Q2 2023 Ascendis Pharma A/S Earnings Call

Okay.

Okay.

Hello, and welcome to lessen this Palmer Q2, 'twenty twenty-three earnings conference call.

At this time, all participants on a listen only mode.

After the Speakers' presentation that would be a question and answer session.

Ask the question during the session you will need to press star one on your telephone.

You will then hear automated message advising your hand is race so.

So withdraw you question plus star one again.

I would now like to hand, the conference over to Tim Lee Senior Director of Investor Relations Austin, just pharma, yes, Sir you may begin.

Thank you operator, and thank you everyone for joining our second quarter three financial results Conference call I'm, Tim Lee Senior director of Investor Relations of our scientists pharma.

Joining me on the call today, Jan Mikkelsen, President and Chief Executive Officer.

Scott Smith, Executive Vice President and Chief Financial Officer.

Doctor Stena single Executive Vice President and head of clinical development in oncology.

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

Examples of such statements May include but are not limited to our U S commercialization and continued development of Skype for the U S market.

Our revenue projections for sky drop that the.

The commercialization of Transcon hgh for the EU market and our planned launch of Skytrooper in Germany State.

Statements regarding our NDA for Transcon, PTH and the expected timing of the potential approval in land and lots of Transcon PTH in the U S market statement.

Statements regarding the expected timing.

Potential approval and launch of Transcon PTH in Europe .

Statements regarding the potential approval of transcon CMP, our expectations regarding our new Transcon technology.

And our progress on our pipeline candidates and our expectations with respect to their continued progress statements regarding our strategic plans our goals regarding our clinical pipeline, including the timing results statements regarding our pipeline product candidates statements regarding our ongoing and planned regulatory filings or expect.

Patients regarding the timing and the results are regularly regulatory decisions our expansion into new therapeutic areas and statements regarding our progress towards vision three by three and our ability to create a sustainable profitable in meeting global pharma company.

These statements are based on information that is available to us today actual results and events could differ materially from those in our forward looking statements and we may not be able to achieve our goals here are our plans or intentions or expectations or projections disclosed in our forward looking statements and you should not place undue reliance on these.

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 as circumstances change except as required by law.

For additional information concerning the factors that could cause actual results to differ materially. Please see our Florida can statements section in today's press release and the risk factors section of our most recent annual report on form 20-F filed February 16th 2023.

Transco on human growth hormone Transcon Hgh is approved by the FDA in the U S. Under the brand name Skytrooper for the treatment of pediatric patients one year and older weighing at least 11, five kilograms and having growth failure due to inadequate secretion of endogenous growth hormone. In addition, the European Commission has granted a mark.

Authorization for Sky Trophy, and just pharma develop.

The named Transcon Hgh as a once weekly subcutaneous injection for the treatment of children and adolescents, aged three months to 18 brought failure due to insufficient excretion of endogenous growth hormone and general referred to this product is transcon growth hormone unless referring to the product in the context of particular jurisdictions, such as the United States or the Europe .

And Union otherwise please note that our product candidates, our investigational and not approved for commercial use.

As investigational products, the safety and effectiveness of our product candidates have not been reviewed or approved by any regulatory agency. None of the statements made on the conference call regarding our product candidates shall be viewed as promotional.

On the call today.

Second quarter 2023 financial results and will provide further business updates. Following some prepared remarks, we'll then open up the call for questions I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer.

Yeah.

Yeah.

Thanks, David.

Good afternoon, everyone.

2019 at the JP Morgan Conference <unk>.

We announced our vision for your battery for building, a leading sustainable global Biopharma company by 2025.

Today I'm pleased to share with you update how close we are to achieving our vision.

As outlined in August and three batteries.

Using our transcon technology platform.

And our algorithm for product innovation.

We are on the pathway to achieve the regulatory approved three independent endocrinology rare disease products transcon growth hormone transcon, PTH and Transcon CMP.

<unk> 25.

In addition.

We are building.

Global commercialization capabilities to break this growing portfolio of highly differentiated product to patients.

In the U S for the second quarter.

Reported Skype over revenue of 36 million euros.

Sky Sofa.

<unk>.

Got home market value leadership in the U S in the second quarter.

Greater penetration of less than 10% of treated U S per day.

Both hormone deficient patients.

Which represent about half of the growth hormone market in the U S. Today.

For the full year of 2023.

We expect Sky Troffer U S revenues to be $1 65 to 117.

17 million Euro.

We believe three factors continue to drive demand first a growing number of physicians have patients with O N E.

Of experience on Skype and.

In this physician has offset the long term benefit for both treatment nave and switch patients.

Second.

Consolidation of the data growth among market continues and the recent approvals of two long acting growth hormone products, which could accelerate this shift to long acting.

Sorry.

As said this has become a trusted partner within the endocrinology community.

As we continue to invest in our products inside.

And our support for patients and health care.

I have to provide them with a reliable supply chain.

In our global commercial reach.

We're ready to launch schedule for this month's in Germany.

Our medical affairs and commercial teams are in place.

And have been actively engaging endocrinologist across the country.

We recently received FDA approval at launcher for a high capacity trucks, often manufacturing sites.

We expect EU approval in the first half next year.

This added drops often manifesting capacity supports our goal to equipment equipment visualized in new markets and additional indications and to achieve our goal of global market leadership and value in a growing global growth hormone market.

Sure.

During the fourth quarter.

We expect to share top line results for our global Phase III.

So I tried.

Transcon growth hormone in the thought co.

<unk> deficiency.

Do you believe adult growth hormone deficiency is underpenetrated indication.

<unk> study showed that less than 4% of adult patients.

Suspected of having growth hormone deficiency are treated <unk> co promote.

Moving to Transcon PTH for adult hydropower retiree Smith.

In June .

<unk> requested a type a meeting paid ft and submitted an updated control strategy.

The type a meeting was held with FDA in late August based on the agency's evel ability.

Following a construct a type a meeting.

<unk> submitted additional information to FDA supporting updated control strategy.

I believe the materials submitted to FDA combined with fit type a meeting discussion will position us to resubmit the NDA for Transcon PTH for Hyperparathyroidism in October 2023.

If our NDA.

Hey, Jay Sexy, but which we expect we did 30 days following resubmission ft.

FDA notified us we have there.

With submission is class, one or class two and provide a new <unk> date with <unk>.

We estimate could be in December this year April 2024.

It is important to note that we will not know when.

New producer date until our submission is accepted and its classification as communicated to us.

Besides this information we will not comment further on the Resubmission procedure, why we are having ongoing communications with the FDA.

In the.

European Union, we received our day 180 assessment report with feedback on.

Hey, Mike Hey for Transcon, PTH and have submitted our response to the list.

Standing issues.

We remain on track for a European Commission decision during the fourth quarter and if approved we plan to launch Transcon PTH in Germany in early 2024.

Finally.

To date, we released new positive data supporting the potential benefit.

The effect of Transcon PTH on Keith.

All of the course of one year patient in our phase III trial demonstrated profound increases in EG.

A key marker of kidney function with increases of Orion plus 90 milligram per meter across all patients.

Importantly in.

In the subset of patients.

Okay.

Therefore less than 60 at baseline.

Threshold for kidney dysfunction.

<unk> PTH demonstrated increases of 11% to spoke milliliter per minute.

Around half of the pathway for patients.

<unk> of less than 60.

After transport treatment for one year experience at Egfr, improving to about 60%, meaning that went for having a diagnosis of unit impairment to be within the normal range of kidney function.

