Q4 2023 Ascendis Pharma A/S Earnings Call
Operator: Good day, and thank you for standing by. Welcome to the fourth quarter of 2023 Ascendis Pharma earnings conference call. At this time, all participants are in a listen-only mode.
Okay.
[laughter].
Speaker Change: Good day, and thank you ever standing by and welcome to the fourth quarter of 2023, Sandoz Pharma 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 a question. During this session. We need to press star one on your telephone you didn't hear an automated message advising your hands raised.
Operator: 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 1-1 on your telephone. You will then hear an automated message advising that your hand is raised.
Operator: To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Tim Lee, Senior Director of Investment Relations. Please go ahead.
Speaker Change: So I would draw your question. Please press star one again, please be advised that today's conference is being recorded I would now like.
Speaker Change: I'll hand, the conference over to your first speaker today, Jim Lee Senior Director of Investor Relations. Please go ahead.
Timothy Lee: Thank you, Operator, and thank you, everyone, for joining our full year 2023 Financial Results Conference call. I'm Tim Lee, the Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today are Yen Mickelson, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Dr. Steena Singhal, Executive Vice President, Head of Clinical Development Oncology; and Joe Kelly, Senior Vice President, Head of U.S. Commercial Endocrinology. Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the safe harbor provided by the Private Securities Litigation Reform Act.
Speaker Change: Thank you operator, and thank you everyone for joining our full year 2023 financial results Conference call I'm, Kimberly Senior director of Investor Relations at the center format.
Jim Lee: Joining me on the call today are yen Mickelson, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Stena single Exec.
Jim Lee: Executive Vice President and head of clinical development oncology and Joe Kelly Senior Vice President head of U S commercial endocrinology.
Jim 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 under the safe Harbor provided by the private Securities Litigation Reform Act. Examples of such statements May include but are not limited to statements regarding our commercialization and continued development of Skype for the U S and European markets.
Timothy Lee: Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SkyTrova for the U.S. and European markets, as well as certain financial expectations for 2024, our commercialization and development of YoverPath in the EU, and expected timing of the FDA review and potential launch of Transcon PTH in the U.S., as well as our pipeline candidates and our expectations with respect to their continued progress and potential Our strategic plan Our goals regarding our clinical pipeline, including the timing of clinical results, our ongoing and planned regulatory filings, and our expectations regarding the timing and the results of regulatory decisions, our ability to create value in multiple therapeutic areas outside of endocrinology rare diseases, our progress towards Vision 2030, and the potential success of Iconis. 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 you should not place undue reliance on these statements.
Jim Lee: As well as certain financial expectations for 2024, our commercialization and development of your path and in the EU and expected timing of the FDA review the potential launch of Transcon PTH in the U S.
Jim Lee: Our pipeline candidates and our expectations with respect to their continued progress and potential commercialization.
Jim Lee: Our strategic plans.
Jim Lee: Our goals regarding our clinical pipeline, including the timing of clinical clinical results are ongoing and planned regulatory filings our expectations regarding the timing and the result of red card decisions, our ability to create value in multiple therapeutic areas outside of endocrinology rare disease, our progress towards vision 2030, and the potential success of <unk>.
Jim Lee: <unk>.
These statements are based on information that is available to us as of today actual results may differ could differ materially from those in our forward looking statements and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change expect except as required by law for additional information.
Timothy Lee: 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 20-F filed with the SEC later today, February 7, 2024. Transcon Growth Hormone, or Transcon 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. The European Commission has granted marketing authorization for TRANSCOMP-PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Otherwise, please note that our product candidates are investigational and not approved for commercial use. As such, the safety and effectiveness of our product candidates have not been reviewed or approved by any regulatory agency.
Jim Lee: The factors that could cause actual results to differ materially. Please see our forward looking statements section in today's press release and the risk factors section of our most recent annual report on form 20-F filed with the SEC later today February seven 2024.
Jim Lee: Congrats on growth hormone or kraft's got Hgh is approved in the U S by FDA and the EU has received a authorization from the European Commission for the treatment of pediatric growth hormone deficiency.
Jim Lee: The European Commission has granted marketing authorization for Transcon PTH as a replacement therapy indicated for the treatment of adult chronic hyperparathyroidism otherwise. Please note that our product candidates, our investigational and not approved for commercial use as investigational products the safety and effectiveness of the product candidates have not been reviewed.
Jim Lee: Approved by any regulatory agency none the statements. During this conference call regarding our product candidates shall be viewed as promotional.
Yan Mickelson: None of the statements during this conference call regarding our product candidates should be viewed as promotional. On the call today, we'll discuss our full year 2023 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, I turn it over to Yan. Thank you. Good afternoon, everyone. 2023 was a transformative year for Ascendis Pharma. We streamlined the company, including our structure, our processes, and our operating expense allocation.
Speaker Change: On the call today, we will discuss our full year 2023 financial results and will provide further business updates. Following some prepared remarks, we'll then open up the call for questions with that let me turn it over yet.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Good afternoon, everyone 2023 wells that transformative to UFO S&P's farmer.
Speaker Change: We streamlined the company, including our structure, our processes and operating expense allocation.
Speaker Change: And at the same time.
Speaker Change: We believe we are on track to achieve our recent guidance.
Yan Mickelson: And at the same time, we believe we are on track to achieve our recent 3x3 by 2025. Skytrova is the leading growth hormone product and value in the US. The launch of Europaths in Europe Direct and International Markets is underway, beginning with Germany and Austria.
Speaker Change: By <unk> 25.
Speaker Change: Okay.
Speaker Change: They are leading glaucoma product and value in the U S.
Speaker Change: The launch of your packs in Europe direct and international margins.
Speaker Change: Underway, beginning with Germany and Austria.
Yan Mickelson: And our clinical program for Transcon CMP is progressing to what people will data expect in Q4. We believe Ascendis is advancing to become a leading biopharma company with a strong focus on endocrinology rare diseases and capabilities to also create value in other therapeutic areas as we are doing in oncology, ophthalmology, and metabolic disease because of the decisions we took in 2023. We believe Ascendis will be a leaner, more efficient organization in 2024, well positioned to fulfill Vision 2030 with three independent endocrinology rare disease blockbuster products and expand our engine for future innovation. Now, let me provide an update on each program. From the beginning, we designed Skytova to be a best-in-class growth hormone product by releasing unmodified somatopoietin and addressing the needs of patients, caregivers, physicians, and payers.
Speaker Change: In our clinical program for Transcon CMP is progressing to both people with data expected in Q4.
Speaker Change: We believe this.
Speaker Change: Is eventually to become a leading Biopharma company with a strong focus on endocrinology rare diseases and capabilities to also create value in other temporary error has to be doing in oncology ophthalmology and bitter body diseases.
Speaker Change: Because of the decisions we took in 2023.
Speaker Change: We believe <unk>.
Speaker Change: As a leaner more efficient organization in 2024.
Speaker Change: Persistent to fulfill vision 2030 with three independent endocrinology.
Speaker Change: These blockbuster products and expand our engine for future innovation.
Speaker Change: Now, let me provide an update on <unk> programs.
Speaker Change: Programs.
Speaker Change: From the beginning we designed Scott over to be best in class procurement product.
Speaker Change: What are you seeing on modified somewhat choppy.
Speaker Change: By addressing the needs of the patients caregivers physicians and payers.
Yan Mickelson: Skytova achieved U.S. market leadership in 2020, just two years after launch. We estimated that sciatopa penetration in the U.S. pediatric growth hormone deficiency patient population was around 16% at the end of 2020. With Skytrofer expanding the U.S. growth market to the potential of 3 billion U.S. dollars, we believe Skytrofer has the potential to be a blockbuster on U.S.
Speaker Change: <unk> achieved U S market leadership in 2023, just two years after launch.
We estimated that sky turbo penetration in the U S.
Speaker Change: Guatemala deficiency patient population was around 16% at the end of.
Speaker Change: <unk> 2003.
Speaker Change: With Scott <unk>, expanding the U S glaucoma market to the potential of $3 billion, we believe Scott sofa.
Speaker Change: The potential to be a blockbuster on U S revenue.
Yan Mickelson: Built on this value leadership, we expect our first label expansion to be adult growth hormone deficiency, for which we plan to submit and supplement BLA to the FDA in the second quarter of this year. In addition, we expect top-line data from our Phase II trial in Turner Syndrome in the fourth quarter of 2024. Now turning to try to compete, last week, we initiated the launch of Transcon PTH in Europe's direct and international market.
Speaker Change: This value leadership, we expect our first label expansion to be adult growth hormone deficiency.
Speaker Change: We plan to submit a supplement BLA to the FDA in the second quarter of this year.
Speaker Change: In addition, we expect topline data from our phase II trial from Turner syndrome in the fourth quarter of 2024.
Speaker Change: Now turning to try to compete against.
Speaker Change: Last week we.
We initiated the launch of Transcon PTH in Europe, direct and international market.
Yan Mickelson: Margaret, like you all, you'll be paying, with full commercial availability in Germany and Austria at an initial list price of €105,000 per patient per year. An estimated 70,000 adult patients in Germany are living with chronic hyperparathyroidism, and our initial launch will target 22,000 of them. Europat Europe Direct is off to a great start, with our first prescriptions and orders perceived on the first day of launch, demonstrating the serenity of the deceased and their unmet medical needs. We are continuing to expand our EU Direct infrastructure and expect availability of Europat across Europe by the end of 2025. In parallel, to meet the needs of the patient, we plan to provide commercial reimbursed products to early access routes such as named patient programs. The U.S. PDUFA date for transcon PTAs is May 14. If approved, we plan to launch our Europass as quickly as possible thereafter on our established U.S. commercial infrastructure. Moving now to Transconcealed.
