Mirum Pharmaceuticals (NASDAQ:MIRM) Q3 2026 Earnings Call

0:00 Good afternoon and welcome to Mirim Pharmaceuticals' third quarter 2026 earnings conference call. My name is Joel 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.

0:28 Thank you, Joel, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' third quarter of 2026 conference call. I'm joined today by our Chief Executive Officer, Chris Peetz, our President and Chief Operating Officer, Peter Radovich, our Chief Medical Officer, Rob Myers, and our Chief Financial Officer, Eric Bjerkholt. Earlier today, Miriam issued a press release announcing the company's results for the third 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'll 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.

1:20 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, I'd like to turn the call over to Chris. Chris?

1:29 Thanks, Andrew. Third quarter was another strong period for Mira, both commercially and across our clinical programs. We generated $186 million in third quarter net product sales. We are increasing our full year net product sales guidance to $715 to $720 million. We've also had great progress across the portfolio since our last earnings call. Positive phase three is your one data for Brilovitug, positive expand data for the Marley, the approval and launch of Atebrios, and another positive Atebrios readout in younger patients. Our recent progress feels quite meaningful as Mirim approaches its eighth anniversary. It's remarkable to think about what this team has accomplished in eight years. We started Mirim around a simple idea. that by identifying important opportunities in rare diseases and combining great medicines with relentless execution, we could have a meaningful impact for patients and build an enduring company.

2:28 Eight years later, we now have four approved medicines, a commercial business approaching three quarters of a billion dollars in annual net product sales, and a late stage pipeline with multiple opportunities to drive our next phase of growth. Coming up, we have two more potentially registrational readouts approaching, with the Dorlevitug-04 study and HTV expected this quarter and the Belixibat-Vantage study and PBC expected in the first quarter of next year. Together, these are part of five potential approvals and label expansions ahead of us as we work towards realizing the greater than $4 billion peak revenue potential of the Mirim portfolio. So, eight years in, we're entering our next phase from a position of real strength, and we're excited to touch on some highlights and updates today.

3:14 With that, I'll turn the call over to Peter. Peter? Thanks, Chris.

3:19 The third quarter was another excellent quarter for Barron's commercial business, with $186 million in net product sales. But Marley continues to be the primary growth driver, with third quarter net product sales of $133 million, including $100 million in the United States. Our bioasset medicines also provide steady growth, generating $52 million in net product sales for them. Continued growth across Livmarlie and our bile acid medicines has allowed us to increase that outlook throughout the year, and based on our performance through the first nine months, we are increasing full-year guidance today to 715 to 720 million. This is a testament to our high-impact medicines and high-performing team dedicated to getting them to patients.

4:06 For a little more color on Livmarlie, In Allergy Yield Syndrome, uptake remains steady and durable, supported by new patient starts, persistence on therapy, and weight-based dose increases. PFIC continues to be an important driver, particularly among adults, where we believe there are at least 2,000 addressable patients in the United States, though the substantial majority of these patients remain undiagnosed. Greater awareness of later-onset PFIC and increasing use of genetic testing will continue to help improve diagnosis rates. And we are expanding our commercial efforts on this front, which should lay a strong foundation for 2027. This expansion will also enable our other upcoming potential launches for Lidmarli, Polifspat, and Olivetam.

4:57 I'm also happy to say that our fourth medicine, Atabrios, was approved in September for adults and pediatric FOP patients ages 12 and older. and our U.S. launch commenced in October. Atebrios is a natural addition to our rare genetic disease business. The FOP community is uniquely engaged and the response to the approval today reinforces our belief that Atebrios can address a significant unmet need for patients and families living with FOP with the convenience of oral dosing and a mechanism designed to address the underlying cause of the disease. Our near-term focus is on patient identification and access, and we're encouraged by the strong early engagement of patients, caregivers, and healthcare professionals.

5:44 Overall, I'm very happy with the progress we made this quarter. We are growing our existing medicines, launching our fourth medicine, and laying a strong foundation for multiple new potential indications and launches in 2027 and beyond.

