Q3 2024 Ascendis Pharma A/S Earnings and Business Update Call
Okay.
Speaker Change: Good day, and thank you for standing by welcome to the Cintas Farmer third quarter earnings call.
Speaker Change: This time, all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.
Speaker Change: To ask a question during the session you will need to press star one one on your telephone you.
Speaker Change: We'll then hear an automated message advisers your hand is raised to.
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Please be advised that today's conference is being recorded.
Speaker Change: I would now like to turn the conference over to your Speaker for today, Scott Smith, Chief Financial Officer. Please go ahead.
Speaker Change: Thanks, so much operator, and thank you everyone for joining our third quarter 2024 financial results Conference call I'm, Scott Smith, Executive Vice President and Chief Financial Officer at a set as far as.
Speaker Change: I'm joined today by yen Nicholson, President and Chief Executive Officer.
Speaker Change: 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 go over the path for the U S and European markets as well as certain financial.
Speaker Change: Expectations, our pipeline candidates and our expectations with respect to their continued progress and potential commercialization, our strategic plans and partnerships our goals regarding our clinical pipeline, including the timing of clinical results and trials are ongoing and planned regulatory filings and our expectations regarding the timing and the results of regulatory decisions expected in market development.
Speaker Change: And our exploration of market opportunities in the therapeutic areas endocrinology rare disease free.
These statements are based on information that is available to us as of today actual results may differ could differ materially from those in our forward looking statements and you should not place undue reliance on these statements. We assume no obligation to update these statements as circumstances change except as required by law for additional information concerning the factors that could cause actual results to differ materially. Please see our forward looking.
Speaker Change: Statements section in today's press release, and the risk factors section of our prospectus supplement filed on September 22024, and our most recent annual report on form 20-F filed with the SEC on February seven 2020 for Transcon growth hormone Transcon Hgh is approved in the U S by the FDA and the EU has received FAA authorization from the European Commission.
One for the treatment of pediatric growth hormone deficiency Transcon PTH is approved in the U S by the FDA for the treatment of hyperparathyroidism in adults and the European Commission and the UK medicines and healthcare products regulatory agency has granted marketing authorization for Transcon PTH replacement therapy indicated for the treatment of adults with chronic hyperparathyroidism otherwise. Please note that.
Speaker Change: Our product candidates, our investigational and not a perfect match for us as investigational products for safety and effectiveness of these product candidates have not been reviewed or approved by any regulatory agency now the statements. During this conference call regarding our product candidates will be viewed as promotional on the call. Today, we will discuss our third quarter 2024 financial results and will provide further business updates following their prepared remarks, well then open.
Speaker Change: It up for questions.
Speaker Change: With that let me turn it over to you.
Speaker Change: Thank you so much Scott.
Speaker Change: 'twenty 'twenty four has been a transformative year for Santos.
Two out of three of our rare endocrinology programs have to deal with clinical defense agent pivotal data.
Speaker Change: Each product or program is demonstrating its potential to address major unmet medical needs.
Speaker Change: <unk> blockbuster status positioning us to be the market leader in each disease are.
Speaker Change: Our first approved product scratch ofer.
Speaker Change: Best in class once we get to optimal.
Speaker Change: And has achieved a leading position in a highly competitive U S market.
Speaker Change: With a single indication sky.
Speaker Change: <unk> performance is a testament to its differentiated profile.
Speaker Change: And the team's excellent execution against competition from multiple pharma companies.
Speaker Change: We expect additional growth opportunity for scratch ofer.
Speaker Change: Yeah.
Speaker Change: Very excited about the upcoming launch of your pet in the U S.
Speaker Change: Europe is the first and only product to be FDA approved for the treatment of hydropower Toggery Smith.
Speaker Change: Yes.
Speaker Change: They are 70 to 90000 adults with HIFU payouts recently in the U S who would.
Speaker Change: Potential benefit from this treatment.
Speaker Change: Yeah.
Speaker Change: The highly positive pivotal data in aqueduct Asia that we announced in September for suite product candidates Transcon CMP.
Philadelphia strengthens our belief.
Speaker Change: That is correct.
Speaker Change: If that becomes a treatment of choice in this multi billion dollar market opportunity.
Speaker Change: Our new partnership with no minorities highlights our ability to attain.
Speaker Change: The success of our transport platform into Dos high.
Speaker Change: High volume therapeutic areas.
Speaker Change: By staying focused on our values of patient signs and passion, we believe youre, creating extraordinary value for patients and stakeholders.
Speaker Change: I will now provide more detailed comments on each of these products and other key areas of progress.
Speaker Change: Starting with cutover.
The fundamental Pescaito first astral.
Speaker Change: The main volume in the third quarter decreased more than 60 year over year expertise physicians caregivers and patients continue to recognize the benefit of structural fit provides.
Speaker Change: We have achieved broad of market assays for Scott children.
Speaker Change: What have not compromise on this value maintaining and net value per patient of around three times that of daily growth hormone.
Speaker Change: Overtime, we see an opportunity to drive this cutover growth.
Speaker Change: They are one pediatric growth hormone deficiency, we had a number of legal expenses.
Speaker Change: In September we submitted and supplement BLA for adult growth hormone deficiency.
Speaker Change: Next month, we expect top line data from our phase II trial in <unk> syndrome.
Speaker Change: And next year do you expect to imitate Scott trophic basket trial in established growth hormone indications such as idiopathic short stay too small for key stage H.
Genetic condition shock.
Speaker Change: Which include Turner syndrome.
Speaker Change: Importantly, the.
Speaker Change: The data growth hormone market is going to a consolidation.
Speaker Change: With players such as Leidy, Ajay mistake announcing plans to exit the market.
Speaker Change: To date, we've ripped.