Speaker Change: Margaret Suo Dolby packs with full commercial.
Speaker Change: <unk> in Germany, and Austria.
Speaker Change: Alicia this price.
Speaker Change: 105000 euros per patient per year.
Speaker Change: An estimated 7000 adult patient in Germany are living with chronic hyperparathyroidism and our initial launch will target 22000 of those.
Europe Europe direct loan is off to a great start with our first prescription and orders proceed at the first day of locks.
Demonstrating the CNS of the disease and the unmet medical need.
Speaker Change: We are continuing to a space.
Speaker Change: Terrific infrastructure and expect a ability of Europe across Europe by the end of 2025.
Speaker Change: In parallel to meet the needs of the patients we plan to provide commercial ramp gross product too early exit routes sauce at main.
Speaker Change: Patient programs.
Speaker Change: The U S. <unk> date for <unk> is may 14.
Speaker Change: If approved we plan to launch our Europe.
Speaker Change: Quickly as possible thereafter to our status U S commercial infrastructure.
Speaker Change: Moving now to Transcon CMT.
Yan Mickelson: Our Clinic World Programme is designed to support approval of transcon CMP as a treatment for patients of all ages with acondoplasia. Transcon CMP dose at 100 micrograms per kilo per week has demonstrated superiority compared to placebo in two 52-week trials. In the open-label extension, we observed unexpected strong patient retention of 97% for now up to four years. As a result of this unexpected finding, we continue to review our own data and scientific literature. We now believe that acondoplasia is both a growth disorder and a muscle disorder.
Speaker Change: Our clinical.
Speaker Change: Program is designed to support approval of Transcon CMP as a treatment for patients of all.
Speaker Change: <unk> agents with our compensation.
Transcon CMP dose at product Michael Graham.
Speaker Change: Per week has demonstrated superiority compared to placebo in 252 week trials.
Speaker Change: In the open label extension re ups.
Speaker Change: Expected strong patient retention of 97% for now up to four years.
Speaker Change: As a result of this unexpected findings, we continue to view our own data and scientific literature.
Speaker Change: We believe now that <unk> is both a growth disorder and a muscle disorder.
Yan Mickelson: As presented at the J.P. Morgan Conference in January, we showed significant improvement in health and quality of life for children with achondroplasia treated with transcon CMP compared to placebo. With this growing insight, we have designed our Pivotal Approach trial to evaluate meaningful benefits related to all aspects of air contemplation, including linear growth and improvements in comorbidity as measured by radiological endpoints, physical function, body composition, and quality of We expect to share top-line data from this trial, and we plan to submit an NDA in the fourth quarter of this year.
Speaker Change: As presented at the Jpmorgan Conference in January we showed significant improvement in health and quality of life for children with achondroplasia treated with transcon CMP compare to placebo.
Speaker Change: With this growing insight we have designed our people approach.
Speaker Change: To emulate meaningful benefits related to or aspect of contemplation.
Speaker Change: Including linear growth and improvements in Cuba, PTC as Smiths us by radiological endpoints through cycle function body composition and quality of life.
Speaker Change: We expect to share top line data from this trial and we plan to submit an NDA in the fourth quarter of this year.
Speaker Change: In addition.
Yan Mickelson: We are pursuing additional treatment opportunities at Contraplasia. Infant tried, age 0-2 years; first patient had already been enrolled. Combination Trial with Skytropha H2-11, Week 26, Top Line, Analyzed Scope Velocity in the 4th Quarter of 2024, an adult planning to file an IMD or similar in the third quarter of this year. Switching now to Oncology. Both Transcon IL-2 Beta Gamma and Transcon Theta-78 Agonist have shown favorable safety profiles and single-agent clinical activities.
Speaker Change: We are pursuing additional treatment opportunities and echoed the queso.
Speaker Change: Try it eight zero to two year first patient already had been enrolled combination trials with Skype sofa eight to 11 two.
Speaker Change: Sick topline annualized scope velocity in the fourth quarter of 2024.
Speaker Change: Adult planned to file an RMT or similar in the third quarter of this year.
Speaker Change: Switching now to oncology.
Speaker Change: Both transcon Iot Peter comment and Transcon tiered up 78 equities have shown favorable safety profiles and sing.
Speaker Change: <unk> clinical.
Speaker Change: Clinical activity.
Yan Mickelson: We expect 2024 to be an extremely important year for our oncology pipeline, with data readout in a well-defined patient population in the fourth quarter. Also, in the fourth quarter, we expect to have completed enrollment of our randomized phase 2 trial in neuroadjuvant head and neck cancer. Longer term, to maximize the potential reach and value of these oncology product candidates, we aspire to commercialize our oncology assets through partnership with companies with specialized oncology experience and capability in late-stage development and commercialization. Moving now to Optimology, we recently announced the formation and launch of an independent company, Iconic, to develop uncommercialized transcon ophthalmology products globally. We have received an equity position in the new company, and we are electable to receive development, regulatory, and sales milestone plus single-digit royalty...
We expect 2024 to be in.
Speaker Change: Can be important year for oncology pipeline with data readout embed defined patient population.
Speaker Change: Fourth quarter.
Speaker Change: Also in the fourth quarter, we expect to have completed enrollment of our randomized phase II trials, and new adjuvant head and neck cancer.
Speaker Change: Longer term.
Speaker Change: To maximize this potential and value of these oncology product candidate <unk> to.
Speaker Change: Commercialized our oncology assets through partnerships with companies with specialized oncology experience and capability in database development and commercialization.
Speaker Change: Yes.
Speaker Change: Moving now to Ophthalmology, where you recently announced the formation of an independent company Iconix to develop and commercialize transcon ophthalmology products globally.
Speaker Change: We have received an equity position in the newly formed company and electrical to receive development regulatory and sales milestones plus significant royalties.
Scott Smith: In January, we introduced Vision 2030, our strategic roadmap to achieve blockbuster status for each of our three endocrinology rare disease products and expand our engine for future innovation. With the broad applicability of the Transcon technology platform, our goal, as laid out in Vision 2030, is to apply our algorithms for product innovation to establish opportunities in greater than 5 billion US dollars, as we did with the anti-BGF, anti-pneumonia class, where we believe we have designed the best in class programs. We are pleased with the interest in our once-monthly GPL-One program, and from our platform technologies, we expect to continue I will now turn the call over to Scott for a financial review before we open it up for questions. Talk again.
Speaker Change: Yes.
Speaker Change: In January we introduced recently 2030.
Speaker Change: Our strategic roadmap to achieve blockbuster status for each of our three eight locality rare disease products and expand our engine for future innovation.
Speaker Change: With the broad applicability of the Transcon technology platform. Our go that's laid out can be seen in 2013 is to apply our echo rhythm for product innovation.
Speaker Change: Is that these opportunities in greater than 5 billion U S dollar syndication.
Speaker Change: Estimated with anti VEGF and deep airborne classes.
Speaker Change: Where we believe we have decided that best in class programs.
Speaker Change: We are pleased with the interest and a once monthly <unk> one program and from our platform technologies, we expect to continue to generate.
Speaker Change: Many more opportunities in the future.
Speaker Change: I will now turn the call over to Scott for a financial review before we open for questions.
Scott Smith: Hi, Ken.
Scott Smith: We continue making significant progress toward our financial goal of becoming operating cash flow breakeven on a quarterly basis by the end of 2024. I will touch on some key points surrounding our financial results, but for further details, please refer to our Form 20-F filed today. As we previously announced in early January, Skytrofa revenue for the fourth quarter of 2023 was 64.2 million euros, compared to 47 million euros reported in the third quarter and 17.1 million euros reported in the same period last year.
Scott Smith: Okay.
Scott Smith: We continue making significant progress toward our financial goal of becoming operating cash flow breakeven on a quarterly basis by the end of 2024.
Scott Smith: I will touch on some key points surrounding our financial results, but for further details. Please refer to our form 20-F filed today.
Scott Smith: As we previously announced in early January Sky trough of revenue for the fourth quarter of 2023 was $64 2 million euro compared to $47 million Euro reported in the third quarter and $17 1 million reported in the same period last year.
Scott Smith: 37% sequential growth in Skytropha revenue from Q3 to Q4 was again driven primarily by strong underlying demand in the U.S. Total revenue for the fourth quarter was €137.7 million, including the one-time $70 million Tazeen upfront payment, recognized as €63.7 million of licensed revenue. Turning to expenses, R&D costs in the quarter totaled €90.9 million, down 18% sequentially from the third quarter of 2023, primarily driven by lower endocrinology rare disease-related costs as trials and development complete, and lower oncology-related costs. SG&A expenses were essentially flat at 64 million euros compared to the third quarter of 2023, reflecting commercialization synergies and expense controls. Total operating expenses were €155 million for the fourth quarter, down 12% sequentially from the third quarter.
Scott Smith: 37% sequential growth in Sky trough of revenue from Q3 to Q4 was again driven primarily by strong underlying demand in the U S.
Scott Smith: Total revenue for the fourth quarter was $137 7 million euro, including the onetime $70 million taken upfront payment recognized at $63 7 million Euro of license revenue.
Scott Smith: Turning to expenses R&D costs in the quarter totaled $99 million Euro down 18% sequentially from the third quarter of 2023, primarily driven by lower endocrinology rare disease related costs as trials and development complete and lower oncology relay.
Scott Smith: Good costs.
Scott Smith: SG&A expenses were essentially flat at $64 million euro compared to the third quarter of 2023 <unk>.
Scott Smith: Reflecting commercialization synergies and expense controls.
Scott Smith: Total operating expenses were $155 million euro for the fourth quarter down 12% sequentially from the third quarter.