6:00 With that, I'll turn it over to Rob. Rob? Thanks, Peter. It's been an exciting couple of months for MIRA. Significant clinical progress across rare liver and rare genetics. We are now working towards five potential regulatory submissions across the board board. NDAs for Velixivat, PSC, and PBC, a BLA for Verlovatog and Hepatitis Delta, a label expansion for Atebrios and FOP, and an SNDA for Livmarli based on the EXPAND study. Starting with Velixivat and PSC, We continue to make progress toward our planned NDA submission in the first half of 2027. We remain confident in the strength of the NISTAS results and the potential for Belixibab to address an important unmet need for patients with PSC and pruritus.

6:45 We look forward to submitting our NDA and will provide an update if there is any material change in our plans or an FDA's prior feedback. We've also recently reported positive results from three important studies across the portfolio. Cohort 2 of the Pivotal Progress Study extended the encouraging atebriose results into children ages 6 to under 12. The results were consistent with Cohort 1, with reductions in heterotopic ossification, encouraging improvements in joint mobility, and a safety profile consistent with that observed in older patients. The mobility findings are particularly encouraging in a progressive disease like epilepsy, where preserving function by intervening early is especially important. Our next step is a planned SMBA submission in the first half of 2027 to potentially expand Atebriose to children ages 6 to under 12. Cohort 3, evaluating Zolingracertib in even younger children, continues to evolve.

7:45 Now turning to the liver portfolio, EXPAND was another positive phase 3 study for Lumbarbin, meeting its primary endpoint and all pre-specified secondary endpoints, with particularly encouraging results in biliary atresia. These findings further strengthen the body of evidence supporting IVAD inhibition for pruritus across a range of underlying cholestatic liver disease. And in hepatitis delta, the positive phase III-AZER1 results provide an important validation for VIRLOVATO, demonstrating meaningful improvements across key measures of virologic and liver disease activity. We'll build on this momentum at AASLD later this week, where we'll present new data across our rare liver disease portfolio. including the full ASR1 results and longer-term Berlovitac data, as well as additional analyses from Vistas and Livmarli data in rare cholestatic liver disease.

8:40 Without getting ahead of these presentations, we're particularly excited by the growing body of evidence with Berlovitac showing deepening virologic suppression and continued improvements in ALT normalization and liver stiffness with longer treatment, including in patients with cirrhosis, a population with particularly urgent unmet medical Looking beyond AASLD, we expect the Azure Fold readout this quarter, an important next milestone for the Belovatog program, and our planned BLA submission in the first half of 2027. Overall, these recent clinical successes, together with the regulatory milestones ahead, give us strong confidence in the potential for our portfolio to deliver meaningful new treatment options for patients. With that, I'll turn it over to Eric to discuss the financials.

9:25 Eric?

9:27 Thanks, Rob, and good afternoon, everyone. Our third quarter financial performance reflects our ongoing operating priorities. Continued top line growth with focused investment in bringing our late stage programs through several potential approvals and launches. As Peter mentioned, net product sales for the third quarter were approximately $186 million, compared with $133 million in the third quarter last year. Through the first nine months of the year, net product sales were approximately $522 million, which I'm excited to point out already equals full year 2025 revenue. In the third quarter, the cash contribution margin from our commercial business was in the high 50% of sales, and cash used in operations was approximately $4 million.

10:20 Total operating expenses for the quarter were approximately $245 million. Cost of sales of approximately $28 million, SG&A expense of approximately $70 million, R&D expense of approximately $94 million, all on a cash basis, in-process research and development of $13 million, and stock-based compensation depreciation and amortization expense of $40 million. Our investment in R&D reflects the breadth of activity across our expanded late-stage pipeline as well as the planned manufacturing expenses for our HDB program. On a cash basis, R&D was approximately 50% of revenues as expected. We expect this level of R&D spend to continue for approximately two more quarters.

