Applications for market approval of lecanemab submitted on three continents
Events during the first quarter 2023
- On January 6, the FDA approved lecanemab (Leqembi™) via the accelerated approval pathway for the treatment of Alzheimer’s disease
- BioArctic’s partner Eisai has filed for full approval for lecanemab in the US, EU, Japan and China. The submissions have all been accepted for review with the ones in the US, Japan and China being granted priority review
- The Prescription Drug User Fee Act (PDUFA) action date for full approval in the US is July 6, 2023
- The approval in the US and submissions in the EU and Japan entitled BioArctic to milestones of MEUR 35 in total, which were recognized as revenue and paid during the first quarter
- U.S. Veterans’ Health Administration decided to provide coverage of Leqembi for veterans with early Alzheimer’s disease
- New lecanemab-data was presented at the AD/PD congress regarding health-related quality of life outcomes, safety and the unique binding profile of the antibody
Events after the end of the period
- A recently published modeling study based on Phase 3 data showed that treatment with lecanemab resulted in a 2 to 3 years delay in the average time to progress to more severe stages of Alzheimer’s disease
Financial summary January – March 2023
- Net revenues for the period amounted to MSEK 393.4 (3.7)
- Operating profit amounted to MSEK 300.6 (-44.2)
- Profit for the period amounted to MSEK 293.9 (-44.3)
- Earnings per share before dilution were SEK 3.33 (-0.50) and after dilution 3.31 (-0.50)
- Cash flow from operating activities amounted to MSEK 299.0 (-39.7)
- Cash and cash equivalents at the end of the period amounted to MSEK 1,106 (801)
Comments from the CEO
“Our greatest driving force is the patients, and since every day matters for them we are working to have development move as quickly as possible.“
Since January 6 of this year, lecanemab has been approved for treatment of Alzheimer’s disease under the accelerated approval pathway in the US. In the first quarter of 2023, our partner Eisai continued to submit a number of applications for market approval of lecanemab, and regulatory reviews are now in progress on three continents. By July 6 at the latest, the US Food and Drug Administration (FDA) will release information on a potential full approval of lecanemab, which is being marketed under the brand name Leqembi in the US. The medical product authorities in the EU and Japan have begun their reviews, with lecanemab being granted a priority review in Japan. The same applies in China, where the National Medical Products Administration (NMPA) initiated a review of lecanemab in December. In total, these regulatory advances resulted in BioArctic receiving MEUR 35 in milestone payments during the first quarter.
The fact that authorities around the world – so soon after the Phase 3 results were presented – are reviewing lecanemab demonstrates both Eisai’s strategic focus and operational capacity to fully manage the potential in lecanemab, and the willingness of society to prioritize a new, potentially revolutionary treatment of Alzheimer’s disease.
The next important step for patients to gain access to lecanemab as quickly as possible are the reimbursement processes that are initiated when a new drug is approved. In the US, the Veterans’ Health Administration has already decided to reimburse Leqembi for US veterans who are living with early stages of Alzheimer’s disease. In parallel, the Centers for Medicare and Medicaid Services (CMS), who decide which pharmaceuticals are to be reimbursed in public healthcare insurance, announced that they would review their position if the FDA issues a full approval of Leqembi. Eisai is preparing for similar procedures around the world, placing great emphasis on demonstrating the value of lecanemab for both patients and society as a whole. A recently published modeling study based on Phase 3 data showed that treatment with lecanemab resulted in a 2 to 3 years delay in the average time to progress to more severe stages of Alzheimer’s disease.
The experiences from the introduction in other countries will be crucial when BioArctic, in conjunction with potential approval from the European Medicines Agency, prepares to launch lecanemab in the Nordic market together with Eisai. BioArctic has now established subsidiaries in Denmark, Finland, and Norway, and the Stockholm-based marketing organization continues to grow. As a result of the organization expansion, we are also pleased to welcome Anders Martin-Löf as the new CFO as of May 1. He succeeds Jan Mattsson, who has made valuable contributions in the same function over the last several years, and is now transitioning to a newly instated position as VP Finance.
At the end of March, it was once again time for the international AD/PD conference, which gathers world-leading experts in neurodegenerative diseases. It was extra exciting that this year’s conference was held in Gothenburg, and that HRH Queen Silvia inaugurated the meeting with a warm and crucial message. At AD/PD, Eisai presented large amounts of new and detailed data, all of which confirmed the safety of lecanemab and the efficacy in patients with early Alzheimer’s disease. BioArctic also presented new data through Professor Lars Lannfelt.
The rest of our project portfolio continues to evolve at a rapid pace, and our Brain Transporter (BT) technology has performed so well that it has now advanced from the research phase to the preclinical phase. The goal of the BT technology is to dramatically improve the transport of antibodies into the brain, which is assumed will lead to better clinical efficacy so that lower doses can be used. We see great potential in our technology further increasing the efficacy of the antibodies that are now being developed for diseases in the brain – both by ourselves and by others.
The tempo is currently quite high in all parts of BioArctic, from our research projects all the way to the preparations ahead of a potential Nordic market introduction of lecanemab. The hope is that our drug candidates will be able to help millions of people around the world. Our greatest driving force is the patients, and since every day matters for them, we are working to speed up development as much as possible for the benefit not only of patients, but also their families and society as a whole.
Gunilla Osswald
CEO, BioArctic AB
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Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, April 27, 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-q1-2023/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=200663
The webcast will afterwards also be available on demand at BioArctic’s corporate website
https://www.bioarctic.se/en/investors/financial-reports-and-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 April 27, 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.