SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
________
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16 OF
THE
SECURITIES EXCHANGE ACT OF 1934
For the
month of February, 2005
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Serono
S.A. |
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(Registrant’s
Name) |
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15
bis, Chemin des Mines |
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Case
Postale 54 |
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CH-1211
Geneva 20 |
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Switzerland |
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(Address
of Principal Executive Offices) |
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1-15096 |
||
|
(Commission
File No.) |
(Indicate
by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F.)
Form 20-F
Ö Form 40-F
____
(Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101 (b)(1).) ______
(Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101 (b)(7).) ______
(Indicate
by check mark whether the registrant by furnishing the information contained in
this form is also thereby furnishing the information to the Commission pursuant
to Rule 12g3-2(b) under the Securities Exchange Act of 1934.)
Yes ____
No Ö
(If “Yes”
is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-______)
Media
Release
FOR
RELEASE FEBRUARY 1, 2005, 4:01 PM EST
|
SERONO REPORTS STRONG FULL YEAR 2004 RESULTS
- Total revenues grew 21.8% and EPS increased
31.3% -
|
Rockland,
MA, February 1, 2005 - 04:01 pm EST - Serono
(virt-x: SEO and NYSE: SRA), the world’s third largest biotechnology company,
today reported its fourth quarter and full year results for the
period ended December 31, 2004.
Key
Points for Full Year 2004
|
Ø |
Total
revenues up 21.8% to $2,458.1m (+16.1% in local
currencies) |
|
Ø |
Product
sales up 17.2% to $2,177.9m (+11.5% in local
currencies) |
|
Ø |
Rebif®
sales up 33.1%
to $1,090.6m (+25.4% in local
currencies) |
|
Ø |
Reported
net income up 26.7% to $494.2m (+21.7% in local
currencies) |
|
Ø |
Reported
EPS up 31.3% to $32.35 per bearer share and $0.81 per
ADS |
|
Ø |
Raptiva®
registered in key markets and now available in 15
countries |
|
Ø |
New
R&D collaborations with CancerVax and Micromet for novel anti-cancer
drug candidates |
|
Ø |
Significant
steps forward in R&D with 6 late-stage clinical development programs
on-going (5 Phase III, 1 post-registration head-to-head
study) |
|
Ø |
2005
outlook for product sales growth between 10% and 15%, total revenues of at
least $2.6 billion and net income between $520m and $540m |
“We had
excellent growth in 2004 and made significant investments for our future,” said
Ernesto Bertarelli, Chief Executive Officer of Serono. “Going forward we have a
number of exciting late-stage development projects to drive our future growth
and we will continue to invest in both internal R&D programs and external
collaborations to sustain that growth over the longer-term.”
-more-
Fourth
Quarter And Full Year Financial Performance
Total
revenues increased by 21.8%
(+16.1% in local currencies) to $2,458.1m in the
full year 2004 (2003: $2,018.6m), and by 20.3% (+15.7% in local
currencies) to
$679.7m in the fourth quarter (2003: $565.1m).
Worldwide
product sales were $2,177.9m in 2004, up 17.2% (2003: $1,858.0m), and up 16.4%
to $604.5m in the fourth quarter (2003: $519.3m). Product sales in local
currencies grew by 11.5% in 2004 and 11.7% in the fourth quarter.
Royalty
and licensing income increased by 74.4% to $280.1m in 2004, representing 11.4%
of total revenues (2003: $160.6m), and was up 64.4% to $75.3m
(2003: $45.8m) in the fourth quarter due to Serono’s strong intellectual
property rights. In the third quarter exceptional license income of $67m was
reported and in the fourth quarter Serono received additional license income
totaling $11m for the grant of technology licenses to third
parties.
Gross
margin increased to 86.0% of product sales in 2004 (2003: 85.0%), as a result of
a more favorable product mix and continuing manufacturing improvements. In the
fourth quarter of 2004, gross margin reached 87.9%
(2003: 84.5%).
Selling,
General and Administrative expenses were $807.9m or 32.9% of total revenues in
2004 (2003: $636.8m or 31.5% of total revenues), and $234.3m or 34.5% of total
revenues in the fourth quarter (2003: $178.9m or 31.7% of revenues). The
increase in SG&A as a percentage of revenues in 2004 reflects expenditures
related to the launch of Raptiva®, the
launch of the Gonal-f®
pre-filled pen and the continued investment to drive Rebif® to
worldwide market leadership.
Research
and Development expenses were $594.8m or 24.2% of total revenues (2003: $467.8m
or 23.2% of total revenues) for the full year, and $221.3m or 32.6% of total
revenues in the fourth quarter (2003: $124.2m or 22.0% of total revenues). The
increase in R&D as a percentage of revenues in 2004, particularly in the
fourth quarter, results from the commencement of several external R&D
collaborations (e.g. ZymoGenetics, Micromet and CancerVax), as well as
significant progress made in R&D. Six late-stage clinical development
programs are currently on-going, involving up to 6,500 patients (five Phase III,
one post-registration head-to-head study).
Other
operating expenses in 2004 were $227.1m (2003: $199.5m), and $66.4m (2003:
$49.2m) in the fourth quarter. The increase in other operating expenses results
from payments made to third parties related to licensing
agreements.
Full year
2004 operating income increased by 20.5% to $524.1m or 21.3% of total revenues
(2003: $434.9m or 21.5% of total revenues). In the
fourth quarter,
operating income was $84.8m or 12.5% of total revenues (2003: $132.4m or
23.4% of total revenues).
-more-
Net
financial income was $63.3m in 2004 (2003: $44.0m) and $20.7m in the fourth
quarter (2003: $15.2m) as a result of
higher returns on our financial assets and foreign exchange gains.
