Good afternoon. Welcome to the final day of the 41st JP Morgan Healthcare Conference. We're thrilled to have you and Intercept Pharmaceuticals here to present. Following the presentation, we'll take live Q&A. At this time, I'd like to welcome Jerry Durso, President and CEO to the stage. Good afternoon, everybody, really glad to be with you this year in person at JP Morgan. I'll be making some forward-looking statements throughout the presentation, definitely proud to be here giving you an update on where we are at Intercept Pharmaceuticals. At Intercept, we're a company that's dedicated to supporting patients with progressive non-viral liver disease, again, a lot to look forward to in what's gonna be an exciting 2023 for the Intercept team and the patients that we serve. Where are we today? At the foundation of our business, we have what's a growing important foundational efforts in market with Ocaliva. Ocaliva is indicated for primary biliary cholangitis or PBC. We did preannounce earlier this week about $343 million in non-GAAP revenue for the year, $285 million with double-digit growth on a U.S. basis. It really is that strong progressive efforts in market which is fueling a lot of the opportunities that we look forward to in the future. Importantly, our efforts in PBC are not just focused on the short term, where we'll continue our momentum in market on a quarter-by-quarter basis with Ocaliva, but also looking to the future. This continues to be in PBC and the second line area where Ocaliva is focused, an area with unmet need. We're in phase II with another potential medicine, which is a fixed-dose combination of obeticholic acid, which is Ocaliva, and bezafibrate. I'll talk in some detail about some of the exciting opportunities with that program. Heavy focus in the company continues in the NASH segment. We announced near the end of last year, on December 23rd, that we successfully resubmitted our NDA for pre-cirrhotic liver fibrosis due to NASH. You can imagine the intensity to get the file in, and now importantly, preparing as we progress through the regulatory cycle, get ready for what we would expect to be an Advisory Committee later in 2023. On the basis of both our submission and the work we're doing, really the strong underlying robust data coming from our development program. It's the largest development program in NASH and the antifibrotic effect we see with obeticholic acid in a NASH population reinforced, not once now, but twice with positive interim looks from our phase III REGENERATE data. I'll summarize some of that data in a few minutes. I think we've also made good progress as we start to expand our pipeline and now placing more opportunities from a future-looking perspective. We did announce in November of 2022 that we moved forward, really our next generation FXR agonist, INT-787, for a lead indication in severe alcohol-associated hepatitis, again, consistent with the view that Intercept takes to target areas of high unmet need, and I'll give you an update on where we are and our thinking there. Importantly, for a company that is dedicated in one therapeutic area at this point, you know, we continue to build our efforts with strong people, with strong experience, and the 350 or some odd team members of Intercept that I feel proud to lead. Really appreciate all the work they're doing every day as we move forward on this mission. I'm gonna talk in a minute about some of the work we did throughout last year to position us for all the exciting work to come, and really a heavy emphasis on strengthening our financial position and improving our capital structure. If we look at the next slide 5, really a transformation of our balance sheet, frankly, last year. In the middle of those efforts was a decision we took to sell the rights of Ocaliva outside of the U.S. in a $450 million sale to Advanz, which really allowed us an infusion of capital to position us for the work to do ahead and really ensuring that we had strategic optionality. Subsequent to that sale, we took the decision to retire quite a bit of the 2026 convertible debt that we had on hand, so decreased that debt by almost $400 million, and importantly also on a forward-looking basis, reducing our cash interest expense to the tune of about $12 million a year. Again, a strong move taken on the balance sheet to put ourselves in a position by at the end of the year, as we announced again with the pre-audited announcement that we made yesterday. We have a roughly $490 million in cash on the balance sheet. Again, puts us in a good position as we look at 2023 and beyond, to maintain that balance sheet, with a sustainable level above debt and to make the right moves, as we progress. It was important that we had the kind of flexibility to both continue to invest smartly, but also to look for growth. Again, one of the big opportunities that we'll be executing on this year is the regulatory process and preparation for a potential commercial launch of OCA in NASH. Really, the ability to do that, with the resources we have on-hand, and also take advantage of the strength and the current infrastructure that we have that's already pointed in market to many of the customers that we'll be looking forward on NASH. Again, a big move, important move, and we feel good that we have the right flexibility, the right foundation, and the right strategic optionality as we progress through the important work this year in 2023. I'll start with some focus on PBC. Again, this is where our foundational business with Ocaliva lies. As I said, PBC is primary biliary cholangitis. It's