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Sanofi-aventis Announces Good First-quarter 2009 Performance

Posted on: Wednesday, 29 April 2009, 07:08 CDT

PARIS, April 29 /PRNewswire-FirstCall/ --

Change at Change on a constant Q1 2009 reported exchange ------- basis rates Net sales euro 7,107m +2.5% -0.2%* Adjusted net income excluding selected items euro 2,178m +15.7% +8.7% Adjusted EPS excluding Selected items euro 1.67 +16.8% +9.8%

*Change mainly impacted (-3.3%) by the end of commercialization by sanofi-aventis of Copaxone(R) in North America effective April 1, 2008; this has no impact on net income. On a constant structure basis and at constant exchange rates, net sales rose by 3.5%.

In order to facilitate an understanding of our operational performance, we comment on our adjusted income statement excluding selected items, a non-GAAP financial measure. Consolidated net income for the first quarter of 2009 was euro 1,578 million, compared with euro 1,325 million for the first quarter of 2008.

Good performance in the first quarter of 2009:

• EPS(1) up 9.8% at constant exchange rates and up 16.8% on a reported basis
• Sales growth(2) driven by a strong performance from our flagship products - Lantus(R) (up 27.1%), Taxotere(R) (up 8.3%), Aprovel(R) (up 11.1%) - and from vaccines (up 9.1%). Robust growth in the worldwide presence of Plavix(R) (up 8.6%)
• Sales up 5.1%(3) in the United States, 8.0% in emerging markets and 13.8% in Japan
• Continuing tight control over industrial and operating costs
• Cash flow for the quarter sufficient to fund the acquisition of Zentiva and a reduction in net debt from euro 1.8bn to euro 1.2bn
• Recommendation by the FDA Advisory Committee for approval of Multaq(R)

Transformation of sanofi-aventis

• Significant boost to our generics business, with 2008 proforma net sales of approximately euro 1.2 billion due to the acquisitions of Zentiva, Medley and Kendrick
• Updating of our R&D portfolio: refocusing on the most promising projects, and acceleration of external R&D alliances
• Acquisition of BiPar Sciences, Inc., strengthening our oncology R&D portfolio with the addition of the PARP inhibitor BSI-201 and demonstrating our strong commitment in oncology

2009 Guidance reiterated

• Sanofi-aventis confirms its expectations for growth in 2009 adjusted EPS excluding selected items of at least 7% at constant exchange rates, barring major adverse events

(1) Adjusted EPS excluding selected items

(2) Growth in net sales is expressed at constant exchange rates unless otherwise indicated

(3) Growth in net sales expressed on a constant structure basis and at constant exchange rates

First-quarter 2009 sales

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates

Sanofi-aventis generated first-quarter net sales of euro 7,107 million, up 2.5% on a reported basis. Exchange rate movements had a net favorable effect of 2.7 points, reflecting the appreciation of the dollar against the euro, which largely compensated for the negative effect of some other currencies. At constant exchange rates and after taking account of changes in structure (in particular the end of commercialization by sanofi-aventis of Copaxone(R) in North America effective April 1, 2008), net sales slightly fell by 0.2%. Excluding changes in structure and at constant exchange rates, net sales rose by 3.5%.

Pharmaceuticals

First-quarter net sales for the Pharmaceuticals business were euro 6,480 million, down 1.0% (but up 3.0% on a constant structure basis and at constant exchange rates).