Scott Smith: Overall, our operating loss for the fourth quarter declined sequentially by 73% to €37 million from €134 million in the third quarter of 2023. We ended the fourth quarter with cash, cash equivalents, and marketable securities totaling €399 million. Last month, we announced the formation and launch, together with an investor syndicate of Iconis, to develop, manufacture, and commercialize Transcon ophthalmology assets globally. As a result, we expect minimal, if any, P&L burden from ophthalmology in 2024. As a reference point, for Q4 2023, external ophthalmology project costs totaled €6.4 million, which was previously announced for the full year 2024 based on current plans. We expect Skytrofa revenue to be in the range of 320 to 340 million euros at average exchange rates in 2023.
Scott Smith: Overall, our operating loss for the fourth quarter declined sequentially by 73% to $37 million Euro from 134 million Euro in the third quarter of 2023.
Scott Smith: We ended the fourth quarter with cash cash equivalence and marketable securities totaling $399 million Euro.
Scott Smith: Okay.
Last month, we announced the formation launch together with an investor syndicate of icon us to develop manufacture and commercialize transcon ophthalmology assets globally.
Scott Smith: As a result, we expect minimal if any P&L burden from ophthalmology in 2024.
Scott Smith: As a reference point for Q4, 2023 external ophthalmology project costs totaled $6 4 million euros.
Scott Smith: As previously announced for the full year 2024 based on current plans.
Scott Smith: We expect Sky <unk> revenue to be in the range of $320 million to $340 million Euro at average 2023 exchange rates.
Scott Smith: Total operating expenses, SG&A, and R&D, together will be approximately 600 million euros, and we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024. Let me now also provide a review of selected key program milestones. For TransCon Growth Hormone, we plan to submit an SBLA to FDA for adult growth hormone deficiency in the second quarter of 2024, and we expect to report top-line results from our Phase 2 Turner Syndrome trial in the fourth quarter of 2024. For Transcon PTH, in the U.S., our PDUFA date is May 14, 2024.
Scott Smith: Yes.
Scott Smith: Total operating expenses SG&A and R&D.
Scott Smith: Together to be approximately 600 million euro.
Scott Smith: And we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024.
Scott Smith: Let me now also provide a review of selected key program milestones.
Scott Smith: For Transcon growth hormone, we plan to submit an SPL law to FDA for adult growth hormone deficiency in the second quarter of 2024.
Scott Smith: And we expect to report topline results from our Phase II Turner syndrome trial in the fourth quarter of 2024.
Scott Smith: For Transcon PTH in the U S. Our <unk> date is May 14 2024.
Scott Smith: If approved we plan to launch it as yorba path as quickly as possible thereafter.
Scott Smith: If approved, we plan to launch it as Yorvapath as quickly as possible thereafter. Outside the U.S., we initiated the launch last month of Transcon PTH, marketed as Yorvapath, with full commercial availability in Germany and Austria. We plan to roll out Yorvapath in our Europe Direct and international markets segments throughout 2024 and 2025.
Scott Smith: Outside the U S. We initiated the launch last month of Transcon PTH marketed as yoga path with full commercial availability in Germany and Austria.
Scott Smith: We plan to rollout yoga path in our Europe direct and international markets segments throughout 2024 and 2025.
Scott Smith: For Transcon CMP, our clinical program evaluating transcon <unk> as a treatment for contemplation advances with top line results from the pivotal approach trial and an expected NDA submission for the treatment of children with achondroplasia.
Scott Smith: For Transcon C&P, our clinical program evaluating Transcon C&P as a treatment for achondroplasia advances with top-line results from the pivotal approach trial and an expected NDA submission for the treatment of children with achondroplasia, both in the fourth quarter of 2024. In addition, during the fourth quarter of 2024, we expect to report Week 26 top-line data from the COACHE trial in combination with transcon growth hormones and submit an IND or similar for adults with achondroplasia. Within our oncology therapeutic area, we plan to provide a clinical update from indication-specific dose expansion cohorts in the I'll Believe and Transcend IT trials during the fourth quarter. In addition, we expect to complete enrollment in our randomized phase 2 trial in neoadjuvant head and neck cancer.
Scott Smith: In the fourth quarter of 2024.
Scott Smith: In addition, during the fourth quarter of 2024, we expect to report week 26 top line data from the coach trial in combination with transcon growth hormone.
Scott Smith: And submit an IND or similar for adults with a contemplation.
Scott Smith: Then our oncology therapeutic area, we plan to provide a clinical update from indication specific dose expansion cohorts in.
Scott Smith: And the I believe and transplant.
Scott Smith: Trials during the fourth quarter.
Scott Smith: In addition, we expect to complete enrollment of our randomized phase II trial in Neo adjuvant head and neck cancer.
Speaker Change: With that operator, we are now ready to take questions.
Thank you and at this time, we will conduct a question and answer session.
Speaker Change: Reminder, to ask a question you will need to press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.
Speaker Change: Please limit yourself to one question one follow up please.
Operator: With that, operator, we are now ready to take questions. Thank you, and at this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for a name to be announced to withdraw your question. Please press star 11 again.
Please stand by with some part of the Q&A roster.
Speaker Change: One moment for your first question.
Speaker Change: Okay.
Speaker Change: Our first question comes from the line of Jessica Fye from Jpmorgan. Your line is open.
Jessica Fye: Hey, guys. Good afternoon, thanks for taking my questions.
Jessica Fye: I realize it's early days, but what can you share with us about the German PTH launch so far and the second one is are you seeing any external interest in your transcon <unk> program and can you remind us what the target profile, you're looking to achieve is with that program. Thank you.
Jessica Fye: Please limit yourself to one question and one follow-up. Please sign by. We comply with the Q&A roster. One moment, one moment for our first question. Our first question will come from the line of Jessica Fye from J.P. Morgan. Your line is open.
Speaker Change: Thanks, Yes, hey gas.
Speaker Change: Before this is a one week into a launch.
Speaker Change: Sure.
Speaker Change: We knew that.
Speaker Change: Maybe can meet is therefore the patients we know how we really are providing a treatment that really are providing meaningful meaningful differentiation for the patients. Both on short term and really also.
Yan Mickelson: Hey guys, good afternoon. Thanks for taking my questions. I realize it's early days, but what can you share with us about the German PTH launch so far? And the second one is, are you seeing any external interest in your Transcom GLP-1 program? And can you remind us what the target profile you're looking to achieve is with that program?
Speaker Change: Helping in eliminating pulls on to risk of the disease and what we observed was that exactly as what we had hoped for that position.
Speaker Change: The day one of the loans.
The prescription got the material from our.
Speaker Change: Distribute already the first day.
Yan Mickelson: Thank you. Thanks, yes. Yes, as I said before, this is one week into a launch, we know the unmet medical need is there for the patients. We know how we really are providing a treatment that really is providing a meaningful differentiation for the patient, both in the short term and really also helping in eliminating the long-term risk of the disease. And what we observed was that exactly as we had hoped for, the position, day one of the long process of making the prescription, got In the U.S., you need to go through a prescription and reimbursement process and then be able to get the drug. In Germany, it's different.
Speaker Change: Sure.
Speaker Change: U S. You need to go to a prescription and reimbursement and then to begin to get the drug in Germany is different.
Speaker Change: It merely youll get a prescription you basically have access to be get the drop immediately at that time, so the lungs.
We really look forward to provide must better update when we come to Q1 much better after Q2 and mobile spit again. After Q3. So if you really really feeling that they launched in Germany and Australia. This is a starting point.
Speaker Change: Basic being positioned to be anywhere on the globe, where those patients and we reached an all of the cases.
Yan Mickelson: And immediately you get a prescription, you basically have access to be, get the drop immediately at that time. So, the long... We really look forward to providing a much better update when we come to Q1, much better after Q2, and much, much better again after Q3. So we're really, really feeling that the launch in Germany and Austria is the starting point for basically being everywhere on the globe where there are patients, and we will reach all the patients, related to how we use licensing of a transcontinuity technology outside rare diseases, endocrinology. Yes, we have our oncology, which I'm really moving forward with, as we only have hoped for. And we're really looking forward to 2024, where we can give you the proof, really, of patient data, how they're differentiated.
Speaker Change: Related to <unk>.
Speaker Change: How are we using licensing of the transcon technology outside the FTC's.
Speaker Change: Endocrinology, yes, we have our oncology with our beauty moving forward SB one year for <unk>.
Speaker Change: And we really looking forward to 2004, where we can keep you the proof really two patient data how differentiated you saw our differentiation in ophthalmology, we meet.
Speaker Change: Economists are.
Speaker Change: A spin out company and we really feel that that really in an optimal value both to create value.
Speaker Change: Really has the patient in this area when we come to the error that we have disclosed we are working on we basic happy with DP, one class going forward once monthly profile and it's not only for PCC is also committed Baltic diseases, and we feel really really that we are getting the interest.
Yan Mickelson: You saw our differentiation in ophthalmology; we made Iconis, a spin-out company, and we really feel that they're really at optimal value, both to create value and really help the patient in this area. When we come to the third area that we have disclosed we are working on, we basically have the DPR1 class, we're going for the once-monthly profile, and it's not only for obesity, it's also for metabolic diseases, and we feel really, really that we are getting the interest that such a product really deserves. But it's not a product; it's a platform that can be utilized basically for the class of GPL-1.
Speaker Change: SASSA product really deserve.
Speaker Change: But it is not a product it's a platform a platform that can be utilized basic for the class of detailed ones.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of <unk> Ahmad from Bank of America. Your line is open.
Ahmad: Hi, guys. Good afternoon, thanks for taking my questions.
Ahmad: Wanted to get your updated thoughts about competition from recently approved growth hormone therapies in particular.
Ahmad: What is your market data, telling you about novo Sequoia how is that if in any way impacting your launch and then.
