Ascendis Pharma A/S Q3 FY2024 Earnings Call

Good day, and thank you for standing by. Welcome to the Ascendis Pharma Third Quarter Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today, Scott Smith, Chief Financial Officer. Please go ahead.

Thanks so much, operator, and thank you, everyone, for joining our Third Quarter 2024 Financial Results Conference Call. I'm Scott Smith, Executive Vice President and Chief Financial Officer at Ascendis Pharma. I'm joined today by Jan Mikkelsen, President and Chief Executive Officer. Before we begin, I would 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 and YORVIPATH for the U.S. and European markets, as well as certain financial expectations, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans and partnerships, 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 results of regulatory decisions, expected market developments and our exploration of market opportunities in the therapeutic areas of endocrinology rare diseases. 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 our forward-looking statements section of today's press release and the Risk Factors section of our prospectus supplement filed on September 20, 2024, and 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. TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults and the European Commission and the UK's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as a 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 these product units 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 third quarter 2024 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open it up for questions. With that, let me turn it over to Jan.

Thank you so much, Scott. 2024 has been another transformative year for Ascendis. Three out of three of our rare endocrinology programs have delivered clinically differentiated pivotal data. Each product or program is demonstrating its potential to address major unmet medical needs and receive blockbuster status, positioning us to be the market leader in each disease area. Our first approved product, SKYTROFA, these are best-in-class once-weekly growth hormone, and has achieved a leading position in a highly competitive U.S. market with a single indication. SKYTROFA's performance is a testament to its differentiated profile and the team's excellent execution against competition from multiple big pharma companies. We expect additional growth opportunity for SKYTROFA ahead. We are very excited about the upcoming launch of YORVIPATH in the U.S. YORVIPATH is the first and only product to be FDA approved for the treatment of hypoparathyroidism in adults. There are 70,000 to 90,000 adults with hypoparathyroidism in the U.S. who would potentially benefit from this treatment. The highly positive pivotal data in achondroplasia that we announced in September for our third product candidate, TransCon CRE, further strengthens our belief that it could, if approved, become the treatment of choice in this multibillion-dollar market opportunity. Our new partnership with Novo Nordisk highlights our ability to transform the success of our TransCon platform into large, high-volume therapeutic areas. By staying focused on our values of patients, science, and passion, we believe we are creating extraordinary value for patients and stakeholders. I will now provide more detailed comments on each of these products and other key areas of progress. Starting with SKYTROFA. The fundamentals for SKYTROFA are strong. Demand volume in the third quarter increased more than 60% year-over-year as physicians, caregivers, and patients continue to recognize the benefit of SKYTROFA provides. We have achieved broader market access for SKYTROFA but have not compromised its value, maintaining a net value per patient of around three times that of daily growth hormone. Over time, we see an opportunity to drive SKYTROFA growth on pediatric growth hormone deficiency with a number of label expansions. In September, we submitted a supplement BLA for adult growth hormone deficiency. Next, we expect top-line data from our Phase II trial on Turner syndrome. Next year, we expect to initiate a SKYTROFA basket trial in established growth hormone indications such as idiopathic short stature, small for age, and the genetic condition shock that includes Turner syndrome. Importantly, the daily growth hormone market is undergoing consolidation, with players such as Lilly and Genentech announcing plans to exit the market. Today, we repeatedly see that when given the choice, SKYTROFA is the preferred product. The market converts to once-weekly treatment. Therefore, we believe SKYTROFA is well positioned to compete for the 85% of prescriptions still being written for daily growth hormone. We are dedicated to making SKYTROFA our blockbuster in the U.S. alone. Our focus will stay on growing its market share with new patients, both treatment-naive and those switching from daily growth hormone, increasing treatment adherence and duration, and through label expansion, supported by pricing that recognizes the value of long-acting therapy. Now moving to YORVIPATH. We are preparing for the imminent launch of YORVIPATH in the U.S. Next month, in December, we plan to begin accepting prescriptions and start the reimbursement process for around 200 patients already being treated with YORVIPATH in preparation for commercial product availability