February 13, 2002
- Aventis Exceeds Ambitious
Growth Targets in 2001:
- Full-year core business sales
activity increases by 15.3% to euro 17.674 billion (15.836
billion USD)
- Core business net income up
39.5%, EPS rises 38.2% to euro 2.07 (1.85 USD) [euro 2.81
(2.52 USD) before goodwill]
- Sales activity of strategic
brands grows 38.1% in 2001, vaccines sales activity up 28.2%
- Strong focus on strategic
brands and U.S. market leads to improved profitability Six
potential blockbuster drugs possible by 2006
- Allegra(R), Lovenox(R) and
Taxotere(R) each generate sales of more than euro 1 billion in
2001
- Delix(R)/Tritace(R) on its way
to become next Aventis blockbuster drug
- Successful launches of
diabetes drug Lantus(R) in U.S. and antibiotic Ketek(R) in
Europe in 2001
- Promising pipeline
complemented by strategic alliances and in-licensing
agreements Expected earnings and sales growth targets through
end of 2004:
- Average annual EPS growth of
25
section on Aventis CropScience >>
Aventis today reported consolidated group net income of euro
1.505 billion (1.348 billion USD) for 2001 compared to a group
net loss of euro 147 million (132 million USD) in 2000. Group
net sales rose to euro 22.941 billion (20.555 billion USD) from
euro 22.304 billion (19.984 billion USD) in 2000. Earnings per
share (EPS) for the Aventis group increased to euro 1.91 (1.71
USD) compared to a loss per share of euro -0.19 (-0.17 USD) in
2000.
The group results still include non-core activities -- namely
Aventis CropScience, Aventis Animal Nutrition and industrial
activities. These activities are in the process of being
divested in order to focus on the core business, which comprises
prescription drugs, human vaccines and therapeutic proteins as
well as the 50% equity interest in the animal health business
Merial, a joint venture with Merck & Co. Inc., and corporate
activities. The results for 2000, which present the core
business retroactively, are calculated before exceptionals.
Core business shows strong growth momentum in 2001:
Sales increase 15.3%, net income rises 39.5%, EPS up 38.2% to
euro 2.07 (1.85 USD) [euro 2.81 (2.52 USD) before goodwill]
In its core business, Aventis achieved full-year sales of euro
17.674 billion (15.836 billion USD), an increase of 15.3%
compared to the previous year excluding currency and structural
effects (activity growth). Net income rose by 39.5% to euro
1.633 billion (1.463 billion USD) from euro 1.171 billion (1.049
billion USD) in 2000. Earnings per share (EPS) increased by
38.2% to euro 2.07 (1.85 USD) in
2001 from euro 1.50 (1.34 USD) in 2000. Before goodwill
amortization, EPS rose to euro 2.81 (2.52 USD) from euro 2.23
(2.00 USD) in 2000. Fourth-quarter sales rose 17.8 % on an
activity basis to euro 4.719 billion (4.228 billion USD)
compared to euro 4.256 billion (3.813 billion USD) in the fourth
quarter of 2000. Fourth-quarter net income improved 32.2% to
euro 479 million (429 million USD) from euro 363 million (325
million USD) in the same period of 2000.
"Aventis had a very successful year in 2001: We exceeded our
performance targets for earnings, profitability and sales, which
made Aventis one of the fastest growing pharmaceutical companies
in the world. At the same time, we strengthened our core
business by focusing on strategic brands and key markets,
particularly in the United States. We successfully launched new,
innovative products, which
offer significant therapeutic advantages and we continued to
maximize the potential of existing products by adding new
indications and launching them in new markets," said Jurgen
Dormann, Chairman of the Management Board. "Aventis has managed
and executed a successful merger thanks to the dedication and
expertise of our employees worldwide. But this is not time for
us to lean back: In 2002, we will continue to adapt to a
changing environment."
