Ascendis Pharma A/S (ASND) 2023 Q1 法說會逐字稿

Thank you for standing by, and welcome to the Q1 2023 Ascendis Pharma Earnings Conference Call. (Operator Instructions) As a reminder, today's call is being recorded.

I would now like to turn the call over to your host, Mr. Tim Lee, Senior Director of Investor Relations. Please go ahead.

Thank you, operator, and thank you, everyone, for joining our first quarter 2023 financial results conference call. I'm Tim Lee, Senior Director of Investor Relations at Ascendis Pharma. Joining me on the call today is Jan Mikkelsen, President and Chief Executive Officer; Scott Smith, Executive Vice President and Chief Financial Officer; Dr. Stina Singel, 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 our U.S. commercialization and continued development of SKYTROFA for the U.S. market, our revenue projections for SKYTROFA, the commercialization of TransCon HGH for the EU market, statements regarding the expected timing of the approval of 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 TransCon 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 of the results of regulatory decisions, our expansion into new therapeutic areas and statements regarding our ability to create a sustainable, 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 our expectations or projections disclosed in our or our projections disclosed in our forward-looking statements, and you should not place undue reliance on these statements.

Our forward-looking statements do not reflect the potential impact of any licensing agreements, acquisitions, mergers, dispositions, joint ventures or investments that we make 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 filed February 16, 2023.

TransCon human growth hormone or TransCon HGH, is approved by the FDA in the U.S. under brand name SKYTROFA for the treatment of pediatric patients 1 year and older weighing at least 11.5 kilograms and having growth failure due to inadequate secretion of endogenous growth hormone.

In addition, the European Commission has granted a marketing authorization for SKYTROFA to Ascendis Pharma developed under the name TransCon HGH as a once-weekly subcutaneous injection for the treatment of children and adolescent age 3 to 18 for growth failure due to insufficient secretion of endogenous growth hormone.

In general, we refer to this product has TransCon Growth Hormone unless referring to the product in the context of a particular 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 safety and effectiveness of the product candidates have not been reviewed or approved by any regulatory agency.

None of the statements made on the conference call regarding our product candidates shall be viewed as promotional. On the call today, 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. Jan to you...

Thanks, Tim. Good afternoon, everyone. Ascendis continues to execute on the strategy we have laid out in our Vision 3x3 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 of patients living with hypoparathyroidism.

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 in EU with an expected regulation regulatory decision later this year.

In the U.S., our PDUFA date of April 30, '23 is coming up, and we expect to get feedback from FDA soon on the next steps forward. Our high multiple possible scenarios.

Our team is well prepared and our belief in the approvability of TransCon PTH in the U.S. is unchanged. We launched SKYTROFA with a commercial strategy built on its product strength with the goal of making it the leading product in value in a growing growth hormone market.

With this quarter, we believe that is more and more clear that SKYTROFA is on track to become the U.S. market leader in value in a growing growth hormone market and a blockbuster product.

We believe the success of SKYTROFA we are seeing now is driven by the following 3 factors.

First, treatment experience. Many physicians have now had patients with 12 months real-world experience with SKYTROFA. The time period that is necessary to observe an improvement in linear growth and other endocrine benefits.

Second, consolidation of daily growth hormone market. This consolidation started 3, 4 years ago when daily growth hormone companies began to realize that their existing daily product will be phased out with time when once weekly treatment came to the market.

We saw daily growth among companies reduce investment and optimize the business in this phaseout period. We believe the current supply channels of daily growth hormone products are a consequence of this, which further support the uptake of SKYTROFA.

Third, Ascendis dedication and investment in endocrinology. We are investing in building relationship with physicians, patient, caregivers providers. With our investment in a dedicated commercial organization and medical affairs team supporting our endocrinology efforts.

We're also building a robust supply chain for SKYTROFA, indicating to patient physician and provider that we are a trusted partner with a solid supply chain.

As a result, first quarter '23 SKYTROFA revenue grew to EUR 31.6 million. Based on the algorithm we described earlier this year for '23 outlook using first quarter sales of EUR 31 million and our goal of adding as many new reimbursed patients in '23 as we did in '22.

We now expect full year '23 SKYTROFA revenue between EUR 150 million and EUR 160 million. Our revised outlook for '22 provides a new higher foundation for '24. We are pushing global market leadership for SKYTROFA to geographic expansion and potential label expansion. The SKYTROFA commercial launch in Germany is on track for the third quarter of '23.

