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Operator
Hello, thank you for standing by. Welcome to Ascended Farmer's second quarter 2024 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask the question during this session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. We ask that you limit yourself to one question and one follow-up. I would now like to turn the call over to Tim Lee, Senior Director of Investor Relations at Ascendus Pharma. 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 due to some technical issues that we had here. I'm Tim Lee, Senior Director of Investor Relations at Ascendus Pharma. Joining me on the call today are Yen Mickelson, President and Chief Executive Officer of Scott Smith, Executive Vice President and Chief Financial Officer. Dr. Stina Singhal, Executive Vice President and Head of Clinical Development Oncology. Camilla Harder Hartvig, Executive Vice President and Global Chief Commercial Officer. And Joe Kelly, US General Manager. Before we begin, I'd like to remind you that this conference call will contain four linking statements that are intended to be covered from the safe harbor provided by the Private Securities Litigation Reform Act. Examples of such statement may include but are not limited to statements regarding our commercialization and continued development of Skytrolipha and Europath, the US 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, are ongoing and planned regulatory filings for expectations regarding the timing and the results of regulatory decisions, and are 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 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 forward-looking statement section in today's press release and the risk factors section of our most recent annual report on Form 20F, filed with the SEC on February 7th, 2024. Kranskon Growth Hormone, or Kranskon HGH, 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 Hormone Deficiency. Kranskon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults, and the European Commission and the United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for Kranskon PTH as a replacement therapy indicated for the treatment of adults with chronic hyperparathyroidism. Otherwise, please note that our product candidates are investigational and not approved for commercial use. 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 Jens.
Jens
Thanks, Tim. Good afternoon, everyone. With the recent U.S. approval of UR-PET as the first and the only FDA-approved treatment of hypothyroidism in adults, Ascendis has successfully obtained approval for two out of three endocrinology rare disease product candidates in two major markets, the US and EU. And with pupil cell data from our third product candidate, Transcon-CMP in Akron, Malaysia, expected in the coming weeks, We are nearing our vision to achieve approval of all three product candidates by the end of 2025. Our algorithm for product innovation, combined with our Transcon technology, have enabled us to bring new, highly differentiated product candidates through the clinical development process faster and with a higher success rate compared to traditional drug development. We attempt to continue to develop new product candidates in endocrine disease and last therapeutic areas such as oncology, obesity, metabolic disease, and cardiovascular with best-in-class potential to make a meaningful difference for patients across the globe based on our strong scientific focus. Let us begin with UROPATS. In the US alone, an estimated 70,000 to 90,000 patients are living with hypoparathyroidism. For those who haven't seen it, please take time to watch the patient-arranged FDA hearing on the hypoparathyroidism associated website, providing an in-depth understanding of the serious consequence of having this disease. With the FDA approval of UROPAD, physicians and adult patients in the United States can now look forward to having a treatment option for treatment of hypopathy. We are preparing for EURAPATH's launch in the US, leveraging our established commercial infrastructure and expertise. We are expanding our dedicated team of sales reps and field medical personnel who will engage with around 6,000 physicians who treat 80% of patients with hyperparalysis in the U.S. Other key long-term initiatives are underway, including the roll-out of our patient support programs designed to support access to UroPaths. For example, eligible patients on commercial insurance will pay as little as $5 a month for the UOPAT prescription. In addition, following our goal to take care of all patients with this disease, we will also introduce a patient assistance program. We have also started engaging US payers and PBMs. We expect product availability in the US in the first quarter of 2025 or sooner if it's possible. Consisting with premium responsible pricing, we will launch with a VAT price corresponding to $285,000 annual per patient, reflecting the value of EUROPED to the U.S. healthcare system. In the U.S., 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. Physicians will begin transplanting these patients over to commercial products as soon as it is available. In Europe, the number of patients and prescribing physicians initiating EUROPAT continues to increase, and we see a good mix of PTH experienced and new patients. This was the first full quarter of commercial loans 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. UroPath patient retention rate is extremely strong and currently around 98%. As physicians gain more experience at UiPath, we expect them to bring more patients on therapy, including those finishing the remaining supplies of NADPAR. The interest for serving patients under named patient programs prior to full commercial loans is increasing. We now have patients in these programs in more than 10 countries and expect more by the end of the year. Moving to Skytrooper. We are proud to have more than 11,000 patients prescribed Skytropha in the first three years since launch, and to have achieved market value leadership while expanding the overall growth hormone market. Key components of our strategy to make Skytropha a blockbuster product in the U.S. include simplifying broadened market assets for both treatment-naive or switched patients, as well as expanding our labels. In the first half of the year, the reset to broader market access for Skytofa was largely completed. While this broader access to Skytofa will support long-term demand, in the short term it negatively impacted our first half net