Based on the financial results of 2001, which were reviewed by
the Supervisory Board at its meeting on February 12, 2002, the
Management Board will propose to the Annual General Meeting of
Shareholders on May 14, 2002 a dividend of euro 0.58 (0.52 USD)
per share to shareholders of record as of May 17, 2002. The
total dividend payment, which is scheduled for distribution on
June 17, 2002, would be approximately euro 461 million (413
million USD).
Strong focus on strategic brands and U.S. market leads to
improved profitability
Gross margin in the core business increased to 71.2% in 2001
compared to 68.4% in 2000, while EBITA margin rose 2.7
percentage points to 21.8% compared to 2000. This significant
profitability improvement reflects the increasing concentration
on high-margin strategic brands and key geographic markets,
namely the United States, Japan, France and Germany.
Full-year sales for the core business in the United States, the
world's biggest pharmaceutical market, rose 27.7% excluding
structural and currency effects (activity variance) to euro
6.477 billion, driven by the ongoing strong performance of
strategic brands. During the fourth quarter, sales activity in
the United States increased 32.1% to euro 1.82 billion. For the
full year 2001, the United States accounted for 36.6% of total
core business sales compared to 33.2% in the previous year.
In Japan, the world's second-largest pharmaceutical market,
Aventis achieved full-year core business sales of euro 1.128
billion, an activity increase of 12.4%. This favorable
development was mainly attributable to the introduction of
allergy drug Allegra(R), which was launched in Japan in November
2000. Sales of the cancer drug Taxotere(R) benefited from new
indications for gastric, ovarian and head
and neck cancer, while stronger sales of Amaryl(R) also
supported the growth of Aventis in the Japanese market. The
osteoporosis drug Actonel(R), which was recently approved in
Japan and is expected to be launched early 2002, will also
contribute to further strengthening the position of Aventis in
this important market. Actonel(R) is being co-developed and
co-marketed with Procter & Gamble, and it will be co-marketed
with Takeda in Japan.
In France, annual sales activity increased 4.3% to euro 2.255
billion, with strategic brands contributing significantly to the
positive sales trend. In Germany, full-year sales rose 4.6% on
an activity basis to euro 1.248 billion compared to the year-ago
period.
Full-year sales activity in the prescription drugs business rose
15.9% to euro 15.168 billion, while the fourth quarter was
particularly strong with sales activity increasing by 18.1% to
euro 4.039 billion. Strategic brands, a group of key
prescription drugs with significant growth potential, recorded
full-year sales of euro 7.319 billion, an activity increase of
38.1%. Fourth-quarter sales of strategic brands increased 40.3%
over the same period one year ago and totaled euro 2.054
billion. For the full year, strategic brands accounted for 48.3%
of total prescription drug sales, this is an improvement of more
than 10 percentage points from 38.1% in 2000.
Outlook for period through end of 2004
"As we continue to focus on our strategic brands, streamline our
processes and under the assumption that we will see no material
change in the market environment for Allegra(R), we expect
average annual earnings growth of 25 to 30% between 2002 and
2004, while our sales activity should grow annually at around 11
to 12% on average during that same period," said Patrick
Langlois, Chief Financial Officer of Aventis. "After we
decreased our net debt to euro 9.2 billion at the end of 2001
from euro 13.1 billion in the previous year, we expect further
significant debt reduction in 2002. This will enhance our
financial flexibility to further strengthen our pharmaceutical
business," added Langlois.
Taxotere(R) - the third blockbuster drug for Aventis
Three blockbuster drugs, i.e. prescription drugs that achieved
sales of more than euro 1 billion, fueled the excellent
performance of Aventis in 2001:
* Allegra(R)/Telfast(R) (fexofenadine) generated a 48.9%
increase in full-year sales activity to euro 1.762 billion,
while fourth-quarter sales activity grew 57% to euro 511
million. Allegra(R), a non-sedating
antihistamine, remained the top-selling product for Aventis in
the U.S., posting a 40.4% increase sales activity to euro 1.495
billion for 2001. In Japan, the world's second-largest allergy
market after the United States, Allegra(R) sales totaled euro
126 million in 2001. Estimated annual peak sales for this
product could exceed euro 3 billion, if no material changes in
the antihistamine market environment occur and Aventis
successfully defends its intellectual property.
Aventis Pharmaceuticals, the U.S. pharmaceutical business of
Aventis, has filed three patent infringement suits against Barr
Laboratories, Inc., related to Allegra(R). In 2001, Aventis
filed two lawsuits against Barr in the U.S. District Court in
New Jersey alleging infringement of certain U.S. patents related
to fexofenadine HCl 60 mg capsules as well as 30, 60 and 180 mg
tablets. A third lawsuit was filed on January 28, 2002, after
Barr filed an ANDA related to Allegra-D(R), extended-release
tablets for oral administration, on December 21, 2001. In the
U.S., Aventis holds multiple methods of use, formulation,
process and composition patents with respect to Allegra(R).
Under applicable federal law, marketing of FDA-approved generic
fexofenadine HCl capsules or tablets may not commence unless and
until a decision favorable to Barr Laboratories is rendered in
the patent litigation or until 30 months have elapsed, whichever
comes first. In addition, the tablet formulations are protected
by regulatory exclusivity until the first quarter of 2003.
* Lovenox(R)/Clexane(R) (enoxaparin sodium) sales activity
increased 37.6% to euro 1.453 billion in 2001, while
fourth-quarter sales activity rose 26.6% to euro 390 million.
Sold as Lovenox(R) in the United States, Canada and France and
as Clexane(R) in the rest of the world, this drug has been used
to treat more than 82 million patients in 96 countries since its
launch. Lovenox(R) has excellent potential for sustained success
since it has the broadest range of indications among
low-molecular-weight heparins (LMWH) and has also benefited from
the launch of a new indication in the United States for the
prevention of DVT (deep vein thrombosis) in medically ill
patients with limited mobility. In addition, sales were
supported by the increasing use of Lovenox(R) for treatment of
various types of serious heart conditions that reduce the flow
of blood to the heart. Aventis targets now annual
peak sales for Lovenox(R) of more than euro 2.5 billion.
* Taxotere(R) (docetaxel), for the treatment of advanced breast
cancer and non-small-cell lung cancer, became the third
blockbuster drug for Aventis, achieving full-year sales of euro
1.003 billion, 34.8% more than in the previous year.
Fourth-quarter sales activity increased 42.5% to euro 278
million. The results of several clinical trials in breast, lung
and ovarian cancer published in 2001 helped to establish
Taxotere(R) as a superior agent in these tumor types and to
differentiate it from existing therapies. The estimated annual
peak sales were raised to euro 2 billion.
Significant contribution to top-line growth:
Delix(R)/Tritace(R), Amaryl(R) and Actonel(R)
The excellent performance of these three blockbuster drugs was
complemented by several other strategic products, which achieved
significant sales and strong growth rates in key markets in
2001:
* Delix(R)/Tritace(R) (ramipril), an ACE inhibitor for the
treatment of high blood pressure and the prevention of
cardiovascular events, generated sales of euro 709 million in
2001; this is an activity
increase of 36.8%. Delix(R)/Tritace(R) is the only ACE inhibitor
indicated for the prevention of stroke, myocardial infarction
and cardiovascular death in patients at risk for cardiovascular
events. Delix(R)/Tritace(R) should be the next drug to reach
annual peak sales of more than euro 1 billion.
* Sales of Amaryl(R) (glimepiride), an oral treatment for type 2
diabetes, totaled euro 478 million in 2001, an activity increase
of 29.6% from 2000. Amaryl (R) offers type 2 diabetes patients
whose blood glucose cannot be controlled by diet and exercise
alone a once-daily oral therapy with 24-hour glucose control.
This drug is the first and only sulfonylurea with three
indications: monotherapy, in combination with insulin, and in
combination with metformin. We are also developing a combination
with Lantus(R), and submission for U.S. and EU approval is
planned for 2003.