Flagship products

euro million Q1 2009 Change at net constant sales exchange rates Lovenox(R) 762 +1.3% Lantus(R) 747 +27.1% Plavix(R) 685 +3.6% Taxotere(R) 534 +8.3% Eloxatin(R) 344 -7.0% Aprovel(R) 314 +11.1% Apidra(R) 31 +42.9%

Net sales of Lovenox(R), the leading low molecular weight heparin on the market, rose by 1.3% to euro 762 million. This modest performance was largely due to abnormally high sales (up 23.3%) in the United States during the first quarter of 2008, when wholesalers placed large orders for the product in response to the withdrawal from the market of some unfractionated heparins. In Europe, Lovenox(R) achieved growth of 5.1% to euro 217 million. In March 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a guideline on pre-clinical and clinical development of biosimilars of low molecular weight heparins. This means that in Europe, a potential product candidate claiming to be biologically similar to Lovenox(R) must show therapeutic equivalence in terms of efficacy and safety in at least one adequately powered, randomized, double-blind, parallel group clinical trial. In the United States, no biosimilar of Lovenox(R) is approved at this point in time.

Lantus(R), the world's leading insulin brand, again reported strong growth (27.1%), driven by the Lantus(R) SoloSTAR(R) injection pen. Lantus(R) achieved significant growth in all three regions: 30.3% in the United States, 14.9% in Europe, and 43.5% in Other Countries. This performance keeps sanofi-aventis on track for achieving its goal of doubling net sales of Lantus(R) by 2012 (relative to the 2008 figure). On April 21, 2009, sanofi-aventis announced that it was making a new investment in China to produce Lantus(R) SoloSTAR(R) locally, in order to meet growing demand in the Chinese market and improve the treatment of diabetes in China.

Net sales of the rapid-acting insulin analog Apidra(R) rose by 42.9% to euro 31 million. In February, the FDA approved Apidra(R) SoloSTAR(R). This means that patients in the United States who use both Lantus(R) and Apidra(R) to help manage their blood sugar (basal-prandial insulin regimens) can now use one pen delivery device for each product, making administration of their insulins more convenient. Apidra(R) and Apidra(R) SoloSTAR(R) were approved in Japan on April 22, 2009.

Boosted by its use in adjuvant breast cancer treatment and in prostate cancer, Taxotere(R) performed well, especially in Europe and Other Countries, where sales rose by 8.1% (to euro 231 million) and by 18.9% (to euro 106 million) respectively. In Japan, net sales of the product were up 15.2% at euro 30 million, notably due to the prostate cancer indication approved in the second half of 2008. In the United States, the product posted 2.9% growth in net sales to euro 197 million.

Net sales of Eloxatin(R), the leading cytotoxic agent in the colorectal cancer market as an adjuvant and as first line treatment in the metastatic phase, were up 3.0% at euro 266 million in the United States, where growth for the product continues to be driven mainly by its indication as an adjuvant in colorectal cancer. In Europe, sales of the product continued to fall due to competition from generics, with net sales for the quarter totaling euro 31 million.

Worldwide presence of Plavix(R)/Iscover(R)

In the United States, sales of Plavix(R), which are consolidated by Bristol Myers Squibb (BMS), recorded strong growth of 13.6%. In Europe, sales held steady despite competition from clopidogrel besylate in the monotherapy segment in Germany, where Plavix(R)/Iscover(R) still had volume market share of around 70% in March 2009 (IMS Pharmatrend: week ending March 27, 2009). The success enjoyed by Plavix(R) in Japan continued, with net sales up 90.2% at euro 70 million.

euro million Q1 2009 Change Europe 446 +0.2% United States 987 +13.6% Other Countries 266 +8.2% TOTAL 1,699 +8.6%

On March 31, 2009, findings from the ACTIVE-A study were presented at the American College of Cardiology Scientific Sessions. The findings demonstrated that for patients with atrial fibrillation who were at increased risk of stroke and could not take oral anticoagulant medication, Plavix(R) plus aspirin significantly reduced major vascular events by 11% over aspirin (6.8% vs. 7.6%, per year, p=0.01). The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs. 3.3% per year, p<0.001), which is the primary goal of physicians treating patients with atrial fibrillation. Filing for approval is scheduled for the third quarter of 2009.