Speaker Change: PTC that when giving the choice Scott Shaw is their preferred product.
Speaker Change: The market Comverse to once weekly treatment.
Speaker Change: We therefore believe this cutover is well positioned to compete for the 85% of prescription.
Speaker Change: Being written for daily growth hormone.
Speaker Change: We are dedicated to make Scott over into a blockbuster in the U S alone.
Speaker Change: Our focus will stay on growing its market share with new patients both treatment.
Speaker Change: Switching from data growth tomorrow.
Speaker Change: Increasing treatment adherence and duration and through label expansion.
Speaker Change: Supported by pricing that recognize the fair value of long acting therapy.
Now moving to your pets.
Speaker Change: We are preparing for the imminent launch of <unk> in the U S mix.
Speaker Change: Next month's into simple be play to begin accepting prescriptions and stopped the reimbursement process for their route 200 patients already being treated with your pets.
Speaker Change: Preparation for commercial product availability in mid January 2025.
Speaker Change: From January 1st we expect to begin accepting prescription for adults with chronic hyperparathyroidism.
To support a strong and successful U S launch, we have invested to expand our commercial infrastructure.
Speaker Change: Including building a field organization for your past that is three times the number that cost cutover.
Speaker Change: Since the approval of our expanded USPS team is focused on engaging endocrinologists, who treat adults, including among key opinion leaders and health care providers.
Speaker Change: Who are actively involved in the treatment of hydropower patients.
This market is driven by endocrinologist.
Speaker Change: Too concentrated speciality and we estimate around 1200 physician.
Speaker Change: Around <unk>.
Speaker Change: Thompson.
Speaker Change: Chronic <unk> patients and their care on average about 25 patients needs.
Speaker Change: We expect initial uptake of your peers in the U S to come from four segments.
Speaker Change: They are around 200 patients already on your pets that 350 to 400 patients and then net par special use program that is ending soon.
The vast population of 4% to five Towson PTA to expand patient and around 75000 broad P. J, it's treatment naive population.
Outside the U S <unk> uptake of Europe, It continues to be robust.
Speaker Change: As of to date.
Speaker Change: There are now around 600 patients on commercial therapy in Germany and Austria.
Speaker Change: Commercial launch became this year in January and of course.
Speaker Change: Patient programs in boots or other countries.
Speaker Change: We believe Europe is a truly unique product.
Speaker Change: We have decided to have the same mode of action and distribution in the parking industrious P. J, It's enterprise ex U P 8 billion Fisher logical levels for 24 hours seven days a week.
We don't see any other compounds that development.
Speaker Change: Here.
Key attributes.
Speaker Change: We believe that <unk> will become the therapy for the majority of adults with hyperparathyroidism.
Speaker Change: Which is aligned with the recently established guidelines for the treatment of hydropower Tory Smith in agile.
Speaker Change: Thanks.
Let me now provide some commentary on transcon CMP.
Speaker Change: Our value proposition for transparency simple.
Speaker Change: Is to establish a treatment for patients of all ages.
Speaker Change: <unk> Asia.
Speaker Change: Our pivotal trial result showed their transparency E&P not only exceeded benchmark for growth.
Speaker Change: That has been the slackness in other randomized clinical trial, but also impacted other inputs that are important for.
Speaker Change: Video ads with Echo location.
Speaker Change: Do you believe transcon CMP has a best in class efficacy profile with safety and Tolerability similar to placebo.
Speaker Change: Intuitive and excellent injection site suitability and once weekly dosing.
Speaker Change: Citrus states poised leadership in co location market.
Speaker Change: We expect to submit an NDA to the FDA for transparency.
Speaker Change: For the treatment of children with Echo location during the first quarter of 2025.
Speaker Change: And then M&A to the EMEA during the third quarter of 2025.
Speaker Change: Once we get growth promoting products in our portfolio, Scott Shaw and Transcon CMP.
Speaker Change: We believe that sandy.
Speaker Change: <unk> is positioned to become the leader in treatment of growth twofold.
Speaker Change: We expect topline week 26 data from copes, our first combination trial of transcon growth hormone and transcon CMP in children with achondroplasia eight to 11 years in the second quarter of 2025.
Speaker Change: Now moving to our recently announced <unk> collaborations.
Speaker Change: We believe this agreement is a strong validation of our ability to drive innovation benefit patients and expand the transcon technology platform to larger therapeutic are best described.
Speaker Change: 2013.
Speaker Change: The lead program in Dakota Basin is a once monthly <unk> debit initial target obesity and type two diabetes.
Speaker Change: The global market for <unk> like semi new type is expected to exceed more than 50.
Speaker Change: Billion this year enter dolphin a triple in the next 10 years.
Speaker Change: Once monthly <unk>, one could become the treatment of choice in this future market.
Speaker Change: And we are pleased to be working with Novo Nordisk.
Speaker Change: It would be done with the manufacturing capacity and commercial infrastructure to realize the value of this opportunity.
Speaker Change: Financially upon closing, we will receive an upfront payment of $100 million U S dollars.
Speaker Change: Escalating tiered mid single digit royalties on global net states of Transcon products, along with development regulatory and sales milestone.
Speaker Change: I will close with an update on our oncology programs.
Speaker Change: September be perceived as first results.
Speaker Change: From the platinum resistant ovarian cancer cohort of the phase one two I believe trial of transcon to Peter Karma at ESMO, showing that antitumor clinical response, but of soup in 29 of efficacy you would pay.
Speaker Change: <unk> treated for transcon <unk> in combination with chemotherapy.
Yeah.
Speaker Change: This was the second indication specific cohorts showing meaningful signs of antitumor activity in heavily pre treated patients.
Speaker Change: Given these results recently be close enrollment to dose expansion cohort in the trends.