revenue. Scott will share more details. With our market assets transition largely completed, Skytrofa is now positioned as a premium product with a net value per patient of around three times compared to daily growth hormone. We are now focusing on using our new market assets coverage to drive further demand, continue to expand the overall growth hormone 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 sclerotrophic label expansion. We also expect top-line data from our phase 2 trial in Turner syndrome in the fourth quarter of 2024. Switching to Transcon-CMP. I have always been extremely excited about our program in achondroplasia, and much more now as we are proposing the results from our February trial in the coming weeks. We have consistently in our messaging over the past eight years since we announced our product candidate that our aim is to develop a treatment that addresses both linear growth and the comorbidities that affect health and quality of life for people living with achondroplasia. Earlier this year, you saw a comprehensive result for our Phase 2 accomplished trial, demonstrating that our once-weekly Transcon-CMP increased analyzed growth velocity similar to Rosoratide about 5.6 cm after 12 months of treatment. In addition, for first-time error for a product in the setting of agronoplasia, We also demonstrated that compared to placebo, Transcon-CMP improved quality of life associated with the physical function of well-being in children with achondroplasia with a favorable side effect and tolerability profile. 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 aged 2 to 11 with achondroplasia. The mean age was 5.7 years, similar to our phase 2 trial. We also continued to enroll in COATS, a phase 2 trial of Transcon-CMP in combination with Transcon-Globetamol-Skytofe. The scientists show that adding scartofa to Transcon CMP could provide cash-up growth for patients who start CMP treatment late. We expect to complete enrollment in this combination trial during the first fourth 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 best-in-class potential of our two product candidates, Transcon IL-2 Beta Gamma and Transcon TLR78 Agonist, in different combination scenarios. We plan to present initial result from our Transcon IL-2 beta gamma in combination with chemotherapy in plasma resistant ovarian cancer from the IL-BELIEVE trial later this month at the ESMO conference in Barcelona. I'm pleased how these programs are progressing. In closing, for a sentence, it's all about the patients. Patients tell us the US approval of UOPAT is transformative for them. We hear from parents that Skytrover 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 with achondroplasia. With our ongoing progress in our oncology program, and exploration of other areas of innovation in large market opportunities such as obesity. We continue to position incentives for sustainable growth with an expanded pipeline and transformative TransCon product candidates. I will now turn it over to Scott for a financial update.
achondroplasia
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 recorded 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 Skytropha 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. Skytrofa revenue for the first half of 2024 totaled €91.2 million, a 35% year-over-year increase 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. We estimate that by the end of Q2 2024, scitrophic 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 and market expansion. Based on year-to-date results and current trends, we now expect full-year 2024 Skytropha revenue to be in the range of €220 million to €240 million. Shifting to Transcon PTH, second quarter YorvaPath 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 Yorvapath 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 totaled 83.5 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 spinoff. 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. 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. 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, cash equivalents, and marketable securities totaling 259 million Euro compared to 399 million Euro as of December 31, 2023. Finally, earlier today and 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 in exchange for a 3% royalty on net sales of Yorvapath 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 Skytropha revenue to be in the range of 220 to 240 million euro. Total operating expenses, which include SG&A and R&D, to be approximately €600 million, including YorvaPath-related launch activities in the U.S. And pending launch timing of YorvaPath in the U.S., we currently expect to achieve operating cash flow 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 lock 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.
Operator
Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 11 on your telephone and then wait to hear your name announced. To withdraw your question, please press star 11 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 Fire with JP Morgan. Your line is open.
spk17
Hey, guys. Good afternoon. Thanks for taking my question. I want to better understand how you project getting Skytropa to a blockbuster in the U.S. 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.
Jens
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 is 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 basically 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. 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 assets, we really see Skytrofa 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 pediatric growth hormone deficiency market, In these next weeks, we are filing for adult growth hormone deficiency. We have Turner data 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 basically can get to the full cohort for all the different growth hormone indications. That gives you the high level how we see we can develop Skytrover to a blockbuster in the US. And with the reset of what we call the market asset, we can keep that value as we have today and expand from there. I do not know, Joe or Camilla, you have further comments, or Jess, you have and want to get more in-depth knowledge about specific commerce from my site.
Joe
Thanks.
Operator
Thank you. Please stand by for our next question. Our next question comes from the line of Tezeem Ahmed with Bank of America Securities. Your line is open.
Tezeem Ahmed
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 relatively recent launch of the Novo competing product? Thanks.
