Q2 2025 Ascendis Pharma AS Earnings Call

August 7, 2025

And there will be a question and answer session to ask a question. During the session you will need to press star one one on your telephone you will then hear an automated message advising that your hand is raised to withdraw. Your question. Please press star one one again you may ask one question and one follow up please be advised that today's conference is being recorded I would now like to hand the conference over.

To your first speaker today, Scott Smith I send this pharmacy UFO. Please go ahead.

Monday talk operator, and thank you everyone for joining our second quarter 2025 financial results Conference call.

I'm Scott Smith.

Executive Vice President and Chief Financial Officer at a service farmer joining.

Joining me on today's call are yen molar Nicholson.

President and Chief Executive Officer, Sherry Glass, Chief Business Officer, Jane <unk> Executive Vice President and President.

U S market, Amy shoe executive Vice President of endocrine and rare disease Medical Sciences, and Chief Medical Officer.

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 statements regarding our commercialization and continued development of Sky Trophy and you over the past as well as certain financial expectations.

Our pipeline candidates and our expectations with respect to their contingent progress and potential commercialization or strategic plans partnerships and investments our goals regarding our clinical pipeline, including the timing of clinical results in trials are ongoing and planned regulatory filings and our expectations regarding the timing and the results of our regulatory regulatory.

These statements are based on information that is available to us as of today actual results may differ materially from those in our forward looking statements and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change except as required by law for additional information concerning the factors that could cause actual results to differ materially. Please.

Good day, and thank you for standing by. Welcome to the Q2, 2025 ascendis Pharma earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session to ask a question during the session. You will need to press star 1, 1 on your telephone. You will then hear an automated message. Advising that your hand is raised to withdraw your question. Please press star 1 1. Again, you may ask 1 question and 1 follow-up. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first Speaker today. Scott Smith ascendis Pharmacy CFO please go ahead.

Talk operator and thank you everyone for joining. Our second quarter of 2025 Financial results conference call.

I'm Scott Smith.

Executive Vice President and Chief Financial Officer at ascentis Farmer.

Joining me on today's call Are Yin Mueller, Mickelson.

See our forward looking statements section in today's press release and the risk factors section of our most recent annual report on form 20-F filed with the SEC on February 12, 2025, Transcon growth hormone Transcon Hgh <unk> is now approved in the United States by the FDA for the replacement of endogenous growth hormone in adults with growth hormone deficiency. In addition to the treatment of <unk>.

Executive officer, Sherry glass Chief business officer, Jae woo, Executive Vice President and president.

Talk operator, and thank you everyone for joining. Our second quarter, 2025 Financial results conference call.

I'm Scott Smith.

Executive Vice President and Chief Financial Officer at ascendis Farmer.

US market, Amy Shu, Executive Vice President, of endocrine and rare disease, medical sciences and chief medical officer.

Trick Ghd and in the EU has received MAA authorization from the European Commission for the treatment of pediatric ghd.

Joining me on today's call Are Yin Mueller, Mickelson.

Transcon PTH is approved in the U S by the FDA for the treatment of hyperparathyroidism in adults and the European Commission in the United Kingdom Medicines, and health products regulatory agency has granted marketing authorization for Transcon PTH as a replacement therapy indicated for the treatment of adults with chronic hyperparathyroidism.

President and chief executive officer. Sherry glass Chief business officer. Jae woo, Executive Vice President and president.

Otherwise please note that our product candidates, our investigational and not approved for commercial use as investigational products the safety and efficacy of the product candidates have not been reviewed or approved by any regulatory agency. None of the statements. During this conference call regarding our product candidates shall be viewed as promotional.

On the call today, we will discuss our second quarter 2025 financial results and we will provide further business updates.

Following some prepared remarks, we will then open up the call for questions.

That.

Let me turn it over to you.

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 provisions of the Private Securities Litigation Reform Act. Examples of such statements may include, but are not limited to, statements regarding our commercialization and continued development of Skyroof and new over-the-path initiatives, as well as certain financial expectations for our pipeline candidates and our expectations with respect to their continued progress and potential commercialization. Our strategic plans, partnerships, investments, and goals regarding our clinical pipeline, including the timing of clinical results and trials, our ongoing and planned regulatory filings, and our expectations regarding the timing and results of our regulatory decisions. These statements are based on information that is available to us as of today. Actual results may differ materially from those in our forward-looking statements, and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change, except as required by law. For additional information concerning the factors that could cause actual results to differ,

Thanks Scott.

Good afternoon, everyone.

The second quarter of 2025 demonstrated strong momentum towards fulfilling our vision 2000 <unk>.

As we progressed towards blockbuster status for multiple products and expand into for future innovation.

The continued strong global launch of your <unk>.

5, transcon growth hormone or transcon HGH is now approved in the United States by the FDA for the replacement of endogenous growth hormone in adults, with growth hormone deficiency, in addition to the treatment of pediatric ghd, and in the EU has received MAA authorization from the European commission for the treatment of pediatric ghd.

Increases our confidence that Europe is on the way to become a blockbuster.

Product with doable global leadership for the treatment of hydropower Tory Smith.

If the granting of <unk> with your footprint.

Transcon pth is approved in the US by the FDA for the treatment of hypoparathyroidism in adults and the European Commission in the United Kingdom. This medicines and Health Products regulatory agency have granted marketing authorization for transcon pth. As a replacement therapy, indicated for the treatment of adults with chronic hypoparathyroidism.

Undue Reliance on these statements, we assume no obligation to update these statements as circumstances change, except as required, by law for additional information, concerning the factors that could cause actual results to differ materially, please see our forward-looking statement section, today's press release and the risk factor section of our most recent annual report on form 20th filed with the SEC on February 12th, 2025, transcon growth hormone or transcon HDH is now approved in the United States by the FDA for the replacement of endogenous growth hormone in adults, with growth in deficiency, in addition to the treatment of pediatric ghd, and in the EU has received MAA authorization from the European commission for the treatment of pediatric GHC.

Recognizing its potential.

Approved to provide a significant improvement in the safety and.

Effectiveness of the treatment of a contemplation.

Otherwise, please note that our product candidates are investigational and not approved for commercial use as investigational products. The safety and efficacy of the product candidates have not been reviewed or approved by any regulatory agency. None of the statements. During this conference call regarding our product candidates shall be viewed as promotional.

The announcement of the interim phase two results from the first combination therapy trial of Transcon, CMP and transcon growth hormone highlights our potential to boost healthy growth.

Transcon pth is approved in the US by the FDA for the treatment of hypoparathyroidism in adults and the European Commission in the United Kingdom's. Medicines and Health Products regulatory agency have granted marketing authorization for transcon pth. As a replacement therapy, indicated for the treatment of adults with chronic hypoparathyroidism.

On the call today, we'll discuss our second quarter 2025 Financial results and we'll provide further business updates.

Completion.

And we achieve first augmenting claimed label expansion for Sky Twofer.

If they approved it for treatment of adult growth hormone deficiency.

I will review these key developments in more detail in my prepared remarks.

Beginning with your pets.

Revenue in the second quarter reached 103 million more than double of Q1.

Quarter of 2025, demonstrated strong, momentum towards fulfilling our vision 2030.

Despite strong currency headwinds.

In the U S.

<unk> launched through June 30, more than 1500 prescribers growth prescription for wrong suite 100 unique patients.

As we progress towards Blockbuster status for multiple products and expand our engine for future innovation.

Reflecting both the deep unmet medical need and compelling product profile.

The continued strong Global Longs of Europeans increases, our confidence that Europe has is on the way to become a plot buster.

For U S patients receiving a prescription for your parents the majority have received.

Product with durable, Global Leadership of the treatment of hypoperfusion.

FDA granting of.

Within three months.

Yes.

Outside of the U S. We continue to see steady.

Revenue growth in both our Europe direct and international market and we currently expect further exploration of the revenue growth to in Europe as reimbursement becomes that the illiquid in additional Europe direct countries.

Priority review for TransCon CMP recognizes its potential, if approved, to provide a significant improvement in the safety and effectiveness of the treatment of a condyloma.

Yes.

With a broad label, calling all types of chronic hydropower supported by international guidelines and a prominent reference to your point in recently published best practice comes into statement, we expect growth to continue.

The announcement of the interim. Phase 2 results from the first combination therapy trial of Trenton CMP and transcon. Go to more highlights our potential to boost Healthy Growth in a pleasure,

We have ongoing clinical program to support label expansion for example in older children and initiated partway 60 trial.

And we achieved that first of many planned labor expansions for Sky. Topher, when they approved it for treatment of the DOT go deficiency,

I will review these key developments in more details, in my prepared remarks.

<unk> safety and efficacy trial to support titration up too.

With your pets.

Revenue in the second quarter reached.

60.

Microgram doses in the U S. The primary endpoint of this trial could be efficacy at 26 weeks the same as our people with the phase III trial input.

103 million euros more than double of q1.

Despite a strong currency headwind.

We are building towards your pets long term global leadership based on three key pillars differentiation.

Pain and access.

I will first speak about differentiation to mode of action.

In the US from long to June 30, more than 1,500 prescribers wrote prescription for around 3,100 unique, patients reflecting both the Deep unmet medical need and compelling product profile.

Replacement therapy for hydrocodone must maintain the same mode of action and doses PTA throughout the body and sustained physiological levels of Pte 824 hours seven days a week.

for us patient receiving as prescription for your pets, the majority have received payer approval within 3 months,

Based on all the data we have seen Europe is the only product to demonstrate we can do this.

Outside of the us, we continue to see steady Europe at Revenue, growth in both our Europe, direct and international market.

With normalization of key elements, such as serum calcium phosphate kidney function bone turnover and quality of life.

And we currently expect further acceleration of the revenue growth. When Europe has reimbursement becomes available in additional Europe, direct countries.

Secondly is domain.

Europe. It is available we see strong interest in growing enrollment.

For the U S market in just two quarters, we had around 3100 unique patients enrolled across more than 1501 <unk>.

With a broad labor, calling all types of chronic hyper pair supported by International guidelines and a prominent reference to Europe pet in recently. Paak is best practice consent to statement. We expect growth to continue.

Describe for US, we're seeing broad uptake across the entire country and.

And we don't.

And with our estimate of 70 to 90000 patients in the U S. We still have ample room to grow.

We have ongoing clinical program to support labor expansion. For example, in Odo children and initiated pathway, 60 trial, a single arm safety, and efficacy trial, to support titration up to

Outside the U S.

60.

We have recognized revenue for more than 30 countries.

And currently we have commercial agreement covering more than 75 countries.

Microgram doses in the US, the primary endpoint of this trial will be efficacy at 26 weeks the same as our pupil phase 3 trial input.

So it is excess in.

In the U S. We see favorable access continue to improve we'll approvals coming across all payer segment in Europe direct we have full commercial launch in Germany, Austria announced speed, we expect additional commercial launch.

we are building towards ufs, long-term Global Leadership, based on 3 key pillars, differentiation demand, and access

I will first speak about differentiation through mode of action.

Later this year, both in Europe direct an interim milestone market.

In Japan, our partner charging expect approval for Europe later this quarter.

And replacement therapy for hyper power. Must maintain the same mode of action as industrious pt8 throughout the body. And sustain, physiological level of pt8 24 hours, 7 days a week.

We consistently hear about how transformative two yogurt has been for patients.

And do not believe that any public disclosed drop in clinical development has the potential to meet this efficacy and safety bar set by your pets.

Based on all the data we have seen, your pet is the only product to demonstrate. It can do this with normalization of key elements, such as serum, calcium phosphate, kidney function, bones, and overall quality of life.

As shown in our clinical trial.

Second is the main.

He has been extended for all patient groups cost surgeon HP pitch.

Where your pet is available, we see strong interest and growing enrollments.

Two small <unk>.

<unk> subtypes like <unk> syndrome, eight years, one and idiopathic hypo Payor, notably Europe. It has broad approval from the FDA.

For the US market in Just 2 full quarters. We had around 3,100 unique patient. Enrolled across more than 1,500 that describe us. We seeing a broad optic across the entire country.

Commission and other regulatory authorities for the treatment of all forms of chronic hyper payroll.

and we don't,

For all of their bulk reason, we are confident that Europe. It has the potential to become a global blockbuster overtime and we continue to expand our global leadership position in the treatment of hydropower.

Moving now to Transcon CMP.

Of 70 to 90,000 patient. In the US. We still have ample room to outside the US. We have recognized revenue for more than 30 countries and currently we have commercial agreement covering more than 75 countries.

Third is access.

We believe transparency is moving the bar on safety efficacy and tolerability and reducing treatment.

In the US.

And we believe transcon CPE is well positioned to become the leading mono therapy treatment for contemplation.

In clinical trials, we have seen the decided in year growth across all ages and to our knowledge. Once weekly transcon therapy is the only product to show statistical significant improvement beyond the near growth compared to placebo in the pivotal trial for example.

We see favorable, access continue to improve will approvals coming across all payers segment in Europe. Direct, we have full commercial Longs in Germany, Austria and now Spain, we expect additional commercial long-term later. This year, both in your direct and international market.

In Japan, our partner chain expects approval for your path later this quarter.

We consistently hear about.

Improvements in Lake Boeing and quality of life.

How transformative to you. Okay? Has been for patient.

We have demonstrated safety and tolerability profile comparable to placebo, including no evidence of HIFU to Institute.

and do not believe that any public disclosed drug in clinical development, have the potential to me this efficacy and safety bar set by Europe has

And extremely low frequency of 1000 injection.

As shown in our clinical trial.

Injection site reaction.

Since our announcement of monotherapy data, we have engaged with patient advocacy.

There has been extended for all patient groups post surgeon HP patient.

Kate physicians and regulators.

Too small genetic subtypes like DDOS syndrome. 8 years 1 and idiopathic hyperair not only

All have appreciated the differentiating epilepsy of transcon CMC in comparison to placebo to increase linear growth, while also leading to stronger muscle function improved body proportionality and licked, Boeing and reducing overall debt burden of a contemplated related complication.

Ufit has brought approval from the FAA, the U, oopen commission and other regulatory authorities for the treatment of all forms of chronic hyperair.

For the majority of treated children and of course patient and caregivers depreciate them, most lower burden of once weekly injection.

For all of the about reason, we are confident that Europe has the potential to become a doable Blockbuster over time and we continue to expand our Global Leadership position in the treatment of hyperair.

Moving now to science on CMP.

During the second quarter of 2025, FDA accepted our NDA submission for priority review with a <unk> date of November 13, recognizing transcon CMP <unk> accrued.

<unk> provide a signal improvement in safety and effectiveness.

We Believe therapy is moving the bar on safety, efficacy, and tolerability, and reducing treatment building. And we believe when it's going to CP is well positioned to become the leading monotherapy treatment for and a contemplation.

Next I will.

To review our combination trial results as we look forward to the anticipated approval of Transcon CMP as mono therapy, we are investigating <unk> in combination with our once weekly transcon growth hormone.

In children with achondroplasia in our coast trial.

In clinical trials, we have seen the desired linear growth across all ages and to our knowledge, once we are the only product to show statistical, significant Improvement Beyond linear growth, compared to Placebo, in a pubal trial. For example, improvements in Lake Boeing and quality, or life.

2025, we announced week 26 interim results, which showed a clear boost in linear growth and body purpose magneti improvements greater safety and Tolerability profile consistent with dues officer for monotherapy.

we have demonstrated a safety and tolerability profile comparable to Placebo, including no evidence of hypothesis effect, and extremely low, frequency of milk price, injection, site reaction,

In the combination trial, both treatment groups exceeded the 97%.

Since our announcement of monotherapy data, we have engaged with patients.

Factor for growth of the average stay to children.

Advocates, physician and regulators.

Meaning they're achieving linear growth at a rate higher than an average check.

The week 26.

Data demonstrate the potential to boost growth of around three X or three times above that observed with mono therapies addressing the hyperactive FTR treat receptor pathway.

Supporting the scientific rationale for treating the transcon and <unk>.

CMP and transcon growth hormone combined.

All have appreciated the differences in ability of trans consumed in comparison to Placebo to increase, linear growth, while also leading to Stronger muscle function improved, body proportionality, and leg bowing and reducing overall, the burden of are places related complication for the majority of treated children. And of course, patient and caregivers appreciate the most lower burden of 1 weekly injection.

These results are without precedent in achondroplasia importantly, we see clear indications that is healthy growth with linear growth accommodated by improvement in body proportionality and readout exploration of bone AIDS all patient continuing the study as of today.

During the second quarter or 2025. If they accepted our NDA submission, for priority review, with a pdufa date of November 30th, we recognizing transcon, CMP, as a therapy, that could be approved, provide a signal Improvement in safety and all effectiveness,

This results enforceable road of Transcon CMP.

Strong fundamentals.

In contemplation.

We look forward to our 12 month data release later this year and tend to start a phase III study of the combination therapy in children. The echo to inflation by the end of 'twenty. Five. In addition, we also expect to Uniti upheaval combination trial in hyper contemplation.

Next, I will review review our combination tribe results as we look forward to, the ncpa approval of transcon cop as Moines therapy. We are investigating it in combination with our 1 weekly transcript of tomorrow in children with a contemplation in our coastline.

I will now turn to slide 12.

In June 2025 we announced week 26, interim results which showed a clear boost in linear growth and body proportionality Improvement.

Scotch Hoover is established as a high value brand and a treatment choice for pediatric Kokomo deficiency.

VA safety and tolerability profile consisting with those observed for monotherapy.

Recently received FDA approval for adult growth hormone deficiency and with further label expansion planned schedule verbal remains and fundamental pillar in our strategy to become the global leader in treatment of cortisol.

Q2 revenue first quarter offer.

And Arabic chart.

51 million Bill.

The week, 26.

We continue to see growth in the number of people treated this cutover based on new patient start.

We expected reason label expansion for adult growth hormone deficiency to further drive long term growth or our market research shows cutover is for treatment of choice for pediatric automotive efficiency among patients and physicians.

Data demonstrate the potential to boost growth of around 3 eggs or 3 times about that observed with monotherapy addressing the hyperactive. FDR tree receptor pathway

supporting the scientific rationale for treating with transcon and

CMP and transcon. Go to Moon combined.

And we believe we can achieve the same status for treatment of adult Kokomo deficiency.

Our phase III basket time of Cutover plan to begin later this year will include a range of established equal tumor indication, including ISS shop deficient tuna and FDA.

These results are without proceeding in a condensed place. Importantly, we see a clear indication that there is healthy growth with linear growth, accommodated by improvement in body proportionality and without acceleration of bone age.

All Patient continued in the study as of today.

I, often say that we're just getting started.

Yes.

Following closely behind this major growth opportunity our sales team is developing the next phase of innovative transcon technology and product candidates in.

these results, enforce the road of, transcon CMP as a strong, fundamental therapy in acondroplasia,

In addition.

Our ongoing collaboration with Novo Nordisk for the development and compensation compensation of Transcon based product and metabolic and cardiovascular diseases continue to make progress towards the clinic.

We look forward to our 12th month later release later this year and plan to start a phase 3, study of the combination therapy in children, with Echo, the Asia by the end of 25. In addition, we also expect to Unity and people combination tried in hyper contemplation.

I will now turn to skyroof.

<unk> is demonstrating a significant inflection in revenue growth.

We are generating.

Important new clinical data.

Looking towards additional key label expansion.

We are advancing new blockbuster opportunity to drive growth for many years to come and fulfill our vision 2030, and we're already preparing for our next region I will now turn over to Scott.

Scott over is established as a high value brand, and a treatment of choice for Pediatric, Co to multi deficiency. We recently received FDA approval, for adult, go to motivi. And with further labor expansion, plan, Scott over remains and fundamental pillar in our strategy to become the global leader in treatment of cro disorder.

Yes.

Thank you.

Sure.

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

Q2 revenue for Scott Smith and Rover was €51 million. We continue to see growth in the number of people treated with this product, based on new patients starting.

We expect that reason label expansion for adult Growth Hormone deficiency will further drive long-term growth.

For Q2, our total product revenue was $153 7 million Euro which includes a negative sequential foreign currency exchange rate impact of $7 6 million Euro.

For market research shows Cut offer is the treatment of choice for Pediatric growth and deficiency among patient and physician.

And we believe we can see the same status for treatment.

Of that do more deficiency.

<unk> revenue for the quarter was $50 7 million euro, including a $1 8 million euro negative currency impact.

Europe has delivered strong performance with revenue more than doubling to $103 million euro up from $44 7 million Euro in Q1 25.

Our phase 3 basket time of Sky TOA plan to begin later. This year will include a reign of established daily growth toone indication including ISS shock deficient Turner and SDA.

I often say that a sentence, we just getting started.

This revenue growth was achieved despite a negative sequential currency headwind of $5 8 million Euro.

Sequential growth across global markets remained strong with continued strong uptake in the U S acting as a key growth catalyst.

Calling closely Behind These major growth opportunity. Our research team is developing the next day of innovative, transcon technology and product candidates.

In addition.

The <unk> U S launch and continued performance outside the U S are having a substantial impact on our financial profile and we expect our centers to become cash flow positive on a quarterly basis. This year.

Our ongoing collaboration with, for the development and conversation conversation of transcon based product in metabolic and cardiovascular disease continued to make progress towards the clinic.

Including $4 4 million Euro of revenue from our collaboration partners total Q2 revenue was 158 million in Europe.

I think this is demonstrating a significant inflection in Revenue growth.

We are General.

Important new clinical data working towards additional key label expansion.

Turning to expenses R&D costs for the second quarter decreased to 72 million euro compared to $83 5 million Euro in the same period last year, primarily driven by lower development cost for growth disorders.

BR and balancing new blockbuster opportunity to drive growth for many years to come. And fulfill our vision 2030. And we already preparing for our next Vision, I will now turn over to Scott.

SG&A expenses in the second quarter of 2025 increased to $107 6 million euro compared to $74 3 million Euro in the same period last year, primarily driven by global commercial expansion.

Thank you. Yeah.

I will touch on some key points surrounding our second quarter financial results. But for further details, please refer to our Form 6-K filed today.

Total Q2, 2025 operating expenses were about $180 million Euro.

Yes.

Net finance income for the second quarter of 2025 was $22 million Euro driven primarily by noncash items net cash financial expenses for the second quarter of 2025 or $5 3 million Euro.

For Q2 our total product. Revenue was 153.7 million Euros, which includes a negative sequential foreign currency exchange rate impact of 7.6 million euro.

skyroof a revenue for the quarter was 50.7 million euro, including a 1.8 million euro negative currency impact

We ended the second quarter of 2025 with cash and cash equivalents totaling 494 million euros compared to $518 million Euro as of March 31.

You over the path, delivered strong performance with Revenue, more than doubling, to 103 million euro up from 44.7 million euro in q125.

Of the $24 million sequential decrease in cash 19 of that was due to the June 30 cash transition to cash translation to euro so pretty close to overall cash breakeven for the quarter for the company.

This Revenue growth was achieved, despite a negative sequential currency headwind of 5.8 million euro.

Sequential growth across Global markets remained strong with continued strong. Uptake in the US acting as a key growth catalyst.

Turning to the remainder of 2025, we expect continued revenue growth driven by the strength of the global launch of Yoga path.

For Sky trough for modeling purposes, we continue to believe that sequential revenue growth for 2025 should track growth in prescriptions offset somewhat by payer mix and normal seasonality. We also expect long term growth for sky <unk> to be driven by label expansion with our recent adult approval expected to only contribute modestly.

The over-the-path U.S. launch and continued performance outside the U.S. are having a substantial impact on our financial profile. We expect Ascendis to become cash flow positive on a quarterly basis this year.

Including 4.4 million euro of revenue from our collaboration Partners. Total Q2 Revenue was 158 million euro

For 2025.

We also continue to watch the Euro US dollar exchange rate for any potential impact related to reported revenue.

For the second quarter, decreased to 72 million euro compared to 83.5 million euro in the same period last year, primarily driven by lower development costs for growth disorders.

For yoga path, our launch is progressing exceptionally well globally, we see or have a path as a standard of care for trading hyperparathyroidism and I believe it has the potential to achieve multiple billions of euros annually in peak sales over time and our focus is on building long term leadership.

Sgna expenses in the second quarter of 2025 increased to 107.6 million euro compared to 74.3 million euro. In the same grade last year, primarily driven by global commercial expansion.

In the near term as investors and analysts seek to model your past growth trajectory I would highlight the following.

Total Q2 2025 operating expenses were about €180 million.

Outside the U S. We currently see continued steady sequential revenue growth.

Net Finance income for the second quarter of 2025 was 22 million, euro driven, primarily by non-cash items.

In the U S. Seven months into launch, we're seeing strong continued demand and continuation of enrollment trends.

Net cash Financial expenses for the second quarter of 2025 or 5.3 million euro.

We are seeing good conversion from enrollment to paid prescriptions with yoga path as Yan mentioned the majority of U S. Patients are approved for reimbursement within three months of enrollment.

We ended the second quarter of 2025 with cash and cash equivalents totaling €494 million, compared to €518 million as of March 31st.

Payer approvals are broad across commercial and government as well as geographies, we expect additional coverage policies in payer agreements to facilitate patient experience access and continued long term uptake.

Of the 24th in cash, 19 of that was due to the June 30th cash. Transition to cash to a pretty close to overall cash break, even for the quarter for the company.

Turning to the remainder of 2025, we expect continued revenue growth driven by the strength of the global launch of the over the past.

Based on our data so far we expect persistence to be high because of the benefits to the patient and we continue to monitor.

For Sky trough for modeling purposes, we continue to believe that sequential revenue growth for 2025 should track growth in prescriptions offset somewhat by payer mix and normal seasonality.

And of course, we will continue to look to help investors understand uptake in reimbursement dynamics as the year progresses.

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

We also expect long term growth for sky trough to be driven by label expansion with our recent adult approval expected to only contribute modestly for 2025.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced until you draw. Your question. Please press star one again.

We also continue to watch the Euro US dollar exchange rate for any potential impact related to reported revenue.

One question and one follow up question. Please standby, while we compile the roster.

Our yoga path, our launch is progressing exceptionally well globally, we see or have a path as a standard of care for trading hyperparathyroidism and I believe it has the potential to achieve multiple billions of euros annually in peak sales over time and our focus is on building long term leadership.

Our first question comes from Jessica Fye from Jpmorgan the floor is yours.

Alright, thanks, guys great quarter.

You mentioned, you're seeing a continuation of enrollment trends and I think the number of unique patients enrolled grew by about 1000.

In the near term as investors and analysts seek to model your past growth trajectory I would highlight the following.

350 in Q.

Outside the U S. We currently see continued steady sequential revenue growth.

Is that the rate you mean that you see continuing.

In the U S. Seven months into launch, we're seeing strong continued demand and continuation of enrollment trends.

So I can start with a few.

Overall view and then perhaps Jay can follow on.

The number be reported was around 1754.

We are seeing good conversion from enrolment to paid prescriptions with yoga path as Yan mentioned the majority of U S. Patients are approved for reimbursement within three months of enrollment.

Q1 and <unk>.

End of Q2 view reported 3100.

What we also said in our Q1 call that 200 patients we will consider some kind of.

Based on our data so far we expect persistence to be high because of the benefits to the patient and we continue to monitor.

Palouse injection because that 200 patient came from our EAP program.

And of course, we will continue to look to help investors understand uptake in reimbursement dynamics as the year progresses.

So when I take the numbers.

From.

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

Q1 number the 200 it gives me about 1550.

Thank you at this time, we will conduct a question and answer session. As a reminder to ask a question you will need to press star one on your telephone and wait for your name to be announced change. All your question. Please press star one again.

And so in some way I have to believe that we see a steady state growth in the patient here between Q1 and Q2.

When I take this consideration to the 200 patient that came from.

I have one question and one follow up question. Please standby, while we compile the roster.

And this is how we basic fee numbers and this is where most aligned with our comments at the Q1 call we expected to see a steady state.

Our first question comes from Jessica Fye from Jpmorgan the floor is yours.

Alright, thanks, guys great quarter.

You mentioned, you're seeing a continuation of enrollment trends.

Development in the prescription and first in the second part of the year, we expect to having an acceleration of the conversion of the patients that have a prescription to be on treatment. So that is basic what we have seen and we look forward to see Q3 and Q.

The number of unique patients enrolled grew by about 1000.

350 into Q.

Is that the rate you mean that you see continuing.

Hey, just so I can start with a few.

Four we are extremely optimistic about this launch is.

Overall view and then perhaps Jay can follow on.

The number be reported was around 1754 at the end of Q1 and <unk>.

And now just talking about U S. We see the same pattern <unk> won't be launching but is really is amazing and we expect to see the same steady state sure that can be a seasonal factor because of the summer vacation at least we know and frames.

End of Q2 view reported 3100.

What we also said in our Q1 call that 200 patients we will consider some kind of.

<unk> disclosed in other places.

Happening the same thing so.

Okay.

Yes.

Palouse injection because that 200 patient came from our EAP program.

Thank you Yan and as mentioned before we are seeing that stabilization in enrollment and again, we're still early in the launch. So we will need more time to observe what that steady state trend will be up as we get more months under our belt with the launch.

So when I take the numbers.

From.

Q1 number the 200 it gives me about 1550.

More importantly, just as Jan mentioned earlier, we're focused beyond just the point of enrollment we're looking across the entire funnel from enrollments to approval from approvals to patients on therapy, and we are seeing continued growth, especially as it relates to the conversion of those patients onto therapy and we're feeling good about what we are seeing.

And so in some way I have to believe that we see a steady state growth in the patient here between Q1 and Q2.

When I take this consideration to the 200 patient that came from.

And this is how we basically been numbers and this is where most aligned with our comments at the Q1 call we expected to see a steady state.

Thanks Jay.

Thank you for your question.

Our next question comes from Derek <unk> from Wells Fargo. The floor is yours.

Hey, Thanks for taking my question and congrats on the progress here I just wanted to confirm something so it sounded like you noted that there is three months from enrollment to conversion I guess I. Just wanted to know what are you doing to kind of improve that and I guess, how much progress can you make on improving on that three months.

Four we are extremely optimistic about this launch is to say.

Nothing has really changed compared to what we said on our Q1 call ties a lot of elements that.

I am not just talking about U S. We see the same pattern everywhere won't be launching but it really is amazing and.

And the entire integrated commercial team.

<unk> working with.

And we expect to see the same steady state sure that can be a seasonal factor because of the summer vacation at least we know and trained all coast East coast and other places.

We can go a little bit more specific but in the overall view.

Sure.

Okay.

