Thank you, operator, and thank you, everyone, for joining our second quarter 2026 financial results conference call. I'm Chad Fugere, Vice President, Investor Relations at Ascendis Pharma.

Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherry Glass, Chief Business Officer; and Jay Wu, Executive Vice President and President, Ascendis US. Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act.

All statements made on this call other than the statements of historical fact are forward-looking statements. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA, YORVIPATH, and YUVIWELL, including label expansion and combination treatment; certain expectations regarding patient access and financial outcomes; our pipeline candidates and our expectation with respect to their continued progress and potential commercialization; our strategic plans, partnerships, and investments; our goals regarding our clinical pipeline, including the timing of clinical results and trials; our ongoing and planned regulatory filings and our expectations regarding the timing and results of regulatory decisions; and our financial outlook and Vision 2030 objectives.

These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements.

We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statement section of today's press release and the risk factors section of our annual report on Form 20-F filed with the SEC on February 11, 2026.

In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results.

A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believe these measures are useful to investors, is included in today's press release. TransCon Growth Hormone, or TransCon hGH, is now approved in the US by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency, and in the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency.

TransCon PTH is approved in the US by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission and the United Kingdom's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP is approved in the US by the FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I have just described, our product candidates are investigational and not approved for commercial use.

As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding our product candidates shall be viewed as promotional.

On the call today, we'll discuss our second quarter 2026 financial results and will provide further business updates. Following some prepared remarks, we'll then open up the call for questions.

With that, let me turn it over to Jan.

Thanks, Chad. Good day, everyone.

During the second quarter, achievement of important milestones and strong demand for our TransCon products continued to drive the transformation of Ascendis into a leading global biopharma company. The uniqueness of the TransCon technology platform, our strong development and global commercialization capability, and our values and visions are the fundamentals driving this transformation.

We believe the same strengths will continue to drive Ascendis' growth in the following years. Starting with the long-term durability of our highly differentiated, approved protein and peptide-based combination products: SKYTROFA, YORVIPATH, and YUVIWELL.

We believe these products will be the key driver of our growth story for the next 10 to 15 years through global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings. The continued expansion of the TransCon technology platform enable us to fulfill our plans to file at least one IND or similar yearly, each based on a new NCE, laying the foundation for strong growth for many decades.

This will this will also enable us to establish new therapeutic areas in addition to hypoparathyroidism and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications.

This is why we believe Ascendis is well-positioned for self-sustained long-term growth. Let's begin with a more detailed look at YORVIPATH.

YORVIPATH is the first and only approved treatment for adults with hypoparathyroidism that address the underlying disease by replacing the missing endogenous PTH throughout the body. Uptake of YORVIPATH has grown steadily since launch, both in the US and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure.

Outside of the US, we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. YORVIPATH is now available commercially or through named patient programs in more than 35 countries.

This illustrates the strength of our ability to execute a rapid, broad global launch of a rare disease product. In the US, new patient demand for YORVIPATH in the second quarter has remained robust, consistent with prior quarters.

In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated YORVIPATH treatment continue to stay on therapy, indicating a high level of satisfaction.

We continue to be excited by the growth of YORVIPATH in the US and outside the US and to see its continued strong launch performance. Data from our long-term Phase 2 and Phase 3 trials of YORVIPATH presented in the second quarter highlight why YORVIPATH is becoming a standing standard of care in post-surgical and all subsets of hypoparathyroidism, including ultra-rare genetic causes like DiGeorge, ADH1, and ADH2.

Results showed sustained response rate of 82% to 86% for multi for the multicomponent endpoint, with clinical benefit across multiple organ systems: CNS, kidney, small intestine, and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after 5 years of treatment, pretty unique.

In parallel, we're working to further advance our leadership in hypoparathyroidism with additional clinical trials that include expanding the label to include the age from 12 to 18 years, and in the US, higher doses for patients, and developing a once-weekly product for the patient that is on stable doses of YORVIPATH. Turning now to YUVIWELL.

We believe YUVIWELL is positioned to be to become the market leader therapy for achondroplasia. Rapid uptake of YUVIWELL is already transforming the US market.

Across the board, we see a highly favorable response among patient and physician to YUVIWELL's differentiated profile. In the US, through June 30, we had more than 170 unique patients enrolled.

