Logo of jester cap with thought bubble.

Image source: The Motley Fool.

Date

Wednesday, May 6, 2026 at 4:30 p.m. ET

Call participants

  • Chief Executive Officer — Christopher Peetz
  • President — Peter Radovich
  • Chief Financial Officer — Eric H. Bjerkholt
  • Chief Medical Officer — Joanne M. Quan

Need a quote from a Motley Fool analyst? Email [email protected]

Takeaways

  • Total Net Product Sales -- $160 million, up from $112 million for the comparable quarter one year ago.
  • U.S. LIVMARLI Sales -- $84 million; International LIVMARLI Sales -- $30 million; Bile Acid Medicines Sales -- $46 million (these itemized components do not sum to total due to revenue classification, as clarified in the remarks).
  • Cash, Cash Equivalents, and Investments -- $421 million as of March 31, up from $391 million at the start of the year.
  • Cash Contribution Margin -- mid-50% range according to management, highlighting profitability at the product level.
  • Cash Flow from Operations -- about $2 million for the quarter, reflecting operational cash generation.
  • Operating Expense -- $949 million, including $761 million tied to the Bluejay Therapeutics acquisition.
  • R&D Expense -- $98 million; SG&A Expense -- $96 million; Cost of Sales -- $29 million.
  • Stock-Based Compensation, Intangible Amortization, and Other Noncash Expenses -- $64 million, with $35 million in stock-based compensation related to Bluejay.
  • Net Cash Out for Bluejay Acquisition -- $253 million, offset by $260 million in net financing proceeds.
  • Full-Year Net Product Sales Guidance (2026) -- Raised to $660 million to $680 million on the basis of higher LIVMARLI demand, particularly in U.S. PFIC.
  • Clinical Progress - VISTA (PSC) -- VISTA study of volixibat showed "significant improvement in pruritus," supporting positioning as a potential first approved medicine in the U.S. for PSC patients.
  • Clinical Progress - AZURE-1 (Hepatitis Delta) -- AZURE-1 Phase 2b study demonstrated further supporting data for berlivatig in a patient population with "extremely limited" treatment options.
  • Pipeline Expansion - Zolergosertib for FOP -- Exclusive license agreement with Incyte includes a $16 million upfront payment, $25 million milestone on FDA approval, additional regulatory/commercial milestones, and a royalty in the mid- to high-single-digits percent range (Incyte retains any rare pediatric disease priority review voucher if awarded).
  • Zolergosertib NDA Progress -- NDA accepted with priority review and a PDUFA date set for September 26, 2026; anticipated U.S. launch by year-end if approved.
  • FOP U.S. Patient Estimate -- Approximately 300 identified patients, covering age 12+ at launch according to current NDA scope.
  • Zolergosertib Peak Sales Guidance -- Company guidance for global peak sales is $200 million plus.
  • Sales Force Expansion Plan -- U.S. liver field team to triple from 20 to approximately 60 personnel by early next year, expanding coverage from 1,500 to over 4,000 liver health care providers across pediatric and adult specialties.
  • Profitability Outlook -- Management reiterates expectation to be operating cash flow positive in 2027, with GAAP profitability targeted for 2028.
  • EXPAND Indication for LIVMARLI -- EXPAND population is projected to be about one-third of at least a $1 billion peak sales opportunity for LIVMARLI, as reiterated by management.

Summary

Mirum Pharmaceuticals (MIRM +4.04%) reported robust revenue growth and raised its 2026 sales guidance based on strong performance from LIVMARLI in the U.S. and international markets. Management underscored pivotal late-stage clinical advances in both primary sclerosing cholangitis and hepatitis delta, citing studies positioning volixibat and berlivatig as leaders in settings with no approved therapies. The company executed a strategic pipeline acquisition with the exclusive global license of zolergosertib for fibrodysplasia ossificans progressiva, with NDA accepted and a PDUFA in September 2026, supported by upfront and milestone financial disclosures. Cash reserves grew quarter over quarter even after completing the Bluejay Therapeutics acquisition, and the upcoming sales force expansion aims to penetrate broader adult and pediatric liver disease markets. The outlook for operating cash flow positivity is set for 2027, with GAAP profitability not expected until 2028, reflecting continued investment in pipeline programs and new product launches.