an autoimmune condition affecting the bile ducts in the liver. It affects one in several thousand individuals, mostly women. It's been where, if we flip to slide 7, we launched back in 2016, the first commercialized product, which is Ocaliva in PBC, which is indicated specifically for the second-line patient population in PBC. These are patients that either have difficulty or are not being controlled with UDCA, which is the standard of care. This is where we've built that progressive growth that I referred to, with our commercial business. I think importantly, the time and market has given us and the prescribers and the patients good, positive experience with Ocaliva, and I'll touch on that. As well as the ability with the time we've been on the market to generate longer-term outcomes data, which we look to the future, and potentially we've had the great opportunity to be the only second-line therapy approved since we launched. If and when new competitors come, that time and market and the ability to have longer-term data is gonna be a real potential differentiator from the competition. I think as we again talk about the growth, I mentioned where we are in the U.S. on an annual basis after making the decision to focus our commercial efforts only on the U.S. after we sold the international rights. We mentioned close to $300 million in audited sales that were announced. Importantly, we continue to say, in spite of the fact that we're now 6, 7 years good progressive growth through the efforts of the commercial team. We anticipate based on some of the dynamics that are continued to point towards more opportunity that the opportunity to grow in PBC will be a focus. There is opportunity and runway for a variety of reasons, in spite of that growth curve that I just referenced, where we see good year-over-year growth to continue. Still over 60% of the patients eligible for second-line treatment have never received it. There are more patients that are eligible that could that are appropriate and could benefit. Again, we're not at a situation where we're tapping out the existing potential patient populations who could really benefit. Our efforts to continue down that path will be important. Secondly, those that have experience are. It's a positive experience. From some of the market research that we typically do in market, over 85% of the patients are telling us they're extremely satisfied with their experience, and that they intend to stay on therapy. Again, chronic therapy patients that feel that they're being managed well on and are stable is a crucial element, and that's leading to very high refill rates, which is important for any chronic medication. Particularly one that is serving a patient population with high unmet need. I think one of the other metrics on the slide I would just point you to, which is sometimes a little unusual for a drug that's been available this long, but just to point out that the opportunity remains. The number of incremental new prescribers, these are hepatologists and gastroenterologists prescribing Ocaliva for the first time, was actually almost about 10% larger in 2022 versus 2021. Again, not the typical dynamic that you see for a medication that's been out this long. You know, this slide is just summarizing the interest we have to continue on this journey for sequential expansion because the patient need is there, and we feel that we're well equipped to continue to grow. As I mentioned, it's not just about growth in today, it's also looking at tomorrow, and one of the things that always helps drive long-term growth is bringing new data to the equation. I mentioned earlier that one of the advantages of being in market for this period of time has been that it's allowed us to continue to generate long-term data. You know, reference the published data in Gastroenterology. We've done quite a bit of work looking at real world analysis on the impact of OCA on long-term clinical benefits in the real world. A 70% lower risk of death or liver transplant. Again, the long-term outcomes, which are so important for a medication like this. We present several other datasets. The HEROES-US study was one from the mid part of last year and presented again at AASLD. We look at the impact in different real world datasets with different methodologies, and this consistent benefit will be part of the comprehensive package that we'll put into the FDA supporting our post-marketing commitments later this year. Again, good progress will continue and really long-term data that we believe differentiates Ocaliva today and in the context potentially of new entrants that could come in the second-line therapy in the coming years. Last point on PBC is, you know, our interests are long term. We are in phase II on what we think is an exciting opportunity on a combination of obeticholic acid and bezafibrate. Bezafibrate is a new chemical entity in the U.S. It is available and used in PBC in other parts of the world. There is, you know, interesting data that exists from European investigator initiated trials. We're in the process now with the phase II program, both in the U.S. and in insights outside of the U.S. of generating what we think is gonna be exciting data, which we'll talk about over the coming months. We think there's good synergy here, not only from an efficacy standpoint, potentially, but also potentially to mitigate some of the side effect profile of OCA alone. As I said, over the coming months, we'll be talking more about the learnings that will start to come through some of the interim reads on the phase II. Also