Sanofi-Aventis ( SNY) said Monday that full-year sales rose 9% to $33 billion as strong gains from its vaccine business and several signature products were partly offset by generic competition for several other drugs. Fourth-quarter sales gained 5% to $8.46 billion. The French company won't issue its earnings results until Feb. 24, although it said last year's earnings per share, excluding one-time items, should be about 25% higher than for 2004. Meanwhile, many analysts are paying more attention to two big upcoming events that will have a major impact during the rest of the decade than to last year's and last quarter's sales and earnings. Next month, the Food and Drug Administration is supposed to rule on Acomplia, a proposed treatment for obesity and addiction to smoking that has made some analysts giddy with excitement. In April, Sanofi-Aventis will ask a U.S. court to prevent another company from selling a cheap, generic copy of the anticoagulant Plavix, the company's second-biggest product and the biggest-selling drug for its marketing partner Bristol-Myers Squibb ( BMY). "Each
event has the ability to impact shares significantly," says Tim Anderson, of Prudential Equity Group, in a research report issued last week. A court defeat for the generic challenger means five more years of patent protection for a drug that produced $2.45 billion of sales for Sanofi-Aventis and $3.82 billion for Bristol-Myers Squibb. The FDA recently allowed the Canadian company Apotex to sell generic Plavix, but Anderson and other analysts doubt Apotex will act until the court has ruled, or unless it settles with Sanofi-Aventis. A favorable FDA decision for Acomplia means the drug could be on the market during the second quarter. "Acomplia is the most promising late-stage pipeline product" among European drug companies, says Gbola Amusa, of Sanford C. Bernstein, in a research report published several days before Sanofi-Aventis issued in earnings report. "The weight is over."
The European Union is expected to act on Acomplia a few months later. Amusa predicts the drug could reach $5.3 billion in worldwide sales by 2010. "We seen an 80% chance of approval for Acomplia by mid-2006 and a 55% chance the label goes beyond weight management and smoking cessation to include claims on diabetes and/or
cholesterol," Amusa says. The drug has met efficacy goals in clinical trials, offers "good safety and tolerability," and has "survived scrutiny" by two major medical journals, The Lancet and The New England Journal of Medicine, Amusa says. The only delay, he adds, could be caused by "slow label discussions" between the company and the agency. Amusa, who doesn't own shares, has an outperform rating on the stock. His firm doesn't have an investment banking relationship. Prudential's Anderson is a bit less enthusiastic, predicting that the FDA may grant conditional approval for Acomplia, pushing the launch back several months to the late second quarter. He speculates the FDA might require Sanofi-Aventis to employ "some form of risk management program" to monitor patients for potential safety issues. This "could temper the drug's initial uptake and launch," says Anderson, who is neutral on Sanofi-Aventis. He doesn't own shares, and his firm doesn't have an investment banking relationship. Anderson says Sanofi-Aventis' fourth-quarter revenue of $8.46 billion was slightly below his estimate because of generic competition for some drugs and lower-than-expected sales for several others. Still, the company ended the year with 10 drugs each producing more than $1 billion in sales. Eight of those drugs posted gains ranging from 10.6% to 47.5% between 2004 and 2005. Generic competition pounded the allergy drug Allegra, whose full-year sales dropped 9% to $1.62 billion. The real damage took place in the fourth quarter as sales plunged 59% to $193 million. The generically-challenged diabetes drug Amaryl was up 1% to $818 million for the year, but fourth quarter sales sank by 29% to $163 million.
On the plus side, sales for the blood thinner Lovenox rose 14% to $2.59 billion last year, and Plavix's sales added 20%. The biggest percentage gainer among the big drugs was Lantus insulin, whose sales soared by 47.5% to $1.47 billion. Eloxatin, for colorectal cancer, recorded a 31% increase in sales to $1.89 billion. Another strong performer was the human vaccines business, up 50% to $776 million in the fourth quarter vs. the same period in 2004, and up 27% to $2.49 billion for all of 2005. The company said the U.S. flu season was the most successful in its history as it sold 64 million doses of vaccine. Flu-vaccine revenue represented about one-third of total vaccine sales last year. By midafternoon, Sanofi-Aventis' stock was down 70 cents, or 1.5%, to $45.17.