Q3 2025 Ascendis Pharma A/S Earnings Call

Speaker #1: To ask a question, please press star 11. If your question has been answered and you'd like to remove yourself from the queue, press star 11 again.

Speaker #1: We ask that you limit yourself to one question and one follow-up. I would like to turn the call over to Chad Fuguere, Vice President of Investor Relations at Ascendis Pharma.

Speaker #1: Please go ahead.

Speaker #2: Thank you, Operator, and thank you, everyone, for joining our third quarter, 2025, financial results conference call. I'm Chad Fuguere, Vice President of Investor Relations at Ascendis Pharma.

Speaker #2: Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Sherry Glass, Chief Business Officer; Jay Wu, EVP and President, U.S.

Speaker #2: Market; and Amy Hsu, EVP and Chief Medical Officer. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act.

Speaker #2: Examples of such statements may include, but are not limited to, statements regarding our commercialization, in continued development of Scitrofa and Yorbipath, as well as certain expectations regarding patient access and financial outcomes; our pipeline candidates; and expectations with respect to their continued progress and potential commercialization; our strategic plans; partnerships and investments; our goals regarding our clinical pipeline, including the timing of clinical results and trials; our ongoing and planned regulatory filings; and our expectations regarding the timing and the result of regulatory decisions.

Speaker #2: 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.

Speaker #2: 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 today's press release and the risk factors section of our most recent annual report on Form 20F, filed with the SEC on February 12th, 2025.

Speaker #2: TransCon Growth Hormone, or TransCon HGH, is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

Speaker #2: 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.

Speaker #2: TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission in the United Kingdom's Medicines and Healthcare Products Regulatory Agency has granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

Speaker #2: Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety effectiveness of product candidates has not been reviewed or approved by any regulatory agency.

Speaker #2: 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 third quarter, 2025, financial results, and we'll provide further business updates.

Speaker #2: Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan.

Speaker #3: Thanks, Chad. Good afternoon, everyone. In the third quarter of 2025, we accelerated our momentum towards fulfilling our Vision 2030. We achieved key milestones in three areas: first, the global launch of Yorbipath continues to be strong.

Speaker #3: With a steady increase in new, unique patient prescription and prescribers, as seen in Q1 and Q2, along with expansion in new geographic markets. Second, we made great advancements towards leadership in growth disorders during the quarter.

Speaker #3: We saw the U.S. approval of Scitrofa in adult growth hormone deficiency. And following our late cycle meeting with FDA, we are progressing toward expected approval of TransCon CMP in the U.S.

Speaker #3: Third, our strong operating fundamentals led to positive operating profits, signaling the beginning of sustained revenue and earnings growth for Ascendis. Now, I will provide some specific comments on our commercial and late-stage portfolio.

Speaker #3: Starting with Yorbipath, Yorbipath continues its strong global launch. With revenue of 143 million euros in the third quarter, nine months in the launch in the biggest markets, the U.S., patient demand continues growing quarter by quarter.

Speaker #3: From launch to the end of September, more than 4,250 patients have been prescribed Yorbipath in the U.S. by over 2,000 unique healthcare providers, highlighting the strong, steady demand for Yorbipath, even during the summer months.

Speaker #3: In October, the positive trend continued with Yorbipath being prescribed for more than 400 new patients in the U.S. alone. Positive physician and patient experience are driving a high rate of compliance, and we expect most patients will be on lifelong PTH therapy.

Speaker #3: We are expanding our physician reach. Each quarter, within the endocrinology community, and we also expand to other physician groups who manage hypoparapatient. As an example, at last week's American Society of Nephrology meeting, we presented three years of kidney function data across our combined clinical trials.

Speaker #3: Demonstrated sustained clinical meaningful improvement in kidney function in the Yorbipath-treated patients. In addition, we continue working hard to expand patient access in the U.S.

Speaker #3: The overall insurance approval rate since the start of the launch is around 70%. Of total, enrollment, and we believe this figure will continue to increase over time.

Speaker #3: We currently see approvals across all payer types, with a majority of approvals within eight weeks. We are pleased by the robust uptake of Yorbipath.

Speaker #3: In our first three quarters of commercialization in the U.S., today, less than 5% of U.S. patients are currently on Yorbipath treatment. We see significant room to grow, with around 80 to 90,000 patients already diagnosed with chronic hypopara in the U.S.

Speaker #3: and three to 4,000 new patients being diagnosed every year. Outside the U.S., Yorbipath is now available commercially all to named patient programs in more than 30 countries.

Speaker #3: In Germany, Austria, and Spain, we have now full commercial reimbursement. In Japan, our partner Chaijen launched Yorbipath commercially last week following approval in August.

Speaker #3: We are looking forward to the commercial launch of Yorbipath in additional countries in the coming years. With a broad label covering hypoparathyroidism for all causes, international treatment guidelines that recommend PTH replacement therapy, and Yorbipath physician as first-in-class therapy, we expect sustained patient growth and revenue growth for years to come.

Speaker #3: As we are building this global market, we are expanding our offerings to patients with hypopara. We are conducting the pathway 60 trial to support doses up to 60 micrograms of Yorbipath in the U.S.

