Earnings call transcript: Egetis Therapeutics Q4 2024 sees revenue decline

Egetis Therapeutics reported a decline in revenue for the fourth quarter of 2024, with figures falling to SEK 10.8 million from SEK 32.6 million in the same period of 2023. The company, currently valued at $170.36 million, saw a modest increase of 0.6% in early trading, reflecting cautious investor optimism amid strategic developments. According to InvestingPro data, the company faces profitability challenges with a negative gross profit margin of -205.6%. The earnings call highlighted significant milestones, including European Commission approval for a key treatment and expansion plans in Europe.

Key Takeaways

• Egetis Therapeutics’ Q4 2024 revenue declined significantly year-over-year.
• The company received European approval for emcetate, targeting MCT8 deficiency.
• Expansion in European markets is underway, with a German launch planned for Q2 2025.
• The stock price showed a slight increase, suggesting tempered market confidence.

Company Performance

Egetis Therapeutics faced a challenging fourth quarter in 2024, with revenues declining to SEK 10.8 million from SEK 32.6 million in the previous year. This downturn reflects broader challenges within the ultra-rare disease market. Despite the revenue fall, the company secured full European Commission approval for emcetate, positioning itself as a leader in treating MCT8 deficiency.

Financial Highlights

• Full year 2024 revenue: SEK 43.4 million, down from SEK 57.6 million in 2023.
• Q4 2024 revenue: SEK 10.8 million, down from SEK 32.6 million in 2023.
• Result after tax for Q4: Negative SEK 110.5 million.
• Cash position as of December 2024: SEK 351 million, bolstered by a SEK 281 million net cash injection in Q4. With a current ratio of 0.98 and moderate debt levels, the company maintains adequate liquidity for its operations. For deeper insights into Egetis’s financial health and over 30 key financial metrics, consider exploring InvestingPro, which offers comprehensive analysis and Fair Value estimates.

Market Reaction

Egetis Therapeutics’ stock price increased by 0.6% following the earnings announcement, closing at SEK 5.02. This movement reflects a cautious yet positive market sentiment, likely driven by strategic advancements and the recent regulatory approval. InvestingPro analysis indicates the stock is in oversold territory based on RSI, while showing a beta of 1.26, suggesting higher volatility than the market. The stock has declined 28.29% year-to-date, currently trading at $0.48, within its 52-week range of $0.38 to $0.88.

Outlook & Guidance

Looking forward, Egetis Therapeutics anticipates the US approval and launch of emcetate in 2026. Analyst consensus is moderately bullish, with price targets ranging from $0.56 to $1.41, suggesting potential upside. The company is expanding its commercial infrastructure in Europe and exploring partnerships in Japan, the Middle East, North Africa, and Turkey. With ongoing studies and a strategic focus on pricing and reimbursement, Egetis aims to strengthen its market position. Get access to detailed analyst forecasts and 8 additional ProTips with an InvestingPro subscription.

Executive Commentary

CEO Niklas Westerholm stated, "This represents the single most important milestone in Egetis’ history," emphasizing the significance of the European approval. Henrik Krup, VP of Commercial Operations, expressed excitement about the upcoming launch in Germany, highlighting the company’s commitment to addressing unmet medical needs.

Risks and Challenges

• Revenue decline poses a challenge to financial stability.
• Competition in the ultra-rare disease market could impact market share.
• Regulatory hurdles in new markets may delay product launches.
• Economic conditions in target markets could affect pricing strategies.
• Patient recruitment for ongoing studies remains critical for future approvals.

Q&A

During the earnings call, analysts inquired about the German launch preparations and pricing strategies. Egetis confirmed that patients are lined up for the launch, and discussions on reimbursement are ongoing. The company also addressed concerns about patient dropout rates in the RETRIQ study, noting minimal dropouts and progress in recruitment efforts.

Full transcript - Egetis Therapeutics AB (publ) (EGTX) Q4 2024:

Conference Operator: Welcome to Ajeetis Therapeutics q four report 2024. For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing 5 on their telephone keypad. If you are listening to the presentation via webcast, you can ask written questions using the form below. Now I will hand the conference over to CEO, Niklas Westerholm.

