Q2 2020 Ascendis Pharma A/S Earnings Call

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<unk> earnings Conference call.

Operator: Earnings Conference Call. At this time, all participant lines are in a listen-only mode.

This time, all participant lines on in listen only mode.

The speakers presentation they'll be a question and answer session to ask the question. During the session you need the press Star then one of your telephone.

Operator: After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star then one on your telephone. At that time, we ask that you please limit yourself to one question and one follow-up. Please be advised that today's conference is also being recorded. If you require any further assistance, please press star then zero.

Tom Yes that you please limit yourself to one question and one follow up.

Please be advised that today's conference is also being recorded if you acquire any further assistance. Please press star then see while I would now like the hand, the topics over to your speaker today, Scott Smith, Senior Vice President and Chief Financial Officer at Ascendis Pharma. Please go ahead.

Operator: I would now like to hand the conference over to your speaker today, Scott Smith, Senior Vice President and Chief Financial Officer of Ascendis Pharma. Please go ahead. Thank you, operator. Thank you, everyone, for joining our second quarter 2020 financial results conference call today. I'm Scott Smith, Chief Financial Officer of Ascendis. Joining me on today's call are Jan Mikkelsen, President and Chief Executive Officer.

Thank you operator.

Thank you everyone for joining our second quarter 2020 financial results conference call today.

Scott Smith, Chief Financial Officer of a son.

Joining me on today's call our.

Yeah, and Mickelson, President and Chief Executive Officer.

Scott Smith: Dr. Dana Pizzutti, Head of Development Operations, and Dr. Yuhua Punanen, 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 progress on our pipeline candidates and our expectations with respect to their continued progress.

Dr., Dan up as Udi head of development operations.

And Dr. you up one of the 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 progress on our pipeline candidates in our expectations with respect to their continued progress.

Statements regarding our strategic plan.

Scott Smith: Statements regarding our strategic plan and our goals regarding our clinical pipeline. Statements regarding the market potential of our pipeline candidates and statements regarding the planned regulatory filing. These statements are based on the information that is available to us today. However, 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, 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, see Notes to Financial Statements.

Our goals regarding our clinical pipeline.

Statements regarding the market potential of our pipeline candidates and statements regarding the planned 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 a tree barkell.

Sorry 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.

Our forward looking statements do not reflect the potential impact of any licensing agreements acquisitions mergers disposition 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 factors that could cause actual results could differ materially.

Scott Smith: Please see the forward-looking statement section in today's press release and the risk factors section of our most recent annual report on Form 20-F. Please note that our TransCon product candidates are investigational products and not approved for commercial use. As investigational products, the safety and effectiveness of the Transcon product candidates have not been reviewed or approved by any regulatory agency. Therefore, none of the statements made on the conference call regarding our TransCon product candidates should be viewed as promotional.

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.

Please note that our transcon product candidate, our investigational product candidates and not approved for commercial use.

As investigational products, the safety and effectiveness of the Trans Con product candidates have not been reviewed or approved by any regulatory agency.

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

On today's call, we will discuss our second quarter 2020 financial results and provide a business update.

Jan Moller Mikkelsen: On today's call, we will discuss our second quarter 2020 financial results and provide a business update. 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.

Following some prepared remarks, we'll then open up the call to questions.

I will now turn the call over to young Mckool Smith, our president and Chief Executive Officer.

Yeah.

Scott.

Good afternoon, everyone.

This second quarter.

Jan Moller Mikkelsen: This is the Second Quarter. We achieved several key milestones for Ascendis, as we continue to advance towards our vision 3x3 to build a fully integrated biopharma company. We submitted our first BLA to the FDA for transcontinental growth hormone for the treatment of pediatric growth hormone deficiency in youth. The BLA submission was completely in line with our stated 2020 corporate goals.

Yes, you several key milestone for us and.

Yes, we continue to advance towards all be should three by tree to build a fully integrated Biopharma company.

Resubmitted, our first BLE too, but if they put trends can go to mea culpa treatment or could that to go Truman deficiency into.

The <unk> submission was completely in line with our stated 2020 corporate goals.

Jan Moller Mikkelsen: And it moves Ascendis another step closer to becoming a fully integrated global biopharma company. To see our first Transcon technology product, Transcon Cotamon, progress from the idea stage, through three phase three clinical programs, covering over 400 sites, and into a regulatory filing, which also includes our auto-injector, makes me proud of what we have.

When it moves I Sandy's I noticed it closer to become a fully integrated global Biopharma company.

[laughter] to see offers trends Cronto technology product trends from Kokomo progressed from the idea stays true sweet taste, we see nickel programs covering over 400 subjects and into a regulatory filing which also includes.

<unk> Ultra addictive makes me proud of what we have issue.

What would be enough stopping here.

Jan Moller Mikkelsen: But we are not stopping. What makes Ascendis unique is that we are a global company with a broad, diversified pipeline where all product candidates are created with the Transcom technology platform and Transcon technology. We are able to leverage the validated biology of existing drugs and create highly differentiated products by identifying significant unmet medical needs with well-defined clinical strategies, studying the science underlying the disease, and applying our transcon technology to an existing clinically validated parent drug or pathway. We are AAPL, to create a new product candidate solving an unmet medical need. Starting with no biology, we are able, quite simply, to create highly differentiated products with large commercial potential and an expected high success rate. To achieve our goal of sustainable long-term growth, we will continue our algorithm of building multiple high-value product opportunities in endocrinology, rare diseases, oncology, and a third therapeutic area. The BLA for transcontinental growth hormone in the US is just one more milestone for Ascendis towards achieving our Vision 3 by 3 strategy to be a leading biopharma company. We also continue to execute across all areas of the company.

What makes I say this unique is that we are global company with a board diversified pipeline.

The old product candidates acquainted with a tragic on technology platform.

With that Transcon technology.

We are able to labor that validated by quality of assisting droke and Kuwait, Heidi decency didnt product candidates.

[laughter], but it did you find significant unmet medical needs. We will define can you could strategies.

Studying the signs underlying the disease.

And applying our trends come to acknowledge deep to an existing clinically validated parent DRONCO, possibly.

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To quite a new product candidate solving the on but maybe you could be.

Starting with no voted to you we are able quite simple to Kuwait highly differentiated products with las commercial potential be done expected high success rate.

To achieve our goal ops, who stayed another both long term group, we continue our eco minimal building multiple high value product opportunities in endocrinology rare disease on quality and a food show beauty care.

The DNA fighting for Transcon Coke terminal in the U.S., It's just one more milestone for incentives towards achieving our vision treaty by treaty strategy to be are leading Biopharma company.

We also continue to execution across all the Arabs all put comp.

Jan Moller Mikkelsen: Let me update you on some of these recent developments for Transcontinental Growth Terminal. After the BLA filing for the treatment of Pediatric Glutamate Deficiency, Ascendis received a positive opinion from the Pediatric Committee of the European Medicine Agency, PEDCO, on its agreement with the proposed Pediatric Investigation Plan or PIPA, covering children from six months to less than 18 years of age.

Let me update you on some of these recent development.

For Transcon broke terminal.

Also the beauty fighting for the treatment of pedantic Altamont deficiency as said just received a prostitute opinion from the pediatric committee off the European Medicines Agency Petco.

On his agreement with that but post pediatric NVS mitigation plane or people.

Coloring children from six months to less than 18 years old seats.

We are pleased by the take cool decision because we believe it's with take the unique product features have tried to conclude optimal.

Jan Moller Mikkelsen: We are pleased by the PEDCO decision because we believe it reflects the unique product features of transconcoctamol, which enables the long-action release of unmodified somatol by releasing unmodified growth hormone, the same molecule as daily growth hormone or endogenous growth hormone. The Transcon technology is designed to leverage both the direct and indirect effects of growth hormone in the same balanced way as daily growth hormone has for decades, to our The approval of our PIP is the first time PECO has concluded that a development program for a long-acting glutamate treatment supports clinical development in children. With the approval of our PIP, we are on track to file the M&A or marketing authorization application in Europe this quarter instead of the planned Q4 2020 filing.

In neighborhood, but long action would these all on modified so much.

By releasing unmodified called come along the same molecule I stayed to cool all endorses kolterman.

The trends can technology is design to labors scope, the direct and indirect effect of Kokomo in the same patents way sdd called come on has for decades.

To our knowledge.

The approval of I'll keep this the first time Peco has concluded that it development program for a long acting coal terminal treatment support the clinical development and children.

But the approval of the people we are on track for fighting the M&A or marketing authorization application in Europe this quarter.

Instead of the plane Q4, 2000 and changing Friday.

Jan Moller Mikkelsen: To establish global clinical reach for transconcoctamol, we continue to advance on several fronts. In Greater China, Wesen Pharmaceuticals, our strategic investment, continues to enroll subjects in a phase 3 trial for transconcrotamol in pediatric grotamotil in Japan. We remain on track to initiate the Phase 3 trial for transcontinental growth hormone in pediatric growth hormone deficiency in the fourth quarter. For indication, label expansion, we continue to execute on our global phase 3 trial, evaluating transcontinental growth hormone in adults with growth hormone deficiency. Why is this trial so exciting?

[noise] Twoish Stafford global clinical weeks for Transco uncomfortable, we continue to advance on several fronts.

In greater China recent pharmaceuticals, our strategic investment continues to inroads subjects in that phase three trial, but trends can go tool in pediatric Kokomo deficiency.

In Japan.

We remain on track to any take the phase three trials for trends can go come in could actually called come on deficiency in the fourth quarter.

For indication label expansion, we continue to execute on all global phase three trial evaluating trends can go to move in that dogs with Goldman deficiency.

Why is this trial so exciting.

[noise] daily growth come on treatment for children and adults bid Kokomo.

Jan Moller Mikkelsen: Daily Growth Hormone Treatment for Children and Adults with Growth Hormone Deficiency supports overall endocrine health, including improved body composition, mental health, cardiovascular health, and bone health, in contrast to pediatric growth hormone deficiency, where we measure height as the primary input. In adult growth hormone deficiency, we typically measure the impact on altered body composition, such as change in truncal fat mass or lean body. To achieve this optimized clinical effect on truncal fat mass, it is essential that growth hormone has its direct effect on the target. The decrease in truncal fat mass by growth hormone is partly facilitated by the direct activation of the growth hormone receptor on truncal fat cells.

Deficiency support own endocrine <unk>, including improved body composition mental health cardiovascular health and build huh.

In contrast to production growth hormone deficiency that'd be measure height as primary endpoint in adult growth hormone deficiency, we typically make sure that impact on onto a body composition, so as to change in trunk effect mess or lean body mass.

To achieve this optimized clinical effect on trunk as Pat mess. It essentially that Cotwo has its direct effect on the talking tissue.

That's the decrease in term confessed massed by Kokomo East property facilitated by the direct activation of the Kokomo receptor on trunk good practices.

Oh, what does it go promote deficiency try the fourth I tried he's a global phase three trial designed to compare the safety and efficacy.

Jan Moller Mikkelsen: Our Adult Growth Hormone Deficiency Trial, the Foresight Trial, is a global phase 3 trial designed to compare the safety and efficacy of once weekly transcribed growth hormone with placebo and a daily growth hormone product. The Foresight trials will be conducted at around 120 sites in North America, Europe, Asia, including China and Japan. Approximately 240 adult subjects with growth hormone deficiency who are treatment-naive or have not received growth hormone therapy for at least 12 months prior to screening will be enrolled in the trial. Subjects will be randomized 1 to 1 to 1 across 3 arms, with expected 80 subjects in each, Once Weekly Transcontinental placebo administered once per week and a daily growth hormone product. The once-weekly transcontingotamol and placebo arms will be double-blinded, and the daily gotamol arm will be open later.

Once weekly trends can go to move with placebo and FDD co promote park.

The first I tried to be can dig conducted in around 120 sites in North America, Europe, Asia, including China and Japan.

[noise] around 240 at dawn subject Kokomo deficiency.

Treatment naive or have not receive go to mono therapy for at least 12 months prior to screening they'll be wrote in the trial.

Subjects will be randomized one to one to one of course three arms.

Expected 80 subject in Utah.

Once weekly trends can kokomo.

Hi, Siebel demonstrated once per week and ideally <unk> products.

But once weekly trends controlled tunnel and to see bombs that be double blinded and that David gold come on Wifi openly.

The treatment period will be 38 weeks with 12 weeks for dose titration and 26 weeks coming to.

Jan Moller Mikkelsen: The treatment period will be 38 weeks, with 12 weeks for dose titration and 26 weeks for maintenance. The primary endpoint is the change from baseline in truncal fat percentage at week 38. Secondary efficacy endpoints are change from baseline in truncated fat mass and change from baseline in total lean body mass. All expiratory endpoints will be assessed along with patient-reported outcome measures, safety, PK, and PD.

The primary endpoint is the change from baseline trunk of that consensus at week 38.

Secondary efficacy endpoints I change from baseline in Cancun fat mass and change from baseline in total the body mass.

Oil exploratory endpoint would be assist along with a patient reported outcome micheaux's safety PK and PD.

The primary regulatory objective is to evenly.

Jan Moller Mikkelsen: The primary regulatory objective is to evaluate the efficacy of once weekly transgone growth hormone versus placebo. From a commercial perspective, it is important to show at least comparable efficacy, safety, and tolerability to data code. Adult growth hormone deficiency is the least penetrated market segment for growth hormone, with well-documented adherence challenges and the Health Channel. We believe Transcon Growth Hormone may provide an alternative to daily growth hormone that addresses overall endocrine health and may provide a convenient alternative, which also leads to a better outcome for adult patients and expansion of the growth hormone market. Moving to Transcon P.T.

If you can see once weekly trends can go to know.

This is because people.

Format commercial perspective, it is important to show at least comparable efficacy safety and Tolerability to date to Cook.

[noise] adult growth hormone deficiency is the least penetrated market segment.

We've been to Commentated here into China.

And health insurance.

We believe transcon Kokomo may provide an upturn in the two two data comfortable that address over all into crime.

In may pull by and convenient and turn into two would also leads to a better outcome for adult patients and expansion of the Kokomo box.

Moving to trends called PT.

The data on behalf of reported from the full week fixed dose double blind period of PUC forward. It put to talk entity combined with.

Jan Moller Mikkelsen: The data we have reported from the four-week, six-dose, double-blinded period of Part 4 in April 2020, combined with the additional data we reported this afternoon, demonstrated for the first time the potential to transform the lives of people living with hyperparathyroidism with a hormone replacement therapy. Earlier this year, in April, we reported top-line data from the four-week, six-dose, double-blinded portion of our Phase 2 Pod Forward trial, which demonstrated that transcon PTAs have the potential to replace the standard of care activated vitamin D and calcium supplements. The data reported to date support our view that transcon PTA could replace standard of care in just four weeks.

The additional data would be reported this often demonstrated for the first time, we believe that potential true to form but dive people living with hybrid Pat talked recently with hormone replacement therapy.

[noise] earlier this year.

We reported topline data from the four weeks fix those double blinded portion of our fees to put forward tried which demonstrated that trends can pj's has the potential to what piece the standard of care activated vitamin D and types of supplement.

The data reported.

To date support Oh view that trends competed.

Okay sustained out of Q in just four weeks.

80% of soft Dick on trend can PG removed standard of care compared to 50% on plan Siebel.

Jan Moller Mikkelsen: 80% of subjects on transcon PTA discontinued standards of care, compared to 50% on placebo, even if subjects were kept to a fixed dose of transcon PTA. In our open-label extension trial, subjects are allowed to optimize up and down their transcon PTH dose. So we expect that additional subjects may be able to remove the standard of care. We have been pleased to see all 58 subjects in the Open Label Extension Trial continued in the trial at six months. These subjects continued regardless of baseline pill burden, severity of disease, and whether they had a response or not in the four-week portion. We believe from this excellent retention that there may be some positive effect of PTH itself, independent of historic pill burden and other biochemical parameters that we have reported on. What we have not known is where PTA therapy may improve quality of life for the Peace.

Even if subjects, but kept to a fixed dose of trends competes.

In our open label extension trial subjects are allowed to optimize up and down that trends can PJ stopes. So we expect that additional subject may be able to move standard of care.

We have been pleased to see all 50 eight's uptick in the open label extension tried our continue in the tried at the six months point.

This topic has been have continued regardless of base night, because book severe TFT Bdcs and will that had the response on north in the four week portion.

We believe for this excellent retention that them at that may be some positive effect on PC. So.

Independent of historic.

And although biochemical parameters that we have reported at all.

What we have not know elsewhere PT to me improved quality of life.

For the patients.

Jan Moller Mikkelsen: Today, we release new data, which we believe is another element in demonstrating that transcon PTH is better than standard healthcare for treating HIV patients and supports transcon PTH as a hormone replacement therapy. It is the first time, to our knowledge, that a treatment for hyperparathyroidism has demonstrated a statistically significant improvement in quality of life compared to placebo in a double-blinded controlled trial using the SF36 health service. A commonly used and validated non-disease-specific PRO instrument for the overall assessment of health and well-being.

Today, we will these new data, which we believe is another element in demonstrating that trends competes is better than standard aquia for treating it to be piece and support trends can PJ hormone replacement therapy.

Just first time and time to our notice that a treatment for hybrid territories has demonstrated a statistically significant improvement in quality of life compared to placebo in adulthood blinded controlled trial using that it's a 36 Jose.

At commonly used and validated non disease specific Pos.

Hello instrument for or assessment of health and wellbeing.

The savvy consists of 36 question and the results I'll summarize critical component summary, PC based and mental component summary.

Jan Moller Mikkelsen: The survey consists of 36 questions, and the results are summarized in a Physical Component Summary, PCS, and Mental Component Summary, MCS, at baseline in the Phase 2 Part 4 trial. Subjects in both arms of the trial had a lower than average SF36 score, suggesting that there is a reduced health-related quality of life in this patient population. This is in alignment with several other studies. Already in the four weeks double-blinded controlled part of the Phase 2 trial, statistically significant and clinically meaningful improvements in PCS and MCS were observed. For the PCS score, using a normative scoring system with a score of 50 as the norm for a general population and an ANCOVA model, transconPCH subjects demonstrated a mean difference of 5.2 points compared to placebo with a p-value of 0.01. The minimal important difference for PCS is 2%. From the Mental Component Summary Score, Transcon PGH subjects demonstrate a difference in mean of 9.8 points compared to placebo with a p-value of 0.0003. Thus, the minimal important difference for MTS is free.

Yes.

At baseline.

In the phase two portfolio tried subjects in bulk of the tried had a lower than average is at 36 scores, suggesting that you said would use health related quality dive into patient properties.

This is in alignment with several stockings.

Already in the four weeks double blinded controlled part of the phase two trial systemically significant and clinically meaningful improvement in Pete CS and Imcs were observed.

For the peak CS score using enormity, scoring system bid a score 50 asked the norm for general population and an Cooper multiple trends can PJ to talk to demonstrated a mean different 5.2 point.

Two placebo with a P value of 1.1.

The minimal important different people see it is two points from the mental component summary, skol transcon PJ subjects demonstrate that different in me of 9.8 points compared to placebo, we had a P value of <unk> point.

Okay.

The minimal important different fall if she is.

Our full week data scientists that sustained Norman Pete's live offer something goes right to adjust normalization of cm types.