11:15 In total, revenues this quarter exceeded expectations while expenses are unplanned. We also took steps this quarter to improve our capital structure. In September, we repurchased $20 million in aggregate principal amount of our 2029 convertible notes for approximately $62 million in cash, thus further reducing both future dilution and ongoing interest expense. This follows the financing we completed in the second quarter when we issued 690 million of zero-coupon convertible notes due in 2032 and settled 75% of the outstanding 2029 notes. Together, these transactions have reduced the outstanding balance of our 2029 notes by over 80% while preserving substantial financial flexibility.

12:09 As of September, cash, cash equivalents, and investments were approximately $500 million. Our commercial business continues to scale, and our balance sheet gives us the resources to support our upcoming launches and late-stage clinical programs. With that, I'll turn the call back to Chris.

12:28 Thanks, Larry. Speaking to the stock of where we are today, Miriam is at a strong inflection point. Commercial business continues to outperform driving an increase in our four-year guidance. We've launched Atebrios as a fourth commercial medicine, and including the Atebrios supplemental NDA for younger patients, we have five upcoming approval opportunities to further accelerate the commercial business. The strong performance commercially paired with our pipeline advancements positions us to be cash flow positive next year. And as we wrap up our prepared remarks, I want to direct attention again to the upcoming Vrlovatec datasets being presented at AISLD this weekend. With data maturity now out two years from the early program, we'll be able to share more of a complete picture of what Prolovatug can achieve for patients with hepatitis delta.

13:19 And as we approach our eighth anniversary, I'm incredibly proud of what this team has built, but even more excited about what's ahead as we enter a unique period of commercial growth, multiple launch opportunities, and strong financial performance. And finally, as always, I want to thank the entire Merum team for their exceptional execution We will now begin the question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. Your first question is from Josh Skimmer with Cantor Fitzgerald. Your line is now open. Please go ahead.

14:19 Great. Thanks for taking the questions. Just a couple of quick ones. First, were there any Takeda purchases of Liv Marley this quarter or expected in the next quarter as part of the revised guidance? And then second, for the Kinadol or the Cobalm Subtech Fleet franchise, at least combined, you're starting to get to levels that I think historically you've suggested might attract generic interest or competition. Not necessarily breaking out the relative contribution of each, but how should we be thinking about modeling the exclusivity of that franchise?

14:55 Josh, thanks for the questions. First, I can hit on the bile acid franchise. We are really excited with how these have grown. Just as a quick reminder on the backdrop on exclusivity, for a coal bomb that is now beyond its orphan exclusivity time period, But Citexly does have orphan protection. They're both contributors here, and for both of them, we've not seen an entrant. That's really all we have visibility to at this point to speak to. So I see the trends we're seeing for the near term, in any case, to roll forward. And I'll ask Eric to maybe speak to Cata Dynamics.

15:37 Thanks, Rick. Yeah, so we had very minimal revenues from Takeda this past quarter, and we don't really expect any new orders in Q4. Got it.

15:49 Thank you. Next question. Your next question is from Kalpit Patel with Wolf Research. Your line is now open. Please go ahead. Hi there, Kelpit. Your line is now open. Please go ahead with your question. We will move on to the next question. Your next question is from Brian Scorny with Baird. Your line is now open. Please go ahead.

16:30 My team, could you provide a little more color on your confidence in the timing of the planned PSC submission? What's the next regulatory touchstone you should be looking for here? This is Luke, by the way. Thank you.

16:44 Hi, Luke. Thanks for the question. On the PSC situation, for the time being, really nothing changed in what we can speak to and the status of the program. Strategies underway, and as we spoke about previously, multiple different touch points as we work towards a potential submission in the first half of next year. I'd say we're really confident in the data sets. Rob's called out some of the abstracts at ASLD that touch on IBD safety, for example, some of that work coming out of our prep for that NDA submission. So just kind of come back to if you feel really confident in our guidance to submit an NDA in the first half of next year. Beyond that, no material updates to what we've seen or heard

17:29 Great, and then Ana Tebrios, I guess has there been any difference in the early launch experience as far as compared to your expectations going into it?

17:42 Yeah, it's early days. I'll hand over to Peter to get some color.