Speaker #3: We plan to begin a clinical trial for people under 18 this quarter, and we are advancing our new once-weekly TransCon PTH product candidate which we believe will be an attractive option for patients on stable doses of Yorbipath.

Speaker #3: In the new year, we will share more on our plans to maximize Yorbipath's value and reach even more patients. There is now turn to growth disorder.

Speaker #3: With today, compiles of our once-weekly growth hormone Scitrofa approved for growth hormone deficiency, and our once-weekly TransCon CP currently under review by FDA in the U.S., and by EMEA in the EU for children with echinoplasia.

Speaker #3: Scitrofa is approved in the U.S. and EU for treatment of pedastic growth hormone deficiency. With this single indication, Scitrofa is established as a high-value brand and treatment of choice for pedastic growth hormone deficiency.

Speaker #3: Q3 revenue for Scitrofa was 51 million euros. In July, we received our first label expansion with FDA approval of for adult growth hormone deficiency.

Speaker #3: The first of multiple planned label expansions. In Q3, we initiated our phase three basket trial of Scitrofa, with a range of established growth disorder, including ISS, shock deficiency, Turner syndrome, and SDA.

Speaker #3: Turning to TransCon CMP, we recently completed a late-cycle meeting with the FDA and are in the final stage of the label discussion. TransCon CMP is under priority review in the U.S., with a due date of November 30, and is also under review in the EU, where our MAA filing was recently validated.

Speaker #3: TransCon CMP once weekly is well positioned to become the leading treatment for children with echinoplasia. With the full degree of linear growth outcome that can be achieved with monotherapies addressing the overactive thyrosine chain kinase in addition, TransCon CMP achieved statistical improvement in leg bowing compared to placebo.

Speaker #3: Increasing spinal canal dimension, a safety and tolerability profile compared to placebo, with a very low rate of injecta site reaction, and no cases of symptomatic hypotension.

Speaker #3: We are confident in TransCon CMP's ability to be a leading therapy. While we believe TransCon CMP monotherapy is transformative by itself, we want to further enhance outcome for people living with echinoplasia.

Speaker #3: Earlier this year, we presented 26 week results from the phase two coach trial, of TransCon CMP in combination with TransCon growth hormone. Which showed around three times improved linear growth compared to what had been observed with monotherapies over the same time period.

Speaker #3: This resulted in healthy linear growth in children with echinoplasia, higher than that observed with an average state of children. Accommodated by improvement in body proportionality and without acceleration of bone age.

Speaker #3: This data has been recognized by key opinion leaders as groundbreaking. Based on this data we believe over time the standard of care in echinoplasia will include combination therapy as a treatment option, building on the potential growth of TransCon CMP as the backbone therapy.

Speaker #3: Following our recent FDA end of phase two meeting related to our combination therapy, we plan to initiate a phase three trial this quarter. We anticipate disclosing 52 week data from the coach trial in early 2026.

Speaker #3: With once-weekly growth hormone and once-weekly CMP, two highly differentiated medicines, both as monotherapy and in combination, we believe ascendis is well positioned to become the global leader in many different growth disorders.

Speaker #3: Our vision 2030 also includes creating value to partnership. And we see that being achieved through the rapid progress of tightening in Japan, recent in China, iconic in ophthalmology, and over notice in metabolic and cardiovascular diseases, where the once-monthly semiglutide program is making fast progress towards the clinic.

Speaker #3: And finally, the commercial success of Yorbipath and Scitrofa has already transformed the financial profile of ascendis. In the third quarter, we achieved positive operating income, along with positive cash flow.

Speaker #3: For the near time, the building out of our commercial organization is largely completed in bands of future global launches. For the medium term, label expansion, LCM activities have been initiated to maximize the value of our current products.

Speaker #3: At the same time, for a long-term sustainability, our R&D organization continues to advance the TransCon technology platform to ensure a constant flow of new programs and potential new products.

Speaker #3: In summary, with TransCon CMP nearing potential approval, ascendis is well positioned to get approval of its third TransCon phase product in a row. This highlights the uniqueness of ascendis, the continuous development of highly differentiated products, created by the TransCon technology platform, and our unique low-risk drug development algorithm.

Speaker #3: Importantly, our current three rare disease endocrine products position us for durable future growth and give us confidence in our aspiration to achieve 5 billion euros or more in annual profit revenue in 2030.

Speaker #3: I will now turn it over to

Speaker #3: Scott. Thank

Speaker #2: you, Ian. I would like to reiterate Ian's comments that the positive operating income development seen in Q3 signals the transformation of our financial profile with sustained revenue and cash flow growth.

Speaker #2: With that, I will touch on some key points surrounding our third quarter financial results and outlook. But for further details, please refer to our Form 6-K filed today.

Speaker #2: In Q3, Yorbipath global revenue grew to 143.1 million euros, up from 103 million euros in Q2, with strong growth partially offset by a 3.6 million euros foreign currency headwind compared to the previous quarter.

Speaker #2: In Q3 2025, Scitrofa contributed 50.7 million euros, with 3% growth in demand offset by a 1.6 million euros foreign currency headwind compared to the previous quarter.

Speaker #2: Including 20 million euros in collaboration revenue driven by a 13 million euros milestone related to Yorbipath and increased partner activity, total Q3 2025 revenue amounted to 214 million euros.