Jan Moller Mikkelsen: Our four-week data suggests that sustained normal PTH levels offer something else, rather than just normalization of CMQ. Both PTH treatment and placebo subjects exceeded high rates of normal calcium, 92% and 80%, respectively. Yet, there was a meaningful difference in quality of life score. Based on clinical experience, clinicians and patients with hypothyroidism have long discussed that physiological PTH levels contribute to optimal function of the central nervous system.

PJ, Sweden, and placebo subject SC high rates of normal keds from 92, and 18% respectively.

Yet there was a meaningful deferred and quality of life scores.

Based on clinical experience clinicians and patients bid hybrid type business had not discussed that piece a lot you could PK slivers contribution to optimal function of the central nervous system.

Our full week data suggest that to sustain normal PK sliver rider rather than just normal cm cuts is a deep extra seats, which helps benefits.

Jan Moller Mikkelsen: Our four-week data suggest that sustained normal PTS levels rather than just normal serum calcium are indeed associated with health benefits. While these data are considered exploratory, they are the first evidence we have ever seen for a randomized double-blinded control trial indicating that a treatment for HB compared to placebo may have significantly improved physical function and well-being towards a normal life. In previous published randomized control trials of PTH products where SF36 was compared to placebo, no significant treatment difference was detected versus placebo. One possible explanation for this finding is the lack of sustained PTSD.

But this data I consider exploratory they have the first dividend we will see for randomized double blinded controlled trial indicated that treatment for HP compared to placebo may have significantly improved physical function as well be two was abnormally.

In Prebuilds pulp is randomized controlled trial of P. taste product, where it's 36, what's compared to placebo no significant treatment difference for us.

This was plus equal.

One possible expansion for this finding is for lack of sustained Ptcs Davis.

We continue working on validate you our own disease specific.

Jan Moller Mikkelsen: We continue working on validating our own disease-specific PRO instrument to help us evaluate additional patient benefits of transcon PTAs that may strengthen our overall value proposition. We plan to discuss our four-week double-blind data and six-month open-label extension data for our own disease-specific PRO instrument and SF36 with FDA in the coming months. We remain on track to report six-month data from the open-label extension portion of the Part 4 trial disk portal and submit regulatory filings to initiate a Global Phase III trial of transcom PTAs in North America and Europe in the fourth quarter. We have held our global end of phase 2 meetings with regulatory authorities and are pleased with the feedback so far.

Instrument to help us equally additional patient benefit of credits competes that Ms strength or that you proposition.

We plan to discuss our four week double blinded data six month open deep with extensive data.

For our own disease specific PEO instrument and it's a 36 with 50 in the coming months.

We remain on track to import six month data from the open label extension portion of that path forward tried this quarter and some be regulatory filings to entity I feel good faced we tried or trends competed in North America and Europe in the fourth quarter.

We have initiated our global end of phase two meetings with regulatory authorities and a piece with the feedback so far.

From real results that you have seen in our phase two power forward tried we believe but trends.

Jan Moller Mikkelsen: From the results that we have seen in our Phase 2 Forward Trial, we believe that Transcon PTA potentially represents a new treatment paradigm for HP as a replacement therapy. A therapy that might be able to replace conventional care, normalize biochemical parameters and associated long-term risk factors, and improve the quality of life for patients. We look forward to sharing the six-month Open Label Extension data with you later this quarter. Meanwhile, a quick update on the rest of the types for Transcon CMP. We continue to work towards escalating dose scores in the ongoing ACCOMPLICE trial, our global phase 2 trial that is evaluating the safety and efficacy of transcon CMP at escalating doses in children with achondroplasia from 2 to 10 years of age.

PT potentially 3% new treatment paradigm for HP asset with Paceman.

Okay.

Terpene demo EBIT to quit please come into Q normalize bear biochemical.

And associated long term prospectus and improve the quality of life for Pete.

We look forward to sharing the six months open label extension data with you later this quarter.

A quick update on the rest of the pipeline.

For Transcon CMP.

We continue to work towards escalating dose cohorts in the ongoing accomplished tried our global phase two trial that is evaluating safety and efficacy of trying to come CMP at escalating doses in children with a conversation from two to 10 years of AIDS.

The received orphan designation from the European Commission for trends can CMP for Echopixel, giving also orphan designation in both Europe and the use.

Jan Moller Mikkelsen: We received orphan designation from the European Commission for Transcon CMP for aconoplasia, giving us orphan designation in both Europe and the US. As part of an integrated global clinical program, clinical development in China is being done through Wiesent Pharmaceutical, where an independent Phase II completed China trial is expected to be initiated in the fourth quarter. Moving to Oncology. Preclinical data for transcon IL-2 beta-gamma A product candidate designed to provide sustained systemic release of receptor-biased IL-2, IL-2 beta-gamma specific, was presented at the American Association of Cancer Research meeting in June. These data show the potential of transcon IL-2 beta-gamma to be a best-in-class IL-2 molecule and demonstrate that a single dose in non-human primates provided a potent expansion and activation of cytotoxic lymphocytes with low activation of T-rex cells and eosinophils.

As part of an integrated global clinical program clinical development in China is being done two vsan from issue there and independent feeds to accomplish China tried is expected to be initiated in the fourth quarter.

Moving to oncology.

Preclinical data flow trends can I had to be to comment.

Product candidate this time to provide state systemic with these offered with Typtap buys to two pizza common specific were presented at the American Association of cancer was whose meeting in June.

These data show the potential of trends going to be to comment to be best in class two mortgage and demonstrated that a single dose in non human primates provided at put potent expansion and activation of Super talked its lymphocyte, though activation of T Reg cells and Cdone field.

In addition.

Jan Moller Mikkelsen: In addition, a long half-life of around 32 hours was observed in non-human primates, which is expected to support potential dosing of every three weeks in patients. We are on track to submit the first IND filing or similar for Transcon TLR78 Agonist in the fourth quarter of 2020, followed by a planned IND filing or similar for Transcon IL-2 Beta Gamma in 2021. Based on the promising preclinical results we have seen in our Transcon EL2 beta-gamma and Transcon TR-78 Aquanis product candidates, we believe our Transcon technologies, which enable both systemic and long-acting intratumoral administration, have the potential to improve treatment outcomes for patients.

No.

Half life of around 32 hours were observed in non human primates.

Which is expected to support potential dosing of every three weeks in patients.

We are on track to submit the first R&D Friday or similar for Transcon TLR seven eight equities in the fourth quarter two kaufman between.

Followed by a plane I in defining of similar for trying to come to pick army.

In 2002 inch going.

Based on the promising preclinical results you have seen in our trend going to be the comment.

Transcon TLR seven eight equities product candidates, we believe our trends come technologies, which indicates that both systemic and don't acting into a tool demonstration has the potential to improve treatment outcome for patients to cancer.

As you can see our clinical pipeline progress has kip, saying just that BC to read the first half two confident.

Scott Smith: As you can see, our clinical pipeline progress has kept Ascendis very busy during the first half of 2020. During the current quarter, we continue to grow our headcount in both R&D and the commercial organization as we prepare for a potential launch of our first product and expand our pipeline and global cleaning. Now, I will turn the call over to Scott for a financial review before we open the call to questions. Thank you, Yen. Now, turning to our financial results for the quarter ended June 30, 2020. We reported a net loss of 94.9 million euros, or 1.97 euros per basic and diluted share, compared to a net loss of 58.9 million euros, or 1.25 euros per basic and diluted share, during the same period in 2018.

During the current quarter, we continued to grow hit come in both R&D and the commercial organization SP preparing for potential launch awful first politics, and expand our pipeline and global.

Now, let me turn the call over to Scott for Financial review before we open for questions.

Thank you again.

Turning to our financial results for the quarter ended June 32020.

We reported a net loss of 94.9 million euro or 1.97 euro per basic and diluted share compared to a net loss of 58.9 million euro or 1.25 year old per basic and diluted share during the same period in 2019.

Now I will run through some of the key components of these results.

Scott Smith: Now I will run through some of the key components of these results. Research and development costs for the second quarter were €63.6 million, compared to €43.8 million during the same period in 2019. The increase in R&D costs reflect continued advancement of our pipeline, with the primary drivers including for Transcon growth hormone, costs were higher compared to the same period of the prior year due to increased costs related to manufacturing of commercial product supply, as well as increased clinical trial activities, including start-up costs for the Global Phase III Adult GHD trial, the Foresight trial, and the Phase III Pediatric GHD Trial in Japan. And for both Transcon PTH and Trans We also saw higher external costs related to the continued build-out of our oncology therapeutic area and across all programs, an overall increase in personnel-related costs. Selling, general, and administrative expenses for the second quarter were €20.8 million compared to €11 million during the same period in 2019.

Research and development cost for the second quarter were 63.6 million euro compared to 43.8 million Euro during the same period in 2019, the increase in R&D costs reflect continued advancement of our pipeline, but the primary drivers, including for Trans Con growth hormone costs were higher compared to the same period of the prior year.

Due to increased costs related to manufacturing of commercial product supply as well as increased clinical trial activities, including startup costs for the global phase three adult ghd trial, the foresight trial.

And the phase three pediatric ghd trial in Japan.

And for both Transcon, PDH and Transcon CNP costs were higher primarily due to increased clinical trial and manufacturing costs.

We also saw higher external costs related to the continued build out of oncology therapeutic area and across all programs and overall increase and personnel related costs.

Selling general and administrative expenses for the second quarter were 20.8 million euro compared to 11 million Euro during the same period in 2019.

These higher costs, primarily reflecting an increase in personnel and related costs as well as expenses associated with the continued build out of our commercial capabilities.

