Earnings Transcript for ICPT - Q1 Fiscal Year 2022

Operator: Good morning, and welcome to Intercept Pharmaceuticals Q1 2022 Earnings Conference Call. At this time all participants are in listen-only mode. . As reminder, today's call is being recorded. I would now turn the conference over your host, Mr. Nareg Sagherian. Sir, you may begin.

Nareg Sagherian: Thank you. Good morning and thank you for joining us on today's call. This morning, we issued a press release announcing our first quarter 2022 results and business update, which 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 approved product and clinical development programs, certain regulatory matters, and our strategy, prospects, financial guidance and future commercial and financial performance. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this call, and we undertake no obligation to update such statements, except as required by law. These forward-looking statements are based on estimates and assumptions that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. Some, but not necessarily all of the risk factors that could cause our actual results to differ materially from our historical results or those anticipated or predicted by our forward-looking statements are discussed in this press release and in our periodic public filings with the SEC. Today's call will begin with prepared remarks from our President and CEO, Jerry Durso; our Chief Commercial Officer, Linda Richardson; President of Research and Development and Chief Medical Officer, Dr. Michelle Berrey; and Chief Financial Officer, Andrew Saik. We will then open the call and take 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.

Jerome Durso: Thanks, Nareg, and good morning, everyone. Thank you for joining us on our first quarter 2022 earnings conference call. As we proceed through this transformational year for Intercept, I'm pleased with the progress that our team made in the first quarter. We reported $88.6 million in worldwide Ocaliva net sales, representing 8% growth compared to the first quarter of 2021. While Ocaliva continued to deliver revenue growth on a worldwide basis in the U.S., as we expected, we saw a slower growth rate versus previous quarters given the cumulative impact of COVID-19 and last year's label update. Overall, our quarterly performance was in line with our expectations. With more than 20,000 patient years of experience for Ocaliva and PBC, we're strategically focused on generating and sharing compelling long-term data to support adoption of Ocaliva. Given the substantial number of patients with PBC who could benefit from second-line treatment, I remain confident in our ability to continue to grow this business over the long term. Turning to NASH. We're nearing completion of the new top line data analysis from our Phase III REGENERATE study, which will include a significantly larger data set than our interim analysis in 2019. NASH is the most rapidly growing cause of liver transplantation in the U.S. and people living with fibrosis due to NASH urgently need improved therapy. As the first company with positive Phase III data in NASH, we look forward to delivering these new analyses and furthering our understanding of OCA's potential role in treating this disease. We continue to target a potential pre-submission meeting with the FDA in June. Our second Phase III trial in NASH, REVERSE, evaluating OCA and patients with compensated cirrhosis due to NASH, is on track for a top line readout in the third quarter. Our team has also made progress on our earlier-stage pipeline programs, which I will elaborate on later in this call. Turning now to the announcement we made yesterday. As you saw from our press release, Advanz Pharma has acquired the rights to our international operations, including the rights to commercialize Ocaliva in PBC in markets outside the U.S. Also, under the terms of the agreement, we'll receive royalties on any future ex-U.S. net sales of obeticholic and NASH should Advanz Pharma pursue marketing authorization for this indication. Upon the closing of this traction, Intercept will continue to be responsible for the manufacturing and supply of a obeticholic acid globally and Advanz Pharma will be responsible for the packaging, distribution and commercialization of the therapy in all markets outside the U.S. INTERCEPT will maintain an office in the U.K. to manage our global supply chain, support our global clinical trials and our quality organization, though the majority of current Intercept employees outside the U.S. will transfer to Advanz Pharma. Importantly, this transaction is consistent with the focus that we've been employing over the last 1.5 years. Since I've assumed the role of CEO, we've been laser-focused on strengthening our financial foundation to support multiple pathways for future growth. Ultimately, this transaction was a financially strategic move for our organization, and the proceeds of the deal will significantly strengthen the company's balance sheet, increase our ability to invest in our core business priorities, including the support for a potential launch of NASH, should we be successful in the U.S. And also, allow us to continue to advance and expand our pipeline. I want to thank our international colleagues for their contributions to Intercept. I'm inspired by their commitment to bettering the lives and building a healthier tomorrow for people throughout the world with progressive non-viral liver diseases. We know that Advanz Pharma will be positioned to drive growth of Ocaliva outside the U.S., and this will ultimately benefit the international PBC community. We look forward to working closely with the Advanz Pharma team to ensure a seamless transition. Now, before we continue with the rest of our quarterly earnings recap, Andrew will now provide additional financial details around the agreement. Andrew?

