After seeing the significant financial news from Pozen, Inc. (NasdaqGM: POZN) this week, we reached out to the management team to brief us on their Q2 profits (which reflect a $20 million milestone payment for VIMOVO from AZ) and outline Pozen’s strategy for the development and commercialization
of its PA family of products (the PA32540 Phase III program is progressing for the secondary prevention of CV events in patients at risk for gastric ulcers). Liz Cermak, Pozen's Chief Commercial Officer has been at the company one year now and is in a unique position to comment on where they’ve been and their blueprint for the future, particularly as they embark on the development and commercialization of their patented technology portfolio:
BioMedReports.Com: Tell us about POZEN and where the company is today:
Liz Cermak (Pozen's Chief Commercial Officer): POZEN is a progressive pharmaceutical company that is transforming how the healthcare industry meets unmet medical needs with a unique business model that transcends many of the pitfalls of traditional drug development and commercialization. With this model, POZEN has been able to gain FDA approval of two self-invented products in two years - something almost no other small pharmaceutical company has done. These products have and will continue to produce milestone and royalty payments to POZEN to fund current development and future commercialization of the PA portfolio. POZEN is applying the science of integrated therapies and the technology proven with VIMOVO to develop a portfolio of products intended to significantly reduce GI ulcers and other GI complications compared to taking aspirin alone. The first product candidate, PA32540, uses POZEN’s patented technology to combine IR omeprazole and EC aspirin, and is being investigated for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers. PA32540 entered Phase 3 in 4Q09, with POZEN targeting NDA submission sometime in 2012 and potential launch in 2013. POZEN will retain control of commercialization of the PA product candidates which we expect will provide even greater shareholder value in this growth oriented specialty pharma company.
BioMedReports.Com: You recently released 2Q earnings and the news was significant. Can you tell us why?
Bill Hodges (Pozen's Chief Financial Officer): POZEN reported 2Q net income of $16.2 million, the highest quarterly profit in the Company’s history. This large profit resulted from the receipt of a $20 million milestone payment from AstraZeneca for the FDA approval of the VIMOVO NDA. The Company continues to invest in its pipeline products and is projecting a $3-$5 million loss for the year. This outlook, in part, assumes phase 3 trials for our higher dose aspirin product, PA65020, will be initiated in 4Q10.
BioMedReports.Com: Why should investors consider POZEN's value proposition over other companies in their space?
Liz Cermak (Pozen's CCO): POZEN is a bit unique in "its space". Unlike others of its size, it has successfully developed and obtained FDA approval for 2 products in 2 years. Its unique in-source business model has achieved a 300% return on investment on those 2 products, securing VIMOVO approval within just 32 months of the start of Phase 3. It has done so without incurring debt or raising money since its IPO in 2000. POZEN is now developing a PA portfolio of integrated aspirin therapies designed to enable to full power of aspirin by reducing its GI toxicity. With 20% of people on low-dose aspirin at risk for serious GI complications, the market opportunity, across a number of indications, can be substantial. The first PA pipeline product, PA32540, as mentioned, is in Phase 3. POZEN plans to retain control of the commercialization of these products which will allow it to capture the full value of the commercial assets. Qualitative market research with physicians, payers and patients indicates a high receptivity to PA32540, including among payers, with POZEN preparing to deliver these products to the marketplace at affordable prices made possible by the lean and efficient infrastructure of the insource model, and a modern approach to customer communications.
BioMedReports.Com: Is there anything investors should be paying attention to going forward?
Liz Cermak (COO): (1) We expect to have a decision around the Treximet litigation in 4Q09/1Q10 and are optimistic about its outcome. (2) We are excited about the prospects for VIMOVO in the hands of our world-class marketing partner AstraZeneca. With a 4Q10 launch, we don't expect much revenue this year, but are optimistic about the progress that will be made in 2011. We also look forward to the $25MM milestone that will be paid to us on the first major ex-US approval and reimbursement decision, which we anticipate in early 2011. (3) PA32540 is in Phase 3, with an NDA filing in 2012. You will begin to see some data on the product and we will be sharing some information around the commercial strategy and market research on the product's market potential in the coming quarters.
With a strong and disciplined financial foundation, we are excited to be investing in the company's growth and look forward to what POZEN can deliver from its PA pipeline.
Disclosure: No Positions
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