Ascendis Pharma A/S (ASND) Q2 2026 earnings call transcript

Chad Fugert Thank you, Operator, and thank you, everyone, for joining our second quarter 2026 Financial Results Conference Call. I'm Chad Fugert, Vice President of Investor Relations at Ascendis Pharma. Joining me on the call today are Yen Mickelson, President of Investor Relations. Scott Smith, Chief Financial Officer, Sherry Glass, Chief Business Officer, and Jay Wu, Executive Vice President and President of Ascendis U. S. Before we begin, I would like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act. All statements made on this call, other than the statements of historical fact, are forward-looking statements.

Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SkyTropha, URVPath, and UVWell, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates and our expectation 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 results of regulatory decisions, and our financial outlook and Vision 2030 objectives. 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 under 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 the forward-looking statements section of today's press release in the risk factors section for annual report on Form 20F filed with the SEC on February 11, 2026. In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting. We have a monitoring standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believes these measures are useful to investors is included in today's press release.

Transcon Growth Hormone, or Transcon HGH, is now approved in the U. S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, Transcon PTH has received MAA authorization for the European Commission for the treatment of pediatric growth hormone deficiency. Transcon PTH is approved in the U. S. by the FDA for the treatment of hypoparathyroidism in adults in the European Commission and the United Kingdom's medicines and healthcare products. The Regulatory Agency have granted marketing authorization for Transcon PTH replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Transcon CMP is approved in the U. S. by the FDA to increase linear growth in pediatric patients two years of age and older with achondroplasia with open PPCs.

Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I've just described, 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 product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter 2026 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions.

With that, let me turn it over to Yen.

Thanks, Chad. Good day, everyone. During the second quarter, achievement of important milestones and strong demand for our Transcom products continue to drive the transformation of the Ascendis into a leading global biopharma company. The uniqueness of the Transcom Technology Platform, our strong development and global commercialization capability, and our values and visions are the fundamentals driving this transformation. We believe the same strength will continue to drive Ascendis growth in the following years. Starting with the long-term durability of our highly differentiated approved protein and peptide-based combination products, SkyTofa, UR-Pads and UR-Valve. We believe this product will be the key driver of our growth story for the next 10 to 15 years to global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings.

The continued expansion of the Transcon technology platform enables us to fulfill our plans by at least one IMD or similarly yearly, each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutic areas in addition to hyperpower and growth disorders. As a further upside, our established partners are advancing trans-con candidates in large indications. This is why we believe Ascendis is well positioned for self-sustained long-term growth. Let's begin with a more detailed look at Uropass. Uropass is the first and only approved treatment for adults with hypopera that addressed the underlying The UAPAD has grown steadily since long, both in the US and many other countries.

Reflecting the significant unmet medical need among the more than 800,000 patients living with this serious disease, Rare disease in the geographic region covered by our global commercial infrastructure. Outside of the US, we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. UiPet is now available commercially or to name patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid, broad, global launch of a rare disease product. In the US, new patient demand for UAPED in the second quarter has remained robust, consists with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated UAPAD treatment continue to stay on therapy, indicating a high level of satisfaction.

We continue to be excited by the growth of UAPADs in the US and outside the US, and to see its continued strong lungs performance. Data from our long-term phase 2 and phase 3 trials of UAPAS presented in the second quarter highlight why UAPAS is becoming a standing standard of care in post-surgiol and all subsets of hyperparam, including ulcer-rare genetic causes like D-George, ADS-1 and ADS-2.

Results showed sustained response rate of 82 to 86% for the multi-component endpoint, with clinical benefit across multiple organ systems, CNS, kidney, small intestine, and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after 5 years of treatment. Pretty unique. In parallel, we are working to further advance our leadership in HypoFAR, with additional clinical trials that include expanding the label to include the age from 12 to 18 years, and in the US, higher doses for patients. And developing a once weekly product for the patient that is on stable doses of uropads. Turning now to UoVel. We believe UoVel is positioned to become the market leader therapy for acondoplasia. Rapid uptake of UoVel is already transforming the US market.