17:46 Yeah, Luke, as Chris mentioned, early days just launched in October, so we're a couple weeks in, but really positive feedback from patients, caregivers, physicians. I think Your next question is from Gavin Clark Gartner with Evercore ISI. Your line is now open. Please go ahead. Hi, this is Yashan for Gavin. We were just wondering if ahead of the Q1 Vantage readout for PBC, There were any blinded baseline or trial conduct metrics you're expecting to share, in particular maybe like baseline itch severity, background therapies, discontinuation rates, anything along that realm. Thank you.

18:39 Thank you, Asha, for the question. I think maybe Rob can speak to a little bit of the trial design, but probably not too much on the actual data to speak to at this point.

18:47 Yeah, yeah, really not much to report at this point, and we're still tracking towards reporting the data in the first quarter of Thanks so much. Your next question is from Kalpit Patel with Wolf Research. Your line is now open. Please go ahead.

19:19 Yeah, hey, good afternoon, and thanks for taking the questions. Two from us. For the guidance raised is most of that related to the adult PFIC patients that are growing for Livmarli or are there other areas that are contributing to that growth? And then for the second question, for the PSC IBD subgroup data that you'll be presenting, can you comment if those data have been submitted previously to the FDA or are these new analysis that need to be sent? Thank you.

19:53 Thanks for the question. I mean, I can just touch on the PSC one briefly and then hand the guidance question over to Peter. I mean, these are new analyses, so kind of more in-detail review of data that FDA had not seen previously.

20:07 Yeah, Calvin, on the guidance question, we do see strength across the portfolio, continued growth in allogeal syndrome, bile acid products doing very well, but adult PFIC is the biggest driver, and We have line of sight now after several quarters of this cadence of 10 to 15 million quarter on quarter step up for that to persist through this year and through next year as well.

20:33 Okay, thank you. Your next question is from Ryan Deschner with Raymond James. Your line is now open. Please go ahead.

20:45 Thanks for the question and congrats on the quarter. I'm curious on sort of your expectations for the relative launch trajectory for Etebrios and if you can expect at least early on any sort of any signs of Ebola is kind of coming in for that to sort of slow down later on in the early launch. Just curious on your thoughts there. Thanks.

21:09 Ryan, thanks for the question. I'll let Peter speak to that and probably even speak to the kind of broader portfolio as we roll into next year.

21:16 Yeah, you know, the Etebrios, you know, early adoption and inbound interest has been really, really strong and we're, you know, excited about that. I think, you know, if I were to compare the Etebrios launch trajectory and adoption curve to the Marley, it probably will be faster. You know, I think if you take the Marley, we're and Alice Yields Syndrome. It's been about five years since the original FDA approval and about 50% of addressable patients with Alice Yields Syndrome have, you know, gone on with Marley and we're still seeing growth quarter over quarter. And I think if you were to think about that as a comparator, we would expect Atebrios to be faster adoption than Amex.

21:59 One thing I'd add on is, you know, as you look at Q4 and even into next year, the cadence of growth we've seen for total revenue in this kind of $10 to $15 million a quarter, we fully expect that to continue throughout next year. Thank you very much. Your next question is from James Condulis with Stiefel. Your line is now open. Please go ahead.

22:28 Hey, thanks for taking my question. And maybe just one on PSC and appreciate, you know, there's only so much you can say. But, you know, I think you've mentioned in the past that in the discussion with the FDA, there was nothing really new you felt was new that wasn't in the original VISTA study. And, you know, just curious if that's still the case, you know, from your perspective. And then Just like in general, do you expect there to be a sort of formal alignment here kind of ahead of filing, or is it just sort of, you know, TBD in terms of, you know, how the discussion evolves? Thanks a lot.

23:00 Yeah, James, thanks for the follow-up there. You know, overall, because of the situation, we're seeking multiple different interaction points, multiple meetings. We're not providing kind of meeting-by-meeting updates, so really what I can say is we're pointing towards that first half NDA. And to kind of remind on the goal here is, given that the data set is so robust and there's a lot to review, the goal of the interactions we're having is to get more familiarity with the data set before submission, not necessarily, in all cases, complete alignment.

