Wyeth Warns of Drug Delays - TheStreet

Wyeth Warns of Drug Delays

Meanwhile, first-quarter results are better than expected.
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Wyeth

(WYE)

posted first-quarter results that easily beat estimates, as powerful gains by a vaccine against dangerous childhood diseases and a drug that treats several inflammatory conditions boosted its results.

However, shares slipped as Wyeth noted that some experimental compounds would be facing regulatory delays. By midafternoon, the stock was off 51 cents, or 1%, to $55.81. It fell as low as $54.26.

For the three months ended March 31, Wyeth earned 94 cents a share, excluding one-time items, on revenue of $5.37 billion. The consensus of analysts' forecasts compiled by Thomson First Call predicted earnings of 87 cents and revenue of $5.21 billion.

When items are added, Wyeth earned $1.25 billion, or 92 cents a share, up from $1.12 billion, or 82 cents a share, a year ago. Revenue in the 2006 first quarter was $4.84 billion.

"It was a very good quarter and a very solid start" to the fiscal year, said Ken Martin, the chief financial officer, during a telephone conference call with analysts. He said it was too early to determine if Wyeth would change its full-year adjusted profit guidance of $3.40 to $3.50.

First-quarter results were propelled by Prevnar, the vaccine for pneumoccocal disease in youngsters. Sales rose 43% to $617 million. Sales of Enbrel, for diseases such as rheumatoid arthritis and psoriasis, rose 33% to $445 million. Wyeth sells Enbrel outside the U.S. and Canada.

Amgen

(AMGN) - Get Report

covers the other markets.

The gains were needed to offset declines in several other prominent products. Sales of the antidepressants Effexor and Effexor XR fell 6% to $891 million as generic competition hit Effexor in the U.S. Sales of the heartburn drug Protonix slipped 2% to $474 million, and sales of the Premarin family of menopause-symptom drugs fell 9% to $241 million.

Although analysts were interested in the past quarter's sales, they were more interested in future prospects because Wyeth has many drugs under regulatory consideration or about to enter regulatory review.

Several of those products can't be manufactured until Wyeth gets clearance from the Food and Drug Administration that a

Puerto Rico plant meets agency standards.

Bernard Poussot, Wyeth's president and chief operating officer, believes that the problems can be fixed "without affecting the timing of our new product launches." The FDA completed a reinspection of the site earlier this month.

Using that guideline, Poussot predicted that the oral contraceptive Lybrel should be ready for a mid-year launch. The FDA is expected to rule in May on Lybrel, which would be the first contraceptive to eliminate menstrual periods. The FDA

granted conditional approval last June, but it asked for more data.

The FDA was scheduled to act next week on Viviant for the prevention of osteoporosis, however, Wyeth executives say now they expect to receive only partial approval. The company is reviewing new research on bone fractures.

Wyeth will submit the results to the FDA by midyear, necessitating an extra six months of review. Test results reveal a "favorable safety profile," and the FDA might act by year-end, the company said. Later this year, Wyeth will seek approval in the European Union and also in the U.S. for the added indication of treating the brittle-bone disease.

Meanwhile, Wyeth said it expects a delay until July for the FDA's decision on Pristiq for treating the symptoms of menopause. The FDA had been scheduled to rule next week. Wyeth, which previously predicted a third-quarter launch, said its submission of additional tests necessitated the extended review. Pristiq will be made at the Puerto Rico plant.

Pristiq also is being developed as an antidepressant. Although the FDA granted

conditional clearance in January, Wyeth has said it's asking the agency to review additional tests of a lower-dose version for treating depression.

Over time, the projected launch has gone from mid-2007 to late 2007 or early 2008. On Thursday, Wyeth said the FDA is expected to review the drug during the first quarter of 2008. Executives said the wait will be worthwhile because tests of the lower-dose drug show fewer side effects.

Meanwhile, the experimental kidney-cancer drug Torisel is scheduled for

FDA action in July, following the agency's decision two weeks ago to take 90 more days to review additional test data.

Executives said they expect the FDA to rule in August on the schizophrenia drug bifeprunox, and they predict they will file an application by year-end for the menopause-symptoms drug Aprela.