Ascendis Pharma A/S Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
September 5, 2023

There are 10 speakers on the call.

Operator

Welcome to the Ascendis Palmer Q2 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. You will then hear an automated message advising your hand is raised. I would now like to hand the conference over to Tim Lee, Senior Director, Investor Relations of Cinders Farmers AS.

Operator

Sir, you may begin.

Speaker 1

Thank you, operator, and thank you, everyone, for joining our Q2 2023 financial results conference call. I'm Tim Li, Senior Director, Investor Relations of Ascendis Joining me on the call today is Jen Michelson, President and Chief Executive Officer Scott Smith, Executive Vice President and Chief Financial Officer And Doctor. Sina Single, Executive Vice President of Henna 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. Examples of such statements may include, but are not limited to our U.

Speaker 1

S. Commercialization and continued development of Skytropha for the U. S. Market, Our revenue projections for Skytrosa, the commercialization of TransCon HGH for the EU market and our planned launch of Skytrosa in Germany, Statements regarding our NDA for TransCon PTH and the expected timing of the potential approval and launch of TransCon PTH in the U. S.

Speaker 1

Market, Statements regarding the expected timing of the potential approval and launch of TransCon PTH in Europe, statements regarding the potential approval of TransCon CNP, our expectations regarding a new TransCon technology and 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 Our expectations regarding the timing and the results of regulatory decisions, our expansion into new therapeutic areas, Statements regarding our progress towards Vision 3x3 and our ability to create a sustainable, profitable and leading global pharma 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. Here are our plans, our intentions, our expectations or projections disclosed in our forward looking statements. And you should not place undue reliance on these statements.

Speaker 1

Our forward looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, Dispositions, joint ventures or investments that we may enter into or terminate. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, Please see our forward looking statements section in today's press release and the Risk 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.

Speaker 1

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. In addition, the European Commission has granted a marketing authorization for SKYTROPHAsendis Pharma Developed under the name TransCon HGH as a once weekly subcutaneous injection for the treatment of children and adolescents aged 3 to 18 Growth failure due to insufficient secretion of endogenous growth hormone. In general, refer to this product as TransCon Growth Hormone unless referring to the product in the context 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 Have been reviewed or approved by any regulatory agency, none of the statements made in the conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our Q2 2023 financial results and we'll provide further business updates following some prepared remarks.

Speaker 1

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?

Speaker 2

Thanks, Tim. Good afternoon, everyone. In 2019, at the JPMorgan Conference, We announced our vision 3 by 3 for building a leading sustainable global biopharma company by 2025. Today, I'm pleased to share with you update how close we are to achieving our vision. As outlined in our Vision 3x3, Using our TransCon technology platform and our algorithm for product innovation, We are on the pathway to achieve the regulatory approval of 3 independent endocrinology rare disease products: TransCon Growth Hormone, TransCon PTH and TransCon CNP by 2025.

Speaker 2

In addition, We are building global commercialization capabilities to bring this growing portfolio of highly differentiated product to patients. In the U. S. For the Q2, we reported SKYTOVA revenue of EUR 36,000,000 Skytruva achieved growth from market value leadership in the U. S.

Speaker 2

In the 2nd quarter, With a penetration of less than 10% of treated U. S. Pediatric growth hormone deficiency patients, which represent about half of the growth hormone market in the U. S. Today.

Speaker 2

For the full year of 2023, we now expect Skytrooper U. S. Revenues Should be €165,000,000 to €117,000,000 We believe three factors continue to drive demand. First, a growing number of physicians Have patients with over a year of experience on SKYTOFRA and these physicians have observed the long term benefit for both treatment naive and switch patients. 2nd, the consolidation of the daily growth hormone market continues And the recent approvals of 2 other long acting growth hormone products, which could activate this shift to long acting.

Speaker 2

3rd, Ascendis has become a trusted partner within the endocrinology community. As we continue to invest in our products, in science and in our support for patient and healthcare and provide them with a reliable supply chain. In our global commercial REIT, we are ready to launch SCOTROV this month in Germany. Our medical affairs and commercial teams are in place and have been active engaging endocrinologists across the country. We recently received FDA approval at Lonza for a high capacity drug softener manufacturing site.

