Ascendis Pharma A/S Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
April 27, 2023

There are 15 speakers on the call.

Operator

You for standing by, and welcome to the Q1 2023 Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentations, there will be a question and answer session. As a reminder, today's call is being recorded. I would now like to turn the call over to your host, Mr.

Operator

Tim Lee, Senior Director, Investor Relations. Please go ahead.

Speaker 1

Thank you, operator, and thank you everyone for joining our Q1 2023 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations Ascendis Pharma. Joining me on the call today is Jan Mickelson, President and Chief Executive Officer Scott Smith, Executive Vice President and Chief Financial Officer Doctor. Stina Singhal, Executive Vice President and Head of Clinical Development Oncology and Joe Kelly, Senior Vice President and Head of Commercial Endocrinology. Before we begin, I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act.

Speaker 1

Examples of such statements may include, but are not limited to, our U. S. Commercialization and development of Skytrufa for the U. S. Market our revenue projections for Skytrufa the commercialization of TransCon HGH for the EU market Statements regarding the expected timing of the approval the expected timing of potential approval and launch of TransCon PTH in the U.

Speaker 1

S. Market, Statements regarding the expected timing of the potential approval of TransCon PTH in Europe, the statements regarding the potential market size for TransCon PTH, Our progress on 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 our ongoing and planned regulatory filings and our expectations regarding the timing of the results of regulatory decisions, Our expansion into new therapeutic areas and statements regarding our ability to create a sustainable, profitable, 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 our forward looking statements and we may not be able to achieve our goals, carry out our plans, our intentions, our expectations, our projections disclosed in our forward looking or our 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 incur or terminate.

Speaker 1

We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that Actual results to differ materially, please see our forward looking statements section in today's press release and the Risk Factors section of our most recent annual report on Form 20F Filed February 16, 2023. TransCon Human Growth Hormone or TransCon HGH is approved by the FDA in the U. S. Under the brand name Skytropha for the treatment of pediatric patients 1 year and older weighing at least 11.5 kilograms And having growth failure due to inadequate secretion of endogenous growth hormone.

Speaker 1

In addition, the European Commission has granted a marketing authorization for Skytrosa Tuasenus Pharma developed under the name TransCon HGH as a once weekly subcutaneous injection for the treatment of children and adolescents aged 3 to 18 were growth failure due to insufficient secretion of endogenous growth hormone. In general, if we refer to This product is TransCon Growth Hormone unless referring to the product in the context of particular jurisdictions such as the United States or the European Union. Otherwise, please note that our product candidates are investigational and are 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 made on the conference call regarding our product candidates shall be viewed as promotional.

Speaker 1

On the call today, We'll discuss our Q1 2023 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer. Jan, to you.

Speaker 2

Thanks, Tim. Good afternoon, everyone. Ascendis continues to execute on the strategy we have laid out in our vision 3x3 And our commitment to improve patient lives by building a sustainable, profitable leading biopharma company. Based on the strength of our clinical data for TransCon PTH, including the positive feedback And the significant unmet medical needs of patients living with hyperparathyroidism. We remain convinced that TransCon PTH can be approved and become an important new treatment option.

Speaker 2

We remain dedicated to working with FDA to bring this product to the U. S. Market as quickly as possible. And we are on track in EU with an expected regulation regulatory decision later this year. In the U.

Speaker 2

S, our PDUFA date of April 30, 23 is coming up, and we expect to get feedback from FDA soon on the next steps forward. Hi, there are multiple possible scenarios. Our team is well prepared and our belief in the approverability of transcompetades In the U. S. Is unchanged.

Speaker 2

We launched Skytrophy with a commercial strategy Built on its product strength with the goal of making it the leading product in value in a growing growth hormone market. With each quarter, we believe that is more and more clear that Skytober is on track To become the U. S. Market leader in value in a growing growth hormone market and a blockbuster product. We believe the success of SCALTOFA we are seeing now is driven by the following three factors.

