Ascendis Pharma A/S

NASDAQ:ASND

Earnings Call Transcript 2022-Q4

[Operator]

Good day, and thank you for standing by. Welcome to the Ascendis Pharma Full Year 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session [Operator Instructions]. Please be advised that, today's conference is being recorded.

I would now like to turn the call over to now your speaker for today, Tim Lee, Senior Director of Investor Relations. Please go ahead, the floor is yours.

[Tim Lee, Senior Director of Investor Relations]

Thank you, operator, and thank you everyone for joining our full year 2022 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today is Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Dr. Stina Singel, Executive Vice President, Head of Clinical Development Oncology; and Joe Kelly, Senior Vice President, Head of U.S. Commercial Endocrinology. 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, our US commercialization and continued development of SKYTROFA for the US market, the commercialization of TransCon hGH for the EU market, statements regarding the expected timing of approval and launch of TransCon PTH in the US market next year, statements regarding expected timing of approval of TransCon PTH in Europe, statements regarding the potential the market size of TransCon PTH, our progress and our pipeline candidates and our expectations with respect to their continued progress, statements regarding our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, statements regarding our pipeline product candidates, statements regarding planned regulatory filings, our expansion into new therapeutic areas and statements regarding the ability to create a sustainable leading global biopharma company.

These statements are based on information that is available to us today. Actual results and events could differ materially from those in the forward-looking statements. And we may not be able to achieve our goals, carry out our plans, our intentions, our expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these statements. Our forward-looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, dispositions, joint ventures or investments that we may enter into or terminate. 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 factor sections of our most annual report on form 20-F, which is being filed today, February 16, 2023.

TransCon Human Growth Hormone or TransCon hGH is approved by the FDA in the US under the brand name SKYTROFA for the treatment of pediatric patients one year older weighing at least 11.5 kilograms and have growth failure due to inadequate secretion of endogenous growth hormone. In addition, the European Commission has granted a marketing authorization for SKYTROFA to Ascendis Pharma developed under the name TransCon hGH is a onceweekly subcutaneous injection for the treatment of children and adolescents aged three to 18 years with growth failure due to insufficient secretion of endogenous growth hormone. In general, we refer to this product as TransCon growth hormone, and unless we are referring to the product in

the context of a particular jurisdictions such as the United States or the European Union. Otherwise, please note that our product candidates are investigational and are not approved commercial use. As investigational products, the safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency. None of the statements made on the conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our full year 2022 financial results and we'll provide further business updates. Following some prepared remarks, we will then open up the call for questions. I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer. Jan?

[Jan Mikkelsen, President and Chief Executive Officer]

Thank you so much. Ascendis is built on the unique TransCon technology platform, which enables development of highly differentiated product candidates across multiple therapeutic areas. Combining the TransCon technology with our [indiscernible] product innovation has enabled us to create and develop product candidates with a higher likelihood of success than seen with conventional drug development. One of our key product selection criteria is to fulfill best-in-class potential on each of the four key pillars of drug development. Safety, efficacy, tolerability and convenience. In addition, each product candidate must have the potential to achieve $1 billion or greater revenue in a single therapeutic indication. With this approach and [terming] by our values of patients, science and passion, we have demonstrated our ability to continuously build out a robust pipeline, while taking product candidates from concept through approval and launch. With expected regulatory approvals of a new product or additional indication every one to two years, we are fulfilling our Vision 3x3 goal of building a sustainable, profitable, leading biopharma company and creating long term value for all stakeholders. This past year, we have advanced our pipelines as planned entering 2023 with an April 30th PDUFA date and expected US launch of TransCon PTH for adult patient with hyperparathyroidism by the end of Q2, along with an expected European Commission decision during Q4 as well. TransCon PTH is our second endocrinology rare disease product opportunity, representing a potential global opportunity greater than $5 billion.

Turning to TransCon CNP. Last November, we reported 12 months data from our first -- from the first ever randomized, double blind, placebo controlled Phase 2 trial in children diagnosed with achondroplasia. These results give me confidence that this third endocrinology rare disease product candidate may have its first approval by 2025 as target in our Vision 3x3. Another covenant of Vision 3x3 its label and geographic expansion. We continue to build the value of our existing programs through additional clinical studies for label expansion and global commercial reads. Starting with our newly expanded European organization, which is preparing for launch of SKYTROFA in Germany this year and if approved TransCon PTH next year. With this great momentum across our pipeline, I would like to review additional details from our major programs.

