Sanofi-Aventis (France) Delivers a Solid Performance in Third Quarter 2009

BRIDGEWATER, N.J., Oct. 30 /PRNewswire-FirstCall/ --

In order to facilitate an understanding of our operational performance, we comment on our adjusted income statement excluding selected items(1), a non-GAAP financial measure. The consolidated income statement for the first 9 months of 2009 is provided in Appendix 6, as are details of adjustments and selected items. Consolidated net income for the first 9 months of 2009 was euro 4,056 million, compared with euro 3,669 million for the first 9 months of 2008. Consolidated earnings per share for the first 9 months of 2009 was euro 3.11, versus euro 2.80 for the first 9 months of 2008.

Third-quarter performance(2) buoyed by key growth drivers

Solid quarterly results and 2009 full-year guidance updated

Ongoing transformation of sanofi-aventis

Commenting on the Group's 2009 third-quarter performance, sanofi-aventis Chief Executive Officer Christopher A. Viehbacher said:

"We pursued our transformation strategy in the third quarter, reinforcing our platforms for growth and forging ahead with our policy of R&D alliances and targeted acquisitions. As promised, we have mobilized substantial resources on the production of A/H1N1 vaccines."

(1) See Appendix 7 for definitions of financial indicators, and details of selected items;

(2) Growth in net sales is expressed at constant exchange rates unless otherwise indicated (see Appendix 7 for a definition)

2009 third-quarter and 9-month net sales

Unless otherwise indicated, all sales growth figures in this press release are stated at constant exchange rates(1).

In the third quarter of 2009, sanofi-aventis generated net sales of euro 7,400 million, up 8.0% on a reported basis. Exchange rate movements had a favorable effect of 2.0 percentage points, with the appreciation of the U.S. dollar (and to a lesser extent the yen) against the euro more than offsetting the unfavorable effects of some other currencies. At constant exchange rates, and after taking account of changes in structure (in particular the consolidation of Zentiva and Medley), net sales rose by 6.0%. Excluding changes in structure and at constant exchange rates, third-quarter organic net sales growth was 3.2%.

Net sales for the first nine months of 2009 were 7.2% higher at euro 21,945 million. Exchange rate movements, primarily the appreciation of the U.S. dollar against the euro, had a favorable effect of 3.1 percentage points. At constant exchange rates, and after taking account of changes in structure (primarily the consolidation of Zentiva and Medley in the second quarter, and the end of commercialization of Copaxone(R) by sanofi-aventis in North America effective April 1, 2008), net sales rose by 4.1%. Excluding changes in structure and at constant exchange rates, organic net sales growth over the first 9 months of 2009 was 3.5%.

Pharmaceuticals

Third-quarter net sales for the Pharmaceuticals business were up 6.2% at euro 6,354 million. Over the nine months to end September, Pharmaceuticals net sales rose by 4.0% to euro 19,560 million.

Flagship products(4)

The strong pace of growth for Lantus(R), the world's leading insulin brand, continued in the third quarter of 2009; net sales were up 21.7% at euro 778 million, boosted by the SoloSTAR(R) injection pen. The product reported strong growth across all three regions: 21.3% in the United States (to euro 478 million), 11.4% in Europe (to euro 189 million) and 48.6% in the Other Countries region (to euro 111 million). Taking into account the performance over the first 9 months of the year (net sales of euro 2,317 million, a rise of 24.9%), Lantus(R) has become the Group's best-selling product in terms of consolidated net sales.

ClikSTAR(R), a new reusable pen for the administration of Lantus(R) and/or Apidra(R), is now available in some European Union countries and in Canada. With the launch of ClikSTAR(R) to complement SoloSTAR(R), sanofi-aventis now offers a full range of injection pens that make it easier for patients to use insulin. ClikSTAR(R) is currently being evaluated by the United States Food and Drug Administration (FDA).

(4) See Appendix 2 for a geographical split of consolidated net sales by product.