Jens
Thanks for the question. I think it's in line with some of the same questions that got asked as the first question. Yes, today there are two other long-acting products in the U.S. market. We basically see one of them in Gentler because of the obvious effect everyone can observe just going to the databases that describe toolability and other things like that. we see we are always doing extremely well. In general, we see the same thing with Zagora. Zagora has 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 SkyTrover had a best-in-class potential. 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 coming into best situation when we also get them for example you should also look on what happening with for example the largest volume supplier of growth hormone in the second quarter. The basic have been 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.
Zagora
Thank you. Please stand by for our next question.
Operator
Our next question comes from the line of Derek Archila with Wells Fargo. Your line is open.
spk03
Hi there. Thanks for taking the questions. Just wanted to know what payer feedback you might have received thus far on the proposed URB pricing in the US. And then I have a follow up.
Jens
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 hyperparathyroidism, we aim to support that that can be treated. In that entire mathematic algorithm, how 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.
spk03
Got it. Very helpful. And then a second question, just in terms of the patients that you've talked about on your VPath 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.
Jens
I can come with some initial comments and And you can get some further comments from Camilla. Our initial aim and how we looked at how we expected the penetration profile would be that we will see typical one to two patient per physician in the beginning. There was what we expected to see. Before each single physician really see the benefit of really what UroPath 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 and more patients 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 prescribers have really prescribed it. We are extremely proud about this penetration to physicians. But I think what is really the most impressive thing for me in these lungs is basic retention. When you think about rehab and retention, when you start to take patients in and really test them, 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 really describes the benefit that is really given to the patient and the state of the treatment exactly as we have observed in our clinical trials. I do not know, Camille, you have further comments to the norms specific in Germany and Austria?
spk09
Yeah, I think you said it very, very well. We are very pleased with the uptake of the YorviPath in Germany. We are benchmarking other rare disease launches, and we are 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 PTH that you patients and the ones that have been on NETPAR. And the switch that we are making from NETPAR to YorviPath is going very, very fast. So all in all, we're very pleased with how it's going and where it will go in the future.
Jens
Yes. What we have seen in different European countries that the net power, basically because of its stop of manufacturing, there is a tendency to keep the patient on that power 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 DASHA taken up from the NAVPOWER patients 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 2025, we will have the next six, seven, eight european countries being added in really are rolling out in the way we are generate revenue from this region in a much faster speed thank you please stand by for our next question our next question comes from the line of lee what's it with cancer your line is open
Skytrofa
Hey, guys. Thanks for taking my questions. Maybe just a follow-up on Sky Trofa. Maybe help us understand what went into the assumptions for the lower guidance for Sky Trofa this year. Just looking for more details on what's driving that 100 million euro reduction. Maybe talk a little bit about the dynamics between broader market access and pricing, and I have a follow-up.
Jens
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 basically giving the lower value. And after we now have reset our market assess portfolio, we are in a position that we 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 materialized, but we also know that it could not materialize. So this is how we have basically taken 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 effects that are getting implemented now that first will provide effect in the second half of this year.
Joe
the healthcare providers right now have extreme clarity about where they can provide Skytropa to patients with a high chance of reimbursement, but also where Skytropa 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 growth 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 and grow the value of the entire growth hormone marketplace.
Skytrofa
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 still break even this year, given the lower schedule for guidance?
Jens
You know, Scott is really good at numbers. So I will some way give you an all 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. Europass, different regions are really starting to take in now. So potentially, we have a Europass outside US. in a situation where we are still discussing with FDA related to how we can really help a patient that is in a shortage of a 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 much faster launch 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're looking about how we can strengthen our revenue, how we're basically still keeping our expenses in control, and this is how we are operating. Scott, comments?
achondroplasia
I think you've said it well, Yen. Lately, 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 U.S. 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. Thank you. Please stand by for our next question. Our next question comes from the line of Gavin Clark-Gartner with Evercore ISI. Your line is open.
Gavin Clark - Gartner
Hey, guys. Thanks for taking the questions. First, I just wanted to ask, for Skytropha, When do these policies with more favorable access go into place and when should we expect a pickup in prescriptions?
Jens
I think it was gradual during 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 double digit number 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 the second half. So I will first see the expected growth coming in in the second half.
Gavin Clark - Gartner
OK, that makes sense. And I just wanted to ask on IQVIA data overall, have you guys noticed any changes in capture rate trends over time?
Jens
I think the issue I personally have with the data is that it's a sampling 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 totally unpredictable out from the perspective at 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. but 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. OK, thanks.
Operator
Thank you. Please stand by for our next question. Our next question comes from the line of Big Ram Purohit with Morgan Stanley. Your line is open.
spk05
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 which parameters of data you expect to report out and how you would currently guide people to compare and contrast the datasets versus competitor CNP datasets available in the space.
