Zogenix (ZGNX) Misses Q3 EPS by 10c, Revenues Beat

Zogenix (NASDAQ: ZGNX) reported Q3 EPS of ($1.08), $0.10 worse than the analyst estimate of ($0.98). Revenue for the quarter came in at $2.86 million versus the consensus estimate of $2.51 million.

“This continues to be a very positive and rewarding year for Zogenix as our deeply experienced international teams successfully advance key clinical, regulatory, and commercial programs,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “The strong physician and patient adoption of FINTEPLA® in this early stage of our U.S. launch and the recent positive opinion from the Committee for Medicinal Products for Human Use (CHMP) speak to FINTEPLA’s effectiveness, safety, and potential to provide meaningful and lasting seizure control for more Dravet syndrome patients. This increases our excitement for our next set of major FINTEPLA milestones – anticipated approval for Dravet syndrome in Europe later this year, regulatory submission for Dravet syndrome in Japan next year, and regulatory submissions for Lennox-Gastaut syndrome (LGS) in the U.S. and Europe, also next year.”

“Equally important,” said Dr. Farr, “following a productive meeting with the U.S. Food and Drug Administration (FDA), we believe we have a clearly defined development and regulatory path for MT1621, our late-stage investigational therapy for the treatment of the often-fatal mitochondrial disease thymidine kinase 2 deficiency (TK2d), for which no approved therapies currently exist. Our goal is to have all required data in hand by the end of 2021 to enable a planned New Drug Application (NDA) submission in 2022.”

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

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