Ascendis Pharma A/S Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 7, 2023

There are 9 speakers on the call.

Operator

Hello, and welcome to the Ascendis Pharma Third Quarter 2023 Earnings Conference Call and Webcast. Following the prepared remarks, there will be a question and answer period. Instructions will be given at that time. I would now like to hand the conference over to Tim Lee, Senior Director, Investor Relations, Ascendis Pharma. Mr.

Operator

You may begin.

Speaker 1

Thank you, operator, and thank you everyone for joining our Q3 2023 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today is Jen Mickelson, President and Chief Executive Officer Scott Smith, Executive Vice President and Chief Financial Officer and Doctor. Sinha Single, Executive Vice President and Head of Clinical Development, Oncology. Before we begin, I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act.

Speaker 1

Examples of such statements may include, but are not limited to statements regarding our commercialization and continued development Skytropha for the U. S. And European markets, as well as our expectations for 2023 Skytropha revenue, The expected timing of the approval and launch of TransCon PTH in the U. S. And the EU, our pipeline candidates and our expectations with respect to their Due to progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, Our ongoing and planned regulatory filings and our expectations regarding the timing and the results of regulatory decisions, Our expansion into new therapeutic areas, our progress toward vision 3x3 and our ability to become cash flow positive and Create a sustainable, profitable and leading global pharma company.

Speaker 1

These statements are based on information that is available to us today. Actual results and events could differ materially from those in our forward looking statements and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that can cause Risk Factors section of our most recent annual report on Form 20 F filed February 16, 2023. TransCon Growth Hormone or TransCon HGH is approved in the U.

Speaker 1

S. By FDA and the EU has received MAA Authorization from the European Commission for the treatment of pediatric growth hormone deficiency. Otherwise, please note that our Product candidates are investigational and not approved for 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 during the conference call regarding our product candidates shall be viewed as promotional.

Speaker 1

On the call today, we'll discuss our Q3 2023 financial results and we'll provide further business updates. Following some We'll then open up the call for questions. And with that, let me hand over to Yan.

Speaker 2

Thanks, Tim. Good afternoon, everyone. Our dedication to the values of patients, science and passion Remains the foundation for Ascendis to create long term value for all stakeholders. In the U. S, We achieved market value leadership with Saltovo within 2 years by sticking to our belief that a premium product deserves a premium Following the same strategy in German, we launched Skatofo in September and also expect We also launched TransCon P sales in January 2024, if approved By the European Commission in November.

Speaker 2

In select other European countries, We will use the same direct sales model to launch our portfolio as we have in the U. S. And Germany, we call this EU direct. In other markets, we will commercialize our portfolio to sales And distribution partners, who are local experts in rare diseases. We refer to this as international indirect markets.

Speaker 2

In Japan, we intend to partner our endocrinology rare disease We believe we have the organization and the manufacturing capacity To support expected launches of 3 independent endocrinology rare disease products by 2025. Driving further growth, we aim to continue to work to create highly differentiated TransCon product candidates, Expanding into additional endocannabinoid disease indication. Last quarter, we announced the expansion of I look forward to share more information with you about this in the near future. Let me provide more details on each of our programs. For Fascon Growth Hormone commercialized Eschatropa, we reported strong revenue growth, finished the 3rd quarter With €47,000,000 including initial revenue from Germany.

Speaker 2

We now expect full year 2023 SKYY TOFA revenue to be between EUR 170,000,000 €175,000,000 To drive differentiation and market leadership, We continue to build out the science and data behind SKYTOKI. We recently announced results from our long term extension trial Showing that the majority of patients treated with transfrangotomy met or exceeded avoparenthal height SIS The data also demonstrated the long term safety of SCAR TOTAL In patient treated up to 6 years. In adult growth hormone deficiency, we expect to share top line results during the Q4 from our global Phase 3 ForeSight trial. Today, we estimate less than 4% of adult Patients suspected of having growth hormone deficiency are treated with growth hormone, making this an opportunity to both expand Skytrophic label and expand the overall growth hormone market. In addition, we plan to launch Skytrophic in certain markets In our international indirect region, with initial revenue contribution expected to begin in 2024.