For patients treated with <unk>.

Steady improvement in Egfr of this magnitude.

Use risk capital pacing to chronic kidney.

Kidney diseases.

This is a major kobo PTT in patients with hyperparathyroidism and.

And a major contribution to Medicare part B.

<unk>, 2% detailed result at our upcoming medical conferences.

The U S expanded access program and German compassionate use program for transcon PTH continuous to be opened.

From an operation.

And we expect to be muted comparable programs in additional countries.

And the ongoing extension portion of our clinical trial 145.

The initial 154 patients from the original clinical trials continue treatment with transcon PTH for what three yes.

We continue to prepare for the expected launch in the U S and Europe .

We are confident that transcon PTH okay.

Keith will become an important new treatment option for adult patients.

This is serious diseases.

Switching now to transparency.

Following our end of phase two meetings with U S and EU regulatory agencies, we have been a great pathway to achieve regulatory approvals for transcon CMP <unk>.

<unk>.

FDA.

EU regulatory agencies confirmed that absolute annualized growth velocity is acceptable as the primary in force people to phase III <unk> trial.

Second.

These regulatory agencies agreed to our dose selection of Honda microgram per kilo per week dose approach.

Third based on this discussion.

The lead indication for treatment of achondroplasia.

Be supported by emulating that beneficial impact on transcon CMP on Comorbidities and all the important aspect of PDC.

In addition to height.

Fort.

Our people do a phase III trial approach is now fully enrolled with topline data expected previous taken half of 2024.

We believe that <unk> approach skeletal growth in Basel disorder.

Based on the rapid functional improvement observed in our ongoing phase two accomplished trial based on literature review that may be a primary muscular covenant to echoed a classic phenotype.

Precise was described effect on skeletal growth.

We believe it's essential to have.

Our continuous exposure to CMP to optimally improve muscle strength and into words.

Our pivotal trial, we will explore endpoint to measure how CMP might modulate the muscular weakness.

In addition, there.

This also means that there could be a treatment option for adults living a co location.

Yes.

Our research and these are continuous and we expect to share more later this year, along with new data from our countries, where all the initial 57 patients continue on treatment with <unk> for over three years.

Turning to oncology, we today announced that we had completed dose escalation for transcon <unk> Karma in combination with pimco and the clear recommended phase two dose at 120 microgram per kilo every three weeks.

No dose limiting toxicity of vascular leak syndrome or quite.

All four cytokine release syndrome were observed at any dose labor related.

Finally, I'm excited to share with you some new development expected to drive sustained.

Sustained growth.

Develop and transcon carrier platform.

Integrate our reversible lingers.

<unk> complements our two established care technologies, the soluble and hydrogel platform among the many application.

We believe this technology support high volume low cost manufacturing, enabling product for new therapeutic areas.

We ask that this proof of principle for once monthly dosing of the Jeep.

One envelope say metro type and on our website you can see our preclinical data.

In summary.

<unk> remains focused on building and maintaining a sustainable profitable leading Biopharma company.

With all programs, making significant progress we are nearing completion of our recent <unk> and have already begun the foundation for the next stage of our cities I will now turn the call over to Scott.

Instant review before we open it up for questions.

Thank you John .

As Ed noted, we are making very strong progress at assembly.

I will touch on key points surrounding our financial results for further details. Please refer to our form 8-K filed today.

Total revenue for the second quarter was $47 4 million euro, including Skype drove our revenue as well as license and services provided to third parties, primarily visa and pharmaceuticals.

Sky trough of revenue for the second quarter of 2023 was $35 9 million euro compared to $31 6 million Euro reported in the first quarter second quarter revenue was negatively impacted by two items.

Negative adjustment to provision for estimated sales rebates of $2 1 million euro, which resulted from stronger than expected payer adoption related to prior periods and a negative foreign currency impact of $1 6 million euro as compared to the first quarter of 2023 due to a weaker U S dollar.

Okay.

Based on reported results from other growth hormone manufacturers Skype <unk> was the U S market leader in the second quarter of 2023 with less than 10% penetration into the U S. Pediatric HD patient population, we see a large opportunity in front of us to grow our patient share in pediatric ghd, which we.

<unk> to be only half of the addressable U S growth hormone market.

Turning to expenses R&D costs declined 1% sequentially, primarily driven by lower endocrinology related costs, partially offset by an increase in oncology related costs.

SG&A expenses grew 6% sequentially, reflecting higher external commercial expenses for <unk> in the U S. Prelaunch activities for <unk> outside the U S global prelaunch activities for Transcon, PTH and higher employee related expenses.

Total operating expenses were 175 million euro for the second quarter up 2% sequentially from the first quarter of 2023.

Overall, our operating loss declined sequentially by 2% to $141 million Euro for the second quarter from 144 million Euro in the first quarter of 2023.

We ended the second quarter with cash cash equivalents and marketable securities totaling $431 million Euro.

Yeah.

Finally, we have entered into a capped synthetic royalty funding agreement with royalty pharma for $150 million in exchange for $9, one 5% royalty on net sales of <unk> within the United States.

With no royalty payments until 2025.

The royalty payments are capped at 165 times the purchase price is fully paid prior to December 31, 2023, or 195 times the purchase price if not fully paid by December 31 2023.

Further details are disclosed in a separate 6K filed today.

Looking forward, we expect continued momentum for <unk> in the United States for the balance of this year and we are raising our expectations for sky trucker revenues to $165 million to $170 million Euro for full year 2023.

Let me now also provide a review of selected key program milestones for Transcon growth hormone. We are on track to launch Sky Trophy in Germany. This month, and we expect to report topline data from the global Phase III <unk> trial in adult Ghd, our first potential label expansion in Q4.

Operator: Hello, and welcome to Ascendis Pharma Q2 2023 Ernest Conference Call. At this time, all participants are to listen only mode. After the speakers presentation, there will be a question and answer session.

For Transcon PTH, we believe we will be in a position to resubmit the NDA for adults with hyperparathyroidism in October and we expect the ERP a European Commission decision in Q4.

Operator: To ask the question during this session, you will need to press star 11 on your telephone. You will be in here automated message, advising your hand is raised. To withdraw your question, press star 11 again.

If approved we plan Transcon PTH is our second product launch in Germany in early 2024.

Timothy Lee: I will now let the hand of conference over to Tim Lee, Senior Director and Investor Relations, Ascendis Pharma AS, so you may begin. Thank you operator, and thank you everyone for joining our second quarter 23 financial results conference call. I'm Tim Lee, Senior Director and Investor Relations of Ascendis Pharma. Joining me on the call today is Jan Mikkelsen, President and Chief Executive Officer, Scott Smith, Executive Vice President and Chief Financial Officer, and Dr. Stina Single, Executive Vice President of Head of Clinical Development Oncology.

For Transcon CMP, we plan to share follow up data from the open label extension of our phase III accomplished trial in Q4 this year and we expect to report topline results from approach.

Our pivotal phase III trial in the second half of 2024.

Within the oncology therapeutic area. During this quarter, we expect to dose the first patient with a combination of transcon <unk> agonist and transcon Iot a beta gamma and during Q4, we will be presenting dose escalation data supporting recommended phase II dose at ESMO on Transcon IL, two beta gamba beta gamma in.