Please go ahead.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you very much, operator, and a warm welcome to Aditi’s quarter four and full year results planned for thirty minutes. For those I haven’t had the privilege to meet, my name is Niklas Westerholm, and I am the CEO of the company. With me today, I also have Yilmaz Masheed, Chief Financial Officer Henrik Krup, our Vice President, Commercial Operations and Karl Haard, Head of Investor Relations. Let’s turn out our attention to the topics to be covered today. But first, let me begin with saying that I’m very proud of the full approval of MCTA in Europe received on the February 13.

This represents the single most important milestone in Aegita’s history and a major step forward for the company building a sustainable rare disease business. And we are also very much delighted to bring this much needed new treatment to patients with MCTA deficiency in Europe. It also, of course, marks a start of a transition for the company from eight stage development company to commercial stage company. What we will cover during the presentation today is a reflection on the key milestones delivered during 2024 and 2025 year to date, including the European Commission’s approval of emcetate. We’ll update on the retryc status, the pivotal study required for the NDA submission in The U.

S. Henrik Krup will update on the commercialization progress and timelines in Europe, and we will then hand over for an update from Yilmaz Masjid on the financial status of the company and wrap it up with key value enhancing milestones expected during 2025 and 2026. First, though, let me start with a short reminder of MCT eight deficiency, a detrimental condition with significant unmet medical need. MCT eight deficiency is a thyroid hormone signaling disorder that causes simultaneously too high and too low thyroid hormone levels in different tissues. So really, a disease with two distinct clinical phenotypes.

The first one is thyrotoxicosis or too much thyroid hormone in the peripheral tissues that actually cause long lifelong morbidity and other very detrimental cardiovascular symptoms, such as, and as you can see on the right hand side of the slide here, severe underweight, cardiac arrhythmias, median life expectancy of thirty five years, and thirty percent of the patients are dying in childhood, with the main cause of mortality being sudden cardiac death. The second clinical phenotype is hypothyroidism, I. E, not enough thyroid hormone in other parts of the bodies like the central nervous system and brain, which causes permanent and severe development delays. And here, most patients are never able to sit or walk and have limited ability to communicate. And therefore, we are of course very proud of emceitate being approved as the first and today only treatment for patients with emceitate deficiency in Europe.

Let’s turn our attention then to reflect on the progress made in 2024 and twenty twenty five year to date, focusing on the several important milestones delivered. The first one is the European Fire Association issuing guidelines. And why is this important? First of all, this is these are guidelines for diagnosis and treatment for MCTA deficiency, stipulating the use of Teraptical as a long term therapy for all patients. Worthwhile recognizing is that these guidelines was developed by independent key opinion leaders, both from Europe and in The US, and were commissioned by the European Firebird Association in July.

This is somewhat unusual, and the reason for it being unusual is that mC state deficiency is ultra orphan condition, and the guidelines were commissioned before an approved treatment. So this is something, of course, we’re very pleased with. This will be very supported for us now moving into commercialization in Europe, and Henrik will reflect on this more in the coming sessions. Next (LON:NXT) important milestone was new data that was presented through an abstract and subsequently physically presented in September at the European Thyroid Association illustrating that treatment with emceitate in patients with emceitate deficiency is associated with a three times lower risk of mortality. And this is important coming back to the disease characteristics where median life expectancy is shorter, thirty five years, and thirty percent of patients dying in early childhood.

So these are very valuable data for us, both for the forthcoming new drug application in The US, but also for upcoming payer interactions. Further details of this data, the survival data, is under review and will be published for in a peer reviewed publication in the not too distant future. Also at the European Thyroid Association, new data was presented from a post hoc analysis that reported effects on emceitate on patient centered outcome measures in patients with mCit8 deficiency. So these are data from TRYPE trial one. In TRYPE trial one, interviews were carried out with parents and caregivers about the most prominent changes, both positive and negative, during MCT treatment.

Improved interactions, alertness, motor skills, and sleep were mentioned according to the numbers you see here on the left hand side of the slide. In one patient, increased constipation and increased unsettledness were reported. Most important here is all parents, 40 out of 40, preferred to continue with MCTA treatments. Let’s turn our attention to another milestone, and this is the submission of the patent application to the US Patent and Trademark Office. As many of you are aware, today, EGT holds orphan drug designation or ODD for mCetate for MCTATE deficiency in U.

S. And Europe. This currently provides marketing exclusivity of seven and ten years respectively from the dates of regulatory approval. Aegis has over the last couple of years invested substantially in updating and refining our manufacturing process and securing it robust and up to the current quality standards. This has also led to generation of new data, which led to this patent application.