Scott Smith: These higher costs primarily reflect an increase in personnel and related costs, as well as expenses associated with the continued build-out of our commercial capabilities. Other income and expenses included an unrealized non-cash loss of 9.9 million euros compared to an unrealized non-cash loss of 8.2 million euros during the same period in 2019 due to foreign currency exchange rate fluctuations. We ended the second quarter with cash, cash equivalents, and marketable securities totaling €471.6 million. In July, subsequent to quarter end, we completed a follow-on financing with net proceeds of 654.7 million U.S. dollars, or approximately 580.7 million euros. Including net proceeds from the July offering, pro forma cash, cash equivalents, and marketable securities as of quarter end would have been approximately 1 billion euros.

Other income and expenses included an unrealized noncash loss of 9.9 million euro compared to an unrealized noncash loss of 8.2 million Euro during the same period in 2019 due to foreign currency exchange rate fluctuations.

We ended the second quarter with cash cash equivalents and marketable securities totaling 471.6 million Euro.

In July subsequent to quarter end, we completed a follow on financing with net proceeds of 654.7 million us dollars or approximately 580.7 million euro.

Including net proceeds from the July offering pro forma cash cash equivalents and marketable securities as of quarter end would've been approximately 1 billion euro.

We also remain on track to achieve the following milestones for the remainder of 2020 for Transcon growth hormone. These include submitting the M&A filing in Europe during the current quarter.

Scott Smith: We also remain on track to achieve the following milestones for the remainder of 2020. For transcon growth hormone, these include submitting the MAA filing in Europe during the current quarter. Executing the Foresight Trial, a global phase three study for adult GHD, and initiating a phase three clinical trial for pediatric GHD in Japan in the fourth quarter. For TransCon PTH, these include reporting six-month open-label extension data in the Phase II path-forward trial in the third quarter and initiating the global Phase III clinical program for adult hypoparathyroidism in the fourth quarter. For Transcon C&P, this includes initiating Accomplished China, a Phase II clinical trial for achondroplasia, through our strategic investment in Visin Pharmaceuticals in the fourth quarter.

Executing the foresight trial, a global phase three study for adult ghd and initiating a phase three clinical trial for pediatric HD in Japan in the fourth quarter.

For Transcon P.T.H. These include reporting six month open label extension data in the phase two path forward trial in the third quarter and initiating the global phase three clinical program for adult hyperthyroidism in the fourth quarter.

For Transcon, saying, Hey, this includes initiation of accomplished China, a phase two clinical trial for a contra pleasure to our strategic investment in basin pharmaceuticals in the fourth quarter.

And lastly, and our oncology therapeutic area, we continue to invest in CMC and preclinical activities related to transcon TLR seven eight agonist and transcon aisle to beta gamma and we plan to submit our first I, India or similar finally in the fourth quarter for our Transcon TLR seven eight agonists.

Scott Smith: And lastly, in our oncology therapeutic area, we continue to invest in CMC and preclinical activities related to transcon TLR78 agonist and transcon IL-2 beta gamma, and we plan to submit our first IND or similar filing in the fourth quarter for our transcon TLR78 agonist. We continue to execute on our goal of building a leading biopharma company with a diverse pipeline of potential high-value product candidates in multiple Combining our TransCon technology with clinically validated parent drugs in areas of well-known biology has allowed us to deliver unique product candidates and clinical results with an expected high probability of success.

We continue to execute on our goal of building, a leading biopharma company with a diverse pipeline of potential high value product candidates and multiple therapeutic areas.

Combining our trans con technology with clinically validated parent drugs in areas of well known biology has allowed us to deliver unique product candidates and clinical results with an expected high probability of success.

We saw that first with transcon growth hormone where for the first time, we are aware of a long acting growth hormone demonstrated in a randomized controlled clinical trial similar a superior efficacy and safety on a broad spectrum of parameters compared to a daily growth.

Today, you see similar results from the four week randomized double blinded fixed dose portion of path forward with Transcon, P.T.H., which demonstrated for the first time to our knowledge that a treatment for Hypoparathyroidism had a statistically significant improvement compared to placebo for the SF 36, a commonly used in validate.

Scott Smith: We saw that first with transcon growth hormone, where, for the first time, we are aware of a long-acting growth hormone that demonstrated, in a randomized controlled clinical trial, similar or superior efficacy and safety on a broad spectrum of parameters compared to a daily growth hormone. Today, you see similar results from the four-week randomized, double-blinded, fixed-dose portion of Path Forward with Transcon PTH, which demonstrated, for the first time to our knowledge, that a treatment for hypoparathyroidism had a statistically significant improvement compared to placebo on the SF36, a commonly used and validated non-disease-specific PRO instrument for overall assessment of health and well-being. We look forward to possibly sharing similar firsts with you in our TransCon C&P, TransCon TLR78 Agonist, and TransCon IL-2 Beta Gamma programs in the coming years. With our recent follow-on financing, we remain well capitalized to execute on our vision 3x3.

Non disease specific tiara, that's true for overall assessment of health and wellbeing.

We look forward to potentially sharing similar first with you in our transcon CNP Transcon TLR seven eight agonist and transcon aisle to beta gamma programs in the coming years.

With our recent follow on financing, we remain well capitalized to execute on our vision three by three.

Operator, we're now ready to take questions.

Thank you.

As a reminder to ask the question you need to press Star then one on your telephone to withdraw your question. Please press the pound team.

Thank you please limit yourself to one question and one follow up.

Our first question comes on line of Michelle Gilson with Canaccord Genuity.

Your line is now open.

Hi.

Congratulations on the data and thanks for taking my question.

I know John apples to apples because of the duration of treatment and the baseline, but perhaps you can expand a little bit.

Comments about 15 Thats first.

Operator: Operator, we are now ready to take questions. Thank you. As a reminder, to ask a question, you would need to press star then 1 on your telephone.

[noise] trial to show a difference in quality of life for 36 results.

In a randomized placebo controlled study and maybe specifically you can understand you can help us understand.

Operator: To withdraw your question, please press the pound key. We ask that you please limit yourself to one question and one follow-up. Our first question comes from the line of Michelle Gilson with Cancord Genuity. Your line is now open.

Theres comparison to be made with the results from the replaced study.

Which.

Jan Moller Mikkelsen: Hi, congratulations on the data. And thank you for taking the time to answer my question. I know it's not apples to apples because of the duration of treatment and the baseline, but perhaps you can expand a little bit on some of your comments about this being the first trial to show a difference in quality of life or SF36 results in a randomized placebo-controlled study. And maybe specifically, you can help us understand if there's a comparison to be made with the results from the REPLACE study, which showed that NEPR treatment Thanks, Michelle.

Showed that nets hard treatment did not result in a statistically significant improvement in either of those Dana.

Compared to placebo.

Thanks Michelle.

Why we really are so excited about the data is because we basically had been missing.

Something because.

And but we started the.

Our transcon pj's products, we had a long discussion about how do we really describe the severity of the disease and people try some way to describe it off from that pill.

And when do you look on the patients.

Democratic That'd be have enrolled in all phase two trial.

Some of the patient Stephanie being.

Based in the group optimize taking low on Mount all activated vitamin D taken a low amount of KCSM supplement and then we have them more moderate and then behalf the severe.

Jan Moller Mikkelsen: Why we really are so excited about the data is because we basically had been missing something. And when we started our Transcon PGH product, we had a long discussion about how do we really describe the severity of the disease. And people tried some ways to describe it from the pillboard. And when we look at the patient demographics that we have enrolled in our phase two trial, some of the patients are definitely being [inaudible] And then we know the burden of daily administration, but still, patients are staying and not dropping out. And typically, I have seen many trials, tried many trials; typically, I would expect in open-label extension, we would already have seen a lot of drops. Why are all the, and then you can say, including the mild patient, there must be something else which we cannot just get from biochemical analysis.

But won't be sold because all the 58 patients now is hospice six months.

And then we know that burden of daily administration, but still patients staying and not dropping out and typical I have seen many trials tried many trial typically I would expect in open label extension Weve already has seen a lot of drops out.

Why all the and then use it including the might patients that must be something which we cannot just get compiled chemical analysis.

And this is why be developed the disease specific.

Patient reported outcome for high proprietary Smith, because we wanted we to cash that and get it validated and see the is it 36 is what we call it non to see specific.

In addition, just describing the.

Benefit you can really a sheet in.

But.

Well being off occurs and what we sold here is that.

Jan Moller Mikkelsen: And this is why we developed the disease-specific pro-patient-reported outcome for hyperparathyroidism because we wanted to really catch that and get it validated and seen. The SF-36 is what we call a non-disease-specific validation, just describing the benefit you can really achieve in... the well-being of a person. And what we saw here is that SF36 came out so clear in just the first four weeks. And we believe that it's because we are providing the physiological PTH level 24 hours, 7 days a week. Meaning it's a flat curve without huge flotation.

This is 36 came out so clear.

Just the first four weeks.

And we believe that is because we are providing the future logical PJ sliver 24, seven days a week, meaning is to flat COO, we don't choose to patients and this is why we believe although product has not been possible to show and the cystic significant.

Chains is to 36.

The have adults blinded period and I actually believe this is just talking about the strength of the product opportunity, but but seeing perhaps more important for me and I say uses we really see the benefit at the patient good.

Jan Moller Mikkelsen: And this is why we believe other products have not been able to show a statistically significant change in SF36 when they have a double-blinded period. And I actually believe this is just talking about the strengths of the product opportunity, but I think perhaps more important for me and Ascendis is that we really see the benefit that the patient gets. We see how they are really changing their lives. They are coming back and adapting more to a normal life because they get the right hormone replacement therapy. Great

We see how that we are changing their life, the upcoming and adapting more to a normal life because they get to the right homed with paced in Twoq.

Great and just as a follow up are you planning to report.

But your six month data later this quarter.

Just looking forward when we do you get those data out without a placebo arm in the open label extension study how should we think about interpreting.

