BioArctic AB

Thank you so much and good morning and welcome to Biotic's presentation for the second quarter of 2026. LeCambi continues to progress really well with new approvals and launches and Biotic has signed additional strategic partnerships and we will talk more about this in today's webcast. Next slide please. Biotic is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. I'm Gunilla Osvald, the CEO of Biotic, and I will share today's presentation with our CFO, Anders Martin Lööf, and our chief R&D officer, Johanna Felting, and our chief commercial officer, Anna-Kaja Grönblad. Next slide, please. I will start our presentation by giving some key highlights. Next slide, please. Biotic is among world leaders in two different areas. The first one is regarding highly selective antibodies, where we are innovative and we are generating highly selective antibodies targeting aggregated, misfolded forms of toxic proteins. And here we have the front runner, leucanumab, and we also have projects targeting alphasnuclein and TDP43, for example. The second area is when we are utilizing our brain transporter platform in an innovative and differentiated way to deliver antibodies. And I also want to highlight that we are broadening the platform to enable more efficient transportation into the brain of other modalities with innovative approaches. This could be utilized for enzymes and genetic medicines like ASOS and siRNA. A lot of new innovation is coming from biotic. Next slide, please. We are already delivering on our 2030 ambitions, and they are in four different areas. The first one is regarding Lekembe to get it as an established treatment for Alzheimer's disease. And the Lekembe demand shows a steady growth to more and more patients on a global level. Sales are progressing in line with our partner ASI's guidance. A true highlight during this summer was the FDA approval of iClick, the subcutaneous formulation with an autoinjector. And we got the approval from the FDA 13th of July, and the US launch was started this week. This means that there is an increased convenience for the patients to have the possibility to get their treatment at home instead of going to the infusion center. So I think it looks really bright also for further approvals and implementation of blood-based biomarkers, which also will simplify the diagnosis for patients. So these two aspects, the subcutaneous formulation together with the blood-based biomarkers for diagnosis are important for patients and for healthcare and is less costly for society and can lead to a broader uptake on the market. The second area is with regard to a balanced and broader pipeline with projects in all stages of development. Here I want to highlight Exidavnimab, our alpha-synuclein project, which is in phase 2a in both Parkinson's disease and multiple systemic atrophy. We had a planned safety review during this summer and it was concluded that Exidavnimab showed a favorable safety profile and it supports progression into phase 2b, which is in planning. The other alpha-synuclein follow-up compound, called BAN2238, is a follow-up compound to Exidavnimab with Brain Transporter. Here we selected a candidate drug late last year, and the IND-enabling activities are progressing really well. The pipeline overall continues to expand, and we have added new projects, for example the ones due to new partnerships. The third area is to have additional successful global partnerships. And we are very pleased with our new license agreement and collaboration with Eli Lilly, as well as our previous collaborations together with Bristol Myers Squibb and Novartis. And of course, our partner since long time ago, ASI. And all these are working in every generation in different approaches. Our latest research collaboration with Messentia, a small Swedish biotech company, opens up utilization of our brain transporter in a new area, oncology, where better penetration into the brain is wanted. And here we are focusing to start with on glioblastoma. I think it's great to see the continued strong interest in our brain transporter technology, as well as in our proprietary programs. The fourth area is that our aim is to be profitable and have recurring dividends in the future. We were highly profitable last year and our strong financial position allows us to continue to invest heavily in our business as well as giving dividends to our shareholders. We have a strong financial position with about 2 billion Swedish crowns in cash at the end of the second quarter. And this is even without the upfront payment from Eli Lilly of 30 million US dollars. And we expect to be profitable this year. Next slide, please. Partnerships is the cornerstone in our business model and the key component behind our success. Our focus has been on big pharma and different business models. So we have two different business models here. The first category, we can see ASI, AbbVie and Bristol-Myers Squibb, where they have done in-license agreements on innovative biotic developed programmes. The second category is Novartis and Eli Lilly, who are utilizing Biotic as a platform company. So they bring their compounds to Biotic. We re-engineer the compounds and build in our brain transporter technology into new compounds. And we check then the transferrin receptor functionality and then hand it back to the partner who drives and finance the program further. Then I also want to add a new kind of addition to our business model is what we are doing with Mesenchia. I think this represents another category that we now are starting with a small research collaboration that could also lead to future business. Next slide, please. Now I hand over to our chief R&D officer, Johanna Felti.

