Earnings call transcript: Egetis Therapeutics sees slight Q1 2025 revenue rise

Egetis Therapeutics AB reported a modest increase in revenues for Q1 2025, with figures reaching SEK 12.7 million, up from SEK 12.1 million in the same period last year. Despite this growth, the company faced challenges with a lower gross profit margin due to royalty and milestone payments. The stock showed minimal movement, with a slight increase of 0.13% in pre-market trading. According to InvestingPro analysis, the company currently appears undervalued, with analysts maintaining a strong buy consensus and projecting significant upside potential.

Key Takeaways

• Q1 2025 revenues rose to SEK 12.7 million, slightly up from last year.
• Gross profit margin affected by royalty and milestone payments.
• Egetis is transitioning from development to a commercial-stage company.
• Launch of MC Tate in Germany set for May 1, 2025.
• Ongoing regulatory preparations for a US launch.

Company Performance

Egetis Therapeutics demonstrated a steady performance in Q1 2025, with revenues increasing slightly compared to the previous year. The company is navigating a transition from a late-stage development company to a commercial-stage entity. This transition includes strategic preparations for launching its key product, MC Tate, in Germany and the United States.

Financial Highlights

• Revenue: SEK 12.7 million, up from SEK 12.1 million in Q1 2024.
• Operating cash flow: -SEK 66.1 million, compared to -SEK 55.4 million last year.
• Cash position: SEK 273 million, up from SEK 252 million in March 2024.
• Gross profit margin impacted by 10% royalty payments to Erasmus Medical Center.

Outlook & Guidance

Egetis Therapeutics remains optimistic about its future prospects, with the full approval of MC Tate in the European Union and an imminent launch in Germany. The company is also preparing for a US launch and NDA submission in 2025. Additionally, Egetis is exploring further indications for its product pipeline and expanding its pricing and reimbursement strategies across Europe. InvestingPro analysts project substantial revenue growth of 233% for FY2025, though the company is not expected to achieve profitability this year.

For deeper insights into Egetis’s growth potential and comprehensive financial analysis, investors can access the detailed Pro Research Report, available exclusively to InvestingPro subscribers.

Executive Commentary

CEO Niklas Westerholm expressed enthusiasm for the European launch, stating, "We are very much delighted to bring this much-needed new treatment to patients in Europe." Henrik Krug, Head of Commercial Operations, highlighted the potential in the US market, noting, "The total potential for Amcetate is clearly largest in The US."

Risks and Challenges

• Royalty and milestone payments could continue to impact profit margins.
• Regulatory hurdles in the US and Japan may delay product launches.
• Potential pharmaceutical tariffs in the US could affect pricing strategies.
• Dependence on successful market penetration in new regions.

Q&A

During the earnings call, analysts inquired about the preparations for the Germany launch, which targets 50 specialized pediatric centers. There were also questions regarding the potential impact of US pharmaceutical tariffs and the company’s ongoing discussions about the regulatory pathway in Japan. Egetis aims to convert managed access program patients to reimbursed patients, ensuring continued access to its treatments.

Full transcript - Egetis Therapeutics AB (publ) (EGTX) Q1 2025:

Conference Operator: Welcome to Agedis Therapeutics Q1 Report 2025. 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 Now I will hand the conference over to CEO, Niklas Westerholm. Please go ahead.

Niklas Westerholm, CEO, Aegis Therapeutics: Thank you, operator. Good morning and a warm welcome to Aegis quarter one results call planned for the coming thirty minutes. For those who haven’t had the privilege to meet before, I’m Niklas Westerholm, I’m the CEO of the company. With me today, I also have Jilmaz Masjid, Chief Financial Officer Henrik Krug, our Head of Commercial Operations and Karl Hord, Head of Investor Relations. Let’s turn our attention to the topics covered today.

But first, let me begin saying that I’m incredibly proud of the full approval of MC Tate in the European Union on the February 13, which represent the single most important milestone in Aegis history and also marks a major step forward in building a sustainable rare disease company. We are very much delighted, of course, to bring this much needed new treatment to patients in Europe through the upcoming launch in the first country, Germany, that takes place tomorrow, the May 1. It also, of course, makes a start of a transition from a late stage development biotech company to a commercial stage company. What we will cover during the call today is, the progress in building a rare disease company, key milestones delivered during 2025 year to date, recap on The U. S.

