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 on a listen-only mode. Following opening remarks, Intercept management will open the lines for a question-and-answer session. I will now turn the call over to Nareg Sagherian, Intercept's Executive Director of Investor Relations. Sir, you may begin. Good morning, and thank you for joining us on today's call. Yesterday, Intercept distributed a news release announcing that the U.S. Food and Drug Administration has issued a complete response letter in response to the company's new drug application for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to NASH. This morning, we issued a follow-up news release announcing steps that we are taking to restructure business operations, including discontinuing all NASH-related investments. Also this morning, Intercept distributed a news release addressing positive results from the first planned interim analysis of our ongoing phase II study of the combination of obeticholic acid and bezafibrate presented at EASL. These news releases are available on our website at interceptpharma.com. 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 our press releases and in our periodic public filings with the SEC. Today, we are joined by Intercept President and CEO, Jerry Durso, and Andrew Saik, our Chief Financial Officer. Also joining us on the call for Q&A are Dr. M. Michelle Berrey, President of Research and Development and Chief Medical Officer, and Linda Richardson, our Chief Commercial Officer. At the conclusion of prepared remarks, 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. Thank you to everyone for joining us on today's call. Let me begin with yesterday's news about Intercept's receipt of a CRL from the FDA in response to our regulatory application in NASH. The FDA indicated in the CRL the agency had completed its review of the NDA and had determined that it cannot be approved in its present form. Based on the content of the CRL, any resubmission of an NDA for OCA in NASH would require, at a minimum, successful completion of the long-term outcome phase of the REGENERATE study, which we expect would be at least three years away. As we've said previously on numerous occasions, our efforts for OCA in NASH have been focused exclusively on the potential for accelerated approval. We believe that Intercept has exhausted all reasonable and responsible steps to demonstrate the evidence necessary to secure accelerated approval in NASH. Therefore, as a result of the CRL, Intercept has decided to discontinue all NASH-related investments and will pivot to profitability by restructuring the company's operations to strengthen our focus on rare and serious liver diseases. While this is clearly not the outcome that we've worked toward, I'm proud of the impact that Intercept has made to move the science of NASH forward and bring the field closer to a treatment option. We're grateful to the scientists, clinicians, and most importantly, the patients, whose contributions to the clinical development of OCA and NASH have significantly advanced the understanding of this deadly disease. Moving forward, Intercept remains committed to the liver community and will continue to advance our leadership in rare and serious liver diseases, where we have a deep expertise and a recognized dedication to therapeutic innovation. We will move quickly to make a strategic shift that recasts our corporate focus and our business profile. This shift, in our view, puts Intercept in the best position to create value for shareholders while fully supporting our patient-driven mission. By taking decisive action, we believe that we will improve our ability to drive long-term growth and maintain leadership with our PBC business, continue to develop innovative new medicines, and achieve profitability beginning in 2024. To reshape our company, we intend to implement our plan in three areas. First, Intercept will begin the process of closing out the REGENERATE study. At this time, we anticipate that we should be able to substantially complete the trial shutdown process by the end of this year, and we'll responsibly collect available data during the study closeout. Second, we will also realize significant savings by quickly winding down all other NASH-related spending within our R&D, commercial, medical affairs, and administrative functions. Progress in this area is already underway. Third, our plan to reduce operating expenses will have an impact on the size of our organization. This will result in a projected workforce reduction of approximately one-third, which will affect most areas of the company. Given the importance of our PBC business, we plan to maintain the scale of our field sales organization to support the growth potential of OCALIVA. Specifically, we will preserve the number of territory business managers and regional sales directors that are currently in place, driving the commercial performance of OCALIVA. Workforce reductions are expected to begin in the coming weeks, we plan to complete the majority of the measures by the end of 2023. These are clearly difficult decisions, and