Ascendis Pharma A/S (ASND) Earnings Call Transcript & Summary

September 7, 2023

NASDAQ US Health Care Biotechnology conference_presentation 43 min

Earnings Call Speaker Segments

David Lebowitz

analyst
#1

Hello again, and welcome to the Citi 18th Annual BioPharma Conference. We are coming up on the end here, but now before that, we have with us on stage Ascendis. They've certainly had some news -- a bundle of news yesterday so they will be able to talk about more specifically and others, which we'll be teased with but will not probably get too much information on. But beforehand, you can -- your requisite disclosures.

Unknown Executive

executive
#2

Thank you, David. We may make forward-looking comments during this presentation. Actual results may differ materially from those expressed or implied and you should not place undue reliance on these statements. For information concerning the factors that could cause actual results to differ materially, please see the Risk Factors section of our most recent annual report on Form 20-F. Before I turn this back over to David, I want to make a comment regarding our PTH regulatory status of -- our U.S. regulatory status of TransCon PTH. Jan provided a status update on our second quarter earnings call earlier this week, and we are not in a position to make additional further comments on this matter.

David Lebowitz

analyst
#3

Not to get rid of all my questions because they were all on TransCon PTH. So with that, let's start. This is a company, a platform company with its TransCon technology. If you could tell us about the history of Ascendis and the modality you have developed. And there you're going.

Jan Mikkelsen

executive
#4

Thanks, David. Thanks for inviting here. And yes, I like to talk about the history about Ascendis Pharma. Ascendis Pharma got founded in [ actually ] for some years ago in 2007, it got founded with the acquisition of the company that really provided us our platform technology, the TransCon technology. And you can say, why did we got inspired by the TransCon technology? Because when we wanted to found a Ascendis Pharma, we have the same vision as we want today. We really wanted to take and develop product and bring it out to the patients. But when we see the risk that was inhere in making highly differentiated products, really addressing some major unmet medical need, we really needed to have a platform where we, at the same time, can make highly differentiated product opportunity, but do it in a highly successful manner. And this was when I first got exposed to the TransCon technology. I said wow, for the first time in my life, I feel there is a platform technology that could be a paradigm shift. A paradigm shift where you can make highly differentiated product without taking the inherent risk of target engagement, if you already work with validated parent drugs. So we build up a pipeline. And the first one was TransCon Growth Hormone. At that time, there has been 20 years or so in making an improved treatment. For example, pediatric growth hormone deficiency and improved treatment that not only was more convenience with a weekly treatment received, but potential also can give an improved treatment outcome. All attempts basic failed. Every time you change the growth hormone molecule, you got unwanted effects hemological antigenicity, side effect or anything like that. So what was unique with the TransCon technology, we couldn't take the native growth hormone. That is the same as in [ industrious ] growth hormone. That is the same as daily growth hormone, take it into the TransCon technology, make this product and then by a predictable release when it got injected into the body, it will be transferred into the blood compartment and then release an unmodified growth hormone, the same as [ industrious ] growth hormone in a predictable release kinetic that just reflect the PK parameter that you're seeing with daily growth hormone. And this is how we develop that pipeline in rare disease endocrinology. So when you can see the pipeline we built on in hypopara, we have PCAs, 134, the same as FORTEO. It got used off label with FORTEO on infusion pump. A lot of clinical trial was coming from peer review publication. Where you can see if you just have a flat physiological profile, 20 hours, 7 days a week, you really got the optimal outcome. That was exactly what we could mimic with a daily, small subcutaneous injection, and that was exactly what we build on that. And the same as CNP. We use wild-type CNP well-known biology, well-known target engagement. So we build up a pipeline in rare disease endocrinology of 3 product opportunities. Those were funded in our Vision 3x3. And what I'm really proud about, we made that vision for many years ago. And we said by 2025, we will have all 3 product opportunity being approved. And when I look at in '21, we get SKYTROFA. I believe we will get the first approval here in '23 with TransCon PTH. And in '25, we have a clear pathway to get TransCon CNP approved for achondroplasia. And this is how we really have built up the unique, diversified pipeline with all 3 product opportunities really addressing major market major potential of each of them. And not only we have a lot of synergy economy of scale of having the 3 product in endocrinology rare diseases, but we also can see to get treatment synergies. For example, now we are planning for a trial between SKYTROFA and TransCon CNP going for achondroplasia because we know if you want to have more linear growth, just combine the 2 products together. And not only there, we also use that in going into oncology and into ophthalmology. It will not be areas that we will be focused as much as we are in commercialization. We believe we will have our 100%, our focus on endocrinology, where we will be from ideal states out to the patients.