Yan Mickelson: Thank you. One moment for our next question. Our next question will come from Tazeen Ahmad from Bank of America. Your line is open. Hi guys, good afternoon.
Ahmad: Can you give us some data about what percent of adults currently take growth hormone replacement therapy and on average how long does the person stay on therapy.
Tazeen Ahmad: Thanks for taking my questions. I wanted to get your updated thoughts about competition from recently approved Growth Hormone Therapies, and in particular, what is your market data telling you about Novosugroya? How is that, if in any way, impacting your launch?
Ahmad: Thanks.
Ahmad: It's really.
Ahmad: Pleasure to take off again, the competitive landscape in the growth hormone market.
Ahmad: And when we launched.
Ahmad: We had a competition the short acting.
Ahmad: Yes.
Ahmad: It was a little bit different.
Ahmad: Six daily growth hormone type youre competing against.
Yan Mickelson: And then, can you give us some data about what percent of adults currently take growth hormone replacement therapy? And on average, how long does a person stay on therapy? Thank you. Thank you. It's really a pleasure to take up the competitive landscape in the growth market again with Wendy Long. We had a competition on the short end.
Ahmad: We showed how we will clinical different stages to this.
Ahmad: This step is standard of treatment, how we've provided a better outcome.
Ahmad: We beat the market basic to allot, two medical exception because of our product strong strengths ops cutover.
Ahmad: Now, we see two emerging therapies.
Yan Mickelson: It was all the different six daily growth hormones that we were competing against. We showed how we were clinically differentiated from this established standard of treatment and how we provided a better outcome. We built the market, FASIC 2, a lot on medical exception because of the product strengths of SkyTrooper. Now we see two emergent therapies coming in the long-acting sphere. Two products. One, Zagroje, coming in, and we don't see it really impacting us because we're still best in class.
Ahmad: Coming in in the long acting spare two product.
Ahmad: One <unk> coming in.
Ahmad: And we don't see really impacting us because we sell best in class reacted belief that these two products have no.
Ahmad: Proven that can show the same outcome.
Enrolment daily growth hormone treatment that you get in the U S. So for us the barrier for medical exception discussed.
Ahmad: Improving.
Ahmad: So for me and attendees.
Ahmad: We don't see that as really a changing anything about how we are progressing.
Yan Mickelson: We actually believe that these two products have never proven that they can show the same outcome as a normal daily growth hormone treatment that you get in the U.S. So for us, the barrier to medical exception is this, improved. So, for me, Ascendis.
Ahmad: Continue and build us too at blockbuster potential just in the U S and we continue to it because of our product strengths.
Ahmad: Related to the adult.
Ahmad: It's.
Ahmad: Compare to the pit.
Ahmad: In many different ways one other thing the majority of.
Yan Mickelson: We don't see that it's really changing anything about how we are progressing to build us to a blockbuster potential just in the U.S., and we will continue to do it because of our product strength, related to the adult. The adult is different compared to pediatrics in many different ways. One of the things the majority of Pediatricians, the typical will have a treatment for a limited year; it can be 4, 5, 6, 7, 8, depending on the initiation of treatment, where the adult is a chronic disease, the typical will be needing treatment for the rest of their life. So I would call it a chronic disease when you are diagnosed and start the treatment. So there is a big difference related to that. We often talk about penetration degree with growth hormone treatment, and what there is a huge difference between the pediatric and the adult is the pediatric, in my view, is penetrated up to, basic your modeling how really to see, and how we can develop the adult growth amount efficiency model.
Ahmad: <unk>.
Ahmad: With two because we'll have a treatment for Olympic year. It can be 45678 dependant on the initiation of treatment.
Ahmad: <unk> is a chronic disease.
Ahmad: We'll be meeting at treatment for rest of your life. So I would call. It a chronic disease when youre diagnosed and stop the treatment. So that is a big difference related to that we often talked about penetration degree with growth hormone treatment and what that is.
Speaker Change: Hello, Stefan to presume that pediatric and adult is Peter ASIC is my view is payment tradeoff too.
Speaker Change: 78%.
Speaker Change: The adult potential is under 10% and I think this is a big difference.
Speaker Change: Basic youre modeling, how really too.
Speaker Change: See and how we can develop the adult growth hormone deficiency market.
Speaker Change: As you said this is our first label expansion we will.
Yan Mickelson: As you said, this is our first label expansion. We will build it up so we basically have access to all places where it's possible to use growth hormone because all the patients deserve to have the best product. Thank you. One moment for our next question. Our next question will come from the line of Leigh Wodczak from Cancer. Your line is open.
Speaker Change: Buildup. So we basically have access to all places where is it possible to use growth hormone because all the patients deserve to have the best product.
Speaker Change: Thank you.
Speaker Change: One moment for our next question.
Speaker Change: Our next question is from the line of Lee <unk> from Cantor Your line is open.
Leigh Wodczak: Hey, great. Thanks for taking our questions. Maybe just to follow up on Transcom PTH's launch in Germany, understanding it's early days, but what could be a good framework for us to think about the rental speed in that market, any clarity that you can give us around the power experience patients and how quickly you may be able to onboard them? And then in terms of the patients that are enrolled in the early access program in Germany, do you have any color there as well? Thanks a lot for the question. I can be bullish now and say that all patients in Germany that have hypoparathy arrhythmia should be on treatment because I think that is certain and hormone replacement therapy as everyone that has type 1 diabetes. Would all of them come on treatment? Like you know?
Lee: Hey, great. Thanks for taking our questions maybe just follow up on Transcon <unk> long term money.
Lee: Understanding it's early days, but what could be explained work for us to think about that ramp.
Lee: Speed in that market any clarity that you can keep.
Speaker Change: <unk> was around that.
Speaker Change: <unk> patients.
Speaker Change: Quickly you may be well.
Sure Dan.
Speaker Change: And then in terms of the patients that are in relatively.
Speaker Change: Early access program in Germany, do you have any color there as well.
Speaker Change: Thanks, a lot for vacation.
Speaker Change: I can be bullish now.
Speaker Change: And saying there is that all patient in Germany.
Speaker Change: Hypo pads high risk should be on treatment.
Speaker Change: Because I think that the suit and hormone replacement therapy as everyone that have type one diabetes.
Speaker Change: With all of them come on treatment.
Speaker Change: Likely not.
Yan Mickelson: But what we want to do, we are dedicated to helping the patient and building up, through scientific and clinical data, our dedication to really developing this market to ensure as many as possible will be treated with transcon P2A or EuroPunch. And this is not only in Germany and Austria; this is the rest of Europe. This is the rest of the international market. It's basic also in Europe.
Speaker Change: But what we want to do.
Speaker Change: We are dedicated to help a patient.
Speaker Change: And building up.
Speaker Change: Two scientific clinical data our.
Speaker Change: Our dedication to really to develop this market to ensure as many as possible will be treated with transcon PTH.
Speaker Change: Europeans and this is not only in Germany, and Austria, So rest of Europe.
Speaker Change: Rest of the international market.
Speaker Change: Basic also in U S.
Yan Mickelson: So, when we see this here, I think there is a different element in how we see penetration will happen. We always see the benefit of physicians really getting the benefit seen in their own eyes. That's to take patients, take them on treatment, typical 2 to 5, really to see how the product functions. The benefit with transcon PTH, after a few weeks, they already see the benefit. So then there is some kind of logical thing to do, how to get patients in, how to ensure there is capacity from the different physician sides really to take the patients in. So when we come into Q2,
Speaker Change: So when we see this year.
Speaker Change: There is different element, how we see the penetration will happen, we always see the benefit of physician really getting the benefit seen in there.
Speaker Change: <unk> is best to take patient take them on treating too because two to five really to see how the product function.
Speaker Change: Benefit returns compete eight after few weeks they will receive the benefit.
Speaker Change: So then there is some kind of.
Speaker Change: Dr coating, how to get patient how to ensure that as capacity in really from the different physician sites really to take the patients and so when we come into Q2.
Yan Mickelson: Q3 I think we will start to see the trend coming in, and you can follow our revenue development mainly coming from where we have full reimbursement in Germany and Austria, and then you can see how we penetrate rest of Europe Direct at the end of 24, 25 and how we basically are building up the international market in the latter part of 24 and really starting to be really penetrated at a much higher level in 25 and 26. Thank you. One moment for our next question. And our next question. Thank you, and our next question will come from David Lebowitz from Citi. Your line is open.
Speaker Change: Yes.
Speaker Change: Q3, I think we will start to see the trend coming in and you can follow our revenue development, mainly coming from where we have full reimbursement in Germany, and Austria and then you can see how we penetrate.
Speaker Change: Rest of Europe, direct and up 24, 25, and how we are building up the international market.
Speaker Change: Later part of 'twenty, four and really starting to be really penetrated in a much higher level in 'twenty five 'twenty six.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: Yes.
Speaker Change: And our next question.
Speaker Change: One moment.
Speaker Change: Hi.
Speaker Change: And our next question comes from the line of David Lebowitz from Citi. Your line is open.
David Neil Lebowitz: Thank you for taking my question. Given the emergence of GLP-1s and their effect on lean muscle mass... Is there a potential role for growth hormone due to the success of GLP-1s? It isn't a question that BASIC is going back to the mode of action and the benefit you see with the cheaper one. I personally was a little bit skeptical about the entire GPL-1 class for obesity, but it's typical because I'm pretty conservative in many ways. But what I'm 100% sure now is going to be a huge, huge cloud.
David Neil Lebowitz: Thank you for taking my question.
Given given the emergence of <unk> ones.
David Neil Lebowitz: And their effect on lean muscle mass.
David Neil Lebowitz: Is there a potential for growth hormone.
David Neil Lebowitz: Due to the due to the success of the <unk>.