give us a good indication as we look at a wide range of doses, what we'll think about in phase III. PBC is at the foundation and also heavy emphasis on NASH, non-alcoholic steatohepatitis. You are probably well aware of the growing concern, health concern, as NASH grows, leading to long-term outcomes. It's a leading indication for liver transplantation. While this is a large number of patients that are, and more every year that are impacted by NASH, we're really focusing on a subset of at-risk patients with pre-cirrhotic liver fibrosis due to NASH, and that's the basis. Fibrosis, which is one of the progressive implications of NASH, we know is the strongest predictor of the outcomes that are trying to be prevented as patients progress and really keeping patients from progressing to the later stage of fibrosis and ultimately into cirrhosis is one of the large treatment goals. It is the area in terms of the anti-fibrotic effect of obeticholic acid that's been demonstrated multiple times in our phase III study, and I'll talk a little bit about that. We know there are no NASH medications currently approved, so the unmet need is high and particularly important in some of these segments as patients progress towards dire consequences. We did resubmit our NDA, and we would anticipate because this is a type 2 resubmission that it would be a PDUFA target review of 6 months. Heavy emphasis, as I said before, as we engage back into the regulatory process with a lot more data to support our efforts. That data is coming from the REGENERATE trial. It is the largest study, about 2,500 patients in the full dataset with NASH. This has been a study that's been ongoing for several years. The main interim analysis is a group of patients that got biopsies at 18 months while we're testing in this study 2 doses of OCA. The 25 milligram dose has been the dose that has been effective as an anti-fibrotic in both endpoints. The readout, initial readout of the 18-month cohort from February 19, and the reanalysis that we announced in July of last year. The endpoint that OCA achieved clinical efficacy on was what we deem as the most important element, the most important primary endpoint. Frankly, I think the way that we look at the endpoint is the most rigorous way that this endpoint is being assessed. It's fibrosis improvement of at least one stage without worsening of any of the three NASH components. We've done that analysis multiple ways. We did it in the initial read with a central pathologist reading methodology. We came back, and really consistent with the FDA's guidance around a preference for a consensus panel deployed a group of three pathologists for the reanalysis that is summarized here on the left-hand side of slide 16, where we saw once again, importantly, consistently, a doubling of the anti-fibrotic effect versus placebo. Again, this is against what we believe is the most robust definition of an endpoint. You had to have an improvement of at least one stage in liver fibrosis without worsening of any of the three NASH components in order to be a responder in that analysis. Also critically importantly, as we focus on the more advanced population and those patients that are pre-cirrhotic but at the highest risk of progressing, we saw in this reanalysis the highest efficacy for OCA was in the more advanced population. This was the subset of the patients in that cohort who were F3 stage fibrosis, according to their entry biopsy as read by the pathologist at baseline, which we think again, importantly bringing the most anti-fibrotic effect to the patients that are at the most risk, we think is critically important and potentially a big differentiator when we think about the clinical considerations that physicians will have if a therapeutic like OCA is available in the market. Last and certainly not least, since we believe the anti-fibrotic impact is the most important, we did look at this particular analysis just at the improvement of liver fibrosis without the components of NASH considered, and these were for patients where there was both a baseline biopsy and a month 18 biopsy, so it's a subset. In the primary analysis, if there was no 18-month biopsy, that patient would by the definition and according to the protocol, be considered a non-responder. Where we had a baseline and matched, you see the 37% impact on liver fibrosis improvement of up to one stage. The anti-fibrotic effect is strong, is consistent, and again, we think is critically important for the patients at risk. The other element which was important in all the work that we did to prepare the dataset, and ultimately submit that to the FDA at the end was a significantly increase both in size and duration on the safety database. For example, in the first submission back in 2019, there were no patients that had been on therapy for up to 4 years. There's roughly 1,000 in this enhanced and increased dataset. It's a much larger dataset on safety, but as importantly for a drug that's requesting approval for use chronically, much longer duration of therapy. I think we've been able to generate a lot more insight of what happens to patients over the course of therapy, which we believe is critically important for patients who will be ultimately on therapeutics if they're approved for a long-term. Again, we feel much more well-equipped as we enter into that dialogue to not only talk about the efficacy of OCA, the consistent anti-fibrotic effect, but we also believe that the monitorable and manageable safety profile is now reinforced by a lot more experience in what we've learned in this