LINZESS Full-Year Net Sales and Demand Growth
LINZESS U.S. net sales for full-year 2025 were $865 million, supported by 11% prescription demand growth and 8% new-to-brand volume growth year over year. The brand surpassed ~5.7 million unique patients treated since launch and finished 2025 with roughly 45% market share.
Regulatory and Label Expansion for LINZESS
FDA approval in November 2025 expanded LINZESS' indication to treat IBS-C in patients 7 years of age and older, making it the first and only prescription drug approved for IBS-C in patients aged 7–17.
2026 Financial Guidance and Outlook
Company reiterated 2026 guidance: LINZESS U.S. net sales expected between $1.125 billion and $1.175 billion (greater than a 30% increase year over year). Ironwood revenue guidance of $450 million–$475 million and an expectation of greater than $300 million in adjusted EBITDA for 2026.
2025 Profitability and Cash Generation
Delivered $138 million in adjusted EBITDA for 2025 and generated $127 million in cash flows from operations. Management emphasized disciplined expense management, including a $61 million reduction in operating expenses year over year, and ended the year with cash and cash equivalents reported at $215 million.
Aproglutide Clinical Progress and STARS II Alignment with FDA
Company met with the FDA in Q4 2025 and aligned on a confirmatory Phase III trial (STARS II). STARS II is planned as a randomized, double-blind, placebo-controlled trial (1:1) with a primary endpoint of relative change from baseline in weekly parenteral support volume at week 24, using a 3.5 mg once-weekly dose and planned enrollment of 124 patients. Site activation is on track to begin in Q2 2026.
Strong Clinical Efficacy Signals for Aproglutide
Prior STARS Phase III and the STARS EXTEND long-term extension showed statistically significant reductions in weekly parenteral support volume and durable improvements (including cases of enteral autonomy maintained for >= 3 months), supporting confidence in aproglutide's efficacy, tolerability, and once-weekly dosing.
Commercial Opportunity for Aproglutide
Management projects greater than $700 million U.S. peak net sales for aproglutide given its clinical profile and the potential to expand GLP-2-treated patient population; company expects additional upside from potential approvals abroad.
Balance Sheet and Deleveraging Plans
Company plans to use cash flow and cash on hand to reduce total debt in 2026, including repayment of 2026 convertible notes at maturity in June, and expects to end 2026 with approximately $300 million of debt (less than 1.0x 2026 adjusted EBITDA).