Q3 2021 Ascendis Pharma A/S Earnings Call

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Yeah.

Operator: Good day, and thank you for standing by. Welcome to the Q3 2021 Ascendis Pharma Earnings Conference Call.

Good day and thank you for standing by welcome to the Q3 2021 send this pharma earnings conference call.

Operator: 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 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker for today, Mr. Scott Smith, Senior Vice President and Chief Financial Officer of Ascendis Pharma. Please go ahead, sir. Thank you, operator.

This time, all participants are in a listen only mode.

After the Speakers' presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone. Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like behind the conference over to your speaker for today Mr. <unk>.

Smith, Senior Vice President and Chief Financial Officer, all of a sudden this pharma. Please go ahead Sir.

Thank you operator, thank you everyone for joining our conference call today, I'm, Scott Smith, Chief Financial Officer of incentives.

Scott Smith: Thank you, Operator. Thank you, everyone, for joining our conference call today. I'm Scott Smith, Chief Financial Officer of Ascendis. Joining me on today's call is Jan Mikkelsen, President and Chief Executive Officer, Jesper Heulen, Global Chief Commercial Officer, Dr. Dana Pezzuti, Head of Development Operations and Chief Medical Officer, and Dr. Yuhua Hunanen, Head of Oncology

Joining me on today's call as Jan Mikkelsen, President and Chief Executive Officer, Jesper Hoiland Global Chief Commercial officer.

Doctor Dana Pizzuti head of development operations, and Chief Medical Officer, and Dr. Hoffman, and then head of oncology.

Before we begin I would like to remind you that this conference call will contain forward looking statements that are intended to be covered under the safe Harbor provided by the private Securities Litigation Reform Act.

Examples of such statements May include but are not limited to.

Our U S commercialization and continued development of Sky trough for the U S market.

Our progress on our pipeline candidates and our expectations with respect to their continued progress.

Statements regarding our strategic plans are.

Our goals regarding regarding our clinical pipeline statement.

Statements regarding the U S market potential of Sky Trophy, and our pipeline product candidates and statements regarding our regulatory filings.

These statements are based on information that is available to us today actual results or events could differ materially from those in the forward looking statements and we may not achieve our goals carry out our plans or intentions or meet the expectations or projections disclosed in our forward looking statements.

Scott Smith: Before we begin, I would like to remind you that this conference call will contain forward-looking statements that are intended to be covered under the Safe Harbor provided by the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, U.S. commercialization and continued development of SkyTrofa for the U.S. market. Our progress on our pipeline candidates and our expectations with respect to their continued progress. Statements regarding our strategic plan. Our goals regarding our clinical pipeline.

And you should not place undue reliance on these statements.

Our forward looking statements do not reflect the potential impact of any licensing agreements acquisitions mergers dispositions joint ventures or investments that we may enter into or terminate.

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 in today's press release and the risk factors section of our most recent annual report on form 20-F.

Sky Trussell was approved by the FDA in August 2021 for the treatment of pediatric patients.

One year and older who way at least 11, and a half kilograms and half growth failure due to inadequate secretion of endogenous growth hormone.

Otherwise please note that our product candidates our investigational product.

Scott Smith: Statements regarding the U.S. market potential for Skytropha and our pipeline product candidates and statements regarding our regulatory filing. These statements are based on information that is available to us today. The actual results or events could differ materially from those in the forward-looking statements. We may not achieve our goals, carry out our plans or intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these statements.

And not approved for commercial use as investigational products, the safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency.

None of the statements made on the conference call regarding our product candidates shall be viewed as promotional.

On today's call, we will discuss the third quarter 2021 financial results and provide further business updates. Following some prepared remarks, we will then open up the call to questions.

I will now turn the call over to Yan Nicholson, our president and Chief Executive Officer.

Yeah.

Thanks, Scott and good afternoon.

If every quarter.

As I reflect on how they extend his team.

Book to Bill the patient interest you should too.

Satisfy meet unmet medical needs.

I want to reflect upon the significant progress we have made towards our key development milestones to bring safe highly differentiated product to patients as fast as possible.

Scott Smith: Our forward-looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, dispositions, joint ventures, or investments that we may enter into or terminate. 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, see Notes to Financial Statements. Please see the forward-looking statements section in today's press release and the risk factor section of our most recent annual report on Form 20-F. Skytropha was approved by the FDA in August 2021 for the treatment of pediatric patients one year and older who weigh at least 11 and a half kilograms and have growth failure due to inadequate secretion of endogenous growth hormone.

This quarter, especially the closer it is deep.

Marks a defining moment for the company and all of you should treat bought three pronged too.

To achieving sustainable growth.

As a fully integrated global Biopharma company.

For Ya.

We have.

So I understand they've already behind Gulf come on deficiency.

We started the times, we learned from previous successes and failures in trying to develop a long acting growth hormone therapies.

And we will diligently in understanding the clinical data and could actually an adult kokomo deficiency.

There have been very little innovation since daily injection of recombinant human growth hormone were introduced.

30 years ago, and now <unk> has the first 50 approved once we deep product that's all for pediatric growth hormone deficient patients caregivers and physicians what they have been seeking full 42 decades.

Scott Smith: Otherwise, please note that our product candidates are investigational products. [inaudible] None of the statements made on the conference call regarding our product candidates should be viewed as promotional. On today's call, we will discuss third quarter 2021 financial results and provide further business updates. Following some prepared remarks, we will then open up the call to questions. I will now turn the call over to Jan Mikkelsen, our President and Chief Executive Officer.

The approval of transcon growth hormone in the U S. Easter elimination of determent efforts by the sales team over many years to bring the first transcon technology called them all the way from the concept staged through non clinical and.

Clinical development.

Manufacturing and device development and regulatory reviews.

So you can finally go out to the patients.

Jan Moller Mikkelsen: Thanks, Scott, and good afternoon. Every quarter, I reflect on how the Ascendis team works together with patients and physicians to satisfy major unmet medical needs. I also reflect upon the significant progress we have made toward our key development milestone to bring safe, highly differentiated products to patients as fast as possible. This quarter was special for Ascendis.

This approval of Scotch over in the U S. Do you believe you have just begun to unlock the potential of what we are seeking to accomplish.

Transcon technology platform and a good weekend for product innovation.

Develop highly differentiated products.

We're seeing major unmet medical needs.

With expected high development upside.

Yes.

A real paradigm shift.

The same excitement we have for transcon growth hormone exists across our entire portfolio of our five independent clinical product candidates.

Jan Moller Mikkelsen: It marks a defining moment for the company on our Vision 3x3 path to Achieving Sustainable Growth, as a fully integrated leading global biopharma, for you. We have worked to understand the biology behind glucose hormones. We started the science.

Why.

I am so optimistic.

Because we believe the first FDA approved product is a strong endorsement for the transcon technology platform.

For product innovation, and infrastructure and expertise product and device development.

Jan Moller Mikkelsen: We learned from previous successes and failures in trying to develop long-acting glutamate therapy, and we were diligent in understanding the clinical data in pediatric and adult growth modes. There have been very limited innovations since daily injections of recombinant human glucose hormone were introduced over 30 years ago, and now Ascendis... has the first FDA-approved one-sweety product that offers pediatric growth hormone-deficient patients, caregivers, and physicians what they have been seeking for decades. The approval of transconcortamol in the U.S. is the culmination of determined efforts by Ascendis Pharma over many years to bring the first transcon technology product all the way from the concept stage to non-clinical and clinical development. Manufacturing and Device Development, and Rectotoy Reviews So you can finally go out to the page.

This is the reason why we are so enthusiastic about the prospects for our pipeline programs Transcon PTH and Transcon CMP.

Okay.

He says.

Well, that's all oncology programs Transcon, Telos, seven eight equities and transcon either to be to comment.

We believe we have built a sustainable robust pipeline.

And do not have the common trend that many biopharma companies.

Face in finding a second act to follow their first product.

We from the beginning set out to build a sustainable pipeline in Wuxi, so punitive tariffs.

Approval in the U S is a major success supposed to inks.

But.

We will of course not stop there.

We expect to achieve European Commission approval of transcon growth hormone for pedestrians going from.

Hormone deficiency later this year or early next year.

Do you expect to report phase III data for Transcon PTH in adult hyperparathyroidism in Q1, 2022.

Jan Moller Mikkelsen: With the approval of SkyTrooper in the U.S., we believe we have just begun to unlock the potential of what we are seeking to accomplish with the Transcon technology platform and algorithm for product innovation, to develop highly differentiated products addressing major unmet medical needs, with expected high development success. A Real Paradigm Shift. The same excitement we have for Transcon Growth at the moment exists across our entire portfolio of our five independent clinical products. Why am I so optimistic?

Followed by a planned U S NDA filing in mid 2022.

Our research and development engine continues to produce promising new product candidate.

Do you expect to continue the clinical development with additional regulatory submission in rare disease endocrinology oncology and also you know therapeutic out there.

After we launch schedule, but in the U S and bid approval quickly.

Quickly received our first commercial auto and first commercial patients on therapy.

The assumed his commercial team is executing on the long strategy, which is designed to the long term value of our go from one product and laying the fundament for future product launches into the endocrinology rare disease there.

Jan Moller Mikkelsen: Because we believe the first FDA-approved product is a strong endorsement for the transcom technology platform, our algorithm for product innovation, and Ascendis' infrastructure and expertise in product and device development. This is the reason why we are so enthusiastic about the prospects for our pipeline program. Transcon PTAs and Transcon CMP in endocrinology vertices, as well as our oncology programs, TRANSCON-TLR78-Aquanist and TRANSCON-IL2-Beta-Glycine. We believe we have built a sustainable, robust pipeline and do not have the common challenge that many biopharma companies face in finding a second act to follow their first product as we, from the beginning, set out to Approval in the U.S. is a major success for us, but we will, of course, not stop there.