Various results from studies of Lantus(R) were presented at the annual meeting of the European Association for the Study of Diabetes (EASD) in September 2009, in particular results from a comparative study that once again demonstrated the efficacy of the 24-hour long-acting basal insulin Lantus(R) administered by daily injection, versus insulin detemir administered by twice-daily injection.

In October 2009, the FDA approved the inclusion in the Lantus(R) labeling of favorable results from a 5year study comparing the effect of Lantus(R) with that of NPH insulin on the progression of retinopathy in patients with type 2 diabetes.

The rapid-acting insulin analog Apidra(R) recorded a 32.0% rise in third-quarter net sales to euro 34 million. Net sales of the product for the nine months to end September were up 42.6% at euro 100 million.

Third-quarter net sales of Lovenox(R), the leading low molecular weight heparin on the market, rose by 13.7% to euro 747 million, driven by strong growth in Europe (+23% at euro 220 million) and in the Other Countries region (+19.2% at euro 85 million). Over the nine months to end September, net sales of the product advanced by 9.1% to euro 2,289 million. No biosimilar of Lovenox(R) has been approved in the United States to date.

Taxotere(R) reported third-quarter net sales of euro 526 million, up 1.4%. Demand for the product remains strong, but sales growth was impacted by fluctuations in inventory levels between the third quarter of 2009 and the third quarter of 2008. In Europe, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new single vial formulation of Taxotere(R). Over the nine months to end September, the product posted a 6.8% rise in net sales, to euro 1,644 million. In October, sanofi-aventis submitted a request for marketing approval in Europe for Taxotere(R) as an adjuvant treatment for early stage breast cancer without lymph node Involvement.

Net sales of Eloxatin(R) in the third quarter were euro 193 million, down 44.3%, reflecting the entry of a number of generics into the U.S. market during August 2009, which negatively impacted the product's U.S. sales by 53.0% to euro 122 million. In Europe, competition from generics is ongoing, with net sales down 55.1% at euro 22 million. In the Other Countries region however, the product achieved growth of 16.7% (net sales: euro 49 million). On September 10, 2009, the U.S. Court of Appeals for the Federal Circuit reversed the summary judgment against sanofi-aventis delivered by the District Court for the District of New Jersey, and referred the case back to the District Court. In light of this judgment, sanofi-aventis has petitioned the District Court for a preliminary injunction to suspend the sale of generics in the United States pending settlement of the patent litigation.

Marketing of Multaq(R), the first anti-arrhythmic with a clinical benefit in reducing cardiovascular hospitalization in patients with atrial fibrillation to be approved, began in the United States on July 28. The promotional material was approved by the FDA Division of Drug Marketing, Advertising and Communication (DDMAC) in September, and is now available for use by our sales forces. Initial indications are very encouraging, in terms both of the level of new prescriptions and the response of prescribers to the product. After eight weeks on the market, over 19,000 prescriptions have been written by around 4,500 physicians. Some regional insurance plans have already granted reimbursement, and Managed Care coverage is set to expand over the next three months thanks to the solid pharmaco-economic case for the product. Third-quarter net sales of Multaq(R) amounted to euro 13 million.

On September 25, 2009, sanofi-aventis announced that the CHMP had issued a positive opinion recommending the granting of marketing authorization for Multaq(R) in the European Union. This positive opinion now needs to be ratified by the European Commission. In addition, Multaq(R) was authorized in Switzerland on September 25, and has been available in Canada since September 28.

Worldwide presence(1) of Plavix(R)/Iscover(R)

Third-quarter sales of Plavix(R) rose by 6.3%, driven by good performances in the United States (up 11.3%, net sales consolidated by Bristol Myers Squibb) and the Other Countries region (up 15.6%). In Europe, the product is facing competition from generics using clopidogrel with a different salt from that used by Plavix(R) (clopidogrel hydrogen sulphate), especially in the United Kingdom and Germany, and sales fell by 7.8%. In Germany, the market share of Plavix(R)/Iscover(R) by volume was around 55% (IMS Pharmatrend, week of September 21, 2009), with alternative salts of clopidogrel granted an extension to their indication during the quarter.

