Stephen J. Farr, Ph.D., president and chief operating officer of Zogenix, said, "In mid-July, the FDA accepted for review our NDA for Zohydro ER and provided a PDUFA date of March 1, 2013, in-line with our expectations for potential launch in the second quarter of 2013. For Relday, we enrolled the first patient in our open-label, safety and pharmacokinetic (PK) trial in July, keeping us on track with our goal to obtain the study data by year-end 2012. We believe that both Zohydro ER and Relday represent large new market opportunities for Zogenix and we continue to evaluate all potential commercialization options in order to maximize their value and potential for success. Finally, we recently announced the initiation of the DosePro technology co-marketing campaign with Battelle, which we believe will accelerate our partnership and out-licensing opportunities for DosePro within the biopharmaceutical industry."
Second Quarter 2012 Financial Results
Net product revenues for the second quarter were $8.0 million, reduced by a $630,000 net increase in the reserve for future product returns bringing the reserve balance to $2.9 million at June 30, 2012. This compares to net product revenues of $8.7 million in the second quarter 2011. In addition, total revenues for the second quarter 2011 included $1.6 million in contract revenue, reflecting the amortization of license and milestone payments received from the Company's co-promotion agreement with Astellas which ended March 31, 2012.
Cost of sales for the second quarter 2012 was $4.2 million, compared to $4.0 million in the second quarter 2011. Product gross margin was 48% in the second quarter 2012, compared to 54% in the second quarter 2011. The decrease in gross margin was driven primarily by a lower average net selling price, partially offset by lower per unit cost of sales.Royalty expense for the second quarter 2012 was $315,000, compared to $333,000 in the second quarter 2011, reflecting the impact of decreased net product revenue.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV