5/6/2026

speaker
Tracy
Operator

Good afternoon and welcome to Merum Pharmaceuticals' first quarter 2026 earnings conference call. My name is Tracy 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. If you would like to ask a question during that time, press star 1 to raise your hand. I would now like to hand the call, the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.

speaker
Andrew McKibben
SVP of Strategic Finance and Investor Relations

Thank you, Tracy, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' first quarter 2026 earnings conference call. For our prepared remarks, I'm joined today by our Chief Executive Officer, Chris Peets, our President and Chief Operating Officer, Peter Radovich, and Eric Bierkhold, our Chief Financial Officer. Our chief medical officer, Joanne Kwan, will be joining us for Q&A. Earlier this afternoon, Merim issued a press release reporting our first quarter 2026 financial results. Copies of the press release and our SEC filings are available in the investor 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 Merim'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?

speaker
Chris Peets
Chief Executive Officer

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 Merriman 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 Liv Marley, and today we are a broader rare disease company with three approved medicines and a pipeline position 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'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 Live Marley 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 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 needs. In PSC, the VISTA study of velixibat showed a significant improvement in pruritus, reinforcing the potential for velixibat to play an important role for these patients who currently have no approved medicines. This is a major advance in PSC research and positions velixibat as a potential first approved medicine for patients in the U.S. And in hepatitis delta, results from the Phase IIb portion of the ZER1 study further support the potential for brelovotug in a patient population where treatment options are extremely limited. We look forward to the upcoming late-breaking presentations for both Vistos 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 Zolurgocertib, recently licensed from Insight. Zolurgocertib 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 impacts life expectancy. Based on the strength of Zolurgicertib's progress study conducted by Insight, an NDA has been accepted with priority review with a PDUFA date of September 26th 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've 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 three upcoming central launches. Peter?

speaker
Peter Radovich
President and Chief Operating Officer

Thank you, Chris. The first quarter was another period of strong commercial execution with total net product sales of approximately $160 million. This included the Marley 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 Live Marley, 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 Live Marley sales, as well as continued new patient ads and allergies 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 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 Melixabat and PSC and the Azure One study of Berlovitug and 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 Lumarly, Citexly, and Colbaum, 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 healthcare 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 healthcare 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 Zolurgicertib 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, and early mortality. 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.

speaker
Lumarly

Patients with FOP are largely managed by specialized tertiary centers With most of these centers also new patients, permits to text lead in a lot of our rare to any commercial circle. We've got data from the mid-study, secondary and more on the basis of application. Look forward to the present data from the progress of upcoming medical Yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah, yeah. We had to adopt the initiative, which means a potential first job for a raised business, peaked at $200 million. This is in addition to her medical and capability passion for support operating from old just left at home. And with that, Eric, to review our results. If Eric has an idea, go on. and disciplined investments behind our pipeline, which remains on track across all programs.

speaker
Eric Bierkhold
Chief Financial Officer

Today, I'll walk you through the financials for the quarter, including an overview of the impact of the BlueJ acquisition and the Zillow Deserted 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 of the March 31st 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 one-time expenses related to the acquisition of Blue Jay 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 31 was $949 million, which includes $761 million in expense associated with the acquisition of Blue Jay 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 non-cash expenses of $64 million, including $35 million of stock-based compensation expense associated with the acquisition of BlueJ. The intangible amortization and other non-cash IRDM expenses are largely reflected in our company's results. As Chris and Peter mentioned, we recently entered into an exclusive license agreement with Insight. In return for worldwide rights, Insight receives 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 FLP, ownership of a rare pediatric disease priority review voucher, if awarded, as well as sales-based milestones and chaired 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 Berlovitac 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 Berlovitas. Importantly, this expense 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'll now turn the call back to Chris for closing remarks.

speaker
Chris Peets
Chief Executive Officer

Thanks, Eric. ERM 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're expanding our rare 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 Merum 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.

speaker
Tracy
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.

speaker
Gavin Clark Gartner

Hi, this is Yasha 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. I'm with Marlee.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, thanks for the questions. Yeah, we point towards the approximately 300 identified patients in the U.S. coming from patient advocacy group, IPOPA, In terms of addressable patients, you know, 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.

speaker
Gavin Clark Gartner

And then in terms of those Marley specifically on the guidance rates, I'm wondering what's kind of driving the bulk of that increase. Is it due to the XUS expansion or kind of the continued PFIC ramp and Within PFIC, is the contribution still skewing towards those older patients?