Speaker 2

For which we expect EU approval in the first half next year. This added drug softening manufacturing capacity Support our goal to commercialize in new markets and additional indication and to achieve our goal of global market leadership in value in a growing global growth hormone market. During the Q4, we expect to share top line results for our global Phase 3 Foresight trial, Our TransCon Growth Hormone in Adult Growth Hormone Deficiency. We believe adult growth hormone deficiency It's an underpenetrated indication. The recent study show that less than 4% of adult patients Suspected of having growth hormone deficiency are treated with growth hormone.

Speaker 2

Moving to TransCon PTH for adult hypoparatirisme. In June, We requested a Type A meeting with FDA and submitted an updated control strategy. The Type A meeting was held with FDA in late August based on the agency's availability. Following a constructive Type A meeting, we submitted additional information to FDA supporting the updated controlled strategy. I believe the materials submitted to FDA combined with that Type A meeting discussion We'll position us to resubmit the NDA for TransCon PTH for adult with hypoparathyroidism in October 2023.

Speaker 2

If our NDA is accepted, which we expect within 30 days following Resubmission. FDA will notified us where the resubmission is Class 1 or Class 2 And provide a new PDUFA date, which we estimate could be in December this year or April 2024. It's important to note that we will not know the new PDUFA date until our submission is accepted and this classification is communicated to us. Besides this information, we will not comment further on the resubmission In the European Union, we received our day 180 assessment report with feedback on our AA for TransCon PTH and have submitted our response to the list of outstanding issues. We remain on track for a new European Commission decision during the Q4.

Speaker 2

And if approved, we plan to launch TransCon PTA Finally, Today, we released new positive data supporting the potential beneficial Effect of TransCon PTH on kidney. Over the course of 1 year, patient in our Phase 3 trial demonstrated profound increases in EGFR, a key marker of kidney function with increases of around plus 9 milligram permitted across all patients. Importantly, In the subset of patients with EGFR less than 60 at baseline, The threshold for kidney dysfunction, TransCon PTAs demonstrated increases of 11 milliliter to 12 milliliter per minute. Around half of the pathway for patients with an eGFR of less than 60 After TransCon pre treatment for 1 year experience at EGFR improving to about 60. Meaning, there went for having a diagnosis of renal impairment to be within the normal range of kidney function.

Speaker 2

For patients treated with TransCon PTA, sustained improvement in eGFR Of this magnitude may reduce risk of progressing to chronic or late stage kidney diseases. This is a major comorbidity in patients with hypoparathyroidism and a major contributor to medical costs. We plan to present detailed results at our upcoming medical conferences. The U. S.

Speaker 2

Expanded SS program and German compassionate use program for Transglen PTA continues to be open for enrollment of patients, and we expect to initiate comparable programs in additional countries. In the ongoing extension portion of our clinical trial, 145 out of the initial 154 patients from the original clinical trials Continue treatment with TransCon PTH for over 3 years. We continue to prepare for the expected launch in U. S. And Europe.

Speaker 2

We are confident that TransCon PGA can, if viforpro become an important new treatment option for adult patients living with serious diseases. Switching now to TransCon CNP. Following our end of Phase 2 meetings with U. S. And EU regulatory agencies.

Speaker 2

We have an agreed pathway to achieve regulatory approvals for Trascon CNP. First, FDA and EU regulatory agencies confirm that absolute annualized growth velocity is 2nd, These regulatory agencies agreed to our dose selection of 100 microgram per kilo per week dose for APPROSE. 3rd, based on this discussion, we expect that an indication for treatment of achondroplasia will be supported by evaluating the beneficial impact on transconcMP on co morbidities and other important aspect of in addition to height. 4th, our pivotal Phase III trial approach Is now fully enrolled with top line data expected in the second half of twenty twenty four. We believe that airchondroplasia is a disease of both skeletal growth and muscle disorder.