Since then, uptake has continued, with more than 220 enrollments and more than 65% approved for reimbursement in the US through the end of July. Really a unique launch.

The rapid uptake is by patient of all kinds of background: those switching, returning to medical therapy, or starting therapy for achondroplasia for the first time. We believe YUVIWELL is really growing the US market, which is exactly the pattern you will love to see when a highly differentiated product is introduced into an area where there still exists a high unmet medical need.

Long-term data for the now completed pivotal ApproaCH trial showed durable and consistent improvement in growth: leg bone, body proportionality, along with a general well-tolerated safety profile compared to placebo, underscoring why the community is quickly adopting YUVIWELL. In the US, in the EU, a regulatory decision for YUVIWELL is expected in the fourth quarter of 2026.

We are also making YUVIWELL available in select international markets through early access programs using the US FDA approval. Longer term, we are pursuing expansion opportunities for TransCon CNP through ongoing and planned trials.

These include ongoing activities such as infants, 0 to less than 2 years of age, and we recently announced completion of this target enrollment faster than expected; adults with achondroplasia; children with hypochondroplasia; and still continue the geographic expansions. Turning now to combination therapy with TransCon CNP and TransCon Growth Hormone.

The biological rationale for this combination treatment is clear and extremely well-founded on science. TransCon CNP is removing the limitation caused by the overactive FGFR3 pathway, TransCon Growth Hormone can provide a strong complementary effect.

In addition, it have has been observed that in achondroplasia, there is a partial impairment of the IGF-1 growth hormone axis. This is illustrated by children with achondroplasia have a negative IGF-1 SDS value, as shown of the demographic in both our Phase 2 and Phase 3 trials.

In our COACH clinical trial of children with achondroplasia, this unique combination has demonstrated sustained transformative annualized growth velocity and AH SDS height score, including improvement in body proportionality. Based on this result, we believe this unique combination of once-weekly TransCon-based therapies will transform the treatment of achondroplasia and other indications over time.

Our recent week 78 COACH trial data showed sustained efficacy over 78 weeks, with no compromises to safety and tolerability. This points to the potential for this novel combination to establish a new treatment standard in achondroplasia.

The Phase 3 combination trial in children with achondroplasia will begin enrolling later this year. Turning to SKYTROFA, a once-weekly growth hormone treatment built on the mode of action of unmodified somatropin, with indications for pediatric and adult growth hormone deficiency, we continue to be the number one long-acting growth hormone by brand value in the US.

We are extremely proud that SKYTROFA recently achieved more than 20,000 unique enrollments. This illustrates the strength of our capabilities from supply chain, commercial infrastructure, and on-market support to benefit such a large number of patient rare disease patients.

We are working to make TransCon Growth Hormone available to more patients through label and geographic expansions. To support label expansion going that described in our achondroplasia program, we are conducting the Phase 3 BASKET trial investigating TransCon Growth Hormone in ISS, SGA, and Turner syndrome.

As an integrated part of our global growth disorder strategy, we expect to launch TransCon Growth Hormone in the same countries where we also expect to launch TransCon CNP. Turning now to our partnerships.

In metabolic disorders and obesity, our once-monthly TransCon semaglutide program with Novo Nordisk continued to advance advance. In ophthalmology, our partner Eyconis recently initiated a first-in-human clinical trial of the anti-VEGF treatment built on the TransCon technology in patients with wet AMD.

In closing, by always putting patients first, Ascendis has delivered three highly differentiated, leading TransCon-based products: YORVIPATH, YUVIWELL, and SKYTROFA. We are on track to achieve our Vision 2030 objective of being a leading global biopharma, building on a strong foundation for the future.

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

Thanks so much, Jan, and good afternoon, everyone. I will touch on some key points surrounding our second quarter financial results.

For further details, please refer to our Form 6-K filed today. Total product revenue was €315 million, more than doubling year-over-year.

Total revenue for Q2 2026 was €339 million, which included non-product collaboration revenue of €24 million, which further included a €17 million milestone related to TransCon CNP. YORVIPATH revenue was €252 million in Q2, reflecting consistent new patient demand in the US and continued growth outside of the US, reaching blockbuster status on a run-rate basis in the second year of launch in the US.

