Intercept Pharmaceuticals, Inc.

Hello, thank you for standing by and welcome to the second quarter Intercept Pharmaceuticals earnings call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star 1-1 on your telephone. Please be advised that today's conference may be recorded. I would now like to hand the conference over to your speaker today, Narek Segarian, Executive Director, Investor Relations. Please go ahead.

Thank you. Good morning and thank you for joining us on today's call. This morning, we issued a press release announcing our second quarter 2022 results and business updates, which is available on our website at interceptpharma.com. Before we begin our discussion, I'd like to note that during our call, we will be making forward-looking statements, including statements regarding our approved product and clinical development program, certain regulatory matters, and our strategy, prospects, financial guidance, and future commercial and financial performance. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this call, and we undertake no obligation to update such statements except as required by law. These forward-looking statements are based on estimates and assumptions that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. Some, but not necessarily all, of the risk factors that could cause our actual results to differ materially from our historical results or those anticipated or predicted by our forward-looking statements are discussed in this morning's press release and in our periodic public filing with the SEC. Today's call will begin with prepared remarks from our President and CEO, Jerry Durso, our Chief Commercial Officer, Linda Richardson, President of Research and Development and Chief Medical Officer, Dr. Michelle Berry, and Chief Financial Officer, Andrew Saik. We will then open the call to take questions. Please limit yourself to one initial question in order to allow time for all questions to be addressed. Let me now turn the call over to our CEO, Jerry Durso.

Thanks, Narag, and good morning, everyone. Thank you for joining us on our second quarter 2022 earnings conference call. As we move past the midway point of this transformational year for Intercept, I'm delighted with the milestones we've reached and the progress we've made to strengthen the foundation of our company. We've built a strong and successful Ocaliba franchise in PBC, and we continue to break new ground in showcasing what this treatment can bring to the appropriate patient populations. We're continuously generating and sharing new long-term data about Ocaliba. And looking ahead, we know there remains a substantial population of patients that could benefit from adding Ocaliba to their treatment regimen. This is evident in the performance we saw in the second quarter of the year, where we reported $71.8 million of U.S. Ocaliba net sales. representing 5% growth compared to the second quarter of 2021. Importantly, the underlying dynamics of Ocaliva indicate that we're moving past the forecasted implications of last year's label change, with prescribing and perception strengthening. We're looking forward to good momentum throughout the rest of the year and beyond. Turning to NASH, I'm thrilled with the results of the top-line readout we announced last month concerning the long-term use of OCA in patients with fibrosis due to NASH. In addition to reinforcing the efficacy of OCA as an antifibrotic, with the second analysis, we now have the benefit of a deeper understanding of safety over a longer period of time. Given the data we've gathered, we're confident in the improved benefit-risk profile of OCA and its potential role as the first therapy in NASH. We had a constructive pre-submission meeting with FDA in July, and we look forward to resubmitting our NDA by the end of this year. At the same time, we're in the process of refining the planning of our commercial strategy in NASH, now that we have data in hand. We expect to take a milestone-driven approach to our commercial preparations, and we'll speak more about that in the future. Regarding our second phase three trial reversed, which is evaluating OCA in patients with compensated cirrhosis due to NASH, we expect a top-line readout in late third quarter. Michelle will provide greater clarity on reverse and our other pipeline programs later in today's call. Finally, the recent sale of our international business has significantly strengthened our balance sheet, which positions us well for future growth and success. We're continuing to drive growth in our foundational business of O'Callaghan PDC, executing the next step in support of OCA's potential as the first therapy in NASH, including the resubmission of our NDA and advancing our key pipeline programs. With that, I'll now turn the call over to Linda. Linda,