Q2 2026 BioArctic AB Earnings Call

August 26, 2026

Speaker #1: The first part of the conference call, participants will be in listen-only mode. During the Q&A session, participants are able to ask questions by dialing #Q5 on their telephone keypad. Now, I will hand the conference over to CEO Gunilla Osswald and colleagues. Please go ahead.

Operator: First part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Gunilla Osswald with colleagues. Please go ahead.

Operator: First part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to CEO Gunilla Osswald with colleagues. Please go ahead.

Speaker #2: Thank you so much, and good morning. Welcome to BioArctic’s presentation for the second quarter of 2026. Lequimby continues to progress really well, with new approvals and launches.

Gunilla Osswald: Thank you so much, and good morning, and welcome to BioArctic's presentation for the Q2 2026. Leqembi continues to progress really well with new approvals and launches. BioArctic has signed additional strategic partnerships, and we will talk more about this in today's webcast. Next slide, please. BioArctic is listed at Nasdaq Stockholm Large Cap, and this is our disclaimer. Next slide, please. I am Gunilla Osswald, the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin-Löf, and our Chief R&D Officer, Johanna Fälting, and our Chief Commercial Officer, Anna-Kaija Grönblad. Next slide, please. I will start our presentation by giving some key highlights. Next slide, please. BioArctic 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.

Gunilla Osswald: Thank you so much, and good morning, and welcome to BioArctic's presentation for the Q2 2026. Leqembi continues to progress really well with new approvals and launches. BioArctic has signed additional strategic partnerships, and we will talk more about this in today's webcast. Next slide, please. BioArctic is listed at NASDAQ Stockholm Large Cap, and this is our disclaimer. Next slide, please. I am Gunilla Osswald, the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin-Löf, and our Chief R&D Officer, Johanna Fälting, and our Chief Commercial Officer, Anna-Kaija Grönblad. Next slide, please. I will start our presentation by giving some key highlights. Next slide, please. BioArctic 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.

Speaker #2: And BioArctic has signed additional strategic partnerships, and we will talk more about this in today's webcast. Next slide, please. BioArctic is listed on Nasdaq Stockholm Large Cap, and this is our disclaimer.

Speaker #2: Next slide, please. I'm Gunilla Osswald, the CEO of BioArctic, and I will share today's presentation with our CFO, Anders Martin Löw; our Chief R&D Officer, Johanna Flting; and our Chief Commercial Officer, Anna-Kaija Gronblad.

Speaker #2: Next slide, please. I will start our presentation by giving some key highlights. Next slide, please. BioArctic 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.

Speaker #2: And here we have the frontrunner, lecanemab, and we also have projects targeting alpha-synuclein and TDP-43, for example. The second area is when we are utilizing our Brain Transporter platform in an innovative and differentiated way to deliver antibodies.

Gunilla Osswald: Here we have the frontrunner lecanemab, and we also have projects targeting alpha-synuclein and TDP-43, for example. The second area is when we are utilizing our brain transporter platform in an innovative and differentiated way to deliver antibodies. 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. So a lot of new innovation is coming from BioArctic. Next slide, please. We are already delivering on our 2030 ambitions, and they are in four different areas. The first one is regarding Leqembi to get it as an established treatment for Alzheimer's disease. The Leqembi demand shows a steady growth to more and more patients on a global level. Sales are progressing in line with our partner, Eisai's guidance.

Speaker #2: 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.

Speaker #2: So, a lot of new innovation is coming from BioArctic. Next slide, please. We are already delivering on our 2030 ambitions, and they are in four different areas.

Speaker #2: The first one is regarding Lequimby, to get it as an established treatment for alpha-miss disease. And Lequimby demand shows a steady growth to more and more patients on a global level.

Speaker #2: Sales are progressing in line with our partner ACIS guidance. A true highlight during this summer was the FDA approval of ICLC, the subcutaneous formulation with an auto-injector.

Gunilla Osswald: A true highlight during the summer was the FDA approval of Leqembi Iqlik, the subcutaneous formulation with an auto-injector. We got the approval from the FDA 13 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 of 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 project in all stages of development.

Gunilla Osswald: A true highlight during the summer was the FDA approval of Leqembi Iqlik, the subcutaneous formulation with an auto-injector. We got the approval from the FDA 13 July 2026, 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 of 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 project in all stages of development.

Speaker #2: And we got the approval from the FDA on July 13, and the U.S. launch started this week. This means that there is increased convenience for patients to have the possibility to get their treatment at home instead of going to the infusion center.

Speaker #2: So I think it looks really bright also for further approvals and implementation of blood-based biomarkers, which will also 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. It's less costly for society and can lead to a broader uptake on the market.

Speaker #2: The second area is with regard to a balanced and broader pipeline, with projects in all stages of development. And here I want to highlight Exsidabmab, our alpha-synuclein project, which is in Phase 2a in both Parkinson's disease and multiple system atrophy.

Gunilla Osswald: Here I want to highlight exidavnemab, our alpha-synuclein project, which is in Phase 2a in both Parkinson's disease and multiple system atrophy. We had a planned safety review during this summer, and it was concluded that exidavnemab 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 exidavnemab with brain transporters. 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. 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.

Gunilla Osswald: Here I want to highlight exidavnemab, our alpha-synuclein project, which is in phase II-a in both Parkinson's disease and multiple system atrophy. We had a planned safety review during this summer, and it was concluded that exidavnemab 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 exidavnemab with brain transporters. 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. 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.

