Earnings Call Transcript - ASND Q1 2025

Operator, Operator

Ladies and gentlemen, thank you for standing by and welcome to Ascendis Pharma First Quarter 2025 Earnings Conference 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 like now to turn the conference over to Scott Smith, Vice President and Chief Financial Officer. Please go ahead, sir.

Scott Smith, CFO

Thank you so much, Operator and thank you everyone for joining our first quarter 2025 financial results conference call. I’m Scott Smith, Chief Financial Officer at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Sherrie Glass, Chief Business Officer; Jay Wu, Executive Vice President, and President Ascendis U.S.; and Aimee Shu, Chief Medical 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., European, and other markets, as well as certain financial expectations, our pipeline visits, and our expectations with respect to their continued progress in potential commercialization, our strategic plans, partnerships and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings and our expectations regarding the timing and the results of regulatory decisions, expected market developments, and our exploration of market opportunities and therapeutic areas outside of endocrinology rare disease. These statements are based on the 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 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 statement 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 12, 2025. TransCon Growth Hormone or TransCon hGH, is approved in the U.S. by FDA and in the EU, has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission and the United Kingdom’s Medicine 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 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 2025 financial results and we’ll provide further business updates. Following some prepared remarks, we will then open up the call for questions. With that, let me turn it over to Jan.

