(Mark
One)
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þ
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ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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o
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TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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A
Delaware Corporation
(State
or other jurisdiction of incorporation or organization)
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94-2347624
(I.R.S.
Employer Identification No.)
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1
DNA Way, South San Francisco, California
(Address
of principal executive offices)
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94080
(Zip
Code)
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Title
of Each Class
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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
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Large
accelerated filer þ
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Accelerated
filer o
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Non-accelerated
filer o
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Portions
of the Definitive Proxy Statement with respect to the 2006 Annual
Meeting of Stockholders to be filed by Genentech, Inc. with the
Securities
and Exchange Commission (hereinafter referred to as “Proxy
Statement”)
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Part III
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(A)
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Excludes
587,254,604 shares of Common Stock held by directors and executive
officers of Genentech and Roche Holdings,
Inc.
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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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23
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Item 2
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23
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Item 3
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24
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Item 4
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26
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27
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Item 5
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29
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Item 6
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31
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Item 7
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32
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Item 7A
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61
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Item 8
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64
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Item 9
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103
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Item 9A
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103
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Item 9B
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106
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Item 10
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107
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Item 11
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107
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Item 12
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107
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Item 13
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107
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Item 14
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107
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Item 15
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108
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113
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Item
1.
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·
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The
treatment of patients with relapsed or refractory, low-grade or
follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma, including
retreatment and bulky disease;
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·
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The
first-line treatment of patients with diffuse large B-cell, CD20-positive,
non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide,
doxorubicin, vincristine and prednisone) or other anthracycline-based
chemotherapy;
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·
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The
first-line treatment of previously untreated patients with follicular,
CD20-positive, B-cell non-Hodgkin’s lymphoma in combination with CVP
(cyclophosphamide, vincristine and prednisone) chemotherapy
regimens;
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·
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The
treatment of patients with low-grade, CD20-positive, B-cell non-Hodgkin’s
lymphoma in patients with stable disease or who achieve a partial
or
complete response following first-line treatment with CVP chemotherapy;
and
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·
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Use
in combination with methotrexate for reducing signs and symptoms
in adult
patients with moderately-to-severely active rheumatoid arthritis
(or “RA”)
who have had an inadequate response to one or more tumor necrosis
factor
antagonist therapies.
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Product
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Trade
Name
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Licensee
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Licensed
Territory
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Trastuzumab
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Herceptin
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F.
Hoffmann-La Roche
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Worldwide
excluding U.S.
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Rituximab
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Rituxan/MabThera®
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F.
Hoffmann-La 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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F.
Hoffmann-La 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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F.
Hoffmann-La 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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F.
Hoffmann-La Roche
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Canada
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Somatropin
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Nutropin
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F.
Hoffmann-La Roche
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Canada
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Etanercept
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ENBREL®
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Immunex
Corporation (whose rights were acquired by Amgen Inc.)
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Worldwide
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D2E7/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
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Cetuximab
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ERBITUX®
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ImClone
Systems, Inc.
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Worldwide
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Antihemophilic
factor, recombinant
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Kogenate®/Helixate®
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Bayer
Corporation
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Worldwide
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Product
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Description
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Estimated
Completion of Current Phase(1)
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Awaiting
U.S. Food and Drug Administration (or “FDA”)
Action
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||
Herceptin
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A
supplemental Biologics Licensure Application (or “sBLA”) was submitted to
the FDA on December 21, 2006 for the use of Herceptin for the treatment
of
patients with early-stage HER2-positive breast cancer based on
the HERA
study to enable a broader label. This product is being developed
in
collaboration with F. Hoffmann-La Roche.
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2007-2008
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Preparing
for Filing
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Avastin
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We
are preparing to resubmit an sBLA to the FDA for the use of Avastin
in
combination with paclitaxel chemotherapy for the treatment of patients
who
have not previously received chemotherapy for their locally recurrent
or
metastatic breast cancer. This product is being developed in collaboration
with F. Hoffmann-La Roche.
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2007
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Avastin
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We
are in discussions with the FDA regarding the submission requirements
for
a potential sBLA 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 F. Hoffmann-La Roche.
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2007-2008
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Herceptin
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We
are preparing to submit an sBLA to the FDA for the use of Herceptin
for
the treatment of patients with early-stage HER2-positive breast
cancer
based on the BCIRG 006 study to enable a broader label. This product
is
being developed in collaboration with F. Hoffmann-La Roche.
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2007
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Rituxan
Immunology
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We
and our collaborator Biogen Idec are preparing to submit an sBLA
to the
FDA seeking expansion of the rheumatoid arthritis (anti-tumor necrosis
factor inadequate responders) indication to include radiographic
data
demonstrating inhibition of joint damage in Rituxan treated patients.
This
product is being developed in collaboration with F. Hoffmann-La
Roche and
Biogen Idec.
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2007
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Phase
III
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||
2nd
Generation anti-CD20
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2nd
Generation anti-CD20 is being evaluated in rheumatoid arthritis.
This
product is being developed in collaboration with F. Hoffmann-La
Roche and
Biogen Idec(2).
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2009-2010
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Avastin
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Avastin
is being evaluated in adjuvant colon cancer, adjuvant rectal cancer,
first- and second-line metastatic breast cancer in combination
with
several chemotherapy regimens, first-line non-squamous NSCLC, first-line
ovarian cancer, and hormone refractory prostate cancer. This product
is
being developed in collaboration with F. Hoffmann-La Roche.
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2007-2012
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Avastin
+/- Tarceva
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Avastin
and Tarceva are being evaluated as combination therapy in first-line
NSCLC
in combination with several chemotherapy regimens. This product
is being
developed in collaboration with F. Hoffmann-La Roche and OSI.
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2009
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Rituxan
Hematology/Oncology
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Rituxan
is being evaluated in first-line follicular non-Hodgkin’s lymphoma with
several chemotherapy regimens and in relapsed chronic lymphocytic
leukemia. This product is being developed in collaboration with
F.
Hoffmann-La Roche and Biogen Idec.
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2010
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Rituxan
Immunology
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Rituxan
is being evaluated in rheumatoid arthritis (DMARD inadequate responders)
in collaboration with F. Hoffmann-La 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.
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2007-2009
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Tarceva
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Tarceva
is being evaluated in adjuvant NSCLC with several chemotherapy
regimens
and first-line NSCLC. This product is being developed in collaboration
with F. Hoffmann-La Roche and OSI.
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2013
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Tarceva
+/- Avastin
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Tarceva
and Avastin are being evaluated as combination therapy in first-line
metastatic pancreatic cancer and second-line NSCLC. This product
is being
developed in collaboration with F. Hoffmann-La Roche and OSI.
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2008
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TNKase
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TNKase
is being evaluated in the treatment of dysfunctional hemodialysis
and
central venous access catheters.
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2008
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Xolair
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Xolair
is being evaluated in pediatric asthma. This product is being developed
in
collaboration with Novartis and Tanox, Inc. (or “Tanox”).
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2008
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Preparing
for Phase III
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2nd
Generation anti-CD20
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We
are preparing Phase III clinical trials in lupus nephritis and
systemic
lupus erythematosus. This product is being developed in collaboration
with
F. Hoffmann-La Roche and Biogen Idec(2).
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2007
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ALTU-238
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Altus
is preparing a Phase III clinical trial in adult growth hormone
deficiency. We have entered into an agreement to develop this product
in
collaboration with Altus, and this transaction is subject to closing
conditions.
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(3)
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Avastin
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We
are preparing for Phase III clinical trials in adjuvant breast
cancer,
first-line metastatic breast cancer in combination with antihormonal
therapy, adjuvant NSCLC, gastrointestinal stromal tumors, and second-line
ovarian cancer. This product is being developed in collaboration
with F.
Hoffmann-La Roche.
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2007
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Herceptin
+/- Avastin
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We
are preparing for a Phase III clinical trial of Herceptin and Avastin
as
combination therapy in first-line HER2-positive metastatic breast
cancer.
This product is being developed in collaboration with F. Hoffmann-La
Roche.
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2007
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Lucentis
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We
are preparing for Phase III clinical trials in diabetic macular
edema and
retinal vein occlusion. This product is being developed in collaboration
with Novartis Ophthalmics.
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2007
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Phase
II
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Anti-CD40
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Anti-CD40
is being evaluated in non-Hodgkin’s lymphoma. We are developing this
product in collaboration with Seattle Genetics Inc.
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2008-2009
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Avastin
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Avastin
is being evaluated in adjuvant HER2-negative breast cancer, relapsed
glioblastoma multiforme, and non-squamous NSCLC with previously
treated
central nervous system metastases. This product is being developed
in
collaboration with F. Hoffmann-La Roche.
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2007
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HAE1
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HAE1
is being evaluated in moderate-to-severe allergic asthma.
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2008-2009
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Omnitarg
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Our
Phase II clinical trial evaluating Omnitarg in combination with
chemotherapy in platinum-resistant ovarian cancer showed encouraging
results. Roche is conducting a clinical trial evaluating Omnitarg
in
combination with chemotherapy in platinum-sensitive ovarian cancer.
This
product is being developed in collaboration with F. Hoffmann-La
Roche.
|
2007
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Topical
VEGF
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Topical
VEGF is being evaluated for the treatment of diabetic foot
ulcers.
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2007
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Preparing
for Phase II
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||
2nd
Generation anti-CD20
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We
are preparing for a Phase II clinical trial in relapsing remitting
multiple sclerosis. This product is being developed in collaboration
with
F. Hoffmann-La Roche and Biogen Idec(2).
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2007-2008
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ALTU-238
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Altus
is preparing for a Phase II clinical trial in pediatric growth
hormone
deficiency. We have entered into an agreement to develop this product
in
collaboration with Altus, and this transaction is subject to closing
conditions.
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(3)
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Avastin
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We
are preparing to initiate a Phase II clinical trial in extensive
small
cell lung cancer. This product is being developed in collaboration
with F.
Hoffmann-La Roche.
|
2007
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Phase
I and Preparing for Phase I
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We
have multiple new molecular entities in Phase I or preparing for
Phase
I.
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(1)
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For
those projects preparing for a Phase, the estimated date of completion
refers to the date the project is expected to enter the Phase for
which it
is preparing.
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(2)
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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.
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(3)
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Our
collaborator is conducting the trial(s) and we are unable to provide
the
estimated date of completion for the current
phase.
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·
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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
reasonably practicable after such material is electronically filed
with
the Securities and Exchange Commission;
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·
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our
policies related to corporate governance, including Genentech’s
Principles
of Corporate Governance, Good
Operating Principles (Genentech’s code of ethics applying to Genentech’s
directors, officers and employees) as well as Genentech’s Code of Ethics
applying to our CEO, CFO and senior financial officials;
and
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·
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the
charters of the Audit Committee and the Compensation Committee
of our
Board of Directors.