Speaker 2

1st, treatment experience. Many physicians have now had patients with 12 months We have world experience with SkyTruth. The time period that is necessary to observe an improvement in linear growth and other endocrine benefits. 2nd, consolidation of daily growth hormone market. This consolidation started 3, 4 years ago.

Speaker 2

When daily growth companies began to realize That their existing daily product will be phased out with time when once weekly treatments came to the market. We saw daily growth hormone companies reduce investment and optimize their business in this phase out period. We believe the current supply channels of daily growth hormone product are a consequence of this, which further support the uptake of SKYTOFA. 3rd, Ascendis' dedication and investment in endocrinology. We are investing in building relationship with physician, Patients, caregivers, providers, with our investment in a dedicated commercial And medical affairs team supporting our endocrinology efforts.

Speaker 2

We're also building a robust Supply chain for SKYTOFA indicating to patient, physician and provider that we are a Trusted partner with a solid supply chains. As a result, Q1 2023 SCTOROVA revenue grew to €31,600,000 Based on the algorithm we described earlier this year for 20 20 3, outlook using 1st quarter sales of €31,000,000 and our goal of adding as many New reimbursed patient in 2023 as we did in 2022. We now expect full year 2023 Skytope revenue between €150,000,000 €160,000,000 Our revised outlook for 2023 provides a new higher foundation for 2024. We are pushing global market leadership for SKYTOFA to geographic expansion and potential label expansion. The SKYTROFA commercial launch in Germany is on track for the Q3 of 2023.

Speaker 2

In the Q4, we expect top line results for the Phase 3 Foresight trial in adult growth hormone deficiency, which is designed to demonstrate the impact of SKYTROFA on body composition in adult patients with growth hormone deficiency. Turning now to TransCon PTH. As I mentioned at the start of today's call, We are dedicated to get TransCon PTH to patients suffering from the serious health and qualify of these Life issues caused by hyperparathyroidism. And we know that the patient community share our goal. We continue to be excited about the potential TransCon PTH could have on addressing the significant un Met medical needs of hyperparathyroidismat patients.

Speaker 2

The open label extension of our Phase 2 PATH FORWARD and Phase III Pathway trials for TransCon PTA are ongoing with 145 Of 154 of the original clinical trial patient continue on treatment with TransCon PTH for now up to 3 years. In addition, in the U. S, our expanded SS program continues to enroll new patients every week. Europe, as previously announced, we received the comprehensive day 120 response from European MediCine Agency and we are very pleased with the feedback. We anticipate a decision on our M and A during the Q4.

Speaker 2

And if approved by the EC, we expect to launch in Germany in early 2024, levering our established commercial infrastructure. We are also applied to initiate an early assets program for TransCon PTH initially in Germany. Assuming approval for this program, we expect to indicate and erode the 1st patient in Germany this quarter. Moving to achondroplasia, TransCon CNP. Our clinical data and positive physician feedback continues to differentiate TransCon CNP and reinforce our commitment that it has a potential best in class product profile in the 4 key pillars of drug development: safety, efficacy, tolerability and convenience.

Speaker 2

More importantly, We believe TransCon CNP also has a beneficial effect on achondroplasia comorbidity besides Promoting increased linear growth. We believe that is why all 57 patients who started in our Phase To accomplish time remain in this open label extension. Later this year, we will have an R and D event Focus on TransCon CNP to share new clinical data and the signs that we believe support its best in class Swearing to oncology. We have 2 programs moving ahead with recommended Phase 2 doses in specific indication, TransCon TLR-seventy eight agonist and TransCon IL-two beta gamma. Next month, in May, we will hold an oncology R and D event in New York Around ASCO to give you an update on these two important programs.

Speaker 2

At this event, Ascenius And key opinion leaders with experience in our clinical studies plan will share key data from the dose escalation portion of Our 2 first in human tribes. Finally, as I said before, We are managing our business for long term value creation and continue to aim to achieve cash flow Breakeven without the need for additional dilutive equity financing. I will now turn the call over to Scott for a financial review before we open for questions.

Speaker 3

Thank you, Ian. I will quickly touch on a few points surrounding our financial results. For further details, please refer to our Form 6 ks filed today. As Jan noted, Skypropha revenue for the Q1 of 2023 was €31,600,000 Revenue in Q1 would have been €1,400,000 higher excluding a negative foreign currency impact compared to the Q4 of 2022. Total revenue was €33,600,000 including Skypropha revenue as well as Wi Sense, Clinical supply and services provided to 3rd parties, primarily Visa and Pharmaceuticals.

Speaker 3

During the quarter, we continued to demonstrate our cost discipline offsetting seasonally higher employee costs in Q1. Total operating expenses were €173,000,000 for the Q1, up 5% sequentially from the Q4 of 2022. Overall, R and D costs declined 2% sequentially, primarily driven by lower endocrinology related costs, partly offset by an increase in oncology related costs. SG and A expenses grew 18% sequentially, primarily due to increased Support for Skytrophic commercialization and pre launch activities for TransCon PTH. Overall, our operating loss Declined sequentially by 3 percent to €144,000,000 for the Q1 from €147,000,000 in the Q4 of 2022.

Speaker 3

Our main 2023 commercial product manufacturing campaigns, which are capitalized rather than expensed, Are expected to be completed in the first half of twenty twenty three, which would further reduce cash expenses in the second half. Finally, we ended the Q1 with cash, cash equivalents and marketable securities totaling €586,000,000 Based on Q1 results, we are on track to exceed the current Ascendis compiled 2023 consensus estimate of €98,000,000 For Skytropa, using the algorithm Jens laid out in his remarks, Skytropa revenue is expected to reach €150,000,000 to 100 and €60,000,000 for full year 2023. Supporting our goal of achieving cash flow breakeven without additional dilutive equity financing, We are implementing additional cost controls and productivity improvements, which we anticipate will be realized starting in Q3 and beyond. Let me now also provide an update on selected key 2023 corporate milestones. For TransCon Growth Hormone, we are on track to Launch SKYTROFA in Germany in Q3 and we expect to report top line data from the global Phase 3 Foresight trial in adult GHD, Our second indication in Q4.

Speaker 3

For TransCon PTH in the U. S, our PDUFA date is April 30th, So we expect additional clarity on our NDA application in the coming days. We expect the European Commission decision in Q4. If approved, we plan TransCon TTH is our 2nd product launch in Germany in early 2023. For TransCon CNP, we are on track to complete enrollment of the Phase 2b APPROACH trial in achondroplasia in Q2.

Speaker 3

And later this year, we will share long term follow-up data from patients on 100 micrograms from our open label extension of our Phase 2 ACCOMPLISH trial. Within our oncology therapeutic area, as Jan mentioned in his remarks, we will host a research event On May 31 in New York to review the science underlying our oncology portfolio, review initial data on transconyel-two beta gamma And hear from KOLs who have clinical experience with both of our oncology product candidates. As you know, the PDUFA date for our NDA for TransCon PTH is this Sunday, April 30, and we expect to receive a response From the FDA by then. Given the proximity to the PDUFA date for the NDA for TransCon PTH, We will not be providing additional details regarding this NDA at this time. With that, operator, we are now ready to take questions.

Operator

Thank Our first question comes from the line of Jessica Fye of JPMorgan. Your line is open.

Speaker 4

Great. Good afternoon. Thanks for taking my question. I know it's difficult to comment in advance of the PTH PDUFA, But at a minimum, can you just say if you now know the deficiencies that the FDA Has regarding the PTH NDA, I believe those were not previously outlined in the letter. Do you know them now?

Speaker 2

I can say no to your question and have no further comments.

Speaker 4

Okay. And then when you talk about managing the business to achieve the goal of cash flow breakeven without the need for Dilutive Equity Financing, can you elaborate just on like what your expectations are For PTH that are kind of embedded in that breakeven assumption?