Across the board, we see a highly favorable response among patients and physicians to UOVL's differentiator profile. In the US, through June 30, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollment and more than 65% approved for reimbursement in the US through the end of July. Really a unique loss. The rapid uptake is by patients of all kinds of background, those who are returning to medical therapy or starting therapy for acrodiplasia for the first time. We believe UOL is really growing the US market, which is exactly the pattern you will love to see when a highly differentiated product is introduced into air where there still exists A high unmet medical need.

Long-term data for the now-complete P-Bullsoul Approach Tribe show durable and consistent improvement growth, leg-bowl, body progression, along with a general well-tolerated safety profile. Compare to placebo, underscoring why the community is quickly In the US, in the EU, a regulatory decision for UoVel is expected in the fourth quarter of 2022. We are also making UoVel available in select international markets to early access programs using the US FDA approval. Longer term, we are pursuing expansion opportunities for trans-consumption to ongoing and planned trials. These include ongoing activities such as infants 0 to less than 2 years of age, and we recently announced completion of this target enrollment faster than expected. Adults with acondroplasia, children with hyperacondroplasia, and still continue with geographic expansions.

Turning now to combination therapy with transconcmp and transconcoptimal. The biological rationale for this combination treatment is clear and extremely well founded on science. Transcon CMP is removing the limitation caused by the overactive FTR3 pathway, so transcon group hormone can provide a strong complementary effect.

In addition, it has been observed that in acrodeplasia there is a partial impairment of the IGF1 group hormone axis. This is illustrated by children with agronyplasia have a negative IDOF1 SDS value, as shown of the demographic in both our Phase 2 and Phase 3 trial. In our COST clinical trial for children with agronyplasia, this unique combination has demonstrated sustained transformative analyzed growth velocity and 88 height score, The next slide is a great score, including improvement in body proportionality. Based on this result, we believe this unique combination of once-weekly trans-con-based therapies will transform the treatment of achondroplasia and other indications over time. Our recent Week 78 Co-stripe data shows sustained efficacy over 78 weeks, with no comparison to safety and tolerability.

This points to the potential for this noble combination to establish a new treatment standard in actual education. The Phase III combination trials in children with a convivation will begin enrolling later this year Turning to SkyTrofa the once growth hormone treatment built on the mode of action of unmodified somatopie With indications for pediatric and adult growth hormone deficiency, we continue to be the number one long-acting growth hormone by brand value in the US. We are extremely proud that Skytova recently achieved more than 20,000 unique enrollment. This illustrates the strength of our capabilities from supply chain, commercial infrastructure, and market support to benefit such a large number of rare disease patients. And we are working to make trans-congroft hormone available to more patients to label and geographic expansions.

To support label expansion growing that's described in our acondoplatia program, we are conducting the Phase 3 basket trial investigating trans-congroft hormone in ISS, SDA, and Turner syndrome. As an integrated part of our global growth disorder strategy, we expect to launch Transcon Growth CMP. Turning now to our partnership. In metabolic disorders and obesity, our once-monthly Transcon Semiglutide program with Novo Nordis continues to advance. In ophthalmology, our partner Conis recently initiated a first in human clinical trial of the NGVGF treatment built on the Transcon technology in patients with vet AMD.

In closing, by always putting patients first, Ascendis had delivered three highly differentiated leading Transcon-based products, Uopass, Uovel, and SkyTrope. We are on track to achieve our vision 2030 objective of being a leading global biopharma, building on a strong foundation for the future.

With that, I will turn the call over to Scott to review our financial results and some additional comments.

Thanks so much, Ian, and good afternoon, everyone. I will touch on some key points surrounding our second quarter financial results. For further details, please refer to our Form 6-K filed today. Total product revenue was 315 million euros, more than doubling year over year. Total revenue for Q2-2026 was 339 million euros, which included non-product collaboration revenue of 24 million euros, which further included a 17 million euro milestone related The Eurvipath revenue was 252 million in Q2, reflecting consistent new patient demand in the U. S. , and continued growth outside of the U. S. , reaching blockbuster status on a run rate basis in the second year of launch in the U. S. Skytropa contributed 55 million euro in Q2, which reflects increased demand in the U. S. and includes product sales to a collaboration partner.