In the fourth quarter, we expect top line results for the Phase III ForesiGHt Trial in adult growth hormone deficiency, which is designed to demonstrate the impact of SKYTROFA of body composition in adult patients with growth hormone deficiency.

Turning now to TransCon PTH. As I mentioned at the start of today's call, we are dedicated to get TransCon PTH to patients suffering from the serious health and qualified of lease life issues caused by hypoparathyroidism.

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 unmedical needs of hypoparathyroidism patients.

The open-label extension of our Phase II FAST-forward and Phase III PaTHway trials for TransCon PTH are ongoing with 145 million of 154 of the original clinical trial patients continue on treatment with TransCon PTH for now up to 2 years.

In addition, in the U.S., our expanded ASAP program continues to enroll new patients every week. In Europe, as previously announced, we received the comprehensive 120 response from European medicine agency, and we are very pleased with the feedback.

We 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 '24, levering our established commercial infrastructure. We are also applied to initiate an early efforts program for TransCon PTH initially in Germany.

Assuming approval for this program, we expect to indicate and erode the first patient in Germany this quarter. Moving to achondroplasia. TransCon CNP.

Our clinical data and positive physician feedback continues to differentiate TransCon CNP and reinforce our convinced that it has a potential best-in-class product profile in the 4 key pillars of drug development, safety, efficacy, tolerability and convenience.

More importantly, we believe TransCon CNP also has a beneficial effect on achondroplasia comorbidity besides promoting increased linear growth. We believe that is why all 57 patients who started in our Phase II accomplished time remain in this urban label extension.

Later this year, we will have an R&D event focused on TransCon CNP to share new clinical data and the signs that we believe support its best-in-class profile.

Switching to oncology. We have 2 programs moving ahead with recommended Phase II doses in specific indications. TransCon TLR 7/8 Agonist and TransCon IL-2 beta/gamma. Next month, in May, we will hold an Oncology R&D event in New York around ASCO to give you an update on these 2 important programs.

At this event, Ascendis and key opinion leaders with experience in our clinical studies plan will share key data from the dose escalation portion of our 2 first in-human tribes. Finally, as I said before, we are managing our business for long-term value creation and continue to aim to achieve cash flow but EBIT without 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, Jan. I will quickly touch on a few points surrounding our financial results. For further details, please refer to our Form 6-K filed today.

As Jan noted, SKYTROFA revenue for the first quarter of 2023 was EUR 31.6 million. Revenue in Q1 would have been EUR 1.4 million higher excluding a negative foreign currency impact compared to the fourth quarter of 2022.

Total revenue was EUR 33.6 million, including SKYTROFA revenue as well as license, clinical supply and services provided to third parties, primarily Visa and Pharmaceuticals.

During the quarter, we continued to demonstrate our cost discipline, offsetting seasonally higher employee costs in Q1. Total operating expenses were EUR 173 million for the first quarter, up 5% sequentially from the fourth quarter of 2022.

Overall, R&D costs 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 SKYTROFA commercialization and prelaunch activities for TransCon PTH.

Overall, our operating loss declined sequentially by 3% to EUR 144 million for the first quarter from EUR 147 million in the fourth quarter of '22.

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 further reduce cash expenses in the second half.

Finally, we ended the first quarter with cash, cash equivalents and marketable securities totaling EUR 586 million. Based on Q1 results, we are on track to exceed the current Ascendis compiled 2023 consensus estimate of EUR 98 million for SKYTROFA.

Using the algorithm Jan laid out in his remarks, SKYTROFA revenue is expected to reach EUR 150 million to EUR 160 million 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. For TransCon Growth Hormone, we are on track to launch SKYTROFA in Germany in Q3, and we expect to report top line data from the global Phase III ForesiGHt Trial in adult GHD, our second indication in Q4.

For TransCon PTH in the U.S., our PDUFA 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 and if approved, we plan TransCon PTH is our second product launch in Germany in early 2023.

For TransCon CNP, we are on track to complete enrollment of the Phase 2b ApproaCH trial in achondroplasia 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 2 ACcomplisH trial.

Within our oncology therapeutic area, as Jan 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 IL-2 beta/gamma and hear from KOLs who have clinical experience with both of our oncology product candidates.

As you know, the PDUFA 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 PDUFA 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.

(Operator Instructions) Our first question comes from the line of Jessica Fye of JPMorgan.

I know it's difficult to comment in advance of the PTH PDUFA. But at a minimum, can you just say if you now know the deficiencies that the FDA has regarding the PTH NDA, I believe those were not previously outlined in the letter. Do you know them now?