Turning to growth hormone. During the fourth quarter of this year, we plan to report the top line results from our global Phase 3 foresiGHt trial in adult growth hormone deficiency, our potential second indication for TransCon growth hormone. Adult growth hormone deficiency is a serious endocrine rare disease characteristic by abnormal body composition, dyslipidemia, insulin resistance and impaired quality of life. Analysis has shown dis consequence of adult growth hormone deficiency result in mean analyzed healthcare cost more than 4 times that of a non-growth hormone deficient population. Because TransCon growth hormone is the only once weekly growth hormone product releasing unmodified somatropin, we expect it to be the first adult growth hormone treatment to meet or exceed the safety, efficacy and tolerability of daily growth hormone. Meanwhile, in the US, SKYTROFA is experienced the commercial success it deserved, because of its unique product strengths. As we pre-announced during JPMorgan, fourth quarter 2022 US SKYTROFA revenue growth to €17.1 million, providing a strong fundament for growth in 2023 and after. With our progress towards label expansion and planned commercial launch in markets outside the US, we believe we can track -- be on track to build SKYTROFA into the leading growth hormone product in value by increasing the total market site. As we have predicted, we are seeing the consolidation of the daily growth hormone market as other manufacturers begin to exit the US market.

Turning to TransCon PTH. Excitement continues to build among stakeholders around this potential treatment for adult patient with hypopara ahead of the upcoming PDUFA date of April 13th. Our expanded teams are hired, trained and working to deepen physician and payor awareness of this serious health and quality of life issue that hypopara causes. We have already made more than 2,000 call to physician related to disease awareness and we are encouraged by their interest in learning more about the multi-organ impact of this disease and its negative effect on patients quality of life. Our commercial team, medical affairs, premium reimbursement and our manufacturing teams are ready to launch TransCon PTH in the US market as soon as possible after approval. Importantly, we are launching TransCon PTH, our second endocrinology rare disease product with the same commercial infrastructure that has proven its success with SKYTROFA. Coming back to CMP. As we did with TransCon Growth Hormone and TransCon PTH, we ran a robust Phase 2 trial to confirm TransCon CNP’s target profile or all four key pillars, safety, efficacy, tolerability and convenience, and derisk it as the Phase 2 level. This can only be done with a robust randomized placebo controlled trial that does mimic the pivotal trial. We saw clear success in ACcomplisH trial with TransCon CNP, demonstrating superiority over placebo at the 12 months primary endpoint in children aged two to 10. In addition, we saw clear dose response. All 57 patients who started this trial remain in the open label extension today.

To extend and confirm these results, including positive treatment effect observed on achondroplasia related comorbidities, we are running our Phase 2b ApproaCH trial. As investigator I’m aware of the Phase 2 results where I experienced very high interest in our ApproaCH trial, and we expect to complete target enrollment of around 80 patients in the next quarter. During our upcoming end of Phase 2 meeting with FDA, we expect to collaborate on how to best achieve a broad treatment labeling rather than a linear labeling alone.

Shifting to oncology. We are progressing with the development of our two novel immuno oncology programs, TransCon TLR7/8 agonist and TransCon IL-2 β/γ. With these two clinical programs, we are positioned this year to start iteration of clinical efficacy in seven specific tumor types, nine different indications with four different combination therapies, including by combining our two TransCon oncology product candidates with each other. Clinical proof of concept Phase 2 top line results are expected starting in 2024. In addition, this year we would initiate the randomized Phase 2 trial βelieγe 201 using TransCon IL-2 β/γ and TLR7 agonist combination therapy in head and neck cancer. As we successfully demonstrated with our endocrinology programs, we are building a solid Phase 2 clinical proof of concept for our oncology products in multiple tumor types in the next one or two years. As you can see, we have and will always focus on [receiving] best-in-class product profile to benefit patients on the four key pillars of safety, efficacy, tolerability and convenience, areas in which we will not compromise. This development approach, including extremely robust clinical trial design, has positioned Ascendis to potentially launch a new product or indication every one to two years, building sustainability, long term value for all stakeholders. This successful clinical trial further confirms the power of the [indiscernible] technology platform and our product innovation [indiscernible] and increase our confidence and likelihood of successful future product candidates. To build on expanded pipeline and commercial successes, Ascendis remains on track to meet or exceed our goals outlined in our Vision 3x3.

I will now turn the call over to Scott for a financial review before we open up for questions.

