Q2 2024 Ascendis Pharma AS Earnings Call
Scott Smith: These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023.
Operator: Pardon me, ladies and gentlemen, this is the operator. I apologize, but there will be a slight delay in today's conference call. Please remain on the line. The conference will begin at 445 Eastern Standard Time. Again, thank you for your patience. Thank you. [inaudible] . . Thank you. . Thank you. . [inaudible][inaudible] . . [inaudible] . . Thank you. [inaudible] . . [inaudible] . . [inaudible] . . Thank you. [inaudible] . . Thank you. [inaudible] . . Thank you. . Thank you. . [inaudible] . . Thank you. .
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Speaker Change: Pardon me, ladies and gentlemen, this is the operator I apologize, but there will be a slight delay in today's conference call.
Speaker Change: Please remain on the line the conference will begin at 445 Eastern standard time again, Thank you for your patience.
Speaker Change: [music].
Operator: Ladies and gentlemen, please stand by. Your conference call will begin in two minutes. Please remain on the line. Your conference call will begin in two minutes. [inaudible] your conference call will begin in two minutes. Your conference call will begin in two minutes. [inaudible] Your conference call will begin in two minutes. Your conference call will begin in two minutes.
Scott Smith: First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Operator: --limit yourself to one question, and one followup. I would now like to turn the call over to Tim Leeds, Director of Investor Relations at Ascendis Pharma. Sir, you may begin. Camilla Hartwig, Executive Vice President and Global Chief Commercial Officer, and Joe Kelly, U.S. General Manager.
Scott Smith: Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Scott Smith: Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Scott Smith: Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Scott Smith: Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Operator: Ladies and gentlemen, as a reminder to ask the question, please first start one one on your telephone and then wait to hear your name announce. To withdraw your question, please first start one one again and please limit yourself to one question and one follow up. Please stand by while we compile the Q&A roster.
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Jessica Fye: Our first question comes from the line of Jessica Fye with JP Morgan. Your line is open. Hey guys, good afternoon. Thanks for taking my question.
Jan Mikkelsen: I want to better understand how you project getting Skytropha to a blockbuster in the US alone. Based on the kind of reset of net price and what you said about where you are in terms of penetration in GHD and the broader created growth hormone market. Can you walk through that a little bit? Thank you. Thanks, Jess. I will start and I have my two commercial colleagues with me yesterday, so that can also some way give you more details is that it's desired.
Jan Mikkelsen: But it currently we see the market is about 1.4 billion US dollars the entire growth hormone market in the US. And as I stated in my prepared remarks when we look on a net value per patient, we basic with Skytropha have about three times the net value on a yearly treatment. When we see our effort when we look about when we are developing the long-acting segment, we see Skytropha as really the preferred brand. And even in places where we just are in the same level of market access clearly, clearly, clearly Skytropha is the preferred product. Even in places where we don't have market access, we really see Skytropha coming in because it's really up avoiding a unique improvement compared to the other products potential. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the peratic growth hormone deficiency market. We in this next weeks we are filing for adult growth hormone deficiency. We have Turner phaser coming in for phase two later this year. We will initiate trials very fast and we can do it in a basket manner so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop Skytropha 2 apoposter in the US. And with the reset of what we call the marketer set. We will keep that value as we have today and expand from there. I do not know Joe or Camilla, you have further comments or just you have and want to get more depth knowledge about specific comments from my site. Thanks. Thank you. Please stand by for our next question.
Jan Mikkelsen: And even in places where we just are in the same level of market access clearly, clearly, clearly Skytropha is the preferred product. Even in places where we don't have market access, we really see Skytropha coming in because it's really up avoiding a unique improvement compared to the other products potential. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the peratic growth hormone deficiency market. We in this next weeks we are filing for adult growth hormone deficiency. We have Turner phaser coming in for phase two later this year. We will initiate trials very fast and we can do it in a basket manner so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop Skytropha 2 apoposter in the US. And with the reset of what we call the marketer set. We will keep that value as we have today and expand from there. I do not know Joe or Camilla, you have further comments or just you have and want to get more depth knowledge about specific comments from my site. Thanks. Thank you. Please stand by for our next question.
Jan Mikkelsen: We in this next weeks we are filing for adult growth hormone deficiency. We have Turner phaser coming in for phase two later this year. We will initiate trials very fast and we can do it in a basket manner so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop Skytropha 2 apoposter in the US. And with the reset of what we call the marketer set. We will keep that value as we have today and expand from there. I do not know Joe or Camilla, you have further comments or just you have and want to get more depth knowledge about specific comments from my site. Thanks. Thank you. Please stand by for our next question.
Jan Mikkelsen: We will keep that value as we have today and expand from there. I do not know Joe or Camilla, you have further comments or just you have and want to get more depth knowledge about specific comments from my site. Thanks. Thank you. Please stand by for our next question.
Tazeen Ahmed: Our next question comes from the line of Tazeen Ahmed with Bank of America Security. Yalan is open. Hi guys. Good afternoon. Thanks for taking my question. With regards to this new net price that you have for SkyTofa, can you talk to us about the competitive dynamics? Namely, are the daily injector manufacturers offering deeper discounts, and can you also talk about the level of impact that you're seeing from the recent relatively recent launch of the NOVO competing products?
Jan Møller Mikkelsen: Thanks for the question. I think it's in the line with some of the same question that got asked, after the first question. Yes, today there is two other long-acting product in the US market, we basically see one of them in [inaudible] because of the obvious effect everyone can observe. Just going to the databases that describe tolerability and other things like that, we see we are always doing extremely well too. In [inaudible], we see the same thing with Sequoia, Sequoia have a preferred position on some of the big PPM and we have other places. But what I'm generally seeing is there is no doubt, we always said that SKYTROFA had a best-in-class potential, but what we also see in the market that is really realizing as the best-in-class product opportunity. And that is the strengths we want to continue build on, not only in pediatric growth hormone deficiency, but also in all the different label expansion when we come into [inaudible] when we also get them. For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone, being the second quarter, that basically have an revenue down on 73%. So clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system. Thank you.
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Tazeen Ahmed: Sequoia have a preferred position on some of the big PPM and we have other places. But what I'm generally seeing is there is no doubt we always said that SkyTofa had a best-in-class potential, but what we also see in the market that is really realizing as the best-in-class product opportunity. And that is the strengths we want to continue build on, not only in pediatric growth hormone deficiency, but also in all the different label expansion when we come into vestidulation when we also get them. For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone being the second quarter that basically have an revenue down on 73%, so clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system. Thank you.
Tazeen Ahmed: For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone being the second quarter that basically have an revenue down on 73%, so clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system. Thank you.
Operator: Please stand by for our next question. Our next question comes from Alana Dirk Achilla with Will Spago, Yalana Sultan. Hi there. Thanks for taking the questions. Just want to know what payer feedback you might have received as far on the proposed U.R.V. Path Pacing in the U.S. And then I have a follow-up. We are coming up with a responsible pricing. We are coming with a pricing where we basically can support the statement we want to go every patient that have hyper-paratterisement.
Alana Dirk Achilla: Our next question comes from Alana Dirk Achilla with Will Spago, Yalana Sultan. Hi there. Thanks for taking the questions. Just want to know what payer feedback you might have received as far on the proposed U.R.V. Path Pacing in the U.S. And then I have a follow-up. We are coming up with a responsible pricing. We are coming with a pricing where we basically can support the statement we want to go every patient that have hyper-paratterisement.
Alana Dirk Achilla: We aim to support that work and be treated. In that entire methametric algorithm to achieve that, we came to this responsible pricing on back. And we have not got any feedback against that. That is not totally acceptable. Got it. Very helpful.
Jan Mikkelsen: And then a second question. Just in terms of the patients that you talked about on your V-path in Germany and Austria, I think you commented about 250 patients on the approval call for the US. I guess how do you think about that penetration relative to the overall market size in Germany? And how do you believe you're tracking thus far in the launch? Is it ahead of where you expected or less than you expected?
Jan Møller Mikkelsen: Thanks. I can come with some initial comments and you can get some further comments from Camila. Our initial aim and how we looked at how we expected the penetration profile would be, that we will see typical 1-2 patient per physician in the beginning, there was what we expected to see. Before each single physician really see the benefit of really what YORVIPATH can give to the patients, when they observe that, we expect later in this year that each patient or each physician will start to prescribe more patient from the number of patients each of them. So when we look on the number of physicians that already have prescribed, in Germany and Austria, around 125 prescriber had really prescribed it, we are extremely proud about this penetration to physicians. But I think what really are the most impressive thing for me in this launch is basic retention. When you think about, we have a [inaudible], when you start to take patient in, and really test it, are they really providing a benefit for the patient? And then they have a retention of 98%. I have never seen that for any product before, that is really, really unique but this really describe the benefit that is really giving to the patient, and the state of the treatment, exactly as we have observed in our clinical trials. I do not know, Camilla, you have further comments to the dorms in, specific in Germany and Austria? Yeah, I think you said it very, very well. We're very pleased with the uptake of the yoga path in Germany. We're benchmarking all the radices, launches, and we're doing very well compared to them. So the team is working hard on both breadth and depth and that's working well and also creating the mix between the pH that you patients and the ones that have been on that path. And the switch that we're making from that part to your path is going very, very fast. So all in all, we're very pleased with how it's going and where we're going to future. Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Jan Mikkelsen: So when we look on the number of physicians that already have prescribed in Germany and Austria around 125 prescriber had really prescribed it. We are extremely proud about this penetration to physicians. But I think what does really are the most impressive thing for me in this launch is basic retention. When you think about we have an extension, when you start to take patient in and really test that are they really providing a benefit for the patient and then they have a retention of 98%. I have never seen that for any product before. That is really, really unique. But it's really describe the benefit that is really giving to the patient and the state of the treatment exactly as we have observed. In our clinical trials, I do not know Camilla, you have further comments to the dorms in specific in Germany and Austria. Yeah, I think you said it very, very well. We're very pleased with the uptake of the yoga path in Germany. We're benchmarking all the radices, launches, and we're doing very well compared to them. So the team is working hard on both breadth and depth and that's working well and also creating the mix between the pH that you patients and the ones that have been on that path. And the switch that we're making from that part to your path is going very, very fast. So all in all, we're very pleased with how it's going and where we're going to future. Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Jan Mikkelsen: I have never seen that for any product before. That is really, really unique. But it's really describe the benefit that is really giving to the patient and the state of the treatment exactly as we have observed. In our clinical trials, I do not know Camilla, you have further comments to the dorms in specific in Germany and Austria. Yeah, I think you said it very, very well. We're very pleased with the uptake of the yoga path in Germany. We're benchmarking all the radices, launches, and we're doing very well compared to them. So the team is working hard on both breadth and depth and that's working well and also creating the mix between the pH that you patients and the ones that have been on that path. And the switch that we're making from that part to your path is going very, very fast. So all in all, we're very pleased with how it's going and where we're going to future. Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Jan Mikkelsen: We're benchmarking all the radices, launches, and we're doing very well compared to them. So the team is working hard on both breadth and depth and that's working well and also creating the mix between the pH that you patients and the ones that have been on that path. And the switch that we're making from that part to your path is going very, very fast. So all in all, we're very pleased with how it's going and where we're going to future. Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Speaker Change: [music].
Jan Mikkelsen: Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Speaker Change: Okay.
Speaker Change: Ladies and gentlemen, thank you for your patience, we apologize for the delay the conference will begin shortly please remain on the line again. Thank you for your patience.
Jan Mikkelsen: But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Speaker Change: [music].
Operator: Please stand by for our next question. Our next question comes from Milan, of Li Watsek, with cancer. Yalan is open. Hey guys, thanks for taking my questions. Maybe just follow up on Skype, Trofa. Maybe help us understand when, when do you need assumptions for the lower guidance for Skype over this year? Just looking for more details on what's driving that 100 million your reduction, maybe talk a little bit about the dynamics between the broader market access and pricing, and I have a follow up.
Operator: I can come with some overall statement, first related to how we did the forecasting, because what we basically did that we saw a growth in volume between Q1 and Q2, and we utilized that growth basically to predict the rest of the year, and it's basically giving the lower value. And after we now have reset our market access portfolio, we are in a position that the expect, that the DTN will be keeping constantly throughout the year, what we have observed, like last year, we saw a last seasonal effect, between the first half compared to the second half. We still see that as an upside, with potential will materialize, but we also know that it could not materialize, so this is how we have basically taking the guidance forward in that. And that is not anything believing in that the potential can actually grow, we see the potential, we see the best-in-class potential on it. Joe that is responsible for our US, you can also give a short summary about all the effect that's getting implemented now, that first will provide effect in the second half of this year. So the healthcare providers right now have extreme clarity about where they can provide scotrophic to patients with a high chance of reimbursement. But also where Sky Troop is not on formulary, healthcare providers are documenting intolerance, growth below the average parental height while on other growth hormones, therefore allowing a resubmission so that pediatric or hormone deficient patients can have access to Sky Troop. So there's time left. In this year, obviously things will stabilize in 25. So we know now where we can continue to add patients and grow our net revenue and expand and grow the value of the entire hormone marketplace.
Operator: What we have observed, like last year, we saw a last seasonal effect between the first half compared to the second half. We still see that as an upside, with potential will materialize, but we also know that it could not materialize. So this is how we have basically taking the guidance forward in that. And that is not anything believing in that the potential can actually growth. We see the potential, we see the best in class potential on it. Jo, that is responsible for our US. You can also give a short summary about all the effect that's getting implemented now, that first will provide effect in the second half of this year. So the healthcare providers right now have extreme clarity about where they can provide scotrophic to patients with a high chance of reimbursement. But also where Sky Troop is not on formulary, healthcare providers are documenting intolerance, growth below the average parental height while on other growth hormones, therefore allowing a resubmission so that pediatric or hormone deficient patients can have access to Sky Troop. So there's time left. In this year, obviously things will stabilize in 25. So we know now where we can continue to add patients and grow our net revenue and expand and grow the value of the entire hormone marketplace.
Jan Mikkelsen: You can also give a short summary about all the effect that's getting implemented now, that first will provide effect in the second half of this year. So the healthcare providers right now have extreme clarity about where they can provide scotrophic to patients with a high chance of reimbursement. But also where Sky Troop is not on formulary, healthcare providers are documenting intolerance, growth below the average parental height while on other growth hormones, therefore allowing a resubmission so that pediatric or hormone deficient patients can have access to Sky Troop. So there's time left. In this year, obviously things will stabilize in 25. So we know now where we can continue to add patients and grow our net revenue and expand and grow the value of the entire hormone marketplace.
Jan Mikkelsen: So there's time left. In this year, obviously things will stabilize in 25. So we know now where we can continue to add patients and grow our net revenue and expand and grow the value of the entire hormone marketplace.
Li Watsek: Okay, and I also wonder if you can talk a little bit about where you can further reduce from the cost perspective? And is there any chance you can do break even this year, given the lower schedule for items?
Jan Mikkelsen: And I also wonder if you can talk a little bit about where you can further reduce from the cost perspective. And is there any chance you can do break even this year, given the lower schedule for items? You know, Scott is really good at numbers. So I will summary, give you an all the perspective and then Scott can go more back to some of the way we are looking at it today.
Jan Mikkelsen: One of the things we are proud about is that we really keep our operating expenses in control. And we really see that we really have a good internal system to keep Ascendis Pharma to be a highly effective organization. We also see that there is revenue, specific Europe has different regions are really starting to take in now. So potentially we have a Europe outside US. We still in a situation where we are still discussing with FDA related to how we can really help the patient that is in shortage of treatment here in the US. We hope we can help them. We will do everything to help them. It means that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients. We hear the voice from the physicians. We will do everything so we can have an earlier launch. And as soon as we get clarity about that, we will come back to you. So we have a lot of potential upsides. We have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control. And this is how we are operating. Scott comments. I think you said it well, Jan. Lee, as you know, we always look to be cost effective in what we do as a company. And we evaluate expenses that aren't tied to getting the product to patient as soon as possible. But at the same time, of course, we don't want to sacrifice doing that and getting the product. So that's part of the reason we announced the new financing today after the close for the additional 150 million US dollars. But we continue to have great scrutiny on costs, particularly where they're not leading to getting our products to patients.
Jan Mikkelsen: We hope we can help them. We will do everything to help them. It means that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients. We hear the voice from the physicians. We will do everything so we can have an earlier launch. And as soon as we get clarity about that, we will come back to you. So we have a lot of potential upsides. We have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control. And this is how we are operating. Scott comments. I think you said it well, Jan. Lee, as you know, we always look to be cost effective in what we do as a company. And we evaluate expenses that aren't tied to getting the product to patient as soon as possible. But at the same time, of course, we don't want to sacrifice doing that and getting the product. So that's part of the reason we announced the new financing today after the close for the additional 150 million US dollars. But we continue to have great scrutiny on costs, particularly where they're not leading to getting our products to patients.
Speaker Change: [music].
Scott Smith: Scott comments. I think you said it well, Jan. Lee, as you know, we always look to be cost effective in what we do as a company. And we evaluate expenses that aren't tied to getting the product to patient as soon as possible. But at the same time, of course, we don't want to sacrifice doing that and getting the product. So that's part of the reason we announced the new financing today after the close for the additional 150 million US dollars. But we continue to have great scrutiny on costs, particularly where they're not leading to getting our products to patients.
Operator: Thank you, please stand by for our next question. Our next question comes from Alan Gavin Clark-Gartner with Evercore ISI. Your line is open.
Alan Gavin Clark-Gartner: We send out for our next question. Our next question comes from Alan Gavin Clark-Gartner with Evacore ISI. Yalan is open. Hey guys, thanks for taking the questions. First, I just wanted to ask, for Sky Trofa, when did these policies with more favorable access go into place, and doing the first half year? So, some of them are first taking in here in Q2. The complexity of these agreements are very complex in this way that potential rebate compared to volume increase are some way not really aligned, and there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume.
Alan Gavin Clark-Gartner: So, from a modeling perspective, we see a doubled digit number in increase in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before is first taking in in the second half.