in mid-January 2025. From January 1, we expect to begin accepting prescriptions for all adults with chronic hypoparathyroidism. To support a strong and successful U.S. launch, we have invested to expand our commercial infrastructure, including building a field organization for YORVIPATH, that is three times the number that covers SKYTROFA. Since approval, our expanded U.S. field team has focused on engaging endocrinologists who treat adults, including many key opinion leaders and healthcare providers who are actually involved in the treatment of hypoparathyroidism. This market is driven by endocrinologists, a relatively concentrated specialty, and we estimate around 1,200 physicians have around 30,000 chronic hypopara patients in their care or an average about 25 patients each. We expect initial uptake of YORVIPATH in the U.S. to come from four segments. There are around 200 patients already on YORVIPATH, the 350 to 400 patients in the NATPARA special use program that is ending soon, the last population of 4,000 to 5,000 PTH experienced patients, and around 75,000 broader PTH treatment-naive population. Outside the U.S., uptake of YORVIPATH continues to be robust. As of today, there are now around 600 patients on commercial therapy in Germany and Austria, where the commercial launch began this year in January and across many patient programs in multiple other countries. We believe YORVIPATH is a truly unique product. We have decided to have the same mode of action and distribution in the body as endogenous PTH and to provide active PTH within physiological levels for 24 hours, seven days a week. We don't see any other compounds in development that share these key attributes. We believe that YORVIPATH will become the therapy for the majority of adults with hypoparathyroidism, which is aligned with the recently established guidelines for the treatment of hypoparathyroidism in adults. I will now provide some commentary on TransCon CNP. Our value proposition for TransCon CNP is simple; it's to establish a treatment for patients of all ages with achondroplasia. Our pivotal trial results showed that TransCon CNP not only exceeded benchmarks for growth that have been slated in other randomized clinical trials but also impacted other endpoints that are important for individuals with achondroplasia. We believe TransCon CNP has a best-in-class efficacy profile with safety and tolerability similar to placebo, including excellent injection site tolerability and once-weekly dosing. This sets the stage for its leadership in the achondroplasia market. We expect to submit an NDA to the FDA for TransCon CNP for the treatment of children with achondroplasia during the first quarter of 2025 and an MAA to the EMEA during the third quarter of 2025. With two once-weekly growth-promoting products in our portfolio, SKYTROFA and TransCon CNP, we believe Ascendis is positioned to become the leader in treating growth disorders. We expect top-line week 26 data from COACH, our first combination trial of TransCon Growth Hormone and TransCon CNP in children with achondroplasia aged two to 11 years in the second quarter of 2025. Now moving to our recently announced Novo Nordisk collaboration. We believe this agreement is strong validation of our ability to drive innovation, benefit patients, and expand the TransCon technology platform to a larger therapeutic area as described in our Vision 2030. The lead program in the collaboration is a once-monthly GLP-1 that will initially target obesity and type two diabetes. The global market for GLP-1s, like semaglutide, is expected to exceed more than $50 billion this year and to double or triple in the next ten years. Once-monthly GLP-1 could become the treatment of choice in this future market. We are pleased to be working with Novo Nordisk, a world leader with the manufacturing capacity and commercial infrastructure to realize the value of this opportunity. Financially, upon closing, we will receive an upfront payment of $100 million and escalating tiered mid-single-digit royalties on global net sales of TransCon products along with development, regulatory, and sales milestones. I will close with an update on our oncology program. In September, we presented results from the platinum-resistant ovarian cancer cohort of the Phase I/II IL-Believe Trial of TransCon IL-2 beta/gamma at ESMO, showing that antitumor clinical response was observed in 29 of efficacy-related patients treated with TransCon IL-2 beta in combination with chemotherapy. This was the second indication-specific cohort showing meaningful signs of antitumor activity in heavily pretreated patients. Given these results, we recently closed enrollment to the dose expansion cohort in the TranscendIT-101 and IL-Believe trial of TransCon TLR7/8 agonist to highly prioritize our effort on TransCon IL-2 beta/gamma. In summary, our progress and position are strong, and we believe the expected product revenue and strength of our balance sheet give us the ability to invest in global launches, label expansion and life cycle management for all of our three rare endocrinology programs to support each of them in reaching blockbuster status. At the same time, we will continue to invest in new product candidates created by our TransCon technology platform to build sustainable growth and profitability. I will now turn it over to Scott for the financial update.

