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Transcript Summary

Mirum Pharmaceuticals delivered a strong Q1 2026, highlighted by total net product sales of $160 million and an upward revision of full-year revenue guidance to $660M-$680M. LIVMARLI remains the primary engine of growth, particularly within the PFIC indication, while the bile acid portfolio continues to track steadily. A major strategic move this quarter was the licensing of zilurgisertib from Incyte for the treatment of FOP. This oral ALK2 inhibitor is currently under FDA priority review with a September PDUFA date, offering a significant near-term launch catalyst for the rare genetic disease platform. Mirum is also advancing its mid-to-late-stage pipeline, including volixibat for PSC and brelovitug for HDV, both showing promising clinical results. To support expansion into adult liver markets, the company is tripling its field sales force. Financially, Mirum absorbed significant acquisition expenses related to Bluejay Therapeutics but maintains a solid $421 million cash position. Management projects achieving positive operating cash flow by 2027. Analyst discussion focused on zilurgisertib’s clinical differentiation, the competitive landscape in FOP and HDV, and the drivers behind the strong LIVMARLI sales performance across both U.S. and international markets.

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Mirum Pharmaceuticals: The Billion-Dollar Deficit and the IPR&D Accounting Shield

Full Earnings Call Transcript — Q1 • 2026-05-06

Operator: Good afternoon, and welcome to Mirum Pharmaceuticals First Quarter 2026 Earnings Conference Call. My name is Tracy, and I will be your operator today. [Operator Instructions] I would now like to hand the call -- the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.
Andrew McKibben: Thank you, Tracy, and good afternoon, everyone. I'd like to welcome you to Mirum Pharmaceuticals First Quarter 2026 Earnings Conference Call. For our prepared remarks, 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. Our Chief Medical Officer, Joanne Quan, will be joining us for Q&A. Earlier this afternoon, Mirum issued a press release reporting our first quarter 2026 financial results. 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 Mirum'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?
Christopher Peetz: Thanks, Andrew, and good afternoon, everyone. We have a number of important updates to cover today, but I'd like to start by grounding in the vision we set when we founded Mirum in 2018. building a company focused on bringing forward medicines for overlooked rare diseases. This quarter reflects the progress we've made in turning that vision into a durable growing business. Our start was based on LIVMARLI. And today, we are a broader rare disease company with 3 approved medicines and a pipeline positioned to deliver multiple new therapies over the next 2 years. These high-impact programs are grouped across 2 focus areas: rare liver disease, where we have built clear leadership and rare genetic disease, where we are establishing a second growth platform, each with distinct commercial capabilities. Across both, we've built a financially self-sustaining business that can support continued investment in the portfolio. Our strategy is driving compelling results. Starting with rare liver disease, uptake of LIVMARLI remains strong, driven in part by performance in PFIC, which continues to exceed expectations. Based on that demand and continued performance across all brands, we are raising our full year revenue guidance to $660 million to $680 million. More importantly, we are now seeing the next phase of our rare liver disease business take shape. Our recent clinical readouts in PSC and hepatitis delta represent important potential expansions for this business, extending beyond our pediatric foundation into larger patient populations with significant unmet need. In PSC, the VISTAS study of volixibat showed a significant improvement in pruritus, reinforcing the potential for volixibat to play an important role for these patients who currently have no approved medicines. This is a major advance in PSC research and positions volixibat as a potential first approved medicine for patients in the U.S. And in hepatitis delta, results from the Phase IIb portion of the AZURE 1 study further support the potential for brelovitug in a patient population where treatment options are extremely limited. We look forward to the upcoming late-breaking presentations for both VISTAS and AZURE at EASL later this month. Now in parallel to this expansion of our rare liver disease business, today, we are announcing another step in building out our rare genetic disease business with the addition of zilurgisertib recently licensed from Incyte. Zilurgisertib is a once-daily oral ALK2 inhibitor in development for fibrodysplasia ossificans progressiva or FOP, an ultra-rare progressive condition where patients develop bone and soft tissues. This accumulation of excess bone leads to profound physical immobilization with most FOP patients becoming wheelchair dependent by early adulthood and severely impact life expectancy. Based on the strength of zilurgisertib's PROGRESS study conducted by Incyte, an NDA has been accepted for priority review with a PDUFA date of September 26 this year. If approved, we expect to launch by year-end. This is a strong strategic fit, aligning with our capabilities in rare genetic disease, where care is concentrated in a small number of specialized centers and requires deep engagement with patients, caregivers and physicians. Stepping back, we built a company with multiple commercial growth drivers, a pipeline of meaningful upcoming catalysts and the financial strength to advance our portfolio independently. This foundation is translating directly into high-impact medicines for patients and into value creation as we deliver on our strategy. And with that, I'll turn the call over to Peter to walk through the commercial portfolio and preparation for the 3 upcoming potential launches. Peter?