  • Chief Financial Officer Bjerkholt stated, "First quarter financials were significantly impacted by one-time expenses related to the acquisition of Bluejay Therapeutics, which closed in January," distinguishing recurring from nonrecurring cost structure impacts.
  • Peter Radovich described the upcoming commercial team expansion as a driver to reach most U.S. liver specialists, saying, "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."
  • CEO Peetz emphasized the fit of zolergosertib with Mirum's existing rare genetic disease platform, noting full access to clinical data and regulatory correspondence before the license agreement, which he described as providing strong confidence in the asset's profile and regulatory progress.
  • Management highlighted that Incyte will "complete the primary role through approval" for zolergosertib's NDA, after which Mirum will assume sponsorship upon U.S. approval, clarifying operational handoff in the collaboration.
  • Mirum disclosed an expected step-up in R&D expense in 2026 as pre-launch investments in berlivatig (HDV) increase, with full funding in place for these pipeline activities.

Industry glossary

  • PFIC: Progressive familial intrahepatic cholestasis—a rare genetic disorder causing progressive liver disease from childhood.
  • PSC: Primary sclerosing cholangitis—a chronic liver disease with no current approved therapies, affecting bile ducts and leading to liver damage.
  • FOP: Fibrodysplasia ossificans progressiva—an ultra-rare disease in which soft tissues progressively turn into bone, causing severe disability.
  • PDUFA date: Prescription Drug User Fee Act deadline—the date by which the FDA commits to completing the review of a new drug application.
  • ALT normalization: Restoration of alanine aminotransferase liver enzyme levels to normal, serving as a marker of improved liver health in clinical trials.
  • BLA: Biologics License Application—FDA submission for approval to market a biologic product in the United States.

Full Conference Call Transcript

Christopher Peetz: Thanks, Andrew, and good afternoon, everyone. We have a number of important updates to cover today, but I would like to start by grounding in the vision we set when we founded Mirum Pharmaceuticals, Inc. in 2018: building a company focused on bringing forward medicines for overlooked rare diseases. This quarter reflects the progress we have made in turning that vision into a durable, growing business. Our start was based on Lipmarly, and today, we are a broader rare disease company with three approved medicines and a pipeline positioned to deliver multiple new therapies over the next two years.

These high-impact programs are grouped across two 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 have 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 Libmarli 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 VISTA study of elixirat showed a significant improvement in pruritus, reinforcing the potential for elixirat to play an important role for these patients who currently have no approved medicines. This is a major advance in PSC research and positions vilixibat as a potential first approved medicine for patients in the U.S. And in hepatitis delta, results from the Phase 2b portion of the AZURE-1 study further support the potential for berlivatig in a patient population where treatment options are extremely limited.

We look forward to the upcoming late-breaking presentations for both VISTA 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 zolergosertib, recently licensed from Incyte. Zolergosertib is a once-daily oral inhibitor in development for fibrodysplasia ossificans progressiva, or FOP, an ultra-rare progressive condition where patients develop bone in soft tissues. This accumulation of excess bone leads to profound physical immobilization, with most FOP patients becoming wheelchair dependent by early adulthood, and severely impacts life expectancy.

Based on the strength of zolergosertib’s PROGRESS study, conducted by Incyte, an NDA has been accepted with priority review, with a PDUFA date of September 26, 2026. 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 have 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.

With that, I will turn the call over to Peter to walk through the commercial portfolio and preparation for the upcoming potential launches.

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 Lemarle 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 us, 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 Lugmarley 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 VISTA study of meloxicimab in PSC and the AZURE-1 study of berlobotib 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 a global commercialization platform we have established for Lumarli, Cetexly, and Cobalt, 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 current 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 zolergocertib 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 and severe disability in early childhood.

