Ascendis Pharma A/S Q4 FY2023 Earnings Call

Thank you, operator, and thank you everyone for joining our full year 2023 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 and Head of Clinical Development, Oncology; and Joe Kelly, Senior Vice President, Head of US Commercial, Endocrinology. 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 US 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 US, 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 results of regulatory decisions. Our ability to create value in multiple therapeutic areas outside of endocrinology rare disease, our progress towards Vision 2030, and the potential success of Eyconis. These statements are based on information that is available to us as of today. Actual results could differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the 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 20-F filed with the SEC later today, February 7th, 2024. TransCon Growth Hormone or TransCon hGH, is approved in the US by FDA and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. The European Commission has 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 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 full year 2023 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan.

Good afternoon, everyone. 2023 was a transformative year for Ascendis Pharma. We streamlined the company, including our structure, our processes, and operating expense allocation. At the same time, we believe we are on track to achieve our Vision 3x3 by 2025. SKYTROFA is the leading growth hormone product in value in the US. The launch of YORVIPATH in Europe, direct and international markets is underway, beginning with Germany and Austria. Our clinical program for TransCon CNP is progressing to what we expect in Q4. We believe Ascendis is advancing to become a leading biopharma company with a strong focus on endocrinology rare diseases and capabilities to also create value in other therapeutic areas as we are doing in oncology, ophthalmology, and metabolic diseases. Because of the decisions we took in 2023, we believe Ascendis is a leaner, more efficient organization in 2024, well-positioned to fulfill Vision 2030 with three independent endocrinology rare disease blockbuster products and expand our engine for future innovation. Now, let me provide an update on each program. From the beginning, we designed SKYTROFA to be the best-in-class growth hormone product by releasing unmodified somatropin. By addressing the needs of the patients, caregivers, physicians, and payers, SKYTROFA achieved US market value leadership in 2023, just two years after launch. We estimate that SKYTROFA penetration in the US pediatric growth hormone deficiency patient population was around 16% at the end of 2023. With SKYTROFA expanding the US growth hormone market to the potential of $3 billion, we believe SKYTROFA has the potential to be a blockbuster on US revenue alone. Built on this value leadership, we expect our first label expansion to be towards adult growth hormone deficiency. For this, we plan to submit a supplementary BLA to the FDA in the second quarter of this year. In addition, we expect topline data from our Phase II trial in Turner syndrome in the fourth quarter of 2024. Now, turning to TransCon PTH. Last week, we initiated the launch of TransCon PTH in Europe direct and international markets, as you know YORVIPATH, with full commercial availability in Germany and Austria at an initial list price of €105,000 per patient per year. An estimated 70,000 adult patients in Germany are living with chronic hypoparathyroidism, and our initial launch will target 22,000 of those. YORVIPATH's Europe Direct launch is off to a great start with our first prescription and orders received on the first day of launch, demonstrating the severity of the disease and the unmet medical need. We are continuing to expand our EU Direct infrastructure and expect the availability of YORVIPATH across Europe by the end of 2025. In parallel, to meet the needs of the patient, we plan to provide commercially reimbursed product to early access routes such as main patient programs. The US PDUFA date for TransCon PTH is May 14th. If approved, we plan to launch YORVIPATH as quickly as possible thereafter through our established US commercial infrastructure. Moving now to TransCon CNP. Our clinical program is designed to support approval of TransCon CNP as a treatment for patients of all ages with achondroplasia. TransCon CNP dosed at 100 mg per kilo per week has demonstrated superiority compared to placebo in two 52-week trials. In the open-label extension, we observed unexpectedly strong patient retention of 97% for now up to four years. As a result of this unexpected finding, we continue to review our own data and scientific literature. We now believe that achondroplasia is both a growth disorder and a muscle disorder. As presented at the JPMorgan Conference in January, we showed significant improvement in health and quality of life for children with achondroplasia treated with TransCon CNP compared to placebo. With this growing insight, we have designed our pivotal ApproaCH to evaluate meaningful benefits related to all aspects of achondroplasia, including linear growth and improvements in comorbidity as measured by radiological endpoints, physical function, body composition, and quality of life. We expect to share topline data from this trial and we plan to submit an NDA in the fourth quarter of this year. In addition, we are pursuing additional treatment opportunities in achondroplasia, with an infant trial age zero to two years with the first patient already enrolled. We have a combination trial with SKYTROFA age two to 11, with a topline annualized growth velocity expected in the fourth quarter of 2024. We plan to file an IND for adults in the third quarter of this year. Switching now to oncology. Both TransCon IL-2 β/γ and TransCon TLR7/8 Agonist have shown favorable safety profiles and single-agent clinical activity. We expect 2024 to be an extremely important year for the oncology pipeline with data readouts in a well-defined patient population in the fourth quarter. Also in the fourth quarter, we expect to have completed enrollment of our randomized Phase II trial in neoadjuvant head and neck cancer. Longer term, to maximize the potential reach and value of these oncology product candidates, we aspire to commercialize our oncology assets through partnerships with companies with specialized oncology experience and capability in late-stage development and commercialization. Moving now to ophthalmology. We recently announced the formation and launch of an independent company, Eyconis, to develop and commercialize TransCon ophthalmology products globally. We have received an equity position in the newly formed company, and we are eligible to receive development, regulatory, and sales milestones, plus single-digit royalties. In January, we introduced Vision 2030, our strategic roadmap to achieve blockbuster status for each of our three endocrinology rare disease products and expand our engine for future innovation. With the broad applicability of the TransCon technology platform, our goal, as laid out in Vision 2030, is to apply our algorithm for product innovation to established opportunities in greater than $5 billion indications as we did with anti-VEGF and anti-PD-1 classes where we believe we have designed the best-in-class programs. We are pleased with the interest in our once-monthly GLP-1 program and from our platform technologies, we expect to continue to generate many more opportunities in the future. I will now turn the call over to Scott for the financial review before we open for questions.

