UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On September 22, 2020, Zogenix, Inc. (the “Company”) provided a business update that based on written feedback from the U.S. Food and Drug Administration received in September 2020 and the Company’s clinical development plan, the Company has confirmed its plans to submit a supplemental New Drug Application in the second quarter of 2021 for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome, which would include data from the Company’s two-year carcinogenicity study in rodents and from the Company’s Phase 1 pharmacokinetic study.
In addition, on September 22, 2020, the Company issued a press release announcing its intention to offer $200,000,000 aggregate principal amount of convertible senior notes due 2027 in a private offering that is exempt from the registration requirements of the Securities Act of 1933, as amended. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.
Forward-Looking Statements
The Company cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding: the Company’s plans to submit an sNDA for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome and the timing thereof; and the completion and size of the notes offering. These statements are based on the Company’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the timing of additional data and the submission of the sNDA could be delayed, including as a result of the COVID-19 pandemic disrupting the Company’s business operations; the results of the non-clinical study and ongoing open label extension study may demonstrate adverse safety data; the FDA may disagree that the Company’s safety and efficacy data is sufficient to approve the sNDA; risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering; and other risks described in the Company’s 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 The Company undertakes no obligation to revise or update this report 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.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press release dated September 22, 2020. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZOGENIX, INC. | ||||||
| Date: September 22, 2020 | By: | /s/ Shawnte M. Mitchell | ||||
| Name: | Shawnte M. Mitchell | |||||
| Title: | Executive Vice President, General Counsel and Secretary | |||||