[Scott Smith]

To follow on Jan’s comments, we are excited to see the realization of Vision 3x3 with a continued flow of new products and additional indications every one to two years. For example, as Jan noted, we expect to launch TransCon PTH in the US and SKYTROFA in Germany this year, followed by the first European country launch of TransCon PTH in early 2024. With results for SKYTROFA in adult growth hormone deficiency and TransCon CNP in achondroplasia on the horizon, we expect this cadence of approvals and launches to continue beyond 2024. In this way, we are creating sustainable long term value for Ascendis and our stakeholders through our proven R&D development capabilities. I will quickly touch on a few points. For further details on our full year 2022 financial results, please refer to our Form 20-F, which is being filed today. As we previously announced in early January, SKYTROFA US revenue for the fourth quarter of 2022 grew to €17.1 million. These results exceeded the algorithme that Jan laid out last May, which projected €16 million.

For the full year 2022, total revenue was €51.2 million, including SKYTROFA revenue of €35.7 million as well as licensed clinical supply and services provided to third parties primarily VISEN Pharmaceuticals. With profitable growth of SKYTROFA, our overall operating loss grew about 2% sequentially to €147.4 million for the fourth quarter from €144.5 million in the third quarter of 2022. Finally, we ended 2022 with cash, cash equivalents and marketable securities totaling €743 million. Looking forward, as Jan described at the JPMorgan conference, annualizing fourth quarter SKYTROFA revenue of €17.1 million provides a foundation for 2023. In addition, we expect to add at least as many reimbursed patients this year as we did in 2022, which would provide even greater growth. As a result, at this time, we believe we are on track to exceed the current Ascendis compiled consensus estimate for 2023 SKYTROFA revenue of €96 million.

Switching to TransCon PTH. Our PDUFA date is April 30th this year. If approved, we expect to begin shipping product by the end of the second quarter. A quick reminder on selected key 2023 corporate milestones. For TransCon Growth Hormone, as mentioned, we plan to launch SKYTROFA in Europe, starting with Germany in Q3. And we also expect to report top line data from the global Phase 3 foresiGHt trial in adult growth hormone deficiency, our second indication in Q4. TransCon PTH, we are planning for FDA approval by the PDUFA date of April 30 and launch in the US by the end of Q2, and we expect the European commission decision in Q4. For TransCon CNP, we are on track to complete enrollment of the Phase 2b ApproaCH trial in achondroplasia in Q2. Within our oncology therapeutic area, we expect to report top line results and declare the recommended Phase 2 dose for monotherapy dose escalation cohorts for TransCon IL- 2 β/γ later this quarter, and to declare the recommended Phase 2 dose from TransCon IL- 2 β/γ combo therapy with checkpoint inhibitor in Q3. Finally, as you see with our reporting to date, continued optimization of finance systems and processes have enabled us to accelerate our year end reporting.

With that, operator, we are now ready to take questions.

[Operator]

Thank you. Our first question for today will be coming from Fye of JPMorgan.

[Jessica Fye, JPMorgan]

Thanks for the comments on how to think about SKYTROFA sales this year. Can you comment on your comfort level with consensus estimates for TransCon PTH this year? And actually while we're at it, where is that consensus figure based on your latest compilation of the analyst numbers?

[Jan Mikkelsen, President and Chief Executive Officer]

Jess, are you reflecting into SKYTROFA or TransCon PTH?

[Jess Fye]

For PTH.

[Jan Mikkelsen, President and Chief Executive Officer]

I actually have not looked at the consensus number for PTH. I don't think we have collected that information. So I don't think we can really address that. We can mainly address the places where we feel confident to give an algorithme that can reflect our expectation as we have done from SKYTROFA.

[Jessica Fye, JPMorgan]

Okay, I'm going to ask something else then. Can you tell us how many cumulative new patient prescriptions there were for SKYTROFA as of your end? I think you were previously giving that quarter by quarter. And can you also tell us when we should look for the next update from the Phase 2 extension for TransCon CNP?

[Jan Mikkelsen, President and Chief Executive Officer]

Let's just go back to how we basically are looking on the forecasting related to the revenue of SKYTROFA in the US in 2023. What we have seen in here in '22 that month by month, we have increased the number of new patients that got reimbursed, and we have continued to see this trend also in 2022. This is why it was important to look on the fourth quarter, because we also seen at the same time, we're seeing and really very strong retention. When you start on SKYTROFA, you stay on SKYTROFA. When we take the €17.5 million and multiply that with 4, Scott is calculating, it’s about €70 million. And we basically will expect an acceleration of the number of new patients, because of a lot of good reason. And I can come back to that, Jesse, if you want that. So we actually expect to see more patients per month of new reimbursed patients that we actually saw in '22. We're feeling really, really, really confident that we will exceed the consensus number that is out on the street today related to SKYTROFA.

