Slide 1: Q3 Report July – September 2024
Q3 Report July – September 2024 Stockholm, November 14, 2024 BioArctic AB
Slide 2: Presenting team
Presenting team GUNILLA OSSWALD, ANDERS MARTIN-LÖF, IR contact: CEO CFO Oskar Bosson, VP Communications & IR +46 704 10 71 80 ir@bioarctic.se Next Report: 2024 Q4 & FY Report February 14, 2024 To subscribe to financial reports/press releases and for more information, please visit www.bioarctic.com 2
Slide 3: Disclaimer
Disclaimer • This presentation has been prepared and produced by BioArctic AB (publ) (“BioArctic”) solely for the benefit of investment analysis of BioArctic and may not be used for any other purpose. Unless otherwise stated, BioArctic is the source for all data contained in this presentation. Such
Slide 4: BioArctic – a global leader in neurodegenerative diseases
BioArctic – a global leader in neurodegenerative diseases Focus on neurodegenerative disorders Highly selective antibodies targeting aggregated forms of toxic proteins • Disorders with very large unmet needs and large patient populations World-class R&D organization leveraging strong collaborations
Slide 5: Pipeline progressing well, with strong new data validating the BrainTransporter platform
Pipeline progressing well, with strong new data validating the BrainTransporter platform presented BioArctic BrainTransporter • Presented validation in NHP at PEGS conference, demonstrating rapid, broad and deep brain distribution of BT-anti amyloid Ab Exidavnemab • Phase 2a study initiated in Parki
Slide 6: The BrainTransporter platform
The BrainTransporter platform Active transport of biotherapeutics across the blood brain barrier Overcome the BBB obstacle Several opportunities to further enhance RMT across the BBB antibodies and other modalities in clinic Opportunities Note Increased brain Promotes active transport across the BBB
Slide 7: Stronger, deeper and broader brain distribution with the BT approach
Stronger, deeper and broader brain distribution with the BT approach Validated in non-human primates with substantially increased brain exposure without affecting hematology including reticulocytes BT substantially increases brain exposure Anti-Abeta Ab mAb BT-anti-Abeta Ab Parietal cortex Striatum
Slide 8: Screening for exidavnemab Phase 2a study ongoing
Screening for exidavnemab Phase 2a study ongoing Offers opportunities in several neuronal synucleinopathies (NSD) Biomarkers available to identify patients with pathological α-syn 8 BioArctic AB
Slide 9: Exidavnemab Phase 2a study "EXIST" in Parkinson's disease
Exidavnemab Phase 2a study “EXIST” in Parkinson's disease Exploring to add a MSA cohort EXIST PHASE 2A STUDY DESIGN Patient inclusion Treatment 3 mo Read-outs Patients with Mild to Moderate Randomized, double-blind, placebo-controlled trial Primary endpoints: Parkinson's Disease (PD) Safety & tolera
Slide 10: A broad project portfolio with a focus on neurodegenerative diseases
A broad project portfolio with a focus on neurodegenerative diseases Regulatory Project Partner Discovery Preclinical Phase 1 Phase 2 Phase 3 & Market ALZHEIMER’S DISEASE Lecanemab (BAN2401) (Clarity AD) Eisai1 Early Alzheimer’s disease2 Lecanemab (BAN2401) (AHEAD 3-45) Eisai1 Preclinical (asymptoma
Slide 11: Number of patients treated with Leqembi continues to expand
Number of patients treated with Leqembi continues to expand with clinical experience safety data on par or better than phase 3 Leqembi Commercial • Royalties grew >60% quarter-on-quarter; 70 MSEK • Continued growth in the US market, Japan and China above expectations • Eisai lowered fiscal year (Apr
Slide 12: Lecanemab is the first AD disease-modifying treatment to receive full approval globally
Lecanemab is the first AD disease-modifying treatment to receive full approval globally, establishing new standard of care USA Japan EU China Rest of World Approved in Approved Approved Marketing authorization Approved South Korea, Israel, July 2023 September 2023 application submitted January 2024
Slide 13: 36-month data showed increasing long-term treatment effect with no new safety findings
36-month data showed increasing clear and meaningful long-term treatment effect with no new safety findings reported No new safety findings were reported and very low frequency of ARIA after the first 6 months of treatment Experience from clinical practice from the US and Japan presented at CTAD: •
Slide 14: Earlier patients benefit more from early initiation and continued dosing
Earlier patients benefit more from early initiation and continued dosing – majority improved or maintained out to 36 months CDR-SB Improvement – No/Low Tau Population CDR-SB – Aβ Baseline < 60 CL 100% 90% 60% improvem 80% ent at 18 51% months improvem 70% Patients (%) ent at 36 60% months 50% 40% 51
Slide 15: Simplified diagnosis and continued development of Leqembi could increase patient population
Simplified diagnosis and continued development of Leqembi could increase patient population and convenience Approved Rolling submission (8 geographies) Submitted (US) finalized (US) To be submitted Intravenous Intravenous Subcutaneous Subcutaneous Convenient treatment maintenance maintenance initial
Slide 16: Financial Summary
Financial Summary 16 BioArctic AB
Slide 17: Leqembi US sales lower than expected, offset by strong development in Japan and China
Leqembi US sales lower than expected, offset by strong development in Japan and China – Eisai revises forecast • Global sales Q3-24 were ¥ 10 B ( ~67 MUSD), ~66% BioArctic royalty increase from Q2-24 − Royalties increased by 64% to SEK 69.8 M 80 69.8 • US expansion slower than expected 70 − ~ ¥ 5.9
Slide 18: Operating loss of SEK 26 M in the third quarter
Operating loss of SEK 26 M in the third quarter Net Revenues (SEK M) OPEX by function (SEK M) Operating Profit/Loss (SEK M) 121 393 101 95 301 88 78 131 209 Other G&A 50 77 3 11 30 M&S -26 2 -60 -78 -73 -76 -101 R&D Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2022 2023 2024 2023 2
Slide 19: Growing royalties further strengthen the financial base
Growing royalties further strengthen the financial base Net Result (SEK M) Cash Flow From Operating Cash Balance (SEK M) Activities (SEK M) 1 106 1 112 294 301 1 042 998 991 125 805 890 804 126 -58 -58 -20 -58 -64 -53 -94 -80 -102 -87 -68 -114 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
Slide 20: Upcoming news flow and closing remarks
Upcoming news flow and closing remarks 20 BioArctic AB
Slide 21: Upcoming news flow
Upcoming news flow Q4 2024 Q1 2025 Q2 2025 Q3 2025 Congresses CTAD, Oct 29 - Nov 1 AD/PD, Apr 1 - Apr 5 AAIC, Jul 27 - Jul 31 Potential US approval Start of Phase 2a with Potential US approval of lecanemab of lecanemab iv exidavnemab subcutaneous maintenance dosing maintenance dosing Final CHMP opin
Slide 22: In summary
In summary Leqembi royalty Early pipeline Finances remain revenue continues progressing well solid to grow 22 BioArctic AB
Slide 23: BioArctic mission statement
” BioArctic will, through world-leading innovative research, create drugs that improve the lives of patients with neurodegenerative diseases. 23 BioArctic AB