Q1 2023 Ascendis Pharma A/S Earnings Call
Okay.
Thank you for standing by and welcome to the Q1 'twenty two 'twenty three ascend is farmer earnings conference call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session.
That's a question at that time, Please press star one on your telephone.
As a reminder, today's call is being recorded.
Now I'll turn the call over to your host Mr. Chairman Lee Senior director of Investor Relations. Please go ahead.
Yeah.
Thank you operator, and thank you everyone for joining our first quarter 2023 financial results Conference call.
I'm Kim Lee Senior director of Investor Relations at Santa Barbara join.
Joining me on the call today, as Jan Mikkelsen, President and Chief Executive Officer Scott.
Scott Smith, Executive Vice President and Chief Financial Officer Dr.
<unk> seen a single executive Vice President and head of clinical development oncology and Joe Kelly Senior Vice President head of commercial endocrinology.
Before we begin I'd like to remind you that this conference call will contain forward looking statements that are intended to be covered under the safe Harbor provided by the private Securities Litigation Reform Act.
Examples of such statements May include but are not limited to limit it to our U S commercialization and continued development of Sky trusts that for the U S market.
Our revenue projections for Skype trough at.
The commercialization of Transcon hgh for the EU market.
Statements regarding the expected timing of the approval.
The expected timing of potential approval and launch of Transcon PTH in the U S market.
Statements regarding the expected timing of the potential approval of Transcon PTH in Europe .
Statements regarding the potential market size for <unk> PTH.
Our progress on our pipeline candidates and our expectations with respect to their continued progress.
Statements regarding our strategic plans our goals regarding our clinical pipeline, including the timing of clinical results.
Statements regarding our pipeline product candidates.
Statements regarding our ongoing and planned regulatory filings and our expectations regarding the timing as a result of regulatory decisions.
Our expansion into new therapeutic areas and statements regarding our ability creatives.
Tenable profitable, leading global Biopharma company.
These statements are based on information that is available to us today actual results and events could differ materially from those in our forward looking statements and we may not be able to achieve our goals carry out our plans or intentions or expectations or projections disclosed in our forward against all of our projections disclosed in our forward looking statements.
And you should not place undue reliance on these statements are forward looking statements do not reflect the potential impact of any licensing agreements acquisitions mergers dispositions joint ventures or investments that we made into or terminate we assume no obligation to update these statements as circumstances change except as required by law.
For additional information concerning the factors that could cause actual results to differ materially. Please see 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.
Final February 16th 2023.
Transcon transcon human growth hormone or transcon Hgh is approved by the FDA in the U S and the brand name Skytrax for the treatment of pediatric patients one year and older weighing at least 11, five kilograms and having growth failure due to inadequate secretion of endogenous growth hormone. In addition, the European Commission has.
Granted marketing authorization for <unk>.
And then just pharma developed under named Transcon Hgh as a once weekly subcutaneous injection for the treatment of children and adolescents age three to 18 for growth failure due to insufficient accretion of endogenous growth hormone.
In general if we refer to this product is transcon growth hormone unless referring to the product in the context of particular jurisdictions jurisdictions, such as the United States or the European Union otherwise. Please note that our product candidates are investigational and are not approved for commercial use as investigational products the safe.
D and effectiveness of the product candidates have not been reviewed or approved by any regulatory agencies. None of the statements made on the conference call regarding our product candidates shall be viewed as promotional.
On the call today, we'll discuss our first quarter 2023 financial results and will provide further business updates. Following some prepared remarks, we'll then open up the call for questions.
I'll now turn the call over to Jan Mikkelsen, President and Chief Executive Officer.
Thanks, David.
<unk> continues to execute on this strategy, we have laid out in our <unk> and our commitment to improve patient lives by building a sustainable profitable leading Biopharma company.
Based on the strength of our clinical data for Transcon PTH.
Including the positive feedback from patients and their physicians.
And the significant unmet medical needs.
<unk> living the hydropower Tory Smith.
We remain convinced that transcon PTH can be approved and become an important new treatment option.
We remain dedicated to working with FDA to bring this product to the U S market as quickly as possible.
And we are on track.
We had unexpected quickly.
Regulatory decision later this year.
In the U S. Our <unk> date of April 30.
'twenty three is coming up and we expect to get feedback from FDA soon on the next steps forward.
Hi.
Possible scenarios, our team is well prepared and belief in Bev who've ability of transcon PTH in the U S is unchanged.
