemotherapy regimens or following CVP chemotherapy in
patients with stable disease or who achieve a partial or complete response
following first-line treatment with CVP chemotherapy. Rituxan is also approved
for treatment of patients with relapsed or refractory, low-grade or follicular,
CD20-positive, B-cell NHL, including retreatment and bulky diseases. Rituxan is
indicated for first-line treatment of patients with diffuse large B-cell,
CD20-positive, NHL in combination with cyclophosphamide, doxorubicin,
vincristine, and prednisone (CHOP) or other anthracycline-based chemotherapy.
Rituxan is also indicated for use in combination with methotrexate to reduce
signs and symptoms and to slow the progression of structural damage in adult
patients with moderately to severely active rheumatoid arthritis who have had an
inadequate response to one or more tumor necrosis factor (TNF) antagonist
therapies.
Herceptin (trastuzumab) is a
humanized anti-HER2 antibody approved for treatment of patients with
node-positive or node-negative BC as part of an adjuvant treatment regimen
containing doxorubicin, cyclophosphamide, and paclitaxel (for patients who have
tumors that overexpress the human epidermal growth factor receptor 2 (HER2)
protein). It is also approved for use as a first-line therapy in combination
with paclitaxel and as a single agent in second- and third-line therapy for
patients with HER2-positive metastatic BC.
Lucentis (ranibizumab) is an
anti-VEGF antibody fragment approved for the treatment of neovascular (wet)
age-related macular degeneration (AMD).
Xolair (omalizumab) is a
humanized anti-IgE antibody, which we commercialize with Novartis Pharma
AG (a wholly owned subsidiary of Novartis AG; Novartis Pharma AG and
affiliates are collectively referred to herein as Novartis). Xolair is approved
for adults and adolescents (age 12 or older) with moderate to severe persistent
asthma who have a positive skin test or in vitro reactivity to a perennial
aeroallergen and whose symptoms are inadequately controlled with inhaled
corticosteroids.
Tarceva (erlotinib), which we
commercialize with OSI Pharmaceuticals, Inc., is a small-molecule tyrosine
kinase inhibitor of the HER1/epidermal growth factor receptor signaling pathway.
Tarceva is approved for the treatment of patients with locally advanced or
metastatic NSCLC after failure of at least one prior chemotherapy regimen. It is
also approved, in combination with gemcitabine chemotherapy, for the
first-line treatment of patients with locally advanced, unresectable, or
metastatic pancreatic cancer.
Nutropin (somatropin [rDNA
origin] for injection) and Nutropin AQ are growth
hormone products approved for the treatment of growth hormone deficiency in
children and adults, growth failure associated with chronic renal insufficiency
prior to kidney transplantation, short stature associated with Turner syndrome,
and long-term treatment of idiopathic short stature.
Activase (alteplase,
recombinant) is a tissue plasminogen activator (t-PA) approved for the treatment
of acute myocardial infarction (heart attack), acute ischemic stroke (blood
clots in the brain) within three hours of the onset of symptoms, and acute
massive pulmonary embolism (blood clots in the lungs).
TNKase (tenecteplase) is a
modified form of t-PA approved for the treatment of acute myocardial infarction
(heart attack).
Cathflo Activase (alteplase,
recombinant) is a t-PA approved in adult and pediatric patients for the
restoration of function to central venous access devices that have become
occluded due to a blood clot.
Pulmozyme (dornase alfa,
recombinant) is an inhalation solution of deoxyribonuclease I, approved for the
treatment of cystic fibrosis.
Raptiva (efalizumab) is a
humanized anti-CD11a antibody approved for the treatment of chronic
moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates
for systemic therapy or phototherapy.
See
“Total Product Sales” under “Results of Operations” in Part II, Item 7 of this
Form 10-K for a discussion of the sales of each of our products in the last
three years, including those that accounted for 10% or more of our consolidated
revenue.
Licensed
Products
Royalty
Revenue
We
receive royalty revenue under license agreements with companies that sell and/or
manufacture products based on technology developed by us or intellectual
property to which we have rights. These licensed products are sometimes sold
under different trademarks or trade names. Significant licensed products,
including all related party licenses with Roche Holding AG and affiliates
(Roche), representing approximately 89% of our royalty revenue in 2007, are
presented in the following table:
|
|
|
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Trastuzumab
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Herceptin
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Roche
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Worldwide
excluding U.S.
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Rituximab
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Rituxan/MabThera®
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Roche
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Worldwide
excluding U.S. and Japan
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Bevacizumab
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Avastin
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Roche
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Worldwide
excluding U.S.
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Dornase
alfa, recombinant
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Pulmozyme
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Roche
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Worldwide
excluding U.S.
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Alteplase
and Tenecteplase
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Activase
and TNKase
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Roche
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Canada
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Somatropin
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Nutropin
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Roche
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Canada
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Daclizumab
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Zenapax®
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Roche
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Worldwide
excluding U.S.
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Ranibizumab
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Lucentis
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Novartis
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Worldwide
excluding U.S.
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Etanercept
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Enbrel®
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Immunex
Corporation (whose rights were acquired by Amgen Inc.)
|
Worldwide
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Adalimumab
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Humira®
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Abbott
Laboratories
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Worldwide
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Infliximab
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Remicade®
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Celltech
Pharmaceuticals plc (which transferred rights to Centocor, Inc. / Johnson
& Johnson)
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Worldwide
|
See
Item 3, “Legal Proceedings,” below for information regarding certain patent
litigation matters, including recent notification from the U.S. Patent and
Trademark Office regarding the Cabilly reexamination.
Other
Revenue
We
have granted a license to Zenyaku Kogyo Co., Ltd. (Zenyaku), a Japanese
pharmaceutical company, for the manufacture, use, and sale of rituximab in
Japan. Zenyaku co-promotes rituximab in Japan with Chugai Pharmaceutical
Co., Ltd., a Japanese affiliate of Roche, under the trademark Rituxan. The
revenue earned from our sales of rituximab to Zenyaku is included in product
sales.
Products
in Development
Our
product development efforts, including those of our collaborators, cover a wide
range of medical conditions, including cancer and immune diseases. Below is a
summary of products and current stages of development. For additional
information on our development pipeline, visit our website at
www.gene.com.
|
|
Awaiting
FDA Action
|
|
Herceptin
|
Supplemental
Biologic License Applications (sBLAs) were submitted to the FDA on June 28
and 29, 2007 for the use of Herceptin for the treatment of patients with
early-stage HER2-positive BC based on the BCIRG 006 study to enable a
broader label. This product is being developed in collaboration with
Roche. The FDA action dates for the June 28 and June 29 submissions are
April 28 and May 4, 2008, respectively.
|
Preparing
for Filing
|
|
Avastin
|
We
are preparing to submit an sBLA to the FDA for the use of Avastin in
combination with interferon alpha-2a for the treatment of patients with
previously untreated advanced renal cell carcinoma. This product is being
developed in collaboration with Roche. We expect to
submit an sBLA to the FDA in 2008.
|
Avastin
|
We
are in preliminary discussions with the FDA regarding the submission
requirements for a potential sBLA for the use of Avastin in combination
with CPT-11 or as a single agent in patients with glioblastoma multiforme
(a form of brain cancer) who have progressed following prior
therapy.
|
Phase
III
|
|
2nd
Generation anti-CD20
|
2nd
Generation anti-CD20 is being evaluated in rheumatoid arthritis. This
product is being developed in collaboration with Roche and Biogen
Idec(1).
|
2nd
Generation anti-CD20
|
2nd
Generation anti-CD20 is being evaluated for systematic lupus
erythematosus. This product is being developed in collaboration with Roche
and Biogen Idec(1).
|
Avastin
|
Avastin
is being evaluated in adjuvant colon cancer, second-line metastatic colon
cancer for patients who have progressed following first-line treatment of
Avastin plus chemotherapy, adjuvant HER2-negative BC, adjuvant lung
cancer, first-line HER2-negative and second-line HER2-negative metastatic
breast cancer in combination with several chemotherapy regimens,
first-line non-squamous NSCLC, first-line and platinum-sensitive relapsed
ovarian cancer, and hormone refractory prostate cancer. This product is
being developed in collaboration with Roche.
|
Herceptin
+/- Avastin
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Avastin
is being evaluated in first-line metastatic HER2-positive BC. This product
is being developed in collaboration with Roche.
|
Avastin
+/- Tarceva
|
Avastin
and Tarceva are being evaluated as combination therapy in first-line NSCLC
in combination with several chemotherapy regimens. Tarceva is being
developed in collaboration with OSI and Roche. Avastin is being developed
in collaboration with Roche.
|
Herceptin
|
Herceptin
is being evaluated for the treatment of patients with early-stage
HER2-positive breast cancer to compare one year duration of treatment with
two years duration of treatment. This product is being developed in
collaboration with Roche.
|
Herceptin
+/- Pertuzumab
|
Pertuzumab
is being evaluated in first-line HER2-positve metastatic BC in combination
with Herceptin and chemotherapy. This product is being developed in
collaboration with Roche.
|
Rituxan
|
Rituxan
is being evaluated in follicular NHL patients who achieve a response
following induction with chemotherapy plus Rituxan and in patients with
relapsed chronic lymphocytic leukemia. This product is being developed in
collaboration with Roche and Biogen Idec.
|
Rituxan
|
Rituxan
is being evaluated in rheumatoid arthritis (DMARD inadequate responders)
in collaboration with Roche and Biogen Idec. Rituxan is also being
evaluated in primary progressive multiple sclerosis, systemic lupus
erythematosus, lupus nephritis, and ANCA-associated vasculitis in
collaboration with Biogen Idec.
|
Tarceva
|
Tarceva
is being evaluated in adjuvant NSCLC and first-line NSCLC. This product is
being developed in collaboration with OSI.
|
Tarceva
+/- Avastin
|
Tarceva
and Avastin are being evaluated as combination therapy in second-line
NSCLC. Tarceva is being developed in collaboration with OSI and Roche.
Avastin is being developed in collaboration with Roche.
|
TNKase
|
TNKase
is being evaluated in the treatment of dysfunctional hemodialysis and
central venous access catheters.
|
Xolair
|
Xolair
is being evaluated in pediatric asthma. A liquid formulation of Xolair is
also being evaluated for adult asthma. Xolair is being developed in
collaboration with Novartis.
|
Lucentis
|
Lucentis
is being evaluated in the treatment of diabetic macular edema in
collaboration with Novartis Ophthalmics. Lucentis is also being evaluated
in the treatment of retinal vein occlusion.
|
Preparing
for Phase III
|
|
2nd
Generation anti-CD20
|
We
are preparing Phase III clinical trials in lupus nephritis. This product
is being developed in collaboration with Roche and Biogen Idec(1).
|
Avastin
|
We
are preparing for Phase III clinical trials in high-risk carcinoid cancer,
first-line glioblastoma multiforme, head and neck cancer, and
gastro-intestinal stromal tumors.
|
Herceptin
|
We
are preparing for Phase III clinical trials in ductal carcinoma in situ.
This product is being developed in collaboration with Roche.
|
Herceptin
+/- Avastin
|
We
are preparing for a Phase III clinical trial of Herceptin and Avastin as
combination therapy in first-line and adjuvant HER2-positve metastatic BC.
These products are being developed in collaboration with Roche. These are
separate trials from that listed in Phase III above.
|
Phase
II
|
|
Anti-CD40
|
Anti-CD40
is being evaluated as a single agent and in combination with Rituxan plus
chemotherapy for patients with relapsed or refractory diffuse large B-cell
lymphoma. This product is being developed in collaboration with Seattle
Genetics, Inc.
|
Apo2L/TRAIL
|
Apo2L/TRAIL
is being evaluated in first-line NSCLC in combination with
chemotherapy/Avastin and in NHL in combination with Rituxan. This product
is being developed in collaboration with Amgen.
|
Apomab
|
Apomab
is being evaluated in first-line NSCLC in combination with
chemotherapy/Avastin, and as a single agent in
chondrosarcoma.
|
Avastin
|
Avastin
is being evaluated in multiple myeloma, platinum-sensitive relapsed
ovarian cancer, extensive small cell lung cancer, and NSCLC with
previously treated brain metastasis and squamous cell histology. This
product is being developed in collaboration with Roche.
|
Herceptin
+/- Pertuzumab
|
Pertuzumab
is being evaluated in HER2-positive metastatic BC patients who have
progressed on Herceptin. This product is being developed in collaboration
with Roche.
|
Pertuzumab
|
Pertuzumab
is being evaluated in ovarian cancer in combination with chemotherapy.
This product is being developed in collaboration with Roche.
|
Trastuzumab-DM1
|
Trastuzumab-DM1
is being evaluated in late stage HER2-positive metastatic BC. This product
is being developed in collaboration with Roche.
|
ABT-869
|
ABT-869
is being evaluated for the treatment of several types of tumors. This
product is being developed in collaboration with Abbott.
|
Preparing
for Phase II
|
|
2nd
Generation anti-CD20
|
We
are preparing for a Phase II clinical trial in relapsing remitting
multiple sclerosis. This product is being developed in collaboration with
Roche and Biogen Idec(1).
|
Rituxan
+/- Apomab
|
We
are preparing for a Phase II clinical trial of Apomab and Rituxan as
combination therapy in NHL.
|
Systemic
Hedgehog Antagonist
|
We
are preparing for Phase II clinical trials for solid tumors. This product
is being developed in collaboration with Curis, Inc.
|
Phase
I and Preparing for Phase I
|
We
have multiple new molecular entities in Phase I or Preparing for Phase
I.
|
________________________
(1)
|
Our
collaborator Biogen Idec disagrees with certain of our development
decisions under our 2003 collaboration agreement with them. We continue to
pursue a resolution of our differences with Biogen Idec, and the disputed
issues have been submitted to arbitration. See Part I, Item 3, “Legal
Proceedings,” of this Form 10-K for further
information.
|
Related
Party Arrangements
See
“Relationship with Roche” and “Related Party Transactions” sections below in
Part II, Item 7 of this Form 10-K for information on our collaboration
arrangements with Roche and Novartis.
Distribution
and Commercialization
We
have a U.S.-based marketing, sales and distribution organization. Our sales
efforts are focused on specialist physicians in private practice or at hospitals
and major medical centers in the U.S. In general, our products are sold largely
to wholesalers, specialty distributors or directly to hospital pharmacies. We
utilize common pharmaceutical company marketing techniques, including sales
representatives calling on individual physicians and distributors,
advertisements, professional symposia, direct mail, and public relations, as
well as other methods.
The
Genentech Access to Care Foundation provides free product to eligible uninsured
patients and those deemed uninsured due to payer denial in the U.S. We have the
Genentech Endowment for Cystic Fibrosis to assist cystic fibrosis patients in
the U.S. with obtaining Pulmozyme. The Genentech Access to Care Foundation and
the Genentech Endowment for Cystic Fibrosis are non-profit entities funded by
Genentech, Inc. We also provide customer service programs related to our
products. We maintain a physician-related product waste replacement program for
Rituxan, Avastin, Herceptin, Activase, TNKase, and Lucentis, that, subject to
specific conditions, gives physicians the right to return these products to us
for replacement. We also maintain expired product programs for
all
of
our products that, subject to certain specific conditions, give customers the
right to return expired products to us for replacement or credit at a price
based on a 12-month rolling average. To further support patient access to
therapies for various diseases we donate to various independent public charities
that offer financial assistance, such as co-pay assistance, to eligible
patients.
In
February 2007, we launched the Avastin Patient Assistance Program, which is a
voluntary program that enables eligible patients who receive greater than 10,000
milligrams of Avastin over a 12-month period to receive free Avastin in excess
of the 10,000 milligrams during the remainder of the 12-month period. Based on
the current wholesale acquisition cost, 10,000 milligrams is valued at $55,000
in gross revenue. Eligible patients include those who are being treated for
an FDA-approved indication and who meet the household income criteria for this
program. The program is available for eligible patients who enroll regardless of
whether they are insured.
As
discussed in Note 13, “Segment, Significant Customer and Geographic
Information,” in the Notes to Consolidated Financial Statements in Part II, Item
8 of this Form 10-K, our combined sales to three major wholesalers constituted
approximately 86% in 2007, 85% in 2006, and 82% in 2005 of our total net U.S.
product sales. Also discussed in the note are net U.S. product sales and net
foreign revenue in 2007, 2006, and 2005.
Manufacturing
and Raw Materials
Manufacturing
biotechnology products is difficult and complex, and requires facilities
specifically designed and validated for this purpose. It can take longer than
five years to design, construct, validate, and license a new biotechnology
manufacturing facility. Production problems in any of our operations or our
contractors’ manufacturing plants could result in failure to produce adequate
product supplies or could result in product defects which could require us to
delay shipment of products, recall products previously shipped, or be unable to
supply products at all. In addition, we may need to record period charges
associated with manufacturing or inventory failures or other production-related
costs or incur costs to secure additional sources of capacity. Alternatively, we
may have an excess of available capacity, which could lead to an idling of a
portion of our manufacturing facilities and incurring unabsorbed or idle plant
charges, costs associated with the termination of existing contract
manufacturing relationships, or other excess capacity charges, resulting in an
increase in our cost of sales (COS). Furthermore, there are inherent
uncertainties associated with forecasting future demand, especially for newly
introduced products of ours or of those for whom we produce products, and as a
consequence we may have inadequate capacity to meet actual demand.
Raw
materials and supplies required for the production of our principal products are
available, in some instances from one supplier and in other instances, from
multiple suppliers. In those cases for which raw materials are available through
only one supplier, that supplier may be either a sole source (the only
recognized supply source available to us) or a single source (the only approved
supply source for us among other sources). We have adopted policies that
attempt, to the extent feasible, to minimize raw material supply risks to us,
including maintenance of greater levels of raw materials inventory and
coordination with our collaborators to implement raw materials sourcing
strategies.
For
risks associated with manufacturing and raw materials, see “Difficulties or
delays in product manufacturing or in obtaining materials from our suppliers, or
difficulties in accurately forecasting manufacturing capacity needs, could harm
our business and/or negatively affect our financial performance” under “Risk
Factors” below in Part I, Item 1A of this Form 10-K.
Proprietary
Technology—Patents and Trade Secrets
We
seek patents on inventions originating from our ongoing research and development
(R&D) activities. We have been issued patents and have patent applications
pending that relate to a number of current and potential products, including
products licensed to others. Patents, issued or applied for, cover inventions
ranging from basic recombinant DNA techniques to processes related to specific
products and to the products themselves. Our issued patents extend for varying
periods according to the date of patent application filing or grant and the
legal term of patents in the various countries where patent protection is
obtained. The actual protection afforded by a patent,
which
can vary from country to country, depends upon the type of patent, the scope of
its coverage as determined by the patent office or courts in the country, and
the availability of legal remedies in the country. We consider that in the
aggregate our patent applications, patents and licenses under patents owned by
third parties are of material importance to our operations. For our five highest
selling products, we have identified in the following table the latest-to-expire
U.S. patents that are owned or controlled by or exclusively licensed to
Genentech having claims directed to product-specific compositions of matter
(e.g., nucleic acids, proteins, protein-producing host cells). This table does
not identify all patents that may relate to these products. For example, in
addition to the listed patents, we have patents on platform technologies (that
relate to certain general classes of products or methods), as well patents on
methods of using or administering many of our products, that may confer
additional patent protection. We also have pending patent applications that may
give rise to new patents relating to one or more of these products.
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Latest-to-expire
product-specific U.S. Patent(s)
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Avastin
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6,884,879
7,169,901
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2017
2019
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Rituxan
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5,677,180
5,736,137
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2014
2015
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Herceptin
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6,339,142
6,407,213
7,074,404
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2019
2019
2019
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Lucentis
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6,884,879
7,169,901
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2017
2019
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Xolair
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6,329,509
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2018
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The
information in this table is based on our current assessment of patents that we
own or control or have exclusively licensed and is subject to revision, for
example, in the event of changes in the law or legal rulings affecting our
patents or if we become aware of new information. Significant legal issues
remain to be resolved as to the extent and scope of available patent protection
for biotechnology products and processes in the U.S. and other important markets
outside of the U.S. We expect that litigation will likely be necessary to
determine the validity, enforceability, and scope of certain of our patents and
other proprietary rights. An adverse decision or ruling with respect to one or
more of our patents could result in the loss of patent protection for a product
and, in turn, the introduction of competitor products or follow-on biologics
onto the market, earlier than anticipated, and could force us to either obtain
third-party licenses at a material cost or cease using a technology or
commercializing a product. We are currently involved in a number of legal
proceedings related to the scope of protection and validity of our patents and
those of others. These proceedings may result in a significant commitment of our
resources in the future and, depending on their outcome, may adversely affect
the validity, enforceability, and/or scope of certain of our patent or other
proprietary rights (such as the Cabilly patent discussed in Item 3, “Legal
Proceedings”), and may cause us to incur a material loss of royalties, other
revenue, and/or market exclusivity for one or more of our products. The patents
that we obtain or the unpatented proprietary technology that we hold may not
afford us significant commercial protection.
We
have obtained licenses from various parties that we deem to be necessary or
desirable for the manufacture, use, or sale of our products. These licenses
(both exclusive and non-exclusive) generally require us to pay royalties to the
parties on product sales. In conjunction with these licenses, disputes sometimes
arise regarding whether royalties are owed on certain product sales or the
amount of royalties that are owed. The resolution of such disputes may cause us
to incur significant additional royalty expenses or other expenses.
Our
trademarks—Activase, Avastin, Cathflo, Genentech, Herceptin, Lucentis, Nutropin,
Nutropin AQ, Nutropin AQ Pen, Pulmozyme, Raptiva, Rituxan (licensed from Biogen
Idec), TNKase, Xolair (licensed from Novartis), and Tarceva (licensed from
OSI)—in the aggregate are considered to be of material importance. All are
covered by registrations or pending applications for registration in the U.S.
Patent and Trademark Office and in other countries. Trademark protection
continues in some countries for as long as the mark is used and, in other
countries, for as long as it is registered. Registrations generally are for
fixed, but renewable, terms.
Our
royalty income for patent licenses, know-how, and other related rights amounted
to $1,984 million in 2007, $1,354 million in 2006, and $935 million in 2005.
Royalty expenses were $712 million in 2007, $568 million in 2006, and $462
million in 2005.
Competition
We
face competition from pharmaceutical companies and biotechnology companies. The
introduction of new competitive products or follow-on biologics, or new
information about existing products or pricing decisions by us or our
competitors, may result in lost market share for us, reduced utilization of our
products, and/or lower prices, even for products protected by patents. For risks
associated with competition, see “We face competition” under “Risk Factors”
below in Part I, Item 1A of this Form 10-K.
Government
Regulation
Regulation
by governmental authorities in the U.S. and other countries is a significant
factor in the manufacture and marketing of our products and in ongoing research
and product development activities. All of our products require regulatory
approval by governmental agencies prior to commercialization. Our products are
subject to rigorous preclinical and clinical testing and other premarket
approval requirements by the FDA and regulatory authorities in other countries.
Various statutes and regulations also govern or influence the manufacturing,
safety, labeling, storage, record keeping, and marketing of such products. The
lengthy process of seeking these approvals, and the subsequent compliance with
applicable statutes and regulations, require the expenditure of substantial
resources.
The
activities that are required before a pharmaceutical product may be marketed in
the U.S. begin with preclinical testing. Preclinical tests include laboratory
evaluation of product chemistry and required animal studies to assess the
potential safety and efficacy of the product and its formulations. The results
of these studies must be submitted to the FDA as part of an Investigational New
Drug Application, which must be reviewed by the FDA before proposed clinical
testing in humans can begin. Typically, clinical testing involves a three-phase
process. In Phase I, clinical trials are conducted with a small number of
subjects to determine the early safety profile and the pattern of drug
distribution and metabolism. In Phase II, clinical trials are conducted with
groups of patients afflicted with a specified disease in order to provide enough
data to evaluate the preliminary efficacy, optimal dosages, and expanded
evidence of safety. In Phase III, large-scale, multi-center clinical trials are
conducted with patients afflicted with a target disease in order to provide
enough data to statistically evaluate the efficacy and safety of the product, as
required by the FDA. The results of the preclinical and clinical testing of a
pharmaceutical product are then submitted to the FDA in the form of a New Drug
Application (NDA), or a Biologics License Application (BLA), for approval to
commence commercial sales. In responding to an NDA or a BLA, the FDA may grant
marketing approval, grant conditional approval, request additional information,
or deny the application if it determines that the application does not provide
an adequate basis for approval. Most R&D projects fail to produce data
sufficiently compelling to enable progression through all of the stages of
development and to obtain FDA approval for commercial sale. See also “The
successful development of pharmaceutical products is highly uncertain and
requires significant expenditures and time” under “Risk Factors” below in Part
I, Item 1A of this Form 10-K.
Among
the conditions for an NDA or a BLA approval is the requirement that the
prospective manufacturer’s quality control and manufacturing procedures conform
on an ongoing basis with current Good Manufacturing Practices (cGMP). Before
approval of a BLA, the FDA will usually perform a preapproval inspection of the
facility to determine its compliance with cGMP and other rules and regulations.
Manufacturers must continue to expend time, money and effort in the area of
production and quality control to ensure full compliance with cGMP. After the
establishment is licensed for the manufacture of any product, manufacturers are
subject to periodic inspections by the FDA.
The
requirements that we and our collaborators must satisfy to obtain regulatory
approval by governmental agencies in other countries prior to commercialization
of our products in such countries can be costly and uncertain.
We
are also subject to various laws and regulations related to safe working
conditions, clinical, laboratory and manufacturing practices, the experimental
use of animals and the use and disposal of hazardous or potentially hazardous
substances, including radioactive compounds and infectious disease agents, used
in connection with our research.
Our
revenue and profitability may be affected by the continuing efforts of
government and third-party payers to contain or reduce the costs of healthcare
through various means. For example, in certain foreign markets, pricing or
profitability of pharmaceutical products is subject to governmental control. In
the U.S. there have been, and we expect that there will continue to be, a number
of federal and state proposals to implement similar governmental
control.
In
addition, in the U.S. and elsewhere, sales of pharmaceutical products are
dependent in part on the availability of reimbursement to the physician or
consumer from third-party payers, such as the government or private insurance
plans. Government and private third-party payers are increasingly challenging
the prices charged for medical products and services, through class action
litigation and otherwise. New regulations related to hospital and physician
payment continue to be implemented annually. To date, we have not seen any
detectable effects of the new rules on our product sales. See also “Decreases in
third party reimbursement rates may affect our product sales, results of
operations and financial condition” under “Risk Factors” below in Part I, Item
1A of this Form 10-K.
We
are also subject to various federal and state laws pertaining to healthcare
fraud and abuse, including anti-kickback laws and false claims laws. For risks
associated with healthcare fraud and abuse, see “If there is an adverse outcome
in our pending litigation or other legal actions our business may be harmed”
under “Risk Factors” below in Part I, Item 1A of this Form 10-K.
Research
and Development
A
significant portion of our operating expenses is related to R&D. Generally,
R&D expenses consist of the costs of our own independent R&D efforts and
the costs associated with collaborative R&D and in-licensing arrangements.
R&D costs, including upfront fees and milestones paid to collaborators, are
expensed as incurred, if the underlying assets are determined to have no
alternative future use. R&D expenses, excluding any acquisition-related
in-process research and development charges, were $2,446 million in 2007, $1,773
million in 2006, and $1,262 million in 2005. We also receive reimbursements from
certain collaborators on some of our R&D expenditures, depending on the mix
of spending between us and our collaborators. These R&D expense
reimbursements are included in contract revenue, and were $196 million in 2007,
$187 million in 2006, and $144 million in 2005.
We
intend to maintain our strong commitment to R&D. Biotechnology products
generally take 10 to 15 years to research, develop, and bring to market in the
U.S. As discussed above, clinical development typically involves three phases of
study: Phase I, II, and III. The most significant costs associated with clinical
development are the Phase III trials, as they tend to be the longest and largest
studies conducted during the drug development process. Product completion dates
and completion costs vary significantly by product and are difficult to
predict.
Human
Resources
As
of December 31, 2007, we had 11,174 employees.
Environment
We
have made, and will continue to make, expenditures for environmental compliance
and protection. Expenditures for compliance with environmental laws have not
had, and are not expected to have, a material effect on our capital
expenditures, results of operations, or competitive position.
Available
Information
The
following information can be found on our website at www.gene.com or can be
obtained free of charge by contacting our Investor Relations Department at (650)
225-4150 or by sending an e-mail message to
investor.relations@gene.com:
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Our
annual report on Form 10-K, quarterly reports on Form 10-Q, current
reports on Form 8-K, and all amendments to those reports as soon as is
reasonably practicable after such material is electronically filed with
the U.S. Securities and Exchange
Commission;
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Our
policies related to corporate governance, including our Principles of
Corporate Governance, Good Operating Principles, and Code of Ethics, which
apply to our Chief Executive Officer, Chief Financial Officer, and senior
financial officials; and
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The
charters of the Audit Committee and the Compensation Committee of our
Board of Directors.
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This
Form 10-K contains forward-looking information based on our current
expectations. Because our actual results may differ materially from any
forward-looking statements that we make, this section includes a discussion of
important factors that could affect our actual future results, including, but
not limited to, our product sales, royalties, contract revenue, expenses, net
income, and earnings per share.
The
successful development of pharmaceutical products is highly uncertain and
requires significant expenditures and time.
Successful
development of pharmaceutical products is highly uncertain. Products that appear
promising in research or development may be delayed or fail to reach later
stages of development or the market for several reasons, including:
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Preclinical
tests may show the product to be toxic or lack efficacy in animal
models.
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Clinical
trial results may show the product to be less effective than desired or to
have harmful or problematic side
effects.
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Failure
to receive the necessary U.S. and international regulatory approvals or a
delay in receiving such approvals. Among other things, such delays may be
caused by slow enrollment in clinical studies; extended length of time to
achieve study endpoints; additional time requirements for data analysis or
BLA or NDA preparation; discussions with the United States (U.S.) Food and
Drug Administration (FDA); FDA requests for additional preclinical or
clinical data; analyses or changes to study design; or unexpected safety,
efficacy, or manufacturing issues.
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Difficulties
in formulating the product, scaling the manufacturing process, or getting
approval for manufacturing.
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Manufacturing
costs, pricing, or reimbursement issues, or other factors may make the
product uneconomical.
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The
proprietary rights of others and their competing products and technologies
may prevent the product from being developed or
commercialized.
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The
contractual rights of our collaborators or others may prevent the product
from being developed or
commercialized.
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Success
in preclinical and early clinical trials does not ensure that large-scale
clinical trials will be successful. Clinical results are frequently susceptible
to varying interpretations that may delay, limit, or prevent regulatory
approvals. The length of time necessary to complete clinical trials and to
submit an application for marketing approval for a final decision by a
regulatory authority varies significantly and may be difficult to predict. If
our large-scale clinical trials are not successful, we will not recover our
substantial investments in the product.
Factors
affecting our research and development (R&D) productivity and the amount of
our R&D expenses include, but are not limited to:
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The
number of and the outcome of clinical trials currently being conducted by
us and/or our collaborators. For example, our R&D expenses may
increase based on the number of late-stage clinical trials being conducted
by us and/or our collaborators.
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The
number of products entering into development from late-stage research. For
example, there is no guarantee that internal research efforts will succeed
in generating a sufficient number of product candidates that are ready to
move into development or that product candidates will be available for
in-licensing on terms acceptable to us and permitted under the anti-trust
laws.
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Decisions
by Roche Holding AG and affiliates (Roche) whether to exercise its options
to develop and sell our future products in non-U.S. markets, and the
timing and amount of any related development cost
reimbursements.
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Our
ability to in-license projects of interest to us, and the timing and
amount of related development funding or milestone payments for such
licenses. For example, we may enter into agreements requiring us to pay a
significant up-front fee for the purchase of in-process R&D, which we
may record as an R&D expense.
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Participation
in a number of collaborative research arrangements. On many of these
collaborations, our share of expenses recorded in our financial statements
is subject to volatility based on our collaborators’ spending activities
as well as the mix and timing of activities between the
parties.
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Charges
incurred in connection with expanding our product manufacturing
capabilities, as described below in “Difficulties or delays in product
manufacturing or in obtaining materials from our suppliers, or
difficulties in accurately forecasting manufacturing capacity needs, could
harm our business and/or negatively affect our financial
performance.”
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Future
levels of revenue.
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Our
ability to supply product for use in clinical
trials.
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We
may be unable to obtain or maintain regulatory approvals for our
products.
We
are subject to stringent regulation with respect to product safety and efficacy
by various international, federal, state, and local authorities. Of particular
significance are the FDA’s requirements covering R&D, testing,
manufacturing, quality control, labeling, and promotion of drugs for human use.
As a result of these requirements, the length of time, the level of
expenditures, and the laboratory and clinical information required for approval
of a BLA or NDA are substantial and can require a number of years. In addition,
even if our products receive regulatory approval, they remain subject to ongoing
FDA regulations, including, for example, obligations to conduct additional
clinical trials or other testing, changes to the product label, new or revised
regulatory requirements for manufacturing practices, written advisements to
physicians, and/or a product recall or withdrawal.
We
may not obtain necessary regulatory approvals on a timely basis, if at all, for
any of the products we are developing or manufacturing, or we may not maintain
necessary regulatory approvals for our existing products, and all of the
following could have a material adverse effect on our business:
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Significant
delays in obtaining or failing to obtain approvals, as described above in
“The successful development of pharmaceutical products is highly uncertain
and requires significant expenditures and
time.”
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Loss
of, or changes to, previously obtained approvals or accelerated approvals,
including those resulting from post-approval safety or efficacy issues.
For example, with respect to the FDA’s accelerated approval of Avastin in
combination with paclitaxel chemotherapy for the treatment of patients who
have not received prior chemotherapy for metastatic HER2-negative BC, the
FDA may withdraw or modify such approval, or request additional
post-marketing studies.
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Failure
to comply with existing or future regulatory
requirements.
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A
determination by the FDA that any study endpoints used in clinical trials
for our products are not sufficient for product
approval.
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Changes
to manufacturing processes, manufacturing process standards or current
Good Manufacturing Practices following approval or changing
interpretations of these factors.
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In
addition, the current regulatory framework could change or additional
regulations could arise at any stage during our product development or
marketing, which may affect our ability to obtain or maintain approval of our
products or require us to make significant expenditures to obtain or maintain
such approvals.
We
face competition.
We
face competition from pharmaceutical companies and biotechnology
companies.
The
introduction of new competitive products or follow-on biologics, and/or new
information about existing products or pricing decisions by us or our
competitors, may result in lost market share for us, reduced utilization of our
products, lower prices, and/or reduced product sales, even for products
protected by patents.
Avastin: Avastin
competes in metastatic colorectal cancer (CRC) with Erbitux®
(Imclone/Bristol-Myers Squibb), which is an epidermal growth factor receptor
(EGFR) inhibitor approved for the treatment of irinotecan refractory or
intolerant metastatic CRC patients; and with Vectibix™ (Amgen), which is
indicated for the treatment of patients with EGFR-expressing metastatic CRC who
have disease progression on or following fluoropyrimidine–, oxaliplatin–, and
irinotecan–containing regimens. Avastin could also face competition from
Erbitux® in metastatic NSCLC. In the third quarter of 2007, ImClone Systems
Incorporated and Bristol-Myers Squibb Company announced that a Phase III study
of Erbitux® in combination with vinorelbine plus cisplatin met its primary
endpoint of increasing overall survival compared with chemotherapy alone in
patients with advanced NSCLC. Data from this study are expected in 2008. In
addition, Avastin competes with Nexavar® (sorafenib, Bayer Corporation/Onyx
Pharmaceuticals, Inc.), Sutent® (sunitinib malate, Pfizer, Inc.), and Torisel®
(Wyeth) for the treatment of patients with advanced renal cell carcinoma (an
unapproved use of Avastin).
Avastin
could face competition from products in development that currently do not have
regulatory approval. Sanofi-Aventis is developing a VEGF inhibitor VEGF-Trap in
multiple indications, including metastatic CRC and metastatic NSCLC. There
are also ongoing head-to-head clinical trials comparing both Sutent® and
AZD2171 (AstraZeneca) to Avastin. Likewise, Amgen has initiated
head-to-head clinical trials comparing AMG 706 and Avastin in NSCLC and
metastatic breast cancer (BC). Overall,
there are more than 65 molecules in clinical development that target VEGF
inhibition, and over 130 companies are developing molecules that, if successful
in clinical trials, may compete with Avastin.
Rituxan: Rituxan’s
current competitors in hematology-oncology include Bexxar® (GlaxoSmithKline
[GSK]) and Zevalin® (Cell Therapeutics), both of which are radioimmunotherapies
indicated for the treatment of patients with relapsed or refractory low-grade,
follicular, or transformed B-cell NHL. Other potential competitors include
Campath® (Bayer Corporation/Genzyme) in previously untreated and relapsed
chronic lymphocytic leukemia (CLL) (an unapproved use of Rituxan); Velcade®
(Millennium Pharmaceuticals, Inc.), which is indicated for multiple myeloma and
more recently, mantle cell lymphoma (both unapproved uses of Rituxan); and
Revlimid® (Celgene), which is indicated for multiple myeloma and myelodysplastic
syndromes (both unapproved uses of Rituxan).
Rituxan’s
current competitors in rheumatoid arthritis (RA) include Enbrel® (Amgen/Wyeth),
Humira® (Abbott Laboratories), Remicade® (Johnson & Johnson), Orencia®
(Bristol-Myers Squibb), and Kineret® (Amgen). These products are approved for
use in a RA patient population that is broader than the approved population for
Rituxan. In addition, molecules in development that, if approved by the FDA, may
compete with Rituxan in RA include: Actemra™, an anti-interleukin-6
receptor being developed by Chugai and Roche; Cimzia™ (certolizumab pegol), an
anti-TNF antibody being developed by UCB; and CNTO 148 (golimumab), an anti-TNF
antibody being developed by Centocor, Inc. (a wholly owned subsidiary of
Johnson & Johnson).
Rituxan
may face future competition in both hematology-oncology and RA from Humax CD20™
(Ofatumumab), an anti-CD20 antibody being co-developed by Genmab and
GSK. Genmab and GSK announced their plans to file for approval of Humax™ in
2008 for monotherapy use in refractory CLL and to complete a monotherapy trial
for refractory indolent NHL. In addition, we are aware of other anti-CD20
molecules in development that, if successful in clinical trials, may compete
with Rituxan. Rituxan could also face competition from Treanda® (Cephalon,
Inc.), a NHL treatment candidate that showed positive results in Phase III
clinical trials for refractory indolent NHL patients and previously
untreated CLL patients. There are several therapeutic vaccines currently in
development that may seek approval in indolent NHL in the future.
Herceptin: Herceptin
faces competition in the relapsed metastatic setting from Tykerb® (lapatinib
ditosylate), manufactured by GSK. On March 13, 2007, the FDA approved Tykerb®,
in combination with capecitabine, for the treatment of patients with advanced or
metastatic BC whose tumors overexpress HER2 and who have received prior therapy,
including an anthracycline, a taxane, and Herceptin. Market research indicates
that lapatinib use in the fourth quarter was primarily within the later lines of
metastatic BC. We will continue to monitor the clinical development of lapatinib
in early lines of metastatic and adjuvant breast cancer.
Lucentis: We are aware
that retinal specialists are currently using Avastin to treat the wet form of
AMD, an unapproved use for Avastin, which results in significantly less revenue
to us per treatment compared to Lucentis. As of January 1, 2008, we no longer
directly supply Avastin to compounding pharmacies. After discussions with
the leadership of the American Society of Retina Specialists and the
American Academy of Ophthalmology, we expect ocular use of Avastin to
continue as physicians can purchase Avastin from authorized distributors and
ship to the destination of the physicians’ choice. Additionally, an independent
head-to-head trial of Avastin and Lucentis in wet AMD is being partially funded
by the National Eye Institute, who announced that it expects to begin enrollment
in the next few months. Lucentis also competes with Macugen® (Pfizer/OSI
Pharmaceuticals), and with Visudyne® (Novartis) alone, in combination with
Lucentis, in combination with Avastin, or in combination with the off-label
steroid triamcinolone in wet AMD. In addition, VEGF-Trap-Eye, a vascular
endothelial growth factor blocker being developed by Bayer Corporation and
Regeneron, is in Phase III clinical trials for treatment of wet
AMD.
Xolair: Xolair faces
competition from other asthma therapies, including inhaled corticosteroids,
long-acting beta agonists, combination products such as fixed-dose inhaled
corticosteroids/long-acting beta agonists and leukotriene inhibitors, as well as
oral corticosteroids and immunotherapy.
Tarceva: Tarceva
competes with the chemotherapy agents Taxotere® (Sanofi-Aventis) and Alimta®
(Eli Lilly and Company), both of which are indicated for the treatment of
relapsed NSCLC. Astra Zeneca recently announced completion of enrollment in
their Phase III study comparing Zactima™ head-to-head with Tarceva in
second-line NSCLC (ZEST). In September 2007, Astra Zeneca announced comparable
survival data for Iressa® versus Taxotere® for the treatment of relapsed NSCLC
in an international study. The results of this study have not yet
been
published,
and it is unclear whether a re-filing of Iressa® with U.S. regulatory
authorities is pending. Eli Lilly recently announced positive Phase III
maintenance therapy data for Alimta®. Since Alimta® has not yet been approved in
this setting, its potential impact on treatment is uncertain. BMS/ImClone/Merck
KGaA announced positive data on the use of Erbitux® in combination with
chemotherapy for the front-line treatment of NSCLC (an unapproved use of
Tarceva). This may have a material impact on the landscape of treatment options
for the management of patients with relapsed NSCLC. In front-line pancreatic
cancer, Tarceva primarily competes with Gemzar® (Eli Lilly) monotherapy and
Gemzar® in combination with other chemotherapeutic agents. Tarceva also faces
competition in the future from products in late-phase development, such as
Erbitux®, in the treatment of relapsed NSCLC and Xeloda® (Roche), in the
treatment of pancreactic cancer; none of these products currently has regulatory
approval for use in NSCLC or pancreatic cancer.
Nutropin: Nutropin faces
competition in the growth hormone market from five (5) branded
competitors:
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Norditropin®
(Novo Nordisk)
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Nutropin
also faces competition from three (3) follow-on biologics:
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Valtropin®
(LG Life Sciences)
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As
a result of this competition, we have experienced and may continue to experience
a loss of patient share and increased competition for managed care product
placement. Obtaining placement on the preferred product lists of managed care
companies may require that we further discount the price of Nutropin. In
addition to managed care placement, patient and healthcare provider services
provided by growth hormone manufacturers are increasingly important to creating
brand preference.
Thrombolytics: Our
thrombolytic products face competition in the acute myocardial infarction
market, with sales of TNKase and Activase affected by the adoption by physicians
of mechanical reperfusion strategies. We expect that the use of mechanical
reperfusion, in lieu of thrombolytic therapy for the treatment of acute
myocardial infarction, will continue to grow. TNKase, for acute myocardial
infarction, also faces competition from Retavase® (PDL BioPharma
Inc.).
Pulmozyme: Pulmozyme
currently faces competition from the use of hypertonic saline, an inexpensive
approach to clearing sputum from the lungs of cystic fibrosis patients.
Approximately 25% of cystic fibrosis patients receive hypertonic saline and it
is estimated that in a small percentage of patients (less than 5%), this use
will impact how a physician may prescribe or a patient may use
Pulmozyme.
Raptiva: Raptiva
competes with established therapies for moderate-to-severe psoriasis, including
oral systemics such as methotrexate and cyclosporin as well as ultraviolet light
therapies. In addition, Raptiva competes with biologic agents Amevive®
(Astellas), Enbrel® (Amgen), and Remicade® (Centocor). Raptiva also competes
with the biologic agent Humira® (Abbott), which was approved by the FDA for use
in moderate-to-severe psoriasis on January 18, 2008, and was used off-label in
psoriasis prior to FDA approval. Raptiva may face future competition from
the biologic Ustekinumab/CNTO-1275 (Centocor), which was filed with the FDA for
approval in the treatment of psoriasis on December 4, 2007.
In
addition to the commercial and late-stage development products listed above,
numerous products are in earlier stages of development at other biotechnology
and pharmaceutical companies that, if successful in clinical trials, may compete
with our products.
Decreases
in third-party reimbursement rates may affect our product sales, results of
operations, and financial condition.
Sales
of our products will depend significantly on the extent to which reimbursement
for the cost of our products and related treatments will be available to
physicians and patients from U.S. and international government health
administration authorities, private health insurers, and other organizations.
Third-party payers and government health administration authorities increasingly
attempt to limit and/or regulate the reimbursement of medical products and
services, including branded prescription drugs. Changes in government
legislation or regulation, such as the Medicare Prescription Drug Improvement
and Modernization Act of 2003, the Deficit Reduction Act of 2005, and the Food
and Drug Administration Amendments Act of 2007; changes in Compendia
listing; or changes in private third-party payers’ policies toward reimbursement
for our products may reduce reimbursement of our products’ costs to physicians,
pharmacies, and distributors. Decreases in third-party reimbursement for our
products could reduce usage of the products, sales to collaborators, and
royalties, and may have a material adverse effect on our product sales, results
of operations, and financial condition.
Difficulties
or delays in product manufacturing or in obtaining materials from our suppliers,
or difficulties in accurately forecasting manufacturing capacity needs, could
harm our business and/or negatively affect our financial
performance.
