Q1 2024 Ascendis Pharma A/S Earnings Call & Business Update

May 2, 2024

Operator: Good day, and welcome to the Q1 2024 Ascendis 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, please press star 1 1. We ask that you please limit yourself to one question and a follow-up. As a reminder, this call may be recorded. I would now like to turn the call over to Tim Lee, Senior Director, Investment Relations, Ascendis Pharma. Please go ahead. Thank you, Operator.

Okay.

Operator: Good day, and welcome to the Q1 2024 Ascendis Pharma Earnings Conference Call. At this time, all participants are in listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question, please press star one one. We ask that you please limit yourself to one question and a follow-up. As a reminder, this call may be recorded. I would now turn the call over to Tim Lee, Senior Director, Investor Relations, Ascendis Pharma. Please go ahead.

Speaker Change: Good day and welcome to the Q1 2020 for Cintas Pharma earnings Conference call. At this time, all participants are almost the only mode.

After the Speakers' presentation there'll be a question answer session to ask a question. Please press star one one we ask that you. Please limit yourself to one question and a follow up.

As a reminder, this call maybe recorded.

I'll now turn the call over to Jim Lee Senior director of Investor Relations of Cintas Farmer. Please go ahead.

Timothy J. Lee: Thank you, operator. And thank you, everyone, for joining our first quarter 2024 Financial Results Conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Stina Singel, Executive Vice President of Clinical Development and Oncology, and Joe Kelly, U.S. General Manager.

Tim Lee: Thank you, operator. Thank you everyone for joining our Q1 2024 Financial Results Conference Call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Stina Singel, Executive Vice President of Clinical Development Oncology, and Jay Wu, US General Manager. 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 statement may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA for the US and European markets, as well as certain financial expectations for 2024.

Timothy Lee: Thank you operator, and thank you everyone for joining our first quarter 2024 financial results Conference call I'm, Kim Lee Senior director of Investor Relations at a standard format joining.

Timothy J. Lee: Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Stina Singel, Executive Vice President of Clinical Development and Oncology, and Joe Kelly, U.S. General Manager.

Timothy Lee: Joining me on the call today are yen Medicine, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, Dr. Casino single Executive Vice President of clinical development oncology and.

Timothy Lee: Joe Kelley U S General manager.

Timothy Lee: Before we begin, I'd like to remind you that this conference call will contain forward-looking statements that are intended to be covered 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 SKYTROFA for the U.S. and European markets, as well as certain financial expectations for 2024, our commercialization and development of [inaudible] in EU and expected timing of the FDA review and potential launch of [inaudible] in the U.S, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, 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, and our progress towards Vision 2030.

Timothy Lee: Before we begin I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered 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 Sky Trophy for the U S and European markets as well as <unk>.

Certain financial expectations for 2024.

Tim Lee: Our commercialization and development of YORVIPATH in the EU and expected timing of the FDA review and potential launch of TransCon PTH in the US. Our pipeline candidates and our expectations with respect to their continued progress and potential commercialization. Our strategic plans, our goals regarding our clinical pipeline, including the timing of clinical results, 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 disease, and our progress towards Vision 2030. These statements are based on information that is available to us 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, except as required by law.

Timothy Lee: Our commercialization and development of your.

Timothy Lee: <unk> in the EU and expected timing of the FDA review and potential launch of Transcon PTH in the U S.

Timothy Lee: Our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans our goals regarding our clinical pipeline, including the timing of clinical results are ongoing and planned regulatory filings and our expectations regarding the timing and the result of regulatory decision.

Timothy Lee: our strategic plans, 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, and our progress towards Vision 2030. These statements are based on information that is available to us 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. We assume no obligation to update these statements as a result of circumstantial change, except as required by law.

our strategic plans, 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, and our progress towards Vision 2030.

Timothy Lee: Our ability to create value in multiple therapeutic areas outside of endocrinology rare disease, and our progress towards vision 2030.

These statements are based on information that is available to us 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. We assume no obligation to update these statements as a result of circumstantial change, except as required by law.

Timothy Lee: These statements are based on information that is available to us today.

Timothy Lee: <unk> 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 at 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.

Tim Lee: For additional information concerning the factors that can cause actual results to differ materially, please see our forward-looking statements section in today's press release, and the risk factors section of our most recent annual report on Form 20-F, filed with the SEC on 7 February 2024. TransCon Growth Hormone or TransCon HGH is approved in the US by FDA, and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency. The European Commission and the United Kingdom Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as 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 investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency.

Timothy Lee: For additional information concerning the factors that can cause actual results to differ materially, please see our forward-looking statements section in today's press release and the risk factors section of our most recent annual report on Form 20-F filed with the SEC on February 7th, 2024. Transcon Growth Hormone, or Transcon HGH, is approved in the US by FDA and the EU has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency.

Timothy Lee: 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 on February seven 2024.

Timothy Lee: Transcon growth hormone Transcon Hgh is approved by the group in the U S by FDA and the EU has received a a authorization from the European Commission for the treatment of pediatric growth hormone deficiency. The European Commission in the United Kingdom medicines, and healthcare products regulatory agency.

Timothy Lee: The European Commission and the United Kingdom of Medicines and Healthcare Product Regulatory Agency have granted marketing authorization for Transcon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. Otherwise, please note that our product candidates are investigational and have not been approved for commercial use. As such, the safety and effectiveness of our product candidates have not been reviewed or approved by any regulatory agency.

Timothy Lee: <unk> has granted marketing authorization for transcon PTH as replacement therapy indicated for the treatment of adults with chronic hyperparathyroidism otherwise. Please note that our product candidates our investigation and not approved for commercial use as investigator products for safety and effectiveness of product candidate that have not been reached.

Timothy Lee: Yet or approved by any regulatory agency management statements. During this conference call regarding our product candidates shall be viewed as promotional.

Timothy Lee: 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 first quarter 2024 financial results, and we'll provide further business updates. Following some prepared remarks, we'll open the call up for questions. Please note, with our PDUFA date for Transcon PGH coming up in less than two weeks, we will not comment on our ongoing discussions with FDA, and we will not be taking any questions on this topic today. With that said, let me turn it over to Jan.

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 first quarter 2024 financial results, and we'll provide further business updates. Following some prepared remarks, we'll open the call up for questions.

Tim Lee: None of the statements during this conference call regarding our product candidates shall be viewed as promotional. On the call today, we'll discuss our Q1 2024 financial results, and we'll provide further business updates. Following some prepared remarks, we'll open the call up for questions. Note, with our PDUFA date for TransCon PTH coming up in less than two weeks, we will not comment on our ongoing discussions with FDA, and we will not be taking any questions on this topic today. With that, let me turn over to Jan.

On the call today, we'll discuss our first quarter 2024 financial revolt results and will provide further business updates. Following some prepared remarks, we'll open the call up for questions note with a particular date for transcon PTH coming up in less than two weeks, we will not comment on our ongoing discussions with FDA.

Please note, with our PDUFA date for Transcon PGH coming up in less than two weeks, we will not comment on our ongoing discussions with FDA, and we will not be taking any questions on this topic today. With that said, let me turn it over to Jan.

And we will not be taking any questions on this topic today with that let me turn it over to yet.

Timothy Lee: Okay.

Jan Mikkelsen: Thank you, Tim. Good afternoon, everyone. Ascendis is applying its TransCon technology platform to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients' lives. Two approved TransCon products and solid progress across programs, growing commercial presence and strong partnerships. We believe Ascendis is on the path to sustainable growth and operating cash flow break-even on a quarterly basis by the end of 2024. Our long-term commitment in the last 3, 4 years to build out profitable and robust supply chains. The decision we took in 2023 to streamline the company have made us a leaner and more efficient organization. You can see the progress towards operating cash flow break-even later this year without compromising our development and commercialization progress.

Jan Mikkelson: Thank you Tim. Good afternoon everyone. Ascendis is applying its transformative technology platform to build a leading fully integrated biopharma company focused on making a meaningful difference in patients' lives. With two approved transcon products and solid progress across programs, a growing commercial presence, and strong partnerships, we believe Ascendis is on the path to sustainable growth and operating cash flow quite evenly on a quarterly basis by the end of 2024. Our long-term commitment over the last three, four years to build a profitable and robust supply chain

Yet: Thank you Tim.

Yet: Good afternoon, everyone.

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Yet: You saw the path to sustainable growth and operating cash flow breakeven on a quarterly basis by the end of 'twenty 'twenty four.

Jan Mikkelson: Our long-term commitment over the last three, four years to build a profitable and robust supply chain and the decision we took in 2023 to streamline the company and make us a leaner and more efficient organization. You can see the progress towards operating cash flow [inaudible] later this year without compromising our development and commercialization process.

Yet: Our long term commitment.

Yet: And the last three four years to build are.

Yet: Profitable and robust supply chains.

Jan Moller Mikkelsen: and the decision we took in 2023 to streamline the company and make us a leaner and more efficient organization. You can see the progress towards operating cash flow [inaudible] later this year without compromising our development and commercialization process.

Yet: And the decision we took in 2023 to streamline the company and be offset leaner and more efficient organization.

Yet: You can see the progress towards operating cash flow breakeven data this year.

Yet: Without compromising our development and commercialization.

Jan Moller Mikkelsen: We believe we are well positioned to successfully deliver on our strategic goals and close out our Vision 2030 with regulatory approvals for three independent endocrinology rare disease products and continue building a pipeline in other therapeutic areas. Looking to Vision 2030, we believe each of our twin vertices is an economic [inaudible] and has the potential to achieve blockbuster status, while we also further expand our pipeline and transport platform for future innovation. We have seen validation of our commercialization approach with the ongoing success of SKYTROFA in the US and are seeing it again with the successful launch of Europass in Germany and Austria. In the U.S., the PDUFA date for transport PTAs is coming up in less than two weeks on May 14th. If approved, we expect to be ready to launch in the U.S soon thereafter in the third quarter.

Jan Mikkelsen: We believe we are well-positioned to successfully deliver on our strategic goals and close out our Vision 3x3 with regulatory approvals for three independent endocrinology rare disease products and continue building a pipeline in other therapeutic areas. Looking to Vision 2030, we believe each of our three rare disease endocrinology programs have the potential to achieve blockbuster status, while we also further expand our pipeline and TransCon platform for future innovation. We have seen validation of our commercialization approach with the ongoing success of SKYTROFA in the US, and are seeing it again with successful launch of YORVIPATH in Germany and Austria. In the US, the PDUFA date for TransCon PTH is coming up in less than 2 weeks on 14 May. If approved, we expect to be ready to launch in the US soon thereafter in Q3.

Yet: We believe we are well positioned to sub six fully deliver on our strategic goals and close out or efficient sweep Archie with regulatory approvals what suite independent into endocrinology rare disease product and continue building a pipeline in other therapeutic.

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Yet: Moving to vision 2030, we believe each of our three rare disease endocrinology and Broadcom.

Yet: With the potential to achieve blockbuster status, while we also further expand our pipeline and transport platform for future innovation.

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Yet: In the U S that could do for data for transport Pkc's coming off in less than two weeks of May.

Jan Moller Mikkelsen: Now, let me give an update on each of our products. When we launched SKYTROFA in the U.S., about two years ago, we had two goals. One, to make SKYTROFA the leading organ there, the second to drive the U.S. growth hormone market to become a $3 billion market. Our strategy is [inaudible] thousand of patients [inaudible] the venue leader in the U.S. We have a reliable supply chain, ensuring that every patient can benefit from SKYTROFA once they have approval from their physician. We estimate that SKYTROFA penetration in the U.S. pediatric growth hormone deficiency patient population grew to about 17 at the end of the first quarter.

Yet: If approved we expect to be ready to launch in the U S. Soon thereafter in the third quarter.

Jan Mikkelsen: Now, let me give an update on each of our programs. When we launched SKYTROFA in the US about two years ago, we had two goals. One, to make SKYTROFA the leading product in there. The second, to drive US growth hormone market to become a $3 billion market. Our strategy is working. Thousands of patients are now treated with SKYTROFA, the value leader in the US. We have a reliable supply chain ensuring that every patient can benefit from SKYTROFA once they have approval from their insurance company. We estimate that SKYTROFA penetration in the US pediatric growth hormone deficiency patient population grow to about 17% at the end of the first quarter. We are proud to observe SKYTROFA extend its market value leadership as the only growth hormone product to grow in value in Q1 2024 based on reported results.

Yet: Now, let me give an update on each of our programs.

Yet: When we launch scheduled for the U S about two years ago.

Jan Moller Mikkelsen: One, to make scottofa the leading organ there. The second to drive the U.S. Gold Hormone Market to become a $3 billion market. [inaudible] Thousand of Patients and Our Treatment is Control, the venue leader in the U.S. We have a reliable supply chain, ensuring that every patient can benefit from scratch-off once they have approval from their Q&A. We estimate that Skytofa penetration in the U.S. pediatric growth hormone deficiency patient population grew to about 17 at the end of the first quarter.

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Yet: We estimate that's got full penetration in the U S pediatric growth hormone deficiency patient population growth to about 70 at the end of the first quarter.

Jan Moller Mikkelsen: We are proud to observe SKYTROFA extend its market value leadership as the only growth hormone product to grow in value in the first quarter of 2024, based on reported results. And we believe SKYTROFA will expand the U.S. [inaudible] with the potential to become a blockbuster in the U.S. alone.

Yet: We are proud to officers cutover.

Yet: Its market value leadership as the only growth hormone product to grow in value in the first quarter of 2004 based on reported results.

Jan Mikkelsen: We believe SKYTROFA will expand the US growth hormone with the potential to become a blockbuster in the US alone. SKYTROFA sales this quarter more than doubled compared to Q1 2022, with a steady quarter-to-quarter increase in treated patients. We expect to continue this trend rest of this year. With these strong SKYTROFA results, we continue to expect the full year 2024 SKYTROFA revenue will be between EUR 320 and 340 million, representing year-to-year growth of 80% to 90%. We expect SKYTROFA sales to continue to grow through further penetration in the pediatric growth hormone setting. To further solidify growth, we're also pursuing our first label expansion in adult growth hormone deficiency, for which we plan to submit a supplemental BLA to the FDA in Q3 this year.

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Jan Moller Mikkelsen: SKYTROFA sales this quarter more than doubled compared to the first quarter of 2023, with a steady quarter-to-quarter increase in [inaudible]. We expect to continue this trend for the rest of this year. With these strong SKYTROFA results, we continue to expect the full year 2021 SKYTROFA revenue will be between 320 to 340 million euros, representing year-to-year growth of 80 to 90 percent.

