Pioneering license agreement with BrainTransporter signed with BMS worth up to USD 1.35 billion plus royalties
Events during the fourth quarter 2024
- The Australian Medicines Agency (TGA) decided not to approve lecanemab. Eisai has requested a reconsideration
- The phase 3 study AHEAD 3-45 in preclinical Alzheimer's disease was fully recruited
- Eisai completed the stepwise application for subcutaneous maintenance therapy with Leqembi in the US
- New data for the BrainTransporter technology was presented, showing a dramatic increase of antibody delivery to the brain
- Eisai lowered Leqembi outlook for fiscal year 2024 (April 2024 - March 2025). Sales are now expected to reach JPY 42.5 B
- EMA's advisory committee, CHMP, issued a positive recommendation for approval of lecanemab in the EU
- BioArctic signed a global exclusive license agreement with the Bristol Myers Squibb (BMS) for BioArctic's anti-bodies BAN1503 and BAN2803. The agreement, which is pending authority approval, is worth up to USD 1.35 B plus royalties
Events after the end of the period
- FDA accepted the Biologics License Application (BLA) for subcutaneous maintenance dosing of Leqembi in the US
- FDA approved less frequent IV maintenance dosing of Leqembi for the treatment of early Alzheimer's disease in the US
- The European Commission has asked the CHMP to consider two additional questions ahead of a final decision on the Market Authorisation Application for lecanemab in the EU
Financial summary October - December 2024
- Net revenues for the period amounted to SEK 101.2 M (11.0), of which SEK 96.7 M (7.3) in royalties for Leqembi
- Operating profit amounted to SEK -53.5 M (-78.1)
- Profits for the period amounted to SEK -31.5 M (-87.2)
- Earnings per share before and after dilution amounted to SEK -0.36 (-0.99)
- Cash flow from operating activities amounted to a negative SEK -27.4 M (125.8)
Financial summary January - December 2024
- Net revenues for the period amounted to SEK 257.4 M (616.0), of which SEK 230.4 M (10.2) in royalties for Leqembi
- Operating profit amounted to SEK -228.5 M (252.6)
- Profit for the period amounted to SEK -177.1 M (229.2)
- Earnings per share was SEK -2.00 (2.60) before dilution and -2.00 (2.59) after dilution
- Cash flow from operating activities amounted to a negative SEK -316.3 M (309.7)
- Cash and cash equivalents and short-term investments at the end of the period amounted to SEK 779 M (1,112)
- The Board in BioArctic proposes that no dividend is to be paid for the fiscal year 2024
Comments from the CEO
"Our business remains solid, both in terms of our research and our financial position."
Reflecting on 2024, I look back on yet another eventful year. We have taken many strategically important steps, and BioArctic is now a more diversified company than just a year ago. Leqembi, the world's first fully approved disease modifying drug for Alzheimer's disease, is now approved in ten markets and already helping tens of thousands of patients across three continents. We have presented groundbreaking data for our BrainTransporter technology, and signed the first licensing agreement which is fantastic. The technology platform is generating significant interest in the pharmaceutical industry, and it is clear that it creates great opportunities for us to grow in the coming years. The licensing agreement we signed in December with Bristol Myers Squibb (BMS), which is pending clearance under the US Antitrust legislation, will give us an even stronger financial position and enables continued investments in our portfolio to build further value. Under the agreement, BMS will become solely responsible for the development and any subsequent global commercialization of BAN1503 and BAN2803 in Alzheimer's disease. When the agreement comes into effect, we will receive USD 100 million upfront and up to USD 1.25 billion in development-related, regulatory, and commercial milestones, as well as tiered low double-digit royalties on global sales. This means that from 2025 and onwards, we expect to be profitable.
I have long been very enthusiastic about what the BrainTransporter technology can offer and have had high expectations on new data. What we have now presented shows that the technology is clearly differentiated from what has previously been generated in the field. It has the potential for both faster and stronger efficacy for treatments targeting the brain with fewer side effects and lower doses. These findings have been well received by the industry and I was energized by the considerable interest we experienced from major pharmaceutical companies during the JP Morgan conference in San Francisco in the beginning of this year. It is clear that BioArctic, with the BrainTransporter technology, has a leading position in the development of next-generation treatments for brain diseases, and I see great opportunities for new collaborations going forward.
We have also initiated the phase 2a study EXIST with exidavnemab in Parkinson's disease, the first clinical study in the neurodegenerative space that we are conducting independently. Patient recruitment is progressing well, and the first part of the clinical trial is already fully recruited thanks to a close collaboration between our highly competent clinical development organization and the participating clinics. EXIST is an important step towards a proof-of-concept study focusing on the efficacy of the drug candidate.
Leqembi sales continue to grow, and more than 20,000 patients are now on treatment. Global sales generated SEK 97 M in royalty during the fourth quarter, an increase of 38 percent compared to the previous quarter. In total, we reported royalties of approximately SEK 230 million in 2024. Eisai continues to work with regulatory authorities to make Leqembi available to more patients. Unfortunately, the EU Commission has not yet finally approved Leqembi following the positive recommendation from EMA's advisory committee CHMP in November. The decision has been postponed as the EU Commission has raised follow-up questions that will be addressed at the CHMP meeting in February 2025. In January 2025, the US FDA approved intravenous maintenance treatment with Leqembi every four weeks for patients who have completed the initial 18 months of treatment every other week. The FDA also announced that they will provide a decision regarding the subcutaneous version of maintenance treatment at the end of August this year. The subcutaneous treatment option uses an autoinjector similar to the one used by people with diabetes, which will simplify treatment for patients and healthcare providers. This administration form could in the future potentially also be used for induction treatment. That requires an approval that could come during the first half of 2026.
Looking ahead, my expectation is that 2025 will bring continued royalty growth from Leqembi, as well as additional milestone payments from Eisai. We will continue to prioritize the work for additional collaboration agreements, which we initiated towards the end of last year. Our business remains solid, both in terms of our research and financial position. We are ready for 2025, and I hope you are with us for the continued journey.
Gunilla Osswald
CEO, BioArctic AB
Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, February 13, at 9:30-10:30 a.m. CET. CEO Gunilla Osswald and CFO Anders Martin-Löf will present BioArctic, comment on the fourth quarter 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/q4-report-2024/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/q4-report-2024/dial-in
The webcast will afterwards also be available on demand at BioArctic's corporate website
https://www.bioarctic.se/sv/investerare/finansiella-rapporter-och-presentationer/
For more information, please contact
Anders Martin-Löf, CFO, anders.martin.lof@bioarctic.com, phone + 46 70-683 79 77
Oskar Bosson, VP Communications & Investor Relations, oskar.bosson@bioarctic.com, phone +46 70 410 71 80
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 February 13, 2025.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on 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.se.
