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spk03: Hello, and welcome to Ascender's Farmer Q2 2023 earnings conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, press star 11 again. I would now like to hand the conference over to Tim Lee, Senior Director, Investor Relations, Ascendus Pharma, AS, so you may begin.
spk07: Thank you, operator, and thank you, everyone, for joining our second quarter 2023 financial results conference call. I'm Tim Lee, Senior Director, Investor Relations of Ascendus 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 Dr. Stina Singel, Executive Vice President of 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.S. commercialization and continued development of Skytropha for the U.S. market, our revenue projections for Skytropha, the commercialization of Transcon HGH for the EU market and our planned launch of Skytropha in Germany, statements regarding our NDA for Transcon PTH and the expected timing of the potential approval and launch of Transcon PTH in the US market, statements regarding the expected timing of the potential approval and launch of Transcon PTH in Europe, statements regarding the potential approval of Transcon CMP, our expectations regarding our 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, and our expectations regarding the timing and the results of regulatory decisions, our expansion into new therapeutic areas, and 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, carry out our plans, our intentions, our expectations, or projections disclosed in our forward-looking statements. And you should not place undue reliance on these statements. Our forward-looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, dispositions, joint ventures, or investments that we may enter into or terminate. We assume no obligation to update these statements as circumstances change except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see our forward-looking statement section in today's press release And the risk factor 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 one 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 Skytropha to Ascendis Pharma, developed under the name Transcon HGH, as a once-weekly sub-case injection for the treatment of children and adolescents aged 3 to 18 with growth failure due to insufficient secretion of endogenous growth hormone. In general, we refer to this product as 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 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 in the conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter 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 Jens Mikkelsen, President and Chief Executive Officer. Jens?
spk06: Thanks, Tim. Good afternoon, everyone. In 2019, at the J.P. Morgan Conference, we announced our vision three by three for building a leading sustainable global biopharma company by 2025. Today, I'm pleased to share with you an update on 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 three independent endocrinology rare disease products, Transcon Grotamo, Transcon PTH, and Transcon CMB by 2025. In addition, we are building global commercialization capabilities to bring this growing portfolio of highly differentiated products to patients. In the US, for the second quarter, we reported Skytrover's revenue of €36 million. Skytrover achieved growth hormone market value leadership in the U.S. in the second 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. For the full year of 2023, we now expect Skytropha U.S. revenues to be €165 to €170 million. We believe three factors continue to drive demand. First, a growing number of physicians have patients with over a year of experience on Skytover, and these physicians have observed the long-term benefit for both treatment-naive and switch patients. The consolidation of the daily growth hormone market continues, and the recent approvals of two other long-acting growth hormone products could accelerate this shift to long-acting. Third, 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 patients and healthcare, and provide them with a reliable supply chain. In our global commercial reach, we are ready to launch SCARTOVA this month in Germany. Our medical affairs and commercial teams are in place and have been active in engaging endocrinologists across the country. We recently received FDA approval at Launce for a high-capacity drug-softened manufacturing site, for which we expect EU approval in the first half next year. This added drug-softened manufacturing capacity supports our goal to commercialize in new markets and additional indications. and to achieve our goal of global market leadership and value in a growing global growth hormone market. During the fourth quarter, we expect to see a top-line result for our global phase 3 foresight trial of transgrown growth hormone in adult growth hormone deficiency. We believe adult growth hormone deficiency is an under-penetrated indication. The recent study showed that less than 4% of adult patients suspected of having growth hormone deficiency are treated with growth hormone. Moving to Transcon PTH for adult hyperparathyroidism. 