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Yet: We expect to continue this trend.

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Yet: With this strong schedule group results, we continue to expect the full year 2020 for Scott Caufield revenue will be between $322 million to $340 million.

Yet: Representing year to year growth.

Yet: Two 9%.

Jan Moller Mikkelsen: We expect SKYTROFA sales to continue to grow through further penetration in the pediatric [inaudible]. To further solidify growth, we are also pursuing our first labelled expansion in adult [inaudible], for which we plan to submit and supplement BLA to the FDA in the third quarter of this year. In addition, we expect top-line data from our Phase II trial internal sample in the fourth quarter of 2024. Now, turning to transcon PTAs, in Europe, Europat was launched in Germany and Austria at the end of January with the early launch objective of building physician experience with Europat.

We expect SKYTROFA sales to continue to grow through further penetration in the pediatric [inaudible]. To further solidify growth, we are also pursuing our first labelled expansion in adult [inaudible], for which we plan to submit and supplement BLA to the FDA in the third quarter of this year.

Yet: We expect <unk> to continue to grow through further penetration in the pediatric option.

Yet: To further our solid <unk> growth. We are also pursuing our firstly with expansion in adults co promote efficiency.

Yet: We plan to submit and supplemental BLA to the FDA in the third quarter of this year.

Jan Mikkelsen: In addition, we expect top-line data from our phase 2 trial in Turner syndrome in Q4 2024. Now turning to TransCon PTH. In Europe, YORVIPATH was launched in Germany and Austria at the end of January with the early launch objective of building physician experience with YORVIPATH. Initial physician feedback from YORVIPATH has been positive. Just 8 weeks in the launch, we estimate prescriptions have been written by 55 doctors, representing around 25% of the target prescribing base, with about 100 patients receiving commercial product. As physicians begin to get comfort with the treatment benefit of YORVIPATH in the first patients, we expect physicians to take more and more of the patients on treatment.

In addition, we expect top-line data from our Phase II trial internal sample in the fourth quarter of 2024. Now, turning to transcon PTAs, in Europe, Europat was launched in Germany and Austria at the end of January with the early launch objective of building physician experience with Europat.

Yet: In addition, we expect top line data from all phase III trials into inner circle in the fourth quarter of 2024.

Yet: Yes.

Yet: Now turning to Transcon PTH in Europe.

Yet: OPEC was locked in Germany, and Austria and the impact January.

Yet: Early launch objective of building future physician experience with your pets.

Jan Moller Mikkelsen: Initial physician feedback from Europe has been positive. Just eight weeks in the launch, we estimate prescriptions have been written by 55% of doctors representing around 25% of the target prescribing base with about 100 patients receiving commercial products. As physicians begin to get comfortable with the treatment benefits that you offer in the first patient, we expect physicians to take more and more of the patient's treatment. As we expand our geographic reach of Europe to our Europe Direct and our international market sector, we are supporting named patients, supply programs, and plan to provide reimbursed product to meet the needs of patients. In the U.S., pre-launch preparations are underway, including the expansion of the U.S. field infrastructure, while we are awaiting FDA's decision.

Yet: Initial physician feedback from Europe has.

Yet: Being positive.

Yet: Eight weeks in the logs, we estimate prescriptions have been written back 55 Dr.

Yet: Doctor represent.

Yet: Around 25% of the target prescriber base.

Yet: About 100 patients receiving conventional crop.

Yet: Exposition begin to get comfort with the treatment benefit if you will appear in the first patients we expect the system to take more and more of the patients are treated.

Jan Mikkelsen: As we expand our geographic reach of YORVIPATH to our Europe direct and our international market segment, we are supporting named patient supply programs and plan to provide reimbursed product to meet the needs of patients. In the US, pre-launch preparations are underway, including the expansion of the US field infrastructure while we are waiting FDA's decision. Moving now to TransCon CNP. Our value proposition with TransCon CNP is simple. It's to establish a treatment for patients of all ages with achondroplasia. Our ambition is to address the significant comorbidities associated with achondroplasia that impact health and quality of life, as well as linear growth. Later this year in Q3, we plan to report top-line results for our pivotal ApproaCH trial, which is measuring not only linear growth, but also physical function, body composition, and quality of life parameters.

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Yet: We are supporting named patient.

Yet: Supply programs and plan to provide reimbursed product to meet the needs of patients.

Jan Moller Mikkelsen: we are supporting named patients, supply programs, and plan to provide reimbursed product to meet the needs of patients. In the U.S., pre-launch preparations are underway, including the expansion of the U.S. field infrastructure, while we are awaiting FDA's decision. Moving now to Transcon CMQ

we are supporting named patients, supply programs, and plan to provide reimbursed product to meet the needs of patients. In the U.S., pre-launch preparations are underway, including the expansion of the U.S. field infrastructure, while we are awaiting FDA's decision.

Yet: In the U S prelaunch preparation underway, including the expansion of the U S infrastructure.

Yet: Beijing Fda's decision.

Moving now to Transcon CMP, our value proposition with Transcon CMP is set to establish a treatment for patients of all ages with achondroplasia. Our ambition is to address the significant comorbidities associated with acondroplasia that impact health and quality of life as well as linear growth. Later this year, in the third quarter, we plan to report top-line results for our [inaudible] approved trial, which is measuring not only linear growth but also physical function, body composition, and quality of life parameters. We are also evaluating Transcon CMP in newborns with achondroplasia less than two years of age. We believe that treatment of achondroplasia with Transcon CMP as early as possible might mitigate associated comorbidities.

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Jan Moller Mikkelsen: our value proposition with Transcon CMP is set to establish a treatment for patients of all ages with achondroplasia. Our ambition is to address the significant comorbidities associated with acondroplasia that impact health and quality of life as well as linear growth. Later this year, in the third quarter, we plan to report top-line results for our [inaudible] approved trial, which is measuring not only linear growth but also physical function, body composition, and quality of life parameters. We are also evaluating Transcon CMP in newborns with achondroplasia less than two years of age. We believe that treatment of achondroplasia with Transcon CMP as early as possible might mitigate associated comorbidities.

Yet: Our value proposition with Transco CMP is simple.

Yet: Is to us that as a treatment for patients of all ages with echo location.

Yet: Our ambition is to address the significant comorbidities associated with excellent location that impact health and quality of life.

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Yet: Later this year in the third quarter, we plan to report top line results for our pivotal approach trial.

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Jan Mikkelsen: We are also evaluating TransCon CNP in newborns with achondroplasia less than 2 years of age. We believe that treating achondroplasia with TransCon CNP as early as possible might mitigate associated comorbidities. In addition, to provide catch-up growth to children who did not receive early treatment, we are evaluating TransCon CNP in combination with TransCon Growth Hormone. We expect to enroll all patients in this trial this quarter and provide 26-week top-line data for this trial in Q3-Q4 this year. This is our integrated approach to address achondroplasia with multiple trials that are all building towards one goal, to treat the disease. We are optimistic that our highly differentiated product candidate will continue to show best-in-class potential across these multiple studies. Switching now to oncology.

Yet: We are also evaluating transcon CMP in newborns.

Yet: Colocation.

Yet: Less than two years offerings.

Yet: We believe that treatment echolocation trial could CMP as early as possible.

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Jan Moller Mikkelsen: In addition, to provide catch-up growth to children who did not receive early treatment, we are evaluating Transcon CMP in combination with Transcon [inaudible]. We expect to enroll all patients in this trial this quarter and provide 26-week top-line data for this trial in the third quarter of this year. This is our integrated approach to address achondroplasia with multiple trials that are all building towards one goal, to treat the disease. And we are optimistic that our highly differentiated product candidate will continue to show best-in-class potential across these multiple studies.

Yet: In a tissue.

Yet: To provide catch outgrowth to children, who did not receive early treatment.

Yet: Transcon, CMP and combination with transcon growth hormone.

Yet: We expect to enroll all patients in this trial this quarter and provide 26 week top line data for this trial in fourth quarter of this year.

Yet: This is our integrated approach.

Yet: To address Eklund, a peso with multiple trials.

Yet: All building towards <unk> to treat the disease and we are optimistic that our highly differentiated product candidate with continued to show a best in class protection across multiple studies.

Yet: The fixing now to oncology.

Jan Moller Mikkelsen: Switching now to oncology, both TRANSCON IL-2 Beta-Garmin and TRANSCON TLR-78 Agonist have shown promising clinical activity as monotherapy and in combination treatment with PEMBO in late stage patients whose disease has progressed after standard of care treatment. Next month at ASCO, we will report updated patient data from the ongoing Phase I/II [inaudible] that was reported last year at ESMO. We will present updated clinical data and new biomarker data that further differentiate our clinical program.

Jan Mikkelsen: Both TransCon IL-2 beta gamma and TransCon TLR7/8 agonist have showed promising clinical activity as monotherapy and in combination treatment with pembro in late-stage patients whose disease has progressed after standard of care treatments. Next month at ASCO, we will report updated patient data from the ongoing phase 1, 2 trial, I believe, that has been reported last year at ESMO. We will present updated clinical data and new biomarker data that further differentiate our clinical program. We will also report promising early data from the ongoing dose expansion cohort of patients with melanoma who have progressed from checkpoint inhibitors using the combination of TransCon IL-2 beta gamma and TransCon TLR agonist in these patients. Later this year, in Q3, Q4, we expect data read out in several well-defined patient populations from our TransCon IL-2 beta gamma and TransCon TLR7/8 agonist programs.

Yet: Both transport <unk> carbon and Transcon <unk> 70 equities.

Yet: Promising clinical activity as monotherapy and in combination treatment the painful in.

Yet: In late stage patient, whose disease has progressed after standard of care treatments.

Yet: Next month at ESMO.

Yet: Report updated patient data from the ongoing phase one two.

Yet: I believe that has been reported last year.

Yet: We will present updated clinical data a new biomarker data that further differentiate our clinical program.

Jan Moller Mikkelsen: We will also report promising early data from the ongoing dose-expansion cohort of patients with melanoma who have progressed from checkpoint to epitopes using the combination of transcon, IL-2-beta-gamma, and transcon-TLR agonists in these patients. Later this year, in the fourth quarter, we expect data from several well-defined patient populations from our TRANSCON IL-2-beta gamma and TRANSCON TLR. Our achievement this quarter gives me further confidence that all the elements are in place to fulfill our strategic goals to deliver three independent endocrinology rare disease blockbuster drugs and a strong pipeline in large cell therapeutic areas such as oncology, ophthalmology, and metabolic diseases, with much more to come. I will now turn it over to Scott.

We will also report promising early data from the ongoing dose-expansion cohort of patients with melanoma who have progressed from checkpoint to epitopes using the combination of transcon, IL-2-beta-gamma, and transcon-TLR agonists in these patients. Later this year, in the fourth quarter, we expect data from several well-defined patient populations from our TRANSCON IL-2-beta gamma and TRANSCON TLR.

Yet: We will also report promising early data from the ongoing dose expansion cohort of patients.

Yet: Melanoma will have progressed on checkpoint.

Yet: So you've seen the combination of <unk> and Transco CLO equities in these patients.

Yet: Later this year in the fourth quarter, we expect data readouts, several well defined patient population from our transcon <unk> Governor and transcoding Telos seven eight.

Our achievement this quarter gives me further confidence that all the elements are in place to fulfill our strategic goals to deliver three independent endocrinology rare disease blockbuster drugs and a strong pipeline in large cell therapeutic areas such as oncology, ophthalmology, and metabolic diseases, with much more to come. I will now turn it over to Scott.

Yet: Programs.

Jan Mikkelsen: Our achievement this quarter give me further confidence that all the elements are in place to fulfill our strategic goals to deliver three independent endocrinology rare disease product, and a strong pipeline in larger therapeutic areas such as oncology, ophthalmology, and metabolic diseases. With much more to come. I will now turn it over to Scott.

Yet: Our achievement this quarter give me further confidence that all the elements are in place to fulfill our strategic goal to deliver three independent endocrinology rare disease Doctor program.

Yet: Our strong product in <unk>.

Speaker Change: So tycho thanks, Eric.

Yet: Quality of commodity and metabolic diseases.

Speaker Change: But more to come.

Yet: I will now turn it over to Scott.

Scott Smith: Jan Mikkelsen. In Q1, we demonstrated significant financial progress toward our 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 6-K filed today. SKYTROFA revenue for Q1 2024 was EUR 65 million compared to EUR 31.6 million reported in Q1 2023, an increase of 106% year-over-year. This growth was driven by significant increase in demand volume, more than doubling compared to the prior year period, with a slight offset by a combination of slower channel build, coverage mix, and a modest negative currency impact of EUR -0.8 million.

Scott Smith: Thanks Jan. In Q1, we demonstrated significant financial progress toward our 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 6-K filed today.

Scott: Tuck in.

Scott: In Q1, we demonstrated significant financial progress toward our goal of becoming operating cash flow breakeven on a quarterly basis by the end of 2024.

Scott: I will touch on some key points surrounding our financial results, but for further details. Please refer to our 6K filed today.

Scott Smith: SKYTROFA revenue for the first quarter of 2024 was €65 million, compared to €31.6 million reported in the first quarter of 2023, an increase of 106% year over year. This growth was driven by a significant increase in demand volume, more than doubling compared to the prior year period, with a slight offset by a combination of slower channel build, coverage mix, and a modest negative currency impact of €0.8 million. On a sequential basis, first quarter SKYTROFA revenue increased 1% compared to the fourth quarter of 2023. Strong mid-teens percent demand volume growth was offset primarily by seasonal channel inventory, copay resets, insurance reauthorizations, and a modest negative currency impact of €0.6 million.

Scott: Sky truckload revenue for the first quarter of 2024 was $65 million euro compared to $31 6 million Euro reported in the first quarter of 2023, an increase of 106% year over year.

Scott: This growth was driven by significant increase in demand volume more than doubling compared to the prior year period with a slight offset by a combination of slower channel build coverage mix and a modest negative currency impact of $1 8 million Europe.