Andrew Saik: Thanks, Jerry. Good morning, everyone. To provide a bit more color on this, under the terms of the agreement with Advanz Pharma, Intercept will receive consideration in the amount of $405 million upfront subject to customary working capital and other adjustments. We will receive an additional $45 million from Advanz Pharma contingent upon receipt of an extension of pediatric orphan exclusivity in Europe. Subject to customary legal and regulatory approvals and other closing conditions, we expect to close 2 to 3 months. As a result, we are suspending our financial guidance as we assess the impact and timing of this transaction on our organization. We anticipate providing a revised 2022 financial guidance after the close of the transaction likely during our second quarter earnings call. Ultimately, and as Jerry mentioned, this agreement reflects our commitment to a strong balance sheet and gives us the ability to invest in our strategic priorities, including support for a potential launch of NASH in U.S. should we be successful. It also gives us flexibility to manage our debt obligations. With that, I'll turn the call over to Linda. Linda?

Linda Richardson: Thanks, Andrew, and good morning, everyone. I'm pleased to share that we continue to drive sales growth in our PBC business in the first quarter of this year. We delivered worldwide Ocaliva net sales of $88.6 million, which is comprised of U.S. sales of $59.2 million and ex U.S. sales of $29.4 million, aligned with our expectations. In the U.S., we historically see evidence of seasonality in Q1 performance caused by benefit verification requirements and patient migration to new plans, which occur at the start of the year. In 2022, this pattern was further exacerbated by a large number of national employers, Advanz, that migrated to new network specialty pharmacies, and this link in the time to process new prescriptions. In Q1 '22, we are also seeing the effect of last year's U.S. label update on reducing the number of patients eligible for Ocaliva. I would remind everyone that Q1 2021 included decompensated PBC patients and those with evidence of portal hypertension, both in total prescriptions and entering this new Ocaliva patients. We believe that this will be just a transient phase and growth will return as we replenish the patient pipeline over the next few quarters. Current U.S. market dynamics show that nearly 90% of our physician interactions are now in person, patient visits are trending up in recent weeks, and we've seen a much quicker turnaround in patients moving through the enrollment process in March. Moving on to our international regions. In the first quarter, we saw continued growth driven by strong new patient starts. Our net sales were 21% higher than the same period last year, with all countries performing above budget. I would like to take a moment to acknowledge the many contributions and outstanding performance that the international team has made to the overall business, especially over the last 15 months, when I've had the opportunity to work closely with them. In closing, we remain confident in our ability to drive growth, increase market penetration and maintain a positive long-term outlook for our PBC business. While we recognize that lowering ALP has been a long-standing marker of improvement in PBC, optimizing care includes additional considerations. We believe outcomes data in PBC will become an important consideration for prescribers and patients, as it addresses the higher goals of avoiding liver transplantation and improving morbidity and mortality. We are committed to generating and evaluating this type of data for Ocaliva, which we believe will be highly differentiating. As we move through 2022, new data from COBALT, additional real-world evidence, information from PBC registries and the publication of the data we presented at ASLD last year, will provide a continuous role of messages on the important role Ocaliva plays as the only approved second-line therapy for patients with PBC. I'll now turn the call over to Dr. Michelle Berrey. Michelle?