Speaker Change: 101.
Believe trial of Transcon Telos, seven eight agonist too.
Highly prioritize or effort on trying to either to beta gamma.
Speaker Change: In summary, our progress and position are strong and we believe the expected product revenue and strength of our balance sheet give us that.
Speaker Change: The ability to invest in global launches.
Labor expenses and lifecycle management for all of our treat rare endocrinology programs to support each of them to reach blockbuster status.
Speaker Change: At the same time, we will continue to invest in new product candidate created by our Transcon technology platform to build sustainable growth and profitability.
Scott Foreign: I will now turn it over to Scott Foreign financial update.
Thanks, Dan.
In tandem with the progress we have made this year with our three endocrinology rare disease programs and the success of extending the application of our transcon platform into obesity and type two diabetes.
Scott Foreign: <unk> also became much stronger financially in 2020 for product revenues have grown significantly.
Scott Foreign: We raised capital in the third quarter.
We are securing additional non dilutive capital through the Novo Nordisk collaboration and we remain disciplined with our spend.
Scott Foreign: We head towards next year with ample financial capability to execute on our key 2025 strategic priorities.
Scott Foreign: Expand the label for <unk> to adult growth hormone deficiency and build on its leadership position as a best in class growth hormone product.
Scott Foreign: Successfully launch <unk> in the U S and in multiple countries in our Europe direct and international markets.
Scott Foreign: And submit transcon CMP for approval in the U S and EU and initiate preparations for launch and a contemplation.
Scott Foreign: I will touch on some key points surrounding our third quarter financial results, but for further details. Please refer to our 6K filed today.
Scott Foreign: Sky truckload volume increased more than 60% in the third quarter of 2024 compared.
Scott Foreign: Compared to the third quarter last year, while reported revenue was $47 2 million euro compared to $47 million Euro reported in the third quarter of 2023.
Scott Foreign: The increase in volume was offset primarily by higher sales deductions compared to the prior year as a result of broader market access.
Scott Foreign: <unk> revenue in the third quarter of 2024 related to channel inventory was approximately $3 5 million euro lower compared to the third quarter last year.
Scott Foreign: Scott drove our revenue in the third quarter of 2024 was also negatively impacted by adjustments related to prior period sales deductions of $2 5 million Europe.
Scott Foreign: Scott drove our revenue for the first nine months of 2024 totaled $138 5 million euro or 21% increase year over year compared to $114 4 million Euro during the same period in 2023.
Scott Foreign: For the first nine months of 2024, skytrooper volume more than doubled but was partially offset by higher sales deductions, including an accrual true up $9 3 million euro related to periods. Prior to January one 2024.
Scott Foreign: Overall, despite the accrual true ups in Q2, and Q3 with more claims in hand, we can see that realized pricing has been stable since the beginning of the year with stable pricing a few extra shipping days and increasing demand. We expect Q4 revenue to increase sequentially and expect full year 2020 for sky drove our revenue.
Scott Foreign: Excluding sales deductions related to prior years to be $200 million to $220 million Euro.
Scott Foreign: We estimate by the end of Q3 2024 based on third party data Scott.
Scott Foreign: <unk> penetration in the overall <unk> growth hormone market was approximately 6% with our single indication for pediatric ghd.
Scott Foreign: In addition, we estimate based on third party data that sales of daily growth hormone products represent about 85% of total U S prescriptions, leaving lots of room for further growth for Skype profile and market expansion.
Scott Foreign: Shifting the transcon PTH third quarter yoga path revenue outside the U S increased more than 60% to $8 5 million euro driven by growing patient and physician demand, partially offset by accruals, reflecting the end of the free pricing period in the third quarter.
Scott Foreign: Final pricing in Germany is expected to be completed next year.
Scott Foreign: Closing out the top line total revenue for the third quarter was $57 8 million euro, including $2 1 million euro tied to rendering that services and license revenue.
Scott Foreign: Turning to expenses R&D costs in the third quarter of 2024 totaled $73 5 million Europe compared to $111 4 million Euro during the third quarter of 2023.
Scott Foreign: The 34% decline was largely due to lower external development cost for transcon, Hgh, Transcon, PTH and transcon CMP as well as the icon transaction.
Scott Foreign: SG&A expenses in the quarter totaled $69 8 million euro compared to $63 6 million euro during the third quarter of 2023.
Scott Foreign: The $6 million Euro increase was primarily due to higher employee costs, including the impact from global commercial expansion.
Scott Foreign: Total operating expenses were $143 4 million euro for the third quarter of 2024, and 18% decrease compared to $175 1 million Euro during the third quarter of 2023.
Scott Foreign: Total operating expenses for the first nine months of 2024 were $439 million Euro.
Scott Foreign: Net finance income in the quarter was $2 9 million euro compared to finance expenses of $20 4 million Euro in the third quarter of last year.
As a reminder, the net finance line can fluctuate quarter to quarter driven in part by noncash items related to our outstanding convertible notes.
Scott Foreign: Finally, we ended the third quarter with cash cash equivalents and marketable securities totaling $626 million euro compared to $399 million Euro as of December 31, 2023.
Scott Foreign: To be clear.
Scott Foreign: Total cash does not include the expected $100 million upfront payment from Novo Nordisk, which is due following closing of the transaction.
Scott Foreign: For the full year 2024 based on current plans, we expect product revenue from Sky Trophy and yoga path ex U S to continue to grow.
Scott Foreign: Specifically, we expect Sky Trophy revenue, excluding sales deductions related to prior years to be $200 million to $220 million Euro and total operating expenses.
Scott Foreign: G&A and R&D to be approximately $600 million euro.
Scott Foreign: Which includes expenses related to launching over the path in the U S.
