Star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Chad Fugere, Vice President, Investor Relations. Please go ahead. Thank you, operator. Thank you everyone for joining our conference call this morning. I'm Chad Fugere, Vice President, Investor Relations of Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive; Rob Smith, EVP and Chief Financial Officer; Jay Wu, EVP, President, US Market; Amy Xu, Chief Medical Officer, and Sherri Glass, Chief Business Officer. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended, and Section 21E of the Securities and Exchange Act of 1934 as amended. Examples of such statements may include, but are not limited to, statements regarding our expected timing of U.S. commercial launch and product shipments for YUVIWEL, our expectations regarding the potential benefits of YUVIWEL, the potential market size and size of the potential patient populations for YUVIWEL, our patient services for YUVIWEL, our Vision 2030, our plans and objectives for future operations and commercialization activities. These statements are based on information that is available to us today. Actual results and events could 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 these factors that could cause actual results to differ materially, please see our forward-looking statements section in the press release filed on 27th February 2026, and the Risk Factors section of our most recent annual report on Form 20-F, filed on 11th February 2026. On the call today, we'll discuss the U.S. Food and Drug Administration's approval of YUVIWEL and our plans to commercially launch YUVIWEL. Following some prepared remarks, we'll then open up the call for your questions. With that, I'll now turn the call over to Jan. Thank you so much. It's a pleasure here Monday morning, 5 P.M. or A.M., I'm not sure what time it is, to be here in celebration to talk about YUVIWEL, our third FDA-approved drug. Before I dive into the details, I would like to thank the patients because that is part of our mission. This is our focus, to be patient-focused. The caregivers, the physician, and the Ascendis team for their commitment and dedication to get YUVIWEL approved here in the U.S. I know it's only the beginning. We have the European and many other countries where we also will go for approval. I would also like to thank the extremely productive interaction discussion we had with the advocacy groups. Discussing with this group, understand the real need, what is important for the patient, has been the guidelines, how we have dedicated our effort to design a patient-focused YUVIWEL. We thank them a lot for this positive interaction. YUVIWEL is the first and only once weekly treatment for children with achondroplasia, where we use the TransCon technology as designed to really get the benefit out of a normal native wild-type CNP molecule. The CNP pathway have been known for many, many, many, many years. How to really make it to a druggable product, this has always been the challenge. It's a peptide with very short half-life. When you think what we did with the TransCon technology, we took a peptide with few minutes half-life, up to five to six days. I've never seen it before, and I only believe it's only that strong technology like TransCon technologies that really is a platform to make that available. Not only that, because by designing it in the TransCon technology, we also addressed some major issues, too. Tolerability ensure we had a compound that basically work as inactive as you would like to have it in a product. Also the element of providing a sustained release, so you never have a high Cmax and have a potential risk for hypertension. When I see the fit between the CNP molecule and the TransCon technology, it's really fit in the most optimal manner to really go out and get the best possible out of this molecule, and it's really improvement in the patient care. FDA approval was based on data for three randomized double-blind placebo-controlled trials, including the pivotal ApproaCH Trial. In addition, we also got a bonus. With the FDA approval, we were also granted a Rare Pediatric Disease Priority Review Voucher, which confers priority review to a future drug application that will not otherwise qualify for priority review. A key takeaway from this slide is the call out box. I believe it's really a point of pride, not only for Sandy, not only for the patient, but also for myself, to be in a position to have the FDA approved in a row for three preclinical candidates that got designed. Scott is still calculating what is the chance of that. He still calculated what is 0.05 up to the third, what is that percentage? I believe that is really, really low. We beat every odds. I would now like to go to slide four, which provide some selected highlights of the U.S. prescribing information. I got asked from investors here during the winter weekend here, "What is your feeling about the labeling? Are you proud?" I said, "Yes, I'm extremely proud." When I look on the labeling, it's providing such a wealth description about the benefit you see with YUVIWEL compared to alternative treatment. It describe in a very, very, very direct manner the positive effect that we wanted to solve to the TransCon technology, the hypertension. It described very, very well the low injection site reaction. Having a product with a chance for every second year to have one single injection. I believe this is why we see this extremely high retention in our clinical trial. I'm really proud about it. When I look on the combination of what we have in our way to go out to the market, we have a strong label to part of the commercial team, and we have a strong application to the other part of the team, really providing all the benefits beyond linear growth we have observed. When I look on the integrated package, I'm proud for that. YUVIWEL is indicated to increase linear growth in pediatric patients two years of age and older. Basically no limitations upwards. From two years and younger, yes, we finalizing here in this year, next quarter must it be, this quarter here, we are finalizing. When we compare trials, when we look on efficacy related to linear growth, the only way where you really can compare is to go in on LS mean treatment difference. This is the only way where you have a meaningful way to compare trial. I know others try to observe value as way to compare it and other things. Yeah, I will not talk so much about that. At least if you want to make a scientific value