Q2 2026 Ascendis Pharma AS Earnings Call

August 13, 2026

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Q2 2026 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 during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. We ask that you please limit to one question and return to the queue for additional questions. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugere, Vice President of Investor Relations. Please go ahead.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. We ask that you please limit yourself to one question and return to the queue for additional questions.

Speaker #1: And to withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Chad Fugure, Vice President of Investor Relations.

Speaker #1: Please go ahead.

Speaker #2: Thank you, operator, and thank you, everyone, for joining our second quarter 2026 financial results conference call. I'm Chad Fugure, Vice President of Investor Relations at Ascendis Pharma.

Chad Fugere: Thank you, operator, and thank you everyone for joining our Q2 2026 financial results conference call. I am Chad Fugere, Vice President, Investor Relations at Ascendis Pharma. Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherri Glass, Chief Business Officer; and Jae Woo, Executive Vice President and President, Ascendis US. Before we begin, I would like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under their safe harbor provided by the Private Securities Litigation Reform Act. All statements made on this call, other than the statements of historical fact, are forward-looking statements.

Speaker #2: Joining me on the call today are Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Chief Financial Officer; Sherry Glass, Chief Business Officer; and Jay Wu, Executive Vice President and President of Ascendis US.

Speaker #2: Before we begin, I'd like to remind you that this conference call, including the Q&A session that follows our prepared remarks, will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. All statements made on this call, other than statements of historical fact, are forward-looking statements.

Chad Fugere: All statements made on this call, other than the statements of historical fact, are forward-looking statements. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA, YORVIPATH, and YUVIWEL, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates, and our expectation with respect to their continued progress and potential commercialization, our strategic plans, partnerships, and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions, and our financial outlook and Vision 2030 objectives.

Speaker #2: Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of Skytrofa, Yorvipath, and Ubiwell, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates, and our expectation with respect to their continued progress and potential commercialization.

Chad Fugere: Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of SKYTROFA, YORVIPATH, and YUVIWEL, including label expansion and combination treatment, certain expectations regarding patient access and financial outcomes, our pipeline candidates, and our expectation with respect to their continued progress and potential commercialization, our strategic plans, partnerships, and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions, and our financial outlook and Vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements.

Speaker #2: Our strategic plans, partnerships, and investments, our goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of regulatory decisions.

Speaker #2: And our financial outlook and vision 2030 objectives. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place under reliance on these statements.

Chad Fugere: These statements are based on information that is available to us as of today. Actual results may 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. For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-Looking Statements section of today's press release and the Risk Factors section of our annual report on Form 20-F filed with the SEC on 11 February 2026.

Speaker #2: We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the forward-looking statements section of today's press release and the risk factors section of our annual report on Form 20-F filed with the SEC on February 11, 2026.

Chad Fugere: We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ materially, please see the Forward-Looking Statements section of today's press release and the Risk Factors section of our annual report on Form 20-F filed with the SEC on 11 February 2026. In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believe these measures are useful to investors, is included in today's press release.

Speaker #2: In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from, or as a substitute for, our IFRS results.

Chad Fugere: In addition, during this call, we will refer to certain non-IFRS financial measures. These measures are not prepared in accordance with IFRS accounting standards and should not be considered in isolation from or as a substitute for our IFRS results. A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believe these measures are useful to investors, is included in today's press release. TransCon hGH is now approved in the US by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency, and in the EU, has received MAA authorization for the European Commission for the treatment of pediatric growth hormone deficiency.

Speaker #2: A reconciliation of each non-IFRS measure to the most directly comparable IFRS measure, together with an explanation of why management believed these measures are useful to investors is included in today's press release.

Speaker #2: TransCon Growth Hormone, or TransCon HGH, is now approved in the U.S. by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency. In the EU, it has received MAA authorization from the European Commission for the treatment of pediatric growth hormone deficiency.

Chad Fugere: TransCon hGH is now approved in the US by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency, in addition to the treatment of pediatric growth hormone deficiency, and in the EU, has received MAA authorization for the European Commission for the treatment of pediatric growth hormone deficiency. TransCon PTH is approved in the US by the FDA for the treatment of hypoparathyroidism in adults and the European Commission and the United Kingdom's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP is approved in the US by the FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphases.

Speaker #2: TransCon PTH is approved in the U.S. by the FDA for the treatment of hypoparathyroidism in adults and the European Commission in the United Kingdom's Medicines and Healthcare Products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism.

Chad Fugere: TransCon PTH is approved in the US by the FDA for the treatment of hypoparathyroidism in adults and the European Commission and the United Kingdom's Medicines and Healthcare products Regulatory Agency have granted marketing authorization for TransCon PTH as a replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism. TransCon CNP is approved in the US by the FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphases.

Speaker #2: TransCon CMP is approved in the U.S. by the FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

Chad Fugere: Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit in confirmatory trials. Other than the approved products I've just described, our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of product candidates have not been reviewed or approved by any regulatory agency. None of the statements during this conference call regarding product candidates shall be viewed as promotional. On the call today, we'll discuss our Q2 2026 financial results, and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan.

Speaker #2: Continued approval for this indication, which was based on an improvement of annualized growth velocity, may be contingent upon verification and description of clinical benefit and confirmatory trials.

Speaker #2: Other than the approved products I've just described, 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.

Speaker #2: None of the statements during this conference call regarding product candidates should be viewed as promotional. On the call today, we'll discuss our second quarter 2026 financial results, and provide further business updates.

Speaker #2: Following some prepared remarks, we'll then open up the call for questions. With that, let me turn it over to Jan.

Jan Mikkelsen: Thanks, Chad. Good day, everyone. During the Q2, achievement of important milestones and strong demand for our TransCon products continue to drive the transformation of Ascendis into a leading global biopharma company. The uniqueness of the TransCon technology platform, our strong development and global commercialization capability, and our values of visions are the fundamentals driving this transformation. We believe the same strength will continue to drive Ascendis growth in the following years. Starting with the long-term durability of our highly differentiated approved protein and peptide-based combination products, SKYTROFA, YORVIPATH, and YUVIWEL. We believe these products will be the key driver of our growth story for the next 10 to 15 years, through global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings.

Speaker #3: Thanks, Chad. Good day, everyone. During the second quarter, achievement of important milestones and strong demand for our TransCon products continued to drive the transformation of Ascendis into a leading global biopharma company.

Speaker #3: The uniqueness of the TransCon technology platform, our strong development and global commercialization capability, and our values and vision are the fundamentals driving this transformation.

Speaker #3: We believe the same strength will continue to drive Ascendis growth in the following years. Starting with the long-term durability of our highly differentiated approved protein and peptide-based combination products.

Speaker #3: Skytrofa, Yorvipath, and Yorvel. We believe these products will be the key driver of our growth story for the next 10 to 15 years. To global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings.

Jan Mikkelsen: We believe these products will be the key driver of our growth story for the next 10 to 15 years, through global commercialization, potential for label expansion, including combination treatments, and investment in patient support offerings. The continued expansion of the TransCon technology platform enables us to fulfill our plans to file at least one IND or CTA yearly, each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutics areas in addition to hypopara and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications.

Jan Mikkelsen: The continued expansion of the TransCon technology platform enables us to fulfill our plans to file at least one IND or CTA yearly, each based on a new NCE, laying the foundation for strong growth for many decades. This will also enable us to establish new therapeutics areas in addition to hypopara and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications. This is why we believe Ascendis is well-positioned for self-sustained long-term growth. Let's begin with a more detailed look at YORVIPATH. YORVIPATH is the first and only approved treatment for adults with hypoparathyroidism that addresses the underlying disease by replacing the missing endogenous PTH throughout the body.

Speaker #3: The continual expansion of the TransCon technology platform enables us to fulfill our plans to drive at least one IMD or a similar IND yearly, each based on a new NCE, laying the foundation for strong growth for many decades.

Speaker #3: This will also enable us to establish new therapeutic areas in addition to hypopar and growth disorders. As a further upside, our established partners are advancing TransCon candidates in large indications.

Speaker #3: This is why we believe Ascendis is well positioned for self-sustained, long-term growth. Let us begin with a more detailed look at Yorvipath. Yorvipath is the first and only approved treatment for adults with hypopar.

Jan Mikkelsen: This is why we believe Ascendis is well-positioned for self-sustained long-term growth. Let's begin with a more detailed look at YORVIPATH. YORVIPATH is the first and only approved treatment for adults with hypoparathyroidism that addresses the underlying disease by replacing the missing endogenous PTH throughout the body. Uptake of YORVIPATH has grown steadily since launch, both in the US and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure.

Speaker #3: That addressed the underlying disease by replacing the missing endogenous PTH throughout the body. Uptake of Yorvipath has grown steadily since launch, both in the U.S.

Jan Mikkelsen: Uptake of YORVIPATH has grown steadily since launch, both in the US and many other countries, reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure. Outside of the US, we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. YORVIPATH is now available commercially or through named patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid, broad global launch of a rare disease product. In the US, new patient demand for YORVIPATH in Q2 has remained robust, consistent with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated YORVIPATH treatment continue to stay on therapy, indicating a high level of satisfaction.

Speaker #3: and many other countries. Reflecting the significant unmet medical need among the more than 800,000 patients living with this serious rare disease in the geographic region covered by our global commercial infrastructure.

Speaker #3: Outside of the U.S., we see consistent new patient demand. And continual expansion of global commercialization launches with full reimbursement. Yorvipath is now available commercially or through named patient programs in more than 35 countries.

Jan Mikkelsen: Outside of the US, we see consistent new patient demand and continued expansion of global commercialization launches with full reimbursement. YORVIPATH is now available commercially or through named patient programs in more than 35 countries. This illustrates the strength of our ability to execute a rapid, broad global launch of a rare disease product. In the US, new patient demand for YORVIPATH in Q2 has remained robust, consistent with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated YORVIPATH treatment continue to stay on therapy, indicating a high level of satisfaction.

Speaker #3: This illustrates the strength of our ability to execute a rapid broad global launch of a rare disease product. In the U.S., new patient demand for Yorvipath in the second quarter has remained robust.

Speaker #3: Consistent with prior quarters. In addition, physician prescribing is broadening and deepening. Patients who have successfully initiated Yorvipath treatment continue to stay on therapy, indicating a high level of satisfaction.

