Mirum Pharmaceuticals, Inc.

Good afternoon, and welcome to Merum Pharmaceuticals' second quarter 2026 earnings conference call. My name is Alexandra, and I will be your operator today. All lines are currently in a listen-only mode, and there will be an opportunity for Q&A after management's prepared remarks. I would now like to hand the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.

Thank you, Alexandra, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' second quarter 2026 conference call. I'm joined today by our Chief Executive Officer, Chris Peetz, our President and Chief Operating Officer, Peter Radovich, and Eric Bjerkholt, our Chief Financial Officer. Lara Longpre, our Chief Development Officer, will be joining us for the Q&A portion of the call. Joanne Quan, our Chief Medical Officer, could not be with us today due to a family matter. Earlier today, Miriam issued a press release announcing the company's results for the second quarter of 2026. Copies of the press release and our SEC filings are available on the Investors section of our website. Before we start, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements based on management's current expectations, including statements regarding Merrim's programs and market opportunities for its approved medicines and product candidates and financial guidance. These statements represent our judgment and knowledge of events as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. We are under no duty to update these statements. Please refer to the risk factors in our latest Form 10-Q and subsequent SEC filings for more information about these risks and uncertainties. With that said, I'd like to turn the call over to Chris. Chris?

Thanks, Andrew, and good afternoon, everyone. At Miriam, we're growing a rare disease leader focused on delivering high-impact medicines for often overlooked diseases. This quarter demonstrates continued progress with strong commercial execution on our approved medicines as we head into the potential launch of our fourth commercial medicine later this year. We have a busy pipeline with multiple pivotal readouts in the quarters ahead, all delivered with a strengthened capital structure and overall financial performance giving us greater capacity to invest throughout the business. In the second quarter, our commercial business generated $176 million in net product sales, reflecting strong demand across the portfolio and excellent execution by our team. Based on this performance, we are increasing our full-year 2026 net product sales guidance to $680 to $700 million. Fueled by this strong commercial performance, we're driving towards the next phase of Miriam's growth with multiple milestones over the coming months. Our next commercial milestone will be the potential launch of Zoloft Certin for FOP with a PDUFA date next month. This is fast progress for a program added to our rare genetic business only in the second quarter. Peter will cover more of the launch profile in his remarks. Moving to the pipeline for our rare liver business, it's important to spend some time today on Velixibatin PFC, which just had some key U.S. regulatory interactions. First, as a reminder of the background of the VISTA study of Velixibatin Cholestatic Curitis in PFC, we designed this adaptive study with input from the FDA as a pivotal trial for this difficult clinical setting, including alignment on study duration, endpoints, and analysis plan. As we've announced previously and presented at EASL this year, This has met its primary endpoint, showing highly significant improvements in pruritus in the primary cohort, with consistent, significant results also observed in a second cohort of patients with milder baseline pruritus. We are excited to share that the FDA has now granted breakthrough therapy designation for Velixibab in cholestatic pruritus due to PFC based on these strong results. We see this as recognition of the potential for Velixibab to address a serious unmet need in PFC. As planned, we recently held a pre-NDA discussion with the agency about the submission of an NDA based on the VISTA study. In the meeting, the FDA recommended conducting a Phase III study. We believe the VISTA study provides a robust and clear data set to characterize the use of BlixVat in patients with pruritus due to PSC and is a clinically and statistically highly persuasive study. VISTAs is the largest randomized clinical study conducted in patients with pruritus due to PSC with an extensive overall data package that includes more than 180 PSC patients randomized, one-year safety exposure data for over 100 PSC patients and growing results from an independent committee evaluating liver safety, all totaling over 600 subjects across the clinical program today. So while we are not currently aligned on the NDA submission package, we will be engaging in discussions with the FDA on how to further supplement our planned submission based on the FISTA study. This engagement will delay the planned timing of our NDA submission, which we are now targeting for the first half of next year. We're positioned to move quickly once we have further clarity from the agency. We'll provide updates as we work towards our goal of bringing a much-needed therapy to this unaddressed clinical setting. In parallel, the Vantage study in PDC is progressing well and has completed enrollment, reaching over 330 patients randomized. In PBC, our earlier breakthrough therapy designation has enabled more dialogue with the agency during the conduct of the study. We have recent feedback from FDA for Vantage to serve as a pivotal study of the Lyxabett enteritis due to PBC if the study is successful at its first quarter top-line readout next year. Our next clinical readout for the rare liver business is expected to be Belovatug's Azure One top-line results later this quarter. This is the readout of the Phase 3 portion, following strong results in the Phase 2b portion earlier this year. And we also continue to expect the year 4 data in the fourth quarter, which keeps us on track for a potential BLA submission for this Breakthrough Therapy designated program in the first half of next year. And rounding out the rare liver pipeline highlights, the Phase 3 EXPAND study of Livmarli and additional rare cholestatic conditions remain on track for top line data in the fourth quarter. So, putting this all together, we are advancing these clinical programs from a position of financial strength. Our commercial business continues to generate meaningful cash, providing the capacity to invest in potential launches, clinical development, and opportunistic business development, where we see a compelling strategic fit and the potential to create value. I'm proud of the team's progress and the promise of our current medicines and pipeline, and I'm excited about what lies ahead for Mirim. And with that, I'll turn the call over to Peter to discuss our commercial performance and launch readiness in more detail. Peter?