Manufacturing
pharmaceutical products is difficult and complex, and requires facilities
specifically designed and validated for this purpose. It can take longer than
five years to design, construct, validate, and license a new biotechnology
manufacturing facility. We currently produce our products at our manufacturing
facilities located in South San Francisco, Vacaville, and Oceanside, California
and through various contract-manufacturing arrangements. Maintaining an adequate
supply to meet demand for our products depends on our ability to execute on our
production plan. Any significant problem in the operations of our or our
contractors’ manufacturing facilities could result in cancellation of shipments;
loss of product in the process of being manufactured; a shortfall, stock-out, or
recall of available product inventory; or unplanned increases in production
costs—any of which could have a material adverse effect on our business. A
number of factors could cause significant production problems or interruptions,
including:
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The
inability of a supplier to provide raw materials used to manufacture our
products;
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Equipment
obsolescence, malfunctions, or
failures;
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Product
quality or contamination problems, due to a number of factors included but
not limited to human error;
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Damage
to a facility, including our warehouses and distribution facilities, due
to events such as fires or earthquakes, as our South San Francisco,
Vacaville, and Oceanside facilities are located in areas where earthquakes
and/or fires have occurred;
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Changes
in FDA regulatory requirements or standards that require modifications to
our manufacturing processes;
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Action
by the FDA or by us that results in the halting or slowdown of production
of one or more of our products or products that we make for
others;
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A
contract manufacturer going out of business or failing to produce product
as contractually required;
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Failure
to maintain an adequate state of current Good Manufacturing Practices
compliance; and
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Implementation
and integration of our new enterprise resource planning system, including
the portions related to manufacturing and
distribution.
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In
addition, there are inherent uncertainties associated with forecasting future
demand for our products or those products we produce for others, and as a
consequence we may have inadequate capacity to meet actual demand.
Alternatively, we may have an excess of available capacity, which could lead to
an idling of a portion of our manufacturing facilities and incurring unabsorbed
or idle plant charges, costs associated with the termination of existing
contract manufacturing relationships, costs associated with a reduction in
workforce, or other excess capacity charges, resulting in an increase in our
COS.
Furthermore,
certain of our raw materials and supplies required for the production of our
principal products, or products that we make for others, are available only
through sole-source suppliers (the only recognized supplier available to us) or
single-source suppliers (the only approved supplier for us among other sources),
and we may not be able to obtain such raw materials without significant delay or
at all. If such sole-source or single-source suppliers were to limit or
terminate production or otherwise fail to supply these materials for any reason,
such failures could also have a material adverse effect on our product sales and
our business.
Because
our manufacturing processes and those of our contractors are highly complex and
are subject to a lengthy FDA approval process, alternative qualified production
capacity may not be available on a timely basis or at all. Difficulties or
delays in our or our contractors’ manufacturing and supply of existing or new
products could increase our costs, cause us to lose revenue or market share,
damage our reputation, and result in a material adverse effect on our product
sales, financial condition, and results of operations.
Protecting
our proprietary rights is difficult and costly.
The
patent positions of pharmaceutical and biotechnology companies can be highly
uncertain and involve complex legal and factual questions. Accordingly, we
cannot predict with certainty the breadth of claims that will be allowed in
companies’ patents. Patent disputes are frequent and may ultimately preclude the
commercialization of products. We have in the past been, are currently, and may
in the future be involved in material litigation and other legal proceedings
related to our proprietary rights, such as the Cabilly reexamination and the
MedImmune lawsuit (discussed in Note 8, “Leases, Commitments and Contingencies,”
in the Notes to Consolidated Financial Statements in Part II, Item 8 of this
Form 10-K) and disputes in connection with licenses granted to or obtained from
third parties. Such litigation and other legal proceedings are costly in their
own right and could subject us to significant liabilities with third parties,
including the payment of significant royalty expenses, the loss of significant
royalty income, or other expenses or losses. Furthermore, an adverse decision or
ruling could force us to either obtain third-party licenses at a material cost
or cease using the technology or commercializing the product in dispute. An
adverse decision or ruling with respect to one or more of our patents or other
intellectual property rights could cause us to incur a material loss of sales
and/or royalties and other revenue from licensing arrangements that we have with
third parties, and could significantly interfere with our ability to negotiate
future licensing arrangements.
The
presence of patents or other proprietary rights belonging to other parties may
lead to our termination of the R&D of a particular product, or to a loss of
our entire investment in the product and subject us to infringement
claims.
If
there is an adverse outcome in our pending litigation or other legal actions,
our business may be harmed.
Litigation
and other legal actions to which we are currently or have been subjected relate
to, among other things, our patent and other intellectual property rights,
licensing arrangements and other contracts with third parties, and product
liability. We cannot predict with certainty the eventual outcome of pending
proceedings, which may include an injunction against the development,
manufacture, or sale of a product or potential product; a judgment with a
significant monetary award including the possibility of punitive damages; or a
judgment that certain of our patent or other intellectual property rights are
invalid or unenforceable. Furthermore, we may have to incur substantial expense
in these proceedings, and such matters could divert management’s attention from
ongoing business concerns.
Our
activities related to the sale and marketing of our products are subject to
regulation under the U.S. Federal Food, Drug, and Cosmetic Act and other federal
statutes. Violations of these laws may be punishable by criminal and/or civil
sanctions, including fines and civil monetary penalties, as well as the
possibility of exclusion from federal
healthcare
programs (including Medicare and Medicaid). In 1999, we agreed to pay $50
million to settle a federal investigation related to our past clinical, sales,
and marketing activities associated with human growth hormone. We are currently
being investigated by the Department of Justice with respect to our promotional
practices, and may in the future be investigated for our promotional practices
related to any of our products. If the government were to bring charges against
us or convict us of violating these laws, or if we were subject to third-party
litigation related to the same promotional practices, there could be a material
adverse effect on our business, including our financial condition and results of
operations.
We
are subject to various U.S. federal and state laws pertaining to healthcare
fraud and abuse, including anti-kickback and false claims laws. Anti-kickback
laws make it illegal for a prescription drug manufacturer to solicit, offer,
receive, or pay any remuneration in exchange for, or to induce, the referral of
business, including the purchase or prescription of a particular drug. Due in
part to the breadth of the statutory provisions and the absence of guidance in
the form of regulations or court decisions addressing some of our practices, it
is possible that our practices might be challenged under anti-kickback or
similar laws. False claims laws prohibit anyone from knowingly and willingly
presenting, or causing to be presented for payment to third-party payers
(including Medicare and Medicaid), claims for reimbursed drugs or services that
are false or fraudulent, claims for items or services not provided as claimed,
or claims for medically unnecessary items or services. Violations of fraud and
abuse laws may be punishable by criminal and/or civil sanctions, including fines
and civil monetary penalties, as well as the possibility of exclusion from
federal healthcare programs (including Medicare and Medicaid). If a court were
to find us liable for violating these laws, or if the government were to allege
against us or convict us of violating these laws, there could be a material
adverse effect on our business, including our stock price.
Other
factors could affect our product sales.
Other
factors that could affect our product sales include, but are not limited
to:
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Efficacy
data from clinical studies conducted by any party in the U.S. or
internationally, showing or perceived to show a similar or an improved
treatment benefit at a lower dose or shorter duration of therapy, could
cause the sales of our products to
decrease.
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Our
pricing decisions, including a decision to increase or decrease the price
of a product; the pricing decisions of our competitors; as well as our
Avastin Patient Assistance Program, which is a voluntary program that
enables eligible patients who have received 10,000 milligrams of Avastin
in a 12-month period to receive free Avastin in excess of the 10,000
milligrams during the remainder of the 12-month
period.
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Negative
safety or efficacy data from new clinical studies conducted either in the
U.S. or internationally by any party could cause the sales of our products
to decrease or a product to be recalled or
withdrawn.
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Negative
safety or efficacy data from post-approval marketing experience or
production-quality problems could cause sales of our products to decrease
or a product to be recalled.
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The
degree of patent protection afforded our products by patents granted to us
and by the outcome of litigation involving our
patents.
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The
outcome of litigation involving patents of other companies concerning our
products or processes related to production and formulation of those
products or uses of those products.
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The
increasing use and development of alternate
therapies.
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The
rate of market penetration by competing
products.
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Our
distribution strategy, including the termination of, or change in, an
existing arrangement with any major wholesalers that supply our
products.
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Our
decision to no longer allow compounding pharmacies the ability to purchase
Avastin directly from wholesale distributors, which could have a negative
impact on Lucentis sales as a result of negative reaction by retinal
specialists to our decision.
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Product
returns and allowances greater than expected or historically
experienced.
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The
inability of one or more of our three major customers to meet their
payment obligations to us.
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Any
of these factors could have a material adverse effect on our sales and results
of operations.
Our
results of operations are affected by our royalty and contract revenue, and
sales to collaborators.
Royalty
and contract revenue, and sales to collaborators in future periods, could vary
significantly. Major factors affecting this revenue include, but are not limited
to:
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Roche’s
decisions about whether to exercise its options and option extensions to
develop and sell our future products in non-U.S. markets, and the timing
and amount of any related development cost
reimbursements.
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Variations
in Roche’s sales and other licensees’ sales of licensed
products.
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The
expiration or termination of existing arrangements with other companies
and Roche, which may include development and marketing arrangements for
our products in the U.S., Europe, and other
countries.
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The
timing of non-U.S. approvals, if any, for products licensed to Roche and
other licensees.
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Government
and third-party payer reimbursement and coverage decisions that affect the
utilization of our products and competing
products.
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The
initiation of new contractual arrangements with other
companies.
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Whether
and when contract milestones are
achieved.
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The
failure or refusal of a licensee to pay
royalties.
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The
expiration or invalidation of our patents or licensed intellectual
property. For example, patent litigation, interferences, oppositions, and
other proceedings involving our patents often include claims by third
parties that such patents are invalid, unenforceable, or unpatentable. If
a court, patent office, or other authority were to determine that a patent
(including the Cabilly patent as discussed in Item 3, “Legal Proceedings”)
under which we receive royalties and/or other revenue is invalid,
unenforceable, or unpatentable, that determination could cause us to
suffer a loss of such royalties and/or revenue, and could cause us to
incur other monetary damages.
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Decreases
in licensees’ sales of product due to competition, manufacturing
difficulties, or other factors that affect the sales of
product.
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Fluctuations
in foreign currency exchange rates.
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We
may be unable to manufacture certain of our products if there is BSE
contamination of our bovine source raw material.
Most
biotechnology companies, including Genentech, have historically used, and we
continue to use, bovine source raw materials to support cell growth in certain
production processes. Bovine source raw materials from within or outside the
U.S. are subject to public and regulatory scrutiny because of the perceived risk
of contamination with the
infectious
agent that causes bovine spongiform encephalopathy (BSE). Should such BSE
contamination occur, it would likely negatively affect our ability to
manufacture certain products for an indefinite period of time (or at least until
an alternative process is approved); negatively affect our reputation; and could
result in a material adverse effect on our product sales, financial condition,
and results of operations.
We
may be unable to retain skilled personnel and maintain key
relationships.
The
success of our business depends, in large part, on our continued ability to (i)
attract and retain highly qualified management, scientific, manufacturing, and
sales and marketing personnel, (ii) successfully integrate large numbers of new
employees into our corporate culture, and (iii) develop and maintain important
relationships with leading research and medical institutions and key
distributors. Competition for these types of personnel and relationships is
intense. We cannot be sure that we will be able to attract or retain skilled
personnel or maintain key relationships, or that the costs of retaining such
personnel or maintaining such relationships will not materially
increase.
Our
affiliation agreement with Roche Holdings, Inc. could adversely affect our cash
position.
Our
affiliation agreement with Roche Holdings, Inc. (RHI) provides that we establish
a stock repurchase program designed to maintain RHI’s percentage ownership
interest in our Common Stock based on an established Minimum Percentage. For
more information on our stock repurchase program, see “Liquidity and Capital
Resources—Cash Used in or Provided by Financing Activities.” For information on
the Minimum Percentage, see Note 9, “Relationship with Roche Holdings, Inc. and
Related Party Transactions,” in the Notes to Consolidated Financial Statements
in Part II, Item 8 of this Form 10-K.
RHI’s
ownership percentage is diluted by the exercise of stock options to purchase
shares of our Common Stock by our employees and the purchase of shares of our
Common Stock through our employee stock purchase plan. See Note 3, “Employee
Stock-Based Compensation,” in the Notes to Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K for information regarding employee stock
plans. In order to maintain RHI’s Minimum Percentage, we repurchase shares of
our Common Stock under the stock repurchase program. Under our current stock
repurchase program, we repurchased 13 million shares for $1.0 billion in 2007.
As of December 31, 2007, there were approximately 39 million in-the-money
exercisable options. While the dollar amounts associated with future stock
repurchase programs cannot currently be determined, future stock repurchases
could have a material adverse effect on our liquidity, credit rating, and
ability to access additional capital in the financial markets.
Our
affiliation agreement with Roche Holdings, Inc. could limit our ability to make
acquisitions or divestitures.
Our
affiliation agreement with RHI contains provisions that:
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Require
the approval of the directors designated by RHI to make any acquisition or
any sale or disposal of all or a portion of our business representing 10
percent or more of our assets, net income, or
revenue.
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Enable
RHI to maintain its percentage ownership interest in our Common
Stock.
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Require
us to establish a stock repurchase program designed to maintain RHI’s
percentage ownership interest in our Common Stock based on an established
Minimum Percentage. For information regarding the Minimum Percentage, see
Note 9, “Relationship with Roche Holdings, Inc. and Related Party
Transactions,” in the Notes to Consolidated Financial Statements in Part
II, Item 8 of this Form 10-K.
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Future
sales of our Common Stock by Roche Holdings, Inc. could cause the price of our
Common Stock to decline.
As
of December 31, 2007, RHI owned 587,189,380 shares of our Common Stock, or 55.8
percent of our outstanding shares. All of our shares owned by RHI are eligible
for sale in the public market subject to compliance with the applicable
securities laws. We have agreed that, upon RHI’s request, we will file one or
more registration statements
under
the Securities Act of 1933 in order to permit RHI to offer and sell shares of
our Common Stock. Sales of a substantial number of shares of our Common Stock by
RHI in the public market could adversely affect the market price of our Common
Stock.
Roche
Holdings, Inc., our controlling stockholder, may seek to influence our business
in a manner that is adverse to us or adverse to other stockholders who may be
unable to prevent actions by Roche Holdings, Inc.
As
our majority stockholder, RHI controls the outcome of most actions requiring the
approval of our stockholders. Our bylaws provide, among other things, that the
composition of our Board of Directors shall consist of at least three directors
designated by RHI, three independent directors nominated by the Nominations
Committee, and one Genentech executive officer nominated by the Nominations
Committee. Our bylaws also provide that RHI will have the right to obtain
proportional representation on our Board until such time that RHI owns less than
five percent of our stock. Currently, three of our directors—Mr. William Burns,
Dr. Erich Hunziker, and Dr. Jonathan K. C. Knowles—also serve as officers and
employees of Roche. As long as RHI owns in excess of 50 percent of our Common
Stock, RHI directors will be two of the three members of the Nominations
Committee. Our certificate of incorporation includes provisions related to
competition by RHI affiliates with Genentech, offering of corporate
opportunities, transactions with interested parties, intercompany agreements,
and provisions limiting the liability of specified employees. We cannot assure
that RHI will not seek to influence our business in a manner that is contrary to
our goals or strategies or the interests of other stockholders. Moreover,
persons who are directors of Genentech and who are also directors and/or
officers of RHI may decline to take action in a manner that might be favorable
to us but adverse to RHI.
Additionally,
our certificate of incorporation provides that any person purchasing or
acquiring an interest in shares of our capital stock shall be deemed to have
consented to the provisions in the certificate of incorporation related to
competition with RHI, conflicts of interest with RHI, the offer of corporate
opportunities to RHI, and intercompany agreements with RHI. This deemed consent
might restrict our ability to challenge transactions carried out in compliance
with these provisions.
We
may incur material product liability costs.
The
testing and marketing of medical products entail an inherent risk of product
liability. Liability exposures for pharmaceutical products can be extremely
large and pose a material risk. Our business may be materially and adversely
affected by a successful product liability claim or claims in excess of any
insurance coverage that we may have.
Insurance
coverage may be more difficult and costly to obtain or maintain.
We
currently have a limited amount of insurance to minimize our direct exposure to
certain business risks. In the future, we may be exposed to an increase in
premiums and a narrowing of scope of coverage. As a result, we may be required
to assume more risk in the future or make significant expenditures to maintain
our current levels of insurance. If we are subject to third-party claims or
suffer a loss or damages in excess of our insurance coverage, we will incur the
cost of the portion of the retained risk. Furthermore, any claims made on our
insurance policies may affect our ability to obtain or maintain insurance
coverage at reasonable costs.
We
are subject to environmental and other risks.
We
use certain hazardous materials in connection with our research and
manufacturing activities. In the event that such hazardous materials are stored,
handled, or released into the environment in violation of law or any permit, we
could be subject to loss of our permits, government fines, or penalties, and/or
other adverse governmental or private actions. The levy of a substantial fine or
penalty, the payment of significant environmental remediation costs, or the loss
of a permit or other authorization to operate or engage in our ordinary course
of business could materially adversely affect our business.
We
also have acquired, and may continue to acquire in the future, land and
buildings as we expand our operations. Some of these properties are
“brownfields” for which redevelopment or use is complicated by the presence or
potential presence of a hazardous substance, pollutant, or contaminant. Certain
events that could occur may require us to pay significant clean-up or other
costs in order to maintain our operations on those properties. Such events
include, but are not limited to, changes in environmental laws, discovery of new
contamination, or unintended exacerbation of existing contamination. The
occurrence of any such event could materially affect our ability to continue our
business operations on those properties.
Fluctuations
in our operating results could affect the price of our Common
Stock.
Our
operating results may vary from period to period for several reasons, including,
but not limited to, the following:
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The
overall competitive environment for our products, as described in “We face
competition” above.
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The
amount and timing of sales to customers in the U.S. For example, sales of
a product may increase or decrease due to pricing changes, fluctuations in
distributor buying patterns, or sales initiatives that we may undertake
from time to time.
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Increased
COS; R&D and marketing, general and administrative expenses;
stock-based compensation expenses; litigation related expenses; asset
impairments; and equity securities
write-downs.
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Changes
in interest rates, and changes in credit ratings and the liquidity of our
interest-bearing investments, and the effects that such changes may have
on the value of those investments.
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Changes
in foreign currency exchange rates and the effects that such changes may
have on our royalty revenue and foreign currency denominated
investments.
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The
amount and timing of our sales to Roche and our other collaborators of
products for sale outside the U.S. and the amount and timing of sales to
their respective customers, which directly affect both our product sales
and royalty revenue.
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The
timing and volume of bulk shipments to
licensees.
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The
availability and extent of government and private third-party
reimbursements for the cost of
therapy.
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The
extent of product discounts extended to
customers.
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The
efficacy and safety of our various products as determined both in clinical
testing and by the accumulation of additional information on each product
after the FDA approves it for sale.
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The
rate of adoption by physicians and the use of our products for approved
indications and additional indications. Among other things, the rate of
adoption by physicians and the use of our products may be affected by the
results of clinical studies reporting on the benefits or risks of a
product.
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The
potential introduction of new products and additional indications for
existing products.
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The
ability to successfully manufacture sufficient quantities of any
particular marketed product.
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Pricing
decisions that we or our competitors have adopted or may adopt, as well as
our Avastin Patient Assistance
Program.
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Our
distribution strategy, including the termination of, or change in, an
existing arrangement with any major wholesalers that supply our
products.
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Our
integration of new information systems could disrupt our internal operations,
which could decrease our revenue and increase our expenses.
Portions
of our information technology infrastructure may experience interruptions,
delays, or cessations of service or produce errors. As part of our enterprise
resource planning efforts, we are implementing new information systems, but we
may not be successful in implementing all of the new systems, and transitioning
data and other aspects of the process could be expensive, time consuming,
disruptive, and resource intensive. Any disruptions that may occur in the
implementation of new systems or any future systems could adversely affect our
ability to report in an accurate and timely manner the results of our
consolidated operations, financial position, and cash flows. Disruptions to
these systems also could adversely affect our ability to fulfill orders and
interrupt other operational processes. Delayed sales, lower margins, or lost
customers resulting from these disruptions could adversely affect our financial
results.
Our
stock price, like that of many biotechnology companies, is
volatile.
The
market prices for securities of biotechnology companies in general have been
highly volatile and may continue to be highly volatile in the future. In
addition, the market price of our Common Stock has been and may continue to be
volatile.
Among
other factors, the following may have a significant effect on the market price
of our Common Stock:
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Announcements
of technological innovations or new commercial products by us or our
competitors.
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Publicity
regarding actual or potential medical results related to products under
development or being commercialized by us or our
competitors.
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Concerns
about our pricing initiatives and distribution strategy, and the potential
effect of such initiatives and strategy on the utilization of our products
or our product sales.
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Developments
or outcomes of litigation, including litigation regarding proprietary and
patent rights (including, for example, the Cabilly patent) and
governmental investigations.
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Regulatory
developments or delays concerning our products in the U.S. and other
countries.
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Issues
concerning the efficacy or safety of our products or of biotechnology
products generally.
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Economic
and other external factors or a disaster or
crisis.
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Period-to-period
fluctuations in our financial
results.
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New
proposals to change or reform the U.S. healthcare system, including, but
not limited to, new regulations concerning reimbursement or follow-on
biologics.
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Our
effective income tax rate may vary significantly.
Various
internal and external factors may have favorable or unfavorable effects on our
future effective income tax rate. These factors include, but are not limited to,
changes in tax laws, regulations, and/or rates, the results of any tax
examinations, changing interpretations of existing tax laws or regulations,
changes in estimates of prior years’ items, past and future levels of R&D
spending, acquisitions, changes in our corporate structure, and changes in
overall levels of income before taxes; all of which may result in periodic
revisions to our effective income tax rate.
To
pay our indebtedness will require a significant amount of cash and may adversely
affect our operations and financial results.
As
of December 31, 2007, we had approximately $2.0 billion of long-term debt
and $600 million of commercial paper notes payable. Our ability to make payments
on or to refinance our indebtedness, and to fund planned capital expenditures,
R&D, as well as stock repurchases and expansion efforts will depend on our
ability to generate cash in the future. This risk, to a certain extent, is
subject to general economic, financial, competitive, legislative, regulatory,
and other factors that are and will remain beyond our control. Additionally, our
indebtedness may increase our vulnerability to general adverse economic and
industry conditions, and require us to dedicate a substantial portion of our
cash flow from operations to payments on our indebtedness, which would reduce
the availability of our cash flow to fund working capital, capital expenditures,
R&D, expansion efforts, and other general corporate purposes, and limit our
flexibility in planning for, or reacting to, changes in our business and the
industry in which we operate.
Accounting
pronouncements may affect our future financial position and results of
operations.
Under
Financial Accounting Standards Board Interpretation No. 46R (FIN 46R), a
revision to FIN 46, “Consolidation of Variable Interest
Entities,” we are required to assess
new business development collaborations as well as reassess, upon certain
events, some of which are outside our control, the accounting treatment of our
existing business development collaborations based on the nature and extent of
our variable interests in the entities, as well as the extent of our ability to
exercise influence over the entities, with which we have such collaborations.
Our continuing compliance with FIN 46R may result in our consolidation of
companies or related entities with which we have a collaborative arrangement,
and this may have a material effect on our financial condition and/or results of
operations in future periods.
None.
Our
headquarter facilities are located in a research and industrial area in South
San Francisco, California, where we currently occupy 32 owned and 13 leased
buildings that house our R&D, marketing and administrative activities, as
well as bulk manufacturing facilities, a fill and finish facility, and a
warehouse. We have made and will continue to make improvements to these
properties to accommodate our growth. We also have a commitment to lease an
additional three buildings in South San Francisco, California, which we will
occupy beginning in 2008. In addition, we own other properties in South San
Francisco for future expansion.
We
own a manufacturing facility in Vacaville, California, which is licensed to
produce commercial materials for select products. We are expanding our Vacaville
site by constructing an additional manufacturing facility adjacent to the
existing facility as well as office buildings to support the added manufacturing
capacity. We expect qualification and licensure of our new Vacaville plant by
the end of 2009.
In
June 2005, we acquired a biologics manufacturing facility in Oceanside,
California. In 2006, we began manufacturing Avastin bulk product at that plant,
and we received FDA licensure in the first half of 2007.
In
September 2006, we acquired land in Hillsboro, Oregon for the construction of a
new fill/finish, warehousing, distribution and related office facility. We broke
ground on the facility in 2006, and we expect completion in 2008 and FDA
licensure in early 2010.
We
have an agreement with Lonza Group Ltd (Lonza) under which we can elect to
purchase Lonza’s manufacturing facility currently under construction in
Singapore. Such facility is expected to be licensed for the production of
Avastin in 2010.
In
May 2007, we acquired land in Dixon, California and began the construction of a
research support facility. We expect completion in late 2009.
In
June 2007, we began construction of a new E. coli manufacturing facility in
Singapore to produce bulk Lucentis for the U.S. market. We anticipate FDA
licensure of the site in the first half of 2010.
In
connection with our acquisition of Tanox, Inc. in August 2007, we acquired a
lease for a manufacturing plant in San Diego, California that has been certified
by the FDA for clinical use. We currently plan to sublease that
plant.
We
also lease additional office facilities as regional offices for sales and
marketing and other functions in several locations throughout the
U.S.
In
general, our existing facilities, owned or leased, are in good condition and are
adequate for all present and near-term uses, and we believe that our capital
resources are sufficient to purchase, lease, or construct any additional
facilities required to meet our long-term growth needs.
We
are a party to various legal proceedings, including patent litigation and
licensing and contract disputes, and other matters.
On
October 4, 2004, we received a subpoena from the U.S. Department of Justice,
requesting documents related to the promotion of Rituxan, a prescription
treatment now approved for five indications. We are cooperating with the
associated investigation, which is both civil and criminal in nature, and
through counsel we are having discussions with government representatives about
the status of their investigation and Genentech’s views on this matter,
including potential resolution of this matter. The government has called, and
may continue to call, former and current Genentech employees to appear before a
grand jury in connection with this investigation. The outcome of this matter
cannot be determined at this time.
We
and the City of Hope National Medical Center (COH) are parties to a 1976
agreement related to work conducted by two COH employees, Arthur Riggs and
Keiichi Itakura, and patents that resulted from that work, which are referred to
as the “Riggs/Itakura Patents.” Since that time, we have entered into license
agreements with various companies to manufacture, use, and sell the products
covered by the Riggs/Itakura Patents. On August 13, 1999, the COH filed a
complaint against us in the Superior Court in Los Angeles County, California,
alleging that we owe royalties to the COH in connection with these license
agreements, as well as product license agreements that involve the grant of
licenses under the Riggs/Itakura Patents. On June 10, 2002, a jury voted to
award the COH approximately $300 million in compensatory damages. On June 24,
2002, a jury voted to award the COH an additional $200 million in punitive
damages. Such amounts were accrued as an expense in the second quarter of 2002
and are included in the accompanying Consolidated Balance Sheets in “accrued
litigation” at December 31, 2007 and 2006. We filed a notice of appeal of the
verdict and damages awards with the California Court of Appeal. On October 21,
2004, the California Court of Appeal affirmed the verdict and damages awards in
all respects. On November 22, 2004, the California Court of Appeal modified its
opinion without changing the verdict and denied Genentech’s request for
rehearing. On November 24, 2004, we filed a petition seeking review by the
California Supreme Court. On February 2, 2005, the California Supreme Court
granted that petition. The California Supreme Court heard our appeal on this
matter on February 5, 2008 and we expect a ruling within 90 days of the hearing
date. The amount of cash paid, if any, or the timing of such payment in
connection with the COH matter will depend on the outcome of the California
Supreme Court’s review of the matter.
We
recorded accrued interest and bond costs related to the COH trial judgment of
$54 million in both 2007 and 2006. In conjunction with the COH judgment, we
posted a surety bond and were required to pledge cash and investments of $788
million at December 31, 2007 and 2006 to secure the bond. These amounts are
reflected in “restricted cash and investments” in the accompanying Consolidated
Balance Sheets. We expect that we will continue to incur interest charges on the
judgment and service fees on the surety bond each quarter through the process of
appealing the COH trial results. Included within current liabilities in
“Accrued litigation” in the accompanying Consolidated Balance Sheet at
December 31, 2007 is $776 million, which represents our estimate of the costs
for the current resolution of the COH matter.
On
April 11, 2003, MedImmune, Inc. filed a lawsuit against Genentech, COH, and
Celltech R & D Ltd. in the U.S. District Court for the Central District of
California (Los Angeles). The lawsuit relates to U.S. Patent No. 6,331,415 (the
Cabilly patent) that we co-own with COH and under which MedImmune and other
companies have been licensed and are paying royalties to us. The lawsuit
includes claims for violation of antitrust, patent, and unfair competition laws.
MedImmune is seeking a ruling that the Cabilly patent is invalid and/or
unenforceable, a determination that MedImmune does not owe royalties under the
Cabilly patent on sales of its Synagis® antibody product, an injunction to
prevent us from enforcing the Cabilly patent, an award of actual and exemplary
damages, and other relief. On January 14, 2004 (amending a December 23, 2003
order), the U.S. District Court granted summary judgment in our favor on all of
MedImmune’s antitrust and unfair competition claims. On April 23, 2004, the
District Court granted our motion to dismiss all remaining claims in the case.
On October 18, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed
the judgment of the District Court in all respects. MedImmune filed a petition
for certiorari with the U.S. Supreme Court on November 10, 2005, seeking review
of the decision to dismiss certain of its claims. The Supreme Court granted
MedImmune’s petition, and the oral argument of this case before the Supreme
Court occurred on October 4, 2006. On January 9, 2007, the Supreme Court issued
a decision reversing the Federal Circuit’s decision and remanding the case to
the lower courts for further proceedings in connection with the patent and
contract claims. On August 16, 2007, the U.S. District Court entered a Claim
Construction Order defining several terms used in the Cabilly patent. On October
29, 2007, MedImmune filed a motion for partial summary judgment of
non-infringement, and in connection with that motion MedImmune conceded that its
Synagis product infringes claim 33 of the Cabilly patent. Genentech responded to
this motion in part by granting MedImmune, with respect to the Synagis product
only, a covenant not to sue for infringement under any claim of the
Cabilly patent other than claim 33. Discovery and motion practice are
ongoing and the trial of this matter has been scheduled for June 23, 2008. The
outcome of this matter cannot be determined at this time.
On
May 13, 2005, a request was filed by a third party for reexamination of the
Cabilly patent. The request sought reexamination on the basis of non-statutory
double patenting over U.S. Patent No. 4,816,567. On July 7, 2005, the U.S.
Patent and Trademark Office (Patent Office) ordered reexamination of the Cabilly
patent. On September 13, 2005, the Patent Office mailed an initial non-final
Patent Office action rejecting the claims of the Cabilly patent. We filed our
response to the Patent Office action on November 25, 2005. On December 23, 2005,
a second request for reexamination of the Cabilly patent was filed by another
third party, and on January 23, 2006, the Patent Office granted that request. On
June 6, 2006, the two reexaminations were merged into one proceeding. On August
16, 2006, the Patent Office mailed a non-final Patent Office action in the
merged proceeding, rejecting the claims of the Cabilly patent based on issues
raised in the two reexamination requests. We filed our response to the Patent
Office action on October 30, 2006. On February 16, 2007, the Patent Office
mailed a final Patent Office action rejecting all 36 claims of the Cabilly
patent. We responded to the final Patent Office action on May 21, 2007 and
requested continued reexamination. On May 31, 2007, the Patent Office granted
the request for continued reexamination, and in doing so withdrew the finality
of the February 2007 Patent Office action and agreed to treat our May 21, 2007
filing as a response to a first Patent Office action. On February 25, 2008, we
received notification from the Patent Office that a final Office action
rejecting claims of the Cabilly patent has been issued and mailed. We intend to
file a response to the final Office action and, if necessary, appeal the
rejection. The Cabilly patent, which expires in 2018, relates to methods that we
and others use to make certain antibodies or antibody fragments, as well as
cells and DNA used in these methods. We have licensed the Cabilly patent to
other companies and derive significant royalties from those licenses. The claims
of the Cabilly patent remain valid and enforceable throughout the reexamination
and appeals processes. Because the above-described proceeding is ongoing, the
outcome of this matter cannot be determined at this time.
In
2006, we made development decisions involving our humanized anti-CD20 program,
and our collaborator, Biogen Idec, disagreed with certain of our development
decisions related to humanized anti-CD20 products. Under our 2003 collaboration
agreement with Biogen Idec, we believe that we are permitted under the agreement
to proceed with further trials of certain humanized anti-CD20 antibodies, and
Biogen Idec disagreed with our position. The disputed issues have been submitted
to arbitration. In the arbitration, Biogen Idec filed motions for a preliminary
injunction and summary judgment seeking to stop us from proceeding with certain
development activities, including planned clinical trials. On April 20, 2007,
the arbitration panel denied both Biogen Idec’s motion for a preliminary
injunction and Biogen Idec’s motion for summary judgment. Resolution of the
arbitration could require that both parties agree to certain development
decisions before moving forward with humanized anti-CD20 antibody clinical
trials, and possibly clinical trials of other collaboration products, including
Rituxan, in which case we may have to alter or cancel planned trials in order to
obtain Biogen Idec’s approval. The hearing of this matter is scheduled to begin
in June 2008. We expect a final decision within six months of the hearing,
unless the parties are able to resolve the matter earlier through settlement
discussions or otherwise. The outcome of this matter cannot be determined at
this time.
On
June 28, 2003, Mr. Ubaldo Bao Martinez filed a lawsuit against Porriño Town
Council and Genentech España S.L. in the Contentious Administrative Court
Number One of Pontevedra, Spain. The lawsuit challenges the Town
Council's decision to grant licenses to Genentech España S.L. for the
construction and operation of a warehouse and biopharmaceutical
manufacturing facility in Porriño, Spain. On January 21, 2008 the Administrative
Court ruled in favor of Mr. Bao on one of the claims in the lawsuit and
ordered the closing and demolition of the facility, subject to certain further
legal proceedings. On February 12, 2008, we and the Town Council filed appeals
of the Administrative Court decision at the High Court in Galicia, Spain. In
addition, we are evaluating with legal counsel in Spain whether there may be
other administrative remedies available to overcome the Administrative Court’s
ruling. We sold the assets of Genentech España S.L., including the Porriño
facility, to Lonza Group Ltd. in December 2006, and Lonza has operated the
facility since that time. Under the terms of that sale, we retained control of
the defense of this lawsuit and agreed to indemnify Lonza against certain
contractually defined liabilities up to a specified limit, which is currently
estimated to be approximately $100 million. The outcome of this matter, and our
indemnification obligation to Lonza, if any, cannot be determined at this
time.
Not
applicable.
Executive
Officers of the Company
The
executive officers of the Company and their respective ages (as of December 31,
2007) and positions with the Company are as follows:
Name
|
Age
|
|
Position
|
Arthur
D. Levinson, Ph.D.*
|
57
|
|
Chairman
and Chief Executive Officer
|
Susan
D. Desmond-Hellmann, M.D., M.P.H.*
|
50
|
|
President,
Product Development
|
Ian
T. Clark*
|
47
|
|
Executive
Vice President, Commercial Operations
|
David
A. Ebersman*
|
38
|
|
Executive
Vice President and Chief Financial Officer
|
Stephen
G. Juelsgaard, D.V.M., J.D.*
|
59
|
|
Executive
Vice President, Secretary and Chief Compliance Officer
|
Richard
H. Scheller, Ph.D.*
|
54
|
|
Executive
Vice President, Research
|
Patrick
Y. Yang, Ph.D.*
|
59
|
|
Executive
Vice President, Product Operations
|
Robert
E. Andreatta
|
46
|
|
Controller
and Chief Accounting Officer
|
Hal
Barron, M.D., F.A.C.C.
|
45
|
|
Senior
Vice President, Development, and Chief Medical Officer
|
________________________
* Members
of the Executive Committee of the Company.
The
Board of Directors appoints all executive officers annually. There is no family
relationship between or among any of the executive officers or
directors.
Business
Experience
Arthur D. Levinson, Ph.D. was
appointed Chairman of the Board of Directors of Genentech, Inc. in September
1999 and was elected its Chief Executive Officer and a director of the Company
in July 1995. Since joining the Company in 1980, Dr. Levinson has been a Senior
Scientist, Staff Scientist and the Director of the Company’s Cell Genetics
Department. Dr. Levinson was appointed Vice President of Research Technology in
April 1989, Vice President of Research in May 1990, Senior Vice President of
Research in December 1992, Senior Vice President of Research and Development in
March 1993 and President in July 1995. Dr. Levinson also serves as a member of
the Board of Directors of Apple Computer, Inc. and Google, Inc.
Susan D. Desmond-Hellmann, M.D.,
M.P.H. was appointed President, Product Development of Genentech in March
2004. She previously served as Executive Vice President, Development and Product
Operations from September 1999 to March 2004, Chief Medical Officer from
December 1996 to March 2004, and as Senior Vice President, Development from
December 1997 to September 1999, among other positions, since joining Genentech
in March 1995 as a Clinical Scientist. Prior to joining Genentech, she held the
position of Associate Director at Bristol-Myers Squibb.
Ian T. Clark was appointed
Executive Vice President, Commercial Operations of Genentech in December 2005.
He previously served as Senior Vice President, Commercial Operations of
Genentech from August 2005 to December 2005 and joined Genentech as Senior Vice
President and General Manager, BioOncology and served in that role from January
2003 through August 2005. Prior to joining Genentech, he served as president for
Novartis Canada from 2001 to 2003. Before assuming his post in Canada, he served
as chief operating officer for Novartis United Kingdom from 1999 to
2001.
David A. Ebersman was
appointed Executive Vice President of Genentech in December 2005 and Chief
Financial Officer in March 2005. Previously, he served as Senior Vice President,
Finance from January 2005 through March 2005 and Senior Vice President, Product
Operations from May 2001 through January 2005. He joined Genentech
in
February
1994 as a Business Development Analyst and subsequently served as Manager,
Business Development from February 1995 to February 1996, Director, Business
Development from February 1996 to March 1998, Senior Director, Product
Development from March 1998 to February 1999 and Vice President, Product
Development from February 1999 to May 2001. Prior to joining Genentech, he held
the position of Research Analyst at Oppenheimer & Company, Inc.
Stephen G. Juelsgaard, D.V.M.,
J.D. was appointed Chief Compliance Officer of Genentech in June 2005,
Executive Vice President in September 2002, and Secretary in April 1997. He
joined Genentech in July 1985 as Corporate Counsel and subsequently served as
Senior Corporate Counsel from 1988 to 1990, Chief Corporate Counsel from 1990 to
1993, Vice President, Corporate Law from 1993 to 1994, Assistant Secretary from
1994 to 1997, Senior Vice President from 1998 to 2002, and General Counsel
from 1994 to January 2007.
Richard H. Scheller, Ph.D.
was appointed Executive Vice President, Research of Genentech in September 2003.
Previously, he served as Senior Vice President, Research from March 2001 to
September 2003. Prior to joining Genentech, he served as Professor of Molecular
and Cellular Physiology and of Biological Sciences at
Stanford University Medical Center from September 1982 to
February 2001 and as an Investigator at the Howard Hughes Medical Institute from
September 1990 to February 2001. He received his first academic appointment to
Stanford University in 1982. He was appointed to the position of Professor
of Molecular and Cellular Physiology in 1993 and as an Investigator in the
Howard Hughes Medical Institute in 1994.
Patrick Y. Yang, Ph.D. was
appointed Executive Vice President, Product Operations of Genentech in December
2005. Previously, he served as Senior Vice President, Product Operations from
January 2005 through December 2005 and Vice President, South San Francisco
Manufacturing and Engineering from December 2003 to January 2005. Prior to
joining Genentech, he worked for General Electric from 1980 to 1992 in
manufacturing and technology and for Merck & Co. Inc. from 1992 to 2003 in
manufacturing. At Merck, he held several executive positions including Vice
President, Supply Chain Management from 2001 to 2003 and Vice President,
Asia/Pacific Manufacturing Operations from 1997 to 2000.
Robert E. Andreatta, was appointed
Controller of Genentech in June 2006 and Chief Accounting Officer in April 2007.
Previously at Genentech, he served as Assistant Controller and Senior Director,
Corporate Finance from May 2005 to June 2006, Director of Corporate Accounting
and Reporting from September 2004 to May 2005, and Director of Collaboration
Finance from June 2003 to September 2004. Prior to joining Genentech, he held
various officer positions at HopeLink Corporation, a healthcare information
technology company, from 2000 to 2003 and was a member of the Board of Directors
of HopeLink from 2002 to 2003. Mr. Andreatta worked for KPMG from 1983 to 2000,
including service as an audit partner from 1995 to 2000.
Hal Barron, M.D., F.A.C.C.
was appointed Senior Vice President, Development in December 2003 and Chief
Medical Officer in March 2004. Dr. Barron joined Genentech in 1996 as a Clinical
Scientist. During the next several years, he held positions as Associate
Director and Director of Cardiovascular Research. In 2001, he was named senior
director of Specialty BioTherapeutics. In 2002, Dr. Barron was promoted to Vice
President of Medical Affairs.
PART
II
See
“Liquidity and Capital Resources—Cash Used in or Provided by Financing
Activities” in “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in Part II, Item 7 of this Form 10-K; Note 1,
“Description of Business—Redemption of Our Special Common Stock”; Note 9,
“Relationship with Roche Holdings, Inc. and Related Party Transactions”; and
Note 11, “Capital Stock,” in the Notes to Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K.
Stock
Exchange Listing
Our
Common Stock trades on the New York Stock Exchange under the symbol “DNA.” No
dividends have been paid on the Common Stock. We currently intend to retain all
future income for use in the operation of our business and for future stock
repurchases and, therefore, do not anticipate paying any cash dividends in the
near future.
Common
Stockholders
As
of December 31, 2007, there were approximately 2,500 stockholders of record of
our Common Stock, one of which is Cede & Co., a nominee for Depository Trust
Company (DTC). All of the shares of Common Stock held by brokerage firms, banks
and other financial institutions as nominees for beneficial owners are deposited
into participant accounts at DTC, and are therefore considered to be held of
record by Cede & Co. as one stockholder.
Stock
Prices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4th
Quarter
|
|
$ |
78.61 |
|
|
$ |
65.35 |
|
|
$ |
86.93 |
|
|
$ |
79.65 |
|
3rd
Quarter
|
|
|
80.57 |
|
|
|
71.43 |
|
|
|
86.65 |
|
|
|
76.80 |
|
2nd
Quarter
|
|
|
83.65 |
|
|
|
72.31 |
|
|
|
84.72 |
|
|
|
75.58 |
|
1st
Quarter
|
|
|
89.73 |
|
|
|
80.12 |
|
|
|
95.16 |
|
|
|
81.15 |
|
Stock
Repurchases
See
“Liquidity and Capital Resources—Cash Used in or Provided by Financing
Activities” in “Management’s Discussion and Analysis of Financial Condition and
Results of Operations” in Part II, Item 7 of this Form 10-K for information
on our stock repurchases.
Performance
Graph
Below
is a graph showing the cumulative total return to our stockholders during the
period from December 31, 2002 through December 31, 2007 in comparison to the
cumulative return on the Standard & Poor’s 500 Index, the Standard &
Poor’s 500 Pharmaceuticals Index, and the Standard & Poor’s 500
Biotechnology Index during that same period.(1) The
results assume that $100 was invested on December 31, 2002.
|
|
Base
Period
|
|
|
|
|
|
|
December
|
|
|
December
|
|
|
December
|
|
|
December
|
|
|
December
|
|
|
December
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genentech,
Inc
|
|
$ |
100 |
|
|
$ |
282.18 |
|
|
$ |
328.35 |
|
|
$ |
557.90 |
|
|
$ |
489.32 |
|
|
$ |
404.52 |
|
S&P
500 Index
|
|
|
100 |
|
|
|
128.68 |
|
|
|
142.69 |
|
|
|
149.70 |
|
|
|
173.34 |
|
|
|
182.86 |
|
S&P
500 Pharmaceuticals Index
|
|
|
100 |
|
|
|
108.78 |
|
|
|
100.69 |
|
|
|
97.31 |
|
|
|
112.74 |
|
|
|
117.99 |
|
S&P
Biotechnology Index
|
|
|
100 |
|
|
|
128.86 |
|
|
|
138.66 |
|
|
|
164.00 |
|
|
|
159.50 |
|
|
|
154.04 |
|
________________________
(1)
|
The
total return on investment (change in year end stock price plus reinvested
dividends) assumes $100 invested on December 31, 2002 in our Common Stock,
the Standard & Poor’s 500 Index, the Standard & Poor’s 500
Pharmaceuticals Index and the Standard & Poor’s 500 Biotechnology
Index. At December 31, 2007, the Standard & Poor’s 500 Pharmaceuticals
Index comprised Abbott Laboratories; Allergan, Inc.; Barr
Pharmaceuticals Inc.; Bristol-Myers Squibb Company; Forest
Laboratories, Inc.; Johnson & Johnson; King Pharmaceuticals, Inc.;
Merck & Co., Inc.; Mylan Laboratories Inc.; Lilly (Eli) and Company;
Pfizer Inc.; Schering-Plough Corporation; Watson Pharmaceuticals, Inc.;
and Wyeth. At December 31, 2007, the Standard & Poor’s 500
Biotechnology Index comprised Amgen Inc.; Biogen Idec Inc.; Celgene
Corporation; Genzyme Corporation; and Gilead Sciences, Inc.
|
The
information under “Performance Graph” is not deemed filed with the
Securities and Exchange Commission and is not to be incorporated by
reference in any filing of Genentech under the Securities Act of 1933, as
amended, or the Securities Exchange Act of 1934, as amended, whether made
before or after the date of this 10-K and irrespective of any general
incorporation language in those
filings.
|
The
following selected consolidated financial information has been derived from our
audited consolidated financial statements. The information below is not
necessarily indicative of the results of future operations and should be read in
conjunction with Item 7, “Management’s Discussion and Analysis of Financial
Condition and Results of Operations,” and Item 1A, “Risk Factors,” of this Form
10-K, and the consolidated financial statements and related notes thereto
included in Item 8 of this Form 10-K, in order to fully understand factors that
may affect the comparability of the information presented below.