UVWELL was commercially launched in the U. S. during Q2 and generated 8 million euro in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking. Continuing to expenses, R&D expenses in Q2 were 76 million euro, up from 59 million euro in Q1, reflecting continued investment in our pipeline and innovation. Recall Q1 included a favorable 11 million euro reversal of prior period write downs of Transcon C&P pre-launch inventories. SG&A expenses were 173 million euro in Q2 compared to 145 million euro in Q1, reflecting additional investments in the commercial launches of Yorba Path and UbiWell to accelerate growth for the long term. Operating profit of 220 million euro in Q2 included 158 million euro of other operating income related to the sale of the PRV.

Non-IFRS operating profit was 92 million euro, and non-IFRS operating margin was 27%. Refer to our press release for details. For Q2-26, net profit was 207 million euro and non-IFRS net profit was 61 million euro. We ended Q2-2026 with 812 million euro in cash and cash equivalents, which includes the use of 56 million euro in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs. Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and 1.4 billion euro of equity.

Turning to our outlook for the rest of 2026, for Yorvipath, we expect growth and performance consistent with prior quarters. For Skytropa, we expect relatively stable revenue in the U. S. For UVL, we are encouraged by the early demand trends. We believe it is expanding the market and is on pace to be the leading echondroplasia therapy in the US, reflecting the large, unmet medical need and the highly differentiated profile of UVL. Our Q2 performance reinforces our belief that we can achieve 5 billion euro in revenues in 2030. With our existing portfolio and our Transcon technology as a strong foundation, we believe we are well positioned to grow revenue to more than 10 billion Euro in the next decades, while developing and launching new Transcon products with blockbuster potential.

We expect significant operating leverage as revenue scales through the balance of the year, while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long-term revenue aspirations. Even with these investments, we expect to generate more than 500 million euro in cash flow from operating activities this year.

Thanks, Jess, for the questions. And the other happy person besides me, Scott. So, Scott got the opportunity to be the first one answering questions. So, please, Scott.

Yeah, with respect to our cash flow guidance, just to be clear, greater than 500 million. I thought you – I heard you say 100, so greater than 500 million. And at this time, we don't want to bound the upper side because we're initial into the launch of Yuba Wealth. And that's Euro, by the way, 500 million Euro, Yen likes to point out.

And just related to the question, and it comes back to what we so many communicated last time we had this call, that we don't have really the insight in exactly the distribution of where the patients are coming from. And our general feeling and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from switches, it's also coming from either patients that have stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of Uovel that we're wanting. I think this is where we have this strong belief that we see an expansion of the market. Thank you.

Thanks, Sasin, for the question. And it's basically a question that is addressing the ongoing legal, I would call it battle, between Ascendis and Biomarine. And let me just come back to some facts. The facts is that this pattern that we discussed got complete invalid in Europe. So we never really come to a discussion if we were infringing or anything like that. So when we see the situation outside US, we got the patent invalid immediately to the patent system in Europe. In the US, we never managed to come into the patent system because BioMarine selected to go to the ICC case, which are a system which we can easily say traditionally never have really dealt with a lot of cases that dealing with branded pharmaceuticals.

In the ITC case there will be a first opinion from a single judge and he will come with an opinion here in August. And then there will be a more next time will be in December. There will be an opinion from the ITC. And then later on, there will be a potential confirmation of the ITC decision two to three months after to a presidential order. So you can see we are not getting any clarification in August in one way or the other way. Even if it's possible for one company and negative for the other one, it's not really any kind of decision where it's going to be ending. And after the first initial opinion from a single judge, because the ITC case will be taken to a decision for, I cannot remember how many judges that will be part of that decision, there is a huge opportunity to provide what we call public interest for this product.

And when we see the public interest, meaning the element of how these product opportunities are really being serving an unmedically in the U. S. market with this rapid, rapid uptake of patients, it's really, really clear that it is a huge public interest to keep that. And just recall, I cannot remember one single case in the US where a branded product that provides a benefit to US patients has been denied. But you can see we just in a case where it's only a US, it has been cleared ex-US, and so whatever it happened, it will not have any material impact on Ascendis Pharma. I can guarantee that. It's some kind of, people take it up as a life and death for Ascendis.

This is a total not taken into the perspective what it means for Ascendis. And out from that, I see it's not really as a material element for our destiny to be a leading biopharma and hit the $5 billion in 2030. Thank you.