Scott Smith: On a sequential basis, Q1 SKYTROFA revenue increased 1% compared to Q4 of 2023. Strong mid-teens% demand volume growth was offset primarily by seasonal channel inventory, co-pay resets, insurance reauthorizations, and a modest negative currency impact of EUR 0.6 million. Q1 was in line with our high internal expectations, and with seasonal headwinds behind and the steady pace of new patient adds expected to persist, we continue to expect full-year SKYTROFA revenue to be in the range of EUR 300 million to 340 million at average 2023 exchange rates. Shifting to TransCon PTH, YORVIPATH contributed for the first time this quarter, with revenue of EUR 1.5 million representing two months of shipments.

Scott: On a sequential basis first quarter Sky revenue increased 1% compared to the fourth quarter of 2023.

Scott Smith: Strong mid-teens percent demand volume growth was offset primarily by seasonal channel inventory, copay resets, insurance reauthorizations, and a modest negative currency impact of €0.6 million. Q1 was in line with our high internal expectations and with seasonal headwinds behind and the steady pace of new patient ads expected to persist,

Strong mid-teens percent demand volume growth was offset primarily by seasonal channel inventory, copay resets, insurance reauthorizations, and a modest negative currency impact of €0.6 million.

Scott: <unk> mid teens percent demand volume growth was offset primarily by seasonal channel inventory co pay resets insurance reauthorization, and a modest negative currency impact of $1 6 million Euro.

Q1 was in line with our high internal expectations and with seasonal headwinds behind and the steady pace of new patient ads expected to persist, we continue to expect full-year SKYTROFA revenue to be in the range of 320 million euros to 340 million euros at average 2023 exchange rates. Shifting to Transcon PTH, [inaudible] contributed for the first time this quarter with revenue of 1.5 million euros, representing two months of shipments.

Scott: Sure.

Scott: Q1 was in line with our high internal expectations and with seasonal headwinds behind and the steady pace of new patient adds expected to persist. We continue to expect full year Sky trial for revenue to be in the range of $320 million Europe to 340 million Euro at average 2023 exchange rates.

Scott Smith: we continue to expect full-year SKYTROFA revenue to be in the range of 320 million euros to 340 million euros at average 2023 exchange rates. Shifting to Transcon PTH, [inaudible] contributed for the first time this quarter with revenue of 1.5 million euros, representing two months of shipments. In Germany and Austria, we ship directly to retail pharmacies for patient pickup, and as a result, there is no channel inventory buildup compared to a typical U.S. launch like we saw with SKYTROFA, where specialty pharmacies hold channel inventory.

we continue to expect full-year SKYTROFA revenue to be in the range of 320 million euros to 340 million euros at average 2023 exchange rates. Shifting to Transcon PTH, [inaudible] contributed for the first time this quarter with revenue of 1.5 million euros, representing two months of shipments.

Scott: Shifting to Transcon PTH yoga path contributed for the first time this quarter with revenue of $1 5 million euro representing two months of shipments.

In Germany and Austria, we ship directly to retail pharmacies for patient pickup, and as a result, there is no channel inventory buildup compared to a typical U.S. launch like we saw with SKYTROFA, where specialty pharmacies hold channel inventory.

Scott Smith: In Germany and Austria, we ship directly to retail pharmacies for patient pickup, and as a result, there is no channel inventory buildup compared to a typical US launch like we saw with SKYTROFA, where specialty pharmacies hold channel inventory. Closing out the top line, total revenue for Q1 was EUR 95.9 million, including EUR 24.8 million of non-cash license revenue recognized in relation to the formation of VISEN, and EUR 3 million of service revenue related to VISEN, which is offset in operating expenses. Turning to expenses, R&D costs in Q1 totaled EUR 70.7 million compared to EUR 106.1 million during Q1 2023.

Scott: In Germany, and Austria, we ship directly to retail pharmacies for patient pickup.

Scott: And as a result, there is no channel inventory buildup compared to a typical U S launch like we saw with Sky Trophy, where specialty pharmacy as whole channel inventory.

Scott Smith: Closing out the top line, total revenue for the first quarter was €95.9 million, including €24.8 million of non-cash license revenue recognized in relation to the formation of Iconis and €3 million of service revenue related to Iconis, which is offset by operating expenses. Turning to expenses, R&D costs in the first quarter totaled 70.7 million euros compared to 106.1 million euros during the first quarter of 2023. The 33% decline was largely tied to lower external development costs for Transcon growth hormone and Transcon PTH, including a reversal of prior period write-downs of prelaunch inventories, as well as oncology programs, partially offset by an increase in Transcon CMP costs.

Closing out the top line, total revenue for the first quarter was €95.9 million, including €24.8 million of non-cash license revenue recognized in relation to the formation of Iconis and €3 million of service revenue related to Iconis, which is offset by operating expenses.

Scott: Closing out the top line total revenue for the first quarter was $95 9 million euro, including $24 8 million Euro of noncash license revenue recognized in relation to the formation of iconic and 3 million of service revenue related to Eikon us, which is offset in operating expenses.

Turning to expenses, R&D costs in the first quarter totaled 70.7 million euros compared to 106.1 million euros during the first quarter of 2023. The 33% decline was largely tied to lower external development costs for Transcon growth hormone and Transcon PTH, including a reversal of prior period write-downs of prelaunch inventories, as well as oncology programs, partially offset by an increase in Transcon CMP costs. Sequentially, R&D costs declined 22%.

Scott Smith: Sequentially, R&D costs declined 22%. SG&A expenses in the quarter totaled 66.8 million euros, essentially flat compared to 66.5 million euros during the first quarter of 2023. Higher employee costs, including the impact from commercial expansion, were partially offset by lower external pre-launch and administrative expenses. Sequentially, SG&A expenses increased 4%. Total operating expenses were €137.5 million for the first quarter, a 20% decrease compared to the €172.7 million during the first quarter of 2023. Sequentially, operating expenses declined 11%.

Sequentially, R&D costs declined 22%.

Scott: Turning to expenses R&D costs in the first quarter totaled $70 7 million euro compared to $106 1 million narrow during the first quarter of 2023.

SG&A expenses in the quarter totaled 66.8 million euros, essentially flat compared to 66.5 million euros during the first quarter of 2023. Higher employee costs, including the impact from commercial expansion, were partially offset by lower external pre-launch and administrative expenses. Sequentially, SG&A expenses increased 4%. Total operating expenses were €137.5 million for the first quarter, a 20% decrease compared to the €172.7 million during the first quarter of 2023. Sequentially, operating expenses declined 11%.

Scott Smith: The 33% decline was largely tied to lower external development costs for TransCon Growth Hormone and TransCon PTH, including a reversal of prior period write-downs of pre-launch inventories, as well as oncology programs, partially offset by an increase in TransCon CNP costs. Sequentially, R&D costs declined 22%. SG&A, sorry, SG&A expenses in the quarter totaled EUR 66.8 million, essentially flat compared to EUR 66.5 million during Q1 2023. Higher employee costs, including the impact from commercial expansion, was partially offset by lower external pre-launch and administrative expenses. Sequentially, SG&A expenses increased 4%. Total operating expenses were EUR 137.5 million for the first quarter, a 20% decrease compared to EUR 172.7 million during Q1 2023. Sequentially, operating expenses declined 11%.

Scott: The 33% decline was largely tied to lower external development cost for transcon growth hormone and transcon PTH, including a reversal of prior period write downs of prelaunch inventories.

Scott: As well as oncology programs, partially offset by an increase in transcon CMP costs sequentially.

Scott: R&D costs declined 22%.

Scott: SG&A, sorry, SG&A expenses in the quarter totaled $66 8 million Euro essentially flat compared to $66 5 million euro during the first quarter of 2023 higher employee costs, including the impact from commercial expansion.

Scott: Was partially offset by lower external prelaunch and administrative expenses sequentially SG&A expenses increased 4%.

Scott: Total operating expenses were $137 5 million euro for the first quarter, a 20% decrease compared to the $172 7 million during the first quarter of 2023 sequentially.

Scott: Sequentially operating expenses declined 11%.

Scott Smith: Overall, our operating loss in the first quarter totaled 49.1 million euros compared to an operating loss of 143.7 million euros during the first quarter of 2023, as a result of increased revenue and lower operating expenses. Sequentially, operating loss increased 34%. Finance expense in the quarter was 77.2 million euros compared to 8.4 million euros expense in the fourth quarter of last year. This higher finance expense was largely driven by a non-cash derivative loss tied to our outstanding convertible notes.

Overall, our operating loss in the first quarter totaled 49.1 million euros compared to an operating loss of 143.7 million euros during the first quarter of 2023, as a result of increased revenue and lower operating expenses. Sequentially, operating loss increased 34%.

Scott Smith: Overall, our operating loss in Q1 totaled EUR 49.1 million compared to an operating loss of EUR 143.7 million during Q1 2023 as a result of increased revenue and lower operating expenses. Sequentially, operating loss increased 34%. Finance expense in the quarter was EUR 77.2 million compared to EUR 8.4 million expense in Q4 last year. This higher finance expense was largely driven by a non-cash derivative loss tied to our outstanding convertible notes. Quick comment on the balance sheet.

Scott: Overall, our operating loss in the first quarter totaled $49 1 million euro compared to an operating loss of $143 7 million Euro during the first quarter of 2023 as a result of increased revenue and lower operating expenses.

Scott: Sequentially operating loss increased 34%.

Finance expense in the quarter was 77.2 million euros compared to 8.4 million euros expense in the fourth quarter of last year. This higher finance expense was largely driven by a non-cash derivative loss tied to our outstanding convertible notes.

Scott: Finance expense in the quarter was $77 2 million compared to $8 4 million Euro expense in the fourth quarter of last year.

Scott: Higher finance expense was largely driven by a noncash derivative loss tied to our outstanding convertible notes.

Scott Smith: A quick comment on the balance sheet. As of March 31, 2024, due to amended IFRS rules which came into effect on January 1, 2024, you'll notice our convertible notes with a face value of 575 million US dollars are now reported as current liabilities. Even though they do not mature until April 2028, it would not require cash settlement in the case of conversion by holders. IFRS still requires the carrying value of the convertible notes and associated derivative liabilities to be presented separately within current liabilities, which together total 622 million euros. As per IFRS rules, comparative amounts have been reclassified to reflect the change in presentation. The applied amendments had no other impact on the financial statements.

Scott: Quick comment on the balance sheet as of March 31, 2024, due to amended Ifr's rules, which came into effect on January one 2024, Youll notice our convertible notes with face value of $575 million are now reported as current liabilities, even though they do not mature until April.

Scott Smith: As of 31 March 2024, due to amended IFRS rules, which came into effect on 1 January 2024, you'll notice our convertible notes with face value of $575 million are now reported as current liabilities, even though they do not mature until April 2028 and would not require cash settlement in case of conversion by holders. IFRS still requires the carrying value of the convertible notes and associated derivative liabilities to be presented separately within current liabilities, which together total EUR 622 million. As per IFRS rules, comparative amounts have been reclassified to reflect the change in presentation. The applied amendments had no other impact on the financial statements. We ended the Q1 with cash and cash equivalents totaling EUR 320 million.

Scott: 2028, and would not require cash settlement in case of conversion by holders IRS still requires the carrying value of the convertible notes and associated derivative liabilities to be presented separately within current liabilities, which together totaled $622 million euro.

Scott: As per <unk> rose comparative amounts have been reclassified to reflect the change in presentation. The applied amendments had no other impact on the financial statements.

Scott Smith: We ended the first quarter with cash and cash equivalents totaling €320 million. And 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 2023 exchange rates. We expect total operating expenses (SG&A) and R&D to be approximately 600 million euros, and we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024.

Scott: We ended the first quarter with cash and cash equivalents totaling $320 million Europe.

Scott Smith: For the full year 2024, based on current plans, we expect SKYTROFA revenue to be in the range of EUR 320 to 340 million at average 2023 exchange rates. We expect total operating expenses, SG&A, and R&D to be approximately EUR 600 million, and we expect to be operating cash flow break even on a quarterly basis by the end of 2024. Let me now also highlight selected key milestones. For TransCon Growth Hormone, we now plan to submit an sBLA to FDA for adult GHD in Q3 2024 compared to the previous plan of Q2, and we expect to report top-line results from our Phase 2 Turner syndrome trial in Q4 2024.

Scott: And for the full year 2024 based on current plans, we expect sky trough of revenue to be in the range of 320 to 330 to sorry to 340 million Euro at average 2023 exchange rates.

Scott: We expect total operating expenses SG&A and R&D to be approximately 600 million euro.

Scott: And we expect to be operating cash flow breakeven on a quarterly basis by the end of 2024.

Scott Smith: Let me now also highlight selected key milestones. For Transcon Growth Hormone, we now plan to submit an SBLA to FDA for adult GHD in the third quarter of 2024 compared to the previous plan of Q2, and we expect to report top-line results from our Phase II Turner Syndrome trial in the fourth quarter of 2024. For Transcon PTH, in the US, our PDUFA date is May 14th, 2024. If approved, we plan to launch it as YORVIPATH as quickly as possible thereafter. Outside the US, with a commercial rollout of YORVIPATH underway in Germany and Austria, we plan to roll out YORVIPATH in our Europe Direct and International Markets segments throughout 2024 and 2025.

Scott: Let me now also highlight selected key milestones for transcon growth hormone, we now plan to submit an S. BLA to FDA for adult ghd in the third quarter of 2024 compared to the previous plan of Q2 and.

Scott: And we expect to report topline results from our Phase III Turner syndrome trial in the fourth quarter of 2024.

Scott Smith: For TransCon PTH, in the US, our PDUFA date is 14 May 2024. If approved, we plan to launch it as YORVIPATH as quickly as possible thereafter. Outside the US, with a commercial rollout of YORVIPATH underway in Germany and Austria, we plan to roll out YORVIPATH in our Europe Direct and international markets segments throughout 2024 and 2025. For TransCon CNP, we expect to report top-line results from the pivotal APPROACH trial, as well as submit our NDA for treatment of children with achondroplasia, both in Q4 2024, and also report week 26 top-line data from the COACH trial in combination with TransCon Growth Hormone, also in Q4 2024.

Scott: For Transcon PTH in the U S. Our <unk> date is May 14, 2024, if approved we plan to launch it as whoever that path as quickly as possible thereafter.

Scott: Outside the U S with a commercial rollout of yoga path underway in Germany, and Austria, we plan to rollout Euro path in our Europe direct and international markets segments throughout 2024 and 2025.