Michelle Berrey: Thank you, Linda, and good morning, everyone. Today, I'll be providing a few updates on our continued work to generate evidence supporting Ocaliva in PBC, as well as updates on our NASH development program and on our pipeline. Looking first at PBC. As we mentioned last quarter, we are focused on completing the analysis for the Phase IV COBALT study and leveraging real-world data sets to help show the clinical benefit of long-term therapy with Ocaliva beyond both chemical measures. The ultimate goal of therapy in PBC, those events that make a difference to someone living with PBC, is to prevent progression to end-stage liver disease, liver transplantation and death, and we are generating substantial evidence from multiple different sources on the positive benefit of Ocaliva on these clinical outcomes. To that end, we were pleased to present pilot data last year at the liver meeting from the Phase III POISE trial open-label extension, which showed that individuals receiving Ocaliva for PBC in the clinical trial setting has statistically longer transplant-free survival when compared to individuals from external databases they were eligible, but who did not receive Ocaliva. These data, which we expect to publish later this year, continue to generate very positive feedback from physicians regarding their impact on clinical decision-making and on the PBC community. Importantly, these data will be included as support for our post-marketing study, COBALT, and regulatory submissions to both FDA and EMA in the second half of this year. As we've previously communicated, we've closed our COBALT study, because of challenges associated with retaining patients in a multiyear placebo-controlled study, especially when there's a commercially available therapy. We are compiling the final available placebo-controlled data from COBALT, including a new expanded primary endpoint that includes earlier clinical events that indicate progression toward decompensation. The new primary endpoint has a higher sensitivity for demonstrating Ocaliva's clinical benefit than the original primary endpoint of hospitalization for liver events, liver transplant and death. We are working on completing top line data analysis in the coming weeks and look forward to sharing them when available. Additionally, our data compilation from COBALT will include a prespecified comparison of randomized patients who received Ocaliva with patients from external data sets. For the same reasons behind the closure of our COBALT study, we've initiated two retrospective real-world studies collectively called Heroes, which leverage real-world evidence to assess Ocaliva's impact on important clinical outcomes. Along with data from the Phase III POISE trial open-label extension and outcomes from Cobalt, we intend to include these data as supportive evidence in our regulatory submissions later this year. Now, on NASH. We're excited to be nearing completion of the new data analyses from our Phase III REGENERATE study and look forward to sharing these results. As a reminder, these new analyses will now include more than 8,000 patient years of safety data compared to around 2,400 in the prior submission, and nearly 1,000 patients who've reached 4 years in REGENERATE. The comprehensive assessment of the safety database will therefore provide a much more robust insight on OCA's benefit-risk profile in NASH. A pre-submission meeting with the FDA is currently scheduled for June, and we intend to continue the discussion on the structure and content of the potential submission. Although FDA has expressed interest in the totality of our data in NASH, which will include over 2,000 subjects with non-invasive tests or NIT, we recently received additional feedback on our final data analysis plan, including details on the different populations of interest for a potential resubmission. The primary population for histology will mirror the original interim analysis population of 931 subjects. Additional analyses will consider the entire histology population, which includes the new 500 subjects. As with any FDA review, the agency can evaluate any patient population within a submission. We are also continuing to work toward a top line data readout from our Phase III REVERSE study, the only active late-stage study in compensated cirrhosis due to NASH. We anticipate delivering top line data from REVERSE in the third quarter. We will assess the role of these data in our ongoing dialogue with the agency once we have the results in hand. Overall, the amount of data we are generating in NASH with REGENERATE and REVERSE is unprecedented. And ultimately, upon completion of these analyses, we will have accumulated the largest Phase III clinical trial data set in the field. Moving on to our pipeline. We continue to screen patients and add clinical sites in our U.S.-based Phase II study of our OCA bezafibrate fixed-dose combination for PBC. In addition, we continue to enroll our international Phase II study that is evaluating different dosing regimens of the OCA-beza combination. Our large Phase I study in the U.S. to better characterize the exposure data and any potential drug-drug interactions of the fixed-dose combination remains ongoing. Together, these 3 studies will inform the dose selection and study design for our Phase III trial. Finally, our comprehensive Phase I study for our next-generation FXR agonist, INT-787, is ongoing, and we are on track to have an open IND in the coming weeks. We look forward to sharing additional information about our intended indication and development plans for INT-787 later this year. I will now turn the call over to Andrew for a financial update. Andrew?

Andrew Saik: Thank you, Michelle. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter ended March 31, 2022. In the first quarter, we recognized $88.6 million in worldwide Ocaliva net sales, representing 8% growth over the prior year quarter. Our worldwide Ocaliva net sales were comprised of U.S. net sales of $59.2 million and ex U.S. net sales of $29.4 million. In the U.S., as anticipated, we experienced a typical seasonality in Q1 patients, as Q1 patients were impacted by the resetting of insurance plans and Medicare coverage gaps at the beginning of the year. Our GAAP operating expenses and non-GAAP adjusted operating expenses for the quarter were $98.9 million and $91.8 million, respectively. This was a decrease of $12.1 million and $9.9 million versus the prior year quarter, as we continue to focus on cost management. As a reminder, our non-GAAP adjusted operating expenses exclude stock-based compensation and depreciation. Non-GAAP adjusted operating expenses is a non-GAAP financial measure under SEC regulations. Please refer to our press release issued earlier this morning for a full explanation and reconciliation of this measure. Our cost of sales was $0.8 million in the quarters ended March 31, 2022 and 2021. Our cost of sales for the quarters ended March 31, 2022 and 2021 consisted primarily of packaging, labeling materials and related expenses. Our selling, general and administrative expenses were $50 million in the first quarter of 2022, down from $59.3 million in the prior year quarter. The decrease was primarily driven by our ongoing efforts to manage our operational costs and to run the business as efficiently as possible. Our research and development expenses were $48.1 million in the first quarter of 2022, down from $50.8 million in the prior year quarter, as we continue to drive efficiencies while progressing our NASH program. Interest expense for the quarter ended March 31, 2022, was $6.7 million. We expect cash interest expense to be approximately $23.5 million for the full year based on our current capital structure. In the first quarter of 2022, we reported a net loss of $17.3 million, a decrease compared to a net loss of $40.4 million in the first quarter of 2021. As of March 31, 2022, we were well positioned with cash, cash equivalents, restricted cash and investment debt securities available for sale of $406.9 million. In summary, I am pleased with our commercial performance, which is on track in the first quarter and our continued cost management during this important time in Intercept's history. We are well positioned to continue investing in the growth of Ocaliva and PBC, supporting our NASH development program and regulatory process with the FDA and furthering our pipeline. With that, I'd now like to turn it over to the operator for any questions. Operator?

Operator: Our first question comes from Yasmeen Rahimi of Piper Sandler. Your line is open.