Speaker #2: Continuing on to expenses, R&D costs in Q3 were 66.9 million euros, down from 73.5 million euros in Q3 2024, primarily driven by completion of certain clinical trials and development activities.

Speaker #2: SG&A expenses rose to 113.4 million euros in Q3 2025 compared to 69.8 million euros in the same period last year, reflecting continued impact of global commercial expansion.

Speaker #2: Total operating expenses for Q3 2025 were 180 million euros and operating profit for Q3 2025 was 11 million euros. Net finance expense for the third quarter of 2025 was 60.9 million euros, primarily driven by non-cash items, including non-cash remeasurement loss of financial liabilities of 47.2 million euros.

Speaker #2: Net cash financial income over this period amounted to 400,000 euros. Note that in our 6-K filed this evening, we provide more detail on the components of finance income and expenses.

Speaker #2: In future periods, we plan to introduce a non-IFRS EPS measure adjusting for the impact of certain non-cash, non-operating items, including those related to our convertible notes.

Speaker #2: This is intended to increase comparability of period-to-period results. Finally, we ended the third quarter of 2025 with €539 million in cash and cash equivalents, up from €494 million at the end of Q2.

Speaker #2: Turning to our commercial outlook, primarily driven by the ongoing global launch of Yorbipath, we expect continued revenue growth in the fourth quarter. For Yorbipath specifically, we expect continued growth driven by new patients, stable pricing, payer mix, and contracting in Q4.

Speaker #2: Longer term, we expect Yorbipath to be driven by continued growth in new patients on therapy, including expansion into additional markets. For Scitrofa, we believe that sequential revenue growth should continue to track growth in prescriptions with stable pricing, payer mix, and no changes in contracting, with offsets potentially driven by currency, as we saw in Q3.

Speaker #2: Longer term, we expect growth for Scitrofa to be driven by geographic and label expansion. With that, operator, we are now ready to take questions.

Speaker #3: Thank you. As a reminder, to ask a question, please press star 11. Our first question comes from Jess Phi with JP Morgan. Your line is

Speaker #3: open. Hey, guys.

Speaker #4: Good afternoon, and thanks so much for taking my question. We're hoping you could speak to your expectations for the rate of new patient enrollments on Yorbipath in the US.

Speaker #4: From here, I think you talked about more than 4,250 as of the end of 3Q, putting you at, what is that, about 1150 ads or maybe a little more, relative to June 30th.

Speaker #4: Can we think of that as kind of like a good number to work off of from here? Should it continue to kind of drift lower a little bit, just hoping you can frame some expectations there?

Speaker #4: Thank you.

Speaker #5: Thanks, Jess. First of all, we see a really stable number of prescriptions being written in the U.S. When we summarize, taking away the bonus that we have from the EFE program about the 200-plus patients we have in the EFE program, when we think about Q3, I'm actually pretty positively surprised about Q3 because I was worried that prescriptions would not be written in the three weeks early, typical of physicians taking time off their quarter during that time.

Speaker #5: And what I saw, we saw nearly the same number of prescription being written that we actually had seen in Q1 and Q2. And it's also following up with what we said in the October months.

Speaker #5: We saw more than 400 prescription being written in October. Unique prescription being written in October. So when I look at this long look in the US, I see a very, very stable longs.

Speaker #5: And what we are also doing, we're building a fundament like a strong, strong fundament because patient stayed on lifelong treatment. And therefore, when you start a patient, it basically is continued quarter by quarter.

Speaker #5: So building out a house where you have a strong fundament, taking one break on around every quarter, and the house getting taller and taller, every, every quarter.

Speaker #4: Thank

Speaker #4: you. Thank you.

Speaker #3: Our next question comes from Tasina Maud with Bank of America. Your line is

Speaker #3: open. Hi, good

Speaker #6: evening, guys. Thanks for taking my questions. I just wanted to get a sense of how you're thinking about the rest of this quarter. Are you expecting to see impact from seasonality?

Speaker #6: I guess we can call it just because of the upcoming holidays, Thanksgiving, Christmas, into New Year's. And do you think that the script trends for December would be directionally lower, let's say, than what you're seeing, what you saw for October?

Speaker #6: And then, if I could ask about the transcon CNP review, you said you're in final labeling discussions, which is good to hear. Can you just confirm whether or not you've had any requests for any type of data from the agency in the review cycle?

Speaker #6: Thanks.

Speaker #5: I'd maybe take the last question, thanks, Tasina, first. But let me take the last question first because it's an easy one because it doesn't know.

Speaker #5: Just know, know, know, know. So it's really simple. So going to the next one, it's more was got looking he didn't read the FLS this time, the FLS this time.

Speaker #5: But when I'm looking forward in the future, yes, there are some holidays coming up. However, when I look back, I was actually more worried about Q3 compared to Q4 because I believe that there is a longer summer vacation in Q3 compared to what you will see in Q4.

Speaker #5: So I see pretty positive on Q4. I see we are actually increasing our prescription base from physicians writing prescriptions with more than 500 new prescribers, meaning that we have a broader boat where there are more and more that can come in rowing on the ship.