Speaker 2

We are dealing with a lot of different scenarios because as we indicated before, we do not know The exact nature of the deficiency and we are working with what we call the best case and worst case. We're looking on our vision 3 by 3. We want still to fulfill that. We want to build up a leading biopharma that's both sustainable and profitable. We can continue to this.

Speaker 2

So from our perspective is that we are taking into the assumption. We are launching SKYTROFA In Germany, here in Q3, we're taking into the assumption we are launching TransCon PTH in Germany and Europe through different systems in beginning of 2024. We are building that CATOVA in the U. S. Is going to the assumption we have laid out in 2023, And we will continue that growth in 2024.

Speaker 2

And even from the worst case to the best case, We can get the 2 things together and still fulfill our vision 3 by 3.

Speaker 5

Thank you.

Operator

Thank you. One moment please. Our next question comes from the line of Tazeen Ahmad of Bank of America. Your line is open.

Speaker 6

Hi, guys. Good afternoon. A couple of questions, if I can, on GHD, you've issued sales guidance for the year. I think as recently as the beginning of the year, you might have been more tentative On that prospect, I guess what's changed during the quarter to, I guess, number 1, make you feel confident that you can project out the rest of the year? And can you tell us some of the major drivers you took into consideration when putting together the sales guidance such as perhaps Switch rates versus new patient starts and any assumptions you can share on compliance would be great as well.

Speaker 6

Thank you.

Speaker 2

Thanks for the question. We're feeling much more confident now when we go to Q1, because now we accumulated on top of a big sum. That is a mathematic algorithm even I can understand without an MBA. So the situation is very, very simple. You have EUR 31,000,000 here in Q1.

Speaker 2

We have seen and our experience for the many Months, we have with Skytova, we're not basically not losing patients. So if I multiply the €31,000,000 with 4 times And then we just add the same amount of new patients as we did in 2022, getting exactly to this number 100 and Between EUR 150,000,000 EUR 160,000,000. I think it's a very simple agreement built on solid number, and this is exactly why I feel I can stand in for this year. I have everyone in the Ascendis organization to sign on for this. So we feel confident that we can fulfill this.

Speaker 2

And this is why I'm feeling we will come up with guidance. When we're feeling we can give you reliable guidance That you can use in the modeling, so you're feeling that we're feeling that we give you a number that we can stand in for.

Operator

Thank you. One moment please. Our next question comes from the line of David Lebowitz of Citi. Your line is open.

Speaker 7

Well, thank you very much for taking my question. When you look at Skytropha into the rest of the year and the dramatic growth you're expecting, how should we look at that in the U. S. Versus Europe.

Speaker 2

The guidance we are providing to you is only reflecting U. S. Sales. We have not given you a guidance related to Europe. There will be on top of that.

Speaker 7

Got it. And I guess, could you just remind us of when we can expect the next TransCon CNP updates and what your expectations are going into that?

Speaker 2

The update we will provide for you as we indicated here in when we come to the beginning of the fall, Likely in Q3, we will host and research event in New York as we do now in oncology here in May, We will go through the science behind the CMP, because I think sometimes it's getting forgotten that Every product has its own mode of action. It signs and the signs in the end will decide the clinical outcome you will get And how to understand the clinical outcome. We have always said, we're not here for just addressing linear growth. We're here for addressing the key element of what a treatment for atcontemplation need Treatment of comorbidities, and that is what we always have been focused on. And I believe we at that resource event can give you The data, the science behind the data that really can give you the way we are thinking and believe That we're building up in best in class product opportunity in this disease area.

Speaker 7

Thanks for taking my question.

Operator

Thank you. One moment please. Our next question comes from the line of Paul Choi Goldman Sachs, your line is open.

