It's rare to find a President and revia Chief Executive Officer of any big board traded company listed as the firm's biggest shareholder. It's refreshing and it's just one of the reasons why we believe the management team at the pharmaceutical firm, POZEN (Nasdaq:POZN), is extra focused and driven to perform well for its investors.
The scenario arguably communicates a direct sense of personal accountability towards building shareholder value and profitable strategic direction to the rest of the firm's investors. After all, the more that CEO is able to create shreholder value, the more he will personally ensure his own compensation and benefits as the firm's largest investor.
John R. Plachetka, Pharm.D., is President, Chief Executive Officer and Chairman of the Board of Directors of POZEN-- a company he founded in 1996 to successfully create novel pharmacologic agents primarily for pain and pain-related conditions. He is the biggest shareholder and also responsible for bringing Liz Cermak, a former Worldwide Vice President for Johnson & Johnson, on as Executive Vice President and Chief Commercial Officer.
Ms. Cermak's vision and ideas about the future of pharma marketing first caught our attention last year, but it wasn't until this week's J.P. Morgan Healthcare Conference in San Francisco that we were able to discuss some of the details that make POZEN quite attractive at current price levels. BioMedReports: Looking back on 2011, what were key highlights for POZEN in terms of corporate milestones and PA32540 news?
Cermak: We’ve had a busy and exciting year at POZEN and are fortunate to look back on a number of highlights. Earlier this summer, a federal court upheld the patents supporting Treximet® (an approved migraine treatment developed by POZEN that is now marketed by GlaxoSmithKline), a decision that prohibits other companies from marketing generic versions of the treatment. The defendants have appealed the decision. In May, Comtex SmarTrend ranked POZEN as the second most efficient company in the pharmaceutical industry, an accolade that we are very proud of and an acknowledgement that supports that our “in-source” business model is effective. We also made industry-leading strides on the digital media front, as we formed an unprecedented advisory board of digital thought-leaders to advance the market preparation for our lead compound PA32540, which is being investigated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. We also have embarked on a search for a strategic licensing partner to help commercialize PA32540. We think the value of the asset can be better maximized with a partnership for the PA portfolio. From a data perspective, we announced top-line results from the Phase 3 trial of PA32540, designed to track its long-term safety in patients at risk for developing aspirin-associated gastric ulcers. We also announced the positive results from our Phase 1 Co-Rx (pronounced “Co-Rex”) study and presented an abstract at the American Heart Association’s annual meeting in Orlando. Finally, we are on track to announce the top-line results of the two ongoing pivotal Phase 3 trials in the second quarter of next year.
BioMedReports: You announced recently that POZEN is monetizing its Treximet royalty stream for $75 million. What do investors need to know about this news, and how does this change, if at all, your financial forecast for 2011?
Cermak: We have sold most of the future royalty and milestone payments covering Treximet sales in the United States to a financial investor for $75 million. Monetizing this portion of the U.S. Treximet royalty unlocks its inherent value and significantly improves our balance sheet without dilution of existing shareholders. With this transaction, we now expect to end 2011 with more than $110 million – or approximately $3.67 per share – in cash, cash equivalents and short-term investments.
BioMedReports: You mentioned that earlier this year, POZEN announced it is exploring partnership opportunities for PA32540. Why did the company make that decision? How does the Treximet royalty stream news affect POZEN’s search for a strategic partner for PA32540?
Cermak: We are looking to secure a strategic license agreement with one or more partners to maximize the sales potential of PA32540, both within the United States and globally. Monetizing the Treximet royalty stream enables us to negotiate with potential partners for PA32540 from a much stronger position and to continue to execute POZEN’s strategic plan.
BioMedReports: What are you looking for in a strategic partner, and what does POZEN bring to the partnership?
Cermak: The ideal strategic partner for PA32540 would have sufficient financial resources to successfully commercialize PA in the U.S. and would have demonstrated success, commercial infrastructure and relationships in the cardiovascular and/or pain spaces. It’s also critical that a potential partner share our therapeutic vision for PA – seeing the treatment as a key strategic asset in their portfolio as well as embracing affordable pricing.