comparison, please use the LS mean treatment difference in that. When we saw AGV of 1.5 cm per year at week 52 for YUVIWEL versus placebo in all children, and when we go in and look on the group where it's easy to compare because previous trial had been made in children from five and all older, we get an LS mean value of 1.8 cm per year. We also saw from our phase II trial that was running now I think about three, four years. For the first two years, we achieved the constant increase in the analyzed growth velocity. Also in the labeling it is clear they recognize the continuous exposure over the week. Low incident of injection site, 4.4. What also surprised me, which was in a very positive way, was the fifth guidance, because we really didn't test children in this way. We actually had nearly an exclusion on this kind of children. Still, I think because of the safety of this compound, we saw a once-weekly UBL start one day after completing the last day of a daily CNP therapy. If you read all the small note and everything else, there is no indication of food or food intake required before administration of the UBL. Going to slide number, it must be six by the same. There is our three approved products. Growth hormone deficiency, TransCon hGH. We are now doing a lot of label expansion for that. YORVIPATH, we have them approved in Europe and U.S. We are now expanding the label too. Now we have the third one, YUVIWEL. This is the beginning. It's definitely not the end. We, for the next three to four years, major label expansion of all this product, also in combination with this soil, and new entities is coming from our research and development groups. All of that leads to slide seven. This is our guiding for how Ascendis is going to be developed to the roadmap from 2025 to 2030. I will not go to our Vision 2030, but the key point is really one bullet point, be the leading endocrine rare disease company. I have no doubt we want to. We're really on a strong way to generate the $5 billion in product revenue in 2030, building from the three product opportunity, TransCon PTH, TransCon Growth Hormone, and TransCon CNP, to worldwide commercialization. I feel really, really strong on how we also investing now in developing the next generation in pipeline in rare disease endocrine. I have the hope that we'll be exactly as successful as the first one, 3/3. We'll never see. At least we have proven it once, and we can do it again. We continue to create value in additional area to our different utilization of our strong TransCon technology in different therapeutic areas. I will now leave it over now to Amy, where we'll go to the next series of slides before Jan will take over. I have the pleasure to round it out with the last two slides. Thank you, Jan. On slide nine, we have a brief overview of achondroplasia. As this group knows, achondroplasia arises from genetic variants that cause gain of FGFR3, fibroblast growth factor receptor 3 function, and affect multiple tissues. Notably, the constitutive overactivation of FGFR3 leads to impaired endochondral ossification, that is impaired chondrocyte differentiation of the skeleton. The clinical and radiographic phenotype of achondroplasia has been well described over the years. The complications represent a variety of medical, functional, and psychosocial challenges that may vary across different stages of life. Distinctive phenotypic features include a long narrow trunk and short limbs, especially in the proximal segment, large head, hyperextensibility of the joints, and restricted extension and rotation of the elbow. Radiographically, the shapes, relative sizes, and alignment of bones are also distinctive with, for instance, thoracolumbar kyphosis, an exaggerated lordosis of the spine, a narrow spinal canal, and leg bowing. Medical complications are the result of these differently shaped bones and body cavities. For example, complications may include hydrocephalus, which is accumulation of cerebral spinal fluid within the cavities of the brain, cervical cord compression, quite problematic, and recurrent otitis media, recurrent middle ear infections. Thus, major treatment goals are to decrease the incidence and severity of achondroplasia-related medical complications, promote healthy and proportionate bone growth, and improve quality of life. I'll now move to slide 11, which explains the design of YUVIWEL. You've heard some of this already from Jan. It's a prodrug of CNP, C-type natriuretic peptide, that acts through the NPR, natriuretic peptide receptor two receptor. It is administered once weekly and is designed to provide continuous exposure to active CNP to tissues throughout the body. The CNP moiety, represented in purple, is transiently conjugated to the carrier, represented in blue. The carrier extends the circulation time of CNP through a shielding effect that minimizes CNP receptor binding and clearance. CNP moiety is inactive when bound to the carrier, and YUVIWEL thus releases CNP in a controlled manner and is designed to provide continuous exposure with a low peak to trough, as heard before, avoiding high peak concentrations and thus avoiding the natriuretic and low blood pressure effects. It's been really nice to see this play out in the clinical trials. Now moving on to slide 12, which is about efficacy at week 52. In the pivotal ApproaCH Trial, superiority of navepegritide over placebo was demonstrated for the primary efficacy endpoint, annualized growth velocity at week 52. Children treated with navepegritide achieved a least squares LS mean AGV of 5.9 cms per year, which was statistically significantly greater than 4.4 cms per year for placebo, with an LS mean treatment difference of 1.5 cms per year, confidence interval 1.0-1.9 cms per year with a P value < 0.0001. Navepegritide increased AGV in each of the age subgroups. For instance, in participants greater than or equal to five years old, the treatment difference was 1.8 cms per year. Similarly, the change from baseline in height Z-scores calculated using reference data from untreated children with achondroplasia, that's called the achondroplasia specific height Z-score, and using reference data from the population with average stature, that's the CDC-based height Z-score, demonstrated statistically significant treatment benefits with navepegritide. For both achondroplasia specific height Z-score and CDC height Z-score, the treatment difference for change from baseline height Z-score was 0.3. Overall, improvements in AGV and height