Speaker 8

Hi, thank you and good afternoon and thanks for taking our questions. Jens and team, I guess one question that investors have with regard to PTHs. As you Think about your earlier statements where you expect a clarification from the FDA shortly. Have you Since the call that you held a few weeks ago provided any additional data updates or have there been any other requests from the agency?

Speaker 2

I think we need to refer to the statement that Scott clearly wrote up that we will not Comments further on any interaction we have of FDA at this time.

Speaker 8

Okay. And then on the commercial side, with regard to the European launch for growth hormone, Can you maybe comment on any preliminary discussions you either have had with IWIG or GKSV And just kind of how to think about the reference pricing versus the potential reference pricing in Germany versus some of the other available products in the category?

Speaker 2

I believe the dynamic we saw in U. S. And how we tackled in U. S. Is Exactly happening in the same way in Europe.

Speaker 2

There is established daily growth hormones. They have the same issue that they have here in the U. S. We will come in with a treatment regime that is superior for the patient. And I believe we will have the same responsible superior pricing that we do in the U.

Speaker 2

S. Also in Europe.

Speaker 8

Okay. Thanks. I'll hop back in queue.

Operator

Thank you. One moment, please. Our next question comes from the line of Leigh Watsack of Cantor. Your line is open.

Speaker 9

Hey, thanks for taking our questions. I guess, can you provide maybe some guidance on the OpEx side? I mean, I guess, starting in Q3, given that you may have a delay with And you mentioned earlier that you have a focus on cost control. Maybe help us And how should we think about, OPAY going forward? And for the early access program in Germany, how many patients are

Speaker 2

Let me take the last question First, because the program in Germany, Where we start in Germany, where we have applied for an approval for INITATE it, it's different compared to the U. S. Program because it's actually delectable for both all patients with hypopara and not as for U. S. Is highly Restricted to patient that basic is highly PGA's experience.

Speaker 2

So it will be a much broader program. The dynamic is also very, very, very different because, for example, the program is terminated automatic the day you're getting Approval and the patient needs automatic conversion over to reimbursed patient. So it's a different system than you actually have in the U. S. System.

Speaker 2

So this is why we will someway give access to the patients. There is the same unmet medical need. There is a series of patient, multiple hundreds of patient on the power today. Then note, they're Under highly restricted constraint because nepar is disappearing in the beginning of 2024. So they want to have time to Really changed this patient over to TransCon PTH.

Speaker 2

At the same time, we opened it up for all other patients because there was so much And you can say strong desire from the treatment physician also to give it to patients that actually never have seen All PTA's program before. So this is why it's a different program. Going back to your Comments about how we are some way of running the financials at Ascendis. And I actually made it very, very simple in this way. We have one bucket with cash in, which is out of the water.

Speaker 2

And then we take something in every day. And you can see we grow it and grow it, grow it now with U. S. SKYTRAFA. We will grow it with U.

Speaker 2

S. Outside U. S. Also revenue there. And we always want to have a solid amount of water into this bucket.

Speaker 2

And we do that by basically ensuring that we run our business, Optimizing our business, optimizing the way we perform our procedure. What function path for 2 years ago is not function today, is not the most way to do it. This is how we adapt it. We are a global company, would give us a lot of benefit to really optimize our business in different means. And that is exactly what we are doing to ensuring we always will have enough water in the bucket to feel safe.

Speaker 2

If we start to Be dry around us. We always have enough to drink.

Operator

Okay. Thank you. One moment please. Our next question comes from the line of Derek Archila of Wells Fargo. Your line is open.

Speaker 8

Hey, great. Good afternoon. Thanks Just two from us. Yan, you mentioned earlier in the call, yes, you're not commenting on interactions with the FDA. So Is it fair to assume that you've had some interactions since the deficiency letter that you do not want to comment on?

Speaker 8

So that's question number 1. Question number 2 is, You talked about this attrition strategy in the growth hormone market. So kind of expecting these competitors to exit the market maybe because it's not profitable for them, Leaving you and maybe 1 or 2 other players in the market. So I guess what catalyst needs to happen for this to play out? And what's kind of the timing on that?