we understand the implications of these changes for our people. We're committed to supporting them fully throughout this process. We intend to continue our strong investment in OCALIVA, the only FDA-approved second-line treatment for people living with PBC. This includes expanding our specialty pharmacy network to ensure broad access to OCALIVA for PBC patients, leveraging data on OCALIVA's positive impact on a range of important biomarkers beyond ALP, all of which contribute to improving PBC management, and broadening our dissemination of real-world evidence with additional publications and presentations. OCALIVA continues to show strong end market performance, illustrated by consistent double-digit net sales growth over the past several quarters. Our success is driven by an experienced specialty sales force that is highly ranked by hepatology and gastroenterology practices. Our commercial representatives have forged a deep understanding of and long relationships with this group of specialists. Market research continues to show that their top priority when treating PBC patients is avoiding negative liver outcomes. OCALIVA is the only second-line therapy in PBC to demonstrate a positive impact on outcomes such as transplant-free survival. Utilizing appropriate avenues to create greater awareness of this real-world evidence, supporting use of OCA in PBC is an important differentiator and part of our long-term strategy. This is in addition to further leveraging our existing data from the POISE open label extension study on fibrosis and bilirubin. With respect to fulfilling our post-marketing requirements for OCALIVA and PBC, we remain on track for a planned regulatory submission to the FDA in 2023. This submission will include data from COBALT, which, as the post-marketing study, will likely be the FDA's primary basis for evaluation and supplementary real-world evidence from five large datasets in the US and Europe. These datasets demonstrate that PBC patients taking OCALIVA had improved transplant-free and decompensation-free survival, which we know to be the most important goals in PBC treatment. The real-world evidence adds significantly to our understanding of the benefit of OCALIVA in a rare disease like PBC. We continue to engage in dialogue with the agency on our planned submission. Continuing to extend our leadership in the PBC segment is one of our long-term objectives. Within our pipeline, Intercept will continue to prioritize investment in our fixed-dose combination of OCA and bezafibrate. We believe this fixed-dose combination offers the potential to establish best-in-class clinical benefits that can help further improve the treatment of PBC. Currently, two ongoing phase II studies are exploring a range of therapeutic doses for the combination, with planned interim analysis from both studies expected to be completed this year. This phase II data, in addition to phase I and preclinical data, will serve as the basis for an end-of-phase II meeting with the FDA. The first of these planned phase II interim analysis were presented earlier today at the 2023 EASL Congress in Vienna. We're very encouraged by this first data from the OCA/bezafibrate combination, which showed that the combination of OCA 5-10 mg and bezafibrate of 400 mg was effective in normalizing a range of biochemical markers beyond just ALP that are associated with PBC-induced liver damage. Perhaps most significant was that nearly 60% of patients in the OCA 5-10 mg and bezafibrate 400 mg combination arm achieved biochemical remission. That is, patients in this, in this arm saw a normalization of all five of the key biomarkers. The compelling data from this first phase II study demonstrate the potential synergy between these two compounds. In our view, a fixed-dose combination of OCA and bezafibrate could reframe the parameters for efficacy in the treatment of PBC. We look forward to sharing more information about our FDC program as we move forward. Moving into the second half of this year, we are reshaping Intercept to become a different company with a strengthened focus and reduced cost structure that will allow us to be profitable starting in 2024. With that, I'll turn it over to Andrew Saik, who will walk you through the financial impact of our planned actions and 2023 guidance. Thank you, Jerry. As Jerry mentioned, due to the CRL from the FDA, we are now taking steps that will get us to profitability as fast as possible. Central to this effort is our decision to no longer pursue an indication in NASH. As such, wind down all NASH-related spending within the company. This relates to our R&D programs, commercial preparation, medical affairs, and infrastructure spending where it relates to NASH. First, we are now moving in earnest to shut down our REGENERATE program. Given the scope of the study, we expect that we should be able to substantially cease trial activities by the end of this year. We anticipate that certain aspects of the trial shutdown process may extend into the first quarter of 2024. We are also well along in our planning to reduce the size of our organization