Z-scores were observed across all predefined subgroups analyzed, including for age, sex, and geographic region. Moving on to slide 13, which Jan promised won't take you a long time to read, and maybe you even need to break out your glasses to see it. This is a cut and paste of table 2 from the US prescribing information that was derived from pediatric participants with achondroplasia who received navepegritide 0.1 milligrams per kilogram per week or placebo during the double-blind periods of the pivotal ApproaCH Trial and phase II ACcomplisH trials. The adverse reactions listed in this table were reported in greater than or equal to 5% of participants treated with navepegritide 0.1 milligrams per kilogram per week and 2% higher than placebo during the placebo-controlled period. There are just four items in this relatively short table. We feel like this is a major point of differentiation. As you can see, this drug is safe and tolerable and appropriate for chronic long-term use in children. Moving on now to slide 14, highlights from dosage and administration sections and storage and handling sections from our USPI. I will read through these, and we're really proud of these. For instance, this is administration once weekly by subcutaneous injection with dosage based on body weight. Physicians are guided to periodically monitor growth and adjust dose according to the body weight, as would be expected. Discontinuation criteria are when no further growth potential is seen, as indicated by epiphyseal closure of the growth plates. There is even switch guidance within this US prescribing information. Start once weekly YUVIWEL on the day after completing the last dose of daily CNP therapy. We'd like to point out there is no guidance for food or 10 ounces of fluid intake when administering YUVIWEL noted within this USPI. Finally, YUVIWEL can be stored at room temperature up to 86 degrees Fahrenheit for up to 6 months and can be returned to refrigeration within these six months if desired. With that, I will pass it along to Jay. Thank you, Aimee. As you mentioned, this is an exciting milestone for the achondroplasia community. We are looking forward to sharing our initial perspectives on how we'll be able to support this approval. If we move to the next slide on 16. The main thing we wanted to start with is that our approach has always been hand in glove with the community. We have really appreciated these groups in particular, not only to help us learn more about this space, but also inform some of the key activities that we have undertaken to support the development and the ultimate approval of YUVIWEL. We've been engaging with these groups since 2017 to gain patient, family advocacy, as well as healthcare provider perspectives. They have supported us in our filing approach as well as strategy towards current and planned trials. Moreover, working with this group, they've also given us a lot of perspective on the diverse treatment goals of this community and what they may be looking for in terms of support should members of the achondroplasia community seek treatment. Lastly, they've also helped inform some of the novel approaches beyond even our approval today, whether it's exploring multiple indications in the future and/or combination regimens to expand treatment options and patient reach in the future. If we move to slide 17. This gives you a sense of the achondroplasia U.S. landscape today. Based on available information and our best estimates, we anticipate the U.S. pediatric achondroplasia prevalence to be around 2,600 in the U.S., of whichApproximately 30% we believe to be on current pharmacological treatment. As I mentioned before, in the U.S. market, those living with achondroplasia have diverse treatment goals. Some may be currently on a daily therapy, some perhaps have previously tried a daily therapy but have since discontinued, whether it's due to tolerability, convenience, or perceived lack of benefit. There's also an ample subset of this community that is not on and have never been on pharmacological treatment. I think what this really underscores is the level of unmet need that still exists in the achondroplasia market today in the U.S., and we believe that with YUVIWEL's clinical value proposition and differentiated profile, we're expected to grow the therapeutic class from both treated and untreated patients. If you move to slide 18, we have a bit of a snapshot on some of the commercial activities that we'll be focused on as it relates to supporting the YUVIWEL approval and launch. We'll be engaging with centers of excellence, thought leaders, as well as patient advocacy groups to educate key stakeholders on YUVIWEL's clinical value proposition. We also recognize the important role that patients and caregivers have in this space, in particular, when determining what is right for them. Really our focus will be meeting where that community is at, knowing that it is a very diverse and heterogeneous group. We'll be investing in multi-channel education as well as support for those caregivers and patients directly. Another big priority for us will be focusing on optimizing the patient experience itself. We know that there are opportunities. We know that it is sometimes challenging, particularly for ultra-rare conditions, and making sure that patients have choice is something that will be a high priority for us. Lastly, we have a lot of experience in rare conditions with the products that we previously have approved. We'll be leveraging our existing infrastructure systems and teams, which have supported over 15,000 patients on SKYTROFA. All in, just to say we are prepared to support YUVIWEL commercial availability in the early part of Q2 2026, as Jan had mentioned earlier. On the topic of focus, if we move on to slide 19, this gives you a brief snapshot of the patient care concentration, which you can see we believe more than half of them to be concentrated in these top 100 healthcare organizations or skeletal dysplasia clinics. Again, as I mentioned before, focus and high impact and patient support is going to be in areas of key focus for us. If we move to slide 20, this gives you a sense. We'll be really again leveraging the infrastructure and experience that we have supporting rare conditions to ensuring affordable and broad access in the U.S. With our Ascendis Signature Access Program that encompasses reimbursement access support, out-of-pocket assistance, as well as resources and training. For patient affordability, we