Speaker #3: We continue to be excited by the growth of Yorvipath in the U.S. and outside the U.S. and to see its continual strong launch performance.

Jan Mikkelsen: We continue to be excited by the growth of YORVIPATH in the US and outside the US, and to see its continued strong launch performance. Data from our long-term phase II and phase III trials of YORVIPATH presented in Q2 highlight why YORVIPATH is becoming a standing standard of care in post-surgical and all subset of hypoparathyroidism, including ultra-rare genetic causes like DiGeorge syndrome, ADS1, and ADS2. Results showed sustained response rate of 82% to 86% for the multicomponent endpoint, with clinical benefit across multiple organ system: CNS, kidney, small intestine, and bone, plus meaningful improvement in quality of life. Patient retention as high as 95% after five years of treatment. Pretty unique.

Speaker #3: Data from our long-term phase two and phase three trials of Yorvipath presented in the second quarter highlight why Yorvipath is becoming a standing standard of care in post-surgical and all subset of hypopar.

Speaker #3: Including ultra-rare genetic causes like DiGeorge’s, ADS-1, and ADS-2. Results showed a sustained response rate of 82 to 86 percent for the multi-component endpoint, with clinical benefit across multiple organ systems: CNS, kidney, small intestine, and bone, plus meaningful improvement in quality of life.

Speaker #3: Patient retention is as high as 95 percent after five years of treatment—pretty unique. In parallel, we are working to further advance our leadership in hypopar with additional clinical trials, including expanding the label to include ages 12 to 18 years in the U.S.

Jan Mikkelsen: In parallel, we are working to further advance our leadership in hypoparathyroidism with additional clinical trials that include expanding the label to include the age from 12 to 18 years, and in the US, higher doses for patients. And developing a once weekly product for the patient that is on stable doses of YORVIPATH. Turning now to YUVIWEL. We believe YUVIWEL is positioned to become the market leader therapy for achondroplasia. Rapid uptake of YUVIWEL is already transforming the US market. Across the board, we see a highly favorable response among patients and physicians to YUVIWEL's differentiator profile. In the US, through 30 June, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollments and more than 65% approved for reimbursement in the US through the end of July. Really a unique launch.

Speaker #3: higher doses for patients. And developing a once-weekly product for the patient that is on stable doses of Yorvipath. Turning now to Yorvel. We believe Yorvel is positioned to be to become the market leader therapy for acondroplasia.

Speaker #3: Rapid uptake of Yorvel is already transforming the U.S. market. Across the board, we see a highly favorable response among patients and physicians to Yorvel's differentiated profile.

Speaker #3: In the U.S., through June 30, we had more than 170 unique patients enrolled. Since then, uptake has continued with more than 220 enrollments and more than 65 percent approved for reimbursement in the U.S.

Speaker #3: through the end of July. Really a unique launch The rapid uptake is by patients of all kinds of background. Those switching returning to medical therapy or starting therapy for acondroplasia for the first time.

Jan Mikkelsen: The rapid uptake is by patients of all kinds of backgrounds, those switches returning to medical therapy or starting therapy for achondroplasia for the first time. We believe YUVIWEL is really growing the US market, which is exactly the pattern you will love to see when a highly differentiated product is introduced into an area where there still exists a high unmet medical need. Long-term data for the now completed ACcomplisH trial show durable and consistent improvement in growth, leg bone, body proportionality, along with a general well-tolerated safety profile compared to placebo, underscoring why the community is quickly adopting YUVIWEL. In the US and the EU, a regulatory decision for YUVIWEL is expected in Q4 2022. We are also making YUVIWEL available in select international markets through early access program using the US FDA approval.

Speaker #3: We believe Yorvel market. Which is exactly the pattern you will love to see when a highly differentiated product is introduced into air where there's still exist a high unmet medical need.

Speaker #3: Long-term data for the now completed people's approach trial showed durable and consistent improvement in growth, leg bone, body proportionality, along with a general well-tolerated safety profile.

Speaker #3: Compare to placebo. Underscoring why the community is quickly adopting Yorvel. In the U.S., in the EU, a regulatory decision for Yorvel is expected in the fourth quarter of 2026.

Speaker #3: We also making Yorvel available in select international markets through early access program using the U.S. FDA approval. Longer term, we are pursuing expansion opportunities for transconceived people to ongoing and planned trials.

Jan Mikkelsen: Longer term, we are pursuing expansion opportunities for TransCon CNP through ongoing and planned trials. These include ongoing activities such as infants 0 to less than 2 years of age, and we recently announced completion of this target enrollment faster than expected. Adults with achondroplasia, children with hypochondroplasia, and still continue with geographic expansions. Turning now to combination therapy with TransCon CNP and TransCon hGH. The biological rationale for this combination treatment is clear and extremely well founded on science. TransCon CNP is removing the limitation caused by the overactive FGFR3 pathway, so TransCon hGH can provide a strong complementary effect. In addition, it has been observed that in achondroplasia there is a partial impairment of the IGF-1 growth hormone axis. This is illustrated by children with achondroplasia having a negative IGF-1 SDS value, as shown of the demographic in both our phase II and phase III trial.

Speaker #3: These include ongoing activities such as infants, zero, to less than two years of age, and we recently announced completion of this target enrollment faster than expected.

Speaker #3: Adults with acondroplasia, children with hypocondroplasia, and still continue with graphic expansions. Turning now to combination therapy with transconceived people and transcon growth enrollment. The biological rationale for this combination treatment is clear and extremely well-founded on science.

Speaker #3: TransCon CNP is removing the limitation caused by the overactive FGFR3 pathway, so TransCon Growth hormone in women can provide a strong complementary effect. In addition, it has been observed that in achondroplasia, there is a partial impairment of the IGF-1 growth hormone axis.

Jan Mikkelsen: In addition, it has been observed that in achondroplasia there is a partial impairment of the IGF-1 growth hormone axis. This is illustrated by children with achondroplasia having a negative IGF-1 SDS value, as shown of the demographic in both our phase II and phase III trial. In our COACH clinical trial for children with achondroplasia, this unique combination has demonstrated sustained transformative analyzed growth velocity and AGS height score, including improvement in body proportionality. Based on this result, we believe this unique combination of once-weekly TransCon-based therapies will transform the treatment of achondroplasia and other indications over time.

Speaker #3: This is illustrated by children with achondroplasia having a negative IGF-1 SDS value, as shown in the demographics in both our phase two and phase three trials.

Speaker #3: In our coastal clinical trial of children with achondroplasia, this unique combination has demonstrated sustained, transformative analyzed growth velocity and ATH height score, including improvement in body proportionality.

Jan Mikkelsen: In our COACH clinical trial for children with achondroplasia, this unique combination has demonstrated sustained transformative analyzed growth velocity and AGS height score, including improvement in body proportionality. Based on this result, we believe this unique combination of once-weekly TransCon-based therapies will transform the treatment of achondroplasia and other indications over time. Our recent week 78 COACH trial data show sustained efficacy over 78 weeks with no compromises to safety and tolerability. This points to the potential for this novel combination to establish a new treatment standard in achondroplasia. The phase III combination trial in children with achondroplasia will begin enrolling later this year. Turning to SKYTROFA. The once-weekly growth hormone treatment built on the mode of action of unmodified somatropin. With indications for pediatric and adult growth hormone deficiency, we continue to be the number 1 long-acting growth hormone by brand value in the US.

Speaker #3: Based on this result, we believe this unique combination of once-weekly transcon-based therapies will transform the treatment of acondroplasia and other indications over time. Our reason week 78 coast trial data show sustained efficacy over 78 weeks, with no compromises to safety and tolerability.

Jan Mikkelsen: Our recent week 78 COACH trial data show sustained efficacy over 78 weeks with no compromises to safety and tolerability. This points to the potential for this novel combination to establish a new treatment standard in achondroplasia. The phase III combination trial in children with achondroplasia will begin enrolling later this year. Turning to SKYTROFA. The once-weekly growth hormone treatment built on the mode of action of unmodified somatropin. With indications for pediatric and adult growth hormone deficiency, we continue to be the number 1 long-acting growth hormone by brand value in the US.

Speaker #3: This points to the potential for this novel combination to establish a new treatment standard in achondroplasia. The Phase 3 combination trial in children with achondroplasia will begin enrolling later this year.

Speaker #3: Turning to SkyTrofa. The once-weekly growth hormone treatment built on the mode of action on unmodified somatopy. With indications for pediatric and adult growth hormone deficiency.

Speaker #3: We continue to be the number one long-acting growth hormone by brand value in the U.S. We are extremely proud that SkyTrofa recently achieved more than 20,000 unique enrollment.

Jan Mikkelsen: We are extremely proud that SKYTROFA recently achieved more than 20,000 unique enrollments. This illustrates the strength of our capabilities from supply chain, commercial infrastructure, and on market support to benefit such a large number of rare disease patients. We are working to make TransCon hGH available to more patients through label and geographic expansions. To support label expansion going that describe in our achondroplasia program, we are conducting the phase III basket trial investigating TransCon hGH in ISS, SGA, and Turner syndrome. As an integrated part of our global growth disorder strategy, we expect to launch TransCon hGH in the same countries where we also expect to launch TransCon CNP. Turning now to our partnership. In metabolic disorders and obesity, our once-monthly TransCon semaglutide program with Novo Nordisk continue to involve events.

Speaker #3: This illustrates the strength of our capabilities from supply chain, commercial infrastructure, unknown market support to benefit such a large number of patients of rare disease patients.

Speaker #3: And we are working to make transcon growth hormone available to more patients to label and geographic expansions. To support label expansion going that described in our acondroplasia program, we are conducting the phase three basket trial investigating transcon growth hormone in ISS, HDA, and Turner syndrome.

Speaker #3: As an integrated part of our global growth disorder strategy, we expect to launch transcon growth hormone in the same countries where we also expect to launch transcon CMP.

Speaker #3: Turning now to our partnership. In metabolic disorders and obesity, our once-monthly transcon semiglutide program with Novo Nordisk continue to involve advance. In ophthalmology, our partner on Conist recently initiated a first in-human clinical trial of the anti-VDF treatment built on the transcon technology in patients with bed AMD.