Jens
Thank you. I think the most easiest way to compare anything is to go through vosorotide because this is two, you can say, mode of action that is very much aligned between them, even if there is a difference in how we function because we have a continuous exposure of CMP molecule where from the vosorotide, The basic is only have an active coverage 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 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 ozorotide with a once weekly dosing profile. But we have seen the improvement in many of the ways that the children, the physician, the caregivers talk about the benefit to the patient. And from that perspective, we also can show when we compare our phase two data directed to placebo and improvement in quality of life related to physical function. And this is why we basically are taking into our trial different measuring on key secondary endpoint that basically hope 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. They're coming in the next week. So it's pretty, pretty, pretty near. So the database has been locked. People are running the stat now. So as soon as they're finished, I will be taken into a room and see the data.
spk01
Got it, thank you.
Operator
Thank you. Please stand by for our next question. Our next question comes from the line of Kelly Shah with Jefferies. Your line is open.
Kelly Shah
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 4Q or first quarter of next year at the moment.
Jens
We have an extremely constructive dialogue with FDA related to how potential to address the shortage of PTH drops in the US. driven by patients that basically are seeing the huge unmet medical need, the situation where patients have been missing that power for a long time, and extremely serious consequences of patients that now, today, are on that power and suddenly need to be disrupted. of the treatment because that 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 will be.
Operator
Thanks. Thank you. Please stand by for our next question. Our next question comes from the line of David Leibowitz with Citi. Your line is open.
David Leibowitz
Thank you for taking my question. I got two here. First, on the SkyTropa adjustments, just to make sure I got this right, you came to an agreement on new net pricing with the payers and
Jens
part of it you had to true up prior sales and in the last couple quarters and then I'll have one more after that I think you have understood it correct this is a true out up that is basic are reflecting net revenue from a mainly net revenue from Q1, but about 7.6 million also from Q23. 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 here. Any comments? Or did I get it right?
achondroplasia
You got it right, Jan.
Jens
Good.
David Leibowitz
I got it. And on CNP, what has occurred to actually essentially accelerate the pivotal data timeline from prior updates?
Jens
I have to say how fast physicians, the setup of our clinical operation has been functioning in this case, have brought the data to come in much, much faster than we ever thought. I believe there is such a dedication that I only can compare to what we have seen for both PTH and Skytrover to get this product out as fast as possible. We also see 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 dedication to get it out to the patients as fast as possible.
David Leibowitz
Got it. Thank you.
Operator
Thank you. Please stand by for our next question. Our next question comes from the line of Alex Thompson with CIFL. Your line is open.
Alex Thompson
Hey, great. Thanks for taking my question. I guess, you know, again, on sort of the Yoruba path 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.
Jens
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. It's not really on anything of the data. It's mainly how fast can we supply, how much material do we have, and other things like that. So we can ensure that when we start with basic iron opposition, we really can manage this entire demand that we expect to come.
Zagora
Thank you. Please stand by for our next question.
Operator
Our 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. To revisit Skytropha, can you maybe comment on what percentage of your payer contracts were affected by this by the TRUOP 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 breakeven either this year or next year. Thank you very much.
Jens
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 through Q1 and Q2. we are now in a position that we have reset it this is why scott used the great work reset we have reset our coverage in the us and out from that perspective the ggn we expect to see in the second half will be aligned to what we saw in the first half and We expect the same GTN in 25, 26, 27, 28, 29, and 30. I can only come with five years' guidance.
Zagora
Thank you.
Operator
Our last question will come from the line of Yaron Weber from TD Cohen. Your line is open.
Yaron Weber
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 the 71 and a half million that you sort of did in the first half for Skytropha on a net basis? Or is that including the 91 million, you know, assuming you did 65 million in Q1? And then secondly, Jan, you said you did 53 million in Q2. Is that a good run rate to then start into Q3? And four, should we really think of the 26 million this quarter as a good run rate into the second half? Thank you.
Jens
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 our numbers. And I see that the real number is basic the reported net sales plus the true out that the basic provided to you. So you take the number that we have in our Q2 sales and then basic at everything what we took in throughout, both from 23 and what we did in Q1. There you will get a basic and net sales of what we had in the 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 calculate it right. That, I think, is the real number for Q2. If I do my calculation, it's 53.4 or something like that, to be concrete. So we see, without doubt, a really good pickup from Q1 to Q2. And when you go back and look on the seasonal variance that pertains to the cup, we will see an improved pickup in Q3 and Q4. And when we did the forecasting, we basically took a conservative approach in 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 answered most questions related to your mathematic algorithm related to the numbers. Scott, you have anything to add?
achondroplasia
Yeah, just one thing, Jaron. 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.
Zagora
Thank you.
Operator
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.
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