Speaker 2

Based on the rapid functional improvement observed in our ongoing Phase 2 ACONPLIS trial and based on literature review, There may be a primary muscular component to achondroplasia phenotype, besides the well described effect on skeletal growth. We believe it's essential to have a continuous exposure to CMP to optimally Improve muscle strength and endurance. In our pivotal trial, we will explore endpoint to measure how CMP might modulate The muscular weakness. In addition, this also mean that there could be a treatment option for adults Our research in this area continues and we expect to share more later this year along with new data from ACCOMPIS where all the initial 57 patients Continue on treatment with TransCon CNP for over 3 years. Turning to oncology.

Speaker 2

We today announced that we have completed dose escalation for TransCon IL-two beta gamma in combination with pimple and declared recommended Phase 2 dose Vascular Leak syndrome or grade 3 or 4 cytokine release syndrome were observed at any dose level evaluated. Finally, I'm excited to share with you some new development expected to drive Astellate's Sustained growth. We have developed a new TransCon carrier platform, which integrates our reversible linkers and Complements our 2 established carrier technologies, the soluble and hydrogel platforms. Among the many applications, We believe this technology support high volume, low cost manufacturing, enabling product for new therapeutic areas. We have established proof of principle for once monthly dosing of the GPL-one 1, analog semaglutide.

Speaker 2

And on our website, you can see our preclinical data. In summary, Ascendis remains focused on building and maintaining a sustainable, profitable leading biopharma company. With all programs making significant progress, we are nearing completion of our vision 3 by 3 and have already begun the foundation for the next date of the sentence. I will now turn the call over to Scott for a financial review before we open up for questions.

Speaker 3

Thank you, Jen. As Jan noted, we are making very strong progress at Ascendiv. I will touch on key points surrounding our financial results. For further details, please refer to our Form 6 ks filed today. Total revenue for the Q2 was €47,400,000 including Skytrophy revenue as well as licensing services provided to 3rd parties, primarily Visa and Pharmaceuticals.

Speaker 3

Skytrophy revenue for the Q2 of 2023 It was €35,900,000 compared to €31,600,000 reported in the Q1. 2nd quarter revenue was negatively impacted by 2 items, A negative adjustment to provision for estimated sales rebates of €2,100,000 which resulted from stronger than expected payer adoption related to prior periods And a negative foreign currency impact of €600,000 as compared to the Q1 of 2023 due to a weaker U. S. Dollar. Based on reported results from other growth hormone manufacturers, Skytrophy was the U.

Speaker 3

S. Market leader in the Q2 of 2023 with less than 10% penetration into the U. S. Pediatric GHD patient population. 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 addressable U.

Speaker 3

S. Growth hormone market. Turning to expenses. R and D costs declined 1% sequentially, primarily driven by lower endocrinology related costs, partially offset by an increase in oncology related costs. SG and A expenses grew 6% sequentially, Reflecting higher external commercial expenses for Skytropha in the U.

Speaker 3

S, pre launch activities for Skytropha outside the U. S, Global pre launch activities for TransCon PTH and higher employee related expenses. Total operating expenses were €175,000,000 for the Q2, up 2% sequentially from the Q1 of 2023. Overall, our operating loss declined sequentially by 2% to €141,000,000 for the 2nd quarter from €144,000,000 in the Q1 of 2023. We ended the 2nd quarter with cash, cash equivalents Within the United States, with no royalty payments until 2025.

Speaker 3

The royalty payments are capped at 1.65 times the purchase price If fully paid prior to December 31, 2023 or 1.925 times the purchase price if not fully paid by December 31, 2023. Further details are disclosed in a separate 6 ks filed today. Looking forward, we expect continued momentum for Skytropha in the United States for the balance of this year and we are raising our expectations for Skytropha revenues to €165,000,000 €5,000,000 to €170,000,000 for full year 2023. Let me now also provide a review of selected key program milestones. For TransCon Growth Hormone, we are on track to launch Skytrosa in Germany this month and we expect to report top line data from the global Phase 3 Foresight trial in adult GHD, Our first potential label expansion in Q4.

