speaker
Liz
Conference Operator

Thank you for standing by. My name is Liz and I'll be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals first quarter 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. 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.

speaker
Greg Martin
Chief Financial Officer

Good morning, and thank you for joining us for our first quarter 2026 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 risk certainties that may cause actual results to differ materially. The 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 31st, 2025, 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. All 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 a brief overview. Tammy Gaskins, our Chief Commercial Officer, will provide a commercial update including discussion of the commercial opportunity for apraglutide in short bowel syndrome with intestinal failure. Mike Schepslein, our chief medical officer, will discuss our pipeline, and I will review our financial results and guidance. 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.

speaker
Tom McCourt
Chief Executive Officer

Good morning, everyone, and thanks for joining us today to review our first quarter 2026 financial guidance, results, and business updates. Earlier this year, we laid out our top priorities for 2026, which are maximizing lenses, advancing efforts blue tide, and delivering sustained profits and cash flow. We believe these priorities are key to achieving our goals of redefining standard of care for patients suffering from GI and rare diseases, while maximizing shareholder value. During the first quarter, we made significant progress on each of these priorities. First, Linzess, which continues to be the prescription leader for the treatment of irritable bowel syndrome with constipation and chronic idiopathic constipation in its 14th year on the market. we reported an outstanding first quarter financial performance with 97% year-over-year net sales growth for Linzess, driven primarily by improved net price and supported by 5% prescription demand growth. These first quarter results position us well to achieve our full year 2026 financial guidance, which will return Linzess to blockbuster status and will set a new all-time high for annual U.S. net sales for the brand since launch. We are also continuing to make progress in bringing Linzess to younger age groups. In the first quarter, the FDA accepted a supplementary new drug application for Linzess for the treatment of functional constipation in patients two to five years of age. The application received a priority review with a PDUFA target action date set for May 24, 2026. At present, Linzess is the only FDA-approved drug for the treatment of children 7 years and older with irritable bowel syndrome with constipation and for children 6 to 17 years old for functional constipation. If approved, the indication in children 2 to 5 years old for the treatment of functional constipation would further broaden the clinical utility of lenses in younger age groups. And we look forward to hearing from the FDA in the coming weeks. Also, in the first quarter, we advanced our stars to confirmatory phase 3 clinical trial. assessing epiglutide for the treatment in patients with short bowel syndrome with intestinal failure, including completion of the clinical site feasibility, and we remain on track for the clinical site initiation in the second quarter. This past weekend, we had a chance to present findings at Digestive Disease Week meeting in Chicago from the landmark survey which underscored the need for therapies that address multiple dimensions of the burden of total parenteral nutrition based on real-world experience of patients suffering from short bowel syndrome with intestinal failure. The survey identified the reduction in days of total parenteral nutrition as the top priority for patients. At DDW, we also presented additional data from the long-term extension study of apraglutide, showing a long-term safety profile consistent with previous studies. Dr. Mike Schatzlein, our Chief Medical Officer, will share more details of these data later in the call. Finally, in the first quarter, we delivered strong profits, with $40.8 million in GAAP net income and $76.7 million in adjusted EBITDA. Looking ahead for the year, we believe the cash flows from LINDSUS will continue to fund development and commercialization of afraglutide while simultaneously reducing our debt. With that, I'll hand the call over to our Chief Commercial Officer, Tammy Gaskin, for a LINDSUS commercial update and an overview of the opportunity in short-volume syndrome with afraglutide. Tammy?

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