Hi Jan. We continue making significant progress towards our financial 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 Form 20-F filed today. As we previously announced in early January, SKYTROFA revenue for the fourth quarter of 2023 was €64.2 million, compared to €47 million reported in the third quarter and €17.1 million reported in the same period last year. A 37% sequential growth in SKYTROFA revenue from Q3 to Q4 was again driven primarily by strong underlying demand in the US. Total revenue for the fourth quarter was €137.7 million, including the one-time $70 million Teijin upfront payment recognized as €63.7 million of license revenue. Turning to expenses, R&D costs in the quarter totaled €90.9 million, down 18% sequentially from the third quarter of 2023, primarily driven by lower endocrinology rare disease-related costs as trials and development completed and lower oncology-related costs. SG&A expenses were essentially flat at €64 million compared to the third quarter of 2023, reflecting commercialization synergies and expense controls. Total operating expenses were €155 million for the fourth quarter, down 12% sequentially from the third quarter. Overall, our operating loss for the fourth quarter declined sequentially by 73% to €37 million from €134 million in the third quarter of 2023. We ended the fourth quarter with cash, cash equivalents, and marketable securities totaling €399 million. Last month, we announced the formation and launch together with an investor syndicate of Eyconis to develop, manufacture, and commercialize TransCon ophthalmology assets globally. As a result, we expect minimal, if any, P&L burden from ophthalmology in 2024. As a reference point for Q4 2023, external ophthalmology project costs totaled €6.4 million. As previously announced for the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of €320 million to €340 million at average 2023 exchange rates. Total operating expenses, SG&A, and R&D together are expected to be approximately €600 million, and we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024. Let me now also provide a review of selected key program milestones. For TransCon Growth Hormone, we plan to submit an sBLA to the FDA for adult growth hormone deficiency in the second quarter of 2024, and we expect to report topline results from our Phase II Turner syndrome trial in the fourth quarter of 2024. For TransCon PTH, in the US, our PDUFA date is May 14, 2024. If approved, we plan to launch it as YORVIPATH as quickly as possible thereafter. Outside the US, we initiated the launch last month of TransCon PTH marketed as YORVIPATH, with full commercial availability in Germany and Austria. We plan to roll out YORVIPATH in our Europe Direct and international markets segments throughout 2024 and 2025. For TransCon CNP, our clinical program evaluating TransCon CNP as a treatment for achondroplasia advances with topline results from the pivotal ApproaCH trial and an expected NDA submission for the treatment of children with achondroplasia both in the fourth quarter of 2024. In addition, during the fourth quarter of 2024, we expect to report week 26 topline data from the COACH trial in combination with TransCon Growth Hormone and submit an IND or similar for adults with achondroplasia. Within our oncology therapeutic area, we plan to provide a clinical update from indication-specific dose expansion cohorts in the IL Believe and TRANSCEND IT trials during the fourth quarter. In addition, we expect to complete enrollment of our randomized Phase II trial in neoadjuvant head and neck cancer. With that, operator, we are now ready to take questions.