do anticipate that eligible commercially insured patients will pay as little as $0 a month with a co-pay card. Government payers will have affordable out-of-pocket as well as patients screened for available assistance programs if they are uninsured or underinsured. With that, I'm going to actually transition it back to Jan to talk to us a little bit more about the 2026 milestones and to close us out. Thanks so much, Jay. This is only the 2026 milestones. We will just focus to give you a few aspects how we continue our progress in with YUVIWEL's, not only in one single indication but also starting our label expansion effort. Here in Q2, we are in a very, very interesting situation. We will have our, as Jay mentioned, our U.S. commercial availability. Little bit later, we will have also for our international market because we can be utilizing the U.S. approval also to start on name patient early access program in countries outside U.S. In Q2, we will have and follow up on 1.5 years data of our combination therapy, TransCon CNP. Just recall you that this is a place where we saw that we basically could achieve in one year the same outcome that it basically took three to four years with monotherapy. Complete paradigm shift, really an unbelievable benefit in treatment outcome I ever have seen before. Perhaps more and more important, safety, safety. Why ever compromise on any treatment, take any risk to safety if you have no kind of improvement in treatment outcome? Going to Q3, we will complete the enrollment for the zero to two children. As I said before, really promising data we have seen until now, and we really look forward to have that integrated in the U.S. approval. In the European approval is much more easier doing the ongoing regulatory interaction to provide more data. Going to Q4. We have the dream, or it was basically Scott dream, to start to do a trial and also give adult with achondroplasia some benefit for CNP treatment. We are now analyzing all the benefit we can provide there and find out which one will be most meaningful for the patients, really to provide a treatment that really will mean that it means something to them in their daily life. Also in Q4, we will be in a position to have the expected European approval. At the same time, you will also get the two years data from our combination trial. There was just 26. Now I come to the last slide, 22, which sum up the few next step. Yes, today YUVIWEL the first and only FDA-approved once-weekly therapy for children with achondroplasia. We got granted and Rare Pediatric Disease PRV. We will have product ability in the early part of the second quarter in 2026. We expect the approval in Europe end of the year. We plan to make YUVIWEL available to our existing infrastructure. I think Jay made it really, really, really clear how he have taken 10,000 of children to the system we are also using right now for YUVIWEL. That is really the power of focus on one single therapeutic area that works with the product, because we can utilize it in a much, much stronger way the established infrastructure in it. When we come to the international market, we really are, through our Europe path effort now are recognizing revenue from more than 30 country, and we have more than 70 countries now under distribution agreements. This is the same infrastructure we will utilizing also for you with that. We are not stopping here as always. This is just the beginning of the beginning. We start on the same phase. We will continue to use YUVIWEL as a strong foundation therapy, specific in combination, not only with risdiplam, but potential other products. We will also go to the expected planned label expansion, which we already have started with hypochondroplasia, and we will continue to do in our indication. I will end where I started. Three pre-clinical candidates, three of FDA-approved products in a row. Scott is still calculating what the chance of that, but I'm really proud of that. Thank you so much today. We are now open for questions. Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. In fairness to all, please limit yourself to one question before reentering the queue. One moment for our first question. Our first question will come from the line of Yaron Werber with TD Cowen. Your line is open. Please go ahead. Hi. Good morning, team. Thanks so much for taking our question and congrats on the approval. This is really great news. This is Sarah on for Yaran. We just have two quick questions both on the label. A, I believe you were expecting enrollment for the reACHin study in patients zero to two to be completed in Q3 of this year. You just guided to that. Can you give us a sense of what the target enrollment is and when we might expect to see data? What would you need to see in order to file for a label extension in age two and under? Second, just on the administration for the injection device. I know right now it's sub-Q vial reconstitution. A key difference between the two labels is the much lower rates of injection site related reactions for YUVIWEL versus Voxzogo. Do you attribute this to the weekly versus daily injections, or are there other factors that support the lower rates of ISRs? Thank you. Thanks a lot for the question. I will take the last one because then can Amy prepare herself for the first question. Let me take the question between the other daily therapy and our YUVIWEL. It's nothing to do with anything else, the technology. What we are doing with the TransCon technology, we making an inactive product. Why I say little bit with a smile, because a product by itself in definition is inactive. What this merely mean that you inject an inert without any biological activity in the injection. Whatever you did daily, weekly, monthly, yearly, it will still be inactive. Then it diffuse into the blood compartment, then it liberate the unmodified native CNP peptides. When you take the daily, it's not really protected. It's fully active when you inject it. This is why you see this kind of injection site reaction. That was how we really designed it. With the TransCon technology. TransCon technology is not only providing the sustained release profile, which provide no risk for hypertension, but also protected in the injection site reaction. This is why when you look at 0.4 injections per year, meaning is that this is why we see this positive results. Aimee, will you take the first question about our young children? Yes. I think the question was, how are things looking for the