SELECTED
CONSOLIDATED FINANCIAL DATA
(In
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating revenue
|
|
$ |
11,724 |
|
|
$ |
9,284 |
|
|
$ |
6,633 |
|
|
$ |
4,621 |
|
|
$ |
3,300 |
|
Product
sales
|
|
|
9,443 |
|
|
|
7,640 |
|
|
|
5,488 |
|
|
|
3,749 |
|
|
|
2,621 |
|
Royalties
|
|
|
1,984 |
|
|
|
1,354 |
|
|
|
935 |
|
|
|
641 |
|
|
|
501 |
|
Contract
revenue
|
|
|
297 |
|
|
|
290 |
|
|
|
210 |
|
|
|
231 |
|
|
|
178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
before cumulative effect of accounting change
|
|
$ |
2,769 |
|
|
$ |
2,113 |
|
|
$ |
1,279 |
|
|
$ |
785 |
|
|
$ |
610 |
|
Cumulative
effect of accounting change, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(47 |
)(3) |
Net
income
|
|
$ |
2,769 |
(1) |
|
$ |
2,113 |
(1) |
|
$ |
1,279 |
|
|
$ |
785 |
|
|
$ |
563 |
(3) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
earnings per share
|
|
$ |
2.63 |
|
|
$ |
2.01 |
|
|
$ |
1.21 |
|
|
$ |
0.74 |
|
|
$ |
0.54 |
|
Diluted
earnings per share
|
|
|
2.59 |
|
|
|
1.97 |
|
|
|
1.18 |
|
|
|
0.73 |
|
|
|
0.53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$ |
18,940 |
|
|
$ |
14,842 |
|
|
$ |
12,147 |
|
|
$ |
9,403 |
(2) |
|
$ |
8,759 |
(2) |
Long-term
debt
|
|
|
2,402 |
(2) |
|
|
2,204 |
(2) |
|
|
2,083 |
(2) |
|
|
412 |
(2) |
|
|
412 |
(2) |
Stockholders’
equity
|
|
|
11,905 |
|
|
|
9,478 |
|
|
|
7,470 |
|
|
|
6,782 |
|
|
|
6,520 |
|
________________________
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We
have paid no dividends.
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All
per share amounts reflect the two-for-one stock split that was effected in
2004.
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Certain
prior year amounts have been reclassified to conform to the current year
presentation.
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(1)
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Net
income in 2007 and 2006 included employee stock-based compensation costs
of $260 million and $182 million, net of tax, respectively, due to our
adoption of Statement of Financial Accounting Standards No. 123(R), “Share-Based Payment,”
on a modified prospective basis on January 1, 2006. No employee
stock-based compensation expense was recognized in reported amounts in any
period prior to January 1, 2006. Net income in 2007
also included certain items associated with the acquisition of Tanox,
Inc., including the recognition of deferred royalty revenue of $4 million,
net of tax, a charge for in-process research and development expense of
$77 million, a gain pursuant to Emerging Issues Task Force Issue No. 04-1
of $73 million, net of tax, and amortization of intangible assets of $17
million, net of tax.
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(2)
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Long-term
debt in 2007, 2006, and 2005 included $2 billion related to our debt
issuance in July 2005, and included $399 million in 2007, $216 million in
2006, and $94 million in 2005 in construction financing obligations
related to our agreements with Health Care Properties (formerly Slough)
and Lonza. Long-term debt in 2005 also reflected the repayment of $425
million to extinguish the consolidated debt and noncontrolling interest of
a synthetic lease obligation related to our manufacturing facility located
in Vacaville, California. Upon adoption of the Financial Accounting
Standards Board Interpretation No. 46 (FIN 46), “Consolidation of Variable
Interest Entities,” in 2003, we consolidated the entity from which
we lease our manufacturing facility located in Vacaville, California.
Accordingly, we included in property, plant and equipment assets with net
book values of $326 million at December 31, 2004 and $348 million at
December 31, 2003. We also consolidated the entity’s debt of $412 million
and noncontrolling interest of $13 million, which amounts are included in
long-term debt and litigation-related and other long-term liabilities,
respectively, at December 31, 2004 and 2003.
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(3)
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Net
income in 2003 included the receipt of $113 million in pretax litigation
settlements with Amgen Inc. and Bayer Inc. Net income in 2003 also
reflected our adoption of FIN 46 on July 1, 2003, which resulted in a $47
million charge, net of $32 million in taxes, (or $0.05 per share) as a
cumulative effect of an accounting change in
2003.
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Overview
The
Company
Genentech
is a leading biotechnology company that discovers, develops, manufactures, and
commercializes pharmaceutical products to treat patients with significant unmet
medical needs. We commercialize multiple biotechnology products and also receive
royalties from companies that are licensed to market products based on our
technology.
Major
Developments in 2007
We
primarily earn revenue and income, and generate cash from product sales and
royalty revenue. Our total operating revenue in 2007 was $11.7 billion, an
increase of 26% from $9.28 billion in 2006. Product sales in 2007 were $9.44
billion, an increase of 24% from $7.64 billion in 2006. Product sales
represented 81% of our operating revenue in 2007 and 82% in 2006. Royalty
revenue was $1.98 billion in 2007, an increase of 47% from $1.35 billion in
2006. Royalty revenue represented 17% of our operating revenue in 2007 and 15%
in 2006. Our net income in 2007 was $2.77 billion, an increase of 31% from $2.11
billion in 2006.
In
2007, we announced our goal to add a total of 30 molecules into development
during the five-year period from the beginning of 2006 through the end of 2010,
an update to our previous goal to add a total of 20 molecules into development
from the beginning of 2006 through the end of 2010. In 2007, we added eight new
molecular entities to the development pipeline, and removed five new
molecules from the development pipeline. We now have 20 new molecules in the
development pipeline, most targeting novel mechanisms based on promising
biology, and five of these new molecules started Phase II clinical trials during
2007.
During
2007, we entered into a number of major new collaborations giving us access
to novel early-stage drug products being developed as potential treatments for
various diseases including cancer and cardiovascular disease, including among
others the following: (i) a collaboration agreement with Abbott Laboratories for
the global research, development, and commercialization of two of Abbott’s
investigational anti-cancer, small molecule compounds: ABT-263 and ABT-869.
ABT-263 is currently in Phase I clinical trials and we, in collaboration with
Abbott, initiated Phase II trials with ABT-869 in solid tumor types in 2007,
(ii) an exclusive worldwide license agreement with Seattle Genetics, Inc. for
the development and commercialization of a humanized monoclonal antibody
currently in Phase I clinical trials for multiple myeloma, chronic lymphocytic
leukemia and non-Hodgkin’s lymphoma (NHL), and a Phase II clinical trial for
diffuse large B-cell lymphoma, (iii) a collaboration with BioInvent to
co-develop and commercialize a monoclonal antibody currently in Phase I for the
potential treatment of cardiovascular disease, and (iv) a collaboration
agreement with Altus to develop, manufacture and commercialize a subcutaneously
administered, once-per-week formulation of human growth hormone. The
collaboration with Altus was subsequently terminated in 2007.
On
February 16, 2007, the Patent Office mailed a final Patent Office action
rejecting all 36 claims of the Cabilly patent. We responded to the final Patent
Office action on May 21, 2007 and requested continued reexamination. On May 31,
2007, the Patent Office granted the request for continued reexamination, and in
doing so withdrew the finality of the February 2007 Patent Office action and
agreed to treat our May 21, 2007 filing as a response to a first Patent Office
action. On February 25, 2008, we received notification from the Patent Office
that a final Office action rejecting claims of the Cabilly patent has been
issued and mailed. We intend to file a response to the final Office action and,
if necessary, appeal the rejection.
In
February 2007, we announced that a Roche-sponsored Phase III study evaluating
two different doses of Avastin in combination with gemcitabine and cisplatin
chemotherapy compared to chemotherapy alone met the primary endpoint of
prolonging progression-free survival (PFS) in patients with previously
untreated, advanced non-small
cell
lung cancer (NSCLC). This study evaluated a 15 mg/kg/every-three-weeks dose of
Avastin (the dose approved in the U.S. for use in combination with carboplatin
and paclitaxel) and a 7.5 mg/kg/every-three-weeks dose of Avastin (a dose not
approved for use in the U.S.). Although the study was not designed to compare
the Avastin doses, a similar treatment effect in PFS was observed between the
two arms.
During
the second quarter of 2007, we achieved four manufacturing milestones: (i) we
received United States (U.S.) Food and Drug Administration (FDA) licensure of
our Oceanside, California manufacturing facility to produce bulk Avastin, (ii)
we received approval for a new aseptic fill-finish line in South San Francisco,
California; (iii) we broke ground on our E. coli production facility in
Singapore, and (iv) we achieved mechanical completion of our second
manufacturing facility in Vacaville, California, for which we continue to
anticipate licensure in 2009.
On
August 2, 2007, we acquired 100% of the outstanding shares of Tanox, Inc. for
$925 million, plus $8 million in transaction costs. The acquired assets include
$202 million of Tanox’s cash and investments, resulting in a net cash and
investment outlay of $731 million. Included in our operating results for 2007
are items related to our acquisition of Tanox, including a non-recurring
in-process research and development charge of $77 million; a non-recurring gain
of $121 million on a pretax basis pursuant to the Emerging Issues Task Force
(EITF) Issue No. 04-1, “Accounting for Preexisting
Relationships between the Parties to a Business Combination” (EITF 04-1); the
recognition of $6 million of deferred royalty revenue; and amortization of
intangible assets of $28 million. Tanox’s post-acquisition operating results
were not material to our consolidated results for 2007. See “Write-off of
In-process Research and Development Related to Acquisition” and “Gain on
Acquisition” in the “Results of Operations” section for more information on
these items.
On
August 24, 2007, we resubmitted a supplemental Biologics License Application
(sBLA) to the FDA for Avastin, in combination with paclitaxel chemotherapy, for
patients with metastatic HER2-negative BC. On February 12, 2008, we announced
that AVADO, Roche’s study evaluating two doses of Avastin in first-line
metastatic BC, met its primary endpoint of prolonging PFS. Both doses of Avastin
in combination with chemotherapy showed statistically significant improvement in
the time patients lived without their disease advancing compared to chemotherapy
and placebo. On February 22, 2008, we received accelerated approval from the FDA
to market Avastin in combination with paclitaxel chemotherapy for the treatment
of patients who have not received prior chemotherapy for metastatic
HER2-negative BC. As a condition of the accelerated approval, we are required to
make future submissions to the FDA, including the final study reports for two
Phase III studies, AVADO and RIBBON, which are ongoing studies of Avastin in
metastatic HER2-negative BC. Based on the FDA’s review of our future
submissions, the FDA may decide to withdraw or modify such approval, request
additional post-marketing studies, or grant full approval.
Our
Strategy and Goals
As
announced in 2006, our business objectives for the years 2006 through 2010
include bringing at least 20 new molecules into clinical development, bringing
at least 15 major new products or indications onto the market, becoming the
number one U.S. oncology company in sales, and achieving certain financial
growth measures. These objectives are reflected in our revised Horizon 2010
strategy and goals summarized on our website at
www.gene.com/gene/about/corporate/growthstrategy.
Economic
and Industry-wide Factors
Our
strategy and goals are challenged by economic and industry-wide factors that
affect our business. Key factors that affect our future growth are discussed
below:
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We
face significant competition in the diseases of interest to us from
pharmaceutical companies and biotechnology companies. The introduction of
new competitive products or follow-on biologics, and/or new information
about existing products, and/or pricing decisions by us or our
competitors, may result in lost market share for us, reduced utilization
of our products, lower prices, and/or reduced product sales, even for
products protected by patents.
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Our
long-term business growth depends upon our ability to continue to
successfully develop and commercialize important novel therapeutics to
treat unmet medical needs, such as cancer. We recognize that the
successful development of pharmaceutical products is highly difficult and
uncertain, and that it will be challenging for us to continue to discover
and develop innovative treatments. Our business requires significant
investment in research and development (R&D) over many years, often
for products that fail during the R&D process. Once a product receives
FDA approval, it remains subject to ongoing FDA regulation, including
changes to the product label, new or revised regulatory requirements for
manufacturing practices, written advisement to physicians, and/or product
recalls or withdrawals.
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Our
business model requires appropriate pricing and reimbursement for our
products to offset the costs and risks of drug development. The pricing
and distribution of our products have received negative press coverage and
public and governmental scrutiny. We will continue to meet with patient
groups, payers, and other stakeholders in the healthcare system to
understand their issues and concerns. The reimbursement environment for
our products may change in the future and become more
challenging.
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As
the Medicare and Medicaid programs are the largest payers for our
products, rules related to coverage and reimbursement continue to
represent an important issue for our business. New regulations related to
hospital and physician payment continue to be implemented annually. To
date, we have not seen any detectable effects of the new rules on our
product sales. As a result of the Deficit Reduction Act, new regulations
became effective in the fourth quarter of 2007 that will affect the
discounted price for our products paid by Medicaid and
government-affiliated customers.
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Intellectual
property protection of our products is crucial to our business. Loss of
effective intellectual property protection could result in lost sales to
competing products, loss of royalty payments (for example, royalty
income associated with the Cabilly patent) from licensees, and may
negatively affect our sales, royalty revenue, and operating results. We
are often involved in disputes over contracts and intellectual property,
and we work to resolve these disputes in confidential negotiations or
litigation. We expect legal challenges in this area to continue. We plan
to continue to build upon and defend our intellectual property
position.
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Manufacturing
pharmaceutical products is difficult and complex, and requires facilities
specifically designed and validated to run biotechnology production
processes. Difficulties or delays in product manufacturing or in obtaining
materials from our suppliers, or difficulties in accurately forecasting
manufacturing capacity needs or complying with regulatory requirements,
could negatively affect our business. Additionally, we may have an excess
of available capacity, which could lead to an idling of a portion of our
manufacturing facilities and incurring unabsorbed or idle plant charges,
or other excess capacity charges, resulting in an increase in our cost of
sales (COS).
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Our
ability to attract and retain highly qualified and talented people in all
areas of the company, and our ability to maintain our unique culture, will
be critical to our success over the long-term. We are working diligently
across the company to make sure that we successfully hire, train, and
integrate new employees into the Genentech culture and
environment.
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Critical
Accounting Policies and the Use of Estimates
The
accompanying discussion and analysis of our financial condition and results of
operations are based on our Consolidated Financial Statements and the related
disclosures, which have been prepared in accordance with U.S. generally accepted
accounting principles (GAAP). The preparation of these Consolidated Financial
Statements requires management to make estimates, assumptions, and judgments
that affect the reported amounts in our Consolidated Financial Statements and
accompanying notes. These estimates form the basis for making judgments about
the carrying values of assets and liabilities. We base our estimates and
judgments on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, and we have established
internal controls related to the preparation of these estimates. Actual results
and the timing of the results could differ materially from these
estimates.
We
believe the following policies to be critical to understanding our financial
condition, results of operations, and expectations for 2008, because these
policies require management to make significant estimates, assumptions, and
judgments about matters that are inherently uncertain.
Contingencies
We
are currently, and have been, involved in certain legal proceedings, including
patent infringement litigation. We are also involved in licensing and contract
disputes, and other matters. See Note 8, “Leases, Commitments
and Contingencies,” in the Notes to Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K for more information on these matters. We
assess the likelihood of any adverse judgments or outcomes for these legal
matters as well as potential ranges of probable losses. We record an estimated
loss as a charge to income if we determine that, based on information available
at the time, the loss is probable and the amount of loss can be reasonably
estimated. The nature of these matters is highly uncertain and subject to
change; as a result, the amount of our liability for certain of these matters
could exceed or be less than the amount of our current estimates, depending on
the final outcome of these matters. The outcomes of such matters that are
different from our current estimates could have a material effect on our
financial position or our results of operations in any one
quarter. Included within current liabilities in “Accrued litigation”
in the accompanying Consolidated Balance Sheet at December 31, 2007 is $776
million, which represents our estimate of the costs for the current resolution
of the City of Hope National Medical Center (COH) matter. The California
Supreme Court heard our appeal on this matter on February 5, 2008 and we expect
a ruling within 90 days of the hearing date. Therefore, we expect that we will
continue to incur interest charges on the judgment and service fees on the
surety bond up to the second quarter of 2008. The amount of cash paid, if any,
or the timing of such payment in connection with the COH matter will depend on
the outcome of the California Supreme Court’s decision.
Revenue
Recognition–Avastin U.S. Product Sales and Patient Assistance
Program
In
February 2007, we launched the Avastin Patient Assistance Program, which is a
voluntary program that enables eligible patients who have received 10,000
milligrams of Avastin in a 12-month period to receive free Avastin in excess of
the 10,000 milligrams during the remainder of the 12-month period. Based on the
current wholesale acquisition cost, the 10,000 milligrams is valued at $55,000
in gross revenue. Eligible patients include those who are being treated for an
FDA-approved indication and who meet the household income criteria for this
program. The program is available for eligible patients who enroll, regardless
of whether they are insured. We defer a portion of our gross Avastin product
sales revenue to reflect our estimate of the commitment to supply free Avastin
to patients who elect to enroll in the program.
In
order to make our estimate of the amount of free Avastin to be provided to
patients under the program, we need to estimate several factors, most notably:
the number of patients who are currently being treated for FDA-approved
indications and the start date for their treatment regimen, the extent to which
doctors and patients may elect to enroll in the program, the number of patients
who will meet the financial eligibility requirements of the program, and the
duration and extent of treatment for the FDA-approved indications, among other
factors. We have based our enrollment assumptions on physician surveys and other
information that we consider relevant. We will continue to update our estimates
in each reporting period as new information becomes available. If the actual
results underlying this deferred revenue accounting vary significantly from our
estimates, we will need to make adjustments to these estimates, which could have
a material effect on revenue and earnings in the period of adjustment. Based on
these estimates, we defer a portion of Avastin revenue on product vials sold
through normal commercial channels. The deferred revenue will be recognized when
free Avastin vials are delivered. As enrollment in the program was lower than
expected in 2007, we did not defer any gross Avastin product sales during
the second half of 2007. Further, we recorded a net decrease in deferred
revenue, and a corresponding net increase to Avastin U.S. product sales, of $7
million for the full year 2007, resulting in a remaining deferred revenue
liability in connection with the Avastin Patient Assistance Program of $2
million in our Consolidated Balance Sheet at December 31, 2007. Usage of the
Avastin Patient Assistance Program may increase with the approval of Avastin for
the treatment of metastatic HER2-negative BC. As we continue to evaluate
the amount of revenue to defer related to the Avastin Patient
Assistance
Program,
we may recognize previously deferred revenue in Avastin U.S. product sales in
future periods or we may increase the amount of revenue deferred.
Product
Sales Allowances
Revenue
from U.S. product sales is recorded net of allowances and accruals for rebates,
healthcare provider contractual chargebacks, prompt-pay sales discounts, product
returns, and wholesaler inventory management allowances, all of which are
established at the time of sale. Sales allowances and accruals are based
on estimates of the amounts earned or to be claimed on the related sales.
The amounts reflected in our Consolidated Statements of Income as product sales
allowances have been relatively consistent at approximately six to eight percent
of gross sales. In order to prepare our Consolidated Financial Statements, we
are required to make estimates regarding the amounts earned or to be claimed on
the related product sales.
Definitions
for the product sales allowance types are as follows:
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Rebate
allowances and accruals include both direct and indirect rebates. Direct
rebates are contractual price adjustments payable to direct customers,
mainly to wholesalers and specialty pharmacies that purchase products
directly from us. Indirect rebates are contractual price adjustments
payable to healthcare providers and organizations such as clinics,
hospitals, pharmacies, Medicaid, and group purchasing organizations that
do not purchase products directly from
us;
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Prompt-pay
sales discounts are credits granted to wholesalers for remitting payment
on their purchases within established cash payment incentive
periods;
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Product
return allowances are established in accordance with our Product Returns
Policy. Our returns policy allows product returns within the period
beginning two months prior to and six months following product
expiration;
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Wholesaler
inventory management allowances are credits granted to wholesalers for
compliance with various contractually defined inventory management
programs. These programs were created to align purchases with underlying
demand for our products and to maintain consistent inventory levels,
typically at two to three weeks of sales depending on the product;
and
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Healthcare
provider contractual chargebacks are the result of contractual commitments
by us to provide products to healthcare providers at specified prices or
discounts.
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We
believe that our estimates related to product returns allowances and wholesaler
inventory management payments are not material amounts, based on the historical
levels of credits and allowances as a percentage of product sales. We believe
that our estimates related to healthcare provider contractual chargebacks and
prompt-pay sales discounts do not have a high degree of estimation complexity or
uncertainty, as the related amounts are settled within a short period of time.
We consider rebate allowances and accruals to be the only estimations that
involve material amounts and require a higher degree of subjectivity and
judgment necessary to account for the rebate allowances or accruals. As a
result of the uncertainties involved in estimating rebate allowances and
accruals, there is a possibility that materially different amounts could be
reported under different conditions or using different assumptions.
Our
rebates are based on definitive agreements or legal requirements (such as
Medicaid). These rebates are primarily estimated using historical and other
data, including patient usage, customer buying patterns, applicable contractual
rebate rates, and contract performance by the benefit providers. Direct rebates
are accrued at the time of sale and recorded as allowances against trade
accounts receivable; indirect (including Medicaid) rebates are accrued at the
time of sale and recorded as liabilities. Rebate estimates are evaluated
quarterly and may require changes to better align our estimates with actual
results. As part of this evaluation, we review changes to Medicaid legislation,
changes to state rebate contracts, changes in the level of discounts, and
significant changes in product sales trends. Although rebates are accrued at the
time of sale, rebates are typically paid out, on average, up to six months after
the sale. We believe that our rebate allowances and accruals estimation process
provides a high degree of confidence in the annual
allowance
amounts established. Based on our estimation, the changes in rebate allowances
and accruals estimates related to prior years have not exceeded 3%. To further
illustrate our sensitivity to changes in the rebate allowances and accruals
process, as much as a 10% change in our rebate allowances and accruals provision
in 2007 (which is in excess of three times the level of variability that we
reasonably expect to observe for rebates) would have an approximate $19 million
effect on our income before taxes (or approximately $0.01 per share after
taxes). The total rebate allowances and accruals recorded in our Consolidated
Balance Sheets were $70 million as of December 31, 2007 and $53 million as of
December 31, 2006.
All
of the aforementioned categories of allowances and accruals are evaluated
quarterly and adjusted when trends or significant events indicate that a change
in estimate is appropriate. Such changes in estimate could materially affect our
results of operations or financial position; however, to date they have not been
material. It is possible that we may need to adjust our estimates in future
periods. Our Consolidated Balance Sheets reflected estimated product sales
allowance reserves and accruals totaling approximately $176 million as of
December 31, 2007 and approximately $139 million as of December 31,
2006.
Royalties
For
substantially all of our agreements with licensees, we estimate royalty revenue
and royalty receivables in the period the royalties are earned, which is in
advance of collection. Our estimates of royalty revenue and receivables in those
instances are based on communication with some licensees, historical
information, forecasted sales trends, and collectibility. Differences between
actual royalty revenue and estimated royalty revenue are adjusted for in the
period in which they become known, typically the following quarter. If the
collectibility of a royalty amount is doubtful, royalty revenue is not accrued
for in advance of payment, but recognized as cash is received. In the case of a
receivable related to previously recognized royalty revenue that is subsequently
determined to be uncollectible, the receivable is reserved for in the period in
which the circumstances that make collectibility doubtful are determined, and
future royalties from the licensee are recognized on a cash basis until it is
determined that collectibility is reasonably assured. Historically, adjustments
to our royalty receivables have not been material to our consolidated financial
condition or results of operations.
We
have confidential licensing agreements with a number of companies on U.S. Patent
No. 6,331,415 (the Cabilly patent), under which we receive royalty revenue on
sales of products that are covered by the patent. The Cabilly patent, which
expires in 2018, relates to methods that we and others use to make certain
antibodies or antibody fragments, as well as cells and DNA used in those
methods. The U.S. Patent and Trademark Office (Patent Office) is performing a
reexamination of the patent and on February 16, 2007 issued a final Patent
Office action rejecting all 36 claims of the Cabilly patent. We responded to the
final Patent Office action on May 21, 2007 and requested continued
reexamination. On May 31, 2007, the Patent Office granted the request for
continued reexamination, and in so doing withdrew the finality of the February
2007 Patent Office action and agreed to treat our May 21, 2007 filing as a
response to a first Patent Office action. On February 25, 2008, we received
notification from the Patent Office that a final Office action rejecting claims
of the Cabilly patent has been issued and mailed. We intend to file a response
to the final Office action and, if necessary, appeal the rejection. The claims
of the patent remain valid and enforceable throughout the reexamination and
appeals processes. In addition, MedImmune, Inc. has filed a lawsuit against us
challenging the Cabilly patent. See also Note 8, “Leases, Commitments and
Contingencies,” in the Notes to Consolidated Financial Statements in Part II,
Item 8 of this Form 10-K for more information on our Cabilly patent
reexamination and the MedImmune lawsuit.
Cabilly
patent royalties are generally due 60 days after the end of the quarter.
Additionally, we pay COH a percentage of our Cabilly patent royalty revenue 60
days after the quarter in which we receive payments from our licensees. As of
December 31, 2007, our Consolidated Balance Sheet included Cabilly patent
receivables totaling approximately $68 million and the related COH payable
totaling approximately $26 million.
Income
Taxes
Income
tax provision is based on income before taxes and is computed using the
liability method. Deferred tax assets and liabilities are determined based on
the difference between the financial statement and tax basis of assets and
liabilities using tax rates projected to be in effect for the year in which the
differences are expected to reverse.
Significant
estimates are required in determining our provision for income taxes. Some of
these estimates are based on interpretations of existing tax laws or
regulations, or the findings or expected results from any tax examinations.
Various internal and external factors may have favorable or unfavorable effects
on our future effective income tax rate. These factors include, but are not
limited to, changes in tax laws, regulations and/or rates, the results of any
tax examinations, changing interpretations of existing tax laws or regulations,
changes in estimates of prior years’ items, past and future levels of R&D
spending, acquisitions, changes in our corporate structure, and changes in
overall levels of income before taxes; all of which may result in periodic
revisions to our effective income tax rate.
On
January 1, 2007, we adopted the provisions of Financial Accounting Standards
Board Interpretation No. 48, “Accounting for Uncertainty in Income
Taxes” (FIN 48).
As a result of the implementation of FIN 48, we evaluated our income tax
position and reclassified $147 million of unrecognized tax benefits from current
liabilities to long-term liabilities as of January 1, 2007, and we also
reclassified the balance as of December 31, 2006, for consistency, in the
accompanying Consolidated Balance Sheets.
Inventories
Inventories
may include currently marketed products manufactured under a new process or at
facilities awaiting regulatory licensure. These inventories are capitalized
based on management’s judgment of probable near-term regulatory licensure.
Excess or idle capacity costs, based on estimated plant capabilities, are
expensed in the period in which they are incurred. The valuation of inventory
requires us to estimate the value of inventory that may expire prior to use or
that may fail to be released for commercial sale. The determination of obsolete
inventory requires us to estimate the future demands for our products, and in
the case of pre-approval inventories, to estimate the regulatory approval date
for the product or for the licensure of either the manufacturing facility or the
new manufacturing process. We may be required to expense previously capitalized
inventory costs upon a change in our estimate, due to, among other potential
factors, the denial or delay of approval of a product or the licensure of either
a manufacturing facility or a new manufacturing process by the necessary
regulatory bodies, or new information that suggests that the inventory will not
be saleable.
Valuation
of Acquired Intangible Assets
We
have acquired intangible assets in connection with our acquisition of Tanox.
These intangible assets consist of developed product technology and core
technologies associated with intellectual property and rights thereon, primarily
related to the Xolair molecule, and assets related to the fair value write-up of
Tanox’s royalty contracts, as well as goodwill. When significant identifiable
intangible assets are acquired, we determine the fair values of these assets as
of the acquisition date using valuation techniques such as discounted cash flow
models. These models require the use of significant estimates and assumptions
including but not limited to determining the timing and expected costs to
complete the in-process projects, projecting regulatory approvals, estimating
future cash flows from product sales resulting from completed products and
in-process projects, and developing appropriate discount rates and probability
rates by project.
We
believe that the fair values assigned to the intangible assets acquired are
based on reasonable estimates and assumptions, given the available facts and
circumstances as of the acquisition date. However, we may record adjustments to
goodwill resulting from our acquisition of Tanox for the resolution of
pre-acquisition contingencies, our restructuring activities, tax matters, and
other estimates related to the acquisition. Further, we will have to continually
evaluate whether any or all intangible assets valued have been
impaired.
Employee
Stock-Based Compensation
Under
the provisions of Statement of Financial Accounting Standards (FAS) No. 123(R),
“Share-Based Payment” (FAS 123R), employee
stock-based compensation is estimated at the date of grant based on the employee
stock award’s fair value using the Black-Scholes option-pricing model and is
recognized as expense ratably over the requisite service period in a manner
similar to other forms of compensation paid to employees. The Black-Scholes
option-pricing model requires the use of certain subjective assumptions. The
most significant of these assumptions are our estimates of the expected
volatility of the market price of our stock and the expected term of the award.
Due to the redemption of our Special Common Stock in June 1999 (Redemption) by
RHI, there is limited historical
information
available to support our estimate of certain assumptions required to value our
stock options. When establishing an estimate of the expected term of an award,
we consider the vesting period for the award, our recent historical experience
of employee stock option exercises (including forfeitures), the expected
volatility, and a comparison to relevant peer group data. As required under the
accounting rules, we review our valuation assumptions at each grant date, and,
as a result, our valuation assumptions used to value employee stock-based awards
granted in future periods may change. See also Note 3, “Employee Stock-Based
Compensation,” in the Notes to Consolidated Financial Statements in Part II,
Item 8 of this Form 10-K for more information.
Results
of Operations
(In
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Product
sales
|
|
$ |
9,443 |
|
|
$ |
7,640 |
|
|
$ |
5,488 |
|
|
|
24
|
% |
|
|
39
|
% |
Royalties
|
|
|
1,984 |
|
|
|
1,354 |
|
|
|
935 |
|
|
|
47 |
|
|
|
45 |
|
Contract
revenue
|
|
|
297 |
|
|
|
290 |
|
|
|
210 |
|
|
|
2 |
|
|
|
38 |
|
Total
operating revenue
|
|
|
11,724 |
|
|
|
9,284 |
|
|
|
6,633 |
|
|
|
26 |
|
|
|
40 |
|
Cost
of sales
|
|
|
1,571 |
|
|
|
1,181 |
|
|
|
1,011 |
|
|
|
33 |
|
|
|
17 |
|
Research
and development
|
|
|
2,446 |
|
|
|
1,773 |
|
|
|
1,262 |
|
|
|
38 |
|
|
|
40 |
|
Marketing,
general and administrative
|
|
|
2,256 |
|
|
|
2,014 |
|
|
|
1,435 |
|
|
|
12 |
|
|
|
40 |
|
Collaboration
profit sharing
|
|
|
1,080 |
|
|
|
1,005 |
|
|
|
823 |
|
|
|
7 |
|
|
|
22 |
|
Write-off
of in-process research and development related to
acquisition
|
|
|
77 |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
Gain
on acquisition
|
|
|
(121 |
) |
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
Recurring
charges related to redemption and acquisition
|
|
|
132 |
|
|
|
105 |
|
|
|
123 |
|
|
|
26 |
|
|
|
(15 |
) |
Special
items: litigation-related
|
|
|
54 |
|
|
|
54 |
|
|
|
58 |
|
|
|
0 |
|
|
|
(7 |
) |
Total
costs and expenses
|
|
|
7,495 |
|
|
|
6,132 |
|
|
|
4,712 |
|
|
|
22 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
|
4,229 |
|
|
|
3,152 |
|
|
|
1,921 |
|
|
|
34 |
|
|
|
64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net
|
|
|
273 |
|
|
|
325 |
|
|
|
142 |
|
|
|
(16 |
) |
|
|
129 |
|
Interest
expense
|
|
|
(76 |
) |
|
|
(74 |
) |
|
|
(50 |
) |
|
|
3 |
|
|
|
48 |
|
Total
other income, net
|
|
|
197 |
|
|
|
251 |
|
|
|
92 |
|
|
|
(22 |
) |
|
|
173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income
before taxes
|
|
|
4,426 |
|
|
|
3,403 |
|
|
|
2,013 |
|
|
|
30 |
|
|
|
69 |
|
Income
tax provision
|
|
|
1,657 |
|
|
|
1,290 |
|
|
|
734 |
|
|
|
28 |
|
|
|
76 |
|
Net
income
|
|
$ |
2,769 |
|
|
$ |
2,113 |
|
|
$ |
1,279 |
|
|
|
31 |
|
|
|
65 |
|
Earnings
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
2.63 |
|
|
$ |
2.01 |
|
|
$ |
1.21 |
|
|
|
31 |
|
|
|
66 |
|
Diluted
|
|
$ |
2.59 |
|
|
$ |
1.97 |
|
|
$ |
1.18 |
|
|
|
31 |
|
|
|
67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales as a % of product sales
|
|
|
17
|
% |
|
|
15
|
% |
|
|
18
|
% |
|
|
|
|
|
|
|
|
Research
and development as a % of total operating revenue
|
|
|
21 |
|
|
|
19 |
|
|
|
19 |
|
|
|
|
|
|
|
|
|
Marketing,
general and administrative as a % of total operating
revenue
|
|
|
19 |
|
|
|
22 |
|
|
|
22 |
|
|
|
|
|
|
|
|
|
Pretax
operating margin
|
|
|
36 |
|
|
|
34 |
|
|
|
29 |
|
|
|
|
|
|
|
|
|
Net
income as a % of total operating revenue
|
|
|
24 |
|
|
|
23 |
|
|
|
19 |
|
|
|
|
|
|
|
|
|
Effective
income tax rate
|
|
|
37 |
|
|
|
38 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
________________________
Percentages
in this table and throughout our discussion and analysis of financial condition
and results of operations may reflect rounding adjustments.
Total
Operating Revenue
Total
operating revenue increased 26% to $11,724 million in 2007 and increased 40% to
$9,284 million in 2006. These increases were primarily due to higher product
sales and royalty revenue, and are further discussed below.
Total
Product Sales
(In
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
Sales
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Net
U.S. product sales
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Avastin
|
|
$ |
2,296 |
|
|
$ |
1,746 |
|
|
$ |
1,133 |
|
|
|
32
|
% |
|
|
54
|
% |
Rituxan
|
|
|
2,285 |
|
|
|
2,071 |
|
|
|
1,832 |
|
|
|
10 |
|
|
|
13 |
|
Herceptin
|
|
|
1,287 |
|
|
|
1,234 |
|
|
|
747 |
|
|
|
4 |
|
|
|
65 |
|
Lucentis
|
|
|
815 |
|
|
|
380 |
|
|
|
– |
|
|
|
114 |
|
|
|
* |
|
Xolair
|
|
|
472 |
|
|
|
425 |
|
|
|
320 |
|
|
|
11 |
|
|
|
33 |
|
Tarceva
|
|
|
417 |
|
|
|
402 |
|
|
|
275 |
|
|
|
4 |
|
|
|
46 |
|
Nutropin
products
|
|
|
371 |
|
|
|
378 |
|
|
|
370 |
|
|
|
(2 |
) |
|
|
2 |
|
Thrombolytics
|
|
|
268 |
|
|
|
243 |
|
|
|
218 |
|
|
|
10 |
|
|
|
11 |
|
Pulmozyme
|
|
|
223 |
|
|
|
199 |
|
|
|
186 |
|
|
|
12 |
|
|
|
7 |
|
Raptiva
|
|
|
107 |
|
|
|
90 |
|
|
|
79 |
|
|
|
19 |
|
|
|
14 |
|
Total
U.S. product sales
|
|
|
8,540 |
|
|
|
7,169 |
|
|
|
5,162 |
|
|
|
19 |
|
|
|
39 |
|
Net
product sales to collaborators
|
|
|
903 |
|
|
|
471 |
|
|
|
326 |
|
|
|
92 |
|
|
|
44 |
|
Total
product sales
|
|
$ |
9,443 |
|
|
$ |
7,640 |
|
|
$ |
5,488 |
|
|
|
24 |
|
|
|
39 |
|
________________________
*
|
Calculation
not meaningful.
|
|
The
totals shown above may not appear to sum due to
rounding.
|
Total
net product sales increased 24% to $9,443 million in 2007 and increased 39% to
$7,640 million in 2006. Net U.S. sales increased 19% to $8,540 million in 2007
and increased 39% to $7,169 million in 2006. These increases in U.S. sales were
due to higher sales across almost all products, in particular higher sales of
our oncology products and sales resulting from the approval of Lucentis on June
30, 2006. Increased U.S. sales volume accounted for 83%, or $1,136 million, of
the increase in U.S. net product sales in 2007, and 89%, or $1,785 million in
2006. Changes in net U.S. sales prices across the majority of products in the
portfolio accounted for most of the remainder of the increases in U.S. net
product sales in 2007 and 2006.
Our
references below to market adoption and penetration, as well as patient share,
are derived from our analyses of market tracking studies and surveys that we
undertake with physicians. We consider these tracking studies and surveys
indicative of trends and information with respect to our direct customers’
buying patterns. We use statistical analyses to extrapolate the data that we
obtain, and as such, the adoption, penetration, and patient share data presented
herein represents estimates. Limitations in sample size and the timeliness in
receiving and analyzing this data result in inherent margins of error; thus,
where presented, we have rounded our percentage estimates to the nearest
5%.
Avastin
Net
U.S. sales of Avastin increased 32% to $2,296 million in 2007 and 54% to $1,746
million in 2006. Net U.S. sales in 2007 included the net recognition of $7
million of previously deferred revenue, mostly due to lower than expected
enrollment in our Avastin Patient Assistance Program. The increase in sales in
2007 was primarily a result of increased use of Avastin in first-line metastatic
NSCLC, approved on October 11, 2006, and in metastatic BC, an unapproved
use of Avastin during 2007.
Among
first-line metastatic NSCLC patients, we estimate that Avastin penetration was
approximately 35% in the fourth quarter of 2007. Among the approximately 50%-60%
of patients in first-line metastatic lung cancer who are eligible for Avastin
therapy, we estimate that penetration was approximately 60%. With respect to
dose, use of the 15mg/kg/every-three-weeks dose during the fourth quarter of
2007 remained stable relative to the third quarter of 2007 at approximately
60%-65%. We expect dose in metastatic NSCLC to continue to be a source of
uncertainty for Avastin. The Roche-sponsored BO17704 study, which was presented
at the American Society of Clinical Oncology in June 2007, evaluated a
15mg/kg/every-three-weeks dose of Avastin (the dose approved in the U.S. for use
in combination with carboplatin and paclitaxel) and a 7.5mg/kg/every-three-weeks
dose of Avastin (a dose not approved for use in the U.S.) in combination
with gemcitabine and cisplatin chemotherapy compared to chemotherapy alone in
patients with previously untreated, advanced NSCLC. Both doses met the primary
endpoint of prolonging PFS compared to chemotherapy alone. Although the study
was not designed to compare the Avastin doses, a similar treatment effect in PFS
was observed between the two arms. We also expect overall survival data from the
BO17704 study during the first half of 2008. Depending on these results,
additional physicians may adopt Avastin at the lower dose of
7.5mg/kg/every-three-weeks.
In
first-line metastatic CRC, penetration in the fourth quarter of 2007 was in line
with penetration in the fourth quarter of 2006. In second-line CRC, we estimate
that Avastin penetration in the fourth quarter of 2007 was consistent with that
seen in the fourth quarter of 2006. Increased competition in second-line CRC
negatively affected Avastin use in the first half of 2007 but use in CRC has
since returned to fourth quarter 2006 levels.
In
first-line metastatic BC patients, Avastin adoption in the fourth quarter of
2007 was approximately 25%. Avastin use in this setting has been supported by
favorable reimbursement, which is partially due to its Compendia listing. On
February 12, 2008, we announced that AVADO, Roche’s study evaluating two doses
of Avastin in first-line metastatic BC, met its primary endpoint of prolonging
PFS. Both doses of Avastin in combination with chemotherapy showed statistically
significant improvement in the time patients lived without their disease
advancing compared to chemotherapy and placebo, although the study was not
designed to compare the Avastin doses. The FDA notified us on February 22, 2008
that Avastin received accelerated approval for use in combination with
paclitaxel chemotherapy, for patients who have not received prior chemotherapy
for metastatic HER2-negative BC. We anticipate increased use of Avastin in
breast cancer as a result of this favorable decision.
The
increase in sales in 2006 was primarily a result of increased use of Avastin in
metastatic NSCLC and metastatic BC, an unapproved use of Avastin
during 2006. In addition, the increase reflected modest gains in the treatment
of first-line metastatic CRC. These increases were partially offset by declining
revenue in metastatic renal cell carcinoma and metastatic
pancreatic cancer, which are both unapproved uses.
Rituxan
Net
U.S. sales of Rituxan increased 10% to $2,285 million in 2007 and 13% to $2,071
million in 2006. Sales growth in 2007 and 2006 resulted from increased use of
Rituxan in the oncology setting and in the rheumatoid arthritis setting, and
from price increases in both years.
In
the oncology setting, the increases came from Rituxan’s use following
chemotherapy in indolent NHL, including areas of unapproved use, and chronic
lymphocytic leukemia (CLL), an unapproved use. We estimate that Rituxan’s
overall adoption rate in combined markets of NHL and CLL increased slightly to
approximately 85% at the end of 2007 from approximately 80% at the end of
2006.
Primary
drivers of growth in the rheumatoid arthritis setting were increased new patient
starts, increased total numbers of prescribers to an estimated 80% of targeted
rheumatologists, and a retreatment interval averaging between six and seven
months. It remains difficult to precisely determine the sales split between
Rituxan use in oncology and immunology settings since many treatment centers
treat both types of patients, but we estimate that sales in the immunology
setting represented approximately 11% of total Rituxan sales for
2007.
On
January 25, 2008, the FDA approved our sBLA to expand the label for Rituxan to
include slowing the progression of structural damage in adult patients with
moderate-to-severe rheumatoid arthritis who have failed anti- tumor necrosis
factor (TNF) therapies. In January 2008, results from Rituxan Phase III SUNRISE
trial met its primary endpoint. This study was a controlled retreatment study
for patients with rheumatoid arthritis who have had an inadequate response to
previous treatment with one or more TNF antagonist therapies. A preliminary
review of the safety data revealed no new safety signals. On January 24, 2008 we
announced that the SERENE Phase III clinical study of Rituxan in patients who
have not been previously treated with a biotherapeutic met its primary endpoint
of a significantly greater proportion of Rituxan-treated patients achieving an
American College of Rheumatology (ACR) 20 response at week 24, compared to
placebo. In this study, patients who received a single treatment course of two
infusions of either 500 mg or 1,000 mg of Rituxan in combination with a stable
dose of methotrexate displayed a statistically significant improvement in ACR20
scores compared to patients who received placebo in combination with
methotrexate. Although the study was not designed to compare the Rituxan doses,
treatment efficacy appears to be similar between both Rituxan
doses.
Herceptin
Net
U.S. sales of Herceptin increased 4% to $1,287 million in 2007 and 65% to $1,234
million in 2006. The sales growth in 2007 and 2006 was due to price increases
that occurred from 2005 through 2007, and increased use of Herceptin in the
treatment of early-stage HER2-positive BC (approved on November 16,
2006). We estimate Herceptin’s penetration in the adjuvant setting was
approximately 75% at the end of 2007. In first-line HER2-positive metastatic BC
patients, we estimate Herceptin’s penetration remained flat at approximately 70%
from the end of 2006.
On
January 18, 2008, the FDA expanded the Herceptin label, based on the HERA study,
for the treatment of patients with early-stage HER2-positive BC to include
treatment for patients with node-negative BC. Herceptin also may now be
administered for one year in an every-three-week dosing schedule, instead of
weekly.
Lucentis
Lucentis
was approved by the FDA for the treatment of neovascular (wet) AMD on June 30,
2006. Net U.S. sales of Lucentis increased 114% to $815 million in 2007
from $380 million in 2006, and sales in the fourth quarter of 2007 decreased 9%
to $197 million from the comparable period in 2006. We believe that
approximately 50% of newly diagnosed patients were treated with Lucentis during
the fourth quarter of 2007, which was flat compared to the third quarter of
2007, and a decrease from 55% in the fourth quarter of 2006. We believe that the
main factors affecting Lucentis sales in 2007 were the continued unapproved use
of Avastin and reimbursement concerns from retinal specialists. Lucentis
received a permanent J-code classification from the Centers for Medicare and
Medicaid Services in January 2008, which we believe may address some of the
reimbursement concerns. In October 2007 we announced that we planned to no
longer allow compounding pharmacies the ability to purchase Avastin directly
from wholesale distributors, and this change in distribution was made effective
on January 1, 2008. However, physicians can purchase Avastin from authorized
distributors and ship to the destination of the physicians’ choice.
The
unapproved use of Avastin and the change in distribution for Avastin, as well as
reimbursement concerns have created a difficult environment for the promotion of
Lucentis and the building of relationships with retinal specialtists. We expect
these factors to persist and limit Lucentis sales growth.
Xolair
Net
U.S. sales of Xolair increased 11% to $472 million in 2007 and 33% to $425
million in 2006. Sales growth in 2007 and 2006 was driven by increased
penetration in the asthma market and, to a lesser extent, price increases
effective between 2005 and 2007. At the FDA’s request, we and Novartis, our
co-promotion collaborator, updated the Xolair product label in June 2007 with a
boxed warning regarding the risk of anaphylaxis in patients receiving Xolair. We
believe that this update had a minimal effect on sales of Xolair in 2007.