In Japan, Plavix(R) performed particularly well in the quarter, with net sales up 50.3% at euro 82 million.

Sales of Plavix(R) for the nine months to end September rose by 8.1% to euro 5,168 million, with Japanese sales up 64.2% at euro 237 million.

In Europe, various generics of Plavix(R) obtained marketing authorization during the third quarter, in particular alternative salts of clopidogrel such as besylate. In some countries, additional time is required for pricing and reimbursement procedures before these generics can be marketed. In France, sanofi-aventis responded to the marketing authorizations granted by the European and French healthcare authorities for alternative salts of clopidogrel by deciding in early October to make an identical copy of Plavix(R) available in France, the generic Clopidogrel Winthrop(R) (clopidogrel hydrogen sulphate).

Worldwide presence of Plavix(R)/Iscover(R): geographic split

Worldwide presence(1) of Aprovel(R)/Avapro(R)/Karvea(R)

Net sales of Aprovel(R) held steady in the third quarter, in a competitive environment. In Europe, where the product is facing competition from generics in monotherapy in Spain and Portugal, sales rose by 0.4%. Over the nine months to end September, the product reported sales growth of 1.2%.

Worldwide presence of Aprovel(R)/Avapro(R)/Karvea(R): geographic split

(1) See Appendix 7 for definitions of financial indicators

Other Pharmaceutical Products

In the United States, net sales of the hypnotic Ambien(R) CR were flat in the third quarter (euro 124 million, down 0.6%), but grew by 0.5% over the first nine months of 2009 to euro 381 million. In Japan, third-quarter net sales of Myslee(R), the leading hypnotic on the market, were up 12.6% at euro 46 million. Over the first nine months of 2009, net sales of the product were 17.6% higher at euro 139 million.

Net sales of Allegra(R) were up 5.3% in the third quarter at euro 153 million, driven by another good performance in Japan (+13.3%). Over the first nine months of 2009, net sales of the product increased by 2.2% at euro 591 million.

Copaxone(R) posted third-quarter net sales of euro 118 million, a rise of 20.0%. The end of commercialization of the product by sanofi-aventis in North America effective April 1, 2008 led to a 31.7% decline in consolidated net sales of Copaxone(R) over the first nine months of 2009.

OTC

Third-quarter net sales for the OTC business grew 26.3% at euro 356 million, reflecting healthy organic growth (7.4% on a constant structure basis and at constant exchange rates) plus the consolidation of Symbion and of Zentiva's OTC activities.

The 6 flagship brands (Doliprane(R), Essentiale(R), Maalox(R), No-Spa(R), Enterogermina(R), Lactacyd(R)) achieved growth of 19.6%, driven by Doliprane(R) and Essentiale(R). OTC net sales for the nine months 2009 were euro 996 million, a rise of 19.6% (or 4.5% on a constant structure basis and at constant exchange rates).

On October 30, the Group announced that it has signed an agreement to acquire 100% of the shares of Oenobiol, the French leader in nutritional supplements for health and beauty. In 2008, Oenobiol had a turnover of 58 million euros, of which 85% generated in France.

Generics

The Generics business posted third-quarter net sales of euro 302 million, a rise of 273.3%. This rate reflects strong organic growth (16.3% on a constant structure basis and at constant exchange rates), plus the consolidation of Zentiva, Kendrick and Medley from the second quarter. Implementation of the new generics platform in Eastern Europe, combining the operations of Zentiva and sanofi-aventis, should be completed by the end of the year. Over the first nine months of 2009, net sales for the Generics business were euro 679 million, a rise of 177.5% (or 12.1% on a constant structure basis and at constant exchange rates).

Animal Health

The acquisition of Merial was completed on September 18. Given the option of a future combination between Merial and Intervet/Schering Plough (subject to completion of the merger between Merck and Schering-Plough), sanofi-aventis has decided in light of the relevant accounting standards (IFRS 5) to recognize the contribution from Merial on a separate line, "Net income from the Merial business".