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, thanks for the question. I mean, certainly Live Marley US, 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 probably still the minority of them are actually doing that. So I think there's probably more adult patients to find out there who could potentially benefit from that.

speaker
Chris Peets
Chief Executive Officer

And just on the international piece, Q1, historically we've seen a bit more seasonality and a little bit of a softer number in Q1, and 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.

speaker
Lisa Walter

Thank you.

speaker
Lumarly

Thanks for the questions.

speaker
Tracy
Operator

Your next call comes from the line of Josh Shimmer with Cantor. Your line is open. Please go ahead.

speaker
Josh Shimmer

Great. Thanks so much for taking the questions. Also on Zalurga-Surtib, how are you thinking about its differentiation versus maybe some of the other programs in development, Gretasmab, 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? Number three, I think I heard you say peak sales for the asset of $200 million. Is that global or U.S.? Thank you.

speaker
Chris Peets
Chief Executive Officer

Thanks, Josh, for the questions. Yeah, just to clarify that peak, that $200 plus is a global number for us. And in terms of kind of positioning here, the programs that you covered there, those are the ones that we're tracking, Sojonos being approved, and the other program being in registration phase. And for Sojonos, you know, the data coming out of the progress study here for Zalurk Assertive 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 a 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, particularly in the 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.

speaker
Josh Shimmer

Got it. And then plans for other ossification disorders?

speaker
Chris Peets
Chief Executive Officer

You know, we have still early days in thinking about it. At this point, I want to stay very focused on getting this launched for FOP. That's certainly something we'll consider as we get further down the road.

speaker
Josh Shimmer

Okay. Thanks very much. Thanks for your questions.

speaker
Tracy
Operator

Your next call comes from the line of John Wollenbin with Citizens. Your line is open. Please go ahead.

speaker
John Wollenbin

Hey, thanks for taking the question. You know, a little unusual having something under review or I haven't seen any of the data for it. Just wondering what you guys have been privy to to make you comfortable with this acquisition, and then, you know, what would be the form for it to make sense to get this out into the public domain?

speaker
Chris Peets
Chief Executive Officer

Yeah, thanks for the question, John. I fully appreciate the uniqueness of the situation. You know, in our review, this is a conversation that actually has been going on for quite some time. a licensed 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 Zoloft Assertive and where they're at in the regulatory process. From the Insight 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.

speaker
John Wollenbin

And will you guys be eligible for a pediatric review voucher if approved?

speaker
Chris Peets
Chief Executive Officer

So we do expect this to be eligible for a voucher. Under the terms of the agreement, Insight will keep that voucher, and we will launch the product. So the way operationally this works is Insight 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. Got it. Okay.

speaker
John Wollenbin

Thanks, Chris.

speaker
Chris

Yeah, thanks for the questions.

speaker
Tracy
Operator

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

speaker
Chris

Hi, this is Rohit on for Mike. Thanks for taking our questions. 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? Thanks.

speaker
Chris Peets
Chief Executive Officer

I can start, and I'll hand it over to Peter. But I think, as you've seen now from Miriam, kind of over the history of the company, we see a priority in staying active on the 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?

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, I mean, nothing more on the BD strategy on those alert assertive pricing. Obviously, we'll make a decision and communicate that, you know, closer to approval. But just, you know, I think for thinking about a U.S., I mean, you can look at the Neiman-Pixie products and other ultra-rare settings like that where you have a strong value proposition and similar FDs probably get you in the ballpark.

speaker
Chris Peets
Chief Executive Officer

Thanks for the question.

speaker
Tracy
Operator

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

speaker
James Condoles

Hey, thanks for taking my question, and congrats on the order. You know, maybe one follow-up on HDV. I think, you know, where we've heard a couple questions is maybe in the 900-meg monthly arm, specifically as it relates to, you know, the TND virologic response is maybe a little bit of an outlier relative to like some of your prior data and other, you know, the rest of your sort of data set, just like carries your perspectives here. And, you know, as you think about the, you know, commercial opportunity here for docs in the real world, what do you think is kind of the most important measure as it relates to you know, evaluating efficacy for these different drugs? Is it that, you know, T and D virologic response, other measures of virologic response, the composite? You know, just curious your perspective there. Thanks.

