Ascendis Pharma A/S Q1 FY2026 Earnings Call

Good day, and thank you for standing by. Welcome to the First Quarter Ascendis Pharma Earnings Conference Call. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Chad Fugure, Vice President of Investor Relations. Please go ahead.

Thank you, operator, and thank you, everyone, for joining our first quarter 2026 financial results conference call. I'm Chad Fugure, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherrie Glass, Chief Business Officer; and Jay Wu, EVP and President, U.S. Market. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of YORVIPATH, YUVIWEL and SKYTROFA, as well as certain expectations regarding patient access and financial outcomes, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization. Our strategic plans, partnerships and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing planned regulatory filings and our expectations regarding timing and the result of regulatory decisions. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements. You should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see our forward-looking statements section in today's press release and the Risk Factors section of our most recent annual report on Form 20-F filed with the SEC on February 11, 2026. TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults and the European Commission and the United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP is approved in the U.S. by the FDA for the treatment of hypochondroplasia in children aged 2 years and older. Continued approval for this indication, which is based on an improvement in annualized growth velocity, may be contingent upon verification and description of clinical benefit and confirmatory trials. TransCon hGH is approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency. In addition to the treatment of pediatric growth hormone deficiency, TransCon hGH in the EU has received marketing authorization from the European Commission for the treatment of pediatric growth hormone deficiency. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our first quarter 2026 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for your questions. With that, let me turn it over to Jan.