Thank you so much, Gunilla. Next slide, please. So our R&D portfolio continues to advance, as Gunilla has described, and this is really built on two complementary platforms, the antibodies and the brain transporter platform. A balanced mix of funded partnerships with ACI, BMS, Noritis and Lilly, together with proprietary programs, provide both external validation and significant long-term value creation opportunities in the portfolio. All brain-transporter collaborations are progressing well. During the quarter, we have further strengthened the platform through two new collaborations, the Lilly Partnership that represents a major validation by a leading neuroscience company and highlights also the platform's broad utility or potential in CNS. And then we have the Mesenchia collaboration that marks our first step into oncology, expanding the brain transporter platform beyond neurodegenerative diseases and broadening its future application potential. So overall, we continue to advance the diverse, increasingly partner validated pipeline with expanding scientific and commercial potential, both for antibody and our brain transport platform. Next slide, please. So taking a closer look at our Alphas & Nuclein portfolio, it is moving forward and expanding. So for Exidabnimab during the quarter, we have evaluated the safety data from the Phase IIa exit study of Exidabnimab in both Parkinson and multiple systemic atrophy. And the results confirmed a favorable safety profile of the antibody, which is an important milestone for the program. So this data will provide a strong foundation for the next step of development. And we are currently planning for Phase IIb studies in both multiple systemic atrophy and Parkinson. disease-related dementia with the ambition to initiate these studies during next year. So Exidabnimab remains the most advanced alpha-synuclein targeting programs in our pipeline and addresses a significant unmet medical need in neurodegenerative diseases. And for BAN 2238, our brain transporter enabled alpha-synuclein antibody. We continue to make progress with the ING enabling activities during the quarter. And BAN 2238, it combines our disease expertise in alpha-synuclein biology with the brain transporter technology. which is then designed to enhance the antibodies delivery across the blood-brain barrier. This program is progressing according to plan and we are currently expecting to initiate clinical development in next year. So together Exidavnimab and BAN2238 represent a complementary strategy combining the most advanced clinical stage asset with the next generation brain transporter enabling program targeting the same underlying disease biology. So next slide, please. So one of the quarters key highlights for us was really the new brain transporter collaboration with Lilly. Lilly selection of the brain transporter for next generation CNS therapies provide a strong validation from a leading pharmaceutical company and reinforces the importance of efficient blood brain delivery for CNS drug development. And this collaboration expands, of course, the further potential of the application of the brain transporter beyond our internal programs. And it combines bioarctic neuroscience expertise with Lilly's global development capabilities, further strengthening the platform for long term strategic and commercial value. The Mesenchia collaboration in oncology marks Bioarctic's entry into the oncology target space and expands the application of the brain transporter beyond neurodegenerative diseases. And the main focus here is glioblastoma, which is a highly aggressive brain cancer with significant unmet medical need. And together with Mesenchia we are now evaluating a novel approach by combining the brain transporter with Mesenchia's HVM targeting antibody, enhancing the drug delivery to the brain and also the capability to reach the tumor cells associated with reoccurrence and treatment resistance. So this initial goal is to generate a drug candidate and establish a preclinical proof of concept in the program, further demonstrating the versatility of the brain transporter platform. So taken together, the Lilly and the Mesenchia collaboration highlights the broad potential of the brain transporter. Lilly validates the platform in newer generation, while Mesenchia extends its application into oncology, demonstrating its versatility across multiple disease areas. So next slide, please. And then I will hand over to our chief commercial officer, Anna-Kaja Granblad.