Speaker 2

Turning to TransCon PTH. In the European Union, EMEA, CHMP adopted a positive opinion in September, recommending approval of TransCon PTAs as The placement therapy for adults with chronic hypoparathyroidism. We expect The European Commission's final decision on our marketing authorization application this month. If approved, we plan to launch In Germany alone, where the annual cost For currently approved PTH treatment is around €77,000 per patient. Our target population is 22,000 chronic hypopaira patient out of the overall patient population of around 17,000 patients.

Speaker 2

Our status team in Germany that launched GATOVA is ready to launch TransCon PTH if approved. An EU approval will also provide the basis for marketing authorization and initiation of commercial activities for TransCon PTH in additional markets in our internal market segment, Where we expect 2 launch starting in 2024 and further launches in Europe direct in 2025, Following standard price and reimbursement pathways. By following our algorithm for product innovation, We will have taken TransGuard PTAs from IDEA to expected regulatory approval all in about 7 years. In the US, all documents have been finalized and we expect to We expect to know where the FDA has accepted our resubmitted NDA with 30 days from the risk submission date. If accepted, we expect the FDA to notify us At the time, the resubmission is Class 1 or Class 2 and provide a new PDUFA date.

Speaker 2

Besides this information, We will not comment further on the resubmission. As we guide over, we continue to build up the science and data behind TransCon In September, we announced a post hoc analysis of Phase II and Phase III data, demonstrating Substantial increase in estimated DFR in adults with hypopioidarism Treated with TransCon PTA. These data suggest that treatment with TransCon PTA can reverse impaired kidney function Turning to Transfrem CNP, this is our 3rd Endocrine rare disease product candidate. Following our end of Phase 2 meeting with U. S.

Speaker 2

And EU Regulatory agencies, we have lined on the pathway to potential assay regulatory approvals in the U. S. And EU. We expect top line results from our pure Phase 3 approach trials with completed enrollment in Q3 in the second half of 2020 4. We continue to have strong patient retention in our trials.

Speaker 2

And during the Q4, we will provide an update and share with you 1 year follow-up data with the open label extension We believe the strong retention in our clinical trial is a result of Additional benefit of TransCon CMP in addition to height improvements. As we have further evaluated the science behind achondroplasia and our own data, we now believe that achondroplasia is a disease Both skeletal growth and muscle function and that with continuous exposure to the CMP At our upcoming update, we will disclose this additional potential benefit of TransCon CMP in addition to HEIGHT. If we are right, that is correct that achondroplasia is a disease for both skeletal growth and muscle function. This means that TransCon's ERP could potentially offer value for adults living with achondroplasia, Who experienced muscle fatigue and other medical and quality of life impacts that may be Potentially addressable with constant exposure to CMP. We are in a Constructed the ILO, which I will update us on how best to evaluate the pretended to support an indication for treatment of achondroplasia.

Speaker 2

While our key focus in the Treatment of echolocation is to address the comorbidities that are associated with this disease. We believe an even more effective way to address height, if needed or desired, could be CNP in combination with Kokomo. We believe that this combination therapy may provide greater analyte high velocity and CNP alone and at the same time address The comorbidity of achondroplasia. Our previously presented preclinical data demonstrates the Additive effect of combining TransCon CNP and growth hormone in animal models. Consistent with stimulation of different growth promoting signaling pathways in the growth rate.

Speaker 2

Supporting this idea, a group out of Osaka University in Japan presented their poster during last month ASBMR, Showing that a last group of 41 aqua and replace the children treated with growth hormone demonstrated 1st year analyzed pipe velocity of around 7.4 centimeters with sustained growth benefit through 5 years of treatment. To explore this concept, we plan to submit an IND amendment or similar Moving to oncology. For TransCon IL-two beta gamma, we recently reported new data From the I BELIEVE trial of TransCon IL-two beta gamma as monotherapy and in combination with Tempo at ESMO. These data confirmed that TransCon IL-two beta gamma dosed every 3 weeks demonstrated clinical activity as monotherapy Our combination TRP, of course, late line heavily preceded patients in multiple tumor types, Further strengthening our confidence in its best in class potential. In 2, out of 3 small Lung cancer patients treated with combination therapy in the trial and confirmed partial response And unconfirmed complete response in the first tumor assessment of an ongoing patient were observed.