Hey guys. Good afternoon. Thanks for taking my questions. I realize it's early days, but what can you share with us about the German PTH launch so far? And the second one is, are you seeing any external interest in your TransCon GLP-1 program and can you remind us what the target profile you're looking to achieve is with that program? Thank you.

Thanks, Jess. Yes, as I've said before, this is one week into our launch. We know the unmet medical need is there for the patients. We know that we are really providing a treatment that is making a meaningful differentiation for the patient, both on short-term and really helping to eliminate the long-term risk of the disease. What we observed was that exactly as we had hoped for, the physicians made prescriptions on the very first day and received materials from our distributor already that same day. In the US, you need to go through a prescription and then reimbursement before you begin to get the drop; in Germany, it's different. Immediately, you get a prescription and basically have access to treatment right away. We look forward to providing a much better update when we come to Q1, even better after Q2, and much more detail again after Q3. We are very optimistic about the launch in Germany and Austria. This is just the starting point for us to reach patients globally, and we will reach them in other places. Related to how we're utilizing the licensing of the TransCon technology outside of rare disease endocrinology, we are really moving forward in oncology as we had hoped. We are looking forward to 2024, where we can provide proof of our differentiation regarding patient data. You saw our differentiation in ophthalmology, which has been our company's focus, and we feel we are really positioned for optimal value both to create value and to help the patient in this area. Regarding the third area we disclosed, we are working on, we have the GLP-1 class with a once-monthly profile. It's not only for obesity; it's also for metabolic diseases, and we feel that we are garnering significant interest that such a product really deserves. But it's not just a product; it's a platform that can be utilized for multiple indications.

Hi guys, good afternoon. Thanks for taking my questions. I wanted to get your updated thoughts about competition from recently approved growth hormone therapies, in particular, what is your market data that's telling you about Novo and how is that, if in any way, impacting your launch? And then, can you give us some data about what percent of adults currently take growth hormone replacement therapy? And on average, how long does that person stay on therapy? Thanks.

Thanks. It's a pleasure to discuss again the competitive landscape in the growth hormone market. When we launched, we had competition from short-acting therapies—various daily growth hormones that we were competing against. We showed how we were clinically differentiated from these established standards of treatment with better outcomes. We built the market largely due to medical exceptions driven by the strength of SKYTROFA. Now, we see two emerging therapies coming into the long-acting space; however, we don’t see them really impacting us because we are still best-in-class. In fact, we believe that these two products have not proven that they can show the same outcomes as a normal daily growth hormone treatment that you receive in the US. So, for us, the barrier for medical exceptions is improving. In my view, the adult market is vastly different from the pediatric market. The majority of pediatric patients typically undergo treatment for a limited number of years, while adults have chronic conditions where they typically require treatment for the rest of their lives. The penetration degree for pediatric growth hormone treatment is around 60% to 80%, while the adult potential is under 10%. This is a significant difference in how we model our potential to develop the adult growth hormone deficiency market. As you mentioned, this is our first label expansion, and we will establish access wherever possible for growth hormone therapy, as all patients deserve the best product.

Hey great. Thanks for taking our questions. Maybe just to follow up on TransCon PTH's launch in Germany. Understanding it's early days, but what could be a good framework for us to think about the ramp in the market? Any clarity that you can give us around experienced patients and how quickly you may be able to onboard them? And then in terms of the patients that are enrolled in the early access program in Germany, do you have any color there as well?

Thanks for the question. I can be optimistic in stating that all patients in Germany who have hypoparathyroidism should be on treatment. It's similar to the situation with Type 1 diabetes, where all of them should receive treatment. Likely not all of them will, but our dedication lies in helping patients through scientific clinical data and building up this market to ensure as many as possible will be treated with TransCon PTH or YORVIPATH. This applies not only in Germany and Austria but also in the rest of Europe and internationally, including the US. From what we anticipate this year, there are different elements that will influence how we see the market penetration. A key component is physicians witnessing the benefits firsthand, taking on treating typical patients—typically 2 to 5 patients—to see how product functions. The benefit of TransCon PTH will become evident after just a few weeks of treatment. Therefore, I believe when we reach Q2 and Q3, we will start to notice upward trends in market penetration, which you can track through our revenue development, primarily coming from where we have full reimbursement in Germany and Austria. You will observe how we penetrate the rest of the Europe Direct market by the end of 2024, 2025, and how we will expand significantly in the later part of 2024 and deeply penetrate in 2025 and 2026.

Thank you for taking my question. Given the emergence of GLP-1s and their effect on lean muscle mass, is there a potential role for growth hormone due to the success of the GLP-1s?

Excellent question that basically goes back to the mode of action and the benefit you see with GLP-1s. I was initially skeptical about the entire GLP-1 trend in obesity, but I can confidently say now that it's becoming a major class. We see its benefits manifest in many treatment aspects, not only weight loss. The downside is that with significant weight loss, you can lose a large amount of muscle mass, especially if one doesn't adhere to the treatment regimen. Consequently, you're in a situation where when not on the medication, you may find yourself gaining fat faster than muscle. I think this brings forth an interesting perspective regarding growth hormone treatment, as it is invaluable in building strong muscle mass in a very normalized manner. I believe you're onto something worth exploring.

Hi there. Thanks very much. I was wondering if you could talk about the work you did to arrive at your estimate that 70,000 adults have chronic hypoparathyroidism in Germany. Who are the 20,000 patients that you're targeting there? And how does the target population in the United States compare to the total hypopara population in the US where we have some guidelines? I'm wondering if that influences the proportion of the market that you think is most addressable here in the United States?

Thanks. You’ve covered several aspects in your questions. When we compare the demographics between Germany and the US, it essentially consists of two groups: the post-surgical individuals and those with more hematological or genetic idiopathic backgrounds, where we typically see a rise much earlier in the life cycle. Germany may have a unique count of patients due to the high volume of intensive head and neck operations leading to strong diagnostic focus. From this perspective, there may be potentially more patients in Germany than in the US or in other countries; for example, in France, the numbers would be much more aligned with treatment seen in the US. All patients would benefit from TransCon PTH treatment, or YORVIPATH, regardless of the subpopulations. Now, regarding the 22,000 patients we are initially addressing, we are focusing on those for whom treatment provides significant pharmacoeconomic benefits: individuals whose impairments significantly affect society and are at higher risk of hospitalization and substantial impairment due to cognitive effects that prevent them from leading a normal life. Our goal is to address the burden on society, which is notably higher for this group of 22,000 patients.

Hey good afternoon and thanks for taking the questions. Just two from us. I just wanted to clarify, is SKYTROFA a $1 billion product in the US just on pediatrics alone? Or does that assume contribution from adult EHG as well? And then just in terms of the cost structure of the Endo business, is this €600 million cost base now how we should be thinking about it for the future? And just your thoughts about the profitability of that business?