Jan Mikkelsen: In ophthalmology, our partner, Eyconis, recently initiated a first-in-human clinical trial of the anti-VEGF treatment built on the TransCon technology in patients with wet AMD. In closing, by always putting patient first, Ascendis has delivered three highly differentiated leading TransCon-based products, YORVIPATH, YUVIWEL, and SKYTROFA. We are on track to achieve our Vision 2030 objective of being a leading global biopharma, building on a strong foundation for the future. With that, I will turn the call over to Scott to review our financial results and some additional comments.

Speaker #3: In closing, by all this putting patients first. Ascendis had delivered three highly differentiated leading transcon-based product. Europass, Yorvel, and SkyTrofa. We are on track to achieve our vision 2030 objective.

Speaker #3: Of being a leading global biopharma. Building on a strong foundation for the future. With that, I will turn the call over to Scott to review our financial results and some additional comments Thanks so much, Jan.

Scott Smith: Thanks so much, Jan, and good afternoon, everyone. I will touch on some key points surrounding our Q2 financial results. For further details, please refer to our Form 6-K filed today. Total product revenue was EUR 315 million, more than doubling year-over-year. Total revenue for Q2 2026 was EUR 339 million, which included non-product collaboration revenue of EUR 24 million, which further included a EUR 17 million milestone related to TransCon CNP. YORVIPATH revenue was EUR 252 million in Q2, reflecting consistent new patient demand in the US and continued growth outside of the US, reaching blockbuster status on a run rate basis in the second year of launch in the US. SKYTROFA contributed EUR 55 million in Q2, which reflects increased demand in the US and includes product sales to a collaboration partner.

Speaker #3: Good afternoon, everyone. I will touch on some key points surrounding our second quarter financial results. For further details, please refer to our Form 6-K filed today.

Speaker #3: Total product revenue was €315 million, more than doubling year over year. Total revenue for Q2 2026 was €339 million, which included non-product collaboration revenue of €24 million, which further included a €17 million milestone related to TransCon CMP.

Speaker #3: Yorvipath revenue was $252 million euro in Q2, reflecting consistent new patient demand in the U.S. and continued growth outside of the U.S. reaching blockbuster status on a run rate basis in the second year of launch in the U.S.

Speaker #3: SkyTrofa contributed €55 million in Q2, which reflects increased demand in the U.S. and includes product sales to a collaboration partner. UVwell was commercially launched in the U.S.

Scott Smith: YUVIWEL was commercially launched in the US during Q2 and generated EUR 8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking. Continuing to expenses, R&D expenses in Q2 were EUR 76 million, up from EUR 59 million in Q1, reflecting continued investment in our pipeline and innovation. Recall Q1 included a favorable EUR 11 million reversal of prior period write-downs of TransCon CNP pre-launch inventories. SG&A expenses were EUR 173 million in Q2 compared to EUR 145 million in Q1, reflecting additional investments in the commercial launches of YORVIPATH and YUVIWEL to accelerate growth for the long term. Operating profit of EUR 220 million in Q2 included EUR 158 million of other operating income related to the sale of the PRV. Non-IFRS operating profit was EUR 92 million, and non-IFRS operating margin was 27%. Refer to our press release for details.

Speaker #3: during Q2, and generated €8 million in revenue in its first quarter on the market, reflecting strong demand and rapid conversion to paid therapy with limited stocking.

Speaker #3: ...continuing, €70 million, up from €59 million in Q1, reflecting continued investment in our pipeline and innovation. Recall, Q1 included a favorable €11 million reversal of prior period write-downs of TransCon CMP pre-launch inventories.

Speaker #3: SG&A expenses were $173 million euro in Q2 compared to $145 million euro in Q1, reflecting additional investments in the commercial launches of Yorvipath and UVwell to accelerate growth for the long term.

Speaker #3: Operating profit of $220 million euro in Q2 included $158 million euro of other operating income related to the sale of the PRV. Non-IFRS operating profit was $92 million euro and non-IFRS operating margin was $27%.

Scott Smith: Operating profit of EUR 220 million in Q2 included EUR 158 million of other operating income related to the sale of the PRV. Non-IFRS operating profit was EUR 92 million, and non-IFRS operating margin was 27%. Refer to our press release for details. For Q2 2026, net profit was EUR 207 million, and non-IFRS net profit was EUR 61 million. We ended Q2 2026 with EUR 812 million in cash and cash equivalents, which includes the use of EUR 56 million in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs. Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and EUR 1.4 billion of equity.

Speaker #3: Refer to our press release for details. For Q2 2026, net profit was €207 million, and non-IFRS net profit was €61 million. We ended Q2 2026 with €812 million in cash and cash equivalents, which includes the use of €56 million in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs.

Scott Smith: For Q2 2026, net profit was EUR 207 million, and non-IFRS net profit was EUR 61 million. We ended Q2 2026 with EUR 812 million in cash and cash equivalents, which includes the use of EUR 56 million in Q2 for our previously announced share repurchase program, including the net settlement of certain RSUs. Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and EUR 1.4 billion of equity. Turning to our outlook for the rest of 2026. For YORVIPATH, we expect growth and performance consistent with prior quarters. For SKYTROFA, we expect relatively stable revenue in the US. For YUVIWEL, we are encouraged by the early demand trends. We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the US, reflecting the large unmet medical need and the highly differentiated profile of YUVIWEL.

Speaker #3: Following the settlement of our convertible notes, we have no bank debt, no convertible debt, and €1.4 billion of equity. Turning to our outlook for the rest of 2026.

Scott Smith: Turning to our outlook for the rest of 2026. For YORVIPATH, we expect growth and performance consistent with prior quarters. For SKYTROFA, we expect relatively stable revenue in the US. For YUVIWEL, we are encouraged by the early demand trends. We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the US, reflecting the large unmet medical need and the highly differentiated profile of YUVIWEL. Our Q2 performance reinforces our belief that we can achieve EUR 5 billion in revenues in 2030. With our existing portfolio and our TransCon technology as a strong foundation, we believe we are well-positioned to grow revenue to more than EUR 10 billion in the next decades while developing and launching new TransCon products with blockbuster potential.

Speaker #3: For Yorvipath, we expect growth and performance consistent with prior quarters. For SkyTrofa, we expect relatively stable revenue in the U.S. For UVwell, we are encouraged by the early demand trends.

Speaker #3: We believe it is expanding the market and is on pace to be the leading achondroplasia therapy in the U.S., reflecting the large unmet medical need and the highly differentiated profile of UVwell.

Speaker #3: Our Q2 performance reinforces our belief that we can achieve €5 billion in revenues by 2030. With our existing portfolio and our TransCon technology as a strong foundation, we believe we are well positioned to grow revenue to more than €10 billion in the next decades, while developing and launching new TransCon products with blockbuster potential.

Scott Smith: Our Q2 performance reinforces our belief that we can achieve EUR 5 billion in revenues in 2030. With our existing portfolio and our TransCon technology as a strong foundation, we believe we are well-positioned to grow revenue to more than EUR 10 billion in the next decades while developing and launching new TransCon products with blockbuster potential. We expect significant operating leverage as revenue scales through the balance of the year while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long-term revenue aspirations. Even with these investments, we expect to generate more than EUR 500 million in cash flow from operating activities this year. With that operator, we are now ready to take questions.

Speaker #3: We expect significant operating leverage as revenue scales through the balance of the year, while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long-term revenue aspirations.

Scott Smith: We expect significant operating leverage as revenue scales through the balance of the year while maintaining new investments in global product launches and patient access to reach as many patients as possible and support our long-term revenue aspirations. Even with these investments, we expect to generate more than EUR 500 million in cash flow from operating activities this year. With that operator, we are now ready to take questions.

Speaker #3: Even with these investments, we expect to generate more than €500 million in cash flow from operating activities this year. With that, operator, we are now ready to take questions.

Operator: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We ask you please limit to one question and return to the queue for additional questions. Our first question is going to come from Jessica Fye with JPMorgan. Your line's open.

Speaker #1: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. And to withdraw your question, please press star 11 again.

Speaker #1: We ask you please limit to one question and return to the queue for additional questions. And our first question is going to come from Jessica Five with JP Morgan.

Speaker #1: You're lines open.

Jessica Fye [Managing Director, Equity Research Analyst: Hey, guys. Good morning. Thanks for taking my question. On that outlook for at least EUR 500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale. I was just wondering if you are able to update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded, but curious if anything more you can add there. On that comment that YUVIWEL seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion? Thank you.

Jessica Fye: Hey, guys. Good morning. Thanks for taking my question. On that outlook for at least EUR 500 million of operating cash flow this year, I think you gave that in the beginning of the year prior to the PRV sale. I was just wondering if you are able to update your cash flow expectations for the year. I know it's sort of like a greater than is unbounded, but curious if anything more you can add there. On that comment that YUVIWEL seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion? Thank you.

Speaker #3: Hey guys, good morning. Thanks for taking my question. On that outlook for at least $500 million of operating cash flow this year—I think you gave that in the beginning of the year prior to the PRV sale—and I was just wondering if you're able to kind of update your cash flow expectations for the year.

Speaker #3: I know it's sort of like a "greater than" is unbounded, but I'm curious if there's anything more you can add there. And then, on that comment that UVwell seems to be expanding the market, is it possible to estimate how much of these patient enrollments are coming from market expansion?

Speaker #3: Thank you.

Speaker #2: Thanks, yes, for the questions and the other happy person besides me, Scott. So Scott got the opportunity to be the first one answering questions.

Jan Mikkelsen: Thanks, Jess, for the questions. I have a happy person besides me, Scott. Scott got the opportunity to be the first one answering questions. Please, Scott.

Speaker #2: So please, Scott.

Speaker #4: Yeah, with respect to our cash flow guidance, just to be clear, greater than $500 million—I thought I heard you say $100. So, greater than $500 million.

Scott Smith: Yeah. With respect to our cash flow guidance, just to be clear, greater than EUR 500 million. I thought I heard you say 100, so greater than EUR 500 million. At this time, we don't want to bound the upper side because we're initial into the launch of YUVIWEL. That's euro, by the way, EUR 500 million, Jan likes to point out.

Speaker #4: And at this time, we don't want to bound the upper side because we're initial into the launch of UVwell. And that's euro, by the way, $500 million euro Ian likes to point out.

