11/5/2026

speaker
Megan
Conference Operator

Hello everyone, my name is Megan and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q3 2026 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. Thank you. I would now like to turn the call over to Chris Stamm, VP of Investor Relations and Communications. Please go ahead.

speaker
Chris Stamm
VP of Investor Relations and Communications

Good morning, and thanks for joining our third quarter 2026 investor update call. A press release issued this morning highlighting third quarter results 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, 2025 and in our subsequent SEC filing. All forward-looking statements speak as of the date of this presentation and we undertake no obligation to update such statements. also included our 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, Chief Executive Officer Tom McCourt will review third quarter business highlights and our progress advancing our 2026 strategic priorities. Following Tom, Chief Commercial Officer and CEO-elect Tammi Gaskins will provide an overview of third quarter Linzess performance. Next, Jeff Silber, our Chief Medical Officer and Head of Research and Drug Development, will provide an update on amperglutide in the STARS II trial. Then Ron Silver, our Interim Chief Financial Officer, will provide a financial update before turning the call back to Tom and Tammi for some closing remarks prior to opening the call for questions. Jeff Ruberti, Ironwood's Chief Strategy Officer, will also be available during the Q&A portion of the call. Today's webcast includes accompanying slides. For those joining by phone, please visit the events section of our website to access the presentation. And with that, I'll turn the call over to Tom.

speaker
Tom McCourt
Chief Executive Officer

Thanks, Chris, and thank you all for joining us this morning to review Ironwood's third quarter 2026 financial results and business updates. Ironwood's momentum carried into the third quarter as we continued our focused execution across three strategic priorities, maximizing the value of Linzess, advancing the development of apriclutide, and delivering sustained profits and cash flow. 2026 continues to be a turnaround year for the company as we make meaningful progress across each of these priorities. We believe Linzess is on its way to returning to blockbuster status this year, demonstrating exceptional durability and growth in its 14th year on the market, and remaining the U.S.-branded leading prescription therapy for both IBSC and chronic constipation. We delivered a strong third quarter, and based on this momentum, are once again raising our full-year 2026 LINZUS guidance now to the range of $1.2 to $1.25 billion, representing growth of more than 35% year-over-year. Turning to apraglutide, we continue to advance the global rollout of the STARS-2, our confirmatory phase 3 trial, evaluating the apraglutide in patients with short bowel syndrome with intestinal failure. With our plans for clinical trial site activation progressing across the U.S. and internationally, Building on the positive results from the Phase III STARS trial, STARS II is designed to confirm apriclutide's efficacy in reducing parenteral support requirements. We believe the strength of the STARS data and apriclutide's once-weekly administrative support is potential to deliver a meaningful benefit to patients with short bowel syndrome who are dependent on parenteral support. We delivered strong financial results during the quarter, generating $60 million in GAAP net income and a record $98 million in adjusted EBITDA. Looking ahead, we expect to utilize LINZUS-generated cash flow to further reduce our debt and are well-positioned to end 2026 with a gross leverage below 1x, while maintaining resources necessary to advance and prepare for the potential commercialization of apriclutide. With that, I'll ask Tammi to provide some additional context on Linzess.

Disclaimer

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