POZEN's CEO Discusses Q2 2012 Results - Earnings Call Transcript


Q2 2012 Earnings Call

August 1, 2012; 11:00 am ET


Dr. John Plachetka - Chairman, President & Chief Executive Officer

Bill Hodges - Chief Financial Officer, Senior Vice President of Finance & Administration

Liz Cermak - Executive Vice President & Chief Commercial Officer

Stephanie Bonestell - Investor Relations


Michael Tong - Wells Fargo Securities

Ken Trbovich - C.K. Cooper

Bert Hazlett - Roth Capital Partners

Eun Yang - Jefferies & Co.

Jason Napodano - Zacks Equity



Greetings and welcome to POZEN’s second quarter 2012 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).

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 Melissa and good morning everyone. On behalf of POZEN I would like to welcome you to today’s second quarter results 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 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 any future trial and our potential commercialization plans, including potential sales and revenue forecasts for our product candidates.

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 1, 2012. 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.

With U.S. 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 Plachetka

Thanks Stephanie, good morning to everybody and thanks for listening in today. Let me start by providing an updated on the recent interactions we’ve had with the FDA with respect to the PA32540 and the PA8140 program.

As we indicated in June we asked the FDA for and we had a teleconference to talk about the results of the 115-bioequivalence study and our NDA submission in general. My team and I feel that the call was quite productive. Still we want a written conformation on several of the issues we discussed with the FDA, because we, along with potential partners and investors, would like the maximum possible clarity about the regulatory path forward.

Both the FDA and our management team agreed during the call that the best mechanism to achieve this goal would be a Type A meeting. This pathway would allow POZEN to make a formal presentation of information and would provide the FDA with sufficient time to evaluate our data and request and formulate their response. And so we submitted our request for a Type A meeting along with our briefing package and I’m pleased to report that this request has been granted and that our type A meeting is on the calendar for late August.

Now I would like to update everyone on our European regulatory efforts. As you may remember, POZEN recently sort advise from the medicines evaluation board in the Netherlands, a potential European reference country with respect to gaining approval for two strikes of PA, PA32540 and PA1004.

Read the rest of this transcript for free on seekingalpha.com

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