The company has not filed an annual or quarterly report since its FY2021 10-K, filed Mar 1, 2022. Its latest SEC filing is a SC 13G/A from May 16, 2022.
10-K for FY2021, filed Mar 1, 2022
The sections below describe the company as of the FY2021 annual report.
Sells Fintepla, a treatment for seizures associated with Dravet syndrome, to specialty distributors and pharmacies. Develops treatments for other rare epilepsy disorders and an inherited mitochondrial disease.
10-K for FY2021, filed Mar 1, 2022Fintepla is approved for marketing in the U.S., the European Union (EU) and in the United Kingdom and is under late-stage development in…View ↗
We own and control worldwide development and commercialization rights to Fintepla. We currently market and commercialize Fintepla for the…View ↗
In September 2019, we acquired all the outstanding equity interests of Modis Therapeutics, Inc. (Modis), a privately-held biopharmaceutical…View ↗
We distribute Fintepla in the U.S. through and arrangement with a specialty distributor who is our customer. The specialty distributor…View ↗
We distribute Fintepla in Europe (currently in Germany and France) through a third-party logistics provider (3PL) for distribution to…View ↗
Makes money from Fintepla sales to a U.S. specialty distributor and European pharmacies; sales are counted when the product is delivered, and invoices are generally issued before or at delivery. Its Japan agreement can also bring payment for distribution rights and regulatory and sales milestones.
10-K for FY2021, filed Mar 1, 2022We distribute Fintepla in the U.S. through and arrangement with a specialty distributor who is our customer. The specialty distributor…View ↗
We distribute Fintepla in Europe (currently in Germany and France) through a third-party logistics provider (3PL) for distribution to…View ↗
Revenue from product sales is recorded at the net sales price (transaction price), which includes estimates of consideration payable to our…View ↗
We recognize product revenues when a customer obtains control of our product, which occurs at a point in time and is typically upon…View ↗
Shinyaku has agreed to support development and regulatory approval of Fintepla in Japan by actively participating in the design of…View ↗
In addition, we can earn up to an additional $42.5 million tied to the achievement of certain net sales milestones by Shinyaku through the…View ↗
$81.7M
10-K for FY2021, filed Mar 2, 2022
$81.7M ↗
In the U.S., a specialty distributor buys Fintepla and resells it through a specialty pharmacy. In Germany and France, a logistics provider distributes it to pharmacies, which buy from Zogenix and resell to patients and health care providers.
10-K for FY2021, filed Mar 1, 2022
No. It lost $227.4M in FY2021.
10-K for FY2021, filed Mar 2, 2022
−$224.1MView ↗
10-K for FY2021, filed Mar 2, 2022
−$227.4MView ↗
10-K for FY2021, filed Mar 2, 2022
−$185.4MView ↗
8-K, filed Mar 7, 2022
Item 2.01.View ↗
Grew. Revenue grew 8.3x in 4 years, from $9.8M in FY2017 to $81.7M in FY2021, about 70% a year.
Fintepla became a marketed medicine
The earlier report describes Fintepla as a product candidate with regulatory applications pending; the latest describes it as approved and being sold in the U.S., Germany and France.
10-K for FY2018, filed Feb 28, 2019 10-K for FY2021, filed Mar 1, 2022
Added a mitochondrial disease program
The earlier report centers its clinical pipeline on Fintepla; the latest also describes a late-stage investigational treatment program for an inherited mitochondrial disease.
10-K for FY2018, filed Feb 28, 2019 10-K for FY2021, filed Mar 1, 2022
Competes with GW Pharmaceuticals, Biocodex, Takeda Pharmaceutical, Longboard Pharmaceuticals, Epygenix Therapeutics, Supernus Pharmaceuticals, Stoke Therapeutics, Neurocrine Biosciences, Encoded Therapeutics, Neucyte, NeuroCycle Therapeutics, Sarepta Therapeutics, Metro International Biotech, PTC Therapeutics, Reata Pharmaceuticals, Reneo Pharmaceuticals, Stealth BioTherapeutics, and Wellstat Therapeutics
10-K for FY2021, filed Mar 1, 2022Prior to 2018, there were no FDA-approved treatments indicated for the treatment of seizures associated with Dravet syndrome. The standard…View ↗
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