Yes.
Relaunched skytrooper with our commercial strategy.
Unused product strength with the goal of making it the leading product in value in a growing growth hormone market.
With this product we believe that is more and more clear desk October is on track to become the U S market data and value in a growing Guatemala Mark.
And the.
The product.
We believe the success of the cutover.
Seeing now is driven by the following three factors.
First treatment experience.
Many physicians have now had patients with 12 months, we would experience with schedules.
The time period that is necessary to observed an improvement in linear growth.
<unk> benefits.
Second.
Consolidation of daily growth hormone market.
This consolidation started three four years ago, when data growth hormone companies became to realize that their existing data product would be spaced out good time, when once weekly treatment came to the market.
Resold David go come on companies reduce investment and optimize the business in this space off periods. We believe the current supply channels of data go command product.
Consequent updates, which further support the uptake of Sky tools.
As Tim just dedication and investment in endocrinology.
We are investing in building relationships with physician patient caregivers providers.
With our investment in a dedicated commercial organization and medical SaaS team supporting our endocrinology efforts.
Building, a robust supply chain for square tool called Sky, Tulsa, indicating two patient physician and provider that we are a trusted partner with a solid supply chain.
As a result first quarter 'twenty three scratch over revenue grew to $31 6 million.
Based on the aggregate may be described earlier this year for 2003.
Outlook.
Using first quarter sales of 31 million euros, and our goal of adding as many new reimburse patient in 'twenty three as we did in 2002, we now expect full year 'twenty two.
Sky to offer revenue.
$150 million and 160 million euros.
Our revised outlook for 'twenty three provides a new higher foundation for 'twenty four.
Yes.
We are pushing global market leadership post cutover to.
Geographic expansion and potential label expansion.
This guy Troffer commercial launched in Germany is on track for the third quarter of 2003.
In the fourth quarter, we expect top line results for the phase III foresight.
In adult growth hormone deficiency, which is designed to demonstrate the impact of Sky Trophy.
Our body composition in adult patients with <unk> deficiency.
Turning now to Transcon pjs.
As I mentioned at the start of today's call.
Dedicated to get Transcon PTH to patients suffering from severe from the Cvs health and qualified.
Life issues caused by hyperparathyroidism.
And we know that the patient community share our goal.
We continue to be excited about the potential transcon PTH could have on addressing the significant.
Medical needs of Hydro paratype recent patients.
The open label extension of our phase III path forward and phase three pathway twice for Transcon PTH are ongoing with 145 of 154 of the original clinical trial patients continue on treatment for Transcon PTH.
For now up to three years.
In addition in the U S. Our expanded access program continues to enroll new patients every week.
Europe as previously announced we received the comprehensive de 120 response from European Medicines Agency and we are very pleased with the feedback.
Anticipate a decision on our M&A during the fourth quarter and if approved by the EC We expect to launch in Germany in early 'twenty four leveraging our established commercial infrastructure.
We will also apply to imitate and early efforts program for Transcon, PTH in Italy and Germany.
Assuming approval for this program, we expect to imitate and erode the first patient in Germany This quarter.
Moving to conduct Asia.
Transcon CMP.
Our clinical data and positive physician feedback continues to differentiate transcon CMP and reinforce our conviction that it as a potential best in class product profile, and therefore key pillars of profitability safety efficacy tolerability and convenience.
More importantly.
We believe transcon CMP also has a beneficial effect on our contemplated comorbidity. Besides promoting increased linear growth, we believe that as <unk> or 57 patients who started in our phase two accomplished time.
Remaining in this open label extension.
Later this year.
Paul.
R&D event focused on transcon CMP to share new clinical data and the signs that we believe support is best in class profile.
Switching to oncology.
We have two programs moving ahead with Recommitting to phase II doses in specific indications.
<unk> continued our 78 agonist and transcon IL two beta gamma.
Next month in May.
Holt and oncology R&D event in New York around ESCO to give you an update on these two important program.
At this event.
And key opinion leaders with experience in our clinical studies clay will share key data from the dose escalation portion of our two first in human trials.
Finally, as I said before.
We are managing our business for long term value creation.
And continue to aim to achieve cash flow breakeven weighed out the need for additional dilutive equity financing.
I will now turn the call over to Scott for a financial review before we open for questions.
Thank you again.
I will quickly touch on a few points surrounding our financial results for.
