This Day On The Street
Continue to site
ADVERTISEMENT
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

Zogenix Reports First Quarter 2013 Financial Results

Provides Update on Zohydro ER Conference Call and Webcast Today, May 9, at 4:30 p.m. ET

SUMAVEL ® DosePro ® (sumatriptan injection) First Quarter 2013 Highlights

  • Net product revenue of $7.0 million, reflecting a $1.2 million net adjustment to future product return reserve
  • Generated approximately 20,000 total prescriptions
  • Maintained positive quarterly refill rate at 41%*

Recent Highlights and Milestones

  • Reported positive top-line results from extended Relday™ Phase 1 clinical trial; initiated efforts to secure strategic development and commercialization partner
  • Extended DosePro® needle-free drug delivery system co-marketing partnership with Battelle

SAN DIEGO, May 9, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today reported financial results for the first quarter ended March 31, 2013.

Roger Hawley, chief executive officer of Zogenix, stated, "We recently had an update call with the FDA regarding the status of the Zohydro ER new drug application (NDA). On the call, the FDA indicated that they are preparing to take action on the Zohydro NDA in the summer 2013. While they declined to provide any specific reasons for the delay, we have concluded the FDA are working on several broader opioid-related issues that need to be addressed prior to an action on our NDA. We were not informed of any deficiencies in the application, which suggests that the remaining steps in the review process are finalizing the Zohydro ER REMS, to be consistent with the updated class-wide REMS, and labeling discussions. We are disappointed with the ongoing delay, and remain prepared to launch the product three to four months after potential approval."

First Quarter 2013 Financial Results

Net product revenues for the first quarter 2013 were $7.0 million, which included a $1.2 million net adjustment to the future product return reserve that was primarily due to shorter dating of products sold in the first quarter 2012, as well as ordering patterns by a large retailer during the same period. This compared to net product revenues of $9.9 million in the first quarter 2012. The decrease in net product revenues was driven by the increase to the return reserve and the resetting of health insurance co-pays and co-insurance at the beginning of the year, which slowed patient volumes to a greater degree than in previous years. Additionally, there were significantly fewer sales representatives promoting SUMAVEL DosePro during the first quarter 2013 compared to the same period of 2012. During the first quarter 2012, total revenues of $18.3 million also included $8.5 million in contract revenue related to the Company's previous co-promotion agreement with Astellas, which ended March 31, 2012.

1 of 5

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
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!
SYM TRADE IT LAST %CHG

Markets

DOW 17,826.30 -279.47 -1.54%
S&P 500 2,081.18 -23.81 -1.13%
NASDAQ 4,931.8150 -75.9760 -1.52%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs