Operator
Good day, and thank you for standing by. Welcome to the first quarter Ascendis Pharma earnings conference call.
At this time, all participants are on listen-only mode. After the speakers' presentation, there will be a question-and-answer session.
To ask a question during the session, you will need to press *11 on your telephone. You will then hear an automated message advising your hand is raised.
To withdraw your question, please press *11 again. 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 Fugere, Vice President of Investor Relations. Please go ahead.
Chad Fugere
Thank you, operator, and thank you, everyone, for joining our first quarter 2026 financial results conference call. I'm Chad Fugere, 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; Sherry Glass, Chief Business Officer; and Jay Wu, EVP and President, US 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, YUVEVELL, 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 and planned regulatory filings, and our expectations regarding the timing and the results 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, and 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 11th, 2026. TransCon PTH is approved in the US 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 US by the FDA for the treatment of achondroplasia 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 in confirmatory trials.
TransCon hGH is approved in the US 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, and in the EU has received MAA 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 will 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.
Jan Mikkelsen
Thanks Chad. Good day, everyone, here from Copenhagen.
The first quarter of 2026 was another inflection point for Ascendis, with the FDA approval of our third TransCon product, YUVEVELL. 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 YUVEVELL, 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, YUVEVELL, 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 differentiated new chemical entities in preclinical development.
Turning now to YORVIPATH. Global YORVIPATH revenue in the first quarter reached €197 million.
Q1 revenue for the first quarter was impacted by two one-time items: a temporary increase of US patients supported by free drug caused by reimbursement disruption, and one-time impact of Europe Direct related to expanded market access. Scott will explain the financial impact of these two events in his remarks.
In the US, 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 healthcare 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 trends we saw in Q1 have continued to improve through April, consistent with our guidance.
Insurance approval rates and median time to approval continue to improve. This strong support as strong foundations for revenue growth in 2026 and many years to come.
Outside the US, YORVIPATH is available commercially or through named patient programs in 35 countries, including full commercial reimbursement in six of our Europe Direct markets, with additional launches expected through '26. Looking ahead, we continue to pursue multiple expansion opportunities for YORVIPATH in new markets and indications.
These include doses up to 60 micrograms in the US, global expansion to patients aged 12 to 18, and continued development of once-weekly TransCon PTH for patients on stable YORVIPATH doses. With 70 to 90,000 patients living with chronic hypoparathyroidism in the US and five to 10 times that number outside the US, we remain highly confident in YORVIPATH's long-term global potential.
I will now turn to our growth disorder franchise. With once-weekly YUVEVELL alongside our once-weekly growth hormone, SKYTROFA, we believe Ascendis is uniquely positioned to strengthen its leadership in growth disorders.
Our US commercial infrastructure, built and refined since SKYTROFA launch in 2021, has enabled a focused and high-impact launch for YUVEVELL, which became commercially available in early April. Since then, YUVEVELL has already been prescribed for more than 60 children by more than 35 unique healthcare providers, with children approved for reimbursement as fast as a few days.
YUVEVELL has shown compelling results compared to placebo across multiple clinical trials. In addition to linear growth outcomes, these results include improvements in leg bowing, spinal canal dimensions, body proportionality, physical function, and health-related quality of life compared to placebo, without compromising safety or tolerability.
We believe these outcomes reflect YUVEVELL's unique ability to provide continuous systemic CNP exposure throughout the body over the weekly dosing interval. Looking ahead, we plan to make YUVEVELL available in selected international markets through early access programs using the US 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 YUVEVELL is expected in the fourth quarter of '26.
We are also pursuing label expansion for YUVEVELL through ongoing trials. These include infants under two years of age with achondroplasia and children with hypochondroplasia, as well as geographic label expansion clinical trials.
Turning now to SKYTROFA. In the US, SKYTROFA maintained consistent performance as a premium product with 70% share of the overall growth hormone market, reflecting steady demand across pediatric and adult patients as the only once-weekly product delivering unmodified somatropin.