Thanks, I will take the first question, and then Scott is really happy today now because he actually has the opportunity to come to some of the financial numbers in a few minutes. When we assess the potential market, yes, you can see we will have adult growth hormone deficiency. We will pursue additional indications as well. But we also need to note that we are leveraging a well-known somatropin molecule for various indications where we see benefits with growth hormone. Observing the market of daily growth hormones and their dynamics, we realize that none of the daily growth hormone efforts have explored all the different indications thoroughly. This indicates a market opportunity. We believe the same will apply to the long-acting products that provide the same somatropin molecule. Scott, would you like to share some thoughts on expenses and numbers?

How much time do we have? Thanks, Derek. It's good to get a finance question. As you saw here in Q4, we are now realizing the benefits of the streamlined operational changes and processes that Jan has discussed, with OpEx going down to about €155 million in total. Next year, you will see additional reductions largely due to minimal P&L burden from ophthalmology. I think you should consider this as a function of the way we have developed our portfolio, which highlights how efficient it can be. If we analyze our costs for TransCon growth hormone, recognizing its maturity stage, the costs should diminish significantly in the coming years. Overall, we will be efficient in R&D, so I expect a shift from 60/40 R&D and SG&A in 2023 to around 50/50 in 2024. In the longer run, we will maintain that efficiency in R&D. As we expand globally, I expect some increase in SG&A as we add new team members across 30, 40, 50 countries, but it should remain quite minimal. Our SG&A was flat even as we launched an additional product and prepared for the launch of a second product in Germany.

To add to what Scott stated, the results we see reflect fundamental changes that began in 2023. Transitioning our company to a streamlined operation takes substantial effort. We initiated that process at the beginning of 2023 and identified how to build a leaner, more productive Ascendis focused on optimizing processes and administration. The success we achieved was significant, but it was certainly not straightforward. Now, we've reached our goals for efficiency, but we still continue to optimize processes as we scale from handling 5,000 to 50,000 processes. We cannot operate as a leading biopharma company in the same manner as a large biotech focused solely on clinical development and limited commercialization.

Thank you for taking my questions. Maybe switch topic or two TransCon CNP, you have talked about the improvement in muscle function and other companies. We feel like you talk about malproportionality, like upper to lower body ratio. I'm curious, have you also looked at proportionality as well? And also, when it comes to the combination with SKYTROFA, what would be the most differentiated clinical benefit compared to TransCon CNP alone? Thank you.

Thanks. Let me address your last question first. When you have a child born with achondroplasia who begins treatment as a newborn, we believe there is the potential for nearly normal growth during the early years of treatment associated with linear growth. However, you cannot entirely address the comorbidities since they persist into adulthood. This highlights the integrated aspects of treating achondroplasia; we must focus on linear growth while also addressing the hyperactive pathways that lead to disorders related to muscle weakness. When we designed our combination trial, we aim to ensure that patients who are untreated, especially those beginning treatment at a later age, can benefit from catch-up growth. We've observed that with growth hormone, children can experience additional growth of 7 to 8 cm due to sustained treatment, which is what we would hope to achieve with a strong adherence to the treatment regimen. If left untreated until later years, a child may not receive sufficient growth benefits. Our rationale for running this trial is thus grounded in the recognized potential for catch-up growth within the first few years of therapy. We expect to see favorable proportionality outcomes over a longer duration as we gather more data, and we have indeed noticed positive trends during the treatment course.

Hi, good afternoon and thanks for taking our questions. I also want to ask about TransCon CNP for your Phase III ApproaCH study. Can you share what metrics or details you'll provide with the topline results? What are your medical conference presentation plans for that data? And on the regulatory strategy, can you help us understand the urgency to file the NDA in the same quarter? Just kind of what the reasoning behind that is, potentially being concerned about a full approval for BioMarin's VOXZOGO? Some color would be helpful. Thank you very much.