Jan Mikkelsen, CEO

Thanks, Scott. Good afternoon, everyone. In the first quarter of 2025, Ascendis continued the strong start of our local YORVIPATH launch as well as key development and regulatory progress supporting our long-term growth strategy to be a leading biopharma company. The strong U.S. launch of our YORVIPATH positions 2025 to be an inflection point for Ascendis with a growing revenue base and a clear path to become cash flow positive. As of March 31, YORVIPATH was prescribed in the U.S. by more than 1,000 unique prescribers for more than 1,750 patients. This represents our first full quarter for the U.S. launch. YORVIPATH, the first and only FDA approved treatment for hypoparathyroidism in adults, is addressing the underlying cause of the disease by providing active PT8 within the physiological range for 24 hours per day. SKYTROFA, our long acting growth hormone, is firmly established as a high value brand and the preferred treatment for patients, physicians, and caregivers. SKYTROFA is well positioned as daily treatment continues to exceed the U.S. market and as SKYTROFA's label has the potential to expand beyond its single indication. SKYTROFA is a key pillar in our strategy to become a global leader in the treatment of growth disorders. TransCon CNP, the first long acting therapy in development for the treatment of achondroplasia, is set to become the second pillar in our growth disorder strategy. We believe that TransCon CNP has treatment benefits, in addition to linear growth, that addresses multiple aspects of the condition that are fundamentally important to patients. We submitted an NDA to the FDA in March and expect to file an MAA with EMEA in Q3 this year. Data from three randomized, double-blind, placebo-controlled clinical trials show that TransCon CNP has the potential to transform the lives of people with achondroplasia. In my remarks, I will discuss each of these products in detail and comment on other recent developments within our business. Beginning with YORVIPATH, first quarter total global YORVIPATH revenue grew to €45 million compared to €40 million in the fourth quarter of last year. Following commercial availability in the U.S. in December of last year, we are seeing strong U.S. demand, reflecting both the deep unmet medical need in the market as well as the patient population. As of March 31, more than 1,750 patients, including the 200 patients from our ERP and clinical program, have been prescribed YORVIPATH in the U.S. by over 1,000 unique healthcare providers. Enrollment of patients new to YORVIPATH continued at a similar weekly rate in April. The majority of patients who have received insurance approval for their YORVIPATH prescription received that approval in four to eight weeks and we are pleased with the approval rate we have seen. We are beginning to see favorable care plans put into place and continue to see approvals across both commercial and government segments. The strong launch performance of YORVIPATH in the U.S. supports our view of its excellent product profile and the significant unmet medical need in the market, and we expect YORVIPATH to contribute significantly to our revenue in 2025. Outside of the U.S., we see steady YORVIPATH revenue growth in both the Europe Direct and international markets, and we expect additional acceleration of the revenue growth when YORVIPATH reimbursement becomes available in additional Europe Direct countries in the second half of the year. The continued rapid uptake, together with high rates of patient adherence, gives us confidence that YORVIPATH is well positioned to uniquely address the unmet medical need of this patient population, and we are regularly reviewing input and data from patients to evaluate if there are additional ways to improve the treatment profile even more. We estimate there are over 400,000 patients globally and around 70,000 to 90,000 patients in the U.S. alone living with chronic hypoparathyroidism. Our claims analysis demonstrates that 10,000 to 15,000 of these U.S. patients are uncontrolled and 30,000 to 35,000 are partly controlled. Based on the latest clinical practice guideline, nearly all these patients are candidates for treatment with YORVIPATH. Our strong global launch gives us high conviction that we can continue to build and lead this market, and YORVIPATH can be a durable multibillion euro drug device product with a patent lifespan extending into the 2040s. Turning to SKYTROFA. Q1 revenues for SKYTROFA were €51 million. With continued patient growth and global expansion offset by the typical first quarter revenue dynamic in the U.S., we have around 7% market share of the total growth hormone market in the U.S. and around 43% of the total U.S. long acting growth hormone market based on third party prescription data. The pediatric growth deficiency indication represents about half of the total growth hormone market. With our premium pricing and SKYTROFA’s leading position in pediatric growth hormone deficiency, we believe we are well positioned to expand the opportunity for SKYTROFA in multiple ways. A key near-term milestone is our first potential label expansion in the established growth hormone indications from our supplement BLA for the potential U.S. approval in adult growth hormone deficiency where we have a PDUFA goal date of July 27, 2025. We are also on track to start a basket trial for SKYTROFA in a range of indications including idiopathic short stature, shock deficiencies, Turner syndrome and SDA. We are planning to discuss this trial with the FDA in an end of Phase 2 meeting this quarter. Importantly, we are also investigating TransCon Growth Hormone outside the established growth hormone indication such as in a potential combination therapy with TransCon CNP for treatment of achondroplasia and other growth disorders, which I will address in a moment. Moving to TransCon CNP. TransCon CNP is the third key product in our endocrinology rare disease product portfolio. The genetic variant that causes achondroplasia changes the way receptors work in multiple tissues throughout the body, not just in the growth plate and in bones, resulting in a wide range of serious medical complications in childhood and lasting throughout adulthood. Because TransCon CNP provides sustained therapeutic levels of CNP throughout the body, it has a uniquely differentiated product profile given its potential to bring growth benefit and important new benefits beyond linear growth as well as reduce the risk of hypertension and injection site reactions. In our pivotal ApproaCH Trial, TransCon CNP demonstrated significant improvement in the primary impact of linear growth compared to placebo, as well as significant improvement in other clinical endpoints meaningful to the achondroplasia community including leg bowing, muscle functionality, body proportionality, and health-related quality of life. Leg bowing is a common complication in achondroplasia that can result in chronic pain and impaired physical function, driving many patients to undergo complex painful corrective surgeries. I have been in meetings with patient organizations in Europe and the U.S. who have confirmed the importance of addressing the complications of achondroplasia beyond linear growth. Just as important to the achondroplasia community, TransCon CNP has shown a safety and durability profile compared to placebo with a low frequency of injection site reactions, all of which were mild and showed no evidence of symptomatic hypertension. After positive interactions with the FDA relating to the content of our NDA submission, we are pleased to have submitted TransCon CNP for their review in March. In the EU, we plan to submit an MAA during the third quarter of this year. Additionally, during the fourth quarter of 2025, we plan to submit an IND or similar to investigate TransCon CNP in combination with TransCon Growth Hormone for the treatment of hypoparathyroidism. Shifting to TransCon CNP and TransCon Growth Hormone combination therapy, we are committed to continue to drive even better outcomes for people living with achondroplasia. This is why we are conducting the COACH Trial, being the first Phase 2 study combining CNP and growth hormone in achondroplasia, each of which stimulates different signaling pathways in the growth plates and other tissues in the body. We look forward to sharing Top Line Week 26 results from the COACH Trial data this quarter and see great potential to further raise the bar for clinical outcomes. With TransCon CNP as the potential future backbone therapy, we believe we can achieve even greater growth while also addressing the medical complications of achondroplasia. Fundamental to the development of each of our three medicines, YORVIPATH, SKYTROFA, and TransCon CNP, is Ascendis' proprietary TransCon technology platform. With the TransCon technology and our deep understanding of disease biology, it is possible to create medicines with highly differentiated treatment benefits not possible with other technologies. At Ascendis, our commitment has always been to the patient. It is one of the company's core values. I believe we have demonstrated multiple times over the history of Ascendis our resilience and our ability to adapt and find solutions to attain this goal. We remain as dedicated as ever to ensure that all our medicines become available to patients. Through our collaboration with Novo Nordisk for the development and commercialization of TransCon technology-based products in metabolic and cardiovascular disease and our collaboration partner Visen, Iconis, and others, we continue to work to execute our Vision 2030 to create value in vast therapeutic areas and through innovative business models. In summary, 2025 is a transformative year for Ascendis as we grow our global revenues from YORVIPATH and SKYTROFA and seek to obtain key regulatory approvals, deliver robust clinical data, and advance drugs with blockbuster potential to drive growth for many years to come. I will now turn it to Scott.

