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NEW YORK - Pfizer's earnings are still growing fast, but the risk due to pain drugs Celebrex and Bextra is only increasing.
In December, new data were unveiled showing a potential heart risk for Celebrex. Celebrex is in the same class of medicines as Merck's (nyse: MRK - news - people ) Vioxx, but had been thought not to pose a heart risk as that drug did. Pfizer (nyse: PFE - news - people ) says it will defend the drug by arguing that it is at least as safe -- and better studied than other medicines. But it also revealed, for the first time, that there may have been other, inconclusive data that could be used to argue that Celebrex poses a heart risk.
" Within [the] accumulated body of data," the company wrote in its earnings release, "there were certain studies in which there was an increased percentage of specific cardiovascular events for patients taking Celebrex versus patients taking placebo or other drugs; in other studies, there was a decreased percentage of specific cardiovascular events. The investigators of those studies determined at the time that the differences were not meaningful and did not establish an increased or decrease cardiovascular risk for Celebrex."
Timothy Anderson, an analyst at Prudential Equity Group, wrote in a note to investors that the statement worried him. "We are unsure of the ultimate significance of more than one negative CV signal, but it could put Celebrex on an even slipperier slope given the totality of CV findings across the entire COX-2 category of products," Anderson wrote.
The issues relating to Celebrex and Bextra will come to a head between February 16 and February 18, when the U.S. Food and Drug Administration will host an advisory panel to evaluate the risks of many widely used painkillers. Three-day meetings are incredibly rare and usually indicate controversial topics. One previous example from several years ago: the debate over the risks and benefits of breast implants.
At any other time, the earnings Pfizer released today would look decidedly weak. After all, the world's largest drug company missed analysts' fourth-quarter earnings per share forecast of 59 cents by a penny. It also did not give 2005 guidance, as it customarily would, and it put off giving such guidance until its analyst meeting. And it put off the analyst meeting, usually held in February, until April. But then again, this is not any other quarter. Pfizer is facing some of the greatest threats to its dominance in years. Earnings before items rose 16%, but sales for the quarter are only up 7%, to $15 billion.
As if it weren't enough that $14 billion worth of annual sales could be lost to generic competition over the next several years, there is also the ill portent of the COX-2 inhibitors, Celebrex and Bextra. Studies have linked these drugs to heart attacks. In the fourth quarter, sales of both were strong, up 24% and 53%, respectively. But raw prescription data shows another story, with the number of new scripts for each drug plummeting since worries about Celebrex arose in mid-December.
The encouraging thing is that none of the problems anticipated for this quarter came true. The Pfizer battleship, so far, looks to be withstanding the onslaught. Sales of flagship Lipitor, the world's best-selling drug, jumped 23% from last year, continuing to rule the cholesterol market and take advantage of the problems being faced by Crestor, from AstraZeneca (nyse: AZN - news - people ). Some of the sales boost may be the result of wholesalers stocking up on medicines.
But it's beyond argument that Pfizer is going to see several more months of rough water. |
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