Speaker #2: And we had a planned safety review during this summer, and it was concluded that Exsidabmab showed a favorable safety profile, and it supports progression into Phase 2b, which is in planning.

Speaker #2: The other alpha-synuclein follow-up compound, called BAN2238, is a follow-up compound to Exsidabmab with a brain transporter. And here, we selected a candidate drug late last year, and the IND-enabling activities are progressing really well.

Speaker #2: And the pipeline overall continues to expand, and we have added new projects—for example, those resulting from new partnerships. The third area is to have additional successful global partnerships.

Speaker #2: 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.

Speaker #2: And of course, our partners since a long time ago, ACI, and all these are working in a generation in different approaches. Our latest research collaboration with Messenchya, 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.

Gunilla Osswald: Of course, our partners since long time ago, Eisai. All these are working in every generation in different approaches. Our latest research collaboration with Mesenkia Therapeutics, 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. Here we are focusing to start with on glioblastoma. I think it is 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.

Speaker #2: 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.

Speaker #2: 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 give dividends to our shareholders.

Speaker #2: We have a strong financial position, with about SEK 2 billion in cash at the end of the second quarter. And this is even without the upfront payment from Eli Lilly of $30 million.

Gunilla Osswald: We have a strong financial position with about 2 billion SEK in cash at the end of Q2. This is even without the upfront payment from Eli Lilly of 30 million US dollars. We expect to be profitable this year. Next slide, please. Partnerships is a cornerstone in our business model and the key component behind our success. Our focus has been on big pharma and different business models. We have two different business models here. The first category, we can see Eisai, AbbVie, and Bristol Myers Squibb, where they have done in-license agreements on innovative BioArctic development programs. The second category is Novartis and Eli Lilly, who are utilizing BioArctic as a platform company. They bring their compounds to BioArctic. We re-engineer the compounds and build in our brain transporter technology into new compounds.

Speaker #2: And we expect to be profitable this year. Next slide, please. Partnerships are a cornerstone of our business model and the key component behind our success.

Speaker #2: 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 ACI, AbbVie, and Bristol Myers Squibb, where they have done in-license agreements on innovative BioArctic-developed programs.

Speaker #2: The second category is Novartis and Eli Lilly, who are utilizing BioArctic as a platform company. So they bring their compounds to BioArctic, we re-engineer the compounds and build in our brain transporter technology into new compounds.

Speaker #2: And we check then the transferrin receptor functionality and then hand it back to the partner who drives and finances the program further. Then I also want to add a new kind of addition to our business model, which is what we are doing with Messenchya.

Gunilla Osswald: We check then the transferrin receptor functionality and then hand it back to the partner who drives and finance the program further. I also want to add a new kind of addition to our business model is what we are doing with Mesenkia Therapeutics. 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 Fälting.

Speaker #2: I think this represents another category, as we are now starting with a small research collaboration that could also lead to future business. Next slide, please.

Speaker #2: Now, I hand over to our Chief R&D Officer, Johanna Fälting.

Speaker #3: Thank you so much, Gunilla. Next slide, please.

Johanna Fälting: Thank you so much, Gunilla. Next slide, please. 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 Eisai, Bristol Myers Squibb, Novartis, 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, and during the quarter, we have further strengthened the platform to 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. Then we have the Mesenkia collaboration that marks our first step into oncology, expanding the brain transporter platform beyond neurodegenerative diseases and broadening its future application potential.

Speaker #2: 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.

Speaker #2: A balanced mix of funded partnerships with ACI, BMS, Novartis, and Lilly, together with proprietary programs, provide both external validation and significant long-term value creation opportunities in the portfolio.

Speaker #2: All brain transporter collaborations are progressing well, and during the quarter we have further strengthened the platform with two new collaborations—the Lilly partnership, which represents a major validation by a leading neuroscience company, and also highlights the platform's broad utility and potential in CNS.

Speaker #2: And then we have the Messenchya collaboration that marks our first step into oncology, expanding the Brain Transporter platform beyond neurodegenerative diseases and broadening its future application potential.

Speaker #2: So overall, we continue to advance the diverse, increasingly partner-validated pipeline with expanding scientific and commercial potential, both for our antibody and our Brain Transporter platform.

Johanna Fälting: Overall, we continue to advance the diverse, increasingly partner-validated pipeline with expanding scientific and commercial potential, both for our antibody and our brain transporter platform. Next slide, please. Taking a closer look at our alpha-synuclein portfolio, it is moving forward and expanding. For exidavnemab, during the quarter, we have evaluated the safety data from the Phase 2a EXIST study of exidavnemab in both Parkinson's and multiple system atrophy. The results confirmed a favorable safety profile of the antibody, which is an important milestone for the program. This data will provide a strong foundation for the next step of development, and we are currently planning for Phase 2b studies in both multiple system atrophy and Parkinson's disease-related dementia with the ambition to initiate these studies during next year.

Speaker #2: Next slide, please. So, taking a closer look at our alpha-synuclein portfolio, it is moving forward and expanding. For Exsidabmab, during the quarter we have evaluated the safety data from the Phase 2a Exsis study of Exsidabmab in both Parkinson's and multiple system atrophy.

Speaker #2: 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 2b studies in both multiple system atrophy and Parkinson's disease-related dementia.

Speaker #2: With the ambition to initiate these studies during next year. So, Exsidabmab remains the most advanced alpha-synuclein targeting program in our pipeline and addresses a significant unmet medical need in neurodegenerative diseases.