Speaker 2

We believe these data are intriguing despite the very small sample size considering the treatment history of the responders and the Sample on with medical need. Enrollment is ongoing in the indication specific 4 of I believe, where we are now enrolling 20 to 40 patients in each indication, And we expect interim results in the second half of twenty twenty four. In summary, with growing revenue Maturing off our pipeline, we continue to progress to our goal of becoming profitable. With our vision 3 by 3 on track to be achieved in 2025, we are preparing for our next vision for growth through 2,030. In our next vision, which I look forward to sharing with you at the beginning of 2024, we will work To lever our fully integrated capability to become the leading endocrinology rare disease company, taking product from contact out In other areas Where we believe TransCon can deliver best in class product candidate, as we have been oncology ophthalmology, we plan to pursue partnership Our business model to take out our product candidate to late stage development to commercialization.

Speaker 2

Such future partnership in oncology and ophthalmology, along with the maturation of our endocrinology program Globally, for our endocrinology rare disease portfolio, we believe Ascendis will deliver sustainable value over the long term I will now turn the call over to Scott for a financial

Speaker 3

Thank you, Jan. As Jan noted, we believe we are making significant progress It's our goal of becoming cash flow positive with Skytrophy revenue growing each quarter combined with diligent expense control. I will touch on some key points surrounding our financial results. But for further details, please refer to our Form 6 ks filed today. Total revenue for the Q3 of 2023 was €48,000,000 Skytrophy revenue for the Q3 was €47,000,000 compared to €35,900,000 reported in the 2nd quarter And €12,300,000 reported in the same period last year.

Speaker 3

The sequential growth in Skytropha revenue Was primarily driven by increased demand in the U. S. With minimal foreign currency impact of around €100,000 Exiting the Q3, we estimate we have low double digit penetration into the U. S. Pediatric GHD patient population, And we see a large opportunity in front of us to grow our patient share in pediatric GHD, which we estimate to be only half of the

Speaker 4

addressable U. S. Growth hormone market.

Speaker 3

In the Q3 totaled €111,400,000 up 6% sequentially from the Q2 of 2023, Primarily driven by higher endocrine rare disease related costs, including clinical expansion and PPQ manufacturing costs related to TransCon C and P, partially offset by lower oncology related costs. SG and A expenses declined 9% sequentially to €3,600,000 compared to the Q2 of 2023, primarily related to lower commercial and G and A external costs. Total operating expenses were €175,000,000 for the 3rd quarter, Flat sequentially from the Q2 of 2023. Overall, our operating loss declined sequentially by 5% to €134,000,000 for the 3rd quarter from €141,000,000 in the Q2 of 2023. We ended the Q3 with cash, cash equivalents and marketable securities totaling €455,000,000 including proceeds from the previously announced $150,000,000 royalty funding agreement.

Speaker 3

Looking ahead, with continued momentum for Skytropha in the U. S, we are increasing full year 2023 Skytropha revenue expectations to €170,000,000 to €175,000,000 Let me now also Provide a review of selected key program milestones. For TransCon Growth Hormone, we expect to report top line data from the global Phase 3 Foresight trial in adult GHD in December, potentially opening an opportunity to both expand As well as expand the overall growth hormone market. For TransCon PTH, As Jen noted, we are on track to resubmit our NDA for TransCon PTH for adults with hypoparathyroidism before mid November. We expect the European Commission decision on TransCon PTH this month.

Speaker 3

If approved, we plan TransCon PTH as our 2nd product launch in Germany starting in January 2024. For TransCon CNP, we to submit an IND amendment or similar for a new clinical trial evaluating TransCon CNP in combination with TransCon Growth Hormone And as a reminder, we expect to report top line results from APPROACH, our Phase 3 trial TransCon CNP in the second half of twenty twenty four. Within our oncology therapeutic area, Enrollment continues in the Phase 2 portion of our ALBA leave trial of transconial 2 beta gamma in indication specific cohorts. We expect initial data from indication specific cohorts in the second half of twenty twenty four. With that, operator, we are now ready to take questions.

Operator

We will pause for a moment to allow questions to queue. Our first question comes from Jessica Fye with JPMorgan. Your line is open. Please go ahead.

Speaker 5

Hey, guys. This is Nick on for Jess. Thanks for taking our questions. Can you talk to us a bit more around your strategy with The oncology and ophthalmology programs and kind of what that means in terms of OpEx, both over the near term and maybe more so over the long term and how that could change?