Thank you, Johanna. So let me go back to Lekembe and the global rollout of the subcutaneous initiation treatment, as Gunilla already mentioned. This is clearly an important step in really expanding the patient access and further strengthening our continued growth. So in the US, the FDA approved, the approval came in July for the Lecambia iClick initiation treatment, and it is available as of this week. So this will increase clearly the momentum as we now move into the second half of 2026. This will allow people the option to inject the drug themselves instead of going to the hospitals. So they can do this at home for the whole course of treatment. So without having to come to the clinic for the time-consuming and more invasive infusions. So this change is really expected to broaden uptake, especially for the people who live far from the clinics or travel frequently. Looking at other benchmarks in the industry, we believe the uptake in the US will happen gradually as the coverage will broaden at different time points within an expected shift, potentially coming in the beginning of 2027. And we hope that the Medicare Party coverage for both the initiation and maintenance can beginning in January 2027. But we believe it will clearly be a commercial game changer and an advantage versus the competition. In Japan, we expect approval soon in this third quarter of 2026 and reimbursement a bit later expected to follow in the fourth quarter. And in China, the product is currently under priority review and we expect the approval in the first half of 2027. So importantly also is that data presented in July this summer at the AAIC Congress in London, it showed really that the efficacy and the safety of the subcutaneous administration is comparable to the IV treatment. So it's clearly supporting the potential of this more convenient treatment option. ACEI also continued to make progress across other international markets. So during the second quarter, Lecambi was launched in Australia, Belgium, Brazil and India. And at the same time, as market interest unfortunately is generally slower in Europe, the process continued to improve patient access across Europe. Here, the less frequent IV maintenance dosing is currently under EMA regulatory review. And if approved, this could not only enhance the convenience of continuous treatment, but also facilitate access discussions in some other countries in Europe. In the UK, commercial discussions between ASI and the NHS England are ongoing. And finally, we are seeing some encouraging interest from several private clinics in the Nordic countries. And as we progress also the discussions for more broader public care reimbursement. So overall, we're very pleased with the progress and together with the uptake of the usage of blood-based biomarkers, we see really significant opportunities to further expand patient access and growth. If you go to the next slide. Coming back to the AI Congress in London this summer, several speakers showed data on how the drug is performing in the real world. Here I'm highlighting a US post-market study called LEADER, which now includes 16 clinical sites across the country. In London, data were presented for more than 400 patients from 13 sites. After an average of 17 months of Lekembe use, approximately 83% had not progressed to more advanced disease, as assessed by a clinician. Of these, 76% remained at the same disease stage and 6.5% improved. For a bit more than 200 people who have reached two years of treatment, the data are similar. 74% were stable and 9% improved. Among the a bit more than 200 patients that has been on treatment for more than 18 months, almost 80% transitioned to maintenance treatment, either with Lecambi IV or subcutaneous iClick. Finally, safety observations in this real-world study were consistent with the FDA-approved label. We're looking forward to the next data cut of approximately 600 patients that will probably be presented in November at the CTET Congress. By that, I hand over to Anders, our CFO.

