Ironwood Pharmaceuticals, Inc.

Hello, my name is Lisa and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals third quarter 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 then 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 Mr. Matt Roach, Director of Investor Relations. Please go ahead, sir.

Thank you, Lisa. Good morning and thanks for joining us for our third quarter 2022 investor update. Our press release issued this morning can be found on our website. Today's call and accompanying slides include forward-looking statements. 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 31st, 2021 and in our future SEC filings. All forward-looking statements speak as of 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 CEO, will review our strategic priorities and provide an update on the commercial performance of Linzess. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrevan Amani, our Chief Financial Officer, 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.

Thanks, Matt. Good morning, everyone, and thanks for joining us today as we share our third quarter results. As we approach the end of the year and look back on the progress we've made across our strategic priorities, we are very pleased with the strides we have made to advance treatment in GI diseases, redefine standard of care, and bring important medicines to GI patients. As we move forward, we remain committed to unlocking new opportunities for LINZUS and strengthening our portfolio with innovative GIS while continuing to deliver sustained profits and cash flows. I'll begin with a brief overview of our strategic priorities on slide six. Our strategy begins with maximizing LINZUS. In the third quarter, we are pleased to report the brand-delivered double-digit extended unit prescription demand growth year-over-year. and for the first time exceeded 1 million total prescriptions in a quarter. A remarkable achievement. Based on the continued strong performance of Linzess through the third quarter, we maintain our full year net sales guidance of low single digit percent growth. Going forward, we believe there's still a significant opportunity to reach appropriate new adult patients and drive additional prescription demand growth. Second, We are seeking to build an innovative portfolio, both through the development of our internal assets and through the in-license acquisition of external assets that target serious organic GI disease that we believe will position our company for continued growth. In the third quarter, we advanced our pipeline programs highlighted by the exciting positive top line data from the phase three trial of LINSA 72 microgram in pediatric patients aged six to 17 with functional constipation. The results of the study add to the body of data supporting the safety of Linzess in this population and brings us one step closer to being able to potentially expand the clinical utility of Linzess to this critically but underserved patient population. As an estimated four to six million six to 17 year old children and adolescents in the US suffer from functional constipation. Mike will discuss the top line data in a few minutes and we look forward to sharing more detail on the potential market opportunity at a future investor update. We, along with Abby, are planning to submit a supplemental NDA by the end of the year. Next, the Phase 2 proof of concept study for CMP104 for the potential treatment of primary biliary cholangitis continues to progress, and we are continuing to study startup activities for IW3300 Phase 2 proof of concept study in patients with interstitial cystitis and bladder pain syndrome. And finally, we continue to generate profits and ended the third quarter with $574 million in cash and cash equivalents in the balance sheet. We're pleased with the progress across our three strategic priorities and believe that we will continue to position ourselves for growth moving forward. Now let's turn to some additional details on the commercial performance of LINZUS on slide seven. LINZUS continues to see high utilization among healthcare practitioners, further reinforcing our position as the number one prescribed branded medicine in the U.S. for the treatment of adults with IBSC and chronic constipation. In both the third quarter and on a year-to-date basis through September, LINZUS extended unit prescription demand increased 10% year-over-year in line with our full year expectations. In the quarter, total prescription share for Linzess continued to lead the market and exceeded 44% in quarterly TRX share, a 1.6 share increase versus the third quarter in 2021. Importantly, this performance was driven by an acceleration in new prescription volume, a key indicator for potential future growth. In fact, an all-time high was achieved for new prescription share of 38% and new to brand volume increased 9% compared to the third quarter in 2021. The foundation for this excellent lens of performance is driven by the strong clinical profile, high patient satisfaction, our focused investment in both consumer and professional promotion, and class leading formulary access to help support healthcare practitioners and patient access. Finally, we're committed to advancing opportunities to broaden the clinical utility of Linzess and help more patients in need of treatment, as evidenced by the recent positive phase three data in our six to 17 year old pediatric program functional conservation. As part of our commitment to leadership in GI, I'm also excited to share that recently we attended the American College of Gastroenterology, or ACG meeting, which included a symposium on updated IBS treatment guidelines and their recommendations. We're proud that in June, Linzess was the only therapy to receive a strong recommendation for the treatment of adults with IBSC in the updated AGA treatment guidelines, a powerful reinforcement that Linzess can help adults living with the highly frustrating symptoms of IBSC. We couldn't be more excited about the strong position we're in today and the opportunities ahead of us. I would like to say a very big thank you to all Ironwood employees who have laid the foundation for our continued momentum and strong execution against our strategic priorities as we continue to help make a real impact in patients' lives. I would now like to hand it over to Mike, who will discuss our pipeline programs. Mike?