Scott Foreign: We are ready and well capitalized to deliver a successful launch of yoga path in the U S with product availability expected in mid January.
Speaker Change: With that operator, we are now ready to take questions.
Speaker Change: Thank you.
Speaker Change: A reminder, if you would like to ask a question. Please press star one one of your telephone.
Also ask that you limit yourself to one question and one follow up.
Speaker Change: Please wait for your name of the company to be announced before you proceed with your question.
And our first question for today comes from Jessica.
Speaker Change: Of Jpmorgan your line is open.
Hey, guys. Good afternoon, thanks for taking my questions.
Speaker Change: <unk> laid out the case for a strong initial U S launch for you argue path and we're clearly seeing that ex U S. Already can you talk about why you have confidence that you'll be able to keep the.
Speaker Change: The patients that you pick up in light of various competitors potentially entering the market.
Speaker Change: And my second one or follow up is just in the past you've talked about an expectation to reach operating cash flow breakeven by the end of 2025 is that still your expectation.
Speaker Change: Thanks, Jess I would take the first question and then our delegated to Scott to take the second question and I think.
Just the basic summary reflected that.
Speaker Change: Our initial remarks, because what we described what is really a true ripped.
Speaker Change: Replacement therapy, because we are talking about patients.
Not have sufficient <unk> to really to have enormous functional life like a type one diabetes and.
Wendy.
Speaker Change: Terrific.
Speaker Change: As have been proven in multiple multiple publication, especially a week form.
Speaker Change: We have a huge infusion pumps.
Speaker Change: King.
Speaker Change: <unk>.
Into short acting <unk>, but they can keep up with pizza logical concentration 24 hours seven days a week. So when we think about what needs to be taken as what we call. A true replacement therapy is that you need to have to see mode.
Speaker Change: Action that you have embedded doctors home.
Speaker Change: And basic.
Speaker Change: You need it because theres so many months.
Speaker Change: Instead meet.
Speaker Change: Some way to get the right receptor activating signaling pathway activating to have the normal seasonal article function. The second thing is that you need also to have the right distribution.
Speaker Change: Because it need to hit both Crucible, Justin augment kicked me both in the blood and urine side need to go to the brain ignore everything else too.
Speaker Change: Last thing is basic.
Speaker Change: PK profile unique to have the right concentration 24 hours seven days a week.
What ever Us too.
Speaker Change: When I look.
Clinical program studies.
I cannot find a new one that just living up to the level of what I call a replacement therapy.
Speaker Change: That was my first question I think Scott could take the second one.
Speaker Change: Okay.
Scott Foreign: With regard to our goal to be cash flow breakeven thats still remains the goal and we believe we can achieve that with the cash and cash equivalents that we have on hand.
Speaker Change: Thanks.
Speaker Change: Thank you for the next question.
Speaker Change: And our next question will be coming from the line of Zee Hello Rod.
Speaker Change: With Bank of America Securities. Your line is open.
Speaker Change: Hi, guys. Good evening, Thanks for taking my question mine's on BNP.
Speaker Change: Can you just give us an update on where you are in preparing.
Speaker Change: For your meeting with FDA and on your application what are the open items that needs to be completed before you can guide us to whether or not the data that you have is indeed going to be sufficient for application and also could there be potentially a pathway, where you start your submission and provide data on a rolling basis.
Speaker Change: The agency is looking for extended data. Thanks.
Speaker Change: Okay.
Speaker Change: Thanks, a lot for the question and to our knowledge.
Speaker Change: And that is after interaction with both.
Speaker Change: Regulatory agencies in Europe.
Speaker Change: We have the integrated data packet that need to be part of the submission.
Speaker Change: So we basically have no <unk>.
Speaker Change: Missing data.
Speaker Change: That would be excellent need to be generated for basic to finalize the application here for example, with ft, we've been doing that and be getting ready to refining whether they're happening in Q1 is pretty Indiana and.
Speaker Change: When I look on the packet, we really are providing a packet that no only providing the best in class growth.
Speaker Change: Of the children.
We also for first time cannot risk co Morbidities and I think that's something we will continue to share with you.
Speaker Change: How we really are providing a treatment of contemplation and state of just providing linear growth.
Speaker Change: Just wanted to have linear growth I would just give them growth hormone is the best home to provide linear growth.
Speaker Change: And I think this is a <unk> unique position because we have the opportunity really to address the comorbidities and we will continue to keep your data how really that is really coming from the data package to be submitted to the regulatory agencies.
Speaker Change: Thank you one moment for the next question.
Okay.
Speaker Change: And our next question will be coming from Derrick.
Speaker Change: Akshay <unk> of Wells Fargo.
Okay.
Speaker Change: Sir your line is open.
Speaker Change: Sorry, Hi, this is Daniel on for Gary Thanks for taking our question.
Speaker Change: So first I will give the approval have you made any progress with the payers.
Speaker Change: Has any update on is it on formulary or if theres any new blocks for market entry.
Speaker Change: And just one on yogurt pack.
Speaker Change: While this launch require a medical exception for access to the drug.
Speaker Change: Okay.
The first part of the schedule.
Sure.
Speaker Change: I think we have been pretty clear, how we are improving our Margaret assess situation, which has happening a lot in this year was really impacting our Q1 results.
Speaker Change: In this way.
Speaker Change: We are still in a situation, where we are getting medical exception in the ers, but we definitely are in a complete different market access situation. This one.
Speaker Change: But I believe what we see here and I think you would need to go back and see how we really want to.
Speaker Change: Balanced.
Speaker Change: Catch all fit into the growth hormone market.
We believe.
Speaker Change: Scott Sofa because of its best in class nature, it's really.
Speaker Change: Can be position as a high value product opportunities.
Speaker Change: Sure.
