Zogenix Provides Corporate Update and Reports Third Quarter Financial Results
- Reported positive top-line results from second pivotal Phase 3 trial of FINTEPLA® (ZX008) in patients with Dravet syndrome, Study 1504
- Initiated rolling NDA submission to
- Continued to advance enrollment of global Phase 3 trial of FINTEPLA for treatment of Lennox-Gastaut syndrome, Study 1601
- Completed successful public offering of
$293 millionin net proceeds to position Company well for next stage of growth
“Following the completion of our positive, confirmatory Study 1504 Phase 3 trial of our investigational drug, FINTEPLA, in patients with Dravet syndrome, we began submission of a New Drug Application (NDA) for rolling review by the
“In parallel to our work on regulatory submissions, we continue to actively prepare for the potential launch of FINTEPLA in the U.S. and Europe,” continued Dr. Farr. “Moreover, we are pleased with the pace of enrollment in our Phase 3 trial of FINTEPLA in Lennox-Gastaut Syndrome (LGS), Study 1601. There are over 30 sites open for patient enrollment, primarily located in the U.S, and we are now focused on the addition of study sites in
- Reported positive top-line results from Study 1504, the second pivotal Phase 3 clinical trial of FINTEPLA in Dravet syndrome. The study achieved statistical significance on the primary and all key secondary endpoints.
- Conducted positive pre-NDA meeting with
FDA; began rolling submission of NDA for FINTEPLA for the treatment of seizures associated with Dravet syndrome.
- Continued U.S. and European commercial preparations for FINTEPLA.
- Continued enrollment in global Phase 3 trial of FINTEPLA for treatment of seizures associated with LGS, Study 1601.
- Successfully raised approximately
$293 millionin net proceeds in a public offering of common stock.
- Presented new findings from multiple studies assessing the psychological and socioeconomic impact of epileptic encephalopathies, such as Dravet syndrome, in the U.S. and Europe, as well as new results from an ongoing open-label prospective study of FINTEPLA in Dravet syndrome, at the 13th
European Congress on Epileptology.
- Detailed results of the Phase 2, open-label study evaluating FINTEPLA for the treatment of refractory patients with LGS were published in the
September 2018issue of Epilepsia.
Third Quarter 2018 Financial Results
- Research and development expenses for the third quarter ended September 30, 2018, totaled
$27.6 million, up from $21.2 millionin the third quarter ended September 30, 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 third quarter ended September 30, 2018, totaled
$11.0 million, compared with $6.1 millionin the third quarter ended September 30, 2017.
- Net loss for the third quarter ended September 30, 2018, was
$42.3 million, or a net loss of $1.08per share, compared with a net loss of $42.8 million, or a net loss of $1.68per share, in the third quarter ended September 30, 2017.
Nine Months Ended
- Due to the wind-down of Sumavel DosePro manufacturing operations in
September 2017, the Company recorded no revenue for the nine months ended September 30, 2018. This compares with total revenue of $9.8 millionin the nine month period ended September 30, 2017, consisting entirely of contract manufacturing revenue for Sumavel DosePro.
- Research and development expenses for the nine months ended
September 30, 2018, totaled $77.3 million, up from $49.4 millionin the nine months ended September 30, 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 nine months ended
September 30, 2018, totaled $27.7 million, compared with $18.1 millionin the nine months ended September 30, 2017.
- Net loss for the nine months ended
September 30, 2018, was $101.5 million, or a net loss of $2.78per share, compared with a net loss of $87.1 million, or a net loss of $3.48per share, in the nine months ended September 30, 2017.
- As of
September 30, 2018, the Company had $539.1 millionin cash and cash equivalents and marketable securities, compared to $293.5 millionat December 31, 2017.
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Forward Looking Statement
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|Condensed Consolidated Balance Sheets (Unaudited)|
|(in thousands, except par value)
|Cash and cash equivalents||$||163,038||$||293,503|
|Other current assets||1,286||5,206|
|Total current assets||547,272||304,703|
|Property and equipment, net||244||245|
|Liabilities and stockholders’ equity|
|Accrued clinical trial expenses||10,674||8,657|
|Other accrued liabilities||2,413||1,842|
|Current portion of contingent consideration||32,500||—|
|Common stock warrant liabilities||607||512|
|Total current liabilities||55,343||20,983|
|Deferred income taxes||17,425||17,425|
|Other long-term liabilities||482||784|
|Commitments and contingencies|
|Preferred stock, $0.001 par value; 10,000 shares authorized; none issued and outstanding||—||—|
|Common stock, $0.001 par value; 50,000 shares authorized; 41,925 and 34,808
shares issued and outstanding at September 30, 2018 and December 31, 2017,
|Additional paid-in capital||1,212,305||873,526|
|Accumulated other comprehensive loss||(46||)||—|
|Total stockholders’ equity||538,780||301,521|
|Total liabilities and stockholders’ equity||$||659,630||$||417,613|
|Condensed Consolidated Statements of Operations (Unaudited)|
|(in thousands, except per share amounts)
|Three Months Ended
|Nine Months Ended
|Contract manufacturing revenue||$||—||$||—||$||—||$||9,821|
|Costs and expenses:|
|Cost of contract manufacturing||—||—||—||10,729|
|Research and development||27,608||21,178||77,329||49,369|
|Selling, general and administrative||11,016||6,073||27,663||18,129|
|Loss on contract termination||—||478||—||478|
|Asset impairment charges||—||196||—||1,116|
|Change in fair value of contingent consideration||5,700||10,500||3,200||11,600|
|Total costs and expenses||44,324||38,425||108,192||91,421|
|Loss from operations||(44,324||)||(38,425||)||(108,192||)||(81,600||)|
|Other income (expense):|
|Loss on extinguishment of debt||—||(3,378||)||—||(3,378||)|
|Change in fair value of common stock warrant liabilities||(64||)||(380||)||(95||)||360|
|Other (expense) income, net||(9||)||62||3,015||71|
|Total other income (expense)||2,060||(4,277||)||6,909||(4,680||)|
|Loss from continuing operations before income taxes||(42,264||)||(42,702||)||(101,283||)||(86,280||)|
|Income tax benefit||—||42||—||41|
|Net loss from continuing operations||(42,264||)||(42,660||)||(101,283||)||(86,239||)|
|Loss from discontinued operations, net of taxes||—||(134||)||(198||)||(870||)|
|Net loss per share, basic and diluted:|
Source: Zogenix, Inc.