BioArctic Reports Record Q4 2025 Results as Leqembi Expands Globally

BioArctic reported net revenues of SEK 184.0 M for the fourth quarter of 2025, compared to SEK 101.2 M in the same period the previous year. The revenues included SEK 127.0 M in royalties for Leqembi and SEK 51.1 M from the agreement with Novartis.

During the fourth quarter of 2025, Leqembi Iqlik was launched for weekly maintenance dosing and Eisai completed rolling sBLA submission for subcutaneous initiation treatment in the US. Leqembi was approved in Brazil and Canada, and received approval for IV maintenance treatment in the United Kingdom. Eisai submitted an application for subcutaneous initiation treatment with Leqembi in Japan.

New Leqembi data presented at CTAD 2025 suggested potential to delay disease progression by up to 8.3 years with continuous treatment. The first Nordic patient was treated with Leqembi at a private clinic in Finland.

After the end of the fourth quarter, the BLA for subcutaneous initiation treatment with Leqembi was accepted and designated for priority review in China. Leqembi Iqlik sBLA for subcutaneous initiation dose was granted Priority Review by the US FDA, with a decision expected by the end of May. Eisai submitted a Marketing Authorisation Variation to EMA for intravenous maintenance dosing every four weeks with Leqembi.

Operating profit for the quarter amounted to SEK 33.2 M, compared to SEK -53.5 M in the prior year period. Profit for the period amounted to SEK -8.8 M, compared to SEK -31.5 M. Earnings per share before and after dilution amounted to SEK -0.10, compared to SEK -0.36.

Cash flow from operating activities amounted to SEK 313.3 M, compared to SEK -27.4 M in the same quarter the previous year. Cash and cash equivalents and short-term investments at the end of the period amounted to SEK 2,190.4 M, compared to SEK 778.9 M.

Royalty revenues in the fourth quarter grew by 31 percent compared to the same quarter the year before, despite significant negative currency impact. In the US, Japan and China, the number of patients on treatment is steadily increasing. In Japan, revenue in local currency was flat compared to the previous quarter following a 15 percent price reduction implemented in November. China showed no significant revenue growth quarter-on-quarter as a consequence of inventory build-up in the second quarter.

In October, the subcutaneous version, Leqembi Iqlik, was launched for maintenance treatment in the US, marking the first time the therapy can easily be administered at home via an autoinjector. In China and Japan, regulatory authorities are conducting reviews, with China also running a priority process.

Leqembi is now approved in more than 50 markets and sales continue to grow every quarter. The company has strengthened its project portfolio with two new projects, one in Huntington's disease and one related to Parkinson's disease. In the fourth quarter, candidate drugs were nominated in two projects: BAN3014 in ALS and BAN2238 in Parkinson-related disorders. The Phase 2a study with exidavnemab in Parkinson's disease and multiple system atrophy is progressing, with completion expected in 2026.

The Board of Directors proposes a dividend of 2.00 SEK per share to be paid for the financial year 2025. The CEO stated that 2025 was a record year for BioArctic, with an operating profit of more than SEK 1.2 billion.