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 control strategy. I believe the materials submitted to FDA combined with the Type A meeting discussion will position us to resubmit the NDA for transcort PTH for adults with hyperparathyroidism in October 2023. If our NDA is accepted, which we expect within 30 days following resubmission, FDA will notify 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 is important to note that we will not know the new PDUFA date until our Resubmission is accepted and its classification is communicated to us. Besides this information, we will not comment further on the Resubmission procedure while we are having ongoing communication with FDA. In the European Union, We received our day 180 assessment report with feedback on our MAA for Transcon PTAs and have submitted our response to the list of outstanding issues. We remain on track for a European Commission decision during the fourth quarter. And if approved, we plan to launch Transcon PTAs in Germany in early 2024. Finally, today we released new positive data supporting the potential beneficial effect of Transcon PTH on kidney. Over the course of one year, patients in our phase 3 trial demonstrated profound increases in EGFR, a key marker of kidney function, with increases of around plus 9 milliliter per minute 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 to 12 milliliters per minute. Around half of the pathway for patients with an EGFR of less than 60 after Transcon-P treatment for one year, experience at EGFR improving to about 60, meaning they went for having a diagnosis of renal impairment to be within the normal range of kidney function. For patients treated with Transcon-PT8, 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 hyperparathyroidism and a major contributor to medical costs. We plan to present detailed results at our upcoming medical conferences. The U.S. Expanded Assess Program and German Compassion Youth Program for Transgender and PTA continues to be old for enrollment of patients. And we expect to imitate 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 continued treatment with Transcom PTH for over three years. We continue to prepare for the expected launch in the U.S. and Europe. We are confident that Transcon PTA can, if approved, become an important new treatment option for adult patients living with these serious diseases. Switching now to Transcon CMP. Following our end-of-phase two meetings with U.S. and EU regulatory agencies, we have an agreed pathway to achieve regulatory approvals for Transcon-CMP. First, FDA and EU regulatory agencies confirmed that absolute analyzed growth velocity is acceptable as the primary input for Roswell Pivotal Phase III approach trial. Second, these regulatory agencies agreed to our dose selection of 100 micrograms per kilo per week dose for approach. Third, based on this discussion, we expect that an indication for treatment of achondroplasia will be supported by evaluating the beneficial impact on Transcon-CMP, on comorbidities, and other important aspects of achondroplasia, in addition to height. Fourth, our PIVOLOL phase 3 trial approach is now fully enrolled with top-line data expected in the second half of 2024. We believe that achondroplasia is a disease of both skeletal growth and muscle disorder. Based on the rapid functional improvement observed in our ongoing Phase II accomplished 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 PUPIL trial, we will explore endpoint to measure how CMP might moderate the muscular weakness. In addition, This also means that there could be a treatment option for adults living with achondroplasia. Our research in this area continues, and we expect to share more later this year, along with new data from a campus where all the initial 57 patients continue on treatment with Transcon-CMP for over three years. Turning to oncology, we today announced that we had completed dose escalation for Transcon IL-2-Basagamma in combination with PEMBO and declared recommended phase 2 dose at 120 micrograms per kilo every three weeks. No dose-limiting toxicity, vascular leak syndrome, or grade 3 or 4 cytokine release syndrome were observed at any dose level evaluated. Finally, I am excited to share with you some new developments expected to drive Ascendi's sustained growth. We have developed a new transcontinental carrier platform, which integrates our reversible linkers and complements our two established carrier technologies, the soluble and hydrogel platforms. Among the many applications, we believe these technologies support high-volume, low-cost manufacturing enabling products for new therapeutic errors. We have established proof of principle for once-monthly dosing of the GPL1 analog semaglutide, and on our website, you can see our preclinical data. In summary, Ascendix 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 3x3 and have already begun the foundation for the next stage of Ascendance. I will now turn the call over to Scott for a financial review before we open up for questions.
