Ladies and gentlemen, thank you for standing by. Welcome to the third quarter 2026 Ascendus Pharma Earnings Conference Call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you would need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. And to withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugure, Vice President, and Investor Relations. Please go ahead.

Thank you, operator, and thank you, everyone, for joining our third quarter 2026 Financial Results Conference Call. I'm Chad Fugure, Vice President, Investor Relations at Ascendus Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Chief Financial Officer, and Jay Wu, Executive Vice President and President, US Market. Before we begin, I would like to remind everyone that certain matters discussed on today's conference call are forward-looking statements relating to future events, future financial performance, and management's plans and objectives for the business. These statements are subject to risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The risk factors may affect results are described in our annual report on Form 20F filed with the SEC on February 11, 2026. As such, report may be updated by other public filings with the SEC from time to time. The forward-looking statements made today are as of the date of this call, and we do not undertake any obligation to update these forward-looking statements. The speakers on today's call may also refer to certain non-IFRS financial measures. A reconciliation of these non-IFRS financial measures to the most directly comparable IFRS measures is available in our press release issued today. Content of this call is not intended to constitute and should not be interpreted as direct or indirect promotion of any of our products or product candidates. A copy of this press release may be obtained by visiting the investor relations page of our website at investors.isendisfarma.com. With that, I'll turn the call over to Yen.