Timothy Lee: Before we begin, I'd like to remind you that this conference call will contain four of the statements that are intended to be covered and in the Safe Harbor provided by the Private Security Certification Reform Act. Examples of such statements may include but are not limited through our U.S, personalization and continued development of Sky Trova for the U.S, market. Our revenue projections for Sky Trova, the commercialization of Crancon HGH for the EU market and our planned launch of Sky Trova in Germany, statements regarding our NDA for Crancon PTH and the expected timing of the potential approval and launch of Crancon PTH in the U.S, market, statements regarding the expected timing of the potential approval and launch of Crancon PTH in Europe, statements regarding the potential approval of Crancon CMP, our expectations regarding our new Crancon technology and our progress on our pipeline candidates and our expectations with respect to their continued progress, statements regarding our strategic plans, our goals regarding our clinical pipeline, including the timing and potential results, statements regarding our pipeline product candidates, statements regarding our ongoing and planned regulatory filings and our expectations regarding the timing and the results of regulatory regulatory decisions, our expansion into new therapeutic areas, and statements regarding our progress towards vision three by three and our ability to create a sustainable, profitable, and leading global pharma company.

Combo with <unk>, Mab and update the monotherapy dose escalation data.

Okay.

You had mentioned we will not comment further on the NDA Resubmission procedure for Transcon PTH, while we are having ongoing communications with FDA.

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

Thank you.

Ladies and gentlemen, as a reminder to ask a question. Please press star one on your telephone and then wait to hear your name announced.

To withdraw your question. Please press star one again.

I ask that you limit yourself to one question and one follow up please.

Please standby, while we compile the Q&A roster.

Okay.

Okay.

Okay.

Our first question comes from the line of Lee <unk> with Cantor Your line is open.

Okay great. Thank.

Thank you for taking my question, so I understand that.

There is limited color that you can provide regarding the MTR with submission, but just wondering if you can sort of elaborate on the additional information that.

Needed from the type a meeting.

What are the gating steps for you to be a file and Dan.

Timothy Lee: These statements are based on information that has available to us today. Actual results and events could differ materially from those in our four-linked statements, and we may not be able to achieve our goals, carry out our plans, our intentions, our expectations, or projections disclosed in our four-linked statements, and you should not place undue reliance on these statements. Our four-linked 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 obligations update these statements as circumstances change except as required by law.

Yes, Lee this is Scott we cannot comment further on the Resubmission procedure, while we're having ongoing communications with FDA.

But we believe will be the resubmitted in October as we stated.

Okay understood.

My second question is maybe just comment on the timing behind doing a rolla Rolla, chief Ahmann deal right now.

Yes.

This is Scott again, I think that we looked at.

Transaction that had very attractive terms and allowed us to lower the cost of capital.

Thank you.

Timothy Lee: For additional information concerning the factors that could cause actual results differently, please see our four-linked statement section in today's press release and the risk factor section of our most recent annual report on form 20F filed February 16, 2023.

Thank you.

Please standby for our next question.

Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is open.

Timothy Lee: Transcon human growth hormone, or Transcon HGH, is approved by the FDA in the U.S, under the brand-name Scytropha for the treatment of pediatric patients one year and older weighing at least 11.5 kilograms and having growth failure due to an adquist creation of endogenous growth hormone.

Hi, good afternoon, and thank you for taking the question.

Just on the commercial piece.

Can you maybe comment on.

Additional share opportunities remain for spectrum.

One thing we noticed was that there was a sequential decline in the gross margin. So can you maybe just comment on whether some of these share gains and opportunities are coming at the expense of potentially higher Rebating and Rguest, Tony and then I had a follow up.

Timothy Lee: In addition, the European Commission has granted a marketing authorization for Scytropha to send its form, developed under the name Transcon HGH as a once-weekly Scytropha injection for the treatment of children and adolescents age 3 to 18 growth failure due to insufficient excretion of endogenous growth hormone. In general, refer to this product as Transcon growth hormone unless referring to the product and the context particular jurisdictions such as the United States or the European Union.

Let us go back and give what was created the fundamentals for us.

In our commercial strategy in the U S market and this is exactly the same strategy basically will begin to each single market, we want to be the leading product in value and we want to do it in a growing growth hormone market. So we basic building on the product strength of schedule.

Timothy Lee: Otherwise, please note that our product candidates are investigational and not approved for commercial use. As investigational products, the safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency, none of the statements in the conference call regarding a product candidates shall be viewed as promotional.

And we have seen that is really happening in the U S. We have seen where you basically come in and we say the market and this is basic what we are doing now.

Timothy Lee: On the call today, discuss our second quarter 2023 financial results and we'll provide further business updates. Following some prepared remarks, we'll then open up the call for questions.

What we see we see a continued stable growth on patients coming both from switch patients patient coming as new patients and we see it in our continued menu coming week by week months by months and we also feel that we are now in a position as we said it's a script.

Jan Mikkelsen: I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer. Jan? Thanks, Tim. Good afternoon, everyone. In 2019, at the DAP Morgan Conference, we announced our Vision 3 by 3, for building a leading sustainable global biopharma company by 2025. Today, I'm pleased to share with you update how close we are to achieving our vision. As outlined in our Vision 3 by 3, using our transcontact naughty platform and our algorithm for product innovation.

The physician the patient.

Everyone have seen really that full potential.

<unk> of that.

Schedule, but because they have seen how we really.

In precision to give a better outcome related to annualized HIFU.

That you would typically see even in highly compliant daily growth hormone safety and it is basic why we see this and it will only be enforced when we basically can get additional indications.

Jan Mikkelsen: We are on the pathway to achieve the regulatory-approved three independent endocrinology where disease products. Transcon, growth hormone, transcon PTAs, and transcon CMB by 2025. In addition, we are building global commercialization capabilities to bring this growing portfolio of highly differentiated products to patients. In the U.S, for the second quarter, we will publish Gaitrover revenue of 36 million euro. Gaitrover achieved growth home market value leadership in the U.S, in the second quarter with a penetration of less than 10 percent of treated U.S, pediatric growth hormone deficiency patients, which represent about half of the growth hormone market in the U.S, today.

We really are trailed industry.

Industry, a year Q fear goof, all come out with data from our <unk> deficiency, which we really can show also that we really can provide it.

Improved treatment option to these patients too.

And Paul on the gross margin question, Scott remember that gross margin is for all revenue, which includes some pass through revenue as we mentioned.

I would say at the <unk> for gross margins are largely unchanged pretty stable over the last several quarters.

Okay got it thanks for the additional color Scott.

A follow up question on <unk>.

Transcon champion for the Phase III trial can you comment on whether the regulators abouts for any additional clinical endpoints. Besides.

As a focal point for potential approval.

In addition to <unk>, our absolute high growth and just sort of.

Any other data you may be collecting to differentiate from the approved product on the market. Thank you.

Jan Mikkelsen: For the full year of 2023, we now expect Gaitrover U.S, revenues to be 165 to 170 million euro. We believe three factors continue to drive demand. First, a growing number of physicians have patients with over a year of experience on Gaitrover, and this physician has observed that long-term benefit for both treatment naive and sweet patients. Second, the consolidation of the data growth hormone market continues, and the recent approvals of two other long-acting growth hormone products, which could accelerate this shift to long-acting.

Yes.

First of all the primary endpoint is annualized height velocity over 12 months.

And that is the primary endpoint.

Discussion additional secondary endpoint in related to the endpoint, we already have which really should go into the biology that deal. How we really can address as we said, it's a script we believe that.

