|January 26, 2005|
|Sanofi-aventis gains market share from year one|
After consultation with the stock market authorities in France and the United States, sanofi-aventis has retained August 20 as the date of first consolidation.
Fourth quarter of 2004
In 2004, sanofi-aventis generated pro forma combined net sales of 25,418 million euros, a rise of 10.0%. Currency fluctuations had an unfavorable impact of 4.1 points, more than two-thirds of which was due to the fall in the US dollar. Changes in Group structure (comprising products divested by Aventis in 2003 and the first half of 2004) had an unfavorable impact of 1.3 points.
In the fourth quarter of 2004, pro forma combined net sales came to 6,614 million euros, an increase of 8.1% after eliminating the negative impact of currency fluctuations (2.9 points) and changes in Group structure (1.4 points).
|Pro forma combined net sales by business segment|
Net sales reported by sanofi-aventis comprise net sales generated by the pharmaceuticals business and net sales generated by the human vaccines business.
Pro forma combined net sales generated by other pharmaceutical products advanced by 0.2% to 9,408 million euros over 2004 as a whole, and fell by 2.0% to 2,413 million euros in the fourth quarter.
The recent approval by the FDA of Menactra® offers for the first time a quadrivalent conjugate vaccine for the prevention of meningococcal disease. Menactra® will be launched in the first quarter of 2005.
The joint venture with Merck & Co in Europe (Sanofi Pasteur MSD), which is not included in pro forma combined net sales, posted sales of 651 million euros (up 10.2%) in 2004, against 591 million euros in 2003. Pediacel® was launched in 2004 in the United Kingdom, where it has rapidly become the standard in pediatric vaccination.
|Pro forma combined net sales by geographical region|
French pro forma combined net sales for the pharmaceuticals business rose by 4.3% in 2004. The Group’s blockbusters recorded further growth in France during the fourth quarter, with net sales up by 28.6% for Plavix®, 40.2% for Taxotere®, 37.5% for Eloxatin® and 13.2% for Lovenox®.
|Pro forma combined developed sales|
Pro forma combined developed sales(2), which give an indication of the overall presence of sanofi-aventis products in the market, reached 28,529 million euros in 2004, an increase of 12.3%. Fourth-quarter pro forma combined developed sales were up 9.1% at 7,503 million euros.
2004 proforma combined developed sales of Plavix®/Iscover®:
Worldwide sales of Plavix®topped 4 billion euros.
|Comments by therapeutic class|
All net sales figures cited for products represent pro forma combined net sales.
In 2004, net sales of Lovenox® were up 22.4% at 1,904 million euros. Net sales rose by 24.0% in the United States (to 1,138 million euros) and by 20.2% in Europe (to 580 million euros). In the United States, the product is benefiting from an intensification of promotional efforts since 2003 and from the ongoing conversion from non-fractioned heparins (which still represent 71% of the market by volume across all indications(7)) to low molecular weight heparins.
Fourth-quarter net sales of Lovenox®advanced by 19.4% (to 307 million euros) in the United States and by 21.3% (to 158 million euros) in Europe.
2004 net sales of Plavix® were 1,694 million euros, an increase of 28.9%.
In 2004, net sales of Delix®/Tritace® were 972 million euros, a fall of 17.3%, due to the impact of generics in Germany and the United Kingdom. However, the product is still achieving double-digit growth in Canada and France.
Fourth-quarter sales of Delix®/Tritace® were 264 million euros.
2004 net sales of Aprovel® came to 790 million euros, an increase of 16.7%.
In 2004, net sales of Taxotere® came to 1,436 million euros, a rise of 11.3%. The product achieved growth of 31.0% in Europe, to 502 million euros, but net sales fell by 1.1% in the United States. The expected change in the US reimbursement system occurred on January 1, 2005, and is expected to lead to an improvement in sales of Taxotere® over the coming months.
Fourth-quarter sales of Taxotere® were 358 million euros, up 8.5%. In Europe, the product achieved robust growth (up 27.4% at 126 million euros), especially in France. In the United States, net sales fell slightly by 0.7%, to 167 million euros.
In 2004, net sales of Eloxatin® were up 56.8% at 1,220 million euros. Net sales of the product advanced by 73.5% (to 722 million euros) in the United States and by 35.7% (to 410 million euros) in Europe.
Fourth-quarter growth in net sales of Eloxatin® was particularly strong in the United States (up 83.2% at 212 million euros). The product is still recording very rapid growth in Europe (up 39.0% at 112 million euros).
In the United States, Eloxatin®is rapidly increasing its share of the adjuvant market, which currently stands at 35.4%(8). Its share of the US first-line metastatic colorectal cancer treatment market is over 45.2%(8).
In November 2004, the FDA approved Eloxatin® for the treatment of colon cancer following surgery.
2004 net sales of Copaxone® were 742 million euros, an increase of 27.3%.
In the fourth quarter, net sales of Copaxone® rose by 23.0% in the United States (to 139 million euros) and by 22.7% in Europe (to 51 million euros), thanks largely to the launch of pre-filled syringes.
CENTRAL NERVOUS SYSTEM
In 2004, net sales of Ambien® in the United States reached 1,198 million euros, an increase of 17.8%. Total prescriptions (TRx) rose by 10.5%(9). In Japan, the portion of Myslee® sales reverting to sanofi-aventis in 2004 was 60 million euros, an increase of 24.1%. Myslee® continues to gain market share, achieving 23.9%(10) of the hypnotics market.
