POZEN Q4 2008 Earnings Call Transcript

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2009-02-25 12:31:16.0

Tags: Accounting, Call Transcript, Earnings, Amortization, Seeking Alpha, Pozen Inc.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question comes from Ken Trbovich with RBC Capital Market. Your line is open.

Ken Trbovich - RBC Capital Market

Thanks for taking the question. I guess first one, Bill just is relates to the fourth quarter. Could you walk us through the license revenue and any changes that occurred to recognizing the deferred milestones.

William Hodges

The licensing revenue at 5.2 million is obviously the royalty that we received as well as amortization of upfronts. The one thing that I didn't mention is there is a million dollar MT 300 milestone that we pulled through this quarter. So that's probably the missing piece for you.

Ken Trbovich - RBC Capital Market

Okay. And so that's a non-recurring piece?

William Hodges

It's a non-recurring piece, yes.

Ken Trbovich - RBC Capital Market

And then just as relates to the filing from an accounting perspective if you file PN 400 and are able to get a priority review would that change the amortization periods for these upfronts?

William Hodges

We amortize through the period that we expect our obligations to end which is subsequent to approval. We have to transition in NDA to our partners. So, we generally go over that period. So if we would receive a priority review, a shorter review we would have to reevaluate the amortization period.

Ken Trbovich - RBC Capital Market

Sure, and I guess sort of I'm asking is do you reevaluate that upon received the priority review or upon receipt of the approval?

John Plachetka, Pharm.D.

I mean that's more of a total software (ph) question, it's not an accounting question. I wouldn't change anything beyond the standards.

Ken Trbovich - RBC Capital Market

Okay. And then just with regard to the application itself, what are the critical time points here? Is there a period in which AstraZeneca has an opportunity to sort of go through the formatting of the NDA and providing any comment or feedback before you actually submit? I mean what procedurally is left to do between now and the filing.

John Plachetka, Pharm.D.

Well I think we mentioned is in the past so let me go back through this. AstraZeneca has an internal decision to make on the filing of the NDA, they look at the overall profile of the product that was in the original contract. And has to do with meeting their target product profile, which by the way we think we have done, but it's still got to go through their system. We're doing the filing. We're collaborating with them on the filing. There is a joint effort underway. But the technical filing is actually coming out of POZEN shop. Their internal reviews are heavier on using that result of content of course the study reports and they're very involved of course in the manufacturing component.

 

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