Speaker #2: And just related to the question—and it comes back to what we communicated last time we had this call—we don't really have the insight into exactly the distribution of where the patients are coming from.

Jan Mikkelsen: Related to the question, it comes back to what we communicated last time we had this call, that we don't have really the insight in exactly the distribution of where the patients are coming from. Our general feelings and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from switches, it's also coming from either patients that had stopped therapy or new patients that basically are coming to a situation because of the highly differentiated nature of YUVIWEL that they want to start therapy. I think this is where we have this strong belief that we see an expansion of the market.

Speaker #2: And our general feeling and how we see it is that with such a strong demand, we have a really strong belief that it's not only coming from Swishes, it must also coming from either patient that had stopped therapy or new patients that basic are coming to a situation because of the highly differentiated nature of UVwell that we want to start therapy.

Speaker #2: And I think this is where we have this strong belief that we will see an expansion of the market.

Speaker #3: Thank you.

Jessica Fye [Managing Director, Equity Research Analyst: Thank you.

Jessica Fye: Thank you.

Operator: Thank you. The next question is going to come from Tazeen Ahmad with Bank of America. Your line's open.

Speaker #1: Thank you. And the next question is going to come from Tazeen Ahmad with Bank of America. Your lines open.

Speaker #5: Hey, good morning. Thanks for taking my question. So Ian, I wanted to get your thoughts about the IT challenge on UVwell. We know obviously what the Blue Sky scenario is for Ascendis and most of the scenarios look positive, but can you just maybe walk us through what the potential outcomes are?

Operator: Hey, good morning. Thanks for taking my question. Jan, I wanted to get your thoughts about the IP challenge on YUVIWEL. We know obviously what the blue-sky scenario is for Ascendis, and most of the scenarios look positive. Can you just maybe walk us through what the potential outcomes are? This is for a patent that expires obviously in 2030. Between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst case scenario could be? Thanks.

Tazeen Ahmad: Hey, good morning. Thanks for taking my question. Jan, I wanted to get your thoughts about the IP challenge on YUVIWEL. We know obviously what the blue-sky scenario is for Ascendis, and most of the scenarios look positive. Can you just maybe walk us through what the potential outcomes are? This is for a patent that expires obviously in 2030. Between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst case scenario could be? Thanks.

Speaker #5: This is for a patent that expires obviously in 2030. And so between now and then, can you just tell us what could happen and what the potential for payments that Ascendis would need to make in the worst case scenario could be?

Speaker #5: Thanks.

Speaker #2: Thanks, Tazeen, for the question. And it's basically a question that is addressing the ongoing legal—I would call it—battle between Ascendis and BioMarin.

Jan Mikkelsen: Thanks, Tazeen, for the question. It basically is a question that is addressing the ongoing legal, I would call it, battle between Ascendis and BioMarin. Let me just come back to some facts. The fact is that this patent that we discussion got complete invalid in Europe. We never really come to an discussion if we were infringing and anything like that. When we see the situation outside US, we got the patent invalid immediately to the patent system in Europe. In the US, we never managed to come into the patent system because BioMarin selected to go to the ITC case, which are a system which we can easily say traditional never have really dealt with a lot of cases that dealing with branded pharmaceutical.

Speaker #2: And let me just come back to some facts. The fact is that this patent that we're discussing got completely invalidated in Europe, so we never really came to a discussion if we were infringing on anything like that.

Speaker #2: So when we see the situation outside the US, we got the patent invalidated immediately through the patent system in Europe. In the US, we never managed to come into the patent system because Biomarine selected to go to the ITC case, which is a system that we can easily say traditionally has never really dealt with a lot of cases dealing with branded pharmaceuticals.

Jan Mikkelsen: In the ITC case, there will be a first opinion from a single judge, and he will come with an opinion here in August, and then there will be a more next time will be in December. There will be an opinion from the ITC, and then later on, there will be an potential confirmation of the ITC decision two to three months after to a presidential order. You can see we are not getting any clarification in August in one way or the other way. Even if it's possible for one company and negative for the other one, it's not really any kind of decision where it's going to be ending. After the first initial opinion from a single judge, because the ITC case will be taken to a decision for, I cannot remember how many judges that will be part of that decision.

Speaker #2: In the ITC case, there will be a first opinion from a single judge and he will come with opinion here in August. And then there will be a more next time will be in December.

Speaker #2: There will be an opinion from the ITC and then later on there will be an potential confirmation of the ITC decision to two to three months after.

Speaker #2: To a presidential order. So you can see we are not getting any clarification in August in one way or the other way. Even as it's possible for one company and negative for the other one, it's not really any kind of decision where it's going to be ending.

Speaker #2: And after the first initial opinion from a single judge, because of the ITC case, it will be taken to a decision for—I cannot remember how many judges will be part of that decision.

Jan Mikkelsen: After the first initial opinion from a single judge, because the ITC case will be taken to a decision for, I cannot remember how many judges that will be part of that decision. There is a huge opportunity to provide what we call public interest for this product. When we see the public interest mean the element of how this product opportunities are really being serving an unmet medical need in the US market with this rapid uptake of patients is really clear that is a huge public interest to keep that.

Speaker #2: There is a huge opportunity to provide what we call interest for this product. And when we see the public interest—meaning the element of how this product’s opportunities are really serving an unmet medical need in the U.S. market, with this rapid, rapid uptake for patients—it’s really, really clear that there is a huge public interest to keep that.

Jan Mikkelsen: There is a huge opportunity to provide what we call public interest for this product. When we see the public interest mean the element of how this product opportunities are really being serving an unmet medical need in the US market with this rapid uptake of patients is really clear that is a huge public interest to keep that. Just recall, I cannot remember one single case in the US where a branded product that provides a benefit to US patients has been denied. You can see we just in a case where it's only is a US, it has been cleared ex-US. Whatever has happened, it will not have any material impact on Ascendis pathway. I can guarantee that. People take it up as a life and death for Ascendis. This is a total not taken into the perspective what it means for Ascendis.

Speaker #2: And just recall, I cannot remember one single case in the US where a branded product that provide a benefit to US patient had been denied.

Jan Mikkelsen: Just recall, I cannot remember one single case in the US where a branded product that provides a benefit to US patients has been denied. You can see we just in a case where it's only is a US, it has been cleared ex-US. Whatever has happened, it will not have any material impact on Ascendis pathway. I can guarantee that. People take it up as a life and death for Ascendis. This is a total not taken into the perspective what it means for Ascendis. Out from that, I see it's not really a material element for our destiny to be a leading biopharma and hit the EUR 5 billion in 2030.

Speaker #2: But you can see we just in a case where it's only is a US, it has been cleared ex-US. And so whatever it happened, it will not have any material impact on Ascendis pathway.

Speaker #2: I can guarantee that. It's as if some people take it up as a life and death matter for Ascendis. This is totally not taking into perspective what it means for Ascendis.

Speaker #2: And out from that, I see it's not really a material element for our destiny to be a leading biopharma and hit the $5 billion in 2030.

Jan Mikkelsen: Out from that, I see it's not really a material element for our destiny to be a leading biopharma and hit the EUR 5 billion in 2030.

Operator: Thank you. Our next question will come from Gavin Clark-Gartner with Evercore. Your line's open.

Speaker #1: Thank you. And our next question will come from Gavin Clark-Gartner with Evercore. Your line is open.

Gavin Clark-Gartner: Hey, guys. Thanks for taking the question. I actually just wanted to ask on the earlier pipeline. You noted in your prepared remarks that TransCon platform can fuel one IND for an NCE annually. I guess there hasn't been one yet this year. Should we expect one in the near term? What exactly are the go-forward plans for the earlier pipeline? Thank you.

Speaker #6: Hey guys. Thanks for taking the question. Actually just wanted to ask on the earlier pipeline. So you noted in your prepared remarks that Transcon platform can fuel one IND for an NCE annually.

Speaker #6: I guess there hasn't been one yet this year. Should we expect one in the near term? And what exactly are the go-forward plans for the earlier pipeline?

Speaker #6: Thank you.

Jan Mikkelsen: It was because I in some way felt that the two product opportunities that we have developed to our partnership built on the TransCon technology will still consider as an NCE. The one that now in clinic with Eyconis and the other one we expect to go into the clinic now with Novo Nordisk, is still some way being developed to the TransCon technology funnel. Gavin, perhaps I shouldn't have done that, but I still believe I feel some kind of little bit ownership on these two product opportunities. At least we have major upside in both of them. So out from that perspective, I still consider we potentially will have this year two new chemical entity being entered into clinical trials.

Speaker #2: There will because having somewhere felt that the two product opportunities that we have developed to our partnership built on the Transcon technology will still consider at the NCE, the one that now clinic with Iconis and the other one we expect to go into the clinic now with Novo Nordisk.

Speaker #2: It's still someway being developed to the Transcon technology funnel. And Kevin, perhaps I shouldn't have done that, but I still believe I feel some kind of little bit ownership on these two product opportunity.

Speaker #2: At least we have major upside in both of them. So out from that perspective, I still consider we potential will have this year two new chemical entity being insert into clinical trials.

Speaker #2: And I can Kenneth and his team and anyone else they are working very hard on that will be at least one of this new chemical entities coming into every year now.

Jan Mikkelsen: And I think Kennett and his team and anyone else, they are working very hard on that will be at least one of these new chemical entities coming into every year now. I am really proud about that. But it is also addressing the sustainability of Ascendis independent of going out and buying something no one else want to have. I think this is where we really feel extremely pleasant by the situation, by being a fundamental company that building on a strong technology platform than provide both sustainability for ourself, but also a continued flow of potential partner licensing.

Speaker #2: And I'm really proud about that. But it's also addressing the sustainability of Ascendis independent or going out and buying something no one else want to have.

Speaker #2: And I think this is where we really feel extremely pleasant by the situation by being a fundamental company that building on a strong, strong technology platform then provide both sustainability for ourselves but also a continue flow of potential partner licensing.

Speaker #6: Great. Thanks.

Gavin Clark-Gartner: Great. Thank you.

Operator: Thank you. The next question will come from Yaron Werber with TD Cowen. Your line is open.

Speaker #1: Thank you. And the next question will come from Joran Werber with TD Cohen. Your lines open.