Johanna Fälting: Exidavnemab remains the most advanced alpha-synuclein targeting programs in our pipeline and addresses a significant unmet medical need in neurodegenerative diseases. For BAN2238, our brain transporter enabled alpha-synuclein antibody, we continue to make progress with the IND enabling activities during the quarter. BAN2238 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. Together, exidavnemab and BAN2238 represent a complementary strategy, combining the most advanced clinical stage asset with a next generation brain transporter enabling program targeting the same underlying disease biology. Next slide, please. One of the quarter's key highlights for us was really the new brain transporter collaboration with Lilly.

Speaker #2: And for BAN2238, our brain transporter-enabled alpha-synuclein antibody, we continue to make progress with the IND-enabling activities. During the quarter, BAN2238 combines our disease expertise in alpha-synuclein biology with the brain transporter technology, which is designed to enhance the antibody’s delivery across the blood-brain barrier.

Speaker #2: And this program is progressing according to plan, and we are currently expecting to initiate clinical development next year. So, together, Exsidabmab and BAN2238 represent a complementary strategy, combining the most advanced clinical-stage asset with a next-generation brain transporter-enabling program, targeting the same underlying disease biology.

Speaker #2: So, next slide, please. One of the quarter's key highlights for us was really the new brain transporter collaboration with Lilly. Lilly's selection of the brain transporter for next-generation CNS therapies provides strong validation from a leading pharmaceutical company and reinforces the importance of efficient blood-brain delivery.

Johanna Fälting: Lilly's 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. This collaboration expands, of course, the further potential in the application of the brain transporter beyond our internal programs, and it combines BioArctic's neuroscience expertise with Lilly's global development capabilities, further strengthening the platform for long-term strategic and commercial value. The Mesenkia collaboration in oncology marks BioArctic's entry into the oncology target space and expands the application of the brain transporter beyond neurodegenerative diseases. The main focus here is glioblastoma, which is a highly aggressive brain cancer with significant unmet medical need.

Speaker #2: For CNS drug development, 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.

Speaker #2: The Messenchya collaboration in oncology marks BioArctic's entry into the oncology target space and expands the application of the brain transporter beyond neurodegenerative diseases. The main focus here is glioblastoma, which is a highly aggressive brain cancer with significant unmet medical need.

Speaker #2: And together with Messenchya, we are now evaluating a novel approach by combining the brain transporter with Messenchya's HVEM-targeting antibody, enhancing drug delivery via this transporter to the brain and also the capability to reach the tumor cells associated with recurrence and treatment resistance.

Johanna Fälting: Together with Mesenkia Therapeutics, we are now evaluating a novel approach by combining the brain transporter with Mesenkia's HVEM targeting antibody, enhancing the drug delivery to the brain, and also the capability to reach the tumor cells associated with reoccurrence and treatment resistance. 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. Taken together, the Lilly and the Mesenkia collaboration highlights the broad potential of the brain transporter. Lilly validates the platform in neurodegeneration, while Mesenkia Therapeutics extends its applications into oncology, demonstrating its versatility across multiple disease areas. Next slide, please. Then I will hand over to our Chief Commercial Officer, Anna-Kaija Grönblad.

Speaker #2: 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.

Speaker #2: So, taken together, the Lilly and the Messenchya collaboration highlights the broad potential of the brain transporter. Lilly validates the platform in neurodegeneration, while Messenchya expands its application into oncology, demonstrating its versatility across multiple disease areas.

Speaker #2: So, next slide, please. And then I will hand over to our Chief Commercial Officer, Anna-Kaija Gronblad—Gronblad, sorry.

Speaker #3: Thank you, Johanna. So let me go back to Leqembi and the global rollout of the subcutaneous initiation treatment, as Gunilla already mentioned. This is clearly an important step in really expanding patient access and further strengthening our continued growth.

Anna-Kaija Grönblad: Thank you, Johanna. Let me go back to Leqembi and the global rollout of the subcutaneous initiation treatment, as Gunilla Osswald already mentioned. This is clearly an important step in really expanding the patient access and further strengthening our continued growth. In the US, this FDA approval came in July for the Leqembi Iqlik initiation treatment, and it is available as of this week. This will increase clearly the momentum as we now move into the H2 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, without having to come to the clinic for the time-consuming and more invasive infusions. This change is really expected to broaden uptake, especially for the people who live far from the clinics or travel frequently.

Speaker #3: So, in the US, the FDA approval came in July for the Leqembi iCLIC initiation treatment, and it is available as of this week.

Speaker #3: So this will clearly increase 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 hospital, so they can do this at home for the whole course of treatment.

Speaker #3: So, without having to come to the clinic for the time-consuming and more invasive infusions, this change is really expected to broaden uptake, especially for people who live far from the clinics or travel frequently.

Speaker #3: 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 at the beginning of 2027.

Anna-Kaija Grönblad: 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. We hope that the Medicare Part D coverage for both the initiation and maintenance can begin 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 Q3 of 2026 and reimbursement a bit later, expected to follow in the Q4. In China, the product is currently under priority review, and we expect the approval in the H1 of 2027.

Speaker #3: And we hope that Medicare Part D coverage for both the initiation and maintenance can begin in January 2027. We believe this will clearly be a commercial game changer and an advantage versus the competition.

Speaker #3: In Japan, we expect the approval soon in this third quarter of 2026, and the reimbursement a bit later, expected to follow in the fourth quarter.

Speaker #3: 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 showed really that the efficacy and the safety of the subcutaneous administration is comparable to the IV treatment.

