Pozen on Monday reported its fourth consecutive profitable quarter as the Chapel Hill company’s revenue doubled to $9.9 million in the fourth quarter.
Pozen reported net income of $7 million, or 21 cents per share, in the quarter, compared with a loss of $2.2 million, or 7 cents per share, during the same period in 2013.
The bulk of Pozen’s $9.9 million in quarterly revenue came from a $5.6 million royalty payment for Vimovo, its arthritis pain reliever. The company also received $4 million of the $15 million upfront fee for the licensing of Yosprala, Pozen’s experimental cardiovascular drug.
Pozen reported in December that the Food and Drug Administration had once again cited deficiencies at a supplier's manufacturing facility that makes an active ingredient in Yosprala, which aims to be an alternative to aspirin for treating heart disease and stroke patients. The FDA cited the same manufacturing deficiencies in a Complete Response Letter sent in April of last year.
In its earnings release Monday, Pozen said that its supplier is now evaluating what “additional corrective actions m ay be required to address the matters raised in the warning letter.” Pozen now believes Yosprala will be available for commercialization in 2016.
In early December, Pozen announced the termination of a licensing agreement with Sanofi that had given the French pharmaceutical company exclusive rights to commercialize Yosprala. Pozen officials said the termination of the agreement had much to do with the fact that the regulatory timeline to get the drug approved has taken longer than expected.
For the year, Pozen reported a profit of $19.7 million, compared with a loss of $16.7 million in 2013.
Pozen shares were down about 3.5 percent in afternoon trading Monday.