Speaker Change: And Christian that basic going back to the mode of action and that benefit Youll see with capital one.
Speaker Change: I personally was little bit skeptical about the entire Q1 comps in obesity, but as typical because I'm pretty conservative in many ways.
Speaker Change: What I'm, 100% sure now is going to be a huge huge clubs and we see that benefit coming out really on a lot of different treatment aspect is not only just losing weight that a lot of other tweaking benefit the discounts there.
Yan Mickelson: And we see the benefit coming out really in a lot of different treatment aspects. It's not only just losing weight. There are a lot of other treatment benefits with this class, but the negative part is that you basically are in a position where you're losing a large amount of muscle mass. And specifically, if you're not adhering to the treatment and take a period of break, start up again, period of break, you can basically be in a position that when you're not treating, you build up fat tissue faster than muscle weight. And I think it's a really, really interesting perspective that could see growth hormone treatment because that is really where the benefit of growth hormone is that it really can build up muscle mass in a much, And I think you are right, and I would like to explore such a possibility. Thanks for taking my question. Thank you. Please take a moment for our next question. In our next question, we'll come from the line of Joseph Schwartz from Layering Partners. Your line is open. Joseph from Lyric Partners. Your line is open.
Speaker Change: The negative part is that is your basic are in a position that you, losing and locks amount of milestone months and specific if youre not been here to the treatment period of brake start I'll begin period of break you can basically be in position that when you are not treating you built up the fat tissue.
Speaker Change: Mr than where most of way.
Speaker Change: I think it's a beauty really interesting perspective at basic could see growth hormone treatment because that is really where the benefit of growth hormone is that it's really can build up than Boston mass in a much more stronger mess in a normalized manner and I think you are right and I would like to.
Speaker Change: <unk> set a possibility.
Speaker Change: Thanks for taking my question.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: Yeah.
Speaker Change: And our next question comes from the line of Joseph Schwartz from Leerink Partners. Your line is open.
Joseph Patrick Schwartz: Joseph from Leerink Partners. Your line is open.
Joseph Patrick Schwartz: Hi there, thanks very much. I was wondering if you could talk about the work you did to arrive at your estimate that 70,000 adults have chronic hypoparathyroidism in Germany, and who are the 20,000 patients that you're targeting there, and how does the target population in the United States compare to the total hypoparapopulation in the U.S., where we have some guidelines? I'm wondering if that influences the proportion of the market that, Thank you. Thank you. Thank you, most addressable here in the United States. Thanks, I think I got all the questions into it, and when we compare the demographics between Germany and the U.S. It consists of the basic two groups, the post-surgical, which is one group, and then you can see the more hemological, genetic, and idiopathic background, where you typically will see it arise most earlier in states of life.
Joseph Patrick Schwartz: Hi, there. Thanks very much I was wondering if you could talk about what work you did to arrive at your estimate that 70000.
Joseph Patrick Schwartz: I'll have chronic high bulk parathyroid as in Germany.
Joseph Patrick Schwartz: 20000 patients that you're targeting there.
Joseph Patrick Schwartz: The target population in the United States compare to the total hydropower population in the U S.
Joseph Patrick Schwartz: Where we have some guidelines.
Wondering if that influences.
Joseph Patrick Schwartz: A portion of the market.
Joseph Patrick Schwartz: Yes.
Joseph Patrick Schwartz: Most addressable here in the United States.
Joseph Patrick Schwartz: Thanks.
Speaker Change: I got the question.
Speaker Change: Good.
Speaker Change: And.
Speaker Change: When we compare the demographic beauty.
Speaker Change: Germany and use it consists of the basic the two group the processor to do it with one group and then you can see the more hematological genetic idiopathic background, where you typically will see a rise must earlier in states of life.
Yan Mickelson: Germany's potential is a little bit unique with the large number of patients because, And I think it could potentially be built on the high level of intensive head and neck surgery because of the really, really strong force of diagnosis. And from that perspective, yes, there are potentially more post-surgical patients in Germany than you see in the U.S. For example, if you take a country like France, France will much more relate to what you will see of treatment as you do in the U.S. So...
Speaker Change: Germany potentially little bit unique with the large number of patient because.
Speaker Change: Okay.
Speaker Change: And I think it potentially is built on the high level of intensive head and neck operation because of really really strong folks off.
Speaker Change: Diagnosis.
Speaker Change: And from that perspective is yes days potentially more post surgery patients in Germany than you see in the <unk>.
Speaker Change: <unk> and <unk>.
Speaker Change: For example, if you take a country like France, France must more more relate to what you would see of treatment.
Way that Youll see in the U S.
Speaker Change: So.
Yan Mickelson: When we see this different patient population... All of them will benefit from transcon, PTAs, treatment, or Europat. It's not like one group of the other one is less beneficial to the treatment on it. So all of them deserve to have a life with transcon PTH. Now, going back to what you say when we talk about the 22,000 patients. And it's not because we see subpopulations that see more benefit or less benefit from that. When we talk about the 22,000 patients, which we try to address first, it's the patients that... from a pharmacoeconomic perspective, have a really, really hard time in society. They can potentially come to a state of real impairment. They can come to a state where they visit the hospitalization a lot. They come to a state where they cannot function because of cognitive effects. They cannot get a normal life.
Speaker Change: When we see this deepened patient population.
Speaker Change: All of them with benefit of the Transcon PTH treatment or Europe, it's not like one group of the IR one list.
Speaker Change: Beneficial in the treatment on it so all of them to.
To have a life with transcon PTH.
Speaker Change: Going back to what you see when we talk about which 82000 patients and it's not because we see sub population to see more benefit or less benefit from that when we talk about with 22000 patients, which we try to address first is the patients that.
Speaker Change: From a pharma co economic perspective.
Speaker Change: Really really hot type on the society that can be potentially come to the state of <unk> impairment that can come to a state of the visit hospitalization alot com to a state where they cannot function because of cotton to effect that cannot get the normal life. So outcome that perspective is not really.
Yan Mickelson: So out of that perspective, it's not really a treatment benefit, it's just more of a burden for society, and this is where we always need to be. We need to benefit the patient, society, and everyone as all stakeholders. And this is the burden on society that is much, much higher for these 22,000.
Speaker Change: At treatment benefit is this more debt burden for this society and this is where we always need to be we need to benefit the patient the society.
As all stakeholders and this is with good of society as much much higher for these <unk> patients.
Derek Archila: Very helpful. Thank you. Thank you. One moment for our next question. Thank you. And our next question will come from Derek Archila from Wells Fargo. Your line is open. Hey, good afternoon, and thanks for taking the questions. Just two from us.
Speaker Change: Very helpful. Thank you.
Speaker Change: Thank you.
Speaker Change: Our next question.
Speaker Change: And our next question comes from the line of Derek <unk> from Wells Fargo. Your line is open.
Derek: Hey, good afternoon, and thanks for taking the questions just two from US I just wanted to clarify thanks, Ralph a $1 billion product in the U S. Just on pediatrics alone or does that assume contribution from adult ghd as well and then just in terms of the cost structure of the Endo business is this 600 million cost base now houses should be.
Yan Mickelson: I just wanted to clarify, is Skytropha a $1 billion product in the US just for pediatrics alone, or does that assume contribution from adult GHG as well? And then just in terms of the cost structure of the endo business, is this 600 million cost-based now? How should we be thinking about it for the future? And just your thoughts about the profitability of that business.
Derek: Thinking about it for the future.
Derek: And just your thoughts about profitability of that business.
Scott Smith: Thanks. I will take the first question, and then Scott is really happy today because he actually has an opportunity to come up with some of the financial numbers he's running so dedicated all the time. When we look at the potential market, yes, you can see we will have adult growth hormone deficiency. But we will pursue some of the other indications too. But we also need to say that we are liberating a normal somatopoietin molecule, which is a well-known entity for all different hormones, indications that have seen the benefit of growth hormone. And if you go to the market for daily growth hormone and see what the dynamic there is, the dynamic is that none of the daily growth hormones, basic, because they're all so much opine too, all of Because none have really taken the effort to go through all the different indications.
Speaker Change: Thanks, I will take the first question and then Scott is really happy today, not because he actually has an opportunity to come to some of the financials numbers is running so dedicated overtime.
Speaker Change: We look on the potential market. Yes, you can see we will have adult growth hormone deficiency, we will pursue some of the other indications, but we also need to say that we are deeper rating in <unk>.
Scott Smith: So much of <unk> molecules, which are well known entity for all different <unk>.
Scott Smith: Indication.
Scott Smith: <unk> seen.
Scott Smith: <unk> seen the benefit on growth hormone.
Scott Smith: And if you go to the market of a daily growth hormone and see what is the dynamic there. The dynamic is that none of the daily growth hormone basic because we're all so much open to all of them basically in a position none of them have all the indications where the exit being reimbursed or used to date because.
Scott Smith: None have really taper effort to go through all the different indication so.
Yan Mickelson: So it could be potential, and the same thing will also be applied to the long-acting products that are providing the same somatopoietin molecule. Scott, will you talk a little bit about expenses and numbers in less than 10 minutes? How much time do we have?
Scott Smith: It could be potential the same thing will be applied also.
Long acting products that are providing somewhat of a molecule.
Scott when you talk little bit about expenses in numbers in just 10 minutes.
Scott Smith: How much time doing it.
Scott Smith: Thanks, Derek. So it's good to get a finance question. So, as you saw here in Q4, we're now realizing the benefits of the streamlined operation, operational changes, and processes that Ian has talked about, with OPEX going down to about $155 total. And then, of course, next year you'll see more come off as a result of basically no P&L burden from ophthalmology. I think you should look at this as a product of the way that we've developed our portfolio and how efficient it can be. I think if you look at our costs for transcon growth hormone and realize the stage of that product and how mature it is, the cost should be dropping pretty substantially in the coming years. And overall, we're going to be pretty efficient in R&D.
