Leqembi approved in the EU and billion-dollar license agreement with Bristol Myers Squibb came into effect
Events during the first quarter 2025
- FDA approved less frequent IV maintenance dosing of Leqembi® for the treatment of early Alzheimer's disease and accepted the Biologics License Application (BLA) for subcutaneous maintenance dosing of Leqembi in the US
- Leqembi sales during BioArctic's partner Eisai's fiscal year 2024 (Apr-24 - Mar-25) exceeded EUR 200 M, resulting in a EUR 10 M milestone payment to BioArctic
- The license agreement with Bristol Myers Squibb came into effect, which meant that BioArctic was entitled to an initial payment of USD 100 million
- According to BioArctic's partner Eisai, Leqembi sales is expected to reach JPY 250 to 280 billion for their fiscal year 2027 (Apr-27 - Mar-28)
Events after the end of the period
- The European Commission has granted Marketing Authorisation (MA) for Leqembi (lecanemab) in the EU. The regulatory approval entitles BioArctic to a milestone payment of EUR 20 M from Eisai
- The European Patent Office, EPO, expanded the patent protection for exidavnemab to 2041 through a substance patent in Europe
- Leqembi was approved in Singapore
- BioArctic received regulatory approval to expand the ongoing Phase 2a study with exidavnemab and include patients with multiple system atrophy (MSA)
- BioArctic's partner Eisai issued Leqembi sales forecast of JPY 76.5 billion for its fiscal year 2025 (Apr-25 - Mar-26), representing a 73% increase year over year
Financial summary January - March 2025
- Net revenues amounted to SEK 1,289.6 M (29.6), of which SEK 96.0 M (21.3) in royalties for Leqembi
- Operating profit amounted to SEK 1,075.3 M (-73.1)
- Profit for the period amounted to SEK 1,021.5 M (-57.6)
- Earnings per share before dilution amounted to SEK 11.55 (-0.65)
- Earnings per share after dilution amounted to SEK 11.53 (-0.65)
- Cash flow from operating activities amounted to SEK 11.8 M (-114.4)
- Cash and cash equivalents and short-term investments at the end of the period amounted to SEK 789 M (991)
Comments from the CEO
"It is gratifying that Leqembi is finally approved in the EU and reaches patients in over 40 countries."
Leqembi has finally been approved in the EU for treatment of early Alzheimer's disease. BioArctic is entering a new growth phase where we will receive recurring royalties and we are making a success with our BrainTransporter technology.
In mid-April we received the long-awaited announcement that the European Commission had granted Marketing Authorisation for Leqembi (lecanemab). This means that Leqembi is now approved in over 40 countries, which is very encouraging, and that patients in the EU - for the first time - can be offered a treatment that targets an underlying cause of Alzheimer's disease. Preparations are under way in our marketing organization for the joint launch, together with Eisai, of Leqembi in the Nordic countries. An important step in this process is ensuring that the treatment is offered to those patients to whom it will provide the greatest benefit. Alzheimer's disease and mild cognitive impairment can be regarded as common diseases - around 19 million Europeans suffer from them - and we are convinced that Leqembi should be regarded as a precision medicine that can make a large difference for the right patients. Registers and follow-up will be especially important in this work, as will the development of diagnostics, which is moving towards both simpler and more precise methods. It is encouraging that the FDA recently approved the first blood test for diagnosing Alzheimer's disease.
In February Eisai reached the first sales milestone of EUR 200 M in a fiscal year, generating a milestone payment to BioArctic of EUR 10 M. A further milestone payment of EUR 20 M is due in the second quarter of 2025 as a result of the EU approval. Moreover, sales in the first quarter generated approximately SEK 100 M in royalties, nearly five times as much as during the year-earlier period. Eisai expects sales to continue growing by more than 70% during its fiscal year 2025 (Apr-25 - Mar-26).
Our financial position was strengthened substantially during the quarter as our global license agreement with Bristol Myers Squibb became effective after antitrust clearance, and we could invoice the upfront payment of USD 100 M. This license agreement with Bristol Myers Squibb includes up to USD 1.25 billion in additional development, regulatory and commercial milestones, as well as tiered low double-digit royalties on global product sales. All together, we made an operating profit of approximately SEK 1.1 billion in the quarter, and we expect to be profitable from this year onwards. Apart from strengthened financial resources from this agreement, we look forward to monitoring the continued development of the antibodies against Alzheimer's disease that are covered by the agreement - especially BAN2803, which uses our BrainTransporter technology. This groundbreaking platform technology is being developed in parallel with our antibody programs and can be used in several different therapy areas for active transportation of biological drugs into the brain. Therefore, it is important that we retain the rights to the technology itself. As the BrainTransporter technology evolves and we demonstrate that it can be used not only for antibodies but also for other modalities such as enzymes and oligopeptides, we see growing potential for more license agreements in various therapeutic areas in the future.
In parallel with the success of the BrainTransporter technology, I am proud to note that our antibody exidavnemab is making great progress. This drug candidate is being developed as a new disease-modifying treatment for synucleinopathies such as for example Parkinson's disease and multiple system atrophy (MSA). In March, the US Food and Drug Administration granted orphan drug designation for exidavnemab for the treatment of MSA. In May, we also received permission to broaden our ongoing Phase 2a study to include MSA patients, in addition to patients with Parkinson's disease, thereby further increasing the potential for exidavnemab. This shows our capacity for innovation and our ability to identify entirely new ways of tackling the diseases of the brain.
BioArctic's research and innovative power is generating significant attention. This can be seen at international conferences - for example, at AD/PD in Vienna in April - where our Chief R&D Officer, Head of Research & Development Johanna Fälting presented exidavnemab. We are also making an impression here in Sweden where I, along with BioArctic's two founders Lars Lannfelt and Pär Gellerfors, recently received Uppsala University's innovation and entrepreneurial award. Receiving this award jointly is particularly gratifying since it is the result of how we work at BioArctic: we work together, using our differing perspectives and competences to bring groundbreaking treatments one step closer to patients every day.
On June 2, BioArctic will host a Capital Markets Day for the first time. At the event, we will present our visions and plans for BioArctic that has now entered a new era with a strong financial position, a global market approval for Leqembi and a new partnership with an associated billion-dollar agreement signed.
Gunilla Osswald
CEO, BioArctic AB
Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, May 21, at 9:30-10:30 a.m. CET. CEO Gunilla Osswald and CFO Anders Martin-Löf will present BioArctic, comment on the report and answer questions.
If you wish to participate via webcast, please use the link below. Via the webcast you are able to ask written questions.
Webcast: https://bioarctic.events.inderes.com/q1-report-2025/register
If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/bioarctic/q1-report-2025/dial-in
The webcast will afterwards also be available on demand at BioArctic's corporate website
https://www.bioarctic.com/en/investors/financial-reports-and-presentations/
For more information, please contact
Anders Martin-Löf, CFO,
E-mail: anders.martin.lof@bioarctic.com
Telephone + 46 70-683 79 77
Charlotte af Klercker, Senior Director Sustainability and Communications
E-mail: charlotte.afklercker@bioarctic.com
Telephone: +46 73 515 09 70
The interim report is such information as BioArctic AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, though the agency of the named contact persons, at 8:00 a.m. CET on May 21, 2025.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) - the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.