* Actonel(R) (risedronate sodium), for the treatment and
prevention of postmenopausal osteoporosis and
corticosteroid-induced osteoporosis, is being co-developed and
co-marketed by Aventis and Procter & Gamble through the Alliance
for Better Bone Health. During 2001, Actonel(R) generated
combined sales for Aventis and Procter & Gamble of euro 309
million, while combined fourth-quarter sales totaled euro 106
million. Actonel(R) was launched in the United States in
mid-2000 and is currently approved in 65 countries, including
the EU. In January 2002, Actonel(R) was also approved in Japan,
which is a US $ 1 billion osteoporosis market and the world's
second-largest after the United States. A once-weekly
formulation of Actonel(R) is currently being reviewed for
approval in the United States and the European Union.
Vaccines business Aventis Pasteur posts sales activity increase
of 28.2%
In 2001, the human vaccines business Aventis Pasteur achieved
above-average growth: Full-year sales rose 28.2% on an activity
basis to euro 1.425 billion, while fourth-quarter sales grew 29%
to euro 384 million. This growth was mainly fueled by the North
American market, where sales activity increased 39.8% to euro
920 million in 2001. Influenza vaccines were particularly
successful, achieving global
annual sales growth of 94% to euro 473 million (includes
non-consolidated sales in Europe through Aventis Pasteur MSD, a
joint venture with Merck & Co.).
Successful launches of new drugs to drive future growth:
Innovative diabetes drug Lantus(R) in U.S. and the antibiotic
Ketek(R) in Europe
In 2001, Aventis launched two innovative drugs with potential
annual peak sales of more than euro 1 billion each:
* Lantus(R) (insulin glargine), is a major advance in the
treatment of type 1 and type 2 diabetes which provides 24-hour
basal insulin coverage with no pronounced peak concentrations in
a once-daily dose. In May 2001, Lantus(R) was successfully
launched in the United States and quickly captured more than
18.9% of new vials dispensed in the long-acting market segment
by year-end. Total sales of Lantus(R) in 2001 -- including
Germany, where the drug was launched mid-2000 -- were euro 94
million.
* As the first ketolide to reach the market, the antibiotic
Ketek(R) (telithromycin) was approved by the European Commission
in July 2001 for the treatment of community-acquired upper and
lower respiratory tract infections, including those caused by
bacteria resistant to some commonly used antibiotics. Launched
in Germany in mid-October, Ketek(R) achieved an impressive
market share of 8% in just eight weeks on the market and has
been considered one of the most successful antibiotic
launches ever in Germany at this early point in its market life.
This innovative drug was also recently launched in two
additional European countries, Spain and Italy, while additional
launches in other European countries are being prepared. In the
U.S., Aventis received an approvable letter in June from the FDA
for various indications. Aventis is working closely with the FDA
to achieve a final approval.
"The strong momentum in our business is apparent. As a result,
we have once again raised the peak sales estimates for our
top-selling products. We could be in a position to have six
blockbuster products within the next five years, from the
current three. In addition, the contributions by our other
strategic brands are becoming more significant. Therefore, we
believe that we can exceed the previously established targets of
strategic brands representing 60% of prescription drugs sales
and generating more than 40% of our pharmaceutical sales in the
United States by 2004," said Igor Landau, the member of the
Management Board of Aventis responsible for the pharmaceutical
business. "Since we are also progressing as expected with
numerous exciting pipeline projects -- coming from our own
research or from partners through strategic in-licensing
agreements -- our target is to achieve double-digit sales growth
beyond 2004," Landau added.
Aventis pipeline positioned to deliver series of therapeutic
innovations
In 2001, the Aventis core business invested euro 2.977 billion
in pharmaceutical research and development (or 16.8% of 2001
core business sales) compared to euro 2.759 billion in 2000.
Aventis is currently moving more than 30 projects through
clinical development to contribute to sustainable long-term
growth.