by approximately one-third. We expect the reorganization to be initiated in the next few weeks and to be materially completed by the end of 2023. With respect to OpEx for this year, we are reissuing guidance for 2023 non-GAAP adjusted operating expense spend to $350 million-$370 million. This guidance includes expenses to wind down the REGENERATE study and stop all other NASH-related activity as well as estimated charges of approximately $16 million relating to our workforce reduction. As a result of these changes, and after the restructuring activities are complete, we expect to be able to run the company at a significantly lower cost than our current run rate. Specifically, we are targeting a net reduction in annual non-GAAP adjusted operating expenses of approximately $140 million relative to our updated 2023 non-GAAP adjusted operating expense guidance. Our new cost structure will be effective upon completion of the restructuring and close out of the REGENERATE study, which will be materially complete in 2023, but as previously mentioned, could extend into the first quarter of next year. Additionally, we are reiterating our full year 2023 OCALIVA net sales guidance of $310 million-$340 million, and we'll continue to ensure that appropriate investment is directed to support our commercial efforts. We anticipate issuing our 2024 financial guidance by early next year. I will remind everyone that as of March 31, 2023, Intercept had cash equivalents, restricted cash, and investment debt securities available for sale of $435.2 million, and that the company was net cash positive by approximately $100 million. As previously disclosed, we will use available cash on hand to settle $110 million in convertible notes on or around July 1, 2023. We have spoken in the past about the highly profitable PBC business that has been the foundation of our company for the past several years, the profits of which have largely gone to fund our efforts in NASH. We will now build a company that continues to support PBC franchise growth while generating meaningful profits to ensure our future success and maximize value for shareholders. I will now turn the call back over to Jerry. Thanks, Andrew. Before going to Q&A, I would like again to thank the liver community for their partnership with Intercept to advance the scientific understanding of deadly liver diseases. We remain deeply committed to continuing to work with them to change the lives of these patients. We will now move quickly to reshape Intercept into a different company with a reduced cost structure that allows us to become profitable beginning in 2024. We'll look forward to updating you on future calls as we progress these decisive actions that we believe strengthen our long-term ability to grow our business, innovate for patients, and create value for shareholders. I'll now turn the call back over to the operator for questions. Operator? Thank you. If you would like to ask a question, please press star one. If your question has been answered and you'd like to remove yourself from the queue, please press star one again. One moment for questions. Our first question comes from Mayank Mamtani with B. Riley Securities. Your line is open. Good morning. Thanks for the comprehensive update, and I know I speak for many industry stakeholders in appreciating your team's work in NASH development over the past decade. Maybe focusing my questions on PBC business pipeline. Just two, two-part questions. On the Dr. Nevens's podium presentation at EASL earlier today, seems like the biochemical complete biochemical response had a more stringent definition, where we saw the bezafibrate 400 mg monotherapy show exactly what it did in its prior phase III, and basically the combination doubled that efficacy. I guess the question is, how your approach to, you know, regulatory interactions is going to be, recognizing you have the OCA monotherapy full NDA dialogue also going on with them. Just would be helpful to understand the roadmap of FDA interactions and maybe also how a benefit-risk discussion is being thought about in these discussions. Then I have a quick follow-up for Andrew. Mayank, thanks for the question. Obviously, we're, it was good for us to progress and start to see now the data stream coming on the, this interim analysis of the first of our two, phase II trials and the podium presentation that you referenced happened just a few hours ago in Vienna. Perhaps, Michelle, you can address the first part of Mayank's question in terms of the kind of, the flavor of Dr. Nevens's presentation and any commentary on the results, and then, the regulatory process as we see it moving forward on the fixed-dose. Okay. Yep, happy to do that. Thanks for the question, Mayank. To reiterate, the primary endpoint of the study was changed from baseline and ALP at week 12. Because we really wanted to get the full information on the range of doses that we're exploring in both of our phase II trials, and remember, these are ongoing trials, and we'll have more data later this year, but we wanted to look at all five of the key parameters that we