Earnings Call Transcript - ASND Q1 2024

Operator, Operator

Good day, and welcome to the Q1 2024 Ascendis Pharma Earnings Conference Call. As a reminder, this call may be recorded. I would now like to turn the call over to Tim Lee, Senior Director, Investor Relations, Ascendis Pharma. Please go ahead.

Timothy Lee, Senior Director of Investor Relations

Thank you, operator, and thank you, everyone, for joining our first quarter 2024 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Dr. Stina Singel, Executive Vice President of Clinical Development Oncology; and Joe Kelly, U.S. General Manager. 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. Examples of such statements may include, but are not limited to: statements regarding our commercialization and continued development of SKYTROFA for the U.S. and European markets as well as certain financial expectations for 2024; our commercialization and development of YORVIPATH in the EU and expected timing of the FDA review and potential launch of TransCon PTH in the U.S.; our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, our ongoing and planned regulatory filings and our expectations regarding the timing and the result of regulatory decisions, our ability to create value in multiple therapeutic areas outside of endocrinology rare disease and our progress towards Vision 2030. These statements are based on information that is available to us 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 statements as circumstances change, except as required by law. For additional information concerning the factors that can 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 20-F filed with the SEC on February 7, 2024. TransCon Growth Hormone or TransCon hGH is approved in the U.S. by the FDA and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. The European Commission and the United Kingdom 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. Otherwise, please note that 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 first quarter 2024 financial results and we'll provide further business updates. Following some prepared remarks, we'll open the call up for questions. Note, with our PDUFA date for TransCon PTH coming up in less than 2 weeks, we will not comment on our ongoing discussions with the FDA and we will not be taking any questions on this topic today. With that, let me turn it over to Jan.

