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POZEN, Inc. (POZN)
Q3 2012 Earnings Call
November 8, 2012 11:00 AM ET
Stephanie Bonestell – IR
Bill Hodges – SVP and CFO
John Fort – Chief Medical Officer
Liz Cermak – EVP and Chief Commercial Officer
Michael Tong – Wells Fargo
Bert Hazlett – ROTH Capital Partners
Ken Trbovich – CK Cooper
Jason Napodano – Zacks Investment Research
Previous Statements by POZN
» POZEN's CEO Hosts Update Conference Call (Transcript)
» POZEN's CEO Discusses Q2 2012 Results - Earnings Call Transcript
» Pozen CEO Discusses Q3 2010 Results - Earnings Call Transcript
» POZEN Inc Q2 2010 Earnings Call Transcript
It is now my pleasure to introduce your host, Stephanie Bonestell with Investor Relations. Thank you. Ms. Bonestell, you may begin.
Thank you, Rob, and good morning. On behalf of POZEN, I would like to welcome you to today’s third 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 have 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, November 8, 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 us today from management we have: Dr. John Fort, Chief Medical Officer; Bill Hodges, Chief Financial Officer, Senior Vice President of Finance and Administration; and Liz Cermak, Executive Vice President and Chief Commercial Officer. Dr. Plachetka is under the weather today and will not be with us.
So I will turn the call over to Bill.
Thank you, Stephanie. Good morning and thanks for listening today. Dr. Fort, Liz and I will divide up the presentation this morning with Dr. Ford providing the clinical and regulatory update, I will providing the financial update and then Liz will be providing our partnering update and an update on VIMOVO. We will take questions at the end.
With that, I will turn the call over to Dr. Fort.
Thank you, Bill. As we announced earlier this week and in our press release this morning, both Phase 3 studies achieved their individual primary endpoints as patients on PA32540 experienced fewer gastric ulcers compared to those taking enteric-coated aspirin 325 mg alone. In addition, the combined data from the two studies demonstrated that patients on PA32540 compared to those on enteric-coated aspirin were able to stay on therapy longer as a result of fewer discontinuations resulting from prespecified GI adverse events. For more details, both the AHA and ACG posters are available on our website.
Overall, the results of the Phase 3 clinical trials demonstrated the superior GI profile of PA32540 compared to enteric-coated aspirin 325 mg. When these results were presented at AHA earlier this week, cardiologists were impressed with the data and the prospect of having a therapeutic option for their secondary cardiovascular patients at risk for gastric ulcers.
But what has really captured the attention of the cardiologists was the improved tolerability of PA compared to aspirin. Adherence to aspirin can be sub-optimal in part due to GI tolerability issues, such as dyspepsia related to chronic aspirin use. Patients who don’t take their aspirin for whatever reasons are at a greater risk for a cardiovascular event, such as heart attack, myocardial infarction or stroke. As Dr. Plachetka has frequently reminded everyone on these calls, medicines don’t work if patients don’t take them, and aspirin is no exception. With PA, more patients should be able to stay on their aspirin therapy and therefore continue to receive the known cardiovascular benefit of aspirin.