For further details please refer to our form 6K filed today.
As Yan noted Skype for revenue for the first quarter of 2023 with $31 6 million Europe .
Revenue in Q1 would have been one 4 million euro higher excluding a negative foreign currency impact compared to the fourth quarter of 2022.
Total revenue was $33 6 million euro, including Skype Copa revenue as well as license clinical supply and services provided to third parties, primarily visa pharmaceuticals.
During the quarter, we continued to demonstrate our cost discipline offsetting seasonally higher employee costs in Q1.
Total operating expenses were $173 million euro for the first quarter up 5% sequentially from the fourth quarter of 2022.
Overall, R&D cost declined 2% sequentially, primarily driven by lower endocrinology related costs, partly offset by an increase in oncology related costs.
SG&A expenses grew 18% sequentially, primarily due to increased support for Skype for commercialization and prelaunch activities for Transcon PTH.
Overall, our operating loss declined sequentially by 3% to 144 million Europe for the first quarter from $147 million Euro in the fourth quarter of 2002.
Our main 2023 commercial product manufacturing campaigns, which are capitalized rather than expense are expected to be completed in the first half of 2023, which would which would further reduce cash expenses in the second half.
Finally, we ended the first quarter with cash cash equivalents and marketable securities totaling 586 million Euro.
Based on Q1 results, we are on track to exceed the current ascend is compiled 2023 consensus estimate of $98 million Euro for Skype for Ofer.
Using the algorithm.
<unk> laid out in his remarks, Skype CRO for revenue is expected to reach $150 million to $160 million Euro for full year 2023.
Supporting our goal of achieving cash flow breakeven without additional dilutive equity financing, we are implementing additional cost controls and productivity improvements, which we anticipate will be realized starting in Q3 and beyond.
Let me now also provide an update on selected key 2023 corporate milestones.
Our transcon growth hormone, we're on track to launch <unk> in Germany in Q3, and we expect to report topline data from the global Phase III <unk> trial in adult Ghd, our second indication in Q4.
For Transcon PTH in the U S. Our <unk> date is April 30, So we expect additional clarity on our NDA application in the coming days.
We expect the European Commission decision in Q4, if approved we plan Transcon PTH is our second product launch in Germany in early 2023.
For Transcon <unk>, we are on track to complete enrollment of the phase two be approached trial and are contemplated in Q2.
And later this year, we will share long term follow up data from patients on 100 micrograms from our open label extension of our phase II accomplished trial.
Within our oncology therapeutic area as Yan mentioned in his remarks, we will host a research event on May 31 in New York to review the science underlying our oncology portfolio review initial data on Transcon, Iot beta gamma and hear from Kols, who have clinical experience with both of our oncology product candidates.
Yes.
As you know the <unk> date for our NDA for Transcon PTH is this Sunday April 30, and we expect to receive a response from the FDA by then.
Given the proximity to the <unk> date for the NDA for Transcon PTH, we will not be providing additional details regarding this NDA at this time.
With that operator, we are now ready to take questions.
Thank you again, ladies and gentlemen, if you'd like to ask a question. Please press star one on your telephone again to ask a question. Please press star one one we do ask that you. Please limit yourself to one question and a follow up and feel free to rejoin the queue. One moment. Please for our first question.
Our first question comes from the line of Jessica Fye of JP Morgan Your line is open.
Great. Good afternoon, Thanks for taking my question.
I know, it's difficult to comment on in advance of the PTH producer.
At a minimum can you just say if you now know the deficiencies.
The FDA.
Has regarding the PTH NDA I believe those were not previously outlined in the letter you know them now.
I can say no to your question and have no further comments.
Yes.
Okay, and then when you talk about managing the business to achieve the goal of cash flow breakeven without the need for dilutive equity financing.
Can you elaborate just on like what your expectations are for PTH that are kind of embedded in that breakeven assumption.
Yes.
We are dealing with a lot of different scenarios because we.
We indicated before we do not know the exact nature of the deficiency.
And we are working with what we call the best case and worst case.
We're looking at on our vision three by three we want to sell to fulfill that we want to build up a leading biopharma that both sustainable and profitable we become continue to this so from our perspective is that.
<unk>.
Taking into assumption, we are launching sky profile.
Germany here in Q3, we are taking into the assumption we are launching transcon PTH in Germany, and Europe two different system in.
Beginning of 'twenty four.
Building that.