I can say no to your question and have no further comments.

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?

It's -- we are dealing with a lot of different scenarios because as 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 on our Vision 3x3. We want still to fulfill that. We want to build up a leading biopharma that both sustainable and profitable where we can continue to this. So from our perspective is that we are taking into the assumption.

We are launching SKYTROFA in Germany here in Q3. We're taking into the assumption. We are launching TransCon PTH in Germany and Europe to different systems in beginning of '24. We are building that SKYTROFA in the U.S. is going to the assumption we have laid out in '23, and we'll continue that growth in '24.

And even from the worst case to the best case, we can get the 2 things together and still fulfill our Vision 3x3.

Our next question comes from the line of Tazeen Ahmad of Bank of America.

A couple of questions, if I can, on GHD. You've issued sales guidance for the year. I think as recently as the beginning of the year, you might have been more tentative on that prospect. I guess what's changed during the quarter to, 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 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.

Thanks for the question. 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 mathematic algorithm even I can understand without an MBA.

So the [ratio] is very, very simple. You have EUR 31 million here in Q1. We have seen and our experience for the many months we have with SKYTROFA, we're not basically not losing patients.

So if I multiply the EUR 31 million, 4x and then we just add the same amount of new patients as we did in '22 are getting exactly to this number 100 and -- between EUR 150 million and EUR 160 million.

I think it were simple agreement built on solid number, and this is exactly why I feel I can stand in for this year. I have everyone in the same organization to sign on for this. So we feel confident that we can fulfill this.

And this is why I'm feeling -- we will come out with guidance. When we're feeling we can give you a reliable guidance that you can use in the modeling, so you're feeling that we feeling that we give you a number that we can stand in for.

Our next question comes from the line of David Lebowitz of Citi.

When you look at SKYTROFA into the rest of the year and the dramatic growth you're 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 given you a guidance related to Europe that will be on top of that.

Got it. And I guess, could you just remind us of when we can expect the next TransCon CNP updates and what your expectations are going into that?

The update we will provide for you as we indicated here in -- when we come to the beginning of the fall, likely in Q3, we will host a reserve event in New York as we do now in oncology here in May, where we will go to the science behind the CNP because I think sometimes...

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

Jan and team, I guess one question that investors have with regard to PTH. As you think about the -- your earlier statements where you expect a clarification from the FDA shortly, have you -- since the call that you held a few weeks ago, provided any additional data updates? Or have there been any other requests from the agency?

I think we need to refer to the statement that Scott clearly brought up that we will not comment further on any interaction we have of FDA at this time.

Okay. And then on the commercial side, with regard to the European launch for growth hormone. Can you maybe comment on any preliminary discussions you either have had with IIG or GKSB 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?

I believe the dynamic we saw in U.S. and how we tackled in U.S. is exactly happening in the same way in Europe. There is state daily growth hormones. They have the same issue that we have here in the U.S.

We will come in with a 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.

Our next question comes from the line of Li Watsek of Cantor.

I guess can you provide maybe some guidance on the OpEx side? I mean, I guess, starting in Q3, given that you may have a delay with TransCon PTH. And you mentioned earlier that you have a focus on cost control.

Maybe help us understand how should we think about OpEx going forward? And for the early access program in Germany, how many patients will be eligible for this?

Let me take the last question first because -- the program in Germany, where we start in Germany, where we have applied for an approval for initiated, it's different compared to the U.S. program because it's actual electable for both all patients with hypopara and not for US is highly restricted to patients that basic is highly PJ's experience.

So it will be a much broader program. The dynamic is also very, very different because for example the program is terminated automatically the day you're getting approval and the patient needs automatic conversion over to reimbursed patients.

So it's a different system that you actually have in the U.S. system. So this is why we will some way, give access to the patients. That is the same unmet medical need. There is a series of patient multiple hundreds of patients on NATPARA today.

There are no they're under highly restricted constraints because NATPARA is disappearing in the beginning of '24. So they want to have time to really change this patient over to TransCon BJs.

At the same time, we opened it up for all other patients because there was some most you can say strong desire from the treatment physician also to give it to patients that actually never have seen other PTH program before.

So this is why it's a different program. Going back to your comments about how we are some way are running the financials at Ascendis. And I actually made it very, very simple in this way.

We had one bucket with cash in, which are the water. And then we take something in every day, and you can see we grow it and grow it now with U.S. SKYTROFA.

We will grow it with U.S. outside U.S. also revenue there. And we always want to have a solid amount of water into this bucket. And we do that by basically ensuring that we run our business, optimizing our business, optimizing the way we perform our procedure.