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Item
1A.
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·
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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 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 Biologic
Licensing Application (or “BLA”) preparation, discussions with the U.S.
Food and Drug Administration (or “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
formulating the product, scaling the manufacturing process or in
getting
approval for manufacturing.
|
·
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Manufacturing
costs, pricing or reimbursement issues, or other factors that make
the
product uneconomical.
|
·
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The
proprietary rights of others and their competing products and technologies
that may prevent the product from being developed or
commercialized.
|
·
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The
contractual rights of our collaborators or others that may prevent
the
product from being developed or
commercialized.
|
·
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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 candidate products 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 F. Hoffmann-La Roche
(or “Hoffmann-La 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 upfront fee for the purchase of in-process R&D, which we
may record as an R&D expense.
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·
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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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·
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Charges
incurred in connection with expanding our product manufacturing
capabilities, as described in “Difficulties or delays in product
manufacturing or in obtaining materials from our suppliers could
harm our
business and/or negatively affect our financial performance”
below.
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·
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Future
levels of revenue.
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·
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Significant
delays in obtaining or failing to obtain approvals as described
in “The
successful development of biotherapeutics is highly uncertain and
requires
significant expenditures and time”
above.
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·
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Loss
of, or changes to, previously obtained approvals, including those
resulting from post-approval safety or efficacy
issues.
|
·
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Failure
to comply with existing or future regulatory
requirements.
|
·
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Changes
to manufacturing processes, manufacturing process standards or
Good
Manufacturing Practices (or “GMP”) following approval or changing
interpretations of these factors.
|
·
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the
inability of a supplier to provide raw materials used for manufacture
of
our products;
|
·
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equipment
obsolescence, malfunctions or
failures;
|
·
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product
quality or contamination problems;
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·
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damage
to a facility, including our warehouses and distribution facilities,
due
to natural disasters, including, but not limited to, earthquakes
as our
South San Francisco, Oceanside and Vacaville facilities are located
in
areas where earthquakes occur;
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·
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changes
in FDA regulatory requirements or standards that require modifications
to
our manufacturing processes;
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·
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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 we make for
others;
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·
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a
contract manufacturer going out of business or failing to produce
product
as contractually required;
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·
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failure
to maintain an adequate state of GMP compliance;
and
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·
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successful
implementation and integration of our new enterprise resource planning
system, including the portions relating to manufacturing and
distribution.
|
·
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The
timing of FDA approval, if any, of competitive
products.
|
·
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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 receive greater than 10,000 milligrams
of
Avastin over a 12-month period to receive free Avastin during the
remainder of the 12-month period. Eligible patients include those
who are
being treated for an FDA-approved
indication.
|
·
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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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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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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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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 who supply our
products.
|
·
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Hoffmann-La
Roche’s decisions 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 Hoffmann-La 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 Hoffmann-La Roche, which may include development and marketing
arrangements for our products in the U.S., Europe and other countries
outside the U.S.
|
·
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The
timing of non-U.S. approvals, if any, for products licensed to
Hoffmann-La
Roche and to other licensees.
|
·
|
Government
and third-party payer reimbursement and coverage decisions that
affect the
utilization of our products and competing
products.
|
·
|
Fluctuations
in foreign currency exchange rates.
|
·
|
The
initiation of new contractual arrangements with other
companies.
|
·
|
Whether
and when contract milestones are
achieved.
|
·
|
The
failure of or refusal of a licensee to pay
royalties.
|
·
|
The
expiration or invalidation of our patents or licensed intellectual
property. For example, patent litigations, 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 under which we receive royalties and/or
other
revenues is invalid, unenforceable, or unpatentable, that determination
could cause us to suffer a loss of such royalties and/or revenues,
and
could cause us to incur other monetary
damages.
|
·
|
Decreases
in licensees’ sales of product due to competition, manufacturing
difficulties or other factors that affect the sales of
product.
|
·
|
Require
the approval of the directors designated by Roche to make any acquisition
or any sale or disposal of all or a portion of our business representing
10% or more of our assets, net income or
revenues.
|
·
|
Enable
Roche to maintain its percentage ownership interest in our Common
Stock.
|
·
|
Require
us to establish a stock repurchase program designed to maintain
Roche’s
percentage ownership interest in our Common Stock based on an established
Minimum Percentage. For information regarding Minimum Percentage,
see Note
9, “Relationship with Roche and Related Party Transactions,” in the Notes
to Consolidated Financial Statements in Part II, Item 8 of this
Form
10-K.
|
·
|
The
overall competitive environment for our products as described in
“We face
competition” above.
|
·
|
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.
|
·
|
The
amount and timing of our sales to Hoffmann-La Roche and our other
collaborators of products for sale outside of the U.S. and the
amount and
timing of sales to their respective customers, which directly affects
both
our product sales and royalty
revenues.
|
·
|
The
timing and volume of bulk shipments to
licensees.
|
·
|
The
availability and extent of government and private third-party
reimbursements for the cost of
therapy.
|
·
|
The
extent of product discounts extended to
customers.
|
·
|
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.
|
·
|
The
rate of adoption by physicians and use of our products for approved
indications and additional indications. Among other things, the
rate of
adoption by physicians and use of our products may be affected
by results
of clinical studies reporting on the benefits or risks of a
product.
|
·
|
The
potential introduction of new products and additional indications
for
existing products.
|
·
|
The
ability to successfully manufacture sufficient quantities of any
particular marketed product.
|
·
|
Pricing
decisions that we or our competitors have adopted or may adopt,
as well as
our Avastin Patient Assistance
Program.
|
·
|
Announcements
of technological innovations or new commercial products by us or
our
competitors.
|
·
|
Publicity
regarding actual or potential medical results relating to products
under
development or being commercialized by us or our competitors.
|
·
|
Concerns
about the pricing of our products, or our pricing initiatives (including
our Avastin Patient Assistance Program), and the potential effect
of such
on their utilization or our product
sales.
|
·
|
Developments
or outcome of litigation, including litigation regarding proprietary
and
patent rights.
|
·
|
Regulatory
developments or delays concerning our products in the U.S. and
foreign
countries.
|
·
|
Issues
concerning the safety of our products or of biotechnology products
generally.
|
·
|
Economic
and other external factors or a disaster or
crisis.
|
·
|
Period
to period fluctuations in our financial
results.
|
Item
1B.
|
Item
2.
|
Item
3.
|
Name
|
Age
|
Position
|
|
Arthur
D. Levinson, Ph.D.*
|
56
|
Chairman
and Chief Executive Officer
|
|
Susan
D. Desmond-Hellmann, M.D., M.P.H.*
|
49
|
President,
Product Development
|
|
Ian
T. Clark*
|
46
|
Executive
Vice President, Commercial Operations
|
|
David
A. Ebersman*
|
37
|
Executive
Vice President and Chief Financial Officer
|
|
Stephen
G. Juelsgaard, D.V.M., J.D.*
|
58
|
Executive
Vice President, Secretary and Chief Compliance Officer
|
|
Richard
H. Scheller, Ph.D.*
|
53
|
Executive
Vice President, Research
|
|
Patrick
Y. Yang, Ph.D.*
|
58
|
Executive
Vice President, Product Operations
|
|
Robert
L. Garnick, Ph.D.
|
57
|
Senior
Vice President, Regulatory, Quality and Compliance
|
|
John
M. Whiting
|
51
|
Vice
President, Finance and Chief Accounting Officer
|
Common
Stock
|
|||||||||||||
2006
|
2005
|
||||||||||||
High
|
Low
|
High
|
Low
|
||||||||||
4th
Quarter
|
$
|
86.93
|
$
|
79.65
|
$
|
100.20
|
$
|
79.87
|
|||||
3rd
Quarter
|
86.65
|
76.80
|
94.99
|
79.71
|
|||||||||
2nd
Quarter
|
84.72
|
75.58
|
84.10
|
54.68
|
|||||||||
1st
Quarter
|
95.16
|
81.15
|
59.00
|
43.90
|
Base
Period
|
Years
Ending
|
||||||||||||||||||
December
|
December
|
December
|
December
|
December
|
December
|
||||||||||||||
Company
/ Index
|
2001
|
2002
|
2003
|
2004
|
2005
|
2006
|
|||||||||||||
GENENTECH,
INC
|
100
|
$
|
61.12
|
$
|
172.48
|
$
|
200.70
|
$
|
341.01
|
$
|
299.10
|
||||||||
S&P
500 INDEX
|
100
|
77.90
|
100.25
|
111.15
|
116.61
|
135.03
|
|||||||||||||
S&P
500 PHARMACEUTICALS
|
100
|
79.96
|
86.98
|
80.51
|
77.81
|
90.14
|
|||||||||||||
S&P
BIOTECHNOLOGY
|
100
|
79.59
|
102.55
|
110.35
|
130.52
|
126.94
|
(1)
|
The
total return on investment (change in year end stock price plus
reinvested
dividends) assumes $100 invested on December 31, 2001 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. The Standard & Poor’s 500 Pharmaceuticals Index was comprised
at December 31, 2006 of 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.
The
Standard & Poor’s 500 Biotechnology Index was comprised at December
31, 2006 of Amgen Inc., Biogen Idec Inc., Genzyme Corporation,
Gilead
Sciences, Inc. and MedImmune, 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.
|
Item
6.
|
2006
|
2005
|
2004
|
2003
|
2002
|
||||||||||||
Total
operating revenues
|
$
|
9,284
|
$
|
6,633
|
$
|
4,621
|
$
|
3,300
|
$
|
2,584
|
||||||
Product
sales
|
7,640
|
5,488
|
3,749
|
2,621
|
2,164
|
|||||||||||
Royalties
|
1,354
|
935
|
641
|
501
|
366
|
|||||||||||
Contract
revenue
|
290
|
210
|
231
|
178
|
54
|
|||||||||||
Income
before cumulative effect of accounting changes
|
$
|
2,113
|
$
|
1,279
|
$
|
785
|
$
|
610
|
$
|
64
|
||||||
Cumulative
effect of accounting changes, net of tax
|
-
|
-
|
-
|
(47
|
)(3)
|
-
|
||||||||||
Net
income
|
$
|
2,113
|
(1) |
$
|
1,279
|
$
|
785
|
$
|
563
|
(3) |
$
|
64
|
(4) | |||
Basic
earnings per share
|
$
|
2.01
|
$
|
1.21
|
$
|
0.74
|
$
|
0.54
|
$
|
0.06
|
||||||
Diluted
earnings per share
|
1.97
|
1.18
|
0.73
|
0.53
|
0.06
|
|||||||||||
Total
assets
|
$
|
14,842
|
$
|
12,147
|
$
|
9,403
|
(2) |
$
|
8,759
|
(2) |
$
|
6,776
|
||||
Long-term
debt
|
2,204
|
(2) |
2,083
|
(2) |
412
|
(2) |
412
|
(2) |
-
|
|||||||
Stockholders’
equity
|
9,478
|
7,470
|
6,782
|
6,520
|
5,339
|
We
have paid no dividends.