The element that basic -- providing our increase in number of monthly new reimbursed patients is that the physician is starting really to get the knowledge about the product strength of SKYTROFA. It's not something you experience in one month, you need to see six months, 12 months of data. And this is what we're starting to see, so we're really seeing how we really have a highly differentiated product compared to daily growth hormone. The other point is that we see the consolidation of the daily growth hormone market that started for about three years ago where we saw after our Phase 2 data that the consolidation of the daily growth hormone market is really kicking in now. So that is a major, major switch away from some of the six daily growth hormone players, which all have the same product. So this is why we feel that confident about how we really would grow SKYTROFA into the most valued product in the growth hormone market in the near future. Related to CNP, you had a question related to CNP. Jess, you can specify exactly what you wanted to know, though.

[Jessica Fye, JPMorgan]

Well, I think in the past, you talked about the high velocity for a proportion of patients that had been on up to a certain time point, and I think we're going to maybe update that one all the patients got out to that time point. Is there kind of plan to update that data and when should we expect that?

[Jan Mikkelsen, President and Chief Executive Officer]

Yes, we are planning to give you this data. And we think is extremely, extremely important to give you this data where we see the continuous effect of Ascendis Pharma’s TransCon CNP, because I'm still in this extremely struggling manner. And this is what we really had got a lot out of analyzing all the data for our ACcomplisH trial to find out why they're staying 100% on this treatment, and we starting to get a much, much better understanding of that. And this is why we now are discussing the regulatory agencies how we can have other secondary endpoint that's really are reflecting how we are addressing really the comorbidities and not just linear growth. Linear growth is not really the biggest issue for this patient group, they seek the comorbidity and other effects of disease. And this is why we believe TransCon CNP is a unique product because it have continuous exposure of the CNP molecule and therefore changing things that is not only related to linear growth.

[Operator]

Our next question will be coming from Ahmad of Bank of America [Operator Instructions].

[Tazeen Ahmad, Bank of America]

As it relates to HPT, can you just give us an update, if you haven't already, on how many patients you've enrolled in the Early Access Program so far? And do you have a sense of how many patients will be enrolled in that program by the time of the PDUFA and then following with the launch?

[Jan Mikkelsen, President and Chief Executive Officer]

I think that is an extreme -- first of all, we are extremely pleased with how the program is progressing and our regulatory interaction, and also that we got approval to start an EAP program with [indiscernible] give the opportunity to get patients under the treatment before we get the expected approval. We are executing on that, really starting the entire system. And we will explain when we come to the approval process, what is the number of patients we will have in this trial, and also how we continue with patients.

[Tazeen Ahmad, Bank of America]

Maybe just a follow-up then. Would you expect that to be an early source of patients to convert to commercial?

[Jan Mikkelsen, President and Chief Executive Officer]

I just think we are addressing a key element in the EAP program. We are addressing the patient group that already were experienced with a PTH treatment regime, a short acting PTH treatment. It could be the [indiscernible], it could be [indiscernible], it could be [time loss] or someone else, but that was exactly what we’re addressing. The vast population where we basically recruited patient to our Phase 2 program and our Phase 3 program, they’re coming from what we call patient that never really had been exposed to PTH treatment. So I don't see -- that is really, really a differentiation between these two patient groups. I think both patient groups have the same high unmet medical need, they have the same benefit of the PTH treatment. So I don't see any kind of difference between these two groups related to be firestarter in our programs.

[Operator]

Our next question will be coming from to Tazeen Ahmad of Bank of America.

[Tim Lee, Senior Director of Investor Relations]

I think she just asked the question, so I'd go to the next one.

[Operator]

The next question is coming from David Lebowitz of Citi.

[David Lebowitz, Citi]

As the PDUFA date is approaching, could you give us any insight into what the label might ultimately look like? I know that NATPARA was considered an adjunct, you seek to be going more as a hormone replacement, and NATPARA has the presence of a blackbox for osteosarcoma, but you didn't really have an osteosarcoma experience. So could that blackbox be removed? Just be curious to hear your thoughts.

