Ironwood Pharmaceuticals, Inc.

Thank you for standing by. My name is Cath and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals first quarter 2024 investor update 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. I would now like to turn the call over to Matt Roach, Director of Industrial Relations. Please go ahead.

Thank you, Cass. Good morning and thanks for joining us for our first quarter 2024 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides include four looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties and 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, 2023, and in our subsequent SEC filings. All four looking statements speak as of the date of this presentation. We undertake no obligation to update such statements. Also included are non-GAAP financial measures, which should be considered only as a supplement and not a substitute for or superior to GATT 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 GATT measures. During today's call, Tom McCourt, our Chief Executive Officer, began with a brief overview. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shravan Imani, our Chief Financial Officer, will provide a commercial update and review our financial results and guidance. Today's webcast includes slides. So for those of you dialing in, please go to the events section on our website to access the accompanying slides separately. With that, I'll turn the call over to Tom.

Thanks, Matt. Good morning, everyone, and thanks for joining us. We're pleased to be here to discuss our significant advancements that we've made across our portfolio so far this year and our mission to become the leading GI healthcare company. I always like to start with the three strategic priorities, which are maximize LINZUS, advance our GI pipeline, and deliver sustained profits and cash flow. In the first quarter of 2024, LINZUS maintained its strong demand momentum with prescription volume increasing 10% year-over-year, supported by robust new-to-brand prescription growth of 18% versus the prior year, marking the fifth consecutive quarter of double-digit new-to-brand growth. As you may have seen in our press release this morning, based on information provided by Abby, we recorded an adjustment to the first quarter collaborative arrangement revenue as a result of a gross net change in estimate for LINZUS related to the year ended December 31, 23, which led to our revised full year 24 outlook. Trevor will provide more detail on the impact of this one-time adjustment later on the call. Moving to our pipeline. We made important progress across our development programs in the quarter. Most notably, we believe we have transformed our company with the positive top-line results in February from the Phase III STARS trial, evaluating the efficacy and safety of apraglitide in patients with short bowel syndrome with intestinal failure. These positive Phase III results demonstrate the potential of preglutide as the first and only weekly GLP-2 therapy for the treatment of adults with short bowel syndrome who are dependent on parental support if approved. Following the top-line results shared in late February, we have continued to analyze the robust data set of the STARS Phase III. and new data was submitted as a late-breaking abstract and selected for an oral presentation at the upcoming digestive disease meeting. These data further strengthened the clinical profile of Priglitide, which we're eager to share with the broader GI medical and scientific community. Based on the combination of demonstrated efficacy, tolerability, and once-weekly dosing, we are confident that Priglitide has a high probability of approval. We believe these three distinguishing factors will drive uptake, compliance, and improvement in quality of life for patients, reinforcing our belief that apricotide has the potential to achieve a billion dollars in peak net sales. We are now focused on ensuring a successful path forward to commercialization, an area where we have significant expertise and a track record of success. We are working swiftly and plan to file the NDA as soon as possible with a label focused on adult SPS patients who are dependent on parental support and continue to expect a commercial launch in 2025. We estimate that there's approximately 17,000 adult patients across the United States and Europe who suffer from short bowel syndrome with intestinal failure, with a significant portion of these patients still untreated by GLP-2s. We have the commercial infrastructure already in place and expect only incremental investments needed to launch Apraglitide successfully. We are well on our way with the launch planning and believe we are equipped to commercialize Apraglitide if approved, with a strong sales presence already established in the offices of GI specialists across the United States. We are confident The positive results from the STARS trial, coupled with our proven track record of effective commercial execution, position us uniquely in the market. We're excited to leverage our expertise to maximize the potential for a preglutide and drive meaningful, impactful outcomes for patients with short bowel syndrome who are dependent on parenteral support. So to wrap up, we are poised for future growth. for the following reasons. First, Lizus continues to deliver robust demand growth and is driving meaningful cash flows for Ironwood, which we expect to continue until generic entry in 2029. Second, we believe we have transformed our company with the positive phase-through results from the STARS trial, which reinforce our conviction in a pragmatized high probability of approval and long-term revenue and profit growth potential. Finally, We're excited to see the Phase II top-line results from CMP104 later this year. We believe CMP104 has the potential to be a disease-modifying therapy for the treatment of primary biliary cholangitis. With that, I'll hand it over to Mike to discuss apraglutide and our pipeline in more detail. Mike?