Scott Smith: Thanks, Derrick so it's good to get a finance question. So as you saw here in the Q4.
Scott Smith: We are realizing now the benefits of the streamlined operation.
Scott Smith: Operational changes and processes that Ian has talked about with opex going down to about 155 total.
Speaker Change: And then of course next year Youll see more come off as a result of base.
Speaker Change: Basically no P&L burden from ophthalmology.
Speaker Change: I think you should look at this as a product of the way that we've developed.
Speaker Change: Our portfolio and how efficient it can be.
Speaker Change: I think if you look at our cost for transcon growth hormone and realize the stage of that product and how mature. It is the cost should be dropping pretty substantially in the coming years and overall, we're going to be pretty efficient in R&D.
Scott Smith: So I would expect more shift from 60-40 R&D SG&A in 23 to maybe 50-50 or so in 24. In the long run, it will be efficient in R&D. And as we expand globally, I would expect some, some increase in SG&A as we add people in 30, 40, 50 countries, but it should be pretty minimal. And as you saw going from Q3 to Q4, our SG&A was basically flat, even though we launched an additional product and got ready to launch a second product in Germany.
So I would expect more of a shift from 60 40, R&D SG&A in 'twenty three to maybe 50 50 or so in 'twenty four.
Speaker Change: Longer run will be efficient in R&D and as we expand globally I would expect some.
Speaker Change: Some increase in SG&A as we add people and $30 $40 50 countries, but it should be pretty minimal and as you saw going from Q3 to Q4, our SG&A was basically flat even if we launched an additional product and got ready to launch a second product in Germany.
Yan Mickelson: Thank you, for one comment. What do you see as the result of something that was a basic element that happened in 2020? You don't suddenly change a company, you don't suddenly streamline a company, it takes a lot of effort, it took us, starting at the beginning at 23, really find out how we could build a leaner Ascendis, more productive, really focus, focus on really optimizing processes, administration, and everything like that, and we worked very, very, very successfully at that.
Speaker Change: Got it thank you.
Speaker Change: One comment what do you see the result of something was basic element that happening in 2003.
Speaker Change: You don't suddenly changed the company you don't suddenly streamline the company it takes a lot of effort.
Speaker Change: Took us started beginning of 'twenty, three where do you find out how can we build a leaner.
Speaker Change: More productive really focus focus on really optimizing processes administration and everything like that.
Speaker Change: And we work bareback successful to that it was a hard task not already always pleasant, but they are now we aren't where we want to be now be still optimizing our processes, because we scaling for potentially having 5000 to have 50000 processes and you cannot use for.
Yan Mickelson: It was a hard task, not always pleasant, but we're there now. We are where we want to be now. We're still optimizing our processes because we're scaling for potentially having 5,000 to have 50,000 processes, and you cannot use the same PV system that you use for 5,000 to 50,000.
Speaker Change: Same PV system.
Speaker Change: Use of 5000 to 50000. So this is why we really are still optimizing process changing the company because we cannot be a leading biopharma company at the same way, we operated asset Sachs Biotech company, where we basic both focus on clinical development and few comments here.
Yan Mickelson: So this is why we really are still optimizing processes, changing the company because we cannot be a leading biopharma company in the same way we operate as a large biotech company where we basically focus on clinical development and fuel commercialization. So we are still transforming. We're still changing our processes, and that is what we need to continue to be truly competitive in this landscape.
Speaker Change: So we are still transforming we still changing our processes and that is what we need to continue to be truly competitive in this landscape.
Kelly Shee: Thank you. One moment for our next question. Our next question will come from Kelly Shee from Jeffries. Your line is open. Thank you for taking my questions. Maybe we could switch topics to transconscient NP.
Speaker Change: Thank you one moment our next question.
Speaker Change: Okay.
Speaker Change: Our next question will come from the line of Kelly <unk> from Jefferies. Your line is open.
Kelly: Thank you for taking my questions maybe switch topics.
Yan Mickelson: You have talked about the improvement in muscle function, and other companies will feel like I talk about more proportionality or like an upper to lower body ratio. I'm just curious have you also looked at proportionality as well and also why it comes to the combination with scatropha. What would be the most differentiated clinical benefit compared to transconscient NP alone? Tang.
Kelly: You have talked about.
Kelly: Improvement.
Kelly: Russell function and auto companies with your line.
Kelly: <unk>.
Kelly: Proportionality ally Com.
Speaker Change: Albert and lower body Rachel I'm, just curious have you also lucado proportionality as well and also when it comes to the combination with <unk>.
Speaker Change: What would be the most differentiated clinical benefit compared to trust Hoffman PLO. Thank you.
Speaker Change: Thanks.
Yan Mickelson: I will start from the back because... if you have a child born with achondroplasia, being started treatment as a newborn, our belief is that your basic will nearly have normal growth in this period of time where you have growth related to linear growth, you will not really address, and stop, all you can stop to address the co-morbidities because there will exist the rest of their lives. And this is when we see the integrated aspect of acondoplasia; we see linear growth as one part of the disease, and we see the other impact of the hyperactive pathway on other aspects, like, for example, muscle weakness and other aspects, which are really from a mode of action that is different compared to what you see in the contoplasts that really are limited in the way they get linear growth.
Speaker Change: I will start from the back because.
Speaker Change: If you have it.
Speaker Change: Chart.
Speaker Change: Born with.
Speaker Change: I kind of pacing.
Speaker Change: Being started treatment as a newborn.
Speaker Change: Our belief is that basic with nearly half normal growth in this period of time, where youll have growth related to linear growth.
Speaker Change: You will not really address.
Speaker Change: And stop off can start to address the comorbidities.
Speaker Change: Because the rest.
Speaker Change: The rest of their life.
And this is when we see on the integrated aspect of echolocation.
Speaker Change: We see the linear growth as one part of the disease and we see the impact of the hydro <unk> pathway have on on aspect like for example, muscle weakness and other aspect, which really from a moat.
Speaker Change: Of action is different compared to what you see on the condo class that really limit in the way vacate linear growth. So when we think about how we.
Yan Mickelson: So when we think about how we are positioning our combination trial, is that what everyone as I have seen of data for the impressive amount of clinical data that has come out from biomarine related to zootite, all of that showing that you normalize growth for the waste-waste majority of the patients. But if you have a child that got born and first started treatment at 8 years old, they still have a lack of growth. So when we saw all the data that had been generated by it, David Grothammer
Speaker Change: Positioning our combination trial is that.
Speaker Change: Everyone have seen of data.
Speaker Change: The impressive amount of clinical data that comes out from Biomarin related to facilitate all of that showing that your normalized growth.
Speaker Change: That waste waste majority of the patients.
Speaker Change: But if you have a chart that got born and first started treatment of eight years, but still have a lack of growth.
Speaker Change: So when we saw all the data that's been generated by.
Yan Mickelson: More than 30-40 publications, really intensive trials with 40-50 children, and we see that they basically can induce catch-up growth as you can do in growth amount efficiency because that is what we do in growth amount efficiency. The most important benefit of growth hormone is that you can reset the growth to be normal at the final height if you are on a good adherent treatment, but you can only do that, in terms of growth amount efficiency, if you have a cash-up growth, meaning that you grow more in the first two, three years than your basic will see of normal growth. That is why, when you think about a child with growth hormone deficiency, who has not been treated for 8-9 years, starting potential treatment, and then suddenly hitting the parents. And you see the same thing in achondroplasia if you start to give them growth hormone. I see growth effects up to 7-8 centimeters, not as much as you see in protomone deficiency, and it's likely because they still have a block down on their contour plates because they also need CMP.
Speaker Change: Daily growth hormone.
Speaker Change: More than 30 40 publications.
Really intensive trials, but 40 50 children and we see that that basically can induce.
Speaker Change: Induce.
Speaker Change: Catch up growth as you can do in growth hormone deficiency, because that is what we do in kokomo deficiency.
Speaker Change: Most of growth hormone is that you can reset the growth to be normal as a final height.
Speaker Change: If you are.
Speaker Change: Good to hear.
Speaker Change: Treatment, but you could only do that.
Speaker Change: In ortho growth hormone deficiency, if you have a catch up growth.
Speaker Change: Meaning that you grow more in the first two three years, then your basics will see off of normal growth.
Speaker Change: That is why when you think about a child with growth hormone deficiency not had been treated for eight nine years, starting potential treatment and then starting to hit their parents.
Speaker Change: As expected this is because of catch up growth and Youll see the same thing in our contemplated if you.
Speaker Change: Start to keep them.
Speaker Change: Growth hormone I see gross profit up 278 centimeters.
Speaker Change: Most of that you see in Baltimore deficiency, and it's likely because they still have that block count under control place because theyre also need CMP. So when we think about the perspective of combination trials.
Yan Mickelson: So, when we think about the perspective of combination trials, this is for children that have not got treated, and this is basically the majority of children today that have not got treated from that got born and really need some cash out growth, really to get a burst in growth. And this is why we are running this trial. My expectation, and now I can be trying to do something that is very, very dangerous, but I believe you can potentially grow them up to eight, nine centimeters just by combination because you get cathart growth for the first 1-2 years.
Speaker Change: This is for children.
Speaker Change: <unk> not got treated.
Speaker Change: And this is basic old majority of children to date that has not got treated from the got newborn and really need some case outgrowth really to get a boost in the growth and this is why we are running destroyed my expectation and now I can be.
Speaker Change: Trying to do something that is very very dangerous, but I believe you can potentially grow them up to $8 nine centimeter just by combination treatment with <unk>.
Speaker Change: <unk>, you'll get the cash outgrowth for the first one two years and this is the rational for us to go out and make that.