It was because I have in some way felt that the two product opportunities that we have developed to our partnership built on the transcon technology will still be considered at the NCE the one that now we clinic with Aconis and the other one we expect to go into the clinic now with Nova Nordisk It's still some way being developed to the trans-con technology funnel.

And I mean, perhaps I shouldn't have done that, but I still believe. I feel some kind of little bit of ownership on these two product opportunities. At least we have major upside in both of them. So, out from that perspective, I still consider the potential that we have this year two new chemical entities being entered into clinical trials. And I think Kenneth and his team and anyone else, they're working very hard on that there will be at least one of these new chemical entities coming into every year now. And I'm really proud about that. But it's also addressing the sustainability of Ascendis, independent of going out and buying something no one else wants to have.

And I think this is where we really feel extremely pleasant by the situation, by being a fundamental company that building on a strong, strong technology platform, Then provide both sustainability for ourselves, but also a continued flow of potential partner licensing.

Thanks for the question. I actually don't think Ascendis has made some clear forward-looking statements related to how we see your well-being accelerating and expanding the market in a quantitative manner. I don't think we have come with any kind of indication related to that. I have no doubt it will do it, but it's not the same thing that we're going to quantify it currently. I think after basic only four months in the market, I feel really not prepared to come with clear guidance to it before we have more quarters really into our, you can say, energy system, We have a system where we basically can look on trends and other things like that. But one person that really can give you a good feedback, now we talk about the US market, is Jay.

And he's extremely enthusiastic about what he's seeing. And you can give the latest weight what you see how the market will develop.

Thanks, Yan. As Yan mentioned before, four months in, we're not prepared to give longer-term guidance, but what we can say is we're incredibly encouraged by what we're seeing today. When you look at some of the fundamentals behind the UVA well uptake, whether it's prescriber reach, we talked a lot of it before around this space, there's quite a few centers of excellences. We're seeing 80% of them, nearly 80% already in a short four month period, already prescribed UVO well to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm, I think you can see in early days, we're seeing a very positive trajectory.

While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy, this is rare disease. So qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from. And those three categories, again, are one, patients that are switching from current therapy, two, patients that have previously discontinued pharmacological therapy and has now wanted to return to pharmacological treatment, and then third, a group of patients that historically have sat out and have said based on the clinical profile of UVO-WELL, they now want to try a therapeutic option for the first time.

So all that again to underscore, there is existing unmet need here, and because of our profile, we're definitely seeing that patients are coming out of the woodwork from growing the market standpoint, and we're just getting started.

Just to summary, to add on to Jay's excellent comments. Ultimately, I have no doubt we will be number one in the accountability space. Ultimately, we will expand the market because of the unmet medical needs. And that is just with the monotherapy. And when you look at how commitment we have to this era, where we now are making a complete new standard with the company treatment. I believe we are dedicated to be not number one in the first year, but continue to build For the next five to 10 years with monotherapy combination, integrated treatment regimes, and I believe with our once-weekly trans-con product built on both Mo and CMP, we are extremely, extremely well positioned really to be the leader in this segment.

Yeah, Derek, thanks for the question. I think that two points. One is the consistent performance with the KPIs that we've given you, for example, with enrollments. We expect those to continue and be consistent. The other would be, and you could refer to our prior quarters, and maybe Chad can point to prior comments, but I think that now that we've seen the full year, you know the various trends that will come into play related to Q3 and Q4 and then Q1 next year. So we think actually folks did a pretty good job modeling out Q2, and now you have all the information you need to model the rest of the year going forward until we update basically the KPIs.

Just to give you some kind of what is our value in this year. The value for us we want to give you, we want to give you not so you basic getting a lower number so we look like heroes. We want to give you the number so you are right nearly every time. And I think this is a way we try to come up with our different mathematical algorithm and how we see it and give you all the information for you really to be right in this manner. And I think this is a way we like to be extremely transparent with everything what we perform, so we're quite sure that you basically can go out and really, some way, feel all this comfort with the guidance we give you.