Speaker #5: And this is where I feel pretty confident about

Speaker #1: you Thank .

Speaker #2: Thank you . Our next question comes from Gavin Clark Gardner with Evercore ISI . Your line is open .

Speaker #3: Hey , guys . Thanks for taking the questions I . wanted to focus in on the conversion rate for your path . I'm wondering why it's only 70% .

Speaker #3: And you noted that you expect it to be higher over time . How much higher do you expect it to be ? And when do you think it'll be higher ?

Speaker #3: Just had a follow up on this to .

Speaker #4: Yeah , this is a question we got multiple times every quarter . And what we have said in previous the quarter , we expect that it's going to be maturing over time , and it will go higher than that .

Speaker #4: And that is typically what we have seen in launches . I still And had a long discussion with Jay about it today . And what is when we see it mature brand is that 85% or it's a 90 or what is really for a mature brand that you basic some way are ending up at that time .

Speaker #4: And I think from a modeling perspective is that we feel extremely well where we are today . We still have a block taking into consideration regarding the patients we're getting , not only the prescription done , we're also getting the approvals done .

Speaker #4: And we're getting it done in a speed . And as Scott also put emphasis on us , we don't expect anything changing in the contracting environment in Q4 .

Speaker #4: So we expect the same for this product that we are seeing in both Q1 , Q2 and here in Q3 . And no changes to it .

Speaker #4: But but you can also take a little bit of our discussion about the future , about what is really for and mature brand .

Speaker #4: that Is where we today ? And also we see a much higher number for Skytrofa after it got matured .

Speaker #5: Yeah . Thank you for the question . As mentioned before , we're really encouraged about the rate that 70% approval we're seeing now .

Speaker #5: It's actually about what we expected or guessed at the beginning of the year , just based on what we know about the clinical value proposition of the drug , which , again , is incredibly positive and has been resonating with a lot of the payer accounts for which we are speaking with .

Speaker #5: To answer your question , Gavin , directly , in terms of what that peak approval rate could be and at what time frame , that's really hard to say , right ?

Speaker #5: When you look at some of the analogs for similar drugs, that could in some instances take multiple years. And the reality is, once you get to a certain high percentage, the remaining becomes a little bit more difficult.

Speaker #5: Simply just given the heterogeneous landscape of the payers . It becomes quite Right ? fragmented . A lot of the government payers might review it on different timetables .

Speaker #5: So we are meeting a lot of those timetables where they're at . And again , we're continuing to talk about the incredible positive clinical value proposition that we're seeing and that alone is resonating with a lot of them , which is why we continue to see that approval rate go up over time .

Speaker #3: That is super helpful . If I could just ask a specific follow up on that for the for the 4250 forms reported through the end of this quarter , are you guys basically saying you expect the conversion on this to be 70% and then trending higher per everything you just laid out after that ?

Speaker #4: No , it's not what we're saying . Because if we go back and look on early cohort , meaning the a cohort for mass April , it's much , much higher than the seven 0% .

Speaker #4: So this is what you see. The longer time it takes, the more approval you get. And that is basically the essence of this element.

Speaker #4: is the And question we have can we really take this tail and shorten down the tail . So we basically getting the higher percentage that we see from the cohort .

Speaker #4: We had, in the beginning of the year, numbers that are much higher than 7%. Can we start that to get it in a shorter time frame?

Speaker #3: Okay . Like the point I'm trying to get at is for a lot of the start for for let's take the 3100 , you had around on June , maybe you've had close to but 70% conversion , the rest of the 30% is not really lost at this point .

Speaker #3: Still may come some more through as conversions. It's just a matter of time.

Speaker #4: Exactly . So if you take , for example , going to the cohort from last April , most higher , if you take the earlier cohort now on that is near this month we have is lower than that .

Speaker #4: So this is how you see it. It's a question only about time.

Speaker #3: Very helpful . Thanks so much .

Speaker #2: you . Our next Thank question comes from Joe Schwartz with Leerink Your line is open Partners . .

Speaker #5: Great . Thanks very much . A question on . Your path . And then on TransCon CNP you give us , can your latest views on how you've been penetrating the different segments of the market ?

Speaker #5: As you see it ? Where is it getting the most traction and it do better where could ? And then you previously emphasized the desire to do more than enhance linear growth and achondroplasia .

Speaker #5: So I'm wondering to what extent do you think you can obtain differentiated label claims on TransCon CNP label ? Thank you .

Speaker #4: Let take the last question me said in . As I the prepared remarks , we are in the stage late discussion about the labeling and I cannot really comment about what will really be in the final labeling in this perspective , what is really the key element for me in my discussion with patient , my discussion with physician and misuse discussion .

Speaker #4: Our medical affairs discussion the with teams is really to explain that benefit the see behind the And growth . it's clear unique effect in leg bone unique effect in changing body proportionality .

Speaker #4: And we will have peer review publication really supporting all this claim that will come out really give us opportunity to an take and talk with the patient , talk with the about physician this benefit in it .

Speaker #4: I think this is the key thing for me . We I saw and I'll so an element once with a hypopara where Pasig was impossible for get into the labeling our element of patient benefit related to cognitive other quality of life and everything like function that .