23:38 Makes sense. Thank you. Thanks for the question. Your next question is from Jessica Fye with JP Morgan. Your line is now open. Please go ahead.

23:51 Hey, guys. Good afternoon. Thanks for taking my question. I was looking at the press release, and it looks like there is a lot of regulatory submissions going in in the first half of 2027. And I was curious if you could just speak to kind of the organizational bandwidth to bring in additional assets via business development during what seems like a really busy time. Basically, should we expect a little breather on the BD side in the near term while you get all these things into the FDA?

24:23 Yeah, Jess, thanks for the question. Yeah, it is a very busy first half of the year for submissions. You're absolutely spot on with that. We saw this coming, so we've done a lot to organize for it, and we're in really good shape from a team standpoint on having these efforts staffed and expect that we'll be able to manage through it without issue. In terms of what it means for BD, we continue to be opportunistic, so if the right opportunity comes, we want to be able to pursue it. However, more of an earlier clinical stage opportunity would be a little easier to add in at this point. But that doesn't mean we're not continuing to have an opportunistic lens on all opportunities.

25:10 Does that include commercial stage?

25:14 Yeah, absolutely. I mean, I pass over to Peter to kind of talk about our lens on, again, more broadly on BD scope and targets that we like.

25:24 Yeah, I mean, as Chris mentioned, I think our philosophy is you always have to be active. We look at the clinical stage through commercial stage. We think about rare disease as a capability in the therapeutic area in and of itself, so we have the know-how to be successful with rare disease medicine, whether it's development, regulatory, patient finding, patient access. We feel really good about the capabilities we've built there and kind of look broadly for underappreciated rare disease assets where we think we could potentially add value.

25:55 Great. Thank you. Thanks for the question. Your next question is from Yigal Nahomovitz from Citi. Your line is now open. Please go ahead.

26:08 Hi, guys. Thank you for taking the questions. Congrats on the strong quarter. I just wanted to switch topics onto HDV and the Azure 4 readout. Obviously, that's a second phase 3 trial, which is good, but can you just speak to what additional nuances or additional learnings you might glean from Azure 4 to further drive the strength of the BLA. And then with regard to, you know, the HDV market, could you just talk to what you're watching for in terms of HDV diagnosis rates potentially expanding as you get closer to a launch? Thank you.

26:44 Yeah, thanks for the question, you all. I'll ask Rob to maybe recap some of Azure 4 design and rationale, and then let Peter speak to the market questions.

26:53 Thanks, Chris. You know, Azure 4 is an important part of the registrational package for Logitug in the U.S. And just as a reminder, it's designed very similarly to Azure 1, with the exception of patients in the delayed treatment arm crossing over at 12 weeks instead of 24 weeks. And in terms of our expectations, of course, we expect to see complementarity or consistency in the virologic responses and ALT normalizations. as well as safety to that which we observed.

27:29 Then in terms of the question on HTV diagnosis rates and kind of how we see this undeveloped market developing over time, we actually have a small team that's pretty active now doing disease state education and awareness with the providers across the country who manage hepatitis B patients and in areas where they likely have and undiagnosed Delta patients as well. I think one of the things we've learned as we've been out in the field is there's really been very little testing to date. There's papers that show low single-digit percentages of B patients have ever received a Delta test. So I think one of the big pushbacks from providers historically has been lack of therapies for this condition, and I think we're seeing that change now.

28:20 look to see increased interest in testing over time and excited about the early trends we're seeing.

28:28 Thanks. Thanks for your question. Your next question is from Mike Uhls with Morgan Stanley. Your line is now open. Please go ahead.

28:40 Good afternoon. Thanks for taking the question and congratulations on the strong quarter as well. Maybe just to follow up on Velixibat, and the upcoming Vantage data next quarter. Can you just remind us, you know, what the bar is on pruritus and then, you know, what you think is sort of a meaningful benefit there?

28:59 Thanks. Thanks, Mike, for the question. I can make a couple of observations and ask Rob to maybe speak to expectations. I think the one thing that I point towards is for this study, we have the interim readout, so we kind of, we know what's possible for Polixibat. Really substantial improvements versus placebo, you know, over a two-point placebo-adjusted difference. That is really compelling and competitive if we're anywhere in the ballpark of what we saw in the interim. And, well, Rob, do you have anything to add on to that?

