Xeris Biopharma Holdings, Inc.

On February 26, 2026 and March 20, 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"), and (ii) Sandoz Inc. (along with its affiliates, "Sandoz") and Zydus Lifesciences Global FZZE (along with its affiliates, "Zydus"), respectively (each, an "ANDA Filer"). These lawsuits were filed following receipt of a Paragraph IV certification notice letter (each, a "Notice Letter") from each Torrent, Somerset, Sandoz, and Zydus regarding their respective filing of an 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 ANDAs each contained Paragraph IV certifications alleging that four of the Company's Orange Book-listed patents covering Recorlev®, which are scheduled to expire in March 2040 (U.S. Patent Nos. 11,020,393, 11,278,547, 11,903,940 and 12,377,096), 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 the ANDAs, each of Torrent, Somerset, Sandoz, and Zydus has infringed the Orange Book patents for Recorlev® that each defendant included in its respective Paragraph IV certification. The complaints further seek: (a) an injunction preventing the FDA from granting final approval of the ANDA before the expiration of the asserted patents; and (b) a permanent injunction to prevent each of the defendants from commercializing a generic version of Recorlev®, until the expiration of the asserted patents, including any applicable extensions and additional periods of exclusivity. No trial date has been set. 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 for up to 30 months in accordance with the Hatch-Waxman Act.

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.

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.