Thanks, Chris. The second quarter was another strong quarter for Merrim's commercial business, with total net product sales of 176 million. The Marley and the bile acid medicines both continue to perform well, and based on the demand we see, we are increasing our full year 2026 net product sales guidance to $680 to $700 million. Second quarter net product sales for Live Marley were $129 million, with the U.S. contributing $92 million. Allergy health growth remains durable, supported by continued new patient starts, sustained persistence on therapy, and weight-based dose increases. PFIT continues to be an important driver of growth, fueled by new diagnoses. We're particularly encouraged by the growing contribution from adult PFIT patients. We're seeing an increase in prescriptions from adult liver providers as awareness of later-onset PFIT grows and genetic testing becomes more routine. Based on claims data, as well as insights from two years in market, we now estimate an addressable adult PFIT population of at least 2,000 patients in the United States, with likely a similar number in Europe. And because genetic testing remains less established in adult practices than in pediatric, We believe the vast majority of the estimated 2,000 addressable patients don't yet have a PFIC diagnosis, and we see a meaningful opportunity to continue expanding diagnosis through education. Internationally, Live Marley continues to grow across our direct and partner markets, contributing $37 million for the quarter. We are seeing contributions from established markets and expanding reimbursement in additional geographies. On the rare genetic disease side of the business, our biolastic medicines continue to provide a steady contribution, generating $48 million in net product sales for the quarter. Like our rare liver business, our rare genetics business is also poised for growth with the recent addition of Zolurgicertib for FOP. Data from the pivotal Phase II Progress Study of Zolerg Assertive presented at ENDO showed a compelling clinical profile in FOP patients ages 12 and older. Based on the strong efficacy observed and the convenience of oral dosing, we believe Zolerg Assertive has the potential to offer an attractive profile to patients with this severely debilitating disease. If approved by the FDA, the initial launch opportunity is expected to focus on patients ages 12 and older with potential future expansion into younger patients supported by additional cohorts in the progress study. And following a recent late cycle meeting with the FDA, we believe the NDA is proceeding as expected towards the September , and we are preparing for potential U.S. launch in the fourth quarter. The U.S. launch will heavily leverage the rare genetics team we have in place now that currently markets our bile acid medicine. as the physicians who manage FOP are largely concentrated in the same specialized centers where Cetexly and Colbomb are prescribed, building on the efficiency of our rare genetics business. Also, a marketing application for Zolid Assertive has been submitted in Europe, and we will provide updates as this filing progresses. Overall, we are pleased with the continued execution across the commercial organization. We're seeing strong demand throughout the existing portfolio while making the investments necessary to support the next wave of potential launches. We believe that we are well positioned for the remainder of the year and beyond. With that, I'll turn it over to Eric to discuss the financial results. Eric?

Thanks, Peter, and good afternoon, everyone. Today, I'll walk through the financials of another excellent quarter for Miriam. Net product sales for the second quarter were $176 million compared to net product sales of $128 million in the second quarter of last year. Cash, cash equivalents, and investments as of June 30 were $561 million compared with $391 million at the beginning of the year. In the second quarter and first half of 2026, the cash contribution margin from our commercial business was in the high 50th percent, approximately a five percentage point improvement over the year before. Total operating expense for the quarter ended June 30th was $219 million, which includes $16 million of in-process R&D expense associated with the upfront payment of licensing the larger circuit. R&D expense of $76 million, including $29 million related to the development of Verlovitag, SG&A expense of $66 million, and cost of sales of $23 million, all excluding stock-based compensation expense and intangible amortization. Stock-based compensation, intangible amortization, and other non-cash expenses total $37 million for the quarter. Operating cash flow was positive in the second quarter despite the expected increase in R&D expense. During the quarter, we significantly improved our capital structure through the issuance of $690 million aggregate principal amount of 0% coupon convertible notes due in June 2032. Net proceeds from the offering were $672 million. In conjunction with this financing, we settled 75% of the outstanding 2029 notes, added $197 million of cash to the balance sheet, and significantly reduced our interest expense. These transactions further strengthen our balance sheet and extend our financial flexibility to execute our strategy. Our commercial business continues to scale, and our pipeline includes multiple near-term value drives. With that, I'll turn the call back to Chris for closing remarks.

