Good day, and welcome to the Intercept Pharmaceuticals conference call. As a reminder, this conference call is being recorded at the company's request, and a webcast of this call will be archived on the company's website and available for one year from today's date. At this time, all participants are in a listen-only mode. Following opening remarks, Intercept management will open the lines for a question-and-answer session. I would now like to introduce Nareg Sagherian, Intercept's Executive Director of Investor Relations. Sir, you may begin. Thank you. Good morning, and thank you for joining us on today's call. On Friday, we issued a news release announcing the outcome of the US Food and Drug Administration Gastrointestinal Drugs Advisory Committee meeting to review the company's new drug application for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis. This release 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 products and clinical development programs, certain regulatory matters, and our strategy, prospects, 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 last week's press release and in our periodic public filings with the SEC. Today, we are joined with prepared remarks by our President and CEO, Jerry Durso. Dr. Michelle Berrey, President of Research and Development and Chief Medical Officer, and Andrew Saik, our Chief Financial Officer, are also with us for the call. At the conclusion, we will open the call to take your 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 Durso. Thanks, Nareg, and thank you everyone for joining us on today's call. On the heels of Friday's FDA Advisory Committee meeting, I'd like to address the results of the meeting and its potential implications, and we'll then answer your questions to provide clarification where we can. I'll remind everyone up front that given the recency of the AdCom and the fact that we're still in the formal regulatory process, we may not be able to provide complete updates on some topics. Clearly, we're disappointed in the negative vote of Friday's meeting that we feel failed to recognize the urgent treatment need in NASH and OCA's potential in pre-cirrhotic fibrosis due to NASH. As we outlined during the meeting, we disagree with the FDA and their views expressed during the AdCom process. This includes the FDA's characterizations of OCA's efficacy and safety, their hypothesis on DILI, the appropriateness of our proposed monitoring plan to mitigate that risk, and the role of non-invasive tests or NITs. I'd like to sincerely thank the Intercept team and also acknowledge the external clinical experts who are aligned with our perspectives and provided their active support and engagement. I would also like to thank representatives of the liver community who independently came forward to make their voices heard during the open public hearing portion of the meeting. The impassioned statements from patients, researchers, and clinicians directly spoke to the potential for OCA as an option to address the urgent unmet need in NASH. I'm proud of the impact Intercept has had as a pioneer in NASH. Through our work and with the strong support of thought leaders, we led the way in developing a deeper understanding of the disease and its mechanisms and ultimately moving the science of NASH forward towards treatment. In the coming weeks, we'll work through the final stages of the regulatory process. As previously announced, the FDA has assigned a PDUFA target action date of June 22nd, 2023. As we said to you previously on a number of occasions, our efforts for OCA and NASH have been focused exclusively on the potential for an accelerated approval. However, Intercept needed to be prepared for multiple scenarios, and we've worked hard to provide ourselves with the right optionality. Given the underlying financial strength of the company as we complete the regulatory process for OCA and NASH, we're well prepared for the future, including pivoting to profitability with a focus on Ocaliva and our pipeline, depending on how circumstances unfold. The coming weeks look forward to sharing our updated plans to continue driving double-digit growth of Ocaliva and highlighting expected progress with our fixed-dose combination, including a podium presentation of phase II interim data at the EASL Congress in June. In terms of immediate next steps, we'll work with the FDA to complete our review of the NDA. As we progress, we'll continue to update you. Let me now turn the call over to the operator for questions. Operator? Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. Our first question comes from Yasmeen Rahimi with Piper Sandler. Your line is open. Thank you so much, team, for taking my question. Could you maybe allude to what are some of the factors that you're gonna consider in the upcoming weeks in regards to making your decision whether you wanna move forward with NASH or maybe abandon the development and really focus on PBC? I'll jump back into the queue. Thanks, Yasmeen, for the question. As I said, upfront, and I'm sure as everybody can understand, we're in the last weeks of the formal regulatory process. Nonetheless, as we said, our focus has been exclusively on the potential for accelerated approval. If we didn't get that accelerated approval, we're prepared to pivot to profitability consistent with what we said, you know, over the past several quarters in the run-up to the Advisory Committee. If we were in that scenario, we would be ready to provide an update to our business and quickly upon that announcement. Again, it has been really important to us over the past period that we were ready with optionality. Of course, as you can imagine, the business team has worked with contingency scenarios in mind and would be fully ready to trigger that pivot to profitability if it's appropriate. Just to make sure I understand, Jerry, we're waiting for June 22nd's verdict, you will communicate with us in regards to pivoting. Yeah. Look, as, yeah, as you can understand, we are still in the formal process- Got it. ... which is an important piece of this. You know, the date, I can't comment any more on that and any details about how the next weeks are put on fold. That's where we are today. Got it. Thank you. Thank you. Thank you. We have a question from Michael Yee with Jefferies. Your line is open. Hey, guys. Thanks for the update and thanks for being out in front, for us. Just wanted to better understand, your estimates around current NASH spend versus current PBC spend, and maybe describe some of the cost structures. We could get some understanding of where the investments are being made and the shape of the business there. Thank you. Michael, thanks for the question. I'll ask Andrew to outline the spend patterns. Sure. Yeah. Thanks, Michael Yee. Look, obviously we're just on the heels of this AdCom, but I'm happy to sort of give you some of the details of our spend as we outlined it earlier in the year. You know, if you recall, guidance on OpEx was around $360 million-$390 million. I think I said at the beginning of the year that we were adding about $50 million of OpEx early to get us ready for a NASH launch. I think I also said that about half of that would be spent in the first half of the year and about half of that in the second half of the year. You know, clearly, given the AdCom and the FDA's position, we're gonna put the brakes on some of that spend and likely be able to take about half of that off if we're not able to achieve a positive outcome in the next couple weeks. That's on the commercial side. On the R&D side, I believe I guided that about a third of our R&D spend this year was going to be NASH related. If you look at our Q1 R&D costs, that's a pretty good proxy for what our spend's gonna be the rest of the year. The one-third is a pretty good approximation of what the NASH run rate is. Does that help, Mike? Perfect. Thank you. Thank you. Our next question comes from Mayank Mamtani with B. Riley Securities. Your line is open. Good morning, team. Thanks for taking our question. It was mentioned during the AdCom that the Study 303 needs another three years to accumulate the full end of study analysis for full approval. In the scenario for corporate decision being made to terminate this earlier, is it fair to assume Intercept will re-release the label outcomes data as it has been accumulated by that time of discontinuation? More specifically, you know, there was a discussion of reversing fibrosis plus halting and stabilization of fibrosis. Obviously there's a lot of interest in establishing some of those correlates of biopsy and NITs and outcomes. If you could comment on that would be great. Yeah. Mayank, thanks for the question. So maybe just how to think about it, if we're in that scenario where we don't get the accelerated approval, again, we would be prepared to pivot to profitability. If you were going to stop the NASH program, of course it takes a few quarters in order to do that. We would do it responsibly. One of the things that would come with the responsible shutdown of any clinical program is that you would collect appropriately the data. I can't really comment any more beyond that. Okay. Thanks for taking the question. Thanks. One moment. Our next question comes from Steven Seedhouse with Raymond James. Your line is open. Thanks so much for taking the question. I'm curious how many events have accrued in the outcome study and what is the cumulative discontinuation rate through the 4-year biopsy in that study? Thank you. Yeah. Thanks, Steve. While the objective of today is not to rehash all the details from Friday, I know that Michelle clearly did comment on the events. Maybe Michelle, you can just reiterate what you said on Friday about the events that we've seen thus far, as we look at the outcomes. Sure. Good morning, Steve. The current estimates are we would require over 400. I think the number is 432 events based on our assumptions. We've currently accrued 225, give or take a few, last numbers that we had. I think your second part of your question was on discontinuations. As we said on Friday, we have stable retention of 70%, and that's been stable over the last 12 months. There are about 10% of those patients who have discontinued investigational product, but who are continuing on the study and would be contributing to outcomes. Yeah. Just a reminder to everybody, of course, as you probably know, with our positions and quite a bit of data is in our briefing document and the presentation, which was posted publicly