Anna-Kaija Grönblad: 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. It is clearly supporting the potential of this more convenient treatment option. Eisai also continued to make progress across other international markets. During this Q2, Leqembi was launched in Australia, Belgium, Brazil, and India. 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. 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 Eisai and the NHS England are ongoing.

Speaker #3: So it's clearly supporting the potential of this more convenient treatment option. ACEI also continues to make progress across other international markets. So, during this second quarter, Leqembi was launched in Australia, Belgium, Brazil, and India.

Speaker #3: And at the same time, as market interest unfortunately is generally slower in Europe, the process continues to improve patient access across Europe. Here, the less frequent IV maintenance dosing is currently under EMR 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.

Speaker #3: In the UK, commercial discussions between ACEI and the NHS England are ongoing. And finally, we are seeing some encouraging interest from several private clinics in the Nordic countries. As we progress, we are also advancing discussions for a broader public reimbursement.

Anna-Kaija Grönblad: And finally, we are seeing some encouraging interest from several private clinics in the Nordic countries. As we progress, also the discussions for a more broader public care reimbursement. Overall, we are very pleased with the progress. 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 AAIC Congress in London this summer, several speakers showed data on how the drug is performing in the real world. Here I am highlighting a US post-market study called LEADER, which now includes 16 clinical sites across the country. In London, data were presented for a bit more than 400 patients from 13 sites.

Speaker #3: 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.

Speaker #3: Did you go to the next slide? So, coming back to the AI Congress in London this summer, several speakers showed data on how the drug is performing in the real world.

Speaker #3: 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 a bit more than 400 patients from 13 sites, and after an average of 17 months of Leqembi use, approximately 83% had not progressed to more advanced disease.

Anna-Kaija Grönblad: After an average of 17 months of Leqembi 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 bit more than 200 patients that have been on treatment for more than 18 months, almost 80% transition to maintenance treatment, either with Leqembi IV or subcutaneous Leqembi Iqlik. Finally, safety observations in this real-world study were consistent with the FDA-approved label. We are looking forward to the next data cut of approximately 600 patients that will probably be presented in November at the CTAD Congress. By that, I hand over to Anders, our CFO.

Speaker #3: 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.

Speaker #3: 74% were stable and 9% improved. Among the slightly more than 200 patients who have been on treatment for more than 18 months, almost 80% transitioned to maintenance treatment, either with Leqembi IV or subcutaneous iCLIC.

Speaker #3: So finally, safety observations in this real-world study were consistent with the FDA-approved label. So we're looking forward to the next data cut, approximately 600 patients.

Speaker #3: That would probably be presented in November at the CTAD Congress. So with that, I hand over to Anders, our CFO.

Speaker #1: Thank you, Anna-Kaija. And if we then turn to the Leqembi numbers, we can see that the Leqembi 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 a 27% increase from the second quarter of 2025.

Anders Martin-Löf: Thank you, Anna-Kaija. If we then turn to the Leqembi numbers, we can see that the Leqembi growth continues. The global Q2 sales were JPY 29.3 billion, or roughly $184 million, representing a healthy 12% increase from the first quarter, or 27% increase from Q2 2025. If we translate that into our royalties, you see that our royalties grew by 12% to SEK 179.4 million in Q2. It does not look as fantastic if you compare with Q2 2025. As you remember, there was a very low stockpiling effect in Q2 2025. If you remove that one-time effect, then the annual growth would have been roughly 43% in terms of royalties. All in all, on a global scale, the growth looks really good.

Speaker #1: 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.

Speaker #1: And if you remove that one-time effect, the annual growth would have been roughly 43% in terms of royalties. So, all in all, the global scale, the growth looks really, really good.

Speaker #1: If we then turn to the US, the growth there—13%—growing to $97 million in the quarter, is now mainly driven by Simplify Diagnosis.

Anders Martin-Löf: But then turning to the US, the growth there, 13% growing to $227 million in the quarter, is now mainly driven by Symplifi Diagnoses. You should understand that there is a very tough competitive situation right now in the US in the period that ended. The Leqembi Iqlik launch that happened earlier this week is going to be really exciting to follow. This has the potential to drive the royalties from Leqembi in a number of ways. First of all, as Anna-Kaija mentioned, the uptake of patients is likely going to increase due to the fact that it is so much easier for patients to access the therapy this way. On top of that, Leqembi should be able to generate a larger share of new patients as it will be the only drug that is available in a subcutaneous formulation.

Speaker #1: And you should understand that there's a very tough competitive situation right now in the US, in the period that ended. So the iCLIC launch that happened earlier this week is going to be really, really exciting to follow.

Speaker #1: This has the potential to drive the royalties from Leqembi in a number of ways. First of all, Anna-Kaija mentioned 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.

Speaker #1: On top of that, Leqembi 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.

Speaker #1: And the third factor is that, since this is a much more efficient way of delivering these therapeutics, a larger share will end up with the pharmaceutical part of the treatment cost.

Anders Martin-Löf: The third factor is that since this is a much more efficient way of delivering these 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. All in all, this will be a very important factor for the royalties in the future, and it will be very exciting to follow. In China, we also saw a 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. Eisai communicated that will start to come into place in Q4 of this year. Also very intriguing development. Japan was tough this quarter. It was flat from Q1, roughly $38 million in sales.

Speaker #1: 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.

Speaker #1: 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 at the beginning of 2027.

Speaker #1: We are also seeing broader insurance coverage. ACEI communicated that will start to come into place in the fourth quarter of this year, also a very intriguing development.