Speaker Change: We believe this is responsible to have a price that on net value is three <unk> higher than <unk> growth hormone because of all of that benefit be providing.
Speaker Change: And I think this is a key element in our commercial strategy on how to make.
Speaker Change: Cutover to our bulk blocks of just in the U S alone is to keep value.
And what is also helping us with the consolidations we saw first that.
Speaker Change: One of the big pharma lifted.
Speaker Change: And obviously, another big pharma, leaving it.
Speaker Change: And I believe if you're sitting with a daily growth hormone and you don't have any kind of once weekly product in one way or the other way you actually are going to leave this market. So the consolidation is happening.
Speaker Change: Okay, it's a little bit slower than we had predicted but it is happening and we repeat there to really be able to utilize this opportunity over time to come. We also have a strong reputation via company that never had been on the shortlist.
Speaker Change: Your company to have the most supply chain that really have not been disrupted by any kind of delivery.
Speaker Change: Related to Europe had interesting comment up from the thing because when you look on the product being launched specific in the rare diseases and to the group of product we belonged to that too.
Speaker Change: Two things that is a key element for uptake.
Is that are you.
Speaker Change: Your basic in on label for the majority of their patients.
Speaker Change: And I can guarantee you beyond that.
Speaker Change: Second point.
Speaker Change: Do we really have guidelines.
Speaker Change: Basic promote that you are inside the guidelines for the majority of patients I am pleased sweep the guidelines that Jeff Scott issue for a few years ago around hydropower patients here in the U S. Adult treatment and I think we are in such a unique position to be both on label.
Speaker Change: We are also in position.
Speaker Change: <unk>.
Speaker Change: Inside the guidelines.
Speaker Change: So we feel that we basically are providing.
Speaker Change: The benefit to the patient and just don't forget we have only product out there.
Speaker Change: No oil products there. So when you see the three element your single product no one else choices.
Speaker Change: <unk>.
Speaker Change: On labor.
Speaker Change: And you're inside the guidelines.
I actually believe you have.
Speaker Change: <unk> strong position to get the journey from a prescription ought to be fully reimbursed in U S.
Speaker Change: Most Ethiopia.
Speaker Change: Okay.
Speaker Change: Thank you one moment for the next question.
Speaker Change: And the next question will be coming from the line of.
Iran.
Speaker Change: Barber of TD Cowen Your line is open.
Speaker Change: Yes, hi, great. Thanks for taking my question.
Speaker Change: And maybe just.
A couple on Europe V pass.
I think in the past, we were sort of expecting that pair.
Speaker Change: <unk> will get pulled off the market by the <unk> by the end of this year can you give us a little bit of a sense. How is this going to work is it driven by like a hard date December 31 or is it just driven by when they run out of supply and then also in Europe.
Speaker Change: I know you're.
Speaker Change: Waiting for the net par inventory to run out before you already passed it really takes off can you give us a little bit of an update on timing youre expectations. Thank you.
Speaker Change: Yes.
Speaker Change: Youre asking me a question that is outside my control.
Speaker Change: So I cannot control win.
Speaker Change: The pace, we're running out of stock we know the same everywhere.
Speaker Change: The production and running all boxes.
Speaker Change: Now we are in a position in the U S.
Speaker Change: I believe that we will try to get out of the U S market as fast as possible, because but basically providing free drug out to each single patient the U S.
Speaker Change: In Europe, we have seen an interesting pattern to them, where they are trying to come out with.
Speaker Change: Inventory theyre doing as fast as possible.
Speaker Change: Using all different means to do that.
Speaker Change: The two hour.
Speaker Change: Chris estimate if somebody will be in next year, you will see the big transition happening.
Speaker Change: Sure.
Speaker Change: But at the same time.
Speaker Change: We saw in the two different patterns in two different countries in Germany.
Speaker Change: The switched the manpower patient because let's say if there was an improved treatment now in Germany.
Speaker Change: And taking new patients now because the pool of PAH patients running out.
Speaker Change: Australia different per se.
Speaker Change: Is keeping their power patient on their part as long as possible and then take new patients.
So what is going to happen in the U S. When I see these two countries to different patterns.
Speaker Change: And we believe from the four groups, we talked about all of them will be switched.
Okay.
Speaker Change: Okay.
Speaker Change: Thank you one moment for the next question.
Speaker Change: Yes.
And our next question will be coming from the line of Gavin Slark Gardner of Evercore. Your line is open.
Speaker Change: Hey, guys. Congrats on all the progress so I just wanted to ask about the 4000 5000 PTH experienced patients in the U S. But you've noted are all these patients actively managed and in the in the health care system and I guess more specifically how long do you believe it could take to get the majority of these patients onto <unk>.
Speaker Change: Could it be within the first year two years any estimate would be helpful. Thank you.
Speaker Change: Thanks for the question.
Speaker Change: I believe.
Speaker Change: This <unk> experience group.
Speaker Change: They're used to do daily illustration, if you're coming from for example photo to curtail some patients are doing injection four times a day.
Speaker Change: But the patio at NOLA short acting many of them have.
Speaker Change: A limited timeframe for you.
Speaker Change: Two years because of the superficial logical pks level, providing so when I look on the four to five Thompson. The majority is net PAH patients that couldn't come into the program that basic.
Speaker Change: Started with the has the record so when that cost base should use program.
Speaker Change: To our best estimate only can take one.
Speaker Change: Out of 10 patients so we're sort of sitting without any kind of.
Speaker Change: P J, it's treatment option.
Speaker Change: I believe.
Speaker Change: These patient group.
Speaker Change: We'll try to be coming into <unk>.
Speaker Change: <unk> as fast as possible.
Speaker Change: This is a wide be talking with the patient organization be talking now that here in the middle of January.
Speaker Change: New basic will have product availability here in the U S and really go in and start to.