And if granted, this will be a significant patent for Aegitis. Generally, the exclusivity term of a new patent is twenty years from the date on which the application for the patent was filed in The US. We were also delighted to share that we carried out a directed share issue amounting approximately 30,000,000 US dollars at the September. This was led by Frasier Life Sciences with a 10,000,000 US dollar investment, and Freis’ ownership is now 17% of the company. And circling back to the highlight over the period, which is, of course, the European Commission approval of mCit8 as the first and only treatment for patients with mCit8 deficiency.

It’s worthwhile stressing here that the marketing authorization is a full marketing authorization. It’s not conditional approval, which means no further clinical trials will be necessary in Europe. And as mentioned, by far, this is the single most important milestone in Aegitus’ history and a major step forward in building a sustainable rare disease company. Aegitus expects to launch mCitake in the first country, Germany, in Europe during the second quarter twenty twenty five, and Henrik will elaborate further on this shortly. Let’s now turn our attention to the RETRIQ study.

As agreed with the US FDA, we’re conducting a pivotal randomized placebo controlled study, the RETRIQ study, in at least 16 evaluable patients with MCTA deficiency to support the submission of a new drug application in The US. To increase the recruitment capacity in the study, four additional clinical study sites were open in The US during 2024, and the last one in December. One each in Texas, Georgia, North Carolina, and Florida. So at the moment, we have seven open sites in the study, two in Europe and five in The US. The current status of the study is that 19 patients have been included, where 11 patients have completed the randomized treatment phase and are evaluable, and three patients are also in the so called running period.

Several additional patients are currently being evaluated for screening, with one patient being scheduled for screening tomorrow. Please note that for any clinical studies, there will be a few dropouts and hence not all patients will be randomized. As previously communicated, we have full focus on the recruitment on the RETRIQ study. We will update the market as soon as the recruitment of the study is closed. And at the time, we will also provide information when we expect top line results and when we plan to submit the new drug application during 2025.

And with that, I will now hand over to Henrik Kruk (WA:KRU) to elaborate further on the commercialization in EU. Henrik, over to you.

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: Thanks, Niklas, and good morning, everyone. As you can imagine, these are exciting and busy times for us, thanks to the recent EMA approval. Given that emceitrate deficiency is such a devastating disorder with no other approved treatments available, we are very excited to soon be able to launch emceitate for the benefit of the affected patients. During the presentation, I will give you a status update on where we are with our European launch preparations for emceitate. However, first, I will just remind everyone of the big picture.

And we are preparing for commercialization of M Cetate through our own team at Agiitis in Europe and U. S. In the rest of the world, we plan to work through partner companies to secure broad access to AMCTATE. For Japan, we have a license deal for development and commercialization by Fujimoto Pharmaceutical (TADAWUL:2070) Corporation. We are also in dialogues with other potential partners for other geographies such as the cluster, Middle East, North Africa and Turkey where we intend to sign partner agreements later this year.

: I would

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: like to take a moment to reflect on these European Thyroid Association’s guidelines that were published in July 2024. The guidelines describe how to manage emceitate deficiency, how to diagnose, etcetera. So they will contribute to disease awareness and support the diagnosis of more patients. And as mentioned earlier by Niklas, we are, of course, very pleased to see that the IITA guidelines recommend emceitate as long term therapy for all patients with emceitate deficiency. It is extraordinary that a treatment is included in these kind of guidelines even before marketing authorization.

So it will be great to leverage these guidelines in our upcoming dialogues with payers in the pricing and reimbursement processes. The next step now after the regulatory approval is to make sure to get the pricing and reimbursement right so that more patients can get access to treatment. National pricing and reimbursement is negotiated country by country and since the 27 EU countries

: have

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: different processes and timelines, this is relatively complex and takes time. There are however some common themes that it is critical to get right in all countries. To get reimbursement, it is important that payers understand the disease and support the benefits of treatment with amcetate. In the pricing and reimbursement processes, we will deliver a solid value proposition

: to

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: payers where we describe MCT8 deficiency and its rarity. And in addition, we will demonstrate the burden of MCT8 deficiency which is further supported by a recent EGLETE sponsored caregiver study. We will also demonstrate the significant unmet medical need and please again remember that emcetate deficiency. And lastly, the benefits of emcetate treatment. And these benefits have actually, to some extent, already been validated by physicians through the ETA guidelines and by regulators through the recent EMA approval.