This is a very interesting question because it's actually going into the situation on how we basic are to genetic testing. Taking a big patient group that was in old days was called ISS, idiopathic me, we have no clue what is the underlying diseases. And then you go out and do more and more and more genetic testing. And then when you find a mutation in the FGR3 receptor, and you find it in the right regions, and then you suddenly are not an ISS patient, but then you are a hypochondroplasia patient, even if you don't have, you can say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia patient that we saw for 10 years ago.

So therefore you can see the ISS population is some way getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason why you, per se, will have a short status without potentially having the other element that you see for the phenotype of that. So this is where you can think when you go into ISS, are you defined it from a genetic perspective, or you define it for a phenotype or anything like that. And we are in a situation where when you see the clinical trial, how we doing it, you will basically see that it's one of the pathway we have selected.

Thank you.

You already alluded to the body segment ratios, but how should we think about benefits on arm span and other metrics? Just to recall, the coach trial is the combination trial where we combine the two Transcon-based products, our Transcon-Gothamone and Transcon-CMP. And I have to say when I look on an element like arm span, it's actually, we already reported some of the data. We have reported the 52 weeks data. And if you cannot find that deck, I can send it to you, or Scott can send it, or Chad can send it, or I don't know, we have so many IR people, I don't know their names more. So, from that perspective, it already came out, and I have to say, there was one of the, I will say, extremely positive surprises I saw, because when we looked on monotherapy, but either a CMP-based one or a growth hormone-based one, we did not see the expected, hopeful development that we could hope for.

But we definitely saw it when we look on the combination therapy. And then you can ask me what is the scientific reason why you see it much more influenced, benefited by the combination therapy. And I have to say I don't know. But what we saw was an arm span that really gave us this hope that with the combination therapy, you basically will be in a position that you basically could avoid all kinds of lymph elongation surgeries in acupuncture, both related to both legs and arms by that.

And it's the slide number five as I remember it, and what we see, Scott, read up. The unprecedented improvements in the arm span with a combination were plus 9.4 centimeters with Transcon CNP naive cohort, 7.9 centimeters with the Transcon CNP treated cohort. So it was really an...

Compared to live lengthening surgery in centimeters. Exactly. I have to say, it was one of the days where I felt it was worth a go to job and really can see the benefit of what we're doing.

You are right. And I think it's starting to be a little bit repetitive every quarter come out and say that we have more than 1,000 patients being unique enrolled per quarter. We have continued that message that we see steady state steady state and steady state And we said in last year that we will stop coming with this because it was too repetitive And then because people doubted for the Q1 then we also come up with the Q1 and it was the same number again And what we're writing is that we see a robust steady state enrollment of unique new patients, and here we're referring to the US with about 1,000 new patients every quarter. And we don't believe really.

Now we went over to Eurovel. So now we're starting to give you a unique prescription enrollment of Eurovel instead. So we always have one product opportunity where you will have something to play with, with numbers and everything like that.

Scott, you have some comments for the last one? I think our comments were directed to assume that the metrics that we've given you are consistent because Yen wants to make our script shorter, so we don't want to repeat them more. And you should just assume that until we change it.

Alex, I think I'm a very flexible person. And one thing I really want to do, I will always do what is best for patients.

I think you're 100% correct. And when we see a patient being successful, coming into a treatment with your pants, coming over titration part on it, And being into the treatment after that, we see extremely, extremely low dropout. And I think that illustrates wanting the patient satisfaction with this treatment. Because I am often being asked, what can we do more for these patients in the therapeutic treatment on it? And when I see the satisfaction that it is in this way, then I feel that there is an extremely good position, retention, and everything which really shows that. We still develop them once weekly for patients on stable doses, just to give patients the choice if they want to do it in this way.

We will look at other ways to improve their life, like for example, at home capture monitoring and anything like that. We can help the patient like it happening in type 1 diabetes and other things like that. So now you are addressing the element where we are saying is, we developed this here with a once weekly profile, even if we could make it, sorry, once daily, Because we wanted to do the titration most easily, because it's really complex to take patient upper conventional therapy at the same time you increase the PTH in replacement therapy. And that was why we made it as I once stated this, really to facilitate the best possible titration. But still we know it can be problematic for some patients.

