POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the fourth quarter and year ended December 31, 2013.
2013 and Recent Corporate Highlights
- In September 2013, POZEN and Sanofi US announced the signing of an exclusive license agreement for the commercialization of PA8140/PA32540. Under the terms of the agreement, Sanofi US will have exclusive rights to commercialize all PA combinations that contain 325 mg or less of enteric-coated aspirin in the United States. POZEN received an upfront payment of $15 million and will be eligible for pre-commercial milestone payments of up to $20 million and other future milestone payments and royalties on product sales. Sanofi US has responsibility for all sales, marketing, ongoing manufacturing and future development for the licensed PA products in the U.S. POZEN retains responsibility for obtaining approval of the NDA, after which time POZEN will transfer the NDA to Sanofi US.
- In November 2013, AstraZeneca AB and Horizon Pharma USA, Inc. (NASDAQ: HZNP) announced that they entered into an agreement for Horizon to acquire the U.S. rights for VIMOVO ® (naproxen / esomeprazole magnesium) delayed release tablets. Under the terms of the agreement, POZEN will continue to receive a 10% royalty on net sales of products sold in the United States, with guaranteed annual minimum royalty payments of $5 million in 2014, and $7.5 million each year thereafter, provided that the patents owned by POZEN which cover VIMOVO are in effect and no generic forms of VIMOVO are on the market. Also under the agreement, Horizon has assumed AstraZeneca’s right to lead the on-going Paragraph IV litigation for VIMOVO and will assume all patent-related defense costs relating to such litigation, including reimbursement for a specified amount of the cost of counsel retained by POZEN. AstraZeneca will continue to have rights to commercialize VIMOVO outside of the United States.
- The POZEN Board of Directors declared a special cash distribution of $1.75 per share to all stockholders of record as of the close of business on December 11, 2013, and payment was made on December 30, 2013. This distribution represented a surplus of corporate cash and was treated as a return of capital to stockholders.
- Results from POZEN’s Phase 1 study, PA10040-101, demonstrated that PA10040, POZEN’s proprietary combination of aspirin (100 mg) and omeprazole (40 mg), had comparable bioavailability, and is bioequivalent to a European Union (E.U.) reference listed enteric-coated (EC) aspirin (100 mg). The 100 mg dose of aspirin is most commonly used in Europe and in other ex-U.S. regions.
- Q4 2013 global net sales of VIMOVO by AstraZeneca, as defined under our agreement, were $25 million, up 36% vs. Q4 2012 and up 9% from Q3 2013. POZEN earned a royalty of $1.7 million in Q4 2013. Total 2013 net sales of VIMOVO were $91 million, up 42% from 2012, and POZEN earned a royalty of $6.3 million, up 30% year on year. We anticipate continued growth in VIMOVO sales and royalties this year.
Fourth Quarter Results
For the fourth quarter of 2013, POZEN reported total revenue of $4.7 million, resulting from $1.7 million VIMOVO royalty and $3.0 million from the amortization of the $15 million upfront fee for the licensing of PA. The upfront payment is being amortized over fifteen months starting in September 2013. For the fourth quarter of 2012, the Company reported total revenue of $1.4 million of VIMOVO royalty.