Unknown Executive: So, I will first see the expected growth coming in in the second half. Okay, that makes sense. And some of that's on a QV data overall. Have you guys noticed any changes in capture rate trends over time? I think the issue I personally have the data is that it's assembling of few places. And if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it. You should give them all the money because the utilization of these days at least I'm not paying for it. I get it for free because I showed so many times they were totally not useful to have, but still buy it if you want. Okay, thanks.
Unknown Executive: So, out from that, I think you should pay it. You should give them all the money because the utilization of these days at least I'm not paying for it. I get it for free because I showed so many times they were totally not useful to have, but still buy it if you want. Okay, thanks.
Operator: Thank you, please stand by for our next question. Our next question comes from the line of Vikram Purohit with Morgan Stanley, Your line is open.
Unknown Executive: Please stand by for our next questions. Our next question comes from the line of big round per per row hit with Morgan Sally, Yelana Salton. Hi, good afternoon. Thank you for taking our questions. I guess switching to Transcon CNP, we were just curious for the upcoming approach readout and then also for the coach readout in 2Q25, just switch parameters of data you expect to report out and how you would currently guide people to compare and contrast the data sets versus a competitor CNP data sets available in the space.
Unknown Executive: Thank you. I think the most easiest way to compare anything is to go to was all the time because this is true. You can say mode of action that is there must align between them even if there is a different in how we function because we have a continuous exposure of CNP molecule. Where? from the Vosualtide, it basically is only have an active covers for two or three hours in every 24 hours dosing cycle. So when we look on our aim, as we have said in the last eight years, we want both to provide linear growth but also provide and address the co-morbidity of the disease. And what we have seen function now and now I'm referring into phase two because this is the data I can talk about today is that we have seen and analyzed high velocity exactly at the same level of Vosualtide with a once-weekly dosing profile. But we have seen the improvement in many of the way that the children, the physician, the caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data directly to placebo and improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from. I need to see the data that coming in the next week. So it's pretty, pretty, pretty near. So the database has been locked. People are running the staff now. So as soon as their fitness, I would be taken into a room and see the data. Got it. Thank you. Please stand by for our next question.
Unknown Executive: So when we look on our aim, as we have said in the last eight years, we want both to provide linear growth but also provide and address the co-morbidity of the disease. And what we have seen function now and now I'm referring into phase two because this is the data I can talk about today is that we have seen and analyzed high velocity exactly at the same level of Vosualtide with a once-weekly dosing profile. But we have seen the improvement in many of the way that the children, the physician, the caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data directly to placebo and improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from. I need to see the data that coming in the next week. So it's pretty, pretty, pretty near. So the database has been locked. People are running the staff now. So as soon as their fitness, I would be taken into a room and see the data. Got it. Thank you. Please stand by for our next question.
Speaker Change: [music].
Unknown Executive: But we have seen the improvement in many of the way that the children, the physician, the caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data directly to placebo and improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from. I need to see the data that coming in the next week. So it's pretty, pretty, pretty near. So the database has been locked. People are running the staff now. So as soon as their fitness, I would be taken into a room and see the data. Got it. Thank you. Please stand by for our next question.
Unknown Executive: And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from. I need to see the data that coming in the next week. So it's pretty, pretty, pretty near. So the database has been locked. People are running the staff now. So as soon as their fitness, I would be taken into a room and see the data. Got it. Thank you. Please stand by for our next question.
Kelly Shi: Our next question comes from the line of Kelly shot with Jeffries. Your line is open. Thank you for taking my questions. Maybe for PDH, could you please elaborate more on your ongoing interactions with regulators regarding commercialization of existing batches? For the US launch, which is likely of a few or first quarter of next year at the moment? We have an extremely constructive dialogue with FDA related to how potential to address the shortest of PTI drops in the US.
Kelly Shi: It's been driven by patients that basic are Seeing the huge, unleavened need, the situation where patients have been missing their power for a long time, and extremely serious consequence of patients that now today are on their path and suddenly need to be disrupted, of the treatment because their power will not be available longer. Out from that, both patient organization, physician and us, and FDA recognize this issue, and I think everyone is working together in an extremely constructive manner to find out how we can help the patient to avoid such a crisis that potentially it would be. Thanks. Thank you.
Unknown Executive: Out from that, both patient organization, physician and us, and FDA recognize this issue, and I think everyone is working together in an extremely constructive manner to find out how we can help the patient to avoid such a crisis that potentially it would be. Thanks. Thank you.
David Lebowitz: Please stand by for our next question. Our next question comes from the line of David Lebowitz with City, Yolana Thulking. Well, thank you for taking my question. I got two here. First, on the sky trofe adjustments. Just to make sure I got this right, that you came to an agreement on unit pricing with the payers, and as part of it, you had to true up prior sales in the last couple quarters, and then I'll have one more after that.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Ladies and gentlemen.
Speaker Change: Again, thank you for your patience and we do apologize for did you like we're having a bit of a technical did it checked.
Jan Møller Mikkelsen: I think you have understood it correctly. This is a true up that is basically reflecting net revenue from mainly net revenue from Q1, but about 7.6 million also from 23, that is the true up, that is being taken away from Q2 revenue. So basically if you want to calculate real sales in Q2, you need to add all this true up to the net revenue from Q2, that is reported to you. Got it. Stuck any comments? Or did I get it right? You got it right, Jan. Good. I got it. And on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates. I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Speaker Change: Technical difficulties, we will stop the conference shortly again, thank you for your patience everyone.
Speaker Change: [music].
Jan Mikkelsen: And on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates. I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Jan Mikkelsen: We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Operator: Please stand by for our next question. Our next question comes from the line of Alex Thompson with Sifu, Yalayan Zolpin.
Alex Thompson: Our next question comes from the line of Alex Thompson with Sifu, Yalayan Zolpin. Great. Thanks for taking my question. I guess, you know, again, on sort of the Yorvig path potential in the US. Could you talk specifically about the data that FEA needs to or wants to see in order to understand whether the material you have currently would be suitable for a US launch in the fourth quarter? Thanks. I actually think that they have all the data to take this decision.
Alex Thompson: And I don't believe any data need to be brought to them. At least the request we have on is not really on anything of the data. It's over, it can ensure that when we start, we basic iron opposition, we really can manage this entire demand that we expect to come. Thank you.
Operator: Please stand by for our next question. Next question comes from a lot of Paul Choi with Goldman Sachs. Yalayan is open.
Paul Choi: Hi, thank you, good afternoon, and thank you for taking our question. On, to revisit, SKYTROFA, can you maybe comment on what percentage of your pair of contracts were affected by this, by the true up, and whether the duration of these changes are multi-year? Basically it would be helpful to understand if this is an issue we'll have to potentially revisit next year, so any comments there would be helpful. And second, just in terms of the Royalty Pharma agreement that was announced this year, I just want to confirm that, from your perspective, is this potentially the last source of external capital that you think you'll need, prior to achieving operating cash flow break even either this year or next year? Thank you very much.
Speaker Change: Yes.
Speaker Change: [music].
Jan Mikkelsen: And second, just in terms of the royalty farm agreement that was announced this year, I just want to confirm that from your perspective, is this potentially the last source of external capital that you think you'll need prior to achieving operating cash flow break even either this year or next year? Thank you very much. The question that you are asking for related to the implementation of the new contracts, the implementation of the new contract was a continued process to Q1 and Q2.
Jan Mikkelsen: We are now in a position that we have resetted. This is why Scott used the great work reset. We have reset power for targets in the US and out from that perspective, the GCN we expect to see in the second half will be aligned to what we saw in the first half and we expect the same GCN in 25, 26, 27, 28, 29 and 30. I can only come with five years guidance. Thank you.
Speaker Change: Okay.
Speaker Change: Ladies and gentlemen, please standby your conference call will begin in two minutes. Please remain on the line your conference call will begin in two minutes.
Yaron Werber: Our last question will come from the line of Yaron Werber from TD Cohen, Yalan is open. Great. Thanks for taking my question. Hope you can hear me. My question is two parts just relating to the, as you think about the guidance for the year, the 220 to 240, does that entail that the 71.5 million that you sort of did in the first half? For Sky Trofa on a net basis? Or is that including the 91 million, you know, assuming you did 65 million in Q1?
Yaron Werber: And then secondly on you said you did 53 million in Q2. Is that a good run rate to then start into Q3? And 4 should we really think of the 26 million this quarter as a good run rate into into the second half?
Speaker Change: [music].
Scott Smith: Thank you. Yeah, there was a lot of question in what you basically gave to a Scott and me and Joe and the commercial team into it. I think when you start on the last question about basic, the reported number today here in in our numbers. And I see that the real number is basic, the reported net sales plus the true out that we basic provided to you. So you take the number that we have in our Q2 sales and then basic and everything what we took in true out, both from 23 and what we did in Q1. There you will get a basic and net sales of what we had in a second quarter of 24. So I think that is the real number. And when you look at that, it is around 53 million euro if I calculated right that I think is the real number for Q2. If I do my calculations is 53.4 or something like that to be concrete. So we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential of a cop, we will see and improved pick up in Q3 and Q4. And when we did the forecasting, we basic to the conservative approach and saying we use the number between Q1 and Q2 and use that as a forthcoming number for every quarter. So the rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have giving you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything for that? Yeah, just one thing you are on the for the first half, we reported 91.2 million euro without any, you know, those were the actual reported numbers. And as we said in the prepared remarks in the press release, that number was reduced, had been reduced by 7.6 million euro of true up for periods prior to January 1. So in other words, it would have been 7.2 higher or about 100 million euro for the first half.
Scott Smith: There you will get a basic and net sales of what we had in a second quarter of 24. So I think that is the real number. And when you look at that, it is around 53 million euro if I calculated right that I think is the real number for Q2. If I do my calculations is 53.4 or something like that to be concrete. So we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential of a cop, we will see and improved pick up in Q3 and Q4. And when we did the forecasting, we basic to the conservative approach and saying we use the number between Q1 and Q2 and use that as a forthcoming number for every quarter. So the rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have giving you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything for that? Yeah, just one thing you are on the for the first half, we reported 91.2 million euro without any, you know, those were the actual reported numbers. And as we said in the prepared remarks in the press release, that number was reduced, had been reduced by 7.6 million euro of true up for periods prior to January 1. So in other words, it would have been 7.2 higher or about 100 million euro for the first half.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Hello, Thank you for standing by welcome to offenders Pharma second quarter 2024 earnings Conference call.
Scott Smith: And when you go back and look on the seasonal variance that potential of a cop, we will see and improved pick up in Q3 and Q4. And when we did the forecasting, we basic to the conservative approach and saying we use the number between Q1 and Q2 and use that as a forthcoming number for every quarter. So the rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have giving you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything for that? Yeah, just one thing you are on the for the first half, we reported 91.2 million euro without any, you know, those were the actual reported numbers. And as we said in the prepared remarks in the press release, that number was reduced, had been reduced by 7.6 million euro of true up for periods prior to January 1. So in other words, it would have been 7.2 higher or about 100 million euro for the first half.
Speaker Change: At this time all participants are in a listen only mode.
Speaker Change: After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you would then here automated message advising your hand is raised to withdraw your question. Please press star one again, we ask that you limit yourself to one question and one follow up.
Speaker Change: I would now like to turn the call over to Tim Lee Senior director of Investor Relations Edison disclaimer, Sir you may begin.
Tim Lee: Thank you operator, and thank you everyone for joining our second quarter 2024 financial results Conference call.
We apologize for the delay.
Kim Lee: Some technical issues that we had here on Kim Lee Senior director of Investor Relations at ascend is pharma.
Scott Smith: I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything for that? Yeah, just one thing you are on the for the first half, we reported 91.2 million euro without any, you know, those were the actual reported numbers. And as we said in the prepared remarks in the press release, that number was reduced, had been reduced by 7.6 million euro of true up for periods prior to January 1. So in other words, it would have been 7.2 higher or about 100 million euro for the first half.
Operator: Thank you. Ladies and gentlemen, I'm showing no further questions in the queue, this concludes today's conference call, thank you for your participation. You may now disconnect.
Speaker Change: Joining me on the call today are you and make US an president Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Christina single Executive Vice President and head of clinical development oncology.
Speaker Change: Camilla harder Harvey Executive Vice President and global Chief Commercial Officer, and Joe Kelley U S General manager.
Speaker Change: Before we begin I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered.
Speaker Change: Harbor provided by the private Securities Litigation Reform Act.
Speaker Change: Examples of such statements May include but are not limited to statements regarding our commercialization and continued development of sky clubs, when you're past the U S and European markets as well as certain financial expectations, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization.
Operator: Ladies and gentlemen, I'm showing no further questions in the queue.
Operator: This concludes today's conference call. Thank you for your participation.
Operator: You may now disconnect.
Speaker Change: Our strategic plan, our goals regarding our clinical pipeline, including the timing of clinical results are ongoing and planned regulatory filings for expectations regarding the timing and the result of regulatory decisions and our exploration of market opportunities in therapeutic areas outside of endocrinology rare disease.
These statements are based on information that is available to us as of today actual results may differ and could.
Speaker Change: Could differ actual results may differ it could differ materially from those are forward looking statements and should not place undue reliance on these statements.
Operator: Thank you for your time, and I'll see you next time.
Speaker Change: Assume no obligation to update these statements as circumstances change except as required by law for additional information concerning the factors that can 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 20-F.
Speaker Change: Bob with the SEC on February seven 2020 for Kras.
Speaker Change: Transcon growth hormone Transcon Hgh <unk> is approved in the U S by FDA and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth.
Speaker Change: Growth hormone deficiency.
Kraft's got PTH is approved in the U S by the FDA for the treatment of hyperparathyroidism adult and the European Commission in the United Kingdom's medicines and healthcare products regulatory agency has granted marketing authorization for Transcon PTH replacement therapy indicated for the treatment of adults with chronic hyperparathyroidism.
Speaker Change: Otherwise please note that our product candidates, our investigational and not approved for commercial use.
Speaker Change: As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency none.
Speaker Change: None of the statements during this conference call regarding our product candidates shall be viewed as promotional.
Yael: On the call today, we'll discuss our second quarter 2024 financial results and our pipeline will provide further business updates. Following some prepared remarks, we will then open up the call for questions with that let me turn it over to yet.
Tim Lee: Thanks, Tim.
Yet: Good afternoon, everyone.
Speaker Change: With the recent U S approval of your Asps.
Speaker Change: That's the first and only FDA approved treatment of hypothermia Smith in adults.
Speaker Change: <unk> has successfully obtained approvals for two out of three endocrinology rare disease product candidate in.
Speaker Change: Two major market the U S and EU.
Speaker Change: And with people show data from our third product candidate Transcon, CMP and conduct Asia expected in the coming weeks.
Speaker Change: <unk> Oh vision to achieve approval of all three product candidate by the end.
Speaker Change: Top 2025.
Speaker Change: Our algorithmic for product innovation combined with our Transcon technology.
Speaker Change: It enabled us to bring new highly differentiated product candidates through the clinical development process.
Speaker Change: Foster and grede at higher success rate compared to traditional drug development.
Speaker Change: We attempt to continue to develop new product candidates into crime.
Speaker Change: Dos two coding errors SASSA on quality piece of cheap metabolic disease, and cardiovascular with best in class potential to make a meaningful difference for patients across the globe.
Speaker Change: First on our strong scientific focus.
Speaker Change: Let us begin with your pets.
Speaker Change: In the U S alone an estimated.
Speaker Change: 70 to 90000 patients living with type of apparel Tyree Smith.
For those who haven't seen it please take time to phosphate patient arranged 58 hearing on the hybrid parents Tory Smith associated website.
Speaker Change: Providing.
Speaker Change: In depth understanding of the serious consequence of having this disease.
Speaker Change: With the FDA approval of your pet physician and adult patients in United States can now look forward to having a treatment option for treatment of high book.
Speaker Change: We are preparing for your pets longs in the U S levering, our established commercial infrastructure and expertise.
Speaker Change: We are expanding our dedicated.
Speaker Change: Allstate's reps and field medical personnel, who will engage with around 6000 physicians would treat aged towers and 80% of patients with hyper parents in the U S.
Speaker Change: Other key launch in nature to us.
Speaker Change: Including the rollout of our patient support programs.
Speaker Change: Signed to support access to your pets for example, liquid both patients on commercial insurance, we pay as little as $5 a month for the U S prescription.
Speaker Change: In addition, following our goal to take kiosks or patients with this disease. We will also introduce a patient assistance program.
Speaker Change: We have also started engaging U S payers and Pbms.
Speaker Change: We expect product availability in the U S. In the first quarter of 'twenty 'twenty five.
Speaker Change: Or sooner if it's possible.
Consistent with.
Speaker Change: Premier responsible pricing.
Speaker Change: Along with our best price corresponding to 285.
Capetian, reflecting the value of your kids to the U S healthcare system.
Speaker Change: In the U S.
Speaker Change: Uh huh.
Speaker Change: Around 140 patients currently active in the expanded access program.
Speaker Change: And about <unk>.
Speaker Change: 50.
Speaker Change: More patients in the open label extension of our clinical studies physicians will be good transplant. These patients over to commercial product as soon as it's available.
Speaker Change: Yeah.
Speaker Change: In Europe, the novel patient and prescribing physician imitating Europe. It continues to increase and we see a good mix of Pega's experience and you know your patients.
Speaker Change: This was the first full quarter of commercial launch in Germany and Austria.
Speaker Change: Our sales momentum continues to build we now have more than 250 patients on treatment.
Speaker Change: And an estimated 125 for.
Chris: Chris' guidance.
Chris: These two markets.
Speaker Change: Europe has a patient which interest rate is extremely strong and currently around 98%.
Speaker Change: As physicians gain more experience that you have pets, we expect them to be more patient on therapy, including those finishing remaining supplies of net par.
Speaker Change: The interest for serving patients on a named patient programs prior to full commercial launch is increasing.
Now have patient disease program in more than 10 countries.
Speaker Change: Spec projects.
Speaker Change: End of the year.
Speaker Change: Okay.
Speaker Change: Moving to Skype chopper.
Speaker Change: Proud to have more than 11000 patients for Skype cutover in the first three years Samsung's and to have achieved market value leadership by expanding the autograft to bond market.
Speaker Change: Key component of our strategy to make schedule for a blockbuster product in the U S.
Speaker Change: Include simplifying broaden market assessed for both treatment nave and switch patients as well as expanding our label.
