Good morning, everyone, and a warm welcome to our Q4 results call planned for the coming 30 minutes. With me today, I also have our CFO, Yilmaz Mahshid; Henrik Krook, Vice President Commercial Operations; Anny Bedard, President Egetis North America; and Karl Hård, Vice President Investor Relations.

Let us turn to the attention of the topics being covered today. First let me start off saying that I'm incredibly pleased with the year in passing and also the delivery of those post the period.

The completion of the US rolling NDA in January 2026 for Emcitate on the back of a successful pre-NDA meeting, a Breakthrough Designation granted by the FDA, leads us to an anticipated regulatory decision in September this year. The commercial performance where Emcitate revenue during 2025 amounted to 62.3 million Swedish kronas, an 40% increase at constant exchange rate versus 2024.

Also in Japan, where we have a license agreement with Fujimoto Pharmaceutical Corporation for the development and commercialization of tiratricol. There, Fujimoto completed in December a so-called pre-application consultation for drugs with the Japanese PMDA.

The NDA in Japan is expected to utilize the existing data generated from the global clinical development program. Moreover, Henrik and Henrik will provide an update on commercialization in Europe and launch preparations in the US, and then Yilmaz at the end will provide an update on our financial performance.

First, let me summarize the year. 2025 was historic for Egetis with very strong execution that led to a number of significant milestones delivered.

First, Emcitate was approved in EU in February as the first and only treatment for patients with MCT8 deficiency, and subsequently, we initiated launch in the first country, Germany, in May 2025. In July, a Breakthrough Designation was granted by the FDA.

The Breakthrough Designation was granted by the agency's review of Egetis' detailed analysis of the entire survival data set from the international real-world cohort study, the so-called EMC survival study, by the Erasmus Medical Center, which demonstrated a significant and substantial improvement in survival in tiratricol-treated versus untreated MCT8 deficiency patients. On the back of the Breakthrough Designation, FDA granted a so-called pre-NDA meeting that took place in October with a very successful outcome.

First, the NDA for Emcitate for the treatment of MCT8 deficiency will be based on currently available data, which means data included from Triac Trial 1, Triac Trial 2, Re-Triac, the EMC cohort study, the EMC survival study, as well as the US expanded access program. All in all, a very large and robust data set considering an ultra-rare condition.

Second, the FDA agreed that in the NDA submission, data from the Re-Triac study will complement the existing data from the EMC survival study and the other clinical components I just referred to. Therefore, the Re-Triac study was closed and data accrued was included in the NDA.

As agreed with FDA and lastly, the agency agreed to submit a rolling New Drug Application for Emcitate. In November, we announced the positive results from the Re-Triac study.

The results demonstrate the statistically significant difference in the rate of change in serum T3 in patients randomized to withdrawal, i.e., placebo, versus in patients continuing therapy. Subsequent to that, we initiated the rolling NDA for Emcitate on the 19th of December with the submission of the preclinical and CMC sections, and completed the NDA on the 29th of January this year by submitting the clinical sections.

Looking ahead, the FDA is now expected to validate within 60 days whether the NDA dossier is complete. Since Emcitate has both Fast Track Designation and Breakthrough Therapy status, we have requested a priority review, which, if granted, would result in FDA's reviewing being completed within 6 months after the validation period and, hence, a regulatory decision is expected in September 2026.

With that, I will hand over to Henrik for an update on commercialization in Europe. Henrik, over to you.

Thank you, Nicklas, and good morning, everyone. I would like to start with some reflections on 2025.

First, a reminder what we have discussed earlier: in Europe, the national pricing and reimbursement processes are complex and take time. In any way, the 2025 Emcitate revenue was 40% higher at constant exchange rates than the revenue we generated through early access in 2024.

The revenue was primarily generated in Germany, combined with successfully implemented alternative reimbursement solutions in countries such as Austria, Poland, and Switzerland. Overall, this demonstrates that our commercialization strategy is delivering tangible results and expanding access to Emcitate for patients.