Total
taxes in 2004 were $90.9m, representing an overall tax rate of 15.5% of profit
before tax (2003: $68.9m, or 15.0% of profit before tax). In the fourth quarter,
taxes were $13.9m, or 13.2% of profit before tax (2003: $19.7m or 15.0% of
profit before tax).
Reported
net income in the full year 2004 was up 26.7% to $494.2m (2003:
$390.0m), or
21.7% in local currencies. In the fourth quarter, reported net income decreased
19.6%, or 19.8% in local currencies, to $89.7m (2003: $111.6m) as a result of
significant R&D expenses resulting from the commencement of three external
R&D collaborations and progress in several late-stage programs.
Basic
earnings per share (EPS) were up 31.3% to $32.35 per bearer share
(2003: $24.63) and $0.81 per American Depositary Share (ADS) (2003: $0.62).
The average number of equivalent bearer shares outstanding for the year ended
December 31, 2004 was 15,276,403.
On April
26, 2005, the Board of Directors will propose to the Annual General Meeting a
cash dividend of CHF9.0 per bearer share, CHF3.6 per registered share, and
CHF0.23 per ADS, representing an increase of 12.5% over the 2003
dividend.
For the
full year ended 2004, net cash flow from operating activities was $471.7m (2003:
$542.9m).
In 2004,
share repurchases were CHF1,017.4m ($833.1m) representing 1,313,644 bearer
shares. As of December 31, 2004, there were 14,531,957 outstanding equivalent
bearer shares of Serono S.A. The company’s liquid financial assets were $1.8
billion at the end of 2004 providing significant flexibility for non-organic
growth.
In 2005,
Serono expects product sales to grow between 10% and 15% leading to total
revenues of at least $2.6 billion and net income between $520m and $540m based
on prevailing currency exchange rates. This outlook does not include expenses
related to any new
business development transactions or other extraordinary items in
2005.
Neurology
Neurology
sales were up 32.1% to
$1,123.0m for the full year 2004, and fourth quarter sales were $319.1m.
Rebif® reached
blockbuster status in 2004 with full year sales up 33.1% (25.4% in local
currencies) to $1,090.6m (2003: $819.4m). In the fourth quarter, worldwide sales
of Rebif®
increased by 32.9% (26.6% in local currencies) to $310.0m (2003: $233.2m). Given
the strong performance of Rebif® in 2004,
the company is on track to achieve its goal of worldwide market leadership in
2006.
-more-
In 2004,
Rebif® was the
fastest growing multiple sclerosis (MS) therapy in the US with $295.6m
sales for
the full year, representing an increase of 56.8% (2003: $188.5m). In the fourth
quarter, sales of Rebif® in the
US were up 54.5% to $86.0m (2003: $55.7m).
Rebif®
continues its market leadership outside the US with 2004 sales increasing by
26.0% to $795.0m (2003: $630.8m). Sales ex-US were up by 26.2% to $224.0m in the
fourth quarter (2003: $177.5m).
On
January 5th 2005,
Serono announced that patient enrolment for a head-to-head study comparing
Rebif® with
Copaxone® in
relapsing remitting MS had been completed. This trial will provide comparative
data that will support an evidence-based approach for rational treatment
decisions in multiple sclerosis, and Serono expects the data to support
Rebif®
as a
foundation therapy for treatment of multiple sclerosis.
On
January 11th 2005,
Serono announced that it will initiate a large Phase III study with
Mylinax® (oral
formulation of cladribine) in Q1 2005. Mylinax® could be
the first oral disease modifying treatment for MS to reach the market. This
multi-center, multi-national study is designed to assess the effectiveness of
Mylinax® in
patients with relapsing forms of multiple sclerosis. It will be a two-year,
double-blind, placebo-controlled study involving over 1,200
patients.
In 2004,
Serono introduced Rebiject II, a new auto-injection device, and an ultra-thin
needle for the Rebif®
pre-filled syringe. A titration pack has also recently been approved by the FDA
simplifying initiation of therapy for new patients.
Reproductive
Health
In 2004,
sales of Gonal-f®
increased by 8.7% (3.6% in local currencies) to $572.7m (2003: $526.9m) and by
2.2% (-1.7% in local currencies) to $151.1m (2003: $147.9m) in the fourth
quarter. Excluding
Germany which was impacted by government and reimbursement issues,
Gonal-f®
worldwide sales grew by 17.5% (12.3% in local currencies) in 2004 reflecting the
availability of the newly
launched Gonal-f®
pre-filled pen.
Serono’s
core reproductive health portfolio consisting of three recombinant hormones
(Gonal-f®,
Ovidrel®/Ovitrelle®,
Luveris®) and two
complementary products (Cetrotide®,
Crinone®) grew by
8.5% (3.4% in local currencies) to $645.6m representing 93.3% of total
reproductive health sales in 2004. With the approval of Luveris® in the
US, the complete portfolio of infertility products is now globally available
with the exception of Japan.
New
initiatives have been undertaken to raise disease and treatment awareness, such
as www.fertility.com and
Fertility
Lifelines (www.fertilitylifelines.com), educational
services that offer customized information and support to people with fertility
concerns.
-more-
Growth
and Metabolism
Total
growth hormone sales increased by 12.3% (8.2% in local currencies) to $269.8m
(2003: $240.2m) in 2004 and by 17.3% (13.8% in local currencies) to $76.4m
(2003: $65.1m) in the fourth quarter driven by a strong performance of
Saizen®.
Saizen® sales
increased by 20.2% (13.6% in local currencies) to $182.1m (2003: $151.5m)
in 2004, and were up 25.8% (20.4% in local currencies) to $53.2m (2003: $42.3m)
during the fourth quarter. Our investment in innovative devices and support
tools to improve the management of growth disorders contributed to making
Saizen® a
popular choice with patients. Saizen® was
recently approved by the FDA in Adult Growth Hormone Deficiency
(AGHD).