infant trial and the target enrollment? There we have shared for approximately 72 kids, including the sentinels who are open label and the blinded kids. This is why we, you can say we had one part on blind and already there we can go to the data and see extremely positive effect as we expected to see. On the, you can say the blinded part, we can basically only look at safety, but if you don't see anything, you're also happy. Thank you. One moment for our next question. Our next question comes from the line of Tazeen Ahmad with Bank of America. Your line is open. Please go ahead. Hi. Good morning. Yes, congratulations on getting your third drug approved. I just wanted to clarify, have you guys announced price yet? If you haven't, can you just let us know when to expect that? Secondly, how do you see the initial uptake as far as the market opportunity? You've talked a lot about it and the focus on these 10,000 patients. Initially, based on what you're hearing from physicians, do you expect uptake to come from switches from the currently approved product, or do you think that there would be significant uptake from frontline or treatment naive patients as well? Thanks. Thanks a lot for this question. First of all, let me go start with the price and then Jay can follow up on the other, what I call the commercial strategy. Price, we have not disclosed yet, but I can give you, Tazeen, some guidance. When you look in our products, we always say that this product that really have provided extreme benefit compared to any other standard that have been in the market. Out from that, we always said we want to share this kind of upside for the patient, for the society, for reimbursement system and other things like that. Doing that, we always come up with a premium price. I don't think we ever have made any product that have been in a situation where we have not been taking this approach because every product we have have been a product that really providing highly differentiated benefit to any kind of standard. Tazeen, from that perspective is I will expect an premium pricing strategy also in this case. Jay, will you talk a little bit about the idea of both groups related to uptake? Yes, happy to go to those questions. Just to follow on Jan's pricing comment as well, and Tazeen, I think the latter part of your question, we do anticipate that we will make price available either later this week or potentially even next. That information should be out there soon. As Jan mentioned before, price should be commensurate with the clinical value proposition that we have, and we also believe in patient choice, so that will be something we will be prioritizing. For the other areas that you had inquired about, we do anticipate broad appeal for YUVIWEL. As I mentioned before, there are a couple segments, right? There are segments of patients that are currently on pharmacological therapy, and we have heard even since the approval that, you know, there are patients asking about potentially the process to switch over and/or commercial availability. We also anticipate that this will bring additional members of the achondroplasia community out of the woodwork who will want to try something new that for whatever reason, did not choose or elect the current available therapy that exists today. Again, as I mentioned before, some of the patients that previously were on therapy that discontinued, whether it's due to tolerability, due to convenience or perceived lack of benefit, we do anticipate that some of those patients will be potentially interested in YUVIWEL as well. Thank you. One moment for our next question. Our next question will come from the line of Gavin Clark-Gartner with Evercore ISI. Your line is open. Please go ahead. Hey, guys. Congrats on getting the approval here. I actually just wanted to ask about current YUVIWEL consensus estimates. If I just focus on the fourth quarter of this year, kind of breezing over the first couple quarters where, you know, establishing access, et cetera, will be going into place. I'm seeing about $25 million, maybe $30 million in 4Q consensus estimates. If I just flip over to BioMarin consensus, I'm seeing about $75 million in fourth quarter of Voxzogo sales. I guess the current consensus is implying a pretty big relative market share shift pretty quickly. Do you think that consensus number could be achievable? How important is the switch versus naive dynamic within that time frame? Thank you. One of the elements which I always are impressed on when research doing some kind of projection of revenue and sales without knowing the price of that product. Because I actually think that gives some kind of uncertainties in it. As Jay said, there is a few days before you will know the price, and I think it will be potentially more relevant when we have disclosed prices. We go back to this question and give us a discussion, and I'm quite sure that both Scott and Chad are really fit for fight to discuss the different modeling perspective with you related to this if you have specific input that you really would like to get. Sounds good. Thanks. Thank you. One moment for our next question. Our next question comes from the line of Joseph Schwartz with Leerink Partners. Your line is open. Please go ahead. Hi, this is Heidi Jacobson on for Joe Schwartz. Wanted to add our congratulations on the approval as well. What feedback have you received from physicians regarding the lack of a predosed food and fluid requirement, and do you view this as a meaningful point of differentiation in practice? Thank you. I believe you always need to take that holistic approach on any treatment element in it, and I will never isolate a single element in how you will select a treatment. You will take the overall perspective of a drug. We decided to design YUVIWEL in a way that we really try to address all known, you can say, downside for not to be the best in class into this area. This is why we addressed both hypertension, and you can see, are this a relevant element? I believe it's relevant when I read publication, for example, from Japan, if you not have seen that, case studies of severe hypertension in small children when they give YUVIWEL, the once daily product, which has the fast Cmax. When I look on injection site reaction and see tolerability, I believe is a really, really important part for the interaction between the child, if you really see big redness to that high frequent you see with a daily treatment. Other effect, if caregivers are