With the expected label expansion that could double the addressable patient population in the US and geographic expansion outside the US, we believe SKYTROFA will remain a cornerstone product in our growth disorder portfolio. Turning to our pipeline.
These include combination therapy with once-weekly TransCon CNP and TransCon Growth Hormone for children with achondroplasia. In our Phase 2 COACH trial, we have reported unprecedented results that exceed the already compelling foundation established by YUVEVELL monotherapy.
Week 52 data from COACH presented in January showed improvement in achondroplasia-specific height Z-score that indicate a tripling of 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 an accelerated improvement in spinal canal dimensions and an improvement in arm span not previously demonstrated with pharmacotherapy within a single treatment year.
Based on these findings, we believe our unique combination therapy of TransCon CNP and TransCon Growth Hormone could potentially eliminate the need for highly invasive procedures such as leg lengthening, arm lengthening, and leg straightening surgeries. We believe that this combination therapy could become the preferred treatment option for achondroplasia.
I will now briefly turn to oncology. In our Phase 1/2 IL-Believe trial, we have evaluated TransCon IL-2 beta/gamma in combination with paclitaxel in patients with late-stage platinum-resistant ovarian cancer or PROC.
Median OS improved up to 10 months from 6 to 7 months from historical controls with a general well-tolerated safety profile validated the science behind TransCon IL-2 beta/gamma. 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 this asset.
Turning now to our partnership. Our once-monthly TransCon Semaglutide with Novo Nordisk continue to advance towards the clinic, and Auris TransCon anti-VEGF also remain on track to enter the clinic this year.
These programs further highlight the broad 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 to support long-term growth. I will now turn the call over to Scott to review our financial results.
Scott Smith
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 €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 US, and a one-time impact in Europe Direct related to expanded market access. The combined impact of these two items was approximately €15 million.
SKYTROFA contributed €44 million in Q1. On a sequential basis, performance reflected consistent underlying demand, with the expected drawdown in channel inventory built in Q4.
Including €6 million in collaboration revenue, total Q1 2026 revenue amounted to €247 million. Continuing to expenses.
R&D expenses in Q1 were €59 million, down from €78 million in Q4 '25. R&D in Q1 was favorably impacted by a write-up of YUVEVELL inventory consisting of €11 million due to US FDA approval and lower clinical activity across the portfolio.
SG&A expenses rose to €145 million in Q1 2026, compared to €136 million in Q4 2025, reflecting continued impact of global commercial expansion. Total operating expenses for Q1 2026 were €204 million, and operating profit was €25 million, reflecting a 10% operating margin.
Non-IFRS operating profit was €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 €63 million, primarily driven by non-cash items, including remeasurement loss of financial liabilities of €34 million. Net cash financial expense for Q1 '26 was about €1 million.
Net profit for Q1 2026 was €629 million, which included recognition of a €679 million deferred tax asset in the P&L. Refer to our 6-K for more detail.
Non-IFRS net profit was €18 million, or 27 euro cents per share. We ended Q1 2026 with €573 million in cash and cash equivalents, which includes the impact of €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 $187.5 million in cash.
The PRV was awarded by the US FDA upon approval of YUVEVELL 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 YUVEVELL, 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.
Operator
Thank you. At this time, we'll conduct a question-and-answer session.
As a reminder, to ask a question, you will need to press *11 on your telephone and wait for your name to be announced. To withdraw your question, please press *11 again.
Please limit yourself to one question, and if you have additional questions, kindly rejoin the queue. Please stand by while we compile the Q&A roster.
Our first question comes from the line of Jessica Fye of J.P. Morgan.
Your line is now open.
Jessica Fye
Hey guys, good morning. Thanks so much for taking my question.
I was wondering if you could help us estimate what US 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.
Just trying to get a better sense of the US versus ex-US split this time around. Thank you.
