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Organization and Description of Business
12 Months Ended
Dec. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Organization and Description of Business Organization and Description of Business
We are global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. We are currently focused on developing and commercializing therapies to address rare or orphan disorders. Our lead product candidate, Fintepla (ZX008, fenfluramine) is currently being developed for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (LGS). In addition to Fintepla, we recently added MT1621 to our late-stage development pipeline.
In September 2019, we acquired all the outstanding equity interests in Modis Therapeutics, Inc. (Modis), a privately-held biopharmaceutical company focused on developing novel therapies for rare genetic diseases with high unmet medical need. Modis’ lead product candidate, MT1621, is an investigational deoxynucleoside substrate enhancement therapy in development for the treatment of thymidine kinase 2 deficiency (TK2d), an inherited mitochondrial DNA depletion disorder that predominantly affects children and is often fatal. See Note 3 for additional information.
Zogenix, Inc., headquartered in Emeryville, California, was founded in May 2006 and was incorporated in the State of Delaware on May 11, 2006 as SJ2 Therapeutics, Inc. In August 2006, we changed our name to Zogenix, Inc. We currently do not generate any revenue from contracts with customers and we have no approved products for commercial marketing or sale. Previously, we performed contract manufacturing services for one customer under a long-term supply agreement, which was terminated in 2017.
Future Funding Requirements
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 $1.1 billion as of December 31, 2019. We expect to continue to incur significant operating losses and negative cash flows from operations as we continue to advance our product candidates through development and commercialization. Additionally, pursuant to our acquisition of Brabant Pharma Limited (Brabant) in 2014 to obtain worldwide development and commercialization rights to Fintepla, we are required to make additional payments to the former shareholders of Brabant in the event we achieve certain regulatory and sales milestones with Fintepla (See Notes 5 and 8). In addition, our asset acquisition of Modis in September 2019 requires us to make additional payments to the former shareholders of Modis in the event we achieve certain regulatory milestones (See Note 3). Historically, we have relied primarily on the proceeds from equity offerings to finance our operations. 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, if such financing is not available at adequate levels when needed, we may be required 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.