spk10: Thank you, Jan. As Jan noted, we are making very strong progress at Ascendance. I will touch on key points surrounding our financial results. For further details, please refer to our Form 6-K filed today. Total revenue for the second quarter was 47.4 million Euro, including Skytrofa revenue, as well as licenses and services provided to third parties, primarily Visa and pharmaceuticals. Skytrofa revenue for the second quarter of 2023 was 35.9 million Euro, compared to 31.6 million Euro reported in the first quarter. Second quarter revenue was negatively impacted by two items, a negative adjustment to provision for estimated sales rebates of 2.1 million euro, which resulted from stronger than expected payer adoption related to prior periods, and a negative foreign currency impact of 0.6 million euro as compared to the first quarter of 2023 due to a weaker U.S. dollar. Based on reported results from other growth hormone manufacturers, Skytropo was the U.S. market leader in the second quarter 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.S. growth hormone market. Turning to expenses, R&D costs declined 1% sequentially, primarily driven by lower endocrinology-related costs, partially offset by an increase in oncology-related costs. SG&A expenses grew 6% sequentially, reflecting higher external commercial expenses for Skytropha in the U.S., prelaunch activities for Skytropha outside the U.S., global prelaunch activities for Transcon PTH, and higher employee-related expenses. Total operating expenses were €175 million for the second quarter, up 2% sequentially from the first quarter of 2023. Overall, our operating loss declined sequentially by 2% to €141 million for the second quarter from €144 million in the first quarter of 2023. We ended the second quarter with cash, cash equivalents, and marketable securities totaling €431 million. Finally, we have entered into a capped synthetic royalty funding agreement with Royalty Pharma for $150 million in exchange for a 9.15% royalty on net sales of Skytropha within the United States with no royalty payments until 2025. 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-K 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 to €170 million 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 Skytropha in Germany this month, and we expect to report top-line data from the Global Phase III Foresight Trial in adult GHD, our first potential label expansion in Q4. For Transcon PTH, we believe we will be in a position to resubmit the NDA for adults with hypoparathyroidism in October, and we expect a European Commission decision in Q4. If approved, we plan Transcon PTH as our second product launch in Germany in early 2024. For Transcon C&P, we plan to share follow-up data from the open-label extension of our Phase 2 accomplished 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 2024. Within the oncology therapeutic area, during this quarter, we expect to dose the first patient with a combination of Transcon TLR78 agonist and Transcon IL-2 beta gamma. And during Q4, we will be presenting dose escalation data supporting recommended phase 2 dose at ESMO on Transcon IL-2 beta gamma in combo with pembrolizumab and updated monotherapy dose escalation data. As Yan mentioned, we will not comment further on the NDA resubmission procedure for TransCon PTH while we are having ongoing communications with FDA. With that, operator, we are now ready to take questions.
spk03: Thank you. Ladies and gentlemen, as a reminder to ask a question, please press star 1-1 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 1-1 again. We ask that you limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster.
spk02: Our first question comes from the line of Lee Waczek with Kansas.
spk03: Your line is open.
spk13: Hey, great. So, thank you for taking my question. So, I understand that, you know, 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?
spk10: Yeah, 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.
spk13: Okay, understood. So my second question is maybe just comment on the timing behind doing a royalty from a deal right now.
spk10: Yeah, this is Scott again. I think that, you know, we looked at a transaction that had very attractive terms and allowed us to lower the cost of capital.
spk02: Thank you. Thank you. Please stand by for our next question.
spk03: Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.
spk09: 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 Skytropa. 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 and opportunities are coming at the expense of potentially higher rebating and or discounting? And then I had a follow up.
spk06: Let us just go back and give what was really the fundamentals for us in our commercial strategy in the US market. And this is exactly the same strategy we basically begin 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 basically building on the product strength of Skytrover. And we have seen that is really happening in the US. We have seen where we basically come in and reset the market, and this is basically what we are doing now. What we see, we see a continued stable growth on patients coming both from switch patients, patients coming as new patients, and we see it in a continued manual coming week by week, month by month. And we also feel that we are now in a position, as we said in the script, the physician, the patient, everyone has seen really the full potential of the scratch-over because they have seen how we really are in position to give a better outcome related to analyze that you would typically see even in a highly compliant daily growth hormone setting. And that is basically why we see this. 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, Q4, 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 this patient too.
spk10: And, Paul, on the gross margin question, the Skytrofa, remember, the gross margin is for all revenue, which includes some pass-through revenue, as we mentioned. So, I would say the Skytrofa gross margins are largely unchanged, pretty stable over the last several quarters.
spk09: Okay. Got it. Thanks for the additional call, Scott. And then as my follow-up question on Transcon CMP for the Phase III trial, Can you comment on whether the regulators have asked for any additional clinical endpoints besides as a focal point for potential approval decisions in addition to AGB or absolute height growth? And just sort of, you know, any other data you may be collecting to differentiate from the approved product on the market? Thank you.