Different politics from the different <unk> to be installed.

The same thing so.

Okay.

There is a lot of elements that it takes time and we also are working a lot on the procedure. How we basically can help patients to be sure and physician and back office. So this is happening for our ISR program that we are helping their patients. So not you can't change compared to what.

Yes.

Thank you Ian and as mentioned before we are seeing that stabilization in enrollment and again, we're still early in the launch. So we will need more time to observe what that steady state trend will be up as we get more months under our belt with the launch.

What we said in Q1.

Wherever you believe that would be reversed in the second part of the year. When many of these activities will be implemented we will see an improvement in the time from prescription.

A patient is on treatment.

A J you can give a little bit more flavor on some of the initial too on a high level because we have so many initiatives going on.

Thanks Jay.

Thank you for your question.

Our next question comes from Derek <unk> from Wells Fargo. The floor is yours.

So and thank you for the question.

From a time to approval standpoint, as we said we're seeing the majority within three months now divide our efforts probably in a few buckets. The first one is upstream right. We're continuing our payer education, whether it's at a commercial level or public level just on the clinical value proposition of the product the full expense of the label.

Hey, Thanks for taking my question and congrats on the progress here I just wanted to confirm something so it sounded like.

That is three months from enrollment to conversion I guess I just wanted to know what are you doing to kind of improve that and I guess, how much progress can you make on improving on that three months. Thanks.

Nothing has really changed compared to what we said on our Q1 call guys lot of elements that.

Because as you can all appreciate whenever there's a new specialty drug on market, particularly a rare disease, one and oftentimes it takes a bit of time for them to consider either a category of product that they may not have previously had on formulary or plan. So we anticipate that to continue to improve.

Jay and the entire integrated commercial team are working with.

We can go a little bit more in specific but in the overall view.

Sure.

We'll of course have downstream impacts on the speed.

Different politics from the different <unk> to be installed.

More downstream from that we're also have a very experienced top right. I think we've mentioned this before we're quite experienced with being in managed care spaces. So some of the bread and butter work as it relates to ensuring that providers and patients are continuing to follow up fill out the paperwork correctly to.

There is a lot of elements that still it takes time.

And we also are working a lot on the procedure, how we basically can help patients to be sure and position and back office. So this is happening for our ISR program that we are helping their patients.

Cycle times to ensure that that paperwork isn't the reason why maybe something goes back and forth one or two extra times, which will then also increase the cycle and then lastly, I would say as we continue to have patients within the funnel.

Nothing has changed compared to what we said in Q1.

Wherever you believe that would be reversed in.

In the second part of the year when many of these activities will be implemented we will see an improvement in the time from prescription.

Just making sure again that.

Our partnership with our specialty pharmacy, so on so forth again streamlining those processes to continue to shave off time as we work through this initial launch phase all that to say, we're incredibly encouraged by the speed in which we're seeing and a reflection of the experienced hub that we have and we continue to look forward to seeing how that will progress.

To a patient is on treatment.

Jay you can give a little bit more flavor on some of the initiatives on a high level because we have so many initiatives going on.

So and thank you for the question.

From a time to approval standpoint, as we said we're seeing the majority within three months now divide our efforts probably in a few buckets.

Yes.

Great. Thank you.

Thank you for your question.

The first one is upstream right, we're continuing our payer education, whether it's at a commercial level or public level just on the clinical value proposition of the product the full expense for label because as you can all appreciate whenever there's a new specialty drug on market, particularly a rare disease and oftentimes it takes a bit of time.

Our next question comes from Jesse <unk> from Bank of America. The floor is yours.

Hey, guys. Thanks for taking my question.

I'm wondering if you could give us some color on the types of patients.

There's been a lot of talk about initially severe patients the most severe patients being put on your behalf.

So then to consider either a category of product that they may not have previously had on formulary or plan. So we anticipate that to continue to approve which will of course have downstream impacts on the speed.

Do you have any color on what the split is.

Definitions.

Versus the type of patients that are getting on that might be on the more moderate.

Okay.

More downstream from that we're also have a very experienced top right I think we've mentioned this before.

Thanks.

For the question first of all there is no medical definition that define severity of hyper care. So we cannot go in and clean database and saying this is Ah severity that you have in the Dcs because all of them is not classified relative so that when we.

Quite experienced with being in managed care spaces. So some of the bread and butter work as it relates to ensuring that providers and patients are continuing to follow up fill out the paperwork correctly to decrease cycle times to ensure that that paperwork isn't the reason why maybe something goes back and forth.

<unk> talked about the element of the uncontrolled partially controls.

One or two extra times, which will then also increase the cycle and then lastly, I would say as we continue to have patients within the funnel.

Or something.

Something we call controlled this was mainly related to one single per meter looking on the clean data basis, and see how often the seating and physician.

Just making sure again that.

Our partnership with our specialty pharmacy, so on so forth again streamlining those processes to continue to shave off time as we work through this initial launch phase all of that to say.

How often they're sitting in physician I think has a lot of mutual aspect that somebody not.

Not only reflecting where you're living in the country, what kind of medical access to here.

We're incredibly encouraged by the speed in which we're seeing and a reflection of the experienced hub that we have and we continue to look forward to seeing how that will progress.

And also.

How often are there and into beauty can cu.

Great. Thank you.

No.

We did offer this perspective, because we wanted to be quite sure via addressing physician that's EBIT.

Thank you for your question.

Our next question comes from Jesse <unk> from Bank of America. The floor is yours.

Hi.

<unk> of patients in hydropower and <unk> address this.

Hey, guys. Thanks for taking my question.

As our priority in our you can say commercial strategies.

I'm wondering if you could give us some color on the type of patients.

There's been a lot of talk about initially severe patients the most severe patients being put on your behalf.

So we can say timna.

Fine.

So your question because there is no way. This is part of the reimbursement system is no part of we can see of the patient because it's not a medical term debt is defined.

Do you have any color on what the split is.

Definition really severe patients versus the type of patients that are getting on that might be on the more moderate.

Yeah.

Thanks.

Christian first of all there is no medical definition that defined severity of hypo care. So we cannot go in and clean database and saying. This is a severity that you have in the disease because all of them.

But I think.

So maybe to give you also the other aspect on it when we look on the guidelines that we see.

Integrated many different places.

They are not using this kind of term either so the guidelines just having a broad aspect on all the deferred element that really qualify to be on PTH treatment and in general all the cards in P&C.

Not classified related to that when we talked about the element of fee.

Uncontrolled partially controls.

Something we call controlled this was mainly related to one thing.

Issued from all different places in the World now there are indicating that 95 two.

Looking on the clean data basis, and see how often the seating and physician.

Percent of all patient basis should be on <unk> treatment and I think that is pretty logical to think about how many patients on type one type pieces.

How often they're sitting in physician I think has a lot of mutual aspect.

Not only reflecting where you living in the country, what kind of medical access too.

Would you ever consider.

And also.

That you will not take all patients that have type one diabetes.

How often are there and into that beauty can see ya.

Insulin treatment.

No.

You will see the same thing happening with HEICO pair.

We did offer this perspective, because we wanted to be quite sure be addressing physician that's EBIT.

A high number of patients in HEICO para <unk> address these precision as our priority in our you can say commercial strategies and so we can defer.

Thank you for your question.

Our next question comes from Johan wherever from TD Cowen the floor is yours.

Great. Thanks for my question and congrats again.

Define and answer your question because there is no way. This is part of the reimbursement system is no part of we can see of the patient because it's not a medical term debt is defined.

A couple of interrelated questions can you give us a little bit of a sense. Scott you mentioned last quarter to expect Europe to grow about $4 million to $5 million. So that puts you at around 24. So it almost seems like you did sort of 79 to 80 in the U S.

But I think.

Am I sort of in the ballpark.

So maybe to give you also the other aspect on it when we look on the guidelines that we see.

I guess secondly.

When one looks at we shouldn't be expecting that you're going to be growing patients 1500 quarter over quarter. So can you give us a little bit of a sense of how to think about what a sequential normalized growth at this point in the U S can be so we don't get out of out of out of hand. Thank you.

Integrated many different places.

They are not using this kind of turn either so the guidelines just having a broad aspect on all the different elements that really qualify to be on pega's treatment and in general all the content you can see it.

I can say I can help Scott.

At this time.

Now often too.

<unk> from all different places in the World now.

Because what we said in our Q1 call. It if you look on <unk>.

Indicating that 95 two.

Q3 to Q4.

Percent of all patient basis should be on Phh's treatment and I think that is pretty logical think about how many patients on type one type pieces.

Revenue increase net revenue in euro.

<unk>.

Was about four to 5 million Euro and.

Would you ever consider.

In this two quarter evolved basic U.

That you will not take all patients that have type one diabetes.

Our ex U S revenue.

Including treatment and I think you will see the same thing happening with HEICO pair.

And we also say that that time.

We expect that to continue in 2005.

When we see more country coming on full commercialization as we just caught us by now and we expect a few country more perhaps increase.

Thank you for your question.

Our next question comes from Johan wherever from TD Cowen the floor is yours.

But even the first type of material impact two to three months after basic.

Great. Thanks for my question and congrats again.

Mutation.

A full commercialization. So therefore I will say your assumption is pretty correct and also reflecting what we said in Q1 this week.

Related to the attrition you come in it's somewhat forward looking statement I know is really being covered by.

Am I sort of in the ballpark.

And I guess secondly.

Scott fast reading, but from my perspective is that we see a strong strong dogs here in the U S. We have seen the same numbers between Q1 and Q2 and we are really looking forward SJC correctly. This is early in the lungs. It will be too early for us to come up with any.

When one looks at we shouldnt be expecting that you're going to be growing patients 1500 quarter over quarter. So can you give us a little bit of a sense of how to think about what a sequential normalized growth at this point in the U S can be so we don't get out of a lot of out of hand. Thank you.

I can say I can help Scott.

Kind of protection, how we really will see the next six seven quarters ago.

This time with all of them too.

Because what we said in our Q1 call. It if you look on.

Okay.

Q3 to Q4.

Revenue increase net revenue in euro.

Thank you for your question.

Okay.

Sure.

Our next question comes from Kevin Clark Gardner from Evercore ISI the floor is yours.

Was about $4 5 million.

And.

In this two quarter evolved basic you Europe.