|
|
All
per share amounts reflect the two-for-one stock split that was
effected in
2004.
|
|
Certain
prior year amounts have been reclassified to conform to the current
year
presentation.
|
|
(1)
|
Net
income in 2006 includes employee stock-based compensation costs
of $182
million, net of tax, due to our adoption of FAS 123R 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.
|
(2)
|
Long-term
debt in 2006 and 2005 includes $1.99 billion related to our debt
issuance
in July 2005, and includes $216 million in 2006 and $94 million
in 2005 in
construction financing obligations related to our agreements with
Slough
and Lonza. Long-term debt in 2005 also reflects 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 (or “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.
|
(3)
|
Net
income in 2003 includes the receipt of $113 million in pre-tax
litigation
settlements with Amgen Inc. and Bayer Inc. Net income in 2003 also
reflects 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.
|
(4)
|
Net
income in 2002 includes $544 million of pre-tax litigation-related
special
charges, which are comprised of the COH litigation judgment in
2002, and
accrued interest and bond costs, and certain other litigation-related
matters.
|
·
|
Lucentis
for the treatment of neovascular (wet) age-related macular degeneration
(or “AMD”);
|
·
|
Avastin
in combination with intravenous 5-fluorouracil (or “5-FU”)-based
chemotherapy for second-line metastatic colorectal
cancer;
|
·
|
Avastin
for use in combination with carboplatin and paclitaxel chemotherapy
for
the first-line treatment of patients with unresectable, locally
advanced,
recurrent or metastatic non-squamous, non-small cell lung cancer
(or
“NSCLC”);
|
·
|
Rituxan
for the treatment of patients with active rheumatoid arthritis
(or “RA”)
who have had an inadequate response to tumor necrosis factor antagonist
therapy;
|
·
|
Rituxan
for use in first-line treatment of patients with diffuse large
B-cell,
CD20-positive, non-Hodgkin’s
lymphoma (or “DLBCL”);
|
·
|
Rituxan
for the first-line treatment of previously untreated patients with
follicular,
CD20-positive, B-cell non-Hodgkin’s
lymphoma in combination with CVP (cyclophosphamide, vincristine,
prednisone) chemotherapy;
|
·
|
Rituxan
for the treatment of low-grade, CD20-positive, B-cell non-Hodgkin’s
lymphoma in patients with stable disease or who achieve a partial
or
complete response following first-line treatment with CVP chemotherapy;
and
|
·
|
Herceptin
for the adjuvant treatment of HER2-positive node-positive breast
cancer
patients in combination with doxorubicin, cyclophosphamide, and
paclitaxel.
|
·
|
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, 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,
reduced
product sales, and/or lower prices, even for products protected
by
patents.
|
·
|
Our
long-term business growth, commercial performance and clinical
success
depend upon our ability to continue to develop and commercialize
important
novel therapeutics to treat unmet medical needs, such as cancer.
We
recognize that the successful development of biotherapeutics 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 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.
|
·
|
We
believe our business model is only sustainable with appropriate
pricing
and reimbursement for our products to offset the costs and risks
of drug
development. The pricing of our products has received negative
press
coverage and public scrutiny. We will continue to meet with patient
groups, payers and other stakeholders in the healthcare system
to
understand their issues and concerns. However, the future reimbursement
environment for our products is
uncertain.
|
·
|
As
the Medicare and Medicaid programs are
the largest payers for our products, rules relating to coverage
and
reimbursement continue to represent an important area of focus.
New
regulations relating 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, and we anticipate minimal effects on our revenues
in
2007.
|
·
|
Manufacturing
biotherapeutics is difficult and complex, and requires facilities
specifically designed and validated to run biotechnology production
processes. The manufacture of a biotherapeutic requires developing
and
maintaining a process to reliably manufacture and formulate the
product at
an appropriate scale, obtaining regulatory approval to manufacture
the
product, and is subject to changes in regulatory requirements or
standards
that may require modifications to the manufacturing
process.
|
·
|
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.
In
keeping with our desire to maintain and protect our culture, we
continued
our broad-based stock option program in
2006.
|
·
|
Intellectual
property protection of our products is crucial to our business.
Loss of
effective intellectual property protection on one or more products
could
result in lost sales to competing products and may negatively affect
our
sales, royalty revenues 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.
|
·
|
Rebate
allowances and accruals are comprised of 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;
|
·
|
Prompt
pay sales discounts are credits granted to wholesalers for remitting
payment on their purchases within established cash repayment incentive
periods;
|
·
|
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;
|
·
|
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
|
·
|
Healthcare
provider contractual chargebacks are the result of contractual
commitments
by us to provide products to healthcare providers at specified
prices or
discounts.
|
Annual
Percentage Change
|
||||||||||||||||
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
||||||||||||
Product
sales
|
$
|
7,640
|
$
|
5,488
|
$
|
3,749
|
39
|
%
|
46
|
%
|
||||||
Royalties
|
1,354
|
935
|
641
|
45
|
46
|
|||||||||||
Contract
revenue
|
290
|
210
|
231
|
38
|
(9
|
)
|
||||||||||
Total
operating revenues
|
9,284
|
6,633
|
4,621
|
40
|
44
|
|||||||||||
Cost
of sales
|
1,181
|
1,011
|
673
|
17
|
50
|
|||||||||||
Research
and development
|
1,773
|
1,262
|
948
|
40
|
33
|
|||||||||||
Marketing,
general and administrative
|
2,014
|
1,435
|
1,088
|
40
|
32
|
|||||||||||
Collaboration
profit sharing
|
1,005
|
823
|
594
|
22
|
39
|
|||||||||||
Recurring
charges related to redemption
|
105
|
123
|
145
|
(15
|
)
|
(15
|
)
|
|||||||||
Special
items: litigation-related
|
54
|
58
|
37
|
(7
|
)
|
57
|
||||||||||
Total
costs and expenses
|
6,132
|
4,712
|
3,485
|
30
|
35
|
|||||||||||
Operating
income
|
3,152
|
1,921
|
1,136
|
64
|
69
|
|||||||||||
Other
income (expense):
|
||||||||||||||||
Interest
and other income (expense), net
|
325
|
142
|
91
|
129
|
56
|
|||||||||||
Interest
expense
|
(74
|
)
|
(50
|
)
|
(7
|
)
|
48
|
614
|
||||||||
Total
other income, net
|
251
|
92
|
84
|
173
|
10
|
|||||||||||
Income
before taxes
|
3,403
|
2,013
|
1,220
|
69
|
65
|
|||||||||||
Income
tax provision
|
1,290
|
734
|
435
|
76
|
69
|
|||||||||||
Net
income
|
$
|
2,113
|
$
|
1,279
|
$
|
785
|
65
|
63
|
||||||||
Earnings
per share:
|
||||||||||||||||
Basic
|
$
|
2.01
|
$
|
1.21
|
$
|
0.74
|
66
|
64
|
||||||||
Diluted
|
$
|
1.97
|
$
|
1.18
|
$
|
0.73
|
67
|
62
|
||||||||
Pretax
operating margin
|
34
|
%
|
29
|
%
|
25
|
%
|
||||||||||
COS
as a % of product sales
|
15
|
18
|
18
|
|||||||||||||
R&D
as a % of operating revenues
|
19
|
19
|
21
|
|||||||||||||
MG&A
as a % of operating revenues
|
22
|
22
|
24
|
|||||||||||||
NI
as a % of operating revenues
|
23
|
19
|
17
|
|||||||||||||
Tax
rate
|
38
|
36
|
36
|
Annual
Percentage Change
|
||||||||||||||||
Product
Sales
|
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
|||||||||||
Net
U.S. Product Sales
|
||||||||||||||||
Avastin
|
$
|
1,746
|
$
|
1,133
|
$
|
545
|
54
|
%
|
108
|
%
|
||||||
Rituxan
|
2,071
|
1,832
|
1,574
|
13
|
16
|
|||||||||||
Herceptin
|
1,234
|
747
|
479
|
65
|
56
|
|||||||||||
Lucentis
|
380
|
-
|
-
|
-
|
-
|
|||||||||||
Xolair
|
425
|
320
|
188
|
33
|
70
|
|||||||||||
Tarceva
|
402
|
275
|
13
|
46
|
*
|
|||||||||||
Nutropin
products
|
378
|
370
|
349
|
2
|
6
|
|||||||||||
Thrombolytics
|
243
|
218
|
194
|
11
|
12
|
|||||||||||
Pulmozyme
|
199
|
186
|
157
|
7
|
18
|
|||||||||||
Raptiva
|
90
|
79
|
52
|
14
|
52
|
|||||||||||
Total
U.S. product sales
|
7,169
|
5,162
|
3,551
|
39
|
45
|
|||||||||||
Net
product sales to collaborators
|
471
|
326
|
198
|
44
|
65
|
|||||||||||
Total
product sales
|
$
|
7,640
|
$
|
5,488
|
$
|
3,749
|
39
|
46
|
*
|
Calculation
not meaningful.
|
The
values shown above are exact; therefore, the totals may not appear
to sum
due to rounding.
|
Annual
Percentage Change
|
||||||||||||||||
Research
and Development
|
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
|||||||||||
Product
development (including post-marketing)
|
$
|
1,269
|
$
|
935
|
$
|
668
|
36
|
%
|
40
|
%
|
||||||
Research
|
326
|
235
|
218
|
39
|
8
|
|||||||||||
In-licensing
|
178
|
92
|
62
|
93
|
48
|
|||||||||||
Total
|
$
|
1,773
|
$
|
1,262
|
$
|
948
|
40
|
33
|
Annual
Percentage Change
|
||||||||||||||||
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
||||||||||||
U.S.
Rituxan profit sharing expense
|
$
|
672
|
$
|
603
|
$
|
518
|
11
|
%
|
16
|
%
|
||||||
U.S.
