The US FDA approved Leqembi™ under the accelerated approval pathway for the treatment of Alzheimer’s disease
Events during the fourth quarter 2022
- Detailed and positive lecanemab data from the Phase 3 study, Clarity AD, were presented by Eisai at the CTAD Alzheimer Congress. The results were simultaneously published in the New England Journal of Medicine
- BioArctic started the two new projects, PD-BT2238, a selective antibody against soluble alpha-synuclein aggregates, and GD-BT6822, an enzyme replacement therapy for Gaucher’s disease. Both projects are combined with the company’s Brain Transporter technology
Events after the end of the period
- FDA approved lecanemab (name Leqembi) via the accelerated approval pathway for treatment of early Alzheimer’s disease
- BioArctic’s partner Eisai submitted a supplemental Biologics License Application in the US to FDA for full approval of Leqembi for the treatment of early Alzheimer’s disease and submitted Marketing Authorization Applications in the EU and Japan. The submissions in the EU and Japan were also accepted and the one in Japan was granted priority review
- The approval in the US and submissions in the EU and Japan entitles BioArctic to milestones of MEUR 35 in total
Financial summary October – December 2022
- Net revenues for the period amounted to MSEK 2.1 (4.7)
- Operating profit amounted to MSEK -60.7 (-39.4)
- Profit for the period amounted to MSEK -57.9 (-19.0)
- Earnings per share before and after dilution were SEK -0.66 (-0.22)
- Cash flow from operating activities amounted to MSEK -58.2 (-39.3)
- Cash and cash equivalents at the end of the period amounted to MSEK 805 (848)
Financial summary January – December 2022
- Net revenues for the period amounted to MSEK 228.3 (23.1)
- Operating profit amounted to MSEK -17.4 (-139.7)
- Profit for the period amounted to MSEK -11.2 (-119.8)
- Earnings per share before and after dilution were SEK -0.13 (-1.36)
- Cash flow from operating activities amounted to MSEK -31.6 (-140.5)
- Cash and cash equivalents at the end of the period amounted to MSEK 805 (848)
Comments from the CEO
“The successes of 2022 have strengthened us ahead of the continued development of our attractive project portfolio in neurodegenerative diseases.“
2022 had every opportunity to become a successful year for BioArctic. Looking back, it’s clear that this was the case.
On November 29, our partner Eisai presented the excellent results from the Clarity AD Phase 3 study with lecanemab in patients with early Alzheimer’s disease at the CTAD conference in San Francisco. At the same time, the New England Journal of Medicine published the results, which confirmed the data previously announced. The results showed that the primary and all secondary endpoints were met with high statistical significance, and that the safety profile was in line with expectations. The results are clinically relevant, and important to patients, their families, and society. A modelling study, based on the Phase 2b study, published in the spring of 2022 showed that the progression of the disease can be slowed and that the late stages can be delayed by about three years.
The focus is now on providing patients access to lecanemab as quickly as possible. It is impressive to see how well Eisai prepared for the regulatory procedures around the globe. Shortly after the end of the quarter, Eisai announced that the US Food and Drug Administration had approved lecanemab via the accelerated approval pathway. The approval was based on data from the Phase 2b study, and on the same day Eisai submitted a supplementary biologics license application to the FDA for full approval. Full approval is a prerequisite for a broader reimbursement of Leqembi, which is the brand name for lecanemab in the US. As a result of the accelerated approval in the US, Leqembi became available to patients in the country already in January. Eisai has announced a gradual launch strategy with the goal of making the drug available to as many patients as possible of those who could benefit from the treatment.
Early 2023, Eisai also submitted applications for market approval in the EU and Japan. In China, the application process was started at the end of last year and lecanemab was registered as Category 1, which indicates that China is highly committed to Alzheimer’s disease and that lecanemab is regarded as an innovative product. All in all, the regulatory development means that BioArctic will receive milestone payments of MEUR 35 from Eisai.
BioArctic has right to commercialize lecanemab in the Nordics under certain conditions and the ramp-up of our Nordic marketing organization continues.
The successes of lecanemab in 2022 have further strengthened BioArctic, supporting the continued development of our project portfolio in neurodegenerative diseases. At present, BioArctic’s experienced researchers and drug developers are involved primarily in our preclinical projects as well as the company’s Brain Transporter (BT) technology. Several advances were made and new projects started during the quarter. In parallel with the advance and expansion of our project portfolio, we are continuously prepared to re-prioritize, and at the end of the year we made a data-driven decision to discontinue the AD1801 project in Alzheimer’s disease.
In November, BioArctic obtained an additional patent in the US for our BT technology, and we initiated a new project in which we are combining BT with an enzyme that needs to be transported into the brain in patients who are suffering from Gaucher disease. During the quarter, our project portfolio also expanded with the PD-BT2238 project in Parkinson’s disease, where we combine BT with a selective antibody targeted at soluble alpha-synuclein aggregates. Moreover, we have nominated a drug candidate in the AD1503 Alzheimer’s project, which means it is now renamed BAN1503. The plan is to also develop this molecule further toward truncated forms of Aβ in combination with BT, under the project name AD-BT2803. The successful development of this technology means that combination projects are being pursued in all of our priority indications, generating the potential to further increase the efficacy and value of our drug candidates.
BioArctic turns 20 this year, and barely five years after listing, BioArctic qualified for Nasdaq Stockholm Large Cap. It is astonishing to think that patients with Alzheimer’s disease now can have the opportunity of an effective treatment, affecting the underlying disease. At the same time, it is incredibly motivating to imagine the future potential we have to help even more critically ill patients who are suffering from various neurodegenerative diseases. We will continue to work in the efficient, creative, and scientifically-driven manner that has become BioArctic’s signature – because for the patient, every day matters.
Gunilla Osswald
CEO, BioArctic AB
Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, February 3, at 9:30–10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson will present BioArctic, comment on the interim 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://ir.financialhearings.com/bioarctic-q4-2022/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://conference.financialhearings.com/teleconference/?id=5008079
The webcast will afterwards also be available on demand at BioArctic’s corporate website
https://www.bioarctic.com/en/section/investors/presentations/
For more information, please contact
Jan Mattsson, CFO, jan.mattsson@bioarctic.se, phone + 46 70 352 27 72
Oskar Bosson, VP Communications & Investor Relations, oskar.bosson@bioarctic.se, phone +46 70 410 71 80
The information was submitted for publication, though the agency of the named contact persons, at 8:00 a.m. CET on February 3, 2023.
About BioArctic AB
BioArctic AB (publ) is a Swedish research-based biopharma company focusing on disease-modifying treatments for neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and ALS. BioArctic focuses on innovative treatments in areas with high unmet medical needs. The company was founded in 2003 based on innovative research from Uppsala University, Sweden. Collaborations with universities are of great importance to the company together with its strategically important global partner Eisai in Alzheimer disease. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. BioArctic’s Class B share is listed on Nasdaq Stockholm Large Cap (ticker: BIOA B). For more information about BioArctic, please visit www.bioarctic.com.