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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.