- 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 FDA for FINTEPLA
- 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 million in net proceeds to position Company well for next stage of growth
EMERYVILLE, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today provided a corporate update and announced financial results for the third quarter and nine months ended September 30, 2018.
“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 U.S. Food and Drug Administration (FDA) under a previously agreed NDA rolling submission plan,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We also recently held a successful pre-NDA meeting with the FDA to discuss certain aspects of the FINTEPLA NDA. Based on discussions at the meeting, we will conduct some additional analyses of our clinical data that could positively impact our product label. As a result, we now anticipate that the submission of the final sections of the NDA will occur in early first quarter 2019 versus the previously anticipated end of this year. Our centralized Marketing Authorization Application (MAA) submission to the European Medicines Agency (EMA) will occur shortly following the NDA submission.”
“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 Europe and Japan over the next several months. With our recently completed public offering raising $293 million in net proceeds, we believe Zogenix is now in a strong position to create significant long-term shareholder value with our advancing FINTEPLA programs in Dravet syndrome, Lennox Gastaut syndrome and other pipeline program opportunities.”
Corporate Update
- 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 million in 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 2018 issue 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 million in 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 million in 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 $1.08 per share, compared with a net loss of $42.8 million, or a net loss of $1.68 per share, in the third quarter ended September 30, 2017.
Nine Months Ended September 30, 2018 Financial Results Compared to Nine Months Ended September 30, 2017
- 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 million in 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 million in 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 million in 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 $2.78 per share, compared with a net loss of $87.1 million, or a net loss of $3.48 per share, in the nine months ended September 30, 2017.
- As of September 30, 2018, the Company had $539.1 million in cash and cash equivalents and marketable securities, compared to $293.5 million at December 31, 2017.
Conference Call
Thursday, November 8th @ 4:30 PM Eastern Time/1:30 PM Pacific Time
| Toll Free: | 877-407-9716 | |
| International: | 201-493-6779 | |
| Conference ID: | 13684016 | |
| Webcast: | http://public.viavid.com/index.php?id=131731 | |
| Replays available through November 22nd: | ||
| Domestic: | 844-512-2921 | |
| International: | 412-317-6671 | |
| Replay PIN: | 13684016 | |
About Zogenix
Zogenix (Nasdaq: ZGNX) is focused on developing therapies for patients with rare central nervous system (CNS) conditions that have limited or no treatment options, but face a critical need. For more information, visit www.zogenix.com.
Forward Looking Statement
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Zogenix's current beliefs and expectations. These forward-looking statements include statements regarding the timing of the NDA and MAA submissions for FINTEPLA in Dravet syndrome; the potential that additional data analyses could lead to enhanced product labeling; continued enrollment and the addition of clinical sites for Study 1601; potential regulatory approval and commercial launches of FINTEPLA in the U.S. and Europe; and the potential for Zogenix to create significant long-term shareholder value. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA, including potential delays in the timing of regulatory submissions; the top-line data Zogenix has reported is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA and other regulatory authorities may not agree with Zogenix’s interpretation of such results; potential delays in the commencement, enrollment and completion of clinical trials; Zogenix’s reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA may limit regulatory approval and/or commercialization, or may result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT:
Investors: Andrew McDonald
Founding Partner, LifeSci Advisors LLC
646-597-6987 | Andrew@lifesciadvisors.com
Media: David Polk
Senior Media Relations Strategist, Syneos Health
310-309-1029 | david.polk@syneoshealth.com
| Zogenix, Inc. | |||||||
| Condensed Consolidated Balance Sheets (Unaudited) | |||||||
| (in thousands, except par value) | |||||||
| September 30, 2018 | December 31, 2017 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 163,038 | $ | 293,503 | |||
| Marketable securities | 376,087 | — | |||||
| Prepaid expenses | 6,861 | 5,994 | |||||
| Other current assets | 1,286 | 5,206 | |||||
| Total current assets | 547,272 | 304,703 | |||||
| Property and equipment, net | 244 | 245 | |||||
| Intangible assets | 102,500 | 102,500 | |||||
| Goodwill | 6,234 | 6,234 | |||||
| Other assets | 3,380 | 3,931 | |||||
| Total assets | $ | 659,630 | $ | 417,613 | |||
| Liabilities and stockholders’ equity | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 4,110 | $ | 3,356 | |||
| Accrued clinical trial expenses | 10,674 | 8,657 | |||||
| Accrued compensation | 5,039 | 6,616 | |||||
| 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 | |||||
| Contingent consideration | 47,600 | 76,900 | |||||
| Deferred income taxes | 17,425 | 17,425 | |||||
| Other long-term liabilities | 482 | 784 | |||||
| Total liabilities | 120,850 | 116,092 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| 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, respectively | 42 | 35 | |||||
| Additional paid-in capital | 1,212,305 | 873,526 | |||||
| Accumulated deficit | (673,521 | ) | (572,040 | ) | |||
| Accumulated other comprehensive loss | (46 | ) | — | ||||
| Total stockholders’ equity | 538,780 | 301,521 | |||||
| Total liabilities and stockholders’ equity | $ | 659,630 | $ | 417,613 | |||
| Zogenix, Inc. | |||||||||||||||
| Condensed Consolidated Statements of Operations (Unaudited) | |||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||||
| 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): | |||||||||||||||
| Interest income | 2,133 | 121 | 3,995 | 332 | |||||||||||
| Interest expense | — | (702 | ) | (6 | ) | (2,065 | ) | ||||||||
| 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 | $ | (42,264 | ) | $ | (42,794 | ) | $ | (101,481 | ) | $ | (87,109 | ) | |||
| Net loss per share, basic and diluted: | |||||||||||||||
| Continuing operations | $ | (1.08 | ) | $ | (1.68 | ) | $ | (2.78 | ) | $ | (3.45 | ) | |||
| Discontinued operations | — | — | — | (0.03 | ) | ||||||||||
| Total | $ | (1.08 | ) | $ | (1.68 | ) | $ | (2.78 | ) | $ | (3.48 | ) | |||