11/9/2023

speaker
Aaron
Conference Operator

Thank you for standing by. My name is Aaron, and I will be your conference operator for today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals Q3 2023 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, and if you would like to ask a question during that time, simply press star followed by the number one your telephone keypad if you'd like to withdraw your question simply press star followed by the number one again i would now like to turn our call over to matt roach director of investor relations matt please go ahead thank you aaron good morning and thanks for joining us for our third quarter 2023 investor update our press release issued this morning can be found on our website today's call and accompanying slides include forward-looking statements

speaker
Matt Roach
Director of Investor Relations

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, the year ended December 31, 2022, and in our quarterly report on Form 10-Q, where the second quarter ended June 30, 2023, and in our subsequent SEC filings. All forward-looking statements speak as 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 a brief overview. Mike Schetzlein, our chief medical officer, will discuss our pipeline, and Shrevan Imani, our chief financial officer, 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.

speaker
Tom McCourt
Chief Executive Officer

Thanks, Matt, and good morning, everyone, and thanks for joining us today. As we approach the end of the year and look back on the progress we've made across our strategic priorities, we are pleased with the strides taken towards realizing our vision to become the leading GI healthcare company in the industry. As you've come to expect from us over the years, we continue to maximize Linzess by driving robust demand growth and expanding its clinical utility while generating strong cash flows. We are on track to deliver on our Linzess net sales guidance of growth between 6% and 8% this year and remain encouraged about the future growth potential of Linzess based on its continued strong performance in the third quarter. But importantly this year, we have also strengthened and progressed our GI portfolio in areas of high unmet need. Earlier this year, we acquired Vector Bio, including its lead investigational asset, Apraglutide, in development for the treatment of short bowel syndrome with intestinal failure, which we believe has the potential to achieve a billion dollars in peak net sales and extend the growth horizon for our company into the 2030s. We couldn't be more excited about the potential for Preglutide. And just a few weeks ago, at the United European Gastroenterology Week, we presented positive final 52-week data from the Phase 2 STARS nutrition study in short bowel syndrome with intestinal failure and colon incontinuity, which were featured during a late-breaker oral presentation. We believe these data highlight the potential for Epirab Gukai to be the best-in-class GLP-2 analog for the whole spectrum of patients in short bowel syndrome with intestinal failure, including those with colon incontinuity, and reinforces our high conviction for the STARS clinical program. In addition, We're also excited about the progress of CMP104, a potentially disease-modifying therapy for the treatment of primary biliary cholangitis, or PBC. The design of the CMP104 program and the structure of the License Option Agreement with Core Pharmaceuticals are examples of our disciplined approach to building and progressing our development portfolio. The sound scientific rationale for CMP104 and the specificity of the target, the PDCE2 antigen, provided an opportunity to review the early effect on T cell response. This assessment showed evidence of T cell responses in patients treated with CMP104, which is very encouraging. Together, these positive developments across our pipeline reinforce our confidence in the tremendous opportunity we have in front of us. with multiple programs that have the potential to improve standard of care and improve quality of life for patients managing GI diseases. And we also have key upcoming data that will help clarify our path forward. Our commitment and optimism to develop and advance innovative GI assets is as strong as it's ever been. We believe the positive momentum across our GI pipeline programs combined with the continued strong performance of Linzess uniquely positions us on our mission to be the leader in GI. We're looking forward to a strong finish in 2023 and are very excited about the key catalysts ahead in 2024, which we believe will propel Ironwood's growth and ability to create value for patients and shareholders for the years to come. I would now like to turn it over to Mike, who will review our pipeline in more detail. Mike?

Disclaimer

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