The focus is on rapidly developing compounds in key therapeutic
areas:
* In cardiovascular disease, the ACE/NEP inhibitor 100240 is
advancing as a potential monotherapy for treatment of both high
blood pressure and congestive heart failure in a single drug,
which could improve efficacy and compliance. This compound
advanced to phase IIb dose-finding for hypertension in 2001, and
submission for U.S. and EU regulatory approval is expected in
2004. Enrollment for a pivotal phase trial is underway for
cariporide, which is being reviewed for its ability to protect
heart muscles from damage during periods of low blood flow. As a
result, cariporide may reduce the risk of heart attack or death
in patients undergoing coronary artery bypass graft surgery. A
filing for U.S. and EU regulatory approval is expected in 2003.
* Aventis is also pressing ahead to expand its diabetes
franchise. Exubera (TM)(inhaled insulin)is a breakthrough
approach to delivering insulin in a dry powder formulation by
inhalation. It is being developed for patients with type 1 and
type 2 diabetes through a collaboration between Aventis and
Pfizer. Exubera(TM) has completed phase III trials and
submission for U.S. and EU approval is under review. Another
important compound intended to expand the range of diabetes
products is 1964, a fast-acting insulin for type 1and type 2
diabetes. Phase III clinical trials began in the summer 2001.
* The oncology pipeline of Aventis includes flavopiridol, an
innovative chemotherapy agent that seeks to reduce the speed at
which tumor cells multiply. Flavopiridol may also increase the
sensitivity of tumors to classic chemotherapy agents. Submission
for U.S. and EU approval is expected in 2003. Also in
development are LIT-976, a new formulation of Taxotere(R)
expected to be highly effective in key tumor types, and Taxoid
109881 that holds promise for treatment of brain metastases and
taxane-resistant tumors. Both compounds are currently in phase
II.
In-licensing and alliances complement growth potential of
Aventis pipeline
In addition to bringing its own therapeutic innovations to the
market, Aventis is an attractive partner for R&D alliances,
licensing and co-commercialization agreements with biotechnology
companies, other pharmaceutical companies and scientific
institutions looking for a powerful international development
and marketing partner.
Aventis has signed several co-development and marketing
agreements during 2001, including the following:
* In March, Aventis and Byk Gulden, now known as Altana Pharma,
agreed to jointly develop ciclesonide for treatment of asthma.
This compound is being developed as an inhaled corticosteroid
and is expected to be submitted for U.S. regulatory approval in
2003.
* Also in April, Aventis agreed with Asta Medica to co-develop
and co-market dexlipotam, which is currently in phase II
development for the treatment and prevention of the consequences
of diabetes, diabetic late complications and related metabolic
diseases.
* In September, Aventis and ViroPharma Inc. formed a
collaboration to co-develop and co-promote Picovir(TM)
(pleconaril) in the United States. Picovir(TM) is a
first-of-a-kind oral antiviral product being studied for the
treatment of the common cold (viral respiratory infection --
VRI). ViroPharma submitted a new drug application to the U.S.
Food and Drug Administration on July 31, 2001, which was
accepted for review on October 1, 2001, seeking approval for the
use of Picovir(TM) to treat VRI in adults.
* In 2001, the joint development alliance between Aventis and
Millennium Pharmaceuticals Inc. expanded their cooperation in
inflammatory diseases to include 11 discovery projects
previously being pursued separately. The alliance now has
approximately 50 jointly funded discovery projects for the
potential treatment of inflammatory diseases in five major
areas: asthma, chronic obstructive pulmonary disease, rheumatoid
arthritis, inflammatory bowel disease and multiple sclerosis. A
goal has been set to move one or more compounds into human
clinical trials as early as the first half of 2003.