speaker
Chris Peets
Chief Executive Officer

Yeah, thanks for the question. I'll maybe make a couple comments and have Joanne speak to some of the data that we're seeing out of the 01 Phase IIb portion. And I think in terms of what we're, you know, focused on, what we think is most relevant for ultimate use and driving adoption here is that composite of virologic response and ALT normalization. Those two 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 of the considerations for both the infection and the liver. Maybe I'll ask Joanne to touch on the data we've seen today.

speaker
Joanne Kwan
Chief Medical Officer

Yeah, and so, you know, Chris is talking about the composites, you know, all very true. When we look at the, you know, curves in terms of the virological response, we do see declines in everyone. So, you know, 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, you know, 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 3 datasets to make a final call on that.

speaker
James Condoles

Makes sense. Thank you. Thanks for the question, James.

speaker
Tracy
Operator

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

speaker
Brian Scorny

Hey, good afternoon, guys. Thanks for taking my question and great quarter. I guess I'd love to also ask a question on FOP2. It seems like you're doubling down on making hits in your corporate nemesis. So I'm just wondering if you could kind of give your broad thoughts on where you think Sojonis' profile leaves an opportunity for another entrant and compare and contrast how might address these, and the timeline 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.

speaker
Chris Peets
Chief Executive Officer

Yeah, 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 a little bit more on positioning.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, I think certainly the feedback we've heard from stakeholders, patients, caregivers, physicians, others, available therapy in the market today. There's a lot to be desired in terms of both advocacy and safety. We'll obviously be able to get into more details once we have the progress data presented at an upcoming medical conference, but you know, from what we've seen in our review, there's a lot of assertive profile, really exciting about, you know, what it can mean for these patients, both efficacy-wise as well as a convenient oral and well-tolerated regimen. Okay, thank you.

speaker
Brian Scorny

Thanks for the question.

speaker
Tracy
Operator

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

speaker
Lisa Walter

Oh, great. Thanks so much for taking our question. Maybe just some more detail 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 Insight? And maybe just one more, you know, given the recent positive results in HEPTI and PSC, wondering if this has impacted your thinking on when Murum could become a profitable company. Thanks so much for taking our questions.

speaker
Chris Peets
Chief Executive Officer

Yeah, maybe I'll ask Peter to kind of speak to the SOP points, and then have Eric kind of give some financial forward-looking views.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, great overlap with our existing team, our rare genetics team that's focused on Cetexly and Colbomb. We mentioned that, you know, the majority, the significant majority of the BOP patients, SOP patients are cared for in settings, centers that also prescribe Cetexly and Colbomb. Different prescribers most of the time. Some overlap in psychogenetics. FOP has, you know, 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 chance business. So excited about adding this product to that team.

speaker
Eric Bierkhold
Chief Financial Officer

Yeah, 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 royalty in 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 Brilovitug and Volixibat, as well as our current commercial business. As we said, we're spending a lot on R&D this year for both of those products. And so profitability will be pushed out probably till 28 on the GAAP basis.

speaker
Chris Peets
Chief Executive Officer

We've reiterated that we expect to be operating cash flow positive next year.

speaker
Ryan Deschner

Yes.

speaker
Tracy
Operator

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

speaker
Jessica Fye

Hey, guys. Good afternoon. Thanks for taking my question. Can you estimate the contribution to first quarters of Marley sales from Alageel versus PFIC? And then another one, FOP, just thinking about that market, what do you see as the penetration for palveritin? And would you envision the ALK being used in combination with that drug? Thanks.

speaker
Chris Peets
Chief Executive Officer

Just for the questions, I mean, just briefly on with Marley, you know, we typically aren't breaking out by indication, but what we can say is that PFIC is, they're both growing, but PFIC is the bigger growth driver. Maybe pass the FOP question over to Peter.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, and when we look at the, you know, the US, the market where this medicine is available, Calveritin, you know, it's probably a minority of diagnosed patients that are currently receiving it. You can see from pharmacy claims data, and that kind of, you know, matches what we've heard in physician and caregiver interviews. You know, it can be tried, but it can often be difficult to tolerate and stay on.

speaker
Chris Peets
Chief Executive Officer

Thank you. Thanks for the questions.

speaker
Tracy
Operator

Your next question comes from the line of Manny Forhar with Learneck Partners. Your line is open. Please go ahead.

speaker
Manny Forhar

Hey guys, you have Ryan on for money. Thanks for taking our question and 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 in the upcoming? And how should we think about upcoming data for the younger age groups that are being tested? Thanks.