Genentech is working with the FDA to finalize a Risk Minimization Action
Plan that emphasizes the incidence of anaphylaxis and
instructs
physicians
that patients should be closely observed for an appropriate period of time after
Xolair administration.
Tarceva
Net
U.S. sales of Tarceva increased 4% to $417 million in 2007 and 46% to $402
million in 2006. Sales in 2007 were positively affected by price increases
during 2007 and 2006. These increases, however, were partially offset by product
returns and return reserve requirements (which were higher than expected in the
second and third quarters of 2007) and by modest decreases in volume in 2007. We
estimate that Tarceva’s penetration in second-line NSCLC was 30% in 2007, which
was stable compared to 2006. In the first-line pancreatic cancer setting, we
estimate that Tarceva’s penetration was 40% in 2007, which was stable compared
to 2006.
The
increase in product sales in 2006 was due to price increases in 2006 and 2005,
and growth in penetration and duration of treatment in both second-line NSCLC
and first-line pancreatic cancer.
Nutropin
Products
Combined
net U.S. sales of our Nutropin products decreased 2% to $371 million in 2007 and
increased 2% to $378 million in 2006. Sales in 2007 and 2006 were positively
affected by price increases in 2005 through 2007. However, decreases in sales
volume resulting from increased managed care contracting and increased
competitive activity offset the price increase in 2007 and partially offset the
price increase in 2006.
Thrombolytics
Combined
net U.S. sales of our three thrombolytics products—Activase, Cathflo Activase,
and TNKase—increased 10% to $268 million in 2007 and 11% to $243 million in
2006. Sales growth in 2007 and 2006 was due to growth in Cathflo Activase sales
in the catheter clearance market and increased Activase sales in the acute
ischemic stroke market. Also contributing to the increases in product sales for
2007 and 2006 were price increases in 2005 through 2007.
Pulmozyme
Net
U.S. sales of Pulmozyme increased 12% to $223 million in 2007 and 7% to $199
million in 2006. The sales growth in both 2007 and 2006 reflects price increases
in 2005 through 2007, as well as a focus on earlier, more aggressive treatment
of cystic fibrosis.
Raptiva
Net
U.S. sales of Raptiva increased 19% to $107 million in 2007 and 14% to $90
million in 2006. The majority of growth in 2007 and 2006 was due to price
increases in 2005 through 2007 and more favorable sales allowance in
2007.
Sales
to Collaborators
Product
sales to collaborators, the majority of which were for non-U.S. markets,
increased 92% to $903 million in 2007 and 44% to $471 million in 2006. The
increase in 2007 was primarily due to more favorable Herceptin pricing terms
that were part of the supply agreement with Roche signed in the third quarter of
2006 and increased sales volume of Avastin and Herceptin. The favorable
Roche Herceptin pricing terms will continue through the end of 2008. The
increase in 2006 was primarily due to higher sales of Herceptin, Avastin, and
Rituxan to Roche.
Royalties
Royalty
revenue increased 47% to $1,984 million in 2007 and 45% to $1,354 million in
2006. The increases were due to higher sales by Roche of Herceptin, Avastin, and
Rituxan in 2007 and 2006, and higher sales by various other licensees. The
increase in 2007 was also due to sales of Lucentis by Novartis and an
acceleration of royalties during
2007,
as discussed below. Royalties from other licensees include royalty revenue on
our patents, including our Cabilly patents noted below. Of the overall royalties
recognized, royalty revenue from Roche represented approximately 61% in 2007,
62% in 2006, and 53% in 2005.
In
June 2007, we entered into a transaction with an existing licensee to license
from them the right to co-develop and commercialize certain molecules. In
exchange, we released the licensee from its obligation to make certain royalty
payments to us that would have otherwise been owed between January 2007 and June
2010, and that period may be extended contingent upon certain events as defined
in the agreement. We estimate that the fair value of the royalty revenue owed to
us over the three-and-a-half-year period, less any amount recognized in the
first quarter of 2007, was approximately $65 million, and this amount was
recognized as royalty revenue in the second quarter of 2007. We also recognized
a similar amount as R&D expense for the purchase of the new license, and
thus the net earnings per share (EPS) effect of entering into this new
collaboration was not significant in 2007.
We
have confidential licensing agreements with a number of companies on the Cabilly
patent, under which we receive royalty revenue on sales of products covered by
the patent. The Cabilly patent expires in December 2018, but is the subject of
an ongoing reexamination and likely appeals process, and the MedImmune
litigation. The net pretax contributions related to the Cabilly patent were as
follows (in
millions, except per
share amounts):
|
|
|
|
Royalty
revenue
|
|
$ |
256 |
|
|
|
|
|
|
Gross
expenses(1)
|
|
$ |
123 |
|
|
|
|
|
|
Net
of tax effect of Cabilly patent on diluted EPS
|
|
$ |
0.08 |
|
______________________
(1)
|
Gross
expenses include COH’s share of royalty revenue and royalty COS on our
U.S. product sales.
|
See
also Note 8, “Leases, Commitments and Contingencies,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form 10-K for more
information on our Cabilly patent reexamination and the MedImmune lawsuit
related to the Cabilly patent.
Cash
flows from royalty income include revenue denominated in foreign currencies. We
currently enter into foreign currency option contracts (options) and forwards to
hedge a portion of these foreign currency cash flows. These options and forwards
are due to expire between 2008 and 2009. See also Note 2, “Summary of
Significant Accounting Policies,” and Note 4, “Investment Securities and
Financial Instruments—Derivative Financial Instruments,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form
10-K.
Royalties
are difficult to forecast because of the number of products involved, potential
licensing and intellectual property disputes, and the volatility of foreign
currency exchange rates. For 2008, we expect moderate royalty revenue growth,
but a number of factors could affect these results. Most notably, versus 2007, a
continued weakened dollar could positively affect royalty revenue. However,
royalty revenue growth could be negatively affected if licensees terminate their
licenses or fail to meet their contractual payment obligations as a result of an
adverse decision or ruling in the Cabilly reexamination, the MedImmune lawsuit,
or appeals of these matters.
Contract
Revenue
Contract
revenue increased 2% to $297 million in 2007, and increased 38% to $290 million
in 2006. The increase in 2007 was primarily due to recognition of a $30 million
milestone payment from Novartis for European Union approval of Lucentis for the
treatment of patients with AMD, higher reimbursements from Biogen Idec related
to R&D efforts on Rituxan, and recognition of previously deferred
revenue from an opt-in payment from Roche on Rituxan. Included in contract
revenue in 2007 was $196 million of R&D expense reimbursements which were
received from certain collaborators. The increase in 2006 was primarily due
to higher contract revenue from Roche driven by higher reimbursements related to
R&D development efforts on Avastin and manufacturing plant start-up costs,
and a Herceptin milestone payment. Also contributing to the increase in 2006
were higher reimbursements
from
Biogen Idec related to R&D development efforts on Rituxan (rheumatoid
arthritis and other immunology indications). Included in contract revenue in
2006 was $185 million of R&D expense reimbursements which were received from
certain collaborators. See “Related Party Transactions” below for more
information on contract revenue from Roche.
Contract
revenue varies each quarter and is dependent on a number of factors, including
the timing and level of reimbursements from ongoing development efforts,
milestones and opt-in payments received, and new contract
arrangements.
Cost
of Sales
Cost
of sales (COS) as a percentage of net product sales was 17% in 2007, 15% in
2006, and 18% in 2005. The increase in COS as a percentage of sales in 2007 was
due to the recognition of employee stock-based compensation expense of $71
million, related to products sold for which employee stock-based compensation
expense was previously capitalized as part of inventory costs in 2006, and
higher volume of lower margin sales to collaborators. COS in 2007 included a
non-recurring charge of approximately $53 million, resulting from our decision
to cancel and buy out a future manufacturing obligation. However, COS as a
percentage of product sales was favorably affected by the U.S. product sales mix
(increased sales of our higher margin products, primarily Avastin, Lucentis,
Rituxan, and Herceptin in 2007). For 2007, COS as a percentage of product sales
also benefited from the effects of a price increase on sales of Herceptin to
Roche, which started in the third quarter of 2006. COS in 2006 was favorably
affected by increased sales of our higher margin products, primarily Lucentis,
Avastin, Herceptin, and Rituxan.
We
continually work to configure our supply chain to balance our objectives of
mitigating supply risk while managing our COS. Significant manufacturing
productivity improvements, ongoing changes in our and Roche’s forecasted product
demand requirements, and recent and expected future additions of new capacity to
our manufacturing network require that we constantly evaluate our manufacturing
resources, including optimizing the size of our workforce. In February 2008, we
established a voluntary severance program for select groups of manufacturing
employees. The program provides these employees the opportunity to voluntarily
resign from the Company in exchange for a severance package. Employees will have
until March 2008 to elect whether to participate in the voluntary severance
program. We currently expect to record compensation charges in COS associated
with this program of approximately $20 million in the first quarter of 2008,
although the charges could be higher or lower depending on the number of
employees who elect to participate.
Research
and Development
Research
and development (R&D) expenses increased 38% in 2007 and 40% in 2006 to
$2,446 million and $1,773 million, respectively. R&D expense as a percentage
of total operating revenue was 21% in 2007 and 19% in 2006 and
2005.
The
major components of R&D expenses were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
Development
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Product
development (including post-marketing)
|
|
$ |
1,742 |
|
|
$ |
1,269 |
|
|
$ |
935 |
|
|
|
37
|
% |
|
|
36
|
% |
Research
|
|
|
423 |
|
|
|
326 |
|
|
|
235 |
|
|
|
30 |
|
|
|
39 |
|
In-licensing
|
|
|
281 |
|
|
|
178 |
|
|
|
92 |
|
|
|
58 |
|
|
|
93 |
|
Total
|
|
$ |
2,446 |
|
|
$ |
1,773 |
|
|
$ |
1,262 |
|
|
|
38 |
|
|
|
40 |
|
Product
development: Product development expenses include costs of
conducting clinical trials, activities to support regulatory filings,
and post-marketing expenses, which include Phase IV and
investigator-sponsored trials and product registries. Such costs include costs
of personnel, drug supply costs, research fees charged by
outside
contractors,
co-development costs, and facility expenses, including depreciation. Total
development expenses increased 37% to $1,742 million in 2007 and 36% to $1,269
million in 2006. See “Products in Development” in the Business section of Part
I, Item 1 of this Form 10-K for further information regarding our development
pipeline.
The
increase in 2007 expense was primarily driven by: (i) $353
million higher development expenses due to increased activity across our entire
product portfolio, including increased spending on clinical programs, including
late-stage clinical trials for Avastin, Lucentis, Rituxan used in immunology,
and other programs, early-stage projects and higher clinical manufacturing
expenses in support of our clinical trials; and (ii) a $40 million increase in
post-marketing expense related to studies of Xolair, Lucentis, Rituxan used in
immunology and Herceptin. In addition, development expenses in 2007 included
$126 million of employee stock-based compensation expense related to FAS
123R.
The
increase in 2006 expense was primarily driven by: (i) $184
million higher development expenses due to increased activity across our entire
product portfolio, including increased spending on clinical programs, including
late-stage clinical trials for Avastin, Rituxan used in immunology, humanized
anti-CD20, and other programs, early-stage projects and higher clinical
manufacturing expenses in support of our clinical trials; and (ii) a $37 million
increase in post-marketing expense related to studies of Avastin, Lucentis,
Rituxan used in immunology and Xolair. In addition, development expenses in 2006
included $113 million of employee stock-based compensation expense related to
FAS 123R.
Research: Research
includes expenses associated with research and testing of our product candidates
prior to reaching the development stage. Such expenses primarily include the
costs of internal personnel, outside contractors, facilities, including
depreciation, and lab supplies. Personnel costs primarily include salary,
benefits, recruiting and relocation costs. Research expenses increased 30% to
$423 million in 2007 and 39% to $326 million in 2006. The
primary driver of the increase in both years was an increase in internal
personnel and related expenses, and outside contractors for research and testing
of product candidates. In addition, research expenses in 2007 and 2006 included
$27 million of employee stock-based compensation expense related to FAS
123R.
In-licensing: In-licensing
includes costs incurred to acquire licenses to develop and commercialize various
technologies and molecules. In-licensing expenses increased 58% to $281
million in 2007 and 93% to $178 million in 2006. The increase in 2007 related to
new in-licensing collaborations with (i) Abbott Laboratories for the global
research, development, and commercialization of two of Abbott’s investigational
anti-cancer, small molecule compounds: ABT-263 and ABT-869, (ii) Seattle
Genetics, Inc. for the development and commercialization of a humanized
monoclonal antibody currently in Phase I clinical trials for multiple myeloma,
chronic lymphocytic leukemia, and NHL, and a Phase II clinical trial for diffuse
large B-cell lymphoma, (iii) BioInvent to co-develop and commercialize a
monoclonal antibody currently in Phase I for the potential treatment of
cardiovascular disease, and (iv) Altus relating to a subcutaneously
administered, once-per-week formulation of human growth hormone. The
collaboration with Altus was subsequently terminated in 2007.
The
increase in 2006 primarily related to new in-licensing collaborations with
(i) Exelixis to co-develop a small-molecule inhibitor of methyl ethyl keyton
(MEK), (ii) AC Immune to research and develop anti-beta-amyloid antibodies for
the potential treatment of Alzheimer’s and other diseases, (iii) Inotek
Pharmaceuticals Corporation related to certain inhibitors of poly (ADP-ribose)
polymerase (PARP) for the potential treatment of cancer (we provided notice to
terminate this agreement in October 2007, effective in April 2008), and (iv) CGI
Pharmaceuticals to research, develop, manufacture, and commercialize
therapeutics for the potential treatment of cancer and immunological
disorders.
For
2008, we expect R&D absolute dollar spending to increase over 2007 levels as
we continue to invest in our late-stage pipeline and add new molecules and
indications to the early-stage pipeline.
Marketing,
General and Administrative
Overall
marketing, general and administrative (MG&A) expenses increased 12% to
$2,256 million in
2007 and 40% to $2,014 million in 2006.
MG&A as a percentage of total operating revenue was 19% in 2007 and 22% in
2006 and 2005. The decline in this ratio primarily reflects the increase in
operating revenue.
The
increase in 2007 expense was primarily due to: (i) an increase of $91
million in royalty expense, primarily to Biogen Idec resulting from higher Roche
sales of Rituxan, (ii) a $64 million increase resulting from ongoing marketing
efforts with established products, primarily Herceptin, and newly launched
products, including Rituxan for rheumatoid arthritis and Lucentis, (iii) an
increase of $47 million in charitable contributions related to increased
donations to independent public charities that provide co-pay assistance to
eligible patients, (iv) an increase of $11 million related to post-acquisition
costs for Tanox, Inc., and (v) an increase of $11 million related to property
and equipment write-offs. In addition, MG&A expenses in 2007 included $179
million of employee stock-based compensation expense related to FAS
123R.
The
increase in 2006 expense was primarily due to: (i) an increase of $149 million
in marketing and sales spending primarily in support of launch activities
related to Lucentis for AMD and Rituxan for rheumatoid arthritis, (ii) an
increase of $84 million in marketing and sales spending on Avastin, primarily in
support of launch activities for NSCLC, a recently approved indication, and
pre-launch activities for BC, (iii) a $47 million increase resulting from
ongoing marketing efforts with established products, primarily Herceptin,
partially offset by a $40 million decrease in Raptiva marketing costs, (iv) an
increase of $131 million in support of our continued corporate growth including
headcount growth and headcount related expenses, charitable donations, of which
$26 million related to increased donations to independent public charities that
provide co-pay assistance to eligible patients, and legal costs, and (v) an
increase of $39 million in royalty expense, primarily to Biogen Idec resulting
from higher Roche sales of Rituxan. In addition, MG&A expenses in 2006
included $169 million of employee stock-based compensation expense related to
FAS 123R.
For
2008, we expect MG&A expense to remain relatively flat compared to 2007
levels as we continue to manage our infrastructure costs.
Collaboration
Profit Sharing
Collaboration
profit sharing expenses increased 7% to $1,080 million in 2007 and 22% to $1,005
million in 2006 due to higher sales of Rituxan, Tarceva and higher U.S. sales of
Xolair and the related profit sharing expenses, partially offset by a decrease
in profit sharing expense related to Xolair operations outside of the
U.S.
The
following table summarizes the amounts resulting from the respective profit
sharing collaborations, for the periods presented (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
U.S.
Rituxan profit sharing expense
|
|
$ |
730 |
|
|
$ |
672 |
|
|
$ |
603 |
|
|
|
9
|
% |
|
|
11
|
% |
U.S.
Tarceva profit sharing expense
|
|
|
165 |
|
|
|
146 |
|
|
|
83 |
|
|
|
13 |
|
|
|
76 |
|
Total
Xolair profit sharing expense
|
|
|
185 |
|
|
|
187 |
|
|
|
137 |
|
|
|
(1 |
) |
|
|
36 |
|
Total
collaboration profit sharing expense
|
|
$ |
1,080 |
|
|
$ |
1,005 |
|
|
$ |
823 |
|
|
|
7 |
|
|
|
22 |
|
Currently,
our most significant collaboration profit sharing agreement is with Biogen Idec,
with whom we co-promote Rituxan in the U.S. Under the collaboration agreement,
Biogen Idec granted us a worldwide license to develop, commercialize, and market
Rituxan in multiple indications. In exchange for these worldwide rights, Biogen
Idec has co-promotion rights in the U.S. and a contractual arrangement under
which we share a portion of the pretax U.S. co-promotion profits of Rituxan and
we pay royalty expense based on sales of Rituxan by collaborators. In
June
2003,
we amended and restated the collaboration agreement with Biogen Idec to include
the development and commercialization of one or more anti-CD20 antibodies
targeting B-cell disorders, in addition to Rituxan, for a broad range of
indications.
Under
the amended and restated collaboration agreement, our share of the current
pretax U.S. co-promotion profit sharing formula is approximately 60% of
operating profits, and Biogen Idec’s share is approximately 40% of operating
profits. For each calendar year or portion thereof following the approval date
of the first new anti-CD20 product, after a period of transition, our share of
the pretax U.S. co-promotion profits will change to approximately 70% of
operating profits, and Biogen Idec’s share will be approximately 30% of
operating profits.
Collaboration
profit sharing expense, exclusive of R&D expenses, related to Biogen Idec
for the years ended December 31, 2007, 2006, and 2005, consisted of the
following commercial activity (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Product
sales, net
|
|
$ |
2,285 |
|
|
$ |
2,071 |
|
|
$ |
1,832 |
|
|
|
10
|
% |
|
|
13
|
% |
Combined
commercial costs and expenses
|
|
|
552 |
|
|
|
489 |
|
|
|
390 |
|
|
|
13 |
|
|
|
25 |
|
Combined
co-promotion profits
|
|
$ |
1,733 |
|
|
$ |
1,582 |
|
|
$ |
1,442 |
|
|
|
10 |
|
|
|
10 |
|
Amount
due to Biogen Idec for their share of co-promotion profits–included in
collaboration profit sharing expense
|
|
$ |
730 |
|
|
$ |
672 |
|
|
$ |
603 |
|
|
|
9 |
|
|
|
11 |
|
In
addition to Biogen Idec’s share of the combined co-promotion profits for
Rituxan, collaboration profit sharing expense includes the quarterly
settlement of Biogen Idec’s portion of the combined commercial costs. Since we
and Biogen Idec each individually incur commercial costs related to Rituxan, and
the spending mix between the parties can vary, collaboration profit sharing
expense as a percentage of sales can also vary accordingly.
Total
revenue and expenses related to our collaboration with Biogen Idec included the
following (in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Contract
revenue
|
|
$ |
108 |
|
|
$ |
79 |
|
|
$ |
59 |
|
|
|
37
|
% |
|
|
34
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promotion
profit sharing expense
|
|
$ |
730 |
|
|
$ |
672 |
|
|
$ |
603 |
|
|
|
9 |
|
|
|
11 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty
expense on ex-U.S. sales of Rituxan and other patent costs–included in
MG&A expense
|
|
$ |
247 |
|
|
$ |
175 |
|
|
$ |
139 |
|
|
|
41 |
|
|
|
26 |
|
Contract
revenue from Biogen Idec primarily reflects the net reimbursement to us for
development and post-marketing costs we incurred on joint development projects
less amounts owed to Biogen Idec on their development efforts on these
projects.
Write-off
of In-process Research and Development Related to Acquisition
In
connection with the acquisition of Tanox in the third quarter of 2007, we
recorded a $77 million charge for in-process research and development. This
charge primarily represents acquired R&D for label extensions for Xolair
that have not yet been approved by the FDA and require significant further
development. We expect to continue further developing these label extensions
until a decision is made to file for a label extension or to discontinue
development efforts. We expect these development efforts to be completed from
2009 to 2013, if not abandoned sooner.
Gain
on Acquisition
The
acquisition of Tanox is considered to include the settlement of our 1996 license
arrangement of certain intellectual property and rights thereon from
Tanox. Under EITF 04-1, a business combination between parties with a
preexisting relationship should be evaluated to determine if a settlement of
that preexisting relationship exists. We measured the amount that the license
arrangement is favorable, from our perspective, by comparing it to estimated
pricing for current market transactions for intellectual property
rights similar to Tanox’s intellectual property rights related to Xolair.
In connection with the settlement of this license arrangement, we recorded a
gain of $121 million on a pretax basis, in accordance with EITF
04-1.
Recurring
Charges Related to Redemption and Acquisition
On
June 30, 1999, RHI exercised its option to cause us to redeem all of our Special
Common Stock held by stockholders other than RHI. The Redemption was reflected
as the purchase of a business, which under GAAP required push-down accounting to
reflect in our financial statements the amounts paid for our stock in excess of
our net book value (see Note 1, “Description of Business—Redemption of Our
Special Common Stock,” in the Notes to Consolidated Financial Statements in Part
II, Item 8 of this Form 10-K).
On
August 2, 2007, we acquired Tanox. In connection with the acquisition, we
recorded approximately $814 million of intangible assets, representing developed
product technology and core technology, which are being amortized over 12
years.
We
recorded recurring charges related to the amortization of intangibles associated
with the Redemption and push-down accounting and our acquisition of Tanox in the
third quarter of 2007. These charges were $132 million in 2007, $105 million in
2006, and $123 million in 2005.
Special
Items: Litigation-Related
We
recorded accrued interest and bond costs related to the COH trial judgment of
$54 million in 2007, 2006, and 2005. The California Supreme Court heard our
appeal on this matter on February 5, 2008
and we expect a ruling within 90 days of the hearing date. Therefore, we expect
that we will continue to incur interest charges on the judgment and service fees
on the surety bond up to the second quarter of 2008. The amount of cash paid, if
any, or the timing of such payment in connection with the COH matter will depend
on the outcome of the California Supreme Court’s decision. See Note 8, “Leases,
Commitments and Contingencies,” in the Notes to Consolidated Financial
Statements in Part II, Item 8 of this Form 10-K for further information
regarding our litigation. Also included in this line in 2005 is a charge related
to a litigation settlement, net of amounts received on a separate litigation
settlement.
Operating
Income
Operating
income increased 34% to $4,229 million in 2007 and increased 64% to $3,152
million in 2006. Our operating income as a percentage of operating revenue
(pretax operating margin) was 36% in 2007, 34% in 2006, and 29% in
2005.
Other
Income (Expense)
The
components of “Other income (expense)” are as follows (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007/2006 |
|
|
|
2006/2005 |
|
Gains
on sales of biotechnology equity securities, net
|
|
$ |
22 |
|
|
$ |
93 |
|
|
$ |
9 |
|
|
|
(76 |
)
% |
|
|
933
|
% |
Write-down
of biotechnology debt and equity securities
|
|
|
(20 |
) |
|
|
(4 |
) |
|
|
(10 |
) |
|
|
400 |
|
|
|
(60 |
) |
Interest
income
|
|
|
270 |
|
|
|
230 |
|
|
|
143 |
|
|
|
17 |
|
|
|
61 |
|
Interest
expense
|
|
|
(76 |
) |
|
|
(74 |
) |
|
|
(50 |
) |
|
|
3 |
|
|
|
48 |
|
Other
miscellaneous income
|
|
|
1 |
|
|
|
6 |
|
|
|
– |
|
|
|
(83 |
) |
|
|
– |
|
Total
other income, net
|
|
$ |
197 |
|
|
$ |
251 |
|
|
$ |
92 |
|
|
|
(22 |
) |
|
|
173 |
|
Other
income, net, decreased 22% to $197 million in 2007, and increased 173% to $251
million in 2006. Gains on sales of biotechnology equity securities, net were
lower in 2007 compared to 2006 due to the timing of certain acquisitions in 2006
which resulted in approximately $79 million in gains on sales related to Amgen’s
acquisition of Abgenix, Pfizer’s acquisition of Rinat, Stiefel Laboratories’
acquisition of Connetics Corporation, and Astra Zeneca’s acquisition of
Cambridge Antibody Technology. For 2007, there were no equivalent gains driven
by acquisition. Investment income in 2007 was higher due to higher average cash
balances, partially offset by lower yields and a $30 million write-down of a
fixed-income investment. In 2006, investment income was higher due to higher
average balances and higher yields. Interest expense in 2007 increased slightly
due to higher average debt levels compared to 2006. Interest expense increased
in 2006 due to new full-year debt service costs.
Income
Tax Provision
The
effective income tax rate was 37% in 2007, 38% in 2006, and 36% in 2005. The
effective tax rate in 2007 was lower than in 2006, primarily due to the increase
in the domestic manufacturing deduction. The effective tax rate in 2006 was
higher than 2005 primarily due to new Final Regulations issued by the U.S.
Department of Treasury, which required a $34 million reduction in research
credits claimed in prior years. The increase in the 2006 effective income tax
rate also resulted from higher income before taxes in 2006.
We
adopted the provisions of FIN 48 on January 1, 2007. Implementation of FIN 48
did not result in any adjustment to our Consolidated Statements of Income or a
cumulative adjustment to retained earnings (accumulated deficit). As a result of
the implementation of FIN 48, we reclassified $147 million of unrecognized tax
benefits from current liabilities to long-term liabilities as of January 1,
2007, and we also reclassified the balance as of December 31, 2006, for
consistency, in the accompanying Consolidated Balance Sheets, none of which
would have been considered due in 2007 in the presentation of our Contractual
Obligations table in our Annual Report on Form 10-K for the year ended December
31, 2006.
In
2008, we expect our annual effective income tax rate to be similar to our 2007
effective income tax rate. Various internal and external factors may have
favorable or unfavorable effects on our future effective income tax rate. These
factors include, but are not limited to, changes in tax laws, regulations and/or
rates, the results of any tax examinations, changing interpretations of existing
tax laws or regulations, changes in estimates to prior years’ items, past and
future levels of R&D spending, acquisitions, changes in our corporate
structure, and changes in overall levels of income before taxes; all of which
may result in periodic revisions to our effective income tax
rate.
Relationship
with Roche
As
a result of the June 1999 redemption of our Special Common Stock (Redemption)
and subsequent public offerings, we amended our certificate of incorporation and
bylaws, amended our licensing and marketing agreement with Roche Holding AG and
affiliates (Roche), and entered into or amended certain agreements with RHI,
which are discussed below.
Affiliation
Arrangements
Our
Board of Directors consists of three RHI directors, three independent directors
nominated by a nominating committee currently controlled by RHI, and one
Genentech employee. However, under our bylaws, RHI has the right to obtain
proportional representation on our Board at any time.
Except
as follows, the affiliation arrangements do not limit RHI’s ability to buy or
sell our Common Stock. If RHI and its affiliates sell their majority ownership
of shares of our Common Stock to a successor, RHI has agreed that it will cause
the successor to agree to purchase all shares of our Common Stock not held by
RHI as follows:
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with
consideration, if that consideration is composed entirely of either cash
or equity traded on a U.S. national securities exchange, in the same form
and amounts per share as received by RHI and its affiliates;
and
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Ÿ
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in
all other cases, with consideration that has a value per share not less
than the weighted-average value per share received by RHI and its
affiliates as determined by a nationally recognized investment
bank.
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If
RHI owns more than 90% of our Common Stock for more than two months, RHI has
agreed that it will, as soon as reasonably practicable, effect a merger of
Genentech with RHI or an affiliate of RHI.
RHI
has agreed, as a condition to any merger of Genentech with RHI or the sale of
our assets to RHI, that either:
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the
merger or sale must be authorized by the favorable vote of a majority of
non-RHI stockholders, provided no person will be entitled to cast more
than 5% of the votes at the meeting;
or
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Ÿ
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in
the event such a favorable vote is not obtained, the value of the
consideration to be received by non-RHI stockholders would be equal to or
greater than the average of the means of the ranges of fair values for the
Common Stock as determined by two nationally recognized investment
banks.
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We
have agreed not to approve, without the prior approval of the directors
designated by RHI:
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any
acquisition, sale, or other disposal of all or a portion of our business
representing 10% or more of our assets, net income, or
revenue;
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any
issuance of capital stock except under certain circumstances;
or
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any
repurchase or redemption of our capital stock other than a redemption
required by the terms of any security and purchases made at fair market
value in connection with any deferred compensation
plans.
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Licensing
Agreements
We
have a July 1999 amended and restated licensing and marketing agreement with
Roche and its affiliates granting an option to license, use and sell our
products in non-U.S. markets. The major provisions of that agreement include the
following:
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Roche’s
option expires in 2015;
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Roche
may exercise its option to license our products upon the occurrence of any
of the following: (1) upon the filing of an Investigational New
Drug Application (IND) for a product, (2) completion of the first Phase II
trial for a product or (3) completion of a Phase III trial for that
product, if Roche previously paid us a fee of $10 million to extend
its option on a product;
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If
Roche exercises its option to license a product, it has agreed to
reimburse Genentech for development costs as follows: (1) If
exercise occurs upon the filing of an IND, Roche will pay 50% of
development costs incurred prior to the filing and 50% of development
costs subsequently incurred; (2) If exercise occurs at the completion
of the first Phase II trial, Roche will pay 50% of development costs
incurred through completion of the trial, 75% of development costs
subsequently incurred for the initial indication, and 50% of subsequent
development costs for new indications, formulations or dosing schedules;
(3) If the exercise occurs at the completion of a Phase III trial,
Roche will pay 50% of development costs incurred through completion of
Phase II, 75% of development costs incurred through completion of Phase
III, and 75% of development costs subsequently incurred; and $5 million of
the option extension fee paid by Roche to preserve its right to exercise
its option at the completion of a Phase III trial will be credited against
the total development costs payable to Genentech upon the exercise of the
option; and (4) Each of Genentech and Roche have the right to “opt-out” of
developing an additional indication for a product for which Roche
exercised its option, and would not share the costs or benefits of the
additional indication, but could “opt-back-in” within 30 days of decision
to file for approval of the indication by paying twice what they would
have owed for development of the indication if they had not opted
out;
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We
agreed, in general, to manufacture for and supply to Roche its clinical
requirements of our products at cost, and its commercial requirements at
cost plus a margin of 20%; however, Roche will have the right to
manufacture our products under certain
circumstances;
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Roche
has agreed to pay, for each product for which Roche exercises its option
upon the filing of an IND or completion of the first Phase II trial, a
royalty of 12.5% on the first $100 million on its aggregate sales of that
product and thereafter a royalty of 15% on its aggregate sales of that
product in excess of $100 million until the later in each country of the
expiration of our last relevant patent or 25 years from the first
commercial introduction of that
product;
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Roche
will pay, for each product for which Roche exercises its option after
completion of a Phase III trial, a royalty of 15% on its sales of that
product until the later in each country of the expiration of our last
relevant patent or 25 years from the first commercial introduction of that
product; however, $5 million of any option extension fee paid by Roche
will be credited against royalties payable to us in the first calendar
year of sales by Roche in which aggregate sales of that product exceed
$100 million; and
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For
certain products for which Genentech is paying a royalty to
Biogen Idec, including Rituxan, Roche shall pay Genentech a royalty
of 20% on sales of such product. Once Genentech is no longer obligated to
pay a royalty to Biogen Idec on sales of such products, Roche shall
then pay Genentech a royalty on sales of 10% on the first $75 million on
its aggregate sales of that product and thereafter a royalty of 8% on its
aggregate sales of that product in excess of $75 million until the later
in each country of the expiration of our last relevant patent or 25 years
from the first commercial introduction of that
product.
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We
have further amended this licensing and marketing agreement with Roche to delete
or add certain Genentech products under Roche’s commercialization and marketing
rights for Canada.
We
also have a July 1998 licensing and marketing agreement related to anti-HER2
antibodies (including Herceptin and pertuzumab) with Roche, providing them with
exclusive marketing rights outside of the U.S. Under the agreement, Roche funds
one-half the global development costs incurred in connection with developing
anti-HER2 antibody products under the agreement. Either Genentech or Roche has
the right to “opt-out” of developing an additional indication for a product and
would not share the costs or benefits of the additional indication, but could
“opt-back-in” within 30 days of decision to file for approval of the indication
by paying twice what would have been owed for development of the indication if
no opt-out had occurred. Roche has also agreed to make royalty payments of 20%
on aggregate net product sales outside the U.S. up to $500 million in each
calendar year and 22.5% on such sales in excess of $500 million in each calendar
year. In December 2007, Roche opted-in to our trastuzumab drug conjugate
products under terms similar to those of the existing anti-HER2
agreement.
Research
Collaboration Agreement
We
have an April 2004 research collaboration agreement with Roche that outlines the
process by which Roche and Genentech may agree to conduct and share in the costs
of joint research on certain molecules. The agreement further outlines how
development and commercialization efforts will be coordinated with respect to
select molecules, including the financial provisions for a number of different
development and commercialization scenarios undertaken by either or both
parties.
Tax
Sharing Agreement
We
have a tax sharing agreement with RHI. If we and RHI elect to file a combined
state and local tax return in certain states where we may be eligible, our tax
liability or refund with RHI for such jurisdictions will be calculated on a
stand-alone basis.
Roche Holdings, Inc.’s Ability to
Maintain Percentage Ownership Interest in Our Stock
We
issue shares of Common Stock in connection with our stock option and stock
purchase plans, and we may issue additional shares for other purposes. Our
affiliation agreement with RHI provides, among other things, that with respect
to any issuance of our Common Stock in the future, we will repurchase a
sufficient number of shares so that immediately after such issuance, the
percentage of our Common Stock owned by RHI will be no lower than 2% below the
“Minimum Percentage” (subject to certain conditions). The Minimum Percentage
equals the lowest number of shares of Genentech Common Stock owned by RHI since
the July 1999 offering (to be adjusted in the future for dispositions of shares
of Genentech Common Stock by RHI as well as for stock splits or stock
combinations) divided by 1,018,388,704 (to be adjusted in the future for stock
splits or stock combinations), which is the number of shares of Genentech Common
Stock outstanding at the time of the July 1999 offering, as adjusted for stock
splits. We have repurchased shares of our Common Stock since 2001 (see
discussion below in “Liquidity and Capital Resources”). The affiliation
agreement also provides that, upon RHI’s request, we will repurchase shares of
our Common Stock to increase RHI’s ownership to the Minimum Percentage. In
addition, RHI will have a continuing option to buy stock from us at prevailing
market prices to maintain its percentage ownership interest. Under the terms of
the affiliation agreement, RHI’s Minimum Percentage is 57.7% and RHI’s ownership
percentage is to be no lower than 55.7%. At December 31, 2007, RHI’s ownership
percentage was 55.8%.
Related
Party Transactions
We
enter into transactions with our related parties, Roche and Novartis. The
accounting policies that we apply to our transactions with our related parties
are consistent with those applied in transactions with independent third
parties, and all related party agreements are negotiated on an arm’s-length
basis.
In
our royalty and supply arrangements with related parties, we are the principal,
as defined under EITF Issue No. 99-19, “Reporting Revenue Gross as a
Principal versus Net as an Agent” (EITF 99-19), because we
bear the manufacturing risk, general inventory risk, and the risk to defend our
intellectual property. For circumstances in which we are the principal in the
transaction, we record the transaction on a gross basis in accordance with EITF
99-19. Otherwise our transactions are recorded on a net basis.
Roche
We
signed two new product supply agreements with Roche in July 2006, each of which
was amended in November 2007. The Umbrella Manufacturing Supply Agreement
(Umbrella Agreement) supersedes our existing product supply agreements with
Roche. The Short-Term Supply Agreement (Short-Term Agreement) supplements the
terms of the Umbrella Agreement. Under the Short-Term Agreement, Roche has
agreed to purchase specified amounts of Herceptin, Avastin and Rituxan through
2008. Under the Umbrella Agreement, Roche has agreed to purchase specified
amounts of Herceptin and Avastin through 2012 and, on a perpetual basis, either
party may order other collaboration products from the other party, including
Herceptin and Avastin after 2012, pursuant to certain forecast terms. The
Umbrella Agreement also provides that either party may terminate its obligation
to purchase and/or supply Avastin and/or Herceptin with six years notice on or
after December 31, 2007. To date, we have not received such notice of
termination from Roche.
In
December 2007, Roche opted-in to our trastuzumab drug conjugate products under
terms similar to those of the existing anti-HER2 agreement. As part of the
opt-in, Roche paid us $113 million and will pay 50% of subsequent development
costs related to the trastuzumab drug conjugate products. We recognized the
payment received from Roche as deferred revenue, which will be recognized over
the expected development period.
We
currently have no active profit sharing arrangements with Roche.
Under
our existing arrangements with Roche, including our licensing and marketing
agreement, we recognized the following amounts (in millions):
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|
|
|
|
|
|
|
|
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Product
sales to Roche
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|
$ |
768 |
|
|
$ |
359 |
|
|
$ |
177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Roche
|
|
$ |
1,206 |
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|
$ |
846 |
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$ |
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Roche
|
|
$ |
95 |
|
|
$ |
125 |
|
|
$ |
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Roche
|
|
$ |
422 |
|
|
$ |
268 |
|
|
$ |
154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with Roche
|
|
$ |
259 |
|
|
$ |
213 |
|
|
$ |
144 |
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Certain
R&D expenses are partially reimbursable to us by Roche. In addition, R&D
expenses may include the net settlement of amounts that we owed to Roche for
R&D expenses that Roche incurred on joint development projects, less amounts
reimbursable to us by Roche on these projects.
Novartis
Based
on information available to us at the time of filing this Form 10-K, we believe
that the Novartis Group holds approximately 33.3% of the outstanding voting
shares of Roche. As a result of this ownership, the Novartis Group is deemed to
have an indirect beneficial ownership interest under FAS 57, “Related Party Disclosures,”
of more than 10% of our voting stock.
We
have an agreement with Novartis Pharma AG (a wholly-owned subsidiary of Novartis
AG) under which Novartis Pharma AG has the exclusive right to develop and market
Lucentis outside of the U.S. for indications related to diseases or disorders of
the eye. As part of this agreement, the parties share the cost of certain of our
ongoing development expenses for Lucentis.
We,
along with Novartis, are co-developing and are co-promoting Xolair in the U.S.
We record all sales, COS, and marketing and sales expenses in the U.S., and
Novartis markets the product in and records all sales, COS,
and
marketing
and sales expenses in Europe. We and Novartis share the resulting U.S. and
European operating profits according to prescribed profit sharing percentages,
and our U.S. and European profit sharing expenses are recorded as collaboration
profit sharing expense. Effective with our acquisition of Tanox on August 2,
2007, Novartis also makes additional profit sharing payments to us on U.S. sales
of Xolair, royalty payments to us on sales of Xolair worldwide, and pays us a
manufacturing fee related to Xolair. See Note 10, “Acquisition of Tanox, Inc.,”
in Part II, Item 8 of this Form 10-K for more information on the
acquisition.
Under
our existing arrangements with Novartis, we recognized the following amounts
(in
millions):
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|
|
|
|
|
|
|
|
Product
sales to Novartis
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|
$ |
10 |
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|
$ |
5 |
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|
$ |
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Novartis
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|
$ |
95 |
|
|
$ |
3 |
|
|
$ |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Contract
revenue from Novartis
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|
$ |
70 |
|
|
$ |
40 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Novartis
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|
$ |
10 |
|
|
$ |
4 |
|
|
$ |
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with
Novartis
|
|
$ |
43 |
|
|
$ |
38 |
|
|
$ |
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
profit sharing expense to Novartis
|
|
$ |
185 |
|
|
$ |
187 |
|
|
$ |
136 |
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Contract
revenue in 2007 included a $30 million milestone payment from Novartis for
European Union approval of Lucentis for the treatment of AMD.
Certain
R&D expenses are partially reimbursable to us by Novartis. In addition,
R&D expenses may include the net settlement of amounts that we owed to
Novartis for R&D expenses that Novartis incurred on joint development
projects, less amounts reimbursable to us by Novartis on these
projects.
See
Note 10, “Acquisition of Tanox, Inc.,” in Part II, Item 8 of this Form 10-K for
information on Novartis’ share of the proceeds resulting from our acquisition of
Tanox.
Liquidity
and Capital Resources
Liquidity and Capital
Resources
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|
|
|
|
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|
December
31:
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|
(in
millions)
|
|
Unrestricted
cash, cash equivalents, short-term investments and long-term marketable
debt and equity securities
|
|
$ |
6,065 |
|
|
$ |
4,325 |
|
|
$ |
3,814 |
|
Net
receivable—equity hedge instruments
|
|
|
24 |
|
|
|
50 |
|
|
|
73 |
|
Total
unrestricted cash, cash equivalents, short-term investments, long-term
marketable debt and equity securities, and equity hedge
instruments
|
|
$ |
6,089 |
|
|
$ |
4,375 |
|
|
$ |
3,887 |
|
Working
capital
|
|
$ |
4,835 |
|
|
$ |
3,547 |
|
|
$ |
2,726 |
|
Current
ratio
|
|
2.2:1
|
|
|
2.6:1
|
|
|
2.6:1
|
|
Year
ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
activities
|
|
$ |
3,230 |
|
|
$ |
2,138 |
|
|
$ |
2,363 |
|
Investing
activities
|
|
|
(1,865 |
) |
|
|
(1,681 |
) |
|
|
(1,776 |
) |
Financing
activities
|
|
|
(101 |
) |
|
|
(432 |
) |
|
|
368 |
|
Capital
expenditures (included in investing activities above)
|
|
|
(977 |
) |
|
|
(1,214 |
) |
|
|
(1,400 |
) |
Total
unrestricted cash, cash equivalents, short-term investments and long-term
marketable securities, including the estimated fair value of the related equity
hedge instruments, were approximately $6.1 billion at December 31, 2007, an
increase of approximately $1.7 billion, or 39%, from December 31, 2006. This
increase primarily reflects cash
generated
from operations, issuance of commercial paper, and increases from stock option
exercises; partially offset by cash used for the repurchase of our Common Stock,
capital expenditures, and Tanox acquisition-related expenditures. To mitigate
the risk of market value fluctuations, certain of our biotechnology equity
securities are hedged with zero-cost collars and forward contracts, which are
carried at estimated fair value. See Note 2, “Summary of Significant Accounting
Policies—Comprehensive Income,” in the Notes to the Consolidated Financial
Statements in Part II, Item 8 of this Form 10-K for further information
regarding activity in our marketable investment portfolio and derivative
instruments.
See
“Our affiliation agreement with Roche Holding, Inc. could limit our ability to
make acquisitions or divestitures” and “To pay our indebtedness will require a
significant amount of cash and may adversely affect our operations and financial
results,” in Part I, Item 1A “Risk Factors” and Note 8, “Leases, Commitments and
Contingencies,” in the Notes to Consolidated Financial Statements in Part II,
Item 8 of this Form 10-K for factors that could negatively affect our cash
position.
Cash
Provided by Operating Activities
Cash
provided by operating activities is primarily driven by increases in our net
income. However, operating cash flows differ from net income as a result of
non-cash charges or differences in the timing of cash flows and earnings
recognition. Significant components of cash provided by operating activities are
as follows:
Accounts
payable, other accrued liabilities, and other long-term liabilities increased
$623 million in 2007 mainly due to the timing of payments and an increase in
accrued clinical expenses, accrued royalties, accrued compensation, taxes
payable, and other accrued liabilities related to growth in the
business.
Investments
in trading securities increased $360 million in 2007 mainly due to a transfer of
$300 million from available-for-sale securities to increase our investments in
certain strategic asset classes; there was an offsetting decrease in our
available-for-sale securities such that the net cash effect to us overall was
neutral. Investments in trading securities increased $29 million in 2006 due to
regular trading activity.
Cash
used for inventories increased $310 million in 2007. The increase was primarily
due to bulk production of our Avastin and Herceptin products. We expect that our
inventory levels will continue to increase in 2008 in support of our sales
growth.
Receivables
and other assets decreased $38 million in 2007. Accounts receivable—product
sales decreased $118 million primarily due to the reduction in the Lucentis
program payment terms from 120 days to 90 days, partially offset by increased
overall product sales. The average collection period of our accounts
receivable—product sales as measured in days sales outstanding (DSO) was 33 days
as of December 31, 2007, 46 days as of December 31, 2006, and 37 days as of
December 31, 2005. The increase in DSO in 2006 over 2005 and the subsequent
decrease in 2007 over 2006 was primarily due to the extended payment terms that
we offered to certain wholesalers in conjunction with the launch of Lucentis on
June 30, 2006, and that we continue to offer, although the extended payment
terms were reduced in 2007. The decrease was partially offset by an increase in
Roche royalty accounts receivable of $108 million due to increased Roche
revenue, and an increase in non-Roche royalty accounts receivable of $57 million
due primarily to increased sales estimates of Synagis®, Lucentis and
Humira®.