Serostim® sales
were $86.8m for the full year (2003: $88.8m), and $22.6m (2003: $22.8m) in
the fourth quarter. A Phase III trial of Serostim in HIV-associated adipose
redistribution syndrome (HARS) completed recruitment at the end of
2004.
Dermatology
In late
September 2004, Raptiva® was
approved by the European Commission for the treatment of patients with
moderate-to-severe chronic plaque psoriasis for whom other systemic treatments
or phototherapy have been inadequate or are inappropriate. Raptiva® was the
first biological treatment for psoriasis to be authorized for marketing in the
25 countries of the European Union.
Raptiva® is also
approved in Switzerland and Australia, as well as Argentina, Mexico and Brazil
and is now available in 15 countries. Sales of Raptiva® were
$4.9m for the full year, and $3.7m in the fourth quarter. The roll-out of
Raptiva® will
continue throughout 2005.
Regional
Sales
North
American sales grew by 20.7% to $837.9m in 2004 (2003: $694.3m). European sales
increased by 12.3% to $895.2m (2003: $796.8m). In the rest of the world, sales
grew by 21.2% to $444.9m (2003: $367.0m).
In the
fourth quarter, North American sales were up 20.8%
to $232.7m (Q4
2003: $192.7m)
while European sales grew by 8.2% to $247.8m (Q4 2003: $229.0m) and sales in the
rest of the world increased by 27.1% to $124.0m (Q4 2003: $97.5m).
-more-
R&D
News
Significant
steps forward in R&D were made in the last twelve months. Serono now has six
late-stage clinical development programs on-going, consisting of five Phase III
programs (onercept in psoriasis; interferon-beta in chronic hepatitis C in Asian
patients; Serostim® in
HIV-associated adipose redistribution syndrome; Canvaxin™ in stage III and IV
melanoma and Mylinax® in
relapsing forms of MS) and one post-registration head-to-head study comparing
Rebif® with
Copaxone® in
relapsing remitting MS.
In
December 2004, Serono announced two significant agreements strengthening its
R&D presence in oncology. One collaboration is with CancerVax for the global
development and commercialization of Canvaxin™, currently in two Phase III
trials for respectively stage III and IV melanoma involving over 1,800 patients.
The second collaboration is a partnership with Micromet for the global
development and commercialization of adecatumumab (MT201). This monoclonal
antibody is currently in Phase II trials for the treatment of metastatic breast
cancer and prostate cancer.
Conference
Call and Webcast
Serono
will hold a conference call on February 2nd, 2005,
starting at 11:00 am Eastern Time (5:00 pm Central European Time) during which
Serono Management will present the Company's Fourth Quarter and Full Year 2004
Results.
The event
will also be relayed by live audio webcast which interested parties may access
via Serono's Corporate home page, www.serono.com. A link
to the webcast will be provided immediately prior to the event. Additionally,
the webcast will be available for replay until close of business on February
20th,
2005.
###
Some
of the statements in this press release are forward looking. Such statements are
inherently subject to known and unknown risks, uncertainties and other factors
that may cause actual results, performance or achievements of Serono S.A. and
affiliates to be materially different from those expected or anticipated in the
forward-looking statements. Forward-looking statements are based on Serono’s
current expectations and assumptions, which may be affected by a number of
factors, including those discussed in this press release and more fully
described in Serono’s Annual Report on Form 20-F filed with the U.S. Securities
and Exchange Commission on March 25, 2004. These factors include any failure or
delay in Serono’s ability to develop new products, any failure to receive
anticipated regulatory approvals, any problems in commercializing current
products as a result of competition or other factors, our ability to obtain
reimbursement coverage for our products, and government regulations limiting our
ability to sell our products. Serono has no responsibility to update the
forward-looking statements contained in this press release to reflect events or
circumstances occurring after the date of this press release.
###
-more-
About
Serono
Serono is
a global biotechnology leader. The Company has eight biotechnology products,
Rebif®,
Gonal-f®,
Luveris®,
Ovidrel®/Ovitrelle®,
Serostim®,
Saizen®,
Zorbtive™ and Raptiva®. In
addition to being the world leader in reproductive health, Serono has strong
market positions in neurology, metabolism and growth and has recently entered
the psoriasis area. The Company's research programs are focused on growing these
businesses and on establishing new therapeutic areas, including oncology.
Currently, there are approximately 30 ongoing development projects.
In 2004,
Serono achieved worldwide revenues of US$2,458.1 million, and a net income of
US$494.2 million, making it the third largest biotech company in the world. Its
products are sold in over 90 countries. Bearer shares of Serono S.A., the
holding company, are traded on the virt-x (SEO) and its American Depositary
Shares are traded on the New York Stock Exchange (SRA).
For
more information, please contact:
|
Serono
in Geneva, Switzerland: | |
|
Media
Relations: |
Investor
Relations: |
|
Tel: +41-22-739
36 00 |
Tel: +41-22-739
36 01 |
|
Fax: +41-22-739
30 85 |
Fax: +41-22-739
30 22 |
|
http://www.serono.com |
Reuters:
SEO.VX / SRA.N |
|
Bloomberg:
SEO VX / SRA US | |
|
Serono,
Inc., Rockland, MA |
|
|
Media
Relations: |
Investor
Relations: |
|
Tel.
+1 781 681 2340 |
Tel.