Thats cutover in the U S is going to the assumption we have laid out in 'twenty three and we will continue that growth in 2004, and even from the worst case best case, we can get the two things together and still fulfilled or we should treat battery.
Thank you.
Thank you one moment please.
Our next question comes from the line of <unk> Ahmad of Bank of America. Your line is open.
Hi, guys good afternoon.
Quick question, if I can on ghd.
Given the sales guidance for the year I think as recently as the beginning of the year you might've been more tentative on that prospect I guess, what's changed during the quarter. So I guess number one make you feel confident that you can project out the rest of the year and can you tell us some of the major drivers you took into <unk>.
Consideration when putting together the sales guidance such as.
Perhaps switch rates versus new patient starts and any assumptions you can share on compliance would be great as well. Thank you.
Thanks for vacation.
We're feeling much more confident now when we go to Q1, because now we accumulated on top of a big sum that is a meta magic algorithm, even I can understand without an MBA.
<unk> simple you have 31 million during Q1, we have seen in our experience over many months.
We have with Sky.
Not basic not losing patients so if im motorbike the surge of one four times and then B just at the same amount of new patient as we did in 'twenty two getting exactly to this number 100 and routine.
Between 150, and 160 I think you said.
Simple agreement built on solid number and this is exactly why I feel I can stand in for this year everyone. In the same as organization to sign on for this so we feel confident that we can fulfill this.
And this is why our feeling.
We've come out with guidance when be feeling we can keep you reliable guidance that you can use in the modeling so you're feeling that refilling that we gave you and number that we can stand info.
Thank you.
One moment please.
Our next question comes from the line of David Lebowitz.
Your line is open.
Thank you very much for taking my question.
When you look at Sky Trophy.
The rest of the year.
And then dramatic growth Youre expecting how should we look at that.
In the U S versus Europe .
The guidance, we are providing to you is only reflecting U S sales, we have not giving you a guidance related to Europe , there would be on top of that.
Got it.
Yes.
And I.
I guess could you just remind us of when we can expect the next transcon CMP updates and what your expectations are going into that.
The update we will provide for you as indicated here in when we come to the beginning of the fall likely in Q3, we will host and resource.
In New York as we do know in oncology here in May where we would go to the science behind the CMP because I think sometimes it's getting forgotten that AAV product has its own mode of action it signs and the signs in the with the site the key.
Initial outcome you would get.
And how to understand the clinical outcome. We have always said we are not here for adjusted dressing linear growth, we hear for addressing the key element of what.
Treatment for echolocation need.
Treatment of Comorbidities and Digest, what we always have been focused on and I believe we have that resource event can give you the data the science behind the data that really can give you. The way we are thinking and believe that we are building up in best in class product opportunity in this.
Sir.
Thanks for taking my question.
Thank you one moment please.
Our next question comes from the line of Paul Choi of Goldman Sachs. Your line is open.
Hi, Thank you and.
Good afternoon, and thanks for taking our questions.
Yes, <unk>, yes.
Question that investors have with regard to to PTH.
As you think about that.
Your earlier statements, where you expect.
Clarification.
From the FDA shortly have you.
Since the call that you held a few weeks ago provided any additional data updates are there any other requests from the agency.
I think we need to refer to the statement that Scott clearly brought up that we have been not comment further on any interaction behalf of ft. At this time.
Okay.
And then on the on the commercial side.
With regards to the European launch for.
Growth hormone.
Can you maybe comment on any preliminary discussions you either have had with IAG.
GK SB and just kind of how to think about the reference pricing versus the potential reference pricing in Germany versus some of the other available products in the category.
F&B the dynamic we saw in U S and how we tackled it in U S is exactly happening in the same way in Europe .
Establish daily growth hormones.
They have the same issue.
I have here in the U S. We've become in.
Treatment regime that is superior for the patient.
And I believe we will have the same responsible superior pricing that we do in the U S. Also in Europe .
Okay. Thanks, I'll hop back in queue.
Thank you one moment please.
Our next question comes from the line of Lee <unk> of Cantor. Your line is open.
Thanks for taking our questions.
I guess can you provide maybe some guidance on the Opex side and I guess, starting in Q3, given that you may have a delay with current comes gtx.
You mentioned earlier that you will have a focus on cost control maybe help us understand how should we think about.
Going forward and for the early access program in Germany, how many patients will.
<unk> will be eligible for that.
Yes, let me take the zoster Christian.
First.
But.