Thank you, Anna-Kaja. If we then turn to the Lecambi numbers, we can see that the Lecambi growth continues. The global Q2 sales were 29.3 billion yen, or roughly $184 million, representing a healthy 12% increase from the first quarter, or 27% increase from the second quarter of 2025. If we translate that into our royalties, you see that our royalties grew by 12% to 179.4 million Swedish in the second quarter. It doesn't look as fantastic if you compare with the second quarter 2025. But as you remember, there was a very low stockpiling effect in the second quarter of 2025. And if you remove that one time effect, the annual growth would have been roughly 43% in terms of royalty. So all in all, on a global scale, the growth looks really, really good. But then turning to the U.S., the growth there, 13% going to $27 million in the quarter, is now mainly driven by simplified diagnosis. And you should understand that there's a very tough competitive situation right now in the U.S., period that ended. So the iClick launch that happened earlier this week is going to be really really exciting to follow. This has the potential to drive the royalties from Lycambi in a number of ways. First of all, and I can mention that the uptake of patients is likely going to increase due to the fact that it's so much easier for patients to access the therapy this way. On top of that, Lecambi should be able to generate a larger share of new patients as it will be the only drug that is available in the subcutaneous formulation. And the third factor is that since this is a much more efficient way of delivering this therapeutics, a larger share will end up with the pharmaceutical part of the treatment cost. So the revenue per patient is likely to go up as well. So all in all, this will be a very important factor for the royalties in the future and it will be very, very exciting to follow. In China, we also saw very healthy growth going up to 30 million. Here we will also most likely see the introduction of the subcutaneous version in the beginning of 2027. We are also seeing broader insurance coverage, ASIC communicated that will start to come into place in the fourth quarter of this year. Also very intriguing development. Japan was tough this quarter, it was flat from the first quarter, roughly 38 million dollars in sales. And it seems like, based on presentations that we saw at the large conferences this summer, that the issue of capacity for infusions in Japan has been tougher there than in other markets. So it would be very very important now that we expect to see the subcutaneous version come out also in Japan. We're expecting approval in the third quarter of this year and the reimbursement and launch towards the end of this year. All in all, I think things are going fairly well, but the subcutaneous introduction will really have an impact here, even though it may not come directly, but gradually this will have a very large impact on the royalties. EU has been slow, we've talked about that in previous presentations, and it's still slow, so we're not well on that too much. All in all, ASI reiterated their forecast of 143.5 billion yen in their fiscal year 2026. That is roughly 900 million dollars of sales this year and that corresponds to roughly 880 million Swedish krona in royalties during the time period. If we then turn to our numbers, starting from the left, you see our net revenues. That amounted to 248 million in the second quarter. That looks like we're shrinking from the second quarter of 2025. But this is all due to the fact that there was a milestone of 223 million in 2025, and there were no milestones that were paid in the second quarter of this year. The underlying recurring revenues did continue to increase. The royalties were roughly 179 million and then also had co-promotion revenues. So we're approaching 200 million in recurring revenues every quarter, which is very healthy. We also have some revenues from our collaborations. We entered into a collaboration with Novartis last year where we recognized 51 million from that upfront payment in the second quarter. And as Gurinil already mentioned, we also entered into a collaboration with Lilly in the second quarter this year. None of that was recognized in the second quarter. will start to recognize that from the third quarter, and we expect that roughly 40% of the $30 million will be recognized during the remainder of 2026. Turning then to our costs, they continue to increase. They were 232 million in the second quarter, up from 193 a year ago. And this is all due to the fact that we're investing more and more in our project portfolio, in preparations for our exciting trials with Exidavnumab. And we reiterate here that for the full year 2026, the operating costs are expected to increase by 40-60% compared to the year before. So if anything, I would say in the low range of that span, but we reiterate roughly 40-60%. And as you see in the right hand graph, we were not making a profit in the second quarter, but all in all in the first half of the year, we made a profit of 179 million and we still expect to be profitable for the full year. If we then turn to the net result, you see that was a slightly negative due to an impact of financial net and tax. The cash flow was very positive, much stronger than the operating profit. That is due to the fact that the ASI 20 million euro sales mison was paid in May. And then cash and cash equivalents was roughly 2 billion at the end of the second quarter. And that's despite us paying a dividend of 177 million in June. And this does not then include the nearly $30 million upfront payment that was paid in July. So at the end of July, we had over 2.3 billion in cash. So all in all, our position remains extremely solid with plenty of room to keep investing in our R&D portfolio. With that, I hand over back to Gunilla.