Speaker #4: And everyone recognized it . Everyone see it . Anything . See , that is the best thing . I think this is the key thing from our discussion is have no restrictions , have a really safe really product , show our efficacy and safety in best the possible manner .

Speaker #4: In this way . Gay , will you take first part of the the question in this one ? To Joe ?

Speaker #5: Yeah . Could we repeat could we repeat the first part of that question ? Yeah , sure . I was just wondering , you know , you've outlined the different segments of the market on how controlled the patients are .

Speaker #5: Yeah . Could we repeat could we repeat the first part of that question ? Yeah , sure . I was just wondering , you know , you've outlined the different segments of the market on how controlled the patients are based So I was wondering , you know , how are you making those inroads into segments lately ?

Speaker #5: Where are you getting the most traction and where could you do better ? Yeah . So when you think about the 80 , 90,000 patients that Yan had referenced earlier in the call , I think there's probably a group that we would describe as highly symptomatic .

Speaker #5: Patients are well aware of their symptoms , articulating symptoms those to a physician . And within those I would say we're doing quite , particularly since the patients well themselves are likely the ones that are in the Most offices .

Speaker #5: frequently and are keeping the appointments to be books on the to essentially get some of that information . And also be on their way to actually get prescribed the product .

Speaker #5: I think where we're continuing to on are some of the patients, the work for which maybe they're not either self-identifying some of their symptoms as being related to the underlying condition.

Speaker #5: And or perhaps they've gotten used to some elements of it . And therefore haven't been as motivated to establish care and established retain care with a think that's specialist .

Speaker #5: why , as we think about how we can And I continue transform this to will be an market , there element of patient activation as well , simply because there is going to be level of disease a certain education required , particularly for a space like this , where it is about redefining what's possible and kind of the status to quo for how manage this type of condition .

Speaker #4: Yeah . If I can add something , we I see it from two different perspectives . How often you into the end come , this is one way and how we target it and define something that is not defined on medical terms , but only on how often you see an endo related to being controlled .

Speaker #4: Partly controlled , and what I also trying to look at or try to on look they coming ? Are they coming from coming from surgical ?

Speaker #4: genetic part ? Are they Are they the coming from immunological part ? And I see them coming from everywhere . So for example .

Speaker #2: Ladies and gentlemen , please stand . by Again , by the please stand conference call will begin . Begin to resume momentarily . Please continue .

Speaker #6: Where did you last hear? Is that? I think this was Joe. You're about to question the.

Speaker #5: Hi Yeah . . Welcome back . I So guess I was wondering about your progress within the different levels of control and where you can do better just how and your been able to penetrate patients in each of these segments .

Speaker #4: Yeah , I think at least I heard so response to it and my additional comments was that when we did the targeting of our physician , we made it out from the claims database where we defined three groups controlled , partly controlled , and in control is nothing to do with medical terms , but Basic is as in how we Basic are looking on the patients .

Speaker #4: Seeing and physician . So what I also are looking at is do we see all patient groups in our patient being coming on Neuropath treatment .

Speaker #4: And when I see that it's pretty clear that we are in a position , we see obvious the that post surgery . But when we look on different elements of generic genetic or immunological , also we see all different groups of patients , even patients from the Aids one , which are really , really are less than 1% in the claim database .

Speaker #4: We already have about 15 patients on treatment with this symptom , which really give us a hope that we basically will see the same penetration everywhere , in all different parts of the hyper patients in this way .

Speaker #5: you Thank .

Speaker #2: Thank you . Our next question comes from Lee Watzig with cancer . Your line is open .

Speaker #7: Thank you guys . Thanks for taking our questions . I guess just on your iPad , can you maybe just give us a little bit of color on pyramids and potential contracting , not just in Q4 , but also in 2026 ?

Speaker #7: Should we sort of expect , you know , still minimal contracting and sort of stable growth to net for the next few quarters ?

Speaker #4: I think Scott , more or less addressed it . It is a prepared remark . That no changes into Q4 would be . If we look forward , will that be potential more we contracting that have seen now and Jake and comments on we are in a position where would contracting not anyway change dramatically .

Speaker #4: Our GCN in any kind of financial modeling . In this perspective , and we see Europe really have all the characteristics of a product .

Speaker #4: It's a first in class . There's only one treatment option , and we see it actually being not only being prescribed , but also being reimbursed to the level that we have hoped for .

Speaker #4: Dave , you have further comment to the long term of contracting perspective

Speaker #5: Yeah , I would

Speaker #5: just . reaffirm what you shared . Consistent contracting strategy in Q4 has previously discussed , given the first and only nature of what we have and the fact that the clinical value proposition speaks for itself , we don't anticipate any major contracting that's going to deviate above and beyond shared what we've before , which is more minor contracting ensuring a frictionless patient experience .

Speaker #5: So again , nothing substantial or anything meaningful above and we've beyond what discussed to date . Any be minor . .

Speaker #4: And changes would when we look at the the we can say the competitive landscape , we don't believe any of the what we see in the competitive landscape will really .

Speaker #4: Make us to move into a much more highly contracted product as we see it , really , with the best in class properties compared to everything what we see .

Speaker #4: .