know impact outcomes. We have the ability to look at that because we now have outcomes for the obeticholic acid across multiple different databases. We knew it was critical for us to drive as many of these different parameters to normalization as possible. There's also been increasing evidence that normalizing bilirubin doesn't accomplish everything if you just get to below the normal range. In fact, we presented a therapeutic, agnostic data set at the meeting earlier this week that showed if you can continue to suppress bilirubin down to 0.8 or even 0.6. ... times upper limit of normal, that there's evidence of increasing benefit, and that's from the Komodo data set. That's why we wanted to give a more stringent baseline to really test what this combination can do. As you saw this, we're pleased that this initial interim data shows us that we're really changing the way we're gonna be thinking about PBC. I think Dr. Nevens captured that really well, what an exciting time it is in a therapeutic area when you start getting responses greater than 50%. More than half of patients are achieving what he describes as a biochemical remission. Again, very, very exciting times. We look forward to sharing the remainder of the data later this year. On the FDA interactions, Michelle, around risk benefit. I do think that we are seeing improvements in tolerability and safety as well. I do want to clarify one difference, that the abstract had a programming error, and it actually included data from the first six months of the 45 patients who were included in the abstract. The presentation today, though, is corrected and includes the interim analysis as planned with the 12-week safety and tolerability. We did have a forced titration up in that higher dosing arm with OCA 5, titrating up to 10 in all patients at week four in the combination arms. Actually, in the first four weeks, which is when we typically see pruritus, we didn't see any pruritus. It was only after titrating up to 10 that we had the two pruritus cases, one that was mild, one that did lead to a discontinuation. However, they didn't start with a dosing holiday, as we have found to be successful in most patients who do experience. Yeah, Mayank, just as a reminder, as I said in the prepared remarks, the goal is we'll co-collect the data from both of the phase II trials, that will be the basis for the formal next interaction with the FDA on the FDC, which will be the end of phase II meeting. Thank you. Our next question comes from Yasmeen Rahimi with Piper Sandler. Your line is open. Good morning, team. Thank you for all of the updates. Could you maybe comment on what the fixed-dose combo looks like in terms of creatinine levels, liver enzyme excursions? Just because historically with bezafibrate alone, there have been some observations made. Could we also allude to whether this fixed combo could not only minimize the pruritus, but actually could benefit pruritus? Would be delighted to hear your thoughts, and I'll jump back into the queue. Michelle? Yep, thank you. Thanks for the question, Yas. The serum creatinine, we didn't see any AEs or any excursions in the labs that were concerning for any of the four cohorts. Of course, this is an interim analysis, and we'll be having a much more fulsome evaluation, including both studies, which will be somewhere between 130 and 140 patients later this year, so a lot more data. We also have, and Dr. Nevens mentioned this, because we started this study right at the beginning of the pandemic, we actually have patients who've been on therapy for more than two years. We do have longitudinal data as well, and I can tell you there's no emergent concerns in that, you know, in our ongoing monitoring of the study. With regard to liver enzyme excursions, none in the combinations. There were a couple of cases in the bezafibrate monotherapy. Actually, it was one in the bezafibrate 400 that was felt to be related to another drug that they were on. They had a rechallenge and successfully remained on drug. Nothing that was felt to be related to the bezafibrate and none in the combination arms. Good questions, though, on. We're continuing to watch that, watch those data carefully. Thank you. Thank you so much, Michelle. I'll jump back in the queue. Thanks, Yas. Thanks, Yas. Thank you. Our next question comes from Ritu Baral with TD Cowen. Your line is open. Hi, guys. Thanks for taking the question, looking forward to hopefully, Michelle, running into you here in Vienna. I wanted to, bear with me here, ask the same question that I did last time, hopefully with a little more color, given the interim data. As you pursue full approval for OCALIVA, how does your thinking on pursuit of potentially accelerated approval for the beza-OCA comp fixed-dose combo change? Have you had any interactions with FDA officially, even unofficially, or have they said anything in writing about the meaningfulness of biochemical remission, especially with what we know they think on bilirubin and the others? Like, could that be something more than an accelerated approval composite endpoint, I