Speaker Change: In the first half of the year that we set two broader mark the Salesforce cutover was largely completed.
Speaker Change: Why this broad access to Skype for Scott Gopher will support long term demand in the short term it negatively impacted our first half net revenue.
Speaker Change: Scott will share more details.
Margaret: Margaret assist transition largely completed skytrooper is now positioned as a premium product with a net value per patient of around three times compare to <unk> optimal.
Speaker Change: We are now focused on using our new market assess covers to drive demand.
Speaker Change: Continue to expand the award growth hormone market.
Speaker Change: Aiming to reach blockbuster status for Sky Trophy in the U S alone.
Speaker Change: Finally to build on our market leadership position, we plan to submit a supplemental BLA in adult growth hormone deficiency.
Speaker Change: Ft in the third quarter of this year.
Speaker Change: Our first schedule with labor expense.
Speaker Change: So I expect topline data from our phase two trial in Turner syndrome in the fourth quarter of 2024.
Speaker Change: Switching to Transcon CMP.
Speaker Change: I have always been extremely excited about our progress in that computation and much more now SBR protein better results from our pivotal trials in the coming weeks.
Speaker Change: We have consistently in our Mississippi over past eight years since we announced our product candidate that our aim is to develop a treatment.
Speaker Change: Address both linear growth and Docomo ptc's.
Speaker Change: Health and quality of life for people living with a contemplation.
Speaker Change: Earlier this year you saw a comprehensive resource for our phase two o'clock. This trial demonstrating that our once weekly transcon CFT.
Speaker Change: <unk> annualized growth velocity similar to restore.
Speaker Change: So very tight about five six centimeters after 12 months of treatment.
Speaker Change: In addition for first time for product in the setting of Pacer. We also demonstrated that compared to placebo transcon CMP improved quality of life.
Speaker Change: Associated with the physical function of LP in children with Achondroplasia, Peter favorable side effect and Tolerability profile.
Now we hope that we can replicate this result with more patients in our people approach trial.
And we are expecting top line data in the next few weeks one quarter earlier that guided disc.
Speaker Change: This trial enrolled 84 children ages, two to 11 with achondroplasia.
Speaker Change: <unk> plus five seven years similar to our phase II trial.
We also continue to enrolling and coax at phase II trial of Transcon CMP in combination with transcon growth hormone Skytrax designed to show that adding Scott talked to transcon CRP could provide cash opco for patients who start CMP treatment late we expect.
Speaker Change: To complete enrollment in this combination trial during the first fourth quarter of 2024 with topline 2006 data expected in the second quarter of 2025.
Speaker Change: Turning now to oncology.
Speaker Change: We continue advancing three phase two trials with multiple indications specific cohort two started with best in class potential of our two product candidates transcon to Peter Governor and Transcon Chiller <unk> equities in different combinations scenarios.
We plan to present initial results from our Transcon <unk> government in combination with chemotherapy impressive system Award bird catcher front there.
Speaker Change: I believe trial data this month at the ESMO conference in Barcelona.
Speaker Change: Im pleased how this program are progressing.
Speaker Change: Closing.
Speaker Change: For us and it's all about the patients.
Speaker Change: Patients tell us the U S approval, if you work it is transformative for them.
Speaker Change: Bcf for parents desk October has changed her life for children and parents both.
Speaker Change: With data expected in the next weeks for Transcon CMP. It is our goal that we are able to show steady also transform the lives of people living a contemplation.
Speaker Change: With our ongoing progress.
Speaker Change: Our oncology program and exploration of all areas of innovation and vast market opportunity such as obesity.
Speaker Change: Continue to put precision messages for sustainable growth with an expanded pipeline of transform more transformative cheap trying to con product candidate.
Speaker Change: Turn it over to Scott.
Scott: From a financial update.
Scott: Thanks Ian.
Scott: Scott trough of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was $26 2 million euro compared to $35 9 million Euro reported in the second quarter of 2023, a decrease of 27% year over year.
Scott: An increase in Sky trough of volume was offset by higher sales deductions for Q2, and an adjustment to Q1 2024 sales deduction accruals as well as for periods in 2023.
Speaker Change: These adjustments reflect the reset of broader market access to support continued growth of <unk> as the market value leader and a potential blockbuster in the U S alone.
Speaker Change: In total.
Speaker Change: Q2, 2024 reported revenue was reduced by a true up of $27 1 million Euro of which $19 5 million Euro was attributable to the first quarter 2024 sales and $7 6 million Euro to sales prior to January one 2024.
Speaker Change: Okay trough of revenue for the first half of 2024 totaled $91 2 million euro at 35% year over year increase compared to $67 4 million Euro during the same period in 2023.
Timothy Lee: Thank you, operator, and thank you, everyone, for joining our second quarter 2024 financial results conference call. We apologize for the delay due to some technical issues that we had here, I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma.
Speaker Change: First half 2020 for Sky trough of volume more than doubled but was partially offset by an accrual true up of $7 6 million Euro which was attributable to periods. Prior to January one 2024.
Timothy Lee: Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Stina Singel, Executive Vice President and Head of Clinical Development Oncology, Camilla Harder Hartvig, Executive Vice President and Global Chief Commercial Officer, and Joe Kelly, U.S. General Manager.
Timothy Lee: Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered and stated parable provided by the Private Security's litigation reform act. Examples of such statements may include, but are not limited to statements regarding our commercialization and contuse development of SKYTROFA and YORVIPATH, the U.S, and European markets. As well as certain financial expectations, our pipeline candidates, and our expectations with respect to their continued progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results.
Speaker Change: With the advent of broader market access we believe the overall growth hormone market will continue to grow the number of patients treated.
Speaker Change: We estimate that by the end of Q2 2020 for Skype trough of penetration in the U S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated pro forma market still.
Speaker Change: Still with our single indication for pediatric ghd, leaving lots of room for further growth and market expansion.
Timothy Lee: Our ongoing and plan regulatory filings for expected expectations regarding the timing and the results of regulatory decisions, and our exploration of market opportunities and therapeutic areas outside of endocrinology rare disease. These statements are based on information that is available to us as of today, actual results may differ, and could differ, actual results may differ and could differ materially from those in our forward-looking statements, and should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that can cause actual results to differ materially, please see our four-looking statements section in today's press release, and the Risk Factor section of our most recent annual report on form 20-F, filed with SEC on February 7th, 2024.
Timothy Lee: Our ongoing and plan regulatory filings for expected expectations regarding the timing and the results of regulatory decisions, and our exploration of market opportunities and therapeutic areas outside of endocrinology rare disease. These statements are based on information that is available to us as of today, actual results may differ, and could differ, actual results may differ and could differ materially from those in our forward-looking statements, and should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law.
Speaker Change: Based on year to date results and current trends, we now expect full year 2020 for Sky drove our revenue to be in the range of $220 million euro to $240 million Euro.
Speaker Change: Shifting the transcon PTH second quarter Europe has revenue of $5 2 million Euro reflected the first full quarter of commercial revenue in Germany, and Austria as well as initial revenue in other markets with you over the past revenue continuing to increase from the $1 5 million Euro in Q1, driven.
Speaker Change: The growing patient and physician demand.
Timothy Lee: For additional information concerning the factors that can cause actual results to differ materially, please see our four-looking statements section in today's press release, and the Risk Factor section of our most recent annual report on form 20-F, filed with SEC on February 7th, 2024.
Speaker Change: Closing out the top line total revenue for the second quarter was 36 million euro, including $4 6 million euro tied to rendering up services and license revenue.
Speaker Change: Turning to expenses R&D costs in the second quarter of 2024 totaled 38, sorry, $83 5 million.
Timothy Lee: TransCon Growth Hormone, or TransCon hGH, is approved in the US by FDA, and the EU has received MAA authorization from the European Commission for the Treatment of Pediatric Growth Formal Deficiency. TransCon PTH is approved in the U.S, by the FDA for the Treatment of Hypo-Parathyroidism and DELF and the European Commission and the United Kingdom's Medicines and Healthcare Products Regatory Agency has granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic Hypo-Parathyroidism. Otherwise, please note that our product candidates are investigational and not approved for commercial use.
Speaker Change: Compared to $105 million euro during the second quarter of 2023.
Speaker Change: The 21% decline was largely tied to lower external development costs for transcon, <unk> agonist and lower costs for transcon PTH as well as the iconic spinoff.
Speaker Change: SG&A expenses in the quarter totaled $74 3 million euro compared to $70 3 million Euro during the second quarter of 2023, the increase was primarily due to higher employee costs, including the impact from global commercial expansion.
Speaker Change: Total operating expenses were $157 8 million euro for the second quarter, a 10% decrease compared to the $175 3 million euro during the second quarter of 2023.
Timothy Lee: As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our second quarter of 2024 financial results, and we'll provide further business updates, following some prepared remarks, we will then open up the call for questions. With that, let me turn it over to Jan.
Speaker Change: Total operating expenses for the first half of 2024 or $295 million Euro.
Speaker Change: Net finance income in the quarter was $29 4 million euro compared to $26 4 million Euro in the second quarter of last year.
Speaker Change: As a reminder, the net finance line can fluctuate quarter to quarter driven in part by noncash items related to our outstanding convertible notes.
Speaker Change: We ended the second quarter with cash cash equivalents and marketable securities totaling 259 million euro compared to $399 million Euro as of December 31, 2023.
Speaker Change: Finally earlier today and subsequent to June 32024, and therefore not included in our reported cash balance we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for $150 million in exchange for a 3% royalty.
Speaker Change: Net sales of yoga path within the United States.
Speaker Change: But the royalty payments are capped at 165 times the purchase price if fully paid prior to December 31, 2029, or two times thereafter.
Speaker Change: Further details are disclosed in a separate 6K.
Speaker Change: Also filed today.
Speaker Change: Looking ahead for the full year 2024 based on current plans, we expect sky Trefor revenue to be in the range of $220 million to $240 million Euro.
Speaker Change: Total operating expenses, which include SG&A and R&D to be approximately 600 million euro, including yoga path related launch activities.
Speaker Change: In the U S.
Speaker Change: And pending launch timing of Europe path in the U S. We currently expect to achieve operating cash flow breakeven on a quarterly basis in 2024 or 2025.
Speaker Change: Before we turn it over to the operator for Q&A I want to reiterate with database lock and the topline results for our pivotal approach trial expected in the coming weeks, we plan to Institute, a quiet period, starting Thursday, and Unfortunately, we will not be able to participate in upcoming investor conferences.
Speaker Change: With that operator, we're now ready to take questions.
Speaker Change: Thank you, ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and wait to hear your name announced to withdraw. Your question. Please press star one again and please limit yourself to one question and one follow up please.
Please standby, while we compile the Q&A roster.
Speaker Change: Our first question comes from the line of Jessica Fye with Jpmorgan. Your line is open.
Jessica Fye: Hey, guys. Good afternoon, Thanks for taking my question.
Jessica Fye: I wanted to better understand how you project getting sky Trop, two a blockbuster in the U S alone.
Jan Møller Mikkelsen: We are expanding our dedicated team of state reps and field medical personnel, who will engage with around 6,000 physician, who would treat 80,000, 80% of patients with hypothyroid in the US. Other key launches in new disease are underway, including the role of our patient support programs, designed to support access to YORVIPATH. For example, a likable patient on commercial insurance will pay as little as $5 a month for the YORVIPATH prescription. In addition, following our goal to take care of all patients with this disease, we will also introduce a patient assistant program.
Speaker Change: Based on.
Speaker Change: They kind of reached that net price and what you said about where you are in terms of penetration in gvhd and the broader accreted growth hormone market.
Speaker Change: Can you walk through that a little bit thank you.
Speaker Change: Thanks, Jess I will start and I have much to commercial colleagues with me here today.
Speaker Change: So that can also.
Speaker Change: Somebody give you more details if that is desired.
Speaker Change: Currently we see the market it's about one four.
Speaker Change: 4 billion U S dollars the entire proximal market in the U S.
Speaker Change: And as I stated in my prepared remarks, when we look on.
Jan Møller Mikkelsen: We have also started engaging US payers and [inaudible], we expect product availability in the US in the first quarter of 2025, or sooner, if it's possible. Consisting with premier responsible pricing, we will launch with a back price corresponding to 285,000 annual per patient, reflecting the value of YORVIPATH to the US health care system. In the US, there are around 140 patients, currently active in the expanded SS program, and about 50 more patients in the open label extension of our clinical studies, physician will begin to transform these patients over to commercial products as soon as it's available. In Europe, the number of patients and prescribing physicians initiating YORVIPATH continues through increase, and we see a good mix of purchase experience and new naive patients. This was the first full quarter of commercial loans in Germany and Austria, where sales momentum continues to build.
Jan Møller Mikkelsen: We have also started engaging US payers and [inaudible], we expect product availability in the US in the first quarter of 2025, or sooner, if it's possible. Consisting with premier responsible pricing, we will launch with a back price corresponding to 285,000 annual per patient, reflecting the value of YORVIPATH to the US health care system. In the US, there are around 140 patients, currently active in the expanded SS program, and about 50 more patients in the open label extension of our clinical studies, physician will begin to transform these patients over to commercial products as soon as it's available.
Speaker Change: Net value per patient.
Speaker Change: Basic which trophy half about three times.
Speaker Change: The net value on a yearly treatment.
Speaker Change: When do we see our effort when we look at our when we.
Speaker Change: Developing the long acting segment, we see schedule for as really the preferred brand.
Speaker Change: Even in places, where we just are in the same level of market access clearly clearly clearly schedule for Easter occurred product.
Speaker Change: Even in places, where we don't have market access we really see.
Speaker Change: <unk> coming in because it's really a couple of lighting.
Jan Møller Mikkelsen: In Europe, the number of patients and prescribing physicians initiating YORVIPATH continues through increase, and we see a good mix of purchase experience and new naive patients. This was the first full quarter of commercial launch in Germany and Austria, where sales momentum continues to build, we now have more than 250 patients on treatment, and an estimated 125 prescribers in these two markets. Europe has patients which entrance rate is extremely strong and currently around 98%. As physicians gain more experience that Europe has, we expect them to bring more patient on therapy, including those finishing or remaining supplies of net power. The interest for serving under named patient programs prior to full commercial loans is increasing, we now have patient in these programs in more than 10 countries and expect more by the end of the year. Moving to SKYTROFA, we are proud to have more than 11,000 patients for SKYTROFA in the first three years since launch, and to have achieved market value leadership by expanding the overall growth among market. Key component of our strategy to make SKYTROFA a blockbuster product in the US, include simplifying broadened market assets for both treatment aid or space patient, as well as expanding our label. In the first half of the year, the reset to broader market assets for SKYTROFA was largely competitive. While this broader access to SKYTROFA would support long term demand, in the short term, it negative impacted our first half net revenue, Scott will share more details. With our market assets transition largely competed, SKYTROFA is now positioned as a premium product, with a net value per patient of around three times compared to [inaudible]. We are now focusing on using our new market assets chorus to drive third demand, continue to expand the overall growth among market, and are aiming to reach blockbuster status for SKYTROFA in the US alone. Finally, to build on our market leadership position, we plan to submit and supplement BLA in adult growth hormone deficiency to the FDA in the third quarter of this year, our first SKYTROFA Label Expansion. We also expect top-line data from our Phase II tried internal syndrome in the fourth quarter of 2024. Switching to TransCon CNP, I have always been extremely excited about our program in [inaudible] and much more now as we are approaching the results from our pivotal trial in the coming weeks. We have consistently, in our [inaudible] over past eight years, [inaudible] our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with achondroplasia.
Jan Møller Mikkelsen: In Europe, the number of patients and prescribing physicians initiating YORVIPATH continues through increase, and we see a good mix of purchase experience and new naive patients. This was the first full quarter of commercial launch in Germany and Austria, where sales momentum continues to build, we now have more than 250 patients on treatment, and an estimated 125 prescribers in these two markets. Europe has patients which entrance rate is extremely strong and currently around 98%. As physicians gain more experience that Europe has, we expect them to bring more patient on therapy, including those finishing or remaining supplies of net power.
Speaker Change: Unique.
Speaker Change: Improvement compare to the product's potential.
Speaker Change: So when we see our label expansion effort, we basic in the coming year will it be possible for us not only to address the pediatric growth hormone deficiency market.
Speaker Change: In this mixed weeks.
Speaker Change: Filing for adult growth hormone deficiency, we have China based or coming in.
Speaker Change: For phase III.
Speaker Change: Later this year.
Speaker Change: In each eight trials vast fast and we can do it in a basket manner. So we basically can get to the full cohort four different tumor indications.
Jan Møller Mikkelsen: As physicians gain more experience that Europe has, we expect them to bring more patient on therapy, including those finishing or remaining supplies of net power. The interest for serving under named patient programs prior to full commercial loans is increasing, we now have patient in these programs in more than 10 countries and expect more by the end of the year. Moving to SKYTROFA, we are proud to have more than 11,000 patients for SKYTROFA in the first three years since launch, and to have achieved market value leadership by expanding the overall growth among market. Key component of our strategy to make SKYTROFA a blockbuster product in the US, include simplifying broadened market assets for both treatment aid or space patient, as well as expanding our label. In the first half of the year, the reset to broader market assets for SKYTROFA was largely competitive. While this broader access to SKYTROFA would support long term demand, in the short term, it negative impacted our first half net revenue, Scott will share more details. With our market assets transition largely competed, SKYTROFA is now positioned as a premium product, with a net value per patient of around three times compared to [inaudible]. We are now focusing on using our new market assets chorus to drive third demand, continue to expand the overall growth among market, and are aiming to reach blockbuster status for SKYTROFA in the US alone. Finally, to build on our market leadership position, we plan to submit and supplement BLA in adult growth hormone deficiency to the FDA in the third quarter of this year, our first SKYTROFA Label Expansion. We also expect top-line data from our Phase II tried internal syndrome in the fourth quarter of 2024. Switching to TransCon CNP, I have always been extremely excited about our program in [inaudible] and much more now as we are approaching the results from our pivotal trial in the coming weeks. We have consistently, in our [inaudible] over past eight years, [inaudible] our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with achondroplasia.