Speaker 3

For TransCon PTH, we believe we will be in a position to Submit the NDA for adults with hypoparathyroidism in October and we expect a European Commission decision in Q4. If approved, we plan TransCon PTH is our 2nd product launch in Germany in early 2024. For TransCon CNP, we plan to share follow-up data from the open label extension of our Phase 2 ACOMPLISH trial in Q4 this year and we expect to report top line results from APPROACH, our pivotal Phase 3 trial in the second half of twenty twenty four. Within the oncology therapeutic area, during this quarter, we expect to dose the first patient with a combination of TransCon TLR-seventy eight agonist And during Q4, we will be presenting dose escalation data supporting recommended Phase 2 dose at ESMO on transconial 2 beta gamma in combo with pembrolizumab and updated monotherapy dose escalation data. As Jan mentioned, we will not comment further on the NDA resubmission procedure for TransCon PTH while we are having ongoing communications with FDA.

Speaker 3

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

Operator

Thank you. We ask that you limit yourself to one question and one follow-up. Please stand by while we compile the Q and A roster. Our first question comes from the line of Leigh Wachsak with Cantor. Your line is open.

Speaker 4

Hey, great. So thank you So I understand that there is limited color that you can provide regarding the NDR resubmission, But just wondering if you can sort of elaborate on sort of the additional information that's Needed from the Type A meeting and what are the gating steps for you to refile NDA?

Speaker 3

Yes, Lee, this is Scott. We cannot comment further on the resubmission procedure while we're having ongoing communications with FDA. But we believe we'll be in a position to resubmit in October as we stated.

Speaker 4

Okay. Understood. So, my second question is maybe just Comment on the timing behind doing a royalty from a deal right now?

Speaker 3

Yes. This is Scott again. I think that we looked at a transaction that had very attractive terms and allowed us

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.

Speaker 5

Hi, good afternoon and thank you for taking the question. Just on the commercial piece, Can you maybe comment on where additional share opportunities remain for Skatropa? One thing we noticed was that there was a sequential decline in the gross margin. So can you maybe just comment on whether some of these share gains Opportunities are coming at the expense of potentially higher rebating and or discounting? And then I had a follow-up.

Speaker 2

Let us just go back and give what was really the fundamentals for us In our commercial strategy in the U. S. Market, and this is exactly the same strategy we basically move again to each single market. We want to be the leading product in value, and we want to do it in a growing growth hormone market. So we're basically building on the product strength of SKYTROFA and we have seen that is really happening in the U.

Speaker 2

S. We have seen where we basically come in and reset the market, and this is basic what we are doing now. What we see, we see a continued stable growth on patient coming both from switch patient, Patient coming as naive patient and we see it in a continuum manual coming week by week, months by once. And we also feel that we are now in a position, as we said in the script, the physician, The patient, everyone have seen really the full potential of the SCARTOFA Because they have seen how we really are in position to give a better outcome related to analyze hyper That you would typically see even in an highly compliant daily growth hormone setting. And that is basic why we see this.

Speaker 2

And it will only be enforced when we basically can get additional indication. This is why we really are thrilled for here end of the year, Q3. Q4 come out with data from our adult growth hormone deficiency, which we really can show also that we really can provide an Improved treatment option to these patients too.

Speaker 3

And Paul, on the gross margin question, the Skytropha, remember the gross margin is for all revenue, which includes some pass through revenue as we mentioned. So I would say the Sky Trofa gross margins are largely unchanged, pretty stable over the last several quarters.