Speaker #1: Japan was tough this quarter. It was flat from the first quarter—roughly $38 million in sales. And it seems like, based on presentations that we saw at the large conferences this summer, the issue of capacity for infusions in Japan has been tougher there than in other markets.

Anders Martin-Löf: 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 will be very important now that we expect to see the subcutaneous version come out also in Japan. We are expecting approval in Q3 this year and 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 have talked about that in previous presentations, and it is still slow, so we will not dwell on that too much. All in all, Eisai reiterated their forecast of JPY 143.5 billion in their fiscal year 2026.

Speaker #1: So it will 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 reimbursement and launch towards the end of this year.

Speaker #1: So 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. Gradually, this will have a very large impact on the royalties.

Anders Martin-Löf: 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 have talked about that in previous presentations, and it is still slow, so we will not dwell on that too much. All in all, Eisai reiterated their forecast of JPY 143.5 billion in their fiscal year 2026.

Speaker #1: The EU has been slow. We've talked about that in previous presentations, and it's still slow, so we'll not dwell on that too much. All in all, ACEI reiterated their forecast of ¥143.5 billion in their fiscal year 2026.

Speaker #1: That is roughly $900 million of sales this year. And that corresponds to roughly 880 million Swedish krona in royalties during the time period.

Anders Martin-Löf: That is roughly $900 million of sales this year, and that corresponds to roughly SEK 880 million in royalties during that time period. If we then turn to our numbers, starting from the left, you see our net revenues that amounted to 248 million in Q2. That looks like we are shrinking from Q2 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 Q2 of this year. The underlying recurring revenues continue to increase. The royalties were roughly 179 million, and then we also had co-promotion revenues. So we are 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 Q2.

Speaker #1: 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.

Speaker #1: It looks like we're seeing a decline from the second quarter of 2025. But this is all due to the fact that there was a milestone of SEK 223 million in 2025, and there were no milestones paid in the second quarter of this year.

Speaker #1: The underlying recurring revenues did continue to increase. The royalties were roughly SEK 179 million, and then we also had co-promotion revenues. So we're approaching SEK 200 million in recurring revenues every quarter, which is very healthy.

Speaker #1: We also have some revenues from our collaborations. We entered into a collaboration with Novartis last year, where we recognized SEK 51 million from that upfront payment in the second quarter.

Speaker #1: And as Gunilla already mentioned, we also entered into a collaboration with Lilly in the second quarter of this year. None of that was recognized in the second quarter.

Anders Martin-Löf: As Gunilla already mentioned, we also entered into a collaboration with Lilly in Q2 this year. None of that was recognized in Q2. We will start to recognize that from Q3, 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. There were 232 million in Q2, up from 193 a year ago. This is all due to the fact that we are investing more and more in our project portfolio in preparations for our exciting trials with exidavnemab. We reiterate here that for the full year 2026, the operating costs are expected to increase by 40% to 60% compared to the year before. If anything, I would say in the low range of that span, but we reiterate roughly 40% to 60%.

Speaker #1: We 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.

Speaker #1: Turning then to our costs, they continue to increase. They were SEK 232 million in the second quarter, up from SEK 193 million 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 ExeDavnemab.

Speaker #1: And we reiterate here that for the full year 2026, the costs, the operating costs, I should say, are expected to increase by 40 to 60% compared to the year before.

Speaker #1: So, if anything, I would say in the low range of that span, but we reiterate roughly 40 to 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 SEK 179 million.

Anders Martin-Löf: As you see in the right-hand graph, we were not making a profit in Q2, but all in all, in the H1 of the year, we made a profit of SEK 179 million, and we still expect to be profitable for the full year. If we turn to the net result, you see that was slightly negative due to an impact of financial net and tax.

Speaker #1: And we still expect to be profitable for the full year. If we then turn to the net result, you see that it was slightly negative, due to the impact of financial net and tax.

Speaker #1: The cash flow was very positive, much stronger than the operating profit. That is due to the fact that the ACEI €20 million sales milestone was paid in May.

Anders Martin-Löf: The cash flow was very positive, much stronger than the operating profit. That is due to the fact that the Eisai EUR 20 million sales milestone was paid in May. Cash and cash equivalents was roughly EUR 2 billion at the end of the Q2, and that is despite us paying a dividend of SEK 177 million in June. This does not then include the Lilly $70 million upfront payment that was paid in July. So at the end of July, we had over EUR 2.3 billion in cash. All in all, our position remains extremely solid, with plenty of room to keep investing in our R&D portfolio. With that, I will hand over back to Gunilla.

Speaker #1: 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.

Speaker #1: And this does not then include the Lilly $30 million upfront payment that was paid in July. So at the end of July, we had over $2.3 billion in cash.

Speaker #1: 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 back over to Gunilla.

Speaker #2: Thank you so much, Anders. We are now coming towards the end of today's presentation, with some upcoming newsflow and a few closing remarks. Next slide, please.

Gunilla Osswald: Thank you so much, Anders. We are coming towards the end of today's presentation with some upcoming news flow and some closing remarks. Next slide, please. If we look at the Q2, I think it was great to see more patients getting access to Leqembi 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. Eisai is driving continued regulatory processes on lecanemab in a great way. The Leqembi Iqlik as a subcutaneous version with an auto injector was recently approved and launched now also for initiation in the US. Later this year we expect response from authorities in Japan and in China next year.

Speaker #2: So if we look at the second quarter, I think it was great to see more patients getting access to Leqembi around the globe, also on a smaller scale in the Nordics so far, through private clinics in Finland.