Jan Møller Mikkelsen: As physicians gain more experience that Europe has, we expect them to bring more patient on therapy, including those finishing or remaining supplies of net power.
Speaker Change: That gives you the high level, how we see we can develop skytrooper too at blockbuster in the U S and with the reset of the what we call the market asset.
Jan Møller Mikkelsen: The interest for serving under named patient programs prior to full commercial loans is increasing, we now have patient in these programs in more than 10 countries and expect more by the end of the year. Moving to SKYTROFA, we are proud to have more than 11,000 patients for SKYTROFA in the first three years since launch, and to have achieved market value leadership by expanding the overall growth among market. Key component of our strategy to make SKYTROFA a blockbuster product in the US, include simplifying broadened market assets for both treatment aid or space patient, as well as expanding our label. In the first half of the year, the reset to broader market assets for SKYTROFA was largely competitive. While this broader access to SKYTROFA would support long term demand, in the short term, it negative impacted our first half net revenue, Scott will share more details. With our market assets transition largely competed, SKYTROFA is now positioned as a premium product, with a net value per patient of around three times compared to [inaudible]. We are now focusing on using our new market assets chorus to drive third demand, continue to expand the overall growth among market, and are aiming to reach blockbuster status for SKYTROFA in the US alone. Finally, to build on our market leadership position, we plan to submit and supplement BLA in adult growth hormone deficiency to the FDA in the third quarter of this year, our first SKYTROFA Label Expansion. We also expect top-line data from our Phase II tried internal syndrome in the fourth quarter of 2024. Switching to TransCon CNP, I have always been extremely excited about our program in [inaudible] and much more now as we are approaching the results from our pivotal trial in the coming weeks. We have consistently, in our [inaudible] over past eight years, [inaudible] our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with achondroplasia.
Jan Møller Mikkelsen: The interest for serving under named patient programs prior to full commercial loans is increasing, we now have patient in these programs in more than 10 countries and expect more by the end of the year. Moving to SKYTROFA, we are proud to have more than 11,000 patients for SKYTROFA in the first three years since launch, and to have achieved market value leadership by expanding the overall growth among market. Key component of our strategy to make SKYTROFA a blockbuster product in the US, include simplifying broadened market assets for both treatment aid or space patient, as well as expanding our label.
Speaker Change: We will keep that value as we have today and expand from there.
Joe: I do not know Joe or can be let you have further comments.
Josh: Josh you have.
Josh: Want to get more in depth knowledge about specific comments from my side.
Josh: Thanks.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Speaker Change: Our next question comes from the line of tasting Ahmed with Banc of America Securities. Your line is open.
Ahmed: Hi, guys. Good afternoon, Thanks for taking my question.
Jan Møller Mikkelsen: In the first half of the year, the reset to broader market assets for SKYTROFA was largely competitive. While this broader access to SKYTROFA would support long term demand, in the short term, it negative impacted our first half net revenue, Scott will share more details. With our market assets transition largely competed, SKYTROFA is now positioned as a premium product, with a net value per patient of around three times compared to [inaudible]. We are now focusing on using our new market assets chorus to drive third demand, continue to expand the overall growth among market, and are aiming to reach blockbuster status for SKYTROFA in the US alone. Finally, to build on our market leadership position, we plan to submit and supplement BLA in adult growth hormone deficiency to the FDA in the third quarter of this year, our first SKYTROFA Label Expansion. We also expect top-line data from our Phase II tried internal syndrome in the fourth quarter of 2024. Switching to TransCon CNP, I have always been extremely excited about our program in [inaudible] and much more now as we are approaching the results from our pivotal trial in the coming weeks. We have consistently, in our [inaudible] over past eight years, [inaudible] our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with achondroplasia.
Jan Møller Mikkelsen: In the first half of the year, the reset to broader market assets for SKYTROFA was largely competitive. While this broader access to SKYTROFA would support long term demand, in the short term, it negative impacted our first half net revenue, Scott will share more details. With our market assets transition largely competed, SKYTROFA is now positioned as a premium product, with a net value per patient of around three times compared to [inaudible]. We are now focusing on using our new market assets chorus to drive third demand, continue to expand the overall growth among market, and are aiming to reach blockbuster status for SKYTROFA in the US alone.
Ahmed: With regards to this this new net price that you have for Scott if I can can.
Speaker Change: Can you talk to us about the competitive dynamics, namely R&D day.
Ahmed: Daily.
Speaker Change: Injector manufacturers offering deeper discounts and can you also talk about the level of impact that you're seeing from the recent relatively recent launch of the Nova a competing product.
Speaker Change: Thanks for the question.
Speaker Change: In that line with some of the same question that got asked us for our first question yes.
Speaker Change: Hey, guys two other long acting product in the U S market.
Speaker Change: Basic C one of them because of the <unk>.
Appears affect everyone kind of observed just going to buy databases that describe tolerability and other things like that we see we are always doing extremely well too.
Jan Møller Mikkelsen: Finally, to build on our market leadership position, we plan to submit and supplement BLA in adult growth hormone deficiency to the FDA in the third quarter of this year, our first SKYTROFA Label Expansion. We also expect top-line data from our Phase II tried internal syndrome in the fourth quarter of 2024. Switching to TransCon CNP, I have always been extremely excited about our program in [inaudible] and much more now as we are approaching the results from our pivotal trial in the coming weeks. We have consistently, in our [inaudible] over past eight years, [inaudible] our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with achondroplasia.
Joe: Hey, Joe.
Joe: The same thing with the Korea, South Korea.
Speaker Change: Preferred position on some of the P. P M.
Speaker Change: And we have other places.
Speaker Change: What im generally seeing as there is no doubt.
Speaker Change: We always said that cutover.
Best in class potential but.
Jan Møller Mikkelsen: Switching to Transcon CMP, I have always been extremely excited about our program in our contemplation and most more now as we are profusing the results from our people tried in the coming weeks. We have consistently in our messaging over past eight years, Symbia Nams, our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with a contemplation. Earlier this year, you saw a comprehensive result for our phase two accomplices tried, demonstrating that our once-weeked Transcon CMP increased analyzed growth velocity similar to Resoratite, Resoratite about 5.6 cm after 12 months of treatment. In addition, for first time ever for a product in the setting of iconoplaser, we also demonstrated that compared to passable Transcon CMP improved quality of life. As you stated with the physical function of well-being in children with iconoplaser, with a favorable side effect and volatility profile.
Jan Møller Mikkelsen: Switching to Transcon CMP, I have always been extremely excited about our program in our contemplation and most more now as we are profusing the results from our people tried in the coming weeks. We have consistently in our messaging over past eight years, Symbia Nams, our product candidate, that our aim is to develop a treatment that addresses both linear growth and the co-morbid disease that affects health and quality of life for people living with a contemplation.
Speaker Change: But what we're also seeing that market that is really realizing as a best in class product opportunity and that is to the strengths. We want to continue to build on not only in pediatric growth hormone deficiency, but also in all the different label expansion.
Speaker Change: <unk> coming.
Speaker Change: Into cash generation when we also get there.
Speaker Change: For example, you should also lupron.
Speaker Change: What happening with for example.
Speaker Change: <unk> volume supplier of crop terminal being best second quarter that basic has been revenue down on 72, 3%, So clearly tables and reset of the entire market that potentially come a little bit more unexpected too many of us that it was.
Jan Møller Mikkelsen: Earlier this year, you saw a comprehensive result for our Phase II [inaudible] trial, demonstrating that our once-weekly TransCon CNP, increased analyzed growth velocity similar to [inaudible], [inaudible] about 5.6 cm after 12 months of treatment. In addition, for first time ever for a product in the setting of achondroplasia, we also demonstrated that compared to placebo TransCon CNP improved quality of life. As you stated with the physical function of well-being in children with achondroplasia, with a favorable side effect and volatility profile.
Speaker Change: Fast adapt it into the system.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Speaker Change: Our next question comes from the line of Derek <unk> with Wells Fargo. Your line is open.
Derek: Hi, there thanks for taking the questions I just want to know what payer feedback you might have received thus far on the proposed <unk> pricing in the U S. And then I have a follow up.
Jan Møller Mikkelsen: Now we hope that we can replicate these results with more patients in our people's approach trial and we are expecting top-line data in the next few weeks, one quarter earlier than guided. This trial enrolled 84 children as two to 11 with iconoplaser. The mean A spots 5.7 years similar to our phase two trial. We also continue to enrolling in codes, a phase two trial of Transcon CMP in combination with Transcon growth hormone, SkyTorfer, designed to show that adding SkyTorfer to Transcon CMP could provide cash outgrowth for patients who start CMP treatment late. We expect to compete enrollment in this combination trial during the first 4th quarter of 2024 with top-line 26 data expected in the second quarter of 2025. Turning now to oncology. We continue advancing three phase two trials with multiple indication-specific cohort to study the besting class potential of our two product candidates. Transcon I'll two beta gamma and Transcon TLR 78 Acroniste in different combinations scenarios. We claim to present initial results from our Transcon I'll two beta gamma in combination with chemotherapy in plasmus system award variant cancer from the I'll believe tried data this month at the ESMO conference in Barcelona. I'm pleased how this program are progressing.
Jan Møller Mikkelsen: Now we hope that we can replicate these results with more patients in our pivotal approach trial, and we are expecting top-line data in the next few weeks, one quarter earlier than guided. This trial enrolled 84 children, age two to 11 with achondroplasia, the mean age was 5.7 years similar to our Phase II trial. We also continue to enrolling in codes, a Phase II trial of TransCon CNP in combination with TransCon growth hormone, SKYTROFA designed to show that adding SKYTROFA to TransCon CNP could provide cash outgrowth for patients who start CMP treatment late. We expect to compete enrollment in this combination trial during the first 4th quarter of 2024, with top-line '26 data expected in the second quarter of 2025.
Jan Møller Mikkelsen: Now we hope that we can replicate these results with more patients in our pivotal approach trial, and we are expecting top-line data in the next few weeks, one quarter earlier than guided. This trial enrolled 84 children, age two to 11 with achondroplasia, the mean age was 5.7 years similar to our Phase II trial. We also continue to enrolling in codes, a Phase II trial of TransCon CNP in combination with TransCon growth hormone, SKYTROFA designed to show that adding SKYTROFA to TransCon CNP could provide cash outgrowth for patients who start CMP treatment late.
Speaker Change: We are coming up with responsible pricing we can.
Speaker Change: Coming with a pricing wherever your basic.
Tyree Smith: Support the statement, we want to go every patient that have hypo payout Tyree Smith.
Tyree Smith: To support that there can be treated.
Speaker Change: In that entire mathematic algorithmically to Ashish that became too this responsible pricing on back and we have not got any feedback against that that is not totally acceptable.
Tyree Smith: Yes.
Speaker Change: Got it very helpful. And then second question just in terms of the patients that you've talked about on your V path in Germany, and Austria, I think you'd commented about 250 patients on the approval call for the U S. I guess, how do you think about that penetration relative to the overall market size in Germany, and how do you believe you're tracking thus far.
Jan Møller Mikkelsen: We expect to compete enrollment in this combination trial during the first 4th quarter of 2024, with top-line '26 data expected in the second quarter of 2025. Turning now to oncology. We continue advancing three Phase II trials, with multiple indication-specific cohort to study the besting class potential of our two product candidates. TransCon IL-2 ??? and TransCon TLR7/8 Agonist, in different combinations scenarios. We claim to present initial results from our TransCon IL-2 ??? in combination with chemotherapy in [inaudible] cancer from the IL-Believe trial data this month at the ESMO conference in Barcelona. I'm pleased how these programs are progressing.
Speaker Change: The launches that are ahead of where you expected or less then than you expected.
Jan Møller Mikkelsen: Turning now to oncology. We continue advancing three phase two trials with multiple indication-specific cohort to study the besting class potential of our two product candidates. Transcon I'll two beta gamma and Transcon TLR 78 Acroniste in different combinations scenarios. We claim to present initial results from our Transcon I'll two beta gamma in combination with chemotherapy in plasmus system award variant cancer from the I'll believe tried data this month at the ESMO conference in Barcelona. I'm pleased how this program are progressing. In closing, for ascended it's a roll about the patients. Patient tell us the U.S, approval of your pet is transformed, for them. We here for parents, Deskajrova has changed the life of children and parents both. With data expected in the next weeks for Transcon CMV, it is our goal that we are able to show that we also can transform the life of people living in a condo place. With our ongoing progress in our oncology programme and exploration of our ears of innovation in the last market opportunity, such as obesity. We continue to put precision ascenses for sustainable growth with an expanded pipeline and transformable transformers to trying to control our candidate. I'm not turning it over to Scott for and finance a lot of data. Thanks Jan. Skytroph of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was 26.2 million euro compared to 35.9 million euro, or did in the second quarter of 2023, a decrease of 27% year over year. An increase in Skytroph of volume was offset by higher sales deductions for Q2 and an adjustment to Q1, 2024 sales deduction of cruels as well as for periods in 2023. These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023.
Jan Møller Mikkelsen: Turning now to oncology. We continue advancing three phase two trials with multiple indication-specific cohort to study the besting class potential of our two product candidates. Transcon I'll two beta gamma and Transcon TLR 78 Acroniste in different combinations scenarios. We claim to present initial results from our Transcon I'll two beta gamma in combination with chemotherapy in plasmus system award variant cancer from the I'll believe tried data this month at the ESMO conference in Barcelona. I'm pleased how this program are progressing.
Speaker Change: I can come with some initial comments and.
Camilla: And you can get some further comments from Camilla our initial aim and how we look at how we expected the penetration profile would be that we will see two because one to two patients per physician in the beginning there was what.
Camilla: <unk> good to see.
Keith: Before Keith single physician really see the benefit of really what your pets can keep to vet patients.
Jan Møller Mikkelsen: In closing, for ascended it's a roll about the patients. Patient tell us the U.S, approval of your pet is transformed, for them. We here for parents, Deskajrova has changed the life of children and parents both. With data expected in the next weeks for Transcon CMV, it is our goal that we are able to show that we also can transform the life of people living in a condo place. With our ongoing progress in our oncology programme and exploration of our ears of innovation in the last market opportunity, such as obesity. We continue to put precision ascenses for sustainable growth with an expanded pipeline and transformable transformers to trying to control our candidate. I'm not turning it over to Scott for and finance a lot of data. Thanks Jan. Skytroph of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was 26.2 million euro compared to 35.9 million euro, or did in the second quarter of 2023, a decrease of 27% year over year. An increase in Skytroph of volume was offset by higher sales deductions for Q2 and an adjustment to Q1, 2024 sales deduction of cruels as well as for periods in 2023. These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023.
Jan Møller Mikkelsen: In closing, for Ascendis it's a roll about the patients. Patient tell us the US, approval of YORVIPATH is transformative for them, we hear from parents that SKYTROFA has changed the life of children and parents both. With data expected in the next weeks for TransCon CNP, it is our goal that we are able to show that we also can transform the life of people living with achondroplasia. With our ongoing progress in our oncology program, and exploration of our areas of innovation in last market opportunity, such as obesity. We continue to put precision Ascendis for sustainable growth, with an expanded pipeline, and transformative TransCon product candidate. I'm now turning it over to Scott for a financial update.
Speaker Change: Wednesday officers that we expect later in this year.
Speaker Change: <unk> patients or is physician with start to prescribe more patients from their non polyp patients each of them. So when we look on the non proficient at already have prescribed.
Speaker Change: In.
Speaker Change: Germany, and Australia around 125 prescriber.
Speaker Change: Really prescribed it.
Speaker Change: Streaming proud about this penetration to physicians, but I think what is really the most.
Speaker Change: Impressive thing for me and this lumps.
Speaker Change: Basic retention.
Speaker Change: When you think about we have been for extension when you start to take patient <unk>.
Speaker Change: And really test the other beauty, providing a benefit for the patient and didn't have the retention of 98%.
Jan Møller Mikkelsen: I'm not turning it over to Scott for and finance a lot of data. Thanks Jan. Skytroph of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was 26.2 million euro compared to 35.9 million euro, or did in the second quarter of 2023, a decrease of 27% year over year. An increase in Skytroph of volume was offset by higher sales deductions for Q2 and an adjustment to Q1, 2024 sales deduction of cruels as well as for periods in 2023. These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023.
Jan Møller Mikkelsen: I'm not turning it over to Scott for and finance a lot of data. Thanks Jan. Skytroph of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was 26.2 million euro compared to 35.9 million euro, or did in the second quarter of 2023, a decrease of 27% year over year. An increase in Skytroph of volume was offset by higher sales deductions for Q2 and an adjustment to Q1, 2024 sales deduction of cruels as well as for periods in 2023.
Jan Møller Mikkelsen: I'm not turning it over to Scott for and finance a lot of data.
Scott Smith: Thanks Jan. Skytroph of volume more than doubled in the second quarter of 2024 compared to the second quarter last year, while reported revenue was 26.2 million euro compared to 35.9 million euro, or did in the second quarter of 2023, a decrease of 27% year over year. An increase in Skytroph of volume was offset by higher sales deductions for Q2 and an adjustment to Q1, 2024 sales deduction of cruels as well as for periods in 2023. These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023. First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: Thanks Jan. SKYTROFA volume more than doubled in the second quarter of 2024, compared to the second quarter last year, while reported revenue was €26.2 million, compared to €35.9 million reported in the second quarter of 2023, a decrease of 27% year over year. An increase in SKYTROFA volume was offset by higher sales deductions for Q2, and an adjustment to Q1, 2024 sales deduction accruals, as well as for periods in 2023. These adjustments reflect the reset of broader market access to support continued growth of SKYTROFA as the market value leader, and a potential blockbuster in the US, alone.
I have never seen that for any product before.
Speaker Change: That is really really unique but it's really described that benefit that is really giving to their patients and the state of the treatment exactly as we have observed in our.
Camille: Clinical trials I do not know Camille you have further comments to the docs.
Camille: Specific in Germany, and Austria.
Yes, I think you said it very very well.
Speaker Change: We are pleased with the uptake of the yogurt path in Germany, we are benchmarking other rare disease launches or we do.
Jan Møller Mikkelsen: These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023. First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Jan Møller Mikkelsen: These adjustments reflect the reset of broader market access to support continued growth of Skytroph as the market value leader and a potential blockbuster in the U.S, alone. In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023. First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Speaker Change: It was very well compared to them and so the team is working hard on both breadth and depth and that's working well and also creating of the mix between the PHH that new patients and the ones that have been.
