EMERYVILLE, Calif., Feb. 28, 2022 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ:ZGNX), a global biopharmaceutical company developing and rare disease therapies, today provided a corporate update and announced financial results for the fourth quarter and full-year ended December 31, 2021.
"The year 2021 represented a transformational period for Zogenix, with our ongoing successful commercial launches of FINTEPLA® in the U.S. and Europe, and significant regulatory progress and advancement of our late-stage development programs. In the past quarter, we announced U.S. Food and Drug Administration (FDA) acceptance of the supplemental New Drug Application (sNDA), a submission of a Type II variation application for FINTEPLA in Europe to potentially expand authorized use of FINTEPLA in a second indication, Lennox-Gastaut syndrome (LGS), as well as a J-NDA submission for FINTEPLA in Dravet syndrome in Japan. The recently announced acquisition by UCB will accelerate our mission to serve rare disease patients globally and deliver innovative therapies to additional patients and families in need," said Stephen J. Farr, Ph.D., President and CEO of Zogenix.
Corporate Update
Fourth Quarter 2021 Financial Results
Year Ended December 31, 2021 Financial Results Compared to Year Ended December 31, 2020
Conference Call/Earnings Materials
Given the recently announced agreement for Zogenix to be acquired by UCB, Zogenix will not be hosting a conference call. Earnings materials are available publicly on the Investor Relations page of our website at http://zogenix.com. Questions may be directed to the Investor Relations team via the contact information below.
Additional Information and Where to Find It
This communication is not an offer to buy nor a solicitation of an offer to sell any securities of Zogenix, Inc. (the "Company"). The solicitation and the offer to buy shares of the Company's common stock is being made pursuant to a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and other related materials that was filed by UCB S.A. (the "Parent") and Zinc Merger Sub, Inc. ("Merger Sub") with the Securities and Exchange Commission ("SEC") on February 1, 2022. In addition, the Company has filed a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer with the SEC on February 1, 2022. Investors can obtain a free copy of these materials and other documents filed by Parent, Merger Sub and the Company with the SEC at the website maintained by the SEC at www.sec.gov. Investors may also obtain, at no charge, any such documents filed or furnished to the SEC by the Company under the "Investors" section of the Company's website at www.zogenix.com. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THESE DOCUMENTS, INCLUDING THE SOLICITATION/RECOMMENDATION STATEMENT OF THE COMPANY AND ANY AMENDMENTS THERETO, AS WELL AS ANY OTHER DOCUMENTS RELATING TO THE TENDER OFFER AND THE MERGER THAT ARE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY PRIOR TO MAKING ANY DECISIONS WITH RESPECT TO WHETHER TO TENDER THEIR SHARES INTO THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION, INCLUDING THE TERMS AND CONDITIONS OF THE TENDER OFFER.
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. Food and Drug Administration (FDA) and the European Medicines Agency and is under regulatory review in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The U.S. FDA recently accepted for filing Zogenix's supplemental New Drug Application (sNDA) and granted Priority Review for the use of FINTEPLA for the treatment of seizures associated with an additional rare epilepsy, Lennox-Gastaut syndrome (LGS). Zogenix is also initiating 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. The company has an additional late-stage development program, MT-1621, in a mitochondrial disease called TK2 deficiency.
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 seizures associated with LGS or 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 structure, timing and completion of the announced merger between us and UCB S.A., and any effects of the announcement, pendency or completion of the announced merger, including the anticipated benefits therefrom; the COVID-19 pandemic may continue to disrupt Zogenix's business operations, impairing the ability to commercialize FINTEPLA in the U.S. and Europe and Zogenix's ability to generate product revenue in the U.S. and 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
corpcomms@zogenix.com
Investors
Brian Ritchie
Managing Director, LifeSci Advisors LLC
+1 (212) 915-2578 | britchie@lifesciadvisors.com
Media
Trish McCall, Porter Novelli
+1 (805) 390-3279 | trish.mccall@porternovelli.com
ZOGENIX INC.