Yan Mickelson: And this is the rationale really for us to go out and make that treatment regime because we do the same as we do with the reservoir type; we normalize growth. So, proportionality.
Speaker Change: Treatment regime, because we do the same as most of which I, we normalized growth.
Speaker Change: So <unk>.
Yan Mickelson: Yes, we see the same positive trend in proportionality that we have seen and expected to see. And we will see it more and more when we see more data from the longer part of treatment because it takes a longer time really to see the right benefit from this or change this proportionality. But we definitely are seeing the same positive development. Thank you. Thank you. Please take a moment for our next question. Our next question will come from the line of Paul Choi from Goldman Sachs. Your line is open.
Speaker Change: Proportionality, yes, we see the same positive trends in copper to seasonality that we have seen and expected to see and we've received more and more when we see more data from longer part of treatment because it takes longer time to really get to see the right benefit on this.
Speaker Change: <unk> changed of Disproportionality, but we definitely are seeing the same positive development.
Speaker Change: Thank you.
Speaker Change: Thank you one moment our next question.
Speaker Change: Our next question comes from the line of Paul Choi from Goldman Sachs. Your line is open.
Paul Choi: Hi, good afternoon, and thanks for taking our questions. I also want to ask about TransCon CMP, for your Phase 3 approach study, can you maybe just share what metrics or details you'll provide with the top-line results, and what are your medical conference presentation plans for that data? And then second, on the regulatory strategy, can you maybe just help us understand the urgency to file the NDA in the same quarter, just kind of what the reasoning behind that is, are you just potentially concerned about a full approval for Biomarin's Vox Ogo, and just maybe some color there would be helpful. Thank you very much. It's pretty simple about the filing.
Paul Choi: Hi, good afternoon, and thanks for taking our questions I also want to ask on Transcon CMP for the phase III approach study can you maybe just.
Paul Choi: Sure what metrics or details you will provide with the topline results and what is your medical conference presentation plans for that data.
Paul Choi: And then second on the regulatory strategy can.
Paul Choi: Can you maybe just help us understand the urgency to file.
Paul Choi: NDA in the same quarter, just kind of what the reasoning behind behind that is higher just potentially concerned about a full approval for Biomarin box I'll go on just maybe some color there would be helpful. Thank you very much.
Speaker Change: It's pretty simple about this finding.
Yan Mickelson: Ascendis' approach is to do it as fast as possible, and at the highest quality. And if anyone else is working for a company and not living up to this, I suspect they should leave. So if I can get someone to do the finding in the same quarter we get the data, we should do it. When we come to the Phase III data, Yes. We have a primary endpoint because that got established as a..., traditional way of a primary endpoint is that we really are, and a rational endpoint for achondroplasia? I have my doubts. I think it's more a surrogate marker, analyzed at high velocity.
Speaker Change: Since it's a process to do it as fast as possible in the highest quality.
Speaker Change: And if anyone else is working at the company and not living up to this.
Speaker Change: Aspect where should leave.
Speaker Change: So if I can get someone to refining in the same quarter, we get the data we should do it.
Speaker Change: When we come to the phase III data.
Yes.
Speaker Change: We have a primary endpoint.
Speaker Change: That got established asset.
Speaker Change: Traditional ways of our primary endpoint is that really.
Speaker Change: And rational in for.
Speaker Change: Excellent patient I have my doubt I think it's more a surrogate marker annualized height velocity.
Speaker Change: Sure.
Yan Mickelson: The treatment is to change the comorbidity of the disease. So the primary endpoint for me is like a surrogate marker as Trunkle fat is for adult growth hormone deficiency.
Speaker Change: The treatment is to change the co morbidity of the disease.
Speaker Change: So the primary end point for me is like a surrogate marker as.
Speaker Change: Trunk fat is for adult growth hormone deficiency. This is not really the key treatment objective in adult growth hormone deficiency youll see other aspect of the treatment that's more important.
Yan Mickelson: This is not really the key treatment objective in adult growth hormone deficiency. You see other aspects of the treatment that's more important, but it's an established endpoint. So when we go to the secondary endpoint... And I said it really very very very simple in my text. We're going in and looking at the effect on comorbidities, and we do it from a lot of different angles. And we want to be sure that we're covering them in the best possible way. And the best possible way we can do it is to look at the co-morbidities basis that has developed into what we can measure in different physical functions, daily function. We do a lot of radiology because we know the texture of the child needs to be perfect, so we are 100% sure.
Speaker Change: But it is established in point so when we go to the secondary endpoint.
Speaker Change: I said is really very simple.
Speaker Change: Sixth we going in and Luke on the effect on Comorbidities and matured and lot of different angles.
Speaker Change: And we want to be sure that be calling them in the best possible way.
Speaker Change: The best possible way, we can do it is to look on the Comorbidities basic debt is develop into.
Speaker Change: What we can measure in different physical function data.
Speaker Change: Daily function, we do a lot of radio loyalty, because we know that texture appetite needs to be perfect. So we hundred percent sure. We had developed telephone health related outcome, Missouri.
Yan Mickelson: We have developed different health-related outcome measures, and I believe that taking all these aspects into it, we will find benefits that never have been, See? And I hope it will both come for quality of life, body composition, physical function, and also the regular logical end point that basic provides a different way of how then improve the taste, and at the medical meeting. I think we are not driven by medical meetings; there are some people that are saying that they lay out data out because of medical meetings. I think when you have material data, you should come out with it so everyone can see the data.
Speaker Change: And I believe that taking all of this is baked into it we will find benefit that <unk> had been.
Speaker Change: <unk>.
Speaker Change: And I hope it will both come for quality of life body composition physical function and also the rating logical endpoint that basic providing different way of helping improve the texture.
Okay.
Speaker Change: And on the medical meeting.
Speaker Change: I think the summary are not driven by medical meeting. So there are some people are saying that delayed data out because of medical meeting I think that you have mature data used to come out of it. So everyone can see EBIT data we have.
Yan Mickelson: We are not waiting to disclose data just because of a medical meeting. Thank you. One moment for our next question. Thank you. Our next question comes from Andreas Argerides from Wedbush. Your line is open. Hey guys, congrats on all the progress and thanks for taking our questions. Just a couple here from us.
Speaker Change: Not waiting with disclosing data just because of medical meetings.
Speaker Change: Sure.
Speaker Change: Thank you one moment for our next question.
Speaker Change: Our next question comes from the line of Andreas <unk> from Wedbush. Your line is open.
Speaker Change: Great.
Andreas: Congrats on all the progress and thanks for taking our questions.
Andreas: Just a couple here from us when you think about CMP.
Andreas Argerides: When you think about CMP, can you give us a little bit of your thoughts around the rationale for expanding into adults with hypochondroplasia instead of going into hypochondroplasia like the other companies in the space? And then looking at Voxogo and the growth that they've seen, primarily driven by XUS. Maybe you can give us a sense of, you know, why it's off to a slower start in the U.S. And is it driven by the fact that they have been focusing on height versus other quality of life measures? And then just one last one on oncology programs. If you don't find a partner to bring these programs forward, would you consider spinning them off like you did with the ophthalmology programs? Thanks. Okay, let me start with the last one because it's very easy.
Andreas: Can you give us a little bit.
Andreas: And your thoughts around the rationale to expand into adults.
Andreas: Please go instead of going into a hypochondriac places like the other comparable space.
Andreas: And then looking at box Sogo.
Andreas: And the growth that they've seen.
Andreas: Similarly, driven by ex U S.
Andreas: Maybe you can give us a sense of.
Andreas: Why its offer off to a slower start in the U S is that <unk>.
Andreas: Driven by the fact that we have been.
Andreas: Focusing on heightened versus other quality of life measures.
Andreas: And then just one last one on the oncology programs if you don't.
Andreas: You don't find a partner to bring these programs. So would you consider spinning them off I think there would be ophthalmology programs. Thanks.
Speaker Change: Okay. Let me start on the last one because it is very easy.
Yan Mickelson: We are here to do the best for the patient, to get our product penetrated into as many as possible patients, and... We believe that we are in a position when we have seen all the data that will come out at the end of this year. We have already seen the interest in our programs now. We feel pretty confident we will do the optimal thing, where we see the fastest, best way to get medicine to the patient, and we create the most value for Ascendis shareholders. That will be the driver for our decision. Then you had two comments to CMP.
Speaker Change: We are here to do the optimal for the patient to get our product being penetrated to as many as possible patients.
Speaker Change: And.
Speaker Change: We believe.
Speaker Change: We are in a position when we have seen all the data that will come out end of this year.
Speaker Change: We already have seen the interest in our programs down.
Speaker Change: We feel pretty confident David do the optimal where we see the fastest best way to come out of a patient and we create most value for shareholders.
Speaker Change: Shareholders that will be a driver for our decision.
Speaker Change: Then you had two comments to CMP <unk>.
Yan Mickelson: The first one was..., is not hypochondroplasia. Why not hypochondroplasia? That is a pretty good, interesting perspective for us because it's something we are discussing a lot. Because hypochondroplasia is a mild form of achondroplasia.
Speaker Change: The first one was on.
Speaker Change: That hypo contemplated why not hydro contemplation that is pretty good interesting perspective.
Speaker Change: For us because it is something we are discussing a lot because hydro conduct Asia is a milestone for achondroplasia.
Yan Mickelson: And I think we will not move over to hypochondroplasia before we really have provided the optimal treatment, the best treatment that really addresses comorbidities in aconteplasia. Why jump over to something where you basically have not provided a treatment option but potentially only provide some limited linear growth.
Speaker Change: And I think we will not move over to hydro contemplation before we really have provided.