SKYTROFA contributed €55 million in Q2, which reflects increased demand in the US and includes product sales to a collaboration partner. YUVIWELL was commercially launched in the US during Q2 and generated €8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking.

Continuing to expenses, R&D expenses in Q2 were €76 million, up from €59 million in Q1, reflecting continued investment in our pipeline and innovation. Recall Q1 included a favorable €11 million reversal of prior-period write-downs of TransCon CNP pre-launch inventories.

SG&A expenses were €173 million in Q2, compared to €145 million in Q1, reflecting additional investments in the commercial launches of YORVIPATH and YUVIWELL to accelerate growth for the long term. Operating profit of €220 million in Q2 included €158 million of other operating income related to the sale of the PRV.

Non-IFRS operating profit was €92 million, and non-IFRS operating margin was 27%. Refer to our press release for details.

For Q2 2026, net profit was €207 million, and non-IFRS net profit was €61 million. We ended Q2 2026 with €812 million in cash and cash equivalents, which includes the use of €56 million in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs.

Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and €1.4 billion of equity. Turning to our outlook for the rest of 2026: For YORVIPATH, we expect growth and performance consistent with prior quarters.

For SKYTROFA, we expect relatively stable revenue in the US. For YUVIWELL, we are encouraged by the early demand trends.

We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the US, reflecting the large unmet medical need and the highly differentiated profile of YUVIWELL. Our Q2 performance reinforces our belief that we can achieve €5 billion in revenues in 2030.

With our existing portfolio and our TransCon technology as a strong foundation, we believe we are well-positioned to grow revenue to more than €10 billion in the next decades, while developing and launching new TransCon products with blockbuster potential. We expect significant operating leverage as revenue scales through the balance of the year, while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long-term revenue aspirations.

Even with these investments, we expect to generate more than €500 million in cash flow from operating activities this year. With that, operator, we are now ready to take questions.

Hey guys, good morning. Thanks for taking my question.

On that outlook for at least $500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale, and I was just wondering if you're able to kind of update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded, but curious if anything more you can add there.

Then on that comment that YUVIWELL seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion? Thank you.

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

Please, Scott.

With respect to our cash flow guidance, just to be clear, greater than 500 million. I heard you say 100, greater than 500 million.

At this time, we don't want to bound the upper side because we're initial into the launch of YUVIWELL. That's euro, by the way, €500 million, Jan likes to point out.

Just related to the question, and it comes back to what someone communicated last time we had this call, that we don't have really the insight in exactly the distribution of where the patients are coming from. Our general feeling and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from switchers.

It must also coming from either patient that had stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of YUVIWELL that they want to start therapy. I think this is where we have this strong belief that we see an expansion of the market.

Thank you.

Hey, good morning. Thanks for taking my question.

Jan, I wanted to get your thoughts about the IP challenge on YUVIWELL. We know obviously what the blue sky scenario is for Ascendis, and most of the scenarios look positive, but can you just maybe walk us through what the potential outcomes are?

This is for a patent that expires obviously in 2030, and so between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst-case scenario could be? Thanks.

Thanks, Tazeen, for the question. It basically is a question that is addressing the ongoing legal, how do we call it, battle between Ascendis and BioMarin.

Let me just come back to some facts. The facts is that this patent that we discussion got complete invalid in Europe, we never really come to an discussion if we were infringing and anything like that.

When we see the situation outside US, we got the patent invalid immediately to the patent system in Europe. In the US, we never managed to come into the patent system because BioMarin selected to go to the ITC case, which are a system which we can easily say traditional never have really dealt with a lot of cases that dealing with branded pharmaceutical.

In the ITC case, there will be a first opinion from a single judge, and he will come with opinion here in August. Then next time will be in December.

There will be an opinion from the ITC. Then later on, there will be and potentially a confirmation of the ITC decision 2 to 3 months after to a presidential order.

You can see we're not getting any clarification in August in one way or the other way, even as it's possible for one company and negative for the other one. It's not really any kind of decision where it's going to be ending.