The rationale for filing is simple: Ascendis aims to obtain the best quality data as rapidly as possible. We should always strive to file in the same quarter that the data is received. When it comes to the Phase III data, we will have a primary endpoint established as a traditional measure, but I do have my doubts about whether this is the most rational endpoint for evaluating achondroplasia. It feels more like a secondary marker based on annualized height velocity, while treatment should ideally confer broader benefits related to comorbidities. We are thus motivated to evaluate comorbidities across multiple objectives and will consider various measurement frameworks for health-related outcomes, including physical functioning, quality of life, and radiological parameters. What we want to present at medical meetings is not a delayed release; we are committed to sharing results promptly so the data can be accessible and visible to all.

Hey guys. Congrats on all the progress and thanks for taking our questions. Just a couple here from us. When considering CNP, could you give us some insights on your rationale behind expanding into adults with achondroplasia instead of moving into hypochondroplasia like the other companies in this space? Looking at VOXZOGO and its growth, primarily driven by its ex-US market, could you provide some perspectives on why it has faced a slower start in the US? Is this related to focusing more on height versus other quality of life measures? Lastly, concerning your oncology programs, if you cannot find a partner to bring these programs forward, would you consider spinning them off as you did with the ophthalmology programs?

Let me tackle the last point first. We are here to ensure the optimal outcomes for our patients and to make our products as accessible as possible. We have seen significant interest in our programs currently. Given the data we expect to be released by year's end, we feel confident we will create the most value for Ascendis shareholders by finding the best route for patient treatment. Regarding your questions surrounding CNP, there are valid points for consideration as we’ve debated the inclusion of hypochondroplasia. However, we will not shift focus there until we have successfully addressed the treatment landscape for achondroplasia. Our primary aim is treating the comorbidities effectively. This is not merely a situation of achieving linear growth—our goal is to deliver comprehensive treatment benefits, not limited to merely increasing height. I don't embrace the notion of short stature as a disease. In some contexts, it's not perceived as such, particularly in the US.

Hello everyone. This is [Indiscernible] filling in for Yaron. I appreciate the opportunity to ask a question. I’d like to hear your insights on the evolving competitive landscape for hypoparathyroidism. You are currently in the market, but there’s another PTH analog in Phase III, along with a few others developing oral or weekly treatment options. Any thoughts or comments on this would be appreciated. Thank you.

Thanks a lot. When I look at endocrinology from a biological perspective, understanding the complexity of treating the hormonal system in our bodies—including the multi-organ effects—is crucial. When considering hormone replacement therapy for conditions like hypoparathyroidism, achieving physiological levels of PTH is necessary. Any treatments altering that may not correlate with overall systems health. I presented at a conference recently with physicians who raised concerns regarding some competitive products. One major inquiry revolved around changing the physiological mode of action, questioning how those alternatives could mirror the natural biological responses our product provides. We designed TransCon PTH to replicate endogenous PTH levels with the proper mode of action in a physiological construct. Thus, I do not believe any treatment deviating from that will furnish the same holistic benefits.

Hey thanks for taking our questions. Two from us, one each on SKYTROFA and TransCon PTH. On SKYTROFA, Jan, you mentioned past commentary about declining investments among daily growth hormone companies and products. I wanted to hear any updated insights you might have about the marketplace regarding daily products if that trend is continuing. As for TransCon PTH, anticipating approval and the subsequent launch this third quarter, could you remind us of the number of patients you have available in the states between both those participating in the open-label studies and those in the EAP? Thank you.

You're correct. We have discussed the long-term outlook for consolidation in the growth hormone market. The trend is unfolding precisely as predicted. Specifically, with the entrance of the two other long-acting products, we are observing that daily growth hormones are increasingly becoming obsolete. These two companies are taking market share away from the daily products, but they cannot fully supplant us. Hence, our market share is remaining stable as projected over the past few years. The two new long-acting products will only cannibalize daily growth hormone sales, solidifying SKYTROFA's market penetration. As for TransCon PTH's specific question, I appreciate the query, but I cannot provide an exact number of patients currently available due to the continued high retention rate across both the Phase II and Phase III trials. However, I can approximate that it might be around 40 to 60 patients, but I cannot confirm the exact number. Scott can share those details afterward.

Thank you. And that's all the time we have for questions and Q&A today. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

Have a great day.