Hey, guys. Congrats on another great quarter first what do you believe the ultimate conversion rate from the enrollment forms to pay drugs will be at any point in time and then secondly, looking ahead do you plan to keep reporting the enrollment forms for your path. Thank you.

Our ex U S revenue.

And we also say that that time.

We expect that to continue in 2005.

When we see more country coming on.

Civilization as we just caught us by now and we expect a few country more perhaps increase.

Jim.

It's really.

Difficult for us to give you.

But do you have a first type of material impact two to three months after the basic <unk>.

Clear number.

But what we always see in the U S that would be a percentage of patients that have been.

<unk>.

Our full commercialization. So therefore I will say your assumption is.

Difficulties to get reimbursed, even if we try and help them multiple times.

Correct and also reflecting what we said in Q1 this week.

To the question you come in.

And what we see during the launch which we have seen before is that what I call. The tail is getting faster and faster cleared out and I can guarantee we will do everything in smbs.

Our forward looking statement I know, it's really difficult.

Scott fast reading, but from my perspective is that we see a strong strong dogs here in the U S. We have seen the same numbers between Q1 and Q2 and we're really looking forward SJC correctly. This is early in the longer it will be too early for us to come up with.

Manner to help that all the patients can come on treatment.

Can we guarantee that everyone can go on treatment.

Any kind of prediction, how we really will see the next six seven quarters ago.

It will be a number of patients even after six 912 months really struggling.

Okay.

I will say it should be.

Really hard to be cohort. So you can ask about my personal success.

Thank you for your question.

Yeah.

Personal success will be if we get.

Our next question comes from Kevin Clark Gardner from Evercore ISI Felicia.

In a steady state lungs, really with a mature product kit around 92% of all patients on treatment.

Hey, guys congrats on another great quarter.

First what do you believe the ultimate conversion rate from the enrollment forms to pay drugs will be at any point in time and then secondly, looking ahead do you plan to keep reporting the enrollment forms for Europe.

You'll feel it as a personal success and my contribution to help patients with hydropower.

You can also come with your personal success number.

Yes.

Q1 to do that.

I appreciate the question.

It really.

I would say layer on a couple of things right I think the enrollment to approval again, it's not just driven by pairs of course, that's a component of it right because as we've discussed before there are certain plans and policies for which you have to go through exception, our appeals process and I think as you.

Difficult for us to give you.

Clear number.

But what we always see in the U S that would be at <unk>.

<unk> of patients that have.

Difficulties to get reimbursed, even if we try and help them multiple times.

Don alluded to that rate tail will take some time to clear depending on the plan and as things evolve.

And what we see during the launch which we have seen before is that what I call. The tail is getting faster and faster and.

The other component from enrollment to approvals is entirely unrelated to payers and it may just be more driven by ensuring again providers are leveraging the paperwork appropriately patients are following up with outreach a lot of that which will continue to pursue across the spectrum. Because we know again that these patients can and should benefit.

And I can guarantee we will do everything in Smbs.

Manner to help that all the patients can come on treatment.

Can be guaranteed that everyone can go on treatment.

From the product.

If they're already in the funnel and we will do everything we can to clear that long tail out knowing that it will take some time and when you look at a lot of rare disease analogs in these types of spaces. It can take some time to get there, but this is a long haul and we're looking at it more from that lens to making sure. We're optimizing every step of the way.

It will be a number of patients even after.

Six 912 months really struggling.

I will say it should be.

Really hard to be cohort. So you can ask about my customer success.

Personal success will be if we get.

In a steady state lungs, really with a mature product kit around nine zero percent of all patients on treatment.

And are you guys planning to report enrollment forms for Europe as in the next quarter also.

I think.

You'll feel it as a personal success and my contribution to help patients with hydropower.

We will give you.

The necessary Kpis that we are doing today, and we will continue to do that in every quarter onto the field will be coming to a state to state.

You can also come with your personal success number.

Q1 to do that.

I appreciate the question.

I would say layer on a couple of things right I think the enrollment to approval again, it's not just driven by pairs of course, that's a component of it right because.

We feel that there is enough information just out from revenue that you can basically do you modeling constant that people.

<unk> to provide the necessary data that support that you can make us on modeling.

As we've discussed before there are certain plans and policies for which you have to go through exception, our appeals process and I think as Dan alluded to that right talent will take some time to clear depending on the plan and as things evolve.

The launches.

Just to say and repeat it again. This is amazing logs Q1 was great Q2 was also amazing great and we have not seen any weakness in the loans.

The other component from enrollment to approvals is entirely unrelated to payers and it may just be more driven by ensuring again providers are leveraging the paperwork appropriately a patients are following up with outreach a lot of that which will continue to pursue across the spectrum. Because we know again that these patients can and should benefit.

Very helpful. Thanks.

Thank you for your questions.

Our next question comes from Al <unk> from Cantor <unk> the floor is yours.

From the product.

If they're already in the funnel and we will do everything we can to clear that long tail out knowing that it will take some time and when you look at a lot of rare disease analogs in these types of spaces. It can take some time to get there, but this is a long haul and when we're looking at it more from that lens to making sure. We're optimizing every step of the way.

Hi, congratulations on the quarter. This is Daniel <unk>.

We're just curious about the pull through of the patients that get onto your RV path, how should we think about compliance.

Especially if you are saying that 1500 PFS number that's net patients going forward. Thank you.

Where we have the best long term data is from.

And are you guys planning to report enrollment forms for Europe as in the next quarter also.

Europe, where the basic startup pro longed about six to nine months before.

I think.

We will give you.

And when we look on a rate what we call to discontinue nation.

The necessary Kpis that we doing today and we will continue to do that in every quarter onto the field will be coming to a stable steady state.

Extremely low a few percentages so.

We really see the benefit of the therapy.

People take the therapy taken it they're keeping doing it and I believe that is the contribution on how we are addressing a major unmet medical need with the treatment of Europe.

We feel that there is enough information just out from revenue that you can basic to your modeling content that people.

<unk> to provide the necessary data that support that you can make us on modeling.

So everything what we see here is far away from what you see with the diabetes stroke people stay on it even much better than.

The launches.

Just to say and repeat it again. This is amazing logs Q1 was great Q2 was also amazing great and we have not seen any weakness in the launch.

And then in Selene that Youll see in type one diabetes and I think this is where many contribution to the positive CNS effect.

<unk> product.

Very helpful. Thanks.

Okay cool. Thank you and just on the just going back to <unk> question earlier about the 500 patient net enrollment per quarter.

Thank you for your questions.

Our next question comes from Al <unk> from Cantor <unk> the floor is yours.

For me to fully understand this.

Patient start forms that you're referring to.

Hi, congratulations on the quarter the sustainable <unk>.

Yes that is what we were referring to is unique prescriptions, meaning is that as new patients that have caught and prescription.

We're just curious about the pull through of the patients that get onto your RV path, how should we think about compliance.

This is what we call unique prescriptions.

Especially if you're saying that 1500 PFS number that's net patients going forward. Thank you.

Great. Thank you so much and congrats again.

Yes.

Thank you for your question.

Where we have the best long term data is from.

Our next question comes from Joseph Schwartz from Leerink partners the floor is yours.

Europe, where the basic startup pro longed about six to nine months before.

Yes, Hi, I'm jewelry park dialing in for Joe. Thank you for taking our questions.

And when we look on a rate what we call to discontinue nation.

Extremely low a few centers.

No.

We really see the benefit of the therapy.

People will take the therapy taken at that keeping doing it and I believe that is the contribution on how we are addressing a major unmet medical need with the treatment of your patents. So everything what you see here is a far away for what Youll see with the diabetes stroke.

Competitor recently announced that they are long Atkins E&P area under the curve PK level with three times greater than the levels of Transcon CMP based.

Based on your experience with Transcon CMP, how could that translate in the clinic in your view and how does that profile differ from your combination approach. Thank you.

People stay on it even much better.

Installing that youll see in type one diabetes and I think this is where many contribution to the positive CNS effect fitness product.

Yeah.

It does.

Let me start with the easy one.

<unk> potential.

Summary.

That over.

Okay.

Okay cool. Thank you and just on the just going back to <unk> question earlier about the 500 patient net enrollment per quarter.

And I would take the <unk>.

Yeah.

Yes.

I can say scientific interesting question as number two.

Sure.

For me to fully understand this is the patient start forms that you're referring to.

So happy to start with the first question.

From a target list standpoint, we're targeting about 8% to 10000.

Yes that is what we are referring to is unique prescriptions, meaning is that is a new case that have caught and prescription.

You can consider that as our universe about 3000 of which we decile as high medium.

And we're seeing pretty good field execution metrics across that so over 80% reach across our high medium priority targets.

This is what we call unique prescriptions.

Great. Thank you so much and congrats again.

Okay.

Thank you for your question.

So the second question is interesting because.

Our next question comes from Joseph Schwartz from Leerink partners the floor is yours.

For many many years there was lot of skip too about our sustained profile.

Yeah, Hi, I'm jewelry park dialing in for Joe. Thank you for taking our questions.

And then suddenly there was a big change where somebody say there is some benefit by having.

First one is on you have a path I believe there were 1500 prescribing health care providers in the U S. By the end of the quarter can you help us understand how much of your target physician base. This represents and secondly on CMP competitor recently announced that they are long Atkins E&P area under the curve PK level with <unk>.

Sustained.

Profile.

Not give hi C. Max that basic can indicate risk of hypertension.

And also you need to have continuous exposure over one week.

Times greater than the levels of Transcon CMP.

So we started and designed our transcon CMP in 2015 and now we are in 2025. They are starting now to go after that concept.

Based on your experience with Transcon CMP, how could that translate in the clinic in your view and how does that profile differ from your combination approach. Thank you.

Yeah.

It does.

From my perspective is that when you look and how we designed it.

Let me start with the easy one.

<unk> potential.

And also all our associated patent filing we have waited all the IP, we have the optimal protocol.

So my take.

Take that over.

Two Jay.

And I would take the <unk>.

Yes.

I can say scientific interesting creation as number two.

Medical treatment benefited us and other things like that.

Sure.

People are now trying to copy.

So happy to start with the first question from.

As a concept.

From a target list standpoint, we're talking about eight to 10000.

And when I think about the concept.

You can consider that as our universe about 3000 of which we decile as high medium and we're seeing pretty good field execution metrics across that so over 80% reach across our high medium priority targets.