Merial's third-quarter sales were flat, falling by 0.5% (or by 4% on a reported basis) to $626 million. Sales of Frontline(R) and other fipronil products held steady at $248 million, despite increased competition and the impact of a decline in household consumption on the companion animal healthcare market.

For the first nine months of 2009, Merial reported net sales of $1,961 million, down 0.5% (or down 7.4% on a reported basis). Net sales of Frontline(R) and other fipronil products were down 1.9% at $834 million. Net sales of vaccines rose by 4.5% to $552 million over the 9-month period, driven by robust growth of 9.1% in companion animal vaccines.

Human Vaccines business

Third-quarter consolidated net sales for the Human Vaccines business rose by 4.8% to euro 1,046 million (representing 14.1% of the Group's total net sales), driven by the strong performance of Pentacel(R), Pentaxim(R) and Menactra(R), as well as the first H1N1 shipments.

Net sales of Pentacel(R) (the first 5-in-1 pediatric combination vaccine licensed in the United States in June 2008 against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type b) reached euro 82 million in the third quarter, versus euro 25 million in the third quarter of 2008. Net Sales of Pentaxim(R) (another 5-in-1 pediatric combo vaccine, which protects against diphtheria, tetanus, pertussis, polio and haemophilus influenzae type b) increased 62.5% to euro 39 million.

Net sales of Menactra(R) (quadrivalent meningococcal meningitis vaccine) advanced by 19.7% to euro 184 million.

Net sales of influenza vaccines for the quarter were 3.2% lower than last year at euro 378 million. In 2009, the low-yielding B strain will result in greater seasonal influenza sales during the fourth quarter of the year versus fourth quarter 2008. In 2009 Sanofi Pasteur should supply over 180 million doses of trivalent seasonal influenza vaccines, representing an estimated 40% of the northern hemisphere and 75% of the southern hemisphere global demand.

In September, Sanofi Pasteur began H1N1 shipments in the United States, third-quarter H1N1 sales amounted to euro 78 million. The bulk of the H1N1 shipments should occur during the fourth quarter of 2009 and early 2010. Sales of H1N1 vaccines should be around $500 million in the fourth quarter of the year.

During the third quarter, Sanofi Pasteur completed the acquisition of ShanH, a subsidiary of Merieux Alliance that owns a majority stake in Shantha Biotechnics, an Indian vaccine manufacturer. Shantha was recently awarded 2010-2012 contracts from a United Nations agency worth a total of $340 million for the supply of SHAN5(TM) (a pediatric combination vaccine against diphtheria, pertussis, tetanus, Haemophilus influenzae type B infections and hepatitis B). These contracts demonstrate Shantha's ability to meet high-quality affordable vaccines needs in international markets.

Consolidated net sales for the Human Vaccines business for the first nine months of 2009 were up 4.2% at euro 2,385 million. Excluding pandemic influenza vaccine contracts (A/H1N1 and H5N1), sales growth was 6.0%. Over the first nine months of 2009, sanofi-aventis recognized net sales of pandemic influenza vaccines amounting to euro 104 million, compared with euro 126 million for the comparable period of 2008.

Third-quarter net sales at Sanofi Pasteur MSD (not consolidated by sanofi-aventis), the joint venture with Merck & Co in Europe, fell by 6.0% on a reported basis to euro 350 million. Sales of Gardasil(R), a vaccine for the prevention of human papillomavirus infections (a major cause of cervical cancer) were down 47.1% on a reported basis at euro 76 million. This decrease was due to extensive catch-up campaigns in the prior year. Excluding Gardasil(R), sales of the rest of the portfolio rose by 20.0% on a reported basis. Sales at Sanofi Pasteur MSD for the first nine months of 2009 were euro 837 million, down 9.4% on a reported basis.