Jan Mikkelsen, President and CEO

Thank you, Tim. Good afternoon, everyone. Ascendis is applying its TransCon technology platform to build a leading fully integrated biopharma company focused on making a meaningful difference in patients' lives. We have two approved TransCon products and solid progress across programs, growing commercial presence and strong partnerships. We believe Ascendis is on the path to sustainable growth and operating cash flow breakeven on a quarterly basis by the end of 2024. Our long-term commitment in the last 3 to 4 years is to build up profitable and robust supply chains, and the decision we took in 2023 to streamline the company to create a more efficient organization. You can see the progress towards operating cash flow per data this year. Without compromising our development and commercialization process, we believe we are well-positioned to successfully deliver on our strategic goals and close out our Vision 3x3 with regulatory approvals for three independent endocrinology rare disease products and continue building a pipeline in other therapeutic areas. Looking to Vision 2030, we believe each of our 3 rare disease endocrinology products will attempt to achieve blockbuster status while we also further expand our pipeline and TransCon platform for future innovation. We have seen validation of our commercialization approach with the ongoing success of SKYTROFA in the U.S. and are seeing it again with the successful launch of YORVIPATH in Germany and Austria. In the U.S., the PDUFA date for TransCon PTH is coming up in less than 2 weeks on May 14. If approved, we expect to be ready to launch in the U.S. soon thereafter in the third quarter. Now let me give an update on each of our programs. When we launched SKYTROFA in the U.S. about 2 years ago, we had two goals: one, to make SKYTROFA the leading product there; the second to drive the U.S. growth hormone market to become a $3 billion market. Our strategy is working. Thousands of patients are now treated with SKYTROFA, the value leader in the U.S. We have a reliable supply chain, ensuring that every patient can benefit from SKYTROFA once they have approval from the insurance company. We estimate that SKYTROFA penetration in the U.S. pediatric growth hormone deficiency patient population has grown to about 17% at the end of the first quarter. We are proud to observe SKYTROFA extending its market value leadership as the only growth hormone product to grow in value in the third quarter of '24 based on reported results. And we believe SKYTROFA will expand the U.S. go-to-market with the potential to become a blockbuster in the U.S. alone. SKYTROFA sales this quarter more than doubled compared to the first quarter of 2022, with a steady quarter-to-quarter increase in speed and pace. We expect to continue this trend for the rest of this year. With these strong SKYTROFA results, we continue to expect the full year 2024 SKYTROFA revenue will be between EUR 320 million to EUR 340 million, representing year-to-year growth of 80% to 90%. We expect SKYTROFA sales to continue to grow through further penetration in pediatric growth hormone deficiency. To further solidify growth, we're also pursuing our first-label expansion in adult growth hormone deficiency for which we plan to submit a supplemental BLA to the FDA in the third quarter of this year. In addition, we expect top-line data from our Phase II trial in Turner syndrome in the fourth quarter of 2024. Now turning to TransCon PTH. In Europe, YORVIPATH was launched in Germany and Austria at the end of January, with the early launch objective of building physician experience with YORVIPATH. Initial physician feedback for YORVIPATH has been positive. Just 8 weeks in the norms, we estimate prescriptions have been written by 55 doctors, representing around 25% of the target prescribing base, with about 100 patients receiving commercial product. As physicians begin to get comfortable with the treatment benefit of YORVIPATH in the first patient, we expect physicians to take more and more patients on. As we expand our geographic reach of YORVIPATH to our Europe direct and our international market segment, we are supporting name patient supply programs and plan to provide reimbursed product to meet the needs of patients. In the U.S., prelaunch preparations are underway, including the expansion of the U.S. field infrastructure while we are waiting for the FDA's decision. Moving now to TransCon CNP. Our value proposition with TransCon CNP is simple. It's to establish a treatment for patients of all ages with achondroplasia. Our ambition is to address the significant comorbidities associated with achondroplasia that impact health and quality of life, as well as linear growth. Later this year, in the third quarter, we plan to report top-line results for our pivotal ApproaCH trial, which is measuring not only linear growth but also physical function, body composition and quality of life parameters. We are also evaluating TransCon CNP in newborns with achondroplasia less than 2 years of age. We believe that treating achondroplasia with TransCon CNP as early as possible might mitigate associated comorbidities in addition to providing catch-up growth to patients who did not receive early treatment. We are evaluating TransCon CNP in combination with TransCon growth hormone. We expect to enroll all patients in this quarter and provide 26-week top-line data for this line into the fourth quarter of this year. This is our integrated approach to address achondroplasia with multiple trials that are all building towards one goal: to treat the disease. And we are optimistic that our highly differentiated product candidate will continue to show best-in-class potential across these multiple studies. Switching now to oncology. Both TransCon IL-2 beta/gamma and TransCon TLR 7/8 Agonist have showed promising clinical activity as monotherapy and in combination treatment with pembrolizumab. In that patient, both diseases have progressed after standard of care treatments. Next month at ASCO, we will report updated patient data from the ongoing Phase I/II trial. We will present updated clinical data and new biomarker data that further differentiates our clinical program. We will also report promising early data from the ongoing dose expansion cohort of patients with melanoma, who have progressed from checkpoint inhibitor using the combination of TransCon IL-2 beta/gamma and TransCon TLR Agonist disease patients. Later this year, in the fourth quarter, we expect data with several well-defined aging populations from our TransCon IL-2 beta/gamma and TransCon TLR 7/8 Agonists programs. Our achievements this quarter give me further confidence that all the elements are in place to fulfill our strategic goal to deliver three independent endocrinology rare disease products and a strong pipeline in larger therapeutic areas such as oncology, ophthalmology, and metabolic diseases with much more to come. I will now turn it over to Scott.