FOP is a highly concentrated, ultra-rare disease with an estimated prevalence of about one 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 [inaudible].

Eric H. Bjerkholt: Thanks, Peter. Good afternoon, everyone. We remain disciplined behind our pipeline, which remains on track across all programs. Today, I will walk you through the financials for the quarter, including an overview of the impacts of the Bluejay acquisition and the zolergosertib transaction. 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-50% range, and cash flow from operations was about $2 million.

First quarter financials were significantly impacted by one-time expenses related to the acquisition of Bluejay Therapeutics, which closed in January. The total net cash out related to this acquisition was $253 million, which was offset through net financing proceeds of $260 million. Total operating expense for the quarter ended March 31 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 expense are largely reflected in our [inaudible]. As Chris and Peter mentioned, we recently entered into an exclusive license agreement with Incyte. In return for worldwide rights to zilogisertib, 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 shared royalties on worldwide net sales in the mid- to high-single-digits percent range.

As we have discussed previously, we expect R&D expense to step up in 2026 as we invest behind berlobitur 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 berlobitide. Importantly, this expected increase is fully funded. We are continuing to scale the business with discipline, 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 will now turn the call back to Chris for closing remarks.

Christopher Peetz: Mirum Pharmaceuticals, Inc. is in a strong position after a very busy start to the year. What is most encouraging about the quarter is not just the number of positive updates, but how clearly they fit together. We continue to grow our commercial medicines, we are expanding our rare liver business into larger indications, and we have added what we believe is a transformational medicine to our rare genetic business. Importantly, this is all coming together within a high-impact, scalable business model. We are excited about the progress ahead as we approach multiple pivotal readouts, potential regulatory submissions, and potential new product launches.

I would also like to thank the entire Mirum Pharmaceuticals, Inc. team for all the hard work in getting us where we are today. Your dedication brings new treatment options to patients around the world. With that, operator, please open the call for questions.

Operator: 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. 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 now while we compile the Q&A roster. Your first question comes from the line of Gavin Clark-Gartner with Evercore ISI. Your line is open. Please go ahead.

Analyst: Hi. This is Yatra 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 with Marley.

Peter Radovich: Yes, thanks for the questions. We point towards approximately 300 identified patients in the U.S., coming from patient group IFOPA. In terms of addressable patients, the main feature there is the NDA application Incyte filed is for age 12 and over, so that would be the majority of the patient population at launch.

Analyst: And then in terms of Lezmarli specifically on the guidance raise, wondering what is driving the bulk of the increase? Is it due to the ex-U.S. expansion or the continued PFIC ramp? And within PFIC, is the contribution skewing towards those older patients?

Peter Radovich: Thanks for the question. Certainly, Live Marley U.S. PFIC was the biggest driver. We continue to see both pediatric and adult patients come to treatment. I think the older adolescents and adults really are the major driver, although we are still in early innings. We have made good progress educating adult providers on genetic testing, but probably still the minority of them are actually doing that. I think there are more adult patients to find out there who could potentially benefit.

Eric H. Bjerkholt: And just on the international piece, Q1 historically has had a bit more seasonality and a little bit of a softer number in Q1, and that just was not as much of a factor this year, somewhat also in part due to not only additional countries performing, but also PFIC starting to show up in that international number.

Peter Radovich: Thank you.

Operator: Your next call comes from the line of Joshua Schimmer with Cantor. Your line is open. Please go ahead.

Joshua Schimmer: Great. Thanks so much for taking the questions. Also on the zolergosertib, how are you thinking about its differentiation versus maybe some of the other programs in development? Garetosmav, if I am pronouncing that right, and sohonos? That is number one. Number two, are you planning to explore the program in other ossification indications or 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.? Thank you.

Peter Radovich: Thanks, Josh, for the questions. Just to clarify, the “$200 plus” is a global number for us.