Yes.
The program in Germany.
Where are we starting Germany wherever you have applied for an approval for the mutated.
Different compared to the U S program, because it's actual electable for both.
Patients with Hyperparasite and not as for U S is highly restricted to patient that basic is highly pta's experience.
So it would be a mosque broader program.
The dynamic.
Dynamic is also different.
Because for example, the program is terminated automatic but youre getting approval and the patient needs automatic converted over to reimburse patient. So it's a different system that you actually have in the U S system. So this is why we did somebody get access to the patients die is the same.
Unmet medical need there is a series of patients.
Hundreds of patient on par to date them know they're.
Highly restricted constrained because net par is disappearing in the beginning of 2004. So they want to have time to really change this patient over to transcon PTH at the same time, we open it up for all other patient because there was some loss.
You can say.
<unk> desire from the treatment physician also to give it to patients that excellent newer have seen oil PTH program before so this is why it is a different program.
Going back to your comments about how we see.
Summary.
Running the financials at Santos and.
Excellent made it very very simple in this way, we had one pocket bit caution, which are the water Adobe take something in every day and you can see we grow it and grow it grow it now with U S. Skype over we would grow it with U S outside the U S. Also revenue there and we always want to have a solid mt.
A quarter into this bucket and we do that by basic ensuring that we run our business optimizing our business optimizing the way we perform our procedure what function path for two years ago is not functioning today is not the most productive way to do it. This is how we adapted we are a global company.
What gives us a lot of benefit to really optimize our business in different means and that is exactly what we are doing to ensure we always will have enough water in their pocket to feel safe. If you start to be dry around us we always have enough to drink.
Okay.
Thank you one moment please.
Our next question comes from the line of Derek <unk> of Wells Fargo. Your line is open.
Hey, great. Good afternoon, thanks for taking the questions just two from us.
And you mentioned earlier in the call that you're not commenting on interactions with the FDA. So is it fair to assume that you've had some interactions since the deficiency letter that you do not want to comment on so thats question number one.
Question number two is you have talked about this attrition strategy and the growth hormone market. So kind of expecting these competitors to exit the market, maybe because it's not profitable for them, leaving you and maybe one or two other players in the market. So I guess, what catalysts needs to happen for this to play out and what kind of the timing on that thank you.
Yeah. The obvious it's easier for me to answer the first question because thats nowhere, so going to the Cigna Christian.
Really.
Our high value creation, because as excellent IP.
Leave someone sued rider textbook of what happening in the growth hormone market.
In the U S. It was the first place you saw Biosimilar, having tivo sandoz coming in we saw how the entire market develop and now be coming to the next phase. The first thing that biosimilar going in then it went over to Margaret exercise and I can guarantee rehab some interaction with nearly every one of them.
The daily.
Optimum company, except one I think.
And somebody got a really really good.
Insight in their thinking and the insight is exactly how I also would act.
And is that when you have a superior treatment coming into that basic making a paradigm.
Paradigm shift in the treatment regime, you know if you are sitting with the what we call. The established that cannot follow up this treatment regime is only really to optimize your business at that time. So you follow the classical textbook first of all you get rid of the Salesforce.
The second one you get rid of all promotion you get basic optimizing the manufacturing sources, where you never invest in it then you terminate their manufacturing after youll have a bulk product city and then you're just selling that and then you're out and I can guarantee is one of our best P&L you can get out of that business is as well.
Are you, where you have a great P&L, but but partner this is not sustainable some of the daily growth hormone you can find that out there trying to sell it no. One wanted to buy a <unk> product does widen to one <unk>.
And Todd consolidation started three or four years, what you'll start to see now is a consequence of it.
You likely right I would only be one or two daily growth hormone provider because that will potentially be a cash segment of it the other thing where the applications will be.
The element of what we can call as low priced element we have it.
Really neat optimal treatment or anything like that and this is where you typically will see one or two player.
Thank you one moment please.
Our next question comes from the line of Leerink Gershon.
Of Oppenheimer. Your line is open.
Hey, good afternoon. Thanks for taking my question just another question on the spectrum.
Trajectory is obviously very healthy bump up from fourth quarter.
Wondering if you can comment is that coincides with the turn of the year were there any aspects related to more favorable reimbursement with the new year and or changing dynamics of the daily growth hormone cadences and you talked about.
Favre.
Scott Thank you.
I think we had the three pillars, we discussed in my part of the script, which are exiting illustrate <unk> was the trough.