Speaker #2: And hopefully soon also in other Nordic countries. ACEI is driving continued regulatory processes on Leqenemab in a great way. And the ICLEC, the subcutaneous version with an auto-injector, was recently approved and launched, now also for initiation in the US.

Speaker #2: And later this year, we expect a response from authorities in Japan and in China next year. We also heard about continued impressive results from real-world usage.

Gunilla Osswald: We also heard about continued impressive results from real world usage when we were at AAIC Congress in London in July as Anna-Kaija Grönblad alluded to, and also for subcutaneous data. We are looking forward to the next big Alzheimer Congress called CTAD, Clinical Trials in Alzheimer's Disease which is in Boston in November, where we also expect more presentations around lecanemab. Exidavnemab, the phase IIa 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. We are preparing for starting phase IIb next year. We will communicate on further potential partnership milestones, et cetera, when that is relevant. Next slide, please. Some key takeaways from today's presentation.

Speaker #2: When we were at AIC, the Congress in London in July, as Anna-Kaija alluded to, and also for subcutaneous data. We are looking forward to the next big Alzheimer Congress called CTAD—Clinical Trials in Alzheimer's Disease—which is in Boston in November.

Speaker #2: We also expect more presentations around Leqenemab. ExeDavnemab, the phase 2a study, study results are expected later this year. We heard some really important safety data.

Speaker #2: That was coming during the summer, but the full study is expected to read out late this year. And we are preparing to start Phase 2b next year.

Speaker #2: We will communicate on further potential partnership milestones, et cetera, when that is relevant. Next slide, please. So, some key takeaways from today's presentation: I think BioArctic shows continued growth, and we have great progress both on Leqembi, as well as the rest of our portfolio and the brain transporter technology.

Gunilla Osswald: I think BioArctic shows continued growth, and we have great progress both on Leqembi 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. Leqembi is well on track to become an established treatment in Alzheimer's disease and sales continue to show increasing demand globally. The subcutaneous auto-injector Leqembi Iqlik 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 Eli Lilly with our brain transporter technology, and we have expanded our project portfolio also into oncology by the new research collaboration with Mesenkia Therapeutics, also utilizing our brain transporter technology.

Speaker #2: As I said, we are delivering on our 2030 ambitions already in a great way. Leqembi is well on track to become an established treatment in Alzheimer's disease, and sales continue to show increasing demand globally.

Speaker #2: The subcutaneous auto-injector, ICLIC, 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 Eli Lilly.

Speaker #2: With our brain transporter technology, we have expanded our project portfolio also into oncology by the new research collaboration with Masenkia, also utilizing our brain transporter technology.

Gunilla Osswald: Last but not least, we have a very strong financial position which was about SEK 2 billion in cash at the end of June. This is after the dividend of SEK 2 per share and before receiving the upfront of EUR 30 million from Lilly. We expect a positive result this year. All in all, I think BioArctic is exceptionally well positioned for continued growth, and the future looks very bright for BioArctic, and that brings hope for many patients. Next slide, please. By that, we say thank you so much for your attention, and we are happy to take some questions.

Speaker #2: And last but not least, we have a very strong financial position, with about 2 billion Swedish crowns in cash at the end of June.

Speaker #2: And this is after the dividend of 2 crowns per share, and before receiving the upfront of $30 million from Lilly. We expect a positive result this year.

Speaker #2: So, all in all, I think BioArctic is exceptionally well positioned for continued growth, and the future looks very bright for BioArctic. It brings hope for many patients.

Speaker #2: Next slide, please. With that, we say thank you so much for your attention, and we are happy to take some questions.

Speaker #1: If you wish to ask a question, please dial #Key5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial #Key6 on your telephone keypad.

Operator: If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Joseph Hedden from Rx Securities. Please go ahead.

Speaker #1: The next question comes from Joseph Hedden from RX Securities. Please go ahead.

Joseph Hedden: Good morning. Thanks for taking my questions. Congratulations on the collaboration with Mesenkia Therapeutics. 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 any details you can give us on additional aspects of the deal. Who will be in control of the clinical development, or are you going to be looking for a partner? Secondly, if I could just on exidavnemab. You stated that you have passed the safety analysis that facilitates phase IIb. Do you still expect to be presenting results from the study this year? Thank you.

Speaker #3: Good morning. Thanks for taking my question. Congratulations on the collaboration with Masenkia. 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.

Speaker #3: And then, any details you can give us on additional aspects of the deal—who will be in control of the clinical development, or are you going to be looking for a partner?

Speaker #3: And secondly, if I could, just on ExeDavnemab—so you stated that you passed the safety analysis. That facilitates Phase 2b. Do you still expect to be presenting results from the study?

Speaker #3: Thank you.

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

Speaker #2: I'm sorry, I had a little bit of difficulty hearing the first question. It was on Masenkia timelines. Masenkia, okay. I thought it was Lilly.

Johanna Fälting: It was on Mesenkia timeline.

Gunilla Osswald: Mesenkia. Okay. I thought it was Lilly. Okay. Mesenkia. Okay, maybe Johanna wants to-

Speaker #2: Okay, so Masenkia. Okay, maybe Johanna wants to?

Speaker #4: Yeah, thank you, Joseph, for that question. So I can start with a question on Masenkia. This is a preclinical research collaboration that will validate, preclinically, the target together with our brain transporter.

Johanna Fälting: Yeah. Thank you, Joseph, for those questions. I can start with your question on Mesenkia. This is a preclinical research collaboration that will validate preclinically the target together with our brain transporter. 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 timeline really and when this kind of program could go into clinic. But this is 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 it positive.