Christopher Peetz: In terms of positioning here, the programs that you mentioned are the ones we are tracking, with Sohonos being approved and the other program being in the registration phase. For Sohonos, the data coming out of the PROGRESS study here for zolergosertib is a real step forward in terms of the overall activity profile and tolerability and safety profile. So we see the clinical data here as a quite meaningful advance on what is currently available in the market, which has quite a few limitations to it.

And compared to the pipeline, this is an oral, which we see as a big advantage, particularly in a setting where you can potentially drive ossifications 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?

Peter Radovich: Early days in thinking about it. At this point, we want to stay very focused on getting this launched for FOP, but it is certainly something we will consider as we get further down the road.

Operator: Your next call comes from the line of Jonathan Wolleben with Citizens. Your line is open. Please go ahead.

Jonathan Wolleben: Hey. Thanks for taking the question. A little unusual having something under review where we have not seen any of the data. Just wondering what you guys have been privy to, to make you comfortable with this acquisition. And then, what would be the forum for it to make sense to get this out into a public domain? And will you guys be eligible for a review voucher if approved?

Christopher Peetz: Thanks for the question, Jonathan. I fully appreciate the unique nature of the situation. In our review—this is a conversation that has been going on for quite some time, typical for a license transaction like this—we have had full access to clinical data, to the regulatory correspondence, and the NDA. So we feel quite confident in the profile for zoligosertib and where they are at in the regulatory process. From the Incyte side, they have done a fantastic job putting together this program and saw it fitting better in a rare disease company like Mirum Pharmaceuticals, Inc., but the work they have done on it is quite strong.

They want to have the data presented first at a medical meeting, so we are hopeful that is happening relatively soon. Once we get that presented, we will be able to share more on the pivotal data and overall product profile. As for a review voucher, 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. Operationally, Incyte, given they are mid-stride with the filing and review, will complete the primary role through approval, and then we will take over sponsorship at the point of U.S. approval.

Peter Radovich: Yep. Thanks for the questions.

Operator: Your next question comes from the line of Michael Eric Ulz with Morgan Stanley. Your line is open. Please go ahead.

Rohit Bhasin: Hi. This is Rohit on for Mike. Thanks for taking our questions. With the recent pipeline acquisitions, can you talk about how you are thinking about BD moving forward? And then also, can you talk about how you are thinking about pricing in FOP? Thanks.

Christopher Peetz: I can start and I will hand it over to Peter. As you have seen now for Mirum Pharmaceuticals, Inc. over the history of the company, we see a priority in staying active on the BD front. That is 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.

Peter Radovich: On zolergosertib pricing, we will make a decision and communicate that closer to approval. For thinking about the U.S., you can look at the Niemann-Pick C products and other ultra-rare settings like that where you have a strong value proposition. Similar epi is probably in the ballpark.

Operator: Your next question comes from the line of James Condulis with Stifel. Your line is open. Please go ahead.

James Condulis: Hey. Thanks for taking my question, and congrats on the quarter. Maybe one follow-up on HDV. I think we have heard a couple questions about the 900 mg monthly arm, specifically as it relates to the TND virologic response and maybe a little bit of an outlier relative to some of your prior data and the rest of your dataset. Curious about your perspectives here. And as you think about the commercial setting, for docs in the real world, what do you think is the most important measure for evaluating efficacy for these different drugs? Is it that TND response, other measures of virologic response, the composite? Thanks.

Christopher Peetz: Thanks for the question. I will make a couple of comments and have Joanne speak to some of the data that we are seeing out of the AZURE-1 Phase IIb portion. In terms of what we are focused on and what we think is most relevant for ultimate use and driving adoption here, it is that composite of virologic response and ALT normalization. Those two factors are what is pointed to in the FDA guidance and show that you are not only addressing the viral load, but you are also addressing the liver inflammation that is part of the disease. Seeing both of those move means you are going after both components—for both the infection and the liver.