Cash
Used in Investing Activities
Cash
used in investing activities was primarily due to capital expenditures, a
business acquisition and purchases, sales and maturities of investments, some of
which were reinvested into our portfolio of trading securities as noted above in
“Cash Provided by Operating Activities.” Capital expenditures were $1.0 billion
during 2007, compared to $1.2 billion during 2006, and $1.4 billion during 2005.
During 2007, capital expenditures were related to ongoing construction of our
second manufacturing facility in Vacaville, California; leasehold improvements
for newly constructed buildings on our South San Francisco, California campus;
construction of our fill/finish facility in Hillsboro, Oregon; and purchases of
equipment and information systems. In addition, we acquired Tanox, Inc. during
the third quarter of 2007, for $833 million, net, which represents the $925
million, plus $8 million in transaction
costs,
less approximately $100 million of Tanox’s cash and cash equivalents that we
acquired. Capital expenditures in 2006 included ongoing construction for the
Vacaville facility; validation costs at our manufacturing facility in Oceanside,
California; the purchase of a second facility in Oceanside; the purchase of
equipment and information systems; and ongoing expenditures to support our
corporate infrastructure needs. Capital expenditures in 2005 included the
purchase of the Oceanside plant for $408 million in cash plus $9 million in
closing costs; ongoing construction of our second manufacturing facility in
Vacaville; $160 million repayment of our synthetic lease obligation on a
research facility in South San Francisco; the purchase of land, equipment, and
information systems; and ongoing construction costs in support of our
manufacturing and corporate infrastructure needs.
Total
cash and investments pledged to secure the COH surety bond were $788 million at
December 31, 2007 and 2006 and $735 million at December 31, 2005, and were
reflected in the Consolidated Balance Sheets in “restricted cash and
investments”. See “Contingencies” in Note 8, “Leases, Commitments and
Contingencies” in the Notes to Consolidated Financial Statements in Part II,
Item 8 of this Form 10-K for further information regarding the COH litigation
and related surety bond.
We
anticipate that the amount of our 2008 capital expenditures will be similar to
the amount of our 2007 capital expenditures.
Cash
Used in or Provided by Financing Activities
Cash
used in or provided by financing activities includes activity under our stock
repurchase program and our employee stock plans. We used cash for stock
repurchases of approximately $1.05 billion in 2007, $1.0 billion during
2006, and $2.02 billion during 2005 pursuant to our stock repurchase program
approved by our Board of Directors. We also received $452 million during
2007, $385 million during 2006, and $821 million during 2005, related to stock
option exercises and stock issuances under our employee stock purchase
plan.
Also
in October 2007, we issued $600 million in unsecured commercial paper notes
payable for funding general corporate purposes. These notes are not redeemable
prior to maturity or subject to voluntary prepayment, and were issued on a
discount basis. The maturities under the program generally vary from overnight
to five weeks and cannot exceed 397 days.
In
July 2005, we received proceeds of $2.0 billion from our long-term debt
issuance, and we used a portion of those proceeds in the third quarter of 2005
to extinguish our remaining $425 million total lease obligation with respect to
our Vacaville, California manufacturing facility.
Under
a stock repurchase program approved by our Board of Directors in December 2003
and most recently extended in April 2007, we are authorized to repurchase up to
100 million shares of our Common Stock for an aggregate price of up to $8.0
billion through June 30, 2008. In this program, as in previous stock repurchase
programs, purchases may be made in the open market or in privately negotiated
transactions from time to time at management’s discretion. We also may engage in
transactions in other Genentech securities in conjunction with the repurchase
program, including certain derivative securities, although as of December 31,
2007, we have not engaged in any such transactions. We intend to use the
repurchased stock to offset dilution caused by the issuance of shares in
connection with our employee stock plans. Although there are currently no
specific plans for the shares that may be purchased under the program, our goals
for the program are (i) to address provisions of our affiliation agreement
with RHI related to maintaining RHI’s minimum ownership percentage, (ii) to make
prudent investments of our cash resources, and (iii) to allow for an effective
mechanism to provide stock for our employee stock plans. See “Relationship with
Roche” above for more information on RHI’s minimum ownership
percentage.
We
enter into Rule 10b5-1 trading plans to repurchase shares in the open market
during those periods when trading in our stock is restricted under our insider
trading policy. The most recent trading plans, which are effective through April
11, 2008, cover approximately 4.25 million shares.
Under
our current stock repurchase program, we repurchased 13 million shares for $1.0
billion in 2007, 12 million shares for $1.0 billion in 2006, and 24 million
shares for $2.0 billion in 2005.
Our
shares repurchased during 2007 were as follows (shares in
millions):
|
|
Total
Number of
Shares
Purchased
|
|
|
Average
Price Paid
per
Share
|
|
January
1–31
|
|
|
3.0 |
|
|
$ |
87.33 |
|
February
1–28
|
|
|
0.9 |
|
|
|
86.54 |
|
March
1–31
|
|
|
0.6 |
|
|
|
82.33 |
|
April
1–30
|
|
|
0.8 |
|
|
|
82.14 |
|
May
1–31
|
|
|
1.4 |
|
|
|
79.65 |
|
June
1–30
|
|
|
1.3 |
|
|
|
75.84 |
|
August
1–31
|
|
|
0.8 |
|
|
|
73.66 |
|
September
1–30
|
|
|
1.2 |
|
|
|
78.67 |
|
October
1–31
|
|
|
0.6 |
|
|
|
76.08 |
|
November
1–30
|
|
|
1.0 |
|
|
|
74.86 |
|
December
1–31
|
|
|
1.5 |
|
|
|
67.96 |
|
Total
|
|
|
13.1 |
|
|
$ |
79.40 |
|
As
of December 31, 2007, 75 million shares have been purchased under our stock
repurchase program for $5.4 billion, and a maximum of 25 million additional
shares for amounts totaling up to $2.6 billion may be purchased under the
program through June 30, 2008.
In
November 2007, we entered into a prepaid share repurchase arrangement with an
investment bank pursuant to which we delivered $300 million to the investment
bank. The investment bank is obligated to deliver to us not less than three
million shares of our Common Stock, subject to certain exceptions, based on a
pre-determined formula. Pursuant to the arrangement, the investment bank is
obligated to deliver the shares to us by March 26, 2008, subject to an extension
based on extraordinary events. The prepaid amount has been reflected as a
reduction of our stockholders’ equity as of December 31, 2007. There was no
effect on EPS for the year ended December 31, 2007 as a result of entering into
this arrangement.
The
par value method of accounting is used for common stock repurchases. The excess
of the cost of shares acquired over the par value is allocated to additional
paid-in capital with the amounts in excess of the estimated original sales price
charged to retained earnings (accumulated deficit).
Off-Balance
Sheet Arrangements
We
have certain contractual arrangements that create potential risk for us and are
not recognized in our Consolidated Balance Sheets. Discussed below are those
off-balance sheet arrangements that have or are reasonably likely to have a
material current or future effect on our financial condition, changes in
financial condition, revenue or expenses, results of operations, liquidity,
capital expenditures, or capital resources.
We
lease various real properties under operating leases that generally require us
to pay taxes, insurance, maintenance, and minimum lease payments. Some of our
leases have options to renew.
Commitments
In
October 2007, we entered into a five-year, $1 billion revolving credit facility
with various financial institutions. The credit facility is expected to be used
for general corporate and working capital purposes, including providing support
for our new $1 billion commercial paper program. As of December 31, 2007, we had
no borrowings under the credit facility.
In
December 2004, we entered into a Master Lease Agreement with Slough SSF, LLC,
which was subsequently acquired by Health Care Properties (HCP), for the lease
of property adjacent to our South San Francisco campus. The property is being
developed into eight buildings and two parking structures. The lease of the
property is taking
place
in two phases pursuant to separate lease agreements for each building as
detailed in the Master Lease Agreement. Phase I building leases began in 2006
and Phase II building leases began in 2007 and will continue through 2008. For
accounting purposes, due to the nature of our involvement with the construction
of the buildings subject to the Master Lease Agreement, we are considered to be
the owner of the assets during the construction period through the lease
commencement date, even though the funds to construct the building shell and
some infrastructure costs are paid by the lessor. As of December 31, 2007, we
have capitalized $283 million of construction costs, including capitalized
interest, in property, plant and equipment. In addition, we separately
capitalized approximately $259 million of leasehold improvements that we have
installed at the property. We have recognized $270 million as a construction
financing obligation, which is primarily included in “long-term debt” in the
accompanying Consolidated Balance Sheets. As of December 31, 2006, we had
capitalized $205 million of construction costs, including capitalized
interest, in property, plant and equipment. In addition, we separately
capitalized approximately $150 million of leasehold improvements that we had
installed at the property. We have recognized $198 million as a construction
financing obligation, which is primarily included in “long-term debt” in the
accompanying Consolidated Balance Sheets. Concurrent with the commencement of
the rental period, during the third quarter of 2006, we began repayment of the
construction financing obligation. We expect that at the time of completion of
the project, our construction asset and related obligation may be as much as
$365 million, excluding costs related to leasehold improvements.
In
November 2006, we entered into a series of agreements with Lonza Group Ltd
(Lonza), including a supply agreement to purchase product produced by Lonza at
their Singapore manufacturing facility, which is currently under construction.
For accounting purposes, due to the nature of the supply agreement and our
involvement with the construction of the buildings, we are considered to be the
owner of the assets during the construction period, even though the funds to
construct the building shell and some infrastructure costs are paid by Lonza. As
such, during 2007 and 2006, we capitalized $141 million and $20 million,
respectively, in construction-in-progress and have also recognized a
corresponding amount as a construction financing obligation in “long-term debt”
in the accompanying Consolidated Balance Sheets. We also entered into a loan
agreement with Lonza to advance $290 million to Lonza for the construction of
this facility and approximately $9 million for a related land lease option, the
majority of which is not expected to be advanced until 2008. See Note 8,
“Leases, Commitments and Contingencies,” in the Notes to Consolidated Financial
Statements in Part II, Item 8 of this Form 10-K for further discussion of the
agreements.
See
also Note 8, “Leases, Commitments and Contingencies,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form
10-K.
Contractual
Obligations
In
the table below, we set forth our enforceable and legally binding obligations
and future commitments, as well as obligations related to all contracts that we
are likely to continue, regardless of the fact that they were cancelable as of
December 31, 2007. Some of the figures that we include in this table are based
on management’s estimate and assumptions about these obligations, including
their duration, the possibility of renewal, anticipated actions by third
parties, and other factors. Because these estimates and assumptions are
necessarily subjective, the obligations we will actually pay in future periods
may vary from those reflected in the table.
|
|
Payments Due by Period
(in
millions)
|
|
Contractual
Obligations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
lease obligations and other(1)
|
|
$ |
261 |
|
|
$ |
35 |
|
|
$ |
69 |
|
|
$ |
60 |
|
|
$ |
97 |
|
HCP(2)
(Financing lease)
|
|
|
524 |
|
|
|
32 |
|
|
|
73 |
|
|
|
78 |
|
|
|
341 |
|
Lonza(3)
(Singapore facility agreement)
|
|
|
510 |
|
|
|
15 |
|
|
|
220 |
|
|
|
275 |
|
|
|
– |
|
Purchase
obligations(4)
|
|
|
1,283 |
|
|
|
799 |
|
|
|
378 |
|
|
|
81 |
|
|
|
25 |
|
Long-term
debt(5)
|
|
|
2,000 |
|
|
|
– |
|
|
|
500 |
|
|
|
– |
|
|
|
1,500 |
|
Deferred
tax liabilities(6)
|
|
|
63 |
|
|
|
63 |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
Accrued
litigation(7)
|
|
|
776 |
|
|
|
776 |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
Other
long-term liabilities(8)
|
|
|
30 |
|
|
|
1 |
|
|
|
7 |
|
|
|
4 |
|
|
|
18 |
|
Interest
expense on long-term debt(9)
|
|
|
1,130 |
|
|
|
95 |
|
|
|
175 |
|
|
|
148 |
|
|
|
712 |
|
Total
|
|
$ |
6,577 |
|
|
$ |
1,816 |
|
|
$ |
1,422 |
|
|
$ |
646 |
|
|
$ |
2,693 |
|
________________________
(1)
|
Operating
lease obligations include Owner Association Fees on buildings that we
own.
|
(2)
|
See
further discussion related to the HCP lease above in “Off-Balance Sheet
Arrangements.”
|
(3)
|
Included
in “2009 and 2010” is a manufacturing milestone payment. See further
discussion of the agreements with Lonza above in “Off-Balance Sheet
Arrangements” and in Note 8, “Leases, Commitments and Contingencies,” in
the Notes to Consolidated Financial Statements in Part II, Item 8 of this
Form 10-K.
|
(4)
|
Purchase
obligations include commitments related to capital expenditures, clinical
development, manufacturing and research operations and other significant
purchase commitments. Purchase obligations exclude capitalized labor and
capitalized interest on construction projects. Included in this line are
our purchase obligations under our contract manufacturing arrangements
with Wyeth Pharmaceuticals, a division of Wyeth, for bulk supply of
Herceptin, and Novartis for the manufacture of Xolair and Lucentis. See
also Note 8, “Leases, Commitments and Contingencies,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form
10-K.
|
(5)
|
See
also Note 7, “Debt,” in the Notes to Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K.
|
(6)
|
Amount
represents the current portion of our tax obligations and related interest
under FIN 48. See also Note 12, “Income Taxes,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form
10-K.
|
(7)
|
Accrued
litigation includes our litigation liabilities and other similar items
which are reflected on our balance sheet. The amount of cash paid, if any,
or the timing of such payment in connection with the COH matter will
depend on the outcome of the California Supreme Court’s review of the
matter; this item is captured in the “2008” category in the table
above.
|
(8)
|
Other
long-term liabilities primarily represent our post-retirement benefit
obligations.
|
(9)
|
Interest
expense includes the effects of an interest rate swap agreement. See also,
Note 4 “Investment Securities and Financial Instruments,” in the Notes to
Consolidated Financial Statements in Part II, Item 8 of this Form
10-K.
|
Excludes
payment obligations associated with our commercial paper
program.
|
In
addition to the above, we have committed to make potential future “milestone”
payments to third parties as well as fund certain development, manufacturing and
commercialization efforts as part of in-licensing and joint product development
programs. Milestone payments under these agreements generally become due and
payable only upon achievement of certain developmental, regulatory, and/or
commercial milestones. Because the achievement of these milestones is generally
neither probable nor reasonably estimable, such contingencies have not been
recorded on our Consolidated Balance Sheets or in the table above. Further, our
obligation to fund development, manufacturing and commercialization efforts is
contingent upon continued involvement in the programs and/or the lack of any
adverse events which could cause the discontinuance of the programs. Under
certain of these arrangements, management can decide at any time to discontinue
the joint programs. Due to the risks associated with the development
manufacturing and commercialization processes, the payments under these
arrangements are not reasonably estimable, and such payments have not been
recorded on our Consolidated Balance Sheets or in the table above. We also
entered into a
loan
agreement, subject to certain mutually acceptable conditions of securitization,
with Lonza to advance up to $290 million to Lonza for the construction of their
Singapore facility, and approximately $9 million for a related land lease
option, the majority of which is not expected to be advanced until 2008. See
Note 8, “Leases, Commitments and Contingencies,” in the Notes to Consolidated
Financial Statements in Part II, Item 8 of this Form 10-K for further
information on these matters.
Stock
Options
Option
Program Description
Our
employee stock option program is a broad-based, long-term retention program that
is intended to attract and retain talented employees and to align stockholder
and employee interests. Our program primarily consists of our 2004 Equity
Incentive Plan (the Plan), a broad-based plan under which stock options,
restricted stock, stock appreciation rights and performance shares and units may
be granted to employees, directors and other service providers. Substantially
all of our employees participate in our stock option program. In the past, we
granted options under our amended and restated 1999 Stock Plan, 1996 Stock
Option/Stock Incentive Plan, our amended and restated 1994 Stock Option Plan and
our amended and restated 1990 Stock Option/Stock Incentive Plan. Although we no
longer grant options under these plans, exercisable options granted under these
plans are still outstanding.
All
stock option grants are made with the approval of the Compensation Committee of
the Board of Directors or an authorized delegate. See “Compensation Discussion
and Analysis” appearing in our 2008 Proxy Statement for further information
concerning the policies and procedures of the Compensation Committee regarding
the use of stock options.
General
Option Information
Summary
of Option Activity
(Shares
in millions)
|
|
|
|
|
|
|
|
|
Shares
Available
for
Grant
|
|
|
|
|
|
Weighted
Average
Exercise
Price
|
|
December 31,
2005
|
|
|
84 |
|
|
|
83 |
|
|
$ |
46.64 |
|
Grants
|
|
|
(17 |
) |
|
|
17 |
|
|
|
79.85 |
|
Exercises
|
|
|
– |
|
|
|
(9 |
) |
|
|
30.42 |
|
Cancellations
|
|
|
3 |
|
|
|
(3 |
) |
|
|
62.09 |
|
December 31,
2006
|
|
|
70 |
|
|
|
88 |
|
|
$ |
54.43 |
|
Grants
|
|
|
(18 |
) |
|
|
18 |
|
|
|
79.40 |
|
Exercises
|
|
|
– |
|
|
|
(10 |
) |
|
|
32.76 |
|
Cancellations
|
|
|
4 |
|
|
|
(4 |
) |
|
|
76.45 |
|
December 31,
2007
|
|
|
56 |
|
|
|
92 |
|
|
$ |
60.94 |
|
In-the-Money
and Out-of-the-Money Option Information
(Shares
in millions)
|
|
|
|
|
|
|
|
|
|
As
of December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-the-Money
|
|
|
39 |
|
|
$ |
35.22 |
|
|
|
3 |
|
|
$ |
52.93 |
|
|
|
42 |
|
|
$ |
36.56 |
|
Out-of-the-Money(1)
|
|
|
15 |
|
|
|
83.68 |
|
|
|
35 |
|
|
|
80.77 |
|
|
|
50 |
|
|
|
81.62 |
|
Total
Options Outstanding
|
|
|
54 |
|
|
|
|
|
|
|
38 |
|
|
|
|
|
|
|
92 |
|
|
|
|
|
________________________
(1)
|
Out-of-the-money
options are those options with an exercise price equal to or greater than
the fair market value of Genentech Common Stock, which was $67.07 at the
close of business on December 31,
2007.
|
Distribution
and Dilutive Effect of Options
Employee
and Executive Officer Option Grants
|
|
|
|
|
|
|
|
|
|
Net
grants during the year as % of outstanding shares
|
|
|
1.36
|
% |
|
|
1.43
|
% |
|
|
1.70
|
% |
Grants
to Executive Officers during the period as % of outstanding
shares
|
|
|
0.13
|
% |
|
|
0.14
|
% |
|
|
0.18
|
% |
Grants
to Executive Officers during the year as % of total options
granted
|
|
|
7.41
|
% |
|
|
8.60
|
% |
|
|
9.44
|
% |
________________________
*
|
Executive
officers as of December 31 for the years
presented.
|
Equity
Compensation Plan Information
Our
stockholders have approved all of our equity compensation plans under which
options are outstanding.
******
This
report contains forward-looking statements regarding our Horizon 2010 strategy
of bringing new molecules into clinical development, bringing major new products
or indications onto the market, becoming the number one U.S. oncology company in
sales, and achieving certain financial growth measures; the timing of data for
clinical studies; an Avastin sBLA submission; label extensions for Xolair;
construction, qualification and licensure of Vacaville and Hillsboro facilities,
and Lonza’s and our Singapore facilities, and completion of construction for our
Dixon facility; the adequacy of our capital resources to meet long-term growth;
Avastin sales growth; reimbursement for Lucentis; royalty revenue; expenditures
to comply with environmental laws; R&D and MG&A expenses; compensation
charges associated with voluntary severance; tax obligations and our effective
income tax rate; inventory levels; capital expenditures; extending a
construction loan to Lonza; and the effect of recent accounting pronouncements
on our financial statements.
These
forward-looking statements involve risks and uncertainties, and the cautionary
statements set forth below and those contained in “Risk Factors” in this Form
10-K identify important factors that could cause actual results to differ
materially from those predicted in any such forward-looking statements. Such
factors include, but are not limited to, difficulty in enrolling patients in
clinical trials; the need for additional data, data analysis or clinical
studies; BLA preparation and decision making; FDA actions or delays; failure to
obtain or maintain FDA approval; difficulty in obtaining materials from
suppliers; unexpected safety, efficacy or manufacturing issues for us or our
contract/collaborator manufacturers; increased capital expenditures including
greater than expected construction and validation costs; product withdrawals;
competition; efficacy data concerning any of our products which shows or is
perceived to show similar or improved treatment benefit at a lower dose or
shorter duration of therapy; pricing decisions by us or our competitors; our
ability to protect our proprietary rights; the outcome of, and expenses
associated with, litigation or legal settlements; increased R&D, MG&A,
stock-based compensation, environmental and other expenses, and increased COS;
variations in collaborator sales and expenses; our indebtedness and ability to
pay our indebtedness; actions by Roche that are adverse to our interests;
decreases in third party reimbursement rates; and greater than expected income
tax rate. We disclaim and do not undertake any obligation to update or revise
any forward-looking statement in this Form 10-K.
We
are exposed to market risk, including changes to interest rates, foreign
currency exchange rates and equity investment prices. To reduce the volatility
related to these exposures, we enter into various derivative hedging
transactions pursuant to our investment and risk management policies and
procedures. We do not enter into derivatives for speculative
purposes.
We
maintain risk management control systems to monitor the risks associated with
interest rates, foreign currency exchange rates and equity investment price
changes. The risk management control systems use analytical techniques,
including sensitivity analysis and market values. Notwithstanding our risk
management control systems, there are inherent risks that may only be partially
offset by our hedging programs should there be unfavorable movements in interest
rates, foreign currency exchange rates or equity investment prices.
Actual
future gains and losses associated with our investment portfolio and derivative
positions may differ materially from the VAR analyses performed due to the
inherent limitations associated with predicting the timing and amount of changes
to interest rates, foreign currency exchanges rates and equity investment
prices, as well as our actual exposures and positions.
Interest
Rate Risk
Our
interest-bearing assets, or interest-bearing portfolio, consisted of cash, cash
equivalents, restricted cash and investments, short-term investments, marketable
debt securities, long-term investments and interest-bearing forward contracts.
The balance of our interest-bearing portfolio, including restricted and
unrestricted cash and investments, was $6,436 million, or 34% of total assets,
at December 31, 2007 and $4,747 million, or 32% of total assets, at December 31,
2006. Interest income related to this portfolio was $270 million in 2007 and
$230 million in 2006. Our interest income is sensitive to changes in the general
level of interest rates, credit ratings of our investments, and market liquidity
for the different types of interest-bearing assets.
Our
short-term borrowings include $600 million in unsecured commercial paper notes
payable. These notes are not redeemable prior to maturity or subject to
voluntary prepayment, and were issued on a discount basis. During the period
from issuance to December 31, 2007, the notes were issued with an effective
interest yield of 4.62%. At December 31, 2007, outstanding commercial paper
notes carried an effective interest yield of 4.46%.
Our
long-term debt is made up of the following debt instruments: $500 million
principal amount of 4.40% Senior Notes due 2010, $1.0 billion principal amount
of 4.75% Senior Notes due 2015, and $500 million principal amount of 5.25%
Senior Notes due 2035. To protect the fair value of our 2010 Notes against
fluctuations in the benchmark U.S. interest rates, we entered into a series of
interest rate swap agreements with respect to the 2010 Notes. See Note 7,
“Debt,” and Note 4, “Investment Securities and Financial Instruments—Derivative
Financial Instruments,” in the Notes to Consolidated Financial Statements in
Part II, Item 8 of this Form 10-K.
Based
on our overall interest rate exposure, which includes the net effect of our
interest rate exposures on our interest-bearing assets, our Senior Note debt
instruments, and our commercial paper, using a 21-trading-day holding period
with a 95% confidence level, the potential loss in estimated fair value of our
interest rate sensitive instruments was $20 million at December 31, 2007 and $24
million at December 31, 2006. A significant portion of the potential loss in
estimated fair value at both December 31, 2007 and 2006 was attributed to the
longer duration of our Senior Notes.
Foreign
Currency Exchange and Foreign Economic Conditions Risk
We
receive royalty revenue from licensees selling products in countries throughout
the world. As a result, our financial results could be significantly affected by
factors such as changes in foreign currency exchange rates or weak economic
conditions in the foreign markets in which our licensed products are sold. Our
exposure to foreign exchange rates is most significant relative to the Swiss
Franc, though we are also exposed to changes in exchange rates elsewhere in
Europe, Asia (primarily Japan) and Canada. When the dollar strengthens against
the currencies in these countries, the dollar value of foreign-currency
denominated revenue decreases; when the dollar weakens, the dollar value of the
foreign-currency denominated revenue increases. Accordingly, changes in exchange
rates, and in particular a strengthening of the dollar, may adversely affect our
royalty revenue as expressed in dollars. Currently, our foreign currency royalty
revenue exceed our foreign currency expenses. In addition, as part of our
overall investment strategy, a portion of our portfolio is in non-dollar
denominated investments. As a result, we are exposed to changes in the exchange
rates of the currencies in which these non-dollar investments are
denominated.
To
mitigate our net foreign exchange exposure, our policy allows us to hedge
certain of our anticipated royalty revenue by entering into option or forward
contracts with one- to five-year expiration dates and amounts of currency that
are based on up to 90% of forecasted future revenue so that the potential
adverse effect of movements in currency exchange rates on the non-dollar
denominated revenue will be at least partly offset by an associated increase in
the value of the option or forward. As of December 31, 2007, these options and
forwards are due to expire in 2008 and 2009.
Based
on our overall currency rate exposure, using a 21-trading-day holding period
with a 95% confidence level, the potential loss in the estimated fair value of
our foreign currency sensitive instruments was $40 million at December 31,
2007 and $17 million at December 31, 2006. Because we use foreign currency
instruments to hedge anticipated future cash flows, losses incurred on those
instruments are generally offset by increases in the fair value of the
underlying future cash flows that they were intended to hedge.
Equity
Security Risks
As
part of our strategic alliance efforts, we invest in publicly traded equity
instruments of biotechnology companies. Our biotechnology equity investment
portfolio totaled $416 million, or 2% of total assets, at December 31, 2007 and
$360 million, or 2% of total assets, at December 31, 2006. Impairment charges on
our biotechnology equity investments were $20 million in 2007 and $4 million in
2006. These investments are subject to fluctuations from market value changes in
stock prices. To mitigate the risk of market value fluctuation, certain equity
securities are hedged with zero-cost collars and forward contracts. A zero-cost
collar is a purchased put option and a written call option in which the cost of
the purchased put and the proceeds of the written call offset each other;
therefore, there is no initial cost or cash outflow for these instruments at the
time of purchase. The purchased put protects us from a decline in the market
value of the security below a certain minimum level (the put “strike” level),
while the call effectively limits our potential to benefit from an increase in
the market value of the security above a certain maximum level (the call
“strike” level). A forward contract is a derivative instrument where we lock-in
the termination price that we receive from the sale of stock based on a
pre-determined spot price. The forward contract protects us from a decline in
the market value of the security below the spot price and limits our potential
benefit from an increase in the market value of the security above the spot
price. Throughout the life of the forward contract, we receive interest income
based on the notional amount and a floating-rate index. Depending on market
conditions, we may determine that in future periods certain of our other
unhedged equity security investments are impaired, which would result in
additional write-downs of those equity security investments.
Based
on our overall exposure to fluctuations from market value changes in marketable
equity prices, using a 21-trading-day holding period with a 95% confidence
level, the potential loss in estimated fair value of our equity securities
portfolio was $27 million at December 31, 2007 and $24 million at
December 31, 2006.
Also,
as part of our strategic alliance efforts, we invest in privately held
biotechnology companies, some of which are in the startup stage. These
investments are primarily carried at cost, which were $31 million
at December 31, 2007 and $33 million at December 31, 2006, and are recorded
in “Other long-term assets” in the Consolidated Balance Sheets. Our
determination of investment values in private companies is based on the
fundamentals of the businesses, including, among other factors, the nature and
success of their R&D efforts.
Counterparty
Credit Risks
We
could be exposed to losses related to the financial instruments described above
if one of our counterparties were to default. We attempt to mitigate this risk
through credit monitoring procedures.
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Stockholders of Genentech, Inc.
We
have audited the accompanying consolidated balance sheets of Genentech, Inc. as
of December 31, 2007 and 2006, and the related consolidated statements of
income, stockholders’ equity and cash flows for each of the three years in the
period ended December 31, 2007. Our audits also included the financial statement
schedule listed in the Index at Item 15(a). These financial statements and
schedule are the responsibility of Genentech, Inc.’s management. Our
responsibility is to express an opinion on these financial statements and
schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In
our opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Genentech, Inc. at
December 31, 2007 and 2006, and the consolidated results of its operations and
its cash flows for each of the three years in the period ended December 31,
2007, in conformity with U.S. generally accepted accounting principles. Also, in
our opinion, the related financial statement schedule, when considered in
relation to the basic financial statements taken as a whole, presents fairly in
all material respects the information set forth therein.
As
discussed in Note 2 to the consolidated financial statements, in 2006 Genentech,
Inc. changed its method of accounting for stock-based compensation in accordance
with guidance provided in Statement of Financial Accounting Standards No.
123(R), “Share-Based Payment.”
We
also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), Genentech, Inc.’s internal control
over financial reporting as of December 31, 2007, based on criteria established
in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated February 5, 2008
expressed an unqualified opinion thereon.
/s/
ERNST & YOUNG LLP
Palo
Alto, California
February
5, 2008
CONSOLIDATED
STATEMENTS OF INCOME
(In
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
Product
sales (including amounts from related parties:
2007-$778;
2006-$364; 2005-$184)
|
|
$ |
9,443 |
|
|
$ |
7,640 |
|
|
$ |
5,488 |
|
Royalties
(including amounts from related parties:
2007-$1,301;
2006-$849; 2005-$501)
|
|
|
1,984 |
|
|
|
1,354 |
|
|
|
935 |
|
Contract
revenue (including amounts from related parties:
2007-$165;
2006-$165; 2005-$115)
|
|
|
297 |
|
|
|
290 |
|
|
|
210 |
|
Total
operating revenue
|
|
|
11,724 |
|
|
|
9,284 |
|
|
|
6,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs
and expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales (including amounts for related parties:
2007-$432;
2006-$272; 2005-$171)
|
|
|
1,571 |
|
|
|
1,181 |
|
|
|
1,011 |
|
Research
and development (associated with related party
collaborations:
2007-$302;
2006-$251; 2005-$183)
(including
amounts where reimbursement was recorded as contract revenue: 2007-$196;
2006-$185; 2005-$144)
|
|
|
2,446 |
|
|
|
1,773 |
|
|
|
1,262 |
|
Marketing,
general and administrative
|
|
|
2,256 |
|
|
|
2,014 |
|
|
|
1,435 |
|
Collaboration
profit sharing (including related party amounts:
2007-$185;
2006-$187; 2005-$136)
|
|
|
1,080 |
|
|
|
1,005 |
|
|
|
823 |
|
Write-off
of in-process research and development related to
acquisition
|
|
|
77 |
|
|
|
– |
|
|
|
– |
|
Gain
on acquisition
|
|
|
(121 |
) |
|
|
– |
|
|
|
– |
|
Recurring
charges related to redemption and acquisition
|
|
|
132 |
|
|
|
105 |
|
|
|
123 |
|
Special
items: litigation-related
|
|
|
54 |
|
|
|
54 |
|
|
|
58 |
|
Total
costs and expenses
|
|
|
7,495 |
|
|
|
6,132 |
|
|
|
4,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
income
|
|
|
4,229 |
|
|
|
3,152 |
|
|
|
1,921 |
|
Other
income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
and other income (expense), net
|
|
|
273 |
|
|
|
325 |
|
|
|
142 |
|
Interest
expense
|
|
|
(76 |
) |
|
|
(74 |
) |
|
|
(50 |
) |
Total
other income, net
|
|
|
197 |
|
|
|
251 |
|
|
|
92 |
|
Income
before taxes
|
|
|
4,426 |
|
|
|
3,403 |
|
|
|
2,013 |
|
Income
tax provision
|
|
|
1,657 |
|
|
|
1,290 |
|
|
|
734 |
|
Net
income
|
|
$ |
2,769 |
|
|
$ |
2,113 |
|
|
$ |
1,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
per share
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
2.63 |
|
|
$ |
2.01 |
|
|
$ |
1.21 |
|
Diluted
|
|
$ |
2.59 |
|
|
$ |
1.97 |
|
|
$ |
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares
used to compute basic earnings per share
|
|
|
1,053 |
|
|
|
1,053 |
|
|
|
1,055 |
|
Shares
used to compute diluted earnings per share
|
|
|
1,069 |
|
|
|
1,073 |
|
|
|
1,081 |
|
See
Notes to Consolidated Financial Statements.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
flows from operating activities
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
2,769 |
|
|
$ |
2,113 |
|
|
$ |
1,279 |
|
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
and amortization
|
|
|
492 |
|
|
|
407 |
|
|
|
370 |
|
Employee
stock-based compensation
|
|
|
403 |
|
|
|
309 |
|
|
|
– |
|
In-process
research and development
|
|
|
77 |
|
|
|
– |
|
|
|
– |
|
Gain
on acquisition
|
|
|
(121 |
) |
|
|
– |
|
|
|
– |
|
Deferred
income taxes
|
|
|
(234 |
) |
|
|
(112 |
) |
|
|
(110 |
) |
Deferred
revenue
|
|
|
(68 |
) |
|
|
(3 |
) |
|
|
(49 |
) |
Litigation-related
liabilities
|
|
|
51 |
|
|
|
51 |
|
|
|
51 |
|
Excess
tax benefit from stock-based compensation arrangements
|
|
|
(193 |
) |
|
|
(179 |
) |
|
|
– |
|
Tax
benefit from employee stock options
|
|
|
– |
|
|
|
– |
|
|
|
632 |
|
Gain
on sales of securities available-for-sale and other
|
|
|
(27 |
) |
|
|
(94 |
) |
|
|
(12 |
) |
Loss
on sales and write-downs of securities available-for-sale and
other
|
|
|
58 |
|
|
|
5 |
|
|
|
13 |
|
Loss
on fixed asset dispositions
|
|
|
32 |
|
|
|
23 |
|
|
|
10 |
|
Changes
in assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Receivables
and other assets
|
|
|
38 |
|
|
|
(628 |
) |
|
|
(128 |
) |
Inventories
|
|
|
(310 |
) |
|
|
(408 |
) |
|
|
(112 |
) |
Investments
in trading securities
|
|
|
(360 |
) |
|
|
(29 |
) |
|
|
(17 |
) |
Accounts
payable, other accrued liabilities, and other long-term
liabilities
|
|
|
623 |
|
|
|
683 |
|
|
|
436 |
|
Net
cash provided by operating activities
|
|
|
3,230 |
|
|
|
2,138 |
|
|
|
2,363 |
|
Cash
flows from investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases
of securities available-for-sale
|
|
|
(1,152 |
) |
|
|
(1,036 |
) |
|
|
(1,000 |
) |
Proceeds
from sales of securities available-for-sale
|
|
|
651 |
|
|
|
256 |
|
|
|
148 |
|
Proceeds
from maturities of securities available-for-sale
|
|
|
486 |
|
|
|
357 |
|
|
|
574 |
|
Capital
expenditures
|
|
|
(977 |
) |
|
|
(1,214 |
) |
|
|
(1,400 |
) |
Change
in other intangible and long-term assets
|
|
|
(40 |
) |
|
|
9 |
|
|
|
(45 |
) |
Acquisition
and related costs, net
|
|
|
(833 |
) |
|
|
– |
|
|
|
– |
|
Transfer
to restricted cash, net
|
|
|
– |
|
|
|
(53 |
) |
|
|
(53 |
) |
Net
cash used in investing activities
|
|
|
(1,865 |
) |
|
|
(1,681 |
) |
|
|
(1,776 |
) |
Cash
flows from financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock
issuances
|
|
|
452 |
|
|
|
385 |
|
|
|
821 |
|
Stock
repurchases and prepaid share repurchase deposits
|
|
|
(1,345 |
) |
|
|
(996 |
) |
|
|
(2,016 |
) |
Excess
tax benefit from stock-based compensation arrangements
|
|
|
193 |
|
|
|
179 |
|
|
|
– |
|
Proceeds
from issuance of commercial paper
|
|
|
599 |
|
|
|
– |
|
|
|
– |
|
Repayment
of long-term debt and noncontrolling interest
|
|
|
– |
|
|
|
– |
|
|
|
(425 |
) |
Proceeds
from issuance of long-term debt
|
|
|
– |
|
|
|
– |
|
|
|
1,988 |
|
Net
cash (used in) provided by financing activities
|
|
|
(101 |
) |
|
|
(432 |
) |
|
|
368 |
|
Net
increase in cash and cash equivalents
|
|
|
1,264 |
|
|
|
25 |
|
|
|
955 |
|
Cash
and cash equivalents at beginning of year
|
|
|
1,250 |
|
|
|
1,225 |
|
|
|
270 |
|
Cash
and cash equivalents at end of year
|
|
$ |
2,514 |
|
|
$ |
1,250 |
|
|
$ |
1,225 |
|
Supplemental
cash flow data
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
paid during the year for:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$ |
60 |
|
|
$ |
68 |
|
|
$ |
8 |
|
Income
taxes
|
|
|
1,673 |
|
|
|
1,038 |
|
|
|
312 |
|
Non-cash
investing and financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Capitalization
of construction in progress related to financing lease
transactions
|
|
|
203 |
|
|
|
128 |
|
|
|
94 |
|
Sale
of subsidiary in exchange for note receivable
|
|
|
– |
|
|
|
135 |
|
|
|
– |
|
Exchange
of XOMA note receivable for a prepaid royalty and other long-term
asset
|
|
|
– |
|
|
|
– |
|
|
|
29 |
|
See
Notes to Consolidated Financial Statements.
CONSOLIDATED
BALANCE SHEETS
(In
millions, except par value)
|
|
|
|
|
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
2,514 |
|
|
$ |
1,250 |
|
Short-term
investments
|
|
|
1,461 |
|
|
|
1,243 |
|
Restricted
cash and investments
|
|
|
788 |
|
|
|
– |
|
Accounts
receivable - product sales (net of allowances:
2007-$116;
2006-$92; including amounts from related parties:
2007-$2;
2006-$57)
|
|
|
847 |
|
|
|
965 |
|
Accounts
receivable - royalties (including amounts from related
parties:
2007-$463;
2006-$316)
|
|
|
620 |
|
|
|
453 |
|
Accounts
receivable - other (including amounts from related parties:
2007-$233;
2006-$150)
|
|
|
299 |
|
|
|
248 |
|
Inventories
|
|
|
1,493 |
|
|
|
1,178 |
|
Deferred
tax assets
|
|
|
614 |
|
|
|
278 |
|
Prepaid
expenses and other current assets
|
|
|
117 |
|
|
|
89 |
|
Total
current assets
|
|
|
8,753 |
|
|
|
5,704 |
|
Long-term
marketable debt and equity securities
|
|
|
2,090 |
|
|
|
1,832 |
|
Property,
plant and equipment, net
|
|
|
4,986 |
|
|
|
4,173 |
|
Goodwill
|
|
|
1,577 |
|
|
|
1,315 |
|
Other
intangible assets
|
|
|
1,168 |
|
|
|
476 |
|
Restricted
cash and investments
|
|
|
– |
|
|
|
788 |
|
Deferred
tax assets
|
|
|
– |
|
|
|
183 |
|
Other
long-term assets
|
|
|
366 |
|
|
|
371 |
|
Total
assets
|
|
$ |
18,940 |
|
|
$ |
14,842 |
|
Liabilities
and stockholders’ equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable (including amounts to related parties:
2007-$2;
2006-$7)
|
|
$ |
420 |
|
|
$ |
346 |
|
Commercial
paper
|
|
|
599 |
|
|
|
– |
|
Deferred
revenue
|
|
|
73 |
|
|
|
62 |
|
Accrued
litigation
|
|
|
776 |
|
|
|
– |
|
Other
accrued liabilities (including amounts to related
parties:
2007-$230;
2006-$136)
|
|
|
2,050 |
|
|
|
1,602 |
|
Total
current liabilities
|
|
|
3,918 |
|
|
|
2,010 |
|
Long-term
debt
|
|
|
2,402 |
|
|
|
2,204 |
|
Deferred
revenue
|
|
|
418 |
|
|
|
199 |
|
Accrued
litigation
|
|
|
– |
|
|
|
726 |
|
Other
long-term liabilities
|
|
|
297 |
|
|
|
225 |
|
Total
liabilities
|
|
|
7,035 |
|
|
|
5,364 |
|
Commitments
and contingencies (Note 8)
|
|
|
|
|
|
|
|
|
Stockholders’
equity
|
|
|
|
|
|
|
|
|
Preferred
stock, $0.02 par value; authorized: 100 shares; none
issued
|
|
|
– |
|
|
|
– |
|
Common
Stock, $0.02 par value; authorized: 3,000 shares;
outstanding: 2007-1,052
shares; 2006-1,053 shares
|
|
|
21 |
|
|
|
21 |
|
Additional
paid-in capital
|
|
|
10,695 |
|
|
|
10,091 |
|
Accumulated
other comprehensive income
|
|
|
197 |
|
|
|
204 |
|
Retained
earnings (accumulated deficit), since June 30, 1999
|
|
|
992 |
|
|
|
(838 |
) |
Total
stockholders’ equity
|
|
|
11,905 |
|
|
|
9,478 |
|
Total
liabilities and stockholders’ equity
|
|
$ |
18,940 |
|
|
$ |
14,842 |
|
See
Notes to Consolidated Financial Statements.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(in
millions)
|
|
|
|
|
|
|
|
|
|
|
Retained
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Earnings
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
Paid-in
|
|
|
(Accumulated
|
|
|
Comprehensive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
December 31, 2004
|
|
|
1,047 |
|
|
$ |
21 |
|
|
$ |
8,002 |
|
|
$ |
(1,532 |
) |
|
$ |
291 |
|
|
$ |
6,782 |
|
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
1,279 |
|
|
|
– |
|
|
|
1,279 |
|
Decrease
in unrealized gain on securities available-for-sale, net of
tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(75 |
) |
|
|
(75 |
) |
Changes
in fair value of cash flow hedges, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
37 |
|
|
|
37 |
|
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,241 |
|
Issuance
of stock upon exercise of options
|
|
|
29 |
|
|
|
1 |
|
|
|
745 |
|
|
|
– |
|
|
|
– |
|
|
|
746 |
|
Income
tax benefits realized from employee stock option exercises
|
|
|
– |
|
|
|
– |
|
|
|
642 |
|
|
|
– |
|
|
|
– |
|
|
|
642 |
|
Issuance
of stock under employee stock purchase plan
|
|
|
2 |
|
|
|
– |
|
|
|
75 |
|
|
|
– |
|
|
|
– |
|
|
|
75 |
|
Repurchase
of Common Stock
|
|
|
(24 |
) |
|
|
(1 |
) |
|
|
(201 |
) |
|
|
(1,814 |
) |
|
|
– |
|
|
|
(2,016 |
) |
Balance
December 31, 2005
|
|
|
1,054 |
|
|
|
21 |
|
|
|
9,263 |
|
|
|
(2,067 |
) |
|
|
253 |
|
|
|
7,470 |
|
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
2,113 |
|
|
|
– |
|
|
|
2,113 |
|
Decrease
in unrealized gain on securities available-for-sale, net of
tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(16 |
) |
|
|
(16 |
) |
Changes
in fair value of cash flow hedges, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(27 |
) |
|
|
(27 |
) |
Change
in post-retirement benefit obligation, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(6 |
) |
|
|
(6 |
) |
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,064 |
|
Issuance
of stock upon exercise of options
|
|
|
9 |
|
|
|
– |
|
|
|
288 |
|
|
|
– |
|
|
|
– |
|
|
|
288 |
|
Income
tax benefits realized from employee stock option exercises
|
|
|
– |
|
|
|
– |
|
|
|
179 |
|
|
|
– |
|
|
|
– |
|
|
|
179 |
|
Issuance
of stock under employee stock purchase plan
|
|
|
2 |
|
|
|
– |
|
|
|
97 |
|
|
|
– |
|
|
|
– |
|
|
|
97 |
|
Stock-based
compensation expense
|
|
|
– |
|
|
|
– |
|
|
|
376 |
|
|
|
– |
|
|
|
– |
|
|
|
376 |
|
Repurchase
of Common Stock
|
|
|
(12 |
) |
|
|
– |
|
|
|
(112 |
) |
|
|
(884 |
) |
|
|
– |
|
|
|
(996 |
) |
Balance
December 31, 2006
|
|
|
1,053 |
|
|
|
21 |
|
|
|
10,091 |
|
|
|
(838 |
) |
|
|
204 |
|
|
|
9,478 |
|
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
2,769 |
|
|
|
– |
|
|
|
2,769 |
|
Increase
in unrealized gain on securities available-for-sale, net of
tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
5 |
|
|
|
5 |
|
Changes
in fair value of cash flow hedges, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(10 |
) |
|
|
(10 |
) |
Change
in post-retirement benefit obligation, net of tax
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(2 |
) |
|
|
(2 |
) |
Comprehensive
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,762 |
|
Issuance
of stock upon exercise of options
|
|
|
10 |
|
|
|
– |
|
|
|
340 |
|
|
|
– |
|
|
|
– |
|
|
|
340 |
|
Income
tax benefits realized from employee stock option exercises
|
|
|
– |
|
|
|
– |
|
|
|
177 |
|
|
|
– |
|
|
|
– |
|
|
|
177 |
|
Issuance
of stock under employee stock purchase plan
|
|
|
2 |
|
|
|
– |
|
|
|
112 |
|
|
|
– |
|
|
|
– |
|
|
|
112 |
|
Stock-based
compensation expense
|
|
|
– |
|
|
|
– |
|
|
|
407 |
|
|
|
– |
|
|
|
– |
|
|
|
407 |
|
Cumulative
effect of change in accounting principle
|
|
|
– |
|
|
|
– |
|
|
|
– |
|
|
|
(26 |
) |
|
|
– |
|
|
|
(26 |
) |
Repurchase
of Common Stock
|
|
|
(13 |
) |
|
|
– |
|
|
|
(132 |
) |
|
|
(913 |
) |
|
|
– |
|
|
|
(1,045 |
) |
Prepaid
repurchase of Common Stock
|
|
|
– |
|
|
|
– |
|
|
|
(300 |
) |
|
|
– |
|
|
|
– |
|
|
|
(300 |
) |
Balance
December 31, 2007
|
|
|
1,052 |
|
|
$ |
21 |
|
|
$ |
10,695 |
|
|
$ |
992 |
|
|
$ |
197 |
|
|
$ |
11,905 |
|
See
Notes to Consolidated Financial Statements.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
In
this Annual Report, “Genentech,” “we,” “us,” and “our” refer to
Genentech, Inc. “Common Stock” refers to Genentech’s Common Stock, par value
$0.02 per share, “Special Common Stock” refers to Genentech’s callable putable
common stock, par value $0.02 per share, all of which was redeemed by Roche
Holdings, Inc. (RHI) on June 30, 1999 (the Redemption).