We are executing our pricing and reimbursement strategy in two ways, starting with the four large EU countries. In Germany, the pricing and reimbursement process lasts for one year, but it is possible to start with reimbursed sales from the initiation of the process. For France, Spain and Italy, the pricing and reimbursement negotiations typically take one to two years, but also in these countries there are possibilities to get funded sales in parallel with the national pricing and reimbursement processes. To optimize the pricing and reimbursement processes, we are working in collaboration with local pricing and access advisors and these are people who have many years experience of getting ultra orphan drugs successfully reimbursed in the respective country. So, we are on good track to optimize pricing and reimbursement.

Germany is the country where we expect the first reimbursement, so I will briefly walk you through this process. It is called the AMLO process and it’s very well defined. In addition to the pharma companies submitting the dossier for pricing and reimbursement, there are three key parties involved. The GBA, which is the authority that sets the favor and includes the benefit statement. EQIC, the Institute for Quality and Efficiency in Healthcare, which assesses the data, the patient population size and the annual therapy cost and then reports back to the GBA.

GKV, the National Association of Statutory Health Insurance Funds with which the pharma company negotiates the final price. And this process lasts exactly twelve months during which the drug can be sold from day one at the price set by the pharmaceutical company with GKV reimbursing it. However, after the twelve month period, if the final negotiated price is lower than the initial price, the former company is required to pay back the excess amount received during the latter six months of the twelve month period. We started the work with preparing the emceitate analog dossier one year ago and it is in good shape. What is happening now is that we are making fine tunings based on the final approved M State labor.

And when finalized, we will submit a dossier to the GBA. Our preparations are progressing well, meaning that we will launch in Germany in Q2 this year. So you can imagine that these are exciting times for us. Our team members have solid experience of successfully launching drugs in the ultra rare setting, but it is, of course, an extra strong feeling to be a part of a company’s first drug launch. And I must say that it is a true privilege to prepare for the first EGRTHIS launch together with our skilled German launch team and to soon be able to provide broader access to emceitate to patients affected by emceitate deficiency.

With that, I would like to hand over to you, Yilmaz, for the financial update.

Yilmaz Masheed, Chief Financial Officer, Aegitis Therapeutics: Thank you, Hendrik. So, I have one slide on the financials. And please call me or our head of Peoria if you have any further questions. So on this slide, we have revenues for the full year 2024 were SEK 43,400,000.0 versus SEK 57,600,000.0 in the same period last year. Revenues for the fourth quarter of the year were SEK 10,800,000.0 versus SEK 32,600,000.0 in the same period last year.

The lower numbers for the full year 2024 versus 2023 are due to one time license income in 2023 of SEK 14,500,000.0 received for the Japanese rights. The same comparison relates to the fourth quarter, but also due to lumpy order patterns and demand’s access income. Results after tax for the fourth quarter of the year were negative SEK110.5 million versus negative SEK86.3 million. Lower amount versus prior periods driven by increased investments in the commercial

: buildup,

Yilmaz Masheed, Chief Financial Officer, Aegitis Therapeutics: but also impacted by a couple of noncash items, such as the IFRS two bookings for the ESOP employee stock option programs of negative SEK8 million in the quarter versus negative SEK3.8 million in the prior period, which is part of the administrative line item in the P and L. But also revaluation of the convertible rights related to the BlackRock (NYSE:BLK) debt of SEK7.6 million versus negative SEK2.7 million in the prior period, and this one is part of the finance line items in the year. Operating cash flow for the fourth quarter of the year were negative SEK53.6 million versus negative SEK41.6 million in the same period last year. The cash position at the December 2024 was SEK351 million versus SEK $3.00 3,000,000 last year, starting the new year on a better footing in 2025. And it was gratifying to see that we had a good support from existing and new shareholders, which did result in a net cash injection to the company of approximately SEK281 million that occurred in the fourth quarter.

During the fourth quarter, we did also issue 29,000,000 C shares as heads for outstanding ESOP programs. These are held in company treasury and will only become outstanding common shares if any of the ESOP programs goes to exercise. And with that, I’ll hand the microphone back to Niklas.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you, Irma, and thank you, Henrik. The last slide will focus on the future looking ahead. And we are very we have a very excited period ahead of us with many upcoming value enhancing key milestones, such as the European launch starting with Germany in the second quarter. We very much also look forward to the top line results of the RETRACT study, followed by the filing of a new application in The U. S.

During this year. This means that we expect The U. S. Approval on launch of emCit8 in 2026 in The U. S.