Third-quarter net sales in Europe rose by 6.8%, driven by Eastern Europe (+39.6%) which since the start of April has included Zentiva. Sales in Western Europe rose by 1.8% over the period, despite ongoing competition from generics of Eloxatin(R) and increased competition from generics of Plavix(R). Over the first nine months of 2009, net sales in Europe were up 3.4%.

The United States reported quarterly growth of 1.1% despite competition from generics of Eloxatin(R) in August. The main growth drivers during the period were again Lantus(R) (+21.3%) and Lovenox(R) (+8%). Over the first nine months of 2009, U.S. net sales were virtually unchanged (+0.3%), reflecting the impact of the end of commercialization of Copaxone(R) by sanofi-aventis effective April 1, 2008.

In the Other Countries region, third-quarter net sales rose by 11.1%, with Latin America, the Middle East and Asia-Pacific all posting double-digit growth. Net sales in China advanced by 38.8% to euro 149 million. In Japan, net sales rose by 4.2% to euro 400 million, compared with a 2008 third-quarter figure that benefited from sales of active ingredients of Aprovel(R) to our local partners. Japanese sales are being boosted by the ongoing success of Plavix(R), and by good growth for Myslee(R) and Allegra(R). Sales in Latin America are being driven by Brazil, thanks to healthy organic growth and the acquisition of Medley. Over the first nine months of 2009, net sales growth in the Other Countries region was 10.0%. Over the same period, net sales grew by 8.4% in Japan (to euro 1,352 million) and by 36.5% in China (to euro 408 million).

Third-quarter net sales in emerging markets(5) were euro 1,888 million, an increase of 20.9% (or 6.7% on a constant structure basis and at constant exchange rates). Emerging markets net sales for the first nine months of the year rose by 16.4% (or 7.0% on a constant structure basis and at constant exchange rates) to euro 5,358 million, representing 24.4% of the Group's total net sales.

(5) World excluding North America, Western Europe (France, Germany, United Kingdom, Italy, Spain, Greece, Cyprus, Malta, Belgium, Portugal, Netherlands, Austria, Switzerland, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia and New Zealand.

Solid results, built on sales growth and ongoing cost control

2009 third-quarter financial results

Adjusted income statement excluding selected items(1)

Sanofi-aventis generated third-quarter net sales of euro 7,400 million, an increase of 8.0% on a reported basis. "Other revenues" rose by 19.2% due to a good performance from Plavix(R) in the United States and a favorable dollar effect.

Gross profit came to euro 5,744 million, a rise of 6.9%, or of 3.7% at constant exchange rates. The ratio of cost of sales to net sales increased by 1.2 percentage points to 27.4% due to a slightly less favorable product mix, a rise in the cost of heparin raw materials, and the impact of generics during the period (arrival of Eloxatin(R) generics in the United States, and increased generic competition for Plavix(R) in Europe).

Research and development expenses were up 1.8% at euro 1,109 million, but down 0.6% at constant exchange rates, reflecting a selective approach to R&D projects and the impact of cost savings in pharmaceuticals R&D, increased R&D spend in vaccines, and the development costs of acquired companies. Overall, the ratio of R&D expenses to net sales was 15.0%, 0.9 percentage point lower than in the comparable period of 2008.

Selling and general expenses increased by 3.4% (or 1.2% at constant exchange rates) to euro 1,707 million, and include the launch costs for Multaq(R) in the United States. The ratio of selling and general expenses to net sales fell by 1 percentage point to 23.1%, reflecting the ongoing adaptation program.

Other current operating income, net of expenses totaled euro 86 million, versus euro 49 million in the third quarter of 2008. The year-on-year change mainly reflects an increase in the royalty collected by sanofi-aventis on sales of Copaxone(R) in North America.

Operating income - current(1) advanced by 11.9% to euro 2,955 million. At constant exchange rates, growth was 4.5%. The ratio of operating income - current(1) to net sales improved by 1.4 points to 39.9%.

Net financial expenses were euro 69 million, against euro 60 million in the comparable period of 2008. The acquisition of 100% of Merial for euro 2.8 billion was completed on September 18, 2009.