following really the labeling, which they should in every treatment, you basically need to ask the child to drink a lot before they basically take the administration. When I see that, I never pinpoint a single element. I always take the holistic view. What is the right best treatment benefit for every subject that need to get a treatment? Some parents, some children are more aligned with one element, some it's more aligned with another one. Some are not saying it's such a hard thing just to take a daily administration. We cannot live a life because we are so busy. We working, we need to do it. This child is screaming. Therefore, we cannot take a daily injection. Therefore, I always believe address all the point and be sure you have the optimal treatment. Thank you. One moment for our next question. Our next question comes from the line of Alex Thompson with Stifel. Your line is open. Please go ahead. A great congrats as well on the approval. I just wanted maybe some additional color on sort of the overlap between your current commercial infrastructure and how that's being leveraged for the YUVIWEL launch. Have you added any additional, you know, sales force elements, et cetera? Thank you. Yeah. Jay can go in. Yes, we have added. Typical, we basically have two, you can say, arms in our sales force. One that is basic focus on hypercare, and the other one is basic the arm that is focusing on the SKYTROFA, the YUVIWEL products. Because our aspiration is also on a long-term perspective. When we get it on label, there will be a utilization, a lot of combination therapy. This is why we have built it this way. You can say, as Jay said, we have already more than 10,000 patients in SKYTROFA treatment. We really have what e call a high capacity system to really to take the patient to it. Jay, you can talk about how you have scaled up in U.S. I can perhaps say in the European side, we also scaling up. All the different direct market and international market, we are ready to the YUVIWEL approve. As Jan mentioned, we have scaled across the U.S. organization for a variety of reasons, right? hypopara, that product obviously has had a very positive trajectory, and we have needed to support that. Even SKYTROFA, we also had a line extension last year as well into adult growth hormone deficiency. I think to Jan's point, as an organization, we are growing overall. We don't comment on explicit field sizing, but generally speaking, the U.S. organization has been growing. I think your second question was pertaining more to overlap. We do have an overlap of certain prescribers. Given SKYTROFA is in the pediatric endocrine rare condition space, there is some natural overlap there for prescribers that are also interested or treat achondroplasia. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Derek Archila with Wells Fargo. Your line is open. Please go ahead. Hi. Good morning. This is Simone on for Derek. Congrats on the approval, and thanks for taking the questions. My first question is, what impact do you think YUVIWEL's approval has on the ongoing ITC case, given the win with the EU case and the citizen petition likely being drawn out? It's always hard for me to comment on an ongoing trial. I would like to refer more to the European case, which has been now resolved. Our from the perspective is that there is three steps that needs to be fulfilled. First, that need to be a validation of the actual patents. Second time, there need to be a discussion, do we actually do an infringement? In the third step, if we ever come so far, which we never came, is are there public interest to have this product in the market? In the European case, we only came to one single step. Was this patent really should be issued or not? Clearly it got basically taken away immediately. We never came into either if we basically had an infringement in any kind of the case. This is also a European way. The U.S. still have the same three different steps. Except that compared to Europe and U.S., there's a much, much higher emphasis on the element of public interest, which are not a strong part in Europe. When I look on this product here, it come from a priority review from FDA, meaning is that if they as a regulatory agency are recognized that it's providing a benefit compared to standard treatment that is out in the market today. That is also what we have seen now through the approval of it. I feel extremely confident that this case would never should have been a case, but at least there are some legal people that earn a lot of money on it, and we also get damage paid back every time we win. That is also fine for us. At least we can have some good parties from that. I feel that in some way we should just let it go and not will interfere anything in this case. We will be in the market. There is no doubt of that. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Yun Zhong with Wedbush Securities. Your line is open. Please go ahead. Hi. Good morning. Congratulations on the FDA approval, and thank you very much for taking the question. I just want to confirm, do you still have a plan to explore hypochondroplasia with TransCon CNP? I saw that you have included the adult subject with achondroplasia. wanted to see if you are able to comment on the size of the opportunity, or any special approach that you need to take for the adult subject with achondroplasia. Thank you very much. We see a lot of opportunities in our product portfolios in the area of we call it growth disorder, but it's not really a right name because it's really is much, much, much, much broader in this way. When we look on indications like hypochondroplasia, we actually see a huge opportunity there for not only Yuviwel, potentially also SKYTROFA, potentially also the combination therapy. This is where we are in the uniqueness because we can make both of them as a single monotherapy, but we can also make it as combination therapy. Today, because of the more extensive genetic testing, patient that came from the ISS group, many of them are basically being relocated into hypochondroplasia. When you find the mutation. You find the mutation is not really longer an ISS. It's not idiopathic because now you know it. Therefore it basically is an patient that came from ISS but now belonging to hypochondroplasia and typical just will be treated with a growth hormone therapy. This is where Aimee Shu really are designing a program so every patient will get the best possible treatment. I think we can do it as the only company