With that, I would like to hand over the call to the operator and start the Q and A session for this call. Operator, please go ahead.

Conference Operator: If you wish to ask a question, please dial 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial 6 on your telephone keypad. The next question comes from Arvind (NSE:ARVN) Nikkander from Carnegie. Please go ahead.

Arvind Nikkander, Analyst, Carnegie: Good morning and thanks for taking my questions. So first off, I was wondering if you could give us some perspective on your targeted launch and reimbursement timelines. I guess first in Germany, I understand that it’s hard to give an exact estimate, but do you anticipate a, let’s say, standard three to four months HTA process with the GBA? Or is there something leading you to believe that it could be longer, for example, due to ongoing cost benefit analysis or other factors? And secondly, when do you anticipate to launch in the remaining EU4 markets?

And in which markets do you believe there are pathways that would you allow would allow you to launch before reimbursement is fully concluded? I’ll start there. Thanks.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you. Henrik, if you don’t mind.

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: Yes. Thank you for the question, Arvid. First, starting then with Germany, there we intend to work according to the regular timelines there. So, we assume that the final reimbursed price will be negotiated twelve months after our submission. Then to the second question related to the other EU four countries, there, the timelines for the pricing and reimbursement processes are a little bit less structured than for Germany.

So there, we anticipate that these will take one to two years. But for these countries, there is possibilities, as I mentioned, to get funded sales in parallel, and that is possible thanks to routes through negotiating with local hospitals and regions, and that is something that and that is something that we are working on to make that.

Arvind Nikkander, Analyst, Carnegie: Okay, great. Thank you. And lastly then, just if I may, do you have visibility on how many patients you currently have on treatment in Germany and The U4?

Niklas Westerholm, CEO, Aegitis Therapeutics: Yes. Thanks, Arvind, and good morning to you as well. We don’t disclose how many patients we have per country. I would like to circle back to the two thirty patients in our managed access program. The majority of the patients there are in Europe, and then population based, one would assume that a major part would be in EU4.

But we don’t disclose patient numbers identified today per country.

Arvind Nikkander, Analyst, Carnegie: Okay. And just a final, if I may follow-up on that. Have you seen any significant growth in terms of the patients on treatment in the EU4 markets over the past year? Or has that mainly been outside

Niklas Westerholm, CEO, Aegitis Therapeutics: specific markets, but when we see patient identification because I think it’s key to understand patient identification versus patient on in under the umbrella of managed access program. So patient under the umbrella of managed access program. There, we see across the world, regions and countries, an uptick in the number of diagnosed patients. And this is obviously driven by a number of factors. Our efforts in driving disease awareness in Europe, especially through the European Fire Association guidelines, etcetera.

So I think when it comes to number of identified patients being diagnosed, it’s across the board.

Conference Operator: The next question comes from Susanna Quechburner from SHB (HM:SHB). Please go ahead.

: Hello. Susanna Quechburner here from Handelsbanken. Thank you for taking my questions. Just to follow-up on Arvid’s question with regards to the German launch. Do you have patients lined up for Q2?

And then also how are you going to handle pricing and reimbursement negotiations in the EU for will you have people on the ground? I remember that you said you have 40 employees as of now. How are you thinking about it? And then one final question regarding the RETRIACT trial. Can you give me a view on how or how patient attrition is in these trials in terms of the run up and screening?

What how long it takes and how that impacts randomization? Thank you.

Niklas Westerholm, CEO, Aegitis Therapeutics: Good morning, Susanna, and great to have your questions. I think the simple answer to the first question on patients lined up in Germany is yes, we of course do. And it comes back to that we have a number of patients under the umbrella of the managed access patients being located in Germany. On top of that, we also have identified a few others other patients in Germany currently not on treatment. So we have a strong belief that already from launch and onwards, these patients will be converted into into the so called commercial space from the managed access program and also newly diagnosed patients.

When it comes to the organization, I think that’s a really good question and something that is very, very important to us when it comes to sufficient capability and capacity. We have a step built up, as you probably know, our commercial and medical affairs infrastructure over the last years, initially focusing on Europe. The focus for the coming twelve months, as you heard from Henrik, is around pricing and reimbursement in EU4. And there, we have people on the ground covering both access, so pricing and reimbursement, and this is governed by our Global Head of Market Access being based here in Europe, but also supported by local consultants, experts in navigating the local reimbursement processes. When it comes to medical affairs, we also have people in the on the ground in the key countries EU for.