Thank you so much, Anders. We're coming towards the end of today's presentation with some upcoming news flow and some closing remarks. Next slide, please. So if we look at the second quarter, I think it was great to see more patients getting access to Lecambia around the globe. Also in smaller scale in the Nordics so far through the private clinics in Finland and hopefully soon also in other Nordic countries. ASI is driving continued regulatory processes on Lecambia in a great way. And the ICLEVC, the subcutaneous version with an autoinjector, was recently approved and launched now also for initiation in the US. And later this year, we expect response from authorities in Japan and in China next year. We also heard about continued impressive results from real-world usage when we were at AIC Congress in London in July, as Anna-Kaja alluded to, and also for subcutaneous data. We are looking forward to the next big Alzheimer's Congress called CTAD, Clinical Trials in Alzheimer's Disease, which is in Boston in November, where we also expect more presentations around leucanumab. The Phase 2A study results are expected later this year. We heard some really important safety data that was coming during the summer, but the full study is expected to read out late this year. And we are preparing for starting Phase 2B next year. We will communicate on further potential partnership milestones, etc., when that is relevant. Next slide, please. So some key takeaways from today's presentation. I think Biotic shows continued growth and we have great progress both on Lekembe as well as the rest of our portfolio and the brain transporter technology. As I said, we are delivering on our 2030 ambitions already in a great way. Lekembe is well on track to become an established treatment in Alzheimer's disease and sales continue to show increasing demand globally. The subcutaneous autoinjector iClick has now been launched in the US also for initiation treatment, which is a major milestone. Our business development efforts continue to deliver and we have just concluded a landmark deal with ALI Lilly with our brain transporter technology and we have expanded our project portfolio also into oncology by the new research collaboration with Mesenchia also utilizing our brain transporter technology. Last but not least, we have a very strong financial position, which was about 2 billion Swedish crowns in cash at the end of June. This is after the dividend of 2 crowns per share and before receiving the upfront of 30 million US dollars from Lilly. We expect a positive result this year. So all in all, I think Biotics is exceptionally well positioned for continued growth. And the future looks very bright for Biotic and that brings hope for many patients. Next slide, please. So by that, we say thank you so much for your attention and we are happy to take some questions.

If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Joseph Hedden from RX Securities. Please go ahead.

Good morning. Thanks for taking my questions. Congratulations on the collaboration with Nisenkia. That certainly looks like an exciting application of Brain Transporter. Just wondering if you could give us your thoughts on the timeline to the preclinical validation. And then, you know, any details you can give us on additional aspects of the deal, who would be in control of the clinical development, or are you going to be looking for a partner? And secondly, if I could, just on Exxon Dabnibab, so you stated that, you know, you passed a safety analysis that facilitates Phase 2B.

I'm sorry I had a little bit difficult to hear the first question.

Okay, maybe Johanna wants to... Yes, thank you, Josef, for those questions. I can start with a question on mesenchia. This is a preclinical research collaboration that will validate preclinically the target together with our brain transporters. After that, we will continue with discussions on how we should progress this. But I think it's a bit too early to talk about the timelines, really, and when this kind of program could go into clinic. a first research collaboration where we do some things and they do some things and we will do a sort of a preclinical evaluation in a disease model and see if the concept works and then we will go on into further discussions on how to progress if positive.

And the second question was with regard to Exidabnumab so maybe you want to take that also Johanna?

Yes, so that was the Exidavnimab EXIST study. And yes, our plan is to conclude this study by the end of the year and then also report some data from that.

Thank you. And just to follow up on Masenkia, if I could, are there any other companies looking at that specific target in glioblastoma? Or is this a completely novel program?

As far as we know, I think this is a unique target and that's why we think it's really, really interesting. And I think it's also unique combining one of these diseases together with the brain transporter platform. As far as we know, there are no other programs out there trying to treat glioblastoma with any target and in combination with the transferrin receptor brain transporter platform. So I think that it's a really interesting program and we really think it's solid and really nice science behind Misenkiya's ideas entering what can be seen as a stem cell for these cancer drugs in an extremely difficult to treat patient population and disease.

Okay, got it. Thank you.

Thank you, Josef. The next question comes from Max Dahl from Goldman Sachs. Please go ahead.

Hi, this is for Rajen Sharma. Thank you for taking my questions. I have a few. The first question is about . So in your Phase IIa study, did you see any efficacy signal? And when should we expect the results from the Phase IIb study? Second question, how will you prioritize between extanimab and BAN38? Also, if I can have another question, could you talk about when Eli Lilly will make a decision to move the program forward to clinical development? Thank you very much.

