EMERYVILLE, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced financial results for the three and six months ended June 30, 2021, and provided a corporate update. The Company will host a conference call today, Thursday, August 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
“We are encouraged by the continued momentum of our launch of FINTEPLA® in Dravet syndrome in the U.S. and Europe and remain focused on driving broader adoption of FINTEPLA as in-person physician visits increase and physicians and families move forward with new treatment decisions,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix.
“In addition to our growing commercial presence, we continue to expand and achieve significant progress in advancing our late-stage development portfolio. Following three productive meetings with the FDA recently, we remain on track with our pipeline initiatives for FINTEPLA and MT1621,” concluded Dr. Farr.
Corporate Update
Second Quarter 2021 Financial Results
Six Months Ended June 30, 2021 Financial Results Compared to Six Months Ended June 30, 2020
Conference Call Details | |
Thursday, August 5, at 4:30 PM Eastern Time / 1:30 PM Pacific Time | |
Toll Free: | 800-347-6311 |
International: | 323-994-2131 |
Conference ID: | 6229003 |
Webcast: | http://public.viavid.com/index.php?id=145894 |
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 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 include: the timing and ability of Zogenix to complete regulatory submissions in the U.S. and Europe for its product candidates; the expected timing of initiation of clinical trials; potential future adoption of FINTEPLA and the potential impact of COVID-19; Zogenix’s plans to commercialize fenfluramine in 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 the company’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 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 commercialization, or that could result in recalls or product liability claims; later developments with FDA that may be inconsistent with the already completed meetings; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval for additional indications and/or commercialization; additional data from Zogenix’s ongoing studies may contradict or undermine the data previously reported; 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
Melinda Baker
Senior Director, Corporate Communications
+1 (510) 788-8732 | [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) | |||||||
June 30, 2021 | December 31, 2020 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 139,083 | $ | 166,916 | |||
Marketable securities | 254,199 | 338,193 | |||||
Accounts receivable, net | 7,702 | 3,824 | |||||
Inventory | 2,923 | 1,026 | |||||
Prepaid expenses and other current assets | 12,487 | 12,215 | |||||
Total current assets | 416,394 | 522,174 | |||||
Property and equipment, net | 7,985 | 8,724 | |||||
Operating lease right-of-use assets | 7,103 | 7,748 | |||||
Intangible asset, net | 94,615 | 98,558 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other non-current assets | 7,742 | 7,692 | |||||
Total assets | $ | 540,073 | $ | 651,130 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 10,831 | $ | 11,945 | |||
Accrued and other current liabilities | 42,774 | 54,964 | |||||
Deferred revenue, current | 4,953 | 5,318 | |||||
Current portion of operating lease liabilities | 1,783 | 1,688 | |||||
Current portion of contingent consideration | 9,000 | 8,800 | |||||
Total current liabilities | 69,341 | 82,715 | |||||
Deferred revenue, noncurrent | 4,742 | 5,479 | |||||
Operating lease liabilities, net of current portion | 9,496 | 10,314 | |||||
Contingent consideration, net of current portion | 30,000 | 33,600 | |||||
Convertible senior notes | 153,634 | 149,353 | |||||
Total liabilities | 267,213 | 281,461 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock and additional paid-in capital | 1,712,350 | 1,694,580 | |||||
Accumulated deficit | (1,439,366 | ) | (1,324,840 | ) | |||
Accumulated other comprehensive loss | (124 | ) | (71 | ) | |||
Total stockholders’ equity | 272,860 | 369,669 | |||||
Total liabilities and stockholders’ equity | $ | 540,073 | $ | 651,130 |
ZOGENIX, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share amounts) | |||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||
Revenues: | |||||||||||||||
Net product sales | $ | 17,523 | $ | — | $ | 29,871 | $ | — | |||||||
Collaboration revenue | 1,266 | 1,032 | 2,601 | 2,281 | |||||||||||
Total revenues | 18,789 | 1,032 | 32,472 | 2,281 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of product sales (excluding amortization of intangible asset) | 1,222 | — | 1,898 | — | |||||||||||
Research and development | 36,644 | 34,373 | 67,613 | 67,613 | |||||||||||
Selling, general and administrative | 33,883 | 24,431 | 65,154 | 45,749 | |||||||||||
Intangible asset amortization | 1,971 | — | 3,942 | — | |||||||||||
Acquired in-process research and development costs | — | 1,500 | — | 3,000 | |||||||||||
Change in fair value of contingent consideration | 500 | 12,200 | 1,100 | 4,300 | |||||||||||
Total costs and expenses | 74,220 | 72,504 | 139,707 | 120,662 | |||||||||||
Loss from operations | (55,431 | ) | (71,472 | ) | (107,235 | ) | (118,381 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest income | 186 | 880 | 494 | 1,968 | |||||||||||
Interest expense | (3,789 | ) | — | (7,525 | ) | — | |||||||||
Other (expense) income, net | 138 | (157 | ) | (260 | ) | 19,864 | |||||||||
Total other (expense) income, net | (3,465 | ) | 723 | (7,291 | ) | 21,832 | |||||||||
Loss before income taxes | (58,896 | ) | (70,749 | ) | (114,526 | ) | (96,549 | ) | |||||||
Income tax benefit | — | (17,425 | ) | — | (17,425 | ) | |||||||||
Net loss | $ | (58,896 | ) | $ | (53,324 | ) | $ | (114,526 | ) | $ | (79,124 | ) | |||
Net loss per share, basic and diluted | $ | (1.05 | ) | $ | (0.96 | ) | $ | (2.05 | ) | $ | (1.53 | ) | |||
Weighted average number of shares used in the calculation of basic and diluted net loss per common share | 55,836 | 55,355 | 55,794 | 51,770 |
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