Thanks, Chad. Good day, everyone. In the third quarter, execution across R&D and commercial continued to drive the transformation of Ascentis into a leading global biopharma company, strengthening our ability to make a meaningful difference for patients. In Q3, we delivered product revenue of $366 We see three complementary drivers of durable growth. Continued growth for our existing three products in already approved indication. Second, expansion of indication for our three existing products, including label extension for monotherapy and combination therapy. Third, new products enabled by our Transcon technology platform. to drive sustainable long-term growth. Importantly, our global geographic commercial expansion will further accelerate growth of all three drivers over the coming years, as more and more countries will be fully commercial. Our R&D and commercial infrastructure Give us confidence that we can achieve our vision 2030 goals of generating over 5 billion euro in annual product revenue in 2030 and develop new multiple blockbuster products with the Transcon technology platform. which also includes a new therapeutic area. Let us start with the first driver. Continued growth for our existing three products, UR-Path, UR-Val, and Skytropha in already approved indication. UR-Path is the first and only approved treatment for hyperparathyroidism in adults and is now available commercially or through name-painting programs In more than 40 countries. Global EUPAT revenue in the third quarter was €291 million, up 103% over last year and up €39 million over last quarter. In the US, EUPAT demand in the third quarter was consistent with prior quarters. Even during the summer months. With an estimated 70,000 to 90,000 adults that live the chronic hyperbaria in the U.S. And more than 90% of the estimated number of patients are still potential candidates for UroPath PTH replacement therapy. In September, we launched A U.S. national disease awareness campaign designed to help patients identify symptoms and empower them to speak with their healthcare provider about treatment options. We expect the campaign's impact to build gradually over the coming quarters and are planning to launch additional awareness campaigns In 2027. Outside the U.S., revenue continues to grow quarter by quarter, with full commercial availability for UiPath in 13 countries and 15 additional markets expected in 2027. UiPath's robust uptake is supported by clinical data that showed its ability To maintain normal serum calcium and phosphate and normalize urinary calcium and phosphate excretion and normalize active vitamin D production, achieve independence from conventional therapy and improve quality of life, skeletal health and kidney function. To our knowledge, neurotherapy in development has shown this depth and breadth of benefit across multiple target organ systems. And as the only approved PTH replacement therapy, we believe UFS has set a high bar and is positioned to be the standard of care in hyperparatreatment for many, many years to come. Looking ahead, We expect sustainable growth in patients on UroPath in both established and new markets as our clinical studies demonstrate that nearly all patients with hyperbar benefit from treatment. Turning now to UroVel. UroVel is the first and only approved therapy for children with achondroplasia to offer continuous systemic exposure to ActiveCNP with a once-weekly dosing. In the third quarter, your overall revenue was €16 million. New patient demand in the US has been steady through Q3. We have now around 340 patients enrolled through October, with more than 80% of these already approved for reimbursement. We see patients veteran from daily therapy returning to medical therapy and starting treatment for the first time. UofL is growing in the U.S. market and is on track to unlock its potential to become the market leading therapy for children with achondroplasia. Through October, the number of new UofL enrollment equals nearly half of all U.S. patients on pharmacological treatment before our April launch. And with around 70% of children with achondroplasia in the U.S. still untreated, we see a sustainable opportunity ahead to address the significant unmet needs and health complications associated with achondroplasia. In addition to showing statistically significant linear growth improvement, such as height and body proportionality, UroVel is, to our knowledge, the only therapy approved and developed to have demonstrated significant improvements in key measures of skeletal proportionality, lower limb alignment, spinal canal dimension compared to placebo. He has also shown improvement in health-related quality of life and physical function, with a safety and tolerability profile compared to placebo, all elements critical for chronic therapy for children. Outside the US, we received a positive CHMP opinion in October and a positive COMP opinion to maintain orphan medical product designation, which if approved, provides the potential for up to 10 years of market exclusivity. We now expect a European Commission decision on our MAA before year end. If approved, We planned our first European launch in Germany in Q1 2027. We are also making UofL available in select international markets through early access programs and expect to recognize revenue from multiple countries outside of the US and EU in the coming quarters. Turning now to Skytofa, the only once-weekly growth hormone treatment to provide unmodified somatopine. Skytofa remains the number one long-acting growth hormone by value in the U.S. Third quarter revenue was 59 million euros driven by higher patient demand. Now to our second driver of growth, expansion of indications across our three marketed products, which are supported by more than 20 ongoing or planned studies. For your path, This includes a U.S. trial to increase dosing up to 60 micrograms as well as ongoing multinational trials in patients aged 12 to 17. We also continue to progress a once-weekly PTH program designed for patients who have attained stable doses of daily UroPaths. For UofL, we are working to expand to additional adcontraplasia, age group, and hypochondraplasia. Our ongoing infant trial is fully enrolled with top-line results expected in 2027. This past quarter, we presented early Sentinel data for this trial that showed once-weekly Transcon-CMV providing stabilization or improvement in forearm and magnum stenosis as well as linear growth benefit. In addition, Transcon CMP was generally well tolerated with no reported of injection site reaction over 52 weeks. Lastly, we plan to initiate a phase 2 proof-of-concept trial in adults with achondroplasia before year-end. where we believe Transcon-CMP may offer benefits in physical function, mobility, chronic pain, fatigue, and other areas that affect daily living. We also expect to initiate a phase 3 trial in children with hyperchondroplasia this quarter. For scartopa, which is being studied in more indications than any other long-acting growth hormone, a basket trial in In patients with ISS, HDA, shock deficiency and Turner syndrome is progressing. With growth hormone deficiency representing only about 50% of the available growth hormone market, approval across these indications could double the patient population addressed by our current label. We anticipate complete enrollment in this trial in the first half of 2027. Combination therapy with Transcon-CMP and Transcon-Glutamone is another important program. Market research suggests this unique combination could become the future standard of care in acondoplasia. Our phase 2 COS trial showed that Transcon-Glutamone added to therapy with Transcon-CMP led to significant improved efficacy versus Transcon CMP monotherapy with up to three to four fold greater improvement in AC8 specific height set score as well as improvement in arm span, body proportionality sustained through 78 weeks without any compromise to safety or tolerability. Patient recruitment for phase 3 combination trials in children with aconthoplasia has started, while a separate phase 3 combination trial in children with hypochondroplasia is planned to be initiated in 2027. We continue to expand our global commercial presence across all three products, working toward Full commercialization of our products in more than 50 countries. Turning now to the third driver, new products. As I mentioned up front, the Transcon Technology Platform enables the creation of highly differentiated new products, which we believe will be a major driver of sustainability for Ascentis. With complete freedom to apply our transplant technology also in metabolic and cardiovascular diseases, we are progressing multiple programs in these areas. We are executing on our goal of advancing at least one new product into clinical development each year. Adding new product to our endocrine rare disease franchise and creating a new therapeutic focus area. which we will disclose in the coming year. We look forward to provide a more comprehensive update on our early state pipeline programs in early 2027. In closing, our three approved products are driving a financial transformation of Ascentis, which we expect to further strengthen with expanded labels and global geographic expansion. We are self-sustaining and our operating cash flow is increasing. We built our company to benefit patients through internal product innovation. By always putting patients first, we believe Ascendis will deliver consistent, durable growth for many years to come. With that, I will turn the call over to Scott to review our financial results.