Regulatory pathway and then the submission plan for 2025 and the retract status, the pivotal study required for completing the NDA dossier. I will then hand over to Henrik that will elaborate further on the commercialization in Europe, but also the launch preparations in The US. Subsequently, Henrik will hand over to Gilmas, who will give an update on the financials and will be finishing off with upcoming key value enhancing milestones. So with the European approval of MCT8 in February and the subsequent launch in Germany tomorrow, we’re making strides to become a sustainable rare disease company with focus on late stage development for commercialization. Furthermore, the pivotal study in The U.

S, the ReTRAC study is well underway to complete The U. S. NDA dossier with a planned submission during this year. Preparations for the EU launch of MCT8 focusing initially on EU four countries are on track. And The U.

S. Launch preparations, including the stepwise buildup of a commercial and medical affairs organization is also on track, ensuring that we’ll maximize the M. Opportunity. For markets outside Europe and The U. S, we have a license agreement with Fujimoto Pharmaceutical Corporation for the development and commercialization of MCT8 in Japan.

Discussions are currently ongoing with the Japanese regulatory authority, PMDA, regarding the development pathway required to obtain approval for MCT8 in Japan. In The Middle East, North Africa, and Turkey region, discussions are underway with potential distribution partners to enable access to MCT8. Henrik here will provide further information and elaborate on these topics later in the presentation. In addition, and as previously communicated in December, we have decided to explore RTH beta as the next indication for Tiatricol or MCT, where we see a significant unmet medical need coupled with a significant market opportunity. MCT deficiency and RTH beta are two distinct indications with no overlap in patient population.

And as mentioned before, we are considering to support a multicentered investigator initiated study, Phase II study in patients with RTH beta in collaboration with academia. Last but not least, we have during the last few years been able to attract and also retain a very seasoned and experienced workforce covering late stage orphan clinical development, registration and commercialization, which makes us well positioned for the future. Reflecting on the progress made over the period, it is worthwhile mentioning a couple of highlights here. You can see depicted on the slide. But one of them worthwhile mentioning is, of course, the ETA guidelines issued in July, recommending all patients with MCT deficiency to be treated with MCT.

Also worthwhile calling out is the data from the retrospective reward cohort study where, it was investigated the effects on of tiratical on mortality. Tiratical treated patients had an approximately three times lower risk of all cause mortality, which is, of course, very valuable data going forward, both for payer interactions as well as the upcoming new drug application in The US. But foremost, as I said before, I’m very proud of the European approval of MCT8, grateful for all the hard work of the Aegis employees, our partners over the years, and in in which we have invested more than hundred million euro in making this happen and ensuring that we have the first and only approved treatment for patients with MCT8 deficiency available. It’s also worthwhile stressing that this is a full marketing authorization in Europe. So it’s not a conditional approval, which means no further clinical trials will be necessary in the European Union.

Let me now review the regulatory pathway for emcetate or teratrochol we’d focus on The United States with a new drug application planned for 2025. Our marketing authorization application or MAA, which formed the basis for the approval in February in the European Union consisted of data from the studies denoted in green on this slide. In the first study, TRI Trial one, the effects of twelve months of MCT treatment on thyroid hormone T3 concentrations and clinical endpoints related to peripheral thyrotoxicosis were established. The Erasmus Medical Center cohort study confirmed these treatment effects in a real life setting in sixty seven patients with treatment up to six years. This third study included was an extensive natural history study of untreated MCT deficiency patients, which enabled an indirect conversation to assess the clinical relevance of the treatment effects seen with MCT.

During the review process of the MAA, the top line data from the TRIAC Trial two was included, which although missed its primary endpoint, provided very important safety data in young patients below 30 of age, which was requested by the EMA. We were also able to include the encouraging survivor results from the abstract that was published as part of the ETA last year in September by EMC. Focusing on the new drug application in The US, the FDA has requested the placebo controlled withdrawal study to verify the effects seen on t three in single arm studies, trial one, and the EMC cohort study. This is what we refer to as the retriag study. I will shortly give an update on the status of the same on the next slide.