Thanks, Eric. Taking stock of where we are, we are continuing to drive our strategy to bring important medicines to underserved rare disease patients. Commercial business is thriving, now tracking towards $680 to $700 million in net product sales for the year, but Marley is well on its way to realizing its over $1 billion peak revenue potential. and our Rare Genetics team is thrilled about the potential launches that are deserted for FOP patients in the coming months. On the pipeline, we are focused on a collaborative discussion with FDA on the VISTA study and PSC. Clinical results are clear and breakthrough therapy designation gives us further opportunity to engage with FDA. All said, we have a plan to advance FELIXABAT to PSC patients. The balance of the pipeline is firing on all cylinders. Recapping our upcoming clinical milestones, We expect clinical readouts from Phase 3 Azure 1 and Azure 4 studies of Belovatug over the balance of the year, which will enable our planned DLA submission in the first half of next year. Next quarter, we also expect to announce top-line results from the EXPAND study of Lickmarlie and additional rare cholestatic diseases, setting up the potential for an SNDA next year as well. And into 2027, we expect top-line results from the VANTAGE study of Belixbat at PBC first quarter. And finally, we're on track with MRM 3379, and Proof of Concept Data in Fragile X Syndrome next year. Importantly, we're building an organization capable of reaching many more people living with overlooked rare diseases while delivering strong financial performance. I want to thank the MIRIAM team for their continued focus and execution and the patients, families and physicians who continue to partner with us in this work. With that, operator, please open the call for questions.

We will now begin the question and answer session. Please limit yourself to one question and one follow-up. If you would like to ask a question, please press star one to raise your hand. To withdraw your question, press star one again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by while we compile the Q&A roster. Your first question comes from the line of Ryan Deschner with Raymond James. Your line is now open. Please go ahead.

Hi, good afternoon. Congrats on the strong results. I'm curious what your overall take is on the potential read-through from the BOLD study evaluating Otavixibat in patients with biliary atresia, and I have a follow-up question.

Thanks, Ryan, for the question. The BOLD study and the study of note in our pipeline that includes biliary atresia patients, the EXPAND study, to put it simply, are asking very different questions. I would equate the BOLD study more to what we ran previously within BARC, looking at patients in the very acute setting, trying to reduce bilirubin or extend transplant-free survival. The question we're asking in EXPAND ties much more to where we've seen IVAT perform quite well in other settings, where we're looking at older patients than what was in BOLD and in BARC and evaluating pruritus changes. It's something that we've seen an impact from IVAT therapy over and over again now in different clinical settings. So we feel there's not really a read-through or connection between BOLD and what we're looking at in the upcoming EXPAND readout.

Appreciate it. And then just on the PST regulatory discussion, you know, what key topics do you anticipate sort of addressing with these future discussions? Thank you.

Yeah, thanks for the follow-up on that. I mean, just kind of to reiterate some of the background here, you know, we did extensively discuss the VISTA study design with FDA. You know, back in the pre-IND setting, you know, the FDA acknowledged the pivotal intent, described the design as reasonable, gave direct feedback on duration, analysis plan, all these things that designed the study that we read out so successfully earlier this year. Frankly, the situation now that we've seen is in the meeting there was a new team from FDA, so we think there's a lot of work to kind of get them up to speed on the backdrop here, so the history, designing and conducting VISTAs, and what the study means in a PSC setting. We think it's going to be an iterative approach to kind of get them up to speed, not only with the current data package, but with the history of the program. Very helpful. Thanks, Chris. Thanks for the question.

Your next question comes from the line of Gavin Clark-Gartner with Evercore ISI. Your line is now open. Please go ahead.

Hey, guys. Thanks for taking the questions first. What was this new FDA's team's rationale to conduct an additional phase three? Like was it more of a safety database question or was it more around the efficacy side?