Note
1.
|
DESCRIPTION
OF BUSINESS
|
Genentech
is a leading biotechnology company that discovers, develops, manufactures and
commercializes pharmaceutical products to treat patients with significant unmet
medical needs. We commercialize multiple biotechnology products, and also
receive royalties from companies that have licensed our technology.
Redemption
of Our Special Common Stock
On
June 30, 1999, RHI exercised its option to cause us to redeem all of our Special
Common Stock held by stockholders other than RHI. The Redemption was reflected
as a purchase of a business, which under U.S. generally accepted accounting
principles (GAAP) required push-down accounting to reflect in our financial
statements the amounts paid for our stock in excess of our net book value. The
aggregate purchase price for the acquisition of all of Genentech’s outstanding
shares, including RHI’s estimated transaction costs of $10 million, was $6,605
million.
Note
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Principles
of Consolidation
The
consolidated financial statements include the accounts of Genentech and all of
our wholly owned subsidiaries. Material intercompany accounts and transactions
have been eliminated.
Use
of Estimates and Reclassifications
The
preparation of financial statements in conformity with GAAP requires management
to make judgments, assumptions, and estimates that affect the amounts reported
in our consolidated financial statements and accompanying notes. Actual results
could differ materially from those estimates.
Certain
reclassifications of prior period amounts, including amounts related to our
adoption of Financial Accounting Standards Board (FASB) Interpretation No. 48,
“Accounting for Uncertainty in Income
Taxes” (FIN 48),
have been made to our consolidated financial statements to conform to the
current period presentation.
Recent
Accounting Pronouncements
In
December 2007, the FASB ratified the final consensuses in Emerging Issues Task
Force (EITF) Issue No. 07-1, “Accounting for Collaborative
Arrangements” (EITF 07-1), which requires certain income statement
presentation of transactions with third parties and of payments between parties
to the collaborative arrangement, along with disclosure about the nature and
purpose of the arrangement. EITF 07-1 is effective for us beginning January 1,
2009. We do not expect this Issue to have a material effect on our consolidated
financial statements.
In
June 2007, the FASB ratified EITF Issue No. 07-3, “Accounting for Nonrefundable
Advance Payments for Goods or Services Received for Use in Future Research and
Development Activities” (EITF 07-3). EITF 07-3 requires that
nonrefundable advance payments for goods and services that will be used or
rendered in future R&D activities
pursuant
to executory contractual arrangements be deferred and recognized as an expense
in the period that the related goods are delivered or services are performed.
EITF 07-3 is effective for us beginning on January 1, 2008. We do not expect
this Issue to have a material effect on our consolidated financial
statements.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements”
(FAS 157), which provides enhanced guidance for using fair value to
measure assets and liabilities. The standard applies whenever other standards
require (or permit) assets or liabilities to be measured at fair value. The
standard does not expand the use of fair value in any new circumstances.
FAS 157 is effective for financial statements issued for fiscal years
beginning after November 15, 2007, and interim periods within those fiscal
years. FAS 157 is effective for us beginning January 1, 2008. We do not
expect this pronouncement to have a material effect on our consolidated
financial statements.
Revenue
Recognition
We
recognize revenue from the sale of our products, royalties earned, and contract
arrangements. Advance payments received in excess of amounts earned are
classified as deferred revenue until earned.
Product
Sales
We
recognize revenue from product sales when there is persuasive evidence that an
arrangement exists, title passes, the price is fixed and determinable, and
collectibility is reasonably assured. Allowances are established for estimated
rebates, healthcare provider contractual chargebacks, prompt pay sales
discounts, product returns, and wholesaler and distributor inventory management
allowances. In our domestic commercial collaboration agreements, we have primary
responsibility for the United States (U.S.) product sales commercialization
efforts, including selling and marketing, customer service, order entry,
distribution, shipping and billing. We record net product sales and related
production and selling costs in our income statement line items on a gross
basis, since we have the manufacturing risk and/or inventory risk, and credit
risk, and meet the criteria as a principal under EITF Issue No. 99-19, “Reporting Revenue Gross as a
Principal Versus Net as an Agent” (EITF 99-19).
The
Avastin Patient Assistance Program is a voluntary program that enables eligible
patients who have received 10,000 milligrams of Avastin in a 12-month period to
receive free Avastin in excess of the 10,000 milligrams during the remainder of
the 12-month period. Based on the current wholesale acquisition cost, 10,000
milligrams is valued at $55,000 in gross revenue. We defer a portion of our
gross Avastin product sales revenue to reflect our estimate of the commitment to
supply free Avastin to patients who elect to enroll in the program. To calculate
our deferred revenue, we estimate several factors most notably: the number of
patients who are currently being treated for FDA-approved indications and the
start date of their treatment regimen, the extent to which doctors and patients
may elect to enroll in the program, the number of patients who meet the
financial eligibility requirements of the program, and the duration and extent
of treatment for the FDA approved indications, among other factors. We will
continue to update our estimates each reporting period as new information
becomes available. Based on these estimates we defer a portion of the Avastin
revenue on product vials sold through normal commercial channels. The deferred
revenue is recognized when free Avastin vials are delivered or after the
associated patient eligibility period has passed.
Royalties
We
recognize revenue from royalties based on licensees’ sales of our products or
products using our technologies. Royalties are recognized as earned in
accordance with the contract terms when royalties from licensees can be
reasonably estimated and collectibility is reasonably assured. If the
collectibility of a royalty amount is not reasonably assured, royalty revenue is
recognized as revenue when the cash is received. For the majority of our royalty
revenue, estimates are made using historical and forecasted sales trends and
used as a basis to record amounts in advance of amounts
collected.
Contract
Revenue
Contract
revenue generally includes upfront and continuing licensing fees, manufacturing
fees, milestone payments and net reimbursements from collaborators on
development, post-marketing and commercial costs. For those contract
arrangements with up-front license fees that were entered into prior to the
effective date of July 1, 2003 for EITF 00-21, “Revenue Arrangements with Multiple
Deliverables” (EITF 00-21), our accounting policy on contract revenue is
as follows:
|
Ÿ
|
Nonrefundable
upfront fees, including product opt-ins, for which no further performance
obligations exist, are recognized as revenue on the earlier of when
payments are received or collection is
assured.
|
|
Ÿ
|
Nonrefundable
upfront licensing fees, including product opt-ins, and certain guaranteed,
time-based payments that require our continuing involvement in the form of
development, manufacturing or other commercialization efforts by us are
recognized as revenue:
|
|
Ÿ
|
ratably
over the development period if development risk is significant,
or
|
|
Ÿ
|
ratably
over the manufacturing period or estimated product useful life if
development risk has been substantially
eliminated.
|
|
Ÿ
|
Upfront
manufacturing fees are recognized as revenue as the related manufacturing
services are rendered, generally on a straight-line basis over the
performance period of the longer of the manufacturing obligation period or
the expected product life. Manufacturing profit is recognized when the
product is shipped and title
passes.
|
|
Ÿ
|
Fees
associated with substantive milestones, which are contingent upon future
events for which there is reasonable uncertainty as to their achievement
at the time the agreement was entered into, are recognized as revenue when
these milestones, as defined in the contract, are
achieved.
|
For
those contract arrangements with up-front license fees that were entered into
subsequent to the effective date of July 1, 2003 for EITF 00-21, our accounting
policy is as follows:
|
Ÿ
|
We
evaluate whether there is stand-alone value to the customer for the
delivered elements and objective evidence of fair value to allocate
revenue to each element in multiple element agreements. When the delivered
element does not have stand-alone value or there is insufficient evidence
of fair value for the undelivered element(s), we recognize the
consideration for the combined unit of accounting in the same manner as
the revenue is recognized for the final deliverable, which is generally
ratably over the longest period of
involvement.
|
Commercial
collaborations resulting in a net reimbursement of development, post-marketing,
and commercial costs are recognized as revenue as the related costs are
incurred. The corresponding development and post-marketing expenses are included
in research and development (R&D) expenses and the corresponding commercial
costs are included in marketing, general and administrative (MG&A) expenses
in the Consolidated Statements of Income.
Product
Sales Allowances
Revenue
from product sales are recorded net of allowances for estimated rebates,
healthcare provider contractual chargebacks, prompt pay sales discounts, product
returns, and wholesaler and distributor inventory management allowances, all of
which are established at the time of sale. These allowances are based on
estimates of the amounts earned or to be claimed on the related sales. These
estimates take into consideration our historical experience, current contractual
and statutory requirements, specific known market events and trends such as
competitive pricing and new product introductions, and forecasted customer
buying patterns and inventory levels, including the shelf life of our products.
Rebates, healthcare provider contractual chargebacks, inventory management
allowances, prompt
pay
sales discounts and product returns are product-specific, which can be affected
by the mix of products sold in any given period. All of our product sales
allowances are based on estimates. If actual future results vary, we may need to
adjust these estimates, which could have an effect on earnings in the period of
the adjustment. Our product sales allowances and accruals are as
follows:
|
Ÿ
|
Rebate
allowances and accruals comprise both direct and indirect rebates. Direct
rebates are contractual price adjustments payable to wholesalers and
specialty pharmacies that purchase products directly from us. Indirect
rebates are contractual price adjustments payable to healthcare providers
and organizations, such as payers, clinics, hospitals, pharmacies, and
group purchasing organizations that do not purchase products directly from
us. Both types of allowances are based on definitive contractual
agreements or legal requirements (such as Medicaid) related to the
dispensing of the product by a pharmacy, clinic, or hospital to a benefit
plan participant. Rebate accruals are recorded in the same period that the
related revenue is recognized, resulting in a reduction to product sales
revenue and the recognition of a contra asset (if due to a wholesaler or
specialty pharmacy) or a liability (if due to a third party, such as a
healthcare provider) as appropriate, which are included in accounts
receivable allowances or other accrued liabilities, respectively. Rebates
are estimated using historical and other data, including patient usage,
customer buying patterns, applicable contractual rebate rates, and
contract performance by the benefit providers. Rebate estimates are
evaluated quarterly and may require adjustments to better align our
estimates with actual results. As part of this evaluation, we review
changes to federal legislation, changes to rebate contracts, changes in
the level of discounts, and changes in product sales trends. Although
rebates are accrued at the time of sale, rebates are typically paid out,
on average, up to six months after the
sale.
|
|
Ÿ
|
Healthcare
provider contractual chargebacks are the result of contractual commitments
by us to provide products to healthcare providers at specified prices or
discounts. These contracted healthcare providers include (i) hospitals
that service a disproportionately high share of economically indigent and
Medicaid patients for which they receive little or no reimbursement (i.e.,
Disproportionate Share Hospitals), (ii) government-owned hospitals that
receive discounts, and (iii) hospitals that have contract pricing for
certain products, usually through a group purchasing agreement.
Chargebacks occur when a contracted healthcare provider purchases our
products through an intermediary wholesaler at fixed contract prices that
are lower than the list prices we charge the wholesalers. The wholesaler,
in turn, charges us back for the difference between the price initially
paid by the wholesaler and the contract price paid to the wholesaler by
the healthcare providers. Chargebacks are accrued at the time of sale and
are estimated based on historical trends, which closely approximate actual
results as we generally issue credits within a few weeks of the time of
sale.
|
|
Ÿ
|
Prompt
pay sales discounts are credits granted to wholesalers for remitting
payment on their purchases within contractually defined cash repayment
incentive periods. The contractually defined cash repayment periods are
generally 30 days; however, for newly launched products, we have offered
and we may offer in the future, extended payment terms to wholesalers. In
connection with the launch of Lucentis, we have offered, and continued to
offer, an extended payment terms program to certain wholesalers. Based
upon our experience that it is rare that a wholesaler does not comply with
the contractual terms to earn the prompt pay sales discount, we accrue 100
percent of the prompt pay sales discounts at the time of original
sale.
|
|
Ÿ
|
Wholesaler
and distributor inventory management allowances are credits granted to
wholesalers and distributors for compliance with various contractually
defined inventory management programs. These programs provide monetary
incentives in the form of a credit for wholesalers and distributors to
maintain consistent inventory levels at approximately two to three weeks
of sales depending on the product. These wholesaler inventory management
credits are calculated based on quarterly product purchases multiplied by
a factor to determine the maximum possible credit for a product for the
preceding quarter. Adjustments to reduce the maximum credit are made if
the wholesaler does not meet and/or comply with the contractually defined
metrics. These metrics include data timeliness, completeness and accuracy
and deviations outside of the contracted inventory days on hand for each
product. The maximum credits are accrued at the time of sale, and are
typically granted to wholesaler accounts within 90 days after the
sale.
|
|
Ÿ
|
Product
return allowances are established in accordance with our returns policy,
which allows buyers to return our products within two months prior to and
six months following product expiration. Most of our products are sold to
our wholesalers with at least six months of dating prior to expiration. As
part of our estimation process, we calculate historical return data on a
production lot basis. Historical rates of return are determined by product
and are adjusted for known or expected changes in the marketplace specific
to each product. In addition, we review expiration dates to determine the
remaining shelf life of each product not yet returned. Although product
return allowances are accrued at the time of sale, the majority of returns
take place up to two years after the
sale.
|
Allowances
against receivable balances primarily relate to product returns,
wholesaler-related direct rebates, prompt pay sales discounts, and wholesaler
inventory management allowances, and are recorded in the same period that the
related revenue is recognized, resulting in a reduction in product sales revenue
and the reporting of product sales receivable net of allowances. Accruals
related to indirect rebates and contractual chargebacks for healthcare providers
are recognized in the same period that the related revenue is recognized,
resulting in a reduction in product sales revenue, and are recorded as other
accrued liabilities.
Commercial
Collaboration Accounting
We
have domestic commercial collaboration profit sharing agreements with Biogen
Idec Inc. on Rituxan, with Novartis Pharma AG on Xolair, and with OSI
Pharmaceuticals, Inc. on Tarceva. In these agreements, we have primary
responsibility for the U.S. commercialization, including sales and/or marketing,
customer support, order entry, distribution, shipping, and billing. In addition
to being primarily responsible for providing the product or service to the
customer, we have general inventory risk prior to the customer placing an order
or upon customer return, and we are exposed to customer credit risk. We record
net product sales and related production and selling costs for our domestic
collaborations in our Consolidated Statements of Income on a gross basis since
we are the principal in the sales transaction, as defined under EITF 99-19. The
collaboration profit sharing expense line in our Consolidated Statements of
Income primarily includes the profit sharing results with Biogen Idec on
Rituxan, with Novartis Pharma AG on Xolair, and with OSI Pharmaceuticals on
Tarceva.
We
have a European commercial collaboration profit sharing agreement with Novartis
Pharma AG on Xolair. We do not record the net product sales and related
production and selling costs for our European collaboration in our Consolidated
Statements of Income on a gross basis since we do not meet the criteria as a
principal under EITF 99-19, and instead record our net share of the European
collaboration profits as contract revenue (or collaboration losses as
collaboration profit sharing expense). See also Note 9, “Relationship with Roche
Holdings, Inc. and Related Party Transactions,” regarding Novartis related
collaboration costs and profit sharing expenses.
Research
and Development Expenses
Research
and development (R&D) expenses include salaries, benefits, and other
headcount related costs; clinical trial and related clinical manufacturing
costs; contract and other outside service fees; employee stock-based
compensation expense; and facilities and overhead costs. R&D expenses
consist of independent R&D costs and costs associated with collaborative
R&D and in-licensing arrangements. In addition, we acquire R&D services
from other companies and fund research institutions under agreements which we
can generally terminate at will. R&D expenses also include post-marketing
activities such as Phase IV and investigator-sponsored trials and product
registries. R&D costs, including upfront fees and milestones paid to
collaborators, are expensed as incurred, if the underlying assets are determined
to have no alternative future use. The costs of the acquisition of technology
are capitalized if they have alternative future uses in other R&D projects
or otherwise. R&D collaborations resulting in a net payment of development
and post-marketing costs are recognized as R&D expense as the related costs
are incurred.
Royalty
Expenses
Royalty
expenses and milestones directly related to product sales are classified in cost
of sales (COS). Other royalty expenses, relating to royalty revenue, are
classified in MG&A expenses and totaled $312 million in 2007, $221 million
in 2006, and $182 million in 2005.
Advertising
Expenses
We
expense the costs of advertising, which also include promotional expenses, as
incurred. Advertising expenses were $400 million in 2007, $439 million in 2006,
and $345 million in 2005.
Research
and Development Arrangements
To
gain access to potential new products and technologies and to utilize other
companies to help develop our potential new products, we establish strategic
alliances with various companies. These strategic alliances often include the
acquisition of marketable and nonmarketable equity investments or debt of
companies developing technologies that complement or fall outside of our
research focus and include companies having the potential to generate new
products through technology licensing and/or investments. Potential future
payments may be due to certain collaborators achieving certain benchmarks as
defined in the collaborative agreements. We also entered into product-specific
collaborations to acquire development and marketing rights for products. See
Note 8, “Leases, Commitments and Contingencies,” and Note 9, “Relationship with
Roche Holdings, Inc. and Related Party Transactions,” below for a discussion of
our more significant collaborations.
Under
FIN 46R, we are required to assess new business development collaborations as
well as to, upon certain events, some of which are outside our control, reassess
the accounting treatment of our existing business development collaborations
based on the nature and extent of our financial interests as well as our ability
to exercise influence in such collaborations. While this standard has not had a
material effect on our financial results during 2006 and 2007, our
continuing compliance may result in our consolidation of companies or related
entities with which we have a collaborative arrangement, and this may have a
material effect on our financial condition and/or results of operations in
future periods.
Cash
and Cash Equivalents
We
consider all highly liquid available-for-sale debt securities purchased with an
original maturity of three months or less to be cash equivalents.
Inventories
Inventories
are stated at the lower of cost or market value. Cost is determined using a
weighted-average approach, assuming full absorption of direct and indirect
manufacturing costs, based on our product capacity utilization assumptions.
Excess capacity charges are recorded as period expenses in COS when actual
production volumes are lower than normal production capabilities, as reasonably
determined by management. If inventory costs exceed expected market value due to
obsolescence or lack of demand, reserves are recorded for the difference between
the cost and the estimated market value. These reserves are determined based on
significant estimates. Inventories may include products awaiting regulatory
approval or products manufactured at facilities awaiting regulatory approval and
are capitalized based on management’s judgment of probable near-term regulatory
approval. In addition, inventories include employee stock-based compensation
expenses capitalized under FAS 123R.
Investments
in Marketable and Nonmarketable Securities
We
invest in short-term and long-term marketable securities, primarily corporate
notes, government, government agency, preferred stock, asset-backed securities,
and municipal bonds. As part of our strategic alliance efforts,
we
may
also invest in equity securities, dividend-bearing convertible preferred stock,
and interest-bearing debt of other biotechnology companies. We record these
investments under the cost method of accounting, as we hold less than a 20%
ownership position in all of these collaborator companies.
We
classify marketable equity and debt securities into one of two
categories: available-for-sale or trading. Trading securities are bought,
held, and sold with the objective of generating returns. We have established
maximum amounts of our total investment portfolio that can be included in our
trading portfolio, the majority of which is managed by investment management
firms that operate within investment policy guidelines that we provide. Trading
securities are classified as short-term investments and are carried at estimated
fair market value. Unrealized holding gains and losses on trading securities are
included in “Interest and other income (expense), net.” Debt securities and
marketable equity securities not classified as trading are considered
available-for-sale. These securities are carried at estimated fair value (see
Note 4, “Investment Securities and Financial Instruments,” below) with
unrealized gains and losses included in accumulated other comprehensive income
in stockholders’ equity. Unrealized losses are charged against “Other income,
net” when a decline in fair value is determined to be other-than-temporary. In
accordance with EITF 03-1, and FAS 155-1, “The Meaning of Other-Than-Temporary
Impairment and Its Application to Certain Investments,” we review several
factors to determine whether a loss is other-than-temporary. These factors
include but are not limited to: (i) the extent to which the fair value is less
than cost and the cause for the fair value decline, (ii) the financial condition
and near term prospects of the issuer, (iii) the length of time a security is in
an unrealized loss position and (iv) our ability to hold the security for a
period of time sufficient to allow for any anticipated recovery in fair value.
Available-for-sale equity securities and available-for-sale debt securities with
remaining maturities of greater than one year are classified as
long-term.
If
the estimated fair value of a security is below its carrying value, we evaluate
whether we have the intent and ability to retain our investment for a period
of time sufficient to allow for any anticipated recovery in market value
and whether evidence indicating that the cost of the investment is recoverable
within a reasonable period of time outweighs evidence to the contrary. Some of
the factors that we consider in determining whether an impairment is
other-than-temporary include, among other things, unfavorable clinical trial
results and the diminished prospect for new products, failure to receive product
approval from a regulatory body, the termination of a major collaborative
relationship and the liquidity position and financing activities of the issuer.
If the impairment is considered to be other-than-temporary, the security is
written down to its estimated fair value. Other-than-temporary declines in
estimated fair value of all marketable securities are charged to “Interest and
other income (expense), net.” The cost of all securities sold is based on the
specific identification method. We recognized charges of $50 million in 2007, $4
million in 2006, and $5 million in 2005 related to other-than-temporary declines
in the estimated fair values of certain of our marketable equity and debt
securities.
Nonmarketable
equity securities are carried at cost, less any write-downs for impairment. We
periodically monitor the liquidity and financing activities and R&D progress
of the respective issuers to determine if impairment write-downs to our
nonmarketable equity securities are necessary.
Derivative
Instruments
We
use derivatives to manage our market exposure to fluctuations in foreign
currencies, U.S. interest rates and marketable equity investments. We record all
derivatives on the balance sheet at estimated fair value. For derivative
instruments that are designated and qualify as a fair value hedge (i.e., hedging
the exposure to changes in the estimated fair value of an asset or a liability
or an identified portion thereof that is attributable to a particular risk), the
gain or loss on the derivative instrument, as well as the offsetting loss or
gain on the hedged item attributable to the hedged risk, is recognized in
current earnings during the period of the change in estimated fair values. For
derivative instruments that are designated and qualify as a cash flow hedge
(i.e., hedging the exposure to variability in expected future cash flows that is
attributable to a particular risk), the effective portion of the gain or loss on
the derivative instrument is reported as a component of other comprehensive
income and reclassified into earnings in the same period or periods during which
the hedged transaction affects earnings. The gain or loss on the derivative
instruments in excess of the cumulative change in the present value of future
cash flows of the hedged transaction, if any, is recognized in current earnings
during the period of change. We do not use derivative instruments for
speculative purposes. See Note 4, “Investment Securities and Financial
Instruments—Derivative Financial Instruments,” below for further information on
our accounting for derivatives.
Property,
Plant and Equipment
The
costs of buildings and equipment are depreciated using the straight-line method
over the estimated useful lives of the assets, but not more than:
|
Useful
Lives
|
Buildings
|
25
years
|
Certain
manufacturing equipment
|
15
years
|
Other
equipment
|
3
to 8 years
|
Leasehold
improvements
|
length
of applicable lease
|
Depreciation
expense on biologics manufacturing facilities constructed or purchased begins
once production activities have commenced at the facility, which is generally at
the point at which qualification lots are being produced. The point at which
depreciation is commenced best represents the point at which the asset is ready
for its intended use, and generally precedes U.S. Food and Drug Administration
(FDA) licensure of the facility.
FDA
Validation Costs
FDA
validation costs are capitalized as part of the effort required to acquire and
construct long-lived assets, including readying them for their intended use, and
are amortized over the estimated useful life of the asset or the term of the
lease, whichever is shorter, and charged to COS. These costs are included in
“Other long-term assets” in the accompanying Consolidated Balance
Sheets.
Goodwill
and Other Intangible Assets
Goodwill
represents the difference between the purchase price and the estimated fair
value of the net assets acquired when accounted for by the purchase method of
accounting and arises from RHI’s purchases of our Special Common Stock and
push-down accounting (refer to “Redemption of Our Special Common Stock” in Note
1 above) as well as from our acquisition of Tanox, Inc. in the third quarter of
2007. In accordance with FAS 142, “Goodwill and Intangible
Assets” (FAS 142), we do not amortize goodwill. Also in accordance with
FAS 142, we perform an annual impairment test of goodwill every September at the
Company level, which is the sole reporting unit, and have found no impairment.
We will continue to evaluate our goodwill for impairment annually and whenever
events and changes in circumstances suggest that the carrying amount may not be
recoverable.
We
amortize intangible assets with definite lives on a straight-line basis over
their estimated useful lives, ranging from five to 15 years, and review for
impairment when events or changes in circumstances indicate that the carrying
amount of such assets may not be recoverable. We capitalize costs of patents and
patent applications related to products and processes of significant importance
to us and amortize these on a straight-line basis over their estimated useful
lives of approximately 12 years.
Restricted
Cash and Investments
We
have entered into an arrangement with third-party insurance companies to post a
bond in connection with the City of Hope trial judgment. As part of this
arrangement, we were required to pledge cash and investments to secure this
bond. As of December 31, 2007 and 2006, we held restricted cash and investments
of $788 million, related to the surety bond. These amounts are reflected in the
Consolidated Balance Sheets in “Restricted cash and investments.” See Note 8,
“Leases, Commitments and Contingencies,” for further discussion of the City of
Hope litigation.
Impairment
of Long-Lived Assets
Long-lived
assets and certain identifiable intangible assets to be held and used are
reviewed for impairment when events or changes in circumstances indicate that
the carrying amount of such assets may not be recoverable. Determination of
recoverability is based on an estimate of undiscounted future cash flows
resulting from the use of the asset and its eventual disposition. In the event
that such cash flows are not expected to be sufficient to recover the carrying
amount of the assets, the assets are written down to their estimated fair
values. Long-lived assets and certain identifiable intangible assets to be
disposed of are reported at the lower of carrying amount or fair value less cost
to sell.
Sabbatical
Leave Benefits
On
January 1, 2007, we adopted EITF Issue No. 06-2, “Accounting for Sabbatical Leave and
Other Similar Benefits Pursuant to FASB Statement No. 43, Accounting for
Compensated Absences” (EITF 06-2). Prior to the
adoption of EITF 06-2, we recorded a liability for a sabbatical leave when the
employee vested in the benefit, which was only at the end of a six-year service
period. Under EITF 06-2, we accrue an estimated liability for a sabbatical leave
over the requisite six-year service period, as the employee’s services are
rendered. Upon our adoption of EITF 06-2, we recorded an adjustment to retained
earnings (accumulated deficit) of $26 million, net of tax, as a cumulative
effect of a change in accounting principle.
Accounting
for Employee Stock-Based Compensation
On
January 1, 2006, we adopted FAS No. 123(R), “Share-Based Payment” (FAS
123R), which supersedes our previous accounting under Accounting Principles
Board Opinion No. 25, “Accounting for Stock Issued to
Employees” (APB 25). FAS 123R requires the recognition of compensation
expense, using a fair-value based method, for costs related to all share-based
payments, including stock options and stock issued under our employee stock
purchase plan (ESPP). FAS 123R requires companies to estimate the fair value of
share-based payment awards on the date of grant using an option-pricing model.
We adopted FAS 123R using the modified prospective transition method, which
requires that compensation expense be recognized in the financial statements for
all awards granted after the date of adoption as well as for existing awards for
which the requisite service has not been rendered as of the date of adoption.
The modified prospective transition method does not require restatement of prior
periods to reflect the effect of FAS 123R.
In
November 2005, the FASB issued FASB Staff Position No. 123R-3, “Transition Election Related to
Accounting for the Tax Effects of Share-Based Payment Awards.” We have
adopted the simplified method to calculate the beginning balance of the
additional paid-in-capital (APIC) pool of the excess tax benefit, and to
determine the subsequent effect on the APIC pool and Consolidated Statements of
Cash Flows of the tax effects of employee stock-based compensation awards that
were outstanding upon our adoption of FAS 123R.
Prior
to the adoption of FAS 123R, we accounted for stock-based awards to employees
and directors using the intrinsic value method in accordance with APB 25 as
allowed under FAS No. 123, “Accounting for Stock-Based
Compensation” (FAS 123). Under the intrinsic value method, no employee
stock-based compensation expense had been recognized in our Consolidated
Statements of Income for any period prior to our adoption of FAS 123R on January
1, 2006, as the exercise price of the stock options granted to employees and
directors equaled the fair market value of the underlying stock at the date of
grant. See Note 3, “Employee Stock-Based Compensation,” for further discussion
of employee stock-based compensation.
401(k)
Plan and Other Postretirement Benefits
Our
401(k) Plan (the 401(k) Plan) covers substantially all of our employees. We
match a portion of employee contributions, up to a maximum of 5% of each
employee’s eligible compensation. Historically, the match was effective and
fully vested at December 31 of each year. Effective October 1, 2006, the match
is funded concurrently with a participant’s semi-monthly contribution to the
401(k) Plan. Additionally, we annually contributed to every
employee’s
account 1% of his or her eligible compensation, regardless of whether the
employee actively participates in the 401(k) Plan. In the third quarter of 2006,
we increased the contribution to 2% of the employee’s compensation, beginning
with the 2006 annual contribution. We recorded expense of $85 million in 2007,
$68 million in 2006, and $46 million in 2005 for our
contributions under the Plan.
In
addition, we provide certain postretirement benefits, primarily healthcare
related, to employees who meet certain eligibility criteria. As of December 31,
2005, the accrued benefit costs and the accumulated benefit obligation related
to these postretirement benefits were not material. In 2006, we adopted FAS No.
158, “Employers’ Accounting
for Defined Benefit Pension and Other Postretirement Plans–an amendment of FASB
Statements No. 87, 88, 106, and 132(R)” (FAS 158). FAS 158 requires
companies to recognize the funded status of their postretirement benefit plan in
the statement of financial position. As of December 31, 2007 and 2006, our
postretirement benefit plan was not funded. The accumulated postretirement
benefit obligation as of December 31, 2007 and 2006 was $27 million and $21
million, respectively, which was primarily included in “Other long-term
liabilities” in the Consolidated Balance Sheets.
Stock
Repurchases
The
par value method of accounting is used for our common stock repurchases. The
excess of the cost of shares acquired over the par value is allocated to
additional paid-in capital with the amounts in excess of the estimated original
sales price charged to retained earnings (accumulated deficit).
Income
Taxes
Our
income tax provision is based on pretax financial accounting income computed
under the liability method. Deferred tax assets and liabilities are determined
based on the difference between the financial statement and tax basis of assets
and liabilities using enacted tax rates in effect for the year in which the
differences are expected to reverse. Significant estimates are required in
determining our provisions for income taxes. Some of these estimates are based
on interpretations of existing tax laws or regulations. We believe that our
estimates are reasonable and that our reserves for income tax related
uncertainties are adequate. Various internal and external factors may have
favorable or unfavorable effects on our future effective income tax rate. These
factors include, but are not limited to, changes in tax laws, regulations,
and/or rates, the results of any tax examinations, changing interpretations of
existing tax laws or regulations, changes in estimates of prior years’ items,
past and future levels of R&D spending, acquisitions, changes in our
corporate structure, and changes in overall levels of income before taxes; all
of which may result in periodic revisions to our effective income tax
rate.
Effective
with the consummation of the public offering of our Common Stock by RHI on
October 26, 1999, we ceased to be a member of the consolidated federal income
tax group (and certain consolidated or combined state and local income tax
groups) of which RHI is the common parent. Accordingly, our tax sharing
agreement with RHI now pertains only to the state and local tax returns in which
we are consolidated or combined with RHI. We will continue to calculate our tax
liability or refund with RHI for these state and local jurisdictions as if we
were a stand-alone entity.
On
January 1, 2007, we also adopted the provisions of FIN 48. Implementation of FIN
48 did not result in a cumulative adjustment to retained earnings (accumulated
deficit). The total amount of unrecognized tax benefits as of the date of
adoption was $147 million. Of this total, $112 million represents the
amount of unrecognized tax benefits that, if recognized, would favorably affect
our effective income tax rate in any future period. As a result of the
implementation of FIN 48, we reclassified $147 million of unrecognized tax
benefits from current liabilities to long-term liabilities as of December 31,
2006 in the accompanying Consolidated Balance Sheets. See Note 12, “Income
Taxes,” for more discussion of FIN 48.
Earnings
Per Share
Basic
earnings per share (EPS) are computed based on the weighted-average number of
shares of our Common Stock outstanding. Diluted EPS is computed based on the
weighted-average number of shares of our Common Stock and other dilutive
securities.
The
following is a reconciliation of the numerators and denominators of the basic
and diluted EPS computations (in millions):
|
|
|
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
|
|
|
Net
income
|
|
$ |
2,769 |
|
|
$ |
2,113 |
|
|
$ |
1,279 |
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
shares outstanding used to compute basic EPS
|
|
|
1,053 |
|
|
|
1,053 |
|
|
|
1,055 |
|
Effect
of dilutive stock options
|
|
|
16 |
|
|
|
20 |
|
|
|
26 |
|
Weighted-average
shares outstanding and dilutive securities used to compute diluted
EPS
|
|
|
1,069 |
|
|
|
1,073 |
|
|
|
1,081 |
|
Outstanding
employee stock options to purchase approximately 39 million shares of our Common
Stock for 2007 were excluded from the computation of diluted EPS because the
effect would have been anti-dilutive. See Note 3, “Employee Stock-Based
Compensation,” for information on option exercise prices and expiration
dates.
Comprehensive
Income
Comprehensive
income comprises net income and other comprehensive income (OCI). OCI includes
certain changes in stockholders’ equity that are excluded from net income.
Specifically, we include in OCI changes in the estimated fair value of
derivatives designated as effective cash flow hedges and unrealized gains and
losses on our available-for-sale securities. In accordance with our adoption of
FAS 158 in 2006, the gains or losses and prior service costs or credits that
arise during the period but are not recognized as components of net periodic
benefit cost have been recognized in other comprehensive income. Comprehensive
income for the years ended December 31, 2007, 2006, and 2005 has been reflected
in the Consolidated Statements of Stockholders’ Equity.
The
components of accumulated other comprehensive income, net of taxes, at December
31, 2007 and 2006 were as follows (in millions):
|
|
|
|
|
|
|
Net
unrealized gains on securities available-for-sale
|
|
$ |
219 |
|
|
$ |
214 |
|
Net
unrealized losses on cash flow hedges
|
|
|
(14 |
) |
|
|
(4 |
) |
Change
in post-retirement benefit obligation
|
|
|
(8 |
) |
|
|
(6 |
) |
Accumulated
other comprehensive income
|
|
$ |
197 |
|
|
$ |
204 |
|
The
activity in OCI was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
Decrease
in unrealized gains on securities available-for-sale (net of
tax: 2007-$(7); 2006-$(11); 2005-$(49))
|
|
$ |
(10 |
) |
|
$ |
(13 |
) |
|
$ |
(74 |
) |
Reclassification
adjustment for net losses (gains) on securities available-for-sale
included in net income (net of tax: 2007-$10; 2006-$(2);
2005-$(1))
|
|
|
15 |
|
|
|
(3 |
) |
|
|
(1 |
) |
(Decrease)
increase in unrealized gains on cash flow hedges (net of
tax: 2007-$(8); 2006-$(12); 2005-$32)
|
|
|
(12 |
) |
|
|
(18 |
) |
|
|
48 |
|
Reclassification
adjustment for net (gains) losses on cash flow hedges included in net
income (net of tax: 2007-$2; 2006-$(6); 2005-$(7))
|
|
|
2 |
|
|
|
(9 |
) |
|
|
(11 |
) |
Change
in post-retirement benefit obligation (net of tax: 2007-$(1);
2006-$(4))
|
|
|
(2 |
) |
|
|
(6 |
) |
|
|
– |
|
Other
comprehensive loss
|
|
$ |
(7 |
) |
|
$ |
(49 |
) |
|
$ |
(38 |
) |
Note
3.
|
Employee
Stock-Based Compensation
|
On
January 1, 2006, we adopted FAS 123R, which supersedes our previous accounting
under APB 25. FAS 123R requires the recognition of compensation expense, using a
fair-value based method, for costs related to all share-based payments including
stock options and stock issued under our ESPP. Under FAS 123R, the value of the
portion of the award that is ultimately expected to vest is recognized as
expense on a straight-line basis over the requisite service periods in our
Consolidated Statements of Income. Also, certain of these costs are capitalized
into inventory on our Consolidated Balance Sheets, and generally will be
recognized as an expense when the related products are estimated to be
sold.
Employee
Stock Plans
Our
ESPP was adopted in 1991 and amended thereafter. The ESPP allows eligible
employees to purchase Common Stock at 85% of the lower of the fair market value
of the Common Stock on the grant date or the fair market value on the purchase
date. The offering period under the ESPP is currently 15 months, and the
purchase price is established during each new offering period. Purchases are
limited to 15% of each employee’s eligible compensation and subject to certain
Internal Revenue Service restrictions. In general, all of our regular full-time
employees are eligible to participate in the ESPP. Of the 52,400,000 shares of
Common Stock reserved for issuance under the ESPP, 48,737,394 shares have been
issued as of December 31, 2007.
We
currently grant options under the Genentech, Inc. 2004 Equity Incentive Plan,
which allows for the granting of non-qualified stock options, incentive stock
options and stock appreciation rights, restricted stock, performance units or
performance shares to our employees, directors and consultants. Incentive stock
options may only be granted to employees under this plan. Generally, stock
options granted to employees have a maximum term of 10 years, and vest over a
four year period from the date of grant; 25% vest at the end of one year,
and 75% vest monthly over the remaining three years. We may grant options with
different vesting terms from time to time. Unless an employee’s termination of
service is due to retirement, disability, or death, upon termination of service,
any unexercised vested options will be forfeited at the end of three months or
the expiration of the option, whichever is earlier.
Stock-Based
Compensation Expense under FAS 123R
Employee
stock-based compensation expense recognized in 2007 and 2006 was calculated
based on awards ultimately expected to vest and has been reduced for estimated
forfeitures. FAS 123R requires forfeitures to be estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates.
Employee
stock-based compensation expense recognized under FAS 123R was as follows (in millions, except per share
data):
|
|
|
|
|
|
|
Cost
of sales
|
|
$ |
71 |
|
|
$ |
– |
|
Research
and development
|
|
|
153 |
|
|
|
140 |
|
Marketing,
general and administrative
|
|
|
179 |
|
|
|
169 |
|
Total
employee stock-based compensation expense
|
|
|
403 |
|
|
|
309 |
|
Tax
benefit related to employee stock-based compensation
expense
|
|
|
(143 |
) |
|
|
(127 |
) |
Net
effect on net income
|
|
$ |
260 |
|
|
$ |
182 |
|
Effect
on earnings per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$ |
0.25 |
|
|
$ |
0.17 |
|
Diluted
|
|
$ |
0.24 |
|
|
$ |
0.17 |
|
As
of December 31, 2007, total compensation cost related to unvested stock options
not yet recognized was $843 million, which is expected to be allocated to
expense and production costs over a weighted-average period of 34
months.
The
carrying value of inventory on our Consolidated Balance Sheets as of December
31, 2007 and 2006 includes employee stock-based compensation costs of $72
million and $67 million, respectively. Substantially all of the products sold
during 2006 were manufactured in previous periods when we did not include
employee stock-based compensation expense in our production costs.
The
following pro forma net income and EPS were determined as if we had accounted
for employee stock-based compensation expense for our employee stock plans under
the fair value method prescribed by FAS 123 in prior periods and had capitalized
certain costs into inventory manufactured in those prior periods, with the
resulting effect on COS for 2006 when previously manufactured products were
sold. (In millions, except per
share data):
|
|
|
|
Net
income as reported
|
|
$ |
2,113 |
|
Deduct: Total
employee stock-based compensation expense includable in cost of sales, net
of related tax effects
|
|
|
(34 |
) |
Pro
forma net income
|
|
$ |
2,079 |
|
Earnings
per share:
|
|
|
|
|
Basic-as
reported
|
|
$ |
2.01 |
|
Basic-pro
forma
|
|
$ |
1.97 |
|
|
|
|
|
|
Diluted-as
reported
|
|
$ |
1.97 |
|
Diluted-pro
forma
|
|
$ |
1.94 |
|
Pro
Forma Information for Periods Prior to Adoption of FAS 123R
The
following pro forma net income and EPS were determined as if we had accounted
for employee stock-based compensation for our employee stock plans under the
fair value method prescribed by FAS 123. (In millions, except per share
data):
|
|
|
|
Net
income as reported
|
|
$ |
1,279 |
|
Deduct: Total
employee stock-based compensation expense determined under the fair value
based method for all awards, net of related tax effects
|
|
|
(175 |
) |
Pro
forma net income
|
|
$ |
1,104 |
|
Earnings
per share:
|
|
|
|
|
Basic-as
reported
|
|
$ |
1.21 |
|
Basic-pro
forma
|
|
$ |
1.05 |
|
|
|
|
|
|
Diluted-as
reported
|
|
$ |
1.18 |
|
Diluted-pro
forma
|
|
$ |
1.02 |
|
Valuation
Assumptions
The
employee stock-based compensation expense recognized under FAS 123R and
presented in the pro forma disclosure required under FAS 123 was determined
using the Black-Scholes option valuation model. Option valuation models require
the input of subjective assumptions and these assumptions can vary over time.
The weighted-average assumptions used are as follows:
|
|
|
|
|
|
|
|
|
|
Risk-free
interest rate
|
|
|
4.3 |
% |
|
|
4.6 |
% |
|
|
4.2 |
% |
Dividend
yield
|
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected
volatility
|
|
|
25.1 |
% |
|
|
27.2 |
% |
|
|
29.3 |
% |
Expected
term (years)
|
|
|
5.0 |
|
|
|
4.6 |
|
|
|
4.2 |
|
Due
to the redemption of our Special Common Stock in June 1999 by RHI, there is
limited historical information available to support our estimate of certain
assumptions required to value our employee stock options. In developing our
estimate of expected term, we have assumed that our recent historical stock
option exercise experience is a relevant indicator of future exercise patterns.
We base our determination of expected volatility predominantly on the implied
volatility of our traded options with consideration of our historical
volatilities and the volatilities of comparable companies.
Stock
Option Activity
The
following is a summary of option activity (shares in
millions):
|
|
|
|
|
|
|
|
|
Shares
Available for Grant
|
|
|
|
|
|
Weighted-Average
Exercise Price
|
|
December
31, 2004
|
|
|
102 |
|
|
|
94 |
|
|
$ |
32.32 |
|
Grants
|
|
|
(20 |
) |
|
|
20 |
|
|
|
84.01 |
|
Exercises
|
|
|
– |
|
|
|
(29 |
) |
|
|
25.88 |
|
Cancellations
|
|
|
2 |
|
|
|
(2 |
) |
|
|
42.16 |
|
December
31, 2005
|
|
|
84 |
|
|
|
83 |
|
|
|
46.64 |
|
Grants
|
|
|
(17 |
) |
|
|
17 |
|
|
|
79.85 |
|
Exercises
|
|
|
– |
|
|
|
(9 |
) |
|
|
30.42 |
|
Cancellations
|
|
|
3 |
|
|
|
(3 |
) |
|
|
62.09 |
|
December
31, 2006
|
|
|
70 |
|
|
|
88 |
|
|
|
54.53 |
|
Grants
|
|
|
(18 |
) |
|
|
18 |
|
|
|
79.40 |
|
Exercises
|
|
|
– |
|
|
|
(10 |
) |
|
|
32.76 |
|
Cancellations
|
|
|
4 |
|
|
|
(4 |
) |
|
|
76.45 |
|
December
31, 2007
|
|
|
56 |
|
|
|
92 |
|
|
$ |
60.94 |
|
The
intrinsic value of options exercised during 2007, 2006, and 2005 was $501
million, $500 million, and $1,473 million, respectively. The estimated fair
value of shares vested during 2007, 2006, and 2005 was $407 million, $376
million, and $276 million, respectively. The weighted-average estimated fair
value of stock options granted during 2007, 2006, and 2005 was $24.40, $24.95,
and $25.00 per option, respectively, based on the assumptions in the
Black-Scholes valuation model discussed above.