Speaker 5

Okay. Got it. Thanks for the additional color, Scott. And then as my follow-up question on TransCon CNP for the Phase 3 trial, Can you comment on whether the regulators have asked for any additional clinical endpoints besides as a focal point for Potential approval positions in addition to AGV or absolute high growth, and just sort of any other data you may be collecting to differentiate from the approved product

Speaker 2

Yes. First of all, the primary endpoint is analyzed high velocity over 12 months, And that is the primary endpoint. We are discussing additional secondary endpoint in related to the endpoint we already have, What really should go into the biology, the idea how we really can address. As we said at the script, we believe that Achondroplasia is not only a skeletal dysfunction, but also have a muscle impact. And we really have seen Benefit there, which really are being supported with our review of literature, where you really can show how achondroplasia has a muscle weakness.

Speaker 2

And we believe that this is one of the reason why we see 100% attention in our trial and it was an immediately effect we observed in our Phase 2 trial. And this is why we really is extremely thrilled to really take this product TransConcion Power. Not only we believe there is a clear benefit for pediatric, but potential that could also be an improvement for adults with achondroplasia.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Jeff Gill with Leerink Partners. Your line is open.

Speaker 1

Great. Thanks so much and congrats on all the progress. I was wondering, how the gross to net for SKYTROFA has been evolving in the United States And what your pricing strategy will be in Germany and other European markets? Thank you.

Speaker 2

Let me take the last part of the equation first. We know we believe we're providing an improved treatment for the patients. We also believe that we're following up to what we said before, a responsible premium pricing. This is how we really have launched our price structure in the U. S.

Speaker 2

And we will continue to implement that throughout All the different markets. This is where we want to be because we're providing an improved treatment. Scott, would you take the last part?

Speaker 3

So Joe, we don't comment on GTN evolution. We just Want you to focus on revenues ultimately, but I think we gave some interesting points that on reported revenues, we were the Market value leader in the quarter with less than 10% penetration into the pediatric GHD market, Which itself is only half of the total growth hormone market in the U. S?

Speaker 2

Yes. And so when you start to make this calculation, which you likely will do, Setting and calculate that what it means, it basically means that we have the vision on being the value Driver the most value product, but in a growing growth hormone market. And it's definitely what we are Managed to do here because of the improvement in treatment we're providing.

Speaker 6

Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Andreas Argueraj with Wedbush Securities. Your line is open.

Speaker 7

Thanks for taking our questions. Congrats on all the progress. With the EGFR data, how should we interpret the 50% response rate. And how do you expect the eGFR analysis to be reflected on the potential label? And looking at the baseline characteristics of patients in pathway 15 And the TransCon PTH group had a history of kidney stones.

Speaker 7

Can you speak to the impact of TransCon PTH had on kidney stones? And if you plan on sharing this data In the future, and I have one follow-up.

Speaker 2

Okay. Thanks a lot. We are extremely thrilled with this data. Why Vutrel? Because we really believe it's providing a huge benefit to the patients.

Speaker 2

A huge benefit because one of the Element that the patient really fear is really unconventional therapy, your basic are dividing renal Impairment, which in the end can be worst case scenario where you go into dialysis and really need To have a new kidney. So out from that perspective, when we looked in the data, we basic selected 60 From the perspective is that some kind of accepted definition of really where you have been insufficient or not. And why we were thrilled with the data that we couldn't take 50%, fifty percent of the patient The basic already were classified of having renal insufficient and basic movement up to what we call normality. I believe that is a key element for how we really can work with and help the patient group here. And I think When we saw the data, we believe that this first time we really seen any compound that basic ever, ever have shown this effect.

Speaker 2

Related to the labeling, we are but did this year as a post hoc analysis. You can say, yes, we should have included in our Key segment there already from the beginning when we saw this major impact. But still for us, it was really unbelievable when we really have seen the data And how well it is. And we will soon when we are presenting this data into publication Through interaction with patient groups, so they really also understand the benefits that can get for TransCon PTH in there. We will go out and also talk with regulatory agencies.

Speaker 2

But we also believe that having it in peer reviewed publication is the key element for us really to be in a position really to communicate about this Fantastic

Speaker 7

data. Fantastic. And then comments on the kidney stones?

Speaker 2

The kidney stones, I believe, I have not seen data on that point, But potential, I can ask them if there is an post hoc analysis we also can do Specifically related to kidney stones, I cannot recall I've seen anyone.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of David Lebowitz with Citi, your line is open.