Worthwhile recognizing here is that we also plan to include the full and detailed dataset from the survival study in The US new drug application later this year. In summary, it should be noted that we have a large and robust dataset for an ultra orphan investigational drug set for the NDA. If you move to the next slide, please. Let’s now turn our attention to the ReTRAC study. As agreed with the US FDA, we’re conducting the pivotal study ReTRAC study in at least 16 evaluable patients with m c t eight deficiency to support the new drug application in The US.

As mentioned before on our previous calls, we opened four additional clinical study sites during 2024 in The US to increase the recruitment capacity. One in Texas, one in Georgia, one in North Carolina, and back end of last year, one also in Florida. Right now, have seven studies, seven study sites open to recruit patients. The current study status is that we have 12 evaluable patients who had completed the randomized treatment phase. One patient is currently in the randomized phase.

One is patient is in the run-in period, and two patients are planned for screening with further patients being evaluated for screening. As previously communicated, we continue to have full focus on the retract study. We’ll update the market as the recruitment of the study is closed. And at that time point in time, we’ll be able to provide information on when to expect top line results and when in 2025 we plan to submit a new drug application. So with that, I will hand over to Hendrik to further give some granularity on the commercialization in Europe and the launch preparations in The U.

S. Henrik?

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: Thanks, Niklas, and good morning, everyone. So we are gearing up for the commercialization of emcetate through our dedicated team at the Geatus in Europe and The U. S. For the rest of the world, we intend to collaborate with partner companies to ensure broad access to MCT8 for patients. In Japan, we have secured a licensing agreement for development and commercialization with Fujimoto Pharmaceutical Corporation.

We have, over the last months, deepened our dialogues with potential partner companies for Middle East, North Africa, and Turkey. In some of the Middle East countries and in Turkey, it is possible to provide access and sell amcetate on a so called named patient basis. And that is based on the EU regulatory approval and based on the German pact and price. For Middle East and Turkey, we interacted with more than 10 companies all being very interested in Amcetate, and we have now advanced these dialogues and come to a short list of companies that we believe would maximize the Amsutate opportunity. So over the next months, we will continue due diligence and negotiations with these companies related to collaboration and financial terms with the ambition to close partnering deals.

I would again like to take a moment to highlight the European Firewood Association’s guidelines, guidelines, which were published in July 2024. These guidelines outline the management and diagnosis of MCT deficiency, aiding the diagnosis of more patients. We are delighted to see that the ETHA guidelines recommend amsutate as a long term therapy for all patients with amsutate deficiency. It is remarkable that the treatment is included in such guidelines even before launch. These m supporting EDA guidelines will be further use utilized in our disease awareness and also in the pricing and reimbursement efforts throughout Europe.

We are executing our pricing and reimbursement strategy in two ways, starting with the four largest EU countries. The French reimbursement dossier was submitted during the April. The German dossier was submitted today. And hence, we are excited about our first launch of Amcetate in Germany as of tomorrow. And I will soon give you some more details related to the German process and launch.

However, first continuing with a brief update on the other EU four countries. For Spain and Italy, we are underway to elixate pricing and reimbursement processes. In France, Spain, Italy, and also in other European countries, these pricing and reimbursement processes normally takes one to two years. We are collaborating with experienced local prices pricing and access advisers to optimize the pricing and reimbursement processes. National pricing and reimbursement is negotiated country by country.

And since the 27 EU countries have different processes and timelines, this is relatively complex and takes time. However, there are some key themes that we are focusing on in all countries. In the pricing and reimbursement processes, we delivered m c eight value proposition, where we describe m c t eight deficiency and its rarity. And in addition, we outline a high burden of m c t eight deficiency, which also is confirmed by the EFT sponsored caregiver study. The significant unmet medical need in amcetate deficiency, with amcetate being the first and only approved treatment.