<unk> is not only a skeletal dysfunction, but also have muscles impact.

Impact and we really have seen benefit there, which are really are being supported with our review of the literature, where you were.

Really can show how echoed Appalachia have muscle weakness and we believe that this is one of the reason why we see 100% attention in our trial and it wasn't immediately effect, we observed in our phase II trial and this is why we really is extremely thrilled to really take this product transcon <unk>.

Jan Mikkelsen: Third, ascended has become a trusted partner within the endocrinology community. As we continue to invest in our products in science, in our support for patients and healthcare, and provide them with a reliable supply chain. In our global commercial weeks, we are ready to lump Gaitrover this month in Germany. Our medical affairs and commercial teams are in place and have been active in Gaiting Endocrinologies across the country. We recently received FDA approval at launch for a high-capacity drug-soft and manufacturing site.

Not only we believe is a clear benefit for <unk> sake, what potentials that could also be in a proven for adults with a contemplation.

Thank you.

Please standby for our next question.

Our next question comes from the line.

With Leerink partners partners. Your line is open.

Jan Mikkelsen: For which we expect EU approval in the first half-next year. This added drug-soft and manufacturing capacity supports our goal to commercialize in new markets and additional indication. And to achieve our goal of global market leadership in value in a global, global, growth hormone market. During the fourth quarter, we expect to share a top-line result for our global phase three four-side trial, our trans-grown growth hormone in adult growth hormone deficiency. We believe adult growth hormone deficiency is an underpinitrated indication. Their recent study showed that less than 4% of adult patients suspected of having growth hormone deficiency are treated with growth hormone.

Great. Thanks, so much and congrats on all the progress I was wondering how the gross to net for Skype drove that has been evolving in the United States.

And what your pricing strategy will be in Germany, and other European markets. Thank you.

Let me take the last part of your question first.

We believe providing an improved treatment for their patients.

We also believe.

That would be following up to what you said before.

Our responsible premium pricing.

This is how we really have launched our price structure in the U S and we will continue to implement that throughout all the different markets does this wherever you want to be because we are providing an improved treatment.

Scott would you take the last part.

So Joe we don't comment on GTS evolution, we just want you to focus on revenues ultimately, but I think we gave some interesting points that on reported revenues we were the.

Jan Mikkelsen: Moving to transcon PGA for adult hyper-parallel tyrosma. In June, we requested a type A meeting with FDA and submitted an updated control strategy. The type A meeting was held with FDA in late August based on the agency's availability. Following a constructive type A meeting, we submitted additional information to FDA supporting the updated control strategy. I believe the material submitted to FDA combined with the type A meeting discussion will position us to resummit the end A for transcode PGA for adult hyper-parallel tyrosma in October 2023.

Market value later in the quarter with less than 10% penetration into the pediatric ghd market, which itself is only half of the total growth hormone market in the U S.

So when you start to make this calculation, which you likely will do sitting in casually that what it means it basic meaning is that we have the vision on that.

Sure.

Driver.

Most value product, but in a growing quarter loan market and definitely what we managed to do here because of the improvement in treatment we are providing.

Okay.

Thank you.

Thank you.

Please standby for our next question.

Jan Mikkelsen: If our end A is accepted, which we expect within 30 days fallen resumission, FDA will notify us where the resumission is class one or class two and provide a new pedophidate, which we estimate could be in December this year or April 2024. It is important to note that we will not know when new pedophidate answers our resumission is accepted and its classification is communicated to us.

Our next question comes from the line of Andrea <unk> with Wedbush Securities. Your line is open.

Thanks for taking my question and congrats on all the progress.

With the Egfr data, how should we interpret that to 50% response rate and how do you expect the egfr analysis to be reflected on the potential label I'm looking at the baseline characteristics of patients in pathway 15 in the Transcon PTH group had a history of kidney stones can you speak to the impact of.

Transcon PTH.

For kidney stones, and if you plan on sharing this data in the future and I have one follow up.

Jan Mikkelsen: Besides this information, we will not comment further on the resumission procedure while we are having ongoing communication with FDA. In the European Union, we received our day 180 assessment report with feedback on our M&A for transcode PGA and have submitted our response to the list of outstanding issues. We will remain on track for a new PN commission decision during the fourth quarter. And if approved, we plan to launch transcode PGA in Germany in early 2024.

Okay. Thanks, a lot.

Extremely thrilled with this data why via truck.

Because we really believe it's providing a huge benefit to the patients a huge benefit because one of the element that.

<unk> really fear is really on conventional therapy do basic are dividing renard impairment with it.

Can be worst case scenario, where you go into dialysis and really needs to happen and your kidney so from that perspective, when we looked at the data.

We basically selected 60.

Jan Mikkelsen: Finally. Today, we released new positive data supporting the potential beneficial effect of Francicon PTAs on kidney. All the calls of one year, patient in our phase three trials, demonstrated profound increases in EGFR, a key Markov kidney function, which increases of a 9 million per minute across all patients. Importantly, in the subset of patient with EGFR, less than 60 at baseline, the threshold for kidney dysfunction, Francicon PTAs demonstrated increases of 11 to 12 million per minute.

From the perspective is that some kind of.

Accepted definition of really where you have it.

Sufficient or not and why we were thrilled with the data that we couldnt take 50% five <unk> of the patients that basic already were classified of having insufficient.

Insufficient and basic bupa up to what we call normality.

I believe that is a key element for how we really can work with that and help the patient group here and I think when we saw the data. We believe that is the first time, we've really seen any compound that basic Eva Eva have shown this effect.

And related to the labeling.

The deep <unk>.

As a post hoc analysis.

Jan Mikkelsen: Around half of the part work for patients with an EGFR of less than 60, after Francicon P treatment for one year, experience at EGFR, improving through about 60, meaning they went for having a diagnosis of unit impairment to be within the normal range of kidney function. For patient treated with Francicon PTAs, state improvement in EGFR of this magnitude may reduce risk of progressing to chronic or less-day kidney diseases. This is a major comorbidity in patient with hyperperiodarism and a major contribution to medical costs.

Can say, yes, we should have included in our key segment there already from the beginning when we saw what is major impact, but still for US. It was really unbelievable when we really have seen the data and how well it is and we will soon when we.

Presenting this data into publication to interaction with patient groups. So they are really also understand that benefits that can get for transcon PTH and there. We will go out and also talking with regulatory agencies, but we also believe that having a peer reviewed publication is a key element for us really to be in a position.

Really to communicate about this fantastic data.

Fantastic and then.

Jan Mikkelsen: We plan to present detailed results at our upcoming medical conferences. The U.S, expanded SS program and German compassion use program for Francicon PTA continues to be open for improvement of patients, and we expect to imitate comparable programs in additional countries. In the ongoing extension portion of our clinical file, 145 out of the initial 154 patients from their original clinical trials continued treatment with Francicon PTAs for over three years. We continue to prepare for the expected long in U.S, and U.S. We are confident that Francicon PTAs can, if they become an important new treatment option for adult patients living with serious diseases.

Comments on kidney stones.

The kidney stones I believe.

I have not seen data on that point, but a potential I can often is studies and post.

Hawk analysis, we also can do.

Specific related to kidney stones, I cannot recall I've seen anyone.

Okay.

Thank you.

Please standby for our next question.

Yes.

Our next question comes from the line of David Leibowitz with Citi. Your line is open.

Thank you very much for taking my question.

Could you run us through the differences of the new Linker you were talking about.

