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8/4/2022
Good morning. My name is Stephanie, and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals second quarter 2022 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, then the number one on your telephone keypad. If you would like to withdraw your question, again, press the star 1. Thank you. Matt Roach, Director of Investor Relations. You may begin your conference.
Thank you, Stephanie. Good morning, and thanks for joining us for our second 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 Statements slide, as well as under the heading Risk Factors in our annual report on Form 10-K for the year ended December 31, 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 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 reconciliation 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 LINZ-S. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shravan Amani, our Chief Financial Officer,
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 second quarter results the positive momentum across our business continued in second quarter as demonstrated by robust lenses prescription demand growth advancement of our clinical programs, completion of our share repurchase program, and repayment of our 2022 convertible notes. The progress we made in the second quarter is a direct result of hard work and strong execution from the team, along with our shared commitment to advancing treatment in GI diseases, redefining standard of care in GI, and bringing important medicines to our patients. Our mission is to become the leading GI healthcare company in the U.S., Now, I'll start with a brief overview of our strategic priorities on slide six. Our strategy starts with maximizing Linzess. Since launch nearly 10 years ago, Linzess continues to experience remarkable prescription demand growth and widespread acceptance among healthcare practitioners as a leading prescription treatment for adults with IBSD and chronic idiopathic constipation. We are proud to report the brand recently surpassed 4 million unique patients treated since launch in 2012. In the second quarter, Linzess prescription demand increased 9% versus the prior year quarter, and Linzess achieved an all-time high in new-to-brand prescription volume, as patients and prescribers turned to Linzess to treat their IBSC or chronic idiopathic constipation symptoms. Through the first half of 2022, Linzess prescription demand has performed in line with expectations with double-digit prescription demand growth year over year. We believe there's still significant opportunity to reach appropriate new patients and drive additional prescription growth for the brand. In addition to the commercial success of Linzess, we continue to make progress with our ongoing clinical trials. We now expect our phase three pediatric study in six to 17-year-olds with functional constipation to read out in the third quarter this year, and we remain on track with previously shared data readout timing for IW3300 and CMP104. We continue to focus on strengthening our pipeline through in-license or acquisition of innovative GIS assets, as we believe it will position our company for continued growth. Mike will provide an update of our pipeline in a few minutes. And finally, we continue to deliver sustained profits and cash flow. We ended Q2 with over $500 million in cash and cash equivalents on the balance sheet after repaying our 2022 convertible notes in cash and completing our share repurchase program during the quarter. We're pleased with the progress across our three strategic priorities and believe we will continue to position ourselves for growth moving forward. Now, let's turn to some additional details on the commercial performance of Linza on slide seven. Linzess continues to perform exceptionally well, powered by both new patient and refill volume, further reinforcing its position as the number one prescribed branded medicine in the U.S. for the treatment of adults with IBSC and chronic idiopathic constipation. As I mentioned earlier, Linzess prescription demand in the second quarter grew 9% year over year. We believe high single-digit demand growth is impressive, particularly relative to the 14% demand growth achieved during the second quarter of 2021 as the market recovered from the COVID-19 pandemic. Overall, the strong double-digit year-over-year lenses demand growth for the first half of 2022 is in line with our expectations for the full year. In addition, 90-day prescriptions have grown as a percentage of total retail prescriptions, now making up 21% of total prescriptions. This has led to an all-time high in the average size of prescriptions. Turning to slide eight, the impressive growth in Linzess prescription demand is a reflection of the strong clinical profile, focused investment in both consumer and professional promotion, and class-leading payer access. As a result of our efforts to maximize Linzess, total prescription share at the end of the second quarter was 44%, an all-time high for the brand. Over the past year, Linzess has grown share approximately two points within the branded and generic IBSC and chronic idiopathic constipation market. New prescription share has also increased, further strengthening the market leadership position of Linzess. Now, slide nine. In addition to being the branded prescription market leader in IBSC and chronic idiopathic constipation, the clinical importance of Linzess was further acknowledged in the quarter in updated treatment guidelines. On June 20th, Linzess received a strong recommendation from the American Gastroenterological Association for the treatment of IBSC supported by a high level of evidence. Linzess was the only treatment 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 millions of adults living with the highly frustrated symptoms of IBSC. These guidelines are a critical tool to help physicians provide evidence-based care for their patients, and we will work to communicate this update during our ongoing interaction with our customers. Finally, we're committed to advancing the lifecycle management program for LensS to broaden the clinical utility for the brand and help even more patients in need of treatment. We are excited about the strong position we're in today and the opportunities ahead of us as we seek to continue to maximize Linzess, advance clinical programs, strengthen our financial position, and grow Ironwood's leadership within GI. We strive to lead the way in GI, both through innovative GI therapeutics and also in our contributions to the broader GI community. Over the next few days, Ironwood will be sponsoring the Young Investigator Forum at the 2022 American Neurogastroenterology and Motility Society Annual Meeting, or ANMS. We also have the honor of sponsoring the ANMS Ironwood Diversity Award, and we hope to see some of you there. Thanks, as always, to the employees, patients, and shareholders for all your support. I will now like to hand it over to Mike to discuss our pipeline programs. Mike?
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