Yaron Werber: Great. Thanks so much. Question in YUVIWEL. Do you expect that there is some seasonality in terms of new patient starts in the summer as kids are going on vacation? We are getting a lot of questions on sort of the 60 patient start forms in April, and now you are sort of at 220. It sounds like there is like 50 per month now. Is that sort of sustainable from now on? Then, it sounds like you think you could be the number one brand by the end of the year. BioMarin, we think has about 750 patients on drug, you think in the US. Are you referring to getting to a higher number than that by, let us say, late February? Thank you.

Speaker #5: Great. Thanks so much. Question: In UV, do you expect that there is some seasonality in terms of new patient starts in the summer?

Speaker #5: It's kind of kids are going on vacation. We're getting a lot of questions on sort of the 60 patient start forms kind of in April and now you're sort of a 220.

Speaker #5: It sounds like there's like 50 per month now. Is that sort of sustainable from now on? And then it sounds like you're planning you think you could be the number one brand by the end of the year.

Speaker #5: Biomarine, we think has about 750 patients on drug. You think in the US, are you kind of referring to getting to a higher number than that by let's say late February?

Speaker #5: Biomarine, we think has about 750 patients on drug. You think in the US, are you kind of referring to getting to a higher number than that by let's say late February? you.

Speaker #2: Thanks for the question. I actually don't think Ascendis have really made some clear forward looking statement related to how we see your value being accelerating and expanding the market in a quantitative manner.

Jan Mikkelsen: Thanks for the question. I actually don't think Ascendis has really made some clear forward-looking statement related to how we see YUVIWEL being accelerating and expanding the market in a quantitative manner. I don't think we have come with any kind of indication related to that. I have no doubt it will do it, but it's not the same thing that we're going to quantify it currently. I think after basically only four months in the market, I feel really not prepared to come with clear guidance to it before we have more quarters really into our, you can say, analytical system where we basically can look on trends and other things like that.

Speaker #2: it will do it, but it's not the same thing that we going to quantify it currently.

Jan Mikkelsen: I think after basically only four months in the market, I feel really not prepared to come with clear guidance to it before we have more quarters really into our, you can say, analytical system where we basically can look on trends and other things like that. But one person that really can give you a good feedback, now we talk about the US market, is Jae, and he's extremely enthusiastic about what he's seeing, and you can give the latest way what you see how the market will develop.

Speaker #2: trends and other things like that. But one person that really can give you good feedback—now, we talk about the U.S. market—is Jay.

Jan Mikkelsen: But one person that really can give you a good feedback, now we talk about the US market, is Jae, and he's extremely enthusiastic about what he's seeing, and you can give the latest way what you see how the market will develop.

Speaker #2: And he's extremely Thank enthusiastic about what he's seeing and you can give the latest way what you see how the market will develop.

Speaker #6: Thanks, Jan. As Jan mentioned before, four months in, we're not prepared to give longer term guidance, but what we can say is we're incredibly encouraged by what we're seeing today.

Jay Donovan Wu: Thanks, Jan. As Jan mentioned before, four months in, we're not prepared to give longer term guidance, but what we can say is we're incredibly encouraged by what we're seeing to date. When you look at some of the fundamentals behind the YUVIWEL uptake, whether it's prescriber reach, we talk a lot a bit before around this space. There's quite a few centers of excellences. We're seeing 80% of them, nearly 80% already in a short four-month period, already prescribe YUVIWEL to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm I think you can see in early days, we're seeing a very positive trajectory.

Jay Woo: Thanks, Jan. As Jan mentioned before, four months in, we're not prepared to give longer term guidance, but what we can say is we're incredibly encouraged by what we're seeing to date. When you look at some of the fundamentals behind the YUVIWEL uptake, whether it's prescriber reach, we talk a lot a bit before around this space. There's quite a few centers of excellences. We're seeing 80% of them, nearly 80% already in a short four-month period, already prescribe YUVIWEL to their patients. So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm I think you can see in early days, we're seeing a very positive trajectory.

Speaker #6: When you look at some of the fundamentals behind the Yuval uptake, whether it's prescriber reach—we talked a little bit before around this space.

Speaker #6: There are quite a few centers of excellence. We're seeing nearly 80% of them, already in a short four-month period, prescribe Yuval to their patients.

Speaker #6: So even in early days, we're seeing a lot of enthusiasm from providers around the clinical profile of this product. I think even more importantly, when you look at the patient enthusiasm, I think you can see in early days, we're seeing a very positive trajectory.

Speaker #6: While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy.

Jay Donovan Wu: While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy. This is rare disease, so qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from. Those three categories, again, are, one, patients that are switching from current therapy. Two, patients that have previously discontinued pharmacological therapy and has now wanted to return to pharmacological treatment. Then third, a group of patients that historically have sat out and have said, based on the clinical profile of YUVIWEL, they now want to try a therapeutic option for the first time.

Jay Woo: While we don't explicitly collect information on what therapy or non-therapy a patient is coming from, and again, that's driven largely by the fact that we have a broad label, so we don't need that information in order to ensure that this patient can get on therapy. This is rare disease, so qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from. Those three categories, again, are, one, patients that are switching from current therapy.

Speaker #6: This is rare disease. So qualitatively, we have heard confirmed anecdotes across all three categories for which our patients are coming from. And those three categories again are one, patients that are switching from current therapy.

Speaker #6: Two, patients that have previously discontinued pharmacological therapy and is now wanting to return to pharmacological treatment. And then third, a group of patients that historically have set out and have said based on the clinical profile of Yuval, they now want to try a therapeutic option for the first time.

Jay Woo: Two, patients that have previously discontinued pharmacological therapy and has now wanted to return to pharmacological treatment. Then third, a group of patients that historically have sat out and have said, based on the clinical profile of YUVIWEL, they now want to try a therapeutic option for the first time. So all that again, to underscore there is existing unmet need here, and because of our profile, we are definitely seeing that patients are coming out of the woodwork from growing the market standpoint, and we are just getting started.

Speaker #6: So all that again to underscore there is existing unmet need here and because of our profile, we're definitely seeing that patients are coming out of the woodwork from growing the market standpoint and we're just getting started.

Jay Donovan Wu: So all that again, to underscore there is existing unmet need here, and because of our profile, we are definitely seeing that patients are coming out of the woodwork from growing the market standpoint, and we are just getting started.

Jan Mikkelsen: Just to summary to add on to Jae Woo's excellent comments. Ultimately, I have no doubt we will be number one in the achondroplasia space. Ultimately, we will expand the market because of the unmet medical need. And that is just with the monotherapy. And when you look at how commitment we have to this area where we now are making a complete new standard with the combination treatment. I believe we are dedicated to be not number one in the first year, but continue to build for the next five to 10 years with monotherapy combination integrated treatment regimes. And I believe with our once-weekly TransCon product built on Ultomiro and CNP, we are extremely well-positioned really to be the leader in this segment.

Speaker #2: Just to summary to add on to Jay's 's excellent comments. Ultimative, I have no doubt we will be number one in the contact patient space.

Speaker #2: Ultimative, we will expand the market because of the unmet medical need. And that is just with the monotherapy and when you look and how commitment we are have to this area, where we now are making a complete new standard with the company treatment.

Speaker #2: I believe we are dedicated to be not number one in the first year, but continue to build for the next 5 to 10 years with monotherapy combination integrated treatment regimes and I believe with our once weekly transplant product, build on growth and CMP we are extremely, extremely well positioned really to be the leader in this segment.

Operator: Thank you. And our next question will come from Derek Archila with Wells Fargo. Your line is open.

Speaker #1: Thank you. And our next question will come from Derek Archila with Wells Fargo. Your line is open.

Derek Archila: Hey, good morning, and thanks for taking the questions. Congrats on the progress. Scott, I just wanted you to clarify a comment on your YORVIPATH growth for the rest of the year. I think you said it is going to be like prior quarters. I guess, which quarters are you referring? Because I think the quarter-over-quarter growth in Q1 was negatively impacted. Saw some catch up here in Q2. So maybe you could just clarify which quarters you are referring to. Thanks.

Speaker #5: Hey, good morning and thanks for taking the questions. Congrats on the progress. Scott, I just wanted you to clarify a comment on your repath growth for the rest of the year.

Speaker #5: I think you said it's going to be like prior quarters. I guess which quarters are you referring? Because I think the quarter over quarter growth in one Q was negatively impacted saw some catch up here in the second quarter.

Speaker #5: So maybe you can just clarify which quarters you are referring to. Thanks.

Speaker #3: Yeah, Derek, thanks for the question. I think that two points. One is the consistent performance with a KPIs that we've given you. For example, with enrollments, we expect those to continue and be consistent.

Scott Smith: Yeah, Derek, thanks for the question. I think that two points. One is the consistent performance with the KPIs that we have given you, for example, with enrollments. We expect those to continue and be consistent. The other would be, you could refer to our prior quarters and maybe Chad can point to prior comments. But I think that now that we have seen a full year, you know, the various trends that will come into play related to Q3 and Q4 and then Q1 next year. So we think actually folks did a pretty good job modeling out Q2, and now you have all the information you need to model the rest of the year going forward until we update basically the KPIs.

Speaker #3: The other would be and you could refer to our prior our prior quarters and maybe Chad maybe Chad can point to prior comments, but I think that now that we've seen a full year, you know the various trends that'll come into play related to Q3 and Q4 and then Q1 next year.

Speaker #3: So we think actually folks did a pretty good job modeling out Q2 and now you have all the information you need to model the rest of the year going forward until we update basically the KPIs.

Speaker #2: Just to give you some kind of what is our value in this year. The value for us, we want to give you—we want to give you—not so you basically get a lower number so we look like heroes.

Jan Mikkelsen: Just to give you some kind of what is our value in this here. The value for us we want to give you, not so you basic getting a lower number, so we look like heroes. We want to give you the number, so you are right nearly every time. I think this is a way we try to come up with our different mathematic algorithm and how we see it and give you all the information for you really to be right in this manner. I think this is a way we like to be extremely transparent with everything what we perform. So we quite sure that you basically can go out and really somewhere feeling always comfort with the guidance we give you.

Speaker #2: We want to give you the number so you are right nearly every time. And I think this is a way we try to come up with our different mathematic algorithm how we see it and give you all the information for you really to be right in this manner.