And.

You have the preclinical data for <unk> one.

Might we see that candidate move towards the clinic. Additionally, other types of candidates do you see applying this towards.

Jan Mikkelsen: Switching now to Francicon PTAs. Following our end of phase two meetings with U.S, and EU regulatory agencies, we have an agreed pathway to achieve regulatory approvals for Francicon PTAs. First, FDA and EU regulatory agencies confirm that absolute analyzed growth velocity is acceptable as the primer in forward.

Yes, we are really really extreme me.

Jan Mikkelsen: Pueblo phase three opposed trial. Second, these regulatory agencies agree to our dose selection of 100 microgram per kilo per week dose for opposed. Third, based on this discussion, we expect that an indication for treatment of Acondyl Placer will be supported by evolating the beneficial impact on Francicon P, on co-morbidities, and all the importance of Acondyl Placer in addition to height. Our People of Phase 3 TRIPOS is now fully enrolled with top-line data expected in the second half of 2024.

Actually Saturday of this expanding of the Transcon technology, because we believe we need to be everywhere.

Patients and it's building on the same principle again, so when you think about the transcon linker.

Tentacle or exactly the same kind of that you have seen on both transcon growth hormone transcon PTH and transcon CMP all the other projects also in oncology all the same we can use all the same linker. The only changes that we have developed what we call in August carrier system. This no.

Carriers are system, we wanted to make one example on and one example was to go into <unk>.

One anecdote because there you're really demand fairly beauty really high level of capability to produce mass production of trucks you need to do at an extremely low cost. So your basic potential have a shiba.

More expensive manufacturing process by having list injection and other things like that and it was why we developed the new novel platform. We believe it can be used many many places and specific we can have 10 targets in metabolic diseases, we have 10 targets now.

Jan Mikkelsen: We believe that our contemplation is a DC approach to skeletal growth and muscle disorder. Based on the rapid functional improvement observed in our ongoing phase 2 account is TRIP, and based on literature review, there may be a primary muscle component to a contemplation phenotype, besides the well-described effect on skeletal growth. We believe it's essential to have a continuous exposure to CMP to optimally improve muscle strength and endurance. In our People of TRIP, we will explore in point to measure how CMP might modulate the muscular weakness.

Looking at him in cotton.

Cardiovascular and other things like that so it's really moving up and open up for Mercedes to move into new areas that would be basic not really couldnt address with that too.

<unk> carrier platform, we already have established our soluble Kara the hydrogen carrier.

Thank you for taking my questions.

Thank you.

Please standby for our next question.

Jan Mikkelsen: In addition, this also means that there could be a treatment option for adults living with a contemplation. Our research in this area continues, and we expect to share more later this year along with new data from a conference where all the initial 57 patients continue on treatment with CMP for over 2 years.

Our next question comes from the line of Juran Weber with TD Cowen Your line is open.

Hi, This is joey on for your own. Thanks, so much for taking our question.

Maybe just a follow up first on the preview.

Question for Q1.

And if you could just clarify whether you plan to file an anda in the future.

Jan Mikkelsen: Turning to our own quality, we today announce that we have completed those escalation for transcon IL-2 bisagama in combination with pimple and declared recommended phase 2 dose at 120 microgram per kilo every 3 weeks. No dose limiting toxicity, vascular leak syndrome, or grade 3 or 4 cytokine release syndrome, were observed at any dose level evaluated.

So how do you think this will fare relative to some of the Johnson your competitors with double and Triple Msas.

And then I just had a follow up on SK telecom.

Yes first of all.

As we said we use similar type because we felt there was a good day.

Pier, one analog really to make an example of our take.

Take new technology platform, but also at the same time <unk> is also an interesting product opportunity itself and you know with the Transcon technology.

Jan Mikkelsen: Finally, I'm excited to share with you some new development expected to drive a state's sustained growth. We have developed a new transcon carrier platform. We integrate our reversible linkers and complements our two established carrier technologies, the soluble and hydrodeal platform. Among the many applications, we believe this technology support high-volume low-cost manufacturing in neighboring products for new-to-operative areas. We have that this proof of principle for once monthly dosing of the G-VL, one analog semi-clotide, and on our website you can see our pre-clinical data.

Release, a complete <unk>.

Modified <unk> tight so we're not changing the mode of action because we are a long acting product technology would make it both a unique pool related to clinical trials, but also reflect unique to regulatory pathways.

So from that perspective is when we look at our pipeline. We are still discussing a lot of which is the optimal product opportunities. Because we can also utilizing <unk>. So this is a wherever you still having internal discussion, where we really want to position that debt and the <unk> really are moving here.

It into a situation, where we will be ready to start to generate clinical data. We will come back to you and explain what is exactly the anode over year of working on.

Jan Mikkelsen: In summary, ascetics remains focused on building and maintaining a sustainable, profitable leading biopharmal company. With all programs making significant progress, we are near in completion of our vision 3 by 3, and have already begun the foundation for the next date of the sentence.

Okay, Great and then for my follow up for Scott can you provide any additional color.

How much share you gain.

Novo has.

Had supply constraints for their daily growth hormone and then also does your new fiscal year 'twenty three guidance reflect competition from once weekly drugs from Novo Pfizer. Thank you.

Scott Smith: I'm now turning the call over to Scott for a financial review before we open up for questions. Thank you, Jan. At the end of the note, we are making very strong progress that is sending us.

The guidance, we have built in the.

Scott Smith: I will touch on key points surrounding our financial results. For further details, please refer to our homepage file today. Total revenue for the second quarter was 47.4 million euro, including Skytrofa revenue as well as licensing services provided to third parties, primarily visa and pharmaceuticals. Skytrofa revenue for the second quarter of 2023 was 35.9 million euro compared to 31.6 million euro reported in the first quarter. Second quarter revenue was negatively impacted by two items, a negative adjustment to provision for estimated sales rebates of 2.1 million euro, which resulted from stronger than expected payer adoption related to prior periods, and a negative foreign currency impact of 0.6 million euro as compared to the first quarter of 2023 due to a weaker US dollar.

Competitive landscape that is out there and the guidance we are fully integrated what we see the trip.

Let's see how it really are helping us basic to converted over to a much more long acting but I also think you need somebody to take the perspective of the shortage of digital automotive, which is a long term process that basic policy all driven by what we call the.

Consultation of the daily growth hormone, we are facing that are leaving the market and <unk> player in the data optimal so what we see here. We just see as we have basic predicted in the last one to two years the development of the competitive landscape and we feel really viewed it.

We are confident.

House Cutover, it will continue to basic being a proceeding to be the leading product.

Scott Smith: Based on reported results from other growth hormone manufacturers, Skytrofa was the US market leader in the second quarter of 2023 with less than 10% penetration into the US pediatric GHD patient population. We see a large opportunity in front of us to grow our patient share in pediatric GHD, which we estimate to be only half of the address both US growth hormone market.

Value and continue to be in the future.

Thank you.

Please standby for our next question.

Our next question comes from the line of Carolina, Pollo Mchugh with Bahrenburg capital markets. Your line is open.

Hi, This is Lucy for Caroline. Thank you so much for taking my question.

Scott Smith: Turning to expenses, R&D costs decline 1% sequentially, primarily driven by lower endocrinology related costs, partially offset by an increase in oncology related costs. SGNA expenses grew 6% sequentially, reflecting higher external commercial expenses for Skytrofa in the US, pre-launch activities for Skytrofa outside the US, global pre-launch activities for transplant PTH, and higher employee related expenses. Total operating expenses were 175 million euro for the second quarter, up 2% sequentially from the first quarter of 2023.

