EMERYVILLE, Calif., Nov. 04, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing rare disease therapies, today announced financial results for the three and nine months ended September 30, 2021, and provided a corporate update. The Company will host a conference call today, Thursday, November 4, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
“In the third quarter, we made significant progress against our corporate objectives in commercial operations and late-stage clinical development programs. We are pleased with the ongoing launch of FINTEPLA in the U.S. and EU and are encouraged with the positive trends that support continued adoption in Dravet syndrome. With the sNDA submitted for LGS, we are moving forward with regulatory submissions for LGS in the EU and a J-NDA in Japan for Dravet syndrome by the end of the year. We are excited to have the opportunity to potentially serve more patients who could benefit from FINTEPLA,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.
“Concurrently, we are advancing our late-stage development pipeline, notably our global Phase 3 study of FINTEPLA in CDD and concluding studies of MT1621 for the treatment of Tk2 deficiency,” concluded Dr. Farr.
Corporate Update
Third Quarter 2021 Financial Results
Nine Months Ended September 30, 2021 Financial Results Compared to Nine Months Ended September 30, 2020
Conference Call Details | |
Thursday, November 4, at 4:30 PM Eastern Time / 1:30 PM Pacific Time | |
Toll Free: | 855-327-6838 |
International: | 604-235-2082 |
Conference ID: | 10016695 |
Webcast: | http://public.viavid.com/index.php?id=146849 |
About Zogenix
Zogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution, has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs: one in a rare epilepsy called Lennox-Gastaut syndrome and one in a mitochondrial disease called TK2 deficiency. Zogenix also plans to initiate a study of FINTEPLA in a genetic epilepsy called CDKL5 Deficiency Disorder (CDD) and is collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies.
Forward Looking Statements
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 include: the timing and ability of Zogenix to complete regulatory submission in the EU and Japan for its product candidates; the expected timing of reporting data from clinical trials; the expected timing of review of Zogenix’s regulatory submissions including the sNDA for the treatment of seizures associated with LGS; Zogenix’s commercialization plans in the U.S. and Europe; and Zogenix’s plans with respect to its development programs. These statements are based on Zogenix’s current beliefs and expectations. 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: FINTEPLA may not achieve broad market acceptance as a treatment option of Dravet syndrome which would limit Zogenix’s ability to general revenues; Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program;; the COVID-19 pandemic may continue to disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA in Europe and Zogenix's ability to generate product revenue in Europe and conduct its development programs; unexpected adverse side effects or inadequate therapeutic efficacy of fenfluramine that could limit regulatory approval or commercialization, or that could result in recalls or product liability claims; later developments with FDA that may be inconsistent with the already completed meetings; additional data from Zogenix's ongoing studies may contradict or undermine the data previously reported; the potential for the FDA to delay timing of review of the sNDA due to the FDA's internal resource constraints or other reasons; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & 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.
CONTACTS:
Zogenix
[email protected]
Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | [email protected]
Media
Trish McCall, Porter Novelli
+1 (805) 390-3279 | [email protected]
ZOGENIX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)
(In thousands, except par value)
September 30, 2021 | December 31, 2020 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 106,138 | $ | 166,916 | ||||
Marketable securities | 236,886 | 338,193 | ||||||
Accounts receivable, net | 9,486 | 3,824 | ||||||
Inventory | 3,502 | 1,026 | ||||||
Prepaid expenses | 13,950 | 7,279 | ||||||
Other current assets | 5,500 | 4,936 | ||||||
Total current assets | 375,462 | 522,174 | ||||||
Property and equipment, net | 7,593 | 8,724 | ||||||
Operating lease right-of-use assets | 6,862 | 7,748 | ||||||
Intangible asset, net | 92,644 | 98,558 | ||||||
Goodwill | 6,234 | 6,234 | ||||||
Other non-current assets | 8,192 | 7,692 | ||||||
Total assets | $ | 496,987 | $ | 651,130 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 12,113 | $ | 11,945 | ||||
Accrued and other current liabilities | 46,111 | 54,964 | ||||||
Deferred revenue, current | 5,048 | 5,318 | ||||||
Current portion of operating lease liabilities | 1,654 | 1,688 | ||||||
Current portion of contingent consideration | 13,500 | 8,800 | ||||||
Total current liabilities | 78,426 | 82,715 | ||||||
Deferred revenue, noncurrent | 3,436 | 5,479 | ||||||
Operating lease liabilities, net of current portion | 9,055 | 10,314 | ||||||
Contingent consideration, net of current portion | 25,900 | 33,600 | ||||||
Convertible senior notes | 155,871 | 149,353 | ||||||
Total liabilities | 272,688 | 281,461 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Common stock and additional paid-in capital | 1,721,694 | 1,694,580 | ||||||
Accumulated deficit | (1,497,370 | ) | (1,324,840 | ) | ||||
Accumulated other comprehensive loss | (25 | ) | (71 | ) | ||||
Total stockholders’ equity | 224,299 | 369,669 | ||||||
Total liabilities and stockholders’ equity | $ | 496,987 | $ | 651,130 |
ZOGENIX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
(In thousands, except per share amounts)
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Revenues: | ||||||||||||||||
Net product sales | $ | 21,398 | $ | 1,520 | $ | 51,269 | $ | 1,520 | ||||||||
Collaboration revenue | 1,212 | 1,340 | 3,813 | 3,621 | ||||||||||||
Total revenues | 22,610 | 2,860 | 55,082 | 5,141 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product sales (excluding amortization of intangible asset) | 1,294 | 140 | 3,192 | 140 | ||||||||||||
Research and development | 33,255 | 34,425 | 100,868 | 102,038 | ||||||||||||
Selling, general and administrative | 39,559 | 24,583 | 104,713 | 70,332 | ||||||||||||
Intangible asset amortization | 1,972 | 1,971 | 5,914 | 1,971 | ||||||||||||
Acquired in-process research and development costs | — | 1,500 | — | 4,500 | ||||||||||||
Change in fair value of contingent consideration | 400 | 1,800 | 1,500 | 6,100 | ||||||||||||
Total costs and expenses | 76,480 | 64,419 | 216,187 | 185,081 | ||||||||||||
Loss from operations | (53,870 | ) | (61,559 | ) | (161,105 | ) | (179,940 | ) | ||||||||
Other income (expense), net: | ||||||||||||||||
Interest income | 85 | 934 | 579 | 2,504 | ||||||||||||
Interest expense | (3,848 | ) | — | (11,373 | ) | — | ||||||||||
Other, net | (371 | ) | 536 | (631 | ) | 20,798 | ||||||||||
Total other (expense) income, net | (4,134 | ) | 1,470 | (11,425 | ) | 23,302 | ||||||||||
Loss before income taxes | (58,004 | ) | (60,089 | ) | (172,530 | ) | (156,638 | ) | ||||||||
Income tax benefit | — | — | — | (17,425 | ) | |||||||||||
Net loss | $ | (58,004 | ) | $ | (60,089 | ) | $ | (172,530 | ) | $ | (139,213 | ) | ||||
Net loss per share, basic and diluted | $ | (1.04 | ) | $ | (1.08 | ) | $ | (3.09 | ) | $ | (2.62 | ) | ||||
Weighted average number of shares used in the calculation of basic and diluted net loss per common share | 55,905 | 55,548 | 55,831 | 53,039 |
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