Speaker 8

Thank you.

Speaker 2

Yes. Obviously, it's easier for me to answer first question because there's no answer. So going to the second question, which are really A high valid question because it's Axel. I believe someone should write a textbook of what happening in the growth hormone market here in the U. S.

Speaker 2

It was the first Place, you saw biosimilar having TAVR centers coming in. We saw how the entire market developed. And now we're coming to the next stage. The first thing, the biosimilar going in, then it went over to market access. And I can guarantee, we had so much interaction with Nearly every one of the daily growth among company except 1, I think.

Speaker 2

And we some way got a really, really good Insight in their thinking. And the insight is exactly how I also would act. The element is that when you have a superior treatment coming into That basic are making a paradigm shift in the treatment regime. You know, if you're sitting with What we call the established that cannot follow this treatment regime is only how really to optimize your business at that time. So you follow the classical textbook.

Speaker 2

First of all, you get rid of the sales force. The second one, you get rid of all promotion. You get Basic optimizing the manufacturing software the way you never invest in it, then you terminate the manufacturing after you have a bulk product sitting And then you're just selling that and then you're out. And I can guarantee it's one of the best P and L you can get out of that business. This is really where you have a great P and L.

Speaker 2

But the problem is, it's not sustainable. Some of the daily growth hormone, you can find that out. They try to sell it. No one wanted to buy a dying product. That's why no one can sell it.

Speaker 2

So therefore, the entire consolidation started 3 or 4 years. What you start to see now is the consequence of it. And you're likely right, there will only be 1 or 2 daily growth hormone Provider because there will potentially be a cash segment, there will be other things where the potential will be an element of what we can call a low priced Element where they don't really need optimal treatment or anything like that. And this is where you typically will see 1 or 2 player be.

Operator

Thank you. One moment please. Our next question comes from the line of Leland Gershell of Oppenheimer. Your line is open.

Speaker 10

Hi, good afternoon and thanks for taking my question. Just another question on the SpectroFA trajectory, it's obviously very healthy bump up from 4th quarter. And wondering if Yaniv, if you can comment, as that coincides with the turn of the year, were there any aspects related to More favorable reimbursement with the New Year and or changing dynamics of the daily growth hormone space as you talked about They may have favored Skytrosa. Thank you.

Speaker 2

I think we had the 3 pillars we discussed in my part of the script, Which I actually think illustrate very well the transition we're coming to. And I believe when we first go to the first treatment experience, It actually takes 12 months for a physician really to see the improved really the improvement in linear growth And other endocrine benefits. And when you see a new product, I think often as a physician, you will wait to see In a few number of patients before you expand further on. The second thing is the consolidation of the market, which sure is happening and there was just a Consequence, when it start to tick in with the tick in the 23, with the tick in the 24, we know it will happen, but we didn't know exactly when it will be. And I also believe, and this is where Joe comes in and will talk about, how we are investing in a dedicated best in class Endocrinology dedicated sales force and our medical affairs teams.

Speaker 11

Yes, yes. So yes, the commercial team Really have done a good job of executing in this particular market where we really disrupted how growth hormone is prescribed and also reimbursed By the PBMs and the payers and really it comes down to the clinical strength of SKYTROFA. It's efficacy, the fact that we don't have a preservative, a best in class auto injector, and again, the support that we can provide The offices and the patient to get reimbursed so that they can enjoy Sky Trova for their entire course of therapy. But the compelling story that we do have from a clinical standpoint is really a motivating factor for these healthcare providers to do the appropriate Documentation so that that patient can get approved and stay on our product.

Speaker 2

Thanks, Joe. Thank you.

Operator

Thank you. One moment please. Our next question comes from the line of Vikram Parrajat Of Morgan Stanley, your line is open.

