Zogenix (ZGNX) Misses Q4 EPS by 20c, Revenues Beat

Zogenix (NASDAQ: ZGNX) reported Q4 EPS of ($1.26), $0.20 worse than the analyst estimate of ($1.06). Revenue for the quarter came in at $1.95 thousand versus the consensus estimate of $440 thousand.

Fourth Quarter 2019 Financial Results

• The Company recorded $1.9 million in revenue for the fourth quarter ended December 31, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
• Research and development expenses for the fourth quarter ended December 31, 2019, totaled $35.8 million, up from $23.6 million in the fourth quarter ended December 31, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
• Selling, general and administrative expenses for the fourth quarter ended December 31, 2019, totaled $18.7 million, compared with $11.3 million in the fourth quarter ended December 31, 2018. The increase was driven by commercial launch preparations.
• Net loss for the fourth quarter ended December 31, 2019, was $56.1 million, or a net loss of $1.26 per share, compared with a net loss of $22.4 million, or a net loss of $0.53 per share, in the fourth quarter ended December 31, 2018.

“The last six months have been especially active as we continued to advance our lead programs through the development and regulatory review processes. In the fourth quarter, the U.S. Food and Drug Administration (FDA) accepted our New Drug Application (NDA) filing for FINTEPLA® in Dravet syndrome with Priority Review,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “While our Prescription Drug User Fee Act (PDUFA) target action date was recently extended by three months to June 25, 2020, in response to an information request from the FDA, we remain very confident in the data supporting our NDA submission, and continue to actively prepare for the potential commercial launch of FINTEPLA.”

“Additionally, we are pleased to announce that the results from an interim analysis of our ongoing open-label extension (OLE) study in Dravet syndrome continues to show clinically meaningful reductions in convulsive seizure frequency for up to two years of treatment, further highlighting that FINTEPLA may be an important new treatment option for patients with Dravet syndrome,” continued Dr. Farr.

“In a different rare epilepsy, Lennox-Gastaut syndrome (LGS), we were very pleased with the recently announced positive top-line results from Study 1601, our global, pivotal Phase 3 trial in LGS, which highlight FINTEPLA’s potential to also be an important new treatment option for LGS, one of the most difficult to treat rare epilepsies,” concluded Dr. Farr.

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

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