Peter Radovich: Thank you, Chris. The first quarter was another period of strong commercial execution with total net product sales of approximately $160 million. This included LIVMARLI net product sales of $84 million in the U.S. and $30 million internationally, with the bile acid medicines contributing $46 million. Robust adoption in PFIC, particularly in adult patients, continues to be a strong point for LIVMARLI as education to increase awareness and recognition of genetic cholestasis among adult liver providers continues to be successful. Additionally, we saw stronger-than-expected performance in Q1 international LIVMARLI sales as well as continued new patient adds in Alagille worldwide. The bile acid medicines grew in a manner consistent with their cadence over the last several quarters, highlighted by our rare genetics team continuing to identify undiagnosed patients with CTX. Overall, we expect these dynamics to continue and as a result, are raising our full year 2026 net product sales guidance to $660 million to $680 million. And as Chris mentioned, we are also beginning to see the next phase of growth in our rare liver disease business take shape. The recent results from the VISTAS study of volixibat in PSC and the AZURE-1 study of brelovitug in hepatitis delta represent important steps in extending our presence into larger, primarily adult liver settings, where patients have limited or no approved treatment options. These programs build directly on the global commercialization platform we have established for LIVMARLI, CTEXLI and CHOLBAM, heavily leveraging our existing technologies, people and infrastructure. We plan to expand our U.S. and international teams starting later this year to reach liver health care providers in adult settings, including GI liver providers, who manage PSC patients and hepatitis delta as well as other care settings like infectious disease and selected primary care providers, where we believe we can increase the number of diagnosed hepatitis delta patients. In the U.S., our current 20-person liver field commercial team reaches about 1,500 health care providers with currently focus on pediatric liver providers and some higher volume adult providers. After our planned expansion to approximately 60 U.S. field commercial personnel, we anticipate being able to reach over 4,000 liver health care professionals, representing the vast majority of potential prescribers for our rare liver business. Turning to our rare genetic disease business, we are very excited by the addition of zilurgisertib for the treatment of FOP, where there remains a desperate need for additional treatment options. FOP is a devastating relentlessly progressive condition in which soft tissues such as muscles, tendons and ligaments gradually turn into a second skeleton, leading to cumulative loss of mobility, severe disability in early childhood. FOP is a highly concentrated ultra-rare disease with an estimated prevalence of about 1 per million, which translates to approximately 300 patients in the United States and around 900 patients globally. Patients with FOP are largely managed by specialized tertiary centers, with most of these centers also managing patients receiving CTEXLI and CHOLBAM, allowing us to leverage our rare genetic disease team to commercialize zilurgisertib. And we've been impressed by the zilurgisertib data from the pivotal PROGRES study, in particular, the secondary endpoints, which form the basis of the NDA application, and we look forward to the presentation of the data from the PROGRESS study at an upcoming medical meeting. The NDA for zilurgisertib has been accepted for priority review by the FDA with a September 2026 PDUFA date. If approved, we expect to launch zilurgisertib in the United States by the end of this year with expansion to additional countries starting in 2027. We are excited about the addition of zilurgisertib, which we believe has the potential to become the cornerstone of our rare genetic disease business and reach peak sales of over $200 million. This high-impact medicine fits perfectly with our medical and commercial team's capabilities and passion for supporting patients suffering from ultra-rare diseases like FOP. And with that, I'll turn it over to Eric to review our financial results. Eric?
