August 5, 2014

Durham’s BioCryst falls short of analyst expectations in Q2

Durham drug developer BioCryst Pharmaceuticals revenue doubled in the second quarter as the company got a boost from federal funding for its treatment for Marburg virus infection, which is almost indistinguishable from Ebola virus fever.

Durham drug developer BioCryst Pharmaceuticals revenue doubled in the second quarter as the company got a boost from federal funding for its treatment for Marburg virus infection, which is related to Ebola virus fever.

Second-quarter revenue rose to $1.5 million this year from $821,000 in the second quarter of 2013, resulting from a new $22 million contract with the National Institute of Allergy and Infectious Diseases to develop BCX4430 as a treatment for Marburg virus disease.

The net loss in the three-month quarter ending June 30 widened to $14.6 million from $12.2 million, falling short of analyst expectations. The company has attracted wider interest on Wall Street since raising $106.6 million in June by selling 11.5 million shares.

BioCryst shares closed Tuesday $13.34, up 12 cents. The stock is up 75 percent this year.

In previous years BioCryst had reported as much as $10 million in quarterly revenue from a federal contract to develop Peramivir as an influenza treatment. BioCryst’s federal contract to develop Peramivir, which yielded the company $201 million since 2007, expired on June 30 as BioCryst now shifts focus to developing a treatment for hereditary angioedema and other conditions.

Peramivir had been slated to be introduced in the United States for the 2014-15 flu season but its prospects for regulatory approval are uncertain. The U.S. Food and Drug Administration raised concerns earlier this year about BioCryst’s contract manufacturer after a federal inspection revealed undisclosed problems.

The contract manufacturer, whom BioCryst has not identified, will have to pass a pre-approval inspection before Permavir can move forward. BioCryst officials assured Wall Street analysts the issues will eventually be resolved, but the timeline remains uncertain.

“We know we’re the only IV antiviral for influenza that, if approved, would be approved for use, and so we think there is absolutely a spot for it in the stockpile,” BioCryst CEO Jon Stonehouse told analysts during a conference call with analysts Tuesday. “They spent about $200 million on advanced development and so that’s a pretty big chunk of money to see this drug get approved and I would hope that ... stockpiling would be the result of that.”

The 24-year-old company, which employes 40 people, doesn’t have a drug on the U.S. market. It is shifting attention from developing Peramivir to meeting regulatory standards for winning approval for the drug and preparing validation batches that would be used for an initial launch.

BioCryst’s treatment for hereditary angioedema, a rare and painful blood disorder, would be the first pill developed to treat the condition. Known as BCX4161, it would replace the current intravenous treatment, which is injected several times a week.

The pill was tested on 24 people over six months, ending in May, and will undergo testing on a larger group starting later this year. Analysts don’t expect this drug, which prevents swelling episodes among angioedema patients, to be available on the market earlier than 2017.

The experimental antiviral for Marburg virus, BCX4430, is one of several anti-Marburg treatments being developed in the pharmaceutical industry for the virus, which has no treatment available. In March, the journal Nature published an article about BioCryst’s drug, reporting that it was successful in treating mice infected with the Ebola virus.

BioCryst is developing BCX4430 as a multivirus treatment in collaboration with the U.S. Army Medical Research Institute of Infectious Diseases. The treatment is expected to be tested on human subjects in 2015 to evaluate for safety, as opposed to its efficacy in combating viruses, and is still several years from being available to the public.

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