After the first initial opinion from a single judge, because the ITC case will be taking to a decision for, I cannot remember how many judges that will be part of that decision, there is a huge opportunity to provide what we call public interest for this product. When we see the public interest, meaning the element of how this product opportunities are really being serving an unmet medical need in the US market with this rapid, rapid uptake of patients, it's really, really clear there is a huge public interest to keep that.

Just recall, I cannot remember one single case in the US where a branded product that provide a benefit to US patient had been denied. You can see we're just in a case where it's only is the US.

It has been cleared ex-US. Whatever it happened, it will not have any material impact on Ascendis' broad way.

I can guarantee that. People take it up as a life and death for Ascendis.

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

Hey guys, thanks for taking the question. I actually just wanted to ask on the earlier pipeline.

You noted in your prepared remarks that TransCon platform can fuel one IND for an NCE annually. I guess there hasn't been one yet this year.

Should we expect one in the near term? What exactly are the go-forward plans for the earlier pipeline?

Thank you.

It was because I'm some way felt that the two product opportunities that we have developed through our partnership built on the TransCon technology will still consider as a NCE, the one that now in clinic with Eyconis and the other one we expect to go into the clinic now with Novo Nordisk, is still some way being developed through the TransCon technology on it. Perhaps I shouldn't have done that, but I still believe I feel some kind of little bit ownership on these two product opportunity.

At least we have major upside in both of them. Out from that perspective, I still consider we potentially will have this year two new chemical entity being entered into clinical trials.

Kennet and his team and anyone else, they're working very hard on that there will be at least one of this new chemical entities coming into every year now. I'm really proud about that.

It's also addressing the sustainability of Ascendis independent of going out and buying something no one else want to have. I think this is where we really feel extremely pleasant by the situation by being a fundamental company that building on a strong, strong technology platform that provide both sustainability for ourselves, but also a continuous flow of potential partner licensing.

Great. Thanks.

Great. Thanks so much.

Do you expect that there is some seasonality in terms of new patient starts in the summer as kind of kids are going on vacation? We're getting a lot of questions on sort of the 60 patient start forms kind of in April and now you're sort of at 220.

It sounds like there's like 50 per month now. Is that sort of sustainable from now on?

Then, you think you could be the number one brand by the end of the year. BioMarin we think has about 750 patients on drug, you think, in the US.

Are you kind of referring to getting to a higher number than that by let's say late February? Thank you.

Thanks for the question. I actually don't think Ascendis have really made some clear forward-looking statement related to how we see YUVIWELL being accelerating and expanding the market in a quantitative manner.

I don't think we have come with any kind of indication related to that. I have no doubt they will do it, but it's not the same thing that we're going to quantify it currently.

I think after basically only 4 months in the market, I feel really not prepared to come with clear guidance to it before we have more quarters really into our, you can say, analytical system where we basically can look on trends and other things like that. One person that really can give you a good feedback now we talk about the US market is Jay, and he's extremely enthusiastic about what he's seeing, and you can give the latest way what you see how the market will develop.

Thanks, Jan. As Jan mentioned before, 4 months in, we're not prepared to give longer-term guidance, but what we can say is we're incredibly encouraged by what we're seeing to date.

When you look at some of the fundamentals behind the YUVIWELL uptake, whether it's prescriber reach, we talk a lot of bit before around this space, there's quite a few centers of excellences. We're seeing 80% of them, nearly 80% already in a short 4-month period, already prescribe YUVIWELL to their patients.

Even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm, I think you can see in early days, we're seeing a very positive trajectory.

While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, we don't need that information in order to ensure that this patient can get on therapy, this is rare disease. Qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from.

Those three categories, again, are: one, patients that are switching from current therapy; two, patients that have previously discontinued pharmacological therapy and is now wanted to return to pharmacological treatment; and then third, a group of patients that historically have sat out and have said, based on the clinical profile of YUVIWELL, they now want to try a therapeutic option for the first time. All that again to underscore there is existing unmet need here, and because of our profile, we're definitely seeing that patients are coming out of the woodwork from growing the market standpoint, and we're just getting started.

I

just to some way to add on to Jay's excellent comments, ultimately, I've no doubt we will be number one in the achondroplasia space. Ultimately, we will expand the market because of the unmet medical need, and that is just with the monotherapy.