Scott Smith, CFO

Thank you so much Jan. I will touch on some key points surrounding our first quarter financial results, but for further details please refer to our 6K filed today. YORVIPATH first quarter revenue increased significantly to €44.7 million, up from €13.6 million in the fourth quarter of 2024. Steady sequential revenue growth outside the U.S. was augmented by the strong U.S. launch. As Jan discussed, the trends we saw for YORVIPATH in Q1 continue in Q2 both outside and inside the U.S., and we anticipate that YORVIPATH will have a substantial impact on our financial profile in 2025. Turning to SKYTROFA, revenue for this quarter was €51.3 million. Sequentially, pricing and market share remained stable, but revenue in the U.S. was negatively impacted by seasonal items including a reduction in channel inventory and higher copay assistance. Those seasonal headwinds should reverse beginning in Q2. We also continue to watch the Euro-dollar exchange rate for any potential impact related to reported revenue. Total revenue for the first quarter was €101 million, which includes non-product revenue from our collaboration partners. Turning to expenses for the first quarter, R&D costs totaled €86.6 million compared to €70.7 million during the first quarter of 2024. The first quarter of 2024 included a favorable €10.6 million reversal of prior period write downs of TransCon PTH prelaunch inventories. SG&A expenses in the first quarter of 2025 totaled €101 million compared to €66.8 million during the first quarter of 2024. The €34 million increase was primarily driven by global commercial expansion. Total operating expenses were €188 million for the first quarter of 2025. As a result of the Visen IPO, we recognized a non-cash gain of €33.6 million as part of share of profit loss of associates, and we retained 39% ownership of Visen. Net finance expenses for the first quarter of 2025 were €15.9 million driven primarily by non-cash items. Net cash financial income for the first quarter of 2025 was €3.3 million. We ended the first quarter of 2025 with cash and cash equivalents totaling €518 million, compared to €560 million as of December 31, 2024. Turning to the remainder of 2025, we expect substantial revenue growth driven by the global launch of YORVIPATH with a continued solid contribution from SKYTROFA. We are not providing revenue guidance for SKYTROFA or YORVIPATH at this time. For SKYTROFA, we believe that growth in prescriptions, visible in third-party data, will track sequential revenue growth for 2025 with expected stability in mix and pricing, including normal seasonality. For YORVIPATH, outside the U.S. we continue steady revenue growth while inside the U.S. our launch is progressing exceptionally well. We will continue to look to help investors understand uptake in reimbursement dynamics as the year progresses. With that operator, we are now ready to take questions.

Operator, Operator

Thank you. And our first question today will come from Jessica Fye with JPMorgan. Your line is open.

Jessica Fye, Analyst

Hey guys, good afternoon. Congrats on the strong results with YORVIPATH. It seems like the numbers reflect very good execution on reimbursement. Can you talk about your latest expectation for the proportion of patients with a prescription who you think will ultimately get reimbursed once YORVIPATH is at steady-state? And then the follow-up would just be, was there any initial channel fill reflected in the first quarter revenue number and if so, can you quantify that? Thank you.

Jan Mikkelsen, CEO

Thanks Jess for the questions and Scott will take the easy one, the last one.

Scott Smith, CFO

Yes, Jess. So channel inventory has averaged about one to two weeks at any one time. We ship once a week, so it’s hard to get less than one week of channel.

Jan Mikkelsen, CEO

The second one, Jess, why it's a little bit more complicated because there's some way looking in the future. What we can see, is we see a positive trend. We see the adoption of the different PPMs, the different payer forms. And if I’m somewhere to come with my own guess about it, and this is more a guess because we don't know exactly, there will never be 100% approval of all the patients. And I believe if we really are successful, and I hope we will be successful, I believe 17% to 18% will get reimbursed. But I think Jay, if you have another comment to it this way.

