Organization and Description of Business

12 Months Ended

Dec. 31, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Organization and Description of Business

Organization and Description of Business

Zogenix Inc., and subsidiaries (also referred to as Zogenix, we, our or us) 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. Our 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 (EMA) for the treatment of seizures associated with Dravet syndrome, a rare, devastating, severe lifelong epilepsy. Fintepla is also currently under development in Japan. We also have two additional late-stage development programs underway: one for Fintepla for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), and one for MT-1621, an investigational therapy for the treatment of thymidine kinase 2 deficiency (TK2d), a rare genetic disease.

We were formed as a Delaware corporation on May 11, 2006 as SJ2 Therapeutics, Inc. We changed our name to Zogenix Inc. on August 28, 2006. We operate as a single operating segment engaged in the research, development and commercialization of pharmaceutical products, and our headquarters are located in Emeryville, California.

Liquidity

As of December 31, 2021, our cash, cash equivalents and marketable securities totaled $301.7 million. Excluding gains from two discrete business divestitures, we have incurred significant net losses and negative cash flows from operating activities since inception resulting in an accumulated deficit of $1.6 billion as of December 31, 2021. We expect to incur operating losses and negative cash flow for additional future periods due to costs associated with the commercialization of Fintepla for Dravet syndrome and pre-commercialization activities related to Fintepla for LGS in the U.S. and in the EU, the advancement of our clinical programs related to MT-1621 and CDD, and other infrastructure support costs. In addition, excluding amounts accrued for contingent consideration related to our acquisition of Brabant, we may be required to pay $100.0 million and $50.0 million in milestone payments upon regulatory approval of MT-1621 by the FDA and the EMA, respectively, related to our acquisition of Modis (See Note 4). These contingent consideration payments have not be recognized in the consolidated balance sheets as the regulatory approval contingency has not been resolved and the consideration is not yet payable. Historically, we have relied primarily on the proceeds from equity and convertible debt offerings to finance our operations. We believe our cash, cash equivalents and marketable securities balances will be sufficient to meet our anticipated operating requirements for at least the next 12 months following the date of issuance of these consolidated financial statements. Until such time, if ever, we can generate a sufficient amount of revenue to finance our cash requirements, we may need to continue to rely on additional financing to achieve our business objectives. However, there is no assurance that such financings could be consummated on acceptable terms or at all. Market volatility resulting from the global novel coronavirus disease (COVID-19) pandemic or other factors could also adversely impact our ability to access capital when and as needed. Failure to raise sufficient capital when needed could require us to significantly delay, scale back or discontinue one or more of our product development programs or commercialization efforts or other aspects of our business plans, and our operating results and financial condition would be adversely affected.