POZEN will bring substantial value to the partnership as well, notably, continuing to lead the development of PA32540, executing the critical New Drug Application (NDA) filing and, hopefully, securing approval. We are also planning to develop the dossier for rest-of-world filings. Through a partnership with POZEN, our strategic licensing partner would secure all intellectual property behind PA32540 in the licensed territory and would benefit from our manufacturing expertise and supply. Additionally, by mid 2012, we will have completed all foundational market research and branding, positioning and innovative commercial strategy work for PA32540.
BioMedReports: What is POZEN’s commercial strategy for PA32540, and how has it changed over the course of this year, if at all?
Cermak: POZEN’s commercial strategy has been focused on building the core brand elements and designing a commercial strategy that is customer-centric, digitally-based and communicates our core brand benefits, including affordable pricing at around a dollar a day.
However, POZEN no longer plans to commercialize the PA portfolio of products themselves, as the company now is seeking one or more strategic licensing partners to commercialize PA, beginning with PA32540 in the United States and all other territories. POZEN has engaged Keelin Reeds Partners LLC to assist in the partner search and expects to secure a partnership deal by the end of 2012. As a result, POZEN is planning to limit pre-commercialization spending in 2012.
BioMedReports: Why did POZEN form a Digital Advisory Board this year? Who are the Advisors, and what is POZEN looking to achieve by working with them?
Cermak: POZEN assembled the Digital Advisory Board to help progress the company’s vision of creating a new pharma commercial model and provide advice as we developed the preliminary launch plans for PA32540. The Board is comprised of digital thought-leaders in technology, social media and digital marketing who offer expertise and insight from a range of industries. The Board includes: • Raj Amin, Chief Executive Officer and Co-Founder, HealthiNation • Bonin Bough, Senior Director of Digital and Social Media, PepsiCo • Marc Monseau, Founder and Principal, MDM Communication, LLC • Daniel Palestrant, M.D., Chief Executive Officer and Founder, Sermo • Meredith Ressi, President, Manhattan Research
More specifically, the Board advises the company on its corporate branding and product commercialization, as well as provides insight to POZEN on the use of digital technology to more effectively and efficiently communicate with customers. POZEN’s goal in collaborating with these Advisors is to look both within and beyond its own industry to identify untapped digital strategies that will help shape a commercial strategy that is highly customer-centric.
BioMedReports: In October, you announced top-line safety results for a pivotal Phase 3 trial of PA32540. What did those results show, and when will the full Phase 3 data be announced?
Cermak: We were happy to announce that the top-line results from the Phase 3 trial of PA32540, designed to track the long-term safety of PA32540 in patients who are at risk for developing aspirin-associated gastric ulcers, demonstrated that adverse events were consistent with what would be expected in this population of patients requiring cardio-aspirin therapy and with the known safety profile of the PA components. The rate of discontinuation due to adverse events was low, and few patients developed major cardiovascular adverse events. These data support the possibility that long-term treatment with PA32540 may provide patients with a safe and effective option for secondary prevention of cardiovascular events, including heart attacks and strokes. We are pleased that the results of this trial support the safety profile that we expected for PA32540. Although we do not know the exact timing of when the full Phase 3 data will be made public next year, we anticipate that we will announce the top-line results in the second quarter.
BioMedReports: What are your biggest challenges as a company at this point?
Cermak: The biggest challenges that POZEN sees within the industry are the overall high healthcare costs in the United States and bringing affordable medicines to patients. However, POZEN is uniquely positioned to address this issue with PA32540, as we are committed to pricing this potentially lifesaving medicine at around a dollar a day. To that end, we are constantly evaluating and re-evaluating aspects of our “in-source” business model so we can pass any savings onto patients. We are proud of our commitment to this pricing philosophy and hope to serve as leaders in affordable pricing within the industry.
BioMedReports: Can you tell us about some of the milestones you're looking at for 2012?
Cermak: We’ll have a lot going on in 2012 that we’re excited about. Of note, the pivotal Phase 3 trials of PA32540 will complete in the first quarter of 2012, and we plan on announcing those top-line results in the second quarter. We also remain on track to file the NDA for PA32540 in the third quarter of 2012.
BioMedReports: From a POZEN perspective, what are you most excited about in 2012?
Cermak: In addition to the pivotal Phase 3 data and NDA filing of PA32540, we also look forward to securing the right strategic licensing partnership deal for PA32540. Aligned with a company with strong commercial capabilities, that embraces the POZEN philosophy and the financial resources to support the launch of PA32540, we are confident in a very successful 2012 and beyond.
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