Turning to pricing and reimbursement, we have made advancements across our key European focus markets: Germany, France, Spain, and Italy. Starting with Germany, the pricing and reimbursement process is progressing well, and we expect a final reimbursed price in Q2.

In Germany, we launched Emcitate in parallel with the ongoing pricing and reimbursement process. Thanks to our focused activities during the year, we were able to double the number of identified patients in Germany and initiate treatment in more patients.

We continue to develop this market through meetings with physicians, congress presence, and educational initiatives. In France, we are now preparing for a resubmission.

This dossier will be strengthened compared to the initial filing and will include additional clinical data, such as results from the Re-Triac study as well as survival data. In Spain, the generation of additional local data for the national dossier is progressing well.

This work is an important part of optimizing the pricing and reimbursement process and ensuring that the value of Emcitate is well supported in national assessment process. In Italy, we made Emcitate available to patients as of November last year through a regional launch.

This will be complemented by the initiation of a national pricing and reimbursement process later during the year. More broadly across Europe, this year we will continue to move towards funded routes in an increasing number of countries, such as Belgium, the Nordics, and Portugal.

This includes named patient sales where possible, while in parallel preparing for national health technology assessments in markets where that is considered the most appropriate long-term solution. In the fourth quarter, we also made important progress in our distribution partnering.

In October, we signed an agreement with Taiba Rare to enable access and named patient sales of Emcitate in the Gulf region. In addition, we expanded our existing partnership with Er-Kim, extending it from Turkey to also cover Central Eastern and Southeastern Europe.

I'm pleased with how these collaborations are developing. During Q4, we received our first order from Er-Kim for Turkey, and both Er-Kim and Taiba are actively identifying patients in their respective territories and are now in the process of initiating funded treatment to more patients.

With that, I would like to hand over to Anny for an update on the launch preparations in the US.

Thank you, Henrik, and good morning, everyone. Let me now turn to the United States, which is our priority commercial market and the foundation also for our long-term growth strategy.

As we approach the anticipated regulatory approval in the third quarter of this year, our focus is clear, which is translate approval into rapid uptake and durable value creation. Over the past several quarters, we've advanced each critical launch pillar and shifted from infrastructure buildout to execution readiness.

We're continuing to build stronger relationships across endocrinology, neurology, and genetics within the established referral network. As a result, and with the support of key opinion leaders and advocacy partners, awareness and recognition of MCT8 deficiency are steadily increasing.

We're seeing steady growth in patient identification, with more than 100 confirmed diagnosed patients to date, which we view as a strong leading indicator of the market formation. In rare disease, awareness is typically limited prior to the first approval therapy.

Once a treatment becomes available, identification and diagnosis tend to accelerate, and that dynamic creates meaningful upside. To date, we've taken a focused and disciplined approach to the US market development.

Even with measured investment, diagnosis rate are trending upwards. Importantly, we believe physicians awareness remains below its full potential, representing a clear opportunity for future growth.

As we increase our investment in education, field presence, and targeted engagement, we're confident that we will continue to grow awareness, drive additional diagnosis, and further strengthen the foundation for launch. Our expanded access program has now grown to 17 active specialist sites nationwide, which reflects both the severity of the condition and the strong clinical engagement.

Beyond patient access, this program allows us to refine logistics, site coordination, and patient services in real-world setting. We're actively preparing the transition from the expanded access to commercial supply to ensure continuity at the approval and preserve early momentum.

Our market access preparation has matured significantly, and we now have a much clearer view of payer expectations and coverage dynamics. We're refining our pricing and the value strategy through benchmarking against comparable orphan drug launches.

At the same time, our specialty pharmacy and patient support infrastructure is being implemented to ensure Day 1 readiness. The objective here is to enable timely coverage and minimize friction from prescription to treatment initiation.

We've remained disciplined in our investment approach. Based on constructive FDA progress, we've appropriately accelerated launch investment.

We have an experienced rare disease leadership team in place across medical, market access, and commercial. Our regional medical directors are active in the field, engaging key referral centers and preparing the clinical community.

By approval, we expect a team of about 25 US-based professionals, a focused team built specifically for a rare disease launch. We're now entering the approval phase fully prepared.