long course of the study. As we prepare and go through all the regulatory process, we're also, as you would expect, getting ready for a potential commercial entry into the market upon approval. And I think, importantly, we look at the market from a position of where we're strong. Importantly, when we think about the types of specialists, the hepatologists, and the gastroenterologists that we deem will be the most important, for a profile like OCA, we're already working with about almost 3/4 of those for our efforts in market. That creates, again, for us, a good understanding of these practices, of the specialists, and the opportunity to not only launch strongly, but to launch extremely efficiently into a target group that we know well. We're bringing with us good understanding of the patient advocacy groups in this segment. We have a well-entrenched medical affairs team working with the specialists and the payor. Again, we look at the NASH opportunity of one that our PBC presence and experience gives us a position that we feel we can leverage as we look forward and prepare and do the right things to enter. Again, a lot of emphasis on both sides of the company right now, obviously on the R&D and regulatory side, but also as we get ready commercially for what we think could be an exciting opportunity to support our patients. PBC and NASH at the foundation of a lot of work, I'll take just a couple of minutes in summary and remind you of the work we're also doing on the pipeline side. I referenced where we are with PBC, with the combination program of OCA and bezafibrate in phase II. The large NASH clinical trial moving through to outcomes. That work on REGENERATE continues. Now excitingly, as I said, expanding out into a new area with a new asset, which is INT-787, which is our next generation FXR agonist. We did announce the lead indication consistent with our approach at Intercept. Again, we look for areas of high unmet need, bring our experience and our dedication in liver disease. We think that the growth of the concern around severe alcohol-associated hepatitis and the potential different compound that 787 is. It's a different FXR than obeticholic acid is. It's much more water-soluble. Based on the work we've done with some of the preclinical models, greater activity, not only in the liver, but also importantly in the gut, which we think is gonna be potentially important for a condition like severe alcohol-associated hepatitis. We're now in the phase IIA program. Sites are up in the U.S. and in the U.K., in France, and again, look forward to sharing more information as we progress and expand our pipeline and look to the opportunity to provide more solutions for patients with liver disease in an area of high unmet need. A lot of focus as we look at 2023. We will continue to move progressively in our foundational business in PBC. Progress, not only in market with our efforts with Ocaliva, which we think has room and runway, but also to bring forward the OCA bezafibrate combination. Intensity around NASH, both from the regulatory process as we have resubmitted and are now going and preparing for an Advisory Committee and also for the appropriate and productive, we expect, dialogue with the FDA. Also look to the future and advance our pipeline, both with the assets that we have in-house, and as always, looking how best to leverage the unique capabilities that Intercept has in liver disease. And last, and certainly not least, doing that all with the strong financial foundation that we worked so hard over the last couple of years to transform the balance sheet, to put ourselves in a situation where we have what we think is a sufficient cash to meet our strategic objectives and to make sure that the discipline that has allowed us to get our balance sheet in the strong position that it is, will be the way that we continue to look to run our business. An important year for Intercept, continuing as we transform the company and look forward to, you know, the updates on the important milestones and catalysts in the months to come. Again, on behalf of all the folks at Intercept, who are doing everything they can every day to support our patients, I wanted to thank them. It's a dedicated team. It's a team that has allowed us to move the company forward, and it's a team that I know is as optimistic as we all are about the good work to do together ahead. Thank you, and that concludes the presentation. Thank you so much, Jerry. At this time, we'll take Q&A up here on the stage. I can start us off with one question here. As you think about the NDA submission, what's the timeline to hearing back? And when you think about the investments in the sales force that may be needed, what's the timeline to kind of, you know, actioning those? As I mentioned, during the presentation, we did submit the resubmission happened on the 23rd of December. We would anticipate that somewhere in the 30-ish day window, we might hear something back from the agency. We would expect that the target PDUFA date would be a 6-month review from when we submitted. We would anticipate and frankly welcome the opportunity for an advisory committee as part of the process. We do think this is an important medication, an important decision, and we know that there is a lot of interest from the stakeholders in a public discussion. That's a lot of the effort that the team is engaged on in parallel. That's kind of the general timeline. Obviously, as we get more insight, as is typically, we'll share that as appropriate. On the commercial preparation side, you know, at once we got