Zogenix Provides Corporate Update and Reports First Quarter 2019 Financial Results
- Type A meeting with U.S.
FDAexpected by early June to discuss FINTEPLA® Dravet syndrome NDA expected by early June
- FINTEPLA Dravet syndrome MAA accepted for review by EMA
- Exclusive distribution agreement for FINTEPLA in
Japansigned with Nippon Shinyaku
“In the U.S., our priority remains working with the
“Our Marketing Authorization Application (MAA) for FINTEPLA in Dravet syndrome submitted to
- FINTEPLA for the treatment of seizures associated with Dravet syndrome
• MAA accepted for review by the EMA.
• RTF letter received from the U.S.
FDAregarding the submitted NDA for FINTEPLA for the treatment of seizures associated with Dravet syndrome.
• FDA Type A meeting expected to take place by early June to gain clarity on NDA resubmission.
FDAhas not requested or recommended additional clinical efficacy or safety studies of FINTEPLA.
- FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS)
• Advanced enrollment in ongoing global Phase 3 clinical trial (Study 1601) of FINTEPLA for the treatment of seizures associated with LGS; full enrollment expected in second half of 2019.
• Top-line LGS study results anticipated in Q1 2020.
- FINTEPLA in
• Entered into an exclusive distribution agreement with
Nippon Shinyaku, Co., Ltd.for the commercialization of FINTEPLA in Japan.
Zogenixretains responsibility for completing its global clinical development programs for FINTEPLA, including those already underway to support the Company’s planned submissions of new drug applications in Japanfor Dravet syndrome and LGS.
Zogenixto receive $20 millionupon signing and over the next two years, and will also be eligible to receive future regulatory and sales-based milestone payments worth up to $108.5 million.
Zogenixto supply product to Nippon Shinyakuand receive a tiered transfer price of up to a high-double digit percentage of the annual net sales of FINTEPLA in Japan.
First Quarter 2019 Financial Results
- Research and development expenses for the first quarter ended
March 31, 2019, totaled $24.4 million, up from $23.0 millionin the first quarter ended March 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 first quarter ended
March 31, 2019, totaled $10.9 million, compared with $8.1 millionin the first quarter ended March 31, 2018.
- Net loss for the first quarter ended
March 31, 2019, was $35.2 million, or a net loss of $0.83per share, compared with a net loss of $30.2 million, or a net loss of $0.87per share, in the first quarter ended March 31, 2018.
- As of
March 31, 2019, the Company had $480.7 millionin cash, cash equivalents, and marketable securities, compared to $514.2 millionat December 31, 2018.
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Forward Looking Statement
Senior Director, Corporate Communications
+1 (858) 449 9575 | firstname.lastname@example.org
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Condensed Consolidated Balance Sheets (Unaudited)
|Cash and cash equivalents||$||58,288||$||68,454|
|Other current assets||6,323||11,825|
|Total current assets||510,589||532,730|
|Property and equipment, net||10,632||2,870|
|Operating lease right-of-use assets||8,423||—|
|Liabilities and stockholders’ equity:|
|Accrued and other current liabilities||18,594||18,086|
|Deferred revenue, current||5,000||—|
|Current portion of operating lease liabilities||1,412||—|
|Current portion of contingent consideration||22,800||32,300|
|Total current liabilities||55,973||58,375|
|Deferred revenue, noncurrent||10,500||—|
|Operating lease liabilities, net of current portion||11,355||—|
|Contingent consideration, net of current portion||48,400||45,900|
|Deferred income taxes||17,425||17,425|
|Other long-term liabilities||—||3,830|
|Commitments and contingencies|
|Additional paid-in capital||1,227,620||1,218,710|
|Accumulated other comprehensive income||373||3|
|Total stockholders’ equity||496,879||522,801|
|Total liabilities and stockholders’ equity||$||640,532||$||648,331|
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except per share amounts)
|Three Months Ended March 31,|
|Research and development||$||24,352||$||22,980|
|Selling, general and administrative||10,918||8,070|
|Change in fair value of contingent consideration||3,000||—|
|Total operating expenses||38,270||31,050|
|Loss from operations||(38,270||)||(31,050||)|
|Other income (expense):|
|Other (expense) income, net||(88||)||37|
|Total other income||3,068||870|
|Net loss per share, basic and diluted||$||(0.83||)||$||(0.87||)|
|Weighted average common shares used in the calculation of basic and diluted net loss per common share||42,236||34,841|
Source: Zogenix, Inc.