Scott Smith: In total, Q2, 2024 reported revenue was reduced by a true up of 27.1 million euro of which 19.5 million euro was attributable to the first quarter 2024 sales and 7.6 million euro to sales prior to January 1, 2024. Skytroph of revenue for the first half of 2024 told of 91.2 million euro at 35% year over year increased compared to 67.4 million euro during the same period in 2023. First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: In total, Q2, 2024 reported revenue was reduced by a true up of €27.1 million, of which €19.5 million was attributable to the first quarter 2024 sales, and €7.6 million to sales prior to January 1, 2024. SKYTROFA revenue for the first half of 2024 told of €91.2 million, at 35% year over year increased compared to €67.4 million, during the same period in 2023. First half, 2024, SKYTROFA volume more than doubled, but was partially offset by an accrual true up of €7.6 million, which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated.
Scott Smith: In total, Q2, 2024 reported revenue was reduced by a true up of €27.1 million, of which €19.5 million was attributable to the first quarter 2024 sales, and €7.6 million to sales prior to January 1, 2024. SKYTROFA revenue for the first half of 2024 told of €91.2 million, at 35% year over year increased compared to €67.4 million, during the same period in 2023. First half, 2024, SKYTROFA volume more than doubled, but was partially offset by an accrual true up of €7.6 million, which was attributable to periods prior to January 1, 2024.
Speaker Change: On net par and the switch that we are making from that power to yoga path is growing very very fast. So all in all we are very pleased with how it's going and where we go like this Joseph.
Joseph: Yes, what we have seen in different European countries.
Joseph: Net par basic because of it.
Joseph: Stop of manufacturing.
Joseph: Tendency to keep the patient on that path until all the you can say accumulated.
Jan Møller Mikkelsen: First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Jan Møller Mikkelsen: First half, 2024, Skytroph of volume more than doubled but was partially offset by an accrual true up of 7.6 million euro which was attributable to periods prior to January 1, 2024. With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Joshua: Truck are being utilized in specific regions and we also see now that is starting to change a lot where we see much more small joshua taking up from when that power patient coming in now.
Scott Smith: With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, SKYTROFA penetration in the US Pediatric growth hormone deficiency, treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 SKYTROFA revenue to be in the range of €220 million to €240 million. Shifting to TransCon PTH, second quarter of YORVIPATH revenue of €5.2 million, reflected the first full quarter of commercial revenue in Germany and Austria, as well as initial revenue in other markets.
Scott Smith: With the advent of broader market access, we believe the overall growth hormone market will continue to grow the number of patients treated. We estimate that by the end of Q2, 2024, SKYTROFA penetration in the US Pediatric growth hormone deficiency, treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 SKYTROFA revenue to be in the range of €220 million to €240 million.
Speaker Change: But one thing we have now been launched in Germany, and Austria in our Europe direct strategy go to France, and then here hopefully in this year and then in 2005, we will have the next 678 European countries being added in really rolling out in the way.
Scott Smith: We estimate that by the end of Q2, 2024, Skytroph of penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 Skytroph of revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: We estimate that by the end of Q2, 2024, SKYTROFA penetration in the U.S. Pediatric growth hormone deficiency treated patient population was 18% or a little under 10% of the overall treated growth hormone market still with our single indication for pediatric GHD leaving lots of room for further growth in market expansion. Based on year-to-day results in current trends, we now expect full year 2024 SKYTROFA revenue to be in the range of 220 million euro to 240 million euro. Shifting to Transcon PTH, second quarter of YORVIPATH revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets.
Speaker Change: We generate revenue from this region and are most fastest speed.
Speaker Change: Thank you.
Speaker Change: Please standby for our next question.
Lee <unk>: Our next question comes from the line of Lee <unk> with Cantor Your line is open.
Scott Smith: Shifting to TransCon PTH, second quarter of YORVIPATH revenue of €5.2 million, reflected the first full quarter of commercial revenue in Germany and Austria, as well as initial revenue in other markets. With YORVIPATH revenue continuing to increase from the €1.5 million in Q1, driven by growing patient and physician demand. Closing out the top line, total revenue for the second quarter was €36 million, including €4.6 million tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total €33.5 million, compared to €105 million during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for TransCon TLR7/8 Agonist and lower costs for TransCon PTH as well as the [inaudible] spin-off.
Scott Smith: Shifting to TransCon PTH, second quarter of YORVIPATH revenue of €5.2 million, reflected the first full quarter of commercial revenue in Germany and Austria, as well as initial revenue in other markets. With YORVIPATH revenue continuing to increase from the €1.5 million in Q1, driven by growing patient and physician demand. Closing out the top line, total revenue for the second quarter was €36 million, including €4.6 million tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total €33.5 million, compared to €105 million during the second quarter of 2023.
Jan Møller Mikkelsen: Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Jan Møller Mikkelsen: Shifting to Transcon PTH, second quarter of Yorva Path revenue of 5.2 million euro reflected the first full quarter of commercial revenue in Germany and Austria as well as initial revenue in other markets. With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Lee <unk>: Hey, guys. Thanks for taking my questions, maybe just a follow up on Sky Chaucer.
Lee <unk>: Maybe help us understand what went went in Chile assumptions for the lower guidance.
Scott Smith: With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: With Yorva Path revenue continuing to increase from the 1.5 million euro in Q1 driven by growing patient and physician demand. Closing out the top line total revenue for the second quarter was 36 million euro, including 4.6 million euro tied to rendering of services and license revenue. Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off.
Cash flow for this year.
Speaker Change: Just looking for more details on what's driving that 100 million your reduction maybe talk a little bit about the dynamics between.
Speaker Change: <unk> market access and pricing and I have a follow up.
Speaker Change: I can come with some awards statement first related to how we did the forecasting because what we basically that we saw a growth.
Jan Møller Mikkelsen: Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023.
Jan Møller Mikkelsen: Turning to expenses, R&D costs in the second quarter of 2024 total 33.5 million euro compared to 105 million euro during the second quarter of 2023. The 21% decline was largely tied to lower external development costs for Transcon TLR78 Agonist and lower costs for Transcon PTH as well as the Iconis spin-off. SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Speaker Change: In volume between Q1 and Q2.
Scott Smith: The 21% decline was largely tied to lower external development costs for TransCon TLR7/8 Agonist and lower costs for TransCon PTH, as well as the [inaudible] spin-off. SG&A expenses in the quarter totaled €74.3 million, compared to €70.3 million, during the second quarter of 2023, the increase was primarily due to higher employee costs, including the impact from global commercial expansion. Total operating expenses were €157.8 million, for the second quarter, a 10% decrease compared to the €175.3 million, during the second quarter of 2023, total operating expenses for the first half of 2024 were €295 million. Net finance income in the quarter was €29.4 million compared to €26.4 million in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter, driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence, and marketable securities, totaling €259 million, compared to €399 million as of December 31, 2023. Finally, earlier today in subsequent to June 30th, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with Royalty Pharma for $150 million US dollars in exchange for a 3% royalty on net sales of YORVIPATH within the United States.
Scott Smith: The 21% decline was largely tied to lower external development costs for TransCon TLR7/8 Agonist and lower costs for TransCon PTH, as well as the [inaudible] spin-off. SG&A expenses in the quarter totaled €74.3 million, compared to €70.3 million, during the second quarter of 2023, the increase was primarily due to higher employee costs, including the impact from global commercial expansion. Total operating expenses were €157.8 million, for the second quarter, a 10% decrease compared to the €175.3 million, during the second quarter of 2023, total operating expenses for the first half of 2024 were €295 million.
Speaker Change: Yes.
Speaker Change: We utilized that growth basically to predict.
Speaker Change: The rest of the year and it basically giving what value.
Speaker Change: After we now have preset our market assess portfolio.
Scott Smith: SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: SGNA expenses in the quarter totaled 74.3 million euro compared to 70.3 million euro during the second quarter of 2023. The increase was primarily due to higher employee costs including the impact from global commercial expansion. Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year.
Speaker Change: We are in a position that we expect that <unk> will be keeping.
Speaker Change: Certainly throughout the year.
Speaker Change: What we have observed.
Speaker Change: Last year, we saw.
Speaker Change: Seasonal effect between the first half compared to the second half, we still see that ethane upside with potential materialized, but we also note that it couldnt not materialized. So this is how we have basic taking the guidance forward in debt and that is not.
Jan Møller Mikkelsen: Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Jan Møller Mikkelsen: Total operating expenses were 157.8 million euro for the second quarter at 10% decrease compared to the 175.3 million euro during the second quarter of 2023. Total operating expenses for the first half of 2024 were 295 million euro. Net finance income in the quarter was 29.4 million euro compared to 26.4 million euro in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: Net finance income in the quarter was €29.4 million compared to €26.4 million in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter, driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence, and marketable securities, totaling €259 million, compared to €399 million as of December 31, 2023. Finally, earlier today in subsequent to June 30th, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with Royalty Pharma for $150 million US dollars in exchange for a 3% royalty on net sales of YORVIPATH within the United States.
Scott Smith: Net finance income in the quarter was €29.4 million compared to €26.4 million in the second quarter of last year. As a reminder, the net finance line can fluctuate quarter to quarter, driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence, and marketable securities, totaling €259 million, compared to €399 million as of December 31, 2023.
Speaker Change: Anything, believing that we potentially can actually growth, we see the potential to receive a best in class potential on it.
Scott Smith: As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: As a reminder, the net finance line can fluctuate quarter to quarter driven in part by non-cash items related to our outstanding convertible notes. We ended the second quarter with cash equivalence and marketable securities totaling 259 million euro compared to 399 million euro as of December 31, 2023. Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States.
Joe: Joe that is responsible for our U S. You can also keep it short summary about all the effect educating implemented now that first will provide effect in the second half of this year.
Joe: So the health care providers right now have extreme clarity about where they can provide sky trophy to patients with a high chance of reimbursement.
Scott Smith: Finally, earlier today in subsequent to June 30th, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with Royalty Pharma for $150 million US dollars in exchange for a 3% royalty on net sales of YORVIPATH within the United States. But the royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6-K. Also filed today. Looking ahead for the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of €220 to €240 million. Total operating expenses, which include SG&A and R&D, to be approximately €600 million, including YORVIPATH-related launch activities in the US. And pending launch timing of YORVIPATH in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025.
Scott Smith: Finally, earlier today in subsequent to June 30th, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with Royalty Pharma for $150 million US dollars in exchange for a 3% royalty on net sales of YORVIPATH within the United States. But the royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6-K. Also filed today.
Jan Møller Mikkelsen: Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Jan Møller Mikkelsen: Finally, earlier today in subsequent to June 30, 2024, therefore not included in the reported cash balance, we announced that we have entered into a new capped synthetic royalty funding agreement with royalty pharma for 150 million US dollars in exchange for a 3% royalty on net sales of your path within the United States. The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Joe: But also where Sky trophy is not on formulary health care providers are documenting and tolerance.
Joe: Both below the average current full height, while on other growth hormones.
Joe: Before allowing a resubmission.
Joe: So that pediatric growth hormone deficient patients can have access to skytrax.
Scott Smith: The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: The royalty payments are capped at 1.65 times the purchase price, if fully paid prior to December 31, 2029, or two times thereafter. Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025.
Joe: So there's time left in this year, obviously things will stabilize.
Joe: 25, So we know now where we can continue to add patients and grow our net revenue and expand.
Jan Møller Mikkelsen: Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Jan Møller Mikkelsen: Further details are disclosed in a separate 6K. Also filed today. Looking ahead for the full year 2024 based on current plans, we expect Sky Trooper revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SGNA and R&D, to be approximately 600 million euro, including your path related launch activities in the US. And pending launch timing of your path in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Scott Smith: Looking ahead for the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of €220 to €240 million. Total operating expenses, which include SG&A and R&D, to be approximately €600 million, including YORVIPATH-related launch activities in the US. And pending launch timing of YORVIPATH in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences. With that, operator, we are now ready to take questions. Thank you.
Scott Smith: Looking ahead for the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of €220 to €240 million. Total operating expenses, which include SG&A and R&D, to be approximately €600 million, including YORVIPATH-related launch activities in the US. And pending launch timing of YORVIPATH in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025. Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences. With that, operator, we are now ready to take questions.
Scott Smith: Looking ahead for the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of €220 to €240 million. Total operating expenses, which include SG&A and R&D, to be approximately €600 million, including YORVIPATH-related launch activities in the US. And pending launch timing of YORVIPATH in the US, we currently expect to achieve operating cash flip break even on a quarterly basis in 2024 or 2025.
Joe: And grow the value of the entire growth hormone marketplace.
Joe: Okay.
Speaker Change: And I also wonder if you can talk a little bit about where you can further reduce from a cost perspective, and Jay is there any chance you can sue breakeven this year, given the lower schedule for guidance.
Joe: Yeah.
Speaker Change: You know Scott this really good numbers. So I will somebody gave you an all perspective.
Scott Smith: Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences. With that, operator, we are now ready to take questions.
Scott Smith: Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Speaker Change: Scott can go more back to some of the way we're looking at it today.
Jan Møller Mikkelsen: Before we turn it over to the operator for Q&A, I want to reiterate with database log and the top line results for our pivotal approach trial expected in the coming weeks. We plan to institute a quiet period starting Thursday, and unfortunately we will not be able to participate in upcoming investor conferences, with that operator, we are now ready to take questions. Thank you.
Speaker Change #100: One other thing we are proud about is that we really keep our operating expenses in control and we really see that we really have a good internal system to keep saying this pharma to be highly effective.
Speaker Change #100: Organization.
Speaker Change #100: We also see that there is revenue specific Europe has different regions are really starting to taking now so potentially we have a Europe had outside U S. We are still in a situation where we are still discussing.
Operator: Thank you, ladies and gentlemen, as a reminder to ask the question, please first star one one on your telephone, and then wait to hear your name announce. To withdraw your question, please press star one one again, and please limit yourself to one question and one follow up. Please stand by while we compile the Q&A roster. Our first question comes from the line of Jessica Fye with JP Morgan. Your line is open.
With FDA related to how we can really help a patient that is in shortage of treatment here in the U S. We hope we can help that we would do everything to help them. It meaning that we will have a most faster launch that would be excellent.
Our first question comes from the line of Jessica Fye with JP Morgan. Your line is open.
Hey guys, good afternoon. Thanks for taking my question. I want to better understand how you project getting Skytropha to a blockbuster in the US alone. Based on the kind of reset of net price and what you said about where you are in terms of penetration in GHD and the broader created growth hormone market. Can you walk through that a little bit? Thank you. Thanks, Jess. I will start and I have my two commercial colleagues with me yesterday, so that can also some way give you more details is that it's desired.
Jessica Fye: Hey guys, good afternoon, thanks for taking my question. I want to better understand how you project getting SKYTROFA to a blockbuster in the US alone? Based on the kind of reset of net price, and what you said about where you are in terms of penetration in GHD and the broader accreted growth hormone market. Can you walk through that a little bit? Thank you.
Speaker Change #100: Taking into our clients.
Speaker Change #100: We hear the voice from the patients we have the voice for the physicians.
Speaker Change #100: We will do everything so became half.
Speaker Change #101: Earlier launch and as soon as we get clarity about that if you ever come back to you. So we have a lot of potential upsides, we have a lot of different ways, where we looking about how we can strengthen.
Strengthen our revenue.
Thanks, Jess. I will start and I have my two commercial colleagues with me here today, so they can also, some way give you more details if that it's desired. Currently we see the market is about $1.4 billion US dollars, the entire growth hormone market in the US, and as I stated in my prepared remarks, when we look on a net value per patient, we basic, with SKYTROFA have about three times the net value on a yearly treatment. When we see our effort, when we look about, when we are developing the long-acting segment, we see SKYTROFA as really the preferred brand, even in places where we just are in the same level of market access clearly, clearly, clearly SKYTROFA is the preferred product. Even in places where we don't have market access, we really see SKYTROFA coming in, because it's really up avoiding, a unique improvement compared to the other products potentially. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the [inaudible] growth hormone deficiency market. We in this next weeks, we are filing for adult growth hormone deficiency, we have [inaudible] coming in for phase two later this year. We will initiate trials very fast, and we can do it in a basket manner, so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop SKYTROFA to a bluckbuster in the US, and with the reset of, what we call the marketer set, we will keep that value as we have today and expand from there. I do not know Joe or Camilla, do you have further comments? Or just you have and want to get more depth knowledge about specific comments from my site? Thanks. Thank you. Please stand by for our next question.
Thanks, Jess. I will start and I have my two commercial colleagues with me here today, so they can also, some way give you more details if that it's desired. Currently we see the market is about $1.4 billion US dollars, the entire growth hormone market in the US, and as I stated in my prepared remarks, when we look on a net value per patient, we basic, with SKYTROFA have about three times the net value on a yearly treatment. When we see our effort, when we look about, when we are developing the long-acting segment, we see SKYTROFA as really the preferred brand, even in places where we just are in the same level of market access clearly, clearly, clearly SKYTROFA is the preferred product. Even in places where we don't have market access, we really see SKYTROFA coming in, because it's really up avoiding, a unique improvement compared to the other products potentially. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the [inaudible] growth hormone deficiency market. We in this next weeks, we are filing for adult growth hormone deficiency, we have [inaudible] coming in for phase two later this year. We will initiate trials very fast, and we can do it in a basket manner, so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop SKYTROFA to a bluckbuster in the US, and with the reset of, what we call the marketer set, we will keep that value as we have today and expand from there. I do not know Joe or Camilla, do you have further comments? Or just you have and want to get more depth knowledge about specific comments from my site? Thanks.
Jan Møller Mikkelsen: Thanks, Jess. I will start and I have my two commercial colleagues with me here today, so they can also, some way give you more details if that it's desired. Currently we see the market is about $1.4 billion US dollars, the entire growth hormone market in the US, and as I stated in my prepared remarks, when we look on a net value per patient, we basic, with SKYTROFA have about three times the net value on a yearly treatment.
Speaker Change #102: How are you.
Scott: Basic still keeping our expenses in control and this is how we are operating Scott comment.