Jay Wu, Executive Vice President

Yes, happy to chime in on that. I think as Jan mentioned, we are still early in the launch, right? So from that perspective, we're still seeing policies being set into place. So it is a bit early to be able to anticipate what that steady-state will be. I do think a few examples that give us a lot of confidence that we are headed in the right direction are a couple. One, you're seeing favorable policies being put into place both from a commercial standpoint as well as government. So we're seeing that start to take hold. And then two, even absent of a formal policy in place, we do see patients getting approved across the board, again agnostic of whether it is a commercial plan or government plan, it just sometimes may take a few more steps. Whether it is through medical exception and in some rare cases even through appeal and or peer to peer. But largely we are seeing many patients get through. You will expect a long tail just given that every payer plan is different given the heterogeneity of it in the U.S., but overall we have a lot to be encouraged about and I think more importantly it just really emphasizes the clinical value proposition of these products and the fact that payers, providers, and patients are all responding to it.

Jan Mikkelsen, CEO

I think, but Jess, I think some way when I talk about my feeling, my feeling is that I believe every patient that somehow has a desire to go on treatment should come on treatment because I have seen, I have heard many patients talk about the benefits they receive from treatment. But I also accept reality in this way here. But I also believe we are in a unique position. We are addressing a major unmet medical need. We have really a product that is genuinely providing benefit to the patient. We are in a position that patients are diagnosed with the disease. At the same time, there are clear guidelines that state treatment should be provided. Can you find a better case for any patient than to receive the ultimate goal? If you want to be on treatment, you should be on treatment.

Operator, Operator

And our next question comes from Tazeen Ahmad with Bank of America Securities. Your line is open.

Tazeen Ahmad, Analyst

Hi, good afternoon. Thanks for taking my question. Jan, can you give us a little bit of color on the split between U.S. and ex-U.S. revenue for the quarter for YORVIPATH? And can you give us a sense because it seems like you do have some patients receiving the drug in the U.S., what the length of time is? I know it's early, but what is the length of time that you’re seeing between when a prescription is written to when the patient is receiving therapy? Thanks.

Jan Mikkelsen, CEO

Yes. Let me first address the question, the split between Europe and U.S. and as you have seen, Tazeen, we are not really describing that in our numbers, but also believe that we provide good guidance on how to potentially calculate it. As we said, when we look at ex-U.S., we see steady growth, a steady acceleration. What we first expect in the second half of this year to see an acceleration of the growth when we get more countries fully reimbursed. So when I look at the difference between Q3 and Q4 last year, there’s an increase around €4 million to €5 million from one quarter to the next quarter. So when you think about that, we increased our base revenue from about €40 million to €45 million, then you can take the difference and subtract about €4 million to €5 million, and then I think you get a number around €26 million reflecting the algorithm I would use if I should look at it.

Operator, Operator

And our next question will come from Gavin Clark Gartner with Evercore. Your line is open.

Gavin Clark Gartner, Analyst

Hey guys, congrats on the very strong launch progress. First, just to follow up on the payer point and the favorable access, have you finished negotiations with the majority of commercial payers at this point? And do you expect the remaining published policies to look similar to the ones that are already published? And has the rebating fallen in line with your expectations with those conversations?

Jan Mikkelsen, CEO

Yes, it’s a question I will take from a global perspective. As you heard about ex-U.S., we are basically fully reimbursed now in Germany. There is a final list price you can find. We also have that for Austria. In France, we have an AP2 program. We also have a different program in Greece. So ex-U.S., we are working on really getting all country-by-country fully reimbursed. It takes time. It’s something that will happen here in 2025 but also in 2026. When we come into the end of 2026 we believe we will have the vast majority of the important countries being fully reimbursed. If you come to the U.S., which has a strong focus on, don't forget there are more than 300,000 patients outside the U.S. I think Jay can give you more color about his discussions with the different plans in the U.S.

Jay Wu, Executive Vice President

Thanks Jan and thanks Gavin for the question. Yes, to answer your question the conversations with payers have been going very well. We have multiple commercial policies in place with our national accounts. So while we don't comment on policy by policy, that gives you a sense that we are gaining a lot of good traction there and the policies that are put in place are favorable and consistent with label. While we don't comment on the gross-to-net arrangements that we have with each, what I will say is that it is commensurate with what we said before. This is a first and only approved product in a rare disease setting with clinical value benefit that we strongly believe in, and we feel we've been able to convey with payers. And from that lens, it is commensurate with the incredible clinical value proposition that we bring. We certainly lead with that and expect it to reflect that.