Speaker #2: And I think this is a way we like to be extremely transparent with everything what we perform so we quite sure that you basic can go out and really somewhere feeling always comfort with the guidance we give you.

Derek Archila: Great. Thank you.

Speaker #5: Great. Thank you.

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

Speaker #1: Thank you. And our next question will come from Joseph Schwartz with Leerink. Your line is open.

Joseph Schwartz: Hi. Congrats on all the progress. Thanks for taking my question. As you embark on a phase III in hypochondroplasia, I wanted to ask how you are defining the enrolled population. How large do you see the diagnosed treatable pool of hypochondroplasia patients who are not already being treated in some cases, if they are at the more severe end versus achondroplasia? Thank you.

Speaker #6: Hi. Congrats on all the progress. Thanks for taking my question. As you embark on a phase three and hypocondroplasia, I wanted to ask how you're defining the enrolled population and how do you how large do you see the diagnosed treatable pool of hypocondroplasia patients who are not already being treated in some cases if they're at the more severe end versus a chondroplasia?

Speaker #6: Thank you.

Jan Mikkelsen: This is a very interesting question because it is actually somewhere going into the situation on how we basically are to genetic testing, taking a big patient group that was in old days were called ISS, idiopathic, meaning we have no clue what is the underlying diseases. Then you go out and do more genetic testing. Then when you find a mutation in the FGFR3 receptor, and you find it in the right regions, then you suddenly are not an ISS patient, but then you are a hypochondroplasia patient, even if you do not have, you could say, the phenotype of looking like an achondroplasia patient or a hypochondroplasia patient that we saw for 10 years ago.

Speaker #2: This is from this is a very interesting question because it's actually a someway going into the situation on how we basic are to genetic testing taking a big patient group that was in old days were called ISS idiopathic meaning we have no clue what is the underlying diseases and then you go out and do more more more genetic testing and then when you find an mutation in the FDR3 receptor and you find it in the right regions and then you suddenly are not an ISS patient but then you are an hypocondroplasia patient even if you don't have you can say the phenotype of looking like an acondroplasia.

Speaker #2: Patient or a hypocondroplasia that we saw for 10 years ago. So therefore you can see the ISS population is someway getting smaller and smaller because of the genetic testing is basic going out and giving them an underlying reason why you perfect will have a short status without potential have the other element that you see for the phenotype of that.

Jan Mikkelsen: Therefore, you can see the ISS population is some way getting smaller and smaller because of the genetic testing is basically going out and giving them an underlying reason why you potentially have a short status without potentially having the other element that you see for the phenotype of that. So this is where you can think when you go into ISS, are you defining it from a genetic perspective, or are you defining it for a phenotype or anything like that? We are in a situation where when you see the clinical trial, how we are doing it, you will basically see that is one of the pathways we have selected.

Speaker #2: So, is this where you can send—when you go into ISS—are you defining it from a genetic perspective, or are you defining it by phenotype, or anything like that?

Speaker #2: And we are in a situation where when you see the clinical trial how we doing it you will basic see that it's a one of the pathway we have selected.

Speaker #6: Thank you.

Joseph Schwartz: Thank you.

Operator: Thank you. Our next question will come from Daniel Bronder with Cantor. Your line's open.

Speaker #1: Thank you. And our next question will come from Daniel Bronder with Canner. Your line's open.

Operator: Hey, team. Congrats on the quarter. I am on for Lee Waczak. We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics?

Daniel Bronder: Hey, team. Congrats on the quarter. I am on for Li Watsek. We were just wondering if you could give us a little more color on the quality of life metrics in the COACH trial. You already alluded to the body segment ratios, but how should we think about benefit on arm span and other metrics?

Speaker #7: Hey team. Congrats on the quarter. I'm on for Lee Wattsack. We were just wondering if you could give us a little more color on the quality of life metrics in the coach trial you already alluded to the body segment ratios but how should we think about benefit on arm span and other metrics?

Jan Mikkelsen: Just to recall, the COACH trial is the combination trial where we are combining the two TransCon-based products, our TransCon hGH and TransCon CNP. I have to say, when I look on an element like arm span, we have already reported some of the data. We have reported the 52 weeks data, and if you cannot find that deck, I can send it to you, or Scott can send it, or Chad can send it. I do not know. We have so many IR people, I do not know their names anymore. From that perspective, it already came out, and I have to say it was one of the, I will say, extremely positive surprises I saw because when we looked on monotherapy, but either a CNP-based one or a growth hormone-based one, we did not see the expected hopeful development that we could hope for.

Speaker #2: Just to recall the coach tribe is the combination tribe where we combining the two transcon based product our transcon growth mode and a transcon CMP.

Speaker #2: And I have to say when I look on an element like arm span it's actually we are already reported some of the data we have reported the 52 weeks data and if you cannot find that deck I can send it to you or Scott can send it or Chad can send it or I don't know we have so many IR people I don't know their names more.

Speaker #2: So from that perspective it is already came out and I have to say there was one of the I will say extremely positive surprises I saw because when we looked on monotherapy but either a CMP based one or a growth hormone based one with not so the expected hopeful development that we can hope for but we definitely saw it when we look on the combination therapy and then you can ask me what is the sound scientific reason why you see it much more influenced benefit by the combination therapy and I have to say I don't know.

Jan Mikkelsen: We definitely saw it when we looked at the combination therapy. You can ask me, what is the scientific reason why you see it much more influenced benefit by the combination therapy? I have to say, I do not know. But what we saw was an arm span that really gave us this hope with the combination therapy, you basically will be in a position that you basically could avoid all kinds of limb elongation surgeries in achondroplasia, both related to both legs and arms by that. It is slide number 5 as I remember it. What we see, Scott, read up.

Speaker #2: But what we saw was an arm span that was really giving us this hope. With the combination therapy, you basically will be in a position that you basically could avoid all kinds of limb elongation surgeries in achondroplasia, both related to both legs and arms, by that.

Speaker #2: And it's slide number five, as I remember it, and what we see—Scott, read up.

Scott Smith: The unprecedented improvements in the arm span with a combination were +9.4 centimeters with TransCon CNP-naive cohort and 7.9 centimeters with the TransCon CNP-treated cohort.

Speaker #3: The unprecedented improvements in the arm span with combination were plus 9.4 centimeters with the TransCon CMP naïve cohort, and 7.9 centimeters with the TransCon CMP treated cohort.

Speaker #2: So it was really an.

Jan Mikkelsen: It was really an-

Speaker #3: Compared to limb lengthening surgery centimeters.

Scott Smith: Compared to limb lengthening surgery centimeters gain.

Jan Mikkelsen: Exactly. I have to say, it was one of the days where I felt it was worth to go to job and really can see the benefit of what we are doing.

Speaker #6: Exactly. Exactly. I have to say it was one of the days where I felt it was worth to go to job and really can see the benefit of what we're doing.

Jan Mikkelsen: Okay. Thank you.

Daniel Bronder: Okay. Thank you.

Speaker #7: Okay. Thank you.

Operator: Thank you. Our next question will come from Yun Zhong with Wedbush. Your line is open.

Speaker #1: Thank you. And our next question will come from Yoon Jong with Wedbush. Your line is open.

Yun Zhong: Hi. Excuse me. Good morning. Thank you very much for taking the question. I wanted to confirm that you have not provided prescription number for YORVIPATH in case I missed anything. I know that you said the patient demand remained robust in the quarter, so I wonder if there is any additional quantitative information that you can provide. Going forward, are you going to provide that number in the coming quarters? I think you had this question before at the beginning of the launch. When do you expect that you will feel comfortable providing a guidance in terms of the sales range on actual revenue? Thank you very much.

Speaker #5: Hi. Excuse me. Good morning. Thank you very much for taking the question. I wanted to confirm that you have not provided prescription number for your path in case I missed anything.

Speaker #5: And so I know that you said the patient demand remained robust in the quarter. So I wonder if there is any additional quantitative information that you can provide, and going forward, are you going to provide that number in the coming quarters? And I think you had this question before, at the beginning of the launch, and when do you expect that you will feel comfortable providing guidance in terms of the sales range on actual revenue?

Speaker #5: Thank you very much.

Jan Mikkelsen: You are right. I think it is starting to be a little bit repetitive every quarter come out and saying that we have about more than 1,000 patients being unique enrolled per quarter. We have continued that message that we see steady state, steady state, and steady state. We said in last year that we will stop coming with this because it was too repetitive. Because people doubted for Q1, then we also come out with Q1, and it was the same number again. What we are writing is that we see a robust steady state enrollment of unique new patients, and here we are referring to the US with about 1,000 new patients every quarter. We do not believe really. Now we went over to YUVIWEL. So now we are starting to give you a unique prescription enrollment of YUVIWEL instead.

Speaker #2: You are right. And I think it's starting to be a little bit repetitive every quarter come out and saying that we have more than 1,000 patient being unique enrolled per quarter.

Speaker #2: We have continued that measure that we see steady state steady state and steady state. And we said in last year that we will stop coming with this because it was too repetitive.

Speaker #2: And then because people doubted for the Q1. Then we also come up with the Q1 and it was the same number again. And what we writing is that we see a robust steady state in Roman of unique new patient.

Jan Mikkelsen: What we are writing is that we see a robust steady state enrollment of unique new patients, and here we are referring to the US with about 1,000 new patients every quarter. We do not believe really. Now we went over to YUVIWEL. So now we are starting to give you a unique prescription enrollment of YUVIWEL instead. We always rather have one product opportunity where you will have something to play with numbers and everything like that. Scott, you have some additional comments for the last one?

Speaker #2: And here we are referring to the US with about 1,000 new patient every quarter. And we don't believe really. Now we went over to Europe.

Speaker #2: So now we starting to you give you a unique prescription enrollment of Europe instead. So we always have one product opportunity where you will have something to play with with numbers and everything like that.

Jan Mikkelsen: We always rather have one product opportunity where you will have something to play with numbers and everything like that. Scott, you have some additional comments for the last one?

Speaker #2: Scott, do you have some additional comments for the last one?

Scott Smith: Yeah. I think, Yun, our comments were directed to assume that the metrics that we have given you are consistent because Jan wants to make our script shorter, so we do not want to repeat them more, and you should just assume that until we change it.