Do you want to take it? Yeah, absolutely. So if we start with the question on Excedavnimab efficacy from the EXIST study, I think that you should remember that this study that we are now concluding is a phase 2a study. So it's a small study and the primary endpoint is safety and tolerability. We are also looking at biomarkers exploratory, but I don't think we should get our hopes up too high on that one because the study is not powered to look for a clinical efficacy And it's not long enough. It's three months. And I think that you need much longer time for that. But we are definitely looking into that. But the primary endpoint is safety and tolerability. And in terms of the Phase 2b results, I think that we haven't communicated externally on those timelines. We're still looking at the design and planning this study. And in terms of the prioritization between Exodamnumab and Ban2238, I mean, I think a real strength with this portfolio is that there are so many diseases here to treat. Alpha-synuclein is a key component in Parkinson's, in MSA, and in DLB, and potentially also some other diseases. I mean, we see a lot of co-pathology also with Alzheimer's. So my hope would be that we don't need to prioritize between these two, that we can actually maybe position them for different diseases, depending on how they span out. So I think that there is a real strength in having two different options that might be able to be positioned to different diseases.

And the third question was with regard to Lilly and the collaboration there, and we do not disclose details on that.

Got it. Thank you very much.

Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Matthias Hegblom from Nordia. Please go ahead.

Yeah, thanks so much. Thanks for taking my question. I had two, please. So firstly, on exit WMAB, now with a confirmed favorable safety profile from the ongoing phase 2A testing in Parkinson's and MSA patients. Sometimes the pushback around this asset is coming back to the fact that it's now roughly four years or somewhat more than four years that the asset was handed back to you. So I guess the question is, point in time where there was a chance to use maybe Bayesian clinical trial design to possibly speed up clinical development and explore the optimal dose, and if not, why? And then secondly, with draft guidance from FDA on Bayesian trial design in January, how is the company thinking about this as a tool across the rest of the portfolio in general terms? Thanks so much.

So should I or do you want to? Yeah, no. So I think I agree with you that, I mean, we got the exit of the mud program back from ABVI 2022. And when they had done two phase one studies and both of those studies showed excellent data with regard to safety, tolerability and pharmacokinetics. So the next thing that needed to be done was, of course, to look at multiple dosing. And we did that then in Parkinson patients and we also add the MSA patients. So we have expanded this into and we see more opportunities for further indications as well. So of course you are right that there is a lot of interest in different kind of innovative clinical design models and with the Bayesian statistics and we did utilize that for leucanumab. So far for XA-davnumab we have done more traditional design and are taking it a bit more stepwise here. So I think that I really think Bayesian design is really interesting when it is the right thing. But so far for ExaDub NEMA we have utilized traditional design.

And any general thoughts around Bayesian trial design for the rest of the portfolio or you know what this draft guidance updated in January may possibly mean?

It's definitely something which is important and will continue to be important. I think that how it was utilized for leucanumab is really also seen as a role model. That Phase IIb study with this adaptive design and with Bayesian design, I think it was really innovative and also came with really good results, understanding the dose that could be used in phase three, whether more traditional design was used. So I really think that it's important sometimes with the traditional design, but also in the future, of course, to look at adaptive designs and patient design.

There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

Thank you so much. We have a couple of written questions here. We'll start with one from Mr. Tillin. He's asking about the research collaboration that we have ongoing for BAN 2802 with ASI, and if there are any updates we can give there.

So I'm so sorry to disappoint you when it comes to different collaborations and discussions with partners. We cannot disclose. We can just say that everything looks really, really great that we have with 2802 and that we are in discussions with ASI, but we cannot disclose anything more at this moment.

Thank you. And then another presentation from Mr. Balder. And he's asking about the Bristol-Myers Squibb collaboration. If it's still in preclinical phase and when it can be expected to enter patients.

So I can say I think we have a really great collaboration also with Bristol-Myers Squibb. And again, we cannot disclose details of their program. Sorry.

Great. Thank you, Gunilla. I think there are no more people in the queue presenting and there are no more written questions either. If you have any follow-up questions, you're obviously always welcome to give us a call or send us an email. But I think that concludes today's call. See you again in three months.

Thank you so much. Have a great day.