Thanks, Jan. In tandem with the progress we have made this year with our three endocrinology rare disease programs and the success of extending the application of our TransCon platform into obesity and type two diabetes, Ascendis also became much stronger financially in 2024. Product revenues have grown significantly. We raised capital in the third quarter. We are securing additional non-dilutive capital through the Novo Nordisk collaboration and we remain disciplined with our spending. We head towards next year with ample financial capability to execute on our key 2025 strategic priorities: expand the label for SKYTROFA to adult growth hormone deficiency and build on its leadership position as a best-in-class growth hormone product; successfully launch YORVIPATH in the U.S. and in multiple countries in our European direct and international markets; and submit TransCon CNP for approval in the U.S. and EU and initiate preparations for launch in achondroplasia. I'll touch on some key points surrounding our third quarter financial results, but for further details, please refer to our 6-K filed today. SKYTROFA volume increased more than 60% in the third quarter of 2024 compared to the third quarter last year, while reported revenue was EUR 47.2 million compared to EUR 47 million reported in the third quarter of 2023. The increase in volume was offset primarily by higher sales deductions compared to the prior year as a result of broader market access. SKYTROFA revenue in the third quarter of 2024 related to channel inventory was approximately EUR 3.5 million lower compared to the third quarter last year. SKYTROFA revenue in the third quarter of 2024 was also negatively impacted by adjustments related to prior period sales deductions of EUR 2.5 million. SKYTROFA for over the first nine months of 2024 totaled EUR 138.5 million, a 21% increase year-over-year compared to EUR 114.4 million during the same period in 2023. For the first nine months of 2024, SKYTROFA volume more than doubled but was partially offset by higher sales deductions including an accrual true-up of EUR 9.3 million related to periods prior to January 1, 2024. Overall, despite the accrual true-ups in Q2 and Q3, with more claims in hand, we can see that realized pricing has been stable since the beginning of the year. With stable pricing, a few extra shipping days, and increasing demand, we expect Q4 revenues to increase sequentially and expect full-year 2024 SKYTROFA revenue, excluding sales deductions related to prior years, to be EUR 200 million to EUR 220 million. We estimate that by the end of Q3 2024, based on third-party data, SKYTROFA penetration in the overall treated growth hormone market is approximately 6% with our single indication for pediatric GHD. In addition, we estimate based on third-party data that sales of daily growth hormone products represent about 85% of total U.S. prescriptions, leaving lots of room for further growth for SKYTROFA and market expansion. Shifting to TransCon PTH, third quarter YORVIPATH revenue outside the U.S. increased more than 60% to EUR 8.5 million, driven by growing patient and physician demand, partially offset by accruals reflecting the end of the free pricing period in the third quarter. Final pricing in Germany is expected to be completed next year. Closing out the topline, total revenue for the third quarter was EUR 57.8 million, including EUR 2.1 million tied to the rendering of services and license revenue. Turning to expenses, R&D costs in the third quarter of 2024 totaled EUR 73.5 million compared to EUR 111.4 million during the third quarter of 2023. The 34% decline was largely due to lower external development costs for TransCon HGH, TransCon PTH, and TransCon CNP as well as the Eyconis transaction. SG&A expenses in the quarter totaled EUR 69.8 million compared to EUR 63.6 million during the third quarter of 2023. The EUR 6 million increase was primarily due to higher employee costs, including the impact from global commercial expansion. Total operating expenses were EUR 143.4 million for the third quarter of 2024, an 18% decrease compared to EUR 175.1 million during the third quarter of 2023. Total operating expenses for the first nine months of 2024 were EUR 439 million. Net finance income in the quarter was EUR 2.9 million compared to finance expenses of EUR 20.4 million in the third quarter of last year. As a reminder, the net finance line can fluctuate quarter-to-quarter, driven in part by noncash items related to our outstanding convertible notes. Finally, we ended the third quarter with cash, cash equivalents, and marketable securities totaling EUR 626 million compared to EUR 399 million as of December 31, 2023. To be clear, total cash does not include the expected $100 million upfront payment from Novo Nordisk, which is due following closing of the transaction. For the full year 2024, based on current plans, we expect product revenue from SKYTROFA and YORVIPATH ex-U.S. to continue to grow. Specifically, we expect SKYTROFA revenue, excluding sales deductions related to prior years, to be EUR 200 million to EUR 220 million, and total operating expenses, SG&A and R&D to be approximately EUR 600 million, which includes expenses related to launching YORVIPATH in the U.S. We are ready and well-capitalized to deliver a successful launch of YORVIPATH in the U.S., with product availability expected in mid-January. With that, operator, we are now ready to take questions.