Give us some kind of making success of a product without disclosing the key element. The key element was AUC I really don't care about AUC I want to know key element what is really the half life. How is this exposure really happening is this something that pick up too.

Okay.

So the second question is interesting because.

Theyre high value there shortly and then new basic are going up to as I call it with bankers.

For many many years there was.

Lot of skeptic about our sustained profile.

Hypertension that is not really an optimal product in this way.

And then suddenly there was a big change where somebody say.

I believe.

What we saw in all of our clinical data.

Some benefit by having sustained.

Really hard to do.

Profile.

A lot when you remove a break because it's really the hill is rolling down.

Not give hi C. Max that basic can indicate risk of hypertension.

That really the type of speed, if you had taken a break off the brachiosaur.

And also you need to have continuous exposure overall one week.

Is it.

Really don't get biological and scientific concept that is related to <unk> growth. When we look some of the fixed where we see more strengthen in other things like that.

So we started and designed our transcon CMP in 2015 and now we are in 2025. They are starting now to go after that concept.

Quite sure having continuous exposure, but we do not know exactly that is maxed out or not so often that perspective is that down food can you get more out on the having an higher AUC first of all it needs to have the right agency is must be and higher <unk>.

From my perspective is that when you look and how we designed it.

And also all our associated patent filing we have.

Okay.

Medical treatment benefited us and other things like that.

Sure completely of the once weekly.

People are now trying to copy with although.

Profile and no one disclose that because then we need to have a longer half life.

Concept.

And when I think about the concept.

Our study is about two and half to three days and I have not got any kind of disclosure then they are there.

There was some kind of making success of a product without disclosing the key element. The key element that was AUC I really don't care about AUC I want to know key element what is really the half life.

When I go out to our combination therapy is basically complete different concept because the concept of debt is BT synergies between different geologic could possibly will have well known from so many of our two according to <unk>.

How is this exposure really happening is this something that pick up to a bad there theyre high value there shortly and then new basic Alco not too as I call it with bankers.

That's the optimal treatment you cannot overcompensate just by one parkway, but your basic providing that benefit in a holistic manner in a much more normal manner by balance different pathway and that is what we do in the company and the team trying to come CMP and.

Hypertension that is not really an optimal product in this way.

I believe.

What we saw in all of our clinical data.

The Kokomo effect with a basic at the same time in a more simplified manner.

<unk> really hot too.

A lot when you remove a break because it's really of the hill is rolling down that.

Craig with what we do with the CMP and then having a sputum.

That really decides the speed if you had taken a break off with bright diesel.

So I feel really really confident with our coach state. Our combination therapy that is really is an unique way where you really can.

Is it.

Really don't get that biological and scientific concept that is related to the <unk> growth. When we look some of the fixed where we see more strengthen in other things like that.

Total provide for patients for precision a complete new treatment standard.

Quite sure having continuous exposure, but we do not know exactly is that is maxed out or not so often that perspective is there can you get more out on the having an higher AUC first of all it needs to have the right agency is must be and higher <unk>.

Got it thank you.

Thank you for your question.

Our next question comes from Atlanta Tomorrow from UBS the floor is yours.

Hey, guys. Thanks for taking my question and congrats on the strong quarter.

Sure completely all of the once weekly.

Curious for Achondroplasia out what's your base case for the indication statement for Transcon CMP, whether it would be for the treatment of achondroplasia are for the increase in linear growth in acres like box that that has.

Profile and no one close that because then they need to have a longer half life than our debt is about two and half to three days and I have not got any kind of details. You then they are there.

And I guess any expectations for differentiation in the label relative to box Aargau that does in terms of the indication statement are saying other secondary endpoints.

When I go out to our combination therapy is basic complete different concept because the concept of debt is between synergies between different geological ponds, which have well known from so many of our two according to.

And then second follow up question just what's your perspective on the IP landscape for weekly CMP, and specifically any thoughts on BMI, and 333, and where that might stand relative to the transcon CMT IPSA. Thanks.

Has the optimal treatment you cannot overcompensate just by one parkway, but your basic providing that benefit in a holistic manner in a much more normal manner by balance different parkway and that is what we do in the companies and the team trying to come to CMP and the core.

Yes.

We are progressing to the breakfast a review with our Transcon CMP exactly SP, who for in an accelerated priority review.

Optimal effect, which have basic at the same time in a more simplified manner remains a break with what we do with the CMP and then having a scooter.

Everything is happening on the right time.

So labeling discussion is one of the last part.

We view cycle. So it's really really difficult for me to come up with any kind of elements.

So I feel really really confident with our coach state. Our combination therapy that is really is an unique way where you really can.

More was referring to is the data we have that is purely banking transcon CMP and I believe this is why because the priority review.

Total provide for patients for precision a complete new treatment standout.

Of course, we have data that keep a strong evidence that we can provide.

Got it thank you.

Thank you for your question.

Treatment benefit.

In year growth and now we're talking about everything what we have seen related to lake Boeing everything booked into more strength because people, saying that they have also seen it but.

Our next question comes from Atlanta morale from UBS the floor is yours.

Hey, guys. Thanks for taking my question and congrats on the strong quarter.

You have not seen it in a real manner unique to seat in a placebo controlled manner, because either body proportionality is actually improving doing and normal development of a child also tube and contemplation China. So how can you discriminate is released between benefit or adjusted.

And I guess any expectations for differentiation in the label relative to box Aargau that does in terms of the indication statement RFA other secondary endpoints.

One development and this is why it's so extremely important to be in a position that you referring to pace things done in a placebo controlled manner in a pivotal trial.

And then second a follow up question just what's your perspective on the IP landscape. Our weekly CMP is specifically any thoughts on gammon, 333, and where that might stand relative to the transcon CMT IPSA. Thanks.

Referring to bother benefit we have no risk of hypertension band low indexing Hi, This is Brian.

Yeah.

We are progressing to the breakfast a review with our Transcon CMP exactly SP, who fall in accelerated priority review.

Sure obvious patient parents parents parents parents really love the once weekly profile exhausted the burden for them to keep it in so.

Everything is happening on the right time.

I think what I see here not so much really.

So lifting cost.

Okay.

Turned about exactly what is coming into it lately.

We view <unk>.

So it's really really difficult for me to come up with any kind of elements.

Interesting.

Benefit that we can go out and explain that transcon CMP is providing with our basic had never seen any below well controlled pivotal trial I think that is the key element for me and I think this is what we see everywhere.

More was referring to.

Is the data we have that is purely banking, our transcon CMP and I believe this is why because the priority review.

Of course, we have data.

And the second question was about the IP.

A strong evidence that we can provide.

I believe when we develop that in 2015 basic five a lot of IP.

Treatment benefit beyond SR growth and now we're talking about everything what we have seen related to lake Boeing everything booked into more strength because people, saying that they have also seen it but.

It was how to make it optimal pro Doc there was the benefit of having approval on that Gabe sustained things as pace and no clear for me exactly what is the.

We have not seen it in a real manner, you need to see in a placebo controlled manner, because either body proportionality is actually improving doing and normal development of a child also tube and a contemplation. So how can you discriminate is released between domestic ore and Justin.

Marine structure, that's there have in the PMA to.

It's impossible for me to say exactly what they are but if you can see me at least you can see you have a great smile on my left in.

In phase because we are pretty good in fortitude, when we file IP.

<unk>.

And this is why it's so extremely important to be in a position that you were referring to data thats done in a placebo controlled manner in a pivotal trial.

Understood. Thank you.

Okay.

Thank you for your questions.

Yes.

Our next question comes from Kelly <unk> from Jefferies. The floor is yours.

Not referring to <unk> benefit.

No risk of hypertension.

No injection type. This is why is that.

Congrats on another strong quarter.

Sure obvious patient parents parents parent expense maybe loss the once weekly profile.

Thank you for taking my question.

Youll recall what is the typical duration.

Lynn Bourdon for them to keep it in so.

Right now across a broad spectrum.

Zinc what I see here.

In our world.

So most really.

While the patients complain of cooperation by the higher lockman cost. Thank you.

<unk> about exactly what is coming into it lately.

More interestingly the benefit that we can go out and explain that transcon CMP is providing with our basic have never seen in any other well controlled pivotal trial I think that's the key element for me and I think this is what we see everywhere.

So at least I got your first question related to the titration period, and I think Amy.

<unk> Medical office and there were a lot of what we have seen in our clinical trials I think be much more uncertain about what is actually happening in what we call in.

And the second question was about the IP.

Our life clinical.

I believe when we develop that in 2015 basic five a lot of IP.

Element, but what the key element for me and I take it from that perspective, do we see a lot of patients on satisfaction at that stage two we see a lot of patients drop out because there's a problem with it and we don't see that so I cannot really comment about what is happening exactly happening in there.

It was how to make it optimal pro Doc there was the benefit of having approval on that Gabe sustained things as no clear for me exactly what is the.

Marine structure that they have in the PMA.

Titration in public patient in real world, but at least we can see that is happening we're successful.

It's impossible for me to say exactly what they are but if you can see me at least you can see I have a great smile online lip.

And your second question was.

And pace, because we are pretty good in fortitude, when we file IP.

Well, one quotation come from penetration has really popped a higher monthly cost.

Okay I'll handle this one.

Understood. Thank you.

I think in the U S. We have an approval too.

Okay.

Thank you for your questions.

Yes.

No.

Our next question comes from Kelly <unk> from Jefferies. The floor is yours.

From 6% to 30 microgram. So basically we are in a position that we're only using 110.

Congrats on another strong quarter.

At the time.

Outside the U S. There have.

Thank you for taking my question.

And possibility to use up to 60 microgram, we have just initiated in what we call our 60.

Youll recall, what is the typical arbitration with <unk>.

So right now across <unk> broad.

<unk>.

Mike Hogan trial, which will facilitate this is our this is a 26 week trial to facilitate that we can keep on labeling.

In railroad.

<unk> completed our cultivation keira, that's generated by the higher lockman costs. Thank you.

Okay.

So at least I got the first question related to the titration period, and I think Amy sheath.

They can use up to 60 micrograms in the U S.

I think when <unk> have seen of the data and be coming from.

Chief Medical office, and there were a lot of what we have seen in our clinical trials I think be much more uncertain about what is exactly happening in what we call in real life clinical.

I called commercial.

Yes.