Worldwide presence of Aprovel(R)/Avapro(R)/Karvea(R)

euro million Q1 2009 Change at constant exchange rates Europe 248 +4.1% United States 132 -0.8% Other Countries 127 +18.5% TOTAL 507 +6.1%

Aprovel(R) reported growth of 18.5% in Other Countries region due to sales of active ingredient to our Japanese partners. In the United States, the product continued to face a highly competitive environment. In Europe, Aprovel(R) posted 4.1% growth. During the quarter, irbesartan generics began to be marketed in the monotherapy segment in Spain and Portugal. In both these countries, as well as in Finland, Norway and some Eastern European countries, irbesartan is not protected by an active ingredient patent. In the main European countries, Aprovel(R) is protected by an active ingredient patent through August 2012. Net sales of Aprovel(R) as a monotherapy in European countries with no active ingredient patent were approximately euro 50 million in 2008.

Other products

In the United States, net sales of the hypnotic Ambien(R) CR fell by 7.1% to euro 128 million. In Japan, Myslee(R), the leading hypnotic on the market, posted further strong growth as net sales advanced by 30.2% to euro 44 million.

Net sales of Allegra(R) were up 3.0% at euro 251 million, thanks to a good performance in Japan.

The end of commercialization of Copaxone(R) by sanofi-aventis in North America effective April 1, 2008 led to a 63.7% fall in net sales of this product at constant exchange rates, to euro 113 million. On a constant structure basis and at constant exchange rates, net sales of the product rose by 21.1%.

OTC

First-quarter net sales for the OTC business were up 9.9% (2.3% on a constant structure basis and at constant exchange rates) at euro 378 million.

The six flagship brands (Doliprane(R), Essentiale(R), Maalox(R), No-Spa(R), Enterogermina(R), Lactacyd(R)) posted robust growth of 10.4%, and accounted for 44% of total OTC sales.

Generics

First-quarter net sales for the generics business were up 18.3% at euro 93 million. These figures do not include net sales from Zentiva, Medley or Kendrick.

Human Vaccines

First-quarter consolidated net sales for the Human Vaccines business were up 9.1% at euro 627 million. Net sales in the United States were 2.6% higher at euro 352 million.

Polio/Pertussis/Hib Vaccines recorded sales growth of 33.9%, boosted by the success of Pentacel(R), the first 5-in-1 pediatric combination vaccine against diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b to be licensed in the United States. Launched in the United States in July 2008, Pentacel(R) achieved net sales of euro 73 million in the first quarter of 2009. Pentaxim(R) continued to perform well in Other Countries, with net sales up 48.2% at euro 39 million.

Net sales of influenza vaccines rose sharply by 44.4% to euro 63 million due to the favorable timing of shipments, which were mainly concentrated in the first quarter in the southern hemisphere.

Net sales of meningitis/pneumonia vaccines amounted to euro 116 million. Net sales of Menactra(R) (quadrivalent meningococcal meningitis vaccine) were down 13.2% at euro 96 million due to a shrinking catch-up opportunity in the adolescent segment of the market. Filing for U.S. approval of Menactra(R) Toddler (for children aged 9 to 12 months) is scheduled for the summer of 2009.

Adult booster vaccines reported net sales of euro 96 million, down 12.7%, including euro 61 million for the adult and adolescent tetanus-diphtheria-pertussis booster Adacel(R).

euro million Q1 2009 Change at net constant sales exchange rates Polio/Pertussis/Hib Vaccines (including Pentacel(R) and Pentaxim(R)) 236 +33.9% Influenza Vaccines* (including Vaxigrip(R) and Fluzone(R)) 63 +44.4% Meningitis/Pneumonia Vaccines (including Menactra(R)) 116 -9.5% Adult Booster Vaccines (including Adacel(R)) 96 -12.7% Travel & Other Endemics Vaccines 77 -3.8% Other vaccines 39 0.0% TOTAL 627 +9.1% * Seasonal and pandemic influenza vaccines