Thanks so much, Jan. I will touch on some key points surrounding our third quarter financial results. For further details, please refer to our Form 6-K file today. The success of our research and development in commercial capabilities has led to three consecutive new product approvals and has transformed Descendis into a leading global biotech company reaching patients around the world. Total product revenue for Q3 2026 was €366 million, up 89% year-over-year and up €51 million sequentially, reflecting continued durable growth of YorgaPath globally, consistent profitable development of Skytrofo, and continued growth of UVWell in the U.S. since its launch in Q2 this year. Uromopath revenue was €291 million in Q3, up €39 million from Q2, reflecting consistent new patient demand, trends, and metrics in the U.S. and continued consistent growth outside of the U.S. In growth disorders, Skytropa performance was steady, with revenue of €59 million in Q3, up €4 million sequentially. UVOL revenue in Q3 was €16 million, doubling from €8 million in Q2, its first quarter on the market in the US, reflecting steady mutation demand and high approval rates. Turning to expenses, operating expenses fell to €217 million in Q3, down €32 million from €249 million in Q2, primarily driven by lower litigation costs and timing of commercial initiatives. Reported operating profit was €125 million in Q3. Non-IFRS operating profit was €156 million, reflecting a margin of 42%. Refer to our press release for more details. Cash flow from operating activities was €189 million in Q3 and for full year 2026, we now expect cash flow from operating activities of at least 600 million euro. We ended Q3 2026 with 964 million euro in cash, an increase of 152 million euro from the end of Q2, primarily reflecting operating cash flow partially offset by 52 million euro of treasury share purchases. Subsequent to September 30 through November 11, 2026, we spent an additional 273 million US dollars repurchasing 1.2 million ordinary shares of Ascendus. Year-to-date total, we have repurchased a total of 2 million shares for approximately 460 million US dollars. Turning to our outlook for the fourth quarter of 2026, for YorvaPath, We expect growth and performance consistent with prior quarters in the U.S. and outside the U.S. For Skytropha, we expect relatively stable revenue in the U.S. For UVWell, we expect demand growth and approval trends to continue in the U.S. In addition to these drivers, we expect additional growth to come from continued global commercial expansion of your staff and availability of Ubiwell in select international markets as well as launches in the EU. Longer term, we expect label expansion activities across our existing portfolio and investments in our new Transcon product pipeline to drive launch of new indications, new major markets or new products each year. Reflecting our solid foundation for achieving our revenue goal of more than 5 billion euro in 2030 and 10 billion euro in 2035. With that, operator, we are now ready to take questions.

Thank you. As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. And we ask you to please limit to one question and please return to the queue for any additional questions. And our first question today is going to come from Jessica Phi with JP Morgan. Your line is now open.

Hey guys, good morning. Thanks for taking my questions. You mentioned ambitions for multiple new blockbuster products and a new therapeutic area. So when could we expect to learn more about what that new therapeutic area might be? And are the new blockbusters you alluded to within endocrinology or in the new area? Thanks.