the once we got the interim data, we did enter into some updated work. We have the advantage of we've done quite a bit of work over the years in terms of understanding the stakeholders in market, whether they be the physicians, the patients, and the payers. We're in the middle of, you know, an update of a lot of those discussions and reconsideration to make sure that we narrow the right commercial strategy. As I mentioned in the presentation, we really think about the strength we have in our existing infrastructure as a great basis to launch. Of course, we'll consider how best to resource the launch. I think importantly, we don't feel a need to annex a large amount of resources on top of our existing structure as we progress, because we're really looking at, you know, a good coverage of the key customers. We'll monitor and manage this. Maybe Andrew, you have some additional comments on the cost side and how we're thinking about the coming quarters towards, you know, potential approval and an entry into the market. Yeah, sure. Thanks, Jerry. I mean, look, I think that as you look out at the NASH landscape, we are the one that is the most effectively positioned to launch in NASH. I mean, with over 70% of our targets currently under coverage, there's nobody who's in a better position to launch efficiently. To Jerry's point, we did a lot of work last year getting the balance sheet into a position where we have strategic optionality going forward. We're not gonna easily give that up. We have $490 million in cash. We came out with that at year-end, $329 million in debt. We are gonna marshal our cash as carefully as we can in the next year to make sure that we maintain sufficient cash balance to go in any direction we need to. It's really important to us to stay focused on growing PBC, to give the R&D group what they need to get an approval in NASH, and then we're gonna launch efficiently. We feel really good about where we are, but we're not going to be reckless with spend going forward. That's very helpful. Thank you. A reminder for anyone in the audience, if you'd like to ask a question, please feel free to raise your hand and we can bring the mic over. In the interim, maybe an update on the timeline to data on the fixed-dose combination and what you view as next steps there. As I said, for us, that's a really exciting and interesting opportunity, not only therapeutically, if, you know, the potential synergy that the data that's out there on bezafibrate and OCA from Europe, for example, plays out. Also from a lifecycle management standpoint, as I mentioned, bezafibrate is a new chemical entity, I think opportunity, to extend the runway from an IP standpoint. As we're in the process of generating phase II data now, we would anticipate in the coming months we'll have some greater insight from some of that interim data that we'll start to get a sense of. I would anticipate, you know, in the first half of the year, we'll have some more color on how things are progressing, how we're starting to think about the program beyond phase II. What we start to see in terms of the translation of some of the data that's out there already through towards the program that we're doing. Again, a wide range of doses that we're studying. I think for us, it's a real unique opportunity with two mechanisms which clearly we know a lot about the impact of OCA in PBC, and again, bezafibrate outside of the U.S. Stay tuned. We do anticipate, as we progress before too long, we'll have some additional color that we'll look forward to sharing as soon as it's ready. That's excellent. Thank you, Jerry. Maybe another one. You've got obviously a number of key catalysts coming up across 2023, a ton to look forward to over the year. Are there any other areas where you anticipate investment? I know you mentioned that, disciplined management of that cash balance. Is there more you're looking to do, or do you wanna just execute the plan on what you've got? Yeah. I mean, look, I think that our goals are fairly straightforward for next year. We're focused on getting approval. We're really happy with FDC, with the fixed dose combination. We think that that is absolutely critical to maintaining our leadership in PBC. We like the IP package around that, and we think that it's potentially a best-in-class product. That's something that we really are looking to accelerate. We're excited about INT-787. That's early data, we have to get that going and see if we have a drug there, but that's our next generation FXR. Again, other than that, it's really NASH. We've got, you know, we've got a lot of exciting things happening. You know, we do have the other thing that we talk a little bit about is we have the ANDA litigation. There's a lot of shareholders that are interested in our IP runway. We're hopeful. We feel really good about our intellectual property package. That litigation is at the end of February. That should give us clarity on our runway with Ocaliva. Obviously, we eventually hope to transition that business over to PBC, but some additional runway on Ocaliva would be great, and we're looking forward to it. Excellent. If no further questions, I'll pass it back to Jerry for closing remarks. Thanks all for joining us today. Again, for us, the roadmap, as Andrew indicated, is clear for 2023, and we look forward to sharing the progress as we progress through what will be another important year, not only for Intercept, but hopefully for the patients that our mission is to continue to support with progressive non-viral liver disease. Thanks, and everybody travel safely home.