Scott Smith: For TransCon CMP, we expect to report top-line results from the Pivotal Approach trial, as well as submit our NDA for treatment of children with achondroplasia, both in the fourth quarter of 2024, and also report Week 26 top-line data from the COACH trial in combination with TransCon Growth Hormone, also in the fourth quarter of 2024. Within our oncology therapeutic area, during the fourth quarter of 2024, we plan to provide a clinical update from the Phase II indication-specific dose expansion cohorts from our TRANSCON IL-2 Beta Gamma and TRANSCON TLR-78 Agonist clinical trials. With that, operator, we are now ready to take questions.

Scott: For Transcon <unk>, we expect to report topline results from the pivotal approach trial as well as submit our NDA for treatment of children with achondroplasia. Both in the fourth quarter of 2024, and also report week 26 top line data from the coach trial in combination with transcon growth hormone.

Scott: Also in the fourth quarter of 2024.

Scott Smith: Within our oncology therapeutic area, during Q4 2024, we plan to provide a clinical update from the phase II indication-specific dose expansion cohorts from our TransCon IL-2 β/γ and TransCon TLR7/8 agonist clinical trials. With that, operator, we are now ready to take questions.

Scott: Within our oncology therapeutic area during the fourth quarter of 2024, we plan to provide a clinical update from the phase II indication specific dose expansion cohorts from our transcon IL, two beta gamma and transcon <unk> agonists clinical trials.

Operator: Thank you. If you would like to ask a question, please press star 1, 1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1, 1 again. We ask that you please limit yourself to one question and a follow-up. Our first question comes from Jessica Fye with J.P. Morgan. Your line is open. Hey guys, good afternoon. Thanks for taking my question. I was hoping you could talk about how April looked for Yorvapth in Europe and maybe elaborate a little more on the 1Q dynamics you mentioned for SKYTROFA. Thank you.

Speaker Change: With that operator, we're now ready to take questions.

Operator: Thank you. If you'd like to ask a question, please press star one one. If your question has been answered and you'd like to remove yourself from the queue, please press star one one again. We ask that you please limit yourself to one question and a follow-up. Our first question comes from Jessica Fye with J.P. Morgan. Your line is open.

Operator: We ask that you please limit yourself to one question and a follow-up. Our first question comes from Jessica Fye with J.P. Morgan. Your line is open.

Speaker Change: Thank you.

Speaker Change: I'd like to ask a question. Please press star one one.

Speaker Change: My question has been answered and you'd like to remove yourself from the queue. Please press star one again, we ask that you. Please limit yourself to one question and a follow up.

Speaker Change: Our first question comes from Jessica Fye with JP Morgan Your line is open.

Jessica Fye [Managing Director and Equity Research Analyst: Hey, guys. Good afternoon. Thanks for taking my question. I was hoping you could talk about how April looked for YORVIPATH in Europe and maybe elaborate a little more on some of those 1Q dynamics you mentioned for SKYTROFA. Thank you.

Jessica Fye: Hey, guys. Good afternoon. Thanks for taking my question. I was hoping you could talk about how April looked for YORVIPATH in Europe and maybe elaborate a little more on some of those 1Q dynamics you mentioned for SKYTROFA. Thank you.

Jessica Macomber Fye: Hey, guys. Good afternoon, Thanks for taking my question.

Jessica Fye: Hey guys, good afternoon. Thanks for taking my question. I was hoping you could talk about how April looked for YORVIPATH in Europe and maybe elaborate a little more on the 1Q dynamics you mentioned for SKYTROFA. Thank you.

Jessica Macomber Fye: Hoping you could talk about how April looked for your B pack in Europe, and maybe elaborate a little more on some of those <unk> dynamics you mentioned four skytrooper. Thank you.

Scott Smith: Should we start, Kasper? Yeah. So related to the Q1 dynamics, what we saw for SKYTROFA, I'll take the second part first. What we saw would be, I would describe as a typical seasonality that you would see with other maturing launches, where coverage updates at the beginning of the year led to insurance reauthorizations, copay resets, and also led to a slightly different mix in the channel. Our channel partners basically updated their inventories as appropriate. It feels like those basically all cleared out by the end of February. Then on the first question related to the development of YORVIPATH in April, you know, we continue to, as we said, you know, we'll come out with an update overall in revenue later this year.

Scott Smith: Yeah, so related to the Q1 dynamics we saw for SKYTROFA, I'll take the second part first, what we saw I would describe as a typical seasonality that you would see with other maturing launches where coverage updates at the beginning of the year led to insurance reauthorizations, copay resets, and also led to a slightly different mix in the channel. And our channel partners basically updated their inventories as appropriate, and it feels like those were basically all cleared out by the end of February.

Jan Mikkelsen: Should we start, Kasper?

Scott Smith: Yeah. So related to the Q1 dynamics, what we saw for SKYTROFA, I'll take the second part first. What we saw would be, I would describe as a typical seasonality that you would see with other maturing launches, where coverage updates at the beginning of the year led to insurance reauthorizations, copay resets, and also led to a slightly different mix in the channel. Our channel partners basically updated their inventories as appropriate. It feels like those basically all cleared out by the end of February. Then on the first question related to the development of YORVIPATH in April, you know, we continue to, as we said, you know, we'll come out with an update overall in revenue later this year.

Scott Smith: Yeah, so related to the Q1 dynamics we saw for Skytrope, I'll take the second part first. What we saw would be, I would describe as, a typical seasonality that you would see with other maturing launches where coverage updates at the beginning of the year led to insurance reauthorizations, copay resets, and also led to a slightly different mix in the channel. And our channel partners basically updated their inventories as appropriate, and it feels like those were basically all cleared out by the end of February.

Jessica Macomber Fye: Sure.

Jessica Macomber Fye: Yes.

Speaker Change: So related to the Q1 dynamics, what we saw for Sky trap I'll take the second part first.

Speaker Change: What we saw would be I would describe as a typical seasonality that you would see with other maturing launches where coverage updates at the beginning of the year led to.

Speaker Change: Insurance reauthorization Copay resets and also led to a slightly different mix in the channel and.

Jessica Macomber Fye: Our channel partners basically updated their inventories as appropriate.

Jessica Macomber Fye: And it feels like those basically all cleared out by the end of February.

Scott Smith: And then on the first question related to the development of YORVIPATH in April, as we said, we'll come out with an update overall on revenue later this year. But essentially, we're pretty happy with the results of the launch, with the primary goals that Jan laid out in his prepared remarks.

Jessica Macomber Fye: And then on the first question related to the development of Euro path in April.

Jessica Macomber Fye: We continue to as we said we will come out with an update overall on revenue later this year.

Scott Smith: You know, essentially, we're pretty happy with the results of the launch, with the primary goals that Jan laid out in his prepared remarks. Jess, just to give you a little bit of flavor from our own expectations, we launched YORVIPATH inside the German market, Austrian market, out from this assumption that we're adapting to the German market. What we typically will see and what we hope for, want to get a broad prescriber base. The broad prescriber base, we expected them to take typical 1 to 2 patients on treatment. Then they get really the feedback, seeing really the unique benefit of this. As soon as we're really getting over that, some get comfort period, where they really get the comfort, you take more on treatment.

Scott Smith: You know, essentially, we're pretty happy with the results of the launch, with the primary goals that Jan laid out in his prepared remarks.

Jessica Macomber Fye: But essentially we're pretty happy with the results of the launch with the primary goals that <unk> laid out in his prepared remarks.

Jan Mikkelsen: Jess, just to give you a little bit of flavor from our own expectations, we launched YORVIPATH inside the German market, Austrian market, out from this assumption that we're adapting to the German market. What we typically will see and what we hope for, want to get a broad prescriber base. The broad prescriber base, we expected them to take typical 1 to 2 patients on treatment. Then they get really the feedback, seeing really the unique benefit of this. As soon as we're really getting over that, some get comfort period, where they really get the comfort, you take more on treatment.

Jan Mikkelson: So, yes, just to give you a little bit of flavor from our own expectations, we launched SKYTROFA in the typical way that you are perhaps inside the. German market, or Austrian market outside from this assumption that we are adapting to the German market. And what we typically will see and what we hope for is that we want to get a broad prescriber base. The broad prescriber base is expected to take typical one to two patients on treatment. Then they get real feedback, really seeing the unique benefit of this and as soon as we're really getting over that, [inaudible] So when we got 25% of our target position, I believe they were some of the most successful growth I have seen, and we have not in ourselves imagined that. The number of patients we've seen is around 100, meaning that there are a few physicians that started early in our ERP program or COP program in Germany. Some of them are up on 20, 30 patients already now because they have already been building up discomfort about how this product is really giving unique benefits to the patients. So this is why we were really feeling this was really the start we had hoped for, the start where we were looking at the different KPIs, it really turned out to be what we wanted to see and what we hoped for.

Jessica Macomber Fye: So just to give you a little bit of flavor from our own expectations.

Scott: <unk> launched cultural fit in that should we could wait.

Scott: So your parts inside.

Scott: German market Austin market upfront. This assumption that we are adapting to the German market and what we typically will see and what we hope for what to get a broad prescriber base. The broad prescriber base, we expected them to take should because one or two patients on treatment.

Jan Moller Mikkelsen: And what we typically will see and what we hope for is that we want to get a broad prescriber base. The broad prescriber base is expected to take typical one to two patients on treatment. Then they get real feedback, really seeing the unique benefit of this

Scott: To get really bad feedback seeing really the unique benefit of fees and as soon as we're really getting over that some cake comfort period, where the beauty get the comfort you take more on treatment. So when we so when we got 25% of our target physician.

Jan Moller Mikkelsen: and as soon as we're really getting over that, [inaudible] So when we got 25% of our target position, I believe they were some of the most successful growth I have seen, and we have not in ourselves imagined that. The number of patients we've seen is around 100, meaning that there are a few physicians that started early in our ERP program or COP program in Germany. Some of them are up on 20, 30 patients already now because they have already been building up discomfort about how this product is really giving unique benefits to the patients.

Scott Smith: When we got 25% of our target physician already in 8 weeks to make a prescription, I believe there was some of the most successful launch I have seen. We have not in ourselves imagined that. The number of patients we're seeing is around 100, meaning is that there is a few physicians that started early in our

Scott: Already in eight week to make a prescription.

Scott: I believe there was some of the most successful launch IFC.

Scott: Have not enough. So imagine that were non bulk patient we see it's around hundred meaning is that a few physicians that started early in our ERP program.

Jan Mikkelsen: EAP program or CoPro in Germany, some of them are up to 20, 30 patients already now because they already had building up this comfort on how really this product are giving unique benefit to the patients. This is why we were really feeling this is really the start we had hoped for, the start where we looking on the different KPI, it really turned out to what we wanted to see and what we hoped for.

Scott: Germany somewhat upward 20 surgery patient already now because they're already building up discomfort on how unique this product television unique benefit to <unk> patients. So this is why we were beauty feeling this is really the stock we had to postpone the start we're looking on the <unk>.

Jan Moller Mikkelsen: So this is why we were really feeling this was really the start we had hoped for, the start where we were looking at the different KPIs, it really turned out to be what we wanted to see and what we hoped for.

Scott: It really turned out to what we wanted to see and what could be hopeful.

Scott Smith: And just to reiterate, the results are essentially sales direct to the patient. They go to the retail pharmacy, the patient picks up, and there's no channel inventory with YORVIPATH.

Scott Smith: Just to reiterate, the results are essentially sales direct to the patient. They go to the retail pharmacy, the patient picks up. There's no channel inventory with the Orpa.

Scott: Okay.

Scott: And just to reiterate the.

Scott: The results are essentially sales direct to the patient that go to the retail pharmacy, the patient picks up there's no channel inventory with yoga mat.

Scott: Yes.

Operator: Thank you. Our next question comes from David Lebowitz with Citi. Your line is open. Well, thank you very much for taking my question. If you jump back about a year, when you were in the run up to YORVIPATH's potential before the regulatory step back, could you juxtapose the current status of your sales preparation, what the market looks like now versus what it looks like then and how you see things similarly or differently?

Operator: Thank you. Our next question comes from David Lebowitz with Citi. Your line is open.

Operator: Thank you. Our next question comes from David Lebowitz with Citi. Your line is open. Well, thank you very much for taking my question.

Operator: Thank you. Our next question comes from David Lebowitz with Citi. Your line is open.

Scott: Thank you. Our next question comes from David Lebowitz with Citi. Your line is open.

David Lebowitz: Well, thank you very much for taking my question. If you jump back about a year when you were in the run-up to your past potential approval for the regulatory setback, could you juxtapose the current status of your sales preparation, what the market looks like now versus what it looked like then, and how you see things similarly or differently?

David Neil Lebowitz: Well, thank you very much for taking my question. If you jump back about a year, when you were in the run up to YORVIPATH's potential before the regulatory step back, could you juxtapose the current status of your sales preparation, what the market looks like now versus what it looks like then and how you see things similarly or differently?

David Lebowitz: Well. Thank you very much for taking my question.

David Lebowitz: Jumping back about a year.

David Lebowitz: The run up to.

David Lebowitz: You are on a path to potential approval.

David Lebowitz: <unk> could you juxtapose your current the current statements sales preparation what the market looks like now versus what it looks like then and how you see things similarly or differently.

Jan Mikkelson: I believe we are in a much, much better place. First of all, the awareness of hyperparameters has really been coming to a much higher level for the physician and the patient. Just in the latest effort, when... if you really want to hear the patient voice, the YouTube that is reflecting how the patient explains the unmedical need that is in hyperpara to add the FDA advisory board. And I think that is only one element of it why I believe we are in a much, much better place.

Jan Mikkelsen: I believe we are in a much, much better place. First of all, the awareness of hypopara has really been coming to a much better awareness level where physician and the patient, just in the latest effort when if you really want to hear the patient voice, was the YouTube that is reflecting how the patient explains the unmet medical need that is in hypopara to at the FDA advisory board. I think that is only one element of it, why I believe we are in a much, much better place. I think the realization of the unmet medical need we have already and always seen up from the patient. I think the awareness of is on a much, much better level today.

Speaker Change: I believe we are.

Speaker Change: Mass mass paid on place.

Speaker Change: First of all the <unk> hydropower has been really be coming too must create off premise levels, where physician and the patient just in the listed airport win.

Speaker Change: If you really want to hear the patient voice was the Youtube that is reflecting how the patient explained the unmet medical need that is in high book here too.

Speaker Change: The FDA Advisory Board and I'd say that is only one element of it.

Speaker Change: While I believe we are in a much much better place and I think the realization of the unmet medical need we have already and always see.