Thanks, Jess. You know, we have a really, really strong focus on building unbelievable sustainability of Ascentis Pharma. And one, when we look at the two fundamental elements we have in our vision 2030 is to drive revenue, which clearly we're doing extremely well. The other one is to focus on building sustainability in it. And what we are accepting is that, yes, we can continue to make a few major blockbusters inside rare Endocrine Diseases, but we also into a situation where we feeling now we are equipped to take up a new therapeutic area. The therapeutic area will build with a foundation for at least two to three new product in a pipeline as we did in rare disease endocrine. This is the only way we believe we can have the responsibility to really to have synergies We will believe that the majority of these new products will be done by internal development, but we are also extremely open when we see a new therapeutic area that we potentially will be analyzing one or two products that can basically work in synergy with the internal development of that. And when do you want to get that knowledge? It will come in the coming year. We feel really the key element for us, we are not discussing so much of our early stage. We feel that from the element of what we see with the Transcon CMP, where we went out too early to discuss it, we got the consequence of that. So from that perspective, we keep it much, much longer by us. We also believe that it's less material for us out from the way when we see how we develop in the product revenue perspective. But there's no doubt we have, which we already started this year, to develop at least one new product every year that is built on a new chemical entity.

Thank you. And the next question will come from Tezeen Ahmad with Bank of America. Your line's open.

Hey guys, good morning. Thanks for taking my question. Quick one for you again and then a follow-up on a bigger picture. Are you still trending at about 1,000 scripts per quarter for your VPath? And then secondly, on operating cash flow, you've given us an increase in guide for that for this year. Can you talk about longer-term How we should be thinking about the importance of that number and the rate of increase next year and beyond. Thanks.

Thanks a lot. What we did with EUROPATH is basically the way we also will do it with EUROVAL. When we came out with EUROPATH, we gave you unique prescription quarter by quarter in the US and gave you some kind of algorithm for ex-US. And when we felt that we have done that in a sufficient many quarters where we basically are moving over to what I call the results of everything revenue, we will stop to give basic unique new enrollment every quarter. We feel that when we have perhaps four to five quarters of Thank you for watching.

Thank you. And the next question will come from Gavin Clark Gartner with Evercore. Your line's open.

Hey, guys. Great quarter. Just on Yorvapath, so the press release noted XUS really strong new patient demand. I just wanted to clarify, are you saying there that the XUS revenue is accelerating or increasing from the trends that you were seeing before? On the US side for JorvaPath, were there any other trends to call out this quarter? Just kind of like a change in continuation rates over time, anything on channel inventory or anything else to call out there?

I think what I would give just a little bit more a big picture about how we see the world and then we can go down to the more concrete definition and I think both Scott and Jay would like to add into at that time. So when I see the world, and I'd like to make it a little bit simplified, I take just US and then I take ex-US. Even ex-US is a big box of many boxes or any different way to do it. US have a pretty fast penetration when we think about Europat. It looks extremely stable as you have seen it quarter by quarter when we referring to The elements of unique new enrollment and nothing has changed to what we have said before. We always expect to more and then get 1000 new patients every quarter. So that can give you a simple modeling in it. When we come to XUS we need to accept that it is built on many many different boxes. Part of that is Europe where we got an approval with EMEA and we now building one country by other country to be fully reimbursed. Many of these countries today basically the vast majority of XUS are built on name patient program and early access program. They are fine, but they are not like a full commercial thing. So XUS is much, much, much slower than the US. And you build it gradually. And you take box by box by box. But in the end, if you have enough 50 boxes, you really have a tall house in the end. And this is what we're doing in the XUS. And you can hear what we said. countries more or less fully commercial. Two of them just came in the last month. I can give you the name. It was basically Switzerland and Norway. So two more coming. Next year, we believe at least 15 new will come in. And when these countries get fully commercial, you start to accelerate. But it's slow in the beginning, but it comes on that. This is why when we look on our progression and peak, The 5 billion in 2030 is not really the peak sale of our current product opportunities, even in the existing indication, because it takes much longer basically to hit peak sales in this way. Jay, Scott, do you have anything to add?

Sure. Go ahead, Scott. I just say from my side, nothing to add.

And on my end, I was just going to reaffirm Jan's narrative around continued momentum in the U.S., right? So no trend break. We're still incredibly encouraged by what we're seeing. When you think about what Jan had shared in his opening remarks in that there's still ample opportunity in the U.S. as you think about the number of patients that have not yet been exposed to Urofapath but could potentially benefit from it. We are seeing that continued steady uptake in those patients that historically have not experienced Yorbapath before. And then across all metrics, when we look at both adoption rate, field execution, whether it's breadth or depth, again, we're seeing that continued stability and momentum that you would hope and expect for a market that's continuing to grow.

