Ironwood Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Ironwood Third Quarter 2020 Investor Update Conference Call. At this time, all participants on the list are in only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press Star 1 on your telephone keypad. Please be advised that today's conference is being recorded. If you require any further assistance, please press Star 0. Thank you. Ms. Meredith Kaya, you may begin.

Good afternoon and thanks for joining us for our third quarter 2020 investor update. Our press release crossed the wire this afternoon and can be found on our website, www.ironwoodpharma.com. 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 quarterly report on Form 10-Q for the quarter ended June 30, 2020 and in our future SEC filing. 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 GAP measures. During today's call, Mark Mallon, our CEO, will begin with an overview of the quarter. Mark Plinio, our Chief Commercial Officer, will review our commercial performance, and Gina Conselman, our CFO, will review our financial results and guidance. Mike Shetzline, our Chief Medical Officer, will also be available during the Q&A portion of the call. Our President, Tom McCourt, is unable to join us today due to a personal matter. We will be referring to slides via the webcast. For those of you dialing in, please go to the events section of our website to access the webcast slides. With that, I'll turn the call over to Mark.

Thanks, Meredith, and good afternoon, everyone, and thanks for joining us today. Just over 18 months ago, we launched Ironwood as a purely GI-focused company. And since then, we've been resolute in our mission of advancing GI medicines and redefining the standard of care for patients. We set out from the beginning with three strategic priorities. Drive Linzess Growth, Advance RGI Portfolio, and Deliver Profits. While we have been presented with challenges along the way, we continue to execute well against our priorities and remain steadfast in our focus on our mission. Today, we believe Ironwood is in strong position. Linzess continues to grow at nearly double-digit rates compared to last year, contributing substantial revenue to our business, and we have now achieved our sixth consecutive quarter of profits. Let me speak briefly to each of these priorities and then turn it over to the team for more detail. Linzess continues to be the prescription market leader within its category. Prescription demand grew 7% year-over-year in the third quarter and in the face of continued COVID-19 pandemic. The resiliency of Linzess has shown over this unprecedented period is remarkable. Linzess' performance resulted in total net sales of $241 million for the third quarter. As you know, Ironwood shares equally with our partner AbbVie in the brand's profits. With a 78% commercial margin, Ironwood recorded $100 million in three-quarter revenue from U.S. lenses sales. We remain confident in the brand's potential to exceed $1 billion in peak net sales, thereby providing a solid foundation to support future growth. We've also thoughtfully invested behind our business. This discipline supported our transition to profitability post-separation, and we've demonstrated our ability to generate profits in every quarter since then. Now with over $300 million in cash in our balance sheet and more than $50 million of cash generated in the third quarter, Ironwood is a strong cash flow generating business. And as Gina will discuss, we are pleased to announce today that we are increasing our 2020 financial guidance. Turning to our pipeline, these past few months have clearly been disappointing as the outcomes of both 3718 and 7246 development programs were certainly not what we had hoped for. I commend the team on executing two very well-designed and robust clinical programs that delivered clear results. Unfortunately, based on the results, we made the quick, data-driven decisions to discontinue both programs and are now restructuring our organization with a planned workforce reduction. I want to emphasize that a decision that impacts our colleagues in this way was not easy to make, but we believe it has the potential to help better position our company moving forward as we seek to continue advancing our GI-focused mission and enhancing shareholder value. As we look to the future, we recognize that GI remains a therapeutic area with significant unmet needs, including highly symptomatic patient populations, many severe and debilitating diseases that often have limited or no treatment options available. We understand the need for new therapeutic approaches to treat these diseases, and we believe we have a strong, tenured team with the knowledge and expertise to advance innovative science and build successful brands. We continue to explore accepting complementary commercial and development-stage GI opportunities with the same high bar that we've always had. At the same time, we regularly review and evolve our strategy as we adapt to the broader market dynamic and continue to assess all options to enhance shareholder value. Working alongside the amazing Iowa team, who are true champions in the GI community, I look forward to what the future holds. Before I turn it over to Mark to discuss our commercial performance, I want to take a moment to welcome Alex Danner. We announced this afternoon we'll be joining Ironwood's board. As many of you know, Alex is a seasoned healthcare investor and has broad experience as a board director in overseeing the operations of companies within our industry. We've developed a strong relationship with Alex over these past few years as Sarissa is one of our largest shareholders, and we look forward to collaborating with him on the Ironwood board. And with that, I'll turn it over to Mark.