We have patient visibility, which is increasing, specialists are engaged, real-world experience is expanding, payer readiness is advanced, and our launch infrastructure is in place. Right now, our team is aligned, our momentum is building, and we're focused on disciplined execution to ensure full readiness at approval.

I will now hand it over to our CFO, Yilmaz Mahshid, for the financial overview.

Thank you, Anny. To start with in the financial section, all numbers, unless called out, are in our reporting currency, Swedish krona.

Revenue for the 12 months were 62.4 million versus 46.1 million in the same period last year, of which 62.3 million is attributed to Emcitate and corresponds to a year-over-year growth of 40% in constant exchange rates. Revenue for the fourth quarter of the year were 17.9 million versus 10.8 million in the same period last year, of which all is attributed to Emcitate and corresponds to a year-over-year growth of 74% in constant exchange rates.

As mentioned in our latest call and worth reminding again, the gross profit margin is visibly lower than historical figures both for the 12 months and the fourth quarter. This comes back to the positive approval in Europe and subsequent depreciation of balance sheet R&D.

As a consequence, the COGS line item numbers not only includes the recurring royalty payments, but also non-recurring milestone payments of approximately 3.5 million to Erasmus Medical Center, as well as 33.7 million of intangible R&D depreciation. The depreciation is a non-cash item, and it was initiated at the end of Q1 2025.

In an apples-to-apples year-over-year comparison, adjusting for the one-time payments and the depreciation, adjusted gross profit is 49.6 million for the 12 months, a significant improvement not only nominally, but also on the gross margin level versus the corresponding period. We hope to improve this further post the US launch.

Operating results were slightly lower for the 12 months at approximately -340 million versus -329 million in the corresponding period, while results after tax were nearly identical for the 12 months of the year at -343 million versus -344 million due to fluctuations in some of the financial line items, especially the revaluation of the convertible right, which continues to fluctuate with the share price. Remember that this is also a non-cash item.

In the quarter, the R&D team worked intensely with the FDA submission and the closeout of the Re-Triac study. Hence, we have a year-over-year one-off higher R&D cost of approximately 18 million.

For the 12 months, cash flow from operating activities were at -267 million versus -227.9 million. Also, as you may have noticed, we do continue to repay our debt and report 29.3 million in repayment for the 12 months.

All in all, cash flow for the 12 months were approximately -130 million versus +42 million in the corresponding period. The cash position end December 2025 was 215.8 million versus 351 million last year.

Also, gratifying to see that we did strengthen the cash position further through the great support from our existing shareholders and new shareholders through a directed issue carried out 2nd of October in the Q4 2025. With that, I will hand back to Nick.

Thank you, Yilmaz. Let's turn our attention to the future then.

On the back of a strong execution in 2025, we're very well positioned for 2026 and onwards. With the completed US NDA submission, we have reached a critical milestone towards making the first treatment for MCT8 deficiency available in the US, our most important market.

Here I would like to take the opportunity to thank patients and families who participated in our clinical trials, the investigators and their teams, and our colleagues at Egetis for their diligence and dedication over the last couple of years in helping us deliver Emcitate to patients affected by this rare genetic condition. The year 2026 will bring several important milestones for Egetis.

Our team is focused really on the following key priorities: working closely with FDA during the review of the Emcitate NDA with the goal of approval in the second half of 2026 and subsequently being able to monetize the priority review voucher. As you've heard from Anny, preparing the US launch, including buildup of the commercial and medical affairs infrastructure, successfully launching Emcitate in the US in the fourth quarter, subject to an approval by the FDA, and further continue optimizing pricing and reimbursement, and continue the rollout of Emcitate in Europe.

Furthermore, with Emcitate US NDA completed for MCT8 deficiency, we will further evaluate subsequent clinical development for Emcitate in the next indication, RTH-beta. With that, I will hand over to the operator for the Q&A session.

Thank you.

Hi, team. Thanks for taking my questions.