Eric Bjerkholt: [Technical Difficulty] and disciplined investment behind our pipeline, which remains on track across all programs. Today, I'll walk you through the financials for the quarter, including an overview of the impact of the Bluejay acquisition and the zilurgisertib transaction. The net product sales for the first quarter were $160 million compared to net product sales of $112 million in the first quarter of last year. Cash, cash equivalents and investments as of March 31 were $421 million compared with $391 million at the beginning of the year. In the first quarter, the cash contribution margin from our commercial business was in the mid-50s percent and cash flow from operations was about $2 million. First quarter financials were significantly impacted by onetime expenses related to the acquisition of Bluejay Therapeutics, which closed in January of this year. The total net cash outflow related to this acquisition was $253 million, which was offset through net financing proceeds of approximately $260 million. Total operating expense for the quarter ended March 31st was $949 million, which includes $761 million in expense associated with the acquisition of Bluejay, R&D expense of $98 million, SG&A expense of $96 million and cost of sales of $29 million. Expenses for the quarter included stock-based compensation, intangible amortization and other noncash expenses of $64 million, including $35 million of stock-based compensation expense associated with the acquisition of Bluejay. The intangible amortization and other noncash item expenses are largely reflected in our [ company's ] results. As Chris and Peter mentioned, we recently entered into an exclusive license agreement with Incyte. In return for worldwide rights to zilurgisertib, Incyte received an upfront payment of $16 million and is eligible to receive additional development and regulatory milestone payments, including $25 million upon U.S. FDA approval for FOP ownership of a rare pediatric disease priority review voucher, if awarded, as well as sales-based milestones and tiered royalties on worldwide net sales in the mid to high single-digit percent range. As we've discussed previously, we expect R&D expense to step up in 2026 as we invest behind brelovitug ahead of the anticipated BLA submission next year. For example, R&D expense in the first quarter included $21 million related to the development of brelovitug. Importantly, this expense expected increase is fully funded. We are continuing to scale the business with disciplined, balancing investment in growth with a strong balance sheet and financial independence. This approach positions us to advance our pipeline and execute on upcoming milestones without compromising our long-term financial strength. I'll now turn the call back to Chris for closing remarks.
Christopher Peetz: Thanks, Eric. Mirum is in a strong position after a very busy start of the year. What is most encouraging about the quarter is not just a number of positive updates, but how clearly they fit together. We continue to grow our commercial medicines. We're expanding our rare business into rare liver business into larger indications. We've added what we believe is a transformational medicine to our rare genetic business. And importantly, this is all coming together within a high-impact scalable business model. We're excited about the progress ahead as we approach multiple pivotal readouts, potential regulatory submissions and potential new product launches. I'd also like to thank the entire Mirum team for all the hard work in getting us where we are today. Your dedication brings new treatment options to patients around the world. And with that, operator, please open the call for questions.
Operator: [Operator Instructions] Your first question comes from the line of Gavin Clark-Gartner with Evercore ISI.
Yesha Patel: This is Yesha on for Gavin. I just had one on FOP. Wondering your current view on the number of diagnosed FOP patients in the U.S. based on claims, patient advocacy and provider research. And then how many of those patients will immediately be treatable at launch? And then I have one follow-up on LIVMARLI.
Christopher Peetz: Yes. Thanks for the questions. Yes, the -- we point towards the approximately 300 identified patients in the U.S. coming from patient [ advocacy ] group [indiscernible]. In terms of addressable patients, probably the main feature there is the NDA application inside filed as for age 12 and over. So that would be the main piece to consider, which would be the majority of the prevalent patients.
Yesha Patel: And then on -- in terms of LIVMARLI specifically on the guidance raise, wondering what's kind of driving the bulk of the increase? Is it due to the ex-U.S. expansion or kind of the continued PFIC ramp? And within PFIC, is the contribution still skewing towards those older patients?
Christopher Peetz: Yes. Thanks for the question. I mean, certainly, LIVMARLI U.S. PFIC was the biggest driver and continue to see both pediatric and adult patients come to treatment. I think the older adolescents and adults really is the major driver, although we're still -- we think still in early innings. We've made good progress educating adult providers on genetic testing, but still the minority of them are actually doing that. So I think there's probably more adult patients to find out there to potentially benefit from LIVMARLI.
Eric Bjerkholt: And yes, on the international piece, in Q1, historically, we've seen a bit more seasonality and a little bit of a softer number in Q1. that just wasn't as much of a factor this year, somewhat in part of not only additional countries performing, but also PFIC starting to show up in that international number.
Operator: Your next call comes from the line of Josh Schimmer with Cantor.
Joshua Schimmer: Also on zilurgisertib, how are you thinking about its differentiation versus maybe some of the other programs in development, garetosmab, if I'm pronouncing that right. And so who knows that's number one. Number two, are you planning to explore the program in other ossification indications disorders? And then number three, I think I heard you say peak sales for the asset of $200 million, is that global or U.S.