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

The share of profits from associates (excluding Merial) was 24.3% higher at euro 235 million, with the share of after-tax profits from the territories managed by BMS under the Plavix(R) and Avapro(R) alliance up 31.6% at euro 204 million thanks to the performance of Plavix(R) in the United States and a favorable dollar effect. The contribution from Sanofi Pasteur MSD was flat year on year.

Net income from the Merial business was euro 59 million; this figure consists of 100% of the net income of Merial from September 18, 2009 (when sanofi-aventis acquired a 100% interest) and 50% prior to that date.

Minority interests were 2.7% higher at euro 114 million. The share of pre-tax profits paid to BMS from territories managed by sanofi-aventis was euro 110 million (versus euro 104 million in the third quarter of 2008).

Adjusted net income excluding selected items(1) was euro 2,229 million, up 15.9% (7.7% at constant exchange rates). The ratio of adjusted net income excluding selected items(1) to net sales improved by 2 points to 30.1%.

Adjusted earnings per share (EPS) excluding selected items(1) was euro 1.71, an increase of 16.3% (8.2% at constant exchange rates) on the 2008 third-quarter figure of euro 1.47.

(1) See Appendix 7 for definitions of financial indicators, and page 10 for details of selected items

2009 9-month financial results

Adjusted income statement excluding selected items(1)

In the first nine months of 2009, sanofi-aventis generated net sales of euro 21,945 million, up 7.2% on a reported basis. "Other revenues" rose by 21.9% thanks to a good performance from Plavix(R) in the United States and a favorable dollar effect.

Gross profit was euro 17,392 million, a rise of 9.0% (4.3% at constant exchange rates). The ratio of cost of sales to net sales improved by 0.8 of a point to 25.6% due to positive currency effects, the end of commercialization of Copaxone(R) by sanofi-aventis in North America, and a favorable product mix.

Research and development expenses rose by 3.1% to euro 3,369 million, but fell by 0.1% at constant exchange rates. These figures include euro 54 million of provisions relating to the discontinuation of various projects following the portfolio review completed at the end of the first quarter.

Selling and general expenses were 2.1% higher at euro 5,334 million, but 1.0% lower at constant exchange rates. The ratio of selling and general expenses to net sales fell by 1.2 percentage points to 24.3%, reflecting the cost-measures implemented by the Group.

Other current operating income, net of expenses totaled euro 366 million, compared with euro 227 million for the first nine months of 2008; these figures reflect the payment by Teva of a royalty equal to 25% of North American sales of Copaxone(R) from the second quarter of 2008.

Operating income - current(1)was 17.6% higher at euro 8,899 million. At constant exchange rates, the growth rate was 9.5%. The ratio of operating income - current(1) to net sales improved by 3.7 points to 40.6%.

The effective tax rate was 29%, in line with the 2009 full-year effective tax rate.

The share of profits from associates (excluding Merial) was 22.2% higher at euro 644 million, with the share of after-tax profits from the territories managed by BMS under the Plavix(R) and Avapro(R) alliance up 34.1% at euro 598 million thanks to the performance of Plavix(R) in the United States and a favorable dollar effect. The contribution from Sanofi Pasteur increased year on year.

The contribution of Merial to net income was euro 189 million; this figure consists of 100% of the net income of Merial from September 18, 2009 (when sanofi-aventis acquired a 100% interest) and 50% prior to that date. Merial generated an operating margin of 32.1% in the first nine months of 2009, slightly lower than the level recorded in the comparable period of 2008.

Minority interests increased by 4.5% to euro 346 million. The share of pre-tax profits paid to BMS from territories managed by sanofi-aventis was euro 329 million (versus euro 316 million for the first nine months of 2008).

Adjusted net income excluding selected items(1)was euro 6,675 million, up 20.1% (11.0% at constant exchange rates). The ratio of adjusted net income excluding selected items(1) to net sales improved by 3.3 points to 30.4%.