Speaker #3: Yeah, I think our comments were directed to assume that the metrics we've given you are consistent, because Yen wants to make our script shorter.

Speaker #3: So we're not don't want to repeat them more. And you should just assume that until we change it.

Yun Zhong: Great. Thank you.

Speaker #5: Great. Thank you.

Operator: Thank you. The next question comes from Alex Thompson with Stifel. Your line is open.

Speaker #1: Thank you. And the next question comes from Alex Thompson with Stiefel. Your lines open.

Speaker #5: Great. Thanks for taking the question and Yen appreciate the color you provided to Zine's question around the ongoing legal battle with Biomerin. I guess as we think about potential scenarios here and again acknowledging sort of this idea around so public interest of the product and unmet need but do you see a settlement as a reasonable scenario to think about or is that really not something that you think is reasonable?

Alex Thompson: Great. Thanks for taking the question, and Jan, appreciate the color you provided to Tahseen's question around the ongoing legal battle with BioMarin. I guess, as we think about potential scenarios here, and again, acknowledging sort of this idea around sort of public interest of the product and unmet need, do you see a settlement as a reasonable scenario to think about, or is that really not something that you think is reasonable. Thank you.

Speaker #5: Thank you.

Jan Mikkelsen: Alex, I think I'm a very flexible person, and one of the things I really want to do, I will always do what is best for patients.

Speaker #2: Alex, I think I'm very flexible person. And one of the thing I really want to do I will always do what is best for patients.

Operator: Thank you. The next question will come from Maxwell Skor with Morgan Stanley. Your line is open.

Speaker #1: Thank you. And the next question will come from Maxwell Score with Morgan Stanley. Your line is open.

Speaker #6: Great, thank you very much for taking my question. Just a quick one on your BPAP durability. I was just wondering if dropouts are still mostly during the titration phase, and if you can comment at all on how reauthorizations are trending.

Maxwell Skor: Great. Thank you very much for taking my question. Just a quick one on YORVIPATH durability. I was just wondering if dropouts are still mostly during the titration phase, and if you can comment at all on how reauthorizations are trending. Thanks.

Speaker #6: Thanks.

Speaker #2: I think you 100% correct. And when we see a patient being successful coming into a treatment with your packs coming over titration part on it and being into the treatment after that, we see extremely extremely low dropout.

Jan Mikkelsen: I think you are 100% correct. When we see a patient being successful coming into a treatment with YORVIPATH, coming over titration part on it, and being into the treatment after that, we see extremely low dropout. I think that illustrates one thing, the patient satisfaction with this treatment. Because I am often being asked, what can we do more for these patients in the therapeutic treatment on it? When I see the satisfaction that is in this way, then I feel that there is an extremely good physician retention and everything which really show that. We are still developing once-weekly for patient on stable doses, just to give patients the choice if they want to do it in this way. We will look at other ways to improve their life, like for example, at home calcium monitoring and anything like that.

Speaker #2: And I think that illustrate one thing that patient satisfaction with this treatment because now often being asked what can we do more for this patients in the therapeutic treatment on it.

Speaker #2: And when I see the satisfaction that is in this way, then I think that there is an extremely good position retention and everything, which really shows that.

Speaker #2: We still develop the once weekly for patient unstable doses. Just to give patient the choice if they want to do it in this way.

Speaker #2: We will look at other ways to improve the life like for example at home caption monitoring and anything like that. We can help the patient like it happening in type one diabetes and other things like that.

Jan Mikkelsen: We can help the patient like it is happening in type 1 diabetes and other things like that. Now you are addressing the element where we are saying is, we developed this here with a once-weekly profile, even if we could make it, sorry, once-daily, because we wanted to do the titration most easily, because it is really complex to take patient off of conventional therapy. At the same time, you increase the PTH in replacement therapy. That was why we made it as a once-daily, is really to facilitate the best possible titration. Still, we know it can be problematic for some patients. Jae Woo can try to explain what we are now doing to basically handhold the patient in this period so we also can make that extremely successful.

Speaker #2: So now you addressing the element where we saying is we developed this year with a once weekly profile even if we could make it sorry once daily because we wanted to do that titration most easily because it's really complex to take patient up a convention therapy at the same time you increase the PTH in replacement therapy.

Jan Mikkelsen: At the same time, you increase the PTH in replacement therapy. That was why we made it as a once-daily, is really to facilitate the best possible titration. Still, we know it can be problematic for some patients. Jae Woo can try to explain what we are now doing to basically handhold the patient in this period so we also can make that extremely successful. When you get a prescription, we know everything will be much more successful for the patient, not just after they are really being stable in the titration. Jae, will you explain of the effort you are building in to really to get that to be as soft as possible?

Speaker #2: And there was a why we made it as a once daily this really to facilitate the best possible titration but still we know it can be problematic for some patients.

Speaker #2: And Jay can try to explain what we now doing to basic handhold the patient in this period. So we also can make that extremely successful.

Speaker #2: So when you get a prescription, we know everything will be much more successful for the patient not just after their baby being stable in the titration.

Jan Mikkelsen: When you get a prescription, we know everything will be much more successful for the patient, not just after they are really being stable in the titration. Jae, will you explain of the effort you are building in to really to get that to be as soft as possible?

Speaker #2: So, Jay, will you explain the effort you're building in to really get that to be as soft as possible?

Jay Donovan Wu: Absolutely. Can chat a little bit more about certainly the investments that we are making and also to answer your questions around drop-off and reoffs. Yes. As we have shared before, the majority of the drop-off is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense. For reoffs, that is actually pretty routine for us, so there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support. We have patients reoffing throughout the year, and it is just part of our day-to-day operations. From an investment standpoint, we have invested heavily in patient-facing roles for which we have deemed our patient access liaisons. They support patients both pre-prescription as well as through the prescription process and post.

Jay Woo: Absolutely. Can chat a little bit more about certainly the investments that we are making and also to answer your questions around drop-off and reoffs. Yes. As we have shared before, the majority of the drop-off is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense. For reoffs, that is actually pretty routine for us, so there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support.

Speaker #5: Absolutely. Can chat a little bit more about certainly the investments that we're making and also to answer your questions around drop-off and reauths. Yes, as we've shared before, the majority of the drop-offs is during that titration period in terms of when patients experience the most amount of change and where additional education and a higher touch support model makes sense.

Speaker #5: And then for reauths, that's actually pretty routine for us, so there really isn't much there in terms of it being a measurable effect on any kind of ongoing patient support.

Speaker #5: We have patients reauthing throughout the year and it's just part of our day-to-day operations. From an investment standpoint, we've invested heavily in patient-facing roles for which we've deemed our patient access liaisons they support patients both pre-prescription as well as through the prescription process and post.

Jay Woo: We have patients reoffing throughout the year, and it is just part of our day-to-day operations. From an investment standpoint, we have invested heavily in patient-facing roles for which we have deemed our patient access liaisons. They support patients both pre-prescription as well as through the prescription process and post. So essentially, we have seen a lot of success in early days with this field team being able to engage with this patient community. They have appreciated this high level of support, and we of course, support them throughout the journey to ensure that we are optimizing for patient experience.

Speaker #5: So essentially we've seen a lot of success in early days with this field team being able to engage with this patient community they've appreciated this high level of support and we of course support them throughout the journey to ensure that we're optimizing for patient experience.

Jay Donovan Wu: So essentially, we have seen a lot of success in early days with this field team being able to engage with this patient community. They have appreciated this high level of support, and we of course, support them throughout the journey to ensure that we are optimizing for patient experience.

Speaker #6: Great. Thank you very much.

Maxwell Skor: Great. Thank you very much.

Jan Mikkelsen: One thing that is in a minute. Now we focus on mostly US, but there is still a world outside US. Outside US, we have not seen the same level of dropout in this space. It looked like the interaction is pretty well established between the physician and the patients and support system, really to see it without this kind of dropout. So it is basically a US issue. And Jae Woo, so therefore, we know we can get it to function. We just need to ensure that the support system also in US is strong enough to be sure that it is not a problem.

Speaker #2: One thing that's in a minute now we focus on also US but there is still a world outside US. Outside US, we have not seen the same level of dropout in this phase.

Speaker #2: It look like the interaction is pretty well established between the physician and the patients and support system really to see it without this kind of dropout.

Speaker #2: So it's basic is a US issue and Jay, so therefore we know we can get it to function. We just need to ensure that the support system also in US is strong enough to be sure that it's not a problem.

Maxwell Skor: Very helpful. Thank you.

Speaker #6: Very helpful. Thank you.

Operator: Thank you. Our next question will come from Eric Joseph with Citi. Your line's open.

Speaker #1: Thank you. And our next question will come from Eric Joseph with City. Your line's open.

Eric Joseph: Hello. Hey, thanks for taking the questions. As far as your named patient programs or your early access programs, can you elaborate a little bit on which markets you are active in, whether eligibility might be determined by treatment status of a patient, and just generally how we should think about whether named patient programs could be meaningful contributors to patient volumes this year? Thanks. For YUVIWEL in particular.

Speaker #7: Hey, thanks for taking the questions. As far as your named access your named patient programs or your early access programs, can you elaborate a little bit on which markets you're active in, whether eligibility might be determined by treatment status of a patient?

Speaker #7: And just generally how we should think about whether named patient programs could be meaningful contributors to patient volumes this year? Thanks. For you, you do well in particular.

Speaker #2: Okay. I just wanted to ask what product you were referring to.

Jan Mikkelsen: Okay. I just wanted to ask what product you were referring to.

Eric Joseph: Ubiwell.

Speaker #7: You do well.

Speaker #2: Yeah. I can guarantee that as we basic in our preferred remark try to put emphasis on, we have an global infrastructure in commercialization and patient support product supply and everything like that.

Jan Mikkelsen: I can guarantee that as we basic in our prepared remarks, try to put emphasis on, we have a global infrastructure in commercialization and patient support, product supply, and everything like that. Just the number of 100 rare disease patients we have taken over through the system, more than 20,000 patients. We are having the system functional more than in 35 different countries. So we are not a company that just need to get started. We already have established all this infrastructure. What we are doing is that we are utilizing this established infrastructure that got established because of YORVIPATH, because this is what we did with YORVIPATH. We are using exactly the same infrastructure also for YUVIWEL. So we will be where patient is, and we will be quite sure we will also serve the patient outside US, and potentially the market is much larger outside US.