Jan Mikkelsen
I think Scott will give you just a little bit more background on the financial element, specific the one-time in Europe Direct. It's actually happening when we sometimes, and specific for one single country, because we had an early access program that was running for nearly 15 months, 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 really happening in other countries, but it was a single-country event which basically impacted our YORVIPATH, you can say, Q1 results. Scott, you can give you a little bit more flavor on the financial numbers.
Scott Smith
Just for modeling purposes, it's probably a little bit more of an impact, but I would say that the best way to think about it is take the algorithm that we laid out where you add 4 to 5 a quarter, and for Q1, basically that addition was just shifted into Q2, and then from there the algorithm continues.
Jan Mikkelsen
I think, yes, one of the key elements I will take into regard is basically the underlying patient demand, because I think the key element is really that we continue the same successful, you can say, rollout of the launch, both in US, where we now, as we have providing you the number of initiated new patients on treatment with YORVIPATH, and as we have given in our previous guidance, we stood 100% correct in that, where we really see the same stability, we see the same flow coming in. Jay can comment about how he already starting to improve both the time to reimbursement and the numbers.
Jay, will you comment about your effort in really improving what we call the reimbursement situation for the US?
Jay Wu
Sure. When you think about our reimbursement, we're seeing improved metrics across the board.
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.
Again, over half approved within eight weeks of enrollment. We are seeing continued progress, again, 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.
Jessica Fye
Great, thank you.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Tazeen Ahmad of Bank of America. Your line is now open.
Tazeen Ahmad
Hi guys, good morning. Thanks for taking my question.
Mine will also be on YORVI, and maybe this is for Jay. Can you talk about the reauthorization rate 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? Then can you talk about usage among physicians?
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 YORVIPATH before? Thanks.
Jan Mikkelsen
Jay, that was multiple questions. I hope you got everyone down.
Will you start on some of them?
Jay Wu
Sure. I think I heard a few questions.
One, which maybe I'll start with towards the end, which is prescriber breadth and depth, I think was the question. We're seeing continued traction across both.
As Jan mentioned earlier in the script, we've had over 2,700 prescribers, which again is an addition of about a 300-plus quarter-over-quarter, which we're feeling really good about. That would answer your question around new prescribers.
Then within existing prescribers, we're also feeling really good because the average prescription per physician continues to increase as well. In fact, over about 10%-ish 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. Generally speaking, we're seeing not only one additional prescribers 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.
Tazeen Ahmad
Thanks. Then reauthorization was the last one.
Jay Wu
Reauthorization, yes, that was the first part of your question. 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 timeframe. We've seen those numbers continue to increase in terms of speed, which I referenced earlier with the first analyst question.
We're not seeing any meaningful difference with a 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 timeline there.
If it's a brand new insurance, then you're obviously going to treat it as just a brand new case, to speak.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Yaron Werber of TD Cowen. Your line is now open.
Yaron Werber
Great. Thanks so much.
Maybe a quick follow-up and then a question on YUVEVELL. A follow-up on YORVI: so of the €15 million, should we roughly kind of split it half in Europe and half in the US?
I don't know if you can give us any sort of view on that. Then for YUVEVELL, in the ITC cases progressing, the briefs are out kind of back and forth, and 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?
Thank you.
Jan Mikkelsen
I believe when you see the uptake in the prescriptions of YUVEVELL in the US, we have more than 60 children being prescribed YUVEVELL treatment in less than four or five weeks. I think it illustrates the unmet medical need that exists in the US related to an improved treatment in achondroplasia.
I believe what we have seen of clinical data in our multiple trials with YUVEVELL, just as a monotherapy, is really describing the reason why we see this takeoff. This is not just of having a once-weekly product.
This is providing a tolerability profile and documented effect on benefit beyond linear growth. I think everyone is aligning with the unmet medical need, the public interest always to have a product as YUVEVELL in the market.
We will continue to be in a position that we have such a strong belief that in this case here too, like it was in Europe, we can prove that this IP case should never have existed and only is built on false premises. I'm 100% confident YUVEVELL is here to stay, and it will always be a treatment option for patients with achondroplasia in the US.
