Commitments and Contingencies |
6 Months Ended |
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Jun. 30, 2026 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | Commitments and Contingencies Commitments Commitments to Taro The Company has a supply agreement with Taro Pharmaceuticals North America, Inc. ("Taro") to produce Keveyis. In 2023, the Company amended the agreement to extend the initial term until March 2027. As part of the agreement, as amended, the Company has agreed to certain annual minimum marketing spend requirements and minimum purchase order quantities for each year, which in the case of the minimum purchase order quantities, is based on the previous year's purchases. Leases As of June 30, 2026, the Company had unused letters of credit of $4.0 million, which were issued primarily to secure leases. These letters of credit are collateralized by $4.0 million of restricted cash, which is recorded in other assets in the consolidated balance sheets. Contingencies Legal Matters On February 26, 2026; March 20, 2026; June 4, 2026; and July 13, 2026, the Company’s wholly owned subsidiaries, Xeris Pharmaceuticals, Inc. and Strongbridge Dublin Limited, filed patent infringement lawsuits under the Hatch-Waxman Act in the United States District Court for the District of New Jersey against defendants (i) Torrent Pharmaceuticals Limited (along with its affiliate, “Torrent”) and Somerset Therapeutics, LLC (along with its affiliates, “Somerset”), (ii) Sandoz Inc. (“Sandoz”) and Zydus Lifesciences Global FZZE (along with its affiliates, “Zydus”), and (iii) Novitium Pharma, LLC (along with its affiliate, “Novitium”) in two separate actions, respectively (each, an “ANDA Filer”). These lawsuits were filed following receipt of a Paragraph IV certification notice letter (each, a “Notice Letter”) from each of Torrent, Somerset, Sandoz, Zydus, and Novitium regarding the filing of its respective Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) seeking approval to manufacture, use, or sell a generic version of Recorlev®. The Notice Letters stated that each ANDA Filer’s ANDAs contained Paragraph IV certifications alleging that four of the Company’s Orange Book-listed patents covering Recorlev® (U.S. Patent Nos. 11,020,393, 11,278,547, 11,903,940 and 12,377,096) (collectively, the “Orange Book Patents), which are scheduled to expire in March 2040, are invalid, unenforceable and/or will not be infringed by each ANDA Filer’s manufacture, use, or sale of the generic product described in its respective ANDA submission. Collectively, the complaints allege that, by filing ANDAs for their respective generic products, each of Torrent, Somerset, Sandoz, Zydus, and Novitium has infringed the Orange Book Patents for Recorlev®. The complaints seek an order preventing the FDA from granting final approval of the respective ANDAs before the expiration of the Orange Book Patents and a permanent injunction to prevent each of the defendants from commercializing a generic version of Recorlev®, until the expiration of the Orange Book Patents, including any applicable extensions and additional periods of exclusivity. On June 8, 2026, the United States District Court for the District of New Jersey entered an order consolidating for all pretrial purposes the actions filed on February 26, 2026 against Somerset and Torrent and the action filed on March 20, 2026 against Sandoz and Zydus (“Consolidated Action”). On July 20, 2026, the United States District Court for the District of New Jersey entered an order consolidating for all pretrial purposes the actions against Novitium filed on June 4, 2026 and July 13, 2026 into the Consolidated Action. A bench trial has been tentatively scheduled for November 2028. The filing of each lawsuit within 45 days of receipt of each of the respective Notice Letters triggered an automatic stay of the FDA’s approval of each of the respective ANDAs in accordance with the Hatch-Waxman Act until up to June 30, 2029, in the absence of a decision from the court finding all asserted claims invalid or not infringed before that date. The Company may receive additional Notice Letters in the future from ANDA filers seeking approval of a generic version of Recorlev and may file additional ANDA lawsuits in the future. From time to time, the Company may become involved in various legal actions arising in the ordinary course of business. As of June 30, 2026, management was not aware of any existing, pending or threatened legal actions that would have a material impact on the financial position or results of operations of the Company.
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