A couple for me, if I may. The first one: what is your latest thinking on the US pricing strategy for Emcitate, especially in the context of similar small-molecule drugs with a survival benefit that are now achieving prices approaching $1 million per patient per year?

The second one would be if you could comment on the possible Emcitate expansion into RTH-beta. How does the possible clinical development look like timeline-wise?

Any outstanding gatekeeping items that could influence the start of a clinical study or not? Thank you.

Thank you, Chiara. I'll start off with the US pricing perspective and the US opportunity and then hand over to Anny for further comments.

Rightly so, Chiara, as you commented, the US market it will be the most important market for Egetis and Emcitate, driven by actually swift not just price points, but also swift access. You heard from Henrik referring to the pricing and reimbursement processes in Europe, which are lengthy.

It takes time, and it's 26 different national pricing and reimbursement processes one needs to walk through. US is very attractive, considering that access in general will span from 0 to 6 months based on a state-by-state basis with a payer mix skewed towards Medicaid.

When it comes to price points, the team together with Anny has done some diligent work, including market research over the last couple of years. Rightly so, as you said, even though we don't give any guidance, when you look at relevant analogues in the review we have done, you're looking at price ranges between $700,000 up until $1 million and above per patient per annum.

Of course it's a very, very attractive opportunity for us. Anny, please, comments and builds.

Thank you. I think you've said that the key elements in terms of the opportunity that the US offers in terms of pricing.

Our key focus is really going to be on the value that tiratricol brings, the severity of the disease, the fact that it's an ultra-rare condition, and also the significant unmet need. That will really drive the framework for our pricing.

We've done a lot of work, and as I mentioned, significantly advance our progress for market access. We've consulted with several external access experts.

We've validated also what will be the key requirements and the evidence that these payers will be requesting, as well as the payer dynamic and the policy considerations. That has been taken into our consideration as well for the pricing because, at the end of the day, what we want to achieve is really to strike a balance between the price and the accessibility of the drug.

As Nick mentioned, in terms of price range, it's hard for us to say more at this time, but it will probably sit in that range of the analogues that we've been assessing. As we progress towards the launch, we'll be providing more detail on that.

As you can imagine, we're looking at a potential launch at the end of the year, we still have some work to do in order to refine our pricing strategy. That's pretty much the approach we're taking.

Thank you, Anny. Then to your second question, Chiara, RTH-beta.

This is an opportunity we're very excited about, and it fits well with our strategy building a sustainable rare disease company. As I'm sure you're familiar with over the last couple of years, there've been a couple of natural history papers published on the disease, illustrating also in this condition a reduced life expectancy.

Furthermore, in September, there was a scientific article published describing clinical benefits of treatment with Emcitate in this condition, RTH-beta. For us, this is an exciting opportunity.

We are now starting to further advance and build our clinical development plan in this condition, with ambition to have one pivotal trial aligned with the EMA and FDA for registration, and, of course, initiate that as soon as possible, caveat to investment decision by the board, of course. I hope that answered your questions, Chiara.

Thank you. Sure.

Thank you very much, very helpful.

Thank you. Let's move to the next question then, operator, please.

Yes, thank you. Hi, team.

Do you have any updates on the number of patients that have been identified in the US in 2025? Then maybe just a follow-up to that, you mentioned that the approval of Emcitate would impact positively the rate of diagnosis.

My question is to what degree do you currently forecast by patient identification to ramp up in the US post-approval? Thank you.

Sorry, Oscar, you were actually breaking up a bit, I had a bit of a difficulty to hear your question. If you don't mind repeating them, please?

Sure. Is it better now?

I think so, yeah. Please.

All right. Let's try again.

It was just regarding the number of patients identified in the US in 2025. Then I have a follow-up on that, but I can wait.

Yeah.

When it comes to the number of, if I heard you correctly, diagnosed patients in the US, again, as Anny mentioned, the team has been very diligently identifying and ensuring diagnosis of patients over the last couple of years. One should recognize that up until October, we have had a very very limited infrastructure in the US, which we have now further invested in, and we have four regional medical affairs directors in place early this year to further engage with key opinion leaders and stimulate patient identification and diagnosis.