I hope that answered your question related to that part. The other part, I think you're somewhere in the right estimate when you think about it.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Gavin Clark-Gartner of Evercore ISI. Your line is now open.
Evie Kao
Hi, this is Evie on for Gavin. We have two quick questions.
Number one is for the Phase 3 A-Con CNP and growth hormone combo trial, can you share any update on the enrollment speed? Secondly, what are you seeing in YORVIPATH discontinuation rates over time?
Jan Mikkelsen
When we talk about, as I understood your question right, it was related to the combination trial, the Phase 2 trial, the trial we call the COACH trial. We basically are now, I do not know how many years we are into the trial now, but I think we're two years, 1 and 1/2 year now in it.
I think we see basic and extremely high element of retention in this trial. To my knowledge, last time I looked, it was 100%.
I think it's really been harder to get more than 100% in a clinical trial, to my knowledge. I think that's a very, very, very few trial where you have 100% retention after nearly 18 months.
From that perspective, I think it's really are illustrating and addressing the satisfaction with the benefit you see in the treatment compared to the burden of treatment. I think that is really the key element that we always are looking in the fundamentals.
We want to see benefit for patients. This is why we're working, and we will continue to focus on that.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Leland Gershell of Cantor. Your line is now open.
Li Watsek
Hey, thanks guys. I guess on YORVI new patient, as 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?
Will you be sharing new script number going forward? Thanks.
Jan Mikkelsen
That's a great question. Now, somewhere going back to last time, I said I would not be come up with more prescription data for YORVIPATH because I believed that the revenue progression was so clear.
When I said that, there was a big, big, big, what I call, element of some interesting funds that pushed back and saying, I didn't want to come out with the numbers because it must be really, really bad. Now we have illustrated for one quarter more that they're not bad.
They're extremely good and exactly as predictable as we have said in this way. I expect a steady-state enrollment in all the quarters, because that is what we expect.
We are only touching a small amount of this patient group. We have so much more patient that is coming, new patients every, every, every, every year.
I'm somewhere giving up to say that I will not come out one quarter more, because last time I said we will not come out in one quarter, and then I got basically pressed because I didn't want to listen to that we didn't want to come out with the number because they're bad. I don't hide anything.
I always want to be transparent. This is why I said come out with the number, then you can see it.
I think we will continue to be so transparent on everything what we're doing, you always have the best possible opportunity to see how well we are performing in our fundamentals.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Alex Thompson of Stifel. Your line is now open.
Patrick Culliton
Hey, thanks for taking the question. This is Patrick on for Alex.
Could you guys just talk about the potential impact of the YORVI 60 micrograms being on the label, and maybe what percentage of those 6,300 patients in the US is dose capped at 30 with maybe less than ideal supplementation levels?
Jan Mikkelsen
This is a question which are very, very difficult for us to answer today, because we see different kind of uptitration in both different situations in clinical trials and also situation in what I call more real world. We are following it a lot.
We are now open for enrollment in our trial, where we are having two arms in our evaluation of dose titration over 30, up to 60. We will enroll that in a decent speed.
We only do that in the US, because this is the only place where we're restricted down to 30 and not have 60. We believe that even if you're coming up to 30 microgram, you still have a major benefit to be still on 30 microgram compared to many of the positive effects that YORVIPATH is still providing to it.
I think you can say, yes, there is someone that would be in the benefit to go higher up, but today we're still providing the benefit to the patient that needs to stop on 30 microgram.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Joseph Schwartz of Leerink Partners. Your line is now open.
Joseph Schwartz
Great. Thanks so much for taking my question.
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 achondroplasia 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?
What can Ascendis do to help support the achondroplasia physician community and encourage uptake? Then my second question is, have any physicians prescribed YUVEVELL in combination with SKYTROFA since YUVEVELL was approved?
Thanks.
Jan Mikkelsen
Answering your first part of the question, I think the number speaks for itself. When you think about it, more than 10 prescription per week for such a rare disease product.