When you look on how commitment we are have to this area, where we now are making a complete new standard with the combination treatment, I believe we are dedicated to be not number one in the first year, but continue to build for the next 5 to 10 years with monotherapy, combination, integrated treatment regimes. I believe with our once-weekly TransCon product built on growth hormone and CNP, we are extremely, extremely well-positioned really to be the leader in this segment.

Hey, good morning and thanks for taking the questions. Congrats on the progress.

Scott, I just wanted you to clarify a comment on YORVIPATH growth for the rest of the year. I think you said it's going to be like prior quarters.

I guess which quarters are you referring, because I think the quarter-over-quarter growth in 1Q was negatively impacted, saw some catch-up here in the second quarter. Maybe you can just clarify which quarters you are referring to.

Thanks.

Derek, thanks for the question. I think that two two points.

One is the consistent performance with the KPIs that we've given you, for example, with enrollments. We expect those to continue and be consistent.

The other would be and you can refer to our prior quarters, and maybe Chad can point to prior comments. I think that now that we've seen a full year, you know the various trends that will come into play related to Q3 and Q4 and then Q1 next year.

We think, actually, folks did a pretty good job modeling out Q2, and now you have all the information you need to model the rest of the year going forward until we update basically the KPIs.

Just to give you some kind of what is our value in this here, the value for us, we want to give you not so you basically getting a lower number so we look like heroes. We want to give you the number so you are right nearly every time.

I think this is a way we tried to come up with our different mathematic algorithm how we see it and give you all the information for you really to be right in this manner. I think this is a way we like to be extremely transparent with everything what we perform, we quite sure that you basically can go out and really some way feeling always comfort with the guidance we give you.

Great. Thank you.

Hi, congrats on all the progress. Thanks for taking my question.

As you embark on a Phase 3 in hypochondroplasia, I wanted to ask how you're defining the enrolled population, and how large do you see the diagnosed treatable pool of hypochondroplasia patients who are not already being treated in some cases, if they're at the more severe end versus achondroplasia? Thank you.

This is a very interesting question because it's actually are some way are going into the situation on how we basically are to genetic testing, taking a big patient group that was in old days were called ISS, idiopathic, meaning we have no clue what is the underlying diseases, and then you go out and do more genetic testing. Then when you find an mutation in the FGFR3 receptor and you find it in the right regions, and then you suddenly are not an ISS patient, but then you are an hypochondroplasia patient, even if you don't have, you can say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia that we saw for 10 years ago.

Therefore, you can see the ISS population is some way getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason why you foreseeably have a short status without potentially have the other element that you see for the phenotype of that. This is a where you can think when you go into ISS, are you define it from a genetic perspective, or are you define it for an phenotype or anything like that?

We are in a situation where when you see the clinical trial how we doing it, you will basically see that it's a one of the pathway we have selected.

Thank you.

Hey team, congrats on the quarter. I'm on for Li Watsek.

We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics?

Just to recall, the COACH trial is the combination trial where we combining the two TransCon-based product, our TransCon Growth Hormone and a TransCon CNP. I have to say, when I look on an element like arm span, it's actually we already reported some of the data.

We have reported the 52 weeks data. If you cannot find that deck, I can send it to you, or Scott can send it, or Chad can send it, or I do not know, we have so many IR people, I don't know the names more.

From that perspective, it's already came out. I have to say, there was one of the I will say extremely positive surprises I saw because when we looked on monotherapy with either a CNP-based one or a growth hormone-based one, we're not saw the expected hopeful development that we could hope for.

We definitely saw it when we looked on the combination therapy. Then you can ask me what is the sound scientific reason why you see it much more influenced benefit by the combination therapy, and I have to say I don't know.

What we saw was an arm span that was really give us this hope with the combination therapy, you basically will be in a position that you basically could avoid all kind of limb elongation surgeries in achondroplasia, both related to both legs and arms by that. It's the slide number 5, as I remember it, and what we see, Scott, read up.

The unprecedented improvements in the arm span with combination were +9.4 cm with TransCon CNP naive cohort and 7.9 cm with the TransCon CNP treated cohort.

It was really an

Compared to limb lengthening surgery, 8 cm was gained. Exactly,

exactly. I have to say it was one of the days where I felt it was worth to go to job and really can see the benefit of what we're doing.

Great. Thank you.