guess? Yeah. Thanks, Ritu. It's a great question. It is certainly one that everyone in the PBC space is watching closely. I'll say with regard to accelerated approval, we do have a relatively well-accepted surrogate endpoint in ALP. However, I think the data are continuing to evolve, and it's clear that it matters how you get there, meaning that different mechanisms have differential activity on ALP. What we are seeing that is specific to obeticholic acid is we can now look at the different parameters and see what are those data that are predictive of improved survival and event-free survival. We're making some progress on that, and that's certainly informing some of what we're going to be looking at for the fixed-dose combination. It's also informing how we're thinking about dose selection for that. I don't think that we've really had time to think as a field about the meaningfulness of biochemical approval from a regulatory perspective. We know what it means clinically, and I know that we've got a lot of excitement from our steering committee and from our investigators about the patients who are achieving biochemical remission and really getting there very quickly. In the first four weeks, we're seeing patients who are normalizing five different parameters, and as was pointed out, with a bilirubin target of 0.6x upper limit of normal. I think this has an opportunity to really change the way that we're thinking about endpoints for the fixed-dose combination. For obeticholic acid, as Jerry mentioned, we have these replicated data sets that have shown very consistently a hazard of 0.3 in event-free survival. We need to get those data published. At least one of those data sets will be formally submitted with our sNDA, and all I can say on that one is watch the space. We do believe that that should give the agency reassurance that we're heading in the right direction. I don't think that we have expectation that that would in and of itself, achieve a fulfillment of all of our post-marketing requirements. I think we do have the opportunity with the fixed-dose phase III to also look at any new hypothesis generating questions that could be answered for OCA that could get us to a full approval. Got it. A very quick follow-up for Linda. I wanted to make sure I understood, you, Andrew's comments about the sales force. Will the footprint that you have in reaching all PBC, clinicians and or patients change at all with the downsizing? The, as I mentioned, the territory business managers and those that manage them, the regional leaders, we will maintain the footprint that we've been in successfully. That's a sales force organization targeting the specialists that was set up specifically for PBC. And we will stay in that configuration and reinforce our investment with the appropriate marketing and medical affairs work. Got it. Thanks, Jerry. Thanks, all. Thanks. Thank you. Our next question comes from Michael Yee with Jefferies. Your line is open. Good morning, Mike. Michael Yee, your line is open? Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is open. Hey, good morning. Thanks so much for taking my question and for all the rapid clarity and transparency on the go-forward path. I was wondering if you could talk a little bit more about the bezafibrate-OCA development path going forward and the timing there. Maybe a little bit more color on the advantages of a fixed-dose combination, practically, I guess, weighing convenience against the ability to titrate components individually or discontinue any one of the two drugs if patients run into pruritus or LFT excursions. Maybe if you could clarify, are you pursuing approval of just the fixed-dose combo, or would you pursue approval of bezafibrate alone as well? Thanks. Yeah, so Brian, maybe I'll start there, and then Michelle can pick up. Our current plan is pursuing specifically exclusively the fixed-dose combination. I think, again, as we start to get data, it's good to start to see an indicator that the hypothesis of potential synergy starts to play out. That was the first part of your question. Maybe just I'll get to the second, and then Michelle can pick. On the regulatory side, so again, what we said is, we have these two phase II trials running. As a reminder, we have some different doses in the two studies, so we're looking at a range of doses and that information, along with some of the ongoing work in phase I, is gonna be the basis for an end of phase II meeting. We continue to say, expect not only this data set but also data from the second study as we progress through the year. We would anticipate, you know, having the full information together to request that meeting with the agency as we progress. Michelle, maybe some commentary from your side on the potential advantages of a fixed-dose. combination with the clear understanding, Brian, again, that we are testing kind of a broad range of doses here, and the goal is that we figure out what's the right combination of both OCA, at which dose, and also bezafibrate. Yep. I think you covered a lot of it, Jerry. I think, between the two phase II trials, we're