Scott Smith, CFO

Thanks, Jan. In Q1, we demonstrated significant financial progress toward our goal of becoming operating cash flow breakeven on a quarterly basis by the end of 2024. I will touch on some key points surrounding our financial results, but for further details, please refer to our 6-K filed today. SKYTROFA revenue for the first quarter of 2024 was EUR 65 million compared to EUR 31.6 million reported in the first quarter of 2023, an increase of 106% year-over-year. This growth was driven by a significant increase in demand volume, more than doubling compared to the prior year period with a slight offset by a combination of slower channel build, coverage mix, and a modest negative currency impact of EUR 0.8 million. On a sequential basis, first quarter SKYTROFA revenue increased 1% compared to the fourth quarter of 2023. Strong mid-teens percent demand volume growth was offset primarily by seasonal channel inventory, co-pay resets, insurance reauthorizations, and a modest negative currency impact of EUR 0.6 million. Q1 was in line with our high internal expectations and with seasonal headwinds behind, and the steady pace of new patient adds expected to persist. We continue to expect full year SKYTROFA revenue to be in the range of EUR 320 million to EUR 340 million at average 2023 exchange rates. Shifting to TransCon PTH, YORVIPATH contributed for the first time this quarter with revenue of EUR 1.5 million, representing 2 months of shipments. In Germany and Austria, we ship directly to retail pharmacies for patient pickup. And as a result, there is no channel inventory buildup compared to a typical U.S. launch like we saw with SKYTROFA, where specialty pharmacies hold channel inventory. Closing out the top line, total revenue for the first quarter was EUR 95.9 million, including EUR 24.8 million of noncash license revenue recognized in relation to the formation of Eyconis and EUR 3 million of service revenue related to Eyconis, which is offset in operating expenses. Turning to expenses, R&D costs in the first quarter totaled EUR 70.7 million compared to EUR 106.1 million during the first quarter of 2023. The 33% decline was largely tied to lower external development costs for TransCon Growth Hormone and TransCon PTH, including a reversal of prior period write-downs of prelaunch inventories as well as oncology programs, partially offset by an increase in TransCon CNP costs. Sequentially, R&D costs declined 22%. SG&A expenses in the quarter totaled EUR 66.8 million, essentially flat compared to EUR 66.5 million during the first quarter of 2023. Higher employee costs, including the impact from commercial expansion, were partially offset by lower external prelaunch and administrative expenses. Sequentially, SG&A expenses increased 4%. Total operating expenses were EUR 137.5 million for the first quarter, a 20% decrease compared to the EUR 172.7 million during the first quarter of 2023. Sequentially, operating expenses declined 11%. Overall, our operating loss in the first quarter totaled EUR 49.1 million compared to an operating loss of EUR 143.7 million during the first quarter of 2023 as a result of increased revenue and lower operating expenses. Sequentially, operating loss increased 34%. Finance expense in the quarter was EUR 77.2 million compared to EUR 8.4 million expense in the fourth quarter of last year. This higher finance expense was largely driven by a noncash derivative loss tied to our outstanding convertible notes. A quick comment on the balance sheet. As of March 31, 2024, due to amended IFRS rules, which came into effect on January 1, 2024, you'll notice our convertible notes with a face value of USD 575 million are now reported as current liabilities even though they do not mature until April 2028 and would not require cash settlement in case of conversion by holders. IFRS still requires the carrying value of the convertible notes and associated derivative liabilities to be presented separately within current liabilities, which together total EUR 622 million. As per IFRS rules, comparative amounts have been reclassified to reflect the change in presentation. The applied amendments had no other impact on the financial statements. We ended the first quarter with cash and cash equivalents totaling EUR 320 million. For the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of EUR 320 million to EUR 340 million at average 2023 exchange rates. We expect total operating expenses, SG&A and R&D to be approximately EUR 600 million and we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024. Let me now also highlight selected key milestones. For TransCon Growth Hormone, we now plan to submit an SBLA to the FDA for adult GHD in the third quarter of 2024 compared to the previous plan of Q2. And we expect to report top-line results from our Phase II Turner syndrome trial in the fourth quarter of 2024. For TransCon PTH, in the U.S., our PDUFA date is May 14, 2024. If approved, we plan to launch it as quickly as possible thereafter. Outside the U.S., with the commercial rollout of YORVIPATH underway in Germany and Austria, we plan to roll out YORVIPATH in our Europe direct and international market segments throughout 2024 and 2025. For TransCon C&P, we expect to report top-line results from the pivotal ApproaCH trial as well as submit our NDA for treatment of children with achondroplasia, both in the fourth quarter of 2024, and also to report week 26 top-line data from the COACH trial in combination with TransCon Growth Hormone, also in the fourth quarter of 2024. Within our oncology therapeutic area, during the fourth quarter of 2024, we plan to provide a clinical update from the Phase II indication-specific dose expansion cohorts from our TransCon IL-2 beta/gamma and TransCon TLR 7/8 agonist clinical trials. With that, operator, we are now ready to take questions.

Operator, Operator

Our first question comes from Jessica Fye with JPMorgan.

Jessica Fye, Analyst

I was hoping you could talk about how April looked for YORVIPATH in Europe and maybe elaborate a little more on some of those Q1 dynamics you mentioned for SKYTROFA.

Scott Smith, CFO

Yes. So related to the Q1 dynamics, regarding SKYTROFA, I'll take the second part first. What we saw would be I would describe as a typical seasonality that you would see with other maturing launches, where coverage updates at the beginning of the year led to insurance reauthorizations, co-pay resets, and also led to a slightly different mix in the channel. Our channel partners basically updated their inventories as appropriate. It feels like those have cleared out by the end of February. And regarding the first question related to the development of YORVIPATH in April, we continue to expect an overall revenue update later this year. But essentially, we're pretty happy with the results of the launch with the primary goals that Jan laid out in his prepared remarks.

