Pozen, Inc. ( POZN)

Q3 2010 Earnings Call

October 28, 2010 11:00 am ET

Executives

Stephanie Bonestell - IR

John Plachetka - Chairman, President and CEO

Liz Cermak - EVP and COO

Bill Hodges - SVP Finance & Administration and CFO

Analysts

Jonathan Aschoff - Brean Murray

Michael Tong - Wells Fargo

Ian Anderson - Cowen & Company

Eun Yang - Jefferies & Company

Jason Napodano - Zacks Investment Research

Presentation

Operator

Greetings and welcome to the POZEN Incorporated Third Quarter 2010 Earnings 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, 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 third quarter 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 homepage of our website at www.pozen.com where you can also access the 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 observations that we may make about the expected timing and amounts of royalty payments from GlaxoSmithKline and 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 particular trial results, future trial plans and the likelihood of results of any of any future trials, and our potential commercialization plans for our product candidates.

The adequacy of financial resources to accomplish our goals or 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 have estimated 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 GlaxoSmithKline for the sales and marketing of Treximet; and 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 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, which is on file with the SEC. In addition, these forward-looking statements represent only the company's expectations as of today. While the company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so. Any forward-looking statements should not be relied upon as representing the company's estimates or views as of any date subsequent to today.

So now 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'd like to turn the call over to Dr. Plachetka.

John Plachetka

Thank you, Stephanie and good morning everyone. As usual I am pleased to be joined this morning by Liz Cermak and Bill Hodges.

I am going to start with the highlights of our performance since we last spoke leaving Liz and Bill to turn on the details for you, then also make some specific comments on the various products in our pipeline and our broad expectations for the future. First I want to talk about my experience with the Treximet patent trial in the Eastern District of Texas which was held earlier this month. I am very pleased with the case put forward about a company and its attorneys and are very proud of everyone on the POZEN team. There were no surprises from the other side and I remain confident that our patents are valid.

With that said and since there are never any guarantees when it comes to litigation, it's now up to Judge Davis to make his determination and he indicated to us that he expects every decision by the end of the year. While we continue to make progress on many other fronts from the third quarter of 2010, POZEN reported revenue of 4.3 million resulting from royalties on sales of Treximet of $3.9 million and $400,000 royalty from sales of VIMOVO which is now officially launched in the Unites States.

Now one of the most important recent developments actually came just as through the close of the quarter and specifically that's the VIMOVO receiving positive agreement for approval in 23 countries across European Union which occurred earlier this month.

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