And last but not the least, the benefits of amcetate treatment as per the label or the EU SNPC, which is supported by publications and the earlier mentioned ITA guidelines. Let’s turn our attention to Germany where the pricing and reimbursement process lasts for one year in the so called annual process. As mentioned earlier, we started this process today by submitting our reimbursement dossier to GBA. The German process is very beneficial from an access to treatment perspective since it is possible for physicians to prescribe the commercial packs with reimbursed costs also in parallel with the ongoing process. This means that as of tomorrow, which is the official German launch date, then we can start to sell reimbursed commercial packs in Germany at an initial price.

However, after the twelve month annual process, if the final negotiated price is lower than the initial price, we will be required to pay back the delta between the initial price and the final negotiated price. However, this will only have to be done for the excess amount received during the latter six months of this twelve month period. The German launch strategy is focused on building an expert base that will support other HFPs in Germany related to the management of MCT deficiency. We are collaborating with experts to enhance disease awareness and enable diagnosis in Germany. Our efforts are centered on diagnosis, monitoring, and providing treatment guidance for MCT deficiency.

We emphasize the importance of local publications and clinical training in managing this condition. We are collaborating with physicians at specialized pediatric centers, the SPZs, and rare disease centers, the ZSEs, both being involved in the management of potential MCT deficiency patients. Our goal is to increase disease awareness and foster discussions in local educational training sessions with multidisciplinary teams at these centers. Additionally, we are developing customized awareness campaigns for HCPs and patient support materials in collaboration with disease experts. It is encouraging to see that our strategy works because over the last months, the German team has had over 30 interactions with physicians, including several meetings at many of these, specialized pediatric centers, the SP sense depicted on the slide.

And these engagements resulted in that we became aware of additional patients diagnosed with MCT deficiency that soon hopefully can be helped by MCT. So we are thrilled to now be on our way out of the starting blocks for the launch of mCetate. This launch represents a significant milestone in our journey to improve the lives of patients affected by this debilitating condition. Up to now, physicians have had to go through some extra work and administration to make the patients become a part of the mCetate managed access program. However, as of tomorrow in Germany, they can instead simply prescribe mCetate as any other available pharmaceutical drug, which makes the access to mCetate easier.

For us as a company, the launch also means that we will start to promote mCetate through branded materials at, for example, congresses in addition to the disease awareness materials, which have been our focus up to now. Raising disease awareness will continue to be a key focus area for us in Germany as well as in other countries to enable fast and accurate diagnosis of MCT deficiency. A few months back, we sponsored an episode on US national TV focused on MCT deficiency. The episode became very informative and featured both real life stories with patients and caregivers living with MCT deficiency. In addition, there was contribution from leading endocrinologists and the international patient advocacy group, the MCT8AHTS Foundation.

There were a lot of viewers when the program aired in February and March, but also afterwards with more than 800,000 social media impressions and over 300,000 video views. So this has been a great success. The link to the video has been spread through social media, and the episode is still available through our educational websites, mct8efficiency.com and mct8efficiencyeu. Lastly, I would like to say a few words about how our disease awareness and our expanded access program help in the preparations for the launch in US. Firstly, we see how our activities year by year makes us aware of more patients being diagnosed with MCT deficiency.

Secondly, related to the expanded access program that was an ask from FDA, this helps diagnose patients to get access to amsutate. And we are happy to be able to support the families in this way, and there are currently 13 EAP centers in US, and the number is growing with interest from more centers. The existence of the EAP also helps more physicians to gain experience of emsatate. Furthermore, it is a great opportunity to generate real world data that can support upcoming regulatory and payer interactions. At the future anticipated US approval, the EAP patients will be converted to reimbursed commercial MCT packs over the first six months period after US approval.

Please note that there are some key and principal differences between sales uptake in The US compared to Europe, and these are actually quite significant. In Europe, the uptake tends to be slower due to relatively lengthy pricing and reimbursement processes. As mentioned, it typically takes one to two years before getting reimbursement. On the other hand, the sales uptake in The US is faster and larger once approval is granted, and this is due to rapid reimbursement and also a potential for higher pricing. Overall, the total potential for Amcetate is clearly largest in The US.

