This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

POZEN Reports Second Quarter 2013 Results

Stocks in this article: POZN

POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, today announced results for the second quarter ended June 30, 2013.

Recent Corporate Highlights

  • POZEN announced that the U.S. Food and Drug Administration (FDA) accepted for review, the New Drug Application (NDA) for PA8140/PA32540. Both products are coordinated-delivery tablets combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. The FDA has assigned a user fee goal date of January 24, 2014. POZEN is seeking approval for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
  • 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.
  • Data from a post-hoc analysis of diabetic subpopulation results from two POZEN Phase 3 PA32540 (325 mg EC aspirin / 40 mg immediate-release omeprazole) studies were presented at the American Diabetes Association’s 73 rd Scientific Session. Nearly 40% of patients in the Phase 3 studies had diabetes and were on aspirin (325 mg) for secondary prevention of cardiovascular (CV) events. In this subpopulation (n=400), PA32540 was associated with a significantly lower rate of endoscopic gastroduodenal ulcers as compared to taking aspirin alone (2.3% vs. 11.2%, p<0.001). A lower rate of treatment discontinuation was also observed in this subpopulation (1.4% vs. 5.9%, p=0.018).
  • On July 26, 2013, the United States Court of Appeals for the Federal Circuit denied a petition by Par Pharmaceuticals Inc. (Par) and Doctor Reddy’s Laboratories (DRL) for a rehearing en banc in connection with its September 2012 decision holding that U.S. Patent 7,332,183 covering the Treximet formulation was valid, enforceable and infringed by their respective Abbreviated New Drug Application (ANDA) products.
  • Partnership discussions for PA continue to progress. While there can be no assurances, the Company continues to expect to close a partnership deal in 2013.
  • Q2 2013 global net sales of VIMOVO by AstraZeneca, as defined under our agreement, were $23.3 million, up 19% from Q1 2013 and 41% vs. Q2 2012. POZEN earned a royalty of $1.7 million in Q2 2013, a 30% increase over Q2 2012. As discussed in our Q1 Earnings Call, AstraZeneca is discontinuing certain promotional activities in countries where they have not seen a positive effect, including the U.S. and most of the E.U.

Second Quarter Results

For the second quarter of 2013, POZEN reported revenue of $1.7 million compared to total revenue of $1.8 million for the second quarter of 2012. Revenue for 2013 was royalty for sales of VIMOVO and revenue for 2012 was comprised of $1.3 million VIMOVO royalty and $0.5 million licensing revenue of MT400.

1 of 5

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
DOW 16,476.57 +76.90 0.47%
S&P 500 1,924.10 +20.09 1.06%
NASDAQ 4,371.1740 +55.10 1.28%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs