Aventis reports full-year results for 2001

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.

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