Jan Moller Mikkelsen: And I think the realization of the unmet medical need we have already and always seen from the patient, which I think the awareness of is on a much, much better level today. And I think this is why we have seen our success with the initial part of our launch in Germany and Austria, we know we can repeat that in all of our EU direct actions as soon as we get fully reimbursed in this country, mainly at the end of this year and at the beginning of next year and during '25.

Speaker Change: Up from the patient what I think awareness is on mass.

Speaker Change: Smart beta level to date.

Jan Mikkelsen: I think this is why when we see our success with the initial part of our launch in Germany, Austria, we know we can repeat that in all our EU direct as soon as we get fully reimbursed in these countries, mainly end of this year, in the beginning of next year, and during 2025. We see it already coming in for the international market, mainly to named patient programs, which are patient-driven program, physician-driven program. The general awareness about the unmet medical need in hypopara, I believe, have really, really gone to a state where I hope we really can understand this unmet medical need to a much better way.

Speaker Change: This is why when we see our success with the initial.

Speaker Change: Part of our launch in Germany, Australia, we know we can repeat that in all oil EU direct as soon as we get fully reimbursed in this countries mainly end of this year.

Jan Moller Mikkelsen: We see it already coming in for the international market; mainly to name patient programs, which are patient-driven programs, physician-driven programs. So the general awareness about the unmet medical need in [inaudible], I believe has really, really gone to a stage where I hope we really can understand this unmet medical need in a much better way. One thing that has also driven this is the new guidelines that came out from the US and other places, really describing how basic conventional therapy is, basic, not providing an optimal treatment, if you can call it a treatment. I was basically saying that it's a balance between treatment for short-term symptoms and to avoid long-term complications, and you can never get that right.

Speaker Change: <unk> of next year and doing 25, we see it already coming in for the international market.

Speaker Change: You may need to named patient programs, which are patient driven program precision drilling program. So the general.

Speaker Change: And about the unmet medical need in <unk> I believe <unk> had really really got to a stage where I hope.

Speaker Change: Really can understand this unmet medical need to a much better way one thing to also have driven is spend new guidelines that came out from U S and other places really describing how basic convinces therapy basic not providing an optimal treatment.

Jan Mikkelsen: One thing that also have driven it is the new guidelines that came out from US and other places, really describing how basic conventional therapy not providing an optimal treatment, if you can call it a treatment. I was basically saying that it's a balance between treatment for short-term symptoms and to avoid long-term complications, and you can never get that right. You are in a position that the recommendation of PTH therapy is really the way to treat this disease, which are pretty obvious. Will you treat insulin diseases with not insulin like diabetes? Yes, you will always treat them with insulin.

Speaker Change: If you can call it a treatment.

Speaker Change: Basic saying that it's a balance between treatment for short term symptoms and to avoid long term complication and you can navigate that right. So it basically are in a position that the recommendation of PTH therapy is.

Jan Moller Mikkelsen: So basically, we are in a position that the recommendation of PTH therapy is really the way to treat this disease, which is pretty obvious. Will you treat insulin diseases with insulin or not insulin, like diabetes? Yes, you will always treat them with insulin. Thanks for taking my question.

So basically, we are in a position that the recommendation of PTH therapy is really the way to treat this disease, which is pretty obvious. Will you treat insulin diseases with insulin or not insulin, like diabetes? Yes, you will always treat them with insulin.

Speaker Change: The way to treat this disease, which are pretty obvious when you treat instantly diseases with not being silly like diabetes, Yes, you will always tweak them with Italy.

David Lebowitz: Thanks for taking my question.

David Neil Lebowitz: Thanks for taking my question.

Speaker Change: Thanks for taking my question.

Operator: Thank you. Our next question comes from Rosemarie Lee with Cantor. Your line is open. Hey, sorry, I should've [inaudible]. So just for TransconPTH, in terms of [inaudible], have you had any pushback from payers on joining clinical benefits such as hospitalization rate or kidney benefits? Thank you.

Operator: Thank you. Our next question comes from Li Watsek with Cantor. Your line is open.

Speaker Change: Thank you. Our next question comes from Rosemary Lee with Cantor Your line is open.

[Analyst] (Cantor Fitzgerald): Hey, sorry, I should have put Li Watsek. I'm on for Li Watsek from Cantor. Just, for TransCon PTH, in terms of payer access and formulary placement, have you had any pushback from payers on showing clinical benefits such as hospitalization rate or kidney benefit? Thank you.

Li Watsek: Hey, sorry, I should have put Li Watsek. I'm on for Li Watsek from Cantor. Just, for TransCon PTH, in terms of payer access and formulary placement, have you had any pushback from payers on showing clinical benefits such as hospitalization rate or kidney benefit? Thank you.

Rosemary Lee: Hey, sorry, I should have put legal I think I'm on for Lee Wassa from Cantor.

Rosemary Lee: So just for Transcon PTH in terms of payer access and permanent placement have you had any pushback from payers on Joanne clinical benefits, such as hospitalization rate or kidney benefit.

Rosemary Lee: Thank you.

unknown: Is that question related to Europe or the US? Um, both, if you may.

Jan Mikkelson: Is that question related to Europe or the US?

Jan Mikkelsen: Is that question related to Europe or US?

Rosemary Lee: Is that question related to Europe or U S.

[Analyst] (Cantor Fitzgerald): Both, if you may.

Rosemarie Lee: Um, both, if you may.

Li Watsek: Both, if you may.

Speaker Change: Both if you may.

Jan Mikkelson: Okay, I think in Europe, when we do make what we call the health economic impact of our treatment, we are integrating all aspects of how we are addressing short-term symptoms, the benefit of the patient having a normal life again, the benefit of having a balanced calcium and, more important, the quality of life this patient is experiencing immediately after starting treatment. The other part is what we call the long-term risk.

Jan Mikkelsen: Okay. I think in Europe, when we do make what we call the health economic impact of our treatment, we are integrating all aspects on how we addressing short-term symptoms, the benefit of the patient to have a normalized life again, benefit of having a balanced calcium, and more important, the quality of life this patient are experiencing immediately after starting treatment. The other part is what we call the long-term risk. One part of the long-term risk is what we call renal impairment, renal damage. There is other long-term complication like cardiovascular impacts. There is calcification on a lot of different organs, cataract, and other things you're also avoiding and will get with hypopara, just dependent on time.

Speaker Change: Okay, I think in Europe when.

Speaker Change: When we do.

Speaker Change: Make what we call the.

Rosemary Lee: Health economic impact of our treatment, we are integrating all aspect oncology addressing short term symptoms.

Rosemary Lee: Effect of that patient to happen formalized.

Rosemary Lee: Any benefit of having a balance kind of some.

Rosemary Lee: And more important the quality of life. These patients are experiencing immediately after starting treatment.

Jan Mikkelson: The other part is what we call the long-term risk. One part of the long-term risk is what we call renal impairment, renal damage. There are other long-term complications like cardiovascular impact that is classification of a lot of different organs, cataracts, and other things you're also achieving and will get with [inaudible] just dependent on time. All of these elements are being built into our health economic evaluation that we are providing to each single European country to be quite sure that we're getting the right reimbursement at the right price. So it's basically built on the European way of really being responsible in our pricing, where we have a health economic calculation on how we basically are providing both a benefit to the patient and a benefit to society in helping the patient at a reasonable accessible cost. Okay, thank you.

Rosemary Lee: That is what we call the long term risk what part of the long term risk is what we call <unk>.

Jan Moller Mikkelsen: One part of the long-term risk is what we call renal impairment, renal damage. There are other long-term complications like cardiovascular impact that is classification of a lot of different organs, cataracts, and other things you're also achieving and will get with [inaudible] just dependent on time. All of these elements are being built into our health economic evaluation that we are providing to each single European country to be quite sure that we're getting the right reimbursement at the right price.

Rosemary Lee: Impairment renal damage.

Rosemary Lee: Long term compensation like cardiovascular.

Rosemary Lee: Okay.

Rosemary Lee: Impacts that is calcification and lot of different organs cataract and other thing you also SUV and Wolf gigabit hydropower just dependent on time all of this element is being built into our health economic deterioration that we are providing to each single QP continues to.

Jan Mikkelsen: All of this element is being built into our health economic evaluation that we are providing to each single European country to be quite sure that we're getting the right reimbursement at right prices. It's basically built on the European way of really being responsible in our pricing where we have a health economic calculation on how we basically are providing both a benefit to the patient, the benefit really to the society in helping the patient at a reasonable, accessible cost.

Speaker Change: <unk> quite sure.

Rosemary Lee: Right.

Jan Moller Mikkelsen: So it's basically built on the European way of really being responsible in our pricing, where we have a health economic calculation on how we basically are providing both a benefit to the patient and a benefit to society in helping the patient at a reasonable accessible cost.

Rosemary Lee: Outright prices.

Rosemary Lee: It's basic built on the European way.

Rosemary Lee: Indeed.

Rosemary Lee: Being responsible in our pricing, where we have and health economic calculation on how <unk> are providing both the benefit to the patient benefit too.

Rosemary Lee: Two of our society and helping the patient on <unk>.

Rosemary Lee: Reasonable accessible cost.

[Analyst] (Cantor Fitzgerald): Okay. Thank you.

Li Watsek: Okay. Thank you.

Rosemarie Lee: Okay, thank you.

Speaker Change: Okay. Thank you.

Operator: Thank you. Our next question comes from Joseph Schwartz with Leerink Partners. Your line is open.

Speaker Change: Okay.

Speaker Change: Thank you. Our next question comes from Joseph Schwartz with Leerink Partners. Your line is open.

Joseph Patrick Schwartz: Thanks very much. I was wondering if you could talk about how many physicians in the U.S. have had experience with YORVIPATH in the EAP versus how many you'll be going out to de novo once it's hopefully launched commercially soon. And could you also talk about how many of the physicians who might be targets for using YORVIPATH and their patients have been interacting with for SKYTROFA already?

Joseph Schwartz: Thanks very much. I was wondering if you could talk about how many physicians in the US have had experience with YORVIPATH in the EAP, versus how many you'll be going out to de novo once it's hopefully launched commercially soon. Could you also talk about how many of the physicians who might be targets for using YORVIPATH in their patients have you been interacting with for SKYTROFA already?

Joseph Patrick Schwartz: Thanks, very much I was wondering if you could talk about how many physicians in the U S have had experience with Europe a path in the EAP.

Joseph Patrick Schwartz: Versus how many you'll.

Joseph Patrick Schwartz: Youll be going out to de Novo.

Joseph Patrick Schwartz: Once it is hopefully launch commercially soon.

Joseph Patrick Schwartz: And could you also talk about how many of the physicians.

Joseph Patrick Schwartz: Who might be targets for.

Joseph Patrick Schwartz: Using your own path in there.

Joseph Patrick Schwartz: Patience.

Joseph Patrick Schwartz: You've been interacting with four.

Joseph Patrick Schwartz: Skype for already.

Jan Mikkelson: I think the first question concerns Europe and the U.S. EAP program, and what I can do, I can give you the general aspects of our EAP program. The general aspect of our U.S. EAP program because it's very, very different compared to what we had in Europe, which has now been stopped after we got our approval and got full commercial rights in Germany. Our EAP program in the U.S. is only addressing patients that really are PHA's experience, meaning that it's a 3, 4, 5 percent subset of patients of hyper [inaudible] that basically are electable to come into our EAP program. The EAP is a very difficult program for basic large academic institutions to handle.

Jan Mikkelsen: I think the first question was regarding YORVIPATH and the US EAP program. What I can do, I can give you the general aspect of our EAP program. The general aspect of our US EAP program, because it's very, very different compared to what we had in Europe, which now has been stopped after we got our approval and got full commercial in Germany. Our EAP program in US is only addressing patients that really are PTH experienced. Meaning is that it's a 3, 4, 5% subset of patients of hypopara that basically are eligible to come into our EAP program. The EAP program is a very difficult program for basically large academic institution to handle. Because of contracting and the incentive for them is not high because it's not really a paid program for the physician.

Joseph Patrick Schwartz: I think the first question versus reflecting Europe, and the U S. ERP program and what I can do I can give you the general aspect.

Joseph Patrick Schwartz: This program the general aspect of alcohol on numerous ERP program, because it's bad.

Joseph Patrick Schwartz: Compared to what we had in Europe with now have been stopped after we got approval and Scott's foods promotions in Germany.

Joseph Patrick Schwartz: Our ERP program.

Joseph Patrick Schwartz: <unk> is only addressing patient test.

Joseph Patrick Schwartz: <unk> experience, meaning is that is at 345% subset of patients of hypo para that basic.

Joseph Patrick Schwartz: Electrical to come into our ERP program.

Joseph Patrick Schwartz: The ERP program is a bit difficult program for basic thus academic institution to handle so because of contracting an incentive for them is not high because it's not the RSV program for the acquisition. So therefore, you will always find a subset of these.

Jan Moller Mikkelsen: So because of contracting, and the incentive for them is not high because it's not really an EAP program for the physician. Therefore, you will always find a subset of this site that typically has a lot of patients in hyper [inaudible] will not really be part of such an EAP program, it will only be more private sites, small sites. We are extremely enthusiastic about what we have seen with our EAP program, and all the treatment benefits that we have observed in our clinical trials, both phase II and phase II, have been 100% confirmed by what we have seen from the EAP program and the patient experience there.

Jan Mikkelsen: You will always find a subset of this site that typically have a lot of patients in hypopara will not really be part of such an EAP program. It will only be more private sites, small site. We are extremely enthusiastic about what we have seen with our EAP program, and all the treatment benefit that we have observed in our clinical trial, both phase 2 and phase 3, has been 100% confirmed what we have seen out from the EAP program and the patient experience there.

Joseph Patrick Schwartz: Sorry that should be could have a lot of patients in hydropower will not really be a subset ERP program. It would only be more private sites more site.

Joseph Patrick Schwartz: <unk>.

Joseph Patrick Schwartz: Extremely anxious ethic about what we have seen with our ERP program and note with treatment benefit that we have observed in our clinical trials, both phase two and phase III has speak Hunter percent confirmed what we have seen from the ERP program and the patient experience there.

Joseph Patrick Schwartz: Okay, and so how many new sites will you have to go to then that treat hypoparathyroidism patients who have not had experience with the EAP or with using SKYTROFA?

Joseph Schwartz: How many new sites will you have to go to then that are, you know, that treat hypoparathyroidism patients who have not had experience in the EAP or with using SKYTROFA?