Speaker Change: Get a prescription.
Speaker Change: We have our hub.
Speaker Change: The ASR program really and unique element that will help the patients and the journey from the prescription to basic to be in a position they're fully reimbursed MP on drug.
Speaker Change: We have the infrastructure to it we know how to get it done.
Speaker Change: And we believe there is so many patients that just waiting for this opportunity to get treatment.
Thank you one moment to the next question.
Speaker Change: Yeah.
Speaker Change: And the next question is coming from the line of Lee <unk> of Cantor. Your line is open.
Speaker Change: Hey, guys. Thank you for taking my questions.
Speaker Change: I guess relative to the pediatric growth hormone market, how should we think about the revenue contribution from the adult market is wow.
Speaker Change: The Turner syndrome.
Jay: Jay It sounds like you're initiating a basket trial, maybe just comment on the market opportunity there relative to the growth hormone market.
Speaker Change: Yeah, when we look on the Croft hormone market.
Speaker Change: On label.
Speaker Change: Only have access to the market segment that is covering by pediatric growth hormone deficiency, we have now five adult growth hormone.
Speaker Change: Deficiency with open offer complete interesting segment currently only status at 10% of the colt hormone market, but you said highly highly underpenetrated treatment population in the U S.
Speaker Change: Best estimate we have is about 5% to 8% is being treated with adult growth hormone deficiency. So it is really to develop and market that can be nearly the same site SBA pediatric market.
Speaker Change: We focused on being quite sure.
We schedule for it should be but choice.
Speaker Change: In all indications, where we have the growth hormone market and this is why we are making.
Speaker Change: The basket trial.
Speaker Change: Taking the ISS SCA and shock.
Speaker Change: This includes internal by having this label expansion.
We redeemed position that we need to coin that tire optimal market and this is our vision to build schedule for it to be a blockbuster should be going to <unk> going to hydropower is quite different because.
Speaker Change: Salt segment is basically the majority of the market.
Speaker Change: Patients are coming.
Peter Karma: Peter It's Mike.
Peter Karma: Recall hydropower, the majority were not coming from cost or just more coming from the more logical genetic diseases. So it's a quite different segment in this way and it's much more smaller and.
Peter Karma: The adult segment.
Peter Karma: We are initiating a trial in the pediatric segment.
It will be just in the planning now and it's a part of also our application to the European charges also make it available if the pediatric segment.
Speaker Change: Thank you one moment for the next question.
Speaker Change: And our next question will be coming from the line of Joe Schwartz.
<unk> partners your line is open.
Joe Schwartz: Great. Thanks, so much.
Speaker Change: First question is on your path I was just wondering how do you expect the launch of European and the U S to compare to Europe.
Speaker Change: And in General and then is the monthly serum calcium monitoring requirement in the U S likely to be a significant deterrent for patients which impacts the launch curve at all in your view.
Speaker Change: Let me start on the last question Joe.
What I've seen I've seen the UN criteria for some of the places.
Speaker Change: And I have never seen that being installed at any kind of criteria. So I don't think this is really the case.
Speaker Change: I know the patients often will have this kind of missing so it's not like it will be appeared to have it but I'm not seeing that in the U S could hear from anyone.
Speaker Change: Related to the U S market is quite different than the.
Speaker Change: German Austrian market.
Speaker Change: Penetration curve.
Speaker Change: Germany, Australia compared to U S.
Quite different slopes.
Speaker Change: So from that perspective is that.
Speaker Change: Just first a unified market segment in the U S.
Speaker Change: If things go faster in the U S.
Speaker Change: There is much more important mindset to try new treatment, but what we're seeing now in Germany, everyone tried with one or two patients and how were going up so the average patient physician was between one and two now we first coming to the states where they are going to be 213 for the physician and this is some.
Speaker Change: Kind of what I call your first payment rates and you broadened it but.
Speaker Change: We expect to see in the U S is a much much larger and fast uptake.
Okay. Thank you very much and then on Sky trough is today's adjustment to the 2020 core revenue guidance due to lower volume price or both.
Speaker Change: US understand why the additional adjustment is necessary beyond what we saw previously and whether these dynamics have any potential to carryover into 2025.
Speaker Change: I think Scott will take that.
Speaker Change: I think Joe in Q3 volume was a little bit lower than expected, but we also had fewer selling days were off to a pretty good start here in Q4.
Speaker Change: We want to be a little bit more cautious until we see more data. So given we had the call today we came in.
Speaker Change: With the number that you saw some dependencies that could.
Speaker Change: <unk>.
Speaker Change: <unk> increased the number for Q for Q4 would be things like channel buying that we haven't seen in previous periods or higher refill rates with prescriptions, but we just don't have enough experience to say that that's something to expect in Q4 yet.
Speaker Change: Okay. Thank you.
Yes.
Speaker Change: Thank you one moment to the next question.
Speaker Change: And the next question will be coming from the line.
Speaker Change: Vikram.
Speaker Change: Right.
Speaker Change: Morgan Stanley Your line is open.
Speaker Change: Hi, good afternoon. Thank you for taking our questions. So we had one on the recently announced Novo Nordisk collaboration we were just curious.
Speaker Change: That moves forward what.
Speaker Change: What the next public disclosures there could be what we can expect to learn from yourself and Novo Nordisk and then secondly.
Speaker Change: For the oncology pipeline, we were curious what the next milestones there might be and how youre thinking about progressing the oncology efforts you have in place with.
Speaker Change: Potential partnerships.
Speaker Change: What partnership economics, or a good partner for those efforts might look like in the future. Thank you.
Speaker Change: Thanks for the questions.
Speaker Change: Related to the first question.