For the follow-up, Gavin, the comments about a phase three recommendation from them really were not specific. So we don't have great clarity on what specifically they're looking for. There were comments across the board on more general on efficacy, which we think VISTAs very clearly addresses, and they actually commented on that at the meeting. On the safety side, the discussion, a couple of things that were brought up were IBD safety in the backdrop with IBAT GI effects and liver safety. Those were designed into VISTAs as key things to evaluate, so we think it's all there in the VISTA study, and this is more about familiarity with and some of the questions that were asked. Another thing I'd point out is that the breakthrough designation actually was issued after the meeting. So I think that gives us a great opportunity to go back in and build up familiarity with this data set and work us towards an NDA.

That makes sense. And just a quick follow-up, is this a team that you have engaged with before on any of your other programs? Do you have any experience working with them? And kind of on a similar point, what other regulatory precedents would support approval based on the similar type of Phase 2b setting? Thank you.

Thanks for the follow-up. In terms of the team, you know, a lot of times the correspondence is written, so you don't have perfect clarity on who's behind some of the written correspondence, so it's difficult to answer that question, to be honest. And in terms of precedent, I mean, really I've looked across all the IBAT settings where you've seen analogy where the first approval was based on four-week randomized withdrawal data. All the way to the more recent Linovoi approval in PVC puritis with a six-month placebo-controlled study that, frankly, looks a lot like VISTAs. It's a little bit larger because PVC is a more prevalent indication. So there's pretty clear precedent for IVAT in cholestatic puritis settings that line up with VISTAs. It goes back to the whole way that we designed the study in the prior conversations with the agency.

I'm sorry, I may have misheard something. Did you say that this was only happening via written correspondence or was this pre-NDA in person with the FDA or virtually?

The pre-NDA was in person. So when you were asking about prior and other interactions, some of those have been written. So we don't know who was behind some of the other written correspondence. This meeting was in person.

Okay, got it. Thanks so much. Yeah, thanks for the question.

Your next question comes from the line of Mike Oltz with Morgan Stanley. Your line is now open. Please go ahead.

Hi, this is Rohit on for Mike. Thanks for taking our questions. Just based on your conversation with the FDA, do you see any read-through to the PBC Vantage study? Is it possible to request a Phase III trial for that one? And also, in terms of commercial prep for FOP, can you talk about where you currently stand and what's outstanding? Thanks.

Thanks. Go ahead. I'll speak to PBC and then pass it over to Peter to talk about FOP. On the Vantage study, as you may recall, we were granted breakthrough designation after the interim analysis in 2024. So that actually gave us a great opportunity to have conversations similar to what we expect to go through here with FISTOs. And so in the correspondence after the breakthrough designation on Vantage, we actually received Pretty clear feedback from FDA on what we should do to consider Vantage a pivotal study. And we were able to address those. So primarily the comments related to the overall size. That's part of why we've ended up with over 330 patients in Vantage and also the analysis plan and some of the specifics on how the pruritus endpoint is analyzed.

And Rohit, yeah, with regards to the commercial prep for those sort of potential approval and launch in Q4, that's going really well. As I mentioned, we were able to drop that in the backs of our rare genetics team and had a couple territories there. A lot of typical pre-launch activity and profiling accounts and understanding where the treaters are. These patients are well-identified. There's about 300 or so diagnosed and managed in the U.S. in highly specialized centers. had a good presence at the Endo meeting earlier this summer as well. So excited about the progress of the Endo review and working towards launch readiness in Q4. Thank you.

Thanks for the question.

Your next question comes from the line of Brian Scorni with Baird. Your line is now open. Please go ahead.

Hey, good afternoon, team. I'm going to be annoying and also ask a little bit on FDA's issues with VISTAs, just given that it seems like a pretty straightforward data set. Can you just refresh our memories? The review team here is within the Division of Hepatology. Is Katie Donahue still the office director? Was she involved in the meeting? Is Frank Ananya still the division director, and was he in the meeting? You know, I mean, I hear they weren't very specific about why they wanted a Phase 3, but I mean, did they sort of mention like a need for replication? It just seems like the p-value here is so robust that there's not really another question that could be answered with a Phase 3 other than maybe longer-term follow-up. So, yeah, any sort of guidance there is helpful.