We attained two great global market, leading brand based on demonstrating clinical benefit and strong value proposition for patient khaki was health care providers and payers.

The transcon growth hormone do you believe you can expand that globally.

Glaucoma market, while at the same time, reducing the cost to society that we saw for soup optimal or lack of treatment.

I'm often been asked about oil pricing strategy and what do we mean by.

Premium responsible pricing.

Our health care economic outcome for service demonstrates that'd be the premium responsible pricing.

<unk> controlled Kimmel, majorly, but meaningful savings to repeal by potentially improving patient outcome compared to tactical command.

Okay.

Covering.

21000, pediatric growth hormone deficient patients in the U S indicates only 22 surgical say Ah patient.

Jan Moller Mikkelsen: We expect to receive European Commission approval of transconcortamol for pediatric glutamate hormone deficiency later this year or early next year. We expect to report Phase 3 data for transcontagion in adult hyperparathyroidism in Q1 2022, followed by a planned U.S. NDA filing in mid-2023. Our research and development engine continues to produce promising new product candidates, and we expect to continue clinical development with additional regulatory submissions in rare disease, endocrinology, oncology, and also in our third therapeutic era. After we launched Skytrover in the U.S. in mid-October, we quickly received our first commercial order and first commercial patient on therapy.

Adhering to daily gypsum therapy, and therefore may experience sub optimal outcomes.

With this in mind, we have established a best price.

Schedule for <unk> in the U S that takes into account expected milligram QD dose difference false sky topper compare strategic cultural moment.

In real World practice also on an.

And all phases the deck pies is Smith.

So high single percent higher compared to the leading digital to more <unk> product.

Is what we mean by premium responsible pricing.

And can be considered.

Patient care physician, including the society.

He also understands the importance of U S market is safe for patients and families and we continue to work with payers to make Scott is finally available as possible.

Jan Moller Mikkelsen: The Ascendis commercial team is executing on the long strategy, which is designed to increase the long-term value of our growth hormone product and lay the foundation for future product launches into the endocrinology rare disease area. We intend to create a global market-leading brand, based on demonstrating clinical benefits and strong value propositions for patients, caregivers, healthcare providers, and payers. Transcon Gros du Monde.

Our priority is contracting based on the value of Sky toolbar right.

Focusing just on volume.

We're committed to building a long term relationship with U S payers and health systems in the rest of it was actually working to bring our portfolio of products to the market in the future.

As we have highlighted before.

As changes commercials.

She is there.

The technology.

Jan Moller Mikkelsen: We believe we can expand the global growth among markets. Why, at the same time, reducing the cost to society that would solve for suboptimal or lack of treatment? I am often asked about our pricing strategy and what we mean by a premium responsible price. Our healthcare economic outcome for SIRS demonstrates that with premium responsible pricing, transcontinental hormones may deliver meaningful savings to the payer by potentially improving patient outcomes compared to daily goals.

Especially in the grocery and PTA segment.

They understand what it takes to create market leading brands.

U S. Commercial organization is in place and we tend to call around the 1400, Cocomo prescribers the pediatric growth hormone market in the U S is concentrated with about 80% of all prescriptions coming from about 20% of the prescribers.

In parallel our experienced U S. Medical affairs team has been out in the feeds creating awareness with key opinion leaders and Peter endocrinologist.

A key component in the Sky tool for longs in the U S has been the successful introduction of our Cintas Cigna two s's program.

Jan Moller Mikkelsen: Our peer resources, covering 21,000 pediatric optimal deficient patients in the U.S., indicate only 20-30% of patients are adhering to daily injection therapy and therefore may experience suboptimal outcomes. With this in mind, we have established a VAC price for Skytrofer in the U.S. that takes into account the expected mg per kilo dose difference for Skytrofer compared to daily gold from home, in real-world Also, on an annual basis, the bagpipes is made to a high single percent higher compared to the leading daily glutamate hormone product.

Yes, several different elements to it but it is basically a personalized patient support program.

With east patient assigning a nurse dedicated to working with them and their families caregivers and precision from decision to treat true long term therapy adherence.

The program offers a suite of services, including but not limited to prior authorization support out of pocket assistance and training on the schedule for all countries.

Yeah.

Jan Moller Mikkelsen: This is what we mean by a premium responsible price and can be considered a win-win for patients, caregivers, physicians, and society. We also understand the importance of U.S. market access for patients and families, and we continue to work with peers to make SCARTOVA as widely available as possible. Our priority is contracting based on the value of SkyTober rather than focusing just on volume. We are committed to building a long-term relationship with U.S. payers and health systems in the rest of the world as we work to bring a portfolio of products to the market in the future. As we have highlighted before,

As you know I, just don't disagree all distinct globally.

And so let us turn now to our clinical development programs for <unk>, you know that part of the World. This week.

<unk> me just see agency community from medical products for human use all C. H P.

Transcon growth hormone.

Uh huh.

Do you believe we are on track to obtain a cost achieve C. H M. P opinion, followed by an expected European Commission approval for trying to go and go through them, but the industry a year or early next year.

In Japan, we continue to screen and enroll patients into 40 subject phase III right.

For pediatric Coca most efficiently and in China recent pharmaceuticals completed enrollment of its phase III clinical trial of transcon growth hormone in children to co promote efficiency in March of this year.

Turning to potential label expansion for transcon growth hormone.

Jan Moller Mikkelsen: Ascendis commercial leadership team is very experienced in the technology, especially growth hormone and PTH. They understand what it takes to create a market-leading brand. Our U.S. commercial organization is in place, and we tend to cover around 1,400 growth hormone prescribers. The pediatric growth hormone market in the U.S. is concentrated, with about 80% of all prescriptions coming from about 20% of the prescribers. In parallel, our experienced U.S. medical affairs team has been out in the field creating awareness with key opinion leaders and pediatric endocrinologists.

We also have the global fifth Street foresight trials underway for adult growth hormone deficiency.

Looking at it we expect to conduct additional trials to support an application for label expansion billing Peter.

I'll go to market efficiency.

Moving to Transcon PTH.

Okay.

Our excitement continues around the clinical progress and caustic.

Physician and patient stories, we have heard so far indicated that transcon PTH has the potential ability to transform patients' lives.

Keeping that 400000 patients globally sulfur for this and the lack of oil treatment option.

We've tried to cut P. J if approved has the potential to be a owens doctors into commodity rare disease product opportunity.

I think it could represent a market opportunity greater than <unk>.

Jan Moller Mikkelsen: A key component in the SkyTrooper launch in the U.S. has been the successful introduction of Ascendis Signature Asset Program. It has several different elements to it, but it is basically a personalized patient support program, with each patient assigned a nurse dedicated to working with them and their families, caregivers, and physicians from the decision to treat to long-term therapy adherence. The program offers a suite of services, including, but not limited to, prior authorization support, out-of-pocket assistance, and training on the Skype software.

5 billion U S dollars.

In September.

You announced the 58 week.

Digital T data from the central lab bleeding into path.

Cohort trial.

Global Phase two trial of Transcon PTH in adult subjects with hyperparathyroidism.

These BMT data.

Comparable with previous unknowns.

<unk> data and demonstrated as expected continued normalization and stabilization of the PMT physical between 26 and 58 weeks.

The BMT safe schools Palin, Microsoft bombed tunable, which we believe is an indicator that the catch them Lisa.

Jan Moller Mikkelsen: As you know, at Ascendis, we always think globally. And so, let us turn now to our clinical development programs for growth hormone in other parts of the world. The European Medicines Agency Committee for Medical Products for Human Use, or CHMP, has transcontrol hormones on its agenda. We believe we are on track to obtain a positive CHMP opinion, followed by expected European Commission approval for Trans-Concordium by the end of the year or early next year.

In our phase II trial are normalizing over time ethics basis.

Th concentration eastwood stored to physiological neighborhoods.

We continue to have extremely high teachings with tension in the open label extension started 58 patients continue in the trial as of November seven 2021.

All of this so pleased when I hear about how many patients are remaining in the open label extension study.

Jan Moller Mikkelsen: In Japan, we continue to screen and enroll patients in the 40-subject Phase III RITE trial for pediatric glutamate deficiency. And in China, Western Pharmaceuticals completed enrollment in its Phase III clinical trial of transconglutamate in children with glutamate deficiency in March of this year. Turning to Potential Label Expansion for Transcontinental.

This is the first time in my career that I have seen such strong patient commitment taken once daily injection and staying on therapy in an open label study.

Do you believe this is a potential indication of how transplant P Chase.

They would be having a positive impact on short term symptom as to the quality of life.

Do you believe that Spca's concentration is to restore to physiological levels. He can improve short term students that could also translate into positive impact on long term complications.

Jan Moller Mikkelsen: We also have the Global Fish Tree Foresight Trial underway for adult growth-promoting fish. Looking ahead, we expect to conduct additional trials to support an application for labeling expansion beyond pediatric and adult growth hormones. Moving to Transcon PTA. Our excitement continues around the clinical progress and prospects. Precision and patient stories we have heard have so far indicated that Transcon PGS has the potential ability to transform patients' lives. Given that 400,000 patients globally suffer from this, and the lack of other treatment options, we believe Transcort PTH, if approved, has the potential to be our largest endocrinology-aware disease product opportunity. We think it could represent a market opportunity greater than... 5 billion US dollars in September.

We remain on track to report the 84 week phase two data this quarter.

We would expect to see similar trends as we sold the first 58 data.

Globally.

All suite phase III <unk> trials that are underway for question.

Parkway, Japan, the Japanese phase III caused is designed to enroll a minimum.

Oh, 12, H b subject.

Possibly China that phase III trial in greater China has been indicated by decent pharmaceuticals.

We are looking forward to reporting the top line phase III results from the North America.

And European trials in adult <unk> patient in Q1 2022.

<unk> constitute our plan is to file an NDA in the U.

I just state for Transcon PTH in mid 2022 for HP.