All up to the 60 microgram, there will be a discussion from <unk> side exactly how we are.

But what the key element for me and.

Handing that reimbursement for that consideration I think it's too early for two comments on that.

I take it from that perspective, do we see a lot of patients understand takes action at that stage two we see a lot of patients drop out because types proppant with it and we don't see that so I cannot really comment about what exactly exactly happening in the titration.

Sure.

Thank you.

Thank you for your question.

Our next question comes from Paul Choi from Goldman Sachs. Your.

Your line is yours.

Hi, good afternoon, and congratulations on the strong quarter result.

Public patient in real world, but at least we can see that is happening we're successful.

Yeah, and just to follow up on your last comment about potentially harmonizing. The U S label with the EU label and the 60 microgram dose.

And your second question was.

Well one of our patients come from penetration as relates to pump to higher monthly cost.

When might you be in a position to submit that data to the FDA.

This is Danielle hurdle.

And then commercially.

I think in the U S.

What portion of the patient population would that potentially allow you to address that as not being currently suited by the available presentations in the U S market. Thank you for taking our questions.

We have an approval too.

From 6% to 30 microgram. So basically we are in a position that we're only using 110.

Thanks, a lot for Christian exiting the system a lot of Christians integration.

Yes.

At the time out.

Outside the U S. There have any possibility to use up to 60 microgram. We have just initiated in what we call our 60.

<unk> what is happening in the U S. Today, and I think there is a lot of different places where telephone.

Element on how to solve the issue if a patient more than 30 days.

Michael Ken trial, which will facilitate this is our <unk>. This is a 26 week trial to facilitate that we can keep on labeling.

Some patients because of the.

Labeled restricting to 30 microgram stay in a position that we're taking 30 microgram and if.

They can use up to 60 micrograms in the U S.

I think when <unk> have seen all the data and become commercial.

Needed potentially boutique additional.

Ketchum supplement or additional active vitamin D that is other places where the basic the patients.

I called commercial.

Launch of October 60, microgram, there will be a discussion from <unk> side exactly how we are.

The.

Physician off label will potentially to get access to and higher dose.

Handing that reimbursement situation I think it's too early for us to comment on that.

We obviously.

Yeah.

Have no any involvement in new recommendation so from my perspective is that.

Thank you.

Thank you for your question.

There is a need for a dose higher than <unk>.

Our next question comes from Paul Choi from Goldman Sachs. Your.

Your line is yours.

And we would do.

Hi, good afternoon, and congratulations on the strong quarter result.

Everything we can do to get it as fast as possible out too.

Yeah, and just to follow up on your last comment about potentially harmonizing U S label with the EU label and the 60 microgram dose.

The patients.

We starting the trial now it's a small trial.

Less than 2000 patients.

Target enrollment of 18, it's only 26 week and be utilizing.

When might you be in a position to submit that data to the FDA.

And then commercially.

Utilizing the same devices that the basic have been already in the market. So there is no CMC component in this way is just for game issue.

Thanks, a lot.

All her people two basic kit.

Christian I exiting the system a lot of Christians integration.

Clinical trials done and get through the regulatory team to get it filed and approved and we will do that as fast as possible, but it looks pretty pretty promising to get it in.

<unk> what is happening in the U S. Today, and I think there is a lot of different places where telephone.

Element on how to solve the issue if a patient needs more than 30 days.

Okay.

Some patients because of the.

Thank you for your question.

Yes.

Labeled restricting to certain microgram stay in a position that <unk> taken 30, microgram and if needed double potentially seek additional.

Our next question comes from Alex Thomson from stifle the floor is yours.

Hey, great. Thanks for taking my questions I guess on uric acid, while you've talked about the breadth of prescribers I Wonder if you could comment on proportion of prescribers that you've seen with multiple prescriptions multiple patients on therapy, and how you see that trend changing over time. Thanks.

Cut some supplement or additional active vitamin D that is other places where the basic the patients on the <unk>.

Physician off label, we'll potentially get access to and higher dose.

We cannot really address that question, we don't have sufficient data that we really feel feel confident to come with data that really support and strong trend analysis currently.

We obviously have no any involvement and new recommendation.

So from my perspective is that.

Nice and neat for a dose higher than 30.

And we will do everything.

Everything we can do to get it as fast as possible out too.

Thank you for your question.

The patients we starting the trial now it's a small trial.

Our next question comes from Luca <unk> from RBC the floor is yours.

Less than 20 patients.

Oh, great. Thanks, so much for taking my question and congrats on the quarter.

Target enrollment of 18, it's only 26 week and be utilizing the same pain.

Maybe Scott lots of questions, obviously on the topline rightly, so, but how about SG&A, I mean up 44% year over year and 6% quarter over quarter. I. Appreciate all that you are launching rock, but how should we think about modeling SG&A for the rest of the year I guess, what I'm trying to ask.

<unk> says that the basic have been already in the market. So there is no CMC component in this way, it's just for game issue.

All her people two basic kit.

Clinical trials done and get through the regulatory team to get it filed and approved and we will do that as fast as possible, but it looks pretty pretty promising to Kennedy.

How should we think about potential to achieve profitability in Q3 versus Q4, and then maybe secondarily can you just remind us about ascend this exposure is around tariffs and understand and appreciate the situation is still fluid and we don't have all the details, but any high level commentary much appreciate it. Thanks again.

Okay.

Thank you for your question.

Okay great.

<unk> expenses overall, so remember last quarter, we did a $190 million euro of Opex, and we said that wasn't a bad run rate plus or minus each quarter. So this quarter were minus about 10 from that so we're about 180 of Opex this quarter and as you point out.

Our next question comes from Alex Thomson from stifle the floor is yours.

Hey, great. Thanks for taking my questions I guess I'm going to recap is while you've talked about the breadth of prescribers I Wonder if you could comment on the proportion of prescribers that you've seen with multiple prescriptions multiple patients on therapy, and how you see that trend changing over time. Thanks.

Probably not best to look year over year, because we had a lot of growth in the last year, it's really the sequential build so I would look at the 6% sequential growth for.

We cannot really address that question, we don't have sufficient data that would be really will feel confident to come with data that really support and strong trend analysis currently.

SG&A is potentially not a bad number to think about but in the overall context of I would still say about 190 opex per quarter is not a bad number to think about.

With respect to profitability, yes, we expect that this year I mean, if you look at our financials and back out.

Thank you for your question.

June 30 currency, thanks to or whatever it was called Liberation day that cost about 20 euro of cash Delta. So overall everything across the company. It was about five euro of burn in.

Our next question comes from Luca <unk> from RBC the floor is yours.

Oh, great. Thanks, so much for taking my question and congrats on the quarter.

In Q2, and actually on an operating basis, where were just slightly positive on cash so that should be relatively doable. This year with respect to MFS and tariff I think you said it pretty well.

Scott lots of questions, obviously on the top line really sell but how about SG&A, I mean up 44% year over year and 6% quarter over quarter. Appreciate all that you are launching a draw but how should we think about modeling SG&A for the rest of the year I guess, what I'm trying to ask.

Really too much in development right now to make any comments specifically on it but we do believe that we're as a flexible company, we're pretty well positioned to mitigate impact of any policy should it emerge.

How should we think about the potential to achieve profitability in Q3 versus Q4, and then maybe secondarily can you just remind us about ascend this exposure is around areas and MFN yen appreciated situations stuffs and we don't have all the details, but any high level commentary much appreciate it. Thanks again.

Just to clarify and also adding Scott comments.

<unk>.

We're not importing finished product to the U S b import them in different states and finalized with them inside the U S.

Okay great.

SG&A expenses.

So in whatever way, we look at it we cannot see how it really should provide and major material impact on our business and how we operate.

Last quarter, we did the $190 million euro of Opex, and we said that wasn't a bad run rate, maybe plus or minus each quarter. So this quarter were minus about 10 from that so we're about 180 of Opex this quarter and as you point out.

Yes.

Thank you so much.

It's probably not best to look year over year, because we had a lot of growth in the last year. It's really the sequential build so I would look at the 6% sequential growth for <unk>.

Thank you for your question.

Our next question comes from Leland <unk> from Oppenheimer the floor is yours.

SG&A is potentially not a bad number to think about but in the overall context of I would still say about 190 opex per quarter is not a bad number to think about.

Hey, good afternoon, and thanks for taking our questions.

I'm just curious in the.

Past you had.

Not expressed interest in a hypochondriac plays.

With respect to profitability, yes, we expect that this year I mean, if you look at our financials and back out June 30 currency, thanks to or whatever it was called Liberation day that cost about 20 euro of of cash Delta. So overall everything across the company. It was about five euro of burn in.

As a development program and maybe you have started to lean towards that earlier this year and now we're seeing a formal announcement.

Intention to go in that direction. So I'm just wondering what may have changed that affected your decision process here unless you could also maybe just briefly what do you think is the opportunity for sandoz.

In Q2, and actually on an operating basis, where were just slightly positive on cash so that should be relatively doable. This year with respect to MFS and tariff I think you said it pretty well.

Thank you.

Yes.

Pleasure.

What I will call.

Sure.

Perhaps the wrong way to define it but I call it a milder form of contemplation.

There is really too much in development right now to make any comments specifically on it but we do believe network as a flexible company, we're pretty well positioned to mitigate impact of any policy should it emerge.

Don't have many of them per se, what we call body Disproportionality, but you can say some in Otis because many of these patients basically will come in the ISS panic short statements and now because of most more influence on genetic testing your basic half and development large.

Just to clarify and also adding those comments.

Yeah.

We are not importing finished product to the U S.

Important in different states and finalize them inside the U S.

Group debt.

More is well defined from genetic testing to be hyper competition.

So in whatever way, we look at it we cannot see how it really should provide and major material impact on our business and how we operate.

One point that they seek are seeing patient tablets. In one took her group is now being moved over in a different telco regroup and meaning the move from ISS over to hydro contemplate share one thing the second thing that is.

Okay.

Thank you so much.

Thank you for your question.

When I sold the element of combination therapy, with transcon, CMP and transcon growth hormone.

Our next question comes from Leland <unk> from Oppenheimer.

Okay.

And then even if you happen, they're most heterogeneous patient population then.

Hey, good afternoon, and thanks for taking our questions.

I'm just curious.

By having a combination product.

In the past you had had not expressed interest in a hypochondriac players.

Basic can ensure all of them will do extremely well.