Scott: I think you said it well yen lately as you know, we always look to be cost effective and what we do as a company.
Scott: And we evaluate expenses that are tied to getting the product to patients as soon as possible.
Speaker Change #103: But at the same time of course, we don't want to sacrifice doing that and getting the product. So that's part of the reason we announced the new financing today. After the close for the additional $150 million, but we continue to have great scrutiny on cost, particularly where they're not leading to getting our products to patients.
Scott: Yes.
Scott: Thank you.
Jan Møller Mikkelsen: When we see our effort, when we look about, when we are developing the long-acting segment, we see SKYTROFA as really the preferred brand, even in places where we just are in the same level of market access clearly, clearly, clearly SKYTROFA is the preferred product. Even in places where we don't have market access, we really see SKYTROFA coming in, because it's really up avoiding, a unique improvement compared to the other products potentially. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the [inaudible] growth hormone deficiency market. We in this next weeks, we are filing for adult growth hormone deficiency, we have [inaudible] coming in for phase two later this year. We will initiate trials very fast, and we can do it in a basket manner, so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop SKYTROFA to a bluckbuster in the US, and with the reset of, what we call the marketer set, we will keep that value as we have today and expand from there. I do not know Joe or Camilla, do you have further comments? Or just you have and want to get more depth knowledge about specific comments from my site? Thanks.
Jan Møller Mikkelsen: When we see our effort, when we look about, when we are developing the long-acting segment, we see SKYTROFA as really the preferred brand, even in places where we just are in the same level of market access clearly, clearly, clearly SKYTROFA is the preferred product. Even in places where we don't have market access, we really see SKYTROFA coming in, because it's really up avoiding, a unique improvement compared to the other products potentially. So when we see our label expansion effort, we basic in the coming year will be possible for us not only to address the [inaudible] growth hormone deficiency market.
Scott: Thank you.
Please standby for our next question.
Speaker Change #104: Our next question comes from the line of Gavin clock Gartner with Evercore ISI. Your line is open.
Speaker Change #105: Hey, guys. Thanks for taking my questions.
Speaker Change #106: First I just wanted to ask for Skype ROFO when did these policies with more favorable access go into place and when should we expect a pickup in prescriptions.
Speaker Change #107: I think it was.
Speaker Change #108: Gradually during the first half year. So some of them are first ticking here in Q2. The complexity of these agreements are complex and this rate that potential rebate compared to what you increased.
Speaker Change #109: Some way not really aligned and towards some of the issue we ranked into that the rebate basic got established must faster than really we can start to grow volume. So from a modeling perspective, we see and toppled.
Jan Møller Mikkelsen: We in this next weeks, we are filing for adult growth hormone deficiency, we have [inaudible] coming in for phase two later this year. We will initiate trials very fast, and we can do it in a basket manner, so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop SKYTROFA to a bluckbuster in the US, and with the reset of, what we call the marketer set, we will keep that value as we have today and expand from there. I do not know Joe or Camilla, do you have further comments? Or just you have and want to get more depth knowledge about specific comments from my site? Thanks.
Jan Møller Mikkelsen: We in this next weeks, we are filing for adult growth hormone deficiency, we have [inaudible] coming in for phase two later this year. We will initiate trials very fast, and we can do it in a basket manner, so we basic can get to the full coverage for all the different growth hormone indications. That give you the high level how we see we can develop SKYTROFA to a bluckbuster in the US, and with the reset of, what we call the marketer set, we will keep that value as we have today and expand from there.
Joe: Due to Napa in increase in volume between Q1, and Q2, but we really would expect first of all the effort that we now have historically as Joe told before its first kicking in in the second half. Okay. So I will first see the expected growth coming in the second half.
Speaker Change #110: Okay that makes sense and just wanted to ask on Q via data overall have you guys noticed any changes in capture rate trends over time.
Speaker Change #111: I think the issue I personally.
Speaker Change #112: Is that is the sampling of few places.
Speaker Change #113: And if you somebody keep everything stable you can use it as an overall trend.
Jan Møller Mikkelsen: I do not know Joe or Camilla, do you have further comments? Or just you have and want to get more depth knowledge about specific comments from my site? Thanks.
Speaker Change #114: It's a shift between different ppm's b team devote.
Margaret: Margaret assess you often will see some difference in volume that.
Speaker Change #115: <unk> totaled unpredictable up from their perspective at a sampling between different pbms are different so often that I think you should paid if you given all the money was the utilization of these days at least I'm not paying for it I get it for free because I showed some many times to totally not.
Operator: Thank you, please stand by for our next question. Our next question comes from the line of Tazeen Ahmad with Bank of America Security. Your line is open.
Operator: Our next question comes from the line of Tazeen Ahmed with Bank of America Security. Yalan is open.
Tazeen Ahmad: Hi guys, good afternoon, thanks for taking my question. With regards to this new net price that you have for SKYTROFA, can you talk to us about the competitive dynamics? Namely, are the daily injector manufacturers offering deeper discounts? And can you also talk about the level of impact that you're seeing from the recent, relatively recent launch of the NOVO competing products? Thanks.
Jan Møller Mikkelsen: Thanks for the question. I think it's in the line with some of the same question that got asked, after the first question. Yes, today there is two other long-acting product in the US market, we basically see one of them in [inaudible] because of the obvious effect everyone can observe. Just going to the databases that describe tolerability and other things like that, we see we are always doing extremely well too. In [inaudible], we see the same thing with Sequoia, Sequoia have a preferred position on some of the big PPM and we have other places. But what I'm generally seeing is there is no doubt, we always said that SKYTROFA had a best-in-class potential, but what we also see in the market that is really realizing as the best-in-class product opportunity. And that is the strengths we want to continue build on, not only in pediatric growth hormone deficiency, but also in all the different label expansion when we come into [inaudible] when we also get them. For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone, being the second quarter, that basically have an revenue down on 73%. So clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system.
Jan Møller Mikkelsen: Thanks for the question. I think it's in the line with some of the same question that got asked, after the first question. Yes, today there is two other long-acting product in the US market, we basically see one of them in [inaudible] because of the obvious effect everyone can observe. Just going to the databases that describe tolerability and other things like that, we see we are always doing extremely well too. In [inaudible], we see the same thing with Sequoia, Sequoia have a preferred position on some of the big PPM and we have other places.
Margaret: Useful.
Speaker Change #116: But still find it if you want.
Speaker Change #117: Okay. Thanks.
Speaker Change #118: Thank you.
Speaker Change #119: Please standby for our next question.
Speaker Change #120: Our next question comes from the line of Big ramp peer Rohit with Morgan Stanley. Your line is open.
Rohit: Hi, good afternoon, Thank you for taking our questions.
Rohit: I guess switching to transcon CMP, we were just curious for the upcoming approach readout and then also for the coach readout.
Speaker Change #122: <unk> 25 to switch parameters of data you expect to report out and how you would currently guide people to.
Speaker Change #123: Compare and contrast, the datasets versus our competitors' <unk> data thats available in the space. Thank you.
Speaker Change #124: I think the most easiest way to compare and it has to go through Wassa overtime, because this is too.
Jan Møller Mikkelsen: But what I'm generally seeing is there is no doubt, we always said that SKYTROFA had a best-in-class potential, but what we also see in the market that is really realizing as the best-in-class product opportunity. And that is the strengths we want to continue build on, not only in pediatric growth hormone deficiency, but also in all the different label expansion when we come into [inaudible] when we also get them. For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone, being the second quarter, that basically have an revenue down on 73%. So clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system.
Jan Møller Mikkelsen: But what I'm generally seeing is there is no doubt, we always said that SKYTROFA had a best-in-class potential, but what we also see in the market that is really realizing as the best-in-class product opportunity. And that is the strengths we want to continue build on, not only in pediatric growth hormone deficiency, but also in all the different label expansion when we come into [inaudible] when we also get them. For example, you should also look on what happening with, for example, the largest volume supplier of growth hormone, being the second quarter, that basically have an revenue down on 73%.
Speaker Change #125: You can say mode of action that is most aligned between them. Even if there is a different in how we function because we have a continuous exposure of CMP molecule.
We are.
Speaker Change #126: From the bookstore tight with <unk>.
Speaker Change #127: Basic is only have been active cohorts for two or three hours.
Speaker Change #127: 24 hour dosing cycle.
Speaker Change #128: So when we look on our team as we have said in the last eight years, we want both to provide linear growth, but also provide and address the.
Speaker Change #127: <unk> of the disease.
Speaker Change #129: And what we have seen answer now and now I am preferring into phase two because this is with data.
Speaker Change #129: I can talk about today is that we have seen and annualized height velocity exactly at the same level of sore type with a once weekly dosing profile, but we have seen the improvement in.
Jan Møller Mikkelsen: So clearly there was a reset of the entire market that potentially come a little bit more unexpected to many of us that it was so fast-adapted into the system.
Speaker Change #130: Many of the way that the children the physician caregivers talk about.
Speaker Change #130: Benefit too.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Derek Achilla with Wells Fargo, Your line is open.
Speaker Change #130: Patient.
Operator: Please stand by for our next question. Our next question comes from Alana Dirk Achilla with Will Spago, Yalana Sultan.
Speaker Change #130: And from that perspective, we also can show when we compare our phase II data directly to placebo and the improvement in quality of life related to physical function and this is why we basically are taking into our trial different measuring on key.
Derek Archila: Hi there, thanks for taking the questions. I just want to know what payer feedback you might have received thus far on the proposed [inaudible] Path Pacing in the US? And then I have a follow-up. We are coming up with a responsible pricing. We are coming with a pricing where we basically can support the statement we want to go every patient that have hyper-paratterisement. We aim to support that work and be treated. In that entire methametric algorithm to achieve that, we came to this responsible pricing on back. And we have not got any feedback against that. That is not totally acceptable. Got it. Very helpful. And then a second question. Just in terms of the patients that you talked about on your V-path in Germany and Austria, I think you commented about 250 patients on the approval call for the US. I guess how do you think about that penetration relative to the overall market size in Germany? And how do you believe you're tracking thus far in the launch? Is it ahead of where you expected or less than you expected?
Derek Archila: Hi there, thanks for taking the questions. I just want to know what payer feedback you might have received thus far on the proposed [inaudible] Path Pacing in the US? And then I have a follow-up.
Secondary endpoint.
Jan Møller Mikkelsen: We are coming up with a responsible pricing, we are coming with a pricing where we basically can support the statement, we want to go every patient that have hypoparathyroidism, we aim to support that [inaudible] and be treated. In that entire mathematic algorithm, to achieve that we came to this responsible pricing on back, and we have not got any feedback against that, that is not totally acceptable. Got it. Very helpful. And then a second question. Just in terms of the patients that you talked about on your V-path in Germany and Austria, I think you commented about 250 patients on the approval call for the US. I guess how do you think about that penetration relative to the overall market size in Germany? And how do you believe you're tracking thus far in the launch? Is it ahead of where you expected or less than you expected?
Jan Møller Mikkelsen: We are coming up with a responsible pricing, we are coming with a pricing where we basically can support the statement, we want to go every patient that have hypoparathyroidism, we aim to support that [inaudible] and be treated. In that entire mathematic algorithm, to achieve that we came to this responsible pricing on back, and we have not got any feedback against that, that is not totally acceptable.
Speaker Change #132: That basis cope for us that it can give and.
Effect that really shows how we address the comorbidity, which test Newark, NEVA being shown by any other product and when do you go to the biochemical process the science behind it which we always love the basic can come with great explanation.
Speaker Change #132: Why do you need to have a continuous exposure of CMP basic to address some of the comorbidities.
Derek Archila: Got it, very helpful, and then a second question. Just in terms of the patients that you talked about on YORVIPATH in Germany and Austria, I think you commented about 250 patients on the approval call for the US. I guess how do you think about that penetration relative to the overall market size in Germany? And how do you believe you're tracking thus far in the launch? Is it ahead of where you expected or less than you expected? Thanks.
Speaker Change #132: No.
Speaker Change #133: It gives you wherever you started from.
Speaker Change #134: I need to see the data that are coming in the next weeks, so it's pretty pretty pretty linear. So the database has been locked people are running the stack now so assumed that finish.
Speaker Change #134: Fitness will be taken into a room and see the data.
Speaker Change #135: Got it thank you.
Speaker Change #135: Thank you.
Speaker Change #137: Please standby for our next question.
Jan Møller Mikkelsen: Thanks. I can come with some initial comments and you can get some further comments from Camila. Our initial aim and how we looked at how we expected the penetration profile would be, that we will see typical 1-2 patient per physician in the beginning, there was what we expected to see. Before each single physician really see the benefit of really what YORVIPATH can give to the patients, when they observe that, we expect later in this year that each patient or each physician will start to prescribe more patient from the number of patients each of them. So when we look on the number of physicians that already have prescribed, in Germany and Austria, around 125 prescriber had really prescribed it, we are extremely proud about this penetration to physicians. But I think what really are the most impressive thing for me in this launch is basic retention. When you think about, we have a [inaudible], when you start to take patient in, and really test it, are they really providing a benefit for the patient? And then they have a retention of 98%. I have never seen that for any product before, that is really, really unique but this really describe the benefit that is really giving to the patient, and the state of the treatment, exactly as we have observed in our clinical trials. I do not know, Camilla, you have further comments to the dorms in, specific in Germany and Austria?
Jan Møller Mikkelsen: Thanks. I can come with some initial comments and you can get some further comments from Camila. Our initial aim and how we looked at how we expected the penetration profile would be, that we will see typical 1-2 patient per physician in the beginning, there was what we expected to see. Before each single physician really see the benefit of really what YORVIPATH can give to the patients, when they observe that, we expect later in this year that each patient or each physician will start to prescribe more patient from the number of patients each of them.
Kelly <unk>: Our next question comes from the line of Kelly <unk> with Jefferies. Your line is open.
Kelly <unk>: Thank you for taking my questions, maybe fall PTH could you. Please elaborate more on your ongoing interactions with regulators regarding the commercialization of existing batches.
Speaker Change #139: For the U S launch of which is likely of <unk>.
Speaker Change #140: First quarter of next year at the moment.
Speaker Change #141: We have a <unk>.
Speaker Change #142: Extremely construct tick.
Speaker Change #142: Diablo.
Ft related to how potential to address the shortage of PTH drops in the U S.
Jan Møller Mikkelsen: So when we look on the number of physicians that already have prescribed, in Germany and Austria, around 125 prescriber had really prescribed it, we are extremely proud about this penetration to physicians. But I think what really are the most impressive thing for me in this launch is basic retention. When you think about, we have a [inaudible], when you start to take patient in, and really test it, are they really providing a benefit for the patient? And then they have a retention of 98%. I have never seen that for any product before, that is really, really unique but this really describe the benefit that is really giving to the patient, and the state of the treatment, exactly as we have observed in our clinical trials. I do not know, Camilla, you have further comments to the dorms in, specific in Germany and Austria?
Jan Møller Mikkelsen: So when we look on the number of physicians that already have prescribed, in Germany and Austria, around 125 prescriber had really prescribed it, we are extremely proud about this penetration to physicians. But I think what really are the most impressive thing for me in this launch is basic retention. When you think about, we have a [inaudible], when you start to take patient in, and really test it, are they really providing a benefit for the patient?
Speaker Change #142: It's being driven by patients that basic.
Sure.
Speaker Change #142: See the shoots.
Speaker Change #142: Unmet medical need.
Speaker Change #142: This generation where.
<unk> had been missing net par for long time.
And extremely serious consequence of patients that now today.
Speaker Change #142: On the Pas and suddenly.
Speaker Change #142: Need to be disrupted.
Jan Møller Mikkelsen: And then they have a retention of 98%. I have never seen that for any product before, that is really, really unique but this really describe the benefit that is really giving to the patient, and the state of the treatment, exactly as we have observed in our clinical trials. I do not know, Camilla, you have further comments to the dorms in, specific in Germany and Austria?
After treatment because net par would not be noncore.
Speaker Change #142: <unk>.
Speaker Change #142: Some debt.
Speaker Change #143: <unk> patient organization physician and us.
Speaker Change #144: And FDA recognized this issue.
Speaker Change #144: And I think everyone is working together.
Speaker Change #144: Extremely constant.
Speaker Change #144: Manner to find out how we can help the patients to avoid suffolk prices that potential.
Jan Møller Mikkelsen: Yeah, I think you said it very, very well, we're very pleased with the uptake of the YORVIPATH in Germany, we're benchmarking all the rare disease launches, and we're doing very well compared to them. And so the team is working hard, on both breadth and depth, and that's working well, and also creating the mix between the PTH [inaudible] patients and the ones that have been on [inaudible]. And the switch that we're making from [inaudible] to YORVIPATH is going very, very fast. So all in all, we're very pleased with how it's going, and where we're going to future. Yes, what we have seen in different European countries, that the Nepal basic because of its stop of manufacturing that is an tendency to keep the patient on Nepal until all the, you can say, accumulated drop are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the Nepal power patient coming in now. But one thing we have now been launched in Germany and Austria in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in 25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Camilla Harder Hartvig: Yeah, I think you said it very, very well, we're very pleased with the uptake of the YORVIPATH in Germany, we're benchmarking all the rare disease launches, and we're doing very well compared to them. And so the team is working hard, on both breadth and depth, and that's working well, and also creating the mix between the PTH [inaudible] patients and the ones that have been on [inaudible]. And the switch that we're making from [inaudible] to YORVIPATH is going very, very fast. So all in all, we're very pleased with how it's going, and where we're going to future.
Speaker Change #144: Sure.
Speaker Change #144: Thanks.
Speaker Change #145: Thank you.
Speaker Change #146: Please standby for our next question.
Speaker Change #146: Our next question comes from the line of David Leibowitz with Citi. Your line is open.
David Leibowitz: Well. Thank you for taking my questions I've got two here first.
Speaker Change #146: <unk>.
Speaker Change #148: Skypes of adjustments.
Speaker Change #149: Just to make sure I got this right.
Speaker Change #150: You came to an agreement on net pricing with payers and as part of it you had to true up.
Speaker Change #150: Prior sales in the last couple of quarters.
Speaker Change #150: And then I'll have one more after that.
Speaker Change #150: I think you have understood. It correct. This is a true.