First-quarter sales at Sanofi Pasteur MSD (not consolidated by sanofi-aventis), the joint-venture with Merck & Co in Europe, were down 8.7% on a reported basis at euro 254 million. Gardasil(R), the first vaccine licensed in Europe against papillomavirus infection (a major cause of cervical cancer), were 25.6% lower at euro 121 million, with the extensive catch-up vaccination campaigns when the product was first launched creating a high comparative base. Excluding Gardasil(R), the rest of the portfolio achieved growth of 14.9%, driven by pediatric combination vaccines in the United Kingdom. In February, the European Commission granted marketing authorization for Intanza(R), the first influenza vaccine to be administered using a novel intradermal microinjection system. The benefits of this vaccine, in particular its convenience and ease of administration, should help improve vaccination coverage in Europe.

Net sales by geographic region

euro million Change at constant Q1 2009 exchange net sales rates Europe 2,948 -0.9% of which Eastern Europe 360 +15.8% United States 2,295 -5.1% Other Countries 1,864 +7.6% of which Japan 510 +13.8% of which Asia-Pacific 505 +12.8% of which Latin America 389 +5.7% TOTAL 7,107 -0.2%

Net sales in Europe were stable on a constant structure basis and at constant exchange rates despite competition from generics of Eloxatin(R). Eastern Europe is still the main growth driver, with net sales up 15.8%.

In the United States, the end of commercialization of Copaxone(R) by sanofi-aventis effective April 1, 2008 resulted in a 5.1% drop in net sales at constant exchange rates. On a constant structure basis and at constant exchange rates, net sales rose by 5.1% on the back of an excellent performance from Lantus(R), despite destocking of some products in distribution channels.

Net sales for Other Countries region rose by 7.6%, boosted by the performance of the Human Vaccines business and by Japan. Growth in the Asia-Pacific region was 12.8%, boosted by a fine performance in China (29.8% growth). Net sales in Japan were up 13.8% at euro 510 million, driven by the success of Plavix(R), Myslee(R) and Allegra(R). Latin America posted growth of 5.7%. The Vaccines business achieved growth of 16.8% in the Other Countries region, to euro 216 million.

First-quarter 2009 financial results

Adjusted income statement excluding selected items

Sanofi-aventis generated first-quarter net sales of euro 7,107 million, an increase of 2.5% on a reported basis. Other revenues were 21.1% higher, driven by a good performance from Plavix(R) in the United States and the appreciation of the dollar.

Gross profit totaled euro 5,684 million, up 6.6% (2.4% at constant exchange rates). The ratio of cost of sales to net sales improved by 2.4 points to 24.8% due to a favorable product mix (amplified by the rise in the dollar), and to the end of the commercialization of Copaxone(R) in North America.

Research and development expenses were up 5.8% (2.8% at constant exchange rates) at euro 1,152 million. This figure includes provisions of euro 54 million associated with the discontinuation of some projects following the recently-completed review of the R&D portfolio.

Selling and general expenses were 2.9% lower (5.6% at constant exchange rates), at euro 1,732 million. The ratio of selling and general expenses to net sales was 24.4%, versus 25.7% for the first quarter of 2008, due to the ongoing measures taken by sanofi-aventis to adapt to market conditions and the end of the commercialization of Copaxone(R) in North America.

Other current operating income and expenses showed net income of euro 148 million, against net income of euro 104 million in the first quarter of 2008. The 2009 figure includes the payment by Teva of a fee equal to 25% of the North American sales of Copaxone(R).

Operating income - current(1) was up 14.9% at euro 2,898 million. At constant exchange rate, the growth rate was 8.6%. The ratio of operating income - current to net sales improved by 4.4 points to 40.8%.

Net financial expenses were euro 44 million, against euro 17 million for the first quarter of 2008 (which included a gain on currency hedging). Interest expense on debt was euro 26 million, lower than the 2008 first-quarter figure of euro 44 million. Sanofi-aventis acquired Zentiva shares related to the public offer on March 11, 2009 for euro 1,197 million.