Speaker #7: And then just curious about the transcon CNP and the phase two meeting in terms of the phase three . You know , trial design , should we assume that the FDA would require a one year data on annualized growth velocity and anything that you can share on the powering assumptions ?

Speaker #4: Yeah, that is an interesting question because I basically have never seen anything longer than a one-year clinical trial in any growth disorder.

Speaker #4: I've seen a lot of perception about something that could be taken up as two years, but I've never seen any regulatory package that has more than one year of controlled treatment in this.

Speaker #4: We have already what we call long term data that will be generated from our phase two trial . So I think that is basically the element of what I never have seen for in this way .

Speaker #4: And Amy, you went to the FDA meeting. So she can basically just give you the view about what the basic got a feedback from that perspective?

Speaker #8: Yes . So Li happy to say that we found our reviewers at FDA to be appropriately open minded about appropriately , clinically open minded about duration here .

Speaker #8: But there's obviously a regulatory that's pathway , and usually one year of data .

Speaker #2: Thank you . Our next question comes from Yaron Werber with TD Cowen . Your line is open .

Speaker #9: Thanks so Great . much . Maybe Yaniv , maybe a couple of questions . Number one , just on gross to net when we're kind of we were at around just over and we had 4200 like a 65% approval , but we were getting to higher numbers for the quarter .

Speaker #9: wondering So I'm whether And we . had 18% gross to net . Is it possible that gross to net discounts are are higher than that , that wouldn't make any sense as the question kind of like , what am I missing ?

Speaker #9: And then maybe secondly , are you it sounds like you may be subtly very intimating to expect some impact from the holidays in Q4 .

Speaker #9: Are we reading you correctly ? Because you didn't see much seasonality in Q3 ? And then finally , us versus European sales for UAV in the quarter ?

Speaker #9: Was it like around 4 million or so in Europe this quarter as well ? Thank you .

Speaker #4: Yeah , that was three questions . The the element of what I will take . What we said in the beginning of the year is still what we really are seeing .

Speaker #4: We said we will expect x us be around 4 to €5 million increase every quarter because we have not really expanded it more to fully countries , which commercial did .

Speaker #4: Now in here in Q3 . But we first see the effect on that perspective in in this way related to the seasonality on it .

Speaker #4: I don't expect any to see any seasonality in Q4 . That is pretty clear . I expect it to potentially to have seen it in Q3 , because I expected the physician to be gone for three weeks .

Speaker #4: when we're not And so a impact major in Q three , I don't expect to see any impact in Q4 . Scott is really the guy with the numbers and everything like that .

Speaker #4: So he really is good at that . So , Scott , can you take the first question ?

Speaker #6: Yes . So I think your question was . The the 70% approvals and the tying to tying to revenue , we could up probably follow offline on on , you know , how you're thinking , how you're thinking about things , but just remember also when there's an approval , this isn't equivalent .

Speaker #6: This isn't the exact same thing as patient on drug right . They get approved and then sometimes , you know , sometimes it's soon , sometimes it takes a while .

Speaker #6: But that's probably that's probably the only thing to keep in mind . Yaron .

Speaker #2: Thank you . Our next question comes from Martin Auster Raymond James . Your line is open with .

Speaker #10: Hey guys . Thanks for taking the question . I'll I'll try not to be too greedy and just keep it to a couple .

Speaker #10: First on the overpass . And I was wondering if you could comment if you've got any sense of early data on what patient retention looks like from folks who've started up on drug this year , and then second on TransCon CNP , I guess from a commercial perspective , when we look at this market , it looks a little under-penetrated for a rare disease market compared to some other comps .

Speaker #10: I'm curious if you guys have a sense as to sort of that's the why case . And if you think TransCon CNP is sort of coming to market , can improve upon that and improve overall penetration rates of treated , treated folks with thanks .

Speaker #4: Thanks , Martin , for that question . The first one is really , really it spent a lot of time on it . Spend a lot on the analytical and we are losing .

Speaker #4: Very few patients when they have initiated treatment . There are few percentage . And if we lose them , it's basically in the first 4 to 6 weeks .

Speaker #4: Meaning is that we are now trying to go back . How can we potentially help them in the titration phase ? And I think that is always the element where you start on a system where you are on conventional therapy , you do it .

Speaker #4: start to You need to take it off . And I believe if there are not is a good interaction between both the physician , the place where they get calcium monitoring and everything like that .

Speaker #4: It are more difficult the time . This is where the titration , is why we started always one daily product , because we know we could never get this titration to function better once we do product .

Speaker #4: that is where we see So when we see after 4 to 6 weeks , when we're starting to be stable , we as exactly as I said , here , we expect nearly all patients to be on lifelong treatment .

Speaker #4: This is like building the fundamental , stronger and stronger and Martin , I agree with you . I will look on Vosoritide . It's doing really poorly in the US .

Speaker #4: They're saying they're doing really good outside the US . I think they're doing really poorly in the US . There should be much , higher .

Speaker #4: They're saying they're doing really good outside the US . I think they're doing really poorly in the US . There should be much , much believe that because we're not really addressing what we really should address the comorbidities .

Speaker #4: And I believe this is where we come in with a differentiated product . This is why when I talk with the different patient organization group and really they asked me a question , simple when will you have taken the primary endpoint to be linear growth ?