Tarceva profit sharing expense
|
146
|
83
|
-
|
76
|
-
|
|||||||||||
U.S.
and ex-U.S. Xolair profit sharing expense
|
187
|
137
|
76
|
36
|
80
|
|||||||||||
Total
collaboration profit sharing expense
|
$
|
1,005
|
$
|
823
|
$
|
594
|
22
|
39
|
Annual
Percentage Change
|
||||||||||||||||
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
||||||||||||
Product
sales, net
|
$
|
2,071
|
$
|
1,832
|
$
|
1,574
|
13
|
%
|
16
|
%
|
||||||
Combined
commercial costs and expenses
|
489
|
390
|
316
|
25
|
23
|
|||||||||||
Combined
co-promotion profits
|
$
|
1,582
|
$
|
1,442
|
$
|
1,258
|
10
|
15
|
||||||||
Amount
due to Biogen Idec for their share of co-promotion profits - included
in
collaboration profit sharing expense
|
$
|
672
|
$
|
603
|
$
|
518
|
11
|
16
|
Annual
Percentage Change
|
||||||||||||||||
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
||||||||||||
Contract
revenue
|
$
|
79
|
$
|
59
|
$
|
41
|
34
|
%
|
44
|
%
|
||||||
Co-promotion
profit sharing expense
|
$
|
672
|
$
|
603
|
$
|
518
|
11
|
16
|
||||||||
Royalty
expense on ex-U.S. sales of Rituxan and other patent costs - included
in
MG&A expense
|
$
|
175
|
$
|
139
|
$
|
119
|
26
|
17
|
Annual
Percentage Change
|
||||||||||||||||
2006
|
2005
|
2004
|
2006/2005
|
2005/2004
|
||||||||||||
Gains
on sales of biotechnology equity securities, net
|
$
|
93
|
$
|
9
|
$
|
13
|
933
|
%
|
(31
|
)%
|
||||||
Write-down
of biotechnology debt and equity securities
|
(4
|
)
|
(10
|
)
|
(12
|
)
|
(60
|
)
|
(17
|
)
|
||||||
Interest
income
|
230
|
143
|
90
|
61
|
59
|
|||||||||||
Interest
expense
|
(74
|
)
|
(50
|
)
|
(7
|
)
|
48
|
614
|
||||||||
Other
miscellaneous income
|
6
|
-
|
-
|
-
|
-
|
|||||||||||
Total
other income, net
|
$
|
251
|
$
|
92
|
$
|
84
|
173
|
10
|
·
|
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 Roche and its affiliates;
and
|
·
|
in
all other cases, with consideration that has a value per share
not less
than the weighted-average value per share received by Roche and
its
affiliates as determined by a nationally recognized investment
bank.
|
·
|
the
merger or sale must be authorized by the favorable vote of a majority
of
non-Roche stockholders, provided no person will be entitled to
cast more
than 5% of the votes at the meeting;
or
|
·
|
in
the event such a favorable vote is not obtained, the value of the
consideration to be received by non-Roche 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.
|
·
|
any
acquisition, sale or other disposal of all or a portion of our
business
representing 10% or more of our assets, net income or
revenues;
|
·
|
any
issuance of capital stock except under certain circumstances;
or
|
·
|
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.
|
·
|
Hoffmann-La
Roche’s option expires in 2015;
|
·
|
Hoffmann-La
Roche may exercise its option to license our products upon the
occurrence
of any of the following: (1) our decision to file an Investigational
New Drug Application (or “IND”) for a product, (2) completion of the first
Phase II trial for a product or (3) if Hoffmann-La Roche previously
paid
us a fee of $10 million to extend its option on a product, completion
of a
Phase III trial for that product;
|
·
|
if
Hoffmann-La Roche exercises its option to license a product, it
has agreed
to reimburse Genentech for development costs as follows: (1) if
exercise occurs at the time of our decision to file an IND is filed,
Hoffmann-La 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,
Hoffmann-La
Roche will pay 50% of development costs incurred through completion
of the
trial, 75% of development costs subsequently incurred for the initial
indications, 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, Hoffmann-La 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 Hoffmann-La 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 Hoffmann-La Roche have the
right to
“opt-out” of developing an additional indication for a product for which
Hoffmann-La 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;
|
·
|
we
agreed, in general, to manufacture for and supply to Hoffmann-La
Roche its
clinical requirements of our products at cost, and its commercial
requirements at cost plus a margin of 20%; however, Hoffmann-La
Roche will
have the right to manufacture our products under certain
circumstances;
|
·
|
Hoffmann-La
Roche has agreed to pay, for each product for which Hoffmann-La
Roche
exercises its option upon either a decision to file 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;
and
|
·
|
Hoffmann-La
Roche will pay, for each product for which Hoffmann-La 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 Hoffmann-La Roche will be credited against royalties
payable
to us in the first calendar year of sales by Hoffmann-La Roche
in which
aggregate sales of that product exceed $100
million.
|
2006
|
2005
|
2004
|
||||||||
Ex-U.S.
product sales to Hoffmann-La Roche
|
$
|
359
|
$
|
177
|
$
|
111
|
||||
Royalties
received from Hoffmann-La Roche
|
$
|
846
|
$
|
500
|
$
|
334
|
||||
Cost
of sales on ex-U.S. product sales to Hoffmann-La Roche
|
$
|
268
|
$
|
154
|
$
|
95
|
||||
Contract
revenue from Hoffmann-La Roche
|
$
|
125
|
$
|
65
|
$
|
73
|
2006
|
2005
|
2004
|
||||||||
Ex-U.S.
product sales to Novartis
|
$
|
5
|
$
|
7
|
$
|
1
|
||||
Royalties
received from Novartis
|
$
|
3
|
$
|
1
|
$
|
1
|
||||
Cost
of sales on ex-U.S. product sales to Novartis
|
$
|
4
|
$
|
17
|
$
|
1
|
||||
Contract
revenue from Novartis
|
$
|
40
|
$
|
50
|
$
|
48
|
||||
Novartis’
share of co-promotion profits - included in collaboration profit
sharing
expense
|
$
|
187
|
$
|
136
|
$
|
75
|
Liquidity
and Capital Resources
|
2006
|
2005
|
2004
|
|||||||
December
31:
|
(in
millions)
|
|||||||||
Unrestricted
cash, cash equivalents, short-term investments and long-term marketable
debt and equity securities
|
$
|
4,325
|
$
|
3,814
|
$
|
2,781
|
||||
Net
receivable — equity hedge instruments
|
50
|
73
|
21
|
|||||||
Total
unrestricted cash, cash equivalents, short-term investments, long-term
marketable debt and equity securities, and equity hedge
instruments
|
$
|
4,375
|
$
|
3,887
|
$
|
2,802
|
||||
Working
capital
|
$
|
3,547
|
$
|
2,726
|
$
|
2,187
|
||||
Current
ratio
|
2.6:1
|
2.6:1
|
2.8:1
|
|||||||
Year
Ended December 31:
|
||||||||||
Cash
provided by (used in):
|
||||||||||
Operating
activities
|
$
|
2,138
|
$
|
2,363
|
$
|
1,195
|
||||
Investing
activities
|
(1,681
|
)
|
(1,776
|
)
|
(450
|
)
|
||||
Financing
activities
|
(432
|
)
|
368
|
(847
|
)
|
|||||
Capital
expenditures (included in investing activities above)
|
(1,214
|
)
|
(1,400
|
)
|
(650
|
)
|
Total
Number of
Shares
Purchased
|
Average
Price Paid
per
Share
|
||||||
January
1-31
|
0.9
|
$
|
88.37
|
||||
February
1-28
|
0.7
|
85.31
|
|||||
March
1-31
|
1.0
|
84.24
|
|||||
April
1-30
|
0.7
|
80.31
|
|||||
May
1-31
|
2.1
|
78.83
|
|||||
June
1-30
|
1.2
|
79.30
|
|||||
July
1-31
|
0.9
|
79.39
|
|||||
August
1-31
|
0.9
|
80.89
|
|||||
September
1-30
|
0.9
|
79.84
|
|||||
October
1-31
|
0.3
|
83.97
|
|||||
November
1-30
|
1.4
|
80.81
|
|||||
December
1-31
|
1.2
|
82.11
|
|||||
Total
|
12.2
|
$
|
81.45
|
Payments
due by period (in
millions)
|
||||||||||||||||
Contractual
Obligations
|
Total
|
2007
|
2008
and 2009
|
2010
and 2011
|
2012
and beyond
|
|||||||||||
Operating
lease obligations and other(1)
|
$
|
218
|
$
|
24
|
$
|
50
|
$
|
45
|
$
|
99
|
||||||
Slough(2)
(Financing lease)
|
541
|
19
|
67
|
75
|
380
|
|||||||||||
Lonza(3)
(Singapore facility agreement)
|
510
|
-
|
75
|
293
|
142
|
|||||||||||
Purchase
obligations(4)
|
1,567
|
958
|
532
|
64
|
13
|
|||||||||||
Long-term
debt(5)
|
2,000
|
-
|
-
|
500
|
1,500
|
|||||||||||
Litigation-related
and other long-term liabilities(6)
|
768
|
-
|
748
|
-
|
20
|
|||||||||||
Interest
expense on long-term debt(7)
|
1,254
|
101
|
198
|
161
|
794
|
|||||||||||
Total
|
$
|
6,858
|
$
|
1,102
|
$
|
1,670
|
$
|
1,138
|
$
|
2,948
|
(1)
|
Operating
lease obligations include Owner Association Fees on buildings we
own. See
further discussion of our operating leases above in “Off-Balance Sheet
Arrangements.”
|
(2)
|
See
further discussion related to the Slough lease above in “Off-Balance Sheet
Arrangements.”
|
(3)
|
Included
in 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 of Part II, Item 8 of this Form
10-K.
|
(4)
|
Purchase
obligations include commitments related to capital expenditures,
clinical
development, collaborations, 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 Lonza Biologics, a subsidiary of
Lonza
Group Ltd, for commercial quantities of Rituxan and 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 of Part II, Item 8 of this Form
10-K.
|
(5)
|
See
also Note
7, “Long-Term Debt,” in the Notes to Consolidated Financial Statements of
Part II, Item 8 of this Form 10-K.
|
(6)
|
Litigation-related
and other long-term liabilities include 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 and 2009”
category in the table above.
|
(7)
|
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 of Part II, Item 8 of this Form
10-K.
|
Excludes
payment obligations associated with deferred tax
liabilities.
|
Options
Outstanding
|
||||||||||
Shares
Available
for
Grant
|
Number
of
Shares
|
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
|
Exercisable
|
Unexercisable
|
Total
|
|||||||||||||||||
As
of December 31, 2006
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
Shares
|
Wtd.
Avg.