So I'm just curious about.

<unk> planned for launch in Bayou, Florida chance PTH, so use that like first and you're going to launch in the German need than what would be done.

Next steps small.

To learn more about that thanks.

Thanks, a lot first of all we are not looking on.

EU is one place where the basic launching now.

We are not stopping there we also going for the interim national operation, We have a strong person that is leading our.

Scott Smith: Overall, our operating loss declined sequentially by 2% to 141 million euro for the second quarter from 144 million euro in the first quarter of 2023. We ended the second quarter with cash equivalents and marketable securities totaling 431 million euro.

Global commercial effort.

She has a strong background in Europe and international operation.

Launching in Germany is the first country, what you do but it will not be a single launch because we first actual long term, but it's cultural fit which we're doing this month's here be launching Skype over here this month in Germany, and we starting to launching <unk>.

Scott Smith: Finally, we have entered into a capped synthetic royalty funding agreement with royalty pharma for 150 million dollars in exchange for a 9.15% royalty on that sale of Skytrofa within the United States, with no royalty payments until 2025. The royalty payments are capped at 1.65 times the purchase price is fully paid prior to December 31, 2023, or 1.925 times the purchase price is not fully paid by December 31, 2023. Further details are disclosed in a separate 6K file today.

<unk> is expected in the beginning of next year really really in the beginning of next year and we will then rollout in all the different EU countries, where we expect to get the approval and including U K, which we still can apply for fast manner and then we are starting to.

Progress in the international operation, meaning is this country, where you can support the launch of a product either from an EU approval or from a U S. Approval. So this is how we really are going to build our global commercial strategy.

Scott Smith: Looking forward, we expect to continue momentum for Skytrofa in the United States for the balance of this year, and we are raising our expectations for Skytrofa revenues to 165 to 170 million euro for full year 2023.

Okay. Thank you very much for taking my question and congrats with all the.

Progress. Thank you. Thanks, so much.

Scott Smith: Let me now also provide a review of selected key program milestones. For Transcon growth hormone, we are on track to launch Skytrofa in Germany this month, and we expect to report top line data from the Global Phase 3 4-Style in Adult GHD, our first potential label expansion in Q4. For Transcon PTH, we believe we will be in a position to resummit the NDA for adults with typo-parathyroidism in October, and we expect a European Commission decision in Q4.

Thank you.

Please standby for our next question.

Our next question comes from Manav either shell.

<unk> with Oppenheimer. Your line is open.

Great. Thanks for taking my question just one question from us as it pertains to Scott discussed.

Discussions with endocrinologists.

I've said that at the same time that you've grown the product. They are also seeing shortages in the daily.

Scott Smith: If approved, we plan Transcon PTH is our second product launch in Germany in early 2024. For Transcon C&P, we plan to share follow-up data from the open label extension of our phase 2 accomplished trial in Q4 this year, and we expect to report top-line results from approach our pivotal phase 3 trial in the second half of 2024. Within the oncology therapeutic area, during this quarter, we expect to dose the first patient with a combination of Transcon TLR-78 agonist and Transcon IL-2 beta gamma, and during Q4 we will be presenting dose escalation data, supporting recommended phase 2 dose at ESMO on Transcon IL-2 beta gamma in combo with Pembro-Luzumab and updated monotherapy dose escalation data. As Jan mentioned, we will not comment further on the NDA resummission procedure for Transcon PTH while we are having ongoing communications with FDA.

Injectables market kind of providing more opportunity for Sky Trophy.

Which may maybe due to some manufacturer is shifting over to <unk> that may be for <unk> ones versus growth hormones. Just wondering if you could comment on that dynamic and how you may see those shortages.

<unk>, we're changing in the near term thank you.

And first of all the daily growth hormone market in the U S is consisting of $5 six player.

To my knowledge I only believe there's one or two of them two of them have a.

Our tier one players so I don't believe that you can take the comments on shifting to the <unk>. One segment is the recent fall short.

Our.

Daily growth hormone.

The key element is basic the long term perspective of what's happening in the daily growth hormone that started already for two or three years ago and they are our phase two data came out where we saw that there was an.

Operator: With that operator, we are now ready to take questions. Thank you. Ladies and gentlemen, as a reminder to ask the question, please press star 1-1 on your telephone, and then wait to hear your name announced. To withdraw your question, please press star 1-1 again. We ask that you limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster.

What I call a classical way to leaf market. We sold most of the basic rate of the sales force that got great off.

Promotion that goes right. After hope today many of them basic has stopped manufacturing for BEC stop subcontracting to European countries and this is a part of what you see is driving that basic the daily growth hormone shorter because of the consolidation got everyone got stopped if there has been in the old days.

Li Watsek: Our first question comes from the land of Lee Wattscac with Cantif.

Scott Smith: Ilana is open. Great. Thank you for taking my question. I understand that there is a limited color that you can provide regarding the NDR resummission, but just wondering if you can sort of elaborate on the additional information that's needed from the type of meeting and what are the gating steps for you to refile on the day. Yeah, and Lee, this is Scott. We cannot comment further on the resummission procedure while we are having ongoing communications with FDA. But we believe we will be able to resummit in October as we stated. Okay, understood.

45 years, everyone else can just taking it's not happening because they're leaving the Gulf demand market. So I think we need to go back to fundamentals fundamentals. These pet that daily growth hormone consolidation or rich data for three to four years, because there is a how you basically optimal financial return to ensure and what you see now is.

And of the consolidation, where you see some shortage in the daily because that is not so many that really want to supply it because it's not really an interesting business. If you have a big pharma a large entity selling for less than $100 million you cannot have a positive P&L of soft product you want to leave and they are leaving and I will leave.

I would get out as fast as possible and this is what you see.

Scott Smith: So, the second question is, maybe just comment on the timing behind doing a roll-a-t from a deal right now. Yeah, this is Scott again. I think that, you know, we looked at a transaction that had very attractive terms and allowed us to lower the cost of capital. Thank you.

Thank you and.

And then also a question with respect to the.

The new GOP, one work that <unk> been doing well.

Operator: Please stand by for our next question.

I wanted to ask about what your freedom to operate there is presumably if you were to move forward with the candidate using one of the API as you would have to be pursued in agreement with.

One of the respective farmers and incentives.

Something we should look out for thank you.

The third one is really interesting from our IP suspected because there's actually a lot of freedom to operate in the <unk> space. This is really surprising but it is not surprising when you think about many of them are old product that basic across developed and diabetes and then godfrey position into the era of obesity. So from that perspective, there's a lot of freedom.

Paul Choi: Our next question comes from the line of Paul Choi with Goldman Sachs.

Paul Choi: Ilana is open. Hi. Good afternoon. And thank you for taking the question. Just on the commercial piece. Can you maybe comment on where additional share opportunities remain for Scentrofa? One thing we noticed was that there was a sequential decline in the gross margin. So, can you maybe just comment on whether some of these sharegames and opportunities are coming at the expense of potentially higher rebating and or discounting? And then I have a follow.

To operate of really interesting what are we doing with our time is basic making to the best in class product opportunities because we can really address some of the tolerability data is by providing for simply if you'd use. It. Once weekly you will have a flat curve, meaning is that a peak set PK curve not really big scores and that gives you a <unk>.