Therapeutics proteins business still affected by supply-chain
problems
Sales activity of the therapeutic proteins business declined by
1.7% to euro 1.129 billion as the business was still affected by
ongoing supply-chain problems for Helixate(R) FS/NexGen, which
is manufactured by a third party. Helixate(R) FS/NexGen is an
enhanced recombinant product for the treatment of hemophilia A
that received regulatory approval in the U.S. and EU in
mid-2000. Total sales of plasma-derived products rose by 6%,
driven by an increase of 25% in Factor VIII replacement
therapies for the treatment of hemophilia A due to higher
manufacturing output and a growth of 11% in sales of immune
globulins.
In 2001, sales by the animal health business Merial -- a 50-50
joint venture with Merck & Co. Inc. accounted for using the
equity method -- rose 7.1% on an activity basis to euro 1.853
billion. Sales by Merial are not consolidated by Aventis.
Divestment of non-core activities to be completed in early 2002
In 2001, Aventis made significant progress in completing the
transformation to focus on its core pharmaceutical business by
divesting non-core activities:
* Allianz Capital Partners and Goldman Sachs Funds agreed on
December 31, 2000 to acquire from Aventis the 66.7% stake in
industrial gases group Messer Griesheim GmbH, which Aventis
holds through Hoechst AG. This transaction closed in April 2001.
* In October,
Aventis and Schering AG agreed with Bayer AG on the divestment
of Aventis CropScience. The transaction, which is currently
being reviewed by the relevant authorities, is expected to close
during the first months of 2002. Despite a challenging market
environment and
the announced divestment process, Aventis CropScience achieved a
7.9% increase in sales activity to euro 4.303 billion. Among the
fastest-growing markets for CropScience in 2001 was France with
sales of 535 million (+ 9% on activity basis), Brazil with sales
of 475 million (+13% on activity basis) and Canada with sales of
euro 177 million (+18.4%). All key businesses contributed to the
above-average growth: Crop Protection increased its sales by
7.2% on activity basis, Environmental Science by 24.6% and
BioScience by 8.6%. Before restructuring charges, full-year
EBITA rose 34% to euro 706 million compared to the year-ago
period.
* In mid-November, Aventis and CVC Capital Partners signed an
agreement on the acquisition of Aventis Animal Nutrition, which
contributed annual sales of euro 572 million. Subject to the
required approval processes, the closing of the transaction is
expected in early 2002.
In total, non-core activities generated sales of euro 5.311
billion in 2001 compared to euro 6.288 billion in 2000. This
decrease was mainly attributable to the divestment of the
industrial gases business Messer as well as the more
difficult business environment for the remaining industrial
activities. For the full year, the non-core activities
contributed an EBITA of euro 513 million compared to euro 714
million.
The proceeds from divestments in combination with the
deconsolidation of debt associated with the divested businesses
led to a reduction in net debt to euro 9.196 billion at the end
of 2001 compared to euro 13.133 billion at the end of 2000.
After the completion of the ongoing and planned divestment
processes by the end of 2002, Aventis would have approximately
euro 3 billion in debt. This foreseeable reduced net debt of
Aventis will lead to additional flexibility for the future
development of the pharmaceutical business, such as targeted
acquisitions and in-licensing of promising compounds.
Merger-related synergies were successfully realized since
formation of Aventis
At the end of 2001, the Aventis core businesses had realized
combined cumulative synergies of euro 660 million, while Aventis
CropScience has achieved cumulative synergies of euro 270
million since the beginning of 2000. With the transformation
into a pure pharmaceutical company in 2002, the reporting of
merger-related synergies will end, since more than 80% of the
total cost savings, which were expected by the time of the
merger, had been realized by the end of 2001.
Employees
On December 31, 2001, Aventis had 91,729 employees worldwide
(92,446 at the end of 2000). This figure comprises the permanent
and temporary staff of our core businesses with 74,931 employees
worldwide (75,174 at year-end 2000) and 16,798 employees in
non-core activities (17,272 at year-end 2000).
Aventis (NYSE: AVE) is dedicated to improving life through
the discovery and development of innovative pharmaceutical
products. Corporate headquarters are in Strasbourg, France.
|