Intercept Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the first quarter 2023 Intercept Pharmaceuticals earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, 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, Nareg Sajarian, Executive Director of Investor Relations. Please go ahead.

Good morning, and thank you for joining us on today's call to review Intercept's first quarter 2023 financial results and key business updates. We are also pleased to share an overview of our commercial launch strategy for OCA and NASH. Our first 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 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 President of Research and Development and Chief Medical Officer, Dr. Michelle Berry, our Chief Financial Officer, Andrew Sake, and our Chief Commercial Officer, Linda Richardson. We will then open the call for questions. Please note that our prepared remarks on today's call are more in-depth than typical, but we have a lot of additional time for Q&A during the call. Let me now turn the call over to our CEO, Jerry Durso.

Thanks, Nirag, and good morning, everyone. Thank you for joining us on our first quarter of 2023 earnings conference call. Today, we will review key business updates for the first three months of the year and preview our commercial launch strategy for OCA and NASH. The strategic actions we took in 2022 established a strong base for us to build on in 23. As we proceed through this critical year for Intercept, I'm pleased with the disciplined execution our team has taken to grow our leadership in PVC, to work through the regulatory review process for OCA and NASH and prepare its potential commercial launch, and to advance our pipelines. First, I want to highlight our important upcoming milestones in NASH, and then I'll discuss the sales performance of Ocaliba and our outlook in PBC. We're actively preparing for our advisory committee meeting on May 19th to review our new drug application for OCA as a treatment for pre-cirrhotic fibrosis due to NASH. Given the robust body of evidence we've gathered through our OCA NASH clinical development program, we're confident in the improved benefit-risk profile of OCA, and believe it has the potential to become an impactful therapy for patients in urgent need of pharmacologic intervention. We look forward to discussing the strong and confirmed anti-fibrotic effect of OCA, as well as its monitorable and manageable safety profile with the advisory committee. At the same time, we look forward to our upcoming PDUFA target action date on June 22nd. In parallel, we're progressing our launch readiness activities, which Linda will elaborate on later in this call. Now, turning to PBC, our PBC business continued to perform well in the first quarter. We recorded $68 million in net sales for Ocaliba and PBC, representing 15% growth over the prior year quarter. This strong performance is evidence of the sustained growth of our foundational PBC business. Importantly, we're seeing a consistent trend in attracting new first-time Ocaliba writers, which is a key factor in our growth trajectory. Specifically, 4 out of 10 total prescribers in the first quarter of 2023 were, in fact, first-time Ocaliba writers. Looking ahead, we have strong conviction in the strength and long-term opportunity of our foundational PBC business for several reasons. First, we know that patients on Ocaliba persist on therapy at a rate better than what is typically seen with many other chronic disease therapies. In fact, over 95% of our business is driven by existing patients. and our refill rate continues to be strong at approximately 90%. Additionally, our market research shows that patient satisfaction on Ocaliba therapy remains high. 85% of patients report a strong intent to remain on therapy and would highly recommend Ocaliba to others living with PBC. This satisfaction rating jumps to 95% when you survey patients from InterConnect, which is our patient assistance platform. Because of these high satisfaction ratings, 65% of currently active patients on Ocaliba have been on therapy for more than two years. Our market research also shows that published data of the impact of Ocaliba on clinical outcomes is a strong motivator among healthcare providers when considering their intent to prescribe PBC therapies in the future. We know the primary treatment goals for managing PBC are to prevent liver transplant or death. We assess the ability of Ocalibur to meet these goals with multiple real-world analysis that were published in Gastroenterology and presented last year at medical meetings. This includes six years of data through our Poise Open Label Extension Study, demonstrating that OCA has a sustained impact on key biomarkers of liver health. Ocalibur is the only second-line therapy in PBC to demonstrate a positive impact on outcomes. driving greater awareness of the real-world applications and benefits of Ocalibus in PBC as an important differentiator and part of our long-term strategy. Supporting our well-established leadership position in the PBC market is strong IP, protecting Ocalibus market exclusivity into the 2030s. And finally, our OCA and Bezafibrate fixed-dose combination program, which Michelle will discuss in a moment, further adds to our long-term leadership in this space. In summary, I'm confident in the strength of Ocala's market position and the long-term opportunity with our foundational PBC business, as evidenced by double-digit sales growth for the third consecutive quarter and clinical development progress for the OCA, Bezafibrate fixed-dose combination. Importantly, our strong financial position gives us the optionality to drive continued growth in PBC, execute on our upcoming milestones in NASH, and develop innovative new medicines through our pipeline programs. I'll now turn the call over to Michelle.