Thanks, everyone. Good day, everyone, here from Copenhagen. The first quarter of 2026 was an inflection point for Ascendis, with the FDA approval of our third TransCon product, YUVIWEL. Our revenues are growing rapidly. We are profitable. We have a pipeline of high-value product opportunities to support long-term growth. Three elements are cementing our position as a leading global biopharma company. First, our diversified product portfolio in one single therapeutic area. Following FDA approval of YUVIWEL, we have now achieved approval of three products in a row across four rare endocrine indications. Second, our rapid revenue growth from our existing endocrine rare disease portfolio, YORVIPATH, YUVIWEL and SKYTROFA, each highly differentiated with long durability; we expect sustained revenue growth for many years to come. Third, expanding our pipeline. We have proven our ability to create transformative medicines addressing unmet medical needs using our TransCon technology platform. To date, we have more than 20 ongoing or planned clinical trials, aiming at label and market expansion, including four new clinical entities in preclinical development. Turning now to YORVIPATH. Global YORVIPATH revenue in the first quarter reached EUR 197 million. YORVIPATH revenue for the first quarter was impacted by two one-time items: a temporary increase of U.S. patients supported by free drug caused by reimbursement disruption, and a one-time impact in Europe Direct related to expanded market access. Scott will explain the financial impact of these two events in his remarks. In the U.S., new patient enrollment in Q1 remained in line with the strong uptake we have seen in Q4 2025, with more than 1,000 new patients prescribed YORVIPATH during the quarter. Through the end of March 2026, more than 6,300 patients have been prescribed YORVIPATH by more than 2,700 unique health care providers. March was our largest revenue month ever for YORVIPATH, supported by an increased number of new patients, as well as patients returning to reimbursement from free drug. Importantly, the enrollment trend we saw in Q1 has continued through April, consistent with our guidance. Insurance approval rates and median time to approval continue to improve. This supports a strong foundation for revenue growth in 2026 and many years to come. Outside the U.S., YORVIPATH is available commercially or through early access patient programs in 35 countries, including full commercial reimbursement in six of our Europe Direct markets, with additional launches expected through 2026. Looking ahead, we continue to pursue multiple expansion opportunities for YORVIPATH in new markets and indications. This includes doses up to 60 micrograms in the U.S., global expansion to patients aged 8 and patients aged 12 to 18, and continued development of once-weekly TransCon PTH for patients on stable YORVIPATH treatment. With 70,000 to 90,000 patients living with chronic hypoparathyroidism in the U.S., and five to ten times that number outside the U.S., we remain highly confident in YORVIPATH's long-term global potential. I will now turn to our growth disorder portfolio. With SKYTROFA, our once-weekly growth hormone, we believe Ascendis is uniquely positioned to strengthen its leadership in those disorders. Our U.S. commercial infrastructure built and refined since SKYTROFA launched in 2021 has enabled a focused and high-impact launch for YUVIWEL, which became commercially available in early April. Since then, YUVIWEL has already been prescribed for more than 60 children by more than 35 unique health care providers. With some children approved for reimbursement as fast as a few days, YUVIWEL has shown compelling results compared to placebo across multiple clinical trials, in addition to linear growth outcomes. These results include improvements in final height dimensions, body proportionality, physical function and health-related quality of life compared to placebo, without compromising safety or tolerability. We believe this outcome reflects YUVIWEL's unique ability to provide continuous systemic CNP exposure throughout the weekly dosing interval. Looking ahead, we plan to make YUVIWEL available in selected international markets through early access programs using the U.S. FDA approval. As a reminder, our global infrastructure covers over 70 countries and has already generated product revenue for us in more than 35 countries. In the EU, a regulatory decision on our marketing authorization application for YUVIWEL is expected in the fourth quarter of 2026. We are also pursuing label expansion for YUVIWEL through ongoing trials. These include infants under 2 years of age with hypochondroplasia as well as geographic label expansion. Turning now to SKYTROFA. In the U.S., SKYTROFA maintained consistent performance as a premium product with a 7% share of the overall growth hormone market, reflecting steady demand across pediatric and adult patients as the only once-weekly product delivering on convenience. With the expected label expansion that could double the addressable patient population in the U.S. and geographic expansion outside the U.S., we believe SKYTROFA will remain a cornerstone product in our growth disorder portfolio. Turning to our pipeline. This includes combination therapy with once-weekly TransCon CNP and TransCon Growth Hormone for children with hypochondroplasia. In our Phase II COACH trial, we have reported unprecedented results that exceed the already compelling foundation established by YUVIWEL monotherapy. Week 52 data from COACH presented in January showed improvement in the hypochondroplasia-specific height score that indicates a threefold improvement in efficacy compared to TransCon CNP monotherapy, along with improvement in body proportionality. More recently, we shared additional week 52 data that showed improvement in lower limb alignment, as well as a statistically significant improvement in spinal canal dimensions and an improvement in arm strength, not previously demonstrated with pharmacotherapy within a single treatment. Based on this finding, we believe our unique combination therapy of TransCon CNP and TransCon Growth Hormone could potentially eliminate the need for highly invasive procedures such as limb-lengthening and leg straightening surgeries. We believe that this combination therapy could become the preferred treatment option for hypochondroplasia. I will now briefly turn to oncology. In our Phase I/II basket trial, we have evaluated TransCon IL-2 beta gamma in combination with other agents in patients with late-stage platinum-resistant ovarian cancer. Median overall survival improved up to 10 months compared to 6 to 7 months historically, and the therapy demonstrated a generally well-tolerated safety profile, which validates the science behind TransCon IL-2. As further internal oncology development does not align with our strategic focus, we have decided to discontinue internal development of TransCon IL-2 beta gamma in oncology and will explore other ways to maximize the value of these assets. Turning now to our partnerships. Our once-monthly TransCon semaglutide with Novo Nordisk continues to advance towards the clinic and our TransCon anti-VEGF program also remains on track to enter the clinic this year. These programs further highlight the broader potential of our TransCon technology platform to address product opportunities in larger indications. In closing, in the first quarter of 2026, we made significant progress across our business and our ability to make a meaningful difference for patients. We have three FDA-approved TransCon products across four indications, growing revenues, improving cash generation and a pipeline that supports long-term growth. I will now turn the call over to Scott to review our financial results.