Yasmeen Rahimi: Good morning, team. And thank you for taking the questions. And congrats on the new partnership with Advanz Pharma. Two quick questions for you. One is directed to Michelle. Maybe, I'll start off with are we going to be seeing the interim data after you've had your meeting with the FDA in June? Or are you planning to meet with the FDA first and then, come back and release the data and kind of provide a comprehensive overview of data as well as the next steps? And then, the second question is in regards to Advanz Pharma deal. What do they want to see in order to motivate them to partner for and NASH and ex U.S. geographies? And thank you so much for taking my questions.

Jerome Durso: Okay. Thanks, Yes. We'll flip it right to Michelle on the first question, and then, I'll come back with the question on the deal.

Michelle Berrey: Great. Good morning guys. So on the data, as you're aware, as soon as have the data that certainly is material for the company that we would be releasing those top line data as soon as we have those and they're ready to share. We do have the pre-submission meeting calendar with the FDA. You don't have to have those data in hand to have the meeting and actually, there are some companies that have their pre-submission meetings planned well before. They have data in hand, because a majority of those conversations, frankly, are around the structure of the submission and making sure that the company and the agency are aligned on the different populations of interest so that you can get all of your tables listings, figures lined up and ready to submit. So we -- again, we will have those data released as soon as we have those in hand. Can't say much more specifically about that at the moment, but you'll hear about it.

Jerome Durso: Yes. And on the considerations around NASH, as Advanz Pharma has the right to commercialization in the territory, they would be determining whether -- or how to pursue on a regulatory basis in NASH. Obviously, as the global developer, we would have the data, we would provide them with the data that we're in preparation for now, and then, they would make a decision. We did think it was important in the structure of this deal that we were able to benefit from a potential upside in NASH outside of the U.S. So we felt good about the inclusion of strong double-digit royalty should Advanz pursue and be successful with securing availability of OCA and NASH outside of the U.S.

Yasmeen Rahimi: Thank you, team. I'll jump back in the queue.

Operator: Our next question comes from Ritu Baral of Cowen. Your line is open.

Ritu Baral: Good morning, everyone. Thanks for taking the question. Could we just go through exactly, what will be part of the resubmission to the FDA, just as far as patient numbers? Michelle, am I sort of reading this right, you're going to have 1,400 patients at the primary end point? And can you tell us, I guess, how many total discrete patients have been treated with drug. And then, I've got a question about REVERSE.

Jerome Durso: Okay. Thanks, Ritu.

Michelle Berrey: Sure. So in the submission, we've -- again been in a lot of dialogue with the FDA about specifically, which populations they wanted to see, as we've talked a lot about over the last year or so, their main area of interest is looking at the primary population of -- that mirrors what was part of the original submission in 2019. So the 931 patients that were part of that ITT analysis read by central readers. So as long as we mirror that population, we don't use any alpha. So that's really critical. They, of course, are interested in looking at all of the histology data that we have for subjects that have both a baseline and a month 18. And that includes the new 500. So that would be part of another analysis, but the group that has both the central read from the original analysis and -- both that, and the new consensus pathology reads would be the primary submission will be the top line. We also have subjects who are out at 4,800. That's the total safety population that we've talked about. We have 1,000 subjects who are now out to 48 months. So that's what comprises our safety population with over 8,000 patient years of data. So again, a substantially more robust package than what was submitted in 2019. I know it gets a little complicated. This is certainly not a straightforward submission. It is an accelerated approval with the surrogate endpoint -- with several surrogate endpoints, including the noninvasive tests, as well as continuing to move towards that full primary analysis for clinical endpoints. This submission is a resubmission on an interim analysis using a new methodology, but importantly, focused on that same population that mirrors the original submission from 2019.

Ritu Baral: Got it. Okay. And then, you mentioned the FDA was interested in a few different populations. Was there any mention of a subpopulation that encompasses potential fast progressors? We've heard a lot of that over the years from KOLs.

Michelle Berrey: We'll certainly be looking at that. I don't anticipate that we will have that with our top line data, but we have multiple populations that will be assessed following the availability of those top line data.

Ritu Baral: Got it. And then, just going back to REVERSE and the primary endpoint on that. Any -- or just the analysis, other companies have moved to moving their endpoint to something more biomarker-based maybe, ELF and other companies are incorporating AI into some of their fibrosis assessments. Any plans to either amend the various endpoints to include AI quantification? Or, I guess, promote the importance of ELF within the analysis?

Michelle Berrey: So we do have secondary endpoints that include all of these at our second -- the non-invasive tests, including the wet biomarkers, as well as the noninvasive fibers, et cetera, that will be included as secondary analyses. And apologies, we're going to ask this to stick to one question and then -- to let everybody get through the queue. They will be available in the third quarter. Thanks, Ritu.

Operator: Our next question comes from Thomas Smith of SVB. Your line is open.

