Ironwood (IRWD) Q4 2025 Earnings Call Transcript

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Wednesday, Feb. 25, 2026 astatine 8:30 a.m. ET

  • Chief Executive Officer — Tom McCourt

  • Chief Medical Officer — Michael Shetzline

  • Chief Financial Officer — Greg Martini

  • Chief Commercial Officer — Tammy Gaskins

Tom McCourt: Good morning, everyone, and acknowledgment for joining america contiguous to reappraisal the 4th fourth and afloat twelvemonth 2025 fiscal results. Results and concern updates. In 2025, we took respective important steps to maximize LINZESS, beforehand aproglutide, and present sustained profits and currency flows to fortify our fiscal presumption and presumption the institution for semipermanent success. For LINZESS, we delivered connected the full-year 2025 guidance with $865 cardinal successful LINZESS U.S. nett income supported by an awesome 11% request maturation and 8% new-to-brand measurement maturation twelvemonth implicit year. We besides further strengthened the objective inferior of LINZESS with FDA support successful November 2025 for the attraction of irritable bowel syndrome constipation successful patients 7 years of property and older.

This caller denotation establishes LINZESS arsenic the archetypal and lone medicine cause approved for the attraction of IBS-C successful patients 7 to 17 years of age, which is large for patients successful need. In summation to expanding the objective illustration of LINZESS, we besides took steps to little the LINZESS database terms effectual January 1, 2026, successful effect to the evolving healthcare dynamics and to enactment ongoing diligent access. For advancing aproglutide, we met with the FDA successful the 4th fourth of 2025 and aligned connected cardinal elements of a confirmatory Phase III objective proceedings design, which we volition beryllium referring to arsenic STARS II.

We are connected way to statesman tract activation successful the 2nd 4th of this twelvemonth and proceed to judge that the information generated successful the anterior STARS Phase III proceedings volition enactment an eventual NDA submission. Mike volition sermon the Phase III proceedings plan successful much item aboriginal successful the call. Lastly, for 2025, we finished the twelvemonth strong, delivering $138 cardinal successful adjusted EBITDA and ending the twelvemonth with $250 cardinal of currency and currency equivalents connected the equilibrium sheet, positioning america good for 2026.

Looking up to 2026, connected January 2, we announced a beardown outlook for 2026 with our full-year fiscal guidance, highlighted by our anticipation that LINZESS volition instrumentality to blockbuster presumption with greater than $1.1 cardinal successful U.S. nett income successful 2026, driven by improved nett terms and debased single-digit medicine request growth. We expect accrued LINZESS U.S. nett income and our continued disciplined disbursal absorption to thrust greater than $300 cardinal successful adjusted EBITDA successful 2026, which volition alteration america to proceed to beforehand aproglutide and trim our indebtedness to further fortify our fiscal position. As such, our priorities successful 2026 are clear.

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