Jan Moller Mikkelsen: And just as a follow-up, are you planning to report the PRO with your six-month data later this quarter? And just moving forward, when we do get those data without a placebo arm in the open-label extension study, how should we think about interpreting the PRO or SS36 results? I think we would both have the surgery.

On the PRB or 36 results.

I think we've both at the 30.

So to six results, but then.

Dana you can comment about Oh.

Right.

As far as our own.

PR ROE instrument the H. pets.

We've already submitted to the FDA say the documentation to get that validated by them.

And so it's really not so much to look at the end of it.

Dr. Dana Pizzutti: Dana, you can comment on our rates. Yeah, as far as our own PRO instrument, the HPIS, you know, we've already submitted the documentation to the FDA to get that validated by them. And so it's really not so much to look at the individual, you know, groups, and how patients did, but more about the instrument itself, how it behaves, how predictive it is. And, you know, as we've talked about before, there were two major aspects of that, which were the symptom side of it, and then the impact side. So we're pretty excited that, you know, it seems to, you know, function quite well. But the thing is that it's not validated.

You know groups and how patients did but more about the instrument itself, how it behaves how predictive business and as we've talked about before there were the two major aspects of that which was the symptom side of it and then the impact side. So we're pretty excited that.

It seems to function quite well.

But the thing is that it's not validated and the reason that we came forward with the us at 36.

Was because.

That was it's a validated instrument again not specific for hyperthyroidism, but.

No well established in terms of.

Patient, while being as John mentioned and so.

You know, we'll be able to sort of correlate actually both of those skills. As we go forward now the issue that we're going to have an interpreting the six month data is that there's no control arm beyond the first four weeks. So we can follow and see how patients do and.

Dr. Dana Pizzutti: And the reason that we came forward with the SF-36 was because, you know, that was, it's a validated instrument, again, not specific to hypoparathyroidism, but, you know, well established in terms of, you know, patient well-being, as you mentioned. And so, you know, we'll be able to sort of correlate, actually, both of those scales as we go forward. Now, the issue that we're going to have in interpreting the six-month data is that there's no control arm beyond the first four weeks. So we can follow and see how patients do. And based upon what we've seen so far with patients, as Yen said, staying in the trial, we would expect nothing less than a maintenance or an improvement in the four-week results we got, you know, from either the SF36 or the HPES data as well. So, you know, again, we will be looking at that very closely once we finalize the six-month data in all of the 58 subjects that are still in the trial We have never had any doubt that there is a reduced health-related quality of life in patients with hyperparathyroidism.

Based upon what Weve.

Seen so far with patients as Jan said staying on the trial, we would expect.

Nothing less than a maintenance or an improvement in.

Four week results we got.

From either the asset 36 for the on the H. Perez data as well so.

You know.

Again, we will be looking at that very closely once we finalize the six month data and all of that 58 subjects that are still in the trial.

We have no one had any doubt that was reduce health related quality of life inpatient bid hyper Petrobras Monday's multimode.

Application thats showing that but what is the interesting part for me from life high level scientific perspective is that it looked like.

This level can be independent on kind of show.

Levels and this is where I think that what we've seen more more it is potential and direct CN. This.

Effect that is providing this benefit related to health related quality of life and.

This is what we would like to sustain for both our own PEO, but also continue missing. This 66, but we are really anxious assessments about this was whos because it's really the best thing you ever can see when you see the Hughes benefit that you can provide we then.

Jan Moller Mikkelsen: There are multiple publications that show that. But what is the interesting part for me from a high-level scientific perspective is that it looks like this level can be independent of calcium levels. And this is where I think that what we're seeing more and more, it is a potential and direct CNS effect that is providing this benefit related to health-related quality of life, and this is what we would like to sustain further with both our own PRO but also continue measuring SF36. But we are really anxious about this result because it really is the best thing you ever can see when you see the huge benefit that you can provide with an endocrine product where Thank you for taking my questions. Thank you. Our next question comes from the line of Joseph Schwartz with SVB LeRinc.

Into crime product way basic also providing high level of health related quality of life.

Okay. Thank you for taking my question.

Thank you. Our next question comes from the line of Joseph Schwartz with SVB Laurie.

Your line is now open.

Hi, I'm jury dialing for Joe Thanks for taking your question.

So first one has to do with.

Well Jeff.

We were just wondering if you talk to the Xplore about FX 36 data and do you have a sense about how the school feels about the study design and primary endpoint for great.

I think we just got that takes a now this is why be released it here together with our Q2 earnings and I.

Operator: Your line is now open. Hi, I'm Jury Dialing for Joe. Thanks for taking our questions. So our first one has to do with the TRANSCOM-PH. We were just wondering if you could talk to the FDA about the SF-36 data, and do you have a sense about how the FDA feels about the study design and primary endpoint for phase three? I think we just got the data now. This is why we released it here together with our Q2 earnings. And I definitely think Dana and her team will really go in and discuss it with FDA. You can comment on that, Dana.

Definitely Dana and her team will really go in that discuss it with if they you can comment on that day and yes, I mean, we actually.

Our preparing to communicate not only these data with just about this has 36, but also the six month data once we get that all compiled and and finalized so.

In addition to our validating our new instrument. The H. pass will talk further about that as at 36, and the long term efficacy and safety of the product after the six month time period. So.

In conclusion, we have not shown regulatory agencies. This data yet we are going to do it in the two because of with our six months data that's coming later this quarter.

Jan Moller Mikkelsen: Yeah, I mean, we actually are preparing to communicate not only these data about the SF-36 but also the six-month data once we get that all compiled and finalized. So in addition to validating our new instrument, the HPES will talk further about the SF-36 and the long-term efficacy and safety of the product after the six-month time period. In conclusion, we have not shown regulatory agencies this data yet.

Okay, Great that's helpful and they never could just dive a little bit Cooper about your piano soccer.

Talk a little bit more about it you know what potential differences could there be between your age has TRL assaf and what do you believe me obviously.

And.

You know, it's it's under it and it hasn't the regulator, but what do you believe or what do you wish to capture what's your appeal Roe.

The off the shelf.

Right.

36 would not be able to.

Well I think that the the major differences that this has been developed and sort of validated in.

Dr. Dana Pizzutti: We are going to do it together with our six-month data that's coming later this quarter. Okay, great. That's helpful. And then I could just dive a little bit deeper into your HPEZ PRO. Could you talk a little bit more about it? You know, what potential differences could there be between your HPEZ PRO and SF? And what do you believe?

Parents Savoured as some patients right and so us at 36 has been around for quite a while it's been using all sorts of therapeutic areas for you know sort of looking at.

How the patients react or respond to therapies. So.

Well, we were able to do though as we look at the different for instance, the symptoms.

Many of them that are sort of more prominent or more of a problem in patients who have a parasitism. So you know CNS things around remembering and concentration which are the big things that patients tell us about this brain five and things like that so we are.

Dr. Dana Pizzutti: Obviously, you just submitted it, and, you know, it's in the hands of the regulator. But what do you believe or what do you wish to capture with your PRO that the off the shelf, you know, endpoint of SF-36 would not be able to do? Well, I think that the major difference is that this has been developed and sort of validated in hypoparathyroidism patients, right. And so SF36 has been around for quite a while; it's been used in all sorts of therapeutic areas for, you know, sort of looking at how patients react or respond to therapies. So, what we were able to do, though, as we looked at the different, for instance, symptoms, many of them that are sort of more prominent or more of a problem in patients who have hyperparathyroidism.

Specific questions about that and then as well you know other like less CNS related.

Symptoms are also part of different.

Queries that we've made to the patients.

So thats the symptoms side and then on the impact side then it becomes a question about so how.

A much better or worse argue with respect to youre sort of.

General physical activity okay.

Your ability to work.

Youre sort of mood and then also your.

So to social relationships.

So those are like the different parameters like on the impact side, but again, the big differences that its validated in patients with Hypoparathyroidism.

Thank you. Our next question comes from the line of Josh Schimmer with Evercore ISI. Your line is open.

Dr. Dana Pizzutti: So, you know, CNS things around remembering and concentration, which are the big things that patients tell us about this brain fog and things like that. So we ask specific questions about that. And then as well, you know, other less CNS-related symptoms are also part of the different queries that we make to the patients. And so that's the symptom side. And then on the impact side, then it becomes a question about how much better or worse you are with respect to your sort of general physical activity, your ability to work, your mood, and then also your, you know, social relationships.

Thanks for taking the questions I have three of them.

First on the fore sight trial can you describe the dose titration schedules for the weekly and daily treatment arms for the for the CN actually still on the on the growth hormone market you indicated that the adult growth hormone Murkiness Underpenetrated, if you talk a little bit of more about the unmet need to some.

From a technology and the benefits that they could derive.

From from convenient.

Option and then.

When do you think we're going to get a clear sense. The trans Con CMP candidate profile in terms of its differentiated effect on growth specifically in patients. Thank you.

Let me start with your last question.

Dr. Dana Pizzutti: So, those are like the different parameters, like on the impact side. But again, the big difference is that it's validated in patients with hypoparathyroidism. Thank you. Our next question comes from the line of Josh Schimmer with Evercore ISI. Your line is now open. Hey, thanks for taking the questions. I have three of them.

Yes.

It's a good question when we are getting the efficacy on the right cohort.

We are dose escalating now and what we already know from our knowledge about the product profile. We basic already think it's highly differentiated because it's continuous exposure CMP molecule without the high peak that is associated.

Operator: First, on the Foresight trial, can you describe the dose and titration schedule for the Kui and Daily Treatment Arms? For the CN, actually still on the growth hormone market, you had indicated that the adult. Although underpenetrated, they could talk a little bit more about the unmet need, the symptoms, and the benefits that they could derive from a convenient growth hormone option. And then when do you think we're going to get a clearer sense of the Transcon C&P candidate profile in terms of... an unreferentiated effect on growth specifically in patients? Let me start with your last question. It's a good question.

