Zogenix Provides Corporate Update and Reports Fourth Quarter and Full-Year 2018 Financial Results
- Completed rolling submission of an NDA to the U.S.
FDAand 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
FDAacceptance 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 millionin 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
“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
- Completed the rolling submission of an NDA to the U.S.
FDAand submitted an MAA to the EMA for FINTEPLA in February 2019, both for the treatment of seizures associated with Dravet syndrome.
-- EMA has accepted the MAA for review; outcome of regulatory review anticipated in the first quarter of 2020.
Zogenixexpects to receive notice from the FDAregarding NDA acceptance for filing and a PDUFA target date in the next several weeks.
- Continued U.S. and European commercial preparations for FINTEPLA. The Company is preparing for a U.S. commercial launch shortly following potential NDA approval.
- Continued enrollment in global Phase 3 trial of FINTEPLA for treatment of seizures associated with LGS (Study 1601).
- Presented data from nine abstracts, including four “late-breakers,” at the 2018
American Epilepsy SocietyAnnual Meeting.
-- Data from second pivotal Phase 3 trial (Study 1504) consistent with results of first pivotal Phase 3 trial (Study 1) in showing highly significant convulsive seizure reduction for FINTEPLA versus placebo.
-- Clinically meaningful reduction in convulsive seizure frequency for FINTEPLA maintained over Phase 3 open-label extension trial (Study 1503).
-- Positive findings on the impact of treatment with FINTEPLA on everyday executive function in patients with Dravet syndrome.
- Concluded year ended
December 31, 2018, with $514.2 millionin cash, cash equivalents, and marketable securities.
Fourth Quarter 2018 Financial Results
- Research and development expenses for the fourth quarter ended
December 31, 2018, totaled $23.6 million, up from $18.1 millionin the fourth quarter ended December 31, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of FINTEPLA in Dravet syndrome and LGS.
- Selling, general and administrative expenses for the fourth quarter ended
December 31, 2018, totaled $11.3 million, compared with $7.8 millionin the fourth quarter ended December 31, 2017.
- Net loss for the fourth quarter ended
December 31, 2018, was $22.4 million, or a net loss of $0.53per share, compared with a net loss of $39.7 million, or a net loss of $1.17per share in the fourth quarter ended December 31, 2017.
- Due to the wind-down of Sumavel DosePro manufacturing operations in
September 2017, the Company recorded no revenue for the year-ended December 31, 2018. This compares with total revenue of $9.8 millionin the year ended December 31, 2017, consisting entirely of contract manufacturing revenue for Sumavel DosePro.
- Research and development expenses for the 12 months ended
December 31, 2018, totaled $101 million, up from $67.4 millionin the 12 months ended December 31, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of FINTEPLA in Dravet syndrome and LGS.
- Selling, general and administrative expenses for the 12 months ended
December 31, 2018, were $39.0 million, compared with $25.9 millionin the 12 months ended December 31, 2017.
- Net loss for the 12 months ended
December 31, 2018, was $123.9 million, or a net loss of $3.27per share, compared with a net loss of $126.8 million, or a net loss of $4.65per share in the 12-months December 31, 2017.
- As of
December 31, 2018, the Company had $514.2 millionin cash, cash equivalents, and marketable securities, compared to $293.5 millionat December 31, 2017.
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Forward Looking Statement
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Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except par value)
|Cash and cash equivalents||$||68,454||$||293,503|
|Other current assets||11,825||5,206|
|Total current assets||532,730||304,703|
|Property and equipment, net||2,870||245|
|Liabilities and stockholders’ equity|
|Accrued clinical trial expenses||10,621||8,657|
|Other accrued liabilities||1,845||1,842|
|Current portion of contingent consideration||32,300||—|
|Common stock warrant liabilities||343||512|
|Total current liabilities||58,375||20,983|
|Deferred income taxes||17,425||17,425|
|Other long-term liabilities||3,830||784|
|Commitments and contingencies|
|Additional paid-in capital||1,218,710||873,526|
|Accumulated other comprehensive loss||3||—|
|Total stockholders’ equity||522,801||301,521|
|Total liabilities and stockholders’ equity||$||648,331||$||417,613|
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except per share amounts)
|Three Months Ended
|Twelve Months Ended
|Contract manufacturing revenue||$||—||$||—||$||—||$||9,821|
|Costs and expenses:|
|Cost of contract manufacturing||—||—||—||10,729|
|Research and development||23,596||18,080||100,925||67,449|
|Selling, general and administrative||11,287||7,756||38,950||25,885|
|Loss on contract termination||—||—||—||478|
|Change in fair value of contingent consideration||(1,900||)||12,500||1,300||24,100|
|Asset impairment charges||—||—||—||1,116|
|Total costs and expenses||32,983||38,336||141,175||129,757|
|Loss from operations||(32,983||)||(38,336||)||(141,175||)||(119,936||)|
|Other income (expense):|
|Loss on extinguishment of debt||—||(1,498||)||—||(4,876||)|
|Change in fair value of common stock warrant liabilities||264||(63||)||169||297|
|Other (expense) income, net||7,111||(24||)||10,126||47|
|Total other income (expense)||10,550||(1,406||)||17,459||(6,086||)|
|Loss from continuing operations before income taxes||(22,433||)||(39,742||)||(123,716||(126,022||)|
|Income tax benefit||-||(41||)||—|
|Net loss from continuing operations||(22,433||)||(39,783||)||(123,716||)||(126,022||)|
|Net loss (income) from discontinued operations, net of taxes||—||75||(198||)||(795||)|
|Net loss per share, basic and diluted||$||(0.53||)||$||(1.17||)||$||(3.27||)||$||(4.65||)|
Source: Zogenix, Inc.