Speaker Change: We have seen extremely powerful transcon technology, making treat out of three endocrinology product from Ikea States until basically people data and two of our proof now and this is the transcon technology with our aggregate for product.
Speaker Change: Patients and Novo Nordisk took that up too.
Speaker Change: So we basically are in a position when I see what we can provide with our transcon technology in obesity.
Speaker Change: Metabolic diseases like.
Speaker Change: Diabetes is we can take a peptide wasn't known provinces.
Speaker Change: <unk> proven safety and proven efficacy and do exactly the same thing.
And at the same time, we can make it to a once monthly but potentially also improve tolerability.
Speaker Change: Potential efficacy in the same time.
Speaker Change: And.
Speaker Change: We really proud to have a partner like no one noticed.
Speaker Change: There's only two company in the World in my view that have been manifest ability capacity really to make.
And commercial infrastructure to really to make this in a billion billion billion.
Speaker Change: Dollar product and this these two companies we actually have an unique great collaboration with and there are not only using it for one of the products that will continue to apply multiple more suitable product on it.
Speaker Change: Related to specific progress related to a specific update about.
Speaker Change: Progress on how they're utilizing the transcon technology.
Speaker Change: I believe the best one to answer that will be Novo Nordisk in this case.
Speaker Change: Going back to oncology we have.
Speaker Change: Extremely and cars.
Speaker Change: The effect, we have seen in platinum resistant ovarian cancer in late stage patients that basically have no hope.
Speaker Change: We actually see meaningful.
Speaker Change: Clinical benefit in this and this is what we really trying to focus on.
Speaker Change: Really pursuing.
Speaker Change: Fastest and face possible manner to really hit this patients.
Speaker Change: As we said.
Speaker Change: We are open in the way we will.
Create value out of oncology pipeline.
Speaker Change: In all different structures, and we will pursue the structure that focus on getting out to as many patients as possible as fast as possible, but also creating most value for stakeholders.
Speaker Change: Okay.
Speaker Change: Thank you Juan this is the next questions.
And our next question will be coming from the line of Kelly shy of Jefferies. Your line is open.
Speaker Change: Kelly Your line is open.
Kelly Shy: Thank you thank.
Kelly Shy: Thank you for taking my question.
Speaker Change: I just wanted to confirm that our numbers in the press release. It was mentioned that the first quarter. This does conclude for Toyota.
Speaker Change: 138 Quantifies.
Amelia Euro dollar Euro and.
Speaker Change: For your guidance that at 202.
Speaker Change: 220, so that gave Q4 sale it will be 61 quantify Amelia.
Speaker Change: And to which the lower bound and this does know Zoopla Jasmine and secondly, a further 12 Carlson.
Speaker Change: Just curious have you talked to.
Speaker Change: So Robert later with agencies that at 12 months data as one of the slides from Michal. Thank you.
Speaker Change: Hi.
Thank you Tim.
Speaker Change: Take the first part of your question to Scott and he just wrote down all your numbers and <unk> taken them now.
Speaker Change: Yes, the updated guidance of 200 to 202000.
Speaker Change: Of revenue excludes the impact of.
Speaker Change: Prior period sales deductions, our sales deductions related to periods prior to January one 2024.
Speaker Change: Related to your second question, it's clear we have not got any request that.
Speaker Change: That deliver more than 12 months data related to efficacy doing filing you always have what we call safety data update and Youll have cut of different safety that OSB, giving doing that.
Speaker Change: Periods, where you have the regulatory evaluation.
Thank you and the woman and the next question.
Speaker Change: Our next question will be coming from the line of David <unk>.
Speaker Change: <unk> of Citi. Your line is open.
Speaker Change: Thank you very much for taking my question I've got two first on long acting <unk>, one agonist and given the lumpy ones are.
Speaker Change: Titrated as part of normal treatment.
Speaker Change: What type of challenge and there is a long acting present in this regard.
Speaker Change: And the second question will be on Sky Trocar.
Speaker Change: Could you I guess give us Chris.
Speaker Change: Perspective on how the net average price.
Speaker Change: Has evolved as you've added new payers and to give his perspective, just for modeling purposes, and how we should view this going forward.
Speaker Change: Okay. Thanks, a lot.
Speaker Change: When you talk about the length of long acting <unk>, one I would like to refer back to the basic biology of the T Pier one because what is really driving the tolerability issue.
And two hour notice is that it's basically when you go from the trough levels.
Speaker Change: Cause the lowest level are off the peak labor and how fast you really are doing that this is where youll see the total ability issuing it. So therefore youll see when patients stopping treatment have problem with that.
Speaker Change: The treatment is because of that.
Speaker Change: Fast up from the trough to peak. This is why you have titration, where you start on a lower dose co op to the next dose. This just to be sure you outcome meeting that you deal with this tool ability when you're taking on our profile that you saw in our JP Morgan take also other.
Speaker Change: Basis, you can see one of the uniqueness with our transcon technology use that we have extremely.
Speaker Change: Long T Max and what would that mean it means that it's take extremely long basic for being a precision that you go from a trough to peak levels and therefore, which we also have seen in our own data in animal studies that you basically have a much better tolerability.
Speaker Change: Profile than you have in more short exiting we're equal bear bear bear fast up to that element of the Max dose.
Speaker Change: Thanks.
Speaker Change: Thank you.
Speaker Change: It's pretty clear we had a clear statement in our prepared.
Speaker Change: Remarks that if you take a leg of the level of daily growth hormone and take it to onex.
Speaker Change: <unk> has three value.
Speaker Change: Thank you one moment for the next question.
Speaker Change: And our next question will be coming from the line of Paul Chow.
Speaker Change: Goldman Sachs. Your line is open.
Paul Chow: Hi, good afternoon, and thank you for taking our questions. I also wanted to ask on your recent novo licensing deal.