Gavin Clark Gartner, Analyst

Okay, great. And then quick follow-up for the new prescriptions that are coming in. What proportion are NATPARA or PTH naïve versus experienced? Thank you.

Jan Mikkelsen, CEO

I don't think we really have the full insight exactly how many patients are coming from NATPARA. Sherrie, you can potentially correct me if we have more insight on that. There was a question we discussed last week. We know that the vast majority of patients coming from conventional therapy, but perhaps, Sherrie, you can discuss how many NATPARA patients we believe have transferred over?

Sherrie Glass, Chief Business Officer

Yes, thanks for the question, Gavin. And yes, Jan's right. The data is not entirely definitive on this point, but we know that the vast majority of our patients overall are coming from conventional therapy. So that’s very clear. And we do have something like 10% to 15% of patients that have been on some sort of PTH in the past and then a subset of those were more recently on NATPARA. The bottom line is overwhelmingly they are coming from conventional therapy.

Jan Mikkelsen, CEO

Yes. From that perspective, we believe that in Q2 and Q3, we will see the majority of the remaining NATPARA patients coming over, because Aimee, you're sitting with the patients, you can explain that there is a letter coming out explaining that the physician, that they're stopping.

Aimee Shu, Chief Medical Officer

There's still, as far as we know, there's still some supply. So they still may be on it, but we know it will exhaust soon.

Jan Mikkelsen, CEO

Yes. So basically, when we look at the patients that are coming over the 1,750, this is not NATPARA patients. This is basically patients coming from conventional therapy. The 35,000 patients we are addressing now. So there is a lot of room to grow in this way.

Derek Archila, Analyst

Yes, congrats on the quarter and thanks for taking the questions. So maybe just first on, can you comment on the depth of prescribing and the number of doctors that are really prescribing, maybe two, three, four patients with YORVIPATH? And then just to follow-up to the last set of questions, just, are you seeing patients that are newly diagnosed or well controlled on conventional therapies move over to YORVIPATH? Thanks.

Jan Mikkelsen, CEO

Yes, if I just could answer all your questions, I will be an unhappy person. I'm still a happy person. But when I, in some way, share you can also add in. We cannot really know if they are well controlled, partly controlled, or not controlled. That is not really anything we can see. We don't believe that it's really part of the reimbursement assessment. I actually think why we call them uncontrolled, we likely will see more of them because we had an algorithm that basically is saying that 10,000 to 15,000 of the patients we define as uncontrolled is because we are seeing and endocrinology in a very, very high frequency. And this is why we know that we just went to this physician that will automatically have all these patients coming in. So, my expectation is that I believe we have a high percent of uncontrolled, partly controlled, but it's mainly only built on the algorithm because we are seeing the endocrinologists much more often than the others. So Sherrie, do you have anything to add?

Sherrie Glass, Chief Business Officer

I think you covered it well. Again, I would maybe just say, one of the things we’re really excited about is, we know there are quite a healthy number of those uncontrolled and partially controlled patients. So something like 10,000 to 15,000 uncontrolled and another 30,000 or so partially controlled. And as Jan said, the uncontrolled patients are seeing their endocrinologists four times or more a year. So we know to Jan’s point that they're getting in and therefore that we expect to see a steady flow of patients coming in and having the option to get on the drug over the course of the year.

Jan Mikkelsen, CEO

Yes. And one of the reasons why we don't know it is because it's not part of being reimbursed or not. So if we’re part of the reimbursement system to have this uncontrolled, partly controlled, or controlled, we would know much more about it, but it’s not a decision in the reimbursement system.

Operator, Operator

And the next question comes from Yaron Werber with TD Cowen. Your line is open.

Yaron Werber, Analyst

Thank you and congrats on the very strong quarter. I was wondering if you have a sense of how many of your target endocrinologists in the U.S. have adequate resources at their centers in order to be able to go back and forth with payers who might not approve reimbursement of YORVIPATH right away. Just given there's so many patients in the U.S. and a finite number of physician offices who treat them, could their ability to navigate this process represent a cap on YORVIPATH revenue growth at some point?