As a development program and maybe you have started to lean towards that earlier this year and now we're seeing a formal announcement.

So you can say that is what really operating up my attention why I believe we need to do it and also because we went out and talked with a lot of patients and I actually think I like to talk with the patient and that patient organization, because talking to them I get much more idea about the unmet medical need.

Intention to go in that direction. So I'm just wondering what may have changed.

If I could your decision process here and if you could also maybe just briefly what what do you think is the opportunity for Sandoz.

Thank you.

We need to address.

Yes. Please.

So basically this is the three pillars that have changed.

What I will call.

And perhaps is wrong way to define it but I call. It a milder form of contemplation that they don't have many of them. The same coffee cold body Disproportionality, but you can say some in Otis with many of these patients basically will come in the ISS panic short statements.

I would say and reshape of the two product groups were the hydro counter pleasure is growing because of allocation of patient from ISS over to hyper contemplation and Theyre heterogeneous group that really I feel when I talk to the patients when I talk to the patient organizations need a treatment and <unk>.

And now because of most more influential genetic testing.

Extremely positive data, we got fourth Cove.

<unk> and development large group, that's more well defined ofcom genetic testing to be hyper compensation.

When you have such as retaining some of the key element will be the CMP growth hormones that hope one cmp's for key element CMP withheld and this is why when you have such a heated delek group, having the combination therapy will be the most.

This is one point.

As a patient that was in one two a critic group is now being moved over.

Tokyo recruit and meaning the move from ISS over to hydro contemplate share one thing the second thing that is there.

Realistic way to treatment in a way where you really will have at fundamental good treatment regime.

When I sold the bill.

Alright, Thank you for that at this time.

Of combination therapy, with transcon, TMP and transcon growth hormone.

Thank you for your question.

Then even if you happen theyre most heterogeneous patient population.

Our next question comes from the line of David Lebowitz from Citi. The floor is yours.

By having a combination product.

Your basic can ensure all of them will do extremely well.

Thank you very much for taking my question.

Curious has there been any evolution in your thinking on the ultimate size of the market for your past.

So you can say that is what really upbringing up my attention.

Believe we need to do it and also because I went out and talked with a lot of patients and I actually think I like to talk with the patient and the patient organization because talking with them.

I'm just curious to know.

You know I will just been bullish and said that is going to be.

528 billion market segment.

Much more idea about the unmet medical need we need to address.

I have no doubt that it would be that.

So basically this is the three pillars that have changed.

<unk>.

I would say and rechange of two product groups.

Thank you for taking my question.

The hydro contemplation is growing because of allocation a patient from ISS over to Ivo contemplation and they're hit with Jamie group that really I feel when I talk to the patients when I talk to the patient organizations need a treatment and extremely positive data would be got fourth Cove.

Thank you for your question.

Our next question comes from Yang Zheng from Wedbush the floor is yours.

Hi.

Thanks, very much 14 questions and.

The first question on Transcon CMP for contemplation.

Where when you have such as retaining some of the key element would be the CMP gotten one would hope one cmp's for key element CMP withheld and this is why when you have such a hatred Delek group, having the combination therapy will be the most.

I assume that you receive FDA approval by the stupidity, how quickly we'll be able to launch the product and second question Hypochondriac pleasure and based on your comments just now.

But the press release, it seems to be seeing that either don't either monotherapy or combination therapy. So is it still a possibility that you might end up going with the monotherapy for hypertension hypo contemplation and if that's the case and what would be the reason why you don't go with combo therapy, given the obvious Ben.

Realistic way to treatment in a way where you really will have at fundamental good treatment regime.

Great. Thank you for that at this time.

Thank you for your question.

From coach study.

The first one is we actually meet some kind of pre seasoned with cutwater.

Our next question comes from the line of David Lebowitz from city the floor is yours.

We will wait until we get the approval and likely discussed will force me to wake up in the morning, Bev are early sort of press release.

Alright, Thank you very much for taking my question.

Curious has it been.

Gains on the ultimate size of the market for your past.

I'm just curious to know.

Some kind of call. It five o'clock in my time in the morning, and two I think at that time, we will explain.

You know I will just been bullish and said that is going to be.

When we have seen that lately and got all the CMC information back from Ft and other places.

528 billion market segment.

I have no doubt that there will be that.

When veeva launch the product and Jay will also be forced to be up in the morning, and he will explain how we go into our strategy in this way so you need to wait a little bit to this early morning call and people.

Thank you for taking my question.

Thank you for your question.

Our next question comes from Yang Zheng from Wedbush the floor is yours.

Try not to do it someday, but we will try to take it one other thing. So the second part is a little bit about what we talked about before.

Hi.

Very much 14 questions and.

The first question on Transcon CMP for contemplation.

<unk>.

This hydrocodone places and my view is extremely ketogenic population now with a lot of what are called.

I assume that you receive FDA approval by the stupidity, how quickly we'll be able to launch the product and second question Hypochondriac pleasure and based on your comments just now.

Burton and different way and also.

Now with the reallocation of patients from the ISS group into the Hypo contemplation.

The press release, it seems to be saying that either don't either monotherapy or combination therapy. So is it still a possibility that you might end up going with the monotherapy for hydro counterparty hypo contemplation and if that's the case and what would be the reason why you don't go was a combo therapy given the obvious.

It will someday.

From my perspective optimal would be to use for <unk>.

Combination.

And we.

We will continue our dialogue with regulatory agencies around the world to be sure.

From coach study.

The first one is we actually meet some kind of pre season with cutwater.

Uh huh.

<unk> view.

Cannot somebody.

We will wait until we get the approval and the likely discussed with forced me to wake up in the morning <unk> press release.

We eliminate the discussion if we will have in.

In the clinical trial.

<unk>.

And also reflecting transcon CMP as a monotherapy.

Some kind of call. It five o'clock my time in the morning, and two I think at that time, we will explain.

But it's our belief that the combination therapy will be what is best for their patients.

When we have seen that lately and got all the CMC information back from Ft and other places.

So this is aware.

For the time being.

When veeva dumps that product and Jay will also be forced to be up in the morning, and he will explain how vehicle into our strategy in this way. So you need to wait a little bit to this early morning call and vehicles.

We believe that the combination is the most robust treatment on it.

But obviously there will be some piece and then also just with benefit of having transcon CMP as a monotherapy.

Yeah.

Thank you.

Try not to do it is Sunday, but we would try to take it one other thing. So the second part is little bit about what we talked about before.

Thank you for your question.

Our final question comes from Maxwell Scar from Morgan Stanley the floor is yours.

Yes.

This hydrocodone places and my view is extremely ketogenic population now.

Great. Thank you for squeezing me in and forgive me. If this question has been asked but given the magnitude of growth velocity improvement in the coach trial do you believe a single pivotal trial could be sufficient for approval of the combination.

A lot of what are called.

Burton and different way and also.

Now with the reallocation of patient from the ISS group into the hyper contemplation.

You received any preliminary feedback from the FDA or EMA. Thank you very much.

Hey, yeah.

It was somebody.

From my perspective optimal would be to use for.

I heard a lot of discussion with Amy shoe above that he is sitting in my side because when we.

Combination.

And we.

We will continue our dialogue with regulatory agencies around the world to be sure.

Started this trial be talk about our own expectations.

And now we sitting with a girl philosophy that is so on preseason.

Uh huh.

<unk> view.

Cannot somebody.

And European team in contemplation.

They are basically growing faster than a normal child.

Eliminate the discussion if we will have in.

In the clinical trial.

Hum.

Single.

I have four children and I remember when they have growth spurts.

Also reflecting transcon CMP as a monotherapy.

Not really good we pretty told we Scandinavian so you've really grow a whole lot. So you're facing will be in a position that is this is really a big change in that.

But it's our belief that the combination therapy will be what is best for their patients.

This is a way out.

For the time being.

Some way I see it in.

We believe that the combination is our most robust treatment on it.

<unk> reached somebody called back and forward that discussion will you take a treatment of one year. We just take a treatment of two years in the combination you vacate major growth and other positive development will do 10 co pack for one or two years to.

But obviously there would be some patients and also just with benefit of having transcon CMP as a monotherapy.

Thank you.

Just have transcon CMP as a monotherapy and then you will boost again, if they desire.

Thank you for your question.

Parents for Charles and other things related today, and if it's really a needed at that time so in summary.

Our final question comes from Maxwell Scar from Morgan Stanley the floor is yours.

Great. Thank you for squeezing me in and forgive me. If this question's been asked but given the magnitude of growth velocity improvement in the coach trial do you believe a single pivotal trial could be sufficient for approval of the combination.

When I think.

Thinking about the overall a way how we will do the best for the patient and the Atlanta paces is basic to give them. The option that we really can be in a position where they can take combination therapy likely for one year, two years or things like that and get all the pain.

Have you received any preliminary feedback from the FDA or EMA. Thank you very much.

Hey, yeah.

I had a lot of discussion with Amy shoe above that you're sitting in my side because when we.

And that Keith and then we can continue with our transcon CMP and if they're happy decided to move into and although one yearly or two yearly treatment that will can do that again that is more or less our thinking in this way.

Started this surprise b talk about our own expectations.

And now we sitting with a growth velocity that is so on precedent.

Great. Thank you very much.

And European CE in contemplation.

Thank you for your question.

Basic probing.

That does conclude the question and answer session portion of this.

Faster than a normal child.

Hum.

I have four children and I remember when they have growth spoke.

Meeting.

This also concludes the meeting itself I'd like to thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Not really good we pretty told we Scandinavian so you've really grow a whole lot. So your basic will be in a position that is this is really a big change impact in some way I see it in.

Thanks, so much thank you.

Just trying to calm CMP as a monotherapy and then you will boost again if ties to sign off on the.

Parents for Charles and other things related to that and if it's really a needed at that time so in summary.

When I think about the overall are we how are we able to have the best for the patients and the patients.

Basic to give them the option that we have.

Really can be in a position where they can take combination therapy likely for one year two years and other things like that and get all the benefit and that Keith and then they can continue with our transcon CMP and if they're happy decided to move into and although one yearly or two yearly.

There will can do that again that is more or less our thinking in this way.

Great. Thank you very much.

Thank you for your question.

That does conclude the question and answer session portion of this.

Meeting this.

It also concludes the meeting itself I'd like to thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Thanks, so much thank you.

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