because we have access to both SKYTROFA and TransCon CNP. Thank you. One moment for our next question. Our next question will come from the line of Eliana Merle with Barclays. Your line is open. Please go ahead. Hey, guys. Thanks for taking the question. Congratulations on the approval. Curious when in early 2Q specifically you anticipate launching, and if you could elaborate on what the gating factors are between now and before you launch. I guess, in other words, why you're not launching sooner than 2Q. In terms of reimbursement, just what are your expectations from your early discussions with payers, and the work that you've done with pricing ahead of the launch in terms of, like, reimbursement timing and the time, I guess, from a script to potential reimbursement? Thanks so much. I think Jay will take the last part of the question and related to the U.S. I can take related to the international market. Your first question is that when you're getting an approval in the last days, you get the final information that you need to have on your packaging information. Therefore, it's impossible to launch directly in the day after because you need to print both primary and secondary packaging, get the insert in the right format that you get from FDA. Even if we have a product supply group headed up by Fleming, that is one of the best and fastest one in the world, we basically are in position that takes some weeks before we can get the paper. Once he can print them, he can sit down and pack them and get them out to the patients. All that is happening here in the U.S. We just need to be quite sure we have the right information from FDA. Jay, will you take the question related to the reimbursement? Yes. Oh, the question pertained to reimbursement. Those conversations are happening in an ongoing fashion. We are encouraged by all the initial conversations we're having in the sense that being able to talk through the clinical value proposition that we have, which we believe is very compelling for this community. We look forward to those opportunities to continue to educate on the label and the data itself. Right now it's a bit premature to give you a bit more of a timeline on when this, when that, primarily because a lot of these reviews can be staggered over time. Much like any product approval that are coming through in the early days, we do anticipate in the beginning it will be primarily through formulary exception as these plans take the time to review the information and the data and label that we have. We look forward to having those conversations and feel confident that the clinical value proposition will speak for itself. Understood. Yeah. I think, Jay, is exactly saying exactly what I was saying to that happening with Europe. You can say you really are prepared. I think perhaps we're one of the best company prepared to run with medical exception because this is what we have done for basic all our product in the beginning. You can see we basically continue launching product, new labeling and other things like that. There is nothing. Related to the international market, which we also can access now, is basically on early access programs. Therefore there is clear rules, regulation, how they are getting reimbursed in all the different countries. Great. Thanks so much. Thank you. One moment for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open. Please go ahead. Hi. Good morning, and let me add my congratulations as well. Can you comment on what the FDA has indicated is required for full approval of YORVIPATH here? Would you potentially be seeking a label for the general treatment of achondroplasia or just maybe seeking to get additional data or clinical benefits on label and just sort of what is required there? My second question is, on the label, there is some commentary on how to switch from the daily CNP drug in terms of the prescribing information. Can you maybe comment on, you know, how you intend to potentially promote that among existing CNP patients on CNP therapy? Are you primarily looking to promote on to data on label, or are you thinking about any incentives for driving switches? Thank you very much. Yeah. You can say it's really important for us to have a labeling because that is basically give us the opportunity to get our commercial effort really to promote it because it's on label. I can say this is a huge benefit that we got that taken up in this expect. I do not know if you have further comments to that, Jay. Yeah. The only other comment I would say, echoing what you said earlier, the guidance is very clear, right? You can start it on the day after completing the last dose. I guess I think about it less from a promotional standpoint, and again, I talked about before, it's meeting patients where they're at. We know there are many patients for which this will be a very interesting option for them. It won't just be limited to patients currently on pharmacological treatment as well. There will be patients that are not on pharmacological treatment that may now be interested based on the value proposition that YUVIWEL will have. I think our approach will be much more holistic than solely looking at patients looking to switch. Related to your first question, Paul. We have two basic two way to progress from that. We can do out and getting what we call an approval on the linear growth, or we can go out and getting a treatment. We actually are finding out that we really have a lot of impressive data that really are showing benefit beyond linear growth, which can be utilized to basic to move it over to a treatment. I think this is something we're now starting to have interaction with the FDA. How really to be quite sure we can take that into label consideration and then potentially be taking into change to a treatment label. Well, we hope that we have sufficient data already now with existing data to get a positive outcome of this discussion. If they some way propose and want to have more data, we are also willing to generate more clinical data to support this data system. You can see we have an active approach how we need to turn it into a treatment. Got it. Thank you very much. Thank you. One moment for our next question. Our next question comes from the line of Luca Issi with RBC Capital Markets. Your line is open. Please go ahead. Great. Thanks so much, team. Good morning and good afternoon, and congrats on the label. This is a question on the PRV, and congrats on that as well. How should we think about the PRV? Would