Thanks a lot, Jan, and good afternoon, everyone. I will touch on some key points surrounding our first quarter financial results, which reinforce our confidence for growing operating profit and cash flow into the future. For further details, please refer to our Form 6-K filed today. YORVIPATH global revenue was EUR 197 million in Q1. The first quarter was characterized by steady global uptake and normal seasonality as well as two one-time items. Patients temporarily transitioned to free drug in the quarter in the U.S. and a one-time impact in Europe Direct related to expanded market access. The combined impact of these two items was approximately EUR 15 million. SKYTROFA contributed EUR 44 million in Q1. On a sequential basis, performance reflected consistent underlying demand with the expected drawdown in channel inventory built in Q4. Including EUR 6 million in collaboration revenue, total Q1 2026 revenue amounted to EUR 247 million. Continuing to expenses. R&D expenses in Q1 were EUR 59 million, down from EUR 78 million in Q4 2025. R&D in Q1 was favorably impacted by a write-up of YUVIWEL inventory consisting of EUR 11 million due to U.S. FDA approval and lower clinical activity across the portfolio. SG&A expenses rose to EUR 145 million in Q1 2026, compared to EUR 136 million in Q4 2025, reflecting continued impact of global commercial expansion. Total operating expenses for Q1 2026 were EUR 204 million and operating profit was EUR 25 million, reflecting a 10% operating margin. Non-IFRS operating profit was EUR 55 million and non-IFRS operating margin was 22%. As revenue scales, we expect meaningful improvement in our operating margin, which will be visible over the course of 2026 and beyond. Net finance expense for Q1 2026 was EUR 63 million, primarily driven by noncash items, including a remeasurement loss of financial liabilities of EUR 34 million. Net cash financial expense for Q1 2026 was about EUR 1 million. Net profit for Q1 2026 was EUR 629 million, which included recognition of a EUR 679 million deferred tax asset in the P&L. Refer to our 6-K for more detail. Non-IFRS net profit was EUR 18 million, or EUR 0.27 per share. We ended Q1 2026 with EUR 573 million in cash and cash equivalents, which includes the impact of EUR 60 million in Q1 from our previously announced share repurchase program and net settlement of certain RSUs. In April, we successfully completed our transition to a direct listing of our ordinary shares on NASDAQ. We believe this will broaden access to global investment in the company, which has the potential to further enhance institutional ownership and trading liquidity for Ascendis shares. In May, we completed the full redemption of all of our outstanding convertible senior notes. Finally, today, we announced that we entered into an agreement to sell our PRV for USD 187.5 million in cash. The PRV was awarded by the U.S. FDA upon approval of YUVIWEL in February. Turning to our commercial outlook. For YORVIPATH, we expect continued steady underlying increase in patients on therapy and the reversal of one-time factors seen in Q1 to drive strong growth sequentially in Q2. For SKYTROFA, we expect stable revenue throughout the year following a similar seasonal pattern to 2025. Regarding YUVIWEL, as Jan indicated earlier, we are encouraged by the early demand trends and look forward to sharing more with you on our Q2 call. With that, operator, we are now ready to take questions.

And our first question comes from the line of Jessica Fye of JPMorgan.

I was wondering if you could help us estimate what U.S. YORVIPATH sales were in the quarter. I think in the past, you had run through an algorithm to consider, but I know the press release noted some one-time impact to Europe Direct as well. So just trying to get a better sense of the U.S. versus ex-U.S. split this time around.

I think that Scott will give you just a little bit more background on the financial element, specific one-time in Europe Direct. And it actually happened when we had an early access program that was running for nearly 15 to 16 months. And it gave us a one-time event where we needed to write down for this single case. It's not something that is really happening in other countries; it was a single-country event, which basically impacted our Q1 results. But Scott, you can give a little bit more flavor on the financial numbers.

Yes. And just for modeling purposes, it's probably a little bit more of an impact. But I would say the best way to think about it is take the algorithm that we laid out where you add four to five thousand patients a quarter. And for Q1, basically that addition was just shifted into Q2. And then from there, the algorithm continues.

But I think just one of the key elements I will take into account is basically the underlying patient demand. Because I think the key element is really that we continue the same successful rollout of the launch, both in the U.S. where we now—as we have provided you the number of indicated new patients on treatment with YORVIPATH. And as we have given in our previous guidance, we're still 100% correct in that; we really see the same stability. We see the same flow coming in. And Jay can comment about how he's already starting to improve both the time to reimbursement and the numbers. Jay, will you comment about your effort in really improving what you call the reimbursement situation for the U.S.?

Sure. When you think about our reimbursement, we're seeing improved metrics across the board. So first and foremost, we've talked a little bit about our upstream coverage now expanding to about 80% of patient lives, which we're feeling really good about given the time on market. And I think, again, a testament to the compelling clinical value proposition that we have. We're also seeing continued rapidity as it relates to patients being approved for reimbursement upon entering the funnel. So again, over half are approved within eight weeks of enrollment. And we are seeing continued progress against patients moving through the funnel whether it's upstream as the enrollments are coming in, but also supporting patients as they're entering into the funnel.

Our next question comes from the line of Tazeen Ahmed of Bank of America.

Mine will also be on YORVI, and maybe this is for Jay. Can you talk about the reauthorization rates that you're seeing now that patients are starting to annualize at this time of year? Any things to point out about things that were maybe unexpected or taking a little bit longer? And then can you talk about usage among physicians? So is there a way of providing a split between how much of use is coming from first-time physicians versus an increasing use among doctors who've tried your YORVIPATH before?