I think it talked about the unmet medical need and the willingness for basic the physician in connection with the parents, in connection with the child, to basically have the desire to take them on a treatment with YUVEVELL. I think it's say everything, the numbers.
You can go out and ask one physician. You can go out and ask one parent.
I look on numbers from a statistic art. The numbers talk for itself.
Related to the last question, I cannot, in some way, discuss an element. We cannot promote, anyway, in titration for combination therapy.
We have disclosed the benefit of the combination therapy, and that is up to the physicians if they really want to prescribe it or not prescribe it. To my knowledge, and I can be pretty open about it, yes, it happens, and I understand why.
This is the only way you basically can be in a position where you basically can avoid any kind of surgeries, which I think is such an positive element for any child with achondroplasia to avoid this invasive surgeries. I think this is a reason why physician do it, and for sure, we looking forward to finalize the Phase 3 trial.
We looking forward to have it on label, we really also can go out and promote it actively.
Joseph Schwartz
Thanks for the insights.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Eliana Merle of Barclays. Your line is now open.
Jasmine Alexandra Fels
Hi, this is Jasmine on for Ellie. Thank you for taking our question.
Just kind of a follow-up to the last question. For YUVEVELL, can you say how many of the 60 enrollments were new starts versus switches?
More generally, do you think the initial population is going to be more new starts or switches? What kind of patients do you think are the most likely to initially want to switch?
Thank you.
Jan Mikkelsen
The insight you're asking for is the insight we will develop in the coming months and quarter. After five weeks, to try to come with a general statement about what kind of patient, what kind of preference they have to go on to YUVEVELL treatment, I think it's too early for us to come with a conclusion, but it is such a topic.
The only thing I can say, and Jay, you can add on, what we see is basically coming from everywhere. It's not just naive patient.
It's not just switch patients. It's coming everywhere from where we expected also to come from.
One of the things we have done at Ascendis that Jay have made an impact on to help the physician, the patient, is really to have a program that can go out and really help the physician, the patients everywhere to get through this journey to be sure they can come on the right treatment. Jay, do you have anything to add?
Jay Wu
I think you summed it up well. The only two additional things I would add is, one, to Jan's point, we're seeing across all segments, and we've discussed before the three areas or types of patients that we envision coming are: one, patients currently on Voxzogo that are switching over; two, patients that were previously on Voxzogo, but since discontinued and were on no therapy; and then three, a patient that perhaps had never made the decision to start therapy at all.
We are seeing, anecdotally, that it's coming across all three of those groups. I think really what that underscores is the continued and existing unmet need that exists in achondroplasia today, even with the existing therapy on market, which I think emphasizes the value of having YUVEVELL on the market and the compelling value proposition that it offers patients.
I think the second area that Jan was talking about is our continued investment in just making sure that everything we're doing is hand-in-glove with patients, both as it relates to partnerships with the patient advocacy groups, but also as it relates to our scaling up of our patient access liaison team, which is our patient-facing field group that invests in the support and the journey as they go through the continuum of prescription to ultimately being on therapy.
Jasmine Alexandra Fels
Great, thank you.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Yigal Nochomovitz of Wedbush. Your line is now open.
Yun Zhong
Hi, good morning. Thank you very much for taking the question.
My question is on the 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, or maybe just wanted to know are you able to share any information regarding the thought process behind the decision if this is the final decision that you are going to just using monotherapy to target hypochondroplasia?
Thank you very much. Yeah.
Jan Mikkelsen
I think the strategy that we have applied to achondroplasia, where we started with monotherapy and then moving on to an addition to combination therapy, I think you will see that as there will be alignment between the strategic approach that we have used in achondroplasia, we will likely also use in hypochondroplasia. I can basically tell you that we're using the same principle between the two indications.
The two indication is very much aligned in the fundamentals of the disease. There is only, you can say, different mutation, different severity, and other things like that.
We will implement the same thinking in treatment regime between these two indications.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Luca Issi of RBC Capital Markets. Your line is now open.
Oh,
Luca Issi
great. Thanks so much for taking my question.