<unk> you can also take it if you have problems with adherence we note that only one third of the patients on treatment. After one year. After TLLP treatment. So we need to do something to improve the hearings are proof that way that vacated product both related to tolerability and adherence which is the most important for that.

Jan Mikkelsen: Let us just go back and give what was really the fundamentals for us in our commercial strategy in the US market, and this is exactly the same strategy we basically begin to eat single market. We want to be the leading product in value, and we want to do it in a growing growth hormone market. So we basic building on the product strength of Skytober. And we have seen a that is really happening in the US.

Patient.

Great. Thanks, very much for taking the question.

Thank you.

As a reminder, ladies and gentlemen that star one to ask the question.

Jan Mikkelsen: We have seen where we basic come in, and we set the market, and this is basic what we are doing now. What we see, we see a continued stable growth on patient coming both from sweet patient patient coming as new patient, and we see it in a continued manual coming week by week, months by once. And we also feel that we are now in a position, as we said in the script, the physician, the patient, everyone have seen really the full potential of the Skytober, because they have seen how we really are in position to give a better outcome related to analyzed hyperc, that you will typically see, even in a highly compliant data growth hormone setting, and that is basic why we see this.

Okay.

I'm showing no further questions, ladies and gentlemen that concludes our Q&A portion. We went out we would like to thank you.

On today's call. This concludes the call you may now disconnect.

So much.

Yeah.

Okay.

[music].

Okay.

Yes.

[music].

Scott Smith: And it will only be enforced when we basically can get additional indication of the why we really are thrilled for here, end of the year, Q4 come out with data from our dog growth hormone deficiency, which we really can show also that we really can provide and improved treatment option to this patient too. And Paul on the gross margin question, the Skytrofoam, remember the gross margin is for all revenue, which includes some past through revenue, as we mentioned. So I would say the Skytrofo gross margins are largely unchanged, pretty stable over the last several quarters.

Scott Smith: Okay, thanks for the additional color Scott, and then I follow up question on transcon CNP for the phase three trial. Can you comment on whether the regulators have asked for any additional clinical endpoints besides as a focal point for actual approval decisions in addition to HPV or absolute high growth, and just sort of any other data you may be collecting to differentiate from the approved product on the market. Thank you. Yeah, first of all, the primary end point is analyze height velocity over 12 months, and that is the primary end point.

Scott Smith: We are discussion additional secondary end point in related to the end point we already have with really should go into the biology. The idea how we really can address as we stated the script, we believe that a condo place is not only a skeletal dysfunction, but also have a muscle impact. And we really have seen benefit there, which are really are being supported with our review of literature, where you really can show how a condo place you have a muscle weakness.

Scott Smith: And we believe that this is one of the reason why we see 100% attention in our trial, and it was an immediately effect we observed in our phase two trial. And this is why we really is extremely thrilled to really take this product transcon CNP out. Not only we believe that there is a clear benefit for pediatric, but potential that can also be in improvement for adults with our condo place.

Paul Choi: Thank you.

Leland Gershell: Please stand by for our next question. Our next question comes from Leland Gershell, with Lee Rick Pontus, a partner. Yalan is open.

Leland Gershell: Great. Thanks so much and congrats on all the progress. I was wondering how the growth to net for Sky Trofa has been evolving in the United States and what your pricing strategy will be in Germany and other European markets. Thank you.

Jan Mikkelsen: Let me take the last part of the equation first. You know, we believe we're providing an improved treatment for their patients. We also believe that we're following up to what we said before, a responsible premium pricing. This is how we really have launched our price structure in the US and with the continue to implement that throughout all the different markets. This is where we want to be because we're providing an improved treatment.

Scott Smith: Scott, would you take the last part? Joe, we don't comment on GTN evolution. We just want you to focus on revenues ultimately, but I think we gave some interesting points that on reported revenues, we were the market value leader in the quarter, with less than 10% penetration into the pediatric DHD market, which itself is only half of the total growth hormone market in the US. Yeah, and so when you start to make this calculation, which you likely will do, setting and calculate that what does mean mean.

Scott Smith: The basic mean is that we have the vision on being the value driver, the most value product, but in a growing growth hormone market, and there's definitely what we are managed to do here because of the improvement in treatment we're providing.

Leland Gershell: Thank you.

Yaron Werber: Please stand by for our next question. Our next question comes from the line of injuries, arborides with wet bush security. Yolanda's open. Thanks for taking our questions and congrats on all the progress. With the EGFR data, how should we interpret the 50% response rate? And how do you expect the EGFR analysis to be reflected on the potential label? And looking at the baseline characteristics of patients in pathway 15 in the transcom PTH group history of kidney stones, can you speak to the impact of a transcom PTH hat on kidney stones? And if you plan on sharing this data in the future, and then I won't follow up. Okay, thanks a lot.

Jan Mikkelsen: We are extremely thrilled with this data. Why we are thrilled because we really believe it's providing a huge benefit to the patients. A huge benefit because one of the elements that the patient really see is really on conventional therapy, you're basic, are dividing really in impairment, which in the end can be worst case scenario where you go into dialysis and really need to have a new kidney. So out from that perspective, when we looked at the data.

Jan Mikkelsen: We basically selected 60 out from the perspective is that some kind of a accepted definition of really where you have really insufficient or not. And why we were thrilled with the data that we could take 50% 50% of the patient that basically already were classified of having really insufficient and basically move them up to what we call normality. I believe that is a key element for how we really can work with and help the patient group here.

Jan Mikkelsen: And I think when we solve the data, we believe that is first time we really seen any compound that basically ever, ever have shown this effect. Related to the labeling, we are that did this here as a post-talk analysis, you can say, yes, we should have included in our key second there already from the beginning when we saw this major impact, but still for us it was really unbelievable when we really have seen the data and how well it is.

Jan Mikkelsen: And we will soon when we are presenting this data into publication, through interaction with patient groups that really also understand the benefits that can get for Transcon PTAs in there. We will go out and also talk with Rectator agencies, but we also believe that having it in peer-renewed publication is a key element for us really to be in a position really to communicate about this fantastic data.

Jan Mikkelsen: Fantastic.

Jan Mikkelsen: And then comments on the kidney stones? The kidney stones, I believe I have not seen data on that point, but potentially I can ask them if there is a post-talk analysis we also can do specifically related to kidney stones. I cannot recall. I have seen anyone. Thank you.

David Lieberwitz: Please stand by for our next question. Next question comes from the line of David Lieberwitz with City. The line is open. Thank you very much for taking my question. Could you run us through the differences of the new linker you were talking about? And, you know, you have a pre-clinical data for GLP1. Can we see that candidate move towards the clinic? Additionally, what other types of candidates do you see applying towards?

David Lieberwitz: Yeah, we are really, really extreme. I actually asked you of this expanding of the Transcon technology because we believe we need to be everywhere where the patients are. And it's building on the same principle again. So when you think about the Transcon linker, they are identical or exactly the same kind that you have seen on both Transcon growth among Transcon PTAs and Transcon CMP or the other product also in oncology. All the same we can use are the same linker.

David Lieberwitz: The only changes that we have developed what we call a novel carrier system. This novel carrier system, we wanted to make one example on. And one example was to go into a GLP1 envelope because there you really demand really, really, really high level of Capability to produce mass production of drugs. You need to do it on extremely low cost. So your basic potential have a cheaper, more non-expensive manufacturing process by having less injection and other things like that.

