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Dynamic growth in 2005 full-year consolidated net sales: up 9.3% on a comparable basis
| January 30, 2006 |
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| Excellent performance from vaccines: up 26.9% on a comparable basis(1). 2005 adjusted earnings(1) guidance raised - Approval of Plavix® in Japan. |
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FOURTH QUARTER
2005 FULL YEAR
2005 ADJUSTED EARNINGS(1) EXPECTATION RAISED
POSSIBILITY OF PEDIATRIC EXTENSION FOR AMBIEN® IN THE UNITED STATES
APPROVAL OF PLAVIX® IN JAPAN
In the fourth quarter of 2005, sanofi-aventis generated net sales of €7,007 million, up 4.8%. Exchange rate movements had a favorable effect of 3 points, and changes in Group structure a negative effect of 0.8 of a point. After allowing for these impacts, reported-basis growth was 7.0%. 2005 full-year net sales were €27,311 million, up 9.3%. Exchange rate movements had a neutral impact over the year as a whole, while changes in Group structure had a negative effect of 0.9 of a point. After allowing for these impacts, reported-basis growth was 8.4%. |
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In Europe, fourth-quarter sales growth was 4.2%, mainly due to less dynamic performances in Germany and France. In Germany, price pressure intensified, due largely to the extension of the reference price system to new therapeutic classes. In France, sales were adversely affected by the healthcare system reforms and by price reductions. Over 2005 as a whole, sales growth in Europe was boosted by a dynamic performance across the entire portfolio, especially Lantus® (up 40.5%), Eloxatin® (up 31.4%), Taxotere® (up 20.1%) and Plavix® (up 20.5%). Fourth-quarter sales growth in the United States, affected by competition from generics of four products, was 2.6%. Excluding the impact of these four products, fourth-quarter sales growth would have reached 21.2%. Over the year as a whole, net sales rose by 11.5%; excluding the impact of the four products affected by competition from generics, 2005 full-year sales growth would have been 17.4%. In other countries, sales growth again accelerated in the fourth quarter, reaching 9.5%. |
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Developed sales give an indication of the overall presence of sanofi-aventis products in the market. 2005 full-year developed sales reached €30,778 million, up 9.7%. Fourth-quarter developed sales rose by 5.5% to €8,046 million.
Developed sales of Plavix®/Iscover®:
Fourth-quarter developed sales of Plavix® were up 13.5% at €1,331 million. Full-year developed sales of the product in 2005 were €4,739 million, a rise of 17.1%. In the United States, total prescriptions (TRx) of Plavix® rose by 12.9%(4) in 2005. Product sales have benefited from a steady increase in the duration of treatment and by increased penetration across all markets. In January 2006, the FDA granted a priority review for a supplemental new drug application for Plavix® for the treatment of patients with acute ST-segment elevation myocardial infarction. The results of the CHARISMA study are to be presented to the American College of Cardiology (ACC) in March 2006. Plavix®, which has just been approved in Japan for the reduction of recurrence after ischemic cerebrovascular disorder, is due to be launched there in the second quarter of 2006. Developed sales of Aprovel®/Avapro®/Karvea®:
Fourth-quarter developed sales of Aprovel®/Avapro®/Karvea® totaled €428 million, a rise of 9.7%. Over 2005 as a whole, the product achieved developed sales of €1,559 million, up 8.9%. In the United States, total prescriptions (TRx) of Avapro® rose by 11.5%(4) in 2005. |
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Geographical split of consolidated net sales by product
Fourth-quarter net sales of Lovenox®, the leading low molecular weight heparin on the market, were up 9.0% at €572 million. Growth of the product continues to be driven by the extension of its use in medical prophylaxis, and by the conversion from non-fractionated heparins. The results of the VITAE study showed that venous thromboembolic disease remains a major cause of mortality in the United States with over 300,000 patients dying every year, only 7% of whom had been diagnosed and treated. The results of the EXTRACT study into acute coronary syndromes with ST-segment elevation are due to be announced to the American College of Cardiology (ACC) in March 2006. In the fourth quarter, Allegra®, which since September has faced competition from generics in the United States, generated net sales of €160 million (down 58.5%), including €87 million (down 72.2%) in the United States. An authorized generic version of the product was launched in the United States by Prasco Laboratories on September 14, 2005, this version accounted for 42.8% of generic fexofenadine prescriptions in December 2005. In Japan, Allegra® achieved net sales of €205 million in 2005, an increase of 34.8%. In the fourth quarter, Taxotere®, recorded an excellent performance in Europe. In the United States, the product returned to growth in 2005, but still faces a tough competitive environment due largely to generics of paclitaxel. The main growth drivers for Taxotere® are its indications as an adjuvant treatment for breast cancer and a treatment for non hormone-resistant prostate cancer, plus potential new indications. In early-stage HER-2 positive breast cancer patients, regimens combining Taxotere® and Herceptin®, with or without doroxubicin, showed a significant improvement in disease-free survival rates (BCIRG 006 study – interim analysis). In the non-doroxubicin arm of the study, the clinical benefit was obtained with reduced toxicity. The product is well placed to obtain two new potential indications, in advanced gastric cancer and head/neck cancer. At end 2005, the FDA granted a priority