Speaker 7

Thank you very much for taking my question. Could you run us through The differences of the new linker you were talking about and you have a preclinical data for GLP-one, When might we see that candidate move towards the clinic? Additionally, what other types of candidates do you see applying this towards?

Speaker 2

Yes. We are really, really extremely anxious yesterday of this expanding of the TransCon technology, Because we believe we need to be everywhere where the patients are. And it's building on the same principle again. So So when you think about the TransCon linker, they are identical or exactly the same kind that you have seen on Both TransCon Growth Tumor, TransCon PTAs and TransCon CNP, all the other projects also in oncology, all the same we can use are the same linker. The only change is that we had developed what we call a novel carrier system.

Speaker 2

This novel carrier system, we wanted to make one example on. And one example was to go into a DLP-1 analog because there you really demand really, really, really High level of capability to produce mass production of drugs, you need to do it on extremely low cost. So your basic potential have a cheaper, more non expensive manufacturing process by having less Injection and other things like that. And it was why we developed the new novel platform. We believe it can be used many, many places.

Speaker 2

And specific, we can have 10 targets in metabolic diseases. We have 10 targets now looking on in cardiovascular and other things like that. So it's really moving up and open up for Mercedes to move into new areas that we basically not really couldn't address with the 2 TransCon carrier platform, we already had established our soluble carrier on the hydrogate carrier.

Speaker 4

Thank you for taking my questions.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Yaron Weber with TD Cowen. Your line is open.

Speaker 8

Hi. This is Joyce on for Yaron. Thanks so much for taking our question. Maybe just to follow-up First on the previous question for GLP-one, if you could just clarify whether you plan to file an IND in the future? And if so, how do you think this will fare relative to some of the drugs from your competitors with double and triple MOAs?

Speaker 8

And then I just had a follow-up on Skytruva.

Speaker 2

Yes. First of all, we as we said, we used semaglutide, because we felt there was a good GPL-one analog really to make an example of our Take new technology platform, but also at the same time semiglutide is also an interesting product opportunity itself. And you know with the TransCon technology, we release a complete unmodified semaglutide. So we're not changing the mode of action because we are a long acting product technology, would make it both unique related to clinical trials, But also really unique to regulatory pathways. So from that perspective is, when we look in our pipeline, we are still Discussing a lot with the optimal product opportunities because we can also utilizing other GPL ones.

Speaker 2

So this is where we still are having internal discussion, where we really want to position it that and the day we really are moving Into a situation where we will be ready to start to generate a clinical data, we will come back And explain what is exactly the analog we are working on.

Speaker 8

Okay, great. And then for my follow-up For Skytrosa, can you provide any additional color on how much share you've gained while Novo has Had supply constraints for their daily growth hormone? And then also, does your new fiscal year 'twenty three guidance reflect competition from

Speaker 2

The guidance we have within The competitive landscape that is out there and the guidance, we are fully integrated what we see, the track or you can say How it really are helping us basic to convert it over to a much more long acting. But I also think you need Samir, to take the perspective of the shortage of daily growth hormone, which is a long term process that basically are partly All driven by what we call the consolidation of the daily growth term. We are basically they are leaving the market and there will be very few Player left in the daily growth term. So what we see here, we just see as we have basic predicted in the last one to 2 years, the development of the competitive landscape, and we feel really, really, really confident with how SCOTROVATE. It will continue To basically be in a proceeding to be the leading product in value and continue to be it in the future.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Caroline Paulo McHugh with Berenberg Capital Markets. Your line is open.

Speaker 9

Hi. This is Lucy for Caroline. Thank you so much for taking my question. So I'm just curious about the Plan for launching EU for the TransCore PTH. So you said Like first, you were going to launch in the Germany, then what would be the next steps?

Speaker 9

So We would love to learn more about that. Thanks.