Jan Mikkelsen, President and CEO

So yes, just to give you a little bit of flavor from our own expectations. We structured over in the typical way that you'll perhaps see inside the German and Austrian markets, up from this assumption that we're adapting to the German market. What we typically will see and what we hope for was to get a broad prescriber base. The broad prescriber base, we expected them to take typical 1 to 2 patients on treatment. Then they get really good feedback about the unique benefit of this. As soon as we are over that comfort period, where they really get comfortable, they'll take more on treatment. When we got 25% of our target position already in 8 weeks to make a prescription, I believe that was one of the most successful launches I have seen. We have not imagined that ourselves. The number of patients we're seeing is around 100, meaning that there are a few physicians that started early in our EAP program in Germany. Some of them are up on 20, 30 patients already now because they have already built up comfort with how this product is providing unique benefits to the patients. This is why we feel this is truly the start we were hoping for, the start where we are looking at various key performance indicators, and it really turned out to what we wanted to see and hoped for.

Scott Smith, CFO

And just to reiterate, the results are essentially sales direct to the patient. They go to the retail pharmacy, and the patient picks up. There's no channel inventory with YORVIPATH.

Operator, Operator

Our next question comes from David Lebowitz with Citi.

David Lebowitz, Analyst

If you jump back about a year and when you were in the run-up to your YORVIPATH's potential approval or a regulatory setback, could you juxtapose your current status of your sales preparation, what the market looks like now versus what it looked like then, and how you see things similarly or differently?

Jan Mikkelsen, President and CEO

I believe we are in a much better place. First of all, the awareness of hypoparathyroidism has really improved to much better awareness levels among physicians and patients. In a recent effort, you can see how the patient explains the unmet medical need to the FDA Advisory Board on YouTube, which reflects how they characterize that condition. I think that is one element of why I believe we are in a much better position. The realization of the unmet medical need was already evident to the patients. The awareness is significantly better today. This is reflected in our early success with the initial part of our launch in Germany and Austria. We know we can repeat that in all our EU direct as soon as we get fully reimbursed in these countries, mainly by the end of this year and the beginning of next year and during 2025. We see it already coming in for the international market, mainly through patient-driven programs.

Operator, Operator

Our next question comes from Li Wang Watsek with Cantor.

Li Wang Watsek, Analyst

Sorry, I should've put Li Watsek. I'm Li Watsek from Cantor. For TransCon PTH, in terms of payer access and formulary placement, have you had any pushback from payers on joint clinical benefits such as hospitalization rate or kidney benefit?

Jan Mikkelsen, President and CEO

Is that question related to Europe or the U.S.?

Li Wang Watsek, Analyst

Both, if you may.

Jan Mikkelsen, President and CEO

Okay. In Europe, when we conduct what we call the health economic impact of our treatment, we integrate all aspects of how we're addressing short-term symptoms, benefits of the patient to have a normal life again, plus the benefits of having advanced calcium management. More importantly, we focus on the quality of life experienced by patients immediately after starting treatment. The long-term risks include renal nerve impairment and other complications like cardiovascular impacts, calcification in various organs, cataracts, and other outcomes. All these elements are incorporated into our health economic evaluation that we provide to individual European countries to ensure we are achieving the right reimbursement and pricing.

Operator, Operator

Our next question comes from Joseph Schwartz with Leerink Partners.

Joseph Schwartz, Analyst

I was wondering if you could talk about how many physicians in the U.S. have had experience with YORVIPATH in the EAP versus how many you'll be going out to de novo once it's hopefully launched commercially soon? Could you also talk about how many of the physicians who might be targets for using YORVIPATH and their patients have you interacted with for SKYTROFA already?

Jan Mikkelsen, President and CEO

I think the first question reflects YORVIPATH and the U.S. EAP program. I can provide a general aspect of our EAP program. The general aspect of our U.S. EAP program is very different compared to what we had in Europe, which has now been stopped after we got approval and established good commercial operations in Germany. Our EAP program in the U.S. only addresses patients that really are experiencing, meaning it's about a 3-5% subset of hypoparathyroidism patients. The EAP program is quite challenging for academic institutions to manage. Because of contracting and minimal incentives for them, it means that many of these institutions with many hypoparathyroidism patients will not participate in an EAP program. It will typically be private or small sites. We are extremely enthusiastic about the results we've seen in our EAP program and the treatment benefits observed in our clinical trials have been fully confirmed by the results from the EAP program with patient experiences there.