Okay. There were multiple questions. I hope you got everyone down. Jay, will you start on some of them?

Sure. I think I heard a few questions. One, which maybe I'll start with towards the end, which is prescriber breadth and depth. We're seeing continued traction across both. So as Jan mentioned earlier, we've had over 2,700 prescribers, which again is an addition of about 300-plus quarter-over-quarter, which we're feeling really good about. So that would answer your question around new prescribers. And then within existing prescribers, we're also feeling really good because the average prescription per physician continues to increase as well. In fact, about 10% of prescribers have now over five enrollments for patients. Again, as you think about the provider landscape here, they all do have a different patient volume just given how diffuse the patient volume is. But generally speaking, we're seeing not only one additional prescriber sign on to YORVIPATH given the strong patient satisfaction scores that we're seeing, but then because of those positive patient experiences, we're also seeing providers expand their scope of who they deem to be eligible given that lab values alone are not the reason that patients should be treated. On reauthorization, we're not seeing any meaningful differences in terms of approval rates for re-auth versus necessarily a patient that's coming in at the top of the funnel. We typically, again, have shared that four- to eight-week time frame. We've seen those numbers continue to increase in terms of speed, which I referenced earlier with the first analyst question, but we're not seeing any meaningful difference with the re-auth coming in versus a new patient coming in. Generally, what you'll see is if it's a re-auth of an existing payer insurance where there hasn't been a change in insurance, you might see some faster timelines there. But if it's a brand-new insurance, then you're obviously going to treat it as just a brand-new case, so to speak.

Our next question comes from the line of Yaron Werber of TD Cowen.

Great. Maybe a quick follow-up and then a question on YUVIWEL. A follow-up on YORVI. So of the approximately $15 million, should we roughly kind of split it like half in Europe and half in the U.S.? I don't know if you can give us any sort of view on that. And then for YUVIWEL, in the ITC case the bridge document and the briefs are out kind of back and forth. It looks like the court is kind of siding with both parties. I know you've been importing drug in the meantime. Any view sort of on how much capacity you might be able to have in the system by the time a decision is rendered?

First of all, I believe when you see the uptake in the prescriptions in the U.S., we have more than 60 children being prescribed YUVIWEL treatment in less than four to five weeks. I think it illustrates the unmet medical need that exists in the U.S. related to an improved treatment in hypochondroplasia. And I believe the clinical data in our multiple trials with YUVIWEL as monotherapy is really describing the reason why we see this take-up. This is not just having a once-weekly product. This is providing a tolerability profile and documented effect on benefit beyond linear growth. And I think everyone is aligning with the unmet medical need and the public interest for this to have a product option in the market. We will continue to be in a position that we have such a strong belief that in this case, too, like it was in Europe, we can prove that this IP case should never have existed and only is built on promises. I'm confident YUVIWEL is here to stay, and it will always be a treatment option for patients with hypochondroplasia in the U.S. I hope that answers your question related to that part. The other part, I think you are somewhere in the right estimate when you think about capacity.

Our next question comes from the line of Gavin Clark-Gartner of Evercore ISI.

This is on for Gavin. We have two quick questions. Number one is for the Phase III combination growth hormone and CNP trial: can you share any update on the enrollment speed? And secondly, what are you seeing in your discontinuation rates over time?

So when we talk about—the combination trial, the Phase II COACH trial—we are now about 18 months into the trial. And I think we see an extremely high level of retention in this trial. To my knowledge, last time it was essentially 100% retention. And I think it's really rare to see 100% retention after nearly 18 months in a clinical trial. From that perspective, I think it's really illustrative of the satisfaction with the benefit you see in the treatment compared to the burden of treatment. And I think that is really the key element that we are always looking at. We want to see benefit for patients. This is why we're working, and we will continue to focus on that.

Our next question comes from the line of Li Wang Watsek of Cantor Fitzgerald.

I guess on new patient adds you mentioned steady growth. Is it reasonable for us to assume 1,000 is sort of the number that we should be looking at for the coming quarters? And will you be sharing new script numbers going forward?

That's a great question. Going back to the last time I said I would not come out with more prescription data for YORVIPATH because I believed that the revenue progression was so clear. When I said that, some pushed back and suggested I should share numbers. We've illustrated for one more quarter that the numbers are not bad; they are extremely good and exactly as predictable as we have said. I expect steady-state enrollment in all the quarters because that is what we expect. We are only touching a small portion of this patient group. We will continue to be transparent about everything we're doing so you always have the best possible opportunity to see how well we are performing in our fundamentals.