Speaker 2

Thanks a lot. First of all, we are not looking EU is one place where we basically are launching now, but we're not stopping there. We're also going for the inter National operation, we have a strong person that is leading our global commercial effort, Camille, she has a very, very strong background in Europe and international operation. We are launching in Germany as the first country what you do. But it will not be a single launch because we first axel launching with Skytrophy, which we're doing this month here.

Speaker 2

We're launching Skytrophy here this month in Germany, And we're starting to launching PGA8 in the expected in the beginning of next year, really, really in the beginning of next year. And we will then roll out in all the different EU countries where we expect to get the approval and Including UK, which we still can apply for in a very fast manner. And then we are starting to progress in the international operation, Meaning, as this country where you can support the launch of a product either from an EU approval or from a U. S. Approval.

Speaker 2

So this is how we really are going to build our global commercial strategy.

Speaker 9

Okay. Thank you very much for taking my questions and congrats with all of the full progress. Thank you.

Speaker 2

Thanks so much.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of William Eberschol with Oppenheimer. Your line is open.

Speaker 6

Just one question from us as it pertains to SKYTROFA. In discussions with endocrinologists, Dave said that at the same time that you've grown the product, they've also seen shortages in the daily injectables market kind of providing more Tunney for SKYTROFA, which may be due to some manufacturers shifting over to pens that may be for GLP-1s versus growth hormones. Just Wondering if you could comment on that dynamic and how you may see those shortages persisting or changing in the near term? Thank you.

Speaker 2

First of all, the daily growth hormone market in the U. S. Is consisting of 5 to 6 player. And I actually to my knowledge, I only believe there's 1 or 2 of them or 2 of them have GLP-one players. So I don't believe that you can general take the comments on Shifting to the GPL1 segment is the reason for our shortest in our Daily growth mode.

Speaker 2

I think the key element is basic the long term perspective of what's happening in the daily growth mode. That Started already for 2, 3 years ago when our Phase II data came out, where we saw that there was an What I call a classical way to leave a market, we saw most of them basically got rid of the sales force, They got rid of every promotion. They got rid of the hope. Today, many of them basically had stopped manufacturing for a year back, Stop subcontracting to European countries. And this is a part what you see is driving the basic the daily Growth hormone shortage, because the consolidation got everyone got stopped.

Speaker 2

If DIR has been in the old days for 4 to 5 years, everyone else can just kick in. It's not happening because they are leaving the growth hormone market. So I think we need to go back to fundamentals. The fundamentals is that the daily growth hormone consolidation Already started for 3 to 4 years because this is how you basically get optimal financial return to ensure. And what you see now is the end of the consolidation Where you see some shortage in the daily because there's not so many that really want to supply it because it's not really an interesting business.

Speaker 2

If you have A big pharma, a large entity selling for less than EUR 100,000,000, you cannot have a positive P and L of such product. You want to leave And they are leaving and I will leave too. I will get out as fast as possible. And this is what you see.

Speaker 6

Thank you. And then also a question with respect to the new GLP-one work that you've been doing. I want to ask about what your freedom to operate there is. Presumably, if you were to move forward with a candidate using one of the APIs, We would see an agreement with 1 of the respective pharma's and Ascendis. Is that something we should look out for?

Speaker 6

Thank you.

Speaker 2

Yes, the GPL1 is really interesting from an IP perspective because there's actually a lot of freedom to operate in the GPL1 space. This is really surprising, but it's not So from that perspective, there is a lot of freedom to operate, a really interesting what we're doing with our them is basically making to the best in class product opportunities Because we can really address some of the tolerability there is by providing for sample, if you use it once weekly, you have a flat curve, Meaning is that a flat PK curve, not really the excursion that gives you a side effect. You can also take it if you have problem with adherence. We know that Only 1 third of the patients are on treatment after 1 year after GLP treatment. So we need to do something to improve the adherence, Improve the way that the gated product, both related to tolerability and adherence, which model is the most important for the patient.

Speaker 6

Great. Thanks very much for taking the question.

Operator

Thank you.

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Earnings Conference Call
Ascendis Pharma A/S Q2 2023
00:00 / 00:00