Speaker Change: Okay and if.

Speaker Change: So how many new sites will you have to go to then that are.

Speaker Change: That treat hypo parathyroid is in patients who have not had experience in the EAP.

David Lebowitz: Or with using Skype Charlestown.

Jan Mikkelson: SKYTROFA, we don't have any EAP site at all in this way. SKYTROFA didn't ever have any EAP program running, so from that perspective, it's really hard for me to compare these two. Well, I meant commercial SKYTROFA or the EAP for your YORVIPATH. I'm just trying to get a sense of the footprint now, how much overlap there is between the two products that you will have shortly.

Jan Mikkelson: SKYTROFA, we don't have any EAP site at all in this way. SKYTROFA didn't ever have any EAP program running, so from that perspective, it's really hard for me to compare these two.

Jan Mikkelsen: SKYTROFA, we don't have any EAP in sight at all in this way. SKYTROFA didn't ever have any EAP program running. From that perspective, it's really hard for me to compare these two.

unknown: Skytrooper, we don't have a need.

Speaker Change: ERP.

Speaker Change: Site at all in this way.

Speaker Change: <unk>.

Joseph Patrick Schwartz: However, at any ERP program Ronnie.

Joseph Patrick Schwartz: Well, I meant commercial SKYTROFA or the EAP for your YORVIPATH. I'm just trying to get a sense of the footprint now, how much overlap there is between the two products that you will have shortly.

Joseph Patrick Schwartz: So from that perspective, it's really hard to compare to.

unknown: Well, I meant Commercial Skytropha or the EAP for your Vipassana. I'm just trying to get a sense of the footprint now, how much overlap there is between the two products that we'll have shortly. You will basically say that is

Joseph Schwartz: Well, I meant commercial SKYTROFA or the EAP for YORVIPATH. I'm just trying to get a sense of the footprint now, how much overlap there is with, you know, between the two products that you'll have shortly.

Joseph Patrick Schwartz: And then commercial type profile or the EAP for Europe.

unknown: I'm, just trying to get a sense of the footprint now how much overlap there is with between the two products that we will have shortly.

Jan Mikkelson: You will basically say there is not a large overlap directly in the physician prescription base because it's typically more specialist sites that take care of both sides. One of them is, for example, a pediatric first indication; the other one is an adult indication. So when you look at the overlap for that, there is not a large overlap. I'm not seeing any data where I would indicate support and say there's a big overlap. Whether it's a great overlap, it's 80-90% of the commercial effort that basically is built on taking the same [inaudible] product out in the same infrastructure. And what we basically are building is independent sales forces that really tailor-made exactly the right physician to have the most prescribing physicians being covered as fast as possible.

Jan Mikkelsen: You will basically say there is not a large overlap in directly to the decision prescription phase because it's typical more specialist sites that take care of both sides. One of them is, for example, a pediatric first indication, the other one is an adult indication. When you look at the overlap for that, then it's. There's not a large overlap. Joe, I'm not seeing any data where I will indicate and support and saying there's a big overlap. Where there is a great overlap, it's 80, 90% of the commercial effort that basically are built on taking the same endocrinology product out in the same infrastructure. What we basically are building, we are building independent sales forces that really will tailor-make exactly the right physician to have the most prescribing physician being covered as fast as possible.

Joseph Patrick Schwartz: You will basically say days not at <unk>.

Joseph Patrick Schwartz: Docs awarded App in directly debate decision prescription base, because it's typically more specialist sites that take care of both sites. One of them is for example, Peter first indication. The other one is an adult indication. So when you look at all of that.

Jan Moller Mikkelsen: So when you look at the overlap for that, there is not a large overlap. I'm not seeing any data where I would indicate support and say there's a big overlap. Whether it's a great overlap, it's 80-90% of the commercial effort that basically is built on taking the same [inaudible] product out in the same infrastructure.

Joseph Patrick Schwartz: That does.

Jan Moller Mikkelsen: That is not a large overlap.

Joseph Patrick Schwartz: Joe I can I.

Joseph Patrick Schwartz: Im not seeing any data of where I would indicate.

Joseph Patrick Schwartz: At the same guys happy call out whether it's a great overlap is.

Joseph Patrick Schwartz: 90% of the commercial effort that basic are built on taking the same endocrinology product out in BC infrastructure and water basic building building independent sales forces that mutual tailor made exactly the right position to.

unknown: And what we basically are building is independent sales forces that really tailor-made exactly the right physician to have the most prescribing physicians being covered as fast as possible. Thank you.

And what we basically are building is independent sales forces that really tailor-made exactly the right physician to have the most prescribing physicians being covered as fast as possible.

Speaker Change: Perhaps the most prescribing physicians being covered as fast as possible.

Joseph Schwartz: Thank you. Thank you.

Speaker Change: Thank you. Thank you.

Joseph Patrick Schwartz: Thank you.

Operator: Thank you. Our next question comes from Gavin Clark Gardner with Evercore ISI. Your line is open. Hey, congrats on the progress and thanks for taking the question. I'm just wondering, out of the 100 YORVIPATH patients in Germany, how many of these were previously on [inaudible] and was this in line with your expectations heading in?

Operator: Thank you. Our next question comes from Gavin Clark Gardner with Evercore ISI. Your line is open.

Operator: Thank you. Our next question comes from Gavin Clark-Gartner with Evercore ISI. Your line is open.

Speaker Change: Thank you. Our next question comes from Gavin Clark Kirt Gardner with Evercore ISI. Your line is open.

Gavin Clark Gardner: Hey, congrats on the progress and thanks for taking the question. I'm just wondering, out of the 100 YORVIPATH patients in Germany, how many of these were previously on [inaudible] and was this in line with your expectations heading in?

Gavin Clark-Gartner: Hey, congrats on the progress, and thanks for taking the question. I'm just wondering, out of the 100 YORVIPATH patients in Germany, how many of these were previously on Natpar, and was this in line with your expectations heading in?

Speaker Change: Hey, congrats on the progress and thanks for taking the question I'm just wondering how did the 100 yorvit path patients in Germany. How many of these were previously on that par and was this in line with your expectations heading in.

Jan Mikkelson: I will say surprisingly, we see many more naive patients than we actually thought we would see. So this is one of the surprises we have seen, that the basic physicians are looking at the patients and saying, we have so many patients that have not been in treatment that we are also focused on taking the naive patient into the treatment regime. And I have to say, that was one of the surprises, at least for me, where I would believe that it was initially just a change in NAPFAR patients, but we have seen many more naive patients than we actually expected. Great. Thank you.

Jan Mikkelsen: I will say, surprisingly, we see many more naive patients than we actually have thought we will see. This is one of the surprises we have seen, that the physicians basically are looking at the patients and saying, "We have so many hypopara patients that have not been in treatment, that we also are focused on taking the naive patient into the treatment regimen." I have to say that was one of the surprises, at least for me, where I will believe that it was initially just a change of Natpar patient, but we have seen many more new patients than we actually expected.

Speaker Change: I would say surprisingly, we see many more net new patient.

Speaker Change: We actually have sold we will see so this is one of the surprises we have seen that with precision basic looking on the patients and seeing is we have so many one patient that not have been in treatment that we also are focused on taking that.

Speaker Change: You patients into the treatment with <unk> and.

Jan Moller Mikkelsen: I have to say there was one of the surprises at least for me, where I would believe that it was initially just a change of that pop patient, but we have seen many more patients that we expected.

Speaker Change: We expected.

[Analyst] (Cantor Fitzgerald): Great. Thank you.

Gavin Clark-Gartner: Great. Thank you.

Speaker Change: Great. Thank you.

Gavin Clark Gardner: Great. Thank you.

Operator: Kelly Shi with Jefferies, your line is open.

Speaker Change: Kelly <unk> with Jefferies. Your line is open.

Kelly Shi: Thank you for taking my questions. Scott, could you provide your perspective on the competitive landscape, given that two other long-acting growth hormone commercial products are there, and one of them, if we check on the script, is actually approaching schedule for both GRX and the NRX. And also, I'm curious whether your launch strategy remains the same.

Kelly Shi: Thank you for taking my questions. On SKYTROFA, could you provide your perspective into the competitive landscape, given that two other long-acting growth hormone commercial products are there, and one of them, if we check on the scripts, actually approaching schedule for on both GRX and the RX. Also like are you curious like whether your launch strategy will remain the same?

Kelly: Thank you for taking my call.

Scott Smith: Scott could you provide your perspective into the competitive landscape.

Scott Smith: Given that.

Scott Smith: Two other long acting growth hormone commercial products out there and one of them if we check on the scrip.

Scott Smith: Actually approaching schedule for both generics and the Rx.

Speaker Change: Uh huh.

Speaker Change: And also like how are you.

Scott Smith: Curious whether your launch strategy.

Scott Smith: Dave.

Scott Smith: Right.

Scott Smith: So one of the complications, at least I always have, is utilizing the different databases you can get to get scripts. In this case, you can use this kind of data set to look at trends, but never absolute levels, because the sampling is really different between different providers. So you are only sampling a small amount of the prescribing base or where you get the information from. So from that perspective, you cannot really compare the absolute level. You cannot compare it also because when we talk about the unit, the unit is really different between the different products. So some unit is providing you with that. So, therefore, if you really want to get the really effective and most solid data, you need to take each single company, go into the line item, and look on the revenue basis. This is where I get the best confirmation about the data and how we see their progression.

Jan Mikkelsen: One of the complications, at least I always have, is utilizing the different databases you can get to get scripts. In this case, you can use this kind of datasets to look on trends, but never absolute levels because the sampling is really different between the different providers. You are only sampling a small amount of the prescribing base of where you get the information from. From that perspective, you cannot really compare the absolute level. You cannot compare it also because when we talk about the unit, the unit is really different between the different products. Some units are giving, providing you that. Therefore, if you really want to get a really effective and most solid data, you need to take each single company, go into the line item and look on the revenue basis.

Scott Smith: So one of the complication at least I always have is to utilizing the different data basis, you can get two cases scripts.

Kelly: In this case you can use this kind of data says is to look on trends, but naval absolute levels, because we're sampling it.

Scott Smith: Really different.

Scott Smith: Different.

Scott Smith: Provider.

Scott Smith:

Scott Smith: Only sampling a small amount of the prescribing base or where you get the information from so often that perspective, you cannot really compare the absolute level you cannot compared also because one but talk about the unit. The unit is really different between different chronic.

Scott Smith: You cannot compare it also because when we talk about the unit, the unit is really different between the different products. So some unit is providing you with that. So, therefore, if you really want to get the really effective and most solid data, you need to take each single company, go into the line item, and look on the revenue basis. This is where I get the best confirmation about the data and how we see their progression.

Scott Smith: So some unit.

Scott Smith: It's giving providing you that so therefore, if you really want to get and really <unk>.

Scott Smith: And most solid data unique to take each single company go into bed line and.

Jan Mikkelsen: This is where I get the best confirmation about data and how we see their progression. There is no doubt when we look on that. For the growth hormone market.

Scott Smith: Look on the revenue basis, this is where I get the best confirmation about data and how we see that progressing and there's no doubt when we look at that.

Scott Smith: And there is no doubt when we look on that. For the growth hormone market, it was a very difficult Q1 and what we saw, really have seen how we were the only one of the reported data really have growing where everyone has declined, which you typically would see in the first quarter. Thank you.

And there is no doubt when we look on that. For the growth hormone market, it was a very difficult Q1 and what we saw, really have seen how we were the only one of the reported data really have growing where everyone has declined, which you typically would see in the first quarter.

Kelly Shi: Thanks so much.

Speaker Change: Thank you Margaret.

Jan Mikkelsen: For the growth hormone market, it was a very difficult Q1. What we really have seen is how we were the only one reporting data really having growth where everyone has declined, which you typically would see in Q1.

Scott Smith: For the glaucoma market. It was a difficult Q1, and what we saw really have see how we were the only one of the reported data really have growing where everyone has decline, which you typically would see in the first quarter.

Kelly Shi: Thank you.

Speaker Change: Thank you.

Kelly Shi: Thank you.

Operator: Thank you. Our next question comes from Derek Archila with Wells Fargo. Your line is open. Hey, thanks for taking the question and congrats on the progress. We have a question on the OPEX progression this year. Just based on the 1Q OPEX, it seems like you might come in a fair bit below the 600 million euro guidance, so just any color there on how we should be thinking about that. Thanks.

Operator: Thank you. Our next question comes from Derek Archila with Wells Fargo. Your line is open.

Scott Smith: Thank you. Our next question comes from Derek <unk> with Wells Fargo. Your line is open.

Derek Archila: Hey, thanks for taking the question. Congrats on the progress. We have a question on the OpEx progression this year. I guess based on the Q1 OpEx, it seems like you might come in a fair bit below the EUR 600 million guidance. Just, you know, any color there on how we should be thinking about that? Thanks.

Derek Christian Archila: Hey, Thanks for taking my questions. Congrats on the progress. So we have a question on the Opex progression. This year, yes based on the <unk> Opex. It seems like you might come in a fair bit below the $600 million Euro guidance. So just.

Derek Christian Archila: Any color there on how we should be thinking about that thanks.

Jan Mikkelson: I think Scott is so happy today because he's really getting a good question.

Jan Mikkelsen: I think Scott is so happy today because he's really getting a good question now.

Derek Christian Archila: I think Scott is so happy today, because he really getting a good question.

Scott Smith: Yeah, Derek, thanks for the question. We're pretty proud of our ability to basically reduce OPEX pretty significantly while doubling revenue. It's not a bad thought, but as of now, our guidance remains 600 million OPEX for the full year based on current plans.

Scott Smith: Yeah, Derek. Thanks for the question. We're pretty proud of, you know, our ability to basically reduce OpEx pretty significantly while growing, you know, doubling revenue. It's not a bad thought, but as of now, our guidance remains EUR 600 million OpEx for the full year based on current plans.

Derek Christian Archila: Yes, Derek Thanks for the question.

Derek Christian Archila: Been pretty.

Derek Christian Archila: Yes, no we're pretty proud of that.

Scott Smith: Our ability to basically reduce opex pretty significantly while growing doubling revenue.

Scott Smith: We've been pretty. Yeah, no, we're pretty proud of the, you know, our ability to basically reduce off X pretty significantly while growing, you know, doubling revenue. It's not a bad thought, but as of now, our guidance, you know, remains $600 million OPEX for the full year, based on current plans.

