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Biotech Stock Mailbag: Vertex Pharma

What should Gilead do with all that moolah?

"While the company will choose between possible dividend, share buybacks, M&A and accumulation, we believe an immediate large one-time buyback in addition to ongoing annual repurchases is the preferred route; this could generate up to 20% earnings-per-share accretion and would boost the three-year EPS CAGR from 14% to 20%," writes Porges in a recent note to clients.

Porges adds: "By buying back stock, management would send a positive outlook to investors about the company's outlook and use of cash, potentially allowing the stock to command a higher multiple. It would also leave plenty of room for tactical M&A and licensing activity. Companies such as Pharmasset and Intermune represent attractive strategic fits but it is unclear if they would provide the post-2017 cash flows Gilead needs. United Therapeutics, with its specialty cardiovascular franchise, is also a viable target."

Moving on. An email from Duncan P.:

" In a recent press release from Adventrx Pharmaceuticals(ANX), it was stated that the company will meet with the FDA in the last week of April to review the rejection of the ANX-530 New Drug Application. Do you foresee this meeting having any impact on the stock price, positive or negative?"

Adventrx shares took a hit on March 1, when the company received a "refuse to file" letter from the FDA, turning away Adventrx's approval application for the chemotherapy drug ANX-530. In the letter, the FDA said drug stability data from the third-party commercial manufacturer of ANX-520 was insufficient.

As Duncan points out, Adventrx is meeting with the FDA in the last week of this month to determine what sort of (and how much) drug stability data on ANX-530 is needed for the agency to accept the application for review.

Adventrx CEO Brian Culley has already said the company is planning for a "worst-case" scenario in which the FDA will require 12 months of stability data on ANX-530 that comes from the actual manufacturing facility to be used for the commercial supply of the drug. If this is what the FDA asks for during April's meeting, Culley has said Adventrx could resubmit the ANX-520 application in six or seven months because the needed drug stability testing of ANX-530 is already underway.

In round figures, let's just say this scenario has Adventrx re-filing ANX-530 in December, so all in, the drug is delayed by a year.

Getting back to Duncan's main question, if Adventrx can emerge from its FDA meeting with a requirement of less than 12 months of new stability testing of ANX-530, then Adventrx may be able to re-file sooner. That should be good for the stock.

Whether or not Culley and his team can convince the FDA to lower its manufacturing requirements won't be known until Adventrx updates investors after the meeting.

For the record, I'm not too high on the commercial prospects for ANX-530, as I've stated in previous Mailbags.
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