+1 781 681 2552 |
|
Fax:
+1 781 681 2935 |
Fax:
+1 781 681 2912 |
|
http://www.seronousa.com |
|
On the
following pages, there are:
|
· |
Tables
detailing sales in dollars by therapeutic area, geographic region and the
top 10 products for the 3 and 12 months ended December 31, 2004 and
2003. |
|
· |
Consolidated
income statements for the 3 and 12 months ended December 31, 2004 and
2003, the consolidated balance sheets as of December 31, 2004 and 2003,
the consolidated statement of changes in equity as of December 31, 2004
and 2003, as well as the consolidated cash flow statements for the 12
months ended December 31, 2004 and 2003. These consolidated financial
statements have been prepared on the basis of International Financial
Reporting Standards. The accompanying notes to these 2004 full-year
consolidated financial statements will be available upon the release of
Serono’s 2004 Annual Report. |
-more-
|
Sales
by therapeutic area |
||||||||||||||||
|
Three
Months Ended |
Three
Months Ended |
|||||||||||||||
|
December
31, 2004 |
December
31, 2003 |
|||||||||||||||
|
|
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
|||||||||||
|
Neurology |
319.1 |
52.8 |
% |
31.9 |
% |
241.9 |
46.6 |
% | ||||||||
|
Reproductive
Health |
181.9 |
30.1 |
% |
(4.8 |
%) |
191.0 |
36.8 |
% | ||||||||
|
Growth
& Metabolism |
76.4 |
12.6 |
% |
17.3 |
% |
65.1 |
12.5 |
% | ||||||||
|
Dermatology |
3.7 |
0.6 |
% |
n/a
|
||||||||||||
|
Others |
23.4 |
3.9 |
% |
10.1 |
% |
21.3 |
4.1 |
% | ||||||||
|
|
|
|
|
|
|
|||||||||||
|
Total
sales (US$ million) |
$ |
604.5 |
100 |
% |
16.4 |
% |
$ |
519.3 |
100 |
% | ||||||
|
Sales
by geographic region |
||||||||||||||||
|
Three
Months Ended |
Three
Months Ended |
|||||||||||||||
|
December
31, 2004 |
December
31, 2003 |
|||||||||||||||
|
|
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
|||||||||||
|
Europe |
247.8 |
41.0 |
% |
8.2 |
% |
229.0 |
44.1 |
% | ||||||||
|
North
America |
232.7 |
38.5 |
% |
20.8 |
% |
192.7 |
37.1 |
% | ||||||||
|
Latin
America |
30.6 |
5.1 |
% |
4.2 |
% |
29.4 |
5.7 |
% | ||||||||
|
Others |
93.4 |
15.4 |
% |
37.0 |
% |
68.2 |
13.1 |
% | ||||||||
|
|
|
|
|
|
||||||||||||
|
Total
sales (US$ million) |
$ |
604.5 |
100 |
% |
16.4 |
% |
$ |
519.3 |
100 |
% | ||||||
|
Sales
by therapeutic area |
||||||||||||||||
|
Twelve
Months Ended |
Twelve
Months Ended |
|||||||||||||||
|
December
31, 2004 |
December
31, 2003 |
|||||||||||||||
|
|
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
|||||||||||
|
Neurology |
1,123.0 |
51.6 |
% |
32.1 |
% |
850.2 |
45.8 |
% | ||||||||
|
Reproductive
Health |
692.3 |
31.8 |
% |
(0.1 |
%) |
692.9 |
37.3 |
% | ||||||||
|
Growth
& Metabolism |
269.8 |
12.4 |
% |
12.3 |
% |
240.2 |
12.9 |
% | ||||||||
|
Dermatology |
4.9 |
0.2 |
% |
n/a
|
||||||||||||
|
Others |
87.9 |
4.0 |
% |
17.7 |
% |
74.7 |
4.0 |
% | ||||||||
|
|
|
|
|
|
|
|||||||||||
|
Total
sales (US$ million) |
$ |
2,177.9 |
100 |
% |
17.2 |
% |
$ |
1,858.0 |
100 |
% | ||||||
|
Sales
by geographic region |
||||||||||||||||
|
Twelve
Months Ended |
Twelve
Months Ended |
|||||||||||||||
|
December
31, 2004 |
December
31, 2003 |
|||||||||||||||
|
|
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
|||||||||||
|
Europe |
895.2 |
41.1 |
% |
12.3 |
% |
796.8 |
42.9 |
% | ||||||||
|
North
America |
837.9 |
38.5 |
% |
20.7 |
% |
694.3 |
37.4 |
% | ||||||||
|
Latin
America |
111.1 |
5.1 |
% |
12.4 |
% |
98.8 |
5.3 |
% | ||||||||
|
Others |
333.7 |
15.3 |
% |
24.5 |
% |
268.1 |
14.4 |
% | ||||||||
|
|
|
|
|
|
||||||||||||
|
Total
sales (US$ million) |
$ |
2,177.9 |
100 |
% |
17.2 |
% |
$ |
1,858.0 |
100 |
% | ||||||
-more-
|
TOP
TEN PRODUCTS |
|||||||||||||||||||
|
Three
Months Ended |
Three
Months Ended |
||||||||||||||||||
|
December
31, 2004 |
|
December
31, 2003 |
|||||||||||||||||
|
*
TA |
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
||||||||||||||
|
Rebif® |
MS |
310.0
|
51.3 |
% |
32.9 |
% |
233.2
|
44.9 |
% | ||||||||||
|
Gonal-f® |
RH |
151.1
|
25.0 |
% |
2.2 |
% |
147.9
|
28.5 |
% | ||||||||||
|
Saizen® |
Growth |
53.2
|
8.8 |
% |
25.8 |
% |
42.3
|
8.1 |
% | ||||||||||
|
Novantrone® |
MS/Oncology |
23.5
|
3.9 |
% |
5.0 |