So in parallel with the launch activities in EU, we are stepwise establishing our US organization to seize the great U. S. Opportunity. With that, I would like to hand over to Gilmas for a financial update.

Jilmaz Masjid, Chief Financial Officer, Aegis Therapeutics: Thank you, Henrik, and good morning to everyone on the call. Revenues for the first quarter of the year were SEK 12,700,000.0 versus the SEK 12,100,000.0 in the same period last year, of which SEK 12,600,000.0 is attributable to MCT’s Managed Access Program. The gross profit margin is visibly lower than historical figures, but comes back to the success we have had with MCT in Europe. As a consequence, the COGS line item not only includes the recurring royalty payments to Erasmus Medical Medical Center of 10%, but also nonrecurring milestones of approximately SEK 3,500,000.0 to Erasmus Medical Center. In addition, the European approval has also triggered the initiation of monthly SEK 3,400,000,000.0 of intangible R and D depreciations, hence one month of depreciation was included in this quarter.

And as many of us know, this is a noncash item. In an apples to apples year over year comparison, excluding the last two items mentioned, the gross profit margin would have been slightly better than the Q1 figure Q1 twenty twenty four figure. Results after tax for the first quarter of the year were minus 62,900,000 versus minus SEK 75,000,000. The higher amount versus prior period is mainly driven by the finance line items and specifically the revaluation of the convertible right, which fluctuates with the share price. Q1 twenty twenty five figures were plus SEK 10,200,000.0 versus the minus SEK 3,400,000.0 in Q1 twenty twenty four.

This is a total year over year difference or deviation of SEK 13,600,000.0. Remember that this is also a noncash item. So it’s better to look on the operating cash flow for the first quarter of the year, which were minus SEK66.1 million versus minus SEK55.4 million in the same period last year. The difference, as you can see, is mainly explained by the working capital line items, where we had a negative change of SEK 7,900,000.0 in Q1 twenty twenty five, while the Q1 twenty twenty four numbers were positive SEK 10,300,000.0. This is a year over year difference of SEK 18,200,000.0.

The cash position at the March was SEK $273,000,000 versus SEK $252,000,000 last year, giving us a better start of the next quarter with a better footing. With that, I would like to hand back to Niklas.

Niklas Westerholm, CEO, Aegis Therapeutics: Thank you very much, Ilmaz. Thank you very much, Hendrik. To summarize, we have a very exciting period ahead of us with quite a few milestones such as the European launch starting with Germany tomorrow, one. We’re also very much looking forward to the top line results of the ReTRAC study following by the new drug application in The U. S.

This year. This means that we expect The U. S. Approval and launch of emcetate in The U. S.

During 2026. With that, I would like to hand over the call to the operator and start the Q and A session. Operator, please go ahead.

Conference Operator: The next question comes from Arvind Niekender from Carnegie. Please go ahead.

Arvind Niekender, Analyst, Carnegie: Good morning, and thanks for for taking my questions. So first off, can you provide any more detail on the progress in Germany ahead of the the launch? How many centers or physicians you believe will be ready to begin prescribing and treating patients from tomorrow. Yes, perhaps I’ll start there.

Niklas Westerholm, CEO, Aegis Therapeutics: Thank you, Arvind, and good morning to you as well. And I think you saw that on one of the slides Henrik elaborated on. We have started actually the launch preparations already two years ago, engaging with the different sites, identifying the specialties sites here for rare diseases and being engaging with with the specific physicians on those sites together with with advisory boards. I don’t know, Henrik, if you wanna want to provide some more granularity on that.

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: Yeah. Of course, I can elaborate a little bit further. So we don’t disclose numbers of patients. But as you can imagine, we have some patients in the managed access program in Germany, and they would be swiftly converted now to reimburse commercial packs. Certainly.

In terms of activities, we have, as Niklas said, been working preparing the German market over the last two years, and we have held advisory boards with key experts in Germany and have now, over the last months, also extended our presence to to more centers. And there, it’s really encouraging to see that we we all the time also have the possibility to to find new patients still in Germany. And that is, of course, a key focus area for now in the launch phase to really make sure that we also drive disease awareness and enable fast and accurate diagnosis of more patients.