The strong data you have generated so far reinforce our confidence in transcon PTH asset potential first with Paceman Hallman Cherokee adult H P.

Jan Moller Mikkelsen: We announced the 58-week bone mineral density data from the central lab reading in the PART4 trial, the global phase 2 trial of transcon PTH in adult subjects with hypoparietal, These BMP data complement the previous Announced Bone Turnover Date and demonstrated, as expected, continued normalization and stabilization of the BMD Z-score between 26 and 58. The BMD test scores parallel markers of bone turnover, which we believe is an indicator that the calcium metabolites in subjects in our Phase 2 trial are normalizing over time as expected when PTH concentration is restored to physiological levels.

Now turning to CMP.

We continue to move forward.

Two phase two double blind placebo controlled study in children with achondroplasia.

The first phase III trial, the Compass trial, you said dose escalation trial of 12 to 15 socket in each cohort conducted mainly in North America, Australia and Europe. The second one but recent pharmaceuticals is to accomplish China trial, which is a cohort expansion tried.

At least 66 year subject conducted in China.

Jan Moller Mikkelsen: We continue to have extremely high patient retention in the Open Label Extension Study, with 58 patients continuing in the trial as of November 7, 2021. I'm always so pleased when I hear about how many patients are remaining in the Open Label Extension study. This is the first time in my career that I have seen such strong patient commitment to taking a one-state injection and staying on therapy in an open-label study. We believe this is a potential indication of how Transcon PKH will be having a positive impact on short-term symptoms and their quality of life. We believe that as BCH concentration is restored to physiological levels, it can improve short-term symptoms that could also translate into a positive impact on long-term complications.

Completing two independent randomized placebo controlled trial.

52 week clinical data on 120 subjects with <unk>.

Ah patients treated we've tried to go on CMP and over 25 structure.

With placebo treatment.

We believe these two blinded trial would be a strong indication of the potential safety and efficacy of Transcon CMP.

Later this quarter.

Our coke on update on Transcon, CMP, which will include a good view of the biology and why we believe tried to come CMP has unique product profile that is highly differentiated from other treatments in development.

We will provide an overview of the program involving the status of the dose escalation cohort cohort expansion and a safety update on the blinded data.

Jan Moller Mikkelsen: We remain on track to report the 84-week Phase 2 data this quarter and would expect to see similar trends as we saw with the 58-week data. Globally, all three Phase III HP trials that are underway are progressing. Hardware Japan, the Japanese phase 3 trial, is designed to involve a minimum of 12 HP Socrates.

We also plan to discuss target engagement to illustrate that trends could see a pea is doing what we expect it to do and we would keep an update unexpected timelines for data next year.

Now moving to oncology.

We want to transform cancer care by improving Ah patients until two outcomes by using transcon systemic anti tumor technology.

At this time to provide sustained modulation of the tumor microenvironment and activating cytotoxic immune says.

Jan Moller Mikkelsen: PartwayChina, the Phase III trial in Greater China has been initiated by Beeson Pharmaceuticals. We are looking forward to reporting the top line phase two results from the North American and European trials in adult HP patients in Q1 2021. If positive, our plan is to file an NDA in the United States for transcontinental PTAs in mid-2022 for adult age. The strong data we have generated so far reinforce our confidence in transgone PTH as a potential first replacement hormone therapy in adult age. Now turning to Transcon CMP, we continue to move forward with two Phase II double-blinded placebo-controlled studies in children with aconoplastia.

We all know that developing effective and safe products has been a challenge within the oncology fee.

Do you believe by using the Transcon technologies and our product.

Product innovation to turn on the body's antitumor immune system.

We expect to improve patient outcome.

This is how we are looking forward to making a real difference to the way cancer is treated.

Our oncology programs have made major advancements this year for our Transcon Chiller seven Eco news program. We believe we have identified a product candidate that is highly differentiated compared to other product candidates.

Mexico, extending the duration of these orphan <unk> immunotherapy compound inside the tumor.

With the Transcon technology.

Aiming to provide to purely efficacy insightful to muscle beaks and at the same time, reducing systemic trucks used to see compare to what has been seen with direct injection of the parent drug until into the tumor.

Jan Moller Mikkelsen: The first phase 2 trial, the COMPLICE trial, is a dose escalation trial of 12 to 15 subjects in each cohort conducted mainly in North America, Australia, and Europe. The second one, by Riesling Pharmaceuticals, is the COMPLICE-China trial, which is a cohort expansion trial of at least 60 subjects conducted in China. Completing two independent, randomized, placebo-controlled trials will give us 52-week clinical data on over 120 subjects with achondroplasia treated with Transcon CMP and over 25 subjects with placebo treatment.

We believe that prolonged activation of the immune system inside the two muscle weeks will also generate a scope effect, killing similar tumor in the path of the parking.

Our transcon.

100, <unk> tried to consider 70 echo in advanced cancer patients is ongoing.

We have been dose escalating subject with transcon Telos seven eight equities in the monotherapy email and we had indicated dose escalation with checkpoint inhibitor and the combination now during the third quarter.

We expect to have initial results from the monotherapy dose escalation for Transcon <unk> agonist.

Agonist by year end.

Jan Moller Mikkelsen: We believe these two blinded trials will be a strong indication of the potential safety and efficacy of transcontinence GMP. Later this quarter, we will provide a program update on Transcon CMP, which will include a review of the biology and why we believe Transcon CMP has a unique product profile that is highly differentiated from other treatments in development. We will provide an overview of the program involving the status of the dose-escalation cohort, cohort expansion, and a safety update on the blinded data. We also plan to discuss target engagement to illustrate that Transcon TFP is doing what we expect it to do, and we will give an update on expected timelines for data next year.

We are presenting additional preclinical data for transcon Telos seven agonist at the society for immunotherapy.

Cancel 36th annual meeting taking place in Boston to D. C. This week.

Also in the third quarter, we submitted a 90 to the U S FDA to any tape the transcon to feature.

<unk> come a kidney code program.

This is a phase one two clinical trial to evaluate transcon two pizza common in patients with cancer Transcon. Two pizza comment you said long acting poodle using the same systemic transcon technology as trends become comfortable.

And is designed to improve cancer immuno therapy, while providing long equity exposure.

Out at heightened Sue mix of highly potent <unk> been selected for the pizza common receptor.

The second oncology clinical stage product candidate is another sign of our commitment to solving unmet medical needs of patients by focus on design.

Jan Moller Mikkelsen: Now moving to oncology, we want to transform cancer therapy by improving a patient's antero-tumor outcomes by using transcon-systemic and inter-tumor technology. Designed to provide sustained modulation of the tumor microenvironment and activate cytotoxic immunocells. We all know that developing effective and safe products has been a challenge within oncology. We believe by using transcon technologies and our algorithmic product innovation to turn on the body's anti-tumor immune system, we expect to improve patient outcomes.

IL two is a highly validated <unk> in the treatment of cancer.

Review of the data generated from.

From the long list of two compounds and we believe transcoding to Peter Com has the potential to be best in class and the first two fully stalled the shortcomings of IL two.

Looking ahead to the rest of 2020 people in the fourth quarter shaping up to be.

These details with the potential to obtain positive C H and <unk>.

The program update for Transcon CMP first patient data on trying to consider <unk> agonist and a 84 week data on Transcon PTH.

We plan to announce the uptake for these R&D programs on a virtual <unk>.

And development program update call in mid to simple.

Jan Moller Mikkelsen: This is how we are looking forward to making a real difference in the way cancer is treated. Our oncology programs have made major advancements. For our Transcon TLR7 Agonist Program, we believe we have identified a product candidate that is highly differentiated compared to other product candidates by dramatically extending the duration of release of an active immunotherapy compound inside the tube. With the TRANSCON technology, we are aiming to provide therapeutic efficacy inside the tumor for weeks and at the same time, reduce systemic toxicity compared to what has been seen with direct injection of a parent drug alone into the We believe the prolonged activation of the immune system inside the tumor for weeks will also generate an ascopal effect, killing similar tumors in other parts of the body.

We will provide additional details in the coming weeks.

It was a great moment assemblies, achieving our first product approval in the U S.

Is there rewarding that pediatric <unk> patients in the U S. Now.

Our new once weekly treatment option.

What makes me even more happy Easter I know you had.

The potential to help many more patients facing significant unmet medical needs.

And as I said before our goal at the centers has not just to get caught up.

But to get products approved that can make a meaningful difference to patient and not just once but multiple times in multiple to a quota gas now let me turn the call over to Scott for his financial review.

Before we open up for questions.

Thank you again.

Turning to our financial results for the quarter ended September 32021, we reported a net loss of $80 3 million euro or $1 47 euro per basic and diluted share compared to a net loss of $121 7 million euro or $2 31 euro per basic and diluted share during the same period in 2020.

Now, let me run through some of the key components of these results.

Research and development costs for the third quarter or <unk>, $58 8 million euro compared to $64 1 million Euro during the same period in 2020.

Jan Moller Mikkelsen: Our TRANSCON IT-101 trial for TRANSCON TLR78 agonist in advanced cancer patients is ongoing. We have been dose-escalating subjects with transconTLR78 agonists in the monotherapy realm, and we have indicated dose-escalation with checkpoint inhibitors in the combination realm during surgery. We expect to have initial results from the monotherapy dose escalation for TRANSCOM TLR70 agonists by year-end. Additionally, we are presenting additional preclinical data for transcon TLR-7 and TLR-8 agonists at the Society for Immunotherapy of Kansas 36th Annual Meeting taking place in Washington, D.C. this week.

The costs were higher primarily due to increased clinical trial will spend device development costs and manufacturing costs, including the completion of multiple drug substance PDQ batches as well as the initial cost of building commercial inventory.