Last but not least, when it comes to to the RETRIAC study, your question was around the attrition, and they’re coming back to 11 patients today, also we get the facts right. Our ambition is to have at least 16 evaluable patients. Today, we have 11 patients that has completed the randomized treatment phase and are available. That’s up by three from December, where we had eight. We have another three patients in the running period, and we have a number of patients being evaluated and planned for screening, one actually tomorrow.

When it comes to the attrition, so to say, and dropouts, we recognize and we mentioned at the previous calls that we have had a few dropouts, not driven by study drug, but family circumstances and other aspects. So those are there, I would say, attrition one would see, which is not unusual for clinical trials. When it comes to screening and screening failure there, attrition is somewhat lower. But there, it’s the majority of the challenges we have had has been driven more by family’s ability to travel, etcetera, etcetera. So I hope that answered your questions, Susanna.

And happy to take the follow-up questions offline. Thank you.

: Yes. Thank you very much.

Conference Operator: The next question comes from Oscar Hafenlam from Brian Garnier. Please go ahead.

: Hi, Steve. Matthew here from Brian Garnier. Thank you for taking my questions. First question maybe on the launch in the EU. I was just wondering how quickly you think the patient in the early access program will translate into commercial revenues upon launch?

And how we should think about pricing revenues in the four biggest European countries except Germany before final price and reimbursement negotiations have concluded? And then as a second question regarding RetryX, so far it looks like you have a good translation of I mean translation of patients between run-in to randomization. But I was wondering how many patients have dropped out if any so far in the run-in period and in the randomization phase? Thank you.

Niklas Westerholm, CEO, Aegitis Therapeutics: Henrik, do you mind starting with the first question?

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: Yes, sure. So related to the transition from the managed access program to commercial sales. And here, just to state first that we will not stop providing drug to any patients and patients will be converted from managed access to traditional prescriptions once national reimbursement is secured. And in Germany, this will happen immediately at the time of our launch in Q2 this year. For France, Spain and Italy, the pricing and reimbursement negotiations typically take one to two years.

But as mentioned also in these countries, there are possibilities to get funded sales in parallel with the national pricing and reimbursement processes. Then I hand over to you, Niklas, for the Vitriact related question.

Niklas Westerholm, CEO, Aegitis Therapeutics: Yeah. Thank you, Oscar. And your question was around dropouts to my understanding and what we have seen. And I think we mentioned this at the quarter three call we had back in November. And there, we have seen a few dropouts, very few, less than a handful that has been dropping out through the different phases of of the study.

This is not unusual, and I reiterate what I said to Susana’s question, that this has been driven not by study drug. It has been driven by actually family circumstances not being able to continue on treatment any longer, or sorry, not continue to participate in the clinical study. So it’s quite a few to answer your question.

: Okay, great. Thank you.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you, Oscar.

Conference Operator: The next question comes from Frederic Thor from Redi. Please go ahead.

: Hello, and thank you. My first question, and maybe you answered this, but when will we know about the initial price in Germany? I mean, the launch price, I would say, before the final reimbursement?

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: Jeff, please, Hendrik. Yes. So the initial German lease price will actually be publicly available at the time of launch, so from Q2 this year. And as

Niklas Westerholm, CEO, Aegitis Therapeutics: you heard from Henrik during the presentation, that’s the initial list price we have from the launch. And then, of course, during the very clearly defined stipulated Abnog process, we’ll end up with a final negotiated price twelve months after the launch.

: Thank you, Frederic. Got it.

Niklas Westerholm, CEO, Aegitis Therapeutics: And please, sorry.

: And I also had a question about the rarity that exists, Vaxei program. If you could give us your view of the status of the program? I know that there have been some budget discussions about it and so on. What’s your view?

Karl Haard, Head of Investor Relations, Aegitis Therapeutics: Yes. Hello, Frederic. This is Karl Hor speaking. I mean, we are following this, of course, with interest. Interestingly, the FDA has continued to issue rare pediatric disease designations also during 2025.

So that’s a very positive sign. There’s big activity going on in the Congress at the moment, both in the House and the Senate. So, you know, we will see how that develops. It has been twice before that there has been a sunset close coming, but then it has been renewed. And we hope that the same happens here as well.

Thank you.

Conference Operator: The next question comes from Alexander Kramer from ABGSC. Please go ahead.