<unk> be coming team and.
And I believe when you first go to the first of a treatment experience. It actually take 12 months for a physician really to see the improved really the improvement in linear growth and other endocrine benefits and when you see a new product I think often as a physician you will wait to see.
In a few number of patient before you expand further on the second thing is the consolidation of the market with Shaw is happening and do is just a consequence when to start with <unk> with a <unk> 23, taking into 'twenty four we know what were happening, but we didn't know exactly when it will be and I also believe and this is where.
Joe campaign, and we'll talk about how we invest.
Investing in a dedicated best in class.
Endocrinology dedicated sales force and medical affairs teams.
Yes, so the commercial team really has done a good job of executing in this particular market where it really disrupted.
Growth hormone is prescribed and also reimbursed by the Pbms and the payers and really it comes down to the clinical strength of <unk>.
Sky Trophy.
Efficacy. The fact that we don't have a preservative.
Our best in class auto injector and again the support that we can provide the offices and the patient to get reimbursed. So that they can enjoy skype for their entire course of therapy, but the compelling story that we do have from a clinical standpoint is really a motivating factor for these health care.
Providers to do the appropriate documentation, so that that patient can get approved and stay on our product.
Thanks, Joe.
Okay.
Thank you one moment please.
Our next question comes from the line of Vikram <unk>.
Of Morgan Stanley Your line is open.
Hi, good afternoon. Thanks for taking our question we had one on Transcon Hgh could you just help us frame expectations for the foresight data expected in adult ghd and the fourth quarter and also speak a bit about how youre viewing the commercial potential for hgh for this part of the ghd population versus the pediatric population.
Yes.
Really really interesting ways to Luke.
Well why the adult growth hormone deficiency.
Trial is so really interesting for us is because we are in a situation where many of the other indications that were used growth hormone you use linear growth as the primary outcome here in <unk>.
<unk> deficiency. The primary endpoint is unchanged and body composition, which are also one of the element you want to achieve in the pediatric population, but it's not really the primary endpoint.
What we also have we have a situation where.
We have a benchmark related to the.
Data growth hormones, we have a benchmark related that both.
The two other long acting half initiated phase III trials have reported phase III trials in adult growth hormone deficiency.
One of them didn't manage to be better than placebo.
The second one showed half of the effect compared to daily growth hormone.
We believe we can.
<unk> is built on so much Pete.
An unmodified molecule that can have the same mode of action.
Data growth mode.
Industrious drove tomorrow, we will be in a position that we hope at least we can see the same benefit aesthetic optimal potential will be will be superior as fewer in acceleration in the <unk>, but we will wait to see the data. So we believe that is a really really strong integrate.
The packet to see because it's the first time, where you really go out and analyzing really the impact on our growth hormone treatment on the into crime helped with body composition is part of it but it's really parallel to some of the other benefit where you need to have good distribution throughout the body.
Thank you one moment please.
Our next question comes from the line of Joseph Schwartz.
<unk> Securities Your line is open.
Hi, Thanks very much.
So how leveraged people as a salesforce across the three endocrine indications.
Indications you're currently pursuing I know when we look for physicians to speak on.
These topics it seems a bit fragmented to ask and we almost never find anyone who can speak on to never mind III.
These endocrine condition. So can you just talk a little bit about.
How the Salesforce is currently structured and whether you won't have to actually expanded significantly in order to reach.
Contemplate share and hyperparathyroidism specialists in addition to growth hormone folks.
Yes, it does.
The holistic picture Youre, basically, saying why keep the focus of building up.
Really really.
Our strong pipeline of three independent product really focused on endocrinology. So the first one we have is cultural fit.
Hey, folks have a pediatric and adult indications we have pursued for Peter I think now.
Got it.
We have transcon PTH.
The main indication is adult but also have a pure ASIC.
We are going now.
I have said before we expect to getting an approval.
What we call the adult hydropower tie recent as soon as we get the feedback what is the deficiencies when we know what the deficiencies.
We can address it and this is what we would do extremely fast and ensure this product going out to the market. We will also pursue the pediatric indication in this segment than we have transcon CMP and people belief this is Peter ethic.
Because they're just focused on linear growth. We believe this basic is a treatment regime for echolocation also rest of their life.
And this is one of the things we also would like to discuss when become too basic.
Resource statement, so when youll see the holistic part on it yes. It gives us a lot of synergy specific when you think about.