For Transcon CMP R&D costs were higher primarily due to increased manufacturing and clinical trial related costs and finally for oncology therapeutic area R&D costs were higher due to increased manufacturing and clinical trial costs for transcon CLR seven eight agonist and also due to increased manufacturing in preclinical cost for transcon.

Jan Moller Mikkelsen: Also in the third quarter, we submitted an R&D application to the U.S. FDA to indicate the Transcon IL-2 Beta Gamma clinical program. This is a Phase I-II clinical trial to evaluate Transcon IL-2 beta-gamma in patients with advanced cancer. Transcon IL-2 beta-gamma is a long-acting protocol using the same systemic transcon technology as transcon GO2, and is designed to improve cancer immunotherapy by providing long-acting exposure, without a high C-Max, of a highly potent IL-2 variant selected for the beta-gamma.

<unk> beta gamma.

Selling general and administrative expenses for the third quarter were 39.3 million euro compared to $17 5 million Euro during the same period in 2020.

Is higher expenses, primarily reflected increase in personnel related and commercial expenses as well as it systems and other infrastructure costs as we prepare to launch skypes rope and the U S.

Finance income and expenses in the third quarter include a foreign exchange rate gain of 21.3 million euro compared to a foreign exchange rate loss of 39.6 million Euro in the third quarter of 2020, primarily related to translation of our U S dollars holdings of cash.

Marketable securities two euros.

We ended the third quarter with cash cash equivalents and marketable securities totaling $929 9 million Euro.

Which includes the net proceeds from our follow on financing completed in September.

Jan Moller Mikkelsen: The second Oncology Clinical Stage Product Candidate is another sign of our commitment to solving unmet medical needs for our patients by focusing on the science. IL-2 is a highly validated cytokine in the treatment of cancer. We have reviewed the data generated by us from the long list of IL-2 compounds.

As of September 30th 2021, the company had 56 million 877723 ordinary shares outstanding.

In November subsequent to the end of the third quarter, we completed our previously announced $25 million share repurchase program in which we purchased 154837 of our Ads's in the open market.

Turning to an update on our U S sponsored sky Troper for pediatric Ghd odd.

Product is currently available in the us and we have shipped multiple orders, thus far into our specialty pharmacy and specialty distributor network for both initial prescriptions and channel inventory stocking.

Jan Moller Mikkelsen: And we believe Transcon IL-2 beta-garmin has the potential to be best in class and the first to fully solve the shortcom of IL-2, looking ahead to the rest of 2020. The fourth quarter is shaping up to be very busy for us, with the potential to obtain a positive CHMP opinion, the program update for Transcon CMP, first patient data on Transcon TLR78 agonist, and our 84-week data on Transcon. We plan to announce the update for these R&D programs on a virtual basis.

We are currently providing sky trophy for pediatric ghd patients through our dedicated patient support program known as the ascended signature access program.

Several insurance plans are providing initial coverage for <unk> through the medical exceptions process. We're also in active discussions with use commercial payers to broaden our access for 2022.

And we are encouraged by the early enthusiasm surrounding the launch and we look forward to updating you on our progress in the coming quarters.

Turning to the remainder of 2021 key activities include for Transcon Hgh execution of use Skype <unk> commercial launch activities.

Investment and expanding commercial manufacturing capacity to support anticipated future demand and continued execution in our ongoing phase III clinical trials, including the enlightened long term extension trial and the right trial in Japan, both for pediatric Ghd and the global foresight trial in adult Ghd.

Jan Moller Mikkelsen: Research and Development Programme update call in mid-December. We will provide additional details in the coming weeks. It was a great moment at Ascendis, achieving our first product approval in the U.S. It is very rewarding that pediatric growth hormone patients in the U.S. now have a new once-a-weekly treatment option. What makes me even happier is that I know we have the potential to help many more patients facing significant unmet medical needs.

For Transcon PTH key activities include continued execution of the phase II path forward trial, which retains 58 subjects in the open Michael extension.

Continued execution of the phase III clinical program, including the pathway trial and the pathway Japan trial.

An ongoing manufacturing of PDQ batches, an initial activities to bill's commercial inventory.

For Transcon CMP key activities include ongoing manufacturing activities, including scaling up production.

Continued execution of our phase two clinical program, which includes the two randomized double blind placebo controlled clinical trials in the contemplation ongoing accomplish trial and the accomplish China trial, which is being coordinated through these and pharmaceuticals.

And lastly in oncology therapeutic area key activities include continued execution of the trade center at 101 trial for our Transcon Tll 78 agonist and the I'll believe trial for Transcon IL two beta gamma.

Jan Moller Mikkelsen: And, as I said before, our goal at Ascendis is not just to get products approved but to get products approved that can make a meaningful difference to patients, not just once but multiple times in multiple therapeutic areas. Now, let me turn the call over to Scott for a financial review before we open up for questions.

In addition to Sky Trophy commercial launch activities in the U S. We expect other SG&A activities will include Transcon, PTH prelaunch activities and continued investments and personnel systems and infrastructure to support our rapidly progressing portfolio and growing organization.

As yen noted we have a lot happening it set at a send us. So let me know also provide an update on our remaining in corporate milestones in other disclosed events.

For Transcon growth hormone, we continued to anticipate European Commission approval for pediatric Ghd by early 2022, as well as completion of enrollment of the foresight trial in adult Ghd by Q1 2022.

Scott Smith: Turning to our financial results for the quarter ended September 30, 2021, we reported a net loss of 80.3 million euros, or 1.47 euros per basic and diluted share, compared to a net loss of 121.7 million euros, or 2.31 euros per basic and diluted share, during the same period in 2020. Now, let me run through some of the key components of these results.

For Transcon PTH, we plan to provide and 84 week update for path forward later this quarter.

We then expect to report topline results from our phase III pathway trial in the first quarter of 2022, followed by unexpected NDA filing in the U S and mid 2022.

For Transcon CMP, we plan to provide a clinical program update in December during the virtual R&D update as you had mentioned in his remarks.

And finally for Transcon tail are seven eight agonist, we plan to present initial mono therapy dose escalation data for the transcend it one on one trial at our virtual R&D update.

With that operator, we are now ready to take questions.

Thank you. The floor is now open for questions I would like to remind everyone in order to ask a question you need to press star one on your telephone.

Scott Smith: Research and development costs for the third quarter were €58.8 million compared to €64.1 million during the same period in 2020. The decline in R&D costs was driven by a one-time benefit to R&D costs. As a reminder, prior to FDA approval, the expense, Pre-launch Inventories of Transcon Growth Hormones at R&D College. Upon FDA approval of Skytropha in Q3, 53.2 million euros were capitalized to inventory as raw materials and work in progress, resulting in this one-time benefit. Including this one-time item, the increase in R&D costs reflect continued advancement of our pipeline, with the primary drivers including the following. An overall increase in personnel-related costs.

Your first question comes from the lineup Jessica. Thank you from J P. Morgan Your line is open.

Hey, guys evening, Thanks for taking my questions I have.

Have several a couple of commercial and a couple of pipeline first the commercial questions. When you talk about playing the lawn lawn game. When you are scheduled for strategy can you elaborate on what that means to you from a tactical standpoint.

And the second one I'd Sky transfer is how should we think about the net price per patient first guy <unk> appreciate the commentary on the relative.

Price, but will net price and a similar to or different from existing products.

And then I got a couple of pipeline follow ups.

Thanks to the.

Mm restarted that I can turn it over to.

Later on.

But first of all.

When you think about the Sky Fulton, we'd think about the breast and clouds political opportunity an opportunity that have not been available for the patient here in the U S for more than sushi use even if I can count on multiple Haynes, how many attempts that has been to develop but there have been market a product on the market.

Scott Smith: And then for Transcon Growth Hormone, R&D costs were higher due to investments to expand our future manufacturing capacity, as well as increased clinical trial-related activities to support increased global clinical reach and label expenditure. For Transcon PTH, R&D costs were higher primarily due to increased clinical trial-related costs, device development costs, and manufacturing costs, including the completion of multiple drug substance PPQ batches, as well as initial costs of building commercial inventory. For Transcon C&P, R&D costs were higher primarily due to increased manufacturing and clinical trial-related costs.

And we got taken away, but couldn't provide the same into crime benefit that you could achieve with digital tomorrow.

But when we sold the Leapling with Ah, reflecting our clinical data Rio really beautiful to be in a position to provide social benefit out to the patient and not all new location the physician, but karaoke was also the society.

So from our perspective is when you have a best in class political opportunity is.

<unk> not to go out to be.

Coming into panic, we want to grow the long term value of this protocol for tuna too because we believe is so unique with the benefit is provide to the page and this is why the basic.

Scott Smith: And finally, for our oncology therapeutic area, R&D costs were higher due to increased manufacturing and clinical trial costs for transcon TLR78 agonist and also due to increased manufacturing and preclinical costs for transcon IL-2 beta gamma. Selling general and administrative expenses for the third quarter were 39.3 million euros compared to 17.5 million euros during the same period in 2020.

<unk>, both be called premium responsible pricing with a basic providing us with a benefit on all aspects from us, but also to the patient that decision, Turkey and also the society and this is what we say and going back to your <unk>, Yes, we have it in higher this enterprise on.

But he also utilizing must list material per patient at the same time. We can then say that yes that is a benefit still for everyone in the.

Really too.

Come out of it for the patient also related to that then you could've been signal from the technical perspective is that.

Scott Smith: These higher expenses primarily reflect an increase in personnel-related and commercial expenses, as well as IT systems and other infrastructure costs, as we prepare to launch Skytropa in the U.S. Finance income and expenses in the third quarter include a foreign exchange rate gain of €21.3 million compared to a foreign exchange rate loss of €39.6 million in the third quarter of 2020, primarily related to translation of our U.S. dollar holdings of cash, and We ended the third quarter with cash, cash equivalents, and marketable securities totaling 929.9 million euros, which included the net proceeds from our follow-on financing completed in September. As of September 30, 2021, the company had 56,877,723 ordinary shares outstanding.