Exercise
Price
|
|||||||||||||
In-the-Money
|
42
|
$
|
32.16
|
27
|
$
|
66.70
|
69
|
$
|
45.81
|
||||||||||
Out-of-the-Money(1)
|
5
|
86.02
|
14
|
85.97
|
19
|
85.99
|
|||||||||||||
Total
Options Outstanding
|
47
|
41
|
88
|
(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 $81.13
at the
close of business on December 29,
2006.
|
2006*
|
2005*
|
2004*
|
||||||||
Net
grants during the year as % of outstanding shares
|
1.43
|
%
|
1.70
|
%
|
1.83
|
%
|
||||
Grants
to Executive Officers during the period as % of outstanding
shares
|
0.14
|
%
|
0.18
|
%
|
0.25
|
%
|
||||
Grants
to Executive Officers during the year as % of total options
granted
|
8.60
|
%
|
9.44
|
%
|
12.29
|
%
|
*
|
Executive
officers as of December 31 for the years
presented.
|
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Revenues
|
||||||||||
Product
sales (including amounts from related parties: 2006-$364;
2005-$184;
2004-$112)
|
$
|
7,640
|
$
|
5,488
|
$
|
3,749
|
||||
Royalties
(including amounts from related parties: 2006-$849;
2005-$501; 2004-$335)
|
1,354
|
935
|
641
|
|||||||
Contract
revenue (including amounts from related parties: 2006-$165;
2005-$115; 2004-$121)
|
290
|
210
|
231
|
|||||||
Total
operating revenues
|
9,284
|
6,633
|
4,621
|
|||||||
Costs
and expenses
|
||||||||||
Cost
of sales (including amounts for related parties: 2006-$272;
2005-$171; 2004-$96)
|
1,181
|
1,011
|
673
|
|||||||
Research
and development (including amounts for related parties: 2006-$251;
2005-$183; 2004-$169)
(including
contract related: 2006-$185;
2005-$144; 2004-$132)
|
1,773
|
1,262
|
948
|
|||||||
Marketing,
general and administrative
|
2,014
|
1,435
|
1,088
|
|||||||
Collaboration
profit sharing (including amounts for a related party: 2006-$187;
2005-$136; 2004-$75)
|
1,005
|
823
|
594
|
|||||||
Recurring
charges related to redemption
|
105
|
123
|
145
|
|||||||
Special
items: litigation-related
|
54
|
58
|
37
|
|||||||
Total
costs and expenses
|
6,132
|
4,712
|
3,485
|
|||||||
Operating
income
|
3,152
|
1,921
|
1,136
|
|||||||
Other
income (expense):
|
||||||||||
Interest
and other income (expense), net
|
325
|
142
|
91
|
|||||||
Interest
expense
|
(74
|
)
|
(50
|
)
|
(7
|
)
|
||||
Total
other income, net
|
251
|
92
|
84
|
|||||||
Income
before taxes
|
3,403
|
2,013
|
1,220
|
|||||||
Income
tax provision
|
1,290
|
734
|
435
|
|||||||
Net
income
|
$
|
2,113
|
$
|
1,279
|
$
|
785
|
||||
Earnings
per share
|
||||||||||
Basic
|
$
|
2.01
|
$
|
1.21
|
$
|
0.74
|
||||
Diluted
|
$
|
1.97
|
$
|
1.18
|
$
|
0.73
|
||||
Shares
used to compute basic earnings per share
|
1,053
|
1,055
|
1,055
|
|||||||
Shares
used to compute diluted earnings per share
|
1,073
|
1,081
|
1,079
|
Year
Ended December 31,
|
||||||||||
2006
|
2005
|
2004
|
||||||||
Cash
flows from operating activities
|
||||||||||
Net
income
|
$
|
2,113
|
$
|
1,279
|
$
|
785
|
||||
Adjustments
to reconcile net income to net cash provided by operating
activities:
|
||||||||||
Depreciation
and amortization
|
407
|
370
|
353
|
|||||||
Employee
stock-based compensation
|
309
|
-
|
-
|
|||||||
Deferred
income taxes
|
(112
|
)
|
(110
|
)
|
(74
|
)
|
||||
Deferred
revenue
|
(3
|
)
|
(49
|
)
|
(15
|
)
|
||||
Litigation-related
liabilities
|
51
|
51
|
35
|
|||||||
Excess
tax benefit from stock-based compensation arrangements
|
(179
|
)
|
-
|
-
|
||||||
Tax
benefit from employee stock options
|
-
|
632
|
329
|
|||||||
Gain
on sales of securities available-for-sale and other
|
(94
|
)
|
(12
|
)
|
(15
|
)
|
||||
Loss
on sales and write-downs of securities available-for-sale and
other
|
5
|
13
|
14
|
|||||||
Loss
on fixed asset dispositions
|
23
|
10
|
5
|
|||||||
Changes
in assets and liabilities:
|
||||||||||
Receivables
and other assets
|
(628
|
)
|
(128
|
)
|
(363
|
)
|
||||
Inventories
|
(408
|
)
|
(112
|
)
|
(121
|
)
|
||||
Investments
in trading securities
|
(29
|
)
|
(17
|
)
|
(76
|
)
|
||||
Accounts
payable, other accrued liabilities, and other long-term
liabilities
|
683
|
436
|
338
|
|||||||
Net
cash provided by operating activities
|
2,138
|
2,363
|
1,195
|
|||||||
Cash
flows from investing activities
|
||||||||||
Purchases
of securities available-for-sale
|
(1,036
|
)
|
(1,000
|
)
|
(890
|
)
|
||||
Proceeds
from sales of securities available-for-sale
|
256
|
148
|
687
|
|||||||
Proceeds
from maturities of securities available-for-sale
|
357
|
574
|
462
|
|||||||
Capital
expenditures
|
(1,214
|
)
|
(1,400
|
)
|
(650
|
)
|
||||
Change
in other intangible and long-term assets
|
9
|
(45
|
)
|
(64
|
)
|
|||||
Transfer
(to) from restricted cash, net
|
(53
|
)
|
(53
|
)
|
5
|
|||||
Net
cash used in investing activities
|
(1,681
|
)
|
(1,776
|
)
|
(450
|
)
|
||||
Cash
flows from financing activities
|
||||||||||
Stock
issuances
|
385
|
821
|
505
|
|||||||
Stock
repurchases
|
(996
|
)
|
(2,016
|
)
|
(1,352
|
)
|
||||
Excess
tax benefit from stock-based compensation arrangements
|
179
|
-
|
-
|
|||||||
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
|
(432
|
)
|
368
|
(847
|
)
|
|||||
Net
increase (decrease) in cash and cash equivalents
|
25
|
955
|
(102
|
)
|
||||||
Cash
and cash equivalents at beginning of year
|
1,225
|
270
|
372
|
|||||||
Cash
and cash equivalents at end of year
|
$
|
1,250
|
$
|
1,225
|
$
|
270
|
||||
Supplemental
cash flow data
|
||||||||||
Cash
paid during the year for:
|
||||||||||
Interest
|
$
|
68
|
$
|
8
|
$
|
7
|
||||
Income
taxes
|
1,038
|
312
|
132
|
|||||||
Non-cash
investing and financing activities
|
||||||||||
Capitalization
of construction in progress related to financing lease
transaction
|
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
|
-
|
December
31,
|
|||||||
2006
|
2005
|
||||||
Assets
|
|||||||
Current
assets
|
|||||||
Cash
and cash equivalents
|
$
|
1,250
|
$
|
1,225
|
|||
Short-term
investments
|
1,243
|
1,140
|
|||||
Accounts
receivable - product sales (net of allowances: 2006-$92;
2005-$84;
including
amounts from related parties: 2006-$57;
2005-$4)
|
965
|
554
|
|||||
Accounts
receivable - royalties (including amounts from related parties:
2006-$316;
2005-$173)
|
453
|
297
|
|||||
Accounts
receivable - other (including amounts from related parties: 2006-$150;
2005-$132)
|
248
|
199
|
|||||
Inventories
|
1,178
|
703
|
|||||
Deferred
tax assets
|
278
|
167
|
|||||
Prepaid
expenses and other current assets
|
89
|
101
|
|||||
Total
current assets
|
5,704
|
4,386
|
|||||
Long-term
marketable debt and equity securities
|
1,832
|
1,449
|
|||||
Property,
plant and equipment, net
|
4,173
|
3,349
|
|||||
Goodwill
|
1,315
|
1,315
|
|||||
Other
intangible assets
|
476
|
574
|
|||||
Restricted
cash and investments
|
788
|
735
|
|||||
Deferred
tax assets
|
183
|
146
|
|||||
Other
long-term assets
|
371
|
193
|
|||||
Total
assets
|
$
|
14,842
|
$
|
12,147
|
|||
Liabilities
and stockholders’ equity
|
|||||||
Current
liabilities
|
|||||||
Accounts
payable (including amounts to related parties: 2006-$7;
2005-$1)
|
$
|
346
|
$
|
339
|
|||
Deferred
revenue
|
62
|
44
|
|||||
Other
accrued liabilities (including amounts to related parties:
2006-$136;
2005-$132)
|
1,749
|
1,277
|
|||||
Total
current liabilities
|
2,157
|
1,660
|
|||||
Long-term
debt
|
2,204
|
2,083
|
|||||
Deferred
revenue
|
199
|
220
|
|||||
Litigation-related
and other long-term liabilities
|
804
|
714
|
|||||
Total
liabilities
|
5,364
|
4,677
|
|||||
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: 2006-1,053
shares; 2005-1,054 shares
|
21
|
21
|
|||||
Additional
paid-in capital
|
10,091
|
9,263
|
|||||
Accumulated
other comprehensive income
|
204
|
253
|
|||||
Accumulated
deficit, since June 30, 1999
|
(838
|
)
|
(2,067
|
)
|
|||
Total
stockholders’ equity
|
9,478
|
7,470
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
14,842
|
$
|
12,147
|
Accumulated
|
|||||||||||||||||||
Additional
|
Other
|
||||||||||||||||||
Common
Stock
|
Paid-in
|
Accumulated
|
Comprehensive
|
||||||||||||||||
Shares
|
Amounts
|
Capital
|
Deficit
|
Income
|
Total
|
||||||||||||||
Balance
December 31, 2003
|
1,049
|
$
|
21
|
$
|
7,360
|
$
|
(1,157
|
)
|
$
|
297
|
$
|
6,521
|
|||||||
Comprehensive
income
|
|||||||||||||||||||
Net
income
|
-
|
-
|
-
|
785
|
-
|
785
|
|||||||||||||
Increase
in unrealized gain on securities available-for-sale, net of
tax
|
-
|
-
|
-
|
-
|
11
|
11
|
|||||||||||||
Changes
in fair value of cash flow hedges, net of tax
|
-
|
-
|
-
|
-
|
(17
|
)
|
(17
|
)
|
|||||||||||
Comprehensive
income
|
779
|
||||||||||||||||||
Issuance
of stock upon exercise of options
|
22
|
1
|
446
|
-
|
-
|
447
|
|||||||||||||
Income
tax benefits realized from employee stock option exercises
|
-
|
-
|
329
|
-
|
-
|
329
|
|||||||||||||
Issuance
of stock under employee stock purchase plan
|
2
|
-
|
58
|
-
|
-
|
58
|
|||||||||||||
Repurchase
of Common Stock
|
(26
|
)
|
(1
|
)
|
(191
|
)
|
(1,160
|
)
|
-
|
(1,352
|
)
|
||||||||
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
|
Note
1.
|
DESCRIPTION
OF BUSINESS
|
Note
2.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING
POLICIES
|
·
|
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 (or “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 cost 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”
(or “EITF 99-19”).
|
·
|
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.