Christopher Peetz: Thanks, Josh, for the questions. Yes, just to clarify that peak, the $200 million plus is a global number for us. And then in terms of kind of positioning here, the programs that you covered there, those are the ones that we're tracking, Sohonos being approved and the other program being in registration phase. And for Sohonos, the data coming out of the PROGRES study here for zilurgisertib is a real step forward in terms of the overall activity profile and tolerability and safety profile. So we see the clinical data here being quite meaningful advance on what's currently available in the market, which has quite a few limitations to it. And then compared to the pipeline, this is an oral, which we see as a big advantage and particularly in the setting, where you can potentially drive ossification from injections and some of these other interventions. So having an oral, we see as a nice differentiator for the program.
Joshua Schimmer: Got it. And then plans for other ossification disorders?
Christopher Peetz: We -- it's still early days in thinking about it. At this point, we want to stay very focused on getting this launched for FOP, but it's certainly something we'll consider as we get further down the road.
Operator: Your next call comes from the line of Jon Wolleben with Citizens.
Jonathan Wolleben: A little unusual having something under review or I haven't seen any of the data for. Just wondering what you guys have been privy to make you comfortable with this acquisition? And then what would be the form for it to make sense to get this out into the public domain?
Christopher Peetz: Yes. Thanks for the question, Jon and fully appreciate the uniqueness of the situation. In our review, we -- this is a conversation that actually has been going on for quite some time as is typical for a license transaction like this. So we've had full access to clinical data, to the regulatory correspondence and the NDA. So we feel quite confident in the profile for zilurgisertib and where they're at in the regulatory process. From the Incyte side, where they've done a fantastic job putting together this program, and saw it fitting better in a rare disease company like Mirum, but the work they've done on it is quite strong. They want to have the data presented first at a medical meeting. So we're hopeful that's happening relatively soon. So once we get that presented, we'll be able to share more on the pivotal data and overall product profile.
Jonathan Wolleben: And will you guys be eligible for a pediatric review voucher if approved?
Christopher Peetz: So we do expect this to be eligible for a voucher under the terms of the agreement, Incyte will keep that voucher, and we will launch the product. So the way operationally, this works is Incyte is kind of given their mid-stride with the filing and review, they'll complete the primary role through approval, and then we'll take over sponsorship at the point of U.S. approval.
Operator: Your next question comes from the line of Mike Ulz with Morgan Stanley.
Rohit Bhasin: This is Rohit on for Mike. With the recent pipeline acquisitions, can you talk about how you're thinking about BD moving forward? And then also, can you just talk about how you're thinking about pricing in FOP?
Christopher Peetz: I can start, and I'll hand it over to Peter. But I think as you've seen now for Mirum kind of over the history of the company, we see a priority in staying active on the BD front. That's how you find unique opportunities that fit and add value to the company. So we will continue to work to find good programs to bring into the team. Maybe have Peter kind of touch on the -- any more on that or the second part of the question?
Peter Radovich: Yes. I mean nothing more on the BD strategy on the zilurgisertib pricing. Obviously, we'll make a decision and communicate that closer to approval. But just I think for thinking about the U.S., I mean, you can look at the Niemann-Pick C products and other ultra-rare settings like that where you have a strong value proposition and similar AbbVie is probably get you in the ballpark.
Operator: Your next question comes from the line of James Condulis with Stifel.
James Condulis: Congrats on the quarter. Maybe one follow-up on HDV. I think where we've heard a couple of questions is maybe in the 900 mg monthly arm, specifically as it relates to the T&D virologic response is maybe a little bit of an outlier relative to like some of your prior data and other -- the rest of your sort of data set. Just like curious your perspectives here. And as you think about the commercial opportunity here, for docs in the real world, what do you think is kind of the most important measure as it relates to evaluating efficacy for these different drugs? Is it that T&D virologic response, other measures of virologic response, the composite? Just curious your perspective there.
Christopher Peetz: Yes. Thanks for the question. I'll maybe make a couple of comments and then have Joanne speak to some of the data that we're seeing out of the AZURE-1 Phase IIb portion. And I think in terms of what we're focused on and what we think is most relevant for ultimate use and driving adoption here is that composite of virologic response and ALT normalization. Those 2 factors are really what's pointed to in the FDA guidance and shows that you're not only addressing the viral load, but you're also addressing the liver inflammation that is part of the disease. So seeing both of those move means you're kind of going after both components of the -- both of the considerations for both the infection and the liver. Maybe I'll ask Joanne to touch on the data we've seen to date.
Joanne M. Quan: Yes. And so Chris is talking about the composites, all very true. When we look at the curves in terms of the virologic response, we do see declines in everyone. So when you structure the endpoint, if you don't meet a certain point by week 24, then you're either on one side of the line or the other. But we do see decreases in all of the patients. There's certainly no evidence of lack of response or resistance or anything like that. So really, partly, it's an artifact of time. We do see deepening response with continued treatment. And again, this is a fairly small -- numerically fairly small group. We'll have a lot more information with the full AZURE-1 and AZURE 4 Phase III data sets to make a final call on that.