Reach out Rico too.
<unk> people come to us perhaps interest in <unk>, perhaps interest in CMP past interest in growth mode and the entire package.
C endocrinologist that precision <unk> dedicated to be a leader in endocrinology because to be so much focused on all different product opportunities. When you go to a dedicated sales force. When you can build up in different means and it's very much dependent on geographic regions. If you just think about you.
I think what Joe and his team have done the extra building up what we call.
Salesforce that basic are dedicated to skytrooper dedicated to <unk>, but the basic can exchange it back and forth between the different sales force because both have all the capability to be ended in this way. So I actually believe that we have some opportunity in this way of operating.
Okay.
Thank you one moment please.
Our next question comes from the line of Andreas on your ads again Andreas on your at your line is open.
Hi, Yes. Good afternoon. Thanks for taking my question a quick one here on <unk>.
Transcon CMP, so looking at the growing contemplate your marketing the competitive landscape could you expand on what data youre tracking and plan to provide to support transcon CMP impact outside of height, we do see a potential to expand into patients are charging on detour Logan.
Forgive me I was already addressed.
No.
I believe that it's a summary.
What we want to do is that you have linear growth with an element, where we believe sure. We can help a lot. We can do a lot. When we can also potential accelerated in a combination between sky Tulsa and Transcon CMP.
Element of what we called.
I Couldnt do place a specific comorbidities and in the presentation. We did when we released our accomplished data basic indicated that we couldnt see any effect on the account of patient specific side effects, meaning is that regardless.
Building on that and we have regulatory interaction, how we potentially can prove that.
More clinical specific manner in our.
Phase <unk>, which we hope is our pivotal trials that would be basic.
Recruiting now for full speed and hope to have all patient in this quarter here. So this is where we see the element of us providing and treatment of <unk> Asia really to ensure that we are not only correcting linear growth, but also addressing the comorbidities.
Great. Thanks for taking my questions.
Thank you one moment please.
Our next question comes from the line of Yaron Werber.
Of Cowen Your line is open.
Hi, This is Jerry.
Thanks, so much for taking our questions.
Historically I think your Q1 call in early May and I think some investors were maybe thinking that the conflict that victory to get ahead of it.
And then we might get an update Brian did the question Steve.
If you could just help us understand this a little bit more that'd be helpful. And then just quickly secondly, I know you are not able to conduct that much but just given the lack of interactions.
With the FDA.
Are you expecting a CRM and.
If that does happen how quickly do you guys think you can re file thank you.
Let me take the last attrition.
I said before we have no knowledge about the deficiencies and we cannot comment further on anything of regulatory interaction related transcon PTH and ft.
We believe what we illustrate to optimize processes optum.
Optimize processes to think to do things smarter and faster and I Echo the thing I keep all the credit to Scott is not ultimately do that but actually given credit to Scott <unk>. The head of finance that is sitting here beside us today too.
They can tell about how they really have optimized all of our financial process. So I think but just pressing a button and then we get everything finalized.
Yes.
Scott Yes.
So just as we reported earlier for the annual report will now report earlier for the quarterly report. So I would say nothing specific to look into it in fact, if anything I think next year, we'll probably report the annual even earlier.
All right.
So the first of January 31 January next year.
I hope that answer your question, it's just because we increased productivity and do it faster.
Alright, thank you so much.
Thank you one moment please.
Our next question comes from the line of Caroline Palo Mick.
Behr Berg your line is open.
Hi, good afternoon, thanks for taking the question.
So.
Any material differences in the MAA application in Europe versus the MBA application in the U S given that.
My understanding there hasnt been any feedback from.
On the European regulatory agencies and then the second question is just a follow up on <unk>.
Just given the.
Updated schedule for revenue guidance do you also anticipate adjustments and SG&A expenses.
Such as Salesforce likely add anymore.
People.
And I'll stop there thanks.
In our breakfast to refining the team but different regions.
Europe and U S.
Basic build an executive at the same data packet that will be five.
Both places with Shaw.
Different.
<unk> offer different.
Filing because back need to be made in a different format, but.
The data is exactly the same for both Europe and U S and related to the last question is a clear no.
Great. Thank you.
Thank you I'm showing no further questions at this time, ladies and gentlemen. This does conclude today's conference. Thank you all for participating you may now disconnect have a great day.
Okay.
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Okay.
Great.
Okay.
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Okay.