David Lebowitz

analyst
#5

In the past, when people thought of technologies to make -- extend the lif,e, they thought in terms of administration, it made it more convenience, but it's clear that this approach is more than that. It adds to the efficacy by more reflecting the way a hormone or a drug might be administered in the body. Now one challenge that certainly investors have always had is they get the logic when it comes to the endocrine side, and especially, there's been plenty of evidence of it to this point. How does it -- should they look at the oncology side? I think a lot of investors have a lot harder time getting their hands around that.

Jan Mikkelsen

executive
#6

Yes, we have 2 product opportunities in oncology. They are basically built on the same fundamentals because if you look on our TransCon TLR7/8, I believe that most people agree with the fundamental of TLR and how they function in an hemological stimulation. They are really functional in really driving the maybe hemological system up to the next level. The question is -- was how really to use is optimal in oncology because if you use the systemic, too much side effect. If you try just to inject the compound inside a tumor, it disappeared after 2 to 3 hours. So we basically inject it in the tumor after 2 or 3 hours, it's gone. So what we did with the TransCon technology, hydrogel technology, is to place the TransCon hydrogen inside the tumor, and it basically release the TLR7 over weeks and by doing that, we really get the right immune stimulation in cyto tumor basically like a kick starter. It's a kick starter. It kicks off the hemological system now inside the tumor, I can see the TLR function. I attract the right cells. I go in and really start with hemological system. This is exactly what we see now in our recommended Phase II, where we both see monotherapy effect. We also see effect in combination therapy with different elements. Our IL-2 is basically to build on all the scientific literature of what not to do and then do it right. Everyone know if you have an hemological stimulator and you can do it in a safe, good manner. Then we basically will have something that really can be at the same level of checkpoint inhibitor because it's a stimulator not removing a break. And this has have been the dream for many companies. What we did with our IL-2 is trying to build on the fundamental of the first immunostimulation compound, proleukin, that came out. We said you need to have at least effect of proleukin, both related to ALC which is our way to look at immunostimulation and then not have associated side effect weighted in because IL-2 function if you can tolerate it, but you cannot tolerate it often. So this is how we develop it. And now we are really coming to recommended Phase II, both as monotherapy, and we have complete -- we have really responders, partial responders in both the monotherapy and also in combination therapy. So I will let the data talk. We are now going into indication-specific areas we're enrolling 20 to 40 patients in each single indication, 7 different indications now and we will have data coming out next year. We're really hopeful will show really the full potential of these 2 unique product opportunities.

David Lebowitz

analyst
#7

Would the data be coming up incrementally based on tumor as it's ready or in one.

Jan Mikkelsen

executive
#8

Yes. When every indication coming to the states where we have the first defined read for each single indication.

David Lebowitz

analyst
#9

SKYTROFA, certainly, the launch has been going well. I know early on the launch, you had a lot of people who are kind of trying to figure things out and understand how it would then actually ultimately progress. One question I have is certainly doing well. To what extent are the patients coming on board switchers from daily? And to what extent are they treatment naive?