Operator: Your next question comes from the line of Brian Skorney with Baird.
Brian Skorney: Great quarter. I guess I'd love to also ask a question on FOP too. It seems like you're doubling down on making Ipsen your corporate nemesis. So I'm just wondering if you could kind of give your broad thoughts on where you think Sohonos' profile leaves an opportunity for another entrant and compare and contrast how zilurgisertib might address these. And the time line would put us right around mid-cycle review with the FDA right now. So I'm just wondering if you could say if that has already happened or is still pending.
Christopher Peetz: Yes. Thanks for the question. On the review, yes, that has happened, and I'd just say things are tracking as expected. But maybe I'll ask Peter to comment on -- a little bit more on positioning.
Peter Radovich: Yes. And I think certainly, the feedback we've heard from stakeholders, patients, caregivers, physicians, others available therapy in the market today. There's just -- there's a lot to be desired in terms of both efficacy and safety. And we'll obviously be able to get into more details once we have the PROGRESS data presented at an upcoming medical conference. But from what we've seen in our review, the zilurgisertib profile, really exciting about what it can mean for these patients, both efficacy-wise as well as a convenient oral and well-tolerated regimen.
Operator: Your next question comes from the line of Lisa Walter with RBC Capital.
Lisa Walter: Maybe just some more details if you can share on the opportunity for FOP. Are there any overlap with your current call points? And did you disclose the deal terms with Incyte? And maybe just one more. Given the recent positive results in [ hep D ] and PSC, wondering if this has impacted your thinking on when Mirum could become a profitable company.
Christopher Peetz: Yes. Maybe I'll ask Peter to kind of speak to the FOP points and then have Eric kind of give some financial forward-looking views.
Peter Radovich: Yes. great overlap with our existing team, our rare genetics team that's focused on CTEXLI, CHOLBAM. We mentioned that the majority -- the significant majority of the FOP patients, FOP patients are cared for in settings -- centers that also prescribe CTEXLI, CHOLBAM. Different prescribers most of the time, some overlap in medical genetics. FOP has the biggest prescriber there will be endocrinologists. So that's a new kind of physician target, but the center overlap is really high with our existing rare genetics business. So excited about adding this product to that team.
Eric Bjerkholt: Yes. And then on the financials, we did disclose the upfront license fee was $16 million, and then the next milestone would be $25 million upon FDA approval. There's some other commercial milestones, but also a royalty in the low to -- well, mid to high single-digit range. And we expect after launch that this product will be accretive very, very quickly. But your question was also about path to profitability, and I think that's much more driven by brelovitug and volixibat as well as our current commercial business. As we've said, we're spending a lot on R&D this year for both of those products. And so, profitability will be pushed out probably until '28 on a GAAP basis.
Christopher Peetz: But I would reiterate that we expect to be operating cash flow positive next year.
Eric Bjerkholt: Yes.
Operator: Your next question comes from the line of Jessica Fye with JPMorgan.
Jessica Fye: Can you estimate the contribution to first quarter LIVMARLI sales from Alagille versus PFIC? And then another one on FOP, just thinking about that market. What do you see as the penetration for palovarotene? And would you envision the ALK being used in combination with that drug?
Christopher Peetz: Jess, for the questions. I mean just briefly on LIVMARLI, we typically aren't breaking out by indication, but what we'd say is that PFIC is -- they're both growing, but PFIC is the bigger growth driver. Maybe pass the FOP question over to Peter.
Peter Radovich: Yes. And when we look at the U.S., the market where this medicine is available, palovarotene, it's probably a minority of diagnosed patients that are currently receiving it. We can see from pharmacy claims data, and that kind of matches what we've heard in physician and caregiver interviews that can be tried, but it can often be difficult to tolerate and stay on.
Operator: Your next question comes from the line of Mani Foroohar with Leerink Partners.
Ryan Mcelroy: You have Ryan on for Mani. Congrats on the quarter. Maybe just circling back to FOP. What's the latest thinking here on an OUS filing and when you guys would expect to launch there? And then just going back to the peak sales of $200 million, we're just wondering, is that in the 12-plus age group that you guys would get approved in the upcoming? And how should we think about upcoming data for the younger age groups that are being tested?
