Ironwood Pharmaceuticals, Inc.

Good day and welcome to the Ironwood Pharmaceuticals Q4 and Full Year 2022 Investor Update Conference Call. Today's call is being recorded. All lines have been placed on mute to prevent any background noise. And 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 one on your telephone keypad. If you would like to withdraw your question, please press star one again. Thank you. And I would now like to turn the conference over to Matt Roach, Director of Investor Relations. Please go ahead.

Thank you, Savannah. Good morning and thanks for joining us for our fourth quarter and full year 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 that 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 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 McCork, our CEO, will review our strategic priorities and provide an update on the commercial performance of WINS-S. Mike Schetzlein, our Chief Medical Officer, will discuss our pipeline, and Shrevan Imani, 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 begin 2023, our commitment to developing and advancing innovative solutions in the area of high unmet need in GI is as strong as ever. Looking back in the past year, we have made important progress in advancing the treatment of GI diseases while redefining standard of care for patients. I'm very proud of the Ironwood team, and thanks to their hard work and dedication, we closed 2022 with a lot to be proud of. You've heard us talk about our focused approach based on three strategic priorities, where we seek to maximize Linzess, strengthen and progress our innovative GI portfolio, and deliver sustained profits and generate cash flow. I'm delighted to say that we continue to drive strong Linzess prescription demand growth delivered on our full year adjusted EBITDA guidance, and we made strides across all three of our key strategic pillars. I remain confident in our strategy and believe we are well positioned for even greater success in 2023. Let's begin on slide six with a quick overview of some of the key achievements against our strategic priorities for 2022 and what we expect in 2023. First, maximize LINZ-S. LINDSUS continues to see strong prescription demand growth, profitability, and widespread acceptance among health care practitioners as the leading branded prescription treatment for adults with IBSC and chronic idiopathic constipation. In 2022, prescription demand increased more than 9% year over year. The brand continued to demonstrate market leadership by achieving an all-time high in new patient starts, which is a lead indicator for its future growth potential, and growing TRX market share, which reached an all-time high of 45% as of the end of December. As we announced earlier this week, we are pleased that the FDA granted priority review of our SNDA for functional constipation in pediatric patients ages 6 to 17, and assigned a PDUFA date of June 14, 2023. We're particularly excited about the potential to expand the clinical utility of LINZUS to this underserved patient population, and we plan to leverage a focused investment to drive growth and improve brand margins over time. Next, strengthen and progress our innovative GI portfolio, starting with CMP104. the potential disease-modifying treatment for primary biliary cholangitis. In 2022, CORE Pharmaceuticals initiated a proof-of-concept study in PBC, which will assess the safety, tolerability, pharmacodynamic effect, and efficacy. We also kicked off Study Start activities at the end of 2022 for IW3300, Ironwood's wholly-owned GCC agonist, for its potential treatment of visceral pain conditions such as interstitial cystitis and bladder pain syndrome. We anticipate several exciting opportunities to advance the value potential of our pipeline this year. First, we expect early data in the second half of the year from patients enrolled into the clinical study for CMP104. Second, we expect to begin patient dosing for a proof-of-concept study in interstitial cystitis and bladder pain syndrome for IW3300 in the near term. Finally, we continue to actively evaluate opportunities to strengthen our portfolio, and we see several potential attractive opportunities in the market that could benefit from Ironwood's expertise in GI. Our third strategic priority is to deliver sustained profits and generate cash flow. We delivered on our guidance of over $250 million in adjusted EBITDA and ended the year with $656 million in cash and cash equivalents on the balance sheet after deploying nearly $250 million in 2022 by completing our share repurchase program and repaying the principal on our 22 convertible notes. We are in a fortunate position of being a profitable biopharma company with a highly skilled and experienced team in the management of gastrointestinal diseases and a strong and growing cash balance. We believe we're well-positioned to execute on our strategy as we strive to become the leading GI healthcare company in the U.S. Now, let's talk a bit more about the performance of Linzess in slide seven. As you can see on the left side of slide seven, the performance of Linzess has been remarkable. as we continue to see a robust linear growth trajectory. Over time, the strong prescription demand growth for LINZ-S has been supported by a combination of high treatment satisfaction, updated clinical guideline support, and class-leading formulary access. We continue to see an acceleration of appropriate new adult patient starts and Anticipate this will be augmented in the future should the FDA approve an indication for functional constipation in patients ages 6 to 17. We believe the pediatric opportunity, if approved, could expand the market potential for Linzess as functional constipation affects roughly 6 million 6 to 17-year-old children and adolescents in the U.S. This is incremental. to the need that still exists amongst approximately 40 million adults in the U.S. that suffer from IBS and chronic constipation. Linzess is well positioned to be the branded market leader across both its current and potential future indication. Looking ahead, we're confident in our strategy and in our future. We believe the investments we're making in the brand and in our pipeline position our company for long-term growth. I would like to say a very big thank you to all the Ironwood employees who have laid the groundwork for continued momentum and strong execution against our strategic priorities as we continue to make meaningful impact on patients' lives. I would now like to turn the call over to Mike to discuss our pipeline. Mike? Thanks, Tom.