Jan Mikkelsen

executive
#10

When we wanted to launch SKYTROFA ,we have 2 fundamentals that we want to achieve to really to capitalize on really on the product strength of SKYTROFA, really get the value out of this product. We wanted to be the market leader in value and we wanted to do in a growing growth hormone market. In Q2 this year, we already achieved to be the market leader in value. And we did it in pediatric growth hormone deficiency with less than 10% of the market share. Meaning is that if you do a simple calculation, if we penetrate the rest of the market and how we're selling, where we're selling, we will grow the entire growth hormone market for $1.5 billion up to $3 billion market segment in the U.S. And I feel that is right because we are providing a much better treatment outcome. We are giving a much better treatment outcome to the patient and we're helping the society by really giving a better outcome. We did it in a way where we are providing patients both to naive and switch. But we get most patients from switch therapy, meaning is that because we are not rebating in the same manner as the short-acting, most patients come on short-acting treatment, and all of them are identical. All the short-acting are identical, the same entity, it's just differentiation related to devices and formulations. And 80% of this patient, it will not get the optimal outcome. So this is why most of them starts on daily growth hormone where switching over to SKYTROFA, and this is where we see most of the patient coming from. And I don't believe that it really will change a lot. It's really improving now because the physician really have seen -- observed now, how we really is -- a treatment different compared to the short-acting growth hormone products.

David Lebowitz

analyst
#11

Treatment experience as it's gone up. I mean, originally, when there was launch, the commentary on switch is that these patients might not necessarily actively coming forward. It might be on their periodic biannual visit to their doctors when the doctors might begin to start introducing them to this. Has that changed at all since -- at this point now that it's been out there a while, and there's probably a little bit more discussion about the nature of what this treatment offers?

Jan Mikkelsen

executive
#12

So when we look on the underlying analytic, we don't see any element on season variation. We see a steady state increase week by week, month by month, quarter by quarter. So we don't see anything that indicates that.

David Lebowitz

analyst
#13

Got it. Got it. And how do you expect the emergence of other long-actings could affect that?

Jan Mikkelsen

executive
#14

We saw 2 other long-acting getting approved in the pediatric growth hormone deficiency here in the U.S. We feel that is basically will improve the conversion over to the long acting. We have never seen a better uptake of SKYTROFA after they launched. And I actually believe that is reflecting when people start to understand the labeling of the 2 other ones. The 2 other ones basically on the prescribing labeling are comparing to a daily dose of 0.24 milligram per kilo per week, which are about 40% under the normal treatment regime of daily growth hormone in the U.S. today. So then you can consider if you're using the prescribing dose of 1 of these 2 products, and not discussion the different side effects and not discussing the different mode of action, the different compound. We are the only one that is somatropin. Giving the full endocrine benefit of somatropin but just looking on linear growth, that basically will have an effect that is far under what you expect to just to see for normal daily growth hormone. And today, we're generating most of the switches for patient that is on daily growth hormone. And now we're suddenly implementing a new standard that basically will be 30%, 40% under what you see with daily growth hormone if you use the prescribing dose of these adult products. So this is why I don't believe anyway, it would just accelerate the uptake of SKYTROFA.

David Lebowitz

analyst
#15

Got it. Later this year, data in adult, how should we think of that?

Jan Mikkelsen

executive
#16

Yes. There's a benchmark for the 2 adult products, as you talked about, in the adult growth hormone deficiency. The agenda basically whatnot from a statistic point improved compared to placebo. Novo Nordisk basically managed to be in a position that only got the treatment effect, half of the daily growth hormone. And we believe because we are the only product that's providing somatropin, we can at least get the same effect as we see the daily growth hormone. That is what our expectation that data comes up in Q4. We're really thrilled about the adult growth hormone deficiency segment. It's very different compared to the pediatric which are highly penetrated. The adult growth hormone deficient segment and our latest estimate is down under 5%, 6%, 7% penetrated. So there's a huge opportunity to further grow the growth hormone market and really providing the benefits to this undertreated patient population.

David Lebowitz

analyst
#17

How do you spur growth in a market that's so underpenetrated?

Jan Mikkelsen

executive
#18

Indication about the benefit of the treatment. And this is why we're really looking forward to have the data. We can indicate about the disease today. What we really want to -- when we have the data, which will be in Q4. We will file as fast as possible. So we basically can get it out to the patient in '25, which is our attention.