For the
majority of our royalty revenues, estimates are made using historical
and
forecasted sales trends and used as a basis to record amounts in
advance
of amounts collected.
|
·
|
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.
Most of
our contract arrangements with up-front license fees were entered
into
prior to the effective date of July 1, 2003 for EITF 00-21. Accordingly,
our accounting policy on contract revenue, as described below,
is focused
on describing transactions entered into prior to the effective
date of
EITF 00-21.
|
·
|
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.
|
·
|
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:
|
·
|
ratably
over the development period if development risk is significant,
or
|
·
|
ratably
over the manufacturing period or estimated product useful life
if
development risk has been substantially
eliminated.
|
·
|
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.
|
·
|
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.
|
·
|
Multiple
element agreements, or amendments to such agreements, entered into
after
July 1, 2003, are evaluated under the provisions of EITF 00-21.
We
evaluate whether there is stand-alone value 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
(or
“R&D”) expenses and the corresponding commercial costs are included
in
marketing, general and administrative (or “MG&A”) expenses in the
Consolidated Statements of Income.
|
·
|
Rebate
allowances and accruals are comprised of 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 upon 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
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.
|
·
|
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 health care 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 or “DSH”), (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 health care 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.
|
·
|
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, for a limited period of time, extended
payment terms to wholesalers. In connection with the launch of
Lucentis we
have offered an extended payment terms program to certain of our
wholesalers. This program will be in effect for 12 months ending
June 30,
2007. 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.
|
·
|
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.
|
·
|
Product
returns 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.
|
Useful
Lives
|
|
Buildings
|
25
years
|
Certain
manufacturing equipment
|
15
years
|
Other
equipment
|
3
to 8 years
|
Leasehold
improvements
|
length
of applicable lease
|
2006
|
2005
|
2004
|
||||||||
Numerator:
|
||||||||||
Net
income
|
$
|
2,113
|
$
|
1,279
|
$
|
785
|
||||
Denominator:
|
||||||||||
Weighted-average
shares outstanding used to compute basic earnings per
share
|
1,053
|
1,055
|
1,055
|
|||||||
Effect
of dilutive stock options
|
20
|
26
|
24
|
|||||||
Weighted-average
shares outstanding and dilutive securities used to compute diluted
earnings per share
|
1,073
|
1,081
|
1,079
|
2006
|
2005
|
||||||
Net
unrealized gains on securities available-for-sale
|
$
|
214
|
$
|
230
|
|||
Net
unrealized gains (losses) on cash flow hedges
|
(4
|
)
|
23
|
||||
Change
in post-retirement benefit obligation
|
(6
|
)
|
-
|
||||
Accumulated
other comprehensive income
|
$
|
204
|
$
|
253
|
2006
|
2005
|
2004
|
||||||||
(Decrease)
increase in unrealized gains on securities available-for-sale (net
of
tax: 2006-$(11); 2005-$(49); 2004-$7)
|
$
|
(13
|
)
|
$
|
(74
|
)
|
$
|
10
|
||
Reclassification
adjustment for net (gains) losses on securities available-for-sale
included in net income (net of tax: 2006-$(2); 2005-$(1);
2004-$1)
|
(3
|
)
|
(1
|
)
|
1
|
|||||
(Decrease)
increase in unrealized gains on cash flow hedges (net of
tax: 2006-$(12); 2005-$32; 2004-($14))
|
(18
|
)
|
48
|
(21
|
)
|
|||||
Reclassification
adjustment for net (gains) losses on cash flow hedges included
in net
income (net of tax: 2006-$(6); 2005-$(7); 2004-$3)
|
(9
|
)
|
(11
|
)
|
4
|
|||||
Change
in post-retirement benefit obligation (net of tax:
2006-$(4))
|
(6
|
)
|
-
|
-
|
||||||
Other
comprehensive loss
|
$
|
(49
|
)
|
$
|
(38
|
)
|
$
|
(6
|
)
|
Note
3.
|
Employee
Stock-Based Compensation
|
2006
|
||||
Research
and development
|
$
|
140
|
||
Marketing,
general and administrative
|
169
|
|||
Total
employee stock-based compensation expense
|
309
|
|||
Tax
benefit related to employee stock-based compensation
expense
|
(127
|
)
|
||
Net
effect on net income
|
$
|
182
|
||
Effect
on earnings per share:
|
||||
Basic
|
$
|
0.17
|
||
Diluted
|
$
|
0.17
|
2006
|
||||
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
|
2005
|
2004
|
||||||
Net
income as reported
|
$
|
1,279
|
$
|
785
|
|||
Deduct: Total
employee stock-based compensation expense determined under the
fair value
based method for all awards, net of related tax effects
|
(175
|
)
|
(191
|
)
|
|||
Pro
forma net income
|
$
|
1,104
|
$
|
594
|
|||
Earnings
per share:
|
|||||||
Basic-as
reported
|
$
|
1.21
|
$
|
0.74
|
|||
Basic-pro
forma
|
$
|
1.05
|
$
|
0.56
|
|||
Diluted-as
reported
|
$
|
1.18
|
$
|
0.73
|
|||
Diluted-pro
forma
|
$
|
1.02
|
$
|
0.54
|
2006
|
2005
|
2004
|
||||||||
Risk-free
interest rate
|
4.6
|
%
|
4.2
|
%
|
3.4
|
%
|
||||
Dividend
yield
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
||||
Expected
volatility
|
27.2
|
%
|
29.3
|
%
|
33.3
|
%
|
||||
Expected
term (years)
|
4.6
|
4.2
|
4.3
|
Options
Outstanding
|
||||||||||
Shares
Available for Grant
|
Number
of Shares
|
Weighted-Average
Exercise Price
|
||||||||
December
31, 2003
|
41
|
96
|
$
|
25.18
|
||||||
Grants
|
(21
|
)
|
21
|
53.04
|
||||||
Exercises
|
-
|
(21
|
)
|
20.81
|
||||||
Cancellations
|
2
|
(2
|
)
|
29.92
|
||||||
Additional
shares reserved(1)
|
80
|
-
|
-
|
|||||||
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
|
(1)
|
Additional
shares have been reserved for issuance under the 2004 Equity Incentive
Plan approved by stockholders on April 16,
2004.
|
Options
Outstanding
|
Options
Exercisable
|
||||||||||||||||||
Range
of
Exercise
Prices
|
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
|
0.4
|
5.04
|
$
|
7.62
|
0.4
|
5.04
|
$
|
7.62
|
|||||||||||
$10.00
- $14.35
|
11.2
|
4.86
|
$
|
13.68
|
11.2
|
4.86
|
$
|
13.68
|
|||||||||||
$15.04
- $22.39
|
7.8
|
4.34
|
$
|
20.85
|
7.8
|
4.33
|
$
|
20.86
|
|||||||||||
$22.88
- $33.00
|
0.2
|
4.49
|
$
|
26.52
|
0.2
|
4.49
|
$
|
26.52
|
|||||||||||
$35.63
- $53.23
|
32.5
|
6.77
|
$
|
46.85
|
21.5
|
6.43
|
$
|
45.45
|
|||||||||||
$53.95
- $75.90
|
1.4
|
7.79
|
$
|
59.23
|
0.7
|
7.73
|
$
|
58.39
|
|||||||||||
$78.99
- $98.80
|
34.8
|
9.20
|
$
|
82.94
|
5.6
|
8.73
|
$
|
85.99
|
|||||||||||
88.3
|
47.4
|
Note
4.
|
INVESTMENT
SECURITIES AND FINANCIAL
INSTRUMENTS
|
December
31, 2006
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Estimated
Fair
Value
|
|||||||||
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
|
December
31, 2005
|
Amortized
Cost
|
Gross
Unrealized
Gains
|
Gross
Unrealized
Losses
|
Estimated
Fair
Value
|
|||||||||
TOTAL
TRADING SECURITIES
|
$
|
615
|
$
|
11
|
$
|
(14
|
)
|
$
|
612
|
||||
SECURITIES
AVAILABLE-FOR-SALE
|
|||||||||||||
Equity
securities
|
$
|
(3
|
)
|
$
|
381
|
$
|
(3
|
)
|
$
|
375
|
|||
Preferred
stock
|
201
|
8
|
(3
|
)
|
206
|
||||||||
Debt
securities maturing:
|
|||||||||||||
within
1 year
|
1,617
|
-
|
(1
|
)
|
1,616
|
||||||||
between
1-5 years
|
1,195
|
4
|
(4
|
)
|
1,195
|
||||||||
between
5-10 years
|
467
|
7
|
(5
|
)
|
469
|
||||||||
TOTAL
SECURITIES AVAILABLE-FOR-SALE
|
$
|
3,477
|
$
|
400
|
$
|
(16
|
)
|
$
|
3,861
|
Less
Than 12 Months
|
12
Months or Greater
|
Total
|
|||||||||||||||||
December
31, 2006
|
Fair
Value
|
Unrealized
Losses
|
Fair
Value
|
Unrealized
Losses
|
Fair
Value
|
Unrealized
Losses
|
|||||||||||||
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
|
)
|
Less
Than 12 Months
|
12
Months or Greater
|
Total
|
|||||||||||||||||
December
31, 2005
|
Fair
Value
|
Unrealized
Losses
|
Fair
Value
|
Unrealized
Losses
|
Fair
Value
|
Unrealized
Losses
|
|||||||||||||
Equity
securities
|
$
|
7
|
$
|
(3
|
)
|
$
|
-
|
$
|
-
|
$
|
7
|
$
|
(3
|
)
|
|||||
Preferred
stock
|
33
|
(1
|
)
|
41
|
(2
|
)
|
74
|
(3
|
)
|
||||||||||
Debt
securities
|
846
|
(5
|
)
|
221
|
(5
|
)
|
1,067
|
(10
|
)
|
||||||||||
Total
|
$
|
886
|
$
|
(9
|
)
|
$
|
262
|
$
|
(7
|
)
|
$
|
1,148
|
$
|
(16
|
)
|
Security
|
2006
|
2005
|
|||||
Cash
|
$
|
495
|
$
|
76
|
|||
Cash
equivalents
|
755
|
1,149
|
|||||
Total
cash and cash equivalents
|
$
|
1,250
|
$
|
1,225
|
|||
Trading
securities
|
$
|
641
|
$
|
612
|
|||
Securities
available-for-sale maturing within one year
|
371
|
322
|
|||||
Preferred
stock
|
231
|
206
|
|||||
Total
short-term investments
|
$
|
1,243
|
$
|
1,140
|
|||
Securities
available-for-sale maturing after one year
|
$
|
1,472
|
$
|
1,074
|
|||
Equity
securities
|
360
|
375
|
|||||
Total
long-term marketable debt and equity securities
|
$
|
1,832
|
$
|
1,449
|
|||
Cash
|
$
|
-
|
$
|
1
|
|||
Securities
available-for-sale maturing within one year
|
223
|
144
|
|||||
Securities
available-for-sale maturing between 1-10 years
|
565
|
590
|
|||||
Total
restricted cash and investments
|
$
|
788
|
$
|
735
|
2006
|
2005
|
||||||
Assets:
|
|||||||
Foreign
exchange forward contracts
|
$
|
-
|
$
|
5
|
|||
Foreign
exchange options
|
1
|
38
|
|||||
Equity
forwards
|
47
|
58
|
|||||
Equity
collars
|
4
|
15
|
|||||
Liabilities:
|
|||||||
Foreign
exchange forwards contracts
|
3
|
-
|
|||||
Interest
rate swap agreements
|
12
|
10
|
Note
5.