it be fair for us to assume that if you had gotten the approval back in November, you wouldn't have gotten the PRV, given Congress just reauthorized the PRV in time for this approval? Also, now that you have gotten the PRV, is it fair for us to assume that you likely is going to monetize it? Thanks so much. I think Scott looks so happy now because he looked like he got a question. Yeah, it doesn't make a difference. We were grandfathered in 'cause we received a Priority Review designation or pediatric review designation years ago. Thanks. Great. Oh, will we sell it? Yeah. Well, most of the products we're developing are getting priority reviews, I'm not sure that we actually need to keep it. I think we sell it. If anyone's interested. Thank you. One moment for our next question. Our next question comes from the line of Maxwell Schorr with Morgan Stanley. Your line is open. Please go ahead. Great. Thank you very much for taking my question and congrats on the approval. Could you help us understand how the EU achondroplasia market breaks out? I know there's more patients on treatment, but kind of looking at slide 17, thinking about specifically the proportion of patients on treatment and what proportion not on treatment are due to discontinuations or just treatment naive. Thank you. Yeah. The problem in answering this question is that we talk about extremely heterogeneous market. There is many countries where daily CNP therapy is not even reimbursed. You can say all patients are naive. Then there is errors or countries where there is approved, and you see a high level of penetration up to 70%-80%. It's extremely heterogeneous in all the different countries, and that is not only in Europe, but it's also in the international market segment. What Jay said, for the U.S., I actually believe it's the same that can be utilized both for the European market and international market, for Asian and other things. It will come from everywhere. There's a huge benefit switching for the daily CNP. There's a huge benefit going in for a treatment now. The possibility is that we believe it can be possible to go to the country where it's not possible to have any kind of CNP therapy when we come with the combination data, because it's basic are providing so much higher efficacy benefit that in all their cost efficient modeling, we can also get an acceptable reimbursement in these countries here. Don't forget one thing. We also saw benefit beyond linear growth, and that was in a well-controlled trial compared to placebo. No one else have done it. It's also meaning is that we can go out and do much better pharmacoeconomic modeling and also hopefully we can get a much better penetration in many countries where it's not possible to do it for the daily CNP. Great. Thank you. Thank you. One moment for our next question. Our next question comes from the line of Kalpit Patel with Wolfe Research. Your line is open. Please go ahead. Yeah. Hey, good morning and congrats on the approval. Maybe just setting aside the ITC case, how are you thinking about the district court and Federal Circuit proceedings? Do these present any meaningful risk to your launch timing or commercialization in your view? In my view, no. I believe this is a product that basically have priority review. It's a product where regulatory agency are saying that it's basic is providing in benefit compared to what is established in the treatment landscape today. If you can give me any case study in the U.S. where a product with priority review has got any kind of temporary injunction, I would like to see that, because I cannot find one. Okay. Thank you. One moment for our next question. Our last question will come from the line of Li Watsek with Cantor Fitzgerald. Your line is open. Please go ahead. Hey, good morning, guys. Wanted to add my congrats as well. Jay, you touched on, you know, different buckets of, you know, patients. Just curious what proportion of these patients may fall into this group of, you know, who might have tried daily but discontinued due to various, you know, reasons that could be, perhaps low-hanging fruit, for you guys, and wondering if you have already identified any of these patients. Would you take it, Jay or Aimee or o kay. Start, Jay. Yeah. Hi, Li. Thanks for the question. We have had inbound patient requests and of course, we're very beholden to compliance. From an approval standpoint, we won't have that responded to any of those inquiries until the actual approval. We, of course, recognize that there are patients coming from all segments that would be interested. I think from a pragmatic standpoint, what you can expect is for patients that have already made the decision that they want to be on pharmacological treatment, that is one fewer question that they may be considering when considering whether or not they wanna start a new one, right? There are other patients that may not have been on treatment yet that are debating whether or not they want to start treatment for which this one might be their first intro into it. I do anticipate that we will have uptake across all segments, although some of them may be further along that journey than others. Again, some of this is just a matter of time as it relates to their comfort level with pharmacological treatment, given the diverse treatment goals that they have, which we fully respect in the achondroplasia community. Aimee, do you have anything to add more to? We have certainly been hearing, you know, through side channels from patients and physicians about their enthusiasm for a weekly therapy. If I can sum up here, we are extremely proud about the YUVIWEL approval. 3/ 3 is nearly like our vision, our last vision was 100% correct, and we fulfilled it 100%, as we also will fulfill Vision 2030. I think still, we should never remember our values. Focus on the patient. When we go to the pediatric segment, key element, safety and safety. No one should take risk in any kind of population that going into any kind of treatment. There can be benefit-risk balance, but what I really are proud about the YUVIWEL, we saw all the expected benefit related to linear growth. We saw effect beyond linear growth that was much better than we ever had hoped and dreamed. Just the leg bone providing bone leg alignment. What we saw from the safety, which are also illustrated in the label, extremely safe product. I think that is what I'm really proud of. Thank you so much for today. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.