[Jan Mikkelsen, President and Chief Executive Officer]

I think when we look on the biology and the product design of TransCon PTH, we are providing a stable physiological level of PTH 24 hours, seven days a week. We are not providing any hyperphysiological concentration of PTH that can provide to the anabolic effect that in animal model have been associated with the osteosarcoma specific to rat model. And from that perspective is that and also why we got a waiver to make a carcinogenic trial or animal trial, we will not expect and we have not seen any indication in our labels discussion that we will be coming in the same, you can see, group of short acting PTH that basically got the same class labeling, because we are providing a complete different product profile than the short acting PTHs. So to our best knowledge today and in our discussions, we don't expect any REMS program or we don't expect any blackbox warning. So that was your first question. And you're quite right. How we designed TransCon PTH was really to prove a product profile that was reflecting hormone replacement instead of an adjunct. That’s why to be successful in the clinical trial you need to stop 100% from active vitamin D and you also need only to take calcium supplements that really are just reflecting a normal multivitamin from [indiscernible]. So we are really addressing a complete different product profile.

[Operator]

And our next question is coming from Li Watsek of Cantor.

[Li Watsek, Cantor]

I guess for TransCon PTH, just wondering if you can share some of the latest feedback that your sales team maybe received from payors and physicians? And then maybe talk about your latest thoughts on how you might approach pricing and market access?

[Jan Mikkelsen, President and Chief Executive Officer]

When I think about the patients, when I think about this physicians, the measures have not been different for the latest. Everyone recognize that hypopara is a serious disease and everyone understand the benefit of replacing a missing with a physiological level 24 hours, seven days a week. How it both address short term symptoms, like quality of life, urinary calcium but also long term risk. And what we’re seeing is that the awareness of that is being building up much, much more about the awareness of the disease. And I believe this is where we come in with our indication, first telling about the awareness of the disease, which are really a big part of what is happening today with all our established infrastructure here in the US. And after an approval, we can go out and explain how we can benefit this kind of disease, both short term and long term. So I really, really, really feel that we are right. What we did with SKYTROFA is the guidance we do with always our product. We develop best in class products, addressing real unmet medical need. And we take a premier responsible pricing situation where we believe if you really develop a product that really address a real unmet medical need with a real product, that is enough for both the patient, the physician, the society and the payor, for us to share that cake, because then everyone is winner, no one is loser. And this is where we want to be with each of our products. We need to have them so highly differentiated, addressing a real unmet medical need and everyone believes it's a win for everyone, and we can see that with TransCon PTH.

[Operator]

Our next question is coming from Paul Choi of Goldman.

[Paul Choi, Goldman]

I want to ask, given that you're using the same infrastructure to market PTH in the US that you're currently using for SKYTROFA. I guess, are there any learnings that you might share on the -- from launch SKYTROFA that you would think be applicable, or what changes would you make I guess in terms of either your thoughts on approaching your payor access and/or contracting compared to SKYTROFA? And then I have a pipeline question as a follow-up.

[Jan Mikkelsen, President and Chief Executive Officer]

We are utilizing the same infrastructure. Sure, we have dedicated sales force, we have dedicated people for the two different products. But you know there's a huge difference to be the first product to go out and launch where you establish all the infrastructure, IT systems, all the different necessary teams that is necessary to really to launch a commercial product. We have big risk at that now. We coming from a stage where we launch and form an already successful status, commercial infrastructure built from Joe and the other people in Princeton here in the US. So what we’re doing is that we basically are placing what I call TransCon PTH into an infrastructure that already has proven it’s capability with a product, I believe, really addressing huge unmet medical need whereas no alternative treatment. I think this is a fundamental -- a huge success.

[Paul Choi, Goldman]

And then as a follow-up, just in terms of the pipeline. Do you plan to publish the baseline patient characteristics for the 80 children that are being enrolled in the ApproaCH trial? And then could you also specify in terms of your oncology program, the head and neck population that you're planning to pursue, is it just HPV positive or is it post PD-1 and post [erbitux], if you can maybe add a little color on that, that'd be great? Thank you for taking our questions.