And just pretend coming to that but I think it's related to Margaret assess where he threw the right negotiations with red White people in the right manner to really build up a leading but with maximal value.

Do you have multiple comments on.

Yeah, I mean at first.

Jessica I appreciate your question.

On the tactical side I can only say that we have hyatt and achieve and has a deep knowledge into the growth hormone space. So everyone that works in the commercial achieve has a background in endocrinology and growth hormone and all in PTH.

Everyone all of the amount of the commercial frontline has one.

Sure Glove excellence.

<unk>.

And basically you can say we have taken the learnings that the team has had over the years and put it together and said that the best plan that we can come forward with.

The Asap program. The ascent. This program is truly standing out in the way that we are approaching the market and the commitments that we are having so we in process of implementing all the things of course in the middle of Covid and everything that's going on in the marketplace, but all in all I feel very confident that we on the right to.

Scott Smith: In November, subsequent to the end of the third quarter, we completed our previously announced $25 million share repurchase program, in which we purchased 154,837 of our ADSs in the open market. Now, an update on our U.S. launch of SkyTravel for Pediatric GHD. The product is currently available in the U.S., and we have shipped multiple orders thus far into our specialty pharmacy and specialty distributor network for both initial prescriptions and channel inventory stock. We are currently providing Skytropa for pediatric GHD patients through our dedicated patient support program known as the Ascendis Signature Access Program. Several insurance plans are providing initial coverage for Skytropa through the medical exceptions process.

Directory, calling.

Going forward on the net price that you asked for basically is Yan is alluding to.

And as you will have also highlighted in Yo survey on how we have set up the pricing we have done it in a responsible way, but also suddenly with a price premium we are in a class of its own we are not in the you could say the commodity market. Once daily we are truly the first in the.

Once weekly segment, and we are going to segment ourself into that because it's the area under the curve accounts for us in terms of generating value investor.

Investors and shareholders for the long term.

Okay.

Okay.

Great and just a couple of pipeline questions. If I could have you dose patients and the accomplish China study and if not when do you think that will happen is the plan still to use one dose and that expansion trial or could it be two dose levels and to clarify will we get timelines for data from these face to CMP trials at the December.

Scott Smith: We are also in active discussions with U.S. commercial payers to broaden our access for 2022. We are encouraged by the early enthusiasm surrounding the launch, and we look forward to updating you on our progress in the coming quarters. Turning to the remainder of 2021, key activities include for Transcon HGH, execution of U.S. SkyTropha commercial launch activities; Investment in Expanding Commercial Manufacturing Capacity to Support Anticipated Future Demand and Continued Execution in our Ongoing Phase III Clinical Trials, including the ENLIGHTEN Long-Term Extension Trial and the RITE Trial in Japan, both for Pediatric GHD, and the Global Foresight Trial in Adult G

<unk> R&D day, and then switching to oncology what type of single agent activity do you Wanna see for your I L. T beta gamma and the I'll believe trial to warrant moving forward.

Okay.

And that was a lot of Christian.

Going back to a desktop on the on quality related to that.

First of all.

Take this generation be half hour research and development update from oncology it would be focused on the transcon Tianna seven eight <unk> and we expect that they've been really to give you an update.

Really good too.

Actually what we believe that describes the uniqueness of this product opportunity with a complete different paradigm shift how really to treat.

Solid tumor by placing a compound inside the tumor that basic beat being released over weeks and generate a mood.

Scott Smith: For TRANSCON PTH, key activities include continued execution of the Phase 2 Path Forward Trial, which retains 58 subjects in the open-label extension, continued execution of the Phase III clinical program, including the PATHWAY trial and the PATHWAY-Japan trial, and ongoing manufacturing of PPQ batches and initial activities to build commercial inventory. For Transcon C&P, key activities include ongoing manufacturing activities, including scaling up production; and continuing execution of our Phase II clinical program, which includes the two randomized double-blind placebo-controlled clinical trials in achondroplasia, the ongoing ACCOMPLISH trial and the ACCOMPLISH China trial, which is being coordinated through Wiesen Pharmaceuticals.

Active environment and I think that is with data you can look forward to see when we come to our to say both meeting.

We will not put some data from two piece of comment because of your first starting dosing.

Patient there so they will excellent need to take a look at more time before the basic was cute and program update two O. Two piece of Karma, we expect of dosing bathroom off the first two years of patients and we really beauty trends about this unique product of opportunity to.

<unk> CMP you've also provide you an update on basic give you all the answers to your Christian.

December Ah months, and it basically will illustrate really the hygiene potential of this highly differentiated products Transcon CMP and you know we have three different bases endocrinology product and all of them are highly different sated each of them to anyone else you have seen before.

And I'm quite sure we can give you all the data that supporting that that this information.

Scott Smith: And lastly, in our Oncology Therapeutic Area, key activities include continued execution of the Transcend IT-101 trial for our Transcon TLR78 agonist and the IL-BELIEVE trial for Transcon IL-2 Beta Gamma. In addition to Skytrofa commercial launch activities in the U.S., we expect other SG&A activities will include Transcon PTH pre-launch activities and continued investments in personnel systems and infrastructure As Yen noted, we have a lot going on at Ascendis, so let me now also provide an update on our remaining corporate milestones and other disclosed events.

Great. Thank you.

Your next question comes from the line is Michelle <unk> City from Canaccord January D. Your line is open.

Hi, Thank you for taking my questions.

And can I get the first one just.

I'm just as questions on the launch.

Have you guys settled on what metrics, you'll provide us to kind of packets lunch and what what what.

What should we be focused on in terms of what's most important for for tracking progress here and then.

Your early discussions around the price <unk> can you give us a sense of what the feedback from Paris has been so far and if they're recognizing.

The best in class profile and some of the other.

Aspects that are benefits that you described that justifies the premium responsible pricing and then I have a couple on the pipeline as well.

Scott Smith: For transcon growth hormone, we continue to anticipate European Commission approval for pediatric GHD by early 2022, as well as completion of enrollment in the Foresight trial in adult GHD by Q1 2022. For Transcon PTH, we plan to provide an 84-week update for Path Forward later this quarter. We then expect to report top-line results from our Phase 3 pathway trial in the first quarter of 2022, followed by an expected NDA filing in the U.S. in mid-2022.

I think we are coming.

Coming through Us states.

<unk>.

Indeed, changing our lumps now we about.

First in the beginning of long snow and we feeling that we are responsible company to give you a clear guidance will come out with guidance may be feeling that the basic half follows the launch peered in such a manner that for Ya feeling confident that we can give you clear direction about.

How this lumps is going.

What we see and getting from the commercial team is I do not know how many kpis status on the lungs, we followed them all of them I have to say, it's going for all over my own expectation, which I actually was always dude was high so I feeling really beauty come.

Scott Smith: For Transcon C&P, we plan to provide a clinical program update in December during the virtual R&D update, as again mentioned in his remarks. And finally, for TransCon TLR78 Agonists, we plan to present initial monotherapy dose escalation data for the Transcend IT-101 trial at our virtual R&D update. With that, Operator, we are now ready to take questions.

But when I see the team's behalf not in doubt that they are the best team. It will have worked with in the go from the market and overdo. It uniquely so when they come into 2022, we shall we the cave you will be feeling we are in a position that we feeling confident that we can keep your peanut they're rich.

In what way biblical but.

Until now I have been highly highly.

Constitute surprised about the feedback we have C.

Operator: Thank you. The floor is now open for questions. I would like to remind everyone, in order to ask a question, you need to press star 1 on your telephone. Your first question comes from the line of Jessica Fye from J.P. Morgan. Your line is open.

<unk> all one one strategy.

But I also have worked for a long time to get it ready. So I think that is basic.

Wait you really fit you into success being extremely well prepared with the right people.

Okay.

On the on the pipeline I guess for for Sam P. In December we give us an update on what the password is four transcon CMP in terms of kind of next studies and next steps for the program and and will we get an update on kind of what you're thinking.

Jessica Macomber Fye: Hey guys, good evening. Thanks for taking my questions. I have several, a couple commercial and a couple pipeline. First, the commercial questions. When you talk about playing the long game with your SkyTropha strategy, can you elaborate on what that means to you from a tactical standpoint? And the second question about Skytropha is, how should we think about the net price per patient for Skytropha? I appreciate the commentary on the relative list price. But will the net price end up similar to or different from existing products? And then I got a couple pipeline follow-ups.

In terms of potentially a phase three trial and point I know that you're running and natural history study that.

One form that and then I'm T T. H U you mentioned alright, I think that this is the first time I've heard you on on this call today that it's a $5 billion opportunity. What are you looking to shell and that's eight three and maybe also from the states to open the naval extinction longterm data.

That.

We get your confidence that you can realize that 5 billion dollar opportunity.

Jan Moller Mikkelsen: Thanks, Jess. Let me start, and then I can turn it over to Jesper later on.

Let me start and see if you've CMP first.

What we would like to give you an update about.

Jan Moller Mikkelsen: But first of all, when we think about Skype Fofa, we think about a best-in-class protocol, an opportunity that has not been available for the patient here in the U.S. for more than 30 years. Even if I can count on multiple hands how many attempts there have been to develop it. There have been products on the market, and they got taken away because they couldn't provide the same end-of-crime benefit that you could achieve with daily growth.

The older teeth behind contemplation.

And also how old are you <unk>.

Treatment with a continuous exposure of CMP will provide a complete different treatment received compared to a short acting CMP.

Understanding that with basic will give you the idea why we believe a long acting.

TMP concept, providing a continuous exposure will basic changed the treatment paradigm.

CMP and that is the other D V 116, more and more to you at the same time, we also would like to give you. The uniqueness you see with social component that is continuous be giving them flat related to safety and target engagement that basic providing.