% |
22.4
|
4.3 |
% | ||||||||||
|
Serostim® |
Wasting |
22.6
|
3.7 |
% |
(0.8 |
%) |
22.8
|
4.4 |
% | ||||||||||
|
Cetrotide® |
RH |
6.7
|
1.1 |
% |
(13.5 |
%) |
7.7
|
1.5 |
% | ||||||||||
|
Crinone® |
RH |
6.2
|
1.0 |
% |
(3.4 |
%) |
6.4
|
1.2 |
% | ||||||||||
|
Ovidrel® |
RH |
5.5
|
0.9 |
% |
50.7 |
% |
3.6
|
0.7 |
% | ||||||||||
|
Metrodin-HP® |
RH |
4.4
|
0.7 |
% |
(16.6 |
%) |
5.3
|
1.0 |
% | ||||||||||
|
Stilamin® |
Other |
4.2
|
0.7 |
% |
9.3 |
% |
3.9
|
0.7 |
% | ||||||||||
|
Twelve
Months Ended |
Twelve
Months Ended |
||||||||||||||||||
|
December
31, 2004 |
|
December
31, 2003 |
|||||||||||||||||
|
*
TA |
$
million |
%
of sales |
%
change $ |
$
million |
%
of sales |
||||||||||||||
|
Rebif® |
MS |
1,090.6 |
50.1 |
% |
33.1 |
% |
819.4
|
44.1 |
% | ||||||||||
|
Gonal-f® |
RH |
572.7
|
26.3 |
% |
8.7 |
% |
526.9
|
28.4 |
% | ||||||||||
|
Saizen® |
Growth |
182.1
|
8.4 |
% |
20.2 |
% |
151.5
|
8.2 |
% | ||||||||||
|
Serostim® |
Wasting |
86.8
|
4.0 |
% |
(2.2 |
%) |
88.8
|
4.8 |
% | ||||||||||
|
Novantrone® |
MS/Oncology |
83.9
|
3.9 |
% |
8.8 |
% |
77.1
|
4.1 |
% | ||||||||||
|
Cetrotide® |
RH |
24.8
|
1.1 |
% |
(0.2 |
%) |
24.8
|
1.3 |
% | ||||||||||
|
Crinone® |
RH |
19.8
|
0.9 |
% |
(4.6 |
%) |
20.8
|
1.1 |
% | ||||||||||
|
Ovidrel® |
RH |
17.7
|
0.8 |
% |
43.3 |
% |
12.3
|
0.7 |
% | ||||||||||
|
Metrodin-HP® |
RH |
15.9
|
0.7 |
% |
(36.0 |
%) |
24.8
|
1.3 |
% | ||||||||||
|
Stilamin® |
Other |
15.8
|
0.7 |
% |
3.6 |
% |
15.3
|
0.8 |
% | ||||||||||
|
*
Therapeutic Areas |
||||||
|
RH |
=
Reproductive Health |
Wasting |
=
AIDS Wasting | |||
|
MS |
=
Multiple Sclerosis |
Growth |
=
Growth Retardation | |||
|
Oncology |
=
Oncology |
|||||
-more-
|
Consolidated
Income Statements |
||||||||||||||||
Three
months ended December 31 |
2004 |
%
of |
2003
|
%
of |
||||||||||||
|
US$'000 |
Revenues |
%
change |
US$'000 |
Revenues |
||||||||||||
Revenues |
||||||||||||||||
|
Product
sales |
604,467
|
16.4 |
% |
519,276
|
||||||||||||
|
Royalty
and license income |
75,259
|
64.4 |
% |
45,788
|
||||||||||||
|
Total
Revenues |
679,726
|
100.0 |
% |
20.3 |
% |
565,064
|
100.0 |
% | ||||||||
|
Operating
Expenses |
||||||||||||||||
|
Cost
of product sales |
73,017
|
(9.2 |
%) |
80,418
|
||||||||||||
|
%
of Sales |
12.1 |
% |
15.5 |
% |
||||||||||||
|
Selling,
general and administrative |
234,302
|
34.5 |
% |
31.0 |
% |
178,865
|
31.7 |
% | ||||||||
|
Research
and development |
221,264
|
32.6 |
% |
78.1 |
% |
124,208
|
22.0 |
% | ||||||||
|
Other
operating expense, net |
66,350
|
9.8 |
% |
35.0 |
% |
49,156
|
8.7 |
% | ||||||||
|
Total
Operating Expenses |
594,933
|
87.5 |
% |
37.5 |
% |
432,647
|
76.6 |
% | ||||||||
|
Operating
Income |
84,793
|
12.5 |
% |
(36.0 |
%) |
132,417
|
23.4 |
% | ||||||||
|
Financial
income, net |
20,667
|
36.4 |
% |
15,154
|
||||||||||||
|
Other
income / (expense), net |
16
|
|
|
(16,124 |
) |
|
||||||||||
|
Total
Non Operating Income/(expense), net |
20,683
|
|
|
(970 |
) |
|
||||||||||
|
Income
Before Taxes and Minority Interests |
105,476
|
15.5 |
% |
(19.8 |
%) |
131,447
|
23.3 |
% | ||||||||
|
Taxes |
13,943
|
|
|
19,742
|
|
|||||||||||
|
Income
Before Minority Interests |
91,533
|
111,705
|
||||||||||||||
|
Minority
interests |
1,835
|
|
|
92
|
|
|||||||||||
|
Net
Income |
89,698
|
13.2 |
% |
(19.6 |
%) |
111,613
|
19.8 |
% | ||||||||
|
2004 |
2003 |
%
Change |
||||||||
|
Basic
Earnings per Share (in U.S. dollars) |
|
|||||||||
|
-
Bearer shares |
6.10
|
7.05
|
(13.6 |
%) | ||||||
|
-
Registered shares |
2.44
|
2.82
|
(13.6 |
%) | ||||||
|
-
American depositary shares |
0.15
|
0.18
|
(13.6 |
%) | ||||||
|
Diluted
Earnings per Share (in U.S. dollars) |
|
|||||||||
|
-
Bearer shares |
6.09
|
7.04
|
(13.5 |
%) | ||||||
|
-
Registered shares |
2.44
|
2.81
|
(13.5 |
%) | ||||||
|
-
American depositary shares |
0.15
|
0.18
|
(13.5 |
%) | ||||||
|
Basic
earnings per share is calculated in accordance with IAS 33 (Earnings per
Share) by dividing the net income of the group, |
|||||||||
|
US$89.7
million (2003 US$111.6 million), by an appropriate number of shares. This
is 10,307,628 bearer shares (2003 11,421,622) | |||||||||
|
and
