Ironwood Pharmaceuticals, Inc.

Good day and welcome to the Ironwood Pharmaceuticals fourth quarter and full year 2023 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, please press star one again. For operator assistance throughout the call, please press star zero. And finally, I would like to advise all participants that this call is being recorded. Thank you. I'd now like to welcome Matt Roche, Director of Investor Relations, to begin the conference. Matt, over to you.

Thank you, Gavin. Good morning, and thanks for joining us for our fourth quarter and full year 2023 investor update. Our press release issued this morning can be found on our website. Today's call accompanying slides include forward-looking statements. Such statements involve risks and uncertainties 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 31, 2022, in our quarterly report on Form 10-Q for the quarters ended June 30, 2023, and September 30, 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 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. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrevan 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 of 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 today. I'm absolutely delighted to share with you the progress we made in 2023 and why we believe our future is bright. We made important progress in 2023 toward realizing our vision of becoming the leading GI healthcare company in the industry. I am very proud of the Ironwood team and the significant headway we made in 2023 across our three strategic priorities, which are maximize lenses, advance our GI pipeline, and deliver sustained profits and cash flows. As we turn our attention to 2024, I'm confident in our strategy and look forward to what we expect to be an exciting and transformational year for our company. Let's begin on slide six with a brief overview of some of our key achievements against our strategic priorities in 2023. First, maximizing Linzess. In its 11th year on the market, Linzess had another terrific year. as the leading prescription treatment for adults with IBSC and chronic idiopathic constipation. In 2023, prescription demand increased a robust 10% year-over-year. New-to-brand prescriptions ramped up significantly, increasing 15% compared to 2022, which we believe is a key indicator for future growth potential. In addition, Linzess reached an all-time high of 46% in TRX share in the combined branded and generic IBSC and chronic adipathic constipation market, strengthening its market leadership. And in June of 2023, Linzess received FDA approval for functional constipation in pediatric patients ages 6 to 17, becoming the first and only approved prescription therapy for this patient population, an achievement we're incredibly proud of. Moving forward, our focus remains on continuing to grow Linzess prescription demand and delivering strong brand profits and cash flow. Next, advance our GI pipeline in areas of high unmet need. Last year, we strengthened our GI pipeline with the acquisition effect of Bio, including its lead asset, Apraglitide. As the next generation, long-acting GLP-2 analog, we believe Apraglitide, if successful, has the potential to become the standard of care in treating patients with short bowel syndrome dependent on parenteral support based on its clinical profile and the potential convenient once-weekly dosing. If approved, we believe Apreglutide can achieve a billion dollars in peak next sales. Apreglutide's unique pharmacologic properties and strong clinical data to date, including the positive data from the STARS nutrition study, gives us confidence in the STARS Phase III study which was on track to read out in March. In addition to apraglitide, we're also excited about the progress of CMP104, a potential disease-modifying therapy for the treatment of primary biliary cholangitis, or PBC. Late last year, we completed an early analysis that showed evidence of favorable T-cell responses in patients treated with CMP-104, supporting the mechanistic rationale for the asset, which we believe could positively impact disease progression in PBC. We're looking forward to the top-line Phase II data in the third quarter. We believe both apraglitide and CMP-104 have the potential to improve standard of care and the quality of life for patients suffering from these serious GI diseases. with key data expected this year. Our third priority is deliver sustained profits and cash flow. We're committed to being thoughtful and disciplined in our capital allocation as we strive to grow the business, achieve our vision, and deliver value to patients and shareholders. Looking ahead to 2024, we expect to deliver greater than $150 million in adjusted EBITDA, while continuing to progress multiple clinical programs with the potential to deliver long-term growth. We believe the positive momentum across the pipeline programs combined with the continued strong performance of LINCES uniquely positions us for success in our mission to be the leader in GI. We're excited about the key near-term data catalysts, which we believe will present the opportunity to propel Ironwood's growth and create value for patients and shareholders for years to come. At the end of this month, we will be celebrating Rare Disease Day. I'd like to take this opportunity to say a special thank you to all the employees, patients, caregivers, and advocates in the rare disease community for their shared dedication to advancing and supporting new therapies for diseases with significant unmet medical needs. I would now like to turn that call over to Mike to review our pipeline. Mike?