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
| December 31, | ||||||||
| (In thousands) | 2021 | 2020 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 101,180 | $ | 166,916 | ||||
| Marketable securities | 200,535 | 338,193 | ||||||
| Accounts receivable, net | 10,139 | 3,824 | ||||||
| Inventory | 5,492 | 1,026 | ||||||
| Prepaid expenses | 12,487 | 7,279 | ||||||
| Other current assets | 24,735 | 4,936 | ||||||
| Total current assets | 354,568 | 522,174 | ||||||
| Property and equipment, net | 7,197 | 8,724 | ||||||
| Operating lease right-of-use assets | 6,605 | 7,748 | ||||||
| Intangible asset, net | 90,673 | 98,558 | ||||||
| Goodwill | 6,234 | 6,234 | ||||||
| Other non-current assets | 3,212 | 7,692 | ||||||
| Total assets | $ | 468,489 | $ | 651,130 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 21,998 | $ | 11,945 | ||||
| Accrued and other current liabilities | 55,413 | 54,964 | ||||||
| Deferred revenue, current | 5,089 | 5,318 | ||||||
| Current portion of operating lease liabilities | 1,694 | 1,688 | ||||||
| Current portion of contingent consideration | 13,500 | 8,800 | ||||||
| Total current liabilities | 97,694 | 82,715 | ||||||
| Deferred revenue, non-current | 3,257 | 5,479 | ||||||
| Operating lease liabilities, net of current portion | 8,617 | 10,314 | ||||||
| Contingent consideration, net of current portion | 21,785 | 33,600 | ||||||
| Convertible debt | 158,165 | 149,353 | ||||||
| Total liabilities | 289,518 | 281,461 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 56 | 56 | ||||||
| Additional paid-in capital | 1,731,153 | 1,694,524 | ||||||
| Accumulated other comprehensive loss | 15 | (71 | ) | |||||
| Accumulated deficit | (1,552,253 | ) | (1,324,840 | ) | ||||
| Total stockholders' equity | 178,971 | 369,669 | ||||||
| Total liabilities and stockholders' equity | $ | 468,489 | $ | 651,130 | ||||
ZOGENIX INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except per share amounts)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product sales | $ | 23,471 | $ | 8,067 | $ | 74,740 | $ | 9,587 | ||||||||
| Collaboration revenue | 3,137 | 435 | 6,950 | 4,056 | ||||||||||||
| Total revenues | 26,608 | 8,502 | 81,690 | 13,643 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of product sales (excluding amortization of intangible asset) | 1,642 | 402 | 4,834 | 542 | ||||||||||||
| Research and development | 41,791 | 35,964 | 142,659 | 138,002 | ||||||||||||
| Selling, general and administrative | 43,811 | 29,242 | 148,524 | 99,574 | ||||||||||||
| Intangible asset amortization | 1,971 | 1,971 | 7,885 | 3,942 | ||||||||||||
| Acquired in-process research and development costs | — | 6,200 | — | 10,700 | ||||||||||||
| Change in fair value of contingent | 385 | 2,500 | 1,885 | 8,600 | ||||||||||||
| Total costs and expenses | 89,600 | 76,279 | 305,787 | 261,360 | ||||||||||||
| Loss from operations | (62,992 | ) | (67,777 | ) | (224,097 | ) | (247,717 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest income | 80 | 387 | 659 | 2,891 | ||||||||||||
| Interest expense | (3,903 | ) | (3,759 | ) | (15,276 | ) | (3,759 | ) | ||||||||
| Other income, net | 12,037 | 979 | 11,406 | 21,777 | ||||||||||||
| Total other income (expense), net | 8,214 | (2,393 | ) | (3,211 | ) | 20,909 | ||||||||||
| Loss before income taxes | (54,778 | ) | (70,170 | ) | (227,308 | ) | (226,808 | ) | ||||||||
| Income tax expense (benefit) | 105 | — | 105 | (17,425 | ) | |||||||||||
| Net loss | $ | (54,883 | ) | $ | (70,170 | ) | $ | (227,413 | ) | $ | (209,383 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.98 | ) | $ | (1.26 | ) | $ | (4.07 | ) | $ | (3.90 | ) | ||||