Speaker 2

Thanks, Nick. The question related to What do we do as a company with a very, very strong platform technology that basic have application in Nearly every therapeutic era. We at Sandys will be focused on rare disease Endocrinology, this is where we will be integrated from my dear state out to the patients where we're building up all the effort. We also know that the Transcom technology would provide paradigm shift product, Best in class product outside our own focus area. And we also feel that we need really to be part of that value creation also to the benefit We will have different business models that will fit exactly to each single telephylaxis.

Speaker 2

Some areas we will basic out licensing on an early stage where the feeling is that is the optimal thing. It could be potentially Last patient indications where we basically never can succeed with running all the big clinical trial, It can be areas like ophthalmology, where we mature it to a stage and then we potentially give it out Either to a spin out or an out licensing or a combination of both where we feel that an independent management team Really with the focus on, for example, ophthalmology really, really can mature it. It's not the same thing as Sandisnod where we continue to be involved. We will still provide service to this entity. We will be part of the upside, both related to royalties, Milestone payment and equity.

Speaker 2

In all areas like oncology, where we feel That we really can make a huge difference on the patient. We made an investment in it and we will continue to make an investment And so we feel that we can get the full value on this. And when I see how we progress with this Oncology effort, I'm really, really proud about it.

Speaker 5

Okay, great. And Maybe can you help set the stage for the update from the Phase 2 ACCOMPLISH trial and what you hope to see when you have all the

Speaker 2

Yes. What we hope to do that We will provide you with the element that we really believe is essential for the patients. We will provide you with the sustainability of how we keep the positive benefit on growth, But we will also come in and trying to give you the explanation both from a scientific base, but also through data, how We feel that we are providing a benefit to the treatment besides just providing them analyzed high velocity. We're 100% in the belief that the key element for us is to address the co morbidities Associated with this disease and that is our focus on that. And this is why we believe that analyzed hypervelocity is an element, If it's desired and if the patient really want to have it, they can always go into perhaps the most Powerful combination of treatment is CMP to move the brake growth hormone to speed up the And you basically will have what we call the wanted, desire, analyze, high velocity

Operator

The next question comes from Paul Choi with Goldman Sachs. Please go ahead.

Speaker 4

Good afternoon and thank you for taking our questions. My first question is just with regard to TransCon PTH Positioning in the major European markets, specifically Germany, and just how you think positioning will be particularly Given surgical complication rates there and then just the pace of reimbursement access. And then I had a follow-up question.

Speaker 2

You're right. The European and the international market, as we call it, is what we call Much, much more diverse way of reimbursement. The fastest one is Germany, where already from January, where we expect to launch TransCon PSA, will be fully reimbursed. The patient population in Germany is actually pretty large compared to the size of the country, Mainly driven by a higher treatment on head and neck operations. So you're right, it's a post surgical patient that is And we believe the addressable element of patient, not the total patient population is about 22,000.

Speaker 2

At the same time, we are in a position where the only approved Treatment for hypopara in Germany is being taken away from the market. So we are in an intensive Discussion with all the key centers how we really can help more than the 400 patients that basic Already, I established on the PTH treatment, how to take 1 on treatment in 2024. Besides that, for many years, there has been a long, long layout of patients that want to be on a PTH treatment, But never have the opportunity to do it. And this is why the European approval give us a fingerprint Starting immediately on a full blown commercial effort in Germany, at the same time, an European Or EC approval give us the opportunity to go to a named patient program and addressing more than the 400 Plus, NATA patient that still is in other European countries, which we feel a huge responsible for also helping and also The patient that didn't come into any treatment in the last many years. Rest of AU will take 12 to 24 months To be fully reimbursed, fully running commercial perspective.

Speaker 2

At the same time, the EU approval, Which we expect to get here in the coming week will provide us with an approval system for addressing patients In the international market, some markets we will have an independent application. Other market we can Directly refer into our European application. So, we are dedicated really to help Patients everywhere in the world, which have a need for the treatment because of The hypo para patient situation that they face

Speaker 1

today. Okay,

Speaker 4

great. Thank you for that. And just as a quick follow-up, With competing HGH products approved here in the U. S, can you maybe just comment on maybe what mix of formulary Access might be up for renegotiation this year. And any general comments you've had into the 2024 renegotiation period?