Jan Mikkelsen, CEO

Joe, it's something that Jay and the commercial organization have really a lot of thoughtful thinking about it. How can we ensure the journey for the patient, the physician, and the office that’s dealing with it is really going to be the smoothest journey we can envision. I think we have so much experience in this area mainly from our SKYTROFA product where we took a big portion of 10,000 patients to medical exceptions. And I think there was learning we gained, which built a system we are currently working on. And I think this is why we are potentially one of the best equipped companies really to deal with medical exceptions from all the elements we’ve learned from SKYTROFA. Jay, you can add more than that.

Jay Wu, Executive Vice President

Yes. Just to add on and to reinforce what Jan said, our hub is a well-oiled machine at this point, right. Incredibly experienced, as we all know, the growth hormone deficiency space is a heavily managed space. So not only is our hub infrastructure equipped both from a volume and speed perspective, we also have a strong field reimbursement manager footprint that is constantly supporting these offices along the way as well. We feel good about our ability to resource and support our customer needs as required. To your question directly, of course, there's going to be some offices, particularly those where perhaps it's low volume, they may see fewer cases. But again, going back to what Jan was sharing earlier, we're well equipped and have the capabilities to ensure that we are allowing that to not be the bottleneck as to why patients will get on therapy.

Joseph Schwartz, Analyst

Thank you for taking my question. First of all, if you look at the NATPARA patients that were left from this withdrawal, how long do you think it takes until that whole population gets worked through? And then further looking back at NATPARA and looking what you've seen during your first quarter of launch, how would you, aside from the fact that the data is just superior, how would you characterize the difference in what patients are showing interest in this therapy?

Jan Mikkelsen, CEO

First of all, you cannot compare the clinical benefit between NATPARA and YORVIPATH. NATPARA had a labeling as an adjunct therapy. Take a little bit of your daily calcium supplement away, take a little bit of your active vitamin away, and then you take NATPARA. You have no positive impact on kidney function. You have no positive quantitative manner on quality of life. I see this as two different products and we can never compare these two together. First question related to when the NATPARA patients will switch. We addressed it a little bit in the beginning here, where we know that there was a letter from Takeda indicating that they’re getting their last shipment now. So, as to our knowledge, the shipment is three months. So we expect that the last series of NATPARA patients will convert over either at the end of Q2 or into Q3. That is our expectations.

Leland Gershell, Analyst

Thanks. Great to see the strong execution on YORVIPATH. A couple of questions from us. Just apologies if this has been asked before, but with respect to potential benefits on renal, I know Jan, you had said that you don’t see that as a key driver for YORVIPATH uptake, but nonetheless, are you able to comment in the early days of the U.S. launch, are you seeing a more difficult or easier time gaining reimbursement or access to the drug for those patients who may have less or more renal impairment along with whatever needs they have in terms of conventional therapy? And that is my second question. Thank you.

Jan Mikkelsen, CEO

It's not a part of the reimbursement process. We don't see that it's the element that decides offers reimbursement or not. So when you look at the labeling, most plans have adapted the way we have in our labeling and it’s not defined in any way or that that is a condition for reimbursement. Aimee, we didn't study the severe renal impairment patients. And that is not part of our labeling. And I think it’s Stage 4.

Aimee Shu, Chief Medical Officer

That's right. CFR lower than 15 or 30...

Jan Mikkelsen, CEO

Which is a very, very low number, which are Stage 4 where we never started the drop.

Leland Gershell, Analyst

Got it. Okay, that’s helpful. And then just looking forward to the COACH data. Is there sort of a bar that you have in mind for linear growth, or is this something that you could see being driven forward principally on secondary benefits, say body composition or others? How are you thinking about the mix of efficacy with your combination? Thank you.

Jan Mikkelsen, CEO

When we think about achondroplasia, the key element for us to address complications, but we cannot avoid also to address linear growth. So when we measure linear growth, which got established from another company that is established as the primary endpoint, I would personally have selected another endpoint if I could ever select that. But we will because we are forced to do it because it's the established clinical endpoint, is that we will look on linear growth and they will be part of the data we basically will report when we come up with the analyzed high velocity height, as there is other things regarding that. And as I said before, I have great expectations. I have a strong belief that we can reset the bar for what you see in achondroplasia treatment and it's not only related to linear growth, but also the associated complications.

Operator, Operator

This is all the time that we do have for questions. This concludes today's conference call and thank you for participating and you may now disconnect.