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Update Conference Call

August 24, 2012 9:00 am ET


Stephanie Bonestell – Manager, Investor Relations & Public Relations

John R. Plachetka – Chairman, President, Chief Executive Officer

William L. Hodges – Chief Financial Officer, Senior Vice President-Finance and Administration

Elizabeth A. Cermak – Executive Vice President, Chief Commercial Officer


Robert Hazlett – Roth Capital Partners LLC

Ken Trbovich – C. K. Cooper & Company



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Greetings and welcome to the POZEN’s Update Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Stephanie Bonestell with Investor Relations. Thank you, Ms. Bonestell, you may begin.

Stephanie Bonestell

Thank you, Rob, and good morning. On behalf of POZEN, I would like to welcome everyone to today's update conference call. By now, you should have received a copy of the company's press release. If you do not have it, you can access it on the home page of our website at, where you can also access a replay of this conference call.

Before we begin, I need to remind you that various remarks that we may make about future expectations, plans and prospects for the company constitute forward-looking statements for the purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Such statements include any forecasts or assumptions about potential size or market opportunity, any observations that we may make about the expected timing and amounts of royalty payments from AstraZeneca and other revenue expected from our collaboration partners; the prospects for approval or timing of approval of any of our drug candidates or the way in which the FDA may consider our new drug applications or any particular clinical trial results; results relating to any pending litigation, future clinical trial plans and the likelihood of results of future trials and our potential commercialization plans, including potential sales and revenue forecasts for our product candidates or our ability to license our PA product candidate on terms and timing acceptable to us.

The adequacy of financial resources to accomplish our goals for future revenues are based on our current expectations and are subject to a number of risks and uncertainties, including our inability to know with certainty what standards the FDA will use to evaluate drug candidates and how that may change or evolve over time; how the FDA evaluates data; what the results of future trials may be, whether those trials will cost much more than we had estimated that they will cost or than they have historically cost; how the FDA weighs risks of drugs, including risks of drugs that have been in use for many years.

The decisions of our collaboration partners; our dependence on our collaboration partners for the sales and marketing of our products once approved, including our dependence on AstraZeneca for the sales and marketing of VIMOVO, and whether our resources will be depleted by events other than clinical trials and efforts to obtain regulatory approval, such as the expenses relating to the lawsuits we have filed against generic companies seeking to market generic versions of Treximet and/or VIMOVO prior to the expiration of our patent.

Additional factors that affect our forward-looking statements are discussed in our most recent quarterly report on Form 10-Q. In addition, these forward-looking statements represent only the company’s expectations as of today August 24, 2012. While the company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so. Any forward-looking statement should not be relied upon as representing the company's estimates or views as of any date subsequent to today.

With us today from management we have Dr. John Plachetka, Chairman, President and Chief Executive Officer; Bill Hodges, Chief Financial Officer, Senior Vice President of Finance and Administration; and Liz Cermak, Executive Vice President and Chief Commercial Officer.

At this point, I would like to turn the call over to Dr. Plachetka.

John R. Plachetka

Thanks Stephanie, good morning and thanks for listening in today. Let me start by talking about this brief statement and we’ll open the call up for questions. I hope you had a chance to read our press release on the outcome of the Type A meeting we had with the FDA this week. And although you can probably tell from the press release that this is a positive outcome, we wanted to provide you an opportunity to get some of your more specific questions answered.

But first, let me just reiterate how pleased I am that we now feel we have a path forward to include both doses in the NDA, giving clinicians and patients a choice of a low and a high-dose version of PA. We’ve been asked many times over the years of this development program, why did we just make the 32540 when it seems that most patients take a lower dose, in fact they do. Well, now we have the best answer, and that is that we’re developing both strengths.

Our clinical and market research data suggests that two-thirds of the aspirin used for cardioprotection is at the lower dose, and about one-third is at the 325 milligram dose. So being able to include both doses in the NDA, not only will be able to offer patients a choice if both products are approved, but PA could be used by all aspirin patients who might be at risk for gastric ulcers instead of just the one-third of the patients who use 325. So that’s a nice impact on the market opportunity.

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