Maybe for 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? Are you expecting any patients still on free drug in Q2, or is this just a kind of Q1 phenomenon?
Any color there, much appreciated. Then super quickly, I think AstraZeneca is presenting the Phase 3 data for ENIBOW this week in the European Congress of Endocrinology.
Wondering if you can comment on what are your expectations for that data. Thanks so much.
Jan Mikkelsen
Yeah. I can somewhere start from the last question, and then I can move it up, and then Jay can take over in the end.
The compound we're talking about in the end is the Amolyt compound. We have discussed that on many earnings calls, the lack of information that was related to data.
Now there is disclosed some kind of information of the data package one year after finalization of the Phase 3 trial. For me, and I think the key question, do this data package provide an approvability of anyway of this compound?
To my best judgment, I hope this product never will be approved, and I don't see really as possibility that it should be and going to be approved. I think when we look on the competitive landscape for treatment in hypoparathyroidism, I see YORVIPATH, our once-weekly approach to stable patient on YORVIPATH, is really providing the fundamentals for a 20-, 30-years treatment regime, where I don't see anything that really can live up to the benefit we will see in the treatment with YORVIPATH for any other product that is currently in clinical development from that perspective.
Related to the first part of your question, you're right. We started to take over in December a group of patients over to free drug because the essential part of YORVIPATH is that you cannot stop.
If you first have started taking you over to basically the element on what we call the conventional therapy, is basically a disaster for the patient. If there was a hiccup in the reimbursement, which there was a hiccup, and it's something we had done corrective action to ensure that we can handle it much better next year, we were in a position that we took, and Scott explained the impact of that here in Q1, to take already from December until March a series of patient on free drug, and they are now coming back to be fully reimbursed.
We are in a position that Jay and the organization in US have built up network, other things that can help it, that we not ending in the same situation one time more. Jay, have you any comments, too?
Jay Wu
Again, I think you summarized the need for bridge program well. I think just to clarify the earlier question, there is two types of free programs.
We have Bridge Program, which again is pretty standard across the industry for those that have experienced a temporary insurance lapse. We also just have our Patient Assistance Program for patients that are underinsured or uninsured.
I think that's an important point to note because there will always be some patients that qualify for the Patient Assistance Programs, and we don't anticipate that that will ever go away completely, knowing that there will always be a certain level of patients that qualify for that.
Jan Mikkelsen
Yeah. I think that is a clarification that's great from Jay, where we talk about this number of patients is only what we exceeded as access compared to the base level of patient.
We always will help and provide free drug if there is an element of something where there is a disruption of the normal way to have drug. It's such an essential drug for the patients that we always will take our patient focus first.
If there is a patient that get it disrupted, we will do everything to help this patient. That include also to take them over for a period on free drugs until the disruption getting solved.
We will always be there for the patients. Great.
Luca Issi
Thanks so much.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Maxwell Skor of Morgan Stanley. Your line is now open.
Selena Zhang
Hello, this is Selena on for Max. Thanks for taking our question.
Given the relatively low treatment penetration in achondroplasia in the US to date, what proportion of patients typically initiate treatment at age two years or older?
Jan Mikkelsen
I think somewhere to roll it a little bit back, because you can ask the question: why do you have under treatment in the US? I think actually this is the key question to find out: how can we really help this patient better?
I think, and we believe, that the under treatment is basically because of lack of the right efficacy to show real benefit beyond linear growth. Many of these parents, children don't see linear growth as a key element.
They really want us to address all the comorbidity, specific if you can avoid leg surgeries or changing the pain complication with leg bowing. You can avoid arm lengthening, leg lengthening.
I believe by having this focus on these elements, and here I talk about the older children. If you go to the younger newborn, yes, if we can avoid any kind of spinal stenosis by having early intervention from newborn, yes, there will be a major benefit for initiate treatment in the newborn state.
I believe our product profile that we have generated with YUVEVELL, showing as the only product clear benefit beyond linear growth compared to placebo. It need always to be placebo controlled because there is a development to the child, you cannot say, 'Oh, are we also improve arm span or arm length?'