Thanks, Jay. And don't forget, There are still new patients coming in every year. 3,000 to 4,000 new patients every year. And I believe when neuropaths will be really taken up as an established treatment, when you get the diagnosis of chronic hyperparathyroidism, I believe a much, much, much larger portion of these 3,000 or 4,000 patients will basically take it very, very naturally to immediately start on a PTH replacement therapy with neuropaths. Great. Thanks, guys.

Thank you. And the next question comes from Yaron Werber with TD Securities. Your line's open.

Great. Thanks so much. Maybe just a couple of questions. One for Scott. I think you announced a $400 million share buyback in September. And from the calculation, I think you've essentially bought back about $273 million just this quarter. How much is left now for you to deploy? And then secondly, on UVWell, I think Byron Morin is saying that they're seeing now a share loss of sort of 5% more recently, kind of ongoing losses. And it sounds like you've done about 60 PFSs in each of the last two months of the quarter. Let's call it August, September. Is that sort of a good runway to consider for Q4 and onwards? Thank you.

Let me take the last question. I don't think we have the capability to understand BioMarine's numbers, and so I will ask you to refer this question to BioMarine directly. We know how many new patients we're getting every week, so I think that is the key element for us. Scott, we'll take the first question.

Yeah, Jeroen, we spent about $330 million out of the $400 million that we announced in the We also in the total we had a program at the beginning of the year and of course you know there's potentially additional programs coming but total about 330 out of the 400 so far.

So we have done what we said we want to do I think we have bought back around 2 million shares now so that is a really sustainable part of this year just this year and you know when we look forward we will have amber free cash flow the coming year I'm not saying we can buy back all the shares, but at least we can buy a sustainable amount of it.

Thank you. And the next question will come from Joe Schwartz with Learing Partners. Your line's open.

Hi, thanks. Can you talk about Yorba Path's progress penetrating the different subpopulations of patients you outlined at the launch, those who are Uncontrolled, partially controlled, and controlled. And is that still the right way for us to best understand how you can continue to generate at least 1,000 new patient enrollments each quarter? Thanks.

Thanks, Joe. Let me go back and give you a little bit the aspect of how we see the fragmentation of the hyperparapatients. First of all, there is no medical definition of mild, moderate or severe of hyperparathyroidism. It's like being pregnant, you're pregnant or not. The same as hyperparathyroidism, you have hyperparathyroidism or not. Then you can say the burden of disease for the society, for the patient can vary. And this is where you can say, When we, for example, make health economic calculation in some countries, we basically are defining patient groups where there is a huge burden for them, and they're taken up as the preferred treatment start in this way. When we look at the clinical data we have generated, that is not one single patient group That we not see a major benefit of being on neuropath treatment. So when you take it from a clinical perspective, I would say basic nearly everyone should be on treatment or with neuropaths. So I'm not feeling that this. Then you can talk about some patient group are much more already motivated to it. And I think Jay can give a really great away how we Thank you for opening that commentary. In addition to severity, what I would say is we also think about patient segmentation in the etiology of the disease, and we also see that whether it's a genetic

Kirsten Moller Mikkelsen, Michael Wolff Jensen, Jay Donovan Wu, Joseph Kelly, Mads Bodenhoff Jensen, Sherrie Glass I mentioned earlier, we're still seeing strong metrics across the board. So for example, we've added another 300 new prescribers in just the last quarter alone, which shows you that despite the fact that this space is incredibly diffuse, we're still seeing additional traction around physicians prescribing for the first time. For existing physicians that had prescribed in an earlier cohort, we're also seeing them prescribe a greater number of patients. So the depth of prescription has also been increasing, which again reaffirms perhaps what your hypothesis was in the original question, which is, are we also seeing uptake in additional types of patients? And from that lens, we do see that the breadth of and the depth specifically of the patient types is also increasing. And then lastly, when you think about How we're continuing to shape this market. It is a large market in the U.S., about 70,000 to 90,000 patients prevalent. So we know that a lot of our efforts needs to be not just about educating physicians, but about educating patients. Since sometimes and often the limiting factor is a patient themselves may not have established care or have not gone in to see their endocrinologist recently. So we've been investing quite a bit in both digital efforts, education and awareness campaigns, in addition to supporting patients throughout the journey, especially as they are seeking to understand to learn more about the therapy itself.