Paul Chow: And given that <unk> ones are validated it would seem like the fiber.
Paul Chow: 505, Btu development pathway is open to all.
Paul Chow: Potential monthly <unk>, one agonists and so development times might be shorter than a full clinical development program for <unk>.
Speaker Change: Do you agree with this and that's the case do you have any sense of what timelines might be for development.
Speaker Change: You might start to recognize royalty revenue from your partners any comment there would be super helpful. Thank you.
Thank you and I can only agree 100% with your comments.
Speaker Change: Secondly, how many cases, you would take a development pathway.
And it would be shorter than a normal development pathway and also you have potentially the opportunity to get a broad label.
Beginning with only one indication that is split benefit of producing <unk>.
Speaker Change: Related to specific timeline, we need to refer to normal notice for this discussion.
Speaker Change: Okay, great. Thank you.
Thank you one moment for the next question.
Speaker Change: And our next question will be coming from the line of Leland.
Speaker Change: Of Oppenheimer. Your line is open.
Speaker Change: Oh, Hey, Thanks for squeezing me in and for taking the questions just one from US I think.
Speaker Change: You had mentioned that <unk>.
Speaker Change: Commercialization in France might be starting by the end of this year not sure. If I missed in your prepared comments is that on track and is also wondering is he further pursue European commercialization if.
Speaker Change: If you have any further clarity on the cadence of rollout in various countries through 2025.
Speaker Change: Yes.
Speaker Change: You are right.
Speaker Change: We have been established as a multi quarter full commercial air is only Germany and Austria.
Speaker Change: In Franks, we got elected two and special program called <unk>.
Speaker Change: This is a program that basic non promotional but we can give them commercial reimbursed.
Speaker Change: Truck.
Speaker Change: And as Scott established for about three four weeks since in.
Franks.
Speaker Change: And the number we have seen coming in where physician really say I belief I believe.
Speaker Change: Because it need to be physician turbine we cannot commercialize this.
Speaker Change: Really unique.
Speaker Change: Going forward we have.
Speaker Change: We'll have fully commercial countries well recall in Europe direct.
Speaker Change: We're <unk>.
Speaker Change: Most of those countries and it will be the majority of the countries in Europe EU debit be basic food commercials next year in different quarters, a lot of them coming into Q2 Q3 next year. So what's your soul of our success in.
Speaker Change: Australia, and Germany, we pacings are repeating that in about.
Speaker Change: Tim Although Europe direct country in our international market, we see a lot of named patient program, but we're also in the national market, where we now have countries covered by distribution agreement about searches for 35 countries and.
Speaker Change: They are currently.
Speaker Change: Giving patients.
Speaker Change: Through named patient program and also next year.
Speaker Change: We will start to see more of this country also going into full commercialization.
Speaker Change: Commercialization is dependent on what we are spending a lot of resources on now is basic gating filing, which we have done in many many countries, but also getting approval none of these countries and be getting approval already beginning this year and meaning is that we know we will be full.
Speaker Change: Most of this year's mix shifts.
Great. Thanks, so much for the clarity.
Speaker Change: Thank you.
And one moment to the next question is.
Our next question will be coming from the line of Alex Thomson of Stifel. Your line is open.
Alex Thomson: Hey, great. Thanks for taking our questions I guess for free Gaumy path can you talk a little bit about your supply commercial site readiness for the mid January launch.
Alex Thomson: You mentioned that you are going to take scripts from current yogurt that patient in December could you open that up to all or is there are there supply constraints or some other constraints and then on CMP.
Alex Thomson: Do you still have an appetite for running a broader basket study of additional indications are you know focused on skytrooper there. Thanks.
Speaker Change: P J.
Speaker Change: We have unlimited supply.
Speaker Change: We can take our patient that'd be one that is no.
Limitation.
Speaker Change: Manufacturing.
Speaker Change: We already have laid out the entire year manufacturing batches.
Every time, we want to have to be sure that we're building up the same robust supply chain that we are done with cutover, which has been unique even if we suddenly got major more demand suddenly.
Speaker Change: The same thing is happening for.
Speaker Change: Your packs.
Speaker Change: And we are really on top to be sure no patient <unk> co and Nox can get the prescription full suite of your Opex.
Speaker Change: Going to CMP.
Speaker Change: Absolutely.
Speaker Change: Youre right.
Speaker Change: We think some indication is best treated with Sky troffer, but definitely it's also indications treated.
Speaker Change: Treated with CMP and some of them are best treated with the combination of both of them either.
Speaker Change: On a constant based only on a short duration.
Speaker Change: So we are planning to go into what we call CMP related diseases, meaning is that thesis diseases, where.
Speaker Change: The growth disorder, or what we call.
Speaker Change: Element of missing CMP.
Speaker Change: Only can be.
Speaker Change: Functional back to what we will see in a normal physiology by providing CMP back. So besides claiming trial in hydrocodone Felicia will be indicated in next year. We are also planning for a basket trial.
Speaker Change: Think that is easy way, where we can take multiple indication of CMP related diseases into one single trial that we also is in the planning for doing that so we are not restricting us just to schedule that label expansion, we dedicated to be leader in growth disorder, we have plus 20.
<unk> has to go through and some of them we will take.
Scott Sofa: Scott Sofa some of them we will take.
Transcon CMP and some of them we've received the optimal treatment happening with a combination of both of them either on a constant basis on shorter duration one other.
Yes.
Thank you so much for your questions and answers today that is all the time that we have for this session. We thank you so much for joining the conference call. Today, you all may disconnect and have a great rest of your day.
Speaker Change: Thanks, Steve.
Speaker Change: Yes.
Speaker Change: Yes.
Yes.
Speaker Change: Okay.
Speaker Change: [music].