BioArctic (BIOA) CMD 2025 summary

Strategic direction and growth ambitions

• Entering a growth era with ambitions to become Sweden's next major biopharma by 2030, focusing on innovation, expanding the R&D portfolio, and global partnerships.

• Plans to broaden the pipeline with projects at all stages, leveraging internal innovation and external partnerships, especially in severe brain diseases.

• Proactive business development, including new collaborations for the BrainTransporter platform and other modalities, supported by a dedicated director.

• Strong company culture and leadership principles underpin growth, collaboration, and sustainable value creation.

• Preparing for the Nordic launch of Leqembi, with a dedicated team and strong academic ties.

Financial outlook and guidance

• Transitioning from milestone-based revenues to recurring royalty income, primarily from Leqembi, enabling long-term strategic planning and sustainable profitability from 2025.

• Achieved SEK 1.1 billion operating profit in Q1, with royalties nearly covering organizational costs; forecasts over SEK 500M in Leqembi royalties for 2025.

• Receives 9% royalties on global Leqembi sales (10% recorded due to pass-through), with sales forecasted to grow 73% year-over-year and potential for blockbuster status.

• License agreement with Bristol Myers Squibb valued at up to $1.25 billion plus double-digit royalties, and additional milestones from Eisai.

• Plans to start paying dividends in the next few years, contingent on sustained profitability and strengthened financial position.

Pipeline and R&D strategy

• Two world-leading platforms: highly selective antibody technology targeting toxic protein aggregates and the BrainTransporter for enhanced brain delivery.

• Leqembi is the first fully approved disease-modifying treatment for Alzheimer's, with global rollout and Nordic launch planned for 2026.

• Exidavnemab, a highly selective alpha-synuclein antibody, is in Phase 2a for Parkinson's, MSA, and other synucleinopathies, with orphan designation and long-lasting patent protection.

• Multiple preclinical programs in ALS (TDP-43), Gaucher disease, and other CNS disorders, with expansion into new modalities such as enzymes and antisense oligos.

• R&D organization is expanding, with 70% of staff in R&D and a focus on innovation, new modalities, and global talent recruitment.