Arvind Niekender, Analyst, Carnegie: Okay. Fair enough. Just a quick follow-up on that. I I assume you’re you’re sort of starting by addressing higher volume centers that can can have a sort of regional center of excellence position. Can you provide any granularity on that?

How many centers are you you really targeting in full effect in the initial launch?

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: Yeah. So so we are focusing on these specialized pediatric centers, the SPZs and rare disease centers, because these are the centers where most of these kind of patients will appear. And there we are working from the the experts, so those that we already now have experience with them state through the managed access program. And then we we leverage them to also educate more physicians and also at other centers. And in total, it’s roughly 50 SPZs and a bit more than 50 rare disease centers.

So those are the ones that we are focusing on.

Niklas Westerholm, CEO, Aegis Therapeutics: And maybe calibrate that some somewhat further, Arvid. It’s about engaging the key opinion leaders locally in Germany, getting their help for further education. As Hendrik said, we have been actually over the last twelve months present at the majority of these centers as well, making sure that we can drive disease awareness and also encourage the upcoming launch.

Arvind Niekender, Analyst, Carnegie: Perfect. Thanks for that additional color. Just an additional one, if I may. I guess in light of the expected tariffs on pharmaceuticals and related ingredients, could you just walk us through your production chain and comment on potential impacts?

Niklas Westerholm, CEO, Aegis Therapeutics: Yes. So I think you’re referring to the potential U. S. Tariffs on pharmacy. You’re breaking up a bit, Arvind, just so you know, the potential U.

S. Tariffs and how do we address that. Obviously, we all know with the new administration that it’s very dynamic, so to say. So it’s difficult to predict what our formal final outcome will be. Our current supply chain setup is as such that we have API production and drug product production in Europe.

What we’re looking at ahead of a US launch is potentially having secondary packaging in The US that might potentially mitigate some of the effects we potentially will see from tariffs. So with that, thank you, Arvind. Let’s move on to the next question, if you please.

Conference Operator: The next question comes from Susannah Quackburner from Handelsbanken. Please go ahead.

Susannah Quackburner, Analyst, Handelsbanken: Hello, Susannah Quackburner, Handelsbanken. I’d like to follow-up on the situation in Japan. Perhaps you can give us an update whether you’re going your partner is going to require further clinical trials? And what’s the time line here?

Niklas Westerholm, CEO, Aegis Therapeutics: Well, thank you, Susana, and good morning to you as well. This is obviously very exciting. I think you’re referring back to the fairly recently issued new guidelines from PMDA that came into place on in October, where the guidelines now stipulate a somewhat more relaxed approach to regulatory pathway in Japan. The guidelines stipulates that that if you fulfill certain criteria such being a rare disease product, such being having a pivotal study or an approval elsewhere together with the combination of it’s difficult execute a clinical trial. You can get an exemption for a local clinical trial in Japan.

We are currently actually together with our partner in the middle of discussions with PMDA on this topic to help to get back to you at some point during the summer on how the regulatory pathway will look like. Obviously, where we’re coming from is that we very much meeting those criteria stipulated in new guidelines. It should be exempted for local clinical trial.

Susannah Quackburner, Analyst, Handelsbanken: Okay. Thank you. And then also to follow-up on the managed access program, is it right to assume that once you’ve launched in a country, those patients will no longer have access?

Niklas Westerholm, CEO, Aegis Therapeutics: No, that’s not fully correct. I can start and Henrik can hand over. Because of course, being a pharmaceutical company like ours, we have, of course, strong ethical commitments making sure that no patients on treatment today will be standing there without the treatment. So I think it goes by country by on a country by country basis. So if you think about Germany, as Henrik mentioned, there we will convert the Managed Access Program patients as quickly as possible to so called reimbursed patients.

In countries like France, for example. Of course, they will continue to receive managed access product throughout their pricing and reimbursement process and until that is completed. But please, Henrik, if you want to elaborate further.

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: Yeah, I think you said it. So, I mean, we are committed to provide MCT8 to the patients in the managed access program until they have a reimbursed funding mechanism in their countries.

