Key Takeaways:
- Reports Q1 revenue of SEK 437.6M, including a EUR 20M sales milestone.
- FDA extends review for subcutaneous Leqembi, new decision date is August 24.
- Swedish NT Council advises against the drug's introduction in national healthcare.
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BioArctic Q1 revenue hits SEK 438M on Leqembi milestone
BioArctic AB reported first-quarter revenue of SEK 437.6 million, driven by a EUR 20 million milestone payment from partner Eisai after global sales of the Alzheimer’s drug Leqembi topped EUR 500 million.
"The royalty income and milestone payment further strengthen our already very strong financial position," CEO Gunilla Osswald said in the report, noting it provides flexibility to invest in the company's research pipeline.
The revenue included SEK 160.8 million in royalties from Leqembi, a 68 percent increase from the prior year. The milestone was triggered by sales performance in Eisai's fiscal year ending March 2026. For its upcoming fiscal year, Eisai forecasts Leqembi sales will grow 63 percent to JPY 143.5 billion.
The positive sales momentum is countered by regulatory headwinds. The U.S. FDA extended its review for a subcutaneous version of Leqembi by three months to August 24, 2026, while the Swedish NT Council recommended against its introduction in Sweden, creating uncertainty for future revenue streams.
The FDA’s decision to extend the review period for the supplemental Biologics License Application (sBLA) for Leqembi Iqlik™, the subcutaneous formulation, followed a request for additional information. The new PDUFA (Prescription Drug User Fee Act) date is now set for August 24, 2026. Priority review processes for the subcutaneous version are also underway in Japan and China.
While new long-term data presented at the AD/PD conference showed Leqembi's disease-slowing effect was sustained for up to four years, market access in BioArctic's home country has hit a roadblock. Osswald called the Swedish NT Council's decision "a great disappointment," but affirmed the company's conviction that "science, clinical experience, and continued dialogue will, over time, also provide Swedish patients with access to treatment."
The strong sales growth confirms significant demand for Leqembi, but the mixed regulatory signals highlight the complex path to market access. Investors will now focus on the FDA's decision on the convenient subcutaneous formulation on August 24 as the next major catalyst.
This article is for informational purposes only and does not constitute investment advice.
[1] BioArctic Interim Report for the period January - March 2026[2] FDA places full clinical hold on Aardvark's drug for extreme hunger in Prader-Willi syndrome[3] Semrush Announces Partnership With Lovable, Bringing Search Intelligence Into the Building Experience[4] BioArctic lifts royalties and milestones as Leqembi expands globally amid mixed regulatory signals - TipRanks
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