Joanne M. Quan: Yes, and to Chris’s point on the composites, all very true. When we look at the curves in terms of the virologic response, we do see declines in everyone. When you stretch to the endpoint, if you do not meet a certain point by week 24, then you are on one side of the line or the other, but we do see decreases in all of the patients. There is certainly no evidence of lack of response or resistance or anything like that. Partly, it is an artifact of time. We do see deepening response with continued treatment. And again, this is a numerically fairly small group.

We will have a lot more information with the full AZURE-1 and AZURE-4 Phase 3 datasets to make a final call on that.

James Condulis: Makes sense. Thank you.

Peter Radovich: Thanks for the questions, James.

Operator: Your next question comes from the line of Brian Skorney with Baird. Your line is open. Please go ahead.

Brian Skorney: Hey. Good afternoon, guys. Thanks for taking my question, and great quarter. I would love to also ask a question on FOP. It seems like you are doubling down on making it your corporate nemesis. I am wondering if you could give broad thoughts on where you think Sohonos’ profile leaves an opening for another entrant and compare and contrast how zolergosertib might address these. And the timeline would put us right around mid-cycle review with the FDA right now. Has that already happened or is it still pending?

Eric H. Bjerkholt: Thanks for the question. On the review, yes, that has happened, and I would just say things are tracking as expected.

Peter Radovich: In terms of positioning, the feedback we have heard from stakeholders—patients, caregivers, physicians—regarding the available therapy in the market today is that there is a lot to be desired in terms of both efficacy and safety. We will be able to get into more details once we have the PROGRESS data presented at an upcoming medical conference, but from what we have seen in our review of the zolergosertib profile, it is really exciting 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. Your line is open. Please go ahead.

Lisa Walter: Thanks so much for taking our questions. Maybe just some more detail, if you can share, on the FOP opportunity. Are there any overlaps with your current call points? And did you disclose the deal terms with Incyte? And given the recent positive results in HDV and PSC, has this impacted your thinking on when you could become a profitable company?

Peter Radovich: Great overlap with our existing team—our rare genetics team that is focused on texlecobalt. We mentioned that a significant majority of FOP patients are cared for in centers that also prescribe Cetaxley and Colbomb. Different prescribers most of the time—some overlap with medical genetics. For FOP, the biggest prescribers will be endocrinologists, so that is a new physician target, but the center overlap is really high with our existing rare genetics business. We are excited about adding this product to that team.

Eric H. Bjerkholt: On the financials, we disclosed the upfront license fee was $16 million, and the next milestone would be $25 million upon FDA approval. There are some other commercial milestones, and a royalty in the mid- to high-single-digits range. We expect after launch that this product will be accretive very, very quickly. On the path to profitability, that is much more driven by brelovitag and voxibat, as well as our current commercial business. We are spending a lot on R&D this year for both of those products, so profitability will be pushed out probably until 2028 on a GAAP basis. We reiterate that we expect to be operating cash flow positive next year.

Operator: Your next question comes from the line of Jessica Fye with JPMorgan. Your line is open. Please go ahead.

Jessica Fye: Hey, guys. Good afternoon. Thanks for taking my question. Can you estimate the contribution in the first quarter of LiveMarly 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 inhibitor being used in combination with that drug?

Christopher Peetz: Thanks for the question. Briefly on Livmarli, we typically are not breaking out by indication, but we can say both Alagille and PFIC are growing, and PFIC is the bigger growth driver.

Peter Radovich: On FOP, in the U.S. market where this medicine is available, palovarotene—based on pharmacy claims data and what we have heard in physician and caregiver interviews—it is probably a minority of diagnosed patients that are currently receiving it. It can be tried; it can often be difficult to tolerate and stay on.

Operator: Next question comes from the line of Ryan Deschner with Leerink Partners. Your line is open. Please go ahead.

Ryan Phillip Deschner: Hey, guys. I have Ryan on for Mani. Thanks for taking our question, and congrats on the quarter. Circling back to FOP, what is the latest thinking on an OUS filing and when you would expect to launch there? And then on the peak sales of $200 million, is that in the 12+ age group that you would get approved in the upcoming filing? How should we think about upcoming data for the younger age groups that are being tested? Thanks.