Speaker #2: Just the number of scratch over rarely sees patient we have taken to the system more than 20,000 patients. We are having the system functional more than in 35 different countries.

Speaker #2: So we not a company that just need to get started. We already have established all this infrastructure. And what we're doing is that we utilizing this established infrastructure basic got that got established because of your patch.

Speaker #2: Because this what we did with your patch, we using exactly the same infrastructure also for your value. So we will be where patient is and we'll be quite sure we will also serve the patient outside US and potentially the market is much larger outside US.

Jan Mikkelsen: We are using exactly the same infrastructure also for YUVIWEL. So we will be where patient is, and we will be quite sure we will also serve the patient outside US, and potentially the market is much larger outside US. I think we hope we also will see a large penetration in the US where another short-acting product really failed to do it. We believe because of the highly differentiated nature of YVIWEUL, we will see a complete different pickup in the US, but it is definitely we have a strong focus on the ex-US. We will give you some guidance when we come later in the year, so you can give also building up a model for the ex-US.

Speaker #2: And I think we hope we also will see a large penetration in the US where another short-acting product really failed to do it. And we believe because of the highly differentiated nature of your value, we will see a complete different pickup in the US.

Jan Mikkelsen: I think we hope we also will see a large penetration in the US where another short-acting product really failed to do it. We believe because of the highly differentiated nature of YUVIWEL, we will see a complete different pickup in the US, but it is definitely we have a strong focus on the ex-US. We will give you some guidance when we come later in the year, so you can give also building up a model for the ex-US.

Speaker #2: But it's definitely we have a strong strong strong focus on the XUS. And we will give you some guidance when we come later in the year so you can give also building up a model for the XUS.

Eric Joseph: Excellent. Thanks for taking the question.

Speaker #7: Excellent. Thanks for taking the question.

Operator: Thank you. The next question will come from Luca Issi with RBC Capital Markets. Your line is open.

Speaker #1: Thank you. And the next question will come from Luca. Is he with RBCM? Your line is open.

[Analyst] (RBC Capital Markets): Great. Thanks so much for taking our question. This is Cassie for Luca. Circling back to YUVIWEL, Jae, the three categories that you very nicely touched on for the naive, switch, and discontinued patients that are not on script. BioMarin mentioned on their Q2 call that less than 100 patients have switched off of Voxzogo. The simple math that we are trying to do here is that it leaves you with about 70 patients in Q2 who are naive or return to treatment. That is taken off the switched patients. Does that align with the numbers or impression that you have, and how does the dynamic look like between the truly naive patients and the patients who were once on Voxzogo, stopped treatment, and are now returning to treatment, but to YUVIWEL?

Cassie Yuan: Great. Thanks so much for taking our question. This is Cassie for Luca. Circling back to YUVIWEL, Jae, the three categories that you very nicely touched on for the naive, switch, and discontinued patients that are not on script. BioMarin mentioned on their Q2 call that less than 100 patients have switched off of Voxzogo. The simple math that we are trying to do here is that it leaves you with about 70 patients in Q2 who are naive or return to treatment. That is taken off the switched patients.

Speaker #8: All right. Thanks so much for taking our question. This is Cassie for Luca. Circling you back to UV well and Jay, the three categories that you very nicely touched on for the naive switch and discontinued patients that are not on script.

Speaker #8: Biomedicine mentioned on their second quarter call that less than 100 patients have switched off of voxovo. So the simple math that we're trying to do here is that at least it was about 70 patients in the second quarter who were naive or returned to treatment.

Speaker #8: So that's taken off the switch patients. So does that align with the numbers or impression that you have? And how does the dynamic look like between the truly naive patients and the patients who were once on voxovo stop treatment and then now returning to treatment?

Cassie Yuan: Does that align with the numbers or impression that you have, and how does the dynamic look like between the truly naive patients and the patients who were once on Voxzogo, stopped treatment, and are now returning to treatment, but to YUVIWEL? And separately, very quickly, if you have commented or not on the ex-US strategy for YUVIWEL, given the decision is pending and the EMA coming very soon this year. Thanks so much.

Speaker #8: But to UV well. And separate very quickly if you've commented or not on the XUS strategy for UV well given the decision is pending an EMA that coming very soon this year.

[Analyst] (RBC Capital Markets): And separately, very quickly, if you have commented or not on the ex-US strategy for YUVIWEL, given the decision is pending and the EMA coming very soon this year. Thanks so much.

Speaker #8: Thanks so much.

Speaker #2: I like you way of doing all the calculation. Anything like that. I cannot support it or I cannot deny it because I don't have the facts of insight to some way to confirm anything of the numbers.

Jan Mikkelsen: I like your way of doing all the calculation, anything like that. I cannot support it, or I cannot deny it because I do not have the factual insight to some way to confirm anything of the numbers. I also saw the number that came out, but I cannot really support it because I do not have the insight from our own numbers to really come out and come with any statement that indicates if I am aligned or not aligned with. Related to the ex-US, for me to understand your question, was this reflecting what is the limitation in the ex-US or what was the question?

Speaker #2: I also saw the numbers that came out. But I cannot really support it because I don't have the insight from our own numbers to really come out and come with any statement that indicate if I'm aligned or not aligned with it.

Speaker #2: Related to the XUS, for me to understand your question was this reflecting what is the limitation in the XUS or what was the question?

[Analyst] (RBC Capital Markets): Oh, thanks for asking to clarify. More about are you committed to running the show by yourselves or you are considering partnering, given that 70% of the Voxzogo sales is historically coming from ex-US can be a quite heavy lifting.

Cassie Yuan: Oh, thanks for asking to clarify. More about are you committed to running the show by yourselves or you are considering partnering, given that 70% of the Voxzogo sales is historically coming from ex-US can be a quite heavy lifting.

Speaker #8: Oh, thanks. Thanks for asking to clarify. More about are you committed to trying to show by ourselves or you're considering partnering given that 70% of the voxovo salves historically coming from XUS can be a quite heavy lifting.

Jan Mikkelsen: Well, basically in the ex-US we have our direct market which are, I think, 60, 70, 80 where we have our own commercial infrastructure, anything like that. It is pretty clear what we are doing there. Then we have our sales and distributions agreement. This is, I think it is 70 countries or something like that. Well, Scott is-

Speaker #2: Yeah, but so basic in the XUS, we have our direct market, which I think 60, 70, 80 where we have our own commercial infrastructure.

Speaker #2: Anything like that. It's pretty, pretty clear what we're doing there. Then we have our sales and distributions agreement. And this is I think it's a 70 countries or something like that.

Speaker #2: Well, it's got—this has 80, oh, 80 countries that it's covering, this sales and distribution agreement. And then the vast majority of all of them are all three products.

Scott Smith: 80.

Jan Mikkelsen: 80 countries that is covering this sales and distributions agreement. The vast majority of all of them are all three products. There is already established infrastructure for the distribution. Then we have the two other for the third model where we have our partnerships, one in Japan, one in China, and it also have all the three products. We do not need to go out and make any new agreements for anything. Everything is established. Everything is running on full speed. For some of the EU direct market, we are just waiting for our expected approval here in Q4 this year.

Speaker #2: So, basically, that is already established infrastructure for the distribution. And then we have the two other four. The third model, where we have our partnerships.

Speaker #2: One in Japan, one in China. And it also have all the three products. So we don't need to go out and make any new agreements for anything.

Speaker #2: Everything is established. Everything is running on full speed. And we for some of the EU direct market, we just waiting for our expected approval here in Q4 this year.

Speaker #8: Okay.

Operator: Thank you. Our last question is going to come from Faisal Khurshid with Jefferies. Your line is open.

Speaker #1: Thank you. And our last question is going to come from Faisal Khurshid with Jeffrey. Your line is open.

Speaker #4: Hey guys, thank you for taking the question. Just wanted to ask a little bit on the Yoruba Path Life Cycle strategy. Can you give us an update on the latest on getting the higher dose into the label for FDA?

Faisal Khurshid: Hey, guys. Thank you for taking the question. Just wanted to ask a little bit on the YORVIPATH life cycle strategy. Can you give us an update on the latest on getting the higher dose into the label for FDA? Also any update on weekly YORVIPATH? Thank you.

Speaker #4: Then also, any update on weekly Yoruba Path? Thank you.

Speaker #2: Yeah. What we see today is that we are enrolling the trial in the US where the evaluating the 30 to 60 dose range in two different means that has been aligned with the FDA in their design what they wanted to see.

Jan Mikkelsen: Yeah. What we see today is that we are enrolling the trial in the US, where we are evaluating the 30 to 60 dose range in two different means that has been aligned with the FDA in their design, what they wanted to see. And we see that enrollment going extremely fast. We expect very fast, and you can say label expansion in the place where we don't have up to the 60. We see that basic just on execution. Your second question was related to?

Speaker #2: And we see that enrollment going extremely fast. So we expect very, very, very fast and you can say label expansion in the place where we don't have up to the 60.

Speaker #2: So we see that basic on just on execution and your second question was related to?

Faisal Khurshid: On weekly YORVIPATH, any update there?

Speaker #4: On weekly overpath, any update there?

Speaker #2: Yeah, I think there’s no news in this way that we’re just executing and getting it into the market as fast as possible, out from the expectation that we see that not as in any kind of LCM activity, but more as patient support for patients that really are in the stable dosing—which are not a lot—after they have been in a situation where they have been stabilized with our daily treatment.

Jan Mikkelsen: Yeah, I think there's no news in this way, that we're just executing and getting it into the market as fast as possible out from the expectation that we see that not as any kind of LCM activity, but more as patient support for patients that really are in the stable dosing, which are not a lot after they have been in a situation where they have been stabilized with our daily treatment.

Speaker #4: Great. Thank you.

Faisal Khurshid: Great. Thank you.

Operator: Thank you. This is all the time that we have for questions today. This does conclude today's conference call, and thank you for participating. You may now disconnect.

Speaker #1: Thank you. This is all the time that we have for questions today. This does conclude today's conference call and thank you for participating. You may now disconnect.

Jan Mikkelsen: Thanks a lot, everyone.

Q2 2026 Ascendis Pharma AS Earnings Call

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