11,013,040 registered shares (2003 11,013,040). The total weighted average
equivalent number of bearer shares is 14,712,844 | |||||||||
|
(2003
15,826,838) for the three months ended December 31, 2004. As each American
depositary share represents ownership interest | |||||||||
|
in
one fortieth of a bearer share, basic and diluted earnings per American
depositary share is calculated as one fortieth of the |
|||||||||
|
earnings
per bearer share. |
|||||||||
|
For
diluted earnings per share, the total number of bearer shares is adjusted
to assume conversion of all in the money share options | |||||||||
|
granted
to employees and directors. The convertible bond is antidilutive and
therefore has not been included in the calculation of | |||||||||
|
diluted
earnings per share. The number of bearer shares used to calculate diluted
earnings per share is 10,327,107 (2003
11,459,708). | |||||||||
|
Consolidated
Income Statements |
||||||||||||||||
Twelve
months ended December 31 |
2004
* |
%
of |
2003
* |
%
of |
||||||||||||
|
US$'000 |
Revenues |
%
change |
US$'000 |
Revenues |
||||||||||||
Revenues |
||||||||||||||||
|
Product
sales |
2,177,949
|
17.2 |
% |
1,858,009
|
||||||||||||
|
Royalty
and license income |
280,101
|
74.4 |
% |
160,608
|
||||||||||||
|
Total
Revenues |
2,458,050
|
100.0 |
% |
21.8 |
% |
2,018,617
|
100.0 |
% | ||||||||
|
Operating
Expenses |
||||||||||||||||
|
Cost
of product sales |
304,111
|
8.8 |
% |
279,619
|
||||||||||||
|
%
of Sales |
14.0 |
% |
15.0 |
% |
||||||||||||
|
Selling,
general and administrative |
807,940
|
32.9 |
% |
26.9 |
% |
636,823
|
31.5 |
% | ||||||||
|
Research
and development |
594,802
|
24.2 |
% |
27.2 |
% |
467,779
|
23.2 |
% | ||||||||
|
Other
operating expense, net |
227,096
|
9.2 |
% |
13.8 |
% |
199,476
|
9.9 |
% | ||||||||
|
Total
Operating Expenses |
1,933,949
|
78.7 |
% |
22.1 |
% |
1,583,697
|
78.5 |
% | ||||||||
|
Operating
Income |
524,101
|
21.3 |
% |
20.5 |
% |
434,920
|
21.5 |
% | ||||||||
|
Financial
income, net |
63,281
|
43.8 |
% |
44,018
|
||||||||||||
|
Other
expense, net |
629
|
|
|
19,743
|
|
|||||||||||
|
Total
Non Operating Income, net |
62,652
|
|
|
24,275
|
|
|||||||||||
|
Income
Before Taxes and Minority Interests |
586,753
|
23.9 |
% |
27.8 |
% |
459,195
|
22.7 |
% | ||||||||
|
Taxes |
90,947
|
|
|
68,905
|
|
|||||||||||
|
Income
Before Minority Interests |
495,806
|
390,290
|
||||||||||||||
|
Minority
interests |
1,653
|
|
|
327
|
|
|||||||||||
|
Net
Income |
494,153
|
20.1 |
% |
26.7 |
% |
389,963
|
19.3 |
% | ||||||||
|
|
||||||||||||||||
|
*
Extracted from the audited consolidated financial
statements |
||||||||||||||||
|
2004 |
2003 |
%
Change |
||||||||
|
Basic
Earnings per Share (in U.S. dollars) |
|
|||||||||
|
-
Bearer shares |
32.35
|
24.63
|
31.3 |
% | ||||||
|
-
Registered shares |
12.94
|
9.85
|
31.3 |
% | ||||||
|
-
American depositary shares |
0.81
|
0.62
|
31.3 |
% | ||||||
|
Diluted
Earnings per Share (in U.S. dollars) |
|
|||||||||
|
-
Bearer shares |
32.29
|
24.59
|
31.3 |
% | ||||||
|
-
Registered shares |
12.92
|
9.84
|
31.3 |
% | ||||||
|
-
American depositary shares |
0.81
|
0.61
|
31.3 |
% | ||||||
|
Basic
earnings per share is calculated in accordance with IAS 33 (Earnings per
Share) by dividing the net income of the group, |
|||||
|
US$494.2
million (2003 US$390.0 million), by an appropriate number of shares. This
is 10,871,187 bearer shares (2003 11,427,194) | |||||
|
and
11,013,040 registered shares (2003 11,013,040). The total weighted average
equivalent number of bearer shares is 15,276,403 | |||||
|
(2003
15,832,410) for the twelve months ended December 31, 2004. As each
American depositary share represents ownership interest | |||||
|
in
one fortieth of a bearer share, basic and diluted earnings per American
depositary share is calculated as one fortieth of the |
|||||
|
earnings
per bearer share. |
|||||
|
For
diluted earnings per share, the total number of bearer shares is adjusted
to assume conversion of all in the money share options | |||||
|
granted
to employees and directors. The convertible bond is antidilutive and
therefore has not been included in the calculation of |
|||||
|
diluted