David Lebowitz

analyst
#19

Got it. And you did a financing deal with SKYTROFA. Could you -- that you just announced a couple of days ago. Could you tell us about that deal, what your thought process was in entering it and I guess, how we should think about it going forward?

Jan Mikkelsen

executive
#20

Scott?

Scott Smith

executive
#21

Yes. So you're referring to the $150 million royalty funding agreement with Royalty Pharma. So we -- we've been in dialogue with various parties, including Royalty Pharma for several years now. And I think that we came to a situation where we had a transaction that was just very attractive and really lowered the overall cost of capital for the company. We basically said we'll give you 9.15% of U.S. SKYTROFA sales, only. So it's limited to U.S. SKYTROFA sales and with a payback of 1.65x if paid back by December 2031. A the first payments are due in Q2 2025. So actually, you could say from the next 1.5 years or so, it's probably cash flow positive because we had pretty good interest on our cash from a carrier perspective, about 5.5%. So I think lower the overall cost of capital, provide some flexibility for the company to do different things if need be. And it was really kind of too good to pass on. And I think we've said repeatedly, we're committed to never issuing equity again. So I think this is probably a good example of what the trend we're going in with the capital structure.

David Lebowitz

analyst
#22

Got it. Let's jump over a TransCon CNP. Certainly, the launch of voxzogo, obviously, going to be a heartening for everyone who's pursuing but there's also been data now from BridgeBio. There's obviously voxzogo and then there's yourselves. How do you see this market shaping up over the years? And ultimately, how do you compare these therapies? I know people traditionally look at growth velocity, but ultimately, the question might become more complex than that.

Jan Mikkelsen

executive
#23

I think the aspiration for us to go into achondroplasia is to buy a treatment for achondroplasia. And we see a treatment is not a focus on analyzed height but addressing the comorbidities. That is the fundamental for us to be into achondroplasia. And I believe that the leading product is that is going to be the element that really are providing the benefit to this patient population will be a product that, from a holistic perspective, address the comorbidity including linear growth is highly tolerable, have an excellent safety profile and also have the convenience that isn't necessary to have it into a pediatric population that need to be on treatment potentially not only in pediatric, but also when it comes to the adults. That is exactly how we define a leading product opportunity. So we designed TransCon CNP to accommodate, not only to provide linear growth, but addressing the element of comorbidity. We see achondroplasia not only as a growth disorder of the bone but also a part of muscle weakness, which are completely different mode of action, which also can be addressed with continuous CNP. And why did we got this aspiration to look on the more holistic view of the phenotype of achondroplasia was when we observed in our Phase II trial, how patients suddenly came and explained things has changed for them. They are feeling much more comfort that basically could have better balance that could have us better motoric muscle action. And then we started really to review literature. And clearly, it's been proven that achondroplasia is also part of a muscle disease. And what we basically could do can address all, both the linear growth and we can address what we call the comorbidity, many of them arising from the combination of muscle weakness and growth disorders. Growth bone disorders. And we did it with a 1 weekly dosing profile because we know in the pediatric, how difficult is to build adherence in a pediatric population with a daily injection. We did it out from the excellent safety profile we want to have and tolerability in it. And when I look at the data now we have in our Phase II trial open-label extension, we started with 57 patients 3 years ago. Today, we have 57 patients still on treatment. And I don't believe then they're just in their for linear growth. They are because we provide a treatment of achondroplasia, providing the benefit that we're seeking for. And now we have the scientific understanding because we integrated most of the component because we cannot understand why after a few months, this patient had a complete different behavior. And that is what we understand. We enrolled all our 80-plus patients in 4.5 months. We enrolled in sites that got exposed to us in our Phase II trial, 90% of the site. On the site, that also have access to vosoritide and other treatment. But still after 4.5 months, we had all the patients. It's fully enrolled now. All the patients next year in second half, we will come out with a Phase III data. We went out to regulatory agencies in Europe and U.S. Our primary endpoint is analyzed height velocity. It's a typical weight, you're looking at growth disorder. The second element we discussed was our dose. Everyone understood 100 microgram per kilo per week is the right dose to give. We talked about the commorbidity, we have it. Continued discussion with the agencies, how we really can prove that we're providing something more than linear growth. We have 3, 4 different ways we are trying to get that integrated in our Phase III trial. So we feel really, really confident we have the strongest package ever that being developed for any achondroplasia treatment. The second part is that people have so much focused on linear growth. There's a lot of element to consider when you talk about linear growth. Linear growth is only meaningful if you look at over 1 year. This is why we ran our Phase II trial over 1 year. Because if you take achondroplasia patients to -- because the average analyzed height velocity in the age group from 3, 4, 5, 6, 7, 8, 9 is about 4 to 4.2 centimeter. And what we observed and everyone has observed, if you start with a patient that, for example, growth 6 months before, that go down of 3.5 centimeter. Without any treatment, anything that growth is in the second half of about 4.5 to 5-centimeter without anything. So this is why you cannot really adjust linear growth without looking on 1-year treatment. So if anyone want to compare any trial, look at 12-month data or it just will be treated in a way where you basically cannot adjust it, if you're not 100% sure that the annualized height velocity is starting on average about 4.3 to 4.2. So when I look at our package be building up, it's going to be highly integrated. We are also initiate a clinical trial in the newborn. We just filed for and starting that trial. We're also going to have a combination trial between SKYTROFA and CNP. If someone wants to grow more, take SKYTROFA to [ calculate it ], it's from a biological system and just look in our IP, where there's a lot of preclinical data about treatment synergy in animal models. Yes, this is how, if you really want to grow more. It's a good way to combine these 2 things, if you want more linear growth. So I believe that the integrated package we're going to develop is that we want to be a leading company in growth disorder. We have the 2 cornerstones for being the leading company in growth disorder the leading TransCon growth hormone and once-weekly CNP, we can really optimize them to really address the 20-plus growth disorder that exists out here.