Jan Møller Mikkelsen: Yes, what we have seen, in different European countries, that the [inaudible] basic because of it's stop of manufacturing, that is a tendency to keep the patient on Nepal, until all the, you can say, accumulated drugs are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the [inaudible] patient coming in now. But one thing we have now been launched in Germany and Austria, in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in '25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed. Thank you.
Jan Møller Mikkelsen: Yes, what we have seen, in different European countries, that the [inaudible] basic because of it's stop of manufacturing, that is a tendency to keep the patient on Nepal, until all the, you can say, accumulated drugs are being utilized in the specific regions. And we also see now that it's starting to change a lot, where we see much, much more pressure taking up from the [inaudible] patient coming in now. But one thing we have now been launched in Germany and Austria, in our Europe direct strategy, we go to France, and then here, hopefully in this year, and then in '25, we will have the next six, seven European countries being added in. Really are rolling out in the way we are generating revenue from this region in our most faster speed.
Speaker Change #150: Up that is basic reflecting net revenue from <unk>.
Speaker Change #151: Mainly net revenue for Q1, but about $7 6 million also from 'twenty three that is a true up that is being taken away from Q2 revenue. So basic if you want to calculate real.
Speaker Change #151: Sales in Q2, you'll need to act all this true up to the net revenue from Q2.
Speaker Change #151: As reported at <unk>.
Speaker Change #152: Got it.
Speaker Change #152: Any comments or did I get it right.
Speaker Change #153: You got it right yes.
Speaker Change #152: Good.
Speaker Change #152: Yes.
Speaker Change #152: Got it and then CMP.
Speaker Change #154: What is what has occurred to actually essentially accelerate the pivotal data timeline.
Speaker Change #154: From prior upticks.
Speaker Change #154: Okay.
Speaker Change #156: I have to say.
Speaker Change #156: How fast physician.
Operator: Thank you. Please stand by for our next question. Our next question comes from Milan, of Li Watsek, with Cantor. Your line is open.
Speaker Change #156: The setup of our clinical operation has been function in this case.
Please stand by for our next question. Our next question comes from Milan, of Li Watsek, with cancer. Yalan is open.
Speaker Change #156: Potato to coming must must faster.
Speaker Change #156: Oversold.
Li Watsek: Hey guys, thanks for taking my questions, maybe just a follow up on SKYTROFA. Maybe help us understand when, when [inaudible] assumptions for the lower guidance for SKYTROFA this year? Just looking for more details on what's driving that 100 million, your reduction, maybe talk a little bit about the dynamics between the broader market access and pricing? And I have a follow up.
Speaker Change #157: I believe there is some dedication that I.
Speaker Change #158: But when you can compare to what we have seen for both <unk> and cutover to get this product out as fast as possible. We're also seeing the same kind of extremely extremely high retention in this year too so I think.
Speaker Change #158: August when I see this data when I see this prostitute thing coming in.
Speaker Change #159: People have wanted vacation to get it out to the patients as fast as possible.
Jan Møller Mikkelsen: I can come with some overall statement, first related to how we did the forecasting, because what we basically did that we saw a growth in volume between Q1 and Q2, and we utilized that growth basically to predict the rest of the year, and it's basically giving the lower value. And after we now have reset our market access portfolio, we are in a position that the expect, that the DTN will be keeping constantly throughout the year, what we have observed, like last year, we saw a last seasonal effect, between the first half compared to the second half. We still see that as an upside, with potential will materialize, but we also know that it could not materialize, so this is how we have basically taking the guidance forward in that. And that is not anything believing in that the potential can actually grow, we see the potential, we see the best-in-class potential on it. Joe that is responsible for our US, you can also give a short summary about all the effect that's getting implemented now, that first will provide effect in the second half of this year.
Jan Møller Mikkelsen: I can come with some overall statement, first related to how we did the forecasting, because what we basically did that we saw a growth in volume between Q1 and Q2, and we utilized that growth basically to predict the rest of the year, and it's basically giving the lower value. And after we now have reset our market access portfolio, we are in a position that the expect, that the DTN will be keeping constantly throughout the year, what we have observed, like last year, we saw a last seasonal effect, between the first half compared to the second half.
Got it.
Speaker Change #160: Thank you.
Speaker Change #160: Thank you.
Speaker Change #161: Please standby for our next question.
Speaker Change #162: Our next question comes from the line of Alex Thomson with Stifel. Your line is open.
Alex Thomson: Hey, great. Thanks for taking my question I guess again on sort of the you already tapped potential in the U S. Could you talk specifically about the data that FDA needs to or wants to see in order to understand whether the material. You have currently would be suitable for a U S launch in the fourth quarter. Thanks.
Speaker Change #164: I actually think they have all the data to take this decision.
Jan Møller Mikkelsen: We still see that as an upside, with potential will materialize, but we also know that it could not materialize, so this is how we have basically taking the guidance forward in that. And that is not anything believing in that the potential can actually grow, we see the potential, we see the best-in-class potential on it. Joe that is responsible for our US, you can also give a short summary about all the effect that's getting implemented now, that first will provide effect in the second half of this year.
Speaker Change #165: I don't believe any data and need to be.
Chris: Brought to them at least the quick Chris we have phone is not really.
Speaker Change #166: Anything after data, it's mainly how fast can be supply are most material to behalf and other things like that so we can ensure that when we start we basic INO position, we really can manage this entire DMA.
Speaker Change #166: We expect to come.
Speaker Change #167: Thank you.
Joe Kelly: So the healthcare providers right now have extreme clarity about where they can provide SKYTROFA to patients, with a high chance of reimbursement. But also where SKYTROFA is not on formulary, healthcare providers are documenting intolerance, growth below the average parental height, while on other growth hormones, therefore allowing a resubmission so that pediatric or hormone deficient patients can have access to SKYTROFA. So there's time left, in this year, obviously things will stabilize in '25, so we know now where we can continue to add patients, and grow our net revenue, and expand,e and grow the value of the entire hormone marketplace.
Speaker Change #168: Please standby for our next question.
Speaker Change #169: Next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi, Thank you good afternoon, and thank you for taking our question.
Speaker Change #169: <unk>.
Speaker Change #171: To revisit sky trough out can you maybe comment on.
Paul Choi: What percentage of your Payor contracts were affected by this.
Paul Choi: By the true up and whether the duration of this these changes are multiyear.
Speaker Change #172: It'd be helpful to understand.
Speaker Change #173: The issue, we will have to potentially revisit next year. So any comments there would be would be helpful.
Speaker Change #173: And second just in terms of the.
Speaker Change #173: Royalty pharma agreement that was announced this year.
Speaker Change #174: I just wanted to confirm that from your perspective is this potentially the last.
External capital that you think youll need.
Speaker Change #174: Prior to achieving.
And I also wonder if you can talk a little bit about where you can further reduce from the cost perspective. And is there any chance you can do break even this year, given the lower schedule for items?
Speaker Change #175: Operating cash flow breakeven either this year or next year. Thank you very much.
The question that you are.
Asking for related to.
Speaker Change #176: The implementation of the new contracts.
You know, Scott is really good at numbers. So I will summary, give you an all the perspective and then Scott can go more back to some of the way we are looking at it today. One of the things we are proud about is that we really keep our operating expenses in control, and we really see that we really have a good internal system to keep Ascendis Pharma to be a highly effective organization. We also see that there is revenue, specific Europe has different regions, are really starting to take in now, so potentially we have a YORVIPATH outside US. We're still in [inaudible] where we are still discussing with FDA, related to how we can really help the patient that is in shortage of treatment here in the US. We hope we can help them, we will do everything to help them, it meaning that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients, we hear the voice from the physicians, we will do everything so we can have an earlier launch, and as soon as we get clarity about that, we will come back to you. So we have a lot of potential upsides, we have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control, and this is how we are operating. Scott comments. I think you said it well, Jan. Lee, as you know, we always look to be cost effective in what we do as a company. And we evaluate expenses that aren't tied to getting the product to patient as soon as possible. But at the same time, of course, we don't want to sacrifice doing that and getting the product. So that's part of the reason we announced the new financing today after the close for the additional 150 million US dollars. But we continue to have great scrutiny on costs, particularly where they're not leading to getting our products to patients.
You know, Scott is really good at numbers. So I will summary, give you an all the perspective and then Scott can go more back to some of the way we are looking at it today. One of the things we are proud about is that we really keep our operating expenses in control, and we really see that we really have a good internal system to keep Ascendis Pharma to be a highly effective organization. We also see that there is revenue, specific Europe has different regions, are really starting to take in now, so potentially we have a YORVIPATH outside US. We're still in [inaudible] where we are still discussing with FDA, related to how we can really help the patient that is in shortage of treatment here in the US. We hope we can help them, we will do everything to help them, it meaning that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients, we hear the voice from the physicians, we will do everything so we can have an earlier launch, and as soon as we get clarity about that, we will come back to you. So we have a lot of potential upsides, we have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control, and this is how we are operating. Scott comments.
Jan Møller Mikkelsen: You know, Scott is really good at numbers. So I will summary, give you an all the perspective and then Scott can go more back to some of the way we are looking at it today. One of the things we are proud about is that we really keep our operating expenses in control, and we really see that we really have a good internal system to keep Ascendis Pharma to be a highly effective organization. We also see that there is revenue, specific Europe has different regions, are really starting to take in now, so potentially we have a YORVIPATH outside US.
Speaker Change #176: The implementation of the new contract was a continued process to Q1 and Q2.
Speaker Change #176: We are now in a position that we have restated. This is why Scott used the great work reset we have wasted power.
Speaker Change #176: Coverage in the U S.
Speaker Change #176: And from that perspective, the tea chain, we expect to see in the second half would be aligned to what we saw in the first half and.
Jan Møller Mikkelsen: We're still in [inaudible] where we are still discussing with FDA, related to how we can really help the patient that is in shortage of treatment here in the US. We hope we can help them, we will do everything to help them, it meaning that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients, we hear the voice from the physicians, we will do everything so we can have an earlier launch, and as soon as we get clarity about that, we will come back to you. So we have a lot of potential upsides, we have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control, and this is how we are operating. Scott comments.
Jan Møller Mikkelsen: We're still in [inaudible] where we are still discussing with FDA, related to how we can really help the patient that is in shortage of treatment here in the US. We hope we can help them, we will do everything to help them, it meaning that we will have a most faster loans that we actually are taking into our plans. We hear the voice from the patients, we hear the voice from the physicians, we will do everything so we can have an earlier launch, and as soon as we get clarity about that, we will come back to you.
Speaker Change #176: We expect the same tidjane in 'twenty five 'twenty six 'twenty 728, 29 and 30.
Speaker Change #176: I can only come with five year guidance.
Speaker Change #177: Thank you.
Iran Weber: Our last question will come from the line of Iran. Weber from.
Speaker Change #179: From TD Cowen Your line is open.
Jan Møller Mikkelsen: So we have a lot of potential upsides, we have a lot of different ways where we are looking about how we can strengthen our revenue. How we are still keeping our expenses in control, and this is how we are operating. Scott comments.
Iran Weber: Great. Thanks for taking my question Hope you can hear me.
Iran Weber: My question is two parts just relating to the as you think about the guidance for the year. The $2 20 to 240 <unk> does that entail. The 71 5 million that you sort of did in the first half for sky profile on a net basis or is that including the $91 million.
Scott Smith: I think you said it well, Jan. Li, as you know, we always look to be cost-effective in what we do as a company, and we evaluate expenses that aren't tied to getting the product to patient as soon as possible. But at the same time, of course, we don't want to sacrifice doing that and getting the product, so that's part of the reason we announced the new financing today after the close for the additional 150 million US dollars. But we continue to have great scrutiny on costs, particularly where they're not leading to getting our products to patients.
Speaker Change #180: You did $65 million in Q1, and then secondly on you said you did $53 million in Q2 is that a good run rate then start into Q3 and four should we really think of the $26 million. This quarter is a good run rate into into the second half. Thank you.
Joe: Yes, there was a lot of question in what you basically gave to Scott and me and Joe and the commercial team into it.
I think when you.
Speaker Change #181: Start on the loss.
Christian: Christian about basic the reported number to date here in <unk>.
Speaker Change #183: In our numbers and I see that the real number is basic the reported net sales plus the true that the basic provided to you. So you take the number that we had in our.
We send out for our next question. Our next question comes from Alan Gavin Clark-Gartner with Evacore ISI. Yalan is open.
Speaker Change #183: Q2 sales and then basic.
Speaker Change #183: What we took in true up both from 'twenty three.
Hey guys, thanks for taking the questions. First, I just wanted to ask, for Sky Trofa, when did these policies with more favorable access go into place, and doing the first half year? So, some of them are first taking in here in Q2. The complexity of these agreements are very complex in this way that potential rebate compared to volume increase are some way not really aligned, and there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume. So, from a modeling perspective, we see a doubled digit number in increase in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before is first taking in in the second half.
Hey guys, thanks for taking the questions. First, I just wanted to ask, for SKYTROFA, when do these policies with more favorable access go into place? And when should we expect a pick up in prescriptions? I think it was gradual doing the first half year,
Gavin Clark-Gartner: Hey guys, thanks for taking the questions. First, I just wanted to ask, for SKYTROFA, when do these policies with more favorable access go into place? And when should we expect a pick up in prescriptions?
Speaker Change #183: Yes.
Speaker Change #183: What we did in Q1 that you would get a basic and net sales of what we had in.
Jan Møller Mikkelsen: I think it was gradual doing the first half year, so, some of them are first taking in here in Q2. The complexity of these agreements are very complex, in this way that potential rebate compared to volume increase are some way not really aligned. And there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume. So, from a modeling perspective, we see a doubled digit number, in increase, in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before, is first taking in in the second half. So, I will first see the expected growth coming in in the second half. Okay, that makes sense. And some of that's on a QV data overall. Have you guys noticed any changes in capture rate trends over time? I think the issue I personally have the data is that it's assembling of few places. And if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it. You should give them all the money because the utilization of these days at least I'm not paying for it. I get it for free because I showed so many times they were totally not useful to have, but still buy it if you want. Okay, thanks.
Jan Møller Mikkelsen: I think it was gradual doing the first half year, so, some of them are first taking in here in Q2. The complexity of these agreements are very complex, in this way that potential rebate compared to volume increase are some way not really aligned. And there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume. So, from a modeling perspective, we see a doubled digit number, in increase, in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before, is first taking in in the second half. So, I will first see the expected growth coming in in the second half.
Jan Møller Mikkelsen: I think it was gradual doing the first half year, so, some of them are first taking in here in Q2. The complexity of these agreements are very complex, in this way that potential rebate compared to volume increase are some way not really aligned.
Our second quarter of 'twenty four.
So, some of them are first taking in here in Q2. The complexity of these agreements are very complex in this way that potential rebate compared to volume increase are some way not really aligned, and there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume. So, from a modeling perspective, we see a doubled digit number in increase in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before is first taking in in the second half. So, I will first see the expected growth coming in in the second half. Okay, that makes sense. And some of that's on a QV data overall. Have you guys noticed any changes in capture rate trends over time? I think the issue I personally have the data is that it's assembling of few places. And if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it. You should give them all the money because the utilization of these days at least I'm not paying for it. I get it for free because I showed so many times they were totally not useful to have, but still buy it if you want. Okay, thanks.
Speaker Change #185: So I think that is the real number and when you look at that it is around 53 million.
Speaker Change #186: If I calculate it right that I think is real.
Jan Møller Mikkelsen: And there was some of the issue we ran into that the rebate basically got established much faster than really we can start to grow the volume. So, from a modeling perspective, we see a doubled digit number, in increase, in volume between Q1 and Q2, but we really will expect first all the effort that we now have installed as Joe told before, is first taking in in the second half. So, I will first see the expected growth coming in in the second half.
Speaker Change #187: Napa for Q2.
Speaker Change #187: Okay.
Speaker Change #187: If I took my calculations, it's $53 four or something like that to be concrete. So we see without doubt a really good pick up from Q1 to Q2.
Speaker Change #187: And when you go back and look on the seasonal barons that potentially we.
Speaker Change #187: We will see.
Speaker Change #187: Improved pick up in Q3, and Q4 and wouldn't be forecasting the basic too conservative approach and saying you spend non booked in Q1, and Q2 and use that as a forthcoming nonprofit every quarter rest of the year.
Jan Møller Mikkelsen: Okay, that makes sense, and some of that's on a QV data overall, have you guys noticed any changes in capture rate trends over time? I think the issue I personally have the data is that it's assembling of few places. And if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it. You should give them all the money because the utilization of these days at least I'm not paying for it. I get it for free because I showed so many times they were totally not useful to have, but still buy it if you want. Okay, thanks.
Gavin Clark-Gartner: Okay, that makes sense, and some of that's on a QV data overall, have you guys noticed any changes in capture rate trends over time?
Jan Møller Mikkelsen: I think the issue I personally have the data is that, it's assembling of few places, and if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it, you should give them all the money, because the utilization of these days, at least I'm not paying for it, I get it for free because I showed so many times they were totally not useful to have. But still buy it if you want. Okay, thanks.
Jan Møller Mikkelsen: I think the issue I personally have the data is that, it's assembling of few places, and if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different. So, out from that, I think you should pay it, you should give them all the money, because the utilization of these days, at least I'm not paying for it, I get it for free because I showed so many times they were totally not useful to have. But still buy it if you want.
Jan Møller Mikkelsen: I think the issue I personally have the data is that, it's assembling of few places, and if you some way keep everything stable, you can use it as an overall trend. If there is a shift between different PPMs, between different market assets, you often will see some difference in volume that really are total unpredictable, out from the perspective of the sampling between the different PPMs are different.
Speaker Change #187: Meaning is that we have not calculated any seasonal effect.
Speaker Change #187: The numbers to be higher.
Speaker Change #187: Year to date.
Speaker Change #188: And so most question related to euro mathematic accurate related to the numbers.
Speaker Change #188: Scott you have anything threat, yes, just one thing you are one day for the first half we reported $91 2 million Euro.
Jan Møller Mikkelsen: So, out from that, I think you should pay it, you should give them all the money, because the utilization of these days, at least I'm not paying for it, I get it for free because I showed so many times they were totally not useful to have. But still buy it if you want.