Thanks, Brian, for the question. On some of the specifics of people kind of in the room, but I would say the office leadership we think maybe has changed and leadership was not in the room in our review meeting. And getting into some of the, specifically on efficacy, I think it's, like you're pointing out, I think it's very easily addressed by the VISTA's data and getting breakthrough afterwards I think is a nod in that direction. So given some of the discussion in the room, I think that's something that we can readily address through iterative conversation with FDA. I don't know if that helps answer your question.

Maybe if I could just ask one thing on the PDUFA with Zoller. Yesterday, I think we would have had probably the late cycle review meeting in the last Thank you for the questions.

Your next question comes from the line of Kalpit Patel with Wolf Research. Your line is now open. Please go ahead.

Yeah, hey, good afternoon and thanks for taking the question. One more on the regulatory interaction here. In your communication with the agency, has there been any dialogue so far on potentially running a Thank you for the question.

The direct answer is that the conversation with FDA didn't get to that level of specifics for post-approval requirements. I can comment a little bit on the pathway here that using Puritus is the basis for full approval. So we don't expect to have a post-approval study in the sense of kind of confirmatory accelerated approval type format. What we would expect and has been added for other IBAT approvals is some level of post-approval registry or kind of long-term monitoring. And so we do think that would be appropriate for this setting as well.

Okay, thank you.

Thanks for the questions.

Your next question comes from the line of James Condales with Stifle. Your line is now open. Please go ahead.

Hey, thanks for taking my question and congrats on a great Live Marley quarter. Just, you know, maybe to be annoying again, one more on PST. I guess like to clarify, is a phase three on the table or are you confident that this can be resolved through, like you said, iterations on the data? Just wondering what your base case is and what informs your confidence of guiding to a first half 27 resubmission? Thanks.

Thanks for the question, James. And as we looked at this proposal for a phase three, and given the VISTA's results, I think the key question is, what would you learn from another study in this setting? and Vistas is the largest ever conducted in PSC pruritus. Clear, definitive results. It's a big enough safety database for a setting like PSC. So we don't see what would be gained by going down that road and find that just the weight of evidence here is really convincing. So feel good about where we stand now with breakthrough designation to work through this.

Thanks.

Your next question comes from the line of Lisa Walter with RBC. Your line is now open. Please go ahead.

Oh, good afternoon. Thanks for taking our questions. Kind of one more on the NDA filing delay here for the looks of that. Could this mean that we see more BD in the near term as potentially PSC revenues may now be pushed out? and I just want to ask as well, could you add any clarity on whether the FDA is still accepting a pruritus as an approvable endpoint? Thanks so much.

Thanks for the questions, Lisa. The first thing, I'll answer your second part first, which is absolute clarity that pruritus is an approvable endpoint. That's what this discussion is all focused on. So there's no question there. On the BD front, we've always approached BD on being always active and always opportunistic, so don't see this really relating to the overall level of activity we have or our criteria and what we're looking to bring in.

Thanks for the question. Your next question comes from the line of Joe Schwartz with LeRinc Partners. Your line is now open. Please go ahead.

Hi, thanks. Hypothetically, if the FDA doesn't budge, does Vantage PBC have any ability to strengthen the Veluxibat regulatory package for PSC? For instance, if a filing in PBC is an NDA, and a filing in PSC as an SNDA, could that order of operations be successful without having to do another phase three?

Joe, thanks for the question. You know, what I'd say is potentially, and we're getting into some hypotheticals down the road, the base plan is to get the PSCs in the NDA submitted first. But as we think about the Vantage data, another large randomized study playing into a very related pruritus condition, I do see like some weight to that and how we approach that in terms of parallel or sequenced NDAs is something that we'll get to if we end up in that scenario.

Okay, thanks. And then a question on Brilovitab. Did any baseline characteristics for patients enrolled in the interim analysis cohort of Azure 1 appear to correlate with better response in the Phase 2b portion of the trial? And how do the baseline characteristics for patients enrolled in the full Azure 1 population and Azure 4 compare?

The quick answer to that is no, nothing obvious that really comes out. And we see response for Brilovitug across really all patients. So it's a very broad-based response. And that cuts across baseline viral RNA levels, ALT levels, geography, kind of every way we've looked at it. You consistently see patients responding to Brutal Overtake.

Thank you. Thanks for the question.

Your next question comes from the line of Jessica Fye with J.P. Morgan. Your line is now open. Please go ahead.

Hey, guys. Good afternoon. Thanks for taking my question. So more on Velexabat. When you, I think, in prepared remarks referred to some options to supplement the VISTAs trial, I'm curious what you could supplement it with. Based on where we stand right now, what gives you the confidence to outline first half of 27 as the new PSE filing timeline? Thank you.