Jan Moller Mikkelsen: So when we saw the labeling which is reflecting our clinical data, we are really, really thrilled to be in a position to provide such a benefit to the patient, and not only the patient, the physician, the caregiver, but also society. So, from our perspective, when you have a best-in-class product opportunity, it's not to go out and be... coming into PANIC, we want to grow the long-term value of this product opportunity because we believe it's so unique in the benefit it provides to the patient.

Confident about the entire our entire understanding about the biology, we did executive was particularly cruel tunnel.

Went down and started and started I started I started to play by odor to your file echolocation designed to target product profile really addressed the unmet medical need them and that is the.

Jan Moller Mikkelsen: And this is why we basically have defined what we call premium responsible pricing, which is basically providing us with a benefit on all aspects from us, but also to the patient, the physician, caregivers, and also society. And this is what we're saying, and going back to your presenters, yes, we have a higher list price on VAC, but we're also utilizing much less material per patient.

That we would like to give you as we have provided for you why is the belief how we can address or into crime benefit with grilled term and we expect that for years and years and we will start to do the same thing would help as sustainable exposure of CMP can provide a complete new treatment paradigm and that is.

The understanding that we would like to keep it.

So going back to <unk>.

Did you ask me why I'm, so comfortable good why I'm, so prudish about <unk>.

Jan Moller Mikkelsen: At the same time, we can then say that yes, there is still a benefit for everyone, and we want to really come out with something for the patient also related to that. Then you can think from the tactical perspective, and Jesper can come into that, but I think it's related to what Margaret says, where he does the right negotiations with the right people in the right manner to really build up a leading brand with maximal value. Jesper, do you have more to comment on? Yeah, I mean, first, Jessica, I appreciate your question.

Because when we look under 58 patients.

Luke an older demographic background looking about if you.

Coming from different genetic diseases from auto immune from plus search of going to look on eight <unk>.

<unk> and other things or that we see a huge benefit for older patients.

So for all the clinical data accumulation and all the clinical data IFC I cannot come in and give you any kind of guidance.

Except that older patients we have been treating have seen a unique benefit of the patient. So from that perspective is I believe all that patients that have chronic.

<unk> now we addressing the dog's segment with about 80 to 100 house in the U S must more in Europe.

Jesper Heulen: On the tactical side, I can only say that we have hired a team that has a deep knowledge of the growth hormone space. So everyone that works in the commercial team has a background in endocrinology, growth hormone, or PTH. And all of them on the commercial front line have won several Circle of Excellence events.

I have not seen any of them not really.

If you look on the clinical data tech not supporting that all of them will have a huge benefited and that just noticed more benefit benefit both too short term and we hope by accumulating <unk>. We also can see that the basic can benefit on the long term risk for this patient group.

Jesper Heulen: And basically, you can say we have taken the learnings that the team has had over the years and put them together and said that's the best plan that we can come forward with. The ASAP program, the Ascendis program, is truly standing out in the way that we're approaching the market and the commitments that we're making. So we are in the process of implementing all the things, of course, in the middle of COVID and everything that's going on in the marketplace.

Okay. Thank you guys. So much for taking my questions Congrats on on launching a chopper.

[noise] Thanks Michelle.

Your next question comes from the line of Josh semi from Evercore. Your line is open.

Hey, thanks for taking the questions.

First on them trophic you've mentioned several times are providing coverage can you provide some details in terms of what tier of Copehan, how many covered labs are.

Where you expect that to be actually start.

2022 in progress throughout the year.

Jesper Heulen: But all in all, I feel very confident that we are on the right trajectory going forward. On the net price that you asked for, basically, as Jan is alluding to and as you have also highlighted in your own survey on how we have set up the pricing, we have done it in a responsible way, but also certainly with a price premium. We are in a class of our own. We are not in, you could say, the commodity market of once daily newspapers.

Second you had mentioned.

Starting trials to expand the scheduled for label beyond pediatric and adult what settings are you considering.

For those trials and then last for the for the PTH device and ultimately the CMP device to me, so they're going to be similar to the schedule. It twice.

And the way different thank you.

Thanks, just.

Let me start from the effects, because then I can still remember [laughter].

[laughter] the device be using for example, P team sky tools and basic.

<unk> is complete different device wherever you have in skytrooper single use room Timbuktu stability.

Jesper Heulen: We are truly the first in the once weekly segment, and we are going to segment ourselves into that because it's the area under the curve that counts for us in terms of generating value for our investors and shareholders for the long term.

Capsule, where it's basic have sale raised though and you think about that.

Giving the optimal for the patient for the kick you want everything your group temperature stability useful unconscious Everytime you are addicted and then your basic FCO based is optimal because coulter moaning. Some geographic region are highly regulated if you go over to <unk>, we have implemented a system.

Jessica Macomber Fye: Great. And just a couple of pipeline questions, if I could. Have you dosed patients in the Accomplish China study? And if not, when do you think that'll happen?

With our learning from.

Jessica Macomber Fye: Is the plan still to use one dose in that expansion trial, or could it be two dose levels? And to clarify, will we get timelines for data from these phase two CNP trials at the December R&D day? And then, switching to oncology, what type of single agent activity do you want to see for your IL-2 beta gamma in the All Believe trial to warrant moving forward?

Peters insulin pen and other things like that how you can have a police of liquid formulation at room temperature that giving optimum competent and these basic is a mood you use.

Devised that look most like in Italy depends where your basic half dosing.

Dosing for about two weeks and then you start on a new.

And we basically providing three different strengths with basic titration in each single can system, meaning is that vehicle or an accepting and what you're also seeing an hour twice that the patient needs to be optimized for each of them.

Jessica Macomber Fye: Hey, that was a lot of work...

Jessica Macomber Fye: That was a lot of questions, Jess. Going back to the start of the oncology related to that, first of all, let me take the situation.

So this is basic complete different thing for about CMP. That's my last question I think you need to wait what we're doing with CMP. This is still a lot of opportunities for you working on though but what the oldest will have into the focus is the patient what is optimal for rotation. We did that to grow to be also doing that for hydropower target.

Jan Moller Mikkelsen: We have our research and development update from oncology. It will be focused on the transcon TLR78 agonist, and we expect at that event to give you an update related to exactly what we believe describes the uniqueness of this product opportunity with a complete different paradigm shift, how really to treat Solid Tumor by placing a compound inside the tumor that basically is being released over weeks to generate a monoactive environment. And I think that is the data you can look forward to seeing when we come to our December meeting.

Smith.

Going back to the.

I Miss Silva Kokomo Christian that was something between the growth of nutrition.

Okay.

Formulary for Sky Trophy, and then new indications for scheduling new indication you know we have and.

We are so lucky.

Just that re molecule that's assigned by liberating the same.

Unmodified so much loopy, you'll see in David Cool terminal and you'll see also the same that is industrious. So when we go to labor expansion become good a complete different way to approach it because the basic are in a position that we know now from growth hormone could actually go to moan.

Jan Moller Mikkelsen: We will not present data from IL-2 beta-gamma because we are first starting to dose a patient there, so they will actually need to take a little bit more time before we basically give a program update to our IL-2 beta-gamma. We expect to start dosing very soon in the first series of patients, and we are really, really thrilled about this unique product opportunity. Transcon CMP, we will also provide you with an update and basically give you all the answers to your questions in December, a month, and it basically illustrates the great potential of this highly differentiated product, Transcon CMP. And you know, we have three different rare disease endocrinology products, and all of them are highly differentiated, each of them different from anyone else you have seen before.

Efficiency, how we basic are providing and unique treatment with all the same benefit that we have analyzed that you will see.

So when we go to our total trust.

We will move to and different primary endpoint the no smoking on growth velocities be looking about how we basic half of Metropolis effect on trunk will fit in Ora element that is basically is a metabolic effect dependent on the penetration out into the tissue of it wouldn't be local too.

The longest dissected five six indication vehicles on on the approved we starving and Dana can talk about this will be trying to find new either can't wait how we basic can get as many as possible indication in the fuse possible tried but just mainly liberal.

Operator: Your next question comes from the line of Michelle Gilson from Canaccord Genuity. Your line is open.

All from the idea that we are in a position that we have the modem action. We have the active ingredient is basic coming from so much will peak data with your comments on it.

Michelle Gilson: Hi, thank you for taking my questions. I guess the first one, just following up on Jessica's questions about the launch, you know, have you guys settled on, you know, what metrics you'll provide us to kind of track this launch? And what will, you know, what should we be focused on, in terms of what's most important for tracking the progress here? And then, you know, in your early discussions around price, can you give us a sense of what the feedback from payers has been so far?

Yes Yan.

I think one of the situations that we're in right now is that.

For the biologic.

We need to sort of.

Stablish that our compound behave the same way.

With these other indications as it does for pediatric like hormone deficiency.

And so we are in discussions with FDA of our time in addition.

We're pursuing other sort of policy options that may.

Enable sort of a.

Expedited pathway.

For Florida.

I will probably be too like pilings for biologics.

Michelle Gilson: And if they're recognizing, you know, the best in class profile and you know some of the other aspects that are benefits that you described that justifies the premium responsible pricing. And then I have a couple in the pipeline as well.

And.

That isn't available now but.

He has also recognized that the gap and.

We are sort of working to try to facilitate getting language into the new the new car reauthorization.

Re authorization, which will be time next year, but in the meantime, we're going to be working very directly with FDA too.

Jan Moller Mikkelsen: I think we are coming to a space where we are just initiating our launch now, at the beginning of the launch now. And we feel that we, as a responsible company, should give you clear guidance. We'll come out with guidance when we feel that we basically have followed the launch period in such a manner that we're feeling confident that we can give you clear direction about how this launch is going. What we're seeing and getting from the commercial team is, I do not know how many KPIs there are for the launch. We followed them, all of them.

To work through in normal process.

We can in an expedited way.

Established advocacy any additional indication.