Our next question comes from the line of Alex Thompson of Stifel.

This is Patrick on for Alex. Could you guys just talk about the potential impact of the YORVIPATH 60 micrograms being on the label? And maybe what percentage of those 6,300 patients in the U.S. are dose-capped at 30 with perhaps less-than-ideal supplementation levels?

This is a question which is very difficult for us to answer today because we see different up-titration patterns in clinical trials and also variation in real world usage. We are following it closely. We are open for enrollment in our trial where we are evaluating dose titration from 30 up to 60 micrograms, and we will enroll that at a decent speed. We are doing that in the U.S. because it's the only place where dosing has been restricted to 30 and not 60. We believe that even if patients are maintained at 30 micrograms, they still derive major benefit compared to many of the positive effects that YORVIPATH provides. So yes, there are patients who may benefit from going higher, but today we are still providing important benefits to patients on 30 micrograms.

Our next question comes from the line of Joe Schwartz of Leerink Partners.

Some physicians we've spoken with have suggested that they might not want to put their office staff through the reimbursement challenges of switching their hypochondroplasia patients to a once-weekly injection only to then later switch them to a once-daily pill in the not-too-distant future. Is this a dynamic that you guys are aware of? And what can Ascendis do to help support the hypochondroplasia patient, or physician community rather, and encourage uptake? And then have any—my second question is, have any physicians prescribed YUVIWEL in combination with SKYTROFA since YUVIWEL was approved?

Answering your first part of the question, I think the numbers speak for themselves. We see strong uptake for an orphan disease product. That shows the unmet need and the willingness among physicians and parents to start children on YUVIWEL. Related to the second question about combination therapy, I cannot promote an off-label combination, but we have disclosed the benefit of the combination therapy. It is up to physicians whether they want to prescribe it. To my knowledge, yes, combination prescribing does happen, and I understand why: it's a way to potentially avoid surgeries. We're looking forward to finalizing the Phase III trial and putting this on label so we can promote it more broadly.

Our next question comes from the line of Ellie Merle of Barclays.

This is Jasmine on for Ellie. For YUVIWEL, can you say how many of those 60 enrollments were new starts versus switches? More generally, do you think the initial population is going to see more new starts or switches? And what kind of patients do you think are most likely to initially want to switch?

The insights you're asking for are the insights we will develop in the coming months and quarters. After five weeks it's too early to draw general conclusions about the mix of patient types. The only thing I can say is that we are seeing demand coming from everywhere: not just treatment-naïve patients, not just switch patients. It's coming from all expected sources. Jay, do you have anything to add?

Yes. Jan summed it up well. The two additional things I'd add: one, we're seeing uptake across the three patient types we previously outlined. One, patients currently on VOXZOGO switching over. Two, patients previously on VOXZOGO who discontinued and are now on no therapy. And three, patients who had never made the decision to start therapy at all. Anecdotally, we're seeing interest across all three groups. That underscores the continued unmet need that exists even with the current therapy on the market. The second area Jan referenced is our continued investment in supporting physicians and patients: partnerships with patient advocacy groups and scaling up our patient access liaison team to support the journey from prescription to being on therapy.

Our next question comes from the line of Yun Zhong of Wedbush.

My question is on monotherapy for hypochondroplasia. I remember that there have been some changes in terms of approach for that program, whether you're going to pursue that indication at all and whether it's going to be mono or combo. Can you share any information regarding the thought process behind the decision if the final decision is to just use monotherapy to target hypochondroplasia?

Yes. The strategy we applied to achondroplasia—where we started with monotherapy and then added combination therapy—is the same principle we will likely use in hypochondroplasia. The two indications are aligned in the fundamentals of the disease, with different mutations and severity. We will implement the same thinking in treatment regimens between these two indications.

Our next question comes from the line of Luca Issi of RBC Capital.

Maybe Jay or Scott, can you educate us on the mechanics of the free drug for YORVIPATH? Who are the patients that got the free drug? For how long do they stay on free drug? And are you expecting any patients still on free drug in Q2? Or is this just a Q1 phenomenon? Any color there would be much appreciated. And super quickly, I think AstraZeneca presented their Phase III data this week in the European Congress on Endocrinology. Wondering if you can comment on what are your expectations for that data?