David Lebowitz

analyst
#24

You talk about how the importance is really more the comorbidities and how it's more meaningful ultimately than just the pure growth velocity. But of course, the way the regulatory process has been set up. It's been set up revolving around growth velocity. And how does that challenge the ability for various players to be able to present that other information when the headline has been set up in a different direction. And does that weaken the nature of the data that gets presented on some of the other topics. How long does it take to that data becomes a headline?

Jan Mikkelsen

executive
#25

I think it's a question where you need to say what is really the audience you are addressing? Is that physicians? Is it investors business? Is this our audience? If I talk with the physician, we went to the site where they have a lot of different option. We get the enrollment in 4 and 5 months indicating that physicians understand the value of TransCon CNP, do investors really understand that in the same manner as the physicians? I think someone understand it. They really understand the fundamental on the way to really just scientific data and really take up and understand and spend the time to understand the data what it really means. But you need to take it from the perspective on linear growth is a single way just to look on one single parameter in the holistic treatment of achondroplasia. If you can come with any correlation that exist between providing linear growth and then address commorbidity is not existing. No one has proven that. Even if they're proving to address linear growth, no one have proven that really address commorbidities. This is where we want to be. We want to address the commorbidities. And this is the differentiation. And I believe firmly that this is what the patient really wish for.

David Lebowitz

analyst
#26

Perfect. Tell us about the data that you presented at this point and what we should expect with future updates?

Jan Mikkelsen

executive
#27

On TransCon CNP, we will have an update later this year. This year is not over for us. It's -- I'll not say it's just beginning, but there is so many things that is happening. We're waiting for the European approval of PTH, which we hope will come soon. We're waiting for resubmitting our PTH filing in the U.S. We're waiting for adult data here in Phase III data, which really could be interesting. We will give you also an update about CNP about where we have all of them treated 57 with the highest dose for I think, 1 year now. So we really are giving an impressive update where we can give you our idea how we look on the biology, how we want to address comorbidity. And Scott, I forgot something obvious. What did I forget?

Scott Smith

executive
#28

For the rest of the...

