on Tuesday reported third-quarter results that easily beat Wall Street's estimates, posting a profit instead of the loss that had been expected.
The company, which specializes in drug-delivery systems, earned $1.6 million, or 2 cents a share, excluding items. Revenue was $41.4 million for the three months ended Dec. 31. Analysts polled by Thomson First Call had forecast a loss of 8 cents a share and sales of $38 million.
On a GAAP basis, Alkermes, based in Cambridge, Mass., earned $1.41 million, or 2 cents a share. For the same period in 2004, it lost $9 million, or 10 cents a share, on revenue of $23.6 million.
Alkermes delivered its financial report after the markets had closed. In regular trading, the stock lost 44 cents, or 1.9%, to $22.60. After hours, however, the stock gained 40 cents.
Among its many experimental products, the one capturing the most immediate attention is Vivitrol, an alcoholism treatment. Vivitrol is an injectable, extended-release version of naltrexone, a pill that's sold generically. Naltrexone and Vivitrol are given to alcoholics to discourage them from resuming drinking.
Alkermes and its marketing partner
say the once-a-month Vivitrol will improve patient compliance vs. the once-a-day naltrexone pill.
However, Vivitrol has run into delays at the FDA.
In late December, the agency granted conditional approval. The companies say full approval depends on their preparation of an acceptable label and providing some preclinical data to the FDA.
Richard F. Pops, Alkermes' CEO, said his company and the FDA have agreed on the guidelines for the data. Alkermes will submit the information by the end of the month, and the FDA is expected to review it in 60 days. Alkermes won't be required to conduct additional tests, Pops said.
Pops reiterated his previous prediction that Vivitrol will reach the market between April and June.
The Vivitrol delay played a role in Alkermes revising its guidance for the fiscal year ending March 31. The company reduced its sales prediction to a range to $145 million to $165 million from an earlier $150 million to $170 million range.
Alkermes expects its fiscal-year bottom line to range from break-even to a loss of 11 cents a share. Previously, Alkermes had predicted a loss of 14 cents to 25 cents. The Thomson First Call consensus was for a loss of 16 cents a share and revenue of $159.1 million.
Alkermes' sole product on the market is Risperdal Consta, an injectable version of Risperdal,
Johnson & Johnson's
schizophrenia drug. Alkermes gets manufacturing and sales royalties from J&J. Once-a-day Risperdal can be taken as a pill, a liquid or a quick-dissolving tablet. Injecetable Risperdal Consta is administered every two weeks.
The company is also working with
to develop an inhaled form of insulin. The product is in late-stage clinical testing.
Alkermes, Lilly and
are working on Exenatide LAR to help diabetics control blood-sugar levels. The drug, which has completed midstage clinical testing, is a once-a-week injectable version of Byetta, the Amylin-Lilly drug that must be injected twice a day. A long-term study is scheduled to start during the first half of 2006.