Derek Christian Archila: It's not a bad thought but as of now our guidance remains $600 million opex for the for the full year based on current plans.

Operator: Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Scott Smith: Thank you. Our next question comes from Paul Choi with Goldman Sachs. Your line is open.

Paul Choi: Good afternoon, and thank you for taking my question. And also, let me offer my congratulations on the progress. I want to turn maybe to CMP for a moment. And if you could maybe sort of comment on what your market research ahead of your top-line results later this year suggests in terms of how endocrinologists might be thinking about using Transcon CMP, either as new patient starts, or do you possibly anticipate switches from Boxogo, just given the different dosing frequency and how you're thinking about what those kind of shares might look like in terms of a launch. And then could you maybe comment on what your sort of post-approval requirements might potentially look like for Transcon CMP pending an approval down the road from the FDA? Thank you.

Paul Choi: Good afternoon, and thank you for taking my question. Also let me offer my congratulations on the progress. I want to turn to CNP for a moment, if you could comment on what your market research ahead of your top line results later this year suggests in terms of how endocrinologists might be thinking about using TransCon CNP either for new patient starts or do you possibly anticipate switches from VOXZOGO, just given the different dosing frequency and how you're thinking about what those kind of shares might look like in terms of the launch? Then could you comment on what your post-approval requirements might potentially look like for TransCon CNP, pending an approval down the road from the FDA? Thank you.

Operator: Okay.

Speaker Change: Good afternoon, and thank you for taking my question and also let me offer my congratulations on the progress.

unknown: I want to turn maybe to CMP for a moment and.

unknown: If you could maybe sort of comment on what your market research ahead of your topline results later this year.

unknown: Just in terms of how.

unknown: Endocrinologists might be thinking about using transcon CMP either.

unknown: As new patient starts are possibly anticipate switching.

unknown: Switches from Baxalta ago, just given the different dosing frequency and how how youre thinking about what those kind of shares might look like in terms of the launch and then could you maybe comment on what your sort of post <unk>.

unknown: <unk>.

unknown: Requirements might potentially look like for transcon CMP pending approval down the road from the FDA. Thank you.

unknown: Okay.

Jan Mikkelson: It's really an extremely interesting question from the perspective of when we're looking at all the research we have done because the key topic and the key feedback we're getting in all interactions with physicians, caregivers, and patients is addressing comorbidities. Being short is not a disease, but really to have this sign of comorbidities is really providing the impact of having achondroplasia. And this is why we have so much strong focus, really to address the co-morbidity and also address also linear growth, but the key objective of our program is to address the comorbidities.

Jan Mikkelsen: It's really extremely interesting question from the perspective on when we're looking on all the research we have done. Because the key topic and the key feedback we getting in all interaction with physician, caregivers, patient is addressing comorbidities. Being short is not a disease. Really to have this kind of comorbidities is really providing really the impact on having achondroplasia. This is why we have so much strong focus really to address the comorbidity and also sure to address also linear growth. The key objective of our program is to do address the comorbidities. We cannot avoid a primary efficacy endpoint is linear growth because it has been established from regulatory agencies both in US and Europe. It's really, really difficult to change that. If we have been the first, it will not have been linear growth.

unknown: Okay.

unknown: It really.

Speaker Change: Extremely interesting creation from their perspective on when we're looking on all the research we have done.

Jan Moller Mikkelsen: Because.

Jan Moller Mikkelsen: The key topic and the key feedback we are getting in all interaction with physician caregivers patient is addressing coupon ptc's.

Speaker Change: Being short is not a disease.

Jan Moller Mikkelsen: but really to have this sign of comorbidities is really providing the impact of having achondroplasia. And this is why we have so much strong focus, really to address the co-morbidity and also address also linear growth, but the key objective of our program is to address the comorbidities. We cannot avoid a primary efficacy endpoint of linear growth because it has been established by regulatory agencies, both in the US and Europe, and it's really, really difficult to change that.

but really to have this sign of comorbidities is really providing the impact of having achondroplasia. And this is why we have so much strong focus, really to address the co-morbidity and also address also linear growth, but the key objective of our program is to address the comorbidities.

Jan Moller Mikkelsen: But really to have this type of Comorbidities is really providing.

Jan Moller Mikkelsen: Really.

Jan Moller Mikkelsen: Impact on having Apple Appalachia.

Jan Moller Mikkelsen: And this is why we have so much strong focus.

Jan Moller Mikkelsen: Really to address with co morbidity.

Jan Moller Mikkelsen: And also secure to address also linear growth.

Jan Moller Mikkelsen: Key objective of our program is to do.

We cannot avoid a primary efficacy endpoint of linear growth because it has been established by regulatory agencies, both in the US and Europe, and it's really, really difficult to change that. If we had been the first, it would not have been linear growth. It would have been addressing comorbidity as the fundamental of the disease. And this is how our integrated program has really been built up to show that in all our programs and I think where we both address linear growth but also muscle weakness and other things like that.

Jan Moller Mikkelsen: Address the Comorbidities.

Jan Moller Mikkelsen: Cannot abort our primary.

Jan Moller Mikkelsen: Efficacy endpoint is linear growth because it has been established from regulatory agencies, both in U S and Europe.

Jan Moller Mikkelsen: And it's really really difficult to change that if we are being the first mover.

Jan Moller Mikkelsen: If we had been the first, it would not have been linear growth. It would have been addressing comorbidity as the fundamental of the disease. And this is how our integrated program has really been built up to show that in all our programs and I think where we both address linear growth but also muscle weakness and other things like that.

Jan Mikkelsen: It will be addressing comorbidity as the fundamental of the disease. This is how our integrated program has really been built up to show that in all our programs. I think where we both addressed the linear growth but also muscle weakness and other things like that. When I see how we can already get the feeling about what it means for the patient is when we look at the quality of life questions that we have given to both patient and caregivers, how they really are adjusting the benefit of our treatment. We also see that in our retentions. When we see the retention and our recruitment, we recruit our pivotal trial in less than four months. On sites which have access to vosoritide, have access to other treatment, it got recruited in four months. I've never seen that before.

Jan Moller Mikkelsen: Not opinions in yogurt.

Jan Moller Mikkelsen: I'll be addressing kobo PTC as the fundamentals of this disease and this is how our integrated program has really been built up to show that in our program and I think wherever you both addressed the linear growth, but also muscle weakness and other things like that.

Jan Moller Mikkelsen: And when I see how we can already get a feeling about what it means for the patient is when we look at the quality of life questions that we have given to both patients and caregivers, how they really are judging the benefit of our treatment. And we also see that in our retentions. When we look at retention and recruitment, we recruit our [inaudible] in less than four months on sites which have access to [inaudible] and have access to other treatments, got cured in four months. I've never seen that before. And this is because the physician could talk to the parents about the benefits they have seen, basically on providing our Transcon CMP product today. Related to commitment afterwards, we have no comments or anything we have received from regulatory agencies in all the different places we have been and discussed the pathway for regulatory approval to any kind of commitment.

Jan Moller Mikkelsen: And when I see how we can already get with feeling about what it means for the patient is when we look at the quality of life questions that we have given to both patients and caregivers how that really are adjusting the benefit of our treatment.

Jan Moller Mikkelsen: And we also see that in our Retentions.

Jan Moller Mikkelsen: We did receive a retention and our recruitment re recruit our pivotal trials in less than four months.

Jan Moller Mikkelsen: on sites which have access to [inaudible] and have access to other treatments, got cured in four months. I've never seen that before. And this is because the physician could talk to the parents about the benefits they have seen, basically on providing our Transcon CMP product today. Related to commitment afterwards, we have no comments or anything we have received from regulatory agencies in all the different places we have been and discussed the pathway for regulatory approval to any kind of commitment. Thank you.

on sites which have access to [inaudible] and have access to other treatments, got cured in four months. I've never seen that before. And this is because the physician could talk to the parents about the benefits they have seen, basically on providing our Transcon CMP product today. Related to commitment afterwards, we have no comments or anything we have received from regulatory agencies in all the different places we have been and discussed the pathway for regulatory approval to any kind of commitment.

Jan Moller Mikkelsen: On site, which have et cetera.

Vikram Purohit: <unk> type except to other treatment it got recruited in four months.

Vikram Purohit: I've never seen that before.

Jan Mikkelsen: This is because the physician could talk to the parents about the benefit they have seen based on providing our TransCon CNP product to them. Related to commitment afterwards, we have no comments or anything we have received from regulatory agencies in all the different places we have been and discussed the pathway for regulatory approval to any kind of commitment.

Vikram Purohit: And this is because the physician.

Vikram Purohit: Talk to the parents about the benefit that Hep C basic on providing.

Vikram Purohit: Our transcon CMP product today.

Vikram Purohit: Related to commitments after voice.

Vikram Purohit: We have new.

Vikram Purohit: Comments or anything we have received from regulatory agencies.

Vikram Purohit: All the different places we have.

Vikram Purohit: Pete I have discussed the pathway for regulatory approval.

Vikram Purohit: Any kind of commitment.

Operator: Thank you.

Paul Choi: Thank you.

Vikram Purohit: Thank you.

Operator: Thank you. Our next question comes from Vikram Purohit with Morgan Stanley. Your line is open. Hi, thanks for taking our questions. We just have one on the pipeline. So a few months ago, you discussed with us a novel Transcon carrier platform and you had cited your work here with semaglutide to a case study. I just wanted to see how your internal work with this novel platform in the GLP-1 program is progressing and what the next milestones could be here that we could learn about. Thanks.

Operator: Thank you. Our next question comes from Vikram Purohit with Morgan Stanley. Your line is open.

Vikram Purohit: Thank you. Our next question comes from Vikram <unk> with Morgan Stanley. Your line is open.

Vikram Purohit: Hi, thanks for taking our questions. We just have one on the pipeline. So a few months ago, you discussed with us a novel Transcon carrier platform and you had cited your work here with semaglutide to a case study. I just wanted to see how your internal work with this novel platform in the GLP-1 program is progressing and what the next milestones could be here that we could learn about. Thanks.

Operator: Hi. Thanks for taking our questions. We just had one on the pipeline. A few months ago, you discussed with us a novel TransCon carrier platform, and you had cited your work here with semaglutide through a case study. I just wanted to see how your internal work with this novel platform and the GLP-1 program is progressing and what the next milestones could be here that we could learn about. Thanks.

Vikram Purohit: Hi. Thanks for taking our questions. We just had one on the pipeline. A few months ago, you discussed with us a novel TransCon carrier platform, and you had cited your work here with semaglutide through a case study. I just wanted to see how your internal work with this novel platform and the GLP-1 program is progressing and what the next milestones could be here that we could learn about. Thanks.

Jan Mikkelson: We are extremely as excited about this lead candidate that we were for when we came out. There's no doubt the monastic treatment regime is the way to go. And we're building up the same fundamentals that we built up all our pipeline. I call it a pipeline because we basically are not taking the target engagement risk that you typically have when you make a highly differentiated product because we're building through the Transcon technology on a semaglutide molecule that basically had the broadest way to show clinical benefit everywhere. We are progressing with that. At the same time, we also have an intense discussion about how we basically are providing the best value proposition of this compound and this era of metabolic diseases, because we talk about metabolic diseases. And we will keep you updated as soon as we have made a decision on which way we're going.

Jan Mikkelsen: We are extremely excited about this lead candidate that we were when we came out. There's no doubt that once the treatment regimen is the way to go, and we're building up the same fundamentals that we built up all our pipeline. I call it a pipeline because we basically are not taking the target engagement risk that you typically have when you make highly differentiated products because we're building through the TransCon technology on a semaglutide molecule that basically had the broadest way to show clinical benefit everywhere. We are progressing with that. At the same time, we also have an intense discussion about how we basically are doing the best value proposition of this compound and this era of metabolic diseases because we're talking about metabolic diseases.

Vikram Purohit: We were when we came out.

Jan Moller Mikkelsen: And we're building up the same fundamentals that we built up all our pipeline. I call it a pipeline because Rebasing, we are not taking the target engagement risk that you typically have when you make a highly differentiated product because we're building through the Transcon technology on and the Simiclotype molecule that BASIC had the broadest way to show clinical benefit everywhere. We are progressing with that. At the same time, we also have an intense discussion about how we BASIC are providing the best value proposition of this compound and this era of metabolic diseases, because we talk about metabolic diseases. And we will keep you updated, as soon as we have made a decision on which way we're going. Thank you. Our next question comes from Yaron Werber with T.D. Cowan, your line is here.

Yaron Benjamin Werber: Not taken bit target engagement risks that you typically when you make highly differentiated product because we are building two per transcon technology.

Yaron Benjamin Werber: And similar type of molecule.

Yaron Benjamin Werber: <unk> had the broad sway to show clinical benefit everywhere, we are progressing with that at the same time. We also have intense discussion about how we basically are doing the best value proposition of this compound and this era of committed Baltic diseases.

Jan Mikkelsen: We will keep you updated as soon as we somehow have made a decision what way we going.

Operator: Thank you. Our next question comes from Yaron Werber with TD Cowen. Your line is open. Hey guys, this is Joyce on for Yaron, thanks for taking our question. In the U.S, can you talk about your plan launch strategy for [inaudible] in terms of the initial target population [inaudible] and how much of it will marry your strategy in Germany where you're targeting roughly one-third of the population? Thank you.

Operator: Thank you. Our next question comes from Yaron Werber with TD Cowen. Your line is open.

Operator: Hey, guys. This is Joyce on for Yaron. Thanks for taking our question. In the US, can you talk about your plan launch strategy for TransCon PTH in terms of the initial target population and prescriber base? How much of it will mirror your strategy in Germany, where you're initially targeting roughly one-third of the total population? Thank you.

[Analyst] (TD Cowen): Hey, guys. This is Joyce on for Yaron. Thanks for taking our question. In the US, can you talk about your plan launch strategy for TransCon PTH in terms of the initial target population and prescriber base? How much of it will mirror your strategy in Germany, where you're initially targeting roughly one-third of the total population? Thank you.

Unknown: Hey guys, this is Joyce on for Yaron, thanks for taking our question. In the U.S, can you talk about your plan launch strategy for [inaudible] in terms of the initial target population [inaudible] and how much of it will marry your strategy in Germany where you're targeting roughly one-third of the population? Thank you.

Jan Mikkelson: I think what we're doing now is really integrating the learning from the first country where you launch a product. And the first country we launched in was Germany, Austria, and we're getting a lot of good learning. I have to say, we basically got confirmation about how we should do it because we basically have seen everything we have hoped for in this launch. So it's not like we're coming up with a completely different strategy.