speaker
Chris Peets
Chief Executive Officer

Thanks for the questions, Ryan. On XUS strategy, actually, a European filing is upcoming. So we could actually still have that in this quarter. Insight is still driving those activities. And again, their team's doing a great job. In terms of the overall peak estimate, that 200 million plus, that's the full brand in FOP over life cycles, 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 two 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. Awesome. Thanks. Great.

speaker
Tracy
Operator

Thanks for the questions. Your next question comes from the line of Ryan Deschner with Raymond James. Your line is open. Please go ahead.

speaker
Ryan Deschner

Thanks for the question. A couple for me. You know, what's your strategy for identifying FOP patients in the U.S. and abroad and addressing the relatively high misdiagnosis rate for FOP? And do you anticipate any early line of sight into a substantial group of patients from insights prior to clinical studies or maybe a compassionate use program or something like that in FOP and have a follow-up? Thanks.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah. Thanks for the question, Ryan. Yeah. You know, I think that FOP patients often have a longer diagnostic odyssey than they should. You know, there are patients who get diagnosed at birth, but often, I think the literature says the average age of diagnosis is seven years, and there's obviously people that wait longer than that. I think that's improved with the availability of genetic testing. But, you know, 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, you know, a pretty substantial majority of the patients are identified with FOV, probably a different story in, you know, middle and lower income countries.

speaker
Chris Peets
Chief Executive Officer

Did you have a follow-up, Ryan?

speaker
Ryan Deschner

Yeah, I just was also wondering if there was anything notable so far in the VISTA's extension in terms of rollover discontinuation rates, pruritus, or other patient metrics that might take a little longer to modulate over time.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, I mean, Insight does have this progress study. It's enrolling well. I think we'll be able to disclose more about what they've seen from that at the upcoming medical conference, but it certainly seems a lot of physician and patient interest in the program.

speaker
Ryan Deschner

Okay, thanks very much.

speaker
Tracy
Operator

Your next question comes from the line of Joseph Tome with TD Cohen. Your line is open. Hi there.

speaker
Joseph Tome

Hi there. Good afternoon. Thank you for taking my questions. Maybe one on an FOP. I guess the level of L2 inhibition you're seeing with the therapy, I guess, do you think that could be enhanced by Geratosmab, Regeneron's active in 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 Live Marley 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 Livmarly, how much is this basket population? Thank you.

speaker
Chris Peets
Chief Executive Officer

I can make a quick comment on the Garitosumab positioning. And it's probably best to get into more detail on this after our data is presented so we can get a better, a more complete picture. But we think the profile for Zoligacirtib and its clinical positioning is really strong as a convenient oral single agent. I'm excited about bringing that forward. Maybe if Peter can follow up.

speaker
Peter Radovich
President and Chief Operating Officer

Yeah, and on expand, you know, we've kind of talked about that indication being about a third of the at least $1 billion peak sales opportunity for Liz Marlin. And, you know, still reiterate that. Thank you.

speaker
Liz Marlin

Thanks for the question.

speaker
Tracy
Operator

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

speaker
Liz Marlin

Hi, this is Charles. I'm for RK. Thanks for taking my question. So for, for FOP, another question on that, how many patients from the progress study of, I think there was 63 in that study. Do you expect we'll could, could come on after launch and do you expect to have some sort of bridging program?

speaker
Chris Peets
Chief Executive Officer

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 just don't want to get into specifics ahead of having that data presented.

speaker
Liz Marlin

Okay, that's fair. And then I guess another question on the Salesforce 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 the team to be fully on board and also when you expect them to be fully functional.

speaker
Peter Radovich
President and Chief Operating Officer

Thank you. Yeah. You know, I kind of prepared a comment with starting later this year. And so I kind of think, you know, early next year we'd be kind of fully on board. And that team would, you know, cover both pediatric and adult settings where, you know, You know, not just algeol and adult PPIC 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.

speaker
Liz Marlin

Great. Thanks for taking my questions, and congrats on the career quarter.

speaker
Chris Peets
Chief Executive Officer

Thanks. Thanks for the questions.

speaker
Tracy
Operator

There are no further questions at this time. I would now like to turn the call back to Chris Peets for closing remarks.

speaker
Chris Peets
Chief Executive Officer

Thank you all for joining us today and for all the support and a great start to 2026. Have a great afternoon.

speaker
Tracy
Operator

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

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-