Alexander Kramer, Analyst, ABGSC: Yes, good morning. I have two questions. One financials question. So I mean today, of course, your OpEx went a little bit up. And my question here is as a retract progresses and of course then finalizes this year, R and D costs are expected to move down while of course SG and A costs will go up.

Do you expect the total OpEx levels this year in 2025 to be net neutral? Or do you expect like a single or single digit growth in the total OpEx levels? And then I have a second question.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you, Alexander. And that’s a really good question. We have shared this before that if you look into 2025, first, let us be clear, we don’t give any guidance on cash burn rate. But I will try to triangulate it for you together with Irma here. So we see absolutely, as you said, that we see the R and D cost declining over the year, obviously, especially compared to last year where we concluded the first part of Tri Trial two, and now we’re going to conclude within short the REIT trial study.

So of course, we believe that the R and D costs will decline over the year. That is offsetted, of course, by increased investments in the commercial and manufacturing of the fair space, both in Europe and in U. S. Of course, we’re ahead of a U. S.

Launch as well, but not giving any guidance. It’s reasonable to assume that it won’t be a substantial uptick in cost, but rather a moderate to flat up tick. Yilmaz, I don’t know if you want to add anything to that.

Yilmaz Masheed, Chief Financial Officer, Aegitis Therapeutics: No, not much really. I mean, most of our investments are dependent on achieving certain operational milestones such as the RISE Rack study, as you all know. I mean, the tax rate is beyond that, but the reason for assumption is that our cash burn will see a minor uptick here at the beginning of the year, but nothing major.

Alexander Kramer, Analyst, ABGSC: All right. And the second question relates to your disease awareness activities in Germany. Are you going to medical conferences there? Like if yes, which ones? And also like as you have your people there outside in Germany, like how good is your knowledge level of like how the diagnosis and the screening of newborns of Rock and Germany and how easy it is to identify newborn patients?

Henrik Krup, Vice President, Commercial Operations, Aegitis Therapeutics: Yes. So Henrik here, I can answer to those questions. So first related to disease awareness and congress attendance. So here, we have planned to attend roughly 10 congresses in the German region this year. And these are something that we have learned from the past that it’s really good to attend this because that is when we are able to have high quality interactions with new physicians as well.

And we support identification of new patients. Then related to your second question about screening in Germany, so there is no national program specifically for MCTA deficiency, but Germany is one of the most advanced countries in Europe when it comes to look and do genetic testing once there comes a patient with unclear diagnosis. So therefore, it’s a well developed country for diagnosing patients.

Niklas Westerholm, CEO, Aegitis Therapeutics: And maybe to add on that on top of what Henrik said and reiterating, 10 conferences is planned for this year for AGTIS attendance. So it’s quite a few. And as I’m sure we appreciate, Alexander, this is something that is important to us. It’s a high return on investments with quality dialogues and patients being identified. We can reflect on that from the past experience.

On top of that, we’re also arranging a number of advisory boards with key opinion leaders who further have dialogues on the topic of diagnosis and treatment of MCT8 deficiency. Thank you, Alexander. We’re running a bit over time, but we have time for one last question from Patrick Ling to my understanding, at DNB.

Conference Operator: The next question comes from

Niklas Westerholm, CEO, Aegitis Therapeutics0: Patrick

Conference Operator: Ling from DNB Markets. Please go ahead.

Niklas Westerholm, CEO, Aegitis Therapeutics0: Yes. Hi. Just a short follow-up, Niklas, to your prepared remarks. I mean, when you talked about the RETRAC trial, did you say that you would communicate timeline in 2025? Or did you actually say that you will be filing in The U.

S. In 2025?

Niklas Westerholm, CEO, Aegitis Therapeutics: Good question, Patrick, and good morning to you. I want to be very, very clear here. We will file that’s what we plan in 2025.

Niklas Westerholm, CEO, Aegitis Therapeutics0: Good, good. That’s what I thought I heard. That was actually all for me. All other questions has been answered. Thank you.

Niklas Westerholm, CEO, Aegitis Therapeutics: Thank you so much. And that takes us to the end of the call. If you have any further questions that I wasn’t able to answer, you can reach out to us through our normal contact channels. We’ll take it from there. Wish you a great day and also a short reminder that the GTS is holding a Key Opinion Leader event on Tuesday, March, focusing on mCTA deficiency, details on the disease characteristics as well as experience in treating these patients with mCTA.

Thank you very much, and I wish you all a good day.

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