Our first question for today comes from Jessica Fye of JPMorgan. Your line is open.

Hey guys, good afternoon. Thanks for taking my questions. You laid out a case for a strong initial U.S. launch for YORVIPATH, and we're clearly seeing that outside the U.S. already. Can you talk about why you have confidence that you'll be able to keep the patients that you pick up in light of various competitors potentially entering the market? And my second one or a follow-up is just in the past, you've talked about an expectation to reach operating cash flow breakeven by the end of 2025. Is that still your expectation?

Thanks, Jess. I will take the first question, and then I'll delegate it to Scott to take the second question. I think, yes, we basically somewhat reflected that in our initial remarks. Because what we described is really a true replacement therapy because we are talking about patients that do not have sufficient endogenous hormone to really have a normal functional life, like with type 1 diabetes. When we look at the characteristics, which have been proven in multiple publications, particularly from NIH, where they used infusion pumps, taking PTH into short-acting PTH, they can maintain physiological concentration 24 hours a day, seven days a week. So when we consider what needs to be taken as a true replacement therapy, you need to have the same mode of action as you have with endogenous hormone. You also need to have the correct distribution reaching all necessary organs that require proper receptor activation and signaling pathways for normal physiological function. The second thing is that you need to have the right concentration profile, maintaining it 24/7. When I look at the clinical data, I cannot find anything that meets the level of a true replacement therapy. That answers your first question, and I think Scott will take the second one.

With regard to our goal to be cash flow breakeven, that still remains the goal, and we believe we can achieve that with the cash and cash equivalents that we have on hand.

And our next question will be coming from the line of Tazeen Ahmad of Bank of America Securities. Your line is open.

Hi guys. Good evening. Thanks for taking my question. Mine's on CNP. Can you just give us an update on where you are in preparing for your meeting with FDA and/or your application? What are the open items that need to be completed before you can guide us to whether or not the data that you have is indeed going to be sufficient for the application? And will there be a potential pathway where you start your submission and provide data on a rolling basis if the agency is looking for extended data?

Thanks a lot for the question. To our knowledge, and based on interactions with both regulatory agencies in Europe and the U.S., we have the integrated data package that needs to be part of the submission. We basically have no missing data that we need to generate for finalizing the application with, for example, the FDA. We've been preparing for this filing, which is approaching in Q1 now. Looking at the packet, we truly are providing a robust dossier that not only demonstrates the best-in-class growth of the children but also addresses comorbidities. This positions us uniquely as we aim to provide a comprehensive treatment for achondroplasia instead of just focusing solely on linear growth. If linear growth were the only goal, we could simply use growth hormone, which is the most effective for that. Our unique position allows us to address the broader aspects of the condition, and we will continue to share data related to the regulatory agencies and the benefits of our treatment paradigm.

And our next question will be coming from Derek Archila of Wells Fargo. Derek, your line is open.