review for a supplemental new drug application for a new indication for Taxotere® in association with the standard treatment (cisplatin and 5-fluorouracil) in advanced gastric cancer. A new drug application for Taxotere® in the treatment of head and neck cancer is due to be filed in 2006. Fourth-quarter net sales of Ambien®/Ambien CR™ in the United States rose by 23.5% to €383 million, lifted by an excellent performance from Ambien CR™ which since October 2005 has been promoted by over 3,000 medical reps. To end December, prescriptions of Ambien CR™ represented some 14,5%(5) of total prescriptions for the Ambien® family. Total market share of the Ambien® family has increased to 44.7%(6) in December. The Group has also received a Written Request from the US healthcare authorities for pediatric studies of Ambien®. In Japan, sales of Myslee® (developed sales) rose by 20.1% in 2005 to €109 million. In 2005, Myslee® attained a market share of 27.0%(7), an increase of more than 3 points. In the fourth quarter, Eloxatin® recorded another very good performance. The product gained market share as an adjuvant treatment for colorectal cancer in Europe and the United States (57.2%(8) US market share – stage III patients). In France and the United States, the new formulation now accounts for over 80% of Eloxatin® use. The Group plans to roll out this formulation in a number of European countries in 2006. In the fourth quarter, Lantus®, the leading insulin in the market and the only insulin analog to provide 24-hour peakless coverage, continued to perform excellently, with net sales up 45.0% at €345 million. In 2005, Lantus® achieved blockbuster status, with net sales advancing by 47.5% to €1,214 million. In the United States, the product’s market share reached 30.4%(6) in December 2005. Since the start of the fourth quarter, Amaryl® has been facing competition from generics in the United States, resulting in a fall of 28.6% in net sales of the product during the period (with US sales down 86.2%). An authorized generic version of Amaryl® was launched by Prasco Laboratories at the start of the fourth quarter, and accounted for 29.6% of glimepiride prescriptions in December 2005. |
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References:
Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expect,” “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 those 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, 2004. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc. |
List of appendices: Appendix 1: Explanatory notes Appendix 2: 2005 fourth-quarter net sales by product Appendix 3: 2005 full-year net sales by product |
| Appendix 1: Explanatory notes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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2004 pro forma net sales:
2004 pro forma net sales are presented for comparability purposes, in accordance with International Financial Reporting Standards (IFRS) and as though the offer for Aventis had occurred on January 1, 2004; they exclude net sales from products divested at the request of the antitrust authorities (Arixtra, Fraxiparine and Campto) and from the Aventis Behring business divested in March 2004. Comparable net sales: When we refer to the change in our sales on a “comparable” basis, we mean that we exclude the impact of exchange rate movements and changes in Group structure (acquisitions and divestments of interests in entities and rights to products, and changes in consolidation method for consolidated entities). For any two periods, we exclude the impact of exchange rates by recalculating sales for the earlier period on the basis of exchange rates used in the later period. We exclude the impact of acquisitions by including sales for a portion of the prior period equal to the portion of the current period during which we owned the entity or product rights based on sales information we receive from the party from whom we make the acquisition. Similarly, we exclude sales in the relevant portion of the prior period when we have sold an entity or rights to a product. For a change in consolidation method, the prior period is recalculated on the basis of the method used for the current period. Reconciliation of 2004 pro forma reported net sales to 2004 pro forma comparable net sales:
Developed sales: When we refer to “developed sales” of a product, we mean consolidated net sales, excluding sales of products to our alliance partners, but including those that are made through our alliances and are not included in our consolidated net sales (with Bristol-Myers Squibb on Plavix®/Iscover® (clopidogrel) and Aprovel®/Avapro®/Karvea® (irbesartan) and with Fujisawa on Stilnox®/Myslee®). Our alliance partners provide us with information regarding their sales in order to allow us to calculate developed sales. We believe that developed sales are a useful measurement tool because they demonstrate the overall presence of our products in the market. Reconciliation of net sales to developed sales:
Adjusted earnings per share (adjusted EPS): We define “adjusted earnings per share” as accounting net income per share (determined under IFRS), adjusted to exclude (i) the material impacts of purchase accounting for the Aventis acquisition and (ii) acquisition-related integration and restructuring costs. Sanofi-aventis believes that eliminating these impacts from net income gives investors a better understanding of the underlying economic performance of the combined Group. The material impacts of the application of purchase accounting to the acquisition are as follows:
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| Appendix 2: 2005 fourth-quarter net sales by product | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Appendix 3: 2005 full-year net sales by product | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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