I can start on the competitor question then Jay can follow up on the free-drug mechanics. The compound you are referring to in the conference is an amyloid compound. We have discussed this on many calls previously and the lack of compelling data in that package. Now that some information has been disclosed about their data package about a year after finalization of the Phase III trial, the key question is whether that data package provides approvability. To my judgment, I do not see a path for approval. I don't view it as a likely competitor to YORVIPATH. I see YORVIPATH's once-weekly approach providing fundamentals for decades of treatment where I don't expect another product to match the benefits we see with YORVIPATH. Related to the free drug, Jay, over to you.

Again, I think Jan summarized the competitor position well. On the free-drug mechanics, there are two types of programs. We have bridge programs, which are standard across the industry for those that experience a temporary insurance lapse. We also have a patient assistance program for patients that are underinsured or uninsured. We started providing free drug to a group of patients beginning in December to bridge temporary reimbursement disruptions, and those patients were covered through March in many cases and are returning to reimbursement. We don't expect the bridge program to be a long-term persistent phenomenon, but the patient assistance program will always exist to support those who are underinsured or uninsured. We took corrective actions to minimize future disruptions and built up our infrastructure to handle similar issues more effectively.

Yes. To clarify, the patients we provided free drug to were those who experienced a disruption in the normal reimbursement process. We will always put patient focus first and support patients with free drug as needed until the disruption is resolved.

Our next question comes from the line of Maxwell Skor of Morgan Stanley.

Given the relatively low treatment penetration in hypochondroplasia in the U.S. to date, what proportion of patients typically initiate treatment at age two years or older?

I think it's useful to step back to ask why there is under-treatment in the U.S. We believe undertreatment is caused in part by lack of awareness of benefits beyond linear growth. Many parents and physicians value improvements in comorbidities and avoiding surgeries more than linear growth alone. Our product profile demonstrates benefits beyond linear growth—such as improvements in proportionality, arm length, spine, and potentially avoiding surgeries. If we can show benefits in younger children, early intervention could prevent complications like spinal stenosis. We believe our profile will be appealing to the majority of parents and children in the U.S. because it addresses comorbidities and quality-of-life issues.

Our next question comes from the line of Paul Choi of Goldman Sachs.

Congrats on the good start with YUVIWEL. I was just wondering if you could clarify in terms of the more than 60 prescriptions you've seen to date, whether it's more driven by treatment-naive patients or switches? Any quantification there would be great. And I'm also curious in terms of early starts through the quarter, if you're seeing potential utilization in the below-two-years-of-age population, even though that's not officially on label yet.

We need more time to develop a meaningful answer; we've been on the market for only four to five weeks. We see patients coming from all three groups—new starts, prior discontinuers, and switches. Over time the mix may shift, and we will provide more data when we can give a representative view. Regarding under-two use, I cannot comment on that currently.

For the 70% cumulative U.S. insurance approval rate that you previously cited, can you give us any more color on what that cumulative rate looks like today? And then second, the EUR 500 million operating cash flow target that you laid out previously, are you reaffirming that guidance given the Q1 trends that you're seeing? And how should we think about the contribution of PRV sale to that target?

We would like to come back on full guidance after our Q2 results because we have a lot of positive data coming in and the YUVIWEL launch is going much stronger than even I hoped. We prefer to provide updated outlook after Q2, and we will give you what will be reflected for 2026. Scott is aligned with that. Jay, do you want to give the latest on approval rate?

Sure. The overall cumulative approval rate since launch has continued to creep up. I think we're now closer to the mid-70% range, which is incredibly high for any rare disease asset, much less one that's been on the market for the amount of time we have. A lot of that is just a function of time given the favorable access policies that exist. Some enrollments that might be many months old are coming through on appeal, which affects the cumulative approval rate over time. Given that it is a lagging indicator, it will take quite a bit of time for that metric to fully mature.

And our last question comes from the line of Cecilia Hernandez.

Given the revenue now from commercial products, the redemption of the convertible notes and the sale of the PRV, can you tell us anything on your capital allocation strategy? What is the order of priority for you guys?

I think Scott will answer that question for today. Scott, go ahead.

Thanks a lot, Jan. Of course, as you've seen with our R&D success, a key component for us is to invest in R&D and allocate capital there to continue to sustain not only into the 2030s, but the 2040s and beyond with the continuous flow of new products. Jan highlighted new NCEs in his prepared remarks, and you'll learn about more of those in the coming future. After we give an update after Q2, as Jan mentioned, we may provide more color at that point as well.

Thank you. That's all the time we have for questions. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.