Speaker #4: So 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.

Speaker #4: And when this kind of program could go into the clinic. But this is a first research collaboration where we do something and they do something, and we will do a sort of preclinical evaluation in a disease model.

Speaker #4: And we will see if the concept works, and then we will continue with further discussions on how to progress, if positive.

Speaker #2: And the second question was with regard to ExeDamvemab. So maybe you want to take that also, Johanna?

Gunilla Osswald: The second question was with regard to exidavnemab. Maybe you want to take that also, Johanna?

Speaker #4: Yes, but that was the ExeDavnemab EXCEED study. And yes, our plan is to conclude this study by the end of the year, and then also report some data from that.

Johanna Fälting: Yes. That was the exidavnemab EXIST study. Yes, our plan is to conclude this study by the end of the year and then also report some data from that.

Speaker #3: 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?

Joseph Hedden: Thank you. Just to follow up on Mesenkia, if I could. Are there any other companies looking at that specific target in glioblastoma, or is this a completely novel program? Thanks.

Speaker #3: Thanks.

Johanna Fälting: As far as we know, I think this is a unique target, and that is why we think it is really, really interesting. I think it is 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 brain transporter platform. So I think that it is a really interesting program, and we really think it is solid and really nice science behind Mesenkia's ideas entering what can be seen as a stem cell for these cancer drugs in extremely difficult-to-treat patient population and disease.

Speaker #2: 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 to combine one of these diseases together with a brain transporter platform.

Speaker #2: 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.

Speaker #2: So I think that it's a really interesting program, and we really think it's solid with really nice science behind Masenkia's ideas—entering what can be seen as a stem cell for these cancer drugs.

Speaker #2: In an extremely difficult-to-treat patient population and disease.

Speaker #3: Okay, got it. Thank you.

Joseph Hedden: Okay, got it. Thank you.

Speaker #2: Thank you, Joseph.

Johanna Fälting: Thank you, Joseph.

Speaker #1: The next question comes from Max Dahl from Goldman Sachs. Please go ahead.

Operator: The next question comes from Max Da from Goldman Sachs. Please go ahead.

Speaker #5: Hi, this is Max Dahl for Rajan Sharma. Thank you for taking my questions. I have a few. The first question is about ExeDavnemab. So, in your Phase 2a study, did you see any efficacy signal?

Max Da: Hi, this is Max Da for Rajan Sharma. Thank you for taking my questions. I have a few. The first question is about exidavnemab. In your Phase 2a study, did you see any efficacy signal, and when should we expect the results from the Phase 2b study? Second question, how will you prioritize between exidavnemab and BAN2238? 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.

Speaker #5: And when should we expect the results from the phase 2b study? Second question, how will you prioritize between ExeDavnemab and BAN38? Also, if I can have another question.

Speaker #5: Could you talk about when Eli Lilly will make a decision to move the program forward to clinical development? Thank you very much.

Gunilla Osswald: You want to take it?

Speaker #2: Do you want to take it?

Johanna Fälting: Yeah, absolutely. If we start with the question on exidavnemab efficacy from the EXIST study, I think that you should remember that this study that we are now concluding is a phase II-A study. It is 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 3 months, and I think that you need much longer time for that. But we are definitely looking into that. The primary endpoint is safety and tolerability. In terms of the phase II-B results, I think that we haven't been communicated externally on those kind of timelines. We are still looking at the design and planning this study.

Speaker #4: Yeah, absolutely. So if we start with the question on ExeDavnemab efficacy, from the Exe study, I think that you should remember that this study that we are now concluding is a Phase 2a study.

Speaker #4: 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 clinical efficacy.

Speaker #4: 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.

Speaker #4: 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 kinds of timelines.

Speaker #4: We're still looking at the design and planning of this study. And in terms of the prioritization between ExeDavnemab and BAN2238, I mean, I think a real strength with this portfolio is that there are so many diseases here to treat.

Johanna Fälting: In terms of the prioritization between exidavnemab and BAN2238, 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. We see a lot of co-pathology also with Alzheimer's. 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. I think that there's a real strength in having two different options that might be able to be positioned to different diseases.

Speaker #4: 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.

Speaker #4: 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 pan out.

Speaker #4: So I think that there's a real strength in having two different options that might be able to be positioned for two different diseases.

Speaker #2: And the third question was with regard to Lilly and the collaboration there, and we do not disclose details on that.

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

Speaker #5: Got it. Thank you very much.

Max Da: Got it. Thank you very much.

Johanna Fälting: Mm-hmm. Thank you.

Speaker #2: Thank you.

Speaker #1: As a reminder, if you wish to ask a question, please dial the pound key followed by five on your telephone keypad. The next question comes from Mattias Heggblom from Nordea.

Operator: As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Mattias Häggblom from Nordea. Please go ahead.

Speaker #1: Please go ahead.

Speaker #5: Yeah, thanks so much. Thanks for taking my question. I had two, please. So, firstly on ExeDavnemab, when will we confirm the safety profile from the ongoing Phase 2a testing in Parkinson's and MSA patients?

Mattias Häggblom: Yeah, thanks so much. Thanks for taking my question. I have two, please. Firstly on exidavnemab, now with a confirmed favorable safety profile from the ongoing phase II-A testing in Parkinson's and MSA patients. Sometimes the pushback around this asset is coming back to the fact that it is now roughly four years, or somewhat more than four years, that the asset was handed back to you. I guess the question is, was there any point in time where there was a chance to use maybe a Bayesian clinical trial design to possibly speed up clinical development and explore the optimal dose? If not, why? 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 real terms? Thanks so much.

