Ironwood Pharmaceuticals, Inc.

Good morning. My name is Joseph and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals first quarter 2022 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'd like to ask a question at this time, simply press the star followed by the number one on your telephone keypad. If you'd like to withdraw your question, Press the star and then the number one on your telephone keypad. Thank you. Matt Roche, Director of Investor Relations. You may begin your conference.

Thank you, Joseph. Good morning and thanks for joining us for our first quarter 2022 investor update. Our press release issued this morning can be found on our website. It is called an accompanying slide to include four building statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. 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, 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, 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 LaCourte, our CEO, will review our strategic priorities and provide an update on the commercial performance of LINDSES. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrovan Ahmadi, 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 will turn the call over to Tom.

Thanks, Matt. Good morning, everyone, and thanks for joining us today. I'm delighted to announce our Q1 results this morning. Maintaining last year's momentum, we're off to a tremendous start this year, as demonstrated by the continued strong LINSA's performance, the initiation of IW3300 and CNT104 clinical studies, and another quarter of delivering profitability and positive cash flow from operations. At Ironwood, we remain committed to advancing the treatment of GI diseases and redefining standard of care for GI patients. We're focused on driving value for our shareholders by bringing important medicines to our patients. I believe the progress we made across the organization in the first quarter demonstrates the steps we're taking to become the leading GI healthcare company in the U.S. Now, I'll begin with a brief overview of our strategic priorities on slide six. Our strategy starts with maximizing LINZUS. We continue to be excited by the performance of LINZUS, which has delivered another quarter of double-digit demand growth. And we believe there's more opportunity ahead. Beyond LINZUS, we're making progress on our clinical trials and remain on track with previously shared data readout timing. We're focused on strengthening our pipeline. through our in-license and acquisition of innovative GI assets, which we believe will position our company for continued growth. And finally, we continue to deliver sustained profits and cash flow. We ended the first quarter with approximately $593 million in cash and cash equivalents on the balance sheet, and we continue to execute on our board-authorized share repurchase program. Through the end of March, we have repurchased $118 million in our common stock. We see these achievements in the first quarter as important progress that we believe will support continued growth and success for our company. Now, let's turn to some additional details on the commercial performance of Linza starting on slide seven. It's hard to believe that 2022 represents year 10 of Linza being on the market. Linzess has grown from being the first in class GCC agonist becoming the number one prescribed branded treatment in the U.S. for adults with IBSC and chronic idiopathic constipation. As you can see on the slide, Linzess is the leader in the category with 83% share and 75% total prescription share with gastroenterologists in the branded IBSC and chronic constipation market. Linzess is also the leader in the combined branded and generic IVS and chronic constipation market, with 43% total prescription share. Most important, we're proud to have supported nearly 4 million unique patients with Linzess since the launch of the brand in 2012. Building that last year's momentum, Linzess prescription demand increased an impressive 11% year-over-year in the first quarter of 2022, as shown on slide 8. continuing the stretch of five consecutive quarters of double-digit prescription demand growth. In addition, 98 prescriptions have grown as a percent of total retail prescriptions, with an all-time high of 21% at the end of Q1. This has also helped increase the average prescription size of Linzess for roughly 43 days. Slide 9 provides a bit more color on what we believe are the key drivers of Linzess demand over the long term. It starts with a strong clinical profile. Lynn says, has FDA-approved labeling demonstrating the improvement of overall abdominal symptoms of bloating, pain, and discomfort in adults with IBSC. And we're committed to helping both patients and providers understand the importance of treating these symptoms beyond constipation. Additionally, the American College of Gets Hydrology Guideline strongly recommends GCC agonists, including Linzess, to treat IBSC symptoms and recognize the high quality of evidence supporting Linzess. Moving to patient activation, Linzess continues to lead the IBSC and chronic constipation branded prescription market in direct-to-consumer promotion, with the goal of educating more appropriate adult patients to seek care for IBSC versus continuing the frustrating cycle of self-managing with OTC therapies. In April, we, together with our partner, AbbVie, launched our newest consumer campaign, which performed extremely well in market research. Of course, patient activation is not possible without the care of physicians and other healthcare professionals. At Ironwood, we are a GI healthcare company with an experienced and highly skilled sales force focused on broadening the use of Linzess with gastroenterologists and high-volume primary care physicians for appropriate patients. In addition, our investment in payer access is helping support clinical decisions by healthcare practitioners. We are proud that after many years, LINZUS has class-leading payer access and is widely available on commercial and Medicare Part D formularies. When looking at key plans, LINZUS is preferred on the top 10 commercial plans and is covered or better on the top 7 Medicare Part D plans. That meant most patients who have access to LINZUS get chosen by their healthcare professional. Finally, we believe we can expand the clinical utility of LensDust through key lifecycle management initiatives, including our ongoing pediatric program. Over time, we continue to refine our marketing mix and investment in the brand to support brand growth and improve brand margins and cash flow generation. We remain focused on the levers that we believe will drive continued demand growth and, in turn, generate profits and cash flow. Looking ahead, we're excited about continuing to maximize Linzess, advancing our clinical programs, strengthening our financial position, and growing Ironwood's leadership position within GI. In a few weeks, we will be presenting eight abstracts at the Digestive Disease Week meeting, or DDW, two of which are oral presentations highlighting our commitment to advancing the science as we strive to deliver better therapies for patients suffering from GI diseases. In particular, we'll be presenting new data on the clinical utility of the abdominal score, which is important to help physicians better understand the symptoms most important to patients suffering from functional GI disorders. We look forward to DDW and sharing data on lenaclidide, as well as preclinical IW3300 data with the brightest minds in the GI community. I would like to say a big thank you to all Ironwood employees who have laid the groundwork for continued momentum and strong execution against strategic priorities as we continue to help make a remarkable impact on patient lives. I would now like to hand the call over to Mike, who will discuss Thanks, Tom.