Thanks for all the color.

Well, Joe, just to follow up on it, you can say when we made the initial way to look at a patient, it was not in a clinical perspective. There was a way how we define how often they're seeing an endo, because we wanted to be quite sure that the Thank you very much. Jay is doing now with his already amazing effort in the for example direct TV campaigns and other thing is he building up that now we start to understand I need to go to the doctor because I'm really have the symptom of having this and this is why we for example have Taking the group that we call control, which was nearly half of them, because they're only seeing perhaps an endo every second year, they're starting now to go the endo and therefore they have the possibility to come in in treatment. So you can see what Jay is doing, he's basically following up on the same way we were thinking when we started the lungs. And this is likely why it's so successful and we see this constant flow every quarter.

Thank you. And our next question is going to come from Derek Archila with Wells Fargo. Your line is now open.

Hi, this is Simona for Derek. Thanks for taking our question. I had a question on the operating leverage. So as the European path orange scales, how should we think about the cadence and key drivers of operating margin expansion into 2027? Where should the greatest leverage come from and how much continued investment should we expect behind the commercial infrastructure?

I think this is such a complicated question that it need to go to Scott.

Yeah, I mean, I think that you've obviously seen pretty dramatic increase in the operating margin in the last three quarters. So, you know, at mid to low 40s is pretty good. I think that part of what you're asking for requires us to give the 27 outlook, which I think potentially we come with that early in 27. But for the time being, I would refer to my prepared remarks on the development of the three products with the three indications as well as near-term launches. And then maybe, you know, maybe if there's other comments to add, but I think that our commercial infrastructure is fairly well built. I don't know, Jay, if you want to comment more on that, but I don't see large developments in our commercial SG&A infrastructure and at the same time, I agree with that, Scott.

From a commercial infrastructure standpoint, we've largely built out to the scale that we need to sustain what we believe will fuel future growth for our products, both in the US as well as I think we're in the right ballpark outside. We do envision that we'll continue to have investment outside of the U.S. as Jan had mentioned in his prepared remarks as well, but I think we're in the right ballpark.

Thank you. Thank you. And our next question is going to come from Lai Watsik with Cantor Fitzgerald. Your line is open.

Hey guys, congrats on the quarter. Maybe just one on your view, well, looks like you've got Pretty strong demand in the US. I wonder if you can just comment on the potential impact from the oral drug coming to the market next year, and what do you hope to accomplish with your recent citizen petition letter?

I think there was a multiple question into your question in this way. The way we have developed Euroval and our Transcon CMP, we have built it on different stages. Stage 1 is the monotherapy, where we have now approved Euroval in the US. We have a positive opinion and 10 years positive opinion for also exclusivity in Europe. We see how it penetrating US with a speed that really talk about how it really being defined as an improvement to existing therapy in this way. We are in a position that this is stage one. because when we look on the combination therapy that is coming now after us we actually see that we are in a position we can have such an integrated treatment regime that we can complete avoid all surgery procedure for a patient and basic generate and treatment regime really addressing All the major comorbidities. This has been our vision. This has been our aspiration to have such a strong integrated packet combined with the mono and the dual therapy that we really can provide to the patient, to the physician, to the society, a treatment regime where you address all the established comorbidity that you have seen today. Any new treatment need to show the same thing. First of all, it need to show the safety and what we have seen with all the years and I will not say, I do not know how many CMP years that have been treated with CMP therapy. It's really have proven to be one of the most safest treatment we ever have seen. That is really been recognized by physician, patient and other element. And the way we providing and giving CMP therapy with our sustained release have really shown complete new improvement that has not been seen with the short acting CMPs. And that is what you need to do. And from that perspective, you can say, That is not only the efficacy that you need to have the integrated packet to, but you also need to show the safety in all aspects living up. Because safety is the key element in any pharmaceutical development and specific when you come to a growing child, there is so many processes throughout the body that need to be matured in the right manner. And this is where there is so much literature that working with unspecific tyrosine kinases have shown unexpected side effects in preclinical models. And we feel obligated to live up to our values about safety first for the patients. And from that perspective, we are not asking any product to be stopped. We believe in choices for patients, but we're asking to be sure that it's going to the right safety perspective in it. And that is the only thing we're asking for. And I feel everyone should do that. You should do it. Everyone should do it. Everyone should do because we're here to benefit the patient and the society and everyone.