[Jan Mikkelsen, President and Chief Executive Officer]

I think Stina will take number two, or you can take one on [Multiple Speakers]. Let me take a number one, it’s a very, very interesting question, because I do not know if the question the words really are addressing, because I actually think we have published all the demographic from our patient population and demographic that have been into the accomplish trial, the 57 that's still in it. So I -- somewhat little bit puzzling with that question, because all data is out/ then you can say, hey, why did you not come in with the analyze high velocity prescreening, because it’s totally irrelevant for the clinical efficacy of it, you cannot use and analyze high velocity that have been collected before they go into the trial, because we have 40% of the channel between two and five, which you look and place [indiscernible] nearly built the normal analyze high velocity. And the first four years, you have a heavily deceleration of analyze high velocity. So if you take and analyze high velocity just collected up to 12 months before they go into a trial, it's not reflecting any meaningful value that go in and compare to the analyze high velocity you compare in this patient group, because the start on the [indiscernible] already two. This is why you do what is obvious in drug development, you’re making a placebo group. This is why you have a placebo group, and I think that is the key element to do, look at our dosing from 6 to 100 and then you can take six like nearly like also placebo group and then you can take the six and -- or the placebo movement into the achondroplasia specific high efficiency of a matching, they're matching 100%. But compare this it’s my basic scientific nonsense and only are misleading and have not reflecting any kind of solid scientific value in interpolating the data. Stina?

[Stina Singel]

In oncology, we are evaluating for proof of concept efficacy in seven different tumor types. You're right, we do have one of our priority areas is head and neck cancer. We are evaluating in first or second line metastatic head and neck cancer as a dose expansion cohort single arm in the IL-βelieγe study, and those patients will be -- will have had no more than one line of chemotherapy containing regimen in the advanced metastatic setting. And the randomized Phase 2 study, βelieγe-IT-201 study will be in the neoadjuvant setting. So these are patients in a non-metastatic setting before they get surgery, they will get systemic treatment before surgery and we're looking at pathologic response as our primary endpoint to look for evidence of proof of concept efficacy.

[Operator]

Our next question is coming from Derek Archila of Wells Fargo.

[Derek Archila, Wells Fargo]

So just two really quick ones from us. Jan, I just wanted to confirm, I thought I caught you saying that you were in labeling discussions for TransCon PTH. So I just wanted to confirm that. And then also, I guess, when should we expect additional updates from ACcomplisH, is that something we should see, again, first half of this year, second half of this year?

[Jan Mikkelsen, President and Chief Executive Officer]

When you go through an approval process, I think, for me, is sort of plan process, four months before an expected approval date [indiscernible] three months before an expected approval [indiscernible] [this need to happen] two months before that. And so if anyone somewhere had been to an approval process, and I think we have 10 weeks before the PDUFA date now. If you're not have started at labeled discussion, the risk of not getting approval is high. So therefore, I believe this is a way by tracking how we are progressing to the approval process, are we really on track of what everything needs to happen in that expected time, is it that’s not happening. I will be extremely worried and find out what is going on. And so yes, we are in a labeling discussion, because you should be that at least three months before an expected approval. And this is why I feel that I'm confident that I have not seen anything that not give me a belief that TransCon PTH isn’t product that is approved. I believe and I cannot really remember all our corporate milestones now. Sorry for that, because that's a little bit too many of them. But I believe that is in Q4 we will give you an update, again, related to that 57 patients that will come out from the ACcomplisH tribe. So it will be in the second half of this year.

[Operator]

The next question is coming from Josh Schimmer of Evercore.

[Josh Schimmer, Evercore]

First on SKYTROFA. Could you elaborate a little further on what you're seeing in terms of daily growth hormone options withdrawn from the market? I know there have been some reported shortages, but it didn't realize that reflected the outfall withdrawals. So who have you seen this drawing and do you expect others to follow? And then how do you anticipate the impact of Novo Nordisk potentially launching a once a week growth hormone option as well iun the market later this year?

[Jan Mikkelsen, President and Chief Executive Officer]

Let me start first on the daily growth hormone, because I believe that is a textbook that really -- and if I have segment it’ll be potential [indiscernible] in my studies and my final project, but it's really, really what I call a textbook [example]. Growth amount or the daily growth among market was the first, I got biosimilar where Sandoz and Teva entered with their bioequivalent version on it. And there, Sandoz had six players, it is daily market segment, all of them providing exactly the same entity, the same treatment. So you can change this back and forth between the product dependent on rebate and other things like that that was different in formulation, that was a little bit different in devices and other things like that. So what we saw for about three, four years when they came out with our Phase 2 data, we saw already that some of the big player -- many started some way to reconsider how to be really played when that's coming and superior treatment into this segment. And that will be -- which will be highly different stages compared to what we call the daily market segment.