Thomas Smith: Hey guys, good morning. Thanks for taking the questions. Just on the Advanz deal, can you comment on how much visibility Advanz has into the ongoing REGENERATE reanalysis and the REVERSE trials? They were conducting their diligence. And then, could you also provide, I guess, any additional details on -- just thinking financially the split of your operational spend that's currently ex U.S. relative to the global total?

Jerome Durso: Thanks, Thomas. Appreciate the question. Obviously, Advanz did a deep diligence process, as you can imagine, can't really comment much further than that, except that they have done it deeper on the company. Andrew, maybe, you want to comment on -- Thomas, as I understand your question, it was kind of color around commercial investment by territory. Was that kind of what we're trying to get at there?

Thomas Smith: Correct. Yes. Yes, operational spend ex U.S.

Andrew Saik: Yes, Thomas, thanks for the question. Look, we don't break out our profitability by segment. But what I can tell you is that both segments, the International business unit, commercial unit and the U.S. business unit are very profitable, right? So you can see the gross margin that we have on the top of our P&L, just by virtue of the U.S. being sized, the majority of our profits come through the U.S. business. Having said that, the international business is also a terrific business. It's showing terrific growth, and we think Advanz is getting a great asset. This made sense for us and -- on a strategic level. So we think it's a very fair, good transaction for both sides. And yes, we do keep the majority of the profits generated by Ocaliva just by the nature of the U.S. business being larger.

Thomas Smith: Okay. Great. Appreciate you taking the question. Yes, that's helpful.

Operator: Our next question comes from Mayank Mamtani of B. Riley. Your line is open.

Mayank Mamtani: Thank you. Thanks for taking the questions. Congrats on the Advanz deal. So just maybe, a quick clarification question on PBC and then, I do have a question also. So on the U.S. component of the previously issued guidance, have you -- has there any underlying assumptions changed? I don't know, your guidance has suspended, but relative to the last time you issued, has anything changed there? And then, the HERO study that you just initiated, can you just clarify the timeline for that data and whether that would be part of the PBC submission? And then, lastly, just on NASH, now that you're out 4 years with some patients, is there an event rate analysis that has been done even in a blinded manner that at least informs you how you're tracking relative to your initial projection?

Jerome Durso: All right. So maybe, we start with the question around guidance and sales, which we have suspended the guidance pending -- closing and an ability to come back later with an update.

Andrew Saik: Yes, sure. With regard to guidance, nothing has fundamentally changed in the business had the Advanz transaction not taken place. We're very comfortable with the guidance that we issued earlier in the year. And we likely would have reiterated. We're on track. We're very happy with where sales were in the first quarter, both in the U.S. and internationally. Expenses are very under control. We're suspending largely due to the fact that we just can't impact the timing of the transaction, and we just think it makes sense to reissue in Q2. But no, nothing fundamentally has changed.

Jerome Durso: So maybe, on HEROES?

Michelle Berrey: Yes. So you'll recall at the Liver Meeting last year, we presented the pilot study from the voice open label extension compared with large external database and shows the impact of Ocaliva on improved and highly statistically significant improved transplant-free survival. We are now turning to two larger external databases to full data from the over 20,000 patient years of data that we know of in Ocaliva and PBC to support the data from our COBALT study. We will be submitting the primary analyses from COBALT to both the FDA and EMA, but we will be supporting those data with these 2 large databases, 1 patient registry and 1 that's a claims database that we hope will also continue to show this transplant-free survival as we showed in the day last year.

Operator: Thank you. Our next question comes from John Wolliben of JMP Securities. Your line is open.

Jonathan Wolliben: Thanks for taking the question and the updates today. Michele, just hoping for clarification to the confusing feedback from FDA. When you use the word mirrors, I just wanted to clarify, are they primarily just wanting you to reread the biopsies from the 931 patients from the interim analysis with your new methodology using 3 readers? Is that their primary focus for the new data package?

Michelle Berrey: Yes. Sir, just to start off. Yes, we are rereading all of those subjects, but importantly, their primary focus for this resubmission of an interim analysis is on those 931 patients that mirrored the original interim analysis and that were read by central -- two central readers. This is using the new methodology, as we've been talking about, for almost a year now. It's really important for the FDA to learn from this very large database. So we're excited to be providing them with those data. But certainly, every patient who has been willing to provide us with a liver biopsy will be included in this database, both for the interim analysis and in the eventual analysis of the full data set. But again, this second interim analysis of the same data set, that's what I was referring to with the mirrored primary analysis.

Operator: Our next question comes from Brian Abrahams of RBC Capital Markets. Your line is open.

Brian Abrahams: Hey guys. Good morning. Thanks for taking my questions. And congratulations on the out licensing deal. So I guess, just kind of along the lines on REGENERATE, maybe, another question for you, Michelle. So just given that you won't be able to -- or you won't be including those additional 500 biopsies in the primary histology endpoint that may have helped broaden the overall database, do you believe that you'll need to show a wider delta on the primary endpoint? Or is a comparable effect to what you showed in the interim with the more reliable methodology now, coupled with the larger long-term safety database that you'll have, do you think that will be sufficient?

Michelle Berrey: That's a great question. And again, remember, the guidance -- the draft guidance had recently been issued, in which the FDA stated that they wanted to look at a consensus methodology. So they want to make sure that they're looking at the same patient population that was previously analyzed using central readers. So they have an apples-to-apples comparison of that same data set to see if that addresses their prior concerns with discordance between two readers. However, they will be looking at the full data set, certainly, ethically, any patient who undergoes a liver transplant will be included in these analyses, and they're going to want to see every single patient included in one of the analyses. But for that first analysis, they wanted to make sure it was mirroring the original patient population.

Operator: Our next question comes from Michael Yee of Jefferies. Your line is open.

Michael Yee: Hi, thanks good morning. I appreciate the questions. Our question relates -- our question relates to maybe, the timing of the transaction, literally, right ahead of the REGENERATE re-read and in front of the reverse cirrhosis study, just from the concept of if someone is getting all the rights as drug outside the United States, wouldn't they want to have some insight into that? And how you thought about the timing of that, personally, given if it was all positive this quarter and next quarter than all value deal asset, including OUS would go up? So maybe, you could just talk a little bit about that? And the second part of that, which is literally the same thing, how do they decide whether they want to file in OUS or not? And is that their NDA or MAA not yours, they fully control of that? Thank you.

Jerome Durso: Thanks, Mike. Appreciate the questions. We've talked and we've been focused as we looked at the transformational period that we're in and will be in as we look at this about ensuring that the financial foundation is as strong as possible. And as we consider the potential next steps for Intercept as on a strategic basis, getting as much optionality as we can. And so the level of value here, we felt comfortable with at this time. And I think when we think ahead to creating the right kind of optionality, I think the strengthening of our balance sheet will allow us, in all scenarios, frankly, to move the company forward and ensure that whichever path we're on, we have a strong ability to invest and make the right financial choices. So again, based on the strength of the deal, we felt it was in the best interest to do the deal. And again, I think a good optionality whichever we pursue. It's difficult for me to speculate on advances, thinking, they will have the decision-making ability to decide whether or not to file. And according to the rights they gain, they will be the regulatory interactor in the territories that they own. So again, that would be their decision. We would, as the global developer, give them access to the data that we generate and the history of our discussion and how it continues in the U.S. on the regulatory side, but it would be their call.

Operator: Our next question comes from Jay Olson of Oppenheimer. Your line is open.

Jay Olson: Congrats on the deal with Advanz. And thank you for taking my question. Can you talk about the process for selling the ex-U.S. Ocaliva business to Advanz? Was that a competitive process with multiple bidders? And does that process also contemplate selling the U.S. Ocaliva business? And does that deal include the rights to the OCA bezafibrate combo? Or do you retain those rights ex U.S? Thank you.

Jerome Durso: So as a reminder, our rights to bezafibrate and our development plan for bezafibrate is a U.S.-specific plan. The agreement with Advanz is specific to Ocaliva and PBC. And obviously, if they pursue OCA monotherapy and NASH, they have the rights to pursue that as well, with the royalty, I mentioned earlier, from $1 sales if they succeed there. Was there -- there was another part to your question. The process. Yes, there were multiple parties involved in the process.

Operator: Our next question comes from Brian Skorney with Baird. Your line is open.

Brian Skorney: Hey, good morning everyone. My question is really, on what your level of commitment completing REGENERATE is, as designed. This deal gives you a substantial cash position, but it just seems like if the FDA doesn't allow OCA to get a review based on this reanalysis. The cost of running this fully out to 2025 or later might kind of too much to bear. So I guess, why not just stop the study now and see what you have? How many events have accrued at this point? And in between any trends and events, 1,000 4-year biopsies, 2,500 72-week biopsies and 8,000 patient years of safety. If this reanalysis isn't sufficient, is that the most likely option of what you would do to move forward?

Jerome Durso: Yes. Maybe, I start on that, and Michelle can add some color on the work that we'll continue. So we've said that we are focused in the interactions with the agency and obviously, with the data sets that we're in the process of generating exclusively on potential of OCA and NASH on an accelerated approval pathway. That's where our focus is. Obviously, the data and the subsequent interactions will define the right next steps, but we are exclusively focused on the accelerated pathway, which is one of the reasons why it's been so important for us, as I mentioned, a bit earlier to make sure that the foundation, financially, was as strong as possible so that we do have good optionality regardless of the strategic path that we choose here. Michelle, any color on the outcomes piece just that we continue to accumulate the data set if we are able to succeed on the accelerated approval pathway, we'll need that data eventually?