looking at 5 and 10 mg, or 5, and the titration up to 10. We're looking at 100, 200, and 400 mg of bezafibrate. We did a very large phase I study, we're pulling in all the PK there. As you know, Brian, there are different ways to skin the cat of a fixed-dose combination. With the goals in mind that we want to maximize the efficacy for patients and address some of the things that we know are problematic for patients even before they're starting any therapy, namely, it's pruritus and questions about long-term lipids. I think we've got some really exciting initial data, and one thing that, at least in this initial data, is very encouraging for me, was the first four weeks of tolerability at that 5-mg dose. Also the efficacy. As I mentioned, we're really driving down many of these parameters in the first four weeks while patients are on 5 mg. We may be able to have even better efficacy with even lower doses, which is the perfect combination for a fixed-dose combination, where you don't need to titrate up for maximum efficacy. The convenience factor is certainly there, but that will be really driven by maximizing efficacy and tolerability, which we think we've been able to see some good hints on how we should get there in our phase III. Timing of that, I mentioned we're gonna have the rest of the data in the second half of this year. That'll lead to our end-of-phase II meeting with the FDA, that will allow us to provide you with much more specific guidance on the timing of the phase III, which we're excited about, talking more about in the second half of this year. Got it. Thanks so much, Michelle. Thanks, Jerry, congrats on the initial data. Thank you. Thank you. Our next question comes from Steve Seedhouse with Raymond James. Your line is open. Hey, good morning. Thanks so much for taking the question. I wanted to just clarify a couple details on the fixed-dose combination study. The abstract had indicated five of 23 patients on OCA discontinued. Michelle, you just made a comment, I think, that the abstract, I think, contained data through six months, if I heard that correct, whereas the presentation through 12 weeks. My question is: I see the one TEAE leading to discontinuation in the presentation and the high-dose fixed combo arm. What were the overall discontinuations through 12 weeks? Is this? Are we to take this as meaning four of those five on OCA would have been discontinuation subsequent to 12 weeks? Just if you could sort of button up some of that data so I'm understanding that correct, that would be great. Then also the, can you share what dose patients are being, or are being planned to switch to in the long-term safety extension of the fixed-dose combo study? Thank you. Sure. I'll answer that one first. We do have, within the protocol, the ability to switch patients to our optimized dose. We really want to pull in the data from both studies to choose that dose. Until that time, they're staying on their double-blind dose, which has given us, as I mentioned, up to two years of data, which is great to have going into the end-of-phase II discussions, and really helps us feel very confident that the doses that we pick are going to be backed up with that longer-term data. The discontinuations, yes, unfortunately, we had a programming error for the abstract. It was also only 45 patients, so that was based on six months of data. The other discontinuations were unrelated to study drug. There was a patient who had a fall and a facial fracture, a patient who had, lung cancer, I think one, cardiovascular atrial fibrillation that was a well-known, historical issue with that patient. I believe that was, I will make sure I'll clarify that that was his later events. The 1 discontinuation in the first 12 weeks was a patient who developed pruritus once they had titrated up to 10 mg at their eight-week visit, did not try a dosing holiday, and the investigator made the decision to discontinue the patient. That was our only discontinuation in the 12 weeks in this, the higher dose group. Okay, thanks so much. That's helpful. Could I just ask that regarding REGENERATE, have you been able, given the decisions made here, regarding NASH, to unblind the outcomes data already and take a look at how that was trending? Curious if you'd be interested in commenting. Thanks. Yeah. Brian, maybe I just take that. The study's been running, as you can imagine, under the existing protocol, so we haven't had access to the outcomes. As I did say in the prepared remarks, we'll capture the available data responsibly as we close out. Thanks so much. Thanks. Thank you. Our next question comes from Brian Skorney with Baird. Your line is open. Hey, this is Luke on for Brian. Thanks for taking our questions. On the combo studies with bezafibrate, can you talk about the decision to have all patients receiving bezafibrate with OCA being the variable? Do you think there would be anything to gain from a study where you test OCA with bezafibrate versus OCA alone? Thanks. Michelle? Yep. Thanks, Luke. The decision in phase II was to have a very well-monitored active control of bezafibrate