Speaker #5: 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, since the asset was handed back to you.

Speaker #5: So, I guess the question is: was there any point in time where there was a chance to use, maybe, bias in clinical trial design to possibly speed up clinical development and explore the optimal dose?

Speaker #5: And if not— and then, secondly, with draft guidance from the FDA on bias and trial design in January, how is the company thinking about this as a tool across the rest of the portfolio in general terms?

Speaker #5: Thanks so much.

Johanna Fälting: Should I or do you want to? You can go first.

Speaker #2: So, should I or do you want to? Yeah, no. So, I think I agree with you that—I mean, we got the ExeDavnemab program back from AbbVie in 2022.

Johanna Fälting: Should I or do you want to? You can go first.

Gunilla Osswald: Yeah, no. I think I agree with you that we got the exidavnemab program back from AbbVie 2022. When they had done two phase I studies, both of those studies showed excellent data with regard to safety, tolerability, and pharmacokinetics. The next thing that needed to be done was, of course, to look at multiple dosing. We did that then in Parkinson patients, and we also added MSA patients. We have expanded this into, and we see more opportunities for further indications as well. Of course, you are right that there is a lot of interest in different kind of innovative clinical design models. With the Bayesian statistics, we did utilize that for lecanemab. So far for exidavnemab, we have done more traditional design and are taking it a bit more stepwise here.

Speaker #2: And when they had done two Phase 1 studies, and both of those studies showed excellent data with regard to safety, tolerability, and pharmacokinetics, the next thing that needed to be done was, of course, to look at multiple dosing.

Speaker #2: And we did that then in Parkinson's patients. And we also added MSA patients. So we have expanded this and we see more opportunities for further indications as well.

Speaker #2: So, of course, you are right that there is a lot of interest in different kinds of innovative clinical design models, and with Bayesian statistics.

Speaker #2: And we did utilize that for lecanemab. So far, for ExeDavnemab, we have done a more traditional design and are taking it a bit more stepwise here.

Speaker #2: So, I think that a Bayesian design is really interesting when it is the right thing. But so far, for ExeDavnemab, we have utilized a traditional design.

Gunilla Osswald: I really think a Bayesian design is really interesting when it is the right thing. So far for exidavnemab, we have utilized traditional design.

Mattias Häggblom: Any general thoughts around Bayesian trial design for the rest of the portfolio, or what this draft guidance updated in January may possibly mean?

Speaker #5: And then, the general thoughts around Bayesian trial design for the rest of the portfolio, or what this draft guidance updated in January may possibly mean?

Mattias Häggblom: Any general thoughts around Bayesian trial design for the rest of the portfolio, or what this draft guidance updated in January may possibly mean?

Speaker #2: Yeah, no, I think—I mean, it's definitely something which is important and will continue to be important. And I think that how it was utilized for lecanemab is really also seen as a role model.

Gunilla Osswald: Yeah. No, I think it is definitely something which is important and will continue to be important. I think that how it was utilized for lecanemab is really also seen as a role model. That Phase IIb study with its adaptive design and with Bayesian design, I think was really innovative and also came with really good results, understanding the dose that could be used in Phase III, where the more traditional design was used. I really think that it is important sometimes for the traditional design, but also in the future, of course, to look at adaptive designs and Bayesian design.

Speaker #2: That Phase 2b study with this adaptive design and with Bayesian design, I think it was really innovative and also came with really good results.

Speaker #2: Understanding the dose that could be used in Phase 3, whether a more traditional design was used. So I really think that it's important.

Speaker #2: Sometimes with the traditional design, but also in the future, of course, to look at adaptive designs and Bayesian design.

Mattias Häggblom: Okay.

Speaker #5: Thanks.

Speaker #1: 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.

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

Speaker #5: 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 BAN2802 with ASI, and if there are any updates we can give there.

[Company Representative] (BioArctic): Thank you so much. We have a couple of written questions here. We will start with one from Mr. Tulin. He is asking about the research collaboration that we have ongoing for BAN2802 with Eisai, and if there are any updates we can give there.

Speaker #2: 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.

Gunilla Osswald: I am 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 Eisai, but we cannot disclose anything more at this moment.

Speaker #2: We are in discussions with ASI, but we cannot disclose anything more at this moment.

Speaker #5: Thank you. And then another presentation from Mr. Balder. He is asking about the Bristol-Myers Squibb collaboration—if it is still in the preclinical phase, and when it can be expected to enter patients.

[Company Representative] (BioArctic): Thank you. Then another presentation from Mr. Balder. He is asking about the Bristol Myers Squibb collaboration, if it is still in preclinical phase and when it can be expected to enter patients.

Speaker #2: So we can say, I think, we have a really great collaboration also with Bristol-Myers Squibb. And again, we cannot disclose details of their program.

Gunilla Osswald: I can say, I think we have a really great collaboration also with Bristol Myers Squibb. Again, we cannot disclose details of that program. Sorry.

Speaker #2: Sorry.

[Company Representative] (BioArctic): 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 are obviously always welcome to give us a call or send us an email. I think that concludes today's call. See you again in three months.

Speaker #5: 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 are, of course, always welcome to give us a call or send us an email.

Speaker #5: But I think that concludes today's call. See you again in three months.

Gunilla Osswald: Thank you so much. Have a great day.

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Q2 2026 BioArctic AB Earnings Call

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