Michelle Berrey: The only thing I'd add on that, Jerry, is that both the histology endpoint and the noninvasive tests are considered potential surrogate markers. And both of those would need to be validated against the clinical outcomes. So without clinical outcomes, neither have been validated to date. So I do believe that the agency continues to have much interest in looking at that potential correlation with those clinical outcomes. But as Jerry said, this interim analysis is focused on the month 18 surrogate analysis of histology and certainly, all those secondary non-invasive tests will be part of the package to be submitted.

Operator: Thank you. Our next question comes from Steve Seedhouse of Raymond James. Your line is open.

Steve Seedhouse: Good morning, thank you. In your prepared comments, you sounded confident that you have not, in fact, peaked in PBC in terms of penetration. I guess, it's unclear from Slide 4 how much U.S. growth should be expected going forward. So I wanted to ask about volume growth, specifically in the U.S. and PBC year-over-year. What was that this quarter? And what do you expect you can achieve in terms of volume growth post COBALT data, assuming that's positive? Thanks.

Michelle Berrey: So I think that we're very confident in our ability. Remember, we need to come through a period where we lost 5% to 7% of our business based on a label change. So we'll look at, moving forward, replenishing that part or new patient starts are very fundamental to that. And as I said in the opening comments, we believe that we have a pipeline of data coming that will help with beta publications and our resubmission for full approval in the U.S. that will allow us to be highly differentiated and offering value unmatched with the amount of time that we've been in the market vis-a-vis others, we're going to be in great stead. So that's our kind of plan and a long-term plan. Focus though is get back to growing the underlying business. And if we look at even units, frankly, units are up because we are going from smaller scripts that could be for those patients who were only taking 2, 4 twice a week for 4 weeks, that's -- those are low volume. Now that we're on the 30-day regimens, and we're moving forward in that capacity, we actually have higher volume.

Jerome Durso: The only other additional point I'd make is just a reminder that we estimate only about one-third of the potential candidates for Ocaliva, according to the label, have been on treatment. So there is still a significant pool of patients who qualify for treatment who are within the label and who Ocaliva would be the only indicated option for, as second-line patients. So we'll continue the good work ahead on Ocaliva in the U.S.

Michelle Berrey: And we're seeing -- we're continuing with our strategy of expansion to community gastros. We're continuing to see new prescribers coming to market, and as we said before, new visits are up, again. Patients are back in and seeing their physicians. So I think this kind of combination of new prescribers, patient visits and new data really does give us a positive path forward.

Operator: Our next question comes from Joseph Stringer of Needham & Company. Your line is open.

Joseph Stringer: Hi, good morning. Thanks for taking our question. Just a quick one on 787, just given the mechanism of action FXR agonist follow-on. Would you consider NASH as an indication? Or would you look to explore other types of indications for that? Thank you.

Michelle Berrey: Great question. Happy to talk about 787, and we look forward to sharing more about this molecule. I'm very excited about it and look forward to rolling out all of the preclinical data that we now have on this molecule, how it differentiates from OCA and the potential indications that we are pursuing later this year. So we look forward to sharing all of that. Again, a really exciting molecule. I think we are continuing to push forward on NASH. I think that our commitment there with OCA, certainly, can't give the questions, but I think we are looking at a molecule that does differentiate and gives us a lot of exciting optionality. We look forward to talking about that later on this year.

Operator: Our next question comes from Ellie Merle of UBS. Your line is open.

Eliana Merle: Thanks for taking the question. Just in terms of the updated data, could you provide maybe, some more color from the safety perspective, in NASH, I guess, what we'll be getting, particularly as it brings to potential longer-term safety updates? And if any sort of liver events such as they progress progression to cirrhosis would be included, I would say, a safety event ahead of a potential longer-term outcome data? Thanks.

Jerome Durso: Thanks for the question, Ellie. Michelle?

Michelle Berrey: Yes. So on safety, we will be giving, with the top line, we are happy that we will be able to include all the adjudications there as well. So you may recall with this much larger, more robust safety database, we did specifically have an independent committee looking at adjudicated cases for hepatic safety events, but not clinical outcomes for this analysis at cardiovascular safety and the renal safety, given that this patient population is a higher incidence of type 2 diabetes, et cetera, that puts them at increased risk there. So we need to make sure that the hepatic cardiovascular and kidney safety are all fully adjudicated. So we will be planning to share that with the top line data. Certainly, all the details along those will later at a scientific conference. The hepatic outcomes will be part of the final analysis for this. Those events are also being adjudicated and that will include the month 48 histopathology, which should represent over half, maybe, even ever two-thirds of those cases of progression to cirrhosis.

Operator: Our next question comes from Salveen Richter of Goldman Sachs. Your line is open.

Unidentified Analyst : Thanks for taking the questions. This is Matt on for Salveen. I just want to see if there's anything special we should consider as we model this transaction. Will the $405 million roughly will be recorded in the next month or 2, you said? And then, the royalties, you said these are double digits. Are these flat or tiered? And then, in terms of -- I'm assuming there's no milestone payments attached to that either. But just wondered if there's anything else we should consider? Thank you very much.

