#Sweden #Stockholm #Leqembi #BioArctic #Novartis

BioArctic's Interim Report for April - June 2025

BioArctic AB, a biopharmaceutical company based in Sweden, has recently released its interim report for the second quarter of 2025, detailing significant developments, financial performance, and future potential for its pioneering drug Leqembi® (lecanemab). With an ambitious focus on addressing neurodegenerative diseases, BioArctic has made significant strides during this quarter.

Major Developments in Q2 2025

One of the most noteworthy achievements during this period occurred when the European Commission granted Marketing Authorisation (MA) for Leqembi®. This crucial milestone triggered a payment of EUR 20 million from Eisai, BioArctic's partner in the development and commercialization of Leqembi. Moreover, this quarter saw the European Union bestow orphan designation upon Exidavnemab for multiple system atrophy (MSA), extending patent protection for the compound until 2041. This sets the stage for a heightened focus on MSA as an area of therapeutic development.

Additionally, BioArctic announced an ambitious sales forecast, with Eisai projecting sales of JPY 76.5 billion for the fiscal year 2025, marking a staggering 73% increase from the previous year. Such projections underscore the robust demand for Leqembi, as the company enhances its global launch strategy, commencing in Austria and Germany.

The acceptance of MSA patients into the phase 2a study for Exidavnemab further expands BioArctic's research initiatives, paving the way for more comprehensive trials that could maximize treatment outcomes for patients suffering from this debilitating condition.

Financial Performance

The company’s financial metrics for this quarter reveal remarkable growth. BioArctic reported net revenues of SEK 392.1 million, a significant rise from SEK 49.8 million year-over-year, with royalties from Leqembi alone contributing SEK 162.5 million. Operating profit surged to SEK 179.1 million, and net profits reached SEK 96.6 million, substantially improving from the negative figures of the same period last year.

Enhanced cash flow positions BioArctic favorably, with SEK 1,147.1 million generated from operating activities during this quarter. As of the end of June 2025, the company's cash reserves totaled SEK 1,916.1 million, showcasing a healthy balance sheet and supporting ongoing investments in innovative therapies.

Strategic Collaborations

In addition to the positive sales trajectory for Leqembi, BioArctic entered into a collaboration and licensing agreement with Novartis, valued at an initial payment of USD 30 million, with further milestone payments expected. This partnership aims to leverage BioArctic's proprietary BrainTransporter™ technology, which enhances the efficacy of drug delivery across the blood-brain barrier, thereby addressing complex neurological conditions more effectively. This collaboration is seen as a critical step towards establishing novel treatment pathways, highlighting the rising need for precise neurological therapies.

Future Directions and Research Initiatives

Looking forward, BioArctic has announced new 2030 ambitions focused on solidifying Leqembi's position as a leading treatment for Alzheimer's disease, expanding its treatment portfolio, and achieving sustainable profitability. The CEO, Gunilla Osswald, expressed excitement over the recent advancements and collaborations, emphasizing that such partnerships and increased investment in research are pivotal for the company's future.

Recent presentations at the Alzheimer's Association International Conference (AAIC) showcased promising data, including studies indicating a significant delay in disease progression in patients treated with Leqembi. According to new findings, a staggering 84% of patients did not progress to the next disease stage after treatment over a year, underlining the drug’s strong potential.

As BioArctic navigates this critical phase in its growth, the integration of innovative treatments and new collaborations offers optimism not just for the company’s future but also for the patients who stand to benefit from these groundbreaking therapies. With a keen eye on the evolving neuropharmaceutical landscape, BioArctic strives to remain at the forefront of developing treatments that can change the course of neurodegenerative diseases.

BioArctic invites investors, analysts, and media to tune into their audiocast scheduled for today, where deeper insights into the report will be shared. This event will provide a platform for questions and further discussions surrounding the company’s developments and future strategies.

For more information regarding BioArctic’s financial updates and initiatives, visit BioArctic's corporate website.