What function Pass for 2 years ago is not function today, it's not the most productive way to do it. This is how we adapt it. We are a global company would give us a lot of benefit to really optimize our business in different means.

And that is exactly what we are doing to ensuring we always will have enough water in the bucket to feel safe. If we start to be dry around us, we always have enough to drink.

Our next question comes from the line of Derek Archila of Wells Fargo.

Just 2 from us. Jan, you mentioned earlier in the call, yes, 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 that's question number one.

Question number two is, you've talked about this attrition strategy in 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 1 or 2 other players in the market. So I guess what catalyst needs to happen for this to play out? And what's kind of the timing on that?

Yes. Obvious, it's easier for me to answer the first question because there's no answer. So going to the second question, which are really a high-value question because it's absolutely -- I believe someone should write a textbook of what's happening in the growth hormone market here in the U.S.

It was the first place you saw biosimilar having TV centers coming in. We saw how the entire market developed. And now we're coming to the next day. The first thing the biosimilar going in, then it went over to market access.

And I can guarantee we had some most interaction with nearly every one of the daily growth hormone company, except one, I think.

And we someway got a really, really good insight in their thinking. And the insight is exactly how I also would act. The element is that when you have a superior treatment coming into that basic are making a paradigm shift in the treatment regime, you know if you're sitting with what we call the establish that cannot follow this treatment regime is only how really to optimize your business at that time.

So you follow the classical textbook. First of all, you get rid of the sales force, the second one, you get rid of or promotion, you get basic optimizing the manufacturing such a way you never invest in it, then you terminate the manufacturing after you have a bulk product sitting and then you're just selling that and then you're out.

And I can guarantee is one of the best P&L you can get out of that business. This is really where you have a great P&L. But the partner is not sustainable. Some of the daily growth hormone, you can find that out, they try to sell it. No one wanted to buy a dying product. That's why no one can sell it.

So therefore, the entire consolidation started 3 or 4 years, what you start to see now is the consequence of it. And you likely write there will only be 1 or 2 daily growth hormone provider because there will potentially be a cash segment, there would be other things where the potential will be an element of what we can call a low-priced element where they don't really need optimal treatment or anything like that. And this is where you typically will see 1 or 2 player be...

Our next question comes from the line of Leland Gershell of Oppenheimer.

Just another question on the spec top trajectory. It's obviously a very healthy bump up from fourth quarter. And one thing that is being comment, is that coincide with the trend 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 case as you talked about that may have favored SKYTROFA.

I think we had the 3 pillars we discussed in my part of the script, which I actually illustrate very well the transition we coming to. And I believe when we first go to the first treatment experience, it actually takes 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 patients before you expand for long. The second thing is the consolidation of the market, which sure is happening. And it was just a consequence when they start to take in where take '23, will it take in '24.

We know it were happening, but we didn't know exactly when it will be. And I also believe -- and this is where Joe comes in and will talk about how we investing in a dedicated best-in-class economic dedicated sales force and our medical affairs teams.

Yes, Jan. So yes, the commercial team really has done a good job of executing in this particular market where we really disrupted how growth hormone is prescribed and also reimbursed by the PBMs and the payers.

And really, it comes down to the clinical strength of SKYTROFA. It's efficacy, the fact that we don't have a preservative, 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 SKYTROFA 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.

Our next question comes from the line of Vikram Purohit of Morgan Stanley.

We had one on TransCon HGH, could you just help us frame expectations for the ForesiGHt data expected in adult GHD in the fourth quarter? And also speak a bit about how you're viewing the commercial potential for HGH for this part of the GHD population versus the pediatric population?

Really, really interesting way to look and -- 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 where you use growth hormone, you use linear growth as the primary outcome.

Here, in adult growth hormone deficiency, the primary endpoint is built on change in body composition, which are also one of the elements 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 daily growth amounts. We have a benchmark related that both the 2 other long-acting have initiated Phase III trial have reported Phase III trial 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 because SKYTROFA is built on (inaudible) an unmodified molecule that can have the same mode of action like daily growth hormone and induces growth hormone, we will be in a position that we hope at least we can see the same benefit as daily growth hormone.

Potentially, we will be superior as we were in acceleration in the pediatric, but we will wait to see the data. So we believe that it's a really, really strong integrated packet to see because it's first time where you really go out and analyzing really the impact on growth hormone treatment on the endocrine health, which body composition is part of it, but it's really parallel to some of the other benefits where you need to have the distribution throughout the body.

