Ironwood Pharmaceuticals, Inc.

Good day and welcome to the Ironwoods Pharmaceuticals Q1 2023 Investor Update conference call. Today's call is being recorded. 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 the star followed by the one on your telephone keypad. Thank you. I will now turn the call over to Matt Roach, Director of Investor Relations. Please go ahead.

Thank you, Angela. Good morning, and thanks for joining us for our first 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. 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 31, 2022 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 Linsess. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrevan Imani, our Chief Financial Officer, or review our financial results and guidance. Today's webcast includes slides, so for those of you dialing in, please go to the event 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 delighted to announce our first quarter results this morning. We are off to a terrific start to the year, as demonstrated by continued strong Linzess demand growth progress of our clinical studies, and another quarter of delivering robust profits and cash flow. At Ironwood, we remain committed to advancing the treatment of GI diseases and redefining standard of care for GI patients. I believe the progress we've made across the organization in the first quarter demonstrate the steps that are taken to become the leading GI healthcare company in the U.S. Let's begin on slide six with our strategic priorities. Our strategy starts with maximizing lenses. Linzess continues to experience remarkable prescription demand growth and widespread adoption amongst healthcare practitioners as a leading branded prescription treatment for adults with IBSC and chronic idiopathic constipation. In the first quarter, Linzess' U.S. net sales growth increased 8% year-over-year. Prescription demand growth increased over 10% as compared to the first quarter of 2022, demonstrating that the momentum of the brand remains strong. We believe there's still a significant opportunity to reach appropriate new patients and drive additional prescription demand growth, including a potential mid-year indication for linactatide in functional constipation for patients 6 to 17 years of age, if approved. Next, we are focused on continuing to strengthen and progress our innovative GI portfolio, starting with CMP-104, a potentially disease-modifying treatment for primary biliary cholangitis. The clinical study is ongoing and we continue to expect early data assessing the T cell response in the second half of the year from the patients enrolled in the studies which will inform the timing of top line data. Second, IW3300. We are continuing the proof of concept study in patients with interstitial cystitis and bladder pain syndrome. Finally, we continue to actively evaluate opportunities to strengthen our portfolio. And we see several attractive opportunities in the market that we believe are accessible and could benefit from Ironwood's expertise and capabilities in GI. Our third strategic priority is delivering sustained profits and generate cash flow. We delivered gap net income and adjusted EBITDA of $46 million and $60 million, respectively, and ended the first quarter with $740 million in cash and cash equivalents on the balance sheet. With our unique profile as a profitable GI-focused biopharma company with a strong and growing cash balance, we believe we're well-positioned to maximize Linza's growth and continue to build an innovative GI portfolio to create the next growth horizon for the company. Now let's turn to the performance of Linza on slide seven. As you can see on the left side of slide 7, Linzess performed exceptionally well in the first quarter. As I mentioned a few moments ago, Linzess prescription demand increased 10% year-over-year and net sales increased 8% year-over-year and generated $250 million in the quarter. Over the first quarter, the adult IBSC and chronic constipation prescription market experienced strong growth, with Linzess experiencing an all-time high in new-to-brand patient volumes. to strengthen its position in the market as the number one prescribed brand for adults with IBSC and chronic constipation. Most importantly, we are proud to have had treated more than four and a half million unique patients since the launch of the brand over 10 years ago. The growing number of patients that are actively seeking care and have been treated with Linzess is evidence of the high treatment satisfaction expressed by both clinicians and patients. We believe these market dynamics, combined with class-leading formulary access, the clinical guideline recommendations from both GI societies, and the strong commercial execution is driving the demand momentum that we continue to see. And we expect this momentum to be augmented mid-year should FDA approve the pediatric functional constipation indication, reinforcing the growth potential for the brand. Looking ahead, We're excited about the continued growth of LensS, the advancement of our clinical program, and our stronger financial position as we advance Ironwood's leadership in GI. In a few days, we'll be presenting five abstracts at the Digestive Disease Week meeting, or DDW, including an oral presentation. These abstracts will highlight new data that reinforce the potential of lenaclutide to treat functional constipation in children and adolescents. We look forward to DDW, where each year we have an important presence demonstrating our commitment to advancing GI therapies, including expanding the clinical utility of lenaclutide. Before handing it over to Mike to discuss the pipeline programs, I'd like to take a moment to say a very big thank you to Jason Rickert for his leadership and immense contributions to Ironwood over the last 11 years. most recently serving as our Chief Operating Officer, and for helping make Ironwood the company it is today. While a change like this is not easy, as an organization committed to maximizing shareholder value, we continue to look for ways to streamline our team and align key functions and resources to meet our current and future needs and support Ironwood through its next phase of growth. I would also like to acknowledge all the Ironwood employees We've continued the momentum and strong execution against our strategic priorities as we continue to help make a remarkable impact in patients' lives. I would now like to hand the call over to Mike. Mike?