Speaker 8

Hi, good afternoon. Thanks for taking our question. We had one on TransCon HGH. Could you just help us frame expectations for the foresight data expected in adult GHD in the 4th quarter? And also speak a bit about And how you're viewing the commercial potential for hGH for this part of the GHD population versus the pediatric population?

Speaker 8

Thanks.

Speaker 2

Really, really interesting way to look and why the adult growth hormone deficiency Trial is so really interesting for us. It's because we are in a situation where many Of the other indication that where you use growth hormone, you use linear growth as the primary outcome. Here In adult growth hormone deficiency, the primary endpoint is built on change in body composition, which are also One of the element you want to achieve in the pediatric population, but it's not really the primary endpoint. What we also have, we have a situation where we have a benchmark related to the daily growth hormones. We have a benchmark related that both the 2 other long acting have initiated Phase 3 trial Have reported Phase 3 trials in adult growth hormone deficiency.

Speaker 2

1 of them didn't manage to be better than placebo. The second one showed half of the effect compared to daily growth hormone. We believe Because SKYTROPHE is built on somatopoe, an unmodified molecule that can have the same mode of action like Daily growth hormone, I am endogenous growth hormone. We will be in a position that we hope at least we can see the same benefit as daily growth hormone. Potentially, we will be superior as we were in a situation in the pediatric, but we will wait to see the data.

Speaker 2

So we believe that it's a really, really strong integrated packet to see because it's first time where you really go out and analyzing Really the impact on a growth hormone treatment on the endocrine health, which body composition is part of it, But it's really parallel to some of the other benefits where you need to have the distribution throughout the body.

Operator

Thank you. One moment please. Our next question comes from the line of Joseph Schwartz SVB Securities, your line is open.

Speaker 12

Hi, thanks very much. So how leverageable is a sales force across 3 endocrine indications you're currently pursuing. I know when we look for physicians to speak on these topics, It seems a bit fragmented to us and we almost never find anyone who can speak on 2, never mind 3 of these endocrine So can you just talk a little bit about, how the sales force is currently structured and whether you won't have to Actually expanded significantly in order to reach achondroplasia and hypoparathyroidism specialists in addition to growth hormone folks?

Speaker 2

Yes. This is the holistic picture. You basically are saying why did we focus on building up as Really, really a strong pipeline of 3 independent products really focused on endocrinology. So the first one we have is Kytrophin. It both have a pediatric and adult indication.

Speaker 2

We have pursued the pediatric, now we go for the adult. We Have transplant PDAs. The main indication is adult, but also have a pediatric. We are going now. As Anna said before, we expect to getting an approval in what we call the adult hypoparathyarrhythmia As soon as we get the feedback, what is the deficiencies, when we know what the deficiencies is, we can address it This is what we will do extremely fast and ensure this product going out to the market.

Speaker 2

We will also pursue the pediatric indication in this segment. Then we have TransCon CNP. And people believe this is pediatric disease Because they're just focused on linear growth, we believe that basic is a treatment regime for achondroplasia also rest of their life. And this is one of the things we also would like to discuss when we come to the basic the research state. So when you see the holistic part on it, yes, it gives us a lot of synergy specific when you think about Reach out.

Speaker 2

We go to end of we have one stand. People come to us perhaps interest in PTH, perhaps interest in CMP, There's interest in growth hormone and they get the entire packet. They see endocrinologists, the physician, they see us Dedicated to be a leader in endocrinology because we so much focused on all different product opportunities. When you go to dedicated sales force, you can build up in different means and it's very much dependent on geographic regions. If you just think about U.

Speaker 2

S, I actually think what Joe and his team have done, they're actually building up what we call a Sales force that basically are dedicated to Skykrova, dedicated to PT8, but the basic can exchange it back and forth between the different sales force Because both have all the capability to be in it in this way. So I actually believe that we have some uncertainty in this way of operating.

Operator

Thank you. One moment please. Our next question comes from the line of Andreas Agueradz, again, Andreas Agueradz, your line is open.