Christopher Peetz: Thanks for the questions, Ryan. On ex-U.S. strategy, a European filing is upcoming. We could still have that in this quarter. Incyte is still driving those activities, and their team is doing a great job. In terms of the overall peak estimate, the $200 million-plus is the full brand in FOP over the lifecycle. For the younger age patients, we do expect that the label would launch at 12 and older. There are two other cohorts in the study that are ongoing that would support potentially taking that age lower over the near term. Those are ongoing and enrolling now, so they are not too far out.

Ryan Phillip Deschner: Awesome. Thanks.

Operator: Your next question comes from the line of Ryan Deschner with Raymond James. Your line is open. Please go ahead.

Ryan Phillip Deschner: Thanks for the question. A couple for me. What is your strategy for identifying FOP patients in the U.S. and abroad, addressing the relatively high misdiagnosis rate for FOP? 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.

Peter Radovich: Thanks for the question, Ryan. FOP patients often have a longer diagnostic odyssey than they should. There are patients who get diagnosed at birth, but the literature says the average age of diagnosis is seven years, and obviously some wait longer. That is improving with the availability of genetic testing, and we see an opportunity to continue to raise awareness—just like in all of our rare genetic diseases—to shorten that diagnostic odyssey as much as we can. In the U.S., we think a substantial majority of patients are identified; it is probably a different story in some middle- and lower-income countries.

Ryan Phillip Deschner: Thanks. Just wondering if there was anything notable so far in the business extension in terms of rollover, discontinuation rates, pruritus, or other patient metrics that might take a little longer to modulate over time.

Peter Radovich: Incyte’s PROGRESS study is enrolling well. We will be able to disclose more about what they have seen at the upcoming medical conference. We have certainly seen a lot of physician and patient interest.

Eric H. Bjerkholt: Great. Thanks for the question.

Operator: Your next question comes from the line of Joseph Thome with TD Cowen. Your line is open. Please go ahead.

Joseph Thome: Good afternoon. Thank you for taking my questions. One on FOP: the level of ALK2 inhibition you are seeing with the therapy—do you think that could be enhanced by garetuzumab, Regeneron’s Activin A drug, or are these largely going to be competitive therapeutics in the landscape? And second, when we think about the potential expansion opportunity for Livmarli and the basket trial that is going to be reading out later this year, how should we think about that in your overall projection for Livmarli? How much is this basket population?

Christopher Peetz: On garetuzumab positioning, it is probably best to get into more detail after our data is presented so we can give a more complete picture. We think the profile for zolugosertib and its clinical positioning is really strong as a convenient oral single agent, and we are excited about bringing that forward.

Peter Radovich: On EXPAND, we have talked about that indication being about a third of at least a $1 billion peak sales opportunity for Livmarli, and we reiterate that.

Operator: Your next question comes from the line of Charles Wallace with HCW. Your line is open. Please go ahead.

Charles Wallace: Hi. This is Charles on for RK. Thanks for taking my question. For FOP, how many patients from the PROGRESS study—I think there were 63 in that study—do you expect could come on after launch? And do you expect to have some sort of bridging program?

Christopher Peetz: Thanks for the question, Charles. Given the nature of the relationship here, we are going to wait until we have the data presented to give specifics. Overall, we think it is a really compelling profile, and the feedback has been positive, but we do not want to get into specifics ahead of having the data presented.

Charles Wallace: That is fair. And then another question on the salesforce expansion. You are growing it to 60 in the field. When do you expect the team to be fully on board and fully functional?

Peter Radovich: As noted in prepared remarks, we are starting later this year. I think by early next year we will be fully on board, and that team will cover both pediatric and adult settings where not just adult PFIC can be found, but also PSC and HDV. By early next year, they would be active in all those areas. Of course, with the pipeline products, the activity would really start upon potential FDA approval.

Charles Wallace: Great. Thanks for taking my questions, and congrats on a great quarter.

Peter Radovich: Thanks for the questions.

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: 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.