|
CONSOLIDATED
FINANCIAL STATEMENT DETAIL
|
2006
|
2005
|
||||||
Raw
materials and supplies
|
$
|
116
|
$
|
79
|
|||
Work
in process
|
818
|
438
|
|||||
Finished
goods
|
244
|
186
|
|||||
Total
|
$
|
1,178
|
$
|
703
|
2006
|
2005
|
||||||
At
cost:
|
|||||||
Land
|
$
|
399
|
$
|
376
|
|||
Land
improvements
|
38
|
43
|
|||||
Buildings
|
1,712
|
1,399
|
|||||
Equipment
|
1,953
|
1,614
|
|||||
Leasehold
improvements
|
146
|
60
|
|||||
Construction-in-progress
|
1,291
|
965
|
|||||
5,539
|
4,457
|
||||||
Less:
accumulated depreciation and amortization
|
1,366
|
1,108
|
|||||
Net
property, plant and equipment
|
$
|
4,173
|
$
|
3,349
|
2006
|
2005
|
||||||
Accrued
compensation
|
$
|
385
|
$
|
253
|
|||
Accrued
royalties
|
224
|
161
|
|||||
Accrued
clinical and other studies (including to related parties:
2006-$67;
2005-$77)
|
218
|
221
|
|||||
Accrued
marketing and promotion costs
|
155
|
161
|
|||||
Taxes
payable
|
258
|
62
|
|||||
Accrued
collaborations (including to a related party: 2006-$53;
2005-$42)
|
291
|
228
|
|||||
Other
(including to related parties: 2006-$16;
2005-$13)
|
218
|
191
|
|||||
Total
other accrued liabilities
|
$
|
1,749
|
$
|
1,277
|
2006
|
2005
|
2004
|
||||||||
Gains
on sales of biotechnology equity securities, net
|
$
|
93
|
$
|
9
|
$
|
13
|
||||
Write-downs
of biotechnology debt, equity securities and other
|
(4
|
)
|
(10
|
)
|
(12
|
)
|
||||
Interest
income
|
230
|
143
|
90
|
|||||||
Other
miscellaneous income
|
6
|
-
|
-
|
|||||||
Total
interest and other income (expense), net
|
$
|
325
|
$
|
142
|
$
|
91
|
Note
6.
|
OTHER
INTANGIBLE ASSETS
|
2006
|
2005
|
||||||||||||||||||
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
Carrying
Amount
|
Gross
Carrying
Amount
|
Accumulated
Amortization
|
Net
Carrying
Amount
|
||||||||||||||
Developed
product technology
|
$
|
1,194
|
$
|
1,003
|
$
|
191
|
$
|
1,194
|
$
|
926
|
$
|
268
|
|||||||
Core
technology
|
444
|
393
|
51
|
444
|
372
|
72
|
|||||||||||||
Tradenames
|
144
|
91
|
53
|
144
|
84
|
60
|
|||||||||||||
Patents
|
197
|
78
|
119
|
167
|
64
|
103
|
|||||||||||||
Other
intangible assets
|
98
|
36
|
62
|
122
|
51
|
71
|
|||||||||||||
Total
|
$
|
2,077
|
$
|
1,601
|
$
|
476
|
$
|
2,071
|
$
|
1,497
|
$
|
574
|
2006
|
2005
|
2004
|
||||||||
Acquisition-related
intangible assets amortization
|
$
|
105
|
$
|
123
|
$
|
145
|
||||
Patents
amortization
|
13
|
11
|
9
|
|||||||
Other
intangible assets amortization
|
10
|
10
|
28
|
|||||||
Total
amortization expense
|
$
|
128
|
$
|
144
|
$
|
182
|
For
the Year Ending December 31,
|
||||
2007
|
$
|
129
|
||
2008
|
127
|
|||
2009
|
78
|
|||
2010
|
28
|
|||
2011
|
26
|
|||
Thereafter
|
88
|
|||
Total
expected future annual amortization
|
$
|
476
|
Note
7.
|
LONG-TERM
DEBT
|
2010
|
$
|
500
|
||
2011
|
-
|
|||
Thereafter
|
1,500
|
|||
Total
|
$
|
2,000
|
Note
8.
|
LEASES,
COMMITMENTS AND
CONTINGENCIES
|
2007
|
2008
|
2009
|
2010
|
2011
|
Thereafter
|
Total
|
||||||||||||||||
Operating
leases
|
$
|
23
|
$
|
24
|
$
|
23
|
$
|
22
|
$
|
22
|
$
|
99
|
$
|
213
|
||||||||
Slough
leases
|
19
|
31
|
36
|
37
|
38
|
380
|
541
|
|||||||||||||||
Total
|
$
|
42
|
$
|
55
|
$
|
59
|
$
|
59
|
$
|
60
|
$
|
479
|
$
|
754
|
Note
9.
|
RELATIONSHIP
WITH ROCHE AND RELATED PARTY
TRANSACTIONS
|
·
|
Hoffmann-La
Roche’s option expires in 2015;
|
·
|
Hoffmann-La
Roche may exercise its option to license our products upon the
occurrence
of any of the following: (1) our decision to file an Investigational
New Drug Application (or “IND”) for a product, (2) completion of the first
Phase II trial for a product or (3) if Hoffmann-La Roche previously
paid
us a fee of $10 million to extend its option on a product, completion
of a
Phase III trial for that product;
|
·
|
if
Hoffmann-La Roche exercises its option to license a product, it
has agreed
to reimburse Genentech for development costs as follows: (1) if
exercise occurs at the time of our decision to file an IND is filed,
Hoffmann-La 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,
Hoffmann-La
Roche will pay 50% of development costs incurred through completion
of the
trial, 75% of development costs subsequently incurred for the initial
indications, 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, Hoffmann-La 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 Hoffmann-La 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 Hoffmann-La Roche have the
right to
“opt-out” of developing an additional indication for a product for which
Hoffmann-La 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;
|
·
|
we
agreed, in general, to manufacture for and supply to Hoffmann-La
Roche its
clinical requirements of our products at cost, and its commercial
requirements at cost plus a margin of 20%; however, Hoffmann-La
Roche will
have the right to manufacture our products under certain
circumstances;
|
·
|
Hoffmann-La
Roche has agreed to pay, for each product for which Hoffmann-La
Roche
exercises its option upon either a decision to file 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;
and
|
·
|
Hoffmann-La
Roche will pay, for each product for which Hoffmann-La 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 Hoffmann-La Roche will be credited against royalties
payable
to us in the first calendar year of sales by Hoffmann-La Roche
in which
aggregate sales of that product exceed $100
million.
|
2006
|
2005
|
2004
|
||||||||
Ex-U.S.
product sales to Hoffmann-La Roche
|
$
|
359
|
$
|
177
|
$
|
111
|
||||
Royalties
received from Hoffmann-La Roche
|
$
|
846
|
$
|
500
|
$
|
334
|
||||
Cost
of sales on ex-U.S. product sales to Hoffmann-La Roche
|
$
|
268
|
$
|
154
|
$
|
95
|
||||
Contract
revenue from Hoffmann-La Roche
|
$
|
125
|
$
|
65
|
$
|
73
|
2006
|
2005
|
2004
|
||||||||
Ex-U.S.
product sales to Novartis
|
$
|
5
|
$
|
7
|
$
|
1
|
||||
Royalties
received from Novartis
|
$
|
3
|
$
|
1
|
$
|
1
|
||||
Cost
of sales on ex-U.S. product sales to Novartis
|
$
|
4
|
$
|
17
|
$
|
1
|
||||
Contract
revenue from Novartis
|
$
|
40
|
$
|
50
|
$
|
48
|
||||
Collaboration
profit sharing expense
|
$
|
187
|
$
|
136
|
$
|
75
|
Note
10.
|
CAPITAL
STOCK
|
Note
11.
|
INCOME
TAXES
|
2006
|
2005
|
2004
|
||||||||
Current:
|
||||||||||
Federal
|
$
|
1,306
|
$
|
723
|
$
|
444
|
||||
State
|
96
|
121
|
64
|
|||||||
Total
current
|
1,402
|
844
|
508
|
|||||||
Deferred:
|
||||||||||
Federal
|
(155
|
)
|
(85
|
)
|
(50
|
)
|
||||
State
|
43
|
(25
|
)
|
(23
|
)
|
|||||
Total
deferred
|
(112
|
)
|
(110
|
)
|
(73
|
)
|
||||
Total
income tax provision
|
$
|
1,290
|
$
|
734
|
$
|
435
|
2006
|
2005
|
2004
|
||||||||
Tax
at U.S. statutory rate
|
35.0
|
%
|
35.0
|
%
|
35.0
|
%
|
||||
Research
and other credits
|
(2.3
|
)
|
(1.5
|
)
|
(3.6
|
)
|
||||
Prior
years’ items
|
0.9
|
(0.7
|
)
|
-
|
||||||
Export
sales benefit
|
(0.3
|
)
|
(0.4
|
)
|
(0.5
|
)
|
||||
State
taxes
|
5.0
|
5.0
|
5.0
|
|||||||
Deduction
for qualified production activities
|
(0.7
|
)
|
(0.8
|
)
|
-
|
|||||
Tax-exempt
investment income
|
(0.2
|
)
|
(0.3
|
)
|
(0.3
|
)
|
||||
Other
|
0.5
|
0.2
|
0.1
|
|||||||
Effective
tax rate
|
37.9
|
%
|
36.5
|
%
|
35.7
|
%
|
2006
|
2005
|
||||||
Deferred
tax liabilities:
|
|||||||
Depreciation
|
$
|
(156
|
)
|
$
|
(189
|
)
|
|
Unrealized
gain on securities available-for-sale
|
(144
|
)
|
(172
|
)
|
|||
Intangibles
- Roche transaction
|
(118
|
)
|
(160
|
)
|
|||
Other
intangible assets
|
(48
|
)
|
(41
|
)
|
|||
Other
|
(46
|
)
|
(11
|
)
|
|||
Total
deferred tax liabilities
|
(512
|
)
|
(573
|
)
|
|||
Deferred
tax assets:
|
|||||||
Capitalized
R&D costs
|
14
|
19
|
|||||
Employee
stock-based compensation costs
|
102
|
-
|
|||||
Expenses
not currently deductible
|
492
|
431
|
|||||
Deferred
revenue
|
101
|
106
|
|||||
Investment
basis difference
|
203
|
209
|
|||||
State
credit carryforwards
|
56
|
114
|
|||||
Other
|
5
|
7
|
|||||
Total
deferred tax assets
|
973
|
886
|
|||||
Total
net deferred tax assets
|
$
|
461
|
$
|
313
|
Note
12.