earnings per share. The number of bearer shares used to calculate diluted
earnings per share is 10,896,618 (2003
11,452,890). | |||||
-more-
Consolidated
Balance Sheets |
|||||||
As
of |
December
31, 2004 * |
December
31, 2003 * |
|||||
|
US$'000 |
US$'000 |
||||||
Assets |
|||||||
|
Current
Assets |
|
||||||
|
Cash
and cash equivalents |
275,979
|
1,003,972
|
|||||
|
Short-term
financial assets |
784,999
|
434,810
|
|||||
|
Trade
accounts receivable |
427,935
|
318,388
|
|||||
|
Inventories |
326,937
|
319,820
|
|||||
|
Prepaid
expenses and other current assets |
237,205
|
220,334
|
|||||
|
Total
Current Assets |
2,053,055
|
2,297,324
|
|||||
|
Non-Current
Assets |
|||||||
|
Tangible
fixed assets |
799,878
|
701,453
|
|||||
|
Intangible
assets |
290,558
|
259,626
|
|||||
|
Deferred
tax assets |
198,467
|
169,693
|
|||||
|
Long-term
financial assets |
929,030
|
1,104,333
|
|||||
|
Other
long-term assets |
133,302
|
39,174
|
|||||
|
Total
Non-Current Assets |
2,351,235
|
2,274,279
|
|||||
|
Total
Assets |
4,404,290
|
4,571,603
|
|||||
|
Liabilities |
|||||||
|
Current
Liabilities |
|||||||
|
Trade
and other payables |
426,616
|
338,862
|
|||||
|
Short-term
financial debts |
34,527
|
51,224
|
|||||
|
Income
taxes |
166,861
|
146,086
|
|||||
|
Deferred
income - current |
33,128
|
47,200
|
|||||
|
Other
current liabilities |
208,071
|
170,019
|
|||||
|
Total
Current Liabilities |
869,203
|
753,391
|
|||||
|
Non-Current
Liabilities |
|||||||
|
Long-term
financial debts |
640,892
|
532,022
|
|||||
|
Deferred
tax liabilities |
24,242
|
15,919
|
|||||
|
Deferred
income - non current |
157,004
|
174,911
|
|||||
|
Provisions
and other long-term liabilities |
261,728
|
213,556
|
|||||
|
Total
Non-Current Liabilities |
1,083,866
|
936,408
|
|||||
|
Total
Liabilities |
1,953,069
|
1,689,799
|
|||||
|
|
|
||||||
|
Minority
Interests |
3,343
|
1,614
|
|||||
|
Shareholders'
Equity |
|||||||
|
Share
capital |
254,420
|
253,895
|
|||||
|
Share
premium |
1,023,125
|
1,002,991
|
|||||
|
Treasury
shares |
(987,489) |
(157,642) |
|||||
|
Retained
earnings |
2,064,499
|
1,669,700
|
|||||
|
Fair
value and other reserves |
23,482
|
22,711
|
|||||
|
Cumulative
foreign currency translation adjustments |
69,841
|
88,535
|
|||||
|
Total
Shareholders' Equity |
2,447,878
|
2,880,190
|
|||||
|
|
|
||||||
|
Total
Liabilities, Minority Interests and Shareholders' Equity |
4,404,290
|
4,571,603
|
|||||
|
*
Extracted from the audited consolidated financial
statements |
|||||||
-more-
Consolidated
Statement of Changes in Equity |
||||||||||||||||||||||
|
Cumulative |
||||||||||||||||||||||
|
foreign |
||||||||||||||||||||||
|
Fair
value |
currency |
|||||||||||||||||||||
|
Share |
Share |
Treasury |
Retained |
and
other |
translation |
|||||||||||||||||
|
capital |
premium |
shares |
earnings |
reserves |
adjustments |
Total |
||||||||||||||||
|
US$'000 |
US$'000 |
US$'000 |
US$'000 |
US$'000 |
US$'000 |
US$'000 |
||||||||||||||||
|
Balance
as of January 1, 2003 |
253,416
|
989,141
|
(126,460 |
) |
1,364,626
|
(44,807 |
) |
25,282
|
2,461,198
|
|||||||||||||
|
Acquisition
of treasury shares |
(42,026 |
) |
(42,026 |
) | ||||||||||||||||||
|
Issue
of share capital |
479
|
13,725
|
10,844
|
25,048
|
||||||||||||||||||
|
Issue
of call options on Serono shares |
125
|
820
|
945
|
|||||||||||||||||||
|
Issue
of convertible debt |
24,605
|
24,605
|
||||||||||||||||||||
|
Net
income |
389,963
|
389,963
|
||||||||||||||||||||
|
Dividend
- bearer shares |
(61,849 |
) |
(61,849 |
) | ||||||||||||||||||
|
Dividend
- registered shares |
(23,860 |
) |
(23,860 |
) | ||||||||||||||||||
|
Fair
value adjustments on available-for sales
investments |
25,903
|
25,903
|
||||||||||||||||||||
|
Recognition
of unrealized loss on available-for-sale
investments |
11,265
|
11,265
|
||||||||||||||||||||
|
Sale
of available-for-sale investments |
5,745
|
5,745
|
||||||||||||||||||||
|
Translation
effects |
|
|
|
|
|
63,253
|
63,253
|
|||||||||||||||
|
Balance
as of December 31, 2003 * |
253,895
|
1,002,991
|
(157,642 |
) |
1,669,700
|
22,711
|
88,535
|
2,880,190
|
||||||||||||||
|
Balance
as of January 1, 2004 |
253,895
|
1,002,991
|
(157,642 |
) |