Speaker 13

Yes. Good afternoon. Thanks for taking our question. A quick one here on TransCon CMP. So looking at the growing econtoplasmic market and the competitive landscape, could you expand on what data you're tracking and plan to provide to support TransCon CMP's impact outside of height.

Speaker 13

And do you see a potential to expand into patients or children under 2 years old? And Forgive us if that was already addressed.

Speaker 2

No, I believe that it's a summary. What we want to do is that you have linear growth with an element where we believe, sure, we can help a lot, we can do a lot When we can also potentially accelerate it in a combination between Skytruva and TransCon CNP. The element of what we call I can't do place specific comorbidities. And in the presentation we did when we released our Accomp this data, we basically indicated that we couldn't see an effect on the acontopasis specific side effects, meaning is that they got less. We are building on that and we have regulatory interaction, how we potentially can prove that in a More clinical specific manner in our Phase 2b, which we hope is our pivotal trial that we basically are Recruiting now for full speed and hope to have all patient in this quarter here.

Speaker 2

So this is where we see the element of us Providing and treatment of atchondroplasia really to ensure that we are not only correcting linear growth, but also addressing the comorbidities.

Speaker 13

Great. Thanks for taking the question.

Operator

Thank you. One moment, please. Our next question comes from the line of Yaron Werber of Cowen. Your line is open.

Speaker 5

Hi. This is Joyce on for General, and thanks so much for taking our questions. Historically, I think you've held this Q1 call in early May, and I think some investors were maybe thinking that the call was moved up this time to get ahead of the PDUFA date and that we might get an update on the deficiencies. If you could just help us understand this a little bit more, that would be helpful. And then Just quickly secondly, I know you're not able to comment that much, but just given the lack of interactions it seems with the FDA, Are you expecting a CRL?

Speaker 5

And if that does happen, how quickly do you guys think you can refile? Thank you.

Speaker 2

Let me take the last question. As I said before, we have no knowledge about the deficiencies, And we cannot comment further on anything of regulatory interaction related TransCon PTH and FDA. I actually believe What we illustrate to optimize processes is optimize processes to do things smarter and faster. And I actually think I give all the credit to Scott. It's not often I do that, but I will actually give him credit to Scott Mast, the Head of Finance that is sitting here beside us today too.

Speaker 2

And they can tell about how they really have optimized all our financial process. So I think by just pressing a button and then we get everything finalized.

Speaker 3

Scott, Matt? Yes. So just as we reported earlier for the annual report, we'll now report earlier for the quarterly report. So I would say nothing Specific to look into it. In fact, if anything, I think next year, we'll probably report the annual even earlier.

Speaker 3

Right, Max?

Speaker 2

31st January.

Speaker 3

31st January next year.

Speaker 2

I hope they answer your question. It's just because we increased productivity and do it faster.

Speaker 5

All right. Thank you so much.

Operator

Thank you. One moment please. Our next question comes from the line of Caroline Palomeque Baerberg, your line is open.

Speaker 14

Hi, good afternoon. Thanks for taking the question. So Were there any material differences in the MAA application in Europe versus the NDA application in the U. S, given that To my understanding, there hasn't been any feedback from the European regulatory agencies. And then a second question is just a follow-up on Expenses, just given the updated Skytrol for revenue guidance, do you also anticipate adjustments in SG and A expenses, Such as in sales force, like we add any more people.

Speaker 14

I'll stop there. Thanks.

Speaker 2

In our regulatory finding between the different regions, Europe and U. S, is Basic built on exactly the same data packet. There will be 5 both places with sure there is a different Formulating of a different filing because they need to be made in a different format, but The data is exactly the same for both Europe and U. S. And related to the last question is a clear no.

Speaker 5

Great. Thank you.

Operator

Thank you. I'm showing no further questions at this time. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating. You may now disconnect.

Operator

Have a great day.

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Earnings Conference Call
Ascendis Pharma A/S Q1 2023
00:00 / 00:00