Good morning. Thank you very much for taking the question.

I wanted to confirm that you have not provided prescription number for YORVIPATH in case I missed anything. I know that you said the patient demand remained robust in the quarter, I wonder if there is any additional quantitative information that you can provide.

Going forward, are you going to provide that number in the coming quarters? I think you had this question before at the beginning of the launch, and when do you expect that you will feel comfortable providing a guidance in terms of the sales range on actual revenue?

Thank you very much.

You're right. I think it's starting to be a little bit repetitive.

Every quarter come out and saying that we have about more than 1,000 patients being unique enrolled per quarter. We have continued that message that we see steady state, steady state, and steady state.

We said in last year that we will stop coming with this because it was too repetitivity. Then because people doubted for the Q1, then we also come out with the Q1, and it was the same number again.

What we're writing is that we see a robust steady state in enrollment of unique new patient, and here we referring to the US, with about 1,000 new patients every quarter. Now we went over to YUVIWELL.

Now we're starting to give you a unique prescription enrollment of YUVIWELL instead, we always will have one product opportunity where you will have something to play with with numbers and everything like that. Scott, you have some comments for the last one?

I think, Yune, our comments were directed to assume that the metrics that we've given you are consistent, because Jan wants to make our script shorter, don't want to repeat them more. You should just assume that until we change it.

Great. Thank you.

Great. Thanks for taking the question.

Jan, appreciate the color you provided to Tazeen's question around the ongoing legal battle with BioMarin. I guess as we think about potential scenarios here, and again, acknowledging sort of this idea around sort of public interest of the product and unmet need, do you see a settlement as a reasonable scenario to think about, or is that really not something that you think is reasonable?

Thank you.

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

Great. Thank you very much for taking my question.

Just a quick one on YORVIPATH durability. I was just wondering if dropouts are still mostly during the titration phase, and if you can comment at all on how reauthorizations are trending.

Thanks.

I think you're 100% correct. When we see a patient being successful coming into a treatment with YORVIPATH, coming over titration part on it and being into the treatment after that, we see extremely, extremely low dropout.

I think that illustrate one thing: the patient satisfaction with this treatment. Because when I often being asked, what can we do more for this patients in the therapeutic treatment on it, and when I see the satisfaction that is in this way, then I feel that there is an extremely good perception, retention, and everything which really show that.

We still develop the once-weekly for patient on stable doses just to give patient the choice if they want to do it in this way. We will look on other ways to improve their life, like, for example, at-home calcium monitoring and anything like that.

We can help the patient like it happened in type 1 diabetes and other things like that. Now you addressing the element where we're saying is we developed this here with a once daily, because we wanted to do the titration most easily, because it's really complex to take patient off of conventional therapy at the same time you increase the PTH in replacement therapy.

That was why we made it as a once daily, this really to facilitate the best possible titration. Still, we know it can be problematic for some patients.

Jay can try to explain what we now doing to basically handhold the patient in this period so we also can make that extremely successful. When you get a prescription, we know everything will be much more successful for the patient, not just after they're very being stable in the titration.

Jay, will you explain of the effort you're building in to really get that to be as soft and as possible?

Absolutely. Can chat a little bit more about certainly the investments that we're making and also to answer your questions around drop-off and re-auths.

Yes, as we've shared before, the majority of the drop-offs is during that titration period in terms of when patients experience the most amount of change, and where additional education and a higher touch support model makes sense. Then for re-auths, that's actually pretty routine for us, there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support.

We have patients re-authing throughout the year, and it's just part of our day-to-day operations. From an investment standpoint, we've invested heavily in patient-facing roles for which we've deemed our patient access liaisons.

They support patients both pre-prescription as well as through the prescription process and post. Essentially, we've seen a lot of success in early days with this field team being able to engage with this patient community.

They've appreciated this high level of support, and we, of course, support them throughout the journey to ensure that we're optimizing for patient experience.

Great. Thank you very much.

One thing as element, now we focus mostly on US, but there is still a world outside US. Outside US, we have not seen the same level of dropout in this phase.

It looked like the interaction is pretty well-established between the physician and the patients and support system really to see it without this kind of dropout. It's basically is a US issue.

Therefore, we know we can get it to function. We just need to ensure that the support system also in the US is strong enough to be sure that it's not a problem.