Just as we said before will be committed to make a global leading Bryant and we know that it's really doing the right investment in the right tried to support that we can build up this global brain and that is what you will see be executed on in the future Vms topic before have you been leading global brain.

This is our aspiration because they have the best in class product.

Going back to the.

You lost Christian and just for can help me coming in but what I will say now yes. As you said before he's working on a strategy related to market assess but we also see patient coming into.

Jan Moller Mikkelsen: I have to say it went far beyond my own expectations, which were actually always high. So I'm feeling really, really confident. But when I see the team we have, I'm not in doubt that they are the best team I've ever worked with in the growth hormone market, and they will do it uniquely. So when we come into 2022, Michel, we will give you, when we feel that we are in a position that we're feeling confident that we can give you clear direction in what way it will go, but, Until now, I have been highly, highly, positive surprised But that also worked for a long time to get it ready. So I think that is basically the way you really put yourself into success by being extremely well prepared with the right tools.

As I said in my part of this.

Prepared remarks that we've seen patients being treated at the commercial patient today, while they're mainly coming up from the exception process and obvious exception process. This is patient which cannot really get the optimal treatment on digital <unk>, which we have known for years and years. That's why is being developed.

And we see this kind of patient now being X is getting approved for commercial patient to the exception cautious and just give me the confidence that particular right to really to develop this product, yes, but do you have further comments.

Yeah, I mean, Josh it's still early days.

But I should know and Sky copay is truly the first.

Growth hormone coming onto the market and we and deep discussions with a P. P M.

Of getting access and we will announce as they will.

When we get access and ask you know is a little off season.

Michelle Gilson: Okay. And on the pipeline, I guess, for CMP in December, will you give us an update on, you know, what the path forward is for TransCon CMP in terms of kind of next studies and next steps for the program? And will we get an update on kind of what you're thinking in terms of potentially a Phase III trial endpoint? What are you looking to show in the Phase III and, you know, maybe also from the Phase II Open Label Extension long-term data that would make you confident that you can realize that $5 billion opportunity?

We have certainly is talking to them and discussing with them and we are confident that we will be able to bring skype software to the patient and again.

Those we get in.

Situation, where we get them off.

Medical exceptions, we get that at full price.

And that will have to ban mind also when you look at the what is the average selling price going to Viva Sky chauffeur, which is going to be a pregnant pricing.

Thanks, a lot yes.

Thanks, so much.

Your next question comes from the line of <unk> from cans are your line is open.

[noise] Lydia.

Can't I have to say, yes, sorry about that and yummy.

Thanks for taking my questions, Okay keep it tight.

[laughter], Nebraska.

No I wanted to ask how I'm talking about like.

Jan Moller Mikkelsen: Let me start on C&P first, which is what we would like to give you an update on. The biology behind acanthoplasia, and also how we explain it. A treatment with a continuous exposure of CMP will provide a completely different treatment regime compared to a short-acting CMP. Understanding that with BASIC will give you an idea why we believe in the long-acting, CMP concept that providing a continuous exposure will basically change the treatment paradigm with CMP. And that is the biology we want to explain more and more to you.

How to handle the blank face a favor I got Ya.

So just a question on Mike the potential commercialization in Europe, just talk a little bit more about how those markets kind of compare I guess.

Practical perspective, as we all have got patients are treated we know their differences. So I. Just wanted you to talk about that kind of versus the United States and then when we were going into oncology again.

Have you guys kind of tight thinking about giving I know you've thought about it but are you ready to give people kind of what the next maybe program or programs can be there in December.

Yeah.

Via European company send us from NASA European company, but we know the European market extremely well, we have been working in the European market.

So what are the basic building up rebuilding of our strategy for.

Europe.

And the element of that is because it's so so diversed.

Group of reimbursement system unique to deal with some of them are far unsettling most of them are slow so for some countries that can take up more than two years basic to get to the right reimbursement. So what were you doing there, which I think is the key element novel like to give to you the building.

Jan Moller Mikkelsen: At the same time, we also would like to give you the uniqueness you see with such a compound that is continuous, beginning in the flat, related to safety and target engagement, which basically are providing confidence about our entire understanding of the biology.

A python perspective.

If you want to be successful in Europe, you cannot cope with secret product I have seen European companies or U S companies going to Europe, and spending 100 million in gaming 528 and.

Jan Moller Mikkelsen: We did exactly what we did with Glotamone, went down and studied and studied and studied the biology of air contemplation, and designed a target product profile that really addressed the unmet medical need there. And that is the learning that we would like to give you, as we have provided for you why we believe in how we can address all endocrine benefits with Glotamone, and we have explained that for years and years, and we will start to do the same thing with how a sustainable exposure of CMP can provide a complete new treatment paradigm. And that is the understanding we would like to give you. So, going back to PTH.

Revenue, we're not going to do that and this is why we happened notice of the European market, we would be extremely responsible but you distill built off the European market in the wait where we believe we create the best patient covered but at the same time also do it in a financially responsible manner.

And Regal assumed SV getting.

I expected approval in Europe of grow tunnel.

Yet at the same time, having a result of oil faith Street HP will basically be the fundament fall all European strategy. So you will see a strategy that it's built on the Python approach filling on too hopeful the status key political opportunity Transcon Kokomo Transcon Peach.

Right and see how we basically penetration.

Pta's.

Could be a <unk> product in Europe, because of the embassy on long term risk how ready to have a patient population that basic could be in a position that could really benefit and the value of a boring long term risk I think is must be recognized.

Jan Moller Mikkelsen: Why do you ask me why I'm so confident, why I'm so bullish about PTA? Because when we look at the 58 patients... look at all the demographic backgrounds. Look at if you are... coming from different genetic diseases, from autoimmune, from post-surgery, going to look at age, Curl Bowden, and other things like that, we see a huge benefit for all of us.

The GOP setting because.

And the stereotype, saying is that 98% of origin Unstained, German Germany rest of their life.

Jan Moller Mikkelsen: So for all the clinical data we are accumulating and all the clinical data I have seen, I cannot come in and give you any kind of guidance except that all the patients we have been treating have seen a unique benefit for the patient. So from that perspective, I believe all the patients that have chronic, Now we are addressing the adult segment with about 80 to 100,000 in the U.S., much more in Europe.

You move from one insurance company to the other insurance company and it gives you a complete different.

About how to build up high value protocol, but two opportunities even on you can see a small price level and this is what you will see the implemented European strategy release thing on I believe we have two paradigm shift come home.

Caller genome.

Transcon Tierra chiller, seven eight agonist and our transplant two piece of gum.

I think you would be trained to see the data that you could come out in the coming years for that but.

Jan Moller Mikkelsen: I have not seen any of them, not really, when we look at the clinical data, that doesn't support that all of them will have a huge benefit. And that is not a small benefit, it's a benefit both in the short term, and we hope by accumulating further and further data, we can also see that we basically can benefit from the long term risk for this patient group.

But as you said, we're not stomach meal, we're still working on pipeline and building up the same strong Python.

In where.

The agencies endocrinology with at least three protocol opportunities. So you will see in the coming years, both new rare disease endocrinology products, you'll receive more oncology product at path.

Many of you will be that.

But time would come up with a new toco together.

Re sub building everything on the same way we have been successful in rare disease endocrinology on the transcon technology and our proven accurate.

Michelle Gilson: Okay, thank you guys so much for taking my questions. Congratulations on launching Skytropa.

Product innovation, which have really have shown how we can be highly different sated product with and at the same time to be successful, which I believe is really true paradigm shift.

Operator: Your next question comes from the line of Josh Schimmer from Evercore. Your line is open. Hey, thanks for joining us.

Joshua Elliott Schimmer: Hey, thanks for taking the questions. First on SkyTropha, you mentioned several points about providing coverage. Can you provide some details in terms of what tier of co-pay and how many covered lives? Where do you expect that to be as you start 2022 and progress throughout the year? Second, you mentioned starting trials to expand the SkyTropha label beyond pediatric and adult patients. What settings are you considering for those trials? And then last, for the PTH device and ultimately the CMP device, are they going to be similar to the SkyTropha device or in any way different?

Awesome Congrats.

The next question we have is from Joseph Schwartz from SBB Leerink. Your line is open.

Oh.

Hi, I'm, Jeremy Italian per gallon. Thank you for taking our questions.

Following up on a previous question.

Charles I know, it's early days, possibly think about the adoption of the treatment naive patients first and will accept <unk>.

Talk about the treatment patients person switched patients for Bob now that you're on.

In the market.

So after three to four weeks, you don't get new patient because just the diagnosis of a patient to be a true go for more deficient.

Patient takes time, it takes more than three or four weeks.

So what you're basically see you will see a different stage where from obvious region. If you have a patient that is not doing well on day to go home, it's already been diagnosed with growth hormone deficiency. All the people all the tests have been done.

Jan Moller Mikkelsen: Let me start from the back because then I can still remember things. The device we're using, for example, between SkyTrova and basic or transcon PTAs is a completely different device. Where we have in SkyTrova, single use, room temperature, stability, capsule where it's the basic, have zero waste or anything like that, giving the optimal solution for the patient, for the caregiver, everything. You have room temperature, stability, you use one cartridge every time you inject it, and then you basically have zero waste.

Fact, just not getting the right treatment outcome.

What can we do to see laid off is expected moving over to a more and more new patient because they go to the entire diagnostic contrary to get a confirmed diagnosis of being terminal deficient.

And this is why you see a different states.

And that is what we expect to see in the coming months.

Okay. That's helpful and my second question is by chance.

Jan Moller Mikkelsen: It's optimal because growth hormone in some geographic regions is highly regulated. If you go over to PTAs, we have implemented a system with our learning from diabetes, insulin pain, and other things like that, so you can have a pre-filled liquid formulation at room temperature that gives optimal confidence. And it's basically a multi-use formula. [inaudible] In our trial, the patient needs to be optimized for each of them. So this is basically a completely different thing.

