Intercept Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by. Your conference call shall begin momentarily. Thank you. Thank you. Thank you for standing by and welcome to Intercept Pharmaceuticals Q1 2022 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question at that time, please press star then one on your touchtone telephone. As a reminder, today's call is being recorded. I will now turn the conference to our host, Mr. Narek Subgerian, so you may begin.

Thank you. Good morning, and thank you for joining us on today's call. This morning, we issued a press release announcing our first 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 food 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, are 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 students are discussed in this morning's press release and in our periodic public findings 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 Say. 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 Dosso.

Thanks, Narek, and good morning, everyone. Thank you for joining us on our first quarter 2022 earnings conference call. As we proceed through this transformational year for Intercept, I'm pleased with the progress that our team made in the first quarter. We reported $88.6 million in worldwide Ocaliba net sales, representing 8% growth, compared to the first quarter of 2021. While Ocaliba continued to deliver revenue growth on a worldwide basis in the U.S., as we expected, we saw a slower growth rate versus previous quarters given the cumulative impact of COVID-19 and last year's label update. Overall, our quarterly performance was in line with our expectations. With more than 20,000 patient years of experience for Ocaliba and PBC, we're strategically focused on generating and sharing compelling long-term data to support adoption of Ocaliba. Given the substantial number of patients with PBC who could benefit from second-line treatment, I remain confident in our ability to continue to grow this business over the long term. Turning to NASH, we're nearing completion of the new top-line data analysis from our Phase III Regenerate study, which will include a significantly larger data set than our interim analysis in 2019. NASH is the most rapidly growing cause of liver transplantation in the U.S., and people living with advanced fibrosis due to NASH urgently need an approved therapy. As the first company with positive Phase III data in NASH, we look forward to delivering these new data analyses and furthering our understanding of OCA's potential role in treating this disease. We continue to target a potential pre-submission meeting with the FDA in June. Our second Phase III trial in NASH reversed, evaluating OCA in patients with compensated cirrhosis due to NASH, is on track for a top-line readout in the third quarter. Our team has also made progress on our earlier stage pipeline programs, which Michelle will elaborate on later in this call. Turning now to the announcement we made yesterday. As you saw from our press release, Advance Pharma has acquired the rights to our international operations, including the rights to commercialize Ocala in PBC in markets outside the U.S., Also under the terms of the agreement, we'll receive royalties on any future ex-U.S. net sales of Obetacolic and NASC should Advanced Pharma pursue marketing authorization for this indication. Upon the closing of this transaction, Intercept will continue to be responsible for the manufacturing and supply of Obetacolic acid globally, and Advanced Pharma will be responsible for the packaging, distribution, and commercialization of the therapy in all markets outside the U.S., Intercept will maintain an office in the U.K. to manage our global supply chain, support our global clinical trials, and our quality organization, though the majority of current Intercept employees outside the U.S. will transfer to Advanced Pharma. Importantly, this transaction is consistent with the focus that we've been employing over the last year and a half. Since I've assumed the role of CEO, we've been laser focused on strengthening our financial foundation to support multiple pathways for future growth. Ultimately, this transaction was a financially strategic move for our organization, and the proceeds of the deal will significantly strengthen the company's balance sheet, increase our ability to invest in our core business priorities, including the support for a potential launch of NASH should we be successful in the U.S., and also allow us to continue to advance and expand our pipeline. I want to thank our international colleagues for their contributions to Intercept. I'm inspired by their commitment to bettering the lives and building a healthier tomorrow for people throughout the world with progressive non-viral liver diseases. We know that Advance Pharma will be positioned to drive growth of Ocaliba outside the U.S., and this will ultimately benefit the international PBC community. We look forward to working closely with the Advance Pharma team to ensure a seamless transition. Now, before we continue with the rest of our quarterly earnings recap, Andrew will now provide additional financial details around the agreement. Andrew?