Andrew Saik: Yes, sure. Happy to take that. Yes, the $405 million is, as described, it's a cash payment upfront, that's going to be net of working capital and other fees on the transaction. That will come through immediately upon close, which, as we said, we expect to be in the next 2 to 3 months, depending upon regulatory. We're hoping to get that in by the end of June, but you can't control the inventory process. In terms of the royalty, the upfront $405 million and subsequent $45 million is really, related to just the Ocaliva PBC business. The royalty is for any new indications in territories outside the U.S. So that would only kick in, in the event that they get essentially a NASH indication in any of the ex U.S. territories. That royalty, as Jerry mentioned, is sort of a strong double-digit royalty. It goes down to $0. It's not tiered. So it starts at sales 1 and stays flat throughout the sales process for NASH. Is that helpful?

Operator: Our next question comes from Jeff Meacham of Bank of America. Your line is open.

Unidentified Analyst: Good morning. This is Jason on for Jeff. Thank you so much for taking our question. Let me also extend my congratulations on the outlying deal as well. I wanted to return to NASH. Appreciating that safety is obviously, a primary focus on the resubmission. Do you have a sense of how critical or at least how much of a focus the additional efficacy data will be, especially given kind of the biopsy outcomes? I guess, along these lines, could you see REVERSE being potentially part of the resubmission package? Thanks.

Michelle Berrey: Jason, thanks for the question. So certainly, the CRL previously was focused on the benefit risk and is now much more robust. Safety database will play a key role there. As I've mentioned in prior calls, I think with the compound that is likely to be used for life after initiation of therapy when patients have progressed to advanced fibrosis, for sure, that -- it's important to have long-term safety data. And we'll be presenting those data with our top line showing especially those cardiovascular hepatic and renal safety parameters. On the efficacy side, we do have an increased patient population with the new 500, but as I've mentioned before, with this new methodology, the FDA has been clear that they want a comparison of the prior analyses with the central reader versus the new consensus panel methodology. So that will be the first analysis. But clearly, we want to include all of those subjects and the FDA as well, have expressed their interest in the total weight of the evidence for the molecule. With regard to REVERSE, yes, I do expect that, that would be an additional data set that will be critical, especially because this will be the first readout that we have in any large study in advanced Phase III setting in patients with compensated cirrhosis. So I think that, that will be of great interest certainly, to all of us, to see where these patients are who are really beginning to get more advanced in their disease process. So we'll be looking to have those conversations with the agency about, as I mentioned earlier, the content and the structure of the potential resubmission. Thanks for the question.

Operator: Our next question comes from Ritu Baral of Cowen. Your line is open.

Ritu Baral: Hi guys. Thanks for taking the follow-up. I did want to just ask about any inclusion of AI on REVERSE or how you're thinking about that end point. Michele, I think you did -- no, sorry, that was on poised, when you were saying that we're going to include earlier events for the Phase IV resubmission. That was my second follow-up question, if you have time.

Michelle Berrey: Yes. Yes. Thanks for your patience on those, Ritu, so -- Yes, in the NASH setting, we are looking at some exploratory and secondary end points. Looking at AI, those are certainly growing in interest, either as a way to assist with a human pathologists and sort of funny, we have to specify that those are human reads now. But there is increasing interest there in sort of addressing some of the concerns that the FDA had, had about variability in human interpretation of histopathology and how AI can be helpful. We've certainly seen that in other therapeutic areas, where AI can be particularly helpful in those outcomes assessments. So we are both in REGENERATE and REVERSE, including AI and a couple of different companies that we've been working with on that front. I think your other question was about COBALT and the new expanded primary endpoint that includes some of the earlier events. Because I think the -- all the regulators have recognized how difficult it is to ask patients to remain on a blinded placebo-controlled study when they have a progressive disease, and they can, frankly, look at their own biochemistries and see whether or not they're on placebo or active drug. It's difficult to ask them to stay on what is probably a placebo arm of a long-term study. So we are grateful that we have been able to work with the regulators to expand that primary endpoint to have a broader composite that we believe, increases the sensitivity for detecting the clinical benefit of Ocaliva in these patients at an earlier phase before they progress to liver transplant, hospitalization for liver events or death.

Operator: Thank you. Ladies and gentlemen, showing no further questions, I'd like to turn the call back over to Jerry Durso for any closing remarks.

Jerome Durso: So thanks, everyone, for joining us today. In closing, I definitely believe that the work that the Intercept team has accomplished in the first quarter, in addition to all the work since then, specifically the recent agreement with Advanz Pharma, puts us in a strong position to manage what we know is an extremely important time for Intercept as we build for the future. I definitely look forward to the work ahead and to sharing more updates as things progress. Last and certainly not least, as we head into this weekend, my best all the mothers out there. Thanks, and we'll talk soon. Take care.

Operator: Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating, and have a great day. You may now disconnect.