Jan Mikkelsen

executive
#29

The first of the year.

Scott Smith

executive
#30

Growth hormone? Adult?

Jan Mikkelsen

executive
#31

Growth and?

Scott Smith

executive
#32

Or approval? I wasn't gonna say that one there. The drug I'm not supposed to mention.

David Lebowitz

analyst
#33

When you -- I know that we're not talking about the regulatory process. And I will spare your question on that. Now, I'm thinking about the question. And you talked to the data you released earlier this week. Is that...

Scott Smith

executive
#34

eGFR?

David Lebowitz

analyst
#35

The eGFR data. Is that within the bounds of it?

Jan Mikkelsen

executive
#36

Yes. We can talk about the CKD data. Yes. So the data came up because we're starting to pull here for launch in Europe. Launch in Europe is going into a lot of health economic calculation about the benefit of providing a treatment to an hypopara patients. One of the key elements we were looking, we were looking about all the data onetime more, we started to look on the impact of kidney. And I think the key element for us is that if you look on the 60 eGFR, if you have less than 60 eGFR, an estimated filtration rate, you basically have what we call kidney dysfunction. Meaning is that you are in a very, very expensive pathway for any treatment for the society. And what we saw with this data after 1 year of treatment, 50% of the patient move for having the diagnostic of facing kidney dysfunction basically to be normal. It's really providing us a lot of the health economic discussion with the authorities in Europe about how we really take off the optimal price. For me, it was surprising. I never seen a drug and perhaps I've not seeing our drug, the basic of providing source of benefit when you have renal impairment. It not only stabilize it, but it's actually improving. Which I think was really, really, really unique. And when we came out and talked with physicians about it, perhaps I was enthusiastic, but the physician was definitely more enthusiastic than me about because they're saying, now we really also can help this comorbidity. Not only can we really give them their life back and a lot of different pyramid normalized, serum calcium normalize, the quality of life, give them normal phosphate, give them a normal bone. Metabolic system, but we also can -- even if you have been having the disease for so many years, you're starting to have renal impairment, we also can help you there. So I actually think it was some of the most impressive data we've seen for a long time.

David Lebowitz

analyst
#37

Now you also earlier this week talked about our kind of next steps for TransCon platform itself. And you provided some data preclinical data. Could you tell us about, number one, the overall move, the overall platform itself and how it will evolve and then specifically about this candidate and the potential for the indication. Obviously, it's GLP-1, it's something a lot of people are talking about these days.

Jan Mikkelsen

executive
#38

Yes. I talked about the TransCon technology in the beginning. And in the TransCon technology, we have TransCon linkers which are the same linkers we use again and again to all the different programs, different families, different generation. And then we have the TransCon carriers. And typical, what you have been talked about is the carriers we used in the product like TransCon Growth Hormone, TransCon PTH, TransCon CNP, our IL-2 program, we use soluble polymers. Then we have the hydrogen technology, which are coming from the TLR7/8. But what we really was missing, we missed a part of an expansion of the TransCon technology, where we basically can go out and really achieved 2 things besides all the other benefits you get out of the TransCon technology, like the product part and other things like that, that we basically couldn't explain to something high volume manufacturing and extremely low cost. Perhaps eating on a drug product basically safe in manufacturing cost. And there is why we developed this new technology platform. And we exampled it with GPL-1 (sic) GLP-1 semaglutide because we saw that there was a good way to show that power, this technology. And when I though what we can do with semaglutide is very simple. We released from the TransCon technology, the same unmodified semaglutide that people are now getting exposed to both in diabetes and obesity today is exactly the same entity. But through the TransCon technology, the basic achieving everything what we want to achieve, have the prolonged release increasing the half-life about 4, 5x on it. And what would that mean? It means that you can position in a different way, you can go for and treatment where you basically from and weekly dosing will have complete flat profile of semaglutide, avoid the flotation that potentially give tolerability, move it potentially higher up in concentration -- in the blood concentration, meaning that you can get better fit or you can go for a [ inherence ] play and saying instead of having the tolerability issue with four time of injection in a month, you only take one time inject and you will have the same peak to trough that you see with semaglutide after what you see with semaglutide today on a weekly dosing profile. We exemplified it with semaglutide. We can use many of the other GLP-1 mimetics, but we thought it was a good compound for us to work on. And make the example on it. But the technology platform will not only work for other GPL-1 (sic) [ GLP-1 ]. It also can be functional in other areas where we believe the same fundamental could be like in cardiovascular, where there's a lot of peptide that really can have major impact if you find an optimal way to produce it and also on the fundament of the -- you can say the cost structure that is in this business -- in it. So we really, really highly in case that we really managed to expand the TransCon technology also to include that part of product opportunities we now really can address with our technology platform.