spk06: Yeah. First of all, the primary endpoint is analyzed height velocity over 12 months. And that is the primary endpoint. We are discussing additional secondary endpoint related to the endpoint we already have, which really should go into the biology. The idea, how we really can address, as we said in 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 acondipalacia has a muscle weakness. And we believe that this is one of the reasons why we see 100% attention in our trial, and it was an immediate effect we observed in our phase 2 trials. And this is why we really is extremely thrilled to really take this product Transcon-CMP out. Not only we believe there is a clear benefit for pediatrics, but potential that could also be an improvement for adults with air contemplation.
spk02: Thank you. Please stand by for our next question.
spk03: Our next question comes from . Your line is open.
spk11: 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.
spk06: Let me take the last part of your question first. 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 US. And we will continue to implement that throughout all the different markets. This is where we want to be because we are providing an improved treatment. Scott, would you take the last part?
spk10: So, Joe, we don't comment on GTN evolution. We just want you to focus on, you know, 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.
spk06: Yeah, and so when you start to make this calculation, which you likely will do, setting and calculate that what it means, the basic meaning is that we have the vision on being the value driver, the most value product, but in a growing growth hormone market. And that's definitely what we managed to do here because of the improvement in treatment we're providing. Thank you.
spk03: Thank you.
spk02: Please stand by for our next question. Our next question comes from the line of Andres Argarides with Wetbush Securities.
spk03: Your line is open.
spk04: 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? I'm looking at the baseline characteristics of patients in pathway 15 in the transcom PTH group history of kidney stones. Can you speak to the impact of transcom PTH had on kidney stones? And if you plan on sharing this data in the future, and then I won't follow up.
spk06: Okay. Thanks a lot. We are extremely thrilled with this data. Why are we thrilled? Because we really believe it's providing a huge benefit to the patients. A huge benefit because one of the element that the patient really fear is really unconventional therapy. Your basic are dividing realness 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 at the data, we basically selected 63. out from the perspective is that some kind of accepted definition of really where you have renal insufficient or not. And why we were thrilled with the data, that we can take 50%, 5-0 of the patient that basically already were classified of having renal insufficient and basically move them 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 have seen any compound that BASIC ever, ever have shown this effect. Related to the labeling, we did this here 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 through publication, through interaction with patient groups, so they really also understand the benefits they can get for transplant PTAs in there, we will go out and also talk with regulatory agencies. 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 data.
spk04: Fantastic. And then comment on the kidney stones?
spk06: The kidney stones, I believe I have not seen data on that point. But the potential, I can ask them if there is a post hoc analysis we also can do specifically related to kidney stones. I cannot recall I've seen anyone.
spk03: Thank you. Please stand by for our next question. Our next question comes from the line of David Leibowitz with Citi. Your line is open.
spk05: 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 know, you have preclinical data for GLP-1. When might we see that candidate move towards the clinic? Additionally, what other types of candidates do you see applying this towards?
spk06: Yeah, we are really, really extremely enthusiastic 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 when you think about the Transcon linker, they are identical or exactly the same kind that you have seen on both Transcon Growth Hormone, Transcon PTAs, and Transcon CMP, all the other products also in oncology. All the same we can use are the same linker. The only change is that we have developed what we call a novel carrier system. This novel carousel system, we wanted to make one example on. And one example was to go into a GLP-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 that was why we developed the novel platform. We believe it can be used many, many places. And specifically, we can have 10 targets in metabolic diseases. We have 10 targets now looking 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 could address with the two Transcon carrier platform, we already had established our soluble carrier and the hydrogen carrier.
spk02: Thank you for taking my questions. Thank you. Please stand by for our next question. Our next question comes from the line of Yaron Webber with TD Cohen. Your line is open.
spk01: Hi. This is Joyce on for your own. Thanks so much for taking our question. Maybe just to follow up first on the previous question for your GLP-1, 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? And then I just had a follow up on Skytropha.
spk06: Yeah. First of all, as we said, we used semi-glutide because we felt there was a good GPL-1 analog really to make an example of our new technology platform. But also at the same time, semi-glutide is also an interesting product opportunity itself. And you know, with the transcontinental technology, we release a complete unmodified semi-glutide. 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, when we look in our pipeline, we are still discussing a lot which is the optimal product opportunities because we can also utilize other GPL1s. So this is where we still are having internal discussion, where we really want to position it, and the day we really are moving it into a situation where we will be ready to start to generate clinical data, we will come back to you and explain what is exactly the analog we are working on.