1,669,700
|
22,711
|
88,535
|
2,880,190
|
||||||||||||||
|
Acquisition
of treasury shares |
(833,148 |
) |
(833,148 |
) | ||||||||||||||||||
|
Issue
of share capital |
525
|
20,134
|
3,301
|
23,960
|
||||||||||||||||||
|
Net
income |
494,153
|
494,153
|
||||||||||||||||||||
|
Dividend
- bearer shares |
(71,096 |
) |
(71,096 |
) | ||||||||||||||||||
|
Dividend
- registered shares |
(28,258 |
) |
(28,258 |
) | ||||||||||||||||||
|
Fair
value adjustments on available-for sales
investments |
14,488
|
14,488
|
||||||||||||||||||||
|
Fair
value adjustments on financial instruments |
(13,717 |
) |
(13,717 |
) | ||||||||||||||||||
|
Translation
effects |
|
|
|
|
|
(18,694 |
) |
(18,694 |
) | |||||||||||||
|
Balance
as of December 31, 2004 * |
254,420
|
1,023,125
|
(987,489 |
) |
2,064,499
|
23,482
|
69,841
|
2,447,878
|
||||||||||||||
|
*
Extracted from the audited consolidated financial
statements |
||||||||||||||||||||||
-more-
Consolidated
Cash Flow Statements |
|||||||
Twelve
months ended December 31 |
2004
* |
2003
* |
|||||
|
US$'000 |
US$'000 |
||||||
Income
before taxes and minority interests |
586,753
|
459,195
|
|||||
|
Reversal
of non-cash items |
|||||||
|
Depreciation
and amortization |
145,221
|
135,607
|
|||||
|
Financial
income |
(68,174 |
) |
(49,815 |
) | |||
|
Unrealized
foreign exchange result |
(39,137 |
) |
(14,671 |
) | |||
|
Financial
expense |
17,440
|
4,884
|
|||||
|
Loss
on sale of available-for-sale investments |
--
|
20,149
|
|||||
|
Other
non-cash items |
(52,248 |
) |
(16,647 |
) | |||
|
Cash
Flow From Operating Activities Before Working Capital
Changes |
589,855
|
538,702
|
|||||
|
Working
Capital Changes |
|||||||
|
Trade
accounts payable, other current liabilities and deferred
income |
127,946
|
104,497
|
|||||
|
Trade
accounts receivable and other receivables |
(141,160 |
) |
(34,245 |
) | |||
|
Inventories |
24,216
|
(7,265 |
) | ||||
|
Prepaid
expenses and other current assets |
(28,253 |
) |
30,818
|
||||
|
Taxes
paid |
(100,895 |
) |
(89,648 |
) | |||
|
Total
working capital changes |
(118,146 |
) |
4,157
|
||||
|
Net
Cash Flow From Operating Activities |
471,709
|
542,859
|
|||||
|
Purchase
of a subsidiary |
--
|
(9,651 |
) | ||||
|
Investment
in tangible fixed assets |
(178,919 |
) |
(162,527 |
) | |||
|
Proceeds
from disposal of tangible fixed assets |
5,569
|
11,081
|
|||||
|
Purchase
of intangible and other long-term assets |
(54,932 |
) |
(30,813 |
) | |||
|
Purchase
of available-for-sale investments |
(849,066 |
) |
(439,669 |
) | |||
|
Proceeds
from sale of available-for-sale investments |
654,628
|
8,058
|
|||||
|
Interest
received |
100,596
|
67,324
|
|||||
|
Net
Cash Flow From Investing Activities |
(322,124 |
) |
(556,197 |
) | |||
|
Acquisition
of treasury shares |
(811,677 |
) |
(42,026 |
) | |||
|
Proceeds
from issue of Serono shares |
10,333
|
13,105
|
|||||
|
Proceeds
from exercise of options on Serono shares |
2,163
|
7,536
|
|||||
|
Proceeds
from issue of options on Serono shares |
--
|
945
|
|||||
|
Proceeds
from issue of convertible bond |
--
|
444,820
|
|||||
|
Increase
in long-term financial debts |
48,661
|
53,948
|
|||||
|
Repayment
of long-term financial debts |
(5,214 |
) |
(23,086 |
) | |||
|
Change
in short-term financial debts |
(12,312 |
) |
(27,096 |
) | |||
|
Other
non-current liabilities |
(6,699 |
) |
(15,717 |
) | |||
|
Interest
paid |
(4,215 |
) |
(4,361 |
) | |||
|
Dividends
paid |
(99,354 |
) |
(85,709 |
) | |||
|
Net
Cash Flow From Financing Activities |
(878,314 |
) |
322,359
|
||||
|
Effect
of Exchange Rate Changes on Cash and Cash Equivalents |
736
|
8,918
|
|||||
|
Net
change in Cash and Cash Equivalents |
(727,993 |
) |
317,939
|
||||
|
Cash
and cash equivalents at the beginning of period |
1,003,972
|
686,033
|
|||||
|
Cash
and cash equivalents at the end of period |
275,979
|
1,003,972
|
|||||
|
*
Extracted from the audited consolidated financial
statements |
|||||||
-more-
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
SERONO
S.A. | ||
|
a
Swiss corporation | ||
|
(Registrant) | ||
|
February
1, 2005 |
By:
/s/
Stuart
Grant
| |
|
Name:
Stuart Grant | ||
|
Title:
Chief Financial Officer | ||