David Lieberwitz: And that was why we developed the new novel platform. We believe it can be used many, many places and specific. We can have 10 targets in metabolic diseases. We have 10 targets now looking on in cardiovascular and other things like that.

Jan Mikkelsen: So it's really moving up and open up from the stages to move into new areas that we basically not really could not dress with the two transcon carrier platform we already had established our soluble carrier on the hydrogen carrier. Thank you for taking my questions.

Jan Mikkelsen: Thank you.

Yaron Werber: Please stand by for our next question. Our next question comes from the line of Yalvan Weber with TV Cohen. Yalvan is open.

Jan Mikkelsen: Hi, this is Joyce on for your own. Thanks so much for taking our question. Maybe just to follow up first on the previous question for your GLP1. If you could just clarify whether you plan to file an I&D in the future. And if so, how do you think this will fare relative to some of the drugs from your competitors with double and triple MOAs? And then I just had to follow up on scatropa.

Jan Mikkelsen: Yeah. First of all, we, as we said, we used semi-glutite because we thought it was a good GL1 analog, really, to make an example of our new technology platform. But also at the same time, semi-glutite is also an interesting product opportunity itself. And you know, with the transcontin technology, it will release a complete unmodified semi-glutite. So we're not changing the mode of action because we are a long action product technology. We would make it both unique, related to clinical trials, but also with unique to rectatory pathways.

Jan Mikkelsen: So from that perspective, when we look at our pipeline, we are still discussing a lot of which is the optimal product opportunities because we can also utilising other GPL wants. So this is where we are still having internal discussion where we really want to position it that and the day we really are moving it into a situation where we will be ready to start to generate a clinical data. We will come back to you and explain what is exactly the analog we are working on.

Jan Mikkelsen: Okay, great. And then for my follow-up for Skatrofa, can you provide any additional color on how much share you've gained while NOVO has had supply constraints for their daily growth hormone? And then also does your new fiscal year 23 guidance reflect competition from once-weekly drugs from NOVO and Pfizer? Thank you. The guidance we have visited in the competitive landscape that is out there. And the guidance we are fully integrated, what we see, the threat, or you can say how it really are helping us basically to convert it over to a much more long action.

Jan Mikkelsen: But I also think you need some way to take the perspective of the shortest of daily growth hormone, which is a long-term process that basically are partially all driven by what we call the consolidation of the daily growth hormone, where basically they are leaving the market and there will be very few players left in the daily growth hormone. So what we see here, we just see as we have basically predicted in the last one to two years the development of the competitive landscape, and we will be very, very confident with how Scott Lover will continue to basically be in a proceeding to be the leading product in value and continue to be in the future.

Jan Mikkelsen: Lee Sandberg for our next question. Our next question comes from the line of Kerala Palomacue with Berenberg Capital Market, Kielaan is open. Hi, this is Lucy for Kerala. Thank you so much for taking my question. So I'm just curious about the plan for launching the EU for the transport PKH. So you said like first you were going to launch in the Germany, then what would be the next step? So we're not to learn more about that. Thanks. Thanks a lot.

Jan Mikkelsen: First of all, we are not looking on the EU is one place where we basic are launching now, but we're not stopping there. We are also going for the national operation. We have a strong person that is leading our global commercial effort, Kiela. She has a very, very strong background in Europe and international operation. We are launching in Germany as the first country, what you do, but it will not be a single launch, because we first act so long soon with Kaitrofer, we're doing this month here.

Jan Mikkelsen: We launched in Kaitrofer here, this month in Germany, and we're starting to launch PKH in the beginning of next year, really, really in the beginning of next year. And we will then roll out in all the different EU countries where we expect to get the approval, including UK, which we still can apply for in a very fast manner. And then we are starting to progress in the international operation, meaning is this country where you can support the launch of a product item from an EU approval or from a US approval. So this is how we really are going to build our global commercial strategy.

Unknown Executive: Okay, thank you very much for picking my question and now congrats with all the full progress. Thank you. Thanks so much. Thank you.

Jan Mikkelsen: Please stand by for our next question. Our next question comes from the new commercial with Oppenheimer. Yalan is open. Great. Thanks for taking my questions. Just one question from us as it pertains to Kaitrofer, you know, discussions with the kind of chronologists, they've said that at the same time that you've grown the product, they've also seen shortages in the daily injectables market, kind of providing more opportunity for Kaitrofer, which may maybe due to some manufacturers shifting over to pens that may be for TLP1 versus growth hormones.

Jan Mikkelsen: Just wondering if you comment on that dynamic and how you may see those shortages persisting or changing in the near term. Thank you. First of all, the daily growth among marketing in the US is consisting of five to six players. And I actually, to my knowledge, I only believe there's one or two of them or two of them have a TLP1 players. So I don't believe that you can general take the comments on shifting to the GPL1 segment is the reason for shortage in our daily growth hormone.

Jan Mikkelsen: I think the key element is basic, the long-term perspective of what's happening in the daily growth hormone. They started already for two, three years ago, when our phase two data came out, where we saw that there was an What I call a classical way to leave a market, we saw most of them basically got rid of the sales force, they got rid of every promotion, they got rid of the hope. Today many of them basically have stopped manufacturing for year back, stopped subcontracting to European countries, and this is a part what you see is driving the basic, the daily growth among shorties, because the consolidation got everyone got stopped, if there has been in the old days for four to five years everyone else could just take in, it's not happening because they are leaving the growth among market.

Jan Mikkelsen: So I think we need to go back to fundamentals, the fundamentals is that the daily growth among consolidation already started for three to four years because this is how you basically get optimal financial return to ensure, and what you see now is the end of the consolidation where you see some shorties in the daily, because there has not so many that really wants to supply it, because it's not really an interesting business, if you have a big firm and large entity selling for less than 100 million, you cannot have a positive P&L of source product, you want to leave, and they are leaving, and I would leave too, I would get out as fast as possible, and this is what you see.

Jan Mikkelsen: Thank you, and then also a question with respect to the new GLP-1 work that you've been doing. I want to ask about what your freedom to operate there is, presumably if you were to move forward with the candidate using one of the APIs, you'd have three to wee bits here in agreement with one of the respective farmers and descendants is that something we should look out for. Thank you. Yeah, the GLP-1 is really interesting from IP suspects, because there's actually a lot of freedom to operate in the GLP-1 space.

Jan Mikkelsen: This is really surprising, but it's not surprising when you think about many of them are old products that basically have worked, developed and diabetes, and then got repositioned into the era of obesity. So from that perspective, there's a lot of freedom to operate of really interesting. What we're doing with our them is basically making to the best things as product opportunities, because we can really address some of the tolerability that is by providing for simply if you use it once weekly, you have a flat curve, meaning is that a P-flat PK curve, not really the excursion that gives you a side effect.

Jan Mikkelsen: You can also take it if you have problems with adherence. We know that only one-third of the patient are on treatment after one year, after GLP treatment. So if we need to do something to improve the adherence, improve the way that they get it product, both related to tolerability and adherence, which one is the most important for the patient. Great, thanks very much for taking the question. Thank you. As a reminder, ladies and gentlemen, that start one one to ask the question. I'm showing no further questions.

Operator: Ladies and gentlemen, that concludes our Q&A portion. We would now like to thank you for your patience and today's call.

Operator: This concludes the call. You may now disconnect. And I'm not the only one who's been here today, I'm not the only one who's been here today, I'm not the only one who's been here today[inaudible]