spk01: Okay, great. And then for my follow-up for Skytropha, 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 23 guidance reflect competition from once weekly drugs from Novo and Pfizer? Thank you.
spk06: The guidance we have within the competitive landscape that is out there and the guidance we are fully integrated what we see the threat or you can say how it really are helping us basically to convert it over to a much more long acting but also think you need some way to take the perspective of the shortage of daily growth hormone which is a long-term process that basic are partially all driven by what we call the consolidation of the daily growth hormone where basically they are leaving the market and there will be very few players left in the daily growth hormone so what we see here we just see as we have basic predicted in the last one to two years the development of the competitive landscape. And we feel really, really, really confident with how Skartrofe will continue to basically be in a proceeding to be the leading product in value and continue to be in the future.
spk03: Thank you. Please stand by for our next question. Our next question comes from the line of Caroline Paula McHugh with Barenberg Capital Markets. Your line is open.
spk08: Hi, this is Lucy for Caroline. Thank you so much for taking my question. So I'm just curious about the plan for launching the EU for the Transco PPH. So you said like first you were going to launch in Germany, then what would be the
spk06: next steps so you're not to learn more about that thanks thanks a lot first of all we are not looking on EU is one place where we basic launching now but we're not stopping there we also going for the international operation we have a strong person that is leading our global commercial effort and Camilla, 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 launched with Skytrover, which we're doing this month here. We launched Skytrover here this month in Germany, and we're starting to launch PTH 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 is this country where you can support the launch of a product either from an EU approval or from a US approval. So this is how we really are going to build our global commercial strategy.
spk08: OK. Thank you very much for taking my question. And I'll congrats with all of the progress. Thank you.
spk06: Thanks so much.
spk03: Thank you.
spk02: Please stand by for our next question. Our next question comes from with Oppenheimer.
spk03: Your line is open.
spk12: Great. Thanks for taking my questions. Just one question from us as it pertains to Skytropha. You know, in discussions with endocrinologists, they've said that, you know, at the same time that you've grown the product, they've also seen, you know, shortages in the daily injectables market, you know, kind of providing more opportunity for Skytropha, which may be due to some manufacturers shifting over to pens that may be for TLP1s 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.
spk06: First of all, the data growth hormone market in the U.S. is consisting of five to six players. And to my knowledge, I only believe there's one or two of them, or two of them have GLP-1 players. So I don't believe that you can generally take the comments on shifting to the GLP-1 segment is the reason for a shortage in our daily growth hormone. I think the key element is basically the long-term perspective. of what's happening in the data growth mode that started already for two, three years ago when our phase two 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 have stopped manufacturing for a year back, stopped subcontracting to European countries. And this is the part what you see is driving the basic, the daily growth hormone shortage. Because the consolidation got, everyone got stopped. If there has been in the old days for four to five years, everyone else could just take 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 three to four years, because this is how you basically get optimal financial return to insure. And what you see now is the end of the consolidation, where you see some shortage in the daily, because there is not so many that really want to supply it, because it's not really an interesting business. If you have a big firm, a large entity selling for less than $100 million, you cannot have a positive P&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'll see.
spk12: Thank you. And then also a question with respect to the new GLP-1 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, you'd have to be here in agreement with one of the respective pharmas and ascendants. Is that something we should look out for? Thank you.
spk06: Yeah, the GPL-1 is really interesting from an IT perspective because there's actually a lot of freedom to operate in the GPL-1 space. This is really surprising, but it's not surprising when you think about many of them are old product that basically was developed and diabetes and then got repositioned into the era of obesity. So from that perspective, there is a lot of freedom to operate, 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 example, if you use it once weekly, you will 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 a problem with adherence. We know that only one-third of the patients are on treatment after one year. after GLP treatment. So we need to do something to improve the adherence, improve the way that they get a product, both related to tolerability and adherence, which one is the most important for the patient.
spk12: Great. Thanks very much for taking the question.
spk03: Thank you. As a reminder, ladies and gentlemen, that's star 11 to ask the question.
spk02: I'm sure no further questions.
spk03: Ladies and gentlemen, that concludes our Q&A portion. We would like to thank you for your patience in today's call. This concludes the call. You may now disconnect.
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