#Sweden #Stockholm #Leqembi #BioArctic #Novartis

BioArctic's Interim Report: April - June 2025

BioArctic has made remarkable strides in the second quarter of 2025, showcasing its commitment to innovation in the field of neurology. The European Commission's recent approval of Marketing Authorisation (MA) for Leqembi® (lecanemab) has triggered a significant milestone payment of €20 million from Eisai, marking a pivotal moment for the company. This reinforces BioArctic's position in the industry as a frontrunner in developing treatments for neurodegenerative diseases.

Major Developments

During this quarter, several key developments have been revealed:

• - The approval for Exidavnemab as an orphan drug for multiple system atrophy (MSA) has been granted, with patent protection extended until 2041 by the European Patent Office.
• - The forecast for Leqembi's sales is substantial, with Eisai predicting revenues of JPY 76.5 billion for the fiscal year 2025, reflecting a remarkable 73% increase year-over-year.
• - In a positive turn, the safety review from the initial phase 2a study with Exidavnemab supports advancing to a higher dose in its ongoing clinical trial. Additionally, MSA patients will now be incorporated into this study.

The excitement surrounding these developments is palpable, and the opportunity for growth in BioArctic's portfolio becomes clearer with the introduction of their 2030 ambitions presented during their recent Capital Markets Day.

Post-Q2 Events

Following the quarter's conclusion, significant findings regarding Leqembi were showcased at the AAIC conference.

• - These findings revealed that early and sustained treatment led to improved outcomes after four years, with safety profiles remaining consistent.
• - Remarkably, out of nine US clinics, it was noted that 84% of patients treated with Leqembi did not advance to the next stage of Alzheimer's disease.
• - Notably, the data confirmed the effectiveness of a 360 mg weekly subcutaneous maintenance treatment, aligning well with the current intravenous options.

With the recent launch of Leqembi in the EU, starting from Austria and Germany, the expectations within the company are high. Additionally, BioArctic has signed a new collaboration agreement with Novartis, which includes an upfront payment of $30 million, paving the way for future milestone achievements and additional royalties. This collaboration marks a significant step forward, as it integrates BioArctic's BrainTransporter™ technology with Novartis' drug candidates.

Financial Summary

The financial metrics from April to June 2025 reflect a robust performance:

• - Net revenues reached SEK 392.1 million, with SEK 162.5 million attributed to Leqembi royalties, signaling a 280% increase compared to the same period last year.
• - Operating profit stood impressively at SEK 179.1 million, compared to a loss of SEK 75.8 million from the previous year.
• - The profit for the period surged to SEK 96.6 million, showing a significant turnaround from a loss of SEK 68.4 million last year.
• - Encouragingly, cash flow from operations reached SEK 1,147.1 million.

The cash reserves position bioArctic strongly, ending the quarter with SEK 1,916.1 million in cash equivalents and short-term investments, up from SEK 889.7 million.

Leadership Comments

CEO Gunilla Osswald expressed optimism about the ongoing advancements,