Speaker 4

Thank you.

Speaker 2

I've been asked in the last 3, 4 months a lot. What is really the impact on having 2 or long acting product in the U. S. Market? And clearly, clearly, we never have seen more interest.

Speaker 2

We have not seen better Numbers ever since it got clear, we really best in class property Skagtober has Compared to the other products, really building up on what we have established in the last 2 years, how we really are changing the treatment we're seeing in treatment of pediatric growth hormone deficient with a better outcome. And that is not going to change with any other long acting. Basic is just providing, I believe, for some of them, and lower

Operator

The next question comes from Joseph Schwartz with Leerink Partners. Please go ahead.

Speaker 6

Great. Thanks so much. So a couple of

Speaker 5

questions on TransCon CNP, if

Speaker 6

I could. First of all, I was intrigued by your commentary about, chondroplasia being not only a bone disease, but having a muscle And I was curious if you could just talk a bit about how you intend to Illustrate the benefit of TransCon CNP on that those aspects of the disease. And then also, in terms of TransCon CNP's potential comp to be combined with TransCon or Skytropha rather, as it's now called. I was wondering, Given I thought a lot of the earlier science suggested that growth hormone supplementation in achondroplasia Just an ephemeral benefit, what are your thoughts on

Speaker 2

Thanks Let me start with your last question about the annualized high velocity. We always have known that Globetamin had a positive effect on achondroplasia. Sometime it has been a little bit unclear what Has been the magnitude on that because it typically have been small trials. When we saw the trials coming out from the Japanese group, pretty well controlled, following patients up to 5 years, The number is nice, 41. Everything looks great.

Speaker 2

They have 1 year before treatment follow on what is the analyzed height velocity before Treatment and it's about 4.2 exactly what you will expect to see out from this kind of demographic. And the 1st year Analyze high velocity up on 7.3, 7.4. That is more than I've seen any kind of CNP treatment ever given. And when you have 41 patients, I always feel that it's a number that gives me some pretty good comfort. And it's the best analyzed hype velocity I have ever seen in any hype trial with achondroplasia patients.

Speaker 2

We went back and analyzed 20 publications about all small trials, some of them all of them. And you know, if we are being smart, really have gone to the literature in-depth, then we can actually have seen it because often this 20 publications, we nearly got the same number when we added everyone out. So this is not surprising. It's something that has been in the literature Have potentially been understated, undervalued, but there is no doubt best analyzed high velocity you can get in air condition today It's on growth hormone. The problem with that is, would it really address comorbidities?

Speaker 2

I don't believe that. I believe that the biology behind the achondroplasia is a much more complicated Biological impact on a hyperactive FDR to U. S. Sector. And there it comes in Because in the end, we're just starting the beginning of the beginning of achondroplasia treatment.

Speaker 2

We're not in the end of the beginning even. We are in the beginning of the beginning because we need to address the comorbidities. So, this is why we believe The treatment is potentially moving to a combination treatment, where CMP will address some of the biological systems Where we believe achondroplasia or the hyperactive FDL3 pathway are modifying and disease That basic are also of the most impact. And you asked me why did we see that? It was basic for patients, The parents, the caregivers that came back to us, we got in the patient reported outcome.

Speaker 2

We can see after 1 or 2 months, There's some mistake that patients are providing much better, function much better And we said it cannot be growth. It cannot be growth. And then we started to analyze this and we realized that is a strong muscle component of that. And what we would like to do when we have our CMP update, we will give you the biology behind it, explain why we do that. And also, we believe that it's important for us also provide you data with the combination therapy, because I believe in the combination therapy, you can get what It will analyze high velocity, potentially the same as you can see in growth hormone deficient up to 10, 12 centimeters.

Operator

The next question comes from Yaron Werber with TD Cowen. Please go ahead.

Speaker 5

Maybe one very quick one and the second one is

Speaker 3

a little bit bigger.

Speaker 5

Just on the PTH, the refiling is going to be sort of in the next week or so. Can you just comment, did you sort of by this point work out all the analysis that FDA is going to want you Do you feel like you have good clarity? And then secondly, on the preclinical GLP-1, The data with CEMA obviously looked interesting on a monthly basis. What are sort of the next steps as you see them before you can start IND enabling Adi, is it you're still trying to fine tune the construct or is it potentially trying to figure out, is this something you want to take yourself or Is this something that you want to ultimately potentially partner? Thank you.