Niklas Westerholm, CEO, Aegis Therapeutics: Thank you, Susanna. Thank you, Henrik. Operator, can we move to the next question and potentially the last question since we are running out of time? I apologize for this.

Conference Operator: The next question comes from Alexander Kramer from ABG Sundal Collier. Please go ahead.

Alexander Kramer, Analyst, ABG Sundal Collier: Yes, good morning. I have a couple of questions, if I may, maybe a simple one to start with. Previously, you talked about the publication of the listed price in Germany in Lower Tax. Could you provide some color on when can we expect that, like, something like in May or like later? And then I have a couple of follow-up questions.

Niklas Westerholm, CEO, Aegis Therapeutics: Yeah. I think the the the simple answer to that, and Henrik can have it, is we, as a company, won’t publish our our prices publicly.

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: And the but there would be a price as of tomorrow in Germany that that would be used when physicians prescribe amcetate as of tomorrow.

Niklas Westerholm, CEO, Aegis Therapeutics: Did you have some follow-up questions? Yeah. Alexander?

Alexander Kramer, Analyst, ABG Sundal Collier: Yes. And my then I have two follow-up questions. One one on the reimbursement process in Germany. And my question is here, like for the treating physician, like if it is a straightforward process actually to prescribe emcetate from tomorrow or if they also have to get like approval from the health insurance company, so the Kankenkasse in Germany and how this translates also into your sales estimates for 2025 in Germany. I mean, of course, if there’s some delay because of some bureaucratic processes still, of course, should we expect to get like first sales in Q2?

Or is it more like a story of like Q3, Q4?

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: Yes. So thank you for the questions. Some countries, it is a little bit of a complex process. But in Germany, it’s actually very smooth. So the physicians can just prescribe now and the drug will be reimbursed.

Niklas Westerholm, CEO, Aegis Therapeutics: Yes. From tomorrow. And I think it’s important to stress. Germany is is maybe somewhat different to other countries, but in Germany, the process is very smooth. It’s actually simpler to prescribe the reimbursed drug tomorrow compared to go through the managed access program.

So it shouldn’t be any hurdles there.

Henrik Krug, Head of Commercial Operations, Aegis Therapeutics: And then related to your follow-up questions on the timing, I mean, there we don’t guide on on sales, but here it depends, of course, related to when the physicians picked up the last packs from the managed access program. And then when the patients run out of treatment, then they will get new prescriptions and get the reimbursed drug from the pharmacies.

Niklas Westerholm, CEO, Aegis Therapeutics: Great. Thank you, Alexander. Maybe we have time for one last question. Operator, please go ahead.

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

Oscar, Analyst, Bryan Garnier: Hi, Tim. Good morning. My question would be around the conversion rates that you have seen so far in The U. S. Trial between the patients being screened and then being subsequently included in the run-in.

So I guess my question would be how confident can we be that the two patients that are currently being screened will eventually end up being included in the run-in?

Niklas Westerholm, CEO, Aegis Therapeutics: So I think thank you. And I think this is a complex question in the sense of depends on if it’s a patient already on treatment where we have of course incredibly high conversion rate or if a treatment naive patients meeting all the eligible criteria required for an inclusion. So I think I can’t give you an exact number there, Oscar, unfortunately. What I can say though is that we have confidence that we will be delivering results this year and also submission this year. I think it’s important to stress that in if you look back, if you can use a history as a bit of a proxy, we had eight patients completed the randomized treatment period in December as of last year.

We’re now April and now we have 12 patients completed the randomized treatment period. We have an additional patient in the the randomized treatment phase. We have an additional patient in the running period or the titration period, and we have an additional two patients being planned for screening in the upcoming period. So it’s difficult to give you some granular detail around that because it’s very much patient by patient dependent.

Oscar, Analyst, Bryan Garnier: Okay. I understand. Thank you.

Niklas Westerholm, CEO, Aegis Therapeutics: Thank you very much, Oscar. And with that, thank you very much to all the participants on the call. Excellent questions and we bid you a very good rest of the Wednesday. Thank you.

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