monotherapy. We have certainly quite a bit of data on obeticholic acid monotherapy already. Because bezafibrate has not been available in the U.S., we didn't have that same quality of randomized controlled blinded decision on the basis of wanting to get that kind of data. We do think that now with this dose ranging of 100, 200, 400, and we actually have two different formulations of the 400, one IR and one SR, that we've got a very good handle now on both the PK, safety, and efficacy for the monotherapy. Have not made a final decision on the phase III. That likely could also contain active controls of monotherapy, whether that's obeticholic acid or bezafibrate or both. Okay, thank you. Thank you. Our next question comes from Jonathan Wolleben with JMP. Your line is open. Hey, thanks for taking the question. Wondering, one on the restructuring and one on the PBC data. Can you remind us what percentage of the SG&A in your prior OpEx for 2023 was related to the NASH launch? Just, you know, simply on the interim analysis, just wondering if this is, you know, interim on a time point or if there's more patients going to be in the full analysis. Can you just talk a little bit about the full analysis that we'll get later this year? Thanks. Maybe we start, Andrew, on the question around the. Yeah, sure. I don't know that we've ever given a percentage, but what I can tell you is, we spend about $60 million on our commercial cost centers related to PBC, and that's been pretty consistent and really won't change that much going forward, given that we're not changing our footprint or changing our promotions. You can expect that to continue. I think the additional part of the question, if I understood it, was also non-R&D spend on NASH. Was that the clarity? Yes, exactly. Yes. that would just be the commercial cost centers. NASH. I'm sorry? NASH. Oh. Non-R&D on NASH. Yeah. R&D, I'm sorry. He's asking for R&D, non-R&D spend on NASH. Yeah. I think at the beginning of this year, I mentioned that we were spending about $170 million on R&D, and about two-thirds of that was non-NASH related. That would give you NASH spend of approximately $70 million, and the rest, non-NASH. Does that get you what you need? Or is... Sorry, my- Yes. Yeah. Just wondering, you know, what's going to be in the full analysis of the phase II PBC data? Yep. It was an interim analysis and was a smaller number of patients. The full data that we'll be able to share are also a larger number of patients and would be longer duration. We'll have data coming from both of those two phase II trials with a full range of doses. More data and more patients and longer exposures. Got it. Maybe one more, if I may. Any guidance on when we might see phase II data for seven eight seven? An ongoing trial. Yeah. Not yet. We're not ready to guide to timing yet. We're watching enrollment, and we'll fill you in when we're at a point where we can provide guidance there. Got it. Thanks for taking the questions. Thank you. Thank you. Our next question comes from Ellie Merle with UBS. Your line is open. Hey, guys. Thanks so much for taking the question. Just a question on pruritus and I guess maybe potential improvements in the bezafibrate OCA combo. Just in terms of the interim data presented today in the sort of AE table, maybe could you help characterize the grades, the severity of the pruritus seen across the different arms? I know it's sort of early data in small numbers, but any sort of color on the different grades of the events seen in the different arms would be helpful. Then just a second question, as we think about expense modeling, I guess, how should we think about the cost of running, like, a phase three OCA/bezafibrate combination? Thanks. Maybe, Michelle, you start on pruritus, and then Andrew, if you have any comments on how we're thinking about cost in that dimension. Thanks, Ellie, for the question. The pruritus that we saw through the trial was generally mild. I think there was a summary within the slide deck that should be available on our website, or if you're registered at EASL, you should be able to watch Dr. Nevens's presentation. It does specifically go into the average of the pruritus events across the two combination arms. Specifically, I think the average across those two, approximately 30 patients, two cohorts of about 15 patients each, was 19% or 20% for the mean. They were predominantly mild. We did have one patient who had a moderate event that was, that then turned into discontinuation. That was the one that I spoke earlier about that came in at week eight and then was discontinued. In general, the rates were much lower, and they were predominantly mild. Ellie, I'll take the question with regard to the phase III study for FDC. Look, obviously, we're very early in the planning. We don't have an actual phase III design locked in yet. Having said that, we would expect only a single-arm study in the phase III, and given that we're running two phase IIs right now, I wouldn't anticipate that our cost base or cost structure would change all that dramatically as we transition from the phase IIs to the phase III. Hopefully, that gets you enough to do your long-range modeling. Great. Thanks so much. Thank you. Our next question comes from Thomas Smith with SVB Securities. Your line is open. Hey, guys. Good morning. Thanks for taking the questions. A couple on my end for the OCA-bezafibrate combo. I guess first on the different titration schemes you're using across the two phase II studies. Can you talk about the decision to evaluate only up to the 5 mg OCA dose in the U.S.