Speaker 1

Hey, Yaron. This is Tim. Let me take the first part. As Jen noted on his prepared remarks, And besides the information that we just discussed, we're not going to provide we're not going to comment further on the resubmission process.

Speaker 2

Okay. Related to the GPL-one, we are in a great state. We came out with the data. It provided the interest that people could see the value in it, both as an improved once weekly treatment, but also on a once monthly Treating for this important segment going up. And we basically continue the dialogue with companies that interested in Daidair.

Operator

The next question comes from Leigh Watson with Cantor Fitzgerald. Please go ahead.

Speaker 7

Thanks for taking the questions. Just first one, we've seen daily products continue To retreat and reduce output in Q3, can you just talk about how much of a tailwind that has been for SKYSHOFAN? Where do you see that trend to track in the coming quarters?

Speaker 2

The question you are addressing, what is really happening in the growth hormone market? And I think what we are seeing is the results of the consolidation That we have predicted, had expected to happen, and that is basically what you see In the marketplace today, 4 years ago, when we came up with our Phase 2 data and we didn't out licensing our TransCon, growth hormone, a lot of this established player, basically said, okay, let us find out how we can milk This year in the best possible way. And you don't invest by investing in production capacity. You don't Really get the highest property to investing in anything. So this is why you're seeing a daily growth hormone market, basic only have 3 player left now with a sales force, infrastructure and other things like that.

Speaker 2

So instead of having a 6 player, you're down to 3 player and likely there will be a fewer player in the coming year when the really the real consolidation will happen. So some way you're saying is that it's a shortage, but the shortage is also indicated in the way that the consolidation of the I can promote it as short as profit because if it were old days with many more company really could provide more It's not changing the fact why Sky Trofa is the leading company, leading brand in value is because we're providing best in class properties and it's getting realized By physician, by caregivers, by patient and I hope and we know that also by the reimbursement system.

Speaker 7

Okay. And then maybe just a question on TransCon L2. You show some pretty nice Data in small cell lung cancer, so is there any point to add this indication to our expansion cohort?

Operator

That's a great question, Lee. Yes, we were very encouraged by our initial signal in small cell lung cancer and we are exploring The next question comes from Leland Gershell with Oppenheimer. Please go ahead.

Speaker 8

Hi, thanks for taking my question. Just wanted to ask further on the plans to explore TransCon CNP for benefit Side of high velocity in terms of other comorbidities. Wondering Anne, if you could just maybe go into, maybe beyond muscle, are there other measures or endpoints That you're contemplating to include

Speaker 2

in upcoming studies. Thank you. We are exploring a lot of different elements. We 1 I would like to group it a little bit. One is the patient reported outcome, where you have both our own developed way to look at it.

Speaker 2

You have Establish one as SF10 and other way that really are catching how you potentially have a physical benefit Of this treatment in ANA. So this is one what we call the patient reported outcome. The other one we're looking for is dedicated co morbidities. Are there a clear pattern where we see less comorbidity over a year period because you need to go through some season to be quite You're picking up what kind of element of coal or other thing could influence it. The other one is more hard Core element where we basically have a lot of x rays of the patient, are they really changing the Scoliosis are the changing elements and we're looking on all different kind of bone development and other things This is in the older children.

Speaker 2

When we go to the newborn, we started now, we go for much more hardcore facts how to, for example, Benefit in spinosis. Do we see the same element of fast fusion of Synchronize or other things like that. And I think this is where we take the different age group, finding out what can we really do with that. And that is what we're analyzing and building into our pivotal Phase III trial now. So we're quite sure when we have The unblinding on that, we basically have already the element of discussion with regulatory agencies how we basically can evaluate that.

Speaker 8

Okay. Thank you. And then, one further question, if I may. As we look forward to the update from the 1 year follow-up from Accomplish Open label extension. Just wondering, would you be able to provide the retention rate in terms of patients who persisted in the OLE?

Speaker 2

At the one the data we will have to have all 47 patients. 57. 57 patients.

Speaker 8

Great. Thanks very

Operator

much. This does conclude today's Ascendis Pharma 3rd quarter earnings call. You may disconnect your line at any time.

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Ascendis Pharma A/S Q3 2023
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