Joseph Schwartz, Analyst

Okay. And so how many new sites will you have to go to then that treat hypoparathyroidism patients who have not had experience in the EAP or with using SKYTROFA?

Jan Mikkelsen, President and CEO

SKYTROFA, we don't have any EAP site at all in this way. SKYTROFA didn't have any EAP program running. Therefore, it's really hard to compare the two. You will find that there isn't much overlapping directly in the physician prescription phase because it's typically more specialized sites that take care of both sides. One of them is, for example, a pediatric first indication. The other one is an adult indication. So when you look at the overlap for that, there is not a large overlap.

Joseph Schwartz, Analyst

I meant commercial SKYTROFA or the EAP for YORVIPATH. I'm just trying to get a sense of the footprint now, and how much overlap there is between the two products that you'll have shortly.

Jan Mikkelsen, President and CEO

You will find that there is not much overlap directly for the physician prescription phase because it's typically more specialized sites that take care of both sides. One of them is a pediatric first indication, and the other one is an adult indication. Thus, while there's no significant overlap in terms of prescribing physicians, it is clear that there's an extensive base of endocrinology product that will be an advantage for our commercial efforts.

Operator, Operator

Our next question comes from Gavin Clark-Gartner with Evercore ISI.

Gavin Clark-Gartner, Analyst

Congrats on the progress. I'm just wondering out of the 100 YORVIPATH patients in Germany, how many of these were previously on NATPAR, and was this in line with your expectations heading in?

Jan Mikkelsen, President and CEO

I would say surprisingly, we see many more naive patients than we actually anticipated. This was one of the surprises we have seen that the physicians are looking at their patient base and recognizing that there are many patients who have not been in treatment. We are also focusing on bringing new patients into the treatment regime. This was indeed one of the surprises, based on my belief, that we would initially only see a change of patients from NATPAR, but we have observed many more new patients than we initially expected.

Operator, Operator

Kelly Shi with Jefferies, your line is open.

Dingding Shi, Analyst

On SKYTROFA, could you provide your perspective into the competitive landscape, given that there are other long-acting growth hormone commercial products out there? Also, like you curious about whether your launch strategy remains the same.

Jan Mikkelsen, President and CEO

One of the challenges I have is utilizing the different databases you can get to retrieve prescriptions. In this case, using these database sets, we can look for trends but never absolute levels because the sampling is really different among different providers. You are sampling just a small amount of the prescribing base, where you gather information from. From that perspective, you cannot really compare the absolute numbers. Additionally, you cannot compare them simply because when we talk about units, the units are vastly different between the products. Therefore, to get the most effective and solid data, we need to review each single company’s performance at the line item level, looking at revenue for the best confirmation about data and how they are progressing. It's indisputable that during the growth hormone market, it was a very difficult Q1; however, we were the only one that reported growing, while others declined, which is typical in the first quarter.

Operator, Operator

Our next question comes from Derek Archila with Wells Fargo.

Derek Archila, Analyst

Congrats on the progress. I have a question on the OpEx progression this year. Based on the 1Q OpEx, it seems like you might come in a fair bit below the EUR 600 million guidance. Could you provide any color on how we should perceive that?

Jan Mikkelsen, President and CEO

I think Scott is quite pleased today because he's receiving great questions.

Scott Smith, CFO

Yes, Derek, thanks for the question. We have been quite proud of our ability to reduce OpEx significantly while doubling revenue. It's not a bad thought that we may come in below guidance, but as of now, our guidance remains EUR 600 million OpEx for the full year based on current plans.

Operator, Operator

Our next question comes from Paul Choi with Goldman Sachs.

Kyuwon Choi, Analyst

Let me offer my congratulations on the progress. I want to turn maybe to CNP for a moment. If you could comment on what your market research ahead of your top-line results later this year suggests in terms of how endocrinologists might think about using TransCon CNP either as mutation starts or possibly anticipating switches from treatments given the different dosing frequency. Also, how do you envision what dose shares might look like in terms of the launch? Lastly, could you comment on potential post-approval requirements for TransCon CNP pending FDA approval?