Very helpful. Thank you.

Hi. Thanks for taking the questions.

As far as the named patient programs or your early access programs, can you elaborate a little bit on which markets you're active in, whether eligibility might be determined by treatment status of a patient, and just generally how we should think about whether named patient programs could be meaningful contributors to patient volumes this year? Thanks.

For YUVIWELL in particular.

I just wanted to ask what product you are referring to.

YUVIWELL.

Yeah. I can guarantee that as we basic in our prepared remarks try to put emphasize on, we have an global infrastructure in commercialization and patient support, product supply, and everything like that.

Just the number of SKYTROFA rare disease patient we have taken over to the system, it's more than 20,000 patients. We are having the system functional more than in 35 different countries.

We're not a company that just need to get started. We already have established all this infrastructure.

What we doing is that we utilizing this established infrastructure basic that got established because of YORVIPATH, because this is what we did with YORVIPATH. We're using exactly the same infrastructure also for YUVIWELL.

We will be where patient is, and we quite sure we will also serve the patient outside US. Potentially the market is much larger outside US.

I think we hope we also will see a large penetration in the US, where another short-acting product really failed to do it. We believe because of the highly differentiated nature of YUVIWELL, we will see a complete different pick-up in the US, but it's definitely we have a strong, strong, strong focus on the ex-US.

We will give you some guidance when we come later in the year, you can give also building up a model for the ex-US.

Excellent. Thanks for taking the question.

Great. Thanks so much for taking our question.

This is Kathy for Luca. Circling back to YUVIWELL and Jay, the three categories that you very nicely touched on for the naive, switched, and discontinued patients that are not on scripts.

BioMarin mentioned on their second quarter call that less than 100 patients have switched off of Voxzogo. The simple math that we're trying to do here is that at least it was about 70 patients in the second quarter for naive or return to treatment, so that's taking off the switched patients.

Does that align with the numbers or impression that you have, and how does the dynamic look like between the truly naive patients and the patients who are once on Voxzogo, stopped treatment, and are now returning to treatment but to YUVIWELL? Separately, very quickly, if you've commented or not on the ex-US strategy for YUVIWELL, given that decision is pending at the EMA coming very soon this year.

Thanks so much.

I like you way of doing all the calculation and anything like that. I cannot support it, or I cannot deny it, because I don't have the factual insight to some way to confirm anything of the numbers.

I also saw the numbers that came out, but I cannot really support it because I don't have the insight from our own numbers to really come out and come with any statement that indicate if I'm aligned or not aligned with. Related to the ex-US, for me to understand your question, was it reflecting what is the limitation in the ex-US, or what was the question?

Thanks. Thanks for asking to clarify.

More about are you committed to going the show by yourselves or you're considering partnering, given that 70% of the Voxzogo sales is historically coming from ex-US and can be quite heavy lifting?

Basically in the ex-US, we have our direct market, which are I think 60, 70, 80 where we have our own commercial infrastructure, anything like that. It's pretty clear what we're doing there.

Then we have our sales and distributions agreement, and this is I think it's a 70 countries or something like that. How's that?

80.

Oh, 80 countries that is covering this sales and distributions agreement. The vast majority of all of them are all three products.

Basically, there is already established infrastructure for the distribution. Then we have the third model where we have our partnerships: one in Japan, one in China, and they also have all the three products.

We don't need to go out and make any new agreements for anything. Everything is established.

Everything is running on full speed. For some of the EU direct market, we just waiting for our expected approval here in Q4 this year.

Thank you.

Hey guys, thank you for taking the question. Just wanted to ask a little bit on the YORVIPATH life cycle strategy.

Can you give us an update on the latest on getting the higher dose into the label for FDA, and then also any update on weekly YORVIPATH? Thank you.

Yeah. What we see today is that we are enrolling the trial in the US where we evaluating the 30 to 60 dose range in two different means that has been aligned with the FDA in their design what they wanted to see.

We see that enrollment going extremely fast, we expect very, very, very fast and you can say label expansion in the place where we don't have up to the 60. We see that basic just on execution.

Your second question was related to?

On weekly YORVIPATH, any update there?

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

Great. Thank you.

Thanks a lot, everyone.