What we know of today is that we have more than 140, 1-4-0, diagnosed patients in the US. That has increased substantially since 2022, where we knew about 28 people diagnosed, but also back end of 2024, we called out around 100 patients being diagnosed.

I think this is a huge effort by a very limited team. I know also already so far this year, the team has identified a handful of patients.

Hopefully that answered your question, Oscar. Also we see that we will find further patients as we strengthen our infrastructure and being more present in the US.

Anny, I don't know if you want to add anything, please?

No, I think that's pretty much it. It's a rare condition.

Typically before the launch, the awareness is still relatively low, and that's common. With the efforts that we're doing, we are very confident that we will quickly identify and activate the majority of the patients post-launch.

Very clear. Thank you.

Sorry.

Just maybe one follow-up. Henrik mentioned that the identification in Germany doubled this year.

Do you think that getting Emcitate approved in the market changed the diagnosis dynamic there? Henrik, you can.

Yeah.

Hi, Oscar. Henrik here.

Yes, I think it's many different things contributing to that we identified more patients in Germany. One, the approval, definitely, because then there is an incentive for the physicians to find the patients when there is a treatment available and correctly diagnose them.

Secondly, I think the activities that we have done in the field, more engagement with HCPs, that did definitely also contribute to finding those patients. That is, I think, what we can expect to see also now in the US, now when we will have four regional medical directors in the field and expanding the team further during this year.

Great. Thank you very much.

Thank you, Oscar. Then we'll move to the last question, operator, please.

Good morning, and thanks for taking my questions. I had two, I'll try my luck.

The first one goes on costs with the conclusion of Re-Triac, how much of a step-down should we expect in Q1? Should we expect OpEx to return sort of closer to Q2 and Q3 levels?

Secondly, if you could just briefly comment on the pace of patients identification in the US. How does this trajectory compared to Europe?

Is it broadly similar right now or are you continuing to see a significantly faster rate of case-finding? Thanks.

Thank you. If we start with the cost question then, I appreciate that you're coming from a somewhat higher increased cost in quarter four, driven by mainly R&D.

That's more, as Yilmaz said, a one-off item driven by the closeout of the Re-Triac study, and then, of course, the very intense activities related to the FDA submission. One would assume that from an R&D perspective, we will see a drop in costs going forward.

However, to a certain extent, that will be offsetted by the increased investments in the US, which are flexible costs and will be driven by opportunity and gated on some certain milestones. As we don't give any further guidance, Arvid, on cost base going forward.

It's reasonable to assume that you'll see a bit of a drop in quarter one this year compared to quarter four from an overall cost perspective. Yilmaz, I don't know if you have anything to add?

No. Thanks, Nick.

I think you mentioned the essence of it.

Moving to your second question then, Arvid, around patient and identification in the US versus Europe. I think there are a couple of components.

I will shortly hand over to Anny, but as Henrik said, we definitely have seen here in Europe, in Germany especially, when we have an approved product that we can refer to and have more presence in the market, the number of patients being identified and aware to us has increased significantly. We have already seen a bit of that in the US last year, where we have seen an increase of number of the identified patients in the US as well.

Anny, please further elaborate from your perspective. You're closer to the market.

Maybe just to give a bit more color in terms of where these patients are, is exclusively in the major pediatric academic centers. We've built our footprint in the US really around those sites so that we can access as quickly as possible.

As we've mentioned, we've already identified 140 genetically confirmed patients. We have our expanded access that is currently active in 17 sites across the US.

That allows us to keep really a close connection with those treating physicians. We're confident that the pace is been good, but with the increased resource that we're putting in place right now, we're very confident that we will accelerate that pace before the launch.

Perfect.

Thank you, Anny. I think, all in all, Arvid, it's reasonable to assume that the number of diagnosed patients aware to us by quarter four, year-end, where we assume a potential launch in the US, will be substantially higher than the number we refer to today, i.e., 140 patients.

Thank you, Arvid.

Great. Thanks, guys.

Thank you. Operator, I think this takes us to the end of the call.

Thank you.