-based study? Was that informed by some of the early data coming from the Europe study? Then just a question on regulatory path. How much data do you expect you need to generate for the bezafibrate monotherapy to enable use in the combo and satisfy the combination products guidance, given that bezafibrate is not yet approved in the U.S.? Thanks for the question, Thomas. Michelle? You're correct because this is an NCE for bezafibrate. We do need to generate some substantial data, which is why it's been so helpful to have beza monotherapy in both of the studies. As I mentioned, we do have patients who've been on the study for a couple of years, especially the 213 study. That will help us there. I'm sorry, second part of your question was on the dose-ranging element. Could you just repeat that? On the decision in the US-based study to only evaluate up to the 5 mg OCA dose, just any insight into kind of the rationale for that, and was that based on anything that was coming out of the early European experience where you went up to the 10 mig? No. If you look across the two and three and two and four different study designs, you'll see that we're exploring staying on the same doses. We are exploring titration up. It's really the important thing in a fixed-dose combination program is to make sure that you've really established that response curve, especially at the lower end. We need to understand the PK parameters for the two drugs in combination and over time. It's a pretty intensive parallel track, phase one and phase two program. All those data are coming in this year, and we're pulling those all together to make a dosing recommendation and justification to take to the FDA for our end-of-phase II meeting. Got it. That's helpful. If I could just squeeze in one, follow-up question on, the comments around the phase III single-arm study. Is it your expectation you'd only be evaluating one sort of fixed-dose titration regimen, or is there potential that you would actually have multiple arms, you just wouldn't have necessarily a placebo control? Can you just clarify that a bit? Thanks. Thomas Smith, let me just clarify. I think what Andrew Saik was referring to, we expect a single phase III versus the fact that we're running two phase IIs. Okay, that was just a comparison of kind of an indicator of the cost basis we're seeing already this year with two studies running, versus when we move to phase III, we'll have one going, one major study going. I think that's the clarity, clarification, not a single arm in phase III. Understood. Not a single arm, single study. Okay, appreciate the clarification. Thanks, guys. Thank you. Our next question comes from Jay Olson with Oppenheimer. Your line is open. Oh, hey, thanks for the question. Can you comment on whether or not you would consider studying the fixed-dose combination of OCA plus bezafibrate in the frontline settings for PBC, or will you continue to focus on the UDCA refractory patient population only? Also, can you please remind us what the rate of biochemical remission was for OCA monotherapy in the POISE study? I think it's a great question, and certainly, biochemical remission is something that we have not seen discussed in the other programs, including for ursodeoxycholic acid monotherapy. It's just, it's something that you see in very low rates, generally low single-digit, which is why these data of over 50% are so exciting to have a potential intervention that could bring that kind of change of disease in over half of the patients. We're very encouraged by these early data. Again, pulling in all our data from our second phase II, I do think that with this changing paradigm, it does, that's a natural question of: Why would you leave somebody on URSO when we know URSO does not induce that kind of biochemical remission? We do see long-term benefit in outcomes with patients who respond, but most patients don't. That response, again, is generally ALP and in patients who have lower bilirubin at baseline. I think this really is opening the door for a different way to think about PBC disease. Thank you. Thank you. That's all the time we have for questions. I'd like to turn the call back over to Jerry Durso for closing remarks. Thanks, everybody, for joining us today. Obviously, there's a lot going on. We look forward to continuing to update you as we progress, both on, you know, the focus on our core objectives as we move through the year and also the key work that we'll do with the restructuring. Thanks, and we'll talk soon. Take care. Thank you. This does conclude the program. You may now disconnect. Everyone, have a great day.