Any effect on.

Base with deflation and other things like that and we see the efficacy is really highly differentiated too.

When we will see the impact on this highly differentiated product opportunity in the clinical trial, we'll see when be going to states in the our dose escalation cohort that be finding the right dose that is providing and.

What we call hi, meaningful efficacy not only related to high but also related to potential.

Cool more pieces.

[music].

I will hope and expect.

What I don't know I hope, we will see date in a time, where the next six to nine months, but I cannot guarantee that because I do not know, which one is basic the.

Jan Moller Mikkelsen: When we are getting the efficacy of the right cohort, we are dose escalating now. And what we already know from our knowledge about the product profile, we basically all three think it's highly differentiated because it's continuous exposure to the CMP molecule without the high peak that is associated with any effect on vasodilation and other things like that, and we see the efficacy is really highly differentiated. When we see the impact of this highly differentiated product opportunity in the clinical tribe, we will see when we are going to a stage in our dose escalation cohort that we are finding the right dose that is providing what we call high meaningful efficacy, not only related to high blood pressure but also related to potential other co-morbidities.

Cohort, where we will see the thick that we want to half.

Related to adult growth hormone deficiency is a quite different patient population that your basic see in co promote deficiency in pedantic, where many of the adult patients coming from a complete different backgrounds, meaning there is only.

15% to 20% that basic are coming from the pediatric growth hormone deficiency. Many of them are coming from the cancel sitting on quality coming from trauma and other places where the half and decrease amount being dropped terminal.

Jan Moller Mikkelsen: I will hope and expect. But I don't know. I hope we will see that in time for the next six to nine months, but I cannot guarantee that because I do not know which one is basic, the right cohort where we will see the effect that we want. Related to adult growth hormone deficiency is a quite different patient population that you basically see in growth hormone deficiency in pediatrics, where many of the adult patients are coming from a completely different background, meaning there's only 15 to 20 percent that basically are coming from the pediatric growth hormone deficiency.

This error is space seek underserved his have been lot of different serves about what is the penetration people are talking about 15% to 20% is really good treated off but total patient population. So it's definitely is and.

Possibility to both help a lot of patients in adult growth hormone deficiency, because it's fair for them to a here to have a daily injection and we can move them over to once weekly dosing.

Jan Moller Mikkelsen: Many of them are coming from cancer-setting oncology, coming from trauma, and other places where they have a decreased amount of growth hormone. This condition is basically underserved; there have been a lot of different surveys about what the penetration is. People are talking about 15 to 20 percent of the total patient population is really getting treated. So it definitely is an option and a possibility to help a lot of patients with adult growth hormone deficiency because it's very hard for them to adhere to the daily injection, and we can move them over to a once weekly dose. Typical and what we wanted to do in our four-site trial, which is built in such a way that we have a one-to-one-to-one randomization because we think it's not only important to show that we are better than placebo from a rectotoxicity perspective, but the real product out there is daily growth hormone.

The two because and what we wanted to do we know foresight tried with built in Saudi Arabia happened one to one to one randomization because we think it's not only important to show that we are better than placebo from a regulatory perspective, but the real product out there is data growth from them.

So we want to be sure that'd be a least get the same efficacy as state to cool terminal and in the site. How we tie treat them up you tried tradesmen up in the same manner that you will see with day decrease optimal where we start on the low dose because the issue is how to get the.

42 at that so on the two half growth from own again and when the body is getting used to that your basic can touch rate up to what I call normal I just wonder payment.

Great. Thank you very much.

Thank you Sir our next question comes from the line of difficult five with JP Morgan. Your line is now open.

Jan Moller Mikkelsen: So we want to be sure that we at least get the same efficacy as daily growth hormone. And at the site, how we hydrate them up, you try to hydrate them up in the same manner that you will see with daily growth hormone, where we start on a low dose because the issue is how to get the body to adapt suddenly to have growth hormone again. And when the body is getting used to that, you basically can hydrate up to what I call a normal IGF-1 dose.

Hi, guys. Good afternoon, thanks for taking my questions.

PPH data today I'm curious if that's four week 36 results or the age class H. That's results track with the biomarker and supplement which all components of the primary in key secondary efficacy endpoints forward essentially were the responders on the primary and secondary more likely to.

Jan Moller Mikkelsen: Great. Thank you very much. Thank you. Our next question comes from the line of Jessica Fye with J.P. Morgan. Your line is now open.

Yeah.

Six or eight seminar spawners and related to that.

It sounds like you're seeing some patients benefited meaningfully on quality of life, even if they did not meet responder criteria for some reason and if so I was hoping we could dig into which element of the responder criteria important for quality of life you alluded to calcium.

Operator: Hey guys, good afternoon. Thanks for taking my questions. On the new PTH data today, I'm curious if the four-week SF-36 results or the HPES results track with the biomarker and supplement withdrawal components of the primary and key secondary efficacy endpoints and path forward. Essentially, were the responders on the primary and secondary more likely to benefit from SF-36 or HPES than the non-responders? And related to that, it sounds like you're saying that some patients benefited meaningfully from quality of life even if they did not meet the responder criteria for some reason. And if so, I was hoping that we could dig into which element of the responder criteria seemed less important for quality of life. You alluded to calcium in response to an earlier question.

Such an earlier question was that serum calcium owner calcium.

I think we have still a lot to alone.

Well, how really trying to compete states have so many positive effect when you have a normal replacement therapy.

What we could not see any correlation loss was reflecting SCM ketchum.

And any kind of the pair meta related to quality offline.

So there was one of the more interesting perspective, we wanted to analyze.

Taking to the Knicks deep dive, we have not reached yet and be able to continue to analyze the any kind of the Sop group or the SF 36, where you can self group would further down in the 36.

Operator: Was that serum calcium or urinary calcium? I think we still have a lot to learn about how really transcon PTAs have so many positive effects when you have normal replacement therapy. What we could not see any clear correlation with was the reflective assay on calcium and any kind of parameter related to quality of life. So that was one of the more interesting aspects we wanted to analyze. Taking to the next deep dive we have not reached yet, and we will continue to analyze, are there any kind of subgroup of the SF36 where you can subgroup it further down in the 36 questions in different domains where some of them are much more reflecting on one single parameter of the other one?

The question in different domains with some of them most more reflecting two one singular parameter of the one we are not to the level well at least not seeing analysis that basic.

Describing any kind of correlation or lack of college, but is basic bath interesting topic, what we really will follow up on.

I want to be basic.

Coming from is that what we see in all areas such as six is also some of the same prostitute trains that BC in our to cease specific PEO. So I think dissect great alignment in the data.

Okay and following up on that do you see any paula stability of changing the.

Jan Moller Mikkelsen: We are not to the level where, at least, I have not seen analysis that basically describes any kind of correlation or lack of correlation. But it's basically a very, very interesting topic that we really will follow up on. What we basically are coming from is that what we see in our SF36 is also some of the same positive trends that we are seeing in our disease-specific PRO. So I think there is great alignment between the data. And following up on that, do you see any possibility of changing the planned phase 3 endpoint to SF36 or HFAS? I actually believe that when we look at our primary endpoint, we actually will include such a parameter potential as a key secondary element, which is a great way to also have an opportunity to isolate and be ensuring that we can either build it on our patient, ProPRO, but we can also include an element such as SF36.

I am phase three endpoint to 36 or eight fabs.

I actually believe it wouldn't be loop in our primary endpoint. We actually will include Sasa parameter potential as a key secondary element, which greatly to also have an opportunity to isolate and be ensuring that we can either build.

And on our patient.

Specific.

Cruel PEO, but you can also include an element.

I said 36, so definitely we havent changed but we're not.

Thinking on building and into the primary endpoint, but basic take it up as a key secondary endpoint.

Okay, great and.

Last one maybe a quick one is it possible to refine when in the third quarter. We can expect the six month forward update.

I'm not so many months lift now in the third quarter.

[laughter] I actually think that they will be.

So what are you more months the lift now basic the September so it will be in to the next to four to six week.

Jan Moller Mikkelsen: So definitely, we have a chance, but we are not thinking of building it into the primary endpoint but basically taking it up as a key secondary endpoint. Great. And last one, maybe a quick one. Is it possible to refine when in the third quarter we can expect the six month fast forward update? It's not so many months left in the third quarter now, so I actually think that it will be, there's only one month left now, basically September, so it will be in the next four to six weeks.

Okay. Thank you.

Thank you. Our next question comes from the line of Jim Merchant off with Wells Fargo. Your line is now open.

Hey, guys congrats on another strong update.

Couple of questions I guess first maybe not to nitpick on data, but just on the mental component of the Fs 36. It just seems like there's a pretty substantial decline in the placebo group from baseline to weak for US is that an expected natural history and is the drug results statistically superior.

Jan Moller Mikkelsen: Okay, thank you. Thank you. Our next question comes from the line of Jim Birchinoff with Wells Fargo. Your line is now open.

To the baseline to the placebo I'm just trying to understand if the decline in the placebo contributed to the results.

Operator: Hey guys, congrats on another strong update. A couple of questions. I guess first, maybe not to nitpick on data, but just on the mental component of the SS-36, it just seems like there's a pretty substantial decline in the placebo group from baseline to week four. Is that an expected natural history?

I have not got any feedback.

Jim that indicate that the decline anyways should be reflecting any kind of the treatment outcome there.

Sure so I've not seen that path in this.

But what do you see is that everyone has been normalized to the 50 account and I think that is where we see the norm.

Jan Moller Mikkelsen: And is the drug result statistically superior to the baseline of the placebo? I'm just trying to understand if the decline in the placebo contributed to the results. I have not got any feedback, Jim, that indicates that the decline, anyway, should be reflecting any kind of treatment outcome there. So I have not seen that part in this.