on Friday as well. You can use that as a source. Thank you. One moment for our next question. We have a question from Jonathan Wolleben with JMP. Your line is open. Hey, thanks for taking the question. I was hoping you could talk a little bit about the OCA bezafibrate combo and expectations for that clinical profile. Are you expecting to see some of the same safety risks that you see with OCA monotherapy or anything as far as what you'd want to see on both efficacy and safety to make us, you know, feel confident in that program moving forward? Thanks, John. It is a program that, you know, we look forward to sharing the first data set coming in a few weeks. We are testing a wide range of doses of both OCA and bezafibrate, and I'm sure Michelle can give you a little more insight on what we're thinking while we look forward to putting out a couple of different datasets as we progress through 2023. Michelle? Good morning. The safety data to date, and we're looking forward to sharing that at EASL in just a few weeks, has been very promising. Again, one of the opportunities with the fixed-dose combination is the ability to take advantage of mechanistic synergies and potentially use even lower doses than we currently are using in PBC. We're keeping all of our options open. We've been very encouraged by the safety and tolerability of the combination. I'll also say on our safety for PBC, as we reviewed in the last couple of years and reviewed again on Friday, since our labeled population changed in which we contraindicated those patients who have clinically significant portal hypertension or any history of or signs of decompensation and contraindicated those patients, we've seen a significant decrease in the frequency of reported hepatic events. Very confident that we have a good handle on the safety for OCA for the post-marketing setting and in our fixed-dose program going forward. Thanks, Jon. Thank you. Our next question comes from Thomas Smith with SVB Securities. Your line is open. Hey, guys. Thanks for the update and thanks for taking the questions. Can you just remind us on where you are with the agency on the PBC side and seeking to fulfill the post-marketing requirements? We heard some discussion of DILI with the 10-milligram OCA dose, which is obviously used in PBC. Just wondering, has there been any recent dialogue with FDA around the PBC label? Are you expecting any further label changes there? Thanks. Michelle, if you can give us an update on the process or reminder on the process for moving towards the sNDA submission. Sure. We are planning an sNDA to address the post-marketing requirements. That would be a combination of the COBALT study that includes an external control compared to those patients who were on OCA in the COBALT study, as well as a fully real-world set of data comparing patients who are from either patient registries or from claims database, and on OCA to patients who are matched but who are not on OCA. That's a supportive set of data. Again, we look forward to that submission later in 2023. Specifically on the different doses, as we, at least attempted to review the cases on Friday, every one of those cases would have been mitigated through our proposed mitigation plan, which includes a contraindication for patients who have any non-invasive test or biopsy evidence of cirrhosis. We did have some retrospective views that we were able to share on the... There were a couple of patients who were on 10 milligrams from some of the earlier studies, but who the Study 209 did include patients with cirrhosis. Again, a contraindicated patient population that was impacted in a couple of cases, but were quickly able to be stopped on therapy and quickly reversed. Yeah. Thomas, just to answer the last part of your question, there's been no updated label discussions on Ocaliva with PBC. Got it. Thanks for taking the question. Thank you. Thank you. We have a question from Ritu Baral with TD Cowen. Your line is open. Ritu, please check your mute button. Thank you. Sorry about that. Good morning, guys. Thanks for hosting the call and taking the question. I wanted to ask about the potential path forward for the beza OCA combination in PBC. In the event that the sNDA is approved, obviously Ocaliva would switch to a full approval. Will that change the potential pivotal trial design for the combination? Also on the flip side, even if it isn't converted in time, given that the traditional confirmatory trial isn't feasible, as evidenced by the Ocaliva program, how does the agency view potential accelerated approval and confirmatory trial? Thanks for the question, Ritu. I think it's premature to speculate on all of those scenarios. What I would say, you know, we'll have a couple of good data sets from our phase II that we believe will be the basis of, you know, an end of phase II meeting. We would have a proposal that we would put on the table with the agency regarding phase III. And of course, you know, in a disease like this where we would be potentially pursuing accelerated approval for the fixed-dose combination, we would start to engage in exactly the kind of questions that you outlined. I think it's probably a little too early to go much further than that. Michelle, anything you would add on the back