The effective tax rate was down 0.6 of a point at 29%, and was in line with the 2008 full-year figure.

The share of profits from associates was up 16.7% at euro 273 million. The share of after-tax profits from territories managed by BMS under the Plavix(R) and Avapro(R) alliance was 28.1% higher at euro 187 million, due to a good performance from Plavix(R) in the United States and a favorable dollar effect.

Minority interests increased by 5.2% to euro 121 million. The share of pre-tax profits paid to BMS from territories managed by sanofi-aventis rose by 3.6% to euro 115 million.

Adjusted net income excluding selected items(1) was euro 2,178 million, up 15.7% (8.7% at constant exchange rate). The ratio of adjusted net income excluding selected items(1) to net sales improved by 3.5 points to 30.6%.

Adjusted earnings per share (EPS) excluding selected items was euro 1.67. This represents growth of 16.8% versus the 2008 first-quarter figure of euro 1.43, or 9.8% growth at constant exchange rates.

Selected Items

Selected items represented a net loss of euro 18 million for the quarter, compared with a net loss of euro 20 million for the first quarter of 2008. The 2009 first-quarter figure comprises:

• euro 8 million of restructuring costs arising on adaptation measures initiated in 2008 in Europe;
• euro 20 million of impairment losses arising from the decision to halt the development of TroVax(R);
• net of the euro 10 million tax effect on the selected items described above.

Adjustments in the consolidated financial statements to reflect the application of purchase accounting to acquisitions, primarily that of Aventis

Research and Development

Review of the R&D portfolio

We have just completed a comprehensive and rigorous review of our R&D portfolio, the first critical phase in the transformation of our Research & Development effort. This was an objective exercise, performed by a mix of in-house teams and external consultants. Our project reassessment process looked not only at scientific and medical criteria (in particular, the degree of innovation) but also at commercial, regulatory and market access criteria (such as the extent of patient needs, the expected value of each project, and the commercial risk). This review has enabled us to refocus our portfolio on the most promising projects and to reallocate resources to external R&D alliances. The following decisions have been taken:

• In Phase III, saredutant is discontinued on the basis of results from the study in association with escitalopram in depression, AVE5530 is halted in hypercholesterolemia due to insufficient efficacy, and the rights to TroVax(R) are returned to Oxford BioMedica. As regards vaccines, resources in the intercontinental zone will be reallocated to the hexavalent vaccine Hexaxim(R) (DTP-HepB-Polio-Hib), with the Unifive(TM) pentavalent project (DTP-HepB-Hib) discontinued.
• In Phase II, we have halted the development of AVE0657 in sleep apnea, SSR180575 in diabetic polyneuropathy, AVE1642* (an anti-IGF 1) in oncology, and the melanoma vaccine.
• We have also halted six projects that were in Phase I.

In addition, we will decide in the next few months whether or not to continue developing four products (AVE1625, xaliprodene, idrabiotaparinux and West Nile virus vaccine), primarily on the basis of results from clinical trials currently under way.

Following this review, our portfolio now comprises 51 projects in clinical development (New Molecular entities and vaccines), of which 21 are either in Phase III or have been submitted for regulatory approval. Vaccines represent 35% of the total, other biological products 14%, and external collaborations 27%.

* Rights returned to Immunogen, Inc.

Main developments in the R&D portfolio

The main developments in our R&D portfolio in the first quarter of 2009 are described below.

