Intercept Pharmaceuticals, Inc.

Welcome to the Q1 2021 Intercept Pharmaceuticals Earnings Call. My name's Annette and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the question and answer session, if you have a question, please press star then one on your touchtone phone. I will now turn the call over to Lisa DeFrancesco. Lisa, 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 2021 results and financial position, which is available on our website at www.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 under 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 Accounting Officer, Acting Chief Financial Officer and Treasurer, Rocco Bonavia, and our Acting Chief Medical Officer, Dr. Gail Cockwell. We'll then open the call up to take your questions, and Linda Richardson, Chief Commercial Officer, will join us for Q&A. 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. Jerry?

Thanks, Lisa, and good morning, everyone. Thank you for joining us on our first quarter 2021 earnings conference call. We've been focused on our priorities in the first quarter of this year and have made progress across all key fronts, including, first, Finalizing our Ocaliba label update in the U.S., which is now nearly complete. We anticipate announcing our updated label in the coming days. Second, advancing our NASH development program, where we've had multiple interactions with FDA and we're in the process of generating a significant amount of additional data in support of our dialogue with the agency. And third, continuing to make progress on our pipeline. I'm going to begin today by discussing our PBC business, including our solid performance in the first quarter. I'll then turn it over to Gail to provide an update on our labeling discussion with FDA, our NASH development program, and our other pipeline activities. Rocco will conclude with an overview of our financial performance and update to our guidance before we take your questions. Let's start with our PBC business, where we had another quarter of double-digit growth. Worldwide Ocala net sales in the first quarter of 2021 were $81.7 million, representing about 12% growth over the prior year quarter. We had solid performance in the U.S. with sales of $57.3 million, representing 13% growth over the prior year quarter. Nearly half of our new prescriptions were generated by new prescribers, demonstrating the success of our efforts to reach community-based gastroenterologists. Importantly, we continue to educate healthcare provider audiences through our RethinkPBC disease education campaign, which highlights important data from the GlobalPBC study group. supporting more ambitious treatment goals for lowering ALP. We believe broader awareness of these data will impact the way healthcare professionals manage PBC and encourage earlier consideration of second-line therapy within the large group of eligible patients who are not achieving ALP goals with ERSO alone. In our international markets, we recorded $24.4 million, which was 11% growth over the same quarter last year. We saw a continued strengthening of new patient starts versus the previous quarter, driven by our digital education activities. I would now like to turn the call over to Dr. Gail Caulkwell to provide an update on our regulatory progress and our pipeline. Gail?