Zogenix, Inc. (NASDAQ:ZGNX) Q3 2019 Earnings Conference Call Transcript

Nov 07, 2019 • 04:30 pm ET

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Zogenix, Inc. (NASDAQ:ZGNX) Q3 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Greetings. Welcome to the Zogenix Inc. Third Quarter 2019 Financial Results Conference Call. [Operator Instructions] Please note this conference is being recorded.

I will now turn the call over to your host Mr. Brian Ritchie from LifeSci Advisors. Please go ahead.

Executive
Brian Ritchie

Thank you operator and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Dr. Stephen Farr; and Chief Financial Officer Michael Smith. In addition Dr. Gail Farfel Chief Development Officer; Ashish Sagrolikar Chief Commercial Officer; and Dr. Joanne Quan Chief Medical Officer of Zogenix's subsidiary Modis Therapeutics will also be available during the Q&A session. This afternoon Zogenix issued a news release announcing financial results and providing a business update for the third quarter ended September 30 2019. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. We caution listeners that during this call Zogenix management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Zogenix's press release issued today and the company's SEC filings including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast November 7 2019. Zogenix undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call.

Now I'd like to turn the call over to Steve.

Executive
Stephen J. Farr

Thank you Brian and good afternoon to everyone who's joining us on today's call. Late in the third quarter on September 26 we were pleased to announce that we had resubmitted our NDA for FINTEPLA our lead product candidate for the treatment of seizures associated with Dravet syndrome to the FDA. Accordingly we expect to lay out the acceptance for filing by the FDA in the early to mid-December time frame. Assuming the FINTEPLA NDA is accepted for review and if the FDA grants priority review our PDUFA target date could be as soon as the end of the first quarter of 2020. In parallel our MAA for FINTEPLA for the treatment of seizures associated with Dravet syndrome which was submitted and accepted in early 2019 remains under active review by the European regulatory authorities. Over the last several quarters we have been actively engaged with reviewers in Europe to assist in their assessment of our application and advance the process towards a final opinion in 2020.

As the review of these important regulatory submissions advances we continue to collaborate with leading experts to further analyze our clinical data set in order to expand the body of evidence in support of FINTEPLA for the treatment of Dravet syndrome. In October we presented 5 posters at the Child Neurology Society Annual Meeting highlighting new data demonstrating