Ironwood Pharmaceuticals, Inc.

Thank you for standing by. My name is Liz and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Ironwood Pharmaceuticals Q4 and full year 2025 investor update conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I would now like to turn the call over to Greg Martin, Chief Financial Officer. Please go ahead.

Good morning, and thank you for joining us for our fourth quarter and full year 2025 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially. A discussion of these statements and risk factors is available on the current Safe Harbor Statement slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 2024, and in our subsequent SEC filings. All forward-looking statements speak as of the date of this presentation, and we undertake no obligation to update such statements. Also included are non-GAAP financial measures, which should be considered only as a supplement to and not a substitute for or superior to GAAP measures. To the extent applicable, please refer to the tables at the end of our press release for reconciliations of these measures to the most directly comparable GAAP measures. During today's call, Tom McCourt, our Chief Executive Officer, will begin with an overview of our 2025 progress on our strategic priorities, and will provide an update on how we are maximizing lenses. Mike Schetzlein, our Chief Medical Officer, will discuss how we are advancing aproglutide, and I will review our financial results and 2026 guidance. Tammy Gaskins, our Chief Commercial Officer, will also be available for Q&A at the end of the call. Today's webcast includes slides. So for those of you dialing in, please go to the events section of our website to access the accompanying slides separately. With that, I'll turn the call over to Tom.

Good morning, everyone, and thanks for joining us today to review the fourth quarter and full year 2025 financial results and business updates. In 2025, we took several important steps to maximize LINZUS, advance Afroglutide, and deliver sustained profits and cash flows to strengthen our financial position and position the company for long-term success. For Linzess, we delivered on the full-year 2025 guidance with $865 million in Linzess U.S. net sales, supported by an impressive 11% demand growth and 8% new-to-brand volume growth year-over-year. We also further strengthened the clinical utility of Linzess with FDA approval in November 2025 for the treatment of irritable bowel syndrome with constipation in patients 7 years of age and older. This new indication establishes Linzess as the first and only prescription drug approved for the treatment of IBSC in patients 7 to 17 years of age, which is great for patients in need. In addition to expanding the clinical profile LensVest, we also took steps to lower the LensVest list price effective January 1, 2026 in response to the evolving healthcare dynamics and to support ongoing patient access. For advancing Afroglutide, we met with the FDA in the fourth quarter 2025 and aligned on key elements of a confirmatory Phase III clinical trial design, which we will be referring to as STARS II. We are on track to begin site activation in the second quarter of this year and continue to believe that the data generated in the prior STARS Phase III trial will support an eventual NDA submission. Mike will discuss the Phase II trial design in more detail later in the call. Lastly, for 2025, we finish the year strong. delivering $138 million in adjusted EBITDA and ending the year with $250 million of cash and cash equivalents on the balance sheet, positioning us well for 2026. Now, looking ahead to 2026. On January 2nd, we announced a strong outlook for 2026 with our full-year financial guidance, highlighted by our expectation that Linzess will return to blockbuster status with greater than $1.1 billion in U.S. net sales in 2026, driven by improved net price and low single-digit prescription demand growth. We expect increased LINZUS U.S. net sales and our continued disciplined expense management to drive greater than $300 million in adjusted EBITDA in 2026, which will enable us to continue to advance apiglutide and reduce our debt to further strengthen our financial position. As such, our priorities in 2026 are clear. We'll continue to maximize LINZUS, we'll advance apraglutide by initiating SARS-2 for short bowel syndrome patients with intestinal failure, and we'll continue to emphasize disciplined expense management to deliver profits and meaningful cash flows, which will enable us to reduce our debt and further strengthen our financial position. With clear 2026 priorities and our improved financial position, we now have a clear path to execute our strategy, and we'll continue to evaluate all options to maximize shareholder value. Moving to slide six. We're particularly excited about the opportunity we have with apraglutide, which has demonstrated strong efficacy and tolerability to date, becoming the first and only GLP-2 to achieve a statistically significant reduction in weekly parenteral support volume with once-weekly administration. Patients in our open-label extension study, STARS EXTEND, continue to reduce parenteral support volumes with longer-term exposure to apraglutide. Data presented at the American College of Gastroenterology meeting in October reported 34 patients have achieved and maintained enteral autonomy or complete weaning of parenteral support for at least three months. Our conviction for the commercial opportunity for apoglute remains high. because of the strength of these data and the fact that many GLP-2 eligible patients with high parenteral support burden go untreated or discontinue therapy. We believe that the clinical profile with demonstrated efficacy, tolerability, and once weekly administration of apriclutide can redefine standard of care for short bowel syndrome with the potential to improve adherence and increase the number of GLP-2 treated patients. to generate greater than $700 million in US peak net sales. The addition of potential approvals in geographies abroad would further increase the opportunity. I'd also like to take a moment to acknowledge that February 1st was Intestinal Failure Awareness Day, and February is Rare Disease Month. As we work towards our goal of developing and commercializing life-changing therapies for patients suffering from GI and rare diseases, We also seek to increase awareness for people we serve who are at the center of our work year round. Short bowel syndrome is a devastating condition and we thank you for your trust as we work with urgency to deliver this important new medicine to short bowel syndrome patients who are dependent on parenteral support. With that, I will now move to our commercial performance update on page seven. Throughout 2025, Linzess continued to maintain its prescription market leadership for the treatment of IBSC and chronic constipation in the US, recently surpassing 5.7 million unique patients treated since launch and ending the year with roughly 45% market share. With over 40 million addressable patients in the US, we believe Linzess still has a significant potential to grow prescription demand over the coming years due to the significant unmet need and the dissatisfaction with OTC therapies. Once again, LINDS has delivered strong double-digit demand growth, increasing 13% year-over-year for the fourth quarter and 11% for the full year in 2025, the second consecutive year delivering 11% prescription demand growth. Linzess demand growth consistently outpaced the market and was supported by all-time highs in new-to-brand patient volumes. Turning to 2026. After two consecutive years of declining Linzess net sales driven by price headwinds associated with legislative changes, we expect to return Linzess U.S. net sales growth in 2026. Effective January 1st, Linzess list price was lowered in response to the evolving healthcare dynamics and to support ongoing patient access. As a result of this change, we expect more than a 30% increase in 2026 Linzess U.S. net sales year over year. Specifically driven by the elimination of the inflationary component of statutory required rebates across the channels, including Medicaid. Due to this decrease in list price we've maintained our class leading payer access in 2026 and expect low single digit prescription demand growth over the course of the year. With this improved pricing and that sales growth, we expect lenses will continue to drive meaningful cash flows to fund the next stage of growth, with the commercialization of Africa tight and for proof. With that, I'll turn the call over to Mike to share more details on the continued development of apraglutide. Mike?