Speaker #4: If you were the first product and I said , no , we will never have done that , we really have will addressed how we really addressing the co-morbidities because we believe that is really why patients should take that treatment , help the comorbidities , really help them in this way .

Speaker #4: And this is where I believe we have an extremely positive dialogue with all the patients and the patient related to that topic .

Speaker #10: and Thanks , looking forward to November 30th .

Speaker #2: Thank you . As a reminder , please limit yourself to one question and a follow up . Our next question comes from Paul Choi with Goldman Sachs .

Speaker #2: Your line is open .

Speaker #10: Hi .

Speaker #11: afternoon , and thanks for taking the Good question . I also to stay on want TransCon CNP and maybe ask on the commercial strategy .

Speaker #11: As you launch it . And particularly next year for , are you primarily going to target de novo patients or are you expecting a good portion of the mix to revenue be from BMP daily injection experience ?

Speaker #11: Patients ? And if you are expecting a decent sized contribution from the latter , can you maybe speak to what your market research suggests the appetite is on potential switch strategies and just sort of what percentage of the existing treated patient base might you might think ultimately convert ?

Speaker #11: Thanks for taking the question .

Speaker #4: much Thanks so for the question . Yes . We that to be a lot of switches . We enrolled patients in the places where Vosoritide commercially were available , free for the patient .

Speaker #4: We enrolled it where there was other treatment alternatives . If you call them treatment alternatives . We were in a position that the preferred it out .

Speaker #4: From their perspective is that not only the one weekly profile , but the lack of injection site reaction , really to be in a position you don't need to worry about any risk of hypertension and anything like that , that was really one of the key development .

Speaker #4: And also at that time , we not even have really the clarity of beyond linear growth , the benefit beyond linear growth . So when I look .

Speaker #4: Today it was going to be at last portion on switch patients . When you have therapy being implemented to a high level , which it is in some European countries , and some European countries .

Speaker #4: 6,070% of all patients will be treated today . And there will be switching . They are just waiting for it . We know they are waiting for it because they asked for it all the time .

Speaker #4: When will it be approved in Europe ? If you go to US because of not high penetration , oh , there will be many more new patients coming in because there's not so many to switch off .

Speaker #4: this is what we see and how we will build up the strategy commercial .

Speaker #11: Okay , great . Thank you .

Speaker #2: Thank you . Our next question comes from Yanzhong with Wedbush . Your line is open .

Speaker #12: Hi . Good afternoon . Thank you very much for taking questions . the So the first question on the label extension to the dose higher , I assume the is going to be the pricing same .

Speaker #12: So, would you expect any direct impact on the number of patients on treatment and reported revenue?

Speaker #4: First of all look , when we on treatment in a dose larger 30 only than the dose , it's restricted to the US and currently when we see in many countries , there is few percentage of patients that really need it in a commercial setting .

Speaker #4: We accept that some patients that really need it and there in many cases already on treatment in the US by having this trial , the patient at Basic will need more 30 in the than US .

Speaker #4: now We have availability because they can join us in the clinical trial . The clinical trial , as Amy , can explain , is where rare , simple , single arm study .

Speaker #4: You can explain how many patients we have. It's basically a trial.

Speaker #13: Right. So, single arm.

Speaker #8: 1818 subjects who will be titrated . I'll as they need based on serum calcium using the higher doses .

Speaker #4: So it's a basic it's an 18 patient six month trial for safety perspective . And that will be the triggering point to also in the US have it .

Speaker #4: I don't think it will have a material impact in any way on our revenue .

Speaker #12: I see thank you for the clarification . Then a follow up question on the payer discussion . I believe that initially you said roughly it takes about eight weeks to get paid approval .

Speaker #12: Then I think last quarter you said three months and then this quarter just now , you probably said a month . Was that just a random maybe a fluctuation or was there any meaningful change in terms of how long it takes for payers to approve coverage ?

Speaker #12: Please . Thank you very much .

Speaker #4: We see an improvement month by month, and when we look at the data today, with about 50% and the eight weeks, that is the data we see today.

Speaker #12: Okay , great . Thank you .

Speaker #2: Thank you. Our next question comes from Alex Thompson with Stiefel. Your line is open.

Speaker #11: Hi . This is Charles on for Alex . Maybe a bit of a different in question , but terms of the sort of adolescent buckets of hyperparathyroid patients you're looking at , I guess , like what kind of patient sizes is represented in the US and what kind of growth do you expect to see from here , assuming there's a successful label expansion ?

Speaker #11: Thank you .

Speaker #4: This patient group is a quite different patient group to compare to the pool of the patient . We talked today in US and other countries .

Speaker #4: Many of these young children are coming from , more pertinently and immunological part and not so much and neck from head operations . Still , that can be posterior to patient at that stage , to these patients are severe a case because if in you have in such a young hypopara age .

Speaker #4: A lot of developmental part is really affected have not to the right calcium hemostasis , phosphate homeostasis and bone hemostasis the in body .

Speaker #4: Today . So I see it as really as high level of severity of disease . To have it also in this extremely young age , I even have seen young people that had it from young that already have kidney transplantation in their 20s because of high the of the treatment that has been been available today with conventional therapy .