end? No, I think you covered it, Jerry. We'll be waiting for our end of phase two meeting to have those discussions with the agency. I do think you highlight an important point that asking patients to remain on placebo for up to a decade for outcomes is going to be a big topic in PBC in the coming months and years. Thanks. Thank you, Ritu. Thank you. Our next question comes from Eliana Merle from UBS. Your line is open. Hey, guys. Thanks for taking the question and hosting the call today. Maybe just on the PBC front, if you could elaborate a little bit more on your latest thinking of the commercial positioning, especially as you think about the sort of potential pivot to profitability there, your latest thinking in terms of the competitive landscape, and potential strategies with respect to that. Thanks. Yeah, thanks for the question, Ellie. I think, of course, our focus and preparation around ensuring that we're doing everything which we can on Ocaliva has been ongoing and frankly, has been part of any of the scenarios that we thought about. We would expect, as you know, to see some potential competitive phase III data as we progress through the next weeks and months with two parties expecting readouts soon. I think, we continue to be encouraged by everything we're learning in market about the potential role of Ocaliva, not just in the short term, but over time. Clearly, the outcomes data that we began publishing last year and that Michelle referenced earlier in the call, has led to an evolution, frankly, of the product profile of Ocaliva, because that long-term outcomes data creates a different perception, perspective in the minds of the potential prescribers as we look at the market research that we've been doing, and really reinforces the uniqueness of Ocaliva. Clearly, we build on our experience and the experience that the prescribers have successfully with Ocaliva. As we've pointed to importantly, you know, one of the dimensions that we'll continue to leverage if new competition comes, is the high level of satisfaction for the patients that are continuing on Ocaliva. Ellie, I'm sure we'll talk about this as we start to see some phase III data emerge. There is quite a bit of work to do in PBC. There are still a large number of patients that qualify currently for second-line who aren't getting any second-line therapy. Again, we'll continue to stay focused on that, and I'm sure talk more about the evolving competitive dynamics as we see some data. We've built a strong presence in PBC, and it's our intention that we continue to maintain that not only with Ocaliva, but hopefully with the fixed-dose combination in the future. Great. Thanks. Thank you. Thank you. Our next question. We have a question from Brian Abrahams from RBC Capital Markets. Your line is open. Good morning, everyone. This is Joanne for Brian. Thank you for taking our question. Can you quickly guide us on how to think about any additional R&D increase that would have to come from the bez combo work, and you know, sort of the timing at which we will see any sort of increase there? Thank you. Thanks for the question. Andrew, can you take that one? Yeah, sure. Look, we gave guidance at the beginning of the year on, you know, SG&A. All of the work that we're gonna be doing on the beza combo is covered in our expense guidance. We're not gonna give additional guidance at this point, other than, you know, I think I pointed out on a previous question that about a third of the R&D costs that are baked into our forecast are NASH related. That's about as detailed as we're gonna go. I think as the regulatory process unfolds, we'll consider updating our guidance later in the year. Until we get through the regulatory process, we're gonna stay where we are for now. Thanks for the clarification. Thank you. We have a question from Ed Arce with H.C. Wainwright. Your line is open. Great. Thanks, everyone, for taking our questions. Just one from me. I wanted to ask about the Ocaliva and bezafibrate combo. I know you were looking forward to updates in a few weeks at EASL on both safety and efficacy, including the mechanistic synergies, potentially. I'm wondering, and perhaps this is a bit too early, but I wanted to know if there's any expectations for an improved rate of ALP normalization or a potential for reduction in pruritus, with this fixed-dose combo. Thanks. Yeah. Ed, thanks for the question. As we've said, we're testing a pretty wide range of doses of both components, right? So 5-10 of OCA and 100-400 milligrams of bezafibrate. We do think that there's potential synergy both on the efficacy and potentially on the safety and tolerability side. Obviously, you have a range of doses. So I think the important thing is that we'll have a lot more insight to see whether or not the potential synergy in the mechanisms, how that plays out on both components of safety and efficacy, at different doses. I think that's gonna be the richness of the phase II experience. That will allow us then to place a good bet in our phase III design. Not much more to add, at this point on that, but as we get data, clearly, Michelle will, I'm sure have some updates as we progress through the year. Thanks so much. Thanks, Ed. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.