Speaker Change: The optimal treatment the best treatment that really addressing Kumar PCT in excellent replaces why job over to something where you basically have not provided a treatment option, but potentially only providing some linear growth in the video growth.
Yan Mickelson: And linear growth, you could get that for the last 20 years just by giving daily growth hormone. So I don't see that it's really a treatment benefit that is just providing linear growth. What we're trying to address is basically the comorbidity of the disease, and we will continue to do that until we find the best possible solution to give them a meaningful improvement in quality of life. And the other thing is that I think these two things are related to each other. I don't believe being short is a disease. Even though I'm pretty tall,
Speaker Change: Could get that for the last 20 years, despite giving daily growth hormone.
Speaker Change: I don't see that as really a treatment benefit.
Speaker Change: Its just providing linear growth what we're trying to address it's basics.
Speaker Change: Comorbidity of the disease, and we will continue to do that until we find the best possible solution to give them a meaningful improvement in quality of life.
Speaker Change: And the other thing is that I think these two things are related to each other I don't believe being short is a disease, even up unpredictable so totally being short 30 seats and I'd like to think that you should never consider short <unk> belief that taking just a linear growth.
Yan Mickelson: So I actually don't believe being short is a disease. And I actually think you should never consider being short to be a disease, taking just linear growth into account. In some ways, it's more appealing in some countries than others, and definitely in the U.S.; it's not a disease, to be sure.
Speaker Change: If somebody is more appealing in some countries than others and destiny in U S is another disease to be short.
Yaron Benjamin Werber: Thank you. One moment for our next question, and our next question will come from the line of Yaron Werber from TD Kallen. Your line is open. Hey guys, this is Joyce on For Your Own.
Speaker Change: Thank you one moment and my next question.
Yaron Benjamin Werber: And our next question comes from the line of your own Werber from TD Cowen Your line is open.
Yes. This is joey on for Ron Thanks for taking our question.
Joyce: Thanks for taking our questions. Just maybe hoping to get your thoughts on the emerging competitive landscape for HypoPARA. You're clearly ahead of market, but there's another one, stairway PTH analog, in phase three, and then there are a couple of others in the pipeline behind it. Some looking to develop oral candidates or once weekly candidates. So just any thoughts or comments there would be great.
Joey: Maybe hoping to get your thoughts on the emerging competitive landscape for hyper para.
Joey: Clearly a hot market, but there is another one is dairy PTH analogue in phase three and then there are a couple of others in the pipeline behind it so I'm looking to develop oral candidates or once weekly candidates.
Yan Mickelson: Thank you. Thanks a lot. When I took a look at the biological system in the body, the complexity of that, how really to provide and Treatment of a Hormone Replacement Therapy in a situation where the biology has been extremely, extremely multiple organ effects. Having the right clothes, not too hyper, not too hyper, and see what we did with Sky Trophy.
Speaker Change: Is there any thoughts or comments there would be great. Thank you.
Speaker Change: Thanks, a lot.
Speaker Change: When I took over.
Speaker Change: Luke from.
Speaker Change: Endocrinologists perspective.
Speaker Change: And look under the electrical system and third party.
Speaker Change: The complexity of that.
Speaker Change: How really to provide and.
Speaker Change: Treatment often hormone replacement therapy.
Speaker Change: In acceleration.
Speaker Change: We are therefore already has been extremely extremely.
Speaker Change: Multiple organs effect.
Speaker Change: Having the right dose not too high but not two HIFU.
Speaker Change: Sure.
Speaker Change: And see what we did with coach Hopper.
Yan Mickelson: We provided vasumotropin, the same molecule that is really being produced by the Indulgist clan, and I believe... When I was a go-to hyperparameter... This patient needs to have a physiological level of PTH, then providing the same mode of action. I actually went to a conference and heard some of the questions from physicians on some of the other competitive products. And one of the key questions that came up: We know PGH has an effect on so many, many different organs. When you change the entire mode of action, how can you really prove and believe you can create the same normal physiological system that you would expect to get with a normal endoscopy?
Speaker Change: We provided with so much of the.
Speaker Change: The same molecule.
Speaker Change: That really be.
Speaker Change: The produce.
Speaker Change: Grant.
Speaker Change: And I believe.
Speaker Change: When hours that go to HEICO apparel.
Speaker Change: These patients need to have a physiological level of <unk> 10, providing the same mode of action I actually went to a conference and heard some of the questions for physician on some of the other competitive product.
Speaker Change: And one of the key question that came up we know <unk> has so many many different organs.
Speaker Change: When you change the entire motive action, how can you really prove and believe you can create the same normal physiological systems that you expect to get enormous in DOCSIS pjs.
Yan Mickelson: This is how we define transcorpitae, to provide a normal same as in Tufts. PJs were exactly the same part that gave the mode of action at the physiological level. And I don't think any treatment that changing that will provide the same holistic benefit on all aspects of hyperparameters for any patient. Thank you. One moment for our next question, and our next question will come from Leland Gershel from Oppenheimer. Your line is open.
Here's how we designed transcon PTH to provide and normal.
Speaker Change: As endorsers P.
Speaker Change: <unk> with.
Speaker Change: Exactly the same path that give the mode of action in the future logical levels and I don't think any treatment that changing that will provide the same holistic benefit on all aspects of hydropower.
Speaker Change: <unk>.
Speaker Change: Thank you.
Speaker Change: Thank you one moment for our next question.
Speaker Change: And our next question comes from the line of Leland <unk> from Oppenheimer. Your line is open.
Leland Gershel: Hey, thanks for taking our questions. We have two from us, one each on Skytropha and Transcon PTH. On Skytropha, again, you mentioned in past commentary about the decreasing investment among the daily growth hormone companies and products. Wanted to just hear any updated color you may be able to share with respect to the marketplace in terms of the dailies, if that's a continuing trend that you're seeing.
Leland: Thanks for taking my questions two from us money John.
Leland: Okay Trophy and Transcon PTH on Sky Trove again, you had mentioned in past commentary about the <unk>.
Leland: Decreasing investment among the daily growth hormone companies and products wanted to just hear any updated color you may be able to share with respect to the marketplace.
Leland: In terms of the dailies, if thats, a continuing trend that youre seeing with respect to.
Yan Mickelson: With respect to Transcon PTH, as we anticipate approval and then launch in the third quarter of this year, if you could remind us the number of patients you have available in the states between both those who may be in the open-label studies as well as those who are in the EAP. Thank you. Yeah. You're right.
Leland: Transcon PTH as we anticipate approval and then launch.
Leland: Third quarter of this year, if you could remind us the number of patients you have available and the states between both those who may be in the open label studies as well as those who are in the in the EAP. Thank you.
Leland: Yeah.
Yan Mickelson: We have discussed a lot what we call the long term or, and many years perspective, of the consolidation in the growth hormone market. And the trend is happening exactly as I expected, specifically with the entrance of the two other long-eyed things.
Speaker Change: You are right we have discussed a lot with what we call the long term for many years perspective.
Speaker Change: The consolidation and the growth hormone market.
Speaker Change: And the trend is happening exactly as expected.
Speaker Change: Specific with the intent of the two other long acting.
Yan Mickelson: The basic, daily growth hormone is starting to disappear more and more because these two companies that are providing them, the key element where we have seen them taking the market is basically taking their own products, their own product in the daily growth hormone class and thentransforming it over to the long acting where we take it everywhere because of our improved treatment. I see our market share being, basically, the same as we predicted in some way from three, four years ago. What is happening is that the two-oil long-acting will just take part of the daily growth turmoil. We never thought we'd actually be basically having access to it. And so our market penetration, our market share, our market value of Skytrofer is basically unaffected by what we have seen. Go to T-Shit. Transcon, PCH, and the U.S. specifically.
Speaker Change: The basic the daily growth hormone is starting to disappear more and more.
Speaker Change: Because these two company that is providing them the key element, where we have seen them taking market is basic taking their own product.
The one product on the daily growth hormone task and then transport over to build on exiting wherever we take it from everywhere because or improve treatment outcome.
Speaker Change: So.
Speaker Change: I see our market share.
Speaker Change: Basic the same SP, some way predicted from three four years.
Speaker Change: What is happening is that the two oil with long acting, but just take part of the daily growth hormone, we never thought we'd exit will.
Speaker Change: Basic having access to <unk>.
Speaker Change: And so our market penetration our market share our market value of cutoff is basic unaffected to what we have seen.
Speaker Change: Go to <unk>.
Speaker Change: Transcon PTH and the U S specific.
Yan Mickelson: The question you are providing me is between, because our both phase 2 and phase 3, which have... We have very high retention and continue to have extremely high retention now for four or five years. I cannot remember anymore more. The problem is that... I cannot really remember how many patients there are in Europe and the US between the different trials, so therefore, my numbers are a little bit weak in that. I would think it's about 40-60 or something like that, but I am not 100% sure about that.
Speaker Change: The question you are providing me is between.
Speaker Change: Because our both phase II and phase III, which should.
Speaker Change: It should be high retention and continue to have extremely high retention now for 15 years I cannot remember now more.
Speaker Change: The problem is that.
Speaker Change: Sure.
Speaker Change: I cannot really remember how many patient diaries in Europe and U S between the different trials. So therefore in my numbers.
Speaker Change: Weak and that I would think it's about 40, 60 or something like that but I am not 100% sure about that so piece of Scott can give you a number when he is finished the year and send it to you.
Yan Mickelson: So please, Scott can give you the number when he's finished here and send it to you. Great, thank you very much. Thank you. And that's all the time we have for questions and Q&A today. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
Speaker Change: Great. Thank you very much.
Speaker Change: Thank you.
Speaker Change: So all the time, we have for questions Q&A today. Thank you for your participation in today's conference. This does conclude the program you may now disconnect everyone have a great day.
Speaker Change: Have a great day.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].