Generation General population. So when you have been number you basic transform it into a normalization.

Got it okay I just looked like the baseline was that around 47 for placebo and then dropped down to maybe 42.

And that was part of the Delta with the treatment effect that week for US I was trying to understand that a bit better.

Jan Moller Mikkelsen: But what you will see is that everyone has been normalized to the 50 account. And I think that is where we see the norm. The general population. So when you have the number, you basically transform it into a normalization.

Exactly but I think this is or how you make the different domains and and make it over in a summary scheme, where you normalize to unknown scheme and this is where you basic we'll see this kind of different coming in.

Jan Moller Mikkelsen: Got it. Okay. It just looked like the baseline was at around 47 for placebo and then dropped down to maybe 42. Um, and that Transcription by CastingWords, Exactly. But I think this is how you make the different domains and then put them over in a summary scheme where you normalize it to a norm scheme.

Got it Okay, and then just in terms of going beyond the six month.

Data this quarter the interactions with regulators.

When would should should we hear back on the results of those interactions and is breakthrough designation part of the discussion.

Jan Moller Mikkelsen: And this is where you basically see this kind of difference coming. God, okay. And then just in terms of, you know, going beyond the six month Data, this quarter, you know, the interactions with regulators, when should we hear back on the results of those interactions? And is breakthrough designation part of the discussion? So currently, we are only discussing with regulatory agencies our first four weeks of data. There was the fixed-dose, double-blinded part. And in this discussion, we had not even included our SF-36 data. What we have discussed is how we look at our four-week data, which basically is proving one single thing, that we have replacement therapy. The rectotoy feedback, where we have got rectotoy feedback now from the U.S., we'll get rectotoy feedback from different European agencies at the beginning of September.

So currently we only discussion, but regulatory agencies, our first full week data there was the fixed dose double blinded pound and this discussion we had not even included our SF 36 data.

What we have discussed is how do the loop about our war four weeks data with basic proving once single thing that we have with Paceman therapy.

Regulatory feedback, where we have caught regulatory feedback now from the U.S., we getting in beginning of the tempo of regulatory feedback for different European agencies.

And I'll from the feedback we got from us that basic.

Sustaining yes. This is basic is in replacement therapy.

Jan Moller Mikkelsen: And all from the feedback we got from viewers, the basic understanding, yes, this is basic, it's in replacement therapy. I believe there is an essential data packet that will come up when we can come and discuss and send in our six-month data in addition to the element we have from our SF36 for the first four-week double-blinded period and also our disease-specific PRO, which we will also include as soon as we have got the six-month data. And maybe just one final question just on adult growth hormone deficiency. Could you maybe give us a sense of the burden of abnormal body composition in adult patients with growth hormone deficiency and what's a clinically relevant change in that metric, and what is the consequence of that?

Belief.

He said essential data package that will come up when we can come and discuss and sending our six months data.

In addition, all the elements we have from our it's a 36 for the first full week blinded double blind appeared and also our disease specific prio, which we also include as soon as via got six months data.

And then maybe just one final question just on the adult growth hormone deficiency could you maybe give us a sense of.

The burden of the.

Abnormal body composition.

Patient in AD adult patients with growth hormone deficiency, and and what the what's a clinically relevant change in that metric and what does the consequence of that.

Jan Moller Mikkelsen: I'm imagining there are drastic metabolic consequences of those change parameters, but maybe just a bit of background on just the body composition metric and what level of change would be meaningful. You can say that in Pediatric Growth Hormone Deficiency, we measure height, but it is not the same thing to say in this patient population that body composition is also extremely important.

I'm imagining there are drastic metabolic consequences of those.

Change parameters, but maybe just a bit of background. If you would on just.

The the body composition metric in and.

What level of change would be meaningful.

Yes.

You can say that the in production growth hormone deficiency Misha height, but is not the same thing to say.

In this patient population that body composition is also extremely important but as a primary endpoint. Your basic is always meshing hyperlocal city.

Jan Moller Mikkelsen: But as a primary endpoint, your basic endpoint is always measuring height velocity for one year as a primary endpoint. If you go to adults, for obvious reasons, they are not growing in height, but typically in a different dimension. And this is where you are often measuring a decrease in truncal fat because growth hormone has a direct effect on breaking down truncal fat. It also has a major impact on other elements like patient-reported outcomes. It also has an impact on cardiovascular parameters.

For one year EPS and.

Primary outcome. If you go to adults of obvious reason, they're not going in height, but typically in a different dimension and this is aware you orphan may shrink and decrease in trunk of fat because kokomo has and.

Direct effect, all breaking down trunk effect, but also have major impact on alert eliminate like a patient reported outcome. I also have in picked on cardiovascular parameter as in picked on exercise capacity, but from a traditional perspective, how it always have elevated.

Jan Moller Mikkelsen: It has an impact on exercise capacity. But from a traditional perspective, how it always has elevated as a primary outcome, growth hormone treatment, it has been done in a pediatric population by high velocity and in adults, population on the decrease in truncal fat, typical as a percent or absolute amount and increase, and secondary, something like increased lean body mass. This is not the same thing that you also would always expect that all the other positive effects you can get on endocrine health by growth hormone treatment are also expected to be associated with this decrease in truncation.

As a primary outcome for optimal treatment there has been done in a pediatric population by high velocity and you don't.

Population on.

The decrease on Tonkel said typical as a percent or absolute amount and increase and second days something like increase being bought IMAST is not the same thing that you also all this would expect that overall positive will take you can get on into crime codes.

By Kokomo treatment is also expected to be associated with this decrease in compensated.

Operator: Thank you. Our next question comes from the line of Taz Ahmad with Bank of America. Your line is now open. Okay, guys. Hi, how are you?

Thank you. Our next question comes from the line of Tab Ahmed with Bank of America. Your line is now open.

Okay, Hi, how are you a few questions from me.

Jan Moller Mikkelsen: A few questions for me. For SF36, at the three doses that you studied, the 15, the 18, and the 21, can you give us an idea of how the responses changed as you went from the low dose to the higher dose? Just trying to get a little bit of granularity on that. Specifically, can you talk about whether the highest dose did show the best results?

For us that's 36 in the three doses that you study the 15 to 18 to 21 can you give an idea of how the bonds.

Range does he went from the low dose at a higher dose.

Jan Moller Mikkelsen: And then I have a couple of follow-up questions. I have not seen the breakdown directly between the three different patient groups. It's mainly being done on a PTH arm and a placebo arm, and that was how the primary analysis was done. I am not sure there is any kind of difference between the different groups because that has not been brought up to my attention, so I actually think there will be the same positive effect on all the three different groups. Okay, I'm going to GHV for a second.

Analysis done I I'm not sure that is any kind of difference between but different groups because that is not being brought up to my attention. So I actually think that will be same pass to affect on all the three different groups.

Okay.

Going to ghd for a second so you have the three now I'm going in China now basically starting in Japan. Soon can you give us a little bit more color on the timeline for how you were thinking about when those studies could read out and then to follow up on that we traditionally have a sense of weird disease launches in Japan and price point.

Jan Moller Mikkelsen: So you have phase three now ongoing in China, and you have phase three starting in Japan soon. Can you give us a little bit more color on the timeline for when those studies could read out? And then to follow up on that, we traditionally have a sense of where disease launches in Japan and price points, but can you talk to us a little bit, Jan, about how you're thinking about the market in China? Yeah.

But can you talk to us a little bit yeah, and about how you were thinking about the market in China.

Yeah.

Jan Moller Mikkelsen: Tantum Croftamon being, evaluated by our strategic investment, Beeson Pharmaceuticals in Greater China, they are in a situation where they are enrolling patients; they expect that at the end of the first quarter next year, they will be fully enrolled. And therefore, you can basically expect that after 12 months, you will see, and some months to clean data, you will see the end point. If we go to the Japanese... Transcripts provided by Transcription Outsourcing, LLC. Japan, it would be much, much, much less.

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Even though you just buy O S.

Investment decent pharmaceuticals, and greater China.

The situation, where the enrolling patient they expect that in the in the first quarter next year, it would be fully and road and therefore, you can basic expect that after 12 months.

And some months to clean data you will see.

Point.

If we go to the Japanese trials is a must larger or smaller trials.

Chinese trials is about 150 patients in.

Japan, It will be Moss Moss Moss less.

And we will start to enroll this patient group here in.

Jan Moller Mikkelsen: And we will start to enroll this patient group here in, filing the IND equivalent in Japan at the end of this. The Koftelman Market in Greater China and Japan is interesting because it's the basic number two or three single largest market. And the growth hormone market in China is typical dominated by local players where there is one company that's providing, I think, the vast majority of growth hormone. And what is interesting is that we can enter this interesting market, which is very different compared to a traditional Chinese market because 75% of that is basic, not in the hospital segment, but basic is direct payment from the hospital. Caregivers. So it's a very, very different market compared to the general segment. And the size of it? It's pretty large.

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A N D April in Japan and of this year.

The Gulf Damone market in.

Greater China, and Japan, Oh interesting because it's basic number two or three single losses market and.

Go from one market in China is is too because dominated a lot with local player where.

One company desk, providing I think the majority of the optimal.

And what is interesting is that we can come in this interesting Margaret with aver different compared to our system Chinese Margaret because 75% of that is basic not in the hospital segment, but basic.

Direct payment from.

Caregivers, so is further different margaret compared to Virginia.

Segment.

And size of it is pretty lunch hour based estimation is about six two $700 million is the status of Chinese Margaret now and extra growing really Dodge every year, but Japan market is nearly in the same sites and also have been pretty well established for many years.

