Intercept Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Intercept Pharmaceuticals' fourth quarter and full year 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 during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being 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 fourth quarter and full year 2022 results, 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 filings 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 Sake. We will then open the call for questions. Let me now turn the call over to our CEO, Jerry Durso.

Thanks, Narek. Good morning, everyone. Thank you for joining us on our fourth quarter and full year conference call. Intercept made significant progress across the business in 2022, and I'm proud to highlight our achievements today. Looking at our performance in PBC, we again delivered double digit sales growth for Ocala and ended 2022 with total U.S. net sales of $285.7 million. This was 10% growth over 2021. Importantly, in the fourth quarter of 2022, Ocala generated $77.2 million in U.S. net sales, which is 13% growth over the prior year quarter. We now look to 2023 as a year to continue driving growth and we're more confident than ever in the longevity of our PBC business. We know there remains a significant number of people living with PBC who could benefit from adding Ocala as a second line therapy. We added more certainty to the runway of our life cycle with the resolution of our patent infringement case for Ocala that was scheduled for trial in the US District Court on February 27th of this year. The settlements protect Ocaliba market exclusivity into the 2030s and reinforce the long-term opportunity we have in PVC. In addition, we continue to progress our next-generation PVC therapy, the fixed-dose combination of OCA and bezafibrate, which is another component of our long-term strategy. We look forward to sharing data on our next-generation medicine later this year and are excited about its potential. Turning now to NASH. At the end of the fourth quarter, we resubmitted our NDA for OCA and presurotic liver fibrosis due to NASH. Following FDA's acceptance in January, the agency assigned a PDUFA target action date of June 22nd. Reaching this point is the result of hard work and dedication from patients, physicians, study personnel, and our team here at Intercept, and is a major milestone for the NASH community. OCA has demonstrated a strong and confirmed anti-fibrotic effect in our rigorous NASH program, and we believe it has the potential to become an impactful therapy. We're now working through the regulatory review process and are advancing our launch readiness planning while taking a measured approach to investment as we progress through the upcoming milestones. We also made strides in our pipeline program with our next-generation FXR agonist, INT787. In November, we announced the lead indication for this investigational therapy, severe alcohol-associated hepatitis, and initiated our phase two fresh trial. Michelle will elaborate on this later in the call. Notably, the progress we made last year was complemented by the transformation of our capital structure. As a result of this work, we finished the year with nearly $500 million of cash on hand. 2023 will be a pivotal year for Intercept, and we're operating from a position of strength. Our balance sheet and foundational PBC business provide us with the financial flexibility and the strategic optionality to drive growth while positioning ourselves for success in NASH. This year I look forward to working alongside the team as we build on the momentum of last year's performance and grow our commercial PBC business. As we work through the regulatory review of OCA while preparing for a commercial launch in NASH, and as we progress our pipeline opportunities while continuing to innovate on behalf of people living with liver diseases. I look forward to sharing updates on our progression of these priorities throughout the year ahead. With that, I'll now turn the call over to Linda.