In the fourth quarter, net sales of Ambien® in the United States were up 10.0% at 297 million euros.
2004 full-year net sales of Depakine® were 303 million euros, up 10.2%, with an excellent performance (up 19.6%) in the area "other countries".
Depakine® posted fourth-quarter net sales growth of 8.5%, to 77 million euros.
2004 net sales of Lantus® were 843 million euros, up 79.7%. Net sales rose by 57.2% in the United States (to 495 million euros) and by 111.4% in Europe (to 295 million euros). In 2004, Lantus® became the best-selling insulin brand in the United States, reaching 24.5%(11)()of total insulin prescriptions.
In the fourth quarter, net sales of Lantus®()advanced by 35.9% in the United States (to 131 million euros) and by 63.3% in Europe (to 88 million euros).
2004 net sales of Amaryl® were up 18.8% at 684 million euros. Net sales growth was 32.0% in the United States (to 216 million euros) and 9.0% in Europe (to 239 million euros).
Amaryl® posted fourth-quarter net sales growth of 42.2% in the United States (to 62 million euros), thanks to increased prescriptions and a favorable price effect. In Europe, net sales rose by 7.9% (to 66 million euros).
2004 net sales of Allegra® came to 1,502 million euros, including 1,197 million euros in the United States.
In the fourth quarter, net sales of Allegra® fell by 5.1% to 373 million euros. In the United States, Allegra® reported a decline of 7.2% to 299 million euros. At end December 2004, the product had market share (TRx) of 43.6%(12) in the United States, against 42.5% at end December 2003.
Actonel®achieved blockbuster status in 2004 as worldwide sales, via the alliance with Procter & Gamble, reached 1,090 million euros. Pro forma combined net sales of the product amounted to 305 million euros, a rise of 59.7%. In Japan, 2004 sales of Actonel® were up 56.5% at 46 million euros. At end 2004, Actonel®had market share of 27.1%(13) in the United States.
In the fourth quarter, worldwide sales of Actonel® came to 258 million euros, while sanofi-aventis pro forma combined net sales of the product rose by 34.9% over the same period to 85 million euros.
2004 net sales of Ketek® were up 66.5% at 189 million euros. Ketek® was launched in the United States in August 2004.
Fourth-quarter net sales of Ketek® were 71 million euros.
2004 net sales of Xatral® were up 27.7% at 281 million euros. In the United States, UroXatral® had market share of 9%(14) of prescriptions at end 2004.
Fourth-quarter net sales of Xatral® were up 15.6% at 74 million euros.
2004 net sales of Eligard®were 58 million euros, an increase of 76.4%.
Fourth-quarter net sales of Eligard® were 13 million euros.
In December 2004, the FDA approved the 6-month formulation of Eligard®, which offers patients a new alternative
|Recent events associated with the offers for Aventis and Hoechst shares|
|2005 Financial Calendar|
|2004 fourth-quarter consolidated net sales of sanofi-aventis|
In the fourth quarter of 2004, sanofi-aventis generated consolidated net sales of 6,614 million euros, up 213.8% on a reported basis.
Fourth-quarter consolidated net sales of sanofi-aventis by business segment
Fourth-quarter consolidated net sales of sanofi-aventis by geographical region
|2004 consolidated net sales of sanofi-aventis|
In 2004, sanofi-aventis generated consolidated net sales of 15,043 million euros, against 8,048 million euros in 2003.
Full-year consolidated net sales of sanofi-aventis by business segment
Full-year consolidated net sales of sanofi-aventis by geographical region
|Pro forma combined figures for the fourth quarter of 2004|
Fourth-quarter proforma combined net sales by geographical region
Fourth-quarter pro forma combined net sales for the top 15 products
|Pro forma combined figures for 2004|
2004 pro forma combined net sales by geographical region
2004 pro forma combined net sales for the top 15 products
Unless otherwise stated, all figures in this press release are in French GAAP.
In this press release, we refer to our historical sales as “reported” sales.
In addition to reported sales, we also present and discuss two other non-GAAP indicators that we believe are useful measurement tools to explain changes in our reported sales:
Comparable sales: When we refer to the change in our sales on a “comparable” basis, we mean that we exclude the impact of exchange rate fluctuations and changes in Group structure (acquisitions and divestitures of entities and rights to products as well as change in the consolidation percentage 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 the consolidation percentage of a consolidated entity, the prior period is recalculated on the basis of the consolidation method used for the current period.
Reconciliation of pro forma combined sales on a reported basis for 2003 to pro forma combined sales on a comparable basis for the equivalent period
Reconciliation of 2004 consolidated sales to 2004 pro forma combined sales
Pro forma Combined Developed sales: When we refer to "pro forma combined developed sales" of a product, we mean consolidated sales, excluding sales of products to our alliance partners, but including those that are made through our alliances and which are not included in our consolidated sales (with Bristol-Myers Squibb on Plavix®/Iscover® (clopidogrel) and Aprovel®/Avapro®/Karvea® (irbesartan) and with Fujisawa on Stilnox®/Myslee®(zolpidem). Our alliance partners provide us with information regarding their sales in order to allow us to calculate developed sales.
We believe that pro forma combined developed sales are a useful measurement tool because they demonstrate trends in the overall presence of our products in the market.
Reconciliation of pro forma combined sales on a reported in 2004 to pro forma combined developed sales for the equivalent period
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 and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis’s annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis’s annual report on Form 20-F for the year ended December 31, 2003. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.