• On March 18, 2009, the FDA Advisory Committee recommended approval of Multaq(R) to treat patients with atrial fibrillation. A new drug application is currently being reviewed in the European Union. The ATHENA study was published in the New England Journal of Medicine in February 2009.
• Based on the findings of the ACTIVE-A study presented at the American College of Cardiology Scientific Sessions in March, we are planning to file an application to extend the indication of Plavix(R) to atrial fibrillation in the third quarter of 2009.
• Three new candidates have entered clinical development:

-- BSI-201, a PARP inhibitor, has entered our portfolio following the acquisition of BiPar Sciences. This product could be a potential first-in-class PARP inhibitor, and is currently in phase II clinical trials for the treatment of triple-negative metastatic breast cancer, ovarian cancer, and other types of cancer. The results of the triple-negative metastatic breast cancer Phase II trial will be presented at a plenary session of the Congress of the American Society of Clinical Oncology (ASCO). -- Two products have entered Phase I: SAR 110894, an H3 receptor antagonist developed for Alzheimer's disease, and an anti-NGF monoclonal antibody developed in collaboration with Regeneron for pain relief.

• Two new applications for marketing approval have been filed with the regulatory authorities: the Plavix(R)/ Aspirin combination in the European Union, and the new influenza vaccine formulation (high dose Fluzone(R)) in the United States.
• Five new drug applications have been approved:

-- the Apidra(R) SoloSTAR(R) pen in the United States, and Apidra(R) and Apidra(R)SoloSTAR(R) in Japan; -- Lovenox(R) in Japan, for the prevention of venous thromboembolic events after abdominal surgery; -- the intradermal influenza vaccine Intanza(R) in Europe, and the pandemic influenza vaccine Emerflu(R) in Australia.

Acquisitions

During the first quarter of 2009, sanofi-aventis completed the offer on Zentiva, which will provide a platform for growth in branded generics in Central and Eastern Europe, Turkey, and Russia. Zentiva is fully consolidated by sanofi-aventis from March 31, 2009.

In addition to Zentiva, the generics business has been further strengthened in April 2009 by the completion of the acquisitions of Kendrick (one of Mexico's leading generics manufacturers) and Medley (Brazil's third-largest pharmaceutical company and no.1 generics manufacturer).

On a 2008 proforma basis, these three acquisitions take net sales from generics to approximately euro 1.2 billion, compared with euro 349 million in 2008. These deals are in line with the strategy of reinforcing our presence in branded generics and expanding our product portfolio in emerging markets, which are characterized by strong growth, low or average disposable incomes, and competitively-priced pharmaceutical products.

Sanofi-aventis has recently acquired BiPar Sciences, Inc., a privately held U.S. biopharmaceutical company which is developing novel tumor-selective approaches for the treatment of different types of cancers. Under the terms of the agreement, the purchase consideration will be contingent on milestone payments linked to the development of BSI-201, but will not exceed $500 million.

Net debt

Sanofi-aventis generated a high level of cash flow from operations in the first quarter of 2009 (euro 2,755 million), more than adequate to finance capital expenditure of euro 392 million and acquisitions of euro 1,851 million (mainly Zentiva, including net debt of euro 551 million). Free cash flow for the quarter was euro 544 million, allowing sanofi-aventis to reduce the level of net debt from euro 1,780 million at December 31, 2008 to euro 1,236 million at March 31, 2009.

2009 Guidance

Thanks to a good first-quarter performance, Sanofi-aventis confirms its 2009 full-year guidance. For the current year, sanofi-aventis expects growth in adjusted EPS excluding selected items(1) of at least 7% at constant exchange rates, barring major adverse events.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, www.sanofi-aventis.us or www.sanofi-aventis.com

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include financial projections and product development projections, estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things the uncertainties inherent in research and development; future clinical data and analysis both before and after marketing approval; decisions by regulatory authorities such as the FDA or the EMEA regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidate, and decisions by such authorities regarding labeling and other matters that could affect the availability or commercial potential of such product candidates; the lack of any assurance that any product candidates that are approved will be successful commercially; the future approval and commercial success of therapeutic alternatives; and those risks and uncertainties discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008.

Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Contact: Jean-Marc Podvin, jean-marc.podvin@sanofi-aventis.com, Phone : (33) 1.53.77.42.23

SOURCE Sanofi-aventis

Source: PR Newswire

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