|
SEGMENT,
SIGNIFICANT CUSTOMER AND GEOGRAPHIC
INFORMATION
|
Product
Sales
|
2006
|
2005
|
2004
|
|||||||
Net
U.S. Product Sales
|
||||||||||
Avastin
|
$
|
1,746
|
$
|
1,133
|
$
|
545
|
||||
Rituxan
|
2,071
|
1,832
|
1,574
|
|||||||
Herceptin
|
1,234
|
747
|
479
|
|||||||
Lucentis
|
380
|
-
|
-
|
|||||||
Xolair
|
425
|
320
|
188
|
|||||||
Tarceva
|
402
|
275
|
13
|
|||||||
Nutropin
products
|
378
|
370
|
349
|
|||||||
Thrombolytics
|
243
|
218
|
194
|
|||||||
Pulmozyme
|
199
|
186
|
157
|
|||||||
Raptiva
|
90
|
79
|
52
|
|||||||
Total
U.S. product sales
|
7,169
|
5,162
|
3,551
|
|||||||
Net
Product Sales to Collaborators
|
||||||||||
Avastin
|
$
|
107
|
$
|
50
|
$
|
10
|
||||
Rituxan
|
181
|
158
|
137
|
|||||||
Herceptin
|
96
|
17
|
4
|
|||||||
Lucentis
|
1
|
-
|
-
|
|||||||
Xolair
|
4
|
7
|
1
|
|||||||
Nutropin
products
|
8
|
5
|
5
|
|||||||
Thrombolytics
|
16
|
8
|
6
|
|||||||
Pulmozyme
|
45
|
35
|
21
|
|||||||
Raptiva
|
14
|
15
|
4
|
|||||||
Enbrel
|
-
|
31
|
11
|
|||||||
Total
product sales to collaborators
|
471
|
326
|
198
|
|||||||
Total
product sales
|
$
|
7,640
|
$
|
5,488
|
$
|
3,749
|
2006
|
2005
|
2004
|
||||||||
Europe:
|
||||||||||
Switzerland
|
$
|
561
|
$
|
320
|
$
|
235
|
||||
Germany
|
133
|
79
|
47
|
|||||||
France
|
100
|
56
|
35
|
|||||||
Italy
|
57
|
35
|
23
|
|||||||
Great
Britain
|
61
|
34
|
23
|
|||||||
Spain
|
49
|
28
|
18
|
|||||||
Others
|
121
|
73
|
51
|
|||||||
Japan
|
119
|
117
|
92
|
|||||||
Canada
|
64
|
39
|
28
|
|||||||
Others
|
181
|
91
|
44
|
|||||||
Total
net foreign revenues
|
$
|
1,446
|
$
|
872
|
$
|
596
|
2006
Quarter Ended(3)
|
|||||||||||||
December 31
|
September 30
|
June 30
|
March 31
|
||||||||||
Total
operating revenues
|
$
|
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
|
2005
Quarter Ended(3)
|
|||||||||||||
December 31
|
September 30
|
June 30
|
March 31
|
||||||||||
Total
operating revenues
|
$
|
1,893
|
$
|
1,752
|
$
|
1,527
|
$
|
1,462
|
|||||
Product
sales
|
1,577
|
1,451
|
1,274
|
1,186
|
|||||||||
Gross
margin from product sales(2)
|
1,332
|
1,215
|
1,000
|
930
|
|||||||||
Net
income
|
339
|
359
|
296
|
284
|
|||||||||
Earnings
per share:
|
|||||||||||||
Basic
|
0.32
|
0.34
|
0.28
|
0.27
|
|||||||||
Diluted
|
0.31
|
0.33
|
0.27
|
0.27
|
(1)
|
Net
income in 2006 includes $182 million, net of tax, in employee stock-based
compensation expense related to our adoption of FAS 123R on January
1,
2006.
|
(2)
|
Certain
costs and expenses of $5 million, $5 million, and $6 million for
the
quarterly periods ended March 31, June 30, and September 30, 2005,
respectively, have been reclassified from MG&A expenses to cost of
sales to conform to the fourth quarter and full year
presentation.
|
(3)
|
The
2006 and 2005 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
|
CONTROLS
AND PROCEDURES
|
OTHER
INFORMATION
|
Item
11.
|
Item
12.
|
Exhibit
No.
|
Description
|
Location
|
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 (or “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
as an exhibit to our Quarterly Report on Form 10-Q for the quarter
ended
October 31, 2006 filed with the Commission and incorporated herein
by
reference.
|
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
on a Current Report on Form 8-K with the Commission on September
26, 2006,
and incorporated herein by reference.
|
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,
2006.
|
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.
|
10.23
|
Promissory
Note, dated as of April 5, 2001, issued to Genentech, Inc. by Richard
H.
Scheller†
|
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.
|
10.24
|
Transition
Agreement between Genentech, Inc. and Myrtle S. Potter dated August
3,
2005†
|
Filed
on a Current Report on Form 8-K with the Commission on August 16,
2005 and
incorporated herein by reference.
|
10.25
|
First
Amendment to Transition Agreement between Genentech, Inc. and Myrtle
S.
Potter dated December 29, 2005†
|
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.
|
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
herewith
|
10.28
|
Purchase
and Sale Agreement and Joint Escrow Instruction, dated as of June
16,
2005, between Genentech and Biogen Idec Inc. *
|
Filed
as an exhibit to our Quarterly Report on Form 10-Q for the quarter
ended
June 30, 2005 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.
|
10.30
|
Manufacturing
and Supply Agreement between Genentech, Inc. and Lonza Biologics,
Inc.
dated December 7, 2003 *
|
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.
|
10.31
|
First
Amendment to the Manufacturing and Supply Agreement between Genentech,
Inc. and Lonza Biologics, Inc. dated March 14, 2005 *
|
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.
|
10.32
|
Second
Amendment to the Manufacturing and Supply Agreement between Genentech
and
Lonza Biologics PLC, effective as of 19 May 2006 *
|
Filed
herewith
|
10.33
|
Third
Amendment to the Manufacturing and Supply Agreement between Genentech
and
Lonza Biologics PLC, dated as of November 6, 2006 *
|
Filed
herewith
|
10.34
|
Toll
Manufacturing Agreement by and between Wyeth, acting through its
Wyeth
Pharmaceuticals Division, and Genentech, Inc. dated September 15,
2004
*
|
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.
|
10.35
|
First
Amendment to the Toll
Manufacturing Agreement by and between Wyeth, acting through its
Wyeth
Pharmaceuticals Division, and Genentech, Inc. dated December 8,
2004
|
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.
|
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
herewith
|
10.39
|
Form
of Voting Agreement between Genentech, Inc. and Certain Stockholders
of
Tanox, Inc.
|
Filed
herewith
|
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
|
GENENTECH,
INC.
Registrant
|
||||
Date:
|
February
23, 2007
|
By:
|
/s/
JOHN M. WHITING
|
|
John
M. Whiting
|
||||
Vice
President, Finance and
Chief
Accounting Officer
|
Signature
|
Title
|
Date
|
||
Principal
Executive Officer:
|
||||
/s/
ARTHUR D. LEVINSON
|
Chairman
and Chief Executive Officer
|
February
23, 2007
|
||
Arthur
D. Levinson
|
||||
Principal
Financial Officer:
|
||||
/s/
DAVID
A. EBERSMAN
|
Executive
Vice
President and
|
February
23, 2007
|
||
David
A. Ebersman
|
Chief
Financial Officer
|
|||
Principal
Accounting Officer:
|
||||
/s/
JOHN M. WHITING
|
Vice
President, Finance and
|
February
23, 2007
|
||
John
M. Whiting
|
Chief
Accounting Officer
|
Signature
|
Title
|
Date
|
||
Directors:
|
||||
/s/
HERBERT W. BOYER
|
Director
|
February
23, 2007
|
||
Herbert
W. Boyer
|
||||
/s/
WILLIAM M. BURNS
|
Director
|
February
23, 2007
|
||
William
M. Burns
|
||||
/s/
ERICH HUNZIKER
|
Director
|
February
23, 2007
|
||
Erich
Hunziker
|
||||
/s/
JONATHAN K.C. KNOWLES
|
Director
|
February
23, 2007
|
||
Jonathan
K.C. Knowles
|
||||
/s/
DEBRA L. REED
|
Director
|
February
23, 2007
|
||
Debra
L. Reed
|
||||
/s/
CHARLES A. SANDERS
|
Director
|
February
23, 2007
|
||
Charles
A. Sanders
|
Balance
at
Beginning
of
Period
|
Addition
Charged
to
Cost
and
Expenses
|
Deductions*
|
Balance
at
End
of
Period
|
||||||||||
Accounts
receivable allowances:
|
|||||||||||||
Year
Ended December 31, 2006:
|
$
|
84
|
$
|
415
|
$
|
(407
|
)
|
$
|
92
|
||||
Year
Ended December 31, 2005:
|
$
|
62
|
$
|
307
|
$
|
(284
|
)
|
$
|
84
|
||||
Year
Ended December 31, 2004:
|
$
|
47
|
$
|
188
|
$
|
(173
|
)
|
$
|
62
|
||||
Inventory
reserves:
|
|||||||||||||
Year
Ended December 31, 2006:
|
$
|
55
|
$
|
29
|
$
|
(16
|
)
|
$
|
68
|
||||
Year
Ended December 31, 2005:
|
$
|
46
|
$
|
33
|
$
|
(24
|
)
|
$
|
55
|
||||
Year
Ended December 31, 2004:
|
$
|
21
|
$
|
57
|
$
|
(32
|
)
|
$
|
46
|
||||
Rebate
accruals:
|
|||||||||||||
Year
Ended December 31, 2006:
|
$
|
38
|
$
|
113
|
$
|
(104
|
)
|
$
|
47
|
||||
Year
Ended December 31, 2005:
|
$
|
35
|
$
|
77
|
$
|
(74
|
)
|
$
|
38
|
||||
Year
Ended December 31, 2004:
|
$
|
23
|
$
|
78
|
$
|
(66
|
)
|
$
|
35
|
Certain
prior year amounts have been reclassified to conform with the current
year
presentation.
|
|
*
|
Represents
amounts written off or returned against the allowance or reserves,
or
returned against earnings.
|