The
following table summarizes outstanding and exercisable options at December 31,
2007 (in millions, except
exercise price data):
|
|
|
|
|
|
|
|
|
|
|
Number
of
Shares
Outstanding
|
|
|
Weighted-Average
Remaining
Contractual
Life
(in
years)
|
|
|
Weighted-Average
Exercise Price
|
|
|
Number
of
Shares
Exercisable
|
|
|
Weighted-Average
Remaining
Contractual
Life
(in
years)
|
|
|
Weighted-Average
Exercise
Price
|
|
|
$6.27
- $8.89
|
|
|
|
0.3 |
|
|
|
4.64 |
|
|
$ |
7.41 |
|
|
|
0.3 |
|
|
|
4.64 |
|
|
$ |
7.41 |
|
|
$10.00
- $14.35
|
|
|
|
8.2 |
|
|
|
3.86 |
|
|
$ |
13.68 |
|
|
|
8.2 |
|
|
|
3.86 |
|
|
$ |
13.68 |
|
|
$15.04
- $22.39
|
|
|
|
6.1 |
|
|
|
3.33 |
|
|
$ |
20.87 |
|
|
|
6.1 |
|
|
|
3.33 |
|
|
$ |
20.87 |
|
|
$22.88
- $33.00
|
|
|
|
0.2 |
|
|
|
3.46 |
|
|
$ |
26.33 |
|
|
|
0.2 |
|
|
|
3.46 |
|
|
$ |
26.33 |
|
|
$35.63
- $53.23
|
|
|
|
26.6 |
|
|
|
5.73 |
|
|
$ |
47.05 |
|
|
|
23.6 |
|
|
|
5.67 |
|
|
$ |
46.31 |
|
|
$53.95
- $75.90
|
|
|
|
1.7 |
|
|
|
7.90 |
|
|
$ |
64.79 |
|
|
|
0.8 |
|
|
|
6.76 |
|
|
$ |
59.09 |
|
|
$75.99
- $98.80
|
|
|
|
49.0 |
|
|
|
8.66 |
|
|
$ |
81.78 |
|
|
|
14.5 |
|
|
|
8.08 |
|
|
$ |
83.79 |
|
|
|
|
|
|
92.1 |
|
|
|
|
|
|
|
|
|
|
|
53.7 |
|
|
|
|
|
|
|
|
|
At
December 31, 2007, the aggregate intrinsic value of the outstanding options was
$1,292 million and the aggregate intrinsic value of the exercisable options was
$1,247 million.
Stock
Repurchase Program
Under
a stock repurchase program approved by our Board of Directors in December 2003
and most recently extended in April 2007, we are authorized to repurchase up to
100 million shares of our Common Stock for an aggregate amount of up to $8.0
billion through June 30, 2008. During 2007, we repurchased approximately 13
million shares at an aggregate cost of $1.0 billion. Since the program’s
inception, we have repurchased approximately 75 million shares at a total price
of $5.4 billion. We intend to use the repurchased stock to offset dilution
caused by the issuance of shares in connection with our employee stock plans and
also to maintain RHI’s minimum percentage ownership interest in our stock. See
Note 9, “Relationship with Roche Holdings, Inc. and Related Party Transactions,”
for further discussion about RHI’s minimum percentage ownership interest in our
stock. See also Note 11, “Capital Stock,” for further discussion of our stock
repurchase program.
Note
4.
|
INVESTMENT
SECURITIES AND FINANCIAL
INSTRUMENTS
|
Investment
Securities
Securities
classified as trading and available-for-sale at December 31, 2007 and 2006 are
summarized below (in
millions). Estimated fair value is based on quoted market prices for
these or similar investments.
December 31,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Trading Securities
|
|
$ |
984 |
|
|
$ |
30 |
|
|
$ |
(13 |
) |
|
$ |
1,001 |
|
Securities
available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
securities
|
|
$ |
42 |
|
|
$ |
389 |
|
|
$ |
(15 |
) |
|
$ |
416 |
|
Preferred
stock
|
|
|
162 |
|
|
|
1 |
|
|
|
(24 |
) |
|
|
139 |
|
Debt
securities maturing:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
within
1 year
|
|
|
1,171 |
|
|
|
– |
|
|
|
(1 |
) |
|
|
1,170 |
|
between
1-5 years
|
|
|
1,886 |
|
|
|
15 |
|
|
|
(11 |
) |
|
|
1,890 |
|
between
5-10 years
|
|
|
521 |
|
|
|
12 |
|
|
|
(3 |
) |
|
|
530 |
|
Total
securities available-for-sale
|
|
$ |
3,782 |
|
|
$ |
417 |
|
|
$ |
(54 |
) |
|
$ |
4,145 |
|
December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Trading Securities
|
|
$ |
639 |
|
|
$ |
12 |
|
|
$ |
(10 |
) |
|
$ |
641 |
|
Securities
available-for-sale:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
securities
|
|
$ |
9 |
|
|
$ |
354 |
|
|
$ |
(3 |
) |
|
$ |
360 |
|
Preferred
stock
|
|
|
226 |
|
|
|
8 |
|
|
|
(3 |
) |
|
|
231 |
|
Debt
securities maturing:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
within
1 year
|
|
|
1,350 |
|
|
|
– |
|
|
|
(1 |
) |
|
|
1,349 |
|
between
1-5 years
|
|
|
1,491 |
|
|
|
7 |
|
|
|
(3 |
) |
|
|
1,495 |
|
between
5-10 years
|
|
|
545 |
|
|
|
4 |
|
|
|
(7 |
) |
|
|
542 |
|
Total
securities available-for-sale
|
|
$ |
3,621 |
|
|
$ |
373 |
|
|
$ |
(17 |
) |
|
$ |
3,977 |
|
The
gain or loss on derivative instruments designated as fair value hedges, as well
as the offsetting loss or gain on the corresponding hedged marketable equity
investment, is recognized currently in earnings. As a result, the cost basis of
our equity securities in the table above includes adjustments related to gains
and losses on fair value hedges.
Unrealized
loss positions for which other-than-temporary impairments have not been
recognized at December 31, 2007 and 2006 are summarized below (in millions):
|
|
|
|
|
|
|
|
|
|
December 31,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
securities
|
|
$ |
19 |
|
|
$ |
(15 |
) |
|
$ |
– |
|
|
$ |
– |
|
|
$ |
19 |
|
|
$ |
(15 |
) |
Preferred
stock
|
|
|
86 |
|
|
|
(18 |
) |
|
|
24 |
|
|
|
(6 |
) |
|
|
110 |
|
|
|
(24 |
) |
Debt
securities
|
|
|
1,004 |
|
|
|
(12 |
) |
|
|
182 |
|
|
|
(3 |
) |
|
|
1,186 |
|
|
|
(15 |
) |
Total
|
|
$ |
1,109 |
|
|
$ |
(45 |
) |
|
$ |
206 |
|
|
$ |
(9 |
) |
|
$ |
1,315 |
|
|
$ |
(54 |
) |
|
|
|
|
|
|
|
|
|
|
December 31,
2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
securities
|
|
$ |
9 |
|
|
$ |
(3 |
) |
|
$ |
– |
|
|
$ |
– |
|
|
$ |
9 |
|
|
$ |
(3 |
) |
Preferred
stock
|
|
|
34 |
|
|
|
(1 |
) |
|
|
53 |
|
|
|
(2 |
) |
|
|
87 |
|
|
|
(3 |
) |
Debt
securities
|
|
|
470 |
|
|
|
(1 |
) |
|
|
490 |
|
|
|
(10 |
) |
|
|
960 |
|
|
|
(11 |
) |
Total
|
|
$ |
513 |
|
|
$ |
(5 |
) |
|
$ |
543 |
|
|
$ |
(12 |
) |
|
$ |
1,056 |
|
|
$ |
(17 |
) |
Unrealized
losses in the preferred stock and debt securities portfolios were related to
various securities, including corporate bonds, U.S. government agency bonds,
municipal bonds and asset-backed securities, and investment-grade preferred
securities. For these securities, the unrealized losses are primarily due to
increases in overall interest rates. Because we have the ability and intent to
hold these investments until a forecasted recovery of fair value, which may be
maturity or call date, we do not consider these investments to be
other-than-temporarily impaired as of December 31, 2007. See Note 2, “Summary of
Significant Accounting Policies—Investments in Marketable and Nonmarketable
Securities,” for further discussion of the criteria used to determine impairment
of our equity and fixed income securities.
The
carrying amount, which approximates fair value, of all cash, cash equivalents
and investment securities held at December 31, 2007 and 2006 (see sections “Cash
and Cash Equivalents” and “Investments in Marketable and Nonmarketable
Securities” in Note 2, “Summary of Significant Accounting Policies”) is
summarized below (in
millions):
Security
|
|
|
|
|
|
|
Cash
|
|
$ |
1,706 |
|
|
$ |
495 |
|
Cash
equivalents
|
|
|
808 |
|
|
|
755 |
|
Total
cash and cash equivalents
|
|
$ |
2,514 |
|
|
$ |
1,250 |
|
|
|
|
|
|
|
|
|
|
Trading
securities
|
|
$ |
1,001 |
|
|
$ |
641 |
|
Securities
available-for-sale maturing within one year
|
|
|
321 |
|
|
|
371 |
|
Preferred
stock
|
|
|
139 |
|
|
|
231 |
|
Total
short-term investments
|
|
$ |
1,461 |
|
|
$ |
1,243 |
|
|
|
|
|
|
|
|
|
|
Securities
available-for-sale maturing after one year
|
|
$ |
1,674 |
|
|
$ |
1,472 |
|
Equity
securities
|
|
|
416 |
|
|
|
360 |
|
Total
long-term marketable debt and equity securities
|
|
$ |
2,090 |
|
|
$ |
1,832 |
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$ |
1 |
|
|
$ |
– |
|
Securities
available-for-sale maturing within one year
|
|
|
41 |
|
|
|
223 |
|
Securities
available-for-sale maturing between 1-10 years
|
|
|
746 |
|
|
|
565 |
|
Total
restricted cash and investments
|
|
$ |
788 |
|
|
$ |
788 |
|
In
2007, proceeds from the sales and maturities of available-for-sale securities
totaled $1.1 billion, of which $300 million was reinvested in our trading
securities. Gross realized gains totaled $26 million and gross realized losses
totaled $8 million. In 2006, proceeds from the sales and maturities of
available-for-sale securities totaled $613 million and gross realized gains
totaled $61 million. In 2005, proceeds from the sales and maturities of
available-for-sale securities totaled $722 million gross realized gains totaled
$9 million and gross realized losses totaled $3 million.
Net
change in unrealized holding (losses) gains on trading securities included in
net income totaled $15 million in 2007, $5 million in 2006, and ($22) million in
2005.
The
marketable debt securities that we hold are issued by a diversified selection of
corporate and financial institutions with strong credit ratings. Our investment
policy limits the amount of credit exposure with any one institution. Other than
asset-backed and mortgage-backed securities, these debt securities are generally
not collateralized. In 2007, we recorded a $30 million impairment charge to
reduce the carrying value of a fixed income investment. In 2006 and 2005, there
were no charges for credit impairment on marketable debt
securities.
Our
nonmarketable investment securities were based on cost less write-downs for
impairments, which approximates fair value. Our nonmarketable investment
securities were $31 million at December 31, 2007 and $33 million at
December 31, 2006, and are classified as “Other long-term assets” on our
Consolidated Balance Sheets.
Derivative
Financial Instruments
Foreign
Currency Instruments
We
have an established foreign currency hedging program to protect against currency
risks, primarily driven by forecasted foreign currency denominated royalties
from licensees’ product sales over a five year period. Other foreign currency
exposures include collaboration development expenses. We hedge portions of our
forecasted
foreign
currency revenue with option or forward contracts. When the dollar strengthens
significantly against the foreign currencies, the decline in value of future
foreign currency revenue or expenses is offset by gains or losses, respectively,
in the value of the option or forward contracts designated as hedges.
Conversely, when the dollar weakens, the increase in the value of future foreign
currency revenue or expenses is offset by losses or gains, respectively, in the
value of the forward contracts. In accordance with FAS No. 133, “Accounting for Derivative
Instruments and Hedging Activities,” hedges related to anticipated
transactions are designated and documented at the hedge’s inception as cash flow
hedges and evaluated for hedge effectiveness at least quarterly.
During
the years ended December 31, 2007, 2006, and 2005, we had no material amounts of
ineffectiveness with respect to our foreign currency hedging instruments. Gains
and losses related to option and forward contracts that hedge future cash flows
are classified in the same manner as the underlying hedged transaction in the
Consolidated Statements of Income.
At
December 31, 2007, net losses on derivative instruments expected to be
reclassified from accumulated other comprehensive income to earnings during the
next 12 months due to the receipt of the related net revenue denominated in
foreign currencies were $18 million.
Interest
Rate Swaps
In
July 2005, we entered into a series of interest rate swap agreements with a
total notional value of $500 million to protect the 4.40% Senior Notes due 2010
against changes in estimated fair value due to changes in U.S. interest rates.
In these swaps, we pay a floating rate and receive a fixed rate that matches the
coupon rate of the five year Notes due in 2010. See also Note 7, “Debt”
below.
Equity
Instruments
Our
marketable equity securities portfolio consists primarily of investments in
biotechnology companies whose risk of market fluctuations is greater than the
stock market in general. To manage a portion of this risk, we enter into
derivative instruments such as zero-cost collar instruments and equity forward
contracts to hedge equity securities against changes in market value. A
zero-cost collar is a purchased put option and a written call option on a
specific equity security such that the cost of the purchased put and the
proceeds of the written call offset each other; therefore, there is no initial
cost or cash outflow for these instruments. Our zero-cost collars expired
in 2007.
As
part of our fair value hedging strategy, we have also entered into equity
forward contracts that mature in 2008 through 2009. An equity forward is a
derivative instrument in which we pay the counterparty the total return of the
security above the current spot price and receive interest income on the
notional amount for the term of the equity forward. A forward contract is a
derivative instrument in which we lock in the termination price that we receive
from the sale of stock based on a pre-determined spot price. The forward
contract protects us from a decline in the market value of the security below
the spot price and limits our potential benefit from an increase in the market
value of the security above the spot price. Throughout the life of the contract,
we receive interest income based on the notional amount and a floating-rate
index.
During
the years ended December 31, 2007, 2006, and 2005, we had no material amounts of
ineffectiveness with respect to our equity hedging instruments. Gains and losses
related to zero-cost collar instruments that hedge future cash flows are
recorded against the gains or losses from the sale of the underlying hedged
marketable equity investment in the Consolidated Statements of
Income.
As
part of our hedging transactions, we have entered, and may in the future enter,
into security lending agreements with our counterparties. For an equity forward
contract, in exchange for lending the hedged shares to the counterparty, we
receive additional interest income throughout the life of the agreement based on
the notional amount and a floating-rate index. For an equity collar, the benefit
is embedded in the call strike price. The total estimated fair value of the
securities lent under these agreements was $161 million at December 31,
2007 and $145 million at December 31, 2006.
Estimated
Fair Value
The
estimated fair value of the foreign exchange options and forwards was based on
the forward exchange rates as of December 31, 2007 and 2006. The estimated fair
value of the equity forward contracts and zero-cost collar instruments was
determined based on the closing market prices of the underlying securities at
each year-end. The estimated fair value of our interest rate swap agreements was
based on forward interest rates at each year-end and does not include
accrued interest. The table below summarizes the estimated fair value, which is
also the carrying value, of our financial instruments at December 31, 2007 and
2006 (in
millions):
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
Foreign
exchange options
|
|
$ |
– |
|
|
$ |
1 |
|
Equity
forwards
|
|
|
24 |
|
|
|
47 |
|
Interest
rate swap agreements
|
|
|
6 |
|
|
|
– |
|
Equity
collars
|
|
|
– |
|
|
|
4 |
|
Liabilities:
|
|
|
|
|
|
|
|
|
Foreign
exchange options
|
|
|
14 |
|
|
|
– |
|
Foreign
exchange forward contracts
|
|
|
5 |
|
|
|
3 |
|
Interest
rate swap agreements
|
|
|
– |
|
|
|
12 |
|
The
financial instruments that we hold are entered into with a diversified selection
of institutions with strong credit ratings, which minimizes the risk of loss due
to nonpayment from the counterparty. Credit exposure is limited to the
unrealized gains on our contracts. We have not experienced any material losses
due to credit impairment of our financial instruments.
Note
5.
|
CONSOLIDATED
FINANCIAL STATEMENT DETAIL
|
Inventories
Inventories
at December 31 are summarized below (in millions):
|
|
|
|
|
|
|
Raw
materials and supplies
|
|
$ |
119 |
|
|
$ |
116 |
|
Work-in-process
|
|
|
1,062 |
|
|
|
818 |
|
Finished
goods
|
|
|
312 |
|
|
|
244 |
|
Total
|
|
$ |
1,493 |
|
|
$ |
1,178 |
|
Property,
Plant and Equipment
Property,
plant and equipment balances at December 31 are summarized below (in millions):
|
|
|
|
|
|
|
At
cost:
|
|
|
|
|
|
|
Land
|
|
$ |
418 |
|
|
$ |
399 |
|
Land
improvements
|
|
|
48 |
|
|
|
38 |
|
Buildings
|
|
|
1,914 |
|
|
|
1,712 |
|
Equipment
|
|
|
2,318 |
|
|
|
1,953 |
|
Leasehold
improvements
|
|
|
285 |
|
|
|
146 |
|
Construction-in-progress
|
|
|
1,675 |
|
|
|
1,291 |
|
|
|
|
6,658 |
|
|
|
5,539 |
|
Less:
accumulated depreciation and amortization
|
|
|
1,672 |
|
|
|
1,366 |
|
Net
property, plant and equipment
|
|
$ |
4,986 |
|
|
$ |
4,173 |
|
On
December 8, 2006, we completed the sale of all of the outstanding capital stock
of our wholly owned subsidiary, Genentech España, to Lonza Group, Inc. The
assets of Genentech España at the time of the sale consisted of a manufacturing
facility located in Porriño, Spain, cash, accounts receivable, and certain
liabilities. The net book value of the assets sold were approximately $159
million, resulting in a loss on the sale of approximately $13 million, which has
been included in our MG&A expenses in 2006. Our total consideration received
from the sale consisted of cash of $11 million; a non-interest bearing,
unsecured note; and other receivables, which had a present value of $135 million
at the close of the sale. The net assets disposed of consisted of $153 million
in property, plant and equipment; $13 million of other assets; and $7 million of
other liabilities.
In
November 2006, we entered into a series of agreements with Lonza Group Ltd
(Lonza), including a supply agreement to purchase product produced by Lonza at
their Singapore manufacturing facility, which is currently under construction.
For accounting purposes, due to the nature of the supply agreement and our
involvement with the construction of the buildings, we are considered to be the
owner of the assets during the construction period. As such, during 2007 and
2006, we capitalized $141 million and $20 million, respectively, in
construction-in-progress and have also recognized corresponding amounts as a
construction financing obligation in “Long-term debt” in the accompanying
Consolidated Balance Sheets.
Included
in construction-in-progress at December 31, 2007 and 2006 are $542 million and
$355 million, respectively, in capitalized costs pursuant to our Master Lease
Agreement with Health Care Properties (HCP), formerly Slough SSF, LLC, for the
construction of buildings in South San Francisco, California. See Note 8,
“Leases, Commitments and Contingencies,” for further discussion of the Slough
Master Lease Agreement.
Depreciation
expense was $334 million in 2007, $279 million in 2006, and $226 million in
2005.
Other
Accrued Liabilities
Other
accrued liabilities at December 31 were as follows (in millions):
|
|
|
|
|
|
|
Accrued
compensation
|
|
$ |
450 |
|
|
$ |
385 |
|
Accrued
royalties
|
|
|
270 |
|
|
|
224 |
|
Accrued
clinical and other studies (including to related
parties:
2007-$106;
2006-$67)
|
|
|
357 |
|
|
|
218 |
|
Accrued
marketing and promotion costs
|
|
|
181 |
|
|
|
155 |
|
Taxes
payable
|
|
|
173 |
|
|
|
258 |
|
Accrued
collaborations (including to a related party:
2007-$50;
2006-$53)
|
|
|
267 |
|
|
|
291 |
|
Other
(including to related parties:
2007-$74;
2006-$16)
|
|
|
352 |
|
|
|
218 |
|
Total
other accrued liabilities
|
|
$ |
2,050 |
|
|
$ |
1,749 |
|
Interest
and Other Income (Expense), Net
Interest
and other income (expense), net for the years ended December 31 were as
follows (in
millions):
|
|
|
|
|
|
|
|
|
|
Gains
on sales of biotechnology equity securities, net
|
|
$ |
22 |
|
|
$ |
93 |
|
|
$ |
9 |
|
Write-downs
of biotechnology debt and equity securities
|
|
|
(20 |
) |
|
|
(4 |
) |
|
|
(10 |
) |
Interest
income
|
|
|
270 |
|
|
|
230 |
|
|
|
143 |
|
Other
miscellaneous income
|
|
|
1 |
|
|
|
6 |
|
|
|
– |
|
Total
interest and other income (expense), net
|
|
$ |
273 |
|
|
$ |
325 |
|
|
$ |
142 |
|
Gains
on sales of biotechnology equity securities, net in 2006 included approximately
$79 million in gains which were recognized upon the acquisition of companies in
which we owned equity securities. Investment income in 2007 was offset by a $30
million write-down of a fixed-income investment.
Note
6.
|
OTHER
INTANGIBLE ASSETS
|
The
components of our other intangible assets, including those arising from the
Redemption and push-down accounting and our acquisition of Tanox, Inc. at
December 31, were as follows (in millions):
|
|
|
|
|
|
|
|
|
Weighted
Average
Useful
Life
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed
product technology
|
12
years
|
|
$ |
1,974 |
|
|
$ |
1,106 |
|
|
$ |
868 |
|
|
$ |
1,194 |
|
|
$ |
1,003 |
|
|
$ |
191 |
|
Core
technology
|
12
years
|
|
|
478 |
|
|
|
414 |
|
|
|
64 |
|
|
|
444 |
|
|
|
393 |
|
|
|
51 |
|
Trade
names
|
12
years
|
|
|
144 |
|
|
|
98 |
|
|
|
46 |
|
|
|
144 |
|
|
|
91 |
|
|
|
53 |
|
Patents
|
12
years
|
|
|
232 |
|
|
|
94 |
|
|
|
138 |
|
|
|
197 |
|
|
|
78 |
|
|
|
119 |
|
Other
intangible assets
|
10
years
|
|
|
99 |
|
|
|
47 |
|
|
|
52 |
|
|
|
98 |
|
|
|
36 |
|
|
|
62 |
|
Total
|
|
|
$ |
2,927 |
|
|
$ |
1,759 |
|
|
$ |
1,168 |
|
|
$ |
2,077 |
|
|
$ |
1,601 |
|
|
$ |
476 |
|
Amortization
expense of our other intangible assets was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
Acquisition-related
intangible assets amortization
|
|
$ |
132 |
|
|
$ |
105 |
|
|
$ |
123 |
|
Patents
amortization
|
|
|
16 |
|
|
|
13 |
|
|
|
11 |
|
Other
intangible assets amortization
|
|
|
10 |
|
|
|
10 |
|
|
|
10 |
|
Total
amortization expense
|
|
$ |
158 |
|
|
$ |
128 |
|
|
$ |
144 |
|
The
expected future annual amortization expense of our other intangible assets is as
follows (in
millions):
For the Year Ending
December 31,
|
|
|
|
2008
|
|
$ |
198 |
|
2009
|
|
|
149 |
|
2010
|
|
|
99 |
|
2011
|
|
|
97 |
|
2012
|
|
|
97 |
|
Thereafter
|
|
|
528 |
|
Total
expected future annual amortization
|
|
$ |
1,168 |
|
Commercial
Paper Program
In
October 2007, we issued $600 million in unsecured commercial paper notes payable
for funding general corporate purposes. These notes are not redeemable prior to
maturity or subject to voluntary prepayment, and were issued on a discount
basis. The maturities under the program generally vary from overnight to five
weeks and cannot exceed 397 days. During the period from issuance to December
31, 2007, the notes were issued with an effective interest yield of 4.62%. At
December 31, 2007, outstanding commercial paper notes carried an effective
interest yield of 4.46%. Interest expense related to the commercial paper
program was $5 million in 2007.
Long-Term
Debt
On
July 18, 2005, we completed a private placement of the following debt
instruments: $500 million principal amount of 4.40% Senior Notes due 2010,
$1.0 billion principal amount of 4.75% Senior Notes due 2015 and $500 million
principal amount of 5.25% Senior Notes due 2035 (collectively, the Notes).
Interest on each series of the Notes is payable on January 15 and July 15 of
each year, beginning on January 15, 2006. Net proceeds resulting from issuance
of the Notes, after debt discount and issuance costs, were approximately $1.99
billion. The Notes contain certain restrictive covenants on incurring property
liens and entering into sale and lease-back transactions, all of which we were
in compliance with at December 31, 2007. Interest expense related to the debt
issuance, net of amounts capitalized of $41 million in 2007 and $27 million in
2006, was $60 million for 2007 and $72 million for 2006. As of December 31,
2007, the future minimum principal payments under the Notes are as follows (in millions):
2010
|
|
$ |
500 |
|
2011
|
|
|
– |
|
Thereafter
|
|
|
1,500 |
|
Total
|
|
$ |
2,000 |
|
At
December 31, 2007 and 2006, the carrying value of the Notes was $2.0 billion,
and the estimated fair value was $1.94 billion and $1.91 billion, respectively.
The fair value of debt was estimated based on the then current rates offered to
us for debt instruments with the same remaining maturities. In July 2005, we
entered into a series of interest rate swap agreements, relating to debt
maturing in 2010. See “Derivative Financial Instruments” in Note 4, “Investment
Securities and Financial Instruments” for further discussion of the interest
rate swaps.
Long-term
debt at December 31, 2007 and 2006 included $399 million and $216 million,
respectively, in construction in progress financing obligations related to our
agreements with HCP and Lonza. See Note 5, “Consolidated Financial Statement
Detail,” for further discussion of the Lonza agreements, and Note 8, “Leases,
Commitments and Contingencies,” for further discussion of the Slough Master
Lease Agreement.
Note
8.
|
LEASES,
COMMITMENTS AND CONTINGENCIES
|
Leases
We
lease various real properties under operating leases that generally require us
to pay taxes, insurance, maintenance and minimum lease payments. Some of our
leases have options to renew.
In
December 2004, we entered into a Master Lease Agreement with Slough SSF, LLC,
which was subsequently acquired by HCP, for the lease of property adjacent to
our South San Francisco campus. The property is being developed into eight
buildings and two parking structures. The lease of the property is taking place
in two phases pursuant to separate lease agreements for each building as
contemplated by the Master Lease Agreement. Phase I building leases began in
2006 and Phase II building leases began in 2007 and will continue through 2008.
For accounting purposes, due to the nature of our involvement with the
construction of the buildings subject to the Master Lease Agreement, we are
considered to be the owner of the assets, even though the funds to construct the
building shell and some infrastructure costs are paid by the lessor. As such, as
of December 31, 2007, we have capitalized $283 million of construction costs,
including capitalized interest, in property, plant and equipment. In addition,
we separately capitalized approximately $259 million of leasehold improvements
that we have installed at the property. We have recognized $270 million as a
construction financing obligation, which is primarily included in “Long-term
debt” in the accompanying Consolidated Balance Sheets. As of December 31, 2006,
we had capitalized $205 million of construction costs, including capitalized
interest, in property, plant and equipment. In addition, we separately
capitalized approximately $150 million of leasehold improvements that we had
installed at the property. We have recognized $198 million as a construction
financing obligation, which is primarily included in “Long-term debt” in the
accompanying Consolidated Balance Sheets. Concurrent with the commencement of
the rental period,
during
the third quarter of 2006, we began repayment of the construction financing
obligation. Included in these lease payments is interest expense of $10 million
in 2007 and $3 million in 2006. We expect that at the time of completion of the
project, our construction asset and related obligation may be as much as $365
million, excluding costs related to leasehold improvements.
Future
minimum lease payments under all leases, exclusive of the residual value
guarantees and executory costs at December 31, 2007 are as follows (in millions). These minimum
lease payments were computed based on interest rates current at that time, which
are subject to fluctuations in certain market-based interest rates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
leases
|
|
$ |
26 |
|
|
$ |
26 |
|
|
$ |
26 |
|
|
$ |
24 |
|
|
$ |
20 |
|
|
$ |
66 |
|
|
$ |
188 |
|
HCP
leases
|
|
|
32 |
|
|
|
36 |
|
|
|
37 |
|
|
|
38 |
|
|
|
40 |
|
|
|
341 |
|
|
|
524 |
|
Total
|
|
$ |
58 |
|
|
$ |
62 |
|
|
$ |
63 |
|
|
$ |
62 |
|
|
$ |
60 |
|
|
$ |
407 |
|
|
$ |
712 |
|
Rental
expenses for our operating leases were $37 million in 2007, $33 million in 2006,
and $19 million in 2005.
Commitments
In
October 2007, we entered into a five-year, $1 billion revolving credit facility
with various financial institutions. The credit facility is expected to be used
for general corporate and working capital purposes, including providing support
for our new $1 billion commercial paper program. As of December 31, 2007,
we had no borrowings under the credit facility.
On
December 8, 2006, Lonza purchased all of the outstanding shares of Genentech
España, our wholly-owned subsidiary, including the FDA-licensed Porriño
facility, which is currently dedicated to the production of Avastin. We also
entered into a supply agreement with Lonza for the manufacture of certain of our
products at Lonza’s facility under construction in Singapore, which is currently
expected to receive FDA licensure in 2010. We are committed to funding the
pre-commissioning production qualification costs at that facility, and, upon FDA
licensure, we are committed to purchasing 100 percent of products successfully
manufactured at that facility for a period of three years after commissioning of
the facility. The total estimated cost of these pre- and post-commissioning
commitments is approximately $440 million, the majority of which will be paid in
2009 through 2012. We also received an exclusive option to purchase the Lonza
Singapore facility during the period from 2007 up to one year after FDA
licensure for a purchase price of $290 million. Regardless of whether the
purchase option is exercised, we will be obligated to make a milestone payment
of approximately $70 million if certain performance milestones are met in
connection with the construction of the facility. As of December 31, 2007, we
have not exercised our option to purchase.
In
addition, we entered into a loan agreement with Lonza to advance up to $290
million to Lonza for the construction of the Singapore facility, subject to
certain mutually acceptable conditions of securitization, and approximately $9
million for a related land lease option, the majority of which is not expected
to be advanced until 2008. If we exercise our option to purchase the facility,
any outstanding advances may be offset against the purchase price. If we do not
exercise our purchase option, the advances will be offset against supply
purchases.
In
September 2004, we entered into a non-exclusive, long-term manufacturing
agreement for the production of Herceptin bulk product with Wyeth
Pharmaceuticals, a division of Wyeth, (Wyeth). Under this agreement, Wyeth will
manufacture Herceptin bulk product for us for approximately $251 million through
2009 at their production facility in Andover, Massachusetts. In the third
quarter of 2006, the FDA approved the manufacture of Herceptin bulk product at
Wyeth’s facility.
Contingencies
We
are a party to various legal proceedings, including patent litigation and
licensing and contract disputes, and other matters.
On
October 4, 2004, we received a subpoena from the U.S. Department of Justice,
requesting documents related to the promotion of Rituxan, a prescription
treatment now approved for five indications. We are cooperating with the
associated investigation, which is both civil and criminal in nature, and
through counsel we are having discussions with government representatives about
the status of their investigation and Genentech’s views on this matter,
including potential resolution of this matter. The government has called, and
may continue to call, former and current Genentech employees to appear before a
grand jury in connection with this investigation. The outcome of this matter
cannot be determined at this time.
We
and the City of Hope National Medical Center (COH) are parties to a 1976
agreement related to work conducted by two COH employees, Arthur Riggs and
Keiichi Itakura, and patents that resulted from that work, which are referred to
as the “Riggs/Itakura Patents.” Since that time, we have entered into license
agreements with various companies to manufacture, use, and sell the products
covered by the Riggs/Itakura Patents. On August 13, 1999, the COH filed a
complaint against us in the Superior Court in Los Angeles County, California,
alleging that we owe royalties to the COH in connection with these license
agreements, as well as product license agreements that involve the grant of
licenses under the Riggs/Itakura Patents. On June 10, 2002, a jury voted to
award the COH approximately $300 million in compensatory damages. On June 24,
2002, a jury voted to award the COH an additional $200 million in punitive
damages. Such amounts were accrued as an expense in the second quarter of 2002
and are included in the accompanying Consolidated Balance Sheets in “Accrued
litigation” at December 31, 2007 and 2006. We filed a notice of appeal of the
verdict and damages awards with the California Court of Appeal. On October 21,
2004, the California Court of Appeal affirmed the verdict and damages awards in
all respects. On November 22, 2004, the California Court of Appeal modified its
opinion without changing the verdict and denied Genentech’s request for
rehearing. On November 24, 2004, we filed a petition seeking review by the
California Supreme Court. On February 2, 2005, the California Supreme Court
granted that petition. The California Supreme Court heard our appeal on this
matter on February 5, 2008 and we expect a ruling within 90 days of the hearing
date. The amount of cash paid, if any, or the timing of such payment in
connection with the COH matter will depend on the outcome of the California
Supreme Court’s review of the matter.
We
recorded accrued interest and bond costs related to the COH trial judgment of
$54 million in both 2007 and 2006. In conjunction with the COH judgment, we
posted a surety bond and were required to pledge cash and investments of $788
million at December 31, 2007 and 2006 to secure the bond. These amounts are
reflected in “Restricted cash and investments” in the accompanying Consolidated
Balance Sheets. We expect that we will continue to incur interest charges on the
judgment and service fees on the surety bond each quarter through the process of
appealing the COH trial results. Included within current liabilities in
“Accrued litigation” in the accompanying Consolidated Balance Sheet at
December 31, 2007 is $776 million, which represents our estimate of the costs
for the current resolution of the COH matter.
On
April 11, 2003, MedImmune, Inc. filed a lawsuit against Genentech, COH, and
Celltech R & D Ltd. in the U.S. District Court for the Central District of
California (Los Angeles). The lawsuit relates to U.S. Patent No. 6,331,415 (the
Cabilly patent) that we co-own with COH and under which MedImmune and other
companies have been licensed and are paying royalties to us. The lawsuit
includes claims for violation of antitrust, patent, and unfair competition laws.
MedImmune is seeking a ruling that the Cabilly patent is invalid and/or
unenforceable, a determination that MedImmune does not owe royalties under the
Cabilly patent on sales of its Synagis® antibody product, an injunction to
prevent us from enforcing the Cabilly patent, an award of actual and exemplary
damages, and other relief. On January 14, 2004 (amending a December 23, 2003
order), the U.S. District Court granted summary judgment in our favor on all of
MedImmune’s antitrust and unfair competition claims. On April 23, 2004, the
District Court granted our motion to dismiss all remaining claims in the case.
On October 18, 2005, the U.S. Court of Appeals for the Federal Circuit affirmed
the judgment of the District Court in all respects. MedImmune filed a petition
for certiorari with the U.S. Supreme Court on November 10, 2005, seeking review
of the decision to dismiss certain of its claims. The Supreme Court granted
MedImmune’s petition, and the oral argument of this case before the Supreme
Court occurred on October 4, 2006. On January 9, 2007, the Supreme Court issued
a decision reversing the Federal Circuit’s decision and remanding the case to
the lower courts for further proceedings in connection with the patent and
contract claims. On August 16, 2007, the U.S. District Court entered a Claim
Construction Order defining several terms used in the Cabilly patent. On October
29, 2007, MedImmune filed a
motion
for partial summary judgment of non-infringement, and in connection with that
motion MedImmune conceded that its Synagis product infringes claim 33 of the
Cabilly patent. Genentech responded to this motion in part by granting
MedImmune, with respect to the Synagis product only, a covenant not to sue
for infringement under any claim of the Cabilly patent other than claim
33. Discovery and motion practice are ongoing and the trial of this matter
has been scheduled for June 23, 2008. The outcome of this matter cannot be
determined at this time.
On
May 13, 2005, a request was filed by a third party for reexamination of the
Cabilly patent. The request sought reexamination on the basis of non-statutory
double patenting over U.S. Patent No. 4,816,567. On July 7, 2005, the U.S.
Patent and Trademark Office (Patent Office) ordered reexamination of the Cabilly
patent. On September 13, 2005, the Patent Office mailed an initial non-final
Patent Office action rejecting the claims of the Cabilly patent. We filed our
response to the Patent Office action on November 25, 2005. On December 23, 2005,
a second request for reexamination of the Cabilly patent was filed by another
third party, and on January 23, 2006, the Patent Office granted that request. On
June 6, 2006, the two reexaminations were merged into one proceeding. On August
16, 2006, the Patent Office mailed a non-final Patent Office action in the
merged proceeding, rejecting the claims of the Cabilly patent based on issues
raised in the two reexamination requests. We filed our response to the Patent
Office action on October 30, 2006. On February 16, 2007, the Patent Office
mailed a final Patent Office action rejecting all 36 claims of the Cabilly
patent. We responded to the final Patent Office action on May 21, 2007 and
requested continued reexamination. On May 31, 2007, the Patent Office granted
the request for continued reexamination, and in doing so withdrew the finality
of the February 2007 Patent Office action and agreed to treat our May 21, 2007
filing as a response to a first Patent Office action. On February 25, 2008, we
received notification from the Patent Office that a final Office action
rejecting claims of the Cabilly patent has been issued and mailed. We intend to
file a response to the final Office action and, if necessary, appeal the
rejection. The Cabilly patent, which expires in 2018, relates to methods that we
and others use to make certain antibodies or antibody fragments, as well as
cells and DNA used in these methods. We have licensed the Cabilly patent to
other companies and derive significant royalties from those licenses. The claims
of the Cabilly patent remain valid and enforceable throughout the reexamination
and appeals processes. Because the above-described proceeding is ongoing, the
outcome of this matter cannot be determined at this time.
In
2006, we made development decisions involving our humanized anti-CD20 program,
and our collaborator, Biogen Idec, disagreed with certain of our development
decisions related to humanized anti-CD20 products. Under our 2003 collaboration
agreement with Biogen Idec, we believe that we are permitted under the agreement
to proceed with further trials of certain humanized anti-CD20 antibodies, and
Biogen Idec disagreed with our position. The disputed issues have been submitted
to arbitration. In the arbitration, Biogen Idec filed motions for a preliminary
injunction and summary judgment seeking to stop us from proceeding with certain
development activities, including planned clinical trials. On April 20, 2007,
the arbitration panel denied both Biogen Idec’s motion for a preliminary
injunction and Biogen Idec’s motion for summary judgment. Resolution of the
arbitration could require that both parties agree to certain development
decisions before moving forward with humanized anti-CD20 antibody clinical
trials, and possibly clinical trials of other collaboration products, including
Rituxan, in which case we may have to alter or cancel planned trials in order to
obtain Biogen Idec’s approval. The hearing of this matter is scheduled to begin
in June 2008. We expect a final decision within six months of the hearing,
unless the parties are able to resolve the matter earlier through settlement
discussions or otherwise. The outcome of this matter cannot be determined at
this time.
On
June 28, 2003, Mr. Ubaldo Bao Martinez filed a lawsuit against Porriño Town
Council and Genentech España S.L. in the Contentious Administrative Court
Number One of Pontevedra, Spain. The lawsuit challenges the Town
Council's decision to grant licenses to Genentech España S.L. for the
construction and operation of a warehouse and biopharmaceutical
manufacturing facility in Porriño, Spain. On January 21, 2008 the Administrative
Court ruled in favor of Mr. Bao on one of the claims in the lawsuit and
ordered the closing and demolition of the facility, subject to certain further
legal proceedings. On February 12, 2008, we and the Town Council filed appeals
of the Administrative Court decision at the High Court in Galicia, Spain. In
addition, we are evaluating with legal counsel in Spain whether there may be
other administrative remedies available to overcome the Administrative Court’s
ruling. We sold the assets of Genentech España S.L., including the Porriño
facility, to Lonza Group Ltd. (Lonza) in December 2006, and Lonza has
operated the facility since that time. Under the terms of that
sale,
we
retained control of the defense of this lawsuit and agreed to indemnify Lonza
against certain contractually defined liabilities up to a specified limit, which
is currently estimated to be approximately $100 million. The outcome of this
matter, and our indemnification obligation to Lonza, if any, cannot be
determined at this time.
Note
9.
|
RELATIONSHIP
WITH ROCHE HOLDINGS, INC. AND RELATED PARTY
TRANSACTIONS
|
Licensing
Agreements
We
have a July 1999 amended and restated licensing and marketing agreement with
Roche and its affiliates granting an option to license, use, and sell our
products in non-U.S. markets. The major provisions of that agreement include the
following:
|
Ÿ
|
Roche’s
option expires in 2015;
|
|
Ÿ
|
Roche
may exercise its option to license our products upon the occurrence of any
of the following: (1) upon the filing of an Investigational New
Drug Application (IND) for a product, (2) completion of the first Phase II
trial for a product or (3) completion of a Phase III trial for that
product, if Roche previously paid us a fee of $10 million to extend
its option on a product;
|
|
Ÿ
|
If
Roche exercises its option to license a product, it has agreed to
reimburse Genentech for development costs as follows: (1) If
exercise occurs upon the filing of an IND, Roche will pay 50% of
development costs incurred prior to the filing and 50% of development
costs subsequently incurred; (2) If exercise occurs at the completion
of the first Phase II trial, Roche will pay 50% of development costs
incurred through completion of the trial, 75% of development costs
subsequently incurred for the initial indication, and 50% of subsequent
development costs for new indications, formulations or dosing schedules;
(3) If the exercise occurs at the completion of a Phase III trial,
Roche will pay 50% of development costs incurred through completion of
Phase II, 75% of development costs incurred through completion of Phase
III, and 75% of development costs subsequently incurred; and $5 million of
the option extension fee paid by Roche to preserve its right to exercise
its option at the completion of a Phase III trial will be credited against
the total development costs payable to Genentech upon the exercise of the
option; and (4) Each of Genentech and Roche have the right to “opt-out” of
developing an additional indication for a product for which Roche
exercised its option, and would not share the costs or benefits of the
additional indication, but could “opt-back-in” within 30 days of decision
to file for approval of the indication by paying twice what they would
have owed for development of the indication if they had not opted
out;
|
|
Ÿ
|
We
agreed, in general, to manufacture for and supply to Roche its clinical
requirements of our products at cost, and its commercial requirements at
cost plus a margin of 20%; however, Roche will have the right to
manufacture our products under certain
circumstances;
|
|
Ÿ
|
Roche
has agreed to pay, for each product for which Roche exercises its option
upon the filing of an IND or completion of the first Phase II trial, a
royalty of 12.5% on the first $100 million on its aggregate sales of that
product and thereafter a royalty of 15% on its aggregate sales of that
product in excess of $100 million until the later in each country of the
expiration of our last relevant patent or 25 years from the first
commercial introduction of that
product;
|
|
Ÿ
|
Roche
will pay, for each product for which Roche exercises its option after
completion of a Phase III trial, a royalty of 15% on its sales of that
product until the later in each country of the expiration of our last
relevant patent or 25 years from the first commercial introduction of that
product; however, $5 million of any option extension fee paid by Roche
will be credited against royalties payable to us in the first calendar
year of sales by Roche in which aggregate sales of that product exceed
$100 million; and
|
|
Ÿ
|
For
certain products for which Genentech is paying a royalty to
Biogen Idec, including Rituxan, Roche shall pay Genentech a royalty
of 20% on sales of such product. Once Genentech is no longer obligated to
pay a royalty to Biogen Idec on sales of such products, Roche shall
then pay Genentech a royalty on sales of 10% on the first $75 million on
its aggregate sales of that product and thereafter a royalty of 8% on its
aggregate sales of that product in excess of $75 million until the later
in each country of the expiration of our last relevant patent or 25 years
from the first commercial introduction of that
product.
|
We
have further amended this licensing and marketing agreement with Roche to delete
or add certain Genentech products under Roche’s commercialization and marketing
rights for Canada.
In
addition, we have a July 1998 licensing and marketing agreement related to
anti-HER2 antibodies (including Herceptin and pertuzumab) with Roche, providing
them with exclusive marketing rights outside of the U.S. Under the agreement,
Roche funds one-half of the global development costs incurred in connection with
developing anti-HER2 antibody products under the agreement. Either Genentech or
Roche has the right to “opt-out” of developing an additional indication for a
product and would not share the costs or benefits of the additional indication,
but could “opt-back-in” within 30 days of decision to file for approval of the
indication by paying twice what would have been owed for development of the
indication if no opt-out had occurred. Roche has also agreed to make royalty
payments of 20% on aggregate net product sales outside the U.S. up to $500
million in each calendar year and 22.5% on such sales in excess of $500 million
in each calendar year. In December 2007, Roche opted-in to our trastuzumab
drug conjugate products under terms similar to those of the existing anti-HER2
agreement.
Research
Collaboration Agreement
In
April 2004, we entered into a research collaboration agreement with Roche that
outlines the process by which Roche and Genentech may agree to conduct and share
in the costs of joint research on certain molecules. The agreement further
outlines how development and commercialization efforts will be coordinated with
respect to select molecules, including the financial provisions for a number of
different development and commercialization scenarios undertaken by either or
both parties.
Tax
Sharing Agreement
We
have a tax sharing agreement with RHI. If we and RHI elect to file a combined
state and local tax return in certain states where we may be eligible, our tax
liability or refund with RHI for such jurisdictions will be calculated on a
stand-alone basis.