29:38 Yeah, no, just that the interim data were quite compelling. You know, as mentioned, we see over a two-point placebo-adjusted improvement in the Elixivat arms. We've done a bit of work to validate the adult itch row to show that this magnitude of reduction is actually clinically important. So I feel very confident going into the readout next quarter. Great. Thank you.

30:05 Thanks for the question. Your next question is from Lisa Walter with RBC Capital Markets. Your line is now open. Please go ahead.

30:16 Oh, great. Thanks for taking our question and congrats on the quarter. Maybe just given the recent challenges with the FDA and PSC, just curious if the same group of regulators will also be reviewing your filings for biliary artresia as part of the EXPAND study, as well as a potential filing for PBC. and if so, what gives you confidence that the FDA will understand those rare diseases a little bit better and your trial designs better versus what we have seen for PSC? Any caller here would be helpful. Thanks so much.

30:54 Thanks, Lisa, for the question. From a simple standpoint, these are all with the liver division. However, knowing who is assigned to the review is something we don't have visibility to at this point in time. What I would say is for Vantage and for Expand, really clear dialogue along the way on study design, all of the choices we made in those studies, and some of it quite recent interactions. So I do feel confident in our position heading into those submissions. And the one thing I'd add on is what the contrast of that to PSC is that Interactions with PSC were really mostly in 2019 and 2020, so a bit more distance just from a time standpoint.

31:46 Your next question is from Joe Schwartz with Lear Inc. Partners. Your line is now open. Please go ahead.

31:55 Thanks very much. Can you talk about what we should watch for at ASLD for Berlovitag? in terms of the full Azure One presentation, what our focus should be. And will any updates from the phase two trials be presented to? And then we noticed that the Berlovitug BLA is now described as subject to supportive Azure Four results. Is that new caution or just standard language? And can you talk about what counts as supportive? And given that Azure First Control Group waits only 12 weeks, Would you file on Azure 1 plus the Phase 2b data if Azure 4 were more mixed?

32:37 Thanks for the question, Joey. On that last point, there's nothing new here. So Azure 1 and 4 have always been the proposed Phase 3 package for Grolovitug. And the simple way to think of it is the study was designed with FDA before orphan designation was granted, so they were looking for two pivotals. Really nothing different from patient population, overall dynamics here that would suggest a big difference between the two. It's just about having two pivotals. Now we do have orphan designations, so, you know, hindsight, hard to say how that would have been treated, but that's the case and has always been the plan for the submission. And I'll ask Rob to maybe give the highlights and directions for ASLD.

33:22 Yeah, we have some exciting data on Vrlovitug at ASLD. As you mentioned, we'll present the ASR1 results in full, 24-week data, Phase III data, and as well the 48-week Phase IIb component of ASR1. And then lastly, we have an abstract on patients with cirrhosis from the original Phase II study who've been treated out to two years. and really that entire data package, it's really robust. I mean, it tells us that we do see excellent rates of virologic suppression and ALT normalization as early as week 24, but that with prolonged treatment, greater virologic suppression, greater rates of ALT normalization, including in patients with advanced disease, cirrhosis, quite significantly elevated ALT.

34:20 I think the Verlovatug package is quite strong. Looking forward to our Azure 4 data by the end of this year.

34:31 Thanks for the color.

34:33 Thanks for the question. Your next question is from John Wolloban with Citizens JMP. Your line is now open. Please go ahead.

34:44 Hey, thanks for taking the question. I was hoping to get some more color on how you guys are thinking about your peak sales guidance in HTV and then PBC, PSC. Just given the relative prevalence and moving dynamics in those markets, what's underlying that billion dollars, or is that just a simple guidepost to think of as a starting point? I'm just wondering how granular you guys have gotten internally there.

35:10 Yeah, thanks for the question, John. The one thing I'd say is Overall, meant to be an approach on how we give these on giving kind of greater than a certain target. Important lens to put on it as you're thinking about it. Peter can speak a little bit to some of the color on how we came to these numbers.

