BioArctic

Events during the third quarter 2024

• Leqembi® received approval and launched in Hong Kong, Israel, United Arab Emirates and Great Britain
• The European Medicines Agency (EMA) issued a negative opinion on the Marketing Authorisation Application for lecanemab. BioArctic's partner, Eisai, has requested a re-examination, with EMA's decision expected shortly
• Data from the lecanemab three-year extension study (OLE) demonstrated continued and increasing patient benefit, with a maintained safety profile

Events after the end of the period

• The Australian Medicines Agency (TGA) initially 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
• Additional lecanemab data presented at the CTAD congress strengthened previously communicated three-year data
• BrainTransporter™ technology data was presented, showing a dramatic increase in quantity of antibody delivery to the brain
• Eisai lowered Leqembi outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billion

Financial summary July - September 2024

• Net revenues for the period amounted to SEK 76.6 M (208.8), of which SEK 69.8 M (2.5) in royalties for Leqembi
• Operating profit amounted to SEK -26.1 M (131.0)
• Profit for the period amounted to SEK -19.6 M (124.9)
• Earnings per share before dilution SEK -0.22 (1.42) and after dilution -0.22 (1.41)
• Cash flow from operating activities amounted to a negative SEK -80.3 M (-52.7)

Financial summary January - September 2024

• Net revenues for the period amounted to SEK 156.1 M (605.0), of which SEK 133.7 M (3.0) in royalties for Leqembi
• Operating profit amounted to SEK -175.0 M (330.7)
• Profit for the period amounted to SEK -145.6 M (316.5)
• Earnings per share before dilution was SEK -1.65 (3.59) and after dilution -1.65 (3.58)
• Cash flow from operating activities amounted to a negative SEK -289.0 M (183.9)
• Cash and cash equivalents and short-term investments at the end of the period amounted to SEK 804 M (998)
   
   

Comments from the CEO
 
"Our BrainTransporter technology provides up to 70 times higher brain exposure of amyloid-beta antibodies with a rapid, broad and deep distribution."

It has, as usual, been a highly eventful period since my last comment. First and foremost, we are very proud that Lars Lannfelt, one of our two founders, has been awarded the prestigious Lifetime Achievement Award presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference. CTAD brings together the world's leading Alzheimer's researchers, so it was especially gratifying to see him being honored there.

Those of you who have followed us for a long time know that, in addition to our flagship Leqembi, I also see great potential in our proprietary BrainTransporter platform. It has possible applications both in neurodegenerative diseases and in other therapeutic areas. I am therefore thrilled that we recently presented data showing preclinical validation of our BrainTransporter platform at the PEGS conference in Barcelona. Among other things, the presentation included results showing that our BrainTransporter technology could provide up to 70 times higher brain exposure of amyloid-beta antibodies, with a rapid, broad, and deep distribution of the antibodies throughout the brain. Thus the technology could potentially provide better clinical efficacy, fewer side effects, and lower doses compared to current treatments. The technology is already being applied in all parts of our project portfolio, and within a couple of years, we expect to have the first BrainTransporter project in the clinic. We also see great interest, which opens up for future partnering opportunities.

In Parkinson's disease, we are now preparing to dose the first patient in the phase 2a exidavnemab study. In October, we visited the study sites, and screening to find the right patients is ongoing. Our plan is that the first patient will start treatment before year-end. This research area is evolving rapidly, and we are well-positioned with both exidavnemab and PD-BT2238, a BrainTransporter-linked alpha-synuclein antibody. We are excited to drive these projects forward.

In Alzheimer's disease, most of the focus has been on Leqembi. In July, the European Medicines Agency, EMA, issued a negative opinion regarding the marketing application for lecanemab. Eisai appealed, and we are awaiting EMA's opinion shortly. Meanwhile, the launch continues in several geographies, and Leqembi is now also available in Great Britain, Hong Kong, Israel and the United Arab Emirates. Sales continue to increase and were over 60 percent higher than in the previous quarter. The US market continues to grow at a good pace, while Japan and China are developing above expectations. There are still bottlenecks in the US healthcare system, mainly related to infusion capacity, something Eisai is working to improve in partnership with different healthcare providers. With this in mind, Eisai last week decreased the sales outlook for Leqembi. Eisai now expects Leqembi sales in their fiscal year 2024, from April 2024 to March 2025, to total JPY 42.5 billion (approximately SEK 3 billion), compared to JPY 56.5 billion announced in May. This would generate approximately SEK 300 M in royalty to BioArctic in the same period, adding close to SEK 200 M to the SEK 112.4 M in royalty we have received so far. Eisai has not, however, changed their view on the medium to long-term potential for Leqembi presented in March this year.

Diagnostics via blood tests and treatment with subcutaneous dosing will be very important to increase the number of patients who can benefit from the treatment. It is pleasing that Eisai recently announced that they have completed the rolling submission for subcutaneous maintenance dosing to the US FDA, with a potential approval already by next summer. This could combined with better diagnostics, lead to a greater patient uptake. This will be followed by an application for induction treatment with Leqembi subcutaneously, with a potential approval in 2026.

Eisai also continues to publish new data from the open label extension study with lecanemab, which has been positively received by global experts in the Alzheimer field. Data presented at CTAD at the end of October further underline the benefit of early and long-term treatment to achieve the best possible outcome for patients. Eisai showed that about half of the patients who had low amyloid levels (less than 60 centiloids) when treatment begun either improved or remained at the same cognitive level during three years of treatment with lecanemab. These results support the ongoing phase 3 study AHEAD 3-45, in which people who have started to accumulate amyloid in the brain but have not yet developed cognitive symptoms are treated with lecanemab for four years. The study was fully recruited in October. At the CTAD congress, positive results were also presented on the use of Leqembi in clinical practice in the USA and Japan. It is reassuring to see that the safety profile continues to be in line with phase 3 results as thousands of patients are now treated worldwide.

In summary, I am glad to note that BioArctic stands strong. We have rapidly increasing royalty revenues from Leqembi, a strong project portfolio with great partnering opportunities, especially with our BrainTransporter technology, and fantastic employees who continue to deliver high quality innovative research.

Gunilla Osswald
CEO, BioArctic AB

Invitation to presentation
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, November 14, at 9:30-10:30 a.m. CET. CEO Gunilla Osswald and CFO Anders Martin-Löf will present BioArctic, comment on the third 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://ir.financialhearings.com/bioarctic-q3-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://conference.financialhearings.com/teleconference/?id=50047208

The webcast will afterwards also be available on demand at BioArctic's corporate website

https://www.bioarctic.com/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 November 14, 2024.

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.com.