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What's The FDA Saying About Valeant's Manufacturing Facility Issues?

August 21, 2017

Valeant Pharmaceuticals Intl Inc (NYSE: VRX) investors can breathe a sigh of relief following the latest updates on the company’s Tampa facility, which was the subject of a Complete Response Letter Valeant received from the FDA earlier this month. IN the letter, the FDA pointed out Current Good Manufacturing Practice deficiencies at the Tampa facility, but H.C. Wainwright analyst Raghuram Selvaraju said on Monday that it appears the issues will not have a meaningful impact on Valeant’s business.

Last week, Valeant management said the FDA plans to issue a Voluntary Action Indicated classification for the Bausch & Lomb Tampa facility indicating issues at the facility were not significant enough to warrant major regulatory action. Valeant also revealed last week that has already submitted a response to the FDA’s CRL.

“Given the current status of the Tampa facility, we believe that Valeant should now be in position to overturn the FDA's CRL and receive approval for Vyzulta, while other drugs — e.g., another Valeant ophthalmology agent, the ocular redness treatment Luminesse — slated to be produced at the Tampa facility should no longer face the prospect of regulatory approval delays,” Selvaraju wrote.

Unfortunately, even with a clear regulatory path, Selvaraju said predicting a timeline for Vyzulta is difficult at this point, and H.C. Wainwright is not currently including any Vyzulta revenue in its 2017 Valeant models.

While Selvaraju said Valeant has already weathered the most difficult part of its turnaround storm and has opportunities for even more strategic divestments down the line, he sees limited near-term upside for the stock. H.C. Wainwright maintains a Neutral rating on Valeant and a $17 price target for the stock.

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Image Credit: By The U.S. Food and Drug Administration - FDA Bldg 31 - Great Room, Public Domain, via Wikimedia Commons