I understand that you're going to give us an overview of the biology behind the program on some kind of blind and analysis I'm wondering how are you doing this just for our benefit or why not just financial both studies are done and I'm blind Nepal at the same time.

And an alliance with Saudi even blindfolded on the height trial of course by telephone with help enable study.

When we were running the phase three trial of height. It was applying to trial for one year too So our high Trust post blinded placebo.

No placebo controlled daily go to move as a comparison so the registration tries to be half full sculptural <expletive> here in the U S was one year blinded trials, where if you look on the growth path.

Jan Moller Mikkelsen: For CMP, as the last question, I think you need to wait to see what we're doing with CMP. There are still a lot of opportunities we're working on now, but what we always will have in the focus is the patient. What is optimal for the patient? We did that for glutamine. We're also doing that for hyperparathyroidism. Going back to then, I missed the growth hormone question; there was something between the growth hormone question.

Paul I'll walk optimal park.

So it was also blinded.

And the Christian you are racing is acting really really interesting.

To be do it for you.

Do we do it for us.

No I think we do it for the patients.

We do it all from their perspective that we want you to keep a comfort that we are progressing with a program that can give a meaningful difference for the patient. This is why we doing it at the same time. We can also give you. The information widely believe we are highly difference 82, and you think.

Jan Moller Mikkelsen: As well as the formulary for Skytropha and then new indications.

Jan Moller Mikkelsen: New indication, you know, we have, and we are so lucky. Just that we are a molecule that is signed by liberating the same. Unmodified somatopoeia you see in daily colonial, and you also see the same that is in Dutch.

This is exactly why we doing it.

Okay. Thank you very much.

At this time, we will now be closing the Q&A session.

This concludes today's conference call. Thank you all for joining you may now disconnect.

Jan Moller Mikkelsen: So when we go to label expansion, we come with a completely different way to approach it. Because we basically are in the position that we know now from pediatric growth hormone deficiency, where we basically are providing a unique treatment with all the same benefits that we have analyzed that we will see. So when we go to our adult trials, we will move to a different primary endpoint. We're not looking at growth velocity.

Thanks, a lot.

[noise] [music].

Jan Moller Mikkelsen: We're looking at how we basically have a metabolic effect on truncal fat and other elements that is basically a metabolic effect dependent on the penetration out into the tissue of fat. When we go to the long list of 5-6 different indications where growth hormone is approved, we are starting, and Dana can talk about it, where we are trying to find a new, elegant way to basically get as many possible indications in a few possible trials. But it's mainly being delivered from the idea that we are in a position that we have a mode of action where the active ingredient is basically coming from somatopoietin. Dana, will you comment on that?

Dana Pezzuti: Well, yeah, again, one of the situations that we're in right now is that, you know, for the biologic, we need to sort of establish that, you know, our compound behaves the same way, you know, with these other indications as it does.

Dana Pezzuti: for Pediatric Lip Hormone Deficiency, and so we are in discussions with the FDA about that. In addition, you know, we are pursuing other, you know, sort of policy options.

Dana Pezzuti: That may, you know, enable sort of an expedited pathway for sort of 505 B2 like, you know, filings for biologicals. And, you know, that isn't available now, but, you know, the FDA has also recognized that there is a gap, and, you know, we're sort of working to try to facilitate getting language into the new PDUPA reauthorization, which will be signed next year. But in the meantime, we are going to be working very directly with FDA to work through the normal process, you know, how we can, in an expedited way, establish advocacy and the additional indication. Yes, as we said before, we are committed to making.

[music].

Jan Moller Mikkelsen: Just as we said before, we are committed to making a global leading brand, and we know that it's really doing the right investment in the right trials to support that we can build up this global brand. And that is what you will see executed on in the future.

Jesper Heulen: We are not stopping before we were leading global brand. This is our aspiration because we have the best in class product. Going back to your last question, and Jesper can help me coming in, but what I will say now, Jesper, as you said before, he's working on a strategy related to market assess, but we also see patient coming into As I said in my part of this, my prepared remark, that we're seeing patients being treated as a commercial patient today, but they're mainly coming up from the exception process and obvious exception process, this is a patient which cannot really get the optimal treatment on daily glutamate, which we have known for years and years, that's why it's being developed, and we see this kind of patient now being, actually getting approved for commercial patient to the exception process, and I, just give me the confidence that we did the right thing really to develop this product. Yes, but do you have further comments? Yeah, I mean, Josh, it's still early days.

Jesper Heulen: But as you know, Skytropa is truly the first pediatric growth hormone coming onto the market, and we are in deep discussions with the PBMs about getting access, and we will announce, as they will, when we get access. And as you know, it's a little off-season, but we are certainly talking to them and discussing with them, and we are confident that we will be able to bring Skytropa to patients. And as Jan said, for those we get in a situation where we get them off medical exceptions, we get that at full price. And that you have to bear in mind also when you look at what the average selling price is going to be for Skytropa, which is going to be a premium price. Thanks a lot, Jesper.

Operator: Your next question comes from the line of Alicia Young from Cancar. Your line is open.

Alicia Young: And then when we're going into oncology again, have you guys kind of started thinking about or given, well, I know you've thought about it, but are you kind of ready to give people kind of what the next maybe program or programs could be there, you know, in December? Thanks.

Jan Moller Mikkelsen: Yeah, you know, we are a European company; Ascendis Pharma is a European company. We know the European market extremely well.

Jan Moller Mikkelsen: We have been working in the European market. So, what we basically are building up is a strategy for Europe. And the element of that is because it's such a diverse group of reimbursement systems you need to deal with. Some of them are fast, and sadly, most of them are slow.

Jan Moller Mikkelsen: So for some countries, it can take more than two years basically to get the right reimbursement. So what we're doing there, which I think is the key element I would like to give you, we're building a pipeline. If you want to be successful in Europe, you cannot go alone. I have seen European companies or U.S. companies going to Europe and spending 100 million and gaining 5 to 8 million out in revenue. We are not going to do that.

Jan Moller Mikkelsen: And this is why we have knowledge of the European market. We will be extremely responsible, but we prefer to build up the European market in a way where we believe we create the best patient coverage but, at the same time, also do it in a financially responsible manner. We will, as soon as we get the expected approval in Europe for growth hormone, we will, nearly at the same time, have a readout of our phase 3 HP, which will basically be the foundation for our European strategy.

[music].

Jan Moller Mikkelsen: So you will see a strategy that is built on a pipeline approach, building on two hopefuls, P.J., which could be a huge, huge product in Europe because of the emphasis on long-term risk and how really to have a patient population that basically could be in a position that could really benefit. And the value of avoiding long-term risk, I think, is much better recognized in the European setting because, as a stereotype saying goes, 98% of all Germans stay in Germany the rest of their lives.

Jan Moller Mikkelsen: Here, you move from one insurance company to the other insurance company, and it gives you a completely different perspective on how to build up high-value product opportunities even on, you can say, a small, low-price level. And this is what you will see being implemented in our European strategy. I believe we have two paradigm shift compounds in oncology now: Transcon TLR78 Agonist and our Transplant IL-2 beta guy. I think you will be thrilled to see the data that we will come out with here in the coming weeks, But as you said, we're not stalling there.

Jan Moller Mikkelsen: We're still working on the pipeline and building up the same strong pipeline we did in rare disease endocrinology with at least three product opportunities. So you will see in the coming years both new rare disease endocrinology products and new treatments for rare diseases. You will see more oncology products, and perhaps many of you will be very thrilled about the time when we come up with our new therapeutic area. We are still building everything on the same way we have been successful in rare disease endocrinology with transcon technology and our proven algorithm.

Operator: [inaudible]

Joseph Patrick Schwartz: The next question we have is from Joseph Schwartz from SVB Layering. Your line is open.

Drury Dalyan: Hi, I'm Drury Dalyan on behalf of Joe. Thank you for taking our questions. Following up on a previous question on scitropha, I know it's early days, but how should we think about the adoption of treatment naive patients versus the exception process? Have your thoughts about treatment naive patients versus switch patients evolved now that you're on?

Jan Moller Mikkelsen: So, after three to four weeks, you don't get new patients because just the diagnosis of a patient to be a true glaucoma deficient... patient takes time. It takes more than three or four weeks.

Jan Moller Mikkelsen: So basically, you will see a different stage where, for obvious reasons, if you have a patient that is not doing well on data growth hormone, it's already been diagnosed with growth hormone. All the people, all the tests have been done, and they are just not getting the right treatment. What we will see later on is expected to move over to more and more new patients because they go through the entire diagnostic pathway to get a confirmed diagnosis of being growth hormone deficient. And this is why you see a different state, and that is what we expect to see in the coming months.

Drury Dalyan: Okay, that's helpful. And my second question is about Transcon CMT. I understand that you're going to give us an overview of the biology behind the program and some kind of blinded analysis. But I'm wondering, you know, are you doing this just for our benefit? Or, you know, why not just wait until both studies are done and unblind them both at the same time? And you know, why is the study even blinded when the height trial of porcicotropha was an open-label study?

[music].

Jan Moller Mikkelsen: When we were running the Phase III trial of HITE, it was a blinded trial for one year. So our high trial was blinded, not placebo-controlled, daily glutamone as a comparison. So the registration trial we had for SkyTrooper here in the U.S. was a one-year blinded trial where we looked at the growth pattern for our global product. So it was also blind.

Jan Moller Mikkelsen: And the question you're raising is actually really, really interesting. Do we do it for you? Do we do it for ourselves? No, I think we do it for the patient. We do it all from the perspective that we want you to be comfortable that we are progressing with a program that can make a meaningful difference for them. This is why we are doing it. At the same time, we can also give you information about why we believe we are highly differentiated from anything else. This is exactly why we are doing it.

Drury Dalyan: Okay, thank you very much.

Operator: At this time, we will now be closing the Q&A session. This concludes today's conference call. Thank you all for joining us. You may now disconnect.

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