Xeris Biopharma Holdings, Inc.

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 FZE (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.

On October 13, 2026, the Company, through its wholly owned subsidiary, Xeris Pharmaceuticals, Inc., filed patent infringement lawsuits in the United States District Court for the District of New Jersey against defendants (i) Torrent Pharma Inc., Torrent Pharmaceuticals Limited, Cycle Pharmaceuticals Limited, Lemed Pharmacy III, LLC, and Lemed Specialty Pharmacy Arizona, LLC; and (ii) Rising Pharma Holdings, Inc. and Rising Pharma Specialties Pvt. Ltd. in two separate actions. These lawsuits were filed following the grant of U.S. Patent No. 12,758,502 (the “’502 patent”) related to the Company’s KEVEYIS® (dichlorphenamide) product.

The complaints allege that each of the defendants will infringe the ’502 patent by making, using, selling, offering for sale, and/or importing their generic dichlorphenamide products. The Company is seeking a judgment of infringement, injunctive relief prohibiting further infringement, monetary damages adequate to compensate for the infringement, enhanced damages where permitted by law, attorneys’ fees, costs, and such other relief as the court deems appropriate.

We are also involved in various other legal proceedings arising in the normal course of business. Although the outcomes of these other legal proceedings are inherently difficult to predict, we do not expect the resolution of these other legal proceedings to have a material adverse effect on our financial position, results of operations, or cash flows.