David Lebowitz

analyst
#39

So with that, when do you think we could see a candidate with this variation of the platform actually enter the clinic?

Jan Mikkelsen

executive
#40

Yes, that is I think when we have all the plans detailed, we will come out. And typically, we always talk on new elements of our pipeline, new elements and timeline at the JPMorgan Conference, it's always a good time when we come with our guidance when we see things happening. What we want to do is to say that we are a company that really are focused on endocrinology. This is where we build out our focus we see a huge use of the TransCon technology in other areas. But in the end, we will not be an oncology player. We will be a concrete player in the way where we will have partnership. We work with paradigm shift compound and really bring the value forward for the patient and Ascendis.

David Lebowitz

analyst
#41

Towards that end, if we look at something like GLP-1 or the diabetes, endocrine space but also the nature of doing trials and is a much grander scale than where have you been? How would you approach such development?

Jan Mikkelsen

executive
#42

Yes. But the element of what we're doing is that it's mainly executing risk you have because you've the [ iron ] provide that active entity is a well-known like growth hormone. When we brought that, there's really a lot of risk in our Phase I, Phase II, Phase III trial? No, that was not major risk because they was liberating the same entity that we know that was functional. Here, we're liberating the same entity in with semaglutide that [ automate ] functions. So sure, it's a larger trial, but the other point is trials where you can see it's pretty predictable the outcome on it, what you will see in this kind of system because you would just see the benefit of what TransCon technology is providing on already established mode of action.

David Lebowitz

analyst
#43

Got it. We have a few minutes left here. I'm going to let you -- I want to let you freestyle. What do you want to tell us about that you haven't told us about to this point?

Jan Mikkelsen

executive
#44

I think the key thing from us in JPMorgan in 2019. We came out with a Vision 3x3. We wanted to be a sustainable leading biopharma company by 2025. The cornerstone for that was 3 product opportunities, TransCon Growth Hormone, TransCon PTH, TransCon CNP and then an opportunistic approach in other therapeutic areas. What we have managed to do is execute on all these 3 product opportunities, keep the time lines, keeping all the elements that we wanted to achieve. And when I look on the SKYTROFA success in the U.S. market, how we're commercializing. We've also proven now we really have a strong solid competitive way to commercialize products. And we will do the same thing with PTH. We will do it same thing with CMP. So we're building Ascendis Pharma to really a profitable company and our goal is to get our first quarter profit next year. We hope we can achieve it. We're doing everything to achieve it. It will be really by growing the revenue on an international operational plan. We out from [ corroborating ], has established what we call our global commercial organization besides the U.S. that both are focused on Europe and international operation, and we will bring what we call revenue from all this side here. So the perspective of Versartis, as Scott has said many, many, many times, we are not here for selling equity more, we're here to show of the value we're getting out of the product opportunities that we already have to the benefit to the patient. And I believe we really are fulfilling our Vision 3x3 where we're adding on, we also want to be highly profitable.

David Lebowitz

analyst
#45

Excellent. With that, thank you very much for your time. I appreciate it, as always, and look forward to seeing you again soon.

Jan Mikkelsen

executive
#46

Thank you so much.

David Lebowitz

analyst
#47

Cheers.

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Programmatic access to Ascendis Pharma A/S earnings transcripts and 32,000+ others is available through the EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments, full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.