Intercept Pharmaceuticals, Inc.

Hello, and thank you for standing by. Welcome to Intercept Pharmaceutical's second quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the 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. I would now like to turn the conference over to your speaker, Narek Segarian. Sir, you may begin.

Good morning, and thank you for joining us on today's call to review Intercept's second quarter 2023 financial results and key business updates. Our second quarter 2023 press release and accompanying slides are now 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, Chief Financial Officer, Andrew Saik, Chief Commercial Officer, Linda Richardson, and our President of Research and Development and Chief Medical Officer, Dr. Michelle Berry. We will then open the call for questions. Let me now turn the call over to our CEO, Jerry Durso.

Thanks, Narek, and good morning, everyone. Thank you for joining us on our second quarter 2023 earnings conference call. In the second quarter, our Ocala business and PBC again performed well, delivering double-digit growth for the fourth consecutive quarter. The $83.7 million in Ocala net sales was 17% growth over the prior year quarter. This outstanding, sustained performance is a result of the execution of our commercial team and the trust and value that hepatologists and gastroenterologists place in Ocala. With more than seven years on the market, positive patient and physician experience and strong outcomes data in multiple real-world analyses, Ocalava's role as a preferred improvement second-line agent for PBC continues to expand. Linda will share more about the dynamics driving our sales growth, as well as our positive outlook on the Ocalava business. Turning to our pipeline, we continue to prioritize investment in our OCA and Vesafibrate combination program in PBC. We were pleased to share positive data from the first of our two Phase II studies at the Easel Congress this past June. These data illustrate the combination's best-in-class potential to deliver biochemical responses across a range of biomarkers that predict improved clinical outcomes in PVC. We look forward to sharing more details from this program and expect to have all the necessary data to submit a request in 2023 for an end of Phase II meeting with the FDA. Finally, we are aggressively implementing the plan that we communicated on June 23rd to restructure our business, strengthen our focus on rare and serious liver diseases, and deliver profitability quickly. We have discontinued all NASH-related investments and fully expect to meet our targeted reductions in operating expenses. We are making rapid progress in evolving our organization and reducing our cost basis. Andrew will discuss our progress in more detail shortly. The shift we have made puts Intercept in the best position to create value for shareholders while supporting our patient-driven mission. We believe that the actions, which are now well underway, will improve our ability to drive long-term growth and leadership for our PBC business, develop innovative new medicines, and achieve meaningful profitability in 2024. With that, I'll now turn the call over to Andrew.