Adjusted earnings per share (EPS) excluding selected items(1) was euro 5.11, an increase of 20.5% (11.6% at constant exchange rates) relative to the first nine months of 2008 (euro 4.24).

(1) See Appendix 7 for definitions of financial indicators and page 10 for details of selected items.

Selected items (see Appendix 6)

In the third quarter of 2009, selected items comprised euro 28 million of restructuring provisions (net of tax) associated with the Group's adaptation program. Selected items in the third quarter of 2008 represented a net after-tax expense of euro 35 million.

Selected items for the first nine months of 2009 represented a net after-tax expense of euro 636 million (compared with a net after-tax expense of euro 203 million for the comparable period of 2008), and comprised:

Adjustments to the consolidated financial statements to reflect the application of purchase accounting to acquisitions, primarily that of Aventis (see Appendix 6)

The material effects of the application of purchase accounting to acquisitions, primarily that of Aventis, on the consolidated income statement were as follows:

These adjustments have no cash impact on the Group.

Net debt

Over the first nine months of 2009, sanofi-aventis generated substantial cash flow of euro 6,834 million, which provided finance for capital expenditure of euro 1,038 million and the dividend payout of euro 2,872 million, plus partial funding for the acquisitions and alliances carried out during the period. Spending on acquisitions totaled euro 5,963 million, and related primarily to Merial, Zentiva, Medley, Shantha and BiPar Sciences, while spending on alliances was euro 223 million. Net debt at end September was euro 5,042 million (debt of euro 7,363 million, net of cash of euro 2,321 million), compared with euro 1,780 million as of December 31, 2008.

Research and Development

The third quarter was a particularly active one for the Group's policy of targeted alliances and acquisitions. In parallel, initiatives designed to transform the Group's Research and Development operations continued to make progress.

The R&D portfolio was boosted by an exclusive worldwide license and collaboration agreement with the U.S. biotechnology company Merrimack relating to MM-121, currently in Phase I for solid malignancies. MM-121 is a first-in-class fully human monoclonal antibody targeting cancer cells that over-express or amplify the ErbB3 receptor. A similar type of agreement was signed with Wellstat Therapeutics for PN2034, a novel oral first-in-class insulin sensitizer for the treatment of type 2 diabetes. As a sensitizer, PN2034 is expected to normalize and therefore enhance insulin action in the liver of diabetic patients. The compound is currently in Phase II clinical testing.

An agreement was also signed with a view to the acquisition of Fovea, a French biopharmaceutical company specializing in ophthalmology. Fovea has an innovative technological platform, a number of ongoing research programs in the treatment of retinal disorders, and a portfolio of three products in clinical development:

In October 2009, sanofi-aventis and Micromet announced a collaboration and worldwide license agreement for the development of a BiTE(R) antibody, directed against an antigen present on the surface of tumor cells. BiTE(R) antibodies are novel therapeutic antibodies that activate T-cells so that they will identify and destroy tumor cells.

(Clearance for the agreements described above is currently being sought from the anti-trust authorities)

2009 Guidance

Based on the good performance achieved over the first nine months of the year, and the expected contribution from approximately $500 million of H1N1 vaccine sales in the fourth quarter, sanofi-aventis has updated its guidance for 2009 full-year growth in adjusted EPS excluding selected items(1) of around 11%, calculated at constant exchange rates and barring major adverse events.

In light of the first-time application of IFRS 8 (Operating Segments), sanofi-aventis has reviewed its segment structure and financial indicators, and now presents disclosures on the following segments in the notes to the financial statements: Pharmaceuticals, Vaccines, and Other Activities. This information is given in the 2009 Half-Year Financial Report. From 2010, financial communications issued by sanofi-aventis will comment on the new indicator disclosed for segment reporting purposes ("Business net income - Pharmaceuticals, Vaccines and Other").

Use of this indicator is not expected to give rise to any material difference as compared with the performance measure currently used by sanofi-aventis. Growth in 2009 net income measured using this new indicator will therefore be close to growth in "Adjusted net income excluding selected items".

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 stat