IRONWOOD PHARMACEUTICALS INC Q4 FY2025 earnings call

• In 2025, LINZESS achieved full-year guidance with $865M in U.S. net sales, had FDA approval for IBS-C in 7 - 17 yr olds, and list price reduced Jan 1, 2026. • Advanced aproglutide by aligning with FDA on STARS II trial design, to begin site activation in Q2 2026. • 2025 ended with $250M cash and cash equivalents. • 2026 priorities: maximize LINZESS, advance aproglutide with STARS II, and disciplined expense management.

In 2025, LINZESS U.S. net sales were $865 million with 11% demand growth and 8% new-to-brand volume growth. Adjusted EBITDA was $138 million. For 2026, LINZESS is expected to have U.S. net sales >$1.1 billion, and adjusted EBITDA >$300 million. Aproglutide is in development with STARS II trial to begin in Q2 2026.

• 2026 U.S. LINZESS net sales expected $1.125B - $1.175B, >30% y/y growth. • Ironwood Pharmaceuticals, Inc. revenue expected $450M - $475M. • Expect to advance aproglutide with STARS II trial beginning in Q2 2026.

Forward - looking statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these is available in the safe harbor statement slide, 10 - K, and subsequent SEC filings.

Q: Just a couple on STARS II. Can you give us any more details on the learnings from STARS and the refined instructions for use that you are now including in STARS II? In repeating the data from STARS I, and then just lastly, when you think about the enrollment timeline?

A: Thanks, Jason. In terms of the learnings, original STARS trial had successful outcome, learned most about dose preparation and administration, refining with better kit components and instructions for use. Endpoints remain same. In terms of timelines, learned a lot from original STARS program, have sites in STARS EXTEND program, and believe can enroll successfully in timely fashion.

Q: On the strategic alternatives process. Can you maybe just update us on your thinking as far as now that you can, you know, at least in our model, clearly continue on as a stand - alone company, you know, retire the debt, kind of how you are thinking about the strategic process as we kind of go forward into 2026?

A: Our strategic alternatives, we have a path forward to leverage revenue from LINZESS, reduce debt and mobilize the trial. We are always open to alternatives that would increase shareholder value, and will focus on executing and always consider other ways to increase shareholder value.

Q: On STARS II, timelines, expectations for full enrollment. Maybe just talk about some of the assumptions you are making as far as that timeline to full enrollment. Kind of talk about some of the assumptions that you are making on total enrollment as it compares to STARS?

A: In a lot of ways, aligned with how we saw STARS I play out, think we can achieve that in STARS II program, assumptions based on what we did in STARS I which was a very successful study. It is a 24 - week trial, have high probability of success, highly effective well - tolerated once - weekly therapy, delighted with FDA alignment on design and length.

Q: Is the FDA allowing you to bridge to the STARS dataset as you said, and is your planned enrollment size meant to reference or bridge to a future NDA? And finally, given the competitive pressure in SBS - IF and the potential for GATTEX generic, could you potentially add a higher - dose arm to maximize efficacy differentiation?

A: In terms of STARS II data, hoping to leverage STARS data, aligned with agency on program key elements, current sample size of 124 patients gives adequate and robust power. Decision on sample size to ensure robust trial. Considered higher doses, but focused on fastest to market by bridging with original STARS dataset and completing trial.

Q: Did you ever see data from the STARS trial to look at patients who could achieve the optimum dose? Did they benefit more than the other patients who could not get to the optimum dose? And second, how you are thinking about market opportunity for aproglutide in the case, you know, you have GATTEX generic potentially reaching the market around the same time. What is the latest on the GATTEX generic at this point?

A: On optimum dose, original STARS dataset had robust efficacy in placebo - like tolerability, took 3.5 mg forward in STARS II. Commercially, have strong conviction in aproglutide's clinical profile and potential to be differentiated. On GATTEX generic, not much specific update provided other than considering the market opportunity.

Q: Can you help us understand what channel mix effects drove the LINZESS rebate in Q4, and whether we should expect ongoing volatility in pricing this year? And my second question is that the LINZESS commercial volume looks to have fallen at the beginning of the year. So can you tell us what your formulary positioning looks like in this year versus the prior year?

A: Fourth - quarter pricing was due to timing of recognition of gross - to - net rebate reserves, not channel mix. 2026 not expected to have same degree of volatility. In terms of formulary positioning, LINZESS has broad patient access across commercial and Medicare Part D, and low single - digit growth expected with Medicaid impact, but maintained branded prescription - leading market access.