Jan Mikkelsen: I think, what we're doing now is to really integrating the learning from the first country where you're launching a product. The first country we launched is in Germany, Austria, and we getting a lot of good learning. I have to say, we basically got confirmation about how we should do it because we basically have seen everything what we have hoped for in this launch. It's not like we're coming up with a complete different strategy. We are more proud about the commercial execution from our people in this region, how they basically made it exactly after the, what I call the playbook. When I come to the playbook of US, there is always heading up, Camilla, that is our head of our global commercial operation.

Jan Moller Mikkelsen: We are more proud about the commercial execution from our people in this region, how we basically made it exactly after what I call the playbook. So when I go to the playbook in the US, there is always heading up a committee that is our head of our global commercial operation. She's coordinating everything from the US to the international market, correlating into EU direct, every place to be sure that we're building up the right strategic approach but basically has the optimal commercial launch on global basis. We've been here and we basically have seen really the use interest. I can say we have the first commercial U.S product or person on commercial product for YORVIPATH. It's a person living in the US that took the consequence of the delay in the U.S to basically fly to Germany and get the product out there. So we know it, we see it, we know YORVIPATH making a really huge difference for the patients, and really getting them their life back, and we really have seen how patients also see this benefit.

Jan Mikkelsen: She's coordinating everything from US, coordinating into international market, coordinating into EU directly, every place to be sure that we're building up the right strategic approach to basically have the optimal commercial launch on a global basis. We will be here, and we basically have seen really the huge interest. I can say we have the first commercial US product or European commercial product for Europe. There's a person living in US that took the consequences of the delay in the US to basically fly to Germany and get the product out there. So we know it, we see it, we know Europe is making a really huge difference for the patient, really get them their life back. We really have seen how patients also see this benefit.

Jan Moller Mikkelsen: or person on commercial product for YORVIPATH. It's a person living in the US that took the consequence of the delay in the U.S to basically fly to Germany and get the product out there. So we know it, we see it, we know YORVIPATH making a really huge difference for the patients, and really getting them their life back, and we really have seen how patients also see this benefit.

[Analyst] (TD Cowen): Thank you.

Operator: Thank you. Our next question comes from Leland Gershell with Oppenheimer. Your line is open.

Leland Gershell: Hey, good afternoon. Thanks for taking our questions. Two from us. First, Jan, if you could just comment on the plan for rolling out YORVIPATH in Great Britain following the approval, is that something you're doing immediately or will there be any delay? And secondly, in the past, you mentioned hypochondroplasia is an indication that you've decided not to pursue. Just wondering if that outlook might change following the data from the achondro phase III that you'll be seeing later this year and or any information that may be coming up from the companies that are pursuing hypochondroplasia. Thank you.

Leland Gershell: Hi, good afternoon. Thanks for taking our questions. Two from us. First, Jan, if you could just comment on the plan for rolling out YORVIPATH in Great Britain following the approval. Is that something you're doing immediately or will there be any delay? Secondly, in the past you had mentioned hypochondroplasia as an indication that you've decided to not pursue. Just wondering if that outlook might change following the data from the achondroplasia Phase III that you'll be seeing later this year and/or any information that may be coming out from the companies that are pursuing hypochondroplasia. Thank you.

unknown: First, if you could just comment on the plan for rolling out your path in Great Britain following approval. Is that something you're doing immediately, or will there be any delay? And secondly, in the past, you mentioned hypochondroplasia is an indication that you've decided not to pursue. Just wondering if that outlook might change following the data from the achondro phase three that you'll be seeing later this year and or any information that may be coming up from the companies that are pursuing hypochondroplasia. Thank you.

Jan Mikkelson: Yeah, the UK is part of our Europe Direct, and we have a rollout in all our countries that is in our EU Direct, and the UK is integrated into this rollout. So after we basically had the UK approval, which is now separated from an EU approval like other countries that we also get approval in now, we continue fighting everywhere from different countries and, for example, Australia, everywhere where we also need an independent approval.

Jan Mikkelsen: Yeah. UK is part of our EU direct plan, and we have a rollout on all our countries that is in our EU direct and UK is integrated in this rollout. After we basically have the UK approval, which is now separated from an EU approval like other countries that we're also getting approval in now, we continue filing everywhere from the different countries and for example, Australia, everywhere where we also need an independent approval. We will then come in and go in and do what we call typical filing of a dossier that really describes the health economic impact as we have done in many EU direct countries, but we're also doing in other countries.

Jan Moller Mikkelsen: We will then come in and do what we call the typical and filing of a dossier that really describes the health economic impact, as we have done in many EU Direct countries, but we're also doing in other countries. And when we have reached an agreement with the agencies in the specific country about the reimbursing price, you will normally come into what we call a full commercial launch. What we're doing in the meantime, until we have this full commercial launch is building up the infrastructure, and we have done that in most of the EU direct countries, where we have a general manager, we have medical affairs, we have market assessment teams, all that is basically already been established, and they are ready to be coming out and doing a full commercial launch, like, for example, which we have done in Germany and Austria.

Jan Mikkelsen: When we have reached an agreement with the agencies in the specific country about the reimbursement price, you typically will come into what we call a full commercial launch. What we're doing in the meantime until we have this full commercial launch, we're building up the infrastructure, and we have done that in most of the EU direct countries where we have a general manager, we have medical affairs, we have market access teams. All that is basically already been established, and they are ready to come out and do a full commercial launch like that, for example, which we have done in Germany and Austria. In the meantime, a physician patient can go to a named patient program where we can get fully reimbursed patient with a build-out of a named patient program or similar structures in a lot of different countries.

Jan Moller Mikkelsen: In the meantime, a physician patient can go to an inpatient program, where we can get fully reimbursed patients with a built on an inpatient program or similar structures in a lot of different countries. In this timeframe, until you are fully commercial, you basically can provide commercial reimbursed product to the patient in all these specific programs. So this is what we call the dual strategy we are utilizing in Europe Direct, which we will also in some way implement in the international market, but we will not be the M&A holder in the international market. It will typically be handed to our sales and distribution agency.

Jan Mikkelsen: In this timeframe, until we will be fully commercial, we basically can provide commercial reimbursed product to the patient in all these specific programs. This is what we call the dual strategy we are utilizing in Europe directly, which we also will someday implement in the international market. We will not be the MA holder in the international market. It will typically be handed to our sales and distribution agents. For the other thing about hypochondroplasia, it really is an interesting aspect for us because we are the only company that have the two cornerstone in growth disorders. Growth disorder is about 30, 40 different diseases. We are the only company that have a once weekly growth hormone, a once weekly CNP molecule with really the best-in-class properties for both of these two mode of actions.

Jan Moller Mikkelsen: Europe direct which we also will someday implement in the international market, but we will not be the M&A holder in the international market EBIT to be behind it to our states and distribution agents.

Jan Moller Mikkelsen: For the other thing about hydro contemplation.

Jan Moller Mikkelsen: For the other thing about hypochondroplasia, it really, really is an interesting aspect for us because we are the only company that has the two corner stone in growth disorder. Growth disorder is about 30-40 different diseases. We are the only company to have a once-weekly [inaudible], a once-weekly CMP molecule with really the best-in-class properties for both of these two modes of action.

Jan Moller Mikkelsen: It's really really is.

Jan Moller Mikkelsen: Kristin.

Jan Moller Mikkelsen: <unk> for us because we are the only company that has two corn.

Jan Moller Mikkelsen: Stone Inc.

Jan Moller Mikkelsen: Growth disorder.

Jan Moller Mikkelsen: Growth disorder is about 30 40 different diseases.

Jan Moller Mikkelsen: We're the only company to have a once weekly growth hormone.

Jan Moller Mikkelsen: At once weekly CMP molecule with really the.

Jan Moller Mikkelsen: Best in class properties for both of these two mode of actions.

Jan Moller Mikkelsen: So what we are doing, and that is part of our Vision 2030, making an integrated strategy how we are going to be the leading company in growth disorder. And that is not only to address hypochondroplasia but address the other 30 other diseases that are in growth disorder. And we believe some of them will be best treated with growth hormones, some of them will be best treated with CMP, but also many of them will potentially be integrated into a combination therapy.

Jan Mikkelsen: What we are doing, that is part of our vision 20 by 30, making an integrated strategy how we are going to be the leading company in growth disorders. That is not only to address hypochondroplasia but to address the other, including the other 30 diseases that is in growth disorders. We believe some of them will be best treated with growth hormone, some of them will be best treated with CNP, but also many of them will potentially be integrated in a combination therapy. This is why we believe we can be positioned to be the leader in growth disorders because we have the two cornerstones basically to handle all the 30 diseases.

Jan Moller Mikkelsen: So what we are doing and that is part of our vision 2000, <unk> <unk>, making an integrated strategy, how we are going to be EBIT leading company.

Jan Moller Mikkelsen: And that is not only to address hypo contemplation, but addressed.

Jan Moller Mikkelsen: Including Sergio.

Jan Moller Mikkelsen: <unk> treated with optimal some of that will be best treated with CMP.

Jan Moller Mikkelsen: But also many of them will put it to be integrated in a combination therapy and this is why we believe why do we can be positioned to be the DJ growth disorder, because we have the two cornerstone for basic to handle all the 32 seats. So much more to come wed become up next year wherever you are.

Jan Moller Mikkelsen: And this is why we believe we can be positioned to be the leader in growth disorders because we have the two cornerstones for basic to handle all the 30 diseases. So much more to come when we come up next year, where we will come with our integrated strategy, how we're building up to be the leading company in growth disorders. Thanks.

And this is why we believe we can be positioned to be the leader in growth disorders because we have the two cornerstones for basic to handle all the 30 diseases. So much more to come when we come up next year, where we will come with our integrated strategy, how we're building up to be the leading company in growth disorders.

Jan Mikkelsen: Much more to come when we come up next year, where we will come with our integrated strategy, how we're building up to be the leading company in growth disorders.

Jan Moller Mikkelsen: We come with our integrated strategy, how were building up to be the leading company improved results.

Leland Gershell: Thanks.

Jan Moller Mikkelsen: Yes.

Leland Gershell: Thanks.

Operator: Thank you. Our last question comes from Sushila Hernandez with Kempen. Your line is open.

Operator: Thank you. And our last question comes from Sushila Hernandez with Kempen. Your line is open. Yes, thank you for taking my question. Could you elaborate on SKYTROFA becoming a blockbuster in the U.S alone, what needs to happen and what are the key drivers? Thank you.

Operator: Thank you. And our last question comes from Sushila Hernandez with Kempen. Your line is open.

Speaker Change: Thank you.

Sushila Hernandez: And our last question comes from Cielo Hernandez with Kempen. Your line is open.

Sushila Hernandez: Yes, thank you for taking my question. Could you elaborate on SKYTROFA becoming a blockbuster in the U.S alone, what needs to happen and what are the key drivers? Thank you.

Speaker 19: Yes, thank you for taking my question. Could you elaborate on SKYTROFA becoming a blockbuster in the US alone? What needs to happen? What are the key drivers? Thank you.

Sushila Hernandez: Yes, thank you for taking my question. Could you elaborate on SKYTROFA becoming a blockbuster in the US alone? What needs to happen? What are the key drivers? Thank you.

Sushila Hernandez: Yes. Thank you for taking my question could you elaborate on the skies drove are becoming a blockbuster in the U S alone.

Jan Mikkelson: The key driver is to continue what we're doing. This is exactly what we're doing. We are doing a continuum, showing the physician, the patient, to really get the treatment benefit of SKYTROFA as the best-in-class product opportunity inside the growth disorder. We will be helped by a lot of different things.

Jan Mikkelsen: The key driver is continue what we're doing. This is exactly what we're doing. We are doing a continuum, showing, get the physician, the patient to really getting the treatment benefit of SKYTROFA as the best-in-class product opportunity inside the growth disorder. We will be helped by a lot of different things. The consolidation of the daily growth hormone market. We saw one of the major player is now stopping. We see other of the major player with daily growth hormone stopping. The consolidation of the daily growth hormone, where potentially one or two player will be left in more or less in a cash segment, it's really only the beginning of it. We're still in a small part of it. We believe we have less than 20% of the growth hormone deficiency, pediatric growth hormone deficiency.

Sushila Hernandez: The key drivers to continue what we're doing.

Jan Moller Mikkelsen: The consolidation of the daily growth hormone market--we saw that one of the major players is now stopping. We see other major players with daily growth hormone stopping. So the consolidation of the daily growth hormone, where potentially one or two players will be left more or less in a cash segment, it's really, really, really only the beginning of it. We're still in a small part of it. We believe we have less than 20% of the growth hormone deficiency, or pediatric growth hormone deficiency. We can also grow it now in adult growth hormone deficiency. We have our Turner trial coming in now. And then we also see the more and more experienced people get of the long-acting, they realize there's only one choice. And I don't need to say that name, because there's only the sky that really, in some ways, gives the limit for this product. Thank you.

The consolidation of the daily growth hormone market--we saw that one of the major players is now stopping. We see other major players with daily growth hormone stopping. So the consolidation of the daily growth hormone, where potentially one or two players will be left more or less in a cash segment, it's really, really, really only the beginning of it. We're still in a small part of it. We believe we have less than 20% of the growth hormone deficiency, or pediatric growth hormone deficiency. We can also grow it now in adult growth hormone deficiency. We have our Turner trial coming in now. And then we also see the more and more experienced people get of the long-acting, they realize there's only one choice. And I don't need to say that name, because there's only the sky that really, in some ways, gives the limit for this product.

Jan Mikkelsen: We can also grow it now in adult growth hormone deficiency. We have our Turner trial coming in now. We also see the more experience people get with the long-acting, they realize there's only one choice. I don't need to say that name because there's only SKYTROFA that really someway give the limit for this product.

Jan Moller Mikkelsen: We can also grow it now in adult growth hormone deficiency. We have our Turner trial coming in now. And then we also see the more and more experienced people get of the long-acting, they realize there's only one choice. And I don't need to say that name, because there's only the sky that really, in some ways, gives the limit for this product.

Speaker 19: Thank you.

Sushila Hernandez: Thank you.

Operator: Thank you. There are no further questions. Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.

Jan Mikkelsen: Thanks so much.

Q1 2024 Ascendis Pharma A/S Earnings Call & Business Update

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