Yes, an achondroplasia child actually have a base increase in arm length, you always need to really show it compared into a placebo-controlled trial. It's the only way you can really adjust the benefit of the medical treatment in it.
The question and the answer to you is, I believe YUVEVELL will be an appealing product to the vast majority of parents, children in the US also because it will provide a way to address the comorbidities, like important one, leg bowing, arm span, everything like that, that you basically will see benefit for not only to quality of life that's associated with it, but also the element of physical strength.
Operator
Thank you. One moment for our next question.
Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is now open.
Paul Choi
Hi, thank you, and good morning, and congrats on the good start with YUVEVELL. I was just wondering if you'd clarify, in terms of the 60 more than 60 prescriptions you've seen to date, whether it's more driven by treatment-naive patients or switches, and any quantification there would be great.
I'm also curious, in terms of your early starts or 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. Thank you.
Jan Mikkelsen
Yeah. Really to come with a meaningful answer, we need longer time, because we only have been there for four, five weeks now, and we want to be sure that what we see in the initial part of the launch is also being representative of what we see in the later stage of launch.
Paul, we can discuss it, as Jay said, in a perfect manner. We see patients coming in for all three different groups, which was naive group, patients that have discontinued with Voxzogo time, and patients that come directly on switching from Voxzogo time.
All from that, we see coming in for all three different groups. In the initial launch, we will expect to see perhaps one mix, and when we come a little bit longer into the launch, we will potentially see a switch in the different three classes.
This is why really to make it meaningful, we need to wait longer time before we can give you something you can do the right modeling on. As when I look at this number, becoming up more than 10 patient per week, it's such an orphan drug indication.
I'm extremely proud that our product profile is getting so well recognized in the society in this way. Under two, I cannot comment on that currently.
Paul Choi
Thank you.
Hey, good morning, and thanks for taking the questions. For the 70% cumulative US insurance approval rate that you previously cited, can you give us any more color on what that cumulative rate looks like today?
Then second, the €500 million operating cash flow target that you laid out previously, are you reaffirming that guidance given the Q1 trends that you're seeing? How should we think about the contribution of YUVEVELL to that target?
Thank you.
Jan Mikkelsen
The last one, we would like to come back in Q2 because we have a lot of positive elements coming in now. We have the selling of our PRV, the decision, and launch of YUVEVELL going much, much stronger than I've even myself had hoped for.
All from that, we will come with a change guidance, but we will prefer to do it after our Q2 call, and we will give you what will be reflected on '26. Scott is saying yes to me.
Jay, you can give the factual number how it's improving the overall numbers.
Jay Wu
Sure. The overall cumulative approval rate since launch has continued to creep up as well.
I think we're now closer to mid-70%, which again is incredibly high for any rare disease asset, much less one that has been on the market for the amount of time that we have. A lot of that is just a function of time, given the favorable access policies that we have.
Even some enrollments that might be many months old are coming through on appeal online, which would affect 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 mature.
Got it, thank you. Thank
Operator
you. One moment for our next question.
Our last question comes from the line of Cecilia Hernandez of Van Lanschot Kempen. Your line is now open.
Sandrine Schootemeijer
Hi, thanks for taking our question. This is Sandrine on for Cecilia.
Given the revenue now from three commercial products, the redemption of the convertible notes, and the sales of the PRV, can you tell us anything on your capital allocation strategy, what is the order of priority for you guys?
Jan Mikkelsen
I think Scott want really to answer the last question for today, Scott get this opportunity now.
Scott Smith
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 '40s and beyond with a continuous flow of new products.
I think Jan highlighted four new NCEs in his prepared remarks, and you'll learn about more of those in the coming future. Of course, I think after we give an update after Q2, as Jan mentioned, to our outlook for the rest of the year, you may get more color at that point as well.
Operator
Thank you. That is all the time we have for questions.
Thank you for your participation in today's conference. This does conclude the program.
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