Speaker #4: And we look when on the number, it will not be a number that ever can come up to the level that you see in the adult population.

Speaker #4: But it's not changing the severity of really making a treatment available for this patient group .

Speaker #2: you . Thank next question Our comes from Luca Izzi with RBC . Your line is open .

Speaker #14: Oh , great . for taking my Thanks so much question . Maybe on the unique patients enrollment . Is that a metric that you're committed to report going forward , or are you sunset that metric at some point ?

Speaker #14: And if it is the latter , can you talk about whether that could be Q4 or would that be that ? And then later than maybe if I can ask about Nordisk , Novo can you just talk about how that collaboration is going ?

Speaker #14: Obviously lots going on . Novo given again , new leadership in place and obviously just lost the deal on Meztira . So wondering if you're seeing any disruption with that collaboration maybe the opposite actually in with them .

Speaker #14: acceleration of that Or collaboration . So any thoughts there . Much appreciate it . Thanks so much .

Speaker #4: Yeah . Let me take the last question first about our collaboration . And when I look at the collaboration and we look on the ones monthly semaglutide , which I believe have an unique profile because of the slowly release from the product system to a level where the Tmax is where late and you therefore don't have a high slope .

Speaker #4: So likely the tolerability as we have seen in animal models , really can also be established in the clinical trials in humans . In this way , as we are responsible for last element of the collaboration , they have not been definitely any disruption , has and that definitely not been lack of any interest in this program .

Speaker #4: And this is not one single program . It's , as I said in press release , it's a series of programs that we are working on .

Speaker #4: So we definitely have not seen any kind of lack of interest and is progressing with the speed which we can do . It to in this really positive collaboration as fast as we can do .

Speaker #4: We believe that when they come to the late stage ? Sure , muscle the of a company like Novo Nordisk to make a last trial in multiple ways is really unique they really have the because capacity and unique level of expertise to do it .

Speaker #4: Certainly . Now I forgot the first question .

Speaker #6: Enrollment is a metric .

Speaker #4: Yeah . The enrollment as a metric is a question that we a lot . discuss And we want comments on it . When you feeling that we are in a position that revenue that we are reporting now really coming are to a level where you're feeling that it's really are coming to state a .

Speaker #4: Where the of new addition really patients are not changing . So much of the overall said , , as I we're building a strong fundamental quarter by quarter .

Speaker #4: The strong fundament is building a really tall house , and we are now taking breaks . By bricks , quarter by quarter . And building we are this revenue base up more and more , and you can nearly just a from a mathematical modeling .

Speaker #4: Think about When it . we are much more further in the launch , the addition of new patients just are not giving the same impact on the overall actual revenue at that stage .

Speaker #4: And therefore I believe and one time the number of new prescriptions is not really meaningful for you , you will just see a quarterly revenue growth .

Speaker #4: That basically are just reflecting at the addition of new patients .

Speaker #2: Thank you . Our question comes from Maxwell Score with Morgan next Stanley . Your line is open .

Speaker #15: Great . Thank you for taking my questions . I was just wondering when we can expect preclinical data supporting your potential for weekly dosing .

Speaker #15: And also , could you share your outlook on your repast trajectory in Europe ? How should we think about a potential year ? Thank you .

Speaker #4: Yeah . Typical . What we're doing is that we like will in the beginning of the year , there is a conference and likely there will be typical will come up with a data and status on our new product opportunities .

Speaker #4: And we expect to repeat the same element year by year . So a good time to expect to see will be data the at beginning of this year .

Speaker #4: The .

Speaker #6: the Oh he's if talking the the guidance on us .

Speaker #4: what we said for this year . Here is a 4 to 5 million increase Excuse quarter by quarter . What we said this will further be accelerated when we come into 26 because we will have an addition of more and more countries when we come into January .

Speaker #4: give you the perspective of what countries we expect to add in to the being fully commercial in 26 and 27 .

Speaker #2: Thank you. And we'll take our last question from Dong with Clara Jefferies. Your line is open.

Speaker #16: Hi . Thanks for taking our question . And just to follow up on the previous question and apologize if you've mentioned already , but it would be great can the if you the confirm and ex-US revenue US for Europe has .

Speaker #16: And then in terms of US launch momentum , is there any specific timeline for any upcoming reimbursement decision in any market and any pricing dynamics we should keep in mind as you expand internationally ?

Speaker #16: Thank you .

Speaker #4: Okay , so we gave you an algorithm Basic in the beginning of the year . We said that when you look in Q4 24 , there was about 14 million in net revenue .

Speaker #4: All this net net revenue was basic ex US and we expected to add 4 to 5 million net revenue in 25 every quarter .

Speaker #4: So you can really add 14 to 5 plus five plus five plus five . And then you have the Q4 . saw What we in here in 25 , we got Spain full commercial .

Speaker #4: We are in a situation where we not compromise the value because we have an doable product that basically will be here for 20 years .

Speaker #4: So for us , it's more important to really have the value being created in the right manner and what we will give you here in the beginning of the year , there perspective of what and how many new countries we expect to add on in 26 .

Speaker #2: Thank you . And that's all the time we have . Thank you for joining . now You may Good disconnect . day .