Our next question comes from the line of Joseph Schwartz of SVB Securities.

So how leverageable is a sales force across the 3 endocrine indications you're currently pursuing? I know when we look for physicians to speak on these topics, it seems a bit fragmented to us, and we almost never find anyone who can speak on 2 never mind 3 of these endocrine conditions.

So can you just talk a little bit about how the sales force is currently structured and whether you won't have to actually expand it significantly in order to reach achondroplasia and hypoparathyroidism specialists in addition to growth hormone folks?

Yes. This is the holistic picture you basically are saying, why could we focus on building up as really, really a strong pipeline of 3 independent product really focused on endocrinology.

So the first one we have is SKYTROFA. It both had a pediatric and adult indication. We have pursued the pediatric. Now we go for the adult. We have TransCon PTH. The main indication is adult but also have a place -- we are going now, as I have said before, we expect to getting an approval in what we call the adult hypoparathyroidism.

As soon as we get the feedback, what is the deficiencies, when we know what the deficiencies is, we can address it, and this is what we will do extremely fast and ensure this product going out to the market.

We will also pursue the pediatric indication in this segment. Then we have TransCon CNP. And people believe this is pediatric disease because they're just focused on linear growth.

We believe that basic is a treatment receding for achondroplasia also rest of their life. And this is one of the things we also would like to discuss when we come to the basic the reserve state.

So when you see the holistic part on it, yes, it gives us a lot of synergy, specific when you think about reach out, we go to Endo. We have one [spend]. People come to us perhaps interest in PTH, perhaps interest in CMP, pays interesting growth hormone and they get the entire packet.

[They see] endocrinologist, a physician where us dedicated to be a leader in endocrinology because we somewhat focused on all different product opportunities. When you go to a dedicated sales force, you can build up in different means, and it's very much dependent on geographic regions.

If you just think about U.S., I actually think what Joe and his team have done, they're actually building up what we call sales force that basically are dedicated to SKYTROFA dedicated to PTH, but the basic can exchange it back and forth between the different sales force because both have all the capability to be it in this way. So I actually believe that we have some much synergy in this way of operating...

We address?

No, I believe that is some way. 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 potentially accelerate it in a combination between SKYTROFA and TransCon CNP.

The element of what we call (inaudible) specific comorbidities. And in the presentation, we did when we released our data, we basic indicated that we could see an effect on the achondroplasia specific side effect, meaning is that they've got less.

We are building on that, and we have regulatory interaction, how we potentially can prove that in a more clinical specific manner in our Phase 2b, which we hope is our pivotal trial that we basically are recruiting now for full speed and hope to have all patients in this quarter here.

So this is where we see the element of us providing and treatment of achondroplasia really to ensure that we are not only correcting linear growth, but also addressing the comorbidities...

Our next question comes from the line of Yaron Werber of Cowen.

This is (inaudible). Historically, I think you've held this Q1 call in early May, and I think some investors were maybe thinking that the call was moved up this time to get ahead of the PDUFA date and then we might get an update on the efficiencies. If you could just help us understand this a little bit more, that would be helpful.

And then just quickly, secondly, I know you're not able to comment that much, but just given the lack of interactions is seen with the FDA, are you expecting a CRO? And if that does happen, how quickly do you guys think you can refile?

Let me take the last question. As I said before, we have no knowledge about the deficiencies, and we cannot comment on anything of regulatory interaction related to TransCon PTH and FDA.

And I actually believe what we illustrate to optimize processes, optimize processes diluting smarter and faster. And I actually think I give all the credit to Scott, it's not often I do that, but I will actually give him credit on Scott on that, the Head of Finance that is sitting here beside us today too.

And they can tell about how they really have optimized all our financial process. So I think we're just pressing a button and then we get everything finalized. Scott Smith?

Yes. So, just as we reported earlier for the annual report, we'll 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 right, Matt?

Over the 1st of January...

31st of January next year.

I hope that answers your question. It's just because we increase productivity and do it faster.

Our next question comes from the line of Caroline Palomeque of Berenberg.

So were there any material differences in the MAA application in Europe versus the NDA application in the U.S. given that to my understanding, there hasn't been any feedback from the European regulatory agencies?

And then a second question is just a follow-up on expenses. Just given the updated SKYTROFA revenue guidance, do you also anticipate adjustments in SG&A expenses such as in sales force like we add any more people.

In our regulatory finding between the different regions, Europe and U.S. is basically built on exactly the same data package that will be fine both places with sure, there is a different format after different filing because there 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.

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.