35:29 Yeah, thanks, John. So I think in Delta, the guidance of greater than a billion, there's a lot of ways to get there, quite frankly. I mean, even if you just look at the The U.S. market today, about 15,000 patients diagnosed with insurance under management. You'd only really need to get a few thousand of those on therapy chronically to get towards that greater than ability to guidance. Obviously, we know this is an underdiagnosed disease, and as we commented, very low rates of testing have happened historically in the U.S. Not to mention, there's a substantial international opportunity for Velovatud as well. So I think, as I say, the theme there is a lot of ways to get to greater than a billion. And as you move over to Velixbat, PSC, PBC, similar addressable patient population in the U.S.

36:20 for PSC, about 20,000 patients with PSC and pruritus. No competition there. And then PBC, a larger addressable market with about 50,000 addressable patients in the U.S., but a bit more competition. But I think you could kind of, you know, do the math a number of different ways to get to the kind of numbers you need to get to to get to the greatest. Real helpful.

36:48 Thanks, Chris.

36:49 Thanks for the question. Your next question is from Charles Wallace with HC Wainwright. Your line is now open. Please go ahead.

37:01 Hi, thanks for taking my question. This is Charles. I'm for RK. Okay. So for my first question, I was wondering how should we think about the R&D spend going forward in the fourth quarter and then also 2027 with the placebo-controlled portion of Azure 1 and 4 studies completing? I'll come back with my second question.

37:22 Speak to some of those trends.

37:24 Yeah. Thank you very much.

37:59 Great, and then for my second question, beyond the, is there four results, what additional items remain before you can file the BLA in the first half? Thank you, for Belovatug.

38:12 Yeah, thanks for the question on that. For Belovatug, it really just comes down to pulling together the submissions, so all of the work streams from both the clinical studies and the CMC submission, all tracking towards being ready first half. So all that's a lot of document prep and write up that's left to do.

38:30 Thanks for taking my questions. Thanks for the questions. Your next question is from Joseph Tome with TD Cowan. Your line is now open. Please go ahead.

38:46 Hi there. Good afternoon. Thank you for taking my questions. Maybe another one on HDV. We may have several agents approved for HDV, I guess, currently or over the next, you know, couple years here. What do you see as sort of the main differentiating features of Belovatug based on the data you have in hand that will drive adoption, you know, of Belovatug over some of these others? And then second, when you think about the potential cadence of VA coming online for Liv Marley, Obviously, the FDA did kind of ask you to do this based on requests. Is there a pocket of patients ready to come on therapy rapidly, or will it be gradual? Kind of how should we think about the cadence of that launch? Thank you.

39:26 Great. Thanks for the question, Joe. I'll make a couple of observations on HDV and let Peter add to it and speak to DA as well. The one thing I'd say is, you know, when we put together the transaction of FluJ around Belovatug, what we found really exciting about this program is that you had a fully human antibody, those treatment that could drive continued improvement over time to some really impressive response rates, both on normalizing liver inflammation and on controlling and lowering viral levels. A lot of that data is what we're looking forward to sharing this weekend at ASLD to show updates on what that can get to at two years. That kind of gives the answer to how we think about our positioning with HDV.

40:12 We'll pass over to Peter to touch up and add the VA comments.

40:16 I think it's very well stated on HDV and on the VA question, you know, these patients are at the same centers with the pediatric liver docs that prescribe Luton-Marley today for pediatric BFIC and LGL patients. So the patients are there, as you noted in your question, The study was really started as a response to inbound interest from clinicians to use the product in this way. So it's a pretty captive audience who are very familiar with the product, who have these patients in their clinic under management now. Great. Thank you. Thanks for your question. There are no further questions at this time.

41:01 I will now turn the call back to Chris Peetz, CEO, for closing remarks.

41:07 Great. Thanks, everyone, for joining today's call. Looking forward to a strong end of the year and a busy 2027. Good afternoon, everyone. This concludes today's call. Thank you so much for attending. You may now disconnect.