Ironwood Pharmaceuticals, Inc.

Ladies and gentlemen, good morning. My name is Abby and I will be your conference operator today. At this time, I would like to welcome everyone to the Ironwood Pharmaceuticals fourth quarter and full year 2021 investor update conference call. Today's conference is being recorded and 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 the star key followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one once again. And I would like to introduce Matt Roach, the Director of Investor Relations. Mr. Roach, you may begin your conference.

Thank you, Andy. Good morning, and thanks for joining us for our fourth quarter of the year 2021 investor update. Our press release across the wire this morning is found on our website. These calls and accompanying slides include four of the key statements. Such statements involve risks and uncertainties that may cause actual results to differ materially. The 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 quarterly report on 410Q, recorded ended September 30th, 2021, and in our future SEC filings. All four of the key statements speak as of the date of this presentation. 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 GAAP measures. Since it's applicable, please refer to the tables at the end of our press release for reconciliation of these measures to the most directly comparable death measures. In today's call, Tom McCourt, our CEO, will begin with an overview, providing an update on the commercial performance of WINS-S. Mike Checkline, our chief medical officer, will provide updates on our pipeline. Shravan Amani, our chief financial officer, will review our financial results and guidance. Today's webcast includes slides to support For those of you dialing in, please go to the Advice section of our website to access the company slides separately. With that, I will turn the call over to Tom.

Thanks, Matt. Good morning, everyone, and thanks for joining us today. When I became CEO last year, I was energized about the commitment to developing innovative solutions in the area of high-end met need in GI. In 2021, we made significant progress against this important mission. I am proud of the Ironwood team, who even through the ongoing pandemic, was resistant in their commitment to advancing the treatment of GI diseases and redefining standard of care for patients. Thanks to their hard work and dedication, we closed out the year with a lot to be proud of. We started 2021 with a clear roadmap, which included three strategic priorities. One, maximizing lenses. Two, strengthening our innovative GI pipeline. And three, deliver sustainability by the end of 2021 i'm excited to report that we made tremendous headway across all three of these key pillars let's begin on slide six with a quick overview of some of our highlights and achievements in 2021 first lindas has been an extraordinarily resilient market leading brand that continues to deliver strong demand growth and profitability In 2021, I'm proud to share that Linzess achieved blockbuster status, exceeding $1 billion in U.S. net sales, representing 8% growth year-over-year. Prescription demand grew a robust 12% year-over-year, and commercial margins were 74%. The continued impressive Linzess performance is no small feat, and I want to acknowledge the dedication of our team who made this achievement of $1 billion in sales a reality. In addition, we previously announced that the FDA approved a revised label for Lindus, modifying the prior box warning, which included all children under 18 years of age, to the warning of a risk of serious dehydration and contraindication against use of children to less than two years of age. This label change is a significant accomplishment for the team as we continue to advance the pediatric program. As a reminder, Lindus is not currently approved for these patients under 18 years of age. Next, we strengthened our pipeline by entering into a collaboration and license option agreement with Core Pharmaceuticals to develop and commercialize CMP104, which, if successful, has the potential to be the first approved disease-modifying therapy for primary biliary cholangitis. In addition, we advance IW3300, our wholly owned asset for the treatment of visceral pain conditions, and our Lenacotide pediatric development program in IVSC and functional conservation. Mike will elaborate on these exciting pipeline updates in a few moments. Finally, we ended the year with $528 million in gap net income, which includes a $338 million non-recurring income tax benefit related to the release evaluation allowance in the second quarter of 2021. Adjusted EBITDA of $234 million at $620 million in cash and cash equivalents, a significant increase from the end of 2020. also we initiated our board authorized share buyback program with 27 million dollars of shares repurchased as of the end of 2021 another important highlight in 2021 was the addition of several experienced leaders including andrew davis our chief business officer john monardo our chief legal officer and most recently shravan amadi our chief financial officer We're thrilled that Andrew, John, and Trevon have joined the team, and I'm honored to be at the helm of a very talented group of leaders, uniquely capable of advancing our mission and ushering in a new era in growth and innovation at Ironwood, as we look to continue to grow the company and our pipeline to address areas of GI diseases. Now, let's turn our attention to Linzess, starting on slide seven. Ironwood has had tremendous success with Linzess from its inception to its recent achievement of blockbuster status. And it continues to serve as a backbone of the company. As I mentioned a few moments ago, Linzess prescription demand increased 12% year-over-year in 2021, resulting in USN sales of over a billion dollars. Linzess ended the year with approximately 44% total prescription share, a new record high for the brand. As you can see in slide 8, new-to-brand prescription growth increased over about 15% year-over-year, which outpaced the market. In addition, 90-day prescription growth has continued to increase over time, making up approximately 20% of the business as of the end of 2021. Turning to slide 9. It's not every day that a brand achieves blockbuster status, and it doesn't happen by accident. First, lymph dust has demonstrated an improvement in constipation plus overall abdominal symptoms, which is important in the treatment for adults with IBSC who are often frustrated by bloating, pain, and discomfort. Additionally, the strong brand awareness has helped Linsys become the number one prescribed branded treatment for adults with IBSC and chronic constipation by gastroenterologists and primary care physicians. This robust momentum and market leadership position has enabled us to refine our overall marketing mix and investment over time while we continue to deliver strong demand growth and expand brand margins. We expect to continue to grow Linzess through patient activation, refined professional promotion, our class-leading payer access, and by pursuing future lifecycle management opportunities. Looking ahead, we're confident in our strategy and in the future, and we will continue to focus on delivering value to our patients and shareholders. We believe the investments we're making in the brand and in our pipeline will position our company for long-term growth. Since joining the company in 2009, I've seen firsthand the outstanding capabilities of the Ironwood team in advancing our development and commercialization strategies, as well as our unsurpassed level of commitment to making a positive difference for millions of patients affected by GI diseases. I'm very honored to lead this organization full of talented people, and I look forward to continuing to build upon Ironwood's success as we plan for 2022 and beyond. I'll now turn the call over to Mike to discuss our pipeline and clinical development efforts. Mike?