At that time, we already saw three of the company's basic removing their sales forms, this is step one, as I call. Your remove sales force. The second one is that you go to the next stage, you remove the [indiscernible], then you stop up manufacturing, which I think three or four them have done it now. And then you basically are in a position where you are providing many patients that already are [established] on your product, because you have no hope where you can change and take new patient in and you're providing them. What happen in setting up for the patient now that it look like a normal audience, when they two showed us of multiple products, multiple presentation of their growth hormone. And because that consolidation of the daily growth hormone happen and really is in the final place, I believe none of the other one could take over. So you actually see a shortage of growth hormone treatment in the US. And sure, I need to accept that the benefit of that is a great thing for us, because it's both accelerating at the same time where people really see the benefit, get the clinical experience how we differentiate it, be having patient for one year or something on treatment. So they really, really, really see this benefit. And I think this is a great thing, sure for us and we’re really hopeful we can help as many, many as patients to avoid going into a shortest of the treatment effect. Your second question?

[Josh Schimmer, Evercore]

Actually, I was going to ask whether, given your view of the differentiation of TransCon CNP, if you’d considered filing for breakthrough designation?

[Jan Mikkelsen, President and Chief Executive Officer]

Yes. First of all, Josh, you also have the question reflecting about potential, the entrant of Novo Nordisk long acting product. When I look on the paradigm shift, I call it paradigm shift, because it comes from the time where all the daily growth hormone were identical, the same treatment, the same mode of action. When you go over to the long acting, all of them are providing complete different clinical profile. They're the only one that really match an improved version of the daily growth hormone where you get all the benefit endocrine benefit, both related to changing not only linear growth in the periodic setting but also the other -- associated endocrine benefit like body composition, metabolic profile, lipid [indiscernible], cognitive effect and everything that you see, because we have the same unmodified somatrope molecule. So this is why it's also important for us to look at our Phase 3 in adult growth hormone deficiency, because the two other potential long acting where we believe there's potential one less now but [indiscernible] showed basic not any improvement on body composition in that Phase 3 trial. Novo Nordisk showed they can only get the half of the stake basic to daily growth hormone. And this is where we believe with our unmodified somatrope potential we will be at least as good as daily growth hormone. So we believe that our product profile is always so highly differentiated to both daily growth hormone and other long acting growth hormone that we always will provide us the clinical benefit compared to all other treatment regimes.

[Operator]

Our next question will be coming from Leland Gershell of Oppenheimer.

[Leland Gershell, Oppenheimer]

Two from me. Jan, I know you had responded earlier that you don't expect a REMS or blackbox warning on the PTH label. But could you comment on any potential for monitoring requirements with patients on the product?

[Jan Mikkelsen, President and Chief Executive Officer]

Could you clarify your question, what do you mean exactly?

[Leland Gershell, Oppenheimer]

Well, in other words, if patients need to be monitored for serum calcium, bone biomarkers whatnot?

[Jan Mikkelsen, President and Chief Executive Officer]

That is an question where you will say will be provide an beta stability for this patient group than they have in the current setup where the basic are being monitored for calcium really, really, really often. And I believe you will see it in different stages. I believe when you transition over from what we call the conventional part of therapy over to TransCon PTH, I think that will be at least the same kind of monitoring, because you want to be quite sure you stabilize the patient in the right manner. When they are stable, which we see after one to two year on a PTH dose, where we see more and more stability coming in because calcium metabolic system or calcium hemostasis starting to be stabilized, I will pretend to see from a patient perspective that you will potentially need a list, what we call, monitoring of it. I think this is where I believe that element like [indiscernible] is not typically something you typically will analyze for any patient group in this way. What we have seen in our clinical study where now patient are for over three, four years, your basically seeing that we do normalization more and more and more of every parameter, and that is includes both bone density and is also including bone markers. So I will not expect that it will be part of a standard monitoring.

[Leland Gershell, Oppenheimer]

And second question from me is with respect to achondroplasia. Obviously, the primary endpoint and for regulatory purposes, it's about type velocity. But as you had mentioned earlier, there are many other benefits that a replacement CNP could provide. Could you just sort of inform us as to which of the other benefits that maybe not captured by primary endpoint type data but would be very important, seen as most important by the [achondro] community?