Christopher Peetz: Thanks for the questions, Ryan. On ex U.S. strategy, actually, a European filing is upcoming. So we could actually still have that in this quarter. Incyte is still driving those activities. And again, their team is doing a great job. In terms of the overall peak estimate, that $200 million plus, that's the full brand in FOP over life cycle is the way we look at it. The younger age patients, we do expect that the label would launch with the 12 and older. There are 2 other cohorts in the study that are ongoing that would support potentially taking that age lower over the near term, frankly. So those are ongoing and enrolling now, so they're not too far out.
Operator: Your next question comes from the line of Ryan Deschner with Raymond James.
Ryan Deschner: A couple for me. What's your strategy for identifying FOP patients in the U.S. and abroad and addressing a relatively high misdiagnosis rate for FOP? And do you anticipate any early line of sight into a substantial group of patients from Incyte's prior clinical studies or maybe a compassionate use program or something like that in FOP? And I have a follow-up.
Christopher Peetz: Yes. Thanks for the question, Ryan. Yes, the -- I think that FOP patients often have a longer diagnostic odyssey than they should. There are patients get diagnosed at birth, but often I think the literature said the average age of diagnosis is 7 years, and so obviously, people that wait longer than that. I think that's improved with the availability of genetic testing. But that's, I think, an opportunity to continue to raise awareness, just like all of our rare genetic diseases to try to shorten that diagnostic odyssey as much as we can. We do think in the U.S., though, most of the -- a pretty substantial majority of the patients are identified with FOP, probably a different story in middle and lower-income countries [ interesting ].
Peter Radovich: And did you have a follow-up, Ryan?
Ryan Deschner: Yes. I just was also wondering if there was anything notable so far in the VISTAS extension in terms of rollover discontinuation rates, pruritus or other patient metrics that might take a little longer to modulate over time.
Christopher Peetz: Yes. I mean Incyte does have this PROGRESS study. It's enrolling well. And I think we'll be able to disclose more about what they've seen from that at the upcoming medical conference, but have certainly seen a lot of physician and patient interest in the program.
Operator: Your next question comes from the line of Joseph Thome with TD Cowen.
Joseph Thome: Maybe one on FOP. I guess the level of ALK2 inhibition you're seeing with the therapy, I guess, do you think that could be enhanced by garetosmab, Regeneron's Activin A drug? Or are these largely just going to be competitive therapeutics in the landscape? And then second, when we think about the potential expansion opportunity for LIVMARLI in the basket trial that's going to be reading out later this year, I guess, how should we think about that in your overall projection for LIVMARLI, how much is this basket population?
Christopher Peetz: I can make a quick comment on the garetosmab positioning, and it's probably best to get into more detail on this after our data is presented, so it can give a better -- a more complete picture. But we think the profile for zilurgisertib and its clinical positioning is really strong as a convenient oral single agent and excited about bringing that forward. Maybe I have Peter take the follow-up.
Peter Radovich: Yes. And expand, we've kind of talked about that indication being about 1/3 of the at least $1 billion peak sales opportunity for LIVMARLI and still reiterate that.
Operator: Your next question comes from the line of Charles Wallace with HCW.
Charles Wallace: This is Charles on for RK. So for FOP, another question on that. How many patients from the PROGRESS study, I think there was 63 in that study, do you expect will -- could come on after launch? And do you expect to have some sort of bridging program?
Christopher Peetz: Thanks for the question, Charles. And given the kind of the nature of the relationship here, we're going to wait until we have that data presented to give some of the detail on it. Overall, I think it's a really compelling profile and the feedback has been positive, but I just don't want to get into specifics ahead of having that data presented.
Charles Wallace: Okay. That's fair. And then I guess another question, if I may, on the sales force expansion. So you're growing it to 60 in the field. And I just wanted to maybe get a little more color on when you expect these -- the team to be fully on board? And also, when do you expect them to be fully functional?
Christopher Peetz: Yes. I -- kind of prepared comment was starting this -- later this year. And so I kind of think early next year, we'd be kind of fully on board. And that team would cover both pediatric and adult settings, where not just Alagille and adult PFIC can be found, but also PSC and delta. So I think by early next year, they'd be active in all those areas. And of course, with the pipeline products, the activity would really start upon potential FDA approval.
Operator: There are no further questions at this time. I would now like to turn the call back to Chris Peetz for closing remarks.
Christopher Peetz: Great. Well, thank you all for joining us today and for all the support and a great start to 2026. Have a great afternoon.
Operator: This concludes today's call. Thank you for attending. You may now disconnect.