Zogenix (ZGNX) Tops Q4 EPS by 51c

Zogenix (NASDAQ: ZGNX) reported Q4 EPS of ($0.53), $0.51 better than the analyst estimate of ($1.04).

• Completed rolling submission of an NDA to the U.S. FDA and an MAA to the EMA for FINTEPLA® for the treatment of seizures associated with Dravet syndrome in February 2019-- EMA has accepted MAA for review; outcome of the MAA review by the EMA expected in Q1 2020-- Notice regarding FDA acceptance of NDA filing and notification of PDUFA target date expected in next several weeks
• Continued to advance enrollment of global Phase 3 trial of FINTEPLA for the treatment of Lennox-Gastaut syndrome (Study 1601)
• Presented data from nine abstracts, including four “late-breakers,” at the 2018 AES Annual Meeting
• Concluded full-year 2018 with $514.2 million in cash, cash equivalents, and marketable securities

“We are pleased that our recently submitted Marketing Authorization Application (MAA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome, an often-catastrophic epileptic encephalopathy that begins in infancy, has been accepted by the European Medicines Agency (EMA),” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We expect an outcome of the MAA review by the EMA in the first quarter of 2020. We are awaiting a filing status and a potential Prescription Drug User Fee Act (PDUFA) target date from the U.S. Food & Drug Administration (FDA) following completion of our rolling submission of a New Drug Application (NDA) for FINTEPLA in early February this year. We remain focused on preparing for the potential launch of FINTEPLA in the U.S. and Europe and have achieved meaningful progress in building and expanding our commercial organization in recent months.”

“Recruitment continues to progress well in our ongoing global Phase 3 trial (Study 1601) of FINTEPLA for the treatment of Lennox-Gastaut syndrome (LGS), another difficult-to-treat childhood-onset epileptic encephalopathy. The study now includes a significant number of European sites, which either have been activated or will shortly open during this quarter. We expect to complete enrollment in Study 1601 later this year and report top-line results in the first quarter of 2020. In addition, we anticipate initiating a randomized placebo-controlled trial in Doose syndrome, another severe and often treatment-resistant childhood epilepsy, in the second half of 2019.

“Importantly, our business is supported by an extremely strong balance sheet, as we ended 2018 with $514.2 million in cash, cash equivalents, and marketable securities,” concluded Dr. Farr.

For earnings history and earnings-related data on Zogenix (ZGNX) click here.

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