[Jan Mikkelsen, President and Chief Executive Officer]

Yes, I think this is why we developing TransCon CNP. We really are developing it to provide an treatment that sure is addressing linear growth, but we can combine it with SKYTROFA and then I can -- from a clinical concept, I will expect nearly you can decide what kind of linear growth you will have. But what we really want to ensuring that we are addressing the underlying comorbidities of the patient and how we measuring them is to have specific achondroplasia specific comorbidities. This is comorbidities that is coming and being reported on high, high, high frequent from the achondroplasia from when you see [Technical Difficulty]. And then we also are developing an patient specific reported outcome measuring where we're trying to catch all the benefits they're feeling, because they're really seeing a huge benefit. One of the things that is clear for us, it's not receive lot of other sectors, not just related to [Technical Difficulty]. We see massive change, we see how the function beta in the physical way to balance, do normal work, do normal operation and other things like that. And this is all those elements we will try to capture. At the same time, we will capture the achondroplasia specific element like -- basically like [Technical Difficulty] patients and other things like that [Technical Difficulty] putting.

[Operator]

Our next question is coming from Andreas Argyrides from Wedbush.

[Andreas Argyrides, Wedbush]

So when you're thinking about -- this is for PTH. When you're thinking about the opportunity -- launching the opportunity of PTH, how are you thinking about it compared to the NATPARA launch? And then maybe you can give us some insights on how NATPARA coming off the market at the end of '23, informing your expectations for the launch? And then I have a follow up?

[Jan Mikkelsen, President and Chief Executive Officer]

I'm not comaring TransCon PTH in any way to NATPARA. It will have complete different labeling, have complete different clinical outcomes, have complete different clinical benefit. So just complete different impact on quality of life. So I'm not using that as a benchmark on anything. I'm not comparing that. There was a product that came out with a labeling as an adjunct, this is not what we’re addressing. It was a product that came out not seeing benefit on quality of life, it was a product that came out not showing any benefit on 24 hour urinary calcium, not really addressing the underlying disease. So you can -- I don't use that also any benchmark, it's completely meaningless for me.

[Andreas Argyrides, Wedbush]

I guess maybe the opportunity that there's no approved product on the market, there were some patients, mostly in Europe as well, there were still on it or they had access to it no longer. Are those going to be early adopters?

[Jan Mikkelsen, President and Chief Executive Officer]

Yes, I think actually -- this is exactly as on somebody's address before. Yes, that is patient that has been exposed to short acting PTH treatment. They are used to daily injection and other elements like that. But where we see the huge benefit is independent of the background is that being exposed to short acting PTH or not. So I don't believe there is a less need for a patient to get on TransCon PTH treatment if you come from the group that has been on short acting PTH or have never seen a short acting PTH. The patient that have been on short acting PTH have perhaps a more common understanding of daily injection, have more common understanding about what they need to do as procedure to get that to happen. But I don't believe that it’s a big barrier for any of the groups.

[Andreas Argyrides, Wedbush]

And then just a quick one on SKYTROFA, and maybe you can elaborate and I don't know if you've covered this already. Sorry, if you did and I missed it. But if you can elaborate on the launch dynamics that are driving growth. Are you seeing higher switch rates from daily growth hormone? And that's it for me. Thanks, guys.

[Jan Mikkelsen, President and Chief Executive Officer]

We only see a higher switch rate from daily growth hormone, but we’re also seeing an increased number of new patient coming on the treatment. But the overall number goes up everywhere. So it's not likely one getting less, both of them are improving up to a really, really new height all the time.

[Operator]

And our next question is coming from Yaron Werber of Cowen.

[Yaron Werber, Cowen]

Jan, I've two interrelated questions on more coverage. With PTH coming soon, there isn't really a competitor. Do you need to contract or will you contract with PBMs to get on formulary, maybe kind of talk about your thoughts there? Obviously, the discounting shouldn't be very high at that point. And then secondly, now that you'll have a second program, second product approved, sort of within the endocrine bag. Does it give you more leverage to negotiate better for a placement for SKYTROFA?

[Jan Mikkelsen, President and Chief Executive Officer]

We know really comments about how our market assess strategy is and will be, and how we are really are addressing the reimbursement system in the US. But for your information, when we always look at a product, because you can do the same thing, I can give you name of products in the US that basically are in a position to generate multiple billion in revenue in the US without basically being provided high rebate. And I think we will follow this pathway, because we are providing such a benefit to the patient, the physician and the society that we feel this is a way we will continue our market versus strategy. Compared to SKYTROFA, we are actually pretty satisfied with our coverage. We believe the strength of the product, the differentiation, don't really lead us to provide into an highly rebated product. I think that is the strengths of having a highly differentiated product.

[Operator]

Thank you. That's all the time that we have for today. Thank you for joining the conference call. You all have a good evening.

[Jan Mikkelsen, President and Chief Executive Officer]

Thank you.

[Tim Lee, Senior Director of Investor Relations]

Thank you so much. See you.