Speaker Change #189: Without any those where the actual reported numbers and as we said in the prepared remarks in the press release that number was reduced had been reduced by $7 6 million Euro.
Speaker Change #190: True up for periods prior to January one so in other words, it would've been seven two higher or about $100 million euro for the first half.
Gavin Clark-Gartner: Okay, thanks.
Speaker Change #191: Thank you.
Speaker Change #192: Ladies and gentlemen, I'm showing no further questions in the queue.
Speaker Change #193: This concludes today's conference call. Thank you for your participation you may now disconnect.
Please stand by for our next questions. Our next question comes from the line of big round per per row hit with Morgan Sally, Yelana Salton.
Speaker Change #193: Okay.
Speaker Change #193: Okay.
Speaker Change #193: [music].
Vikram Purohit: Hi, good afternoon, thank you for taking our questions. I guess switching to TransCon CNP, we were just curious for the upcoming approach readout? And then also for the coach readout in 2Q '25, just which parameters of data you expect to report out? And how you would currently guide people to compare and contrast the data sets, versus a competitor CNP data sets available in the space. Thank you.
Okay.
[music].
Thank you.
I think the most easiest way to compare anything is to go through [inaudible] because this is true, you can say mode of action that is there must align between them, even if there is a different in how we function, because we have a continuous exposure of CNP molecule. Where? from the [inaudible], it basically is only have an active covers for two or three hours, in every 24 hours dosing cycle. So when we look on our aim, as we have said in the last eight years, we want both to provide linear growth, but also provide and address the co-morbidity of the disease. And what we have seen, until now, and now I'm referring into Phase II because this is the data I can talk about today, is that we have seen and analyzed high velocity exactly at the same level of [inaudible] with a once-weekly dosing profile. But we have seen the improvement in many of the way that these children, their physician, their caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data, directly to placebo, an improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from, I need to see the data that coming in the next week, so it's pretty, pretty, pretty near, so the database has been locked, people are running the staff now. So as soon as they're finished, I would be taken into a room and see the data. Got it, thank you. Please stand by for our next question.
Jan Møller Mikkelsen: I think the most easiest way to compare anything is to go through [inaudible] because this is true, you can say mode of action that is there must align between them, even if there is a different in how we function, because we have a continuous exposure of CNP molecule. Where? from the [inaudible], it basically is only have an active covers for two or three hours, in every 24 hours dosing cycle. So when we look on our aim, as we have said in the last eight years, we want both to provide linear growth, but also provide and address the co-morbidity of the disease. And what we have seen, until now, and now I'm referring into Phase II because this is the data I can talk about today, is that we have seen and analyzed high velocity exactly at the same level of [inaudible] with a once-weekly dosing profile. But we have seen the improvement in many of the way that these children, their physician, their caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data, directly to placebo, an improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from, I need to see the data that coming in the next week, so it's pretty, pretty, pretty near, so the database has been locked, people are running the staff now. So as soon as they're finished, I would be taken into a room and see the data.
Jan Møller Mikkelsen: I think the most easiest way to compare anything is to go through [inaudible] because this is true, you can say mode of action that is there must align between them, even if there is a different in how we function, because we have a continuous exposure of CNP molecule. Where? from the [inaudible], it basically is only have an active covers for two or three hours, in every 24 hours dosing cycle. So when we look on our aim, as we have said in the last eight years, we want both to provide linear growth, but also provide and address the co-morbidity of the disease.
Jan Møller Mikkelsen: And what we have seen, until now, and now I'm referring into Phase II because this is the data I can talk about today, is that we have seen and analyzed high velocity exactly at the same level of [inaudible] with a once-weekly dosing profile. But we have seen the improvement in many of the way that these children, their physician, their caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data, directly to placebo, an improvement in quality of life related to physical function. And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from, I need to see the data that coming in the next week, so it's pretty, pretty, pretty near, so the database has been locked, people are running the staff now. So as soon as they're finished, I would be taken into a room and see the data.
Jan Møller Mikkelsen: And what we have seen, until now, and now I'm referring into Phase II because this is the data I can talk about today, is that we have seen and analyzed high velocity exactly at the same level of [inaudible] with a once-weekly dosing profile. But we have seen the improvement in many of the way that these children, their physician, their caregivers talked about the benefit to the patient. And from that perspective, we also could show when we compared our phase two data, directly to placebo, an improvement in quality of life related to physical function.
Jan Møller Mikkelsen: And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities. So it gives you where we started from, I need to see the data that coming in the next week, so it's pretty, pretty, pretty near, so the database has been locked, people are running the staff now. So as soon as they're finished, I would be taken into a room and see the data.
Jan Møller Mikkelsen: And this is a why we basically are taking into our trial different measuring on key secondary endpoint that basically cope for us that it can give an effect that really shows how we address the co-morbidity, which have never, never been shown by any other product. And when we go to the biochemical process, the science behind it, which we always love, then we basically can come with great explanation why you need to have a continuous exposure of CNP basic to address some of the co-morbidities.
Jan Møller Mikkelsen: So it gives you where we started from, I need to see the data that coming in the next week, so it's pretty, pretty, pretty near, so the database has been locked, people are running the staff now. So as soon as they're finished, I would be taken into a room and see the data.
Got it, thank you. Please stand by for our next question.
Got it, thank you.
Operator: Thank you, please stand by for our next question. Our next question comes from the line of Kelly Shi with Jeffries. Your line is open.
Our next question comes from the line of Kelly shot with Jeffries. Your line is open.
Thank you for taking my questions. Maybe for PDH, could you please elaborate more on your ongoing interactions with regulators regarding commercialization of existing batches? For the US launch, which is likely of a few or first quarter of next year at the moment? We have an extremely constructive dialogue with FDA related to how potential to address the shortest of PTI drops in the US.
Kelly Shi: Thank you for taking my questions. Maybe for PTH, could you please elaborate more on your ongoing interactions with regulators regarding commercialization of existing batches for the US launch? Which is likely of a 4QQ, or first quarter of next year at the moment?
For the US launch, which is likely of a few or first quarter of next year at the moment? We have an extremely constructive dialogue with FDA related to how potential to address the shortest of PTI drops in the US.
For the US launch, which is likely of a few or first quarter of next year at the moment?
We have an extremely constructive dialogue with FDA, related to how potential to address the shortest of [inaudible] drops in the US. It's been driven by patients that basic are seeing the huge, unmet medical need. The [inaudible] where patients have been missing their power for a long time, and extremely serious consequence of patients that now, today, are on their path and suddenly need to be disrupted of the treatment because [inaudible] will not be available longer. Out from that, both patient organization, physician and us, and FDA recognize this issue, and I think everyone is working together in an extremely constructive manner to find out how we can help the patient, to avoid suffer crisis that potentially it would be. Thanks. Thank you.
Jan Møller Mikkelsen: We have an extremely constructive dialogue with FDA related to how potential to address the shortest of PTI drops in the US. It's been driven by patients that basic are Seeing the huge, unleavened need, the situation where patients have been missing their power for a long time, and extremely serious consequence of patients that now today are on their path and suddenly need to be disrupted, of the treatment because their power will not be available longer. Out from that, both patient organization, physician and us, and FDA recognize this issue, and I think everyone is working together in an extremely constructive manner to find out how we can help the patient to avoid such a crisis that potentially it would be.
Jan Møller Mikkelsen: We have an extremely constructive dialogue with FDA related to how potential to address the shortest of PTI drops in the US. It's been driven by patients that basic are Seeing the huge, unleavened need, the situation where patients have been missing their power for a long time, and extremely serious consequence of patients that now today are on their path and suddenly need to be disrupted, of the treatment because their power will not be available longer.
Jan Møller Mikkelsen: Out from that, both patient organization, physician and us, and FDA recognize this issue, and I think everyone is working together in an extremely constructive manner to find out how we can help the patient to avoid such a crisis that potentially it would be.
be. Thanks. Thank you.
be.
Thanks. Thank you.
Kelly Shi: Thanks.
Operator: Thank you. Please stand by for our next question. Our next question comes from the line of David Lebowitz with City, Your line is open.
Please stand by for our next question. Our next question comes from the line of David Lebowitz with City, Yolana Thulking.
David Neil Lebowitz: Well, thank you for taking my question, I got two here. First, on the SKYTROFA adjustments. Just to make sure I got this right, that you came to an agreement on unit pricing with the payers, and as part of it, you had to true up prior sales in the last couple quarters, and then I'll have one more after that.
Jan Møller Mikkelsen: I think you have understood it correctly. This is a true up that is basically reflecting net revenue from mainly net revenue from Q1, but about 7.6 million also from 23, that is the true up, that is being taken away from Q2 revenue. So basically if you want to calculate real sales in Q2, you need to add all this true up to the net revenue from Q2, that is reported to you.
Jan Møller Mikkelsen: Got it. Stuck any comments? Or did I get it right? You got it right, Jan. Good. I got it. And on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates. I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
David Neil Lebowitz: Got it.
Jan Møller Mikkelsen: Scott any comments? Or did I get it right? You got it right, Jan. Good. I got it. And on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates. I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Jan Møller Mikkelsen: Scott any comments? Or did I get it right?
Jan Møller Mikkelsen: You got it right, Jan. Good. I got it. And on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates. I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Scott Smith: You got it right, Jan.
Jan Møller Mikkelsen: Good, I got it, and on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates? I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
David Neil Lebowitz: Good, I got it, and on CNP, what has occurred to actually, essentially, accelerate the pivotal data timeline from prior updates?
Jan Møller Mikkelsen: I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming much, much faster than we ever saw. I believe there is such a dedication, that I only can compare to what we have seen for both PJs and SKYTROFA to get this product out as fast as possible, qe also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got it. Thank you.
Jan Møller Mikkelsen: I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible. Got
Jan Møller Mikkelsen: I have to say how fast physicians, the setup of our chemical operation has been functioned in this case, have brought the data to coming must must faster than the result. I believe there is such a dedication that I only can compare to what we have seen for both PJs and SkyTover to get this product out as fast as possible. We also seen the same kind of extremely extremely high retention in this year too. So I think always when I see this data, when I see this positive thing coming in, I think people have one indication to get it out to the patients as fast as possible.
Jan Møller Mikkelsen: Got it, thank you. Thank you.
David Neil Lebowitz: Got it, thank you.
Jan Møller Mikkelsen: it. Thank you.
Operator: Thank you, please stand by for our next question. Our next question comes from the line of Alex Thompson with Stifel, Your line is open.
Our next question comes from the line of Alex Thompson with Sifu, Yalayan Zolpin.
Great. Thanks for taking my question. I guess, you know, again, on sort of the Yorvig path potential in the US. Could you talk specifically about the data that FEA needs to or wants to see in order to understand whether the material you have currently would be suitable for a US launch in the fourth quarter? Thanks. I actually think that they have all the data to take this decision.
Alex Thompson: Great, thanks for taking my question, I guess, you know, again, on sort of the YORVIPATH potential in the US. Could you talk specifically about the data that FDA needs to, or wants to see in order to understand whether the material you have currently would be suitable for a US launch in the fourth quarter? Thanks.
Thanks. I actually think that they have all the data to take this decision. And I don't believe any data need to be brought to them. At least the request we have on is not really on anything of the data. It's over, it can ensure that when we start, we basic iron opposition, we really can manage this entire demand that we expect to come. Thank you.
Thanks.
Jan Møller Mikkelsen: I actually think that they have all the data to take this decision, and I don't believe any data need to be brought to them, at least the request we have on is not really on anything of the data. It's mainly how fast can we supply? How much material do we have? And a lot of thing like that, so we can can ensure that when we start, we basic iron opposition, we really can manage this entire demand that we expect to come. Thank you.
Jan Møller Mikkelsen: I actually think that they have all the data to take this decision, and I don't believe any data need to be brought to them, at least the request we have on is not really on anything of the data. It's mainly how fast can we supply? How much material do we have? And a lot of thing like that, so we can can ensure that when we start, we basic iron opposition, we really can manage this entire demand that we expect to come.
Operator: Thank you, please stand by for our next question. Next question comes from a lot of Paul Choi with Goldman Sachs. Your line is open.
Paul Choi: Hi, thank you, good afternoon, and thank you for taking our question. On, to revisit, SKYTROFA, can you maybe comment on what percentage of your pair of contracts were affected by this, by the true up, and whether the duration of these changes are multi-year? Basically it would be helpful to understand if this is an issue we'll have to potentially revisit next year, so any comments there would be helpful.
And second, just in terms of the royalty farm agreement that was announced this year, I just want to confirm that from your perspective, is this potentially the last source of external capital that you think you'll need prior to achieving operating cash flow break even either this year or next year? Thank you very much.
Paul Choi: And second, just in terms of the Royalty Pharma agreement that was announced this year, I just want to confirm that, from your perspective, is this potentially the last source of external capital that you think you'll need, prior to achieving operating cash flow break even either this year or next year? Thank you very much.
Jan Møller Mikkelsen: The question that you are asking for related to the implementation of the new contracts, the implementation of the new contract was a continued process to Q1 and Q2. We are now in a position that we have resetted, this is why Scott used the great work reset. We have reset [inaudible]s in the US and out from that perspective, the [inaudible] we expect to see in the second half would be aligned to what we saw in the first half. And we expect the same [inaudible] in '25, '26, '27, '28, '29 and '30. I can only come with five years guidance. Thank you.
Jan Møller Mikkelsen: The question that you are asking for related to the implementation of the new contracts, the implementation of the new contract was a continued process to Q1 and Q2. We are now in a position that we have resetted, this is why Scott used the great work reset. We have reset [inaudible]s in the US and out from that perspective, the [inaudible] we expect to see in the second half would be aligned to what we saw in the first half. And we expect the same [inaudible] in '25, '26, '27, '28, '29 and '30. I can only come with five years guidance.
Operator: Thank you. Our last question will come from the line of Yaron Werber from TD Cohen, Your line is open.
Operator: Our last question will come from the line of Yaron Werber from TD Cohen, Yalan is open.
Yaron Benjamin Werber: Great, thanks for taking my question, I hope you can hear me. My question is two parts, just relating to the, as you think about the guidance for the year, the 220 to 240, does that entail that the 71.5 million that you sort of did in the first half for SKYTROFA on a net basis? Or is that including the 91 million, you know, assuming you did 65 million in Q1? And then secondly on you said you did 53 million in Q2, is that a good run rate to then start into Q3? And 4 should we really think of the 26 million this quarter as a good run rate into into the second half? Thank you.
Thank you.
Yeah, there was a lot of question in what you basically gave to Scott, and me, and Joe, and the commercial team into it. I think when you start on the last question about basic, the reported number today here in, in our numbers. And I see that the real number is basic, the reported net sales plus the true out that we basic provided to you. So you take the number that we have in our Q2 sales, and then basic add everything what we took in true out, both from 23 and what we did in Q1. There you will get a basic and net sales of what we had in a second quarter of '24. So I think that is the real number, and when you look at that, it is around €53 million, if I calculated right, that I think is the real number for Q2. If I do my calculations is €53.4 or something like that to be concrete, so we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential [inaudible], we will see an improved pick up in Q3 and Q4, and when we did the forecasting, we basic took the conservative approach. And saying we use the number between Q1 and Q2, and use that as a forthcoming number for every quarter, rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have given you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything to add? Yeah, just one thing you are on the for the first half, we reported 91.2 million euro without any, you know, those were the actual reported numbers. And as we said in the prepared remarks in the press release, that number was reduced, had been reduced by 7.6 million euro of true up for periods prior to January 1. So in other words, it would have been 7.2 higher or about 100 million euro for the first half.
Yeah, there was a lot of question in what you basically gave to Scott, and me, and Joe, and the commercial team into it. I think when you start on the last question about basic, the reported number today here in, in our numbers. And I see that the real number is basic, the reported net sales plus the true out that we basic provided to you. So you take the number that we have in our Q2 sales, and then basic add everything what we took in true out, both from 23 and what we did in Q1. There you will get a basic and net sales of what we had in a second quarter of '24. So I think that is the real number, and when you look at that, it is around €53 million, if I calculated right, that I think is the real number for Q2. If I do my calculations is €53.4 or something like that to be concrete, so we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential [inaudible], we will see an improved pick up in Q3 and Q4, and when we did the forecasting, we basic took the conservative approach. And saying we use the number between Q1 and Q2, and use that as a forthcoming number for every quarter, rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have given you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything to add?
Yeah, there was a lot of question in what you basically gave to Scott, and me, and Joe, and the commercial team into it. I think when you start on the last question about basic, the reported number today here in, in our numbers. And I see that the real number is basic, the reported net sales plus the true out that we basic provided to you. So you take the number that we have in our Q2 sales, and then basic add everything what we took in true out, both from 23 and what we did in Q1. There you will get a basic and net sales of what we had in a second quarter of '24.
So I think that is the real number, and when you look at that, it is around €53 million, if I calculated right, that I think is the real number for Q2. If I do my calculations is €53.4 or something like that to be concrete, so we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential [inaudible], we will see an improved pick up in Q3 and Q4, and when we did the forecasting, we basic took the conservative approach. And saying we use the number between Q1 and Q2, and use that as a forthcoming number for every quarter, rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have given you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything to add?
So I think that is the real number, and when you look at that, it is around €53 million, if I calculated right, that I think is the real number for Q2. If I do my calculations is €53.4 or something like that to be concrete, so we see without doubt a really good pick up in from Q1 to Q2. And when you go back and look on the seasonal variance that potential [inaudible], we will see an improved pick up in Q3 and Q4, and when we did the forecasting, we basic took the conservative approach.
And saying we use the number between Q1 and Q2, and use that as a forthcoming number for every quarter, rest of the year, meaning is that we have not calculated any seasonal effect in the numbers we have given you today. I think it's answered most question related to your mathematic algorithm related to the numbers. Scott, you have anything to add?
Scott Smith: Yeah, just one thing, Yaron the, for the first half, we reported €91.2 million without any, you know, those were the actual reported numbers. And as we said in the prepared remarks, in the press release, that number was reduced, had been reduced by €7.6 million of true up for periods prior to January 1. So in other words, it would have been €7.2 higher or about €100 million for the first half.