Roche Holdings, Inc.’s Ability to
Maintain Percentage Ownership Interest in Our Stock
We
issue shares of Common Stock in connection with our stock option and stock
purchase plans, and we may issue additional shares for other purposes. Our
affiliation agreement with RHI provides, among other things, that with respect
to any issuance of our Common Stock in the future, we will repurchase a
sufficient number of shares so that immediately after such issuance, the
percentage of our Common Stock owned by RHI will be no lower than 2% below the
“Minimum Percentage” (subject to certain conditions). The Minimum Percentage
equals the lowest number of shares of Genentech Common Stock owned by RHI since
the July 1999 offering (to be adjusted in the future for dispositions of shares
of Genentech Common Stock by RHI as well as for stock splits or stock
combinations) divided by 1,018,388,704 (to be adjusted in the future for stock
splits or stock combinations), which is the number of shares of Genentech Common
Stock outstanding at the time of the July 1999 offering, as adjusted for stock
splits. We have repurchased shares of our Common Stock since 2001 (see
discussion above in “Liquidity and Capital Resources”). The affiliation
agreement also provides that, upon RHI’s request, we will repurchase shares of
our Common Stock to increase RHI’s ownership to the Minimum Percentage. In
addition, RHI will have a continuing option to buy stock from us at prevailing
market prices to maintain its percentage ownership interest. Under the terms of
the affiliation agreement, RHI’s Minimum Percentage is 57.7% and RHI’s ownership
percentage is to be no lower than 55.7%. At December 31, 2007, RHI’s ownership
percentage was 55.8%.
Related
Party Transactions
We
enter into transactions with our related parties, Roche and Novartis. The
accounting policies that we apply to our transactions with our related parties
are consistent with those applied in transactions with independent third
parties, and all related party agreements are negotiated on an arm’s-length
basis.
In
our royalty and supply arrangements with related parties, we are the principal,
as defined under EITF 99-19, because we bear the manufacturing risk, general
inventory risk, and the risk to defend our intellectual property. For
circumstances in which we are the principal in the transaction, we record the
transaction on a gross basis in accordance with EITF 99-19. Otherwise our
transactions are recorded on a net basis.
Roche
We
signed two new product supply agreements with Roche in July 2006, each of which
was amended in November 2007. The Umbrella Manufacturing Supply Agreement
(Umbrella Agreement) supersedes our existing product supply agreements with
Roche. The Short-Term Supply Agreement (Short-Term Agreement) supplements the
terms of the Umbrella Agreement. Under the Short-Term Agreement, Roche has
agreed to purchase specified amounts of Herceptin, Avastin and Rituxan through
2008. Under the Umbrella Agreement, Roche has agreed to purchase specified
amounts of Herceptin and Avastin through 2012 and, on a perpetual basis, either
party may order other collaboration products from the other party, including
Herceptin and Avastin after 2012, pursuant to certain forecast terms. The
Umbrella Agreement also provides that either party may terminate its obligation
to purchase and/or supply Avastin and/or Herceptin with six years notice on or
after December 31, 2007. To date, we have not received such notice of
termination from Roche.
In
December 2007, Roche opted-in to our trastuzumab drug conjugate products under
terms similar to those of the existing anti-HER2 agreement. As part of the
opt-in, Roche paid us $113 million and will pay 50% of subsequent development
costs related to the trastuzumab drug conjugate products. We recognized the
payment received from Roche as deferred revenue, which will be recognized over
the expected development period.
We
currently have no active profit sharing arrangements with Roche.
Under
our existing arrangements with Roche, including our licensing and marketing
agreement, we recognized the following amounts (in millions):
|
|
|
|
|
|
|
|
|
|
Product
sales to Roche
|
|
$ |
768 |
|
|
$ |
359 |
|
|
$ |
177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Roche
|
|
$ |
1,206 |
|
|
$ |
846 |
|
|
$ |
500 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Roche
|
|
$ |
95 |
|
|
$ |
125 |
|
|
$ |
65 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Roche
|
|
$ |
422 |
|
|
$ |
268 |
|
|
$ |
154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with Roche
|
|
$ |
259 |
|
|
$ |
213 |
|
|
$ |
144 |
|
Certain
R&D expenses are partially reimbursable to us by Roche. In addition, R&D
expenses may include the net settlement of amounts that we owed to Roche for
R&D expenses that Roche incurred on joint development projects, less amounts
reimbursable to us by Roche on these projects.
Novartis
Based
on information available to us at the time of filing this Form 10-K, we believe
that the Novartis Group holds approximately 33.3% of the outstanding voting
shares of Roche. As a result of this ownership, the Novartis Group is deemed to
have an indirect beneficial ownership interest under FAS 57, “Related Party
Disclosures,” of more than 10% of our
voting stock.
We
have an agreement with Novartis Pharma AG (a wholly-owned subsidiary of Novartis
AG) under which Novartis Pharma AG has the exclusive right to develop and market
Lucentis outside of the U.S. for indications related to diseases or disorders of
the eye. As part of this agreement, the parties will share the cost of certain
of our ongoing development expenses for Lucentis.
We,
along with Novartis, are co-developing and are co-promoting Xolair in the U.S.
We record all sales, COS, and marketing and sales expenses in the U.S., and
Novartis markets the product in and records all sales, COS, and marketing
and sales expenses in Europe. We and Novartis share the resulting U.S. and
European operating profits according to prescribed profit sharing percentages,
and our U.S. and European profit sharing expenses are recorded as collaboration
profit sharing expense. Effective with our acquisition of Tanox, Inc. on August
2, 2007, Novartis also makes additional profit sharing payments to us on U.S.
sales of Xolair, royalty payments to us on sales of Xolair worldwide, and pays
us a manufacturing fee related to Xolair.
Under
our existing arrangements with Novartis, we recognized the following amounts
(in
millions):
|
|
|
|
|
|
|
|
|
|
Product
sales to Novartis
|
|
$ |
10 |
|
|
$ |
5 |
|
|
$ |
7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalties
earned from Novartis
|
|
$ |
95 |
|
|
$ |
3 |
|
|
$ |
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract
revenue from Novartis
|
|
$ |
70 |
|
|
$ |
40 |
|
|
$ |
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales on product sales to Novartis
|
|
$ |
10 |
|
|
$ |
4 |
|
|
$ |
17 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
R&D
expenses incurred on joint development projects with
Novartis
|
|
$ |
43 |
|
|
$ |
38 |
|
|
$ |
39 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
profit sharing expense to Novartis
|
|
$ |
185 |
|
|
$ |
187 |
|
|
$ |
136 |
|
Contract
revenue 2007 included a $30 million milestone payment from Novartis for European
Union approval of Lucentis for the treatment of neovascular (wet) age-related
macular degeneration.
Certain
R&D expenses are partially reimbursable to us by Novartis. In addition,
R&D expenses may include the net settlement of amounts that we owed to
Novartis for R&D expenses that Novartis incurred on joint development
projects, less amounts reimbursable to us by Novartis on these
projects.
See
Note 10, “Acquisition of Tanox, Inc.,” in Part II, Item 8 of this Form 10-K for
information on Novartis’ share of the proceeds resulting from our acquisition of
Tanox.
Note
10.
|
ACQUISITION
OF TANOX, INC.
|
On
August 2, 2007, we completed our acquisition of 100% of the outstanding shares
of Tanox, Inc., a biotechnology company specializing in the discovery and
development of biotherapeutics based on monoclonal antibody technology, for $925
million in cash, plus $8 million in transaction costs. The purchase price
allocation is as follows; however, we may record adjustments to goodwill
resulting from our acquisition of Tanox for the resolution of our restructuring
activities related to the sublease of our San Diego facility.
(In
millions)
|
|
|
|
Assets
|
|
|
|
Cash
|
|
$ |
100 |
|
Investments
|
|
|
102 |
|
Working
capital and other, net
|
|
|
54 |
|
In-process
research and development (IPR&D)
|
|
|
77 |
|
Developed
product technology
|
|
|
780 |
|
Core
technology
|
|
|
34 |
|
Goodwill
|
|
|
261 |
|
Deferred
revenue
|
|
|
(185 |
) |
Deferred
tax liability, net
|
|
|
(217 |
) |
Total
acquisition consideration and gain
|
|
$ |
1,006 |
|
Consideration
and Gain
|
|
|
|
Consideration
|
|
$ |
925 |
|
Transaction
costs
|
|
|
8 |
|
Gain
on settlement of preexisting relationship, net of tax
|
|
|
73 |
|
|
|
$ |
1,006 |
|
In
accordance with FAS No. 141, “Business Combinations” (FAS
141), assets and liabilities acquired were valued at their fair values at the
date of acquisition. We recorded deferred revenue associated with Tanox’s
intellectual property license with Novartis related to Xolair of $185 million,
which will be recognized as additional royalty revenue over the duration of the
estimated remaining patent lives of approximately 12 years.
In
connection with our acquisition of Tanox, we terminated certain officers and
employees of Tanox. The total amount of the severance packages offered to these
officers and employees was approximately $4 million. Tanox also leased a plant
in San Diego, California that has been certified by the FDA for clinical use.
Our current estimate of the present value of the future lease payments we owe,
less the expected sublease income if we are able to sublease the facility, is
approximately $5 million. The restructuring programs are substantially complete,
with the exception of the San Diego plant, for which we are actively pursuing a
sublease arrangement.
We
recorded a $77 million charge for IPR&D. This charge primarily represents
acquired R&D for label extensions for Xolair that have not yet been approved
by the FDA and require significant further development.
Under
FAS 141, acquired
identifiable intangible assets are measured and recognized apart from goodwill,
even if it would not be practical to sell or exchange the acquired intangible
assets and any related license agreements apart from one another. In our
accounting for our acquisition of Tanox’s developed product technology and core
technology in accordance with FAS 142, the fair value assigned to those
intangible assets was based on valuations using a present value technique
referred to as the income approach, with estimates and assumptions determined by
management, including valuing Tanox’s intellectual property and rights thereon
at assumed current fair values, which, for developed product technology, were in
excess of existing contractual rates. The developed product technology that we
valued relates to intellectual property and rights thereon primarily related to
the Xolair molecule. The core technology asset that we valued represents the
value of Tanox’s intellectual property and rights thereon
expected
to be leveraged in the design and development of future products and
indications. The developed product technology and core technology, which totaled
$814 million, are being amortized over 12 years. The excess of purchase price
over tangible assets, identifiable intangible assets, and assumed liabilities
represents goodwill.
The
intangible assets and goodwill acquired are not deductible for income tax
purposes. As a result, we recorded a net deferred tax liability of $262 million,
based on the tax effect of the amount of the acquired intangible assets other
than goodwill with no tax basis. We also recorded a net deferred tax asset of
approximately $45 million, primarily related to net operating loss carryforwards
acquired in the transaction.
Under
EITF Issue No. 04-1, “Accounting for Preexisting
Relationships between the Parties to a Business Combination” (EITF 04-1), a business
combination between parties with a preexisting relationship should be evaluated
to determine if a settlement of a preexisting relationship exists. The
acquisition of Tanox is considered to include the settlement of our 1996 license
of certain intellectual property and rights thereon from Tanox. We measured the
amount that the preexisting license arrangement is favorable, from our
perspective, by comparing it to estimated pricing for current market
transactions for intellectual property rights similar to Tanox’s intellectual
property rights related to Xolair. In connection with the settlement of this
license arrangement, we recorded a gain of $121 million, or $73 million
net of tax, in accordance with EITF 04-1.
On
August 2, 2007, we understand that Novartis owned approximately 14% of the
outstanding shares of Tanox, representing approximately $127 million of the
total cash paid to acquire the outstanding shares of Tanox.
Assuming
that the Tanox acquisition was consummated as of January 1, 2006, pro forma
consolidated financial results of the company for the year ended December 31,
2007 and 2006 would not have been materially different from the amounts
reported.
Common
Stock and Special Common Stock
On
June 30, 1999, we redeemed all of our outstanding Special Common Stock held by
stockholders other than RHI. Subsequently, in July and October 1999, and March
2000, RHI consummated public offerings of our Common Stock. On January 19, 2000,
RHI completed an offering of zero-coupon notes that were exchanged prior to the
April 5, 2004 expiration for an aggregate of approximately 26 million shares of
our Common Stock held by RHI. See Note 1, “Description of Business—Redemption of
Our Special Common Stock” and Note 9, “Relationship with Roche Holdings,
Inc. and Related Party Transactions,” above for a discussion of the
Redemption and the related transactions.
Stock
Repurchase Program
Under
a stock repurchase program approved by our Board of Directors in December 2003
and most recently extended in April 2007, we are authorized to repurchase up to
100 million shares of our Common Stock for an aggregate price of up to $8.0
billion through June 30, 2008. In this program, as in previous stock repurchase
programs, purchases may be made in the open market or in privately negotiated
transactions from time to time at management’s discretion. We also may engage in
transactions in other Genentech securities in conjunction with the repurchase
program, including certain derivative securities, although as of December 31,
2007, we have not engaged in any such transactions. We intend to use the
repurchased stock to offset dilution caused by the issuance of shares in
connection with our employee stock plans. Although there are currently no
specific plans for the shares that may be purchased under the program, our goals
for the program are (i) to address provisions of our affiliation agreement with
RHI related to maintaining RHI’s minimum ownership percentage (see Note 9,
“Relationship with Roche Holdings, Inc. and Related Party Transactions” above),
(ii) to make prudent investments of our cash resources, and (iii) to allow
for an effective mechanism to provide stock for our employee stock
plans.
We
enter into Rule 10b5-1 trading plans to repurchase shares in the open market
during those periods when trading in our stock is restricted under our insider
trading policy. The most recent trading plans, which are effective through April
11, 2008, cover approximately 4.25 million shares.
In
November 2007, we entered into a prepaid share repurchase arrangement with an
investment bank pursuant to which we delivered $300 million to the investment
bank. The investment bank is obligated to deliver to us not less than three
million shares of our Common Stock, subject to certain exceptions, based on a
pre-determined formula. Pursuant to the arrangement, the investment bank is
obligated to deliver the shares to us by March 26, 2008, subject to an extension
based on certain extraordinary events. The prepaid amount has been reflected as
a reduction of our stockholders’ equity as of December 31, 2007. There was no
effect on EPS for the year ended December 31, 2007 as a result of entering into
this arrangement.
The
income tax provision consisted of the following amounts (in millions):
|
|
|
|
|
|
|
|
|
|
Current:
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
1,729 |
|
|
$ |
1,306 |
|
|
$ |
723 |
|
State
|
|
|
162 |
|
|
|
96 |
|
|
|
121 |
|
Total
current
|
|
|
1,891 |
|
|
|
1,402 |
|
|
|
844 |
|
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
(251 |
) |
|
|
(155 |
) |
|
|
(85 |
) |
State
|
|
|
17 |
|
|
|
43 |
|
|
|
(25 |
) |
Total
deferred
|
|
|
(234 |
) |
|
|
(112 |
) |
|
|
(110 |
) |
Total
income tax provision
|
|
$ |
1,657 |
|
|
$ |
1,290 |
|
|
$ |
734 |
|
Tax
benefits of $177 million in 2007, $179 million in 2006, and $642 million in 2005
related to employee stock options and stock purchase plans. These amounts
reduced current income taxes payable and deferred income taxes and were credited
to stockholders’ equity.
A
reconciliation between our effective tax rate and the U.S. statutory tax rate
follows:
|
|
|
|
|
|
|
|
|
|
Tax
at U.S. statutory rate
|
|
|
35.0
|
% |
|
|
35.0
|
% |
|
|
35.0
|
% |
Research
and other credits
|
|
|
(2.1 |
) |
|
|
(2.3 |
) |
|
|
(1.5 |
) |
In-process
research and development
|
|
|
0.6 |
|
|
|
– |
|
|
|
– |
|
Prior
years’ items
|
|
|
– |
|
|
|
0.9 |
|
|
|
(0.7 |
) |
Export
sales benefit
|
|
|
– |
|
|
|
(0.3 |
) |
|
|
(0.4 |
) |
State
taxes
|
|
|
4.8 |
|
|
|
5.0 |
|
|
|
5.0 |
|
Deduction
for qualified production activities
|
|
|
(1.2 |
) |
|
|
(0.7 |
) |
|
|
(0.8 |
) |
Tax-exempt
investment income
|
|
|
(0.2 |
) |
|
|
(0.2 |
) |
|
|
(0.3 |
) |
Other
|
|
|
0.5 |
|
|
|
0.5 |
|
|
|
0.2 |
|
Effective
tax rate
|
|
|
37.4
|
% |
|
|
37.9
|
% |
|
|
36.5
|
% |
Prior
years’ items in 2006 related to a decrease in research credits resulting from
new income tax regulations issued by the U.S. Department of Treasury in 2006.
Prior years’ items in 2005 included a $39 million benefit for increased research
credits resulting from new Temporary Regulations issued by the U.S. Department
of Treasury during 2005, partially offset by other changes in estimates of prior
years’ research credits.
The
components of deferred taxes consisted of the following at December 31 (in millions):
|
|
|
|
|
|
|
Deferred
tax liabilities:
|
|
|
|
|
|
|
Depreciation
|
|
$ |
(147 |
) |
|
$ |
(156 |
) |
Unrealized
gain on securities available-for-sale
|
|
|
(136 |
) |
|
|
(144 |
) |
Intangibles
- Roche transaction
|
|
|
(75 |
) |
|
|
(118 |
) |
Other
intangible assets
|
|
|
(258 |
) |
|
|
(48 |
) |
Other
|
|
|
(14 |
) |
|
|
(46 |
) |
Total
deferred tax liabilities
|
|
|
(630 |
) |
|
|
(512 |
) |
Deferred
tax assets:
|
|
|
|
|
|
|
|
|
Capitalized
R&D costs
|
|
|
11 |
|
|
|
14 |
|
Employee
stock-based compensation costs
|
|
|
217 |
|
|
|
102 |
|
Expenses
not currently deductible
|
|
|
598 |
|
|
|
492 |
|
Deferred
revenue
|
|
|
125 |
|
|
|
101 |
|
Investment
basis difference
|
|
|
204 |
|
|
|
203 |
|
State
credit carryforwards
|
|
|
– |
|
|
|
56 |
|
Other
|
|
|
5 |
|
|
|
5 |
|
Total
deferred tax assets
|
|
|
1,160 |
|
|
|
973 |
|
Total
net deferred tax assets
|
|
$ |
530 |
|
|
$ |
461 |
|
Net
operating loss carryforwards related to the Tanox acquisition of $107 million
expire in the years 2020 through 2026.
We
file income tax returns in the U.S. federal jurisdiction and various state and
local and foreign jurisdictions. With few exceptions, we are no longer subject
to U.S. federal, state and local, or foreign income tax examinations by tax
authorities for the years before 2002. The Internal Revenue Service (IRS) is
currently examining our U.S. income tax returns for 2002 through 2004. As of
December 31, 2007, the IRS has not proposed any adjustments. We believe it is
reasonably possible that during 2008, the unrecognized tax benefits related to
R&D credits could decrease (by payment, release, or a combination of both)
by as much as $47 million. We are also currently under examination by several
state jurisdictions and one foreign jurisdiction. As of December 31, 2007, no
material adjustments have been proposed. We believe that we have adequately
provided for any reasonably foreseeable outcomes related to our tax audits and
that any settlements will not have material adverse effects on our consolidated
financial position or results of operations. However, there can be no assurances
as to possible outcomes.
We
adopted the provisions of FIN 48 on January 1, 2007. As a result of the
implementation of FIN 48, we reclassified $147 million of unrecognized tax
benefits from current liabilities to long-term liabilities as of December 31,
2006 in the accompanying Consolidated Balance Sheets. A reconciliation of the
beginning and ending amount of unrecognized tax benefits is as
follows (in
millions):
Balance
at January 1, 2007
|
|
$ |
147 |
|
Additions
based on tax positions related to the current year
|
|
|
1 |
|
Additions
for tax positions of prior years
|
|
|
5 |
|
Balance
at December 31, 2007
|
|
$ |
153 |
|
Of
the $153 million total, $127 million represents the amount of unrecognized tax
benefits that, if recognized, would favorably affect our effective income tax
rate in a future period. We accrue tax-related interest and penalties and
include such expenses with income tax expense in the Consolidated Statements of
Income. We recognized approximately $8 million in tax-related interest expense
during 2007, and had approximately $18 million of tax-related interest accrued
at December 31, 2007. Interest amounts are net of tax benefit. No penalties have
been accrued.
Note
13.
|
SEGMENT,
SIGNIFICANT CUSTOMER AND GEOGRAPHIC
INFORMATION
|
Our
chief operating decision-makers (CODMs) comprise our executive management with
the oversight of our Board of Directors. Our CODMs review our operating results
and operating plans, and make resource allocation decisions on a company-wide or
aggregate basis. Accordingly, we operate as one segment.
Information
about our product sales, major customers, and material foreign sources of
revenue is as follows (in
millions):
Product
Sales
|
|
|
|
|
|
|
|
|
|
Net
U.S. Product Sales
|
|
|
|
|
|
|
|
|
|
Avastin
|
|
$ |
2,296 |
|
|
$ |
1,746 |
|
|
$ |
1,133 |
|
Rituxan
|
|
|
2,285 |
|
|
|
2,071 |
|
|
|
1,832 |
|
Herceptin
|
|
|
1,287 |
|
|
|
1,234 |
|
|
|
747 |
|
Lucentis
|
|
|
815 |
|
|
|
380 |
|
|
|
– |
|
Xolair
|
|
|
472 |
|
|
|
425 |
|
|
|
320 |
|
Tarceva
|
|
|
417 |
|
|
|
402 |
|
|
|
275 |
|
Nutropin
products
|
|
|
371 |
|
|
|
378 |
|
|
|
370 |
|
Thrombolytics
|
|
|
268 |
|
|
|
243 |
|
|
|
218 |
|
Pulmozyme
|
|
|
223 |
|
|
|
199 |
|
|
|
186 |
|
Raptiva
|
|
|
107 |
|
|
|
90 |
|
|
|
79 |
|
Total
U.S. product sales
|
|
|
8,540 |
|
|
|
7,169 |
|
|
|
5,162 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
Product Sales to Collaborators
|
|
|
|
|
|
|
|
|
|
|
|
|
Avastin
|
|
$ |
157 |
|
|
$ |
107 |
|
|
$ |
50 |
|
Rituxan
|
|
|
230 |
|
|
|
181 |
|
|
|
158 |
|
Herceptin
|
|
|
417 |
|
|
|
96 |
|
|
|
17 |
|
Lucentis
|
|
|
10 |
|
|
|
1 |
|
|
|
– |
|
Xolair
|
|
|
– |
|
|
|
4 |
|
|
|
7 |
|
Nutropin
products
|
|
|
12 |
|
|
|
8 |
|
|
|
5 |
|
Thrombolytics
|
|
|
20 |
|
|
|
16 |
|
|
|
8 |
|
Pulmozyme
|
|
|
43 |
|
|
|
45 |
|
|
|
35 |
|
Raptiva
|
|
|
12 |
|
|
|
14 |
|
|
|
15 |
|
Enbrel®
|
|
|
– |
|
|
|
– |
|
|
|
31 |
|
Total
product sales to collaborators
|
|
|
903 |
|
|
|
471 |
|
|
|
326 |
|
Total
product sales
|
|
$ |
9,443 |
|
|
$ |
7,640 |
|
|
$ |
5,488 |
|
________________________
The
totals shown above may not appear to sum due to rounding.
Three
of our major customers—AmerisourceBergen, Corp., Cardinal Health, Inc. and
McKesson Corp.—each contributed 10% or more of our U.S. product sales in each of
the last three years. AmerisourceBergen Corp., a national wholesale distributor
of all of our major products lines, represented 55% in 2007, 50% in 2006,
and 36% in 2005 of our total net U.S. product sales. Cardinal Health, Inc., a
national wholesale distributor of all our major product lines, represented 13%
in 2007, 18% in 2006, and 23% in 2005 of our total net U.S. product sales.
McKesson Corp., a national wholesale distributor of all of our major product
lines, represented 17% in 2007 and 2006 and 23% in 2005 of our total net U.S.
product sales. The combined net accounts receivable balance for our three major
customers was $773 million as of December 31, 2007, $778 million as of December
31, 2006, and $478 million as of December 31, 2005.
We
currently sell primarily to distributors and healthcare companies throughout the
U.S. under an extension of trade credit terms based on an assessment of each
customers’ financial condition. Trade credit terms are generally offered without
collateral and may include a discount for prompt payment for specific customers.
To manage our credit
exposure,
we perform ongoing evaluations of our customers’ financial condition and also
participate in third party contracts to reduce the risk of financial loss. In
2007, 2006, and 2005, we did not record any material additions to, or losses
against, our allowance for bad debts.
Net
foreign revenue, consisting of sales to collaborators, royalty revenue, and
contract revenue, were as follows (in millions):
|
|
|
|
|
|
|
|
|
|
Switzerland
|
|
$ |
983 |
|
|
$ |
561 |
|
|
$ |
320 |
|
Other
foreign countries
|
|
|
1,327 |
|
|
|
885 |
|
|
|
552 |
|
Total
net foreign revenue
|
|
$ |
2,310 |
|
|
$ |
1,446 |
|
|
$ |
872 |
|
Net
property, plant and equipment by country was as follows (in millions):
|
|
|
|
|
|
|
|
|
|
United
States
|
|
$ |
4,753 |
|
|
$ |
4,153 |
|
|
$ |
3,349 |
|
Singapore
|
|
|
233 |
|
|
|
20 |
|
|
|
– |
|
Total
property, plant, and equipment, net
|
|
$ |
4,986 |
|
|
$ |
4,173 |
|
|
$ |
3,349 |
|
QUARTERLY
FINANCIAL DATA (unaudited)
(in
millions, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating revenue
|
|
$ |
2,970 |
|
|
$ |
2,908 |
|
|
$ |
3,004 |
|
|
$ |
2,843 |
|
Product
sales
|
|
|
2,349 |
|
|
|
2,321 |
|
|
|
2,443 |
|
|
|
2,329 |
|
Gross
margin from product sales
|
|
|
2,005 |
|
|
|
1,915 |
|
|
|
2,014 |
|
|
|
1,937 |
|
Net
income(1)
|
|
|
632 |
|
|
|
685 |
|
|
|
747 |
|
|
|
706 |
|
Earnings
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
0.60 |
|
|
|
0.65 |
|
|
|
0.71 |
|
|
|
0.67 |
|
Diluted
|
|
|
0.59 |
|
|
|
0.64 |
|
|
|
0.70 |
|
|
|
0.66 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating revenue
|
|
$ |
2,714 |
|
|
$ |
2,384 |
|
|
$ |
2,199 |
|
|
$ |
1,986 |
|
Product
sales
|
|
|
2,244 |
|
|
|
1,941 |
|
|
|
1,810 |
|
|
|
1,644 |
|
Gross
margin from product sales
|
|
|
1,906 |
|
|
|
1,644 |
|
|
|
1,526 |
|
|
|
1,382 |
|
Net
income(1)
|
|
|
594 |
|
|
|
568 |
|
|
|
531 |
|
|
|
421 |
|
Earnings
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
0.56 |
|
|
|
0.54 |
|
|
|
0.50 |
|
|
|
0.40 |
|
Diluted
|
|
|
0.55 |
|
|
|
0.53 |
|
|
|
0.49 |
|
|
|
0.39 |
|
________________________
(1)
|
Net
income in 2007 and 2006 includes $260 million and $182 million, net of
tax, respectively, in employee stock-based compensation expense
related to our adoption of FAS 123R on January 1, 2006.
|
(2)
|
The
2007 and 2006 amounts were computed independently for each quarter,
and the sum of the quarters may not total the annual
amounts.
|
|
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
|
Not
applicable.
(a) Evaluation of Disclosure Controls
and Procedures: The Company’s principal executive and
financial officers reviewed and evaluated the Company’s disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the
period covered by this Form 10-K. Based on that evaluation, the Company’s
principal executive and financial officers concluded that the Company’s
disclosure controls and procedures are effective in timely providing them with
material information relating to the Company, as required to be disclosed in the
reports the Company files under the Exchange Act.
(b) Management’s Annual Report on
Internal Control Over Financial Reporting: The Company’s
management is responsible for establishing and maintaining adequate internal
control over the Company’s financial reporting. Management assessed the
effectiveness of the Company’s internal control over financial reporting as of
December 31, 2007. In making this assessment, management used the criteria set
forth by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO) in Internal
Control-Integrated Framework. Based on the assessment using those
criteria, management concluded that, as of December 31, 2007, our internal
control over financial reporting was effective. The Company’s independent
registered public accountants, Ernst & Young LLP, audited the consolidated
financial statements included in this Annual Report on Form 10-K and have issued
an audit report on the Company’s internal control over financial reporting. The
report on the audit of internal control over financial reporting appears
below.
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Stockholders of Genentech, Inc.
We
have audited Genentech, Inc.’s internal control over financial reporting as of
December 31, 2007, based on criteria established in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission (the COSO criteria). Genentech, Inc.’s management is responsible for
maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting
included in the accompanying Management’s Annual Report on Internal Control Over
Financial Reporting. Our responsibility is to express an opinion on the
company’s internal control over financial reporting based on our
audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, evaluating management’s assessment, testing and evaluating
the design and operating effectiveness of internal control, and performing such
other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company; (2)
provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of
the company; and (3) provide reasonable assurance regarding prevention or timely
detection of unauthorized acquisition, use, or disposition of the company’s
assets that could have a material effect on the financial
statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In
our opinion, Genentech, Inc. maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2007, based on the
COSO criteria.
We
also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), the consolidated balance sheets of
Genentech, Inc. as of December 31, 2007 and 2006, and the related consolidated
statements of income, stockholders’ equity and cash flows for each of the three
years in the period ended December 31, 2007 and our report dated February 5,
2008 expressed an unqualified opinion thereon.
/s/
ERNST & YOUNG LLP
Palo
Alto, California
February
5, 2008
(c)
Changes in Internal Controls
over Financial Reporting: There were no changes in the Company’s internal
control over financial reporting that occurred during the Company’s last fiscal
quarter that have materially affected, or are reasonably likely to materially
affect, the Company’s internal control over financial reporting.
Not
applicable.
(a)
The sections labeled “Nominees for Directors,” “Board Committees and
Meetings,” “Audit Committee Matters,” “Corporate Governance” and
“Section 16(a) Beneficial Ownership Reporting Compliance” of our Proxy Statement
in connection with the 2008 Annual Meeting of Stockholders are incorporated
herein by reference.
(b)
Information concerning our Executive Officers is set forth in Part I of this
Form 10-K.
The
sections labeled “Director Compensation for 2007,” “Compensation,
Discussion and Analysis,” “Compensation of Named Executive
Officers,” “Summary Compensation Table for 2007,” “Grants of Plan
Based Awards in 2007,” “Outstanding Equity Awards at Fiscal 2007 Year
End,” “ Option Exercises and Stock Vested in 2007,” “Non-Qualified
Deferred Compensation for 2007” and “Compensation Committee Interlocks and
Insider Participation” of our Proxy Statement in connection with the 2008 Annual
Meeting of Stockholders are incorporated herein by reference.
The
sections labeled “Relationship with Roche,” “Equity Compensation Plans” and
“Beneficial Ownership of Principal Stockholders, Directors and Management” of
our Proxy Statement in connection with the 2008 Annual Meeting of Stockholders
are incorporated herein by reference.
The
sections labeled “Relationship with Roche,” “Certain Relationships and
Related Persons Transactions” and “Director Independence” of our Proxy Statement
in connection with the 2008 Annual Meeting of Stockholders is incorporated
herein by reference.
The
section labeled “Audit Committee Matters” and “Principal Accounting Fees and
Services” of our Proxy Statement in connection with the 2008 Annual Meeting of
Stockholders is incorporated herein by reference.
(a) The
following documents are included as part of this Annual Report on Form
10-K.
1.
Index to Financial Statements
Report
of Independent Registered Public Accounting Firm
Consolidated
Statements of Income for the years ended December 31, 2007, 2006, and
2005
Consolidated
Statements of Cash Flows for the years ended December 31, 2007, 2006, and
2005
Consolidated
Balance Sheets at December 31, 2007 and 2006
Consolidated
Statements of Stockholders’ Equity for the year ended December 31, 2007, 2006,
and 2005
Notes
to Consolidated Financial Statements
Quarterly
Financial Data (unaudited)
2.
Financial Statement Schedule
The
following schedule is filed as part of this Form 10-K:
Schedule
II- Valuation and Qualifying Accounts for the years ended December 31, 2007,
2006, and 2005.
All
other schedules are omitted as the information required is inapplicable or the
information is presented in the consolidated financial statements or the related
notes.
3.
Exhibits
The
documents set forth below are filed herewith or incorporated by reference to the
location indicated.
|
|
|
3.1
|
Amended
and Restated Certificate of Incorporation
|
Filed
as an exhibit to our Current Report on Form 8-K filed with the U. S.
Securities and Exchange Commission (Commission) on July 28, 1999 and
incorporated herein by reference.
|
3.2
|
Certificate
of Amendment of Amended and Restated Certificate of
Incorporation
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2000 filed with
the Commission and incorporated herein by
reference.
|
3.3
|
Certificate
of Amendment of Amended and Restated Certificate of
Incorporation
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2001 filed with the Commission and incorporated herein by
reference.
|
3.4
|
Certificate
of Third Amendment of Amended and Restated Certificate of
Incorporation
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004 filed with the Commission and incorporated herein by
reference.
|
3.5
|
Bylaws
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2005 filed with
the Commission and incorporated herein by
reference.
|
4.1
|
Form
of Common Stock Certificate
|
Filed
as an exhibit to Amendment No. 3 to our Registration Statement (No.
333-80601) on Form S-3 filed with the Commission on July 16, 1999 and
incorporated herein by reference.
|
4.2
|
Indenture,
dated as of July 18, 2005, between the Company and Bank of New York,
as trustee
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
4.3
|
Officers’
Certificate of Genentech, Inc. dated July 18, 2005, including forms
of the Company’s 4.40% Senior Notes due 2010, 4.75 Senior Notes due 2015
and 5.25% Senior Notes due 2035
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
4.4
|
Form
of 4.40% Senior Note due 2010
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
4.5
|
Form
of 4.75% Senior Note due 2015
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
4.6
|
Form
of 5.25% Senior Note due 2035
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
4.7
|
Registration
Rights Agreement, dated as of July 18, 2005, among Genentech, Inc.
and Citigroup Global Markets, Inc. and Goldman, Sachs & Co. as
representatives of the initial purchasers
|
Filed
on a Current Report on Form 8-K with the Commission on July 19, 2005 and
incorporated herein by reference.
|
10.1
|
Form
of Affiliation Agreement, dated as of July 22, 1999, between Genentech and
Roche Holdings, Inc.
|
Filed
as an exhibit to Amendment No. 3 to our Registration Statement (No.
333-80601) on Form S-3 filed with the Commission on July 16, 1999 and
incorporated herein by reference.
|
10.2
|
Amendment
No. 1, dated October 22, 1999, to Affiliation Agreement between Genentech
and Roche Holdings, Inc.
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 1999 filed with the Commission and incorporated herein by
reference.
|
10.3
|
Form
of Amended and Restated Agreement, restated as of July 1, 1999, between
Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of
Genentech’s Products outside the United States
|
Filed
as an exhibit to Amendment No. 3 to our Registration Statement (No.
333-80601) on Form S-3 filed with the Commission on July 16, 1999 and
incorporated herein by reference.
|
10.4
|
Amendment
dated March 10, 2000, to Amended and Restated Agreement between Genentech
and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s
Products outside the United States
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.5
|
Amendment
dated June 26, 2000, to Amended and Restated Agreement between Genentech
and F. Hoffmann-La Roche Ltd regarding Commercialization of Genentech’s
Products outside the United States
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.6
|
Third
Amendment dated April 30, 2004, to Amended and Restated Agreement between
Genentech and F. Hoffmann-La Roche Ltd regarding Commercialization of
Genentech’s Products outside the United States
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.7
|
Form
of Tax Sharing Agreement, dated as of July 22, 1999, between Genentech,
Inc. and Roche Holdings, Inc.
|
Filed
as an exhibit to Amendment No. 3 to our Registration Statement (No.
333-80601) on Form S-3 filed with the Commission on July 16, 1999 and
incorporated herein by reference.
|
10.8
|
Collaborative
Agreement, dated April 13, 2004, among Genentech, F. Hoffmann-La Roche Ltd
and Hoffmann-La Roche Inc.
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.9
|
Genentech,
Inc. Tax Reduction Investment Plan, as amended and restated †
|
Filed
herewith
|
10.10
|
Genentech,
Inc. 1990 Stock Option/Stock Incentive Plan, as amended effective October
16, 1996 †
|
Filed
as an exhibit to our Registration Statement (No. 333-83157) on Form S-8
filed with the Commission on July 19, 1999 and incorporated herein by
reference.
|
10.11
|
Genentech,
Inc. 1994 Stock Option Plan, as amended effective October 16, 1996
†
|
Filed
as an exhibit to our Registration Statement (No. 333-83157) on Form S-8
filed with the Commission on July 19, 1999 and incorporated herein by
reference.
|
10.12
|
Genentech,
Inc. 1996 Stock Option/Stock Incentive Plan, as amended effective October
16, 1996 †
|
Filed
as an exhibit to our Registration Statement (No. 333-83157) on Form S-8
filed with the Commission on July 19, 1999 and incorporated herein by
reference.
|
10.13
|
Genentech,
Inc. 1999 Stock Plan, as amended and restated as of February 13, 2003
†
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2003 filed with the Commission and incorporated herein by
reference.
|
10.14
|
Genentech,
Inc. 1999 Stock Plan, Form of Stock Option Agreement †
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.15
|
Genentech,
Inc. 1999 Stock Plan, Form of Stock Option Agreement (Director Version)
†
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2004 filed with the Commission and incorporated herein by
reference.
|
10.16
|
Genentech,
Inc. 2004 Equity Incentive Plan †
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2004 filed with the Commission and incorporated herein by
reference.
|
10.17
|
Form
of Genentech, Inc. 2004 Equity Incentive Plan Nonqualified Stock Option
Grant Agreement (Employee Version) †
|
Filed
herewith
|
10.18
|
Form
of Genentech, Inc. 2004 Equity Incentive Plan Nonqualified Stock Option
Grant Agreement (Director Version) †
|
Filed
on a Current Report on Form 8-K with the Commission on September 26, 2006,
and incorporated herein by reference.
|
10.19
|
Genentech,
Inc. Supplemental Plan †
|
Filed
on a Current Report on Form 8-K with the Commission on February 24, 2005
and incorporated herein by reference.
|
10.20
|
Genentech,
Inc. 1991 Employee Stock Plan, as amended
|
Filed
on a Current Report on Form 8-K with the Commission on April 25, 2006, and
incorporated herein by reference.
|
10.21
|
Bonus
Program †
|
Incorporated
by reference to the description under “Bonus Program” in the Current
Report on Form 8-K filed with the Commission on December 21,
2007.
|
10.22
|
Form
of Indemnification Agreement for Directors and Officers †
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
March 31, 2005 filed with the Commission and incorporated herein by
reference.
|
10.26
|
Master
Lease Agreement dated as of November 1, 2004, between Genentech and Slough
SSF, LLC
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2004 filed with the Commission and incorporated herein by
reference.
|
10.27
|
First
Amendment to Master Lease Agreement and First Amendment to Building Leases
between Genentech and Slough SSF, LLC, dated October 2, 2006
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2006 filed with the Commission and incorporated herein by
reference.
|
10.29
|
Purchase
Agreement, dated as of July 13, 2005, among Genentech, Inc. and Citigroup
Global Markets, Inc. and Goldman, Sachs & Co. as representatives of
the initial purchasers
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
October 31, 2005 filed with the Commission and incorporated herein by
reference.
|
10.36
|
Amended
and Restated Collaboration Agreement between Genentech, Inc. and Idec
Pharmaceuticals Corporation dated as of June 19, 2003 *
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2006, filed with the Commission on August 3, 2006, and
incorporated herein by reference.
|
10.37
|
Letter
Amendment dated as of August 21, 2003, to the Amended and Restated
Collaboration Agreement between Genentech, Inc. and Idec Pharmaceuticals
Corporation
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2006, filed with the Commission on August 3, 2006, and
incorporated herein by reference.
|
10.38
|
Agreement
and Plan of Merger by and among Genentech, Inc., Green Acquisition
Corporation and Tanox, Inc., dated as of November 9, 2006
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2006 filed with the Commission and incorporated herein by
reference.
|
10.39
|
Form
of Voting Agreement between Genentech, Inc. and Certain Stockholders of
Tanox, Inc.
|
Filed
as an exhibit to our Annual Report on Form 10-K for the year ended
December 31, 2006 filed with the Commission and incorporated herein by
reference.
|
23.1
|
Consent
of Independent Registered Public Accounting Firm
|
Filed
herewith
|
24.1
|
Power
of Attorney
|
Reference
is made to the signature page.
|
28.1
|
Description
of the Company’s capital stock
|
Incorporated
by reference to the description under the heading “Description of Capital
Stock” relating to our Common Stock in the prospectus included in our
Amendment No. 2 to the Registration Statement on Form S-3 (No. 333-88651)
filed with the Commission on October 20, 1999, and the description under
the heading “Description of Capital Stock” relating to the Common Stock in
our final prospectus filed with the Commission on October 21, 1999
pursuant to Rule 424(b)(1) under the Securities Act of 1933, as amended,
including any amendment or report filed for the purpose of updating that
description.
|
31.1
|
Certification
of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as
amended
|
Filed
herewith
|
31.2
|
Certification
of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a)
promulgated under the Securities Exchange Act of 1934, as
amended
|
Filed
herewith
|
32.1
|
Certifications
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
Furnished
herewith
|
________________________
|
* Pursuant
to a request for confidential treatment, portions of this Exhibit have
been redacted from the publicly filed document and have been furnished
separately to the Securities and Exchange Commission as required by Rule
24b-2 under the Securities Exchange Act of
1934.
|
† Indicates
a management contract or compensatory plan or arrangement.
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
|
|
GENENTECH,
INC.
Registrant
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Date:
|
|
|
By:
|
|
|
|
|
|
Robert
E. Andreatta
|
|
|
|
|
Controller
and Chief Accounting Officer
|
POWER
OF ATTORNEY
KNOW
ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints David A. Ebersman, Executive Vice President and Chief
Financial Officer, and Robert E. Andreatta, Controller and Chief Accounting
Officer, and each of them, his or her true and lawful attorneys-in-fact and
agents, with the full power of substitution and resubstitution, for him or her
and in his or her name, place and stead, in any and all capacities, to sign any
amendments to this report, and to file the same, with exhibits thereto and other
documents in connection therewith, with the Securities and Exchange Commission,
granting unto each said attorney-in-fact and agent full power and authority to
do and perform each and every act in person, hereby ratifying and confirming all
that said attorney-in-fact and agent, or either of them, or their or his or her
substitute or substitutes, may lawfully do or cause to be done by virtue
hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the
capacities and on the dates indicated:
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
Principal
Executive Officer:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
ARTHUR D. LEVINSON
|
|
Chairman
and Chief Executive Officer
|
|
February
25, 2008
|
Arthur
D. Levinson
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal
Financial Officer:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
DAVID A. EBERSMAN
|
|
Executive
Vice President and
|
|
February
25, 2008
|
David
A. Ebersman
|
|
Chief
Financial Officer
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal
Accounting Officer:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
ROBERT E. ANDREATTA
|
|
Controller
and
|
|
February
25, 2008
|
Robert
E. Andreatta
|
|
Chief
Accounting Officer
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
Directors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
HERBERT W. BOYER
|
|
Director
|
|
February
25, 2008
|
Herbert
W. Boyer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
WILLIAM M. BURNS
|
|
Director
|
|
February
25, 2008
|
William
M. Burns
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
ERICH HUNZIKER
|
|
Director
|
|
February
25, 2008
|
Erich
Hunziker
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
JONATHAN K.C. KNOWLES
|
|
Director
|
|
February
25, 2008
|
Jonathan
K.C. Knowles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
DEBRA L. REED
|
|
Director
|
|
February
25, 2008
|
Debra
L. Reed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
/s/
CHARLES A. SANDERS
|
|
Director
|
|
February
25, 2008
|
Charles
A. Sanders
|
|
|
|
|
SCHEDULE
II
GENENTECH,
INC.
VALUATION
AND QUALIFYING ACCOUNTS
Years
Ended December 31, 2007, 2006 and 2005
(in
millions)
|
|
Balance
at
Beginning
of
Period
|
|
|
Addition
Charged
to
Cost
and
Expenses
|
|
|
|
|
|
|
|
Accounts
receivable allowances:
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended December 31, 2007:
|
|
$ |
92 |
|
|
$ |
521 |
|
|
$ |
(497 |
) |
|
$ |
116 |
|
Year
Ended December 31, 2006:
|
|
$ |
84 |
|
|
$ |
415 |
|
|
$ |
(407 |
) |
|
$ |
92 |
|
Year
Ended December 31, 2005:
|
|
$ |
62 |
|
|
$ |
307 |
|
|
$ |
(284 |
) |
|
$ |
84 |
|
Inventory
reserves:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended December 31, 2007:
|
|
$ |
71 |
|
|
$ |
41 |
|
|
$ |
(50 |
) |
|
$ |
62 |
|
Year
Ended December 31, 2006:
|
|
$ |
57 |
|
|
$ |
50 |
|
|
$ |
(36 |
) |
|
$ |
71 |
|
Year
Ended December 31, 2005:
|
|
$ |
46 |
|
|
$ |
35 |
|
|
$ |
(24 |
) |
|
$ |
57 |
|
Rebate
accruals:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year
Ended December 31, 2007:
|
|
$ |
47 |
|
|
$ |
144 |
|
|
$ |
(131 |
) |
|
$ |
60 |
|
Year
Ended December 31, 2006:
|
|
$ |
38 |
|
|
$ |
113 |
|
|
$ |
(104 |
) |
|
$ |
47 |
|
Year
Ended December 31, 2005:
|
|
$ |
35 |
|
|
$ |
77 |
|
|
$ |
(74 |
) |
|
$ |
38 |
|
________________________
*
|
Represents
amounts written off or returned against the allowance or reserves, or
returned against earnings.
|