- Total revenue of
$26.6 million in the fourth quarter and$81.7 million for the full year - FINTEPLA® net product sales of
$23.5 million in the fourth quarter and$74.7 million for the full year Announced U.S. Food and Drug Administration acceptance with Priority Review of Supplemental New Drug Application for FINTEPLA in Lennox-Gastaut Syndrome (LGS)- Submitted Type II Variation Application to the
European Medicines Agency to expand the use of FINTEPLA for LGS - Submitted New Drug Application to Japan’s
Ministry of Health, Labour & Welfare for the marketing approval of FINTEPLA in Dravet syndrome - Previously announced agreement to be acquired by UCB; transaction expected to close in the first half of 2022
“The year 2021 represented a transformational period for
Corporate Update
- FINTEPLA for the treatment of seizures associated with Dravet syndrome:
- As of
December 31, 2021 , the total number of unique prescribers was 375 and 1,129 patients were prescribed FINTEPLA and referred to the REMS program in theU.S. - European commercial launches in
Germany andFrance continue momentum with increasing adoption of FINTEPLA among prescribers and patients - Zogenix Access Program is now providing FINTEPLA to patients in 9 countries where the therapy is not yet commercially reimbursed as the company pursues country-by-country reimbursement in
Europe - Announced submission of a J-NDA to the
Japanese Ministry of Health, Labour & Welfare - Presented new safety and efficacy data for FINTEPLA in eight abstracts at the American Epilepsy Society Annual Meeting
- As of
- FINTEPLA for the treatment of seizures associated with LGS:
- Announced FDA acceptance with Priority Review of sNDA for FINTEPLA in LGS. PDUFA target action date is
March 25 th, 2022 - Submitted Type II variation application to
European Medicines Agency (EMA) for approval in LGS
- Announced FDA acceptance with Priority Review of sNDA for FINTEPLA in LGS. PDUFA target action date is
- FINTEPLA for the treatment of seizures associated with CDKL5 Deficiency Disorder (CDD):
- Based on a positive meeting with FDA, a single Phase 3 study, if successful, could be sufficient to support an sNDA submission
- Targeting enrollment of first patient in global Phase 3 study in Q1 2022
- MT1621 for the treatment of thymidine kinase 2 (TK2) deficiency:
- Scientific Advice from EMA supportive of marketing authorization for the treatment of patients with age of TK2d symptom onset < 12 years old
- Ongoing studies continue to proceed as planned to support potential NDA submission in the second half of 2022
- Announced support of a no-cost genetic testing program, the
United Mitochondrial Disease Foundation (UMDF) Pilot Genetic Testing Project , in partnership with UMDF and Probably Genetic, to help patients obtain a confirmed genetic diagnosis of mitochondrial disease
- UCB Acquisition of
Zogenix :- On
January 19, 2022 , UCB andZogenix announced that the companies have entered into a definitive agreement under which UCB would acquireZogenix, Inc. Under the terms of the agreement, UCB commenced a tender offer to purchase all outstanding shares ofZogenix for a purchase price per share ofUS$ 26.00 in cash at closing, plus a contingent value right (CVR) for a potential cash payment ofUS$ 2.00 upon EU approval byDecember 31, 2023 , of FINTEPLA as an orphan medicine for treatment of LGS. The upfront consideration represented a 72% premium toZogenix shares based on the 30-day volume weighted average closing stock price ofZogenix prior to signing. The total transaction is valued at up to approximatelyUS$ 1.9 billion / € 1.7 billion. The transaction is subject to regulatory approvals and other customary closing conditions and is expected to close in the first half of 2022.
- On
Fourth Quarter 2021 Financial Results
- The Company recorded
$26.6 million in revenue for the fourth quarter endedDecember 31, 2021 . This included total net product sales of FINTEPLA of$23.5 million , in addition to$3.1 million in revenue as a result of theMarch 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded$8.5 million in revenue for the corresponding period of 2020. - Research and development expenses for the fourth quarter ended
December 31, 2021 , totaled$41.8 million , compared to$36.0 million in the fourth quarter endedDecember 31, 2020 . - Selling, general and administrative expenses for the fourth quarter ended
December 31, 2021 , totaled$43.8 million , up from$29.2 million in the fourth quarter endedDecember 31, 2020 . The increase was driven by ongoing Fintepla launch activities in Dravet syndrome in theU.S. andEurope and preparations for potential launches for FINTEPLA in LGS. - Net loss for the fourth quarter ended
December 31, 2020 , was$54.9 million , or a net loss of$0.98 per share, compared with a net loss of$70.2 million , or a net loss of$1.26 per share, in the fourth quarter endedDecember 31, 2020 .
Year Ended December 31, 2021 Financial Results Compared to Year Ended December 31, 2020
- The Company recorded $81.7 million in revenue for the year ended December 31, 2021. This included total net product sales of FINTEPLA of
$74.7 million , in addition to$7.0 million in revenue as a result of theMarch 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded in$13.6 million revenue for the corresponding period of 2020. - Research and development expenses for the year ended December 31, 2021, totaled $142.7 million, up from $138.0 million in the year ended December 31, 2020.
- Selling, general and administrative expenses for the year ended December 31, 2021, totaled $148.5 million, up from $99.6 million in the year ended December 31, 2020, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the
U.S. andEurope and preparations for a potential launch for FINTEPLA in LGS. - Net loss for the year ended December 31, 2021, was $227.4 million, or a net loss of $4.07 per share, compared with a net loss of $209.4 million, or a net loss of $3.90 per share, in the year ended December 31, 2020.
- As of December 31, 2021, the Company had $301.7 million in cash, cash equivalents, and marketable securities, compared to $505.1 million at December 31, 2020
Conference Call/Earnings Materials
Given the recently announced agreement for
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
About
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
CONTACTS:
corpcomms@zogenix.com
Investors
Managing Director,
+1 (212) 915-2578 | britchie@lifesciadvisors.com
Media
+1 (805) 390-3279 | trish.mccall@porternovelli.com
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
(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 | ||||||
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 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
(in thousands, except per share amounts)
Three Months Ended | Twelve Months Ended | |||||||||||||||
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 | ) |
Source:
2022 GlobeNewswire, Inc., source