Thank you. And our next question will come from Yin Zhang with Wedbush. Your line is open.

Hi, good morning. Thank you very much for taking the question. And this is actually related to your comments to the previous question. So combo therapies for a contraplasia. I believe you said before that you don't expect the treatment option to be chronic one for patients. I'm just curious, what do you see as the potential impact on the revenue growth? Is it mainly for patients that are already on monotherapy or potentially can drive new patient adoption? And on the revenue, so X US versus US, do you expect the same pattern as Voxoco that eventually majority of the revenue will be coming from X US? And so at what point do you expect that change to happen? Thank you very much.

OK. The question is about how do we really, if I understood you right, the combination therapy, how do we see that into the fundamental of the therapy we have with UofL. No doubt UofL is the fundamental CMP therapy. What we have seen with The combination and dual therapy by adding in growth hormone you basically are boosting the effect three to four effects in effect size. Meaning is that if you just look on linear growth you're basically getting in one year the basic element of three to four years monotherapy treatment in it. And I believe that it's a really unique opportunity for any child to reach a new level. But what it's also doing is unlocking new biology where we see Much less effect, for example, on arm span. I'm just taking one thing, arm span, on monotherapy. But when we combine it, basically, in the element of a dual therapy with growth hormone, we see that you are in a position that you're getting such a growth that you basically can avoid arm lengthening procedure because it's growing to a completely different level, which you can't even achieve with monotherapy. So therefore, the combination of these two, where you have a paracrine system with CMP to overcome the active FGF receptor, you basically unlock a complete new biology treatment with a growth stimulation effect by growth hormone. And I believe this is a paradigm shift that's totally taken up in a complete new bar. And you ask me a question, how do I see it? Because when you look on butyrotide, it has a very unnatural way to have revenue recognition from, you can say, a typical, typical rare disease product. Because it's recognized about 75% of ex-U.S. compared to 25% in it. Typical, you would say, will be 60, 40 or 50-50 or 60-40 is perhaps the most normal, where 60 will come from US. And so when I see it, what is really the missing factor? Missing factor is US. People saying this product is doing exactly well ex-US. I have a completely different view. It's too horrible in the US. And why did it not do up really good in the U.S.? Because it was not really going in and providing the benefit to the patients. What they really wanted to have, they wanted to see that you can address comorbidities, and that is what we are focused on. We accept that we will provide length, but we also know that what we really are focused and really addressing, which are really appealing for everyone, If you can avoid a child to go to years of operations, leg bone, other things like that, then everyone can say it makes sense to be on treatment. So what I expect to see, I expect that we will see the same great penetration ex-US, we will take over the market exactly as we do in US, and we will see a much larger growth inside the US.

Thank you. And our next question will come from Faisal Khurshid with Jefferies. Your line's open.

Hey, guys. Thank you for the question. Congratulations on starting the CATCH phase three combination study. I just want to ask one quick detailed question on the trial design. So could you explain why there is a monotherapy growth hormone arm in the study and also like how you're thinking about sort of the potential for long duration of benefit for the combination? Thank you.

Yeah, the question is referring to why we redesigned our phase three trial and I'm We are totally honest. Yes, we redesigned it because we got strong regulatory feedback. And we don't want to run a phase three trial without being successful and get it approved in the end. And from the US, there was a strong side to live up to what we call the rules of combination. And that is meaning you need to evaluate the contribution of each single element in a combination trial. And this is why that came. We built in an independent arm that only provides a transcon growth hormone.