Jan Moller Mikkelsen: Our best estimation is about 600 to 700 million US dollars is the established Chinese market now and is actually growing really large every year. The Japanese market is nearly the same size and has been pretty well established for many. So when we think about transcontinental, and really we want to be the leading brand, we want to be the leading brand in a global manner. This is one of the reasons why we have hired a person like Jesper Huyland who is coming from a global commercial background and wants to implement our rare disease endocrinology products on a global basis. Some of the countries we will go to directly as the US and select European countries.

So when we think about Transcon Grove tunnel, and really we want to be the leading brain, we want to be the leading brain global manner. This is one of the reason why we have.

Hi, the personal banker.

Island with coming from a global commercial background and want to implement are rare disease endocrinology products on a global basis. Some of the countries. We would go direct as the U S and selectee European countries.

Jan Moller Mikkelsen: In other places, you will see, we use our innovative way of really building up strategic alliances where we can, at the same time, be part of really getting the value that we are creating, like we did with Wiesent Pharmaceuticals in greater China. And you will see this kind of way of thinking be implemented in a lot of other geographic regions where we accept that we need to have local knowledge, local people, really to make it a leading brand. Thank you. Our next question comes from the line of Alethea Young with Cantor Fitzgerald. Your line is now open.

Places you will see we use our to our way of really building up.

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At the same time can be part of really getting the values that we are creating like we did a decent pharmaceuticals in greater China and you will see it is kind of way of thinking be implemented in a lot of olokola graphic regions, where we accept that we need to have local knowledge local people really to make it to a leading brown.

And.

Thank you. Our next question comes from the line our Lithia Young what's Cantor Fitzgerald. Your line is now open.

Operator: Hey guys, thanks for taking my question. A couple of questions. Can you talk a little bit about why you kind of decided to focus first on TLR7 and 8 versus maybe like IL-2? I just wonder if there's anything you're seeing preclinically or commercially that kind of makes you think about the landscape.

Hey, guys. Thanks for taking my question.

A couple one.

Can you talk a little bit about.

Why kind of decided to focus first until or seven eight.

Versus maybe like I'll tell you I, just wonder if there's anything or.

Clinically or our commercial that kind of makes you think about the landscape.

Jan Moller Mikkelsen: The second question is, you know, talking a little bit about the CNT trial, has it been potentially impacted by COVID, or is it just an element of dose escalation? And then my third question is, have you gotten any feedback from the FDA on the growth hormone submission since you filed it probably about late June? Yeah, let's start with the backlog of your questions because then I can easily remember them.

The second question is.

A little bit CMT trial has it been potentially impacted by telephone or is it just an element of those escalation and then my third question. I was just have you got any feedback from the FDA on the Grand Slam on submissions since you filed probably about late Jan Thanks.

Yes, let's start from the backlog of your creation, because then I can easily remember them. So [laughter] you're right. The 60 days period have passed and.

Jan Moller Mikkelsen: So, you're right, the 60-day period has passed, and Dana, please inform me. Well, right, so the agency has confirmed that they filed it, but we're still waiting for the day 74 letter. So that will disclose what the review period will be, whether they think we might go to the advisory committee or any other issues they've identified, but they have confirmed that they've filed the application. Second question related to Transcon CMP

Dana please inform well right.

The agency has confirmed that they filed it.

But we're still waiting for the day 74 letter so that will.

Disclose what the review period, it'll be whether they think we might go to advisory committee or.

Any other issues they've identified but.

They have confirmed.

The.

Second question related to trying to come CMP I don't think we have disclosed any kind of information about when we expect to have and.

Dr. Dana Pizzutti: I don't think we have disclosed any kind of information about when we expect to have the data and what we call the cohort where we may expect to see our own expectation of efficacy. We have not disclosed that, and we are still on track to follow the pattern that we have laid out. The only thing we have disclosed was trials which are also double-blinded placebo controlled trials with a chondroplasia patient down to the age of two. We have disclosed that we expect to imitate this end of this year. We call it Accomplished China, and we still expect to replicate this trial by the end of this year. And then my first question was on TLR7 and TLR8, using that program for research stuff. That is a good question, and the two projects were competing at the same time. And basically,

What we call the cohort were <unk> expect to see.

Sure one expectation too efficacy, we have not disclose that and we are still on track to follow the patent that'd be have laid out the only thing we have disclose was we expect to imitate and.

Drive.

Which are also is a double buying the placebo controlled trials.

I contemplate your patient down to the eighth of too.

We have disclose that'd be expect to indicate that eight of this year, we call. It accomplished China and we still expect to initiate this trial.

Eight of this year.

My first question was M DLR seven and eight.

I would refresh on in it and the two project was competing at the same timeframe and basically.

Both of them, we believe is transformative too high value product opportunity they're different in concept.

Jan Moller Mikkelsen: Both of them, we believe, are transformative, high-value product opportunities, very different in concept, is our Transcon TLR78, where we basically can provide a long-term exposure to a tumour for weeks, months of an agent that can turn tumors from being basically unreactive to reactive. We believe that it's a real paradigm shift and never been done before, what we're doing with our buyers. I, too, really believe that it's going to be a best-in-class product opportunity, move both of them up to a unique position as our two first most advanced product opportunities in our oncology. That one is coming before the other one, it's basic from the practical perspective that we need to have a product opportunity going to clinical operation, initiation of trials, filings, and other elements like that, and we will have one coming at the end of this year, and the other one will come around six months later. So there is nothing that has changed for that.

One.

Is our Transcon T T L. A 708, maybe basic can provide.

One term exposure info to move four weeks months of an agent that can turn to most from being basic unreactive. Two reactive we believe that is really paradigm shifts and never been done before.

What we're doing with.

Our biocidal to really believes that is going to be facing task product opportunity <unk>.

Both of them up to a unique position as our to first most of them veins product opportunity in our on quality that one is coming before the other one it's basic out from the.

Practical perspective is that we need to have a product opportunity being going too clinical operation indication of trials filings and elements like that and we will have one coming eight of this year and the other one become around six months. After so nothing that have changed for that we are extremely answer.

Jan Moller Mikkelsen: We are extremely excited about both of these product opportunities and continue to build up a unique pipeline in oncology. Thank you. Our next question comes from the line of Trevor Allred with Oppenheimer. Your line is not open.

<unk> on both of this product opportunity and continue to build up a unique pipeline in oncology.

Thank you. Our next question comes from the line of Charva Alright with Oppenheimer. Your line is now open.

Hey, guys. Thanks for squeezing man.

Cable for me. So following near recent capital raise are you guys thinking about doing a M&A.

Operator: So following your recent capital raise, are you guys thinking about doing an M&A? And if so, what therapeutic category do you think you're focusing on? And then also, are you hearing anything about the pace of enrollment that Bison is having in China? And how do you expect that to translate to your other trials that you're enrolling? Thanks.

And if so what therapeutic category do you think your focus loan and then also are you hearing anything about the patient enrollment devising is having in China and how do you expect that to translate to your other trials that you are enrolling thanks.

When we having our portfolio review, we just had it here on our oncology pipeline.

Jan Moller Mikkelsen: When we were having our portfolio review, we just had it here now on our Oncology Pipeline. We are looking at these unique product opportunities we can build. We're thinking about how we have built Ascendis Pharma to the stage we are today. We do it with Transcom technology because we don't believe that we have not seen other technology where we basically can make highly differentiated product opportunities, really addressing major unmet medical needs, but still having a high success rate because the Transcom technology enables us to be in a position that we can work on validated, Why should we ever go away from that and We have a huge competitive edge with our transcom technology, and we will continue to build on the algorithm that has proven so successful, and because there are so many still low-hanging fruit that we can address. So I don't expect us to see and move into any kind of M&A era.

We're looking on this unique product opportunities we can build.

Thinking about how we have bills snd's farmer to the states. We are today, we're doing trying to come technology, because we don't believe we have not seen or technology will be basic can make hi.

Different stated product opportunities really interesting major unmet millikan.

But still having a high success rate because the transcon technology enables us to be in a position that we can work on valid data target validated parents trucks.

Why should be able go away from that and starting to be like any one of.

We have a huge competitive with our transcon technology, and we will continue to build.

Algorithmic that has proven so successful and because there's so many still low hanging proves that we can address so I don't expect us to see and move into any kind of a mini error.

Related to how we.

Jan Moller Mikkelsen: Related to how we are executing in other geographic regions, for example, to our strategic investment in Vision Pharmaceutical, I think they have a very highly talented company set up, and they are working to the same standards as we do; they are working with the same dedication. So I actually believe they are coming, and you will see the same kind of results coming out of their pipeline with our product as you have seen coming out of Ascendis. Okay, and any impact that you're seeing from enrollment in COVID-related things with Vizen? And then do you see that translating, like those learnings translating to anything that you're going to be doing with your initiations later this year? I have to believe that if you look at Greater China, I think it's one of the areas which has less COVID-19 issues compared to other areas. And we have not seen any kind of restriction after the first quarter in greater China on how to really enroll a child.

Executing in although geographic region for example to our strategic investment envision pharmaceutical I think the Heather they're highly talent.

Company setup and they're working in the same standards as we do they're working with the same dedication. So I actually believe coming and you receive the same kind of results coming out of their pipeline with our product suse out of coming out of the seventies.

Okay, and any impact your seeing from enrollment from Covid related things with <unk>.

And then do you see that translating like those learnings translate into anything that you are going to be doing with your initiations later this year.

At the belief that if you look on the greater China axle zinc is one of the arrows with half lifts Kobe 19 issued compared to errors and we have not seen any kind of a restriction.

But first quarter in greater China, how really too enrolled the trials.

Alright sounds great. Thanks.

Thank you there are no further questions and thank you.

Jan Moller Mikkelsen: All right, sounds great. Thanks. Thank you. There are no further questions in the queue. Ladies and gentlemen, this concludes today's conference call. We thank you for participating. You may now disconnect. Everyone, have a great day.

[music].