Sorry. This is Simona on for Derek. So for SKYTROFA approval, have you made any progress with the payers? And do you have any updates on if it's on formulary or if there are any new blocks for market entry? And just one on YORVIPATH. Will this launch require a medical exception for access to the drug?

Regarding SKYTROFA, we have been improving our market access situation quite significantly this year. While we are still seeing some medical exceptions, we are in a completely different market access situation compared to earlier. When we look at SKYTROFA's positioning, we believe it stands out as a high-value product opportunity given its best-in-class nature. It is responsible to maintain a price such that our net value is three times higher than daily growth hormone due to the numerous benefits it provides. This is a critical element in our commercial strategy to make SKYTROFA a blockbuster in the U.S. alone, and also the consolidation we see, with big pharma exiting the market, contributes to this opportunity. There has been a strong reputation for reliable supply chains that have not been disrupted. Related to YORVIPATH, when launching in rare diseases, two key elements for uptake are important: being on-label for the majority of patients and being supported by guidelines for treatment. I can assure we meet those criteria. We're the only product available, which strengthens our position for reimbursement as we can guarantee value to patients.

And the next question will be coming from the line of Yaron Werber of TD Cowen. Your line is open.

Yes, hi, great. Thanks for taking my question. Jan, maybe just a couple on YORVIPATH. I think in the past, we expected that the payer would be pulled from the market by Takeda by the end of this year. Can you give us a little bit of a sense of how this is going to work? Is it driven by a hard date like December 31? Or is it just driven by when they run out of supply? And then also in Europe, I know you're waiting for the NATPARA inventory to run out before YORVIPATH really takes off. Can you give us a little bit of an update on timing, your expectations?

You're asking a question outside my control. I cannot dictate when NATPARA runs out of stock. They have ceased production and are depleting their inventory. We believe they will exit the U.S. market as quickly as possible as they are currently providing free drugs to each patient. In Europe, we have observed differing patterns: in Germany, they have switched NATPARA patients over to our treatment, while in Austria, they are maintaining NATPARA patients as long as feasible. Both scenarios will allow for our treatment to become the preferred option; we anticipate that this transition will occur over the next year.

And our next question will be coming from the line of Gavin Clark-Gartner of Evercore. Your line is open.

Hey guys, Congrats on all the progress. So I just wanted to ask about the 4,000 to 5,000 PTH experienced patients in the U.S. that you've noted. Are all these patients actively managed in the healthcare system? And I guess more specifically, how long do you believe it could take to get the majority of these patients onto YORVIPATH? Could it be within the first year, two years? Any estimate would be helpful.

Thanks for the question. I believe this PTH-experienced group is accustomed to daily administration, like with FORTEO, where patients may have had to inject themselves several times a day. However, FORTEO is short-acting and typically limits administration to two years due to the physiological levels they provide. Most of the 4,000 to 5,000 patients consist of those who previously used NATPARA but couldn't join the program when it was recalled. We believe that many in this group will seek treatment with endocrinologists as soon as YORVIPATH becomes available. Our upcoming hub program will assist patients in transitioning from prescription to reimbursement, enhancing accessibility to the product. We are equipped to manage this process effectively. We believe that many patients are eager for this treatment opportunity.

And the next question is coming from the line of Li Watsek of Cantor. Your line is open.

Hey guys, thank you for taking my questions. I guess relative to the pediatric growth hormone market, how should we think about the revenue contribution from the adult market as well by the Turner syndrome? And it sounds like you're initiating a basket trial. Maybe just comment on the market opportunity there relative to the growth hormone market?

Regarding the growth hormone market, our on-label access currently permits participation in the segment relevant to pediatric growth hormone deficiency. We have recently filed for the adult growth hormone deficiency, opening opportunities in an underpenetrated treatment population in the U.S. Best estimates indicate only 5-8% of adult growth hormone deficiency patients are being treated, which suggests significant growth potential. We plan to ensure SKYTROFA becomes the treatment of choice for all indications within the growth hormone market. The basket trial will address several conditions, including Turner syndrome, leading to nearly capturing the entire growth hormone market. This is our vision to develop SKYTROFA into the blockbuster it should be. For PTH and hypopara, the adult segment represents the majority of the market, providing further growth opportunities.