That is why it started with three active arms instead of two active arms.

To sum up, you have a transcon CMP active arm, you have a transcon growth hormone active arm, and then you have a combination or dual therapy arm. All of them are randomized. and all of them are aligned in a... ...mathematic way, how we really can show improvement compared to each single arm. And it was why the trial exactly got enlarged and also got delayed a few months. Got it, thank you.

Thank you, and the next question will come from Kaupit Patel with Wolff Research, your line is open.

Hey, this is Guggen on for Colpit. Thanks for taking the question. Curious about what impact you'd expect the existing and new DTC campaigns in 2027 to make, and if there are also DTC campaigns going on in or planned in Europe. And I know you mentioned there's no medical definition of severity, but as a result of these efforts, are you seeing any shifts in patient mix with respect to disease severity? Thanks.

Yeah, I think just I would take only one part of that question is disease severity. There is no definition of disease severity from medical terms. We define something like controlled or uncontrolled, but it was mainly defined for how often they will see an endo. There is not in any guidelines or any place, any element that define the severity of the disease in this way. Jay will explain how he's rolling out all the different campaigns and but the element is that's where there are few countries I actually think there's only two countries in the world where you can make direct-to-TV campaigns and one of them are US yeah that's right so in the US specifically we are seeing initial encouraging signs

The educational and advertisement campaigns that we've been making have been reaching the right communities in order for them to be able to learn more about the product and then ultimately actually initiate conversations with their endocrinologist. As an example, we've seen an uptick in the number of patients or prospective patients Leveraging Find Provider Tools. And then anecdotally, we've also heard a number of patients that have come through the funnel actually cite some of the educational campaigns as the first time that they actually saw something that mirrored what they were experiencing and that actually inspired them to go see an endocrinologist. So while a lot of that information is anecdotal to start, what is typical with some of these campaigns is that it does take multiple impressions for them to actually inspire some kind of change in action or behavior. So a lot of that deeper, more quantitative analysis, it'll take some time to be able to get a better view for what that full picture looks like. As Yan had mentioned before as well around patient severity, because this is not a clinical definition that can be traced back to something quantitative in claims, what we are resting on is mostly qualitative insight and again, Based on what we said before, both in terms of the depth of prescribing, which is increasing at a physician level, which suggests that they're prescribing to a broader case of patients that they're seeing, coupled with qualitatively, we do hear patients, again, historically not connect symptom to disease that are now doing so. Both of those things in tandem suggest that we are fundamentally shaping The types of patients that come in, even if it is not a clinically defined type of patient.

Great. Thanks.

Thank you. And our last question will come from Maxwell Score with Morgan Stanley. Your line is open.

Great. Thank you very much for taking my question.

So just on hypochondriplasia, how are you thinking about the size of the diagnosed treatable population relative to a chondriplasia? And where do you see Transcon CMP fitting into the treatment landscape as it evolves? Thank you.

An interesting question, because with genetic testing, you are actually redefining patients so that, for example, orphan was qualified into ISS idiopathic short status. If you didn't have clear phenotypic, you can say, Phenotypic that got associated with the hyperactive FDR3 receptor system. And today, when we defined it, we likely are defining from genetic testing, where people always need to have a genetic testing, but also at the same time have phenotypical effect on it. So we have trials going on in ISS which are pretty successful in this way and we see growth hormone as really the fundamental treatment in the ISS population but if we go over to hypochondroplasia There should be a well-defined mutation in the FDR3 receptor and it should be localized such a way that it also has so huge impact that it provides a phenotypic effect on it. So you could say we use a little bit more a narrow definition of hyperchondoplasia, but it's also related to the reimbursement system that exists in many countries. Where if you want to do utilizing in more costly therapy, you also need to justify it to the clinical benefit you get to the therapy. Thank you.

Thank you. And this is all the time that we have for questions today. We'd like to, this will also conclude today's conference call. We'd like to thank you for joining. And now you may disconnect.