Jan Mikkelsen, President and CEO

It's an extremely interesting topic from the perspective of looking at all the research we’ve conducted. The key topic and feedback we receive in all interactions with physicians, caregivers, and patients is about addressing comorbidities. Being short is not a disease, but having these comorbidities does have a major impact on achondroplasia. This is why we focus strongly on addressing the comorbidities as well as linear growth. We cannot dismiss the primary efficacy endpoint, which is linear growth, as it has been established by regulatory agencies in both the U.S. and Europe. Thus, it's challenging to shift away from that. If we were the first to launch, we wouldn't have linear progress; it would need to include connotations about comorbidities as they define the disease. Our integrated program has been designed to highlight this. Our key objectives are around linear growth but also muscle weakness and related issues. The positive impact of our treatment on the quality of life of both patients and caregivers is reflected in our retention rates. We are seeing how quickly we can recruit for our pivotal trial; it is phenomenal that we achieved this within four months. This is because physicians can share tangible benefits they are observing when speaking to parent regarding our TransCon CNP product. Regarding commitments post-approval, we have not received comments or requirements from regulatory agencies across various jurisdictions about any commitments.

Operator, Operator

Our next question comes from Vikram Purohit with Morgan Stanley.

Vikram Purohit, Analyst

We just had one on the pipeline. A few months ago, you discussed the novel TransCon carrier platform, and you cited your work here with semaglutide through a case study. I wanted to check on the progress of your internal work with this novel platform and the GLP-1 program. What are the next milestones we might learn about?

Jan Mikkelsen, President and CEO

We are extremely excited about this lead candidate that we have developed. There's no doubt that once the treatment regime is established, we will be building on the same fundamentals that we built into our pipeline. I refer to it as a pipeline because we're not taking the target engagement risk typically associated with highly differentiated products. We are developing an integrated approach that is intended to showcase clinical benefits across various indications. We are making steady progress. We will keep you updated once a decision has been made regarding the next steps.

Operator, Operator

Our next question comes from Yaron Werber with TD Cowen.

Joyce Zhou, Analyst

In the U.S., can you talk about your planned launch strategy for TransCon PTH in terms of the initial target population and prescriber base? How much of it will mirror your strategy in Germany, where you're initially targeting roughly a third of the total population?

Jan Mikkelsen, President and CEO

We are integrating the learnings from the first country where we launched the product. The first country launch was Germany and Austria, and we have gained valuable insights. I have to say we received confirmation about our execution strategy based on how we have assessed this project. Therefore, we will not come in with a completely different strategy. We are proud of the commercial execution our team has accomplished in this region, aligning closely with what we called our playbook. When I refer to our U.S. playbook, that is coordinated by our Head of Global Commercial Operations. She is ensuring best practices in the U.S. and coordinating with international markets. We will implement this strategy to ensure we have optimal commercial relationships globally. We see a tremendous interest from the market for our offering, and I can confirm that we already have the first commercial patient from the U.S. receiving the product from Germany due to the delay in the U.S. This validates the effectiveness and potential demand of our therapy.

Operator, Operator

Our last question comes from Leland Gershell with Oppenheimer.

Leland Gershell, Analyst

Two from us. First, if you could comment on the plan for rolling out YORVIPATH in Great Britain following the approval. Is that something you're doing immediately, or will there be any delay? Secondly, you mentioned hypochondroplasia as an indication you decided not to pursue. I wonder if the data from the recent Phase III studies could change that?

Jan Mikkelsen, President and CEO

Yes, the U.K. is part of our Europe direct line. We have a rollout plan for all our countries that are in our EU direct, and the U.K. will be integrated into this rollout. After we receive U.K. approval, which is now separate from EU approvals, we continue filing throughout different countries. We plan to implement our pricing strategy designed to reflect the health economic impact, as we've done successfully in many EU direct countries. We will then conduct full commercial launches across all territories. Until we achieve full commercialization, physicians and patients can access the therapy through named patient programs, ensuring that patients receive reimbursed products through various frameworks. The dual strategy we employ in Europe is one we also plan to implement in international markets, albeit with different distribution structures via our sales and distribution agents. Regarding hypochondroplasia, it's an interesting concept for us because we are the only company focused on growth disorders. Growth disorders encompass 30 to 40 different diseases. We are the only company with a once-weekly growth hormone and a once-weekly CNP molecule, each with best-in-class properties for both mechanisms. We are formulating our integrated strategy to position ourselves as the leading company in growth disorders. This will not only include hypochondroplasia but also address other disorders within that category. Some will respond better to growth hormone administration, while others will benefit from CNP treatments or possible combination therapies. This strategy is central to our Vision 2030 initiative. We will provide more updates when this integrated strategy is presented next year.

Operator, Operator

And that concludes the program. You may now disconnect. Everyone, have a great day.