And our next question will be coming from the line of Joe Schwartz of Leerink Partners. Your line is open.

Great, thanks so much. First question is on YORVIPATH. I was just wondering how you expect the launch of YORVIPATH in the U.S. to compare to Europe in general? And then is the monthly serum calcium monitoring requirement in the U.S. likely to be a significant deterrent for patients, potentially impacting the launch curve?

Let me start with the last question, Joe. I've seen the UM criteria for some locations. I've never seen serum calcium monitoring set as a criterion for access. Therefore, I don't perceive it becoming a challenge. Patients often require monitoring but I haven’t seen that as a significant access hurdle. With respect to the U.S. market, we expect a markedly different uptake compared to the German or Austrian markets, where penetration rates have been slower initially. In the U.S., however, there's generally a more open mindset to trying new treatments. We're seeing that the average patient per physician in Germany has shifted from one to two. In contrast, the uptake in the U.S. may be quicker and more substantial.

Okay. And then on SKYTROFA, is today's adjustment to the 2024 revenue guidance due to lower volume, price, or both? Can you help us understand why the additional adjustment is necessary beyond what we saw previously and whether these dynamics could carry over into 2025?

I think Scott will take that.

I think, Joe, in Q3, volume was a little bit lower than expected, but we also had fewer selling days. We're off to a good start here in Q4 but we want to be cautious until we see more data. Given we had the call today, we provided the updated revenue guidance. Dependencies could increase the number for Q4, including channel buying and higher refill rates through prescriptions, yet we don’t have enough experience at this point to predict this decisively.

And the next question will be coming from the line of Vikram Purohit of Morgan Stanley. Your line is open.

Hi, good afternoon. Thank you for taking our questions. So we had one on the recently announced Novo Nordisk collaboration. We were just curious as it moves forward what the next public disclosures there could be and what we can expect to learn from yourself and/or Novo Nordisk? And then secondly, for the oncology pipeline, we were curious about what the next milestones there might be and how you're thinking about progressing the oncology efforts you have in place with potential partnerships and what partnership economics or a good partner for those efforts might look like in the future?

Thanks for the questions. Concerning the first question, the strength of our TransCon technology has yielded three successful endocrinology products from concept to pivotal data and two have been approved thus far. Novo Nordisk recognized this capability as well. We can provide a peptide with known properties that have established safety and efficacy and make it a once-monthly product, improving tolerability and efficacy simultaneously. We are honored to partner with such a prominent company as Novo Nordisk, as they possess the manufacturing capacity and commercial infrastructure to fully realize the potential of this opportunity. For specific updates on how they utilize the TransCon technology, it’s best to refer to Novo Nordisk for comments. Concerning oncology, we are exceptionally encouraged by the results we've seen in platinum-resistant ovarian cancer, particularly in late-stage patients, many of whom have little hope. We are observing noteworthy clinical benefits, and we are dedicated to advancing these efforts as efficiently as possible to help the patients who need it. As we’ve mentioned, we are open to exploring various structures for value creation in our oncology pipeline, focusing on rapidly reaching as many patients as possible while creating substantial value for our stakeholders.

And our next question will be coming from the line of Kelly Shi of Jefferies. Your line is open.

Thank you for taking my questions. I want to confirm several numbers in the press release: it was mentioned that the first three quarters of 2024 totaled EUR 138.5 million and the full-year guidance at EUR 200 million to EUR 220 million. This would imply Q4 sales of EUR 61.5 million to meet the lower bound. Is this the sales without any adjustments? For the TransCon CNP NDA submission, have you had conversations with regulatory agencies about whether 12-month data will be sufficient for the submission?

I will delegate the first part of the question to Scott to confirm your figures.

Yes. Our updated guidance of EUR 200 million to EUR 220 million in revenue excludes any impact from prior period sales deductions or sales deductions related to periods prior to January 1, 2024.