Thanks for the questions, Jessica. In terms of supplementing it, the real simple one is actually something I mentioned in the prepared remarks as well, is kind of the data cutoff timing. were able to pretty easily allow more safety data to approve, like to get to 100 patients at the 12-month mark in the open-label follow-up. So that was one of the kind of quick offerings in there. I think some of the other things could be towards things that were mentioned in earlier questions and what could be offered up for post-marketing registry work and things like that. In terms of the timing, We feel first half is very achievable, and it's really based on having enough room to have an iteration or two with FDA. So it's less about time we need to prepare the submission, frankly, because things are ready to go quite quickly after we have the input we need. It's more about that iteration with FDA. And really, that's kind of an estimate based on experience. The applications like this before back to the original Al-Azil application where it took a couple of meetings along the way to kind of build up to that NDA filing for Marley and Al-Azil. And so it's a type of situation that we've worked through before.

Your next question comes from the line of Joseph Tomey with TD Cohen. Your line is now open. Please go ahead.

Hi there. Good afternoon and thank you for taking my questions. maybe just in setting expectations in terms of when we should hear next steps on sort of the filing progress. I guess, what are you anticipating in terms of relaying kind of your FDA interactions to the street? And then I think in your prepared remarks, you indicated that this necessarily won't flip over to PBC and that you have some feedback that Vantage will be a recreational study. I guess, to your knowledge, is that this new group that conveyed that information and then one point of clarification just on the updated guidance. Is there anything for FOP in your updated product guidance or would that be above and beyond what you've outlined today? Thank you.

Yeah, thanks for the questions. I'll take the first couple and pass it over for the FOP question. You know, in terms of providing an update, our thinking is that this is likely an iterative process and so we would plan to give an update when we have kind of a material update. So you don't want to be sharing the blow-by-blow on what might be email correspondence even with FDA. And shifting on to the PDC question, those interactions were written correspondence, so don't know exactly if it's the same exact people behind it, but what gives a lot of comfort there is recency. So this has happened over the past year that we've had those PDC written correspondence.

And on guidance, the 680 to 700 million does not include FOP. So anything we see in Q4 would be above and beyond, although we really expect the revenue to start more in 2027.

Thank you.

Your next question comes from the line of John Vullaben with Citizen. Your line is now open. Please go ahead.

Hey, Chris. I'm wondering if you could just Talk us through what this iterative dialogue looks like in terms of using breakthrough therapy or formal meeting status and scheduling of these just for a little bit more expectations on that flow of information between you and the agency.

Thanks for the follow-up, John. One of the benefits of breakthrough designation is it does allow for more frequent advice from FDA, more frequent interactions. And so quite simply, that just means we'll be able to reach out more informally and also have more advice meetings. How those sequence out really depends on basically how the dialogue with FDA progresses. So we can't really give too much more specific at this point, but we will keep you guys updated as we make progress through it.

Your next question comes from the line of Ramakant Swayampukula with HC Wainwright. Your line is now open. Please go ahead.

Thank you. This is RK from HC Wainwright. A couple of really quick questions. You know, based on the interactions that you have had so far for the PSC and PSC indication, Are you planning to make any changes at all in your approach for the PPC indication once the advantage data comes out? And also, if you do go ahead and submit in the first half, 27, notwithstanding the recommendation, do you run into a risk of refuse to file kind of a situation? And let's say everything goes fine and you still continue to apply, would you expect an adcom at the end of this?

Thanks, RK, for the question. You know, in terms of the PBC approach, given the recent interactions, I think we have direct input for that indication for Vantage. So I feel like that is on a good course. So I wouldn't make changes at this point to what we're doing at PBC. We've kind of already made recent adjustments to accommodate what FDA asked for for having Vantage being confirmed as a pivotal study. And then on some of these questions about submission risks, I think is how I would describe the question. That's the reason for this interactive interaction with FDA is try to work through things that might be an RTF risk and try and get those off the table. And frankly, you know, an ADCOM, it might be something that could be helpful given the huge impact that felixibat has shown in a really terrible setting for patients. You know, the relief, pruritus relief, improvement in sleep and fatigue that patients There are no further questions at this time. I will now turn the call back to Chris Peetz for closing remarks. Thank you all for joining us today and hope you have a great afternoon.

This concludes today's call. Thank you for attending. You may now disconnect.