BioArctic AB (BRCTF) (Q2 2026) Earnings Call Highlights: FDA Approval of Leqembi Autoinjector ...

Negative Points

• BioArctic AB ( BRCTF ) reported a net loss in Q2 2026 due to increased operating costs, which rose to SEK 232 million from SEK 193 million a year ago, reflecting heavy investments in the R&D portfolio.

• The US market for Leqembi faced a tough competitive environment during the quarter, with growth of only 13% primarily driven by simplified diagnosis rather than broader patient uptake.

• Japan's Leqembi sales declined significantly from Q1 2026 (roughly $38 million), attributed to capacity issues for infusions, which is expected to persist until the subcutaneous version is approved and launched.

• European market uptake for Leqembi remains slow, with ongoing commercial discussions in the UK and limited public reimbursement progress, despite some interest from private clinics in the Nordics.

• The company's net revenues appeared to shrink year-over-year in Q2 2026 due to the absence of milestone payments that were received in Q2 2025, creating a perception of declining top-line performance.

• BioArctic AB ( BRCTF ) expects operating costs to increase by 40% to 60% for the full year 2026, which could pressure near-term profitability despite the strong cash position.

Q & A Highlights

Q: What are the key highlights from the second quarter of 2026, particularly regarding the Leqembi rollout and new partnerships? A: CEO Gunilla Osswald highlighted the FDA approval of Leqembi's subcutaneous formulation (iClick) with an autoinjector on July 13, 2026, with the US launch starting this week. This allows patients to self-administer at home, increasing convenience and potentially broadening market uptake. Additionally, BioArctic signed a landmark license and collaboration agreement with Eli Lilly for its brain transporter technology and a new research collaboration with Mesenkia to expand into oncology (glioblastoma). The company remains on track to deliver on its 2030 ambitions, with a strong cash position of approximately SEK2 billion at the end of Q2, excluding the USD30 million upfront from Lilly.

Q: Can you provide details on the financial performance and royalty growth for the second quarter of 2026? A: CFO Anders Martin-Loef reported that global Q2 sales of Leqembi reached JPY29.3 billion (roughly $184 million), a 12% increase from Q1 and a 27% increase year-over-year. Royalties grew 12% to SEK179.4 million. Excluding a one-time stockpiling effect from Q2 2025, annual royalty growth would have been roughly 43%. The company's net revenues were SEK248 million, with recurring revenues approaching SEK200 million per quarter. Operating costs increased to SEK232 million due to investments in the pipeline, but the company remains profitable for the first half of the year and expects to be profitable for the full year 2026.

Q: What is the expected impact of the subcutaneous iClick formulation on Leqembi's market performance, especially in the US? A: CFO Anders Martin-Loef explained that the iClick launch is expected to drive royalties in several ways: increased patient uptake due to easier access, a larger share of new patients as it will be the only subcutaneous option available, and higher revenue per patient due to more efficient delivery. The US growth of 13% in Q2 was mainly driven by simplified diagnosis, but the competitive situation is tough. The company expects a gradual uptake in the US with a potential shift in early 2027, particularly if Medicare Part D coverage begins in January 2027. This is seen as a potential commercial game changer versus competition.

Q: What are the latest developments and future plans for the alpha-synuclein portfolio, specifically exidavnimab and BAN 2,238? A: Chief R&D Officer Johanna Falting stated that the planned safety review for exidavnimab's Phase 2a AXIS study in Parkinson's disease and multiple system atrophy (MSA) confirmed a favorable safety profile, supporting progression into Phase 2b. The company is planning Phase 2b studies in both MSA and Parkinson's disease-related dementia, with the ambition to initiate them next year. Full Phase 2a study results are expected later this year. For BAN 2,238, the brain transporter-enabled follow-up compound, IND-enabling activities are progressing well, with clinical development expected to begin next year. The two programs represent a complementary strategy targeting the same underlying disease biology.

Q: Can you elaborate on the new Eli Lilly collaboration and the Mesenkia oncology partnership? A: Johanna Falting noted that the Lilly collaboration is a major validation of the brain transporter platform by a leading neuroscience company, expanding its potential in CNS therapies. The Mesenkia collaboration marks BioArctic's entry into oncology, focusing on glioblastoma, a highly aggressive brain cancer. The partnership combines BioArctic's brain transporter technology with Mesenkia's HVEM-targeting antibody to enhance drug delivery to the brain and reach tumor cells associated with recurrence. The initial goal is to generate a drug candidate and establish preclinical proof of concept. CEO Gunilla Osswald added that the Lilly deal is a landmark validation, and the company does not disclose specific details on timelines for Lilly's clinical development decisions.

Q: What is the timeline for the Mesenkia collaboration to reach preclinical validation, and who will control clinical development? A: Johanna Falting explained that this is a preclinical research collaboration focused on validating the target with the brain transporter platform. It is too early to discuss timelines for clinical entry. The collaboration involves a division of work where both companies contribute, followed by a preclinical evaluation in a disease model. If the concept works, further discussions will determine how to progress. She also noted that as far as they know, this is a unique target and a unique combination with the brain transporter platform, with no other programs attempting this approach in glioblastoma.

Q: Did the Phase 2a study of exidavnimab show any efficacy signals, and how will the company prioritize between exidavnimab and BAN 2,238? A: Johanna Falting clarified that the Phase 2a study is small and primarily designed for safety and tolerability, not powered for clinical efficacy. While exploratory biomarkers are being examined, the three-month duration is too short to expect efficacy signals. Regarding prioritization, she emphasized that alpha-synuclein is a key component in multiple diseases (Parkinson's, MSA, DLB), and the hope is that the two programs can be positioned for different diseases rather than competing, leveraging the strength of having two options.

Q: Given that exidavnimab was handed back by AbbVie over four years ago, is the company considering Bayesian clinical trial designs to speed up development? A: CEO Gunilla Osswald acknowledged the timeline, noting that after receiving the program back in 2022, the next step was multiple dosing studies in Parkinson's and MSA patients. While BioArctic utilized Bayesian design for lecanemab, they have used more traditional, stepwise designs for exidavnimab so far. She noted that Bayesian design is interesting when appropriate, and the company will continue to consider adaptive and Bayesian designs across the portfolio, especially given the FDA's draft guidance on the topic.

Q: What are the expectations for Leqembi approvals and launches in Japan and China? A: Chief Commercial Officer Anna-Kaija Groenblad stated that in Japan, approval for the subcutaneous version is expected soon in Q3 2026, with reimbursement and launch expected to follow in Q4. In China, the product is under priority review with approval expected in the first half of 2027. CFO Anders Martin-Loef added that Japan was tough in Q2 due to infusion capacity issues, making

For the complete transcript of the earnings call, please refer to the full earnings call transcript .