Ironwood Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Ironwood Pharmaceuticals second quarter 2020 investor update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker today, Meredith Kaya. Thank you. Please go ahead.

Good morning, and thanks for joining us for our second quarter 2020 investor update. Our press release crossed the wire this morning and can be found on our website, www.ironwoodpharma.com. Today's call and accompanying slides include four 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 Statements slide, as well as under the heading Risk Factors in our annual report on Form 10-Q for the quarter ended March 31, 2020 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, Mark Mallon will begin with an overview of the quarter. Tom McCourt will review our commercial and pipeline performance, and Jean and Councilman will review our financial results and guidance. Mike Shetzline, our Chief Medical Officer, and Mark Plinio, our Chief Commercial Officer, will also be available during the Q&A portion of the call. 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. Good morning, everyone, and thanks for joining us today. The last few months have been an important period for Ironwood, marked by continued execution across each of our strategic priorities. We demonstrated solid Linzess demand growth, made important updates designed to strengthen our 3718 Phase III program for refractory GERD, made the tough but data-driven decision to discontinue 7246 development following the Phase II results, and delivered our fifth consecutive profitable quarter since separation. All of this was despite challenges resulting from the ongoing COVID-19 pandemic. I'll spend a few moments on each of these and then turn it over to the team for more detail. Linzette's prescription demand grew 9% year-over-year in the second quarter, an impressive number for a brand that is already the market leader within its category, and when considering the challenges that the healthcare sector has faced due to the pandemic. On 37-18, we recently gained alignment with the FDA on important program updates, that are designed to strengthen our pivotal Phase III trials. We believe these updates represent a clear advancement for the two 3718 trials, providing us with an opportunity to obtain an early indication of the efficacy of 3718 in the refractory GERD population. Now, at the time of the announcement of these changes or upgrades for 3718, one of the updates we shared was that we were in discussions with the agency regarding its request for additional long-term safety data as part of an NDA submission. We are pleased to share today that the agency has since indicated to Ironwood that we will not be required to conduct a long-term safety study in connection with a potential NDA submission. Turning to 7246, we and our partner, AbbVie, decided to discontinue 7246 following the top-line results from our Phase II trial. We are in the process of analyzing the full data set to better understand the disparity between these results and our previous positive page 2B findings in IBSC. Finally, our focus on generating profits continued in the second quarter with the delivery of both GAAP and non-GAAP profitability. Given the strong results in the first half of 2020 and our confidence in our continued performance in the second half, we are reinstating our previously withdrawn 2020 full year, Lynn says, next sales Total Ironwood Revenue Guidance, and reiterating our Adjusted EBITDA Guidance. Our vision of becoming the leading GI-focused company is grounded on our ability to advance new GI treatments and our goal of redefining the standard of care for millions of patients. We strive to bring multiple innovative medicines to market over time, both organically and inorganically. Our bar for accessing inorganic opportunities remains high, but we will not hesitate to act on an asset that we will believe will generate long-term value and make a difference for patients. With that, I'll turn it over to Tom to discuss our commercial and development progress in more detail.