Regarding your second question, we have not received any requests to produce more than the 12-month data related to efficacy. During a filing, the regulatory bodies will always require updated safety data and other relevant safety reports throughout their evaluation period.

Our next question will be coming from the line of David Lebowitz of Citi. Your line is open.

Thank you very much for taking my question. First, on the long-acting GLP-1 agonist. Given that GLP-1s are titrated as part of normal treatment, what type of challenges does the long-acting format present in this regard? And then the second question is on SKYTROFA. Could you give us perspective on how the net or average price has evolved as you've added new payers to give us perspective just for modeling purposes and how we should view this going forward?

When discussing long-acting GLP-1s, it is essential to consider the basic biological mechanisms of GLP-1, as tolerability issues arise largely from the rate of titration. Patients often face challenges when transitioning from trough to peak levels too rapidly, causing tolerability issues. Titration helps by allowing gradual increases in dosage to facilitate acclimating patients to the treatment. One of the unique aspects of our TransCon technology is its extended Tmax, resulting in a slower transition from trough to peak levels. This helps in achieving a better tolerability profile compared to short-acting formulations that elevate levels quickly. We highlighted in our prepared remarks that even if you take the standard daily growth hormone level and compare it to SKYTROFA, SKYTROFA maintains a net value that is three times higher.

And our next question will be coming from the line of Paul Choi of Goldman Sachs. Your line is open.

Hi, good afternoon and thank you for taking our questions. I want to ask about your recent Novo licensing deal. Given that GLP-1s are validated, it seems like the 505(b)(2) development pathway is open to a potential monthly GLP-1 agonist. Therefore, development times may be shorter than a full clinical development program for a monthly GLP-1. Do you agree with this? And if that's the case, do you have any sense of what timelines might be for development here? When might you start to recognize royalty revenue from your partners? Any comment there would be super helpful.

I fully agree with your assessment on the potential of the 505(b)(2) pathway leading to shorter development durations. It allows for broader labeling opportunities right from the start with potentially only one indication. However, for specific timelines, we need to refer to Novo Nordisk for additional commentary on that.

And our next question will be coming from the line of Leland Gershell of Oppenheimer. Your line is open.

Oh hey, thanks for squeezing me in and for taking the questions. Just one from us. I think you had mentioned that commercialization in France might be starting by the end of this year. I'm not sure if I missed it in your prepared comments. Is that on track? And I was also wondering as you further pursue European commercialization, if you have any further clarity on the cadence of rollout in various countries through 2025?

You are correct. We are only operationally fully commercial in Germany and Austria. In France, we were accepted into a special AP2 program that is non-promotional, allowing for the provision of commercially reimbursed drug. This program has been in place for about three to four weeks now, with physicians expressing interest. Looking ahead, we anticipate rolling out full commercialization in multiple European countries as we have successfully done in Germany and Austria. We are focusing our resources on securing regulatory approvals across various regions, and we expect that by next year, we will see a broader rollout of our products.

And our next question will be coming from the line of Alexander Thompson of Stifel. Your line is open.

Great, thanks for taking my questions. For YORVIPATH, could you talk about your commercial supply readiness for the mid-January launch? I think you mentioned that you're going to take scripts from current YORVIPATH patients in December. Could you open that up to all? Or are there supply constraints or some other constraints? And then on CNP, do you still have an appetite for running a broader basket study of additional indications? Or are you now focused on SKYTROFA?

For YORVIPATH, we have ensured we have an unlimited supply for our launch. We can accept all patients and there are no manufacturing limitations. We've already established the entire year’s manufacturing schedule and confirmed that we can supply robustly, similar to SKYTROFA. There will be no patient left without prescription fulfillment for YORVIPATH. Regarding CNP, we believe some indications will be optimally treated with SKYTROFA, but we also see indications suited for CNP. Some patients may benefit from combinations of both products. We’re in the process of planning CNP-related trials, including a basket study that will address various CNP-related indications.

Thank you so much for your questions and answers today. That is all the time that we have for the session. We thank you for joining the conference call today. You all may disconnect and have a great rest of your day.