And Jay can try to explain what we are now doing to basically handhold the patient in this period, so we also can make that extremely successful. So when you get a prescription, we know everything will be much more successful for the patient, not just after their baby being stable in the titration. So Jay, will you explain of the effort you're building in to really to get that to be as soft as possible? Absolutely.

I can chat a little bit more about certainly the investments that we're making, and also to answer your questions around drop-off and re-offs. Yes, as we've shared before, the majority of the drop-offs is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense. And then for re-offs, that's actually pretty routine for us, so there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support. We have patients re-offing throughout the year, and it's just part of our day-to-day operations. From an investment standpoint, we've invested heavily in patient-facing roles for which we've deemed our patient access liaisons.

They support patients both pre-prescription as well as through the prescription process and post. So essentially, we've seen a lot of success in early days with this field team being able to engage with this patient community. They have appreciated this high level of support, and we, of course, support them throughout the journey to ensure that we're optimizing for patient experience.

One thing that's in a minute, now we focus on US, but there is still a world outside US. Outside US, we have not seen the same level of dropout in this space. It looks like the interaction is pretty well established between the physician and the patient and support system, really to see it without this kind of dropout. So it's basically a US issue and J. So therefore we know we can get it to function. We just need to ensure that the support system, also in the US, is strong enough to be sure that it's not a problem.

Okay, I just wanted to ask what product you were referring to. UV-Well. Yeah, I can guarantee that as we basically, in our preferred remarks, try to put emphasis on, we have a global infrastructure in commercialization and patient support, product supply and everything like that. Just the number of scrythrope rare disease patients we have taken over to the system, more than 20,000 patients. We are having the system function more than in 35 different countries. So we are not a company that just needs to get started. We already have established all this infrastructure. And what we are doing is that we are utilizing this established infrastructure that got established because of UOpaps. Because this is what we did with UOpaps.

We are using exactly the same infrastructure also for UO value. So we will be where patient is, and we will be quite sure we will also serve the patient outside US. And potentially the market is much larger outside US. And I think, we hope we also will see a large penetration in the US where another short acting product really failed to do it. And we believe because of the highly differentiated nature of UOVL, we will see a complete different pickup in the U. S. But it's definitely, we have a strong, strong, strong focus on the ex-U. S. And we will give you some guidance when we come later in the year, so you can give also building up a model for the ex-U.

I like your way of doing all the calculation, anything like that. I cannot support it, or I cannot deny it, because I don't have the factual insight to some way to confirm anything of the numbers. I also saw the numbers that came out, but I cannot really support it because I don't have the insight from my own numbers to really come out and come with any statement that indicates if I'm aligned or not aligned with.

Related to the ex-US, for me to understand your question, was this reflecting what is the limitation in the ex-US, or what was the question? Thanks for asking to clarify. More about, are you committed to running the show by yourself, or are you considering partnering, given that 70% of the mock focus office historically coming from ex-US can be a quite heavy lifting? Yeah, but so basically in the XUS we have our direct market which are I think 60, 70, 80 where we have our own commercial infrastructure, anything like that. It's pretty pretty clear what we're doing there. Then we have our sales and distributions agreement. And this is, I think it's 70 countries or something like that.

Well, it's got this, how's it? 80 countries that is covering this sales and distributions agreement. And then the vast majority of all of them are all three products. So basic, there is already established infrastructure for the distribution. And then we have the two other, the third model, where we have our partnerships, one in Japan, one in China, and we also have all the three products. So we don't need to go out and make any new agreements for anything. Everything is established. Everything is running on full speed. And for some of the EU direct market, we're just waiting for our expected approval here in Q4 this year.

Yeah, what we see today is that we are enrolling the trial in the US where we are evaluating the 30 to 60 dose range in two different means that has been aligned with the FDA in their design, what they wanted to see. And we see that enrollment going extremely fast, so we expect very, very, very fast and you can say label expansion in the place where we don't have up to the 60. So we see that basic on just on execution. And your second question was related to?

On weekly over path, any update there? Yeah, I think there's no news in this way that we just executing and getting it into the market as fast as possible. Out from the expectation that we see that not as in any kind of LCM activity, but more as patient support for patients that really are in the stable dosing, which are not a lot after they have been in a situation where they have been stabilized with our daily treatment.