Slide 1: Q1 Report January – March 2024
Q1 Report January – March 2024 Stockholm, May 17, 2024 BioArctic AB
Slide 2: Presenting team
Presenting team GUNILLA OSSWALD, ANDERS MARTIN-LÖF, ANNA-KAIJA GRÖNBLAD, To subscribe to financial CEO CFO CCO reports/press releases and for more information, please visit www.bioarctic.com IR contact: Oskar Bosson, VP Communications & IR +46 704 10 71 80 ir@bioarctic.se Next Report: Q2 Report Apri
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 unique Swedish biopharma company
BioArctic – a unique Swedish biopharma company Improving life for patients with central nervous system disorders Focus on neurodegenerative disorders with large unmet medical need World-class research and development organization, collaborations with leading academic researchers and pharma companies
Slide 5: Important events in and after Q1 2024
Important events in and after Q1 2024 • Leqembi approved China – launch planned for July 2024 • The EMA announced that its deliberations on lecanemab regarding the Marketing Authorisation Application has been rescheduled due to procedural reasons • Eisai submitted an sBLA for less frequent IV mainte
Slide 6: Lecanemab first disease-modifying Alzheimer treatment with full approval globally
Lecanemab is the first disease-modifying Alzheimer disease treatment to receive full approval globally, establishing new standard of care USA Japan EU China Rest of World Applications submitted in FDA granted Leqembi PMDA approval Marketing authorization NMPA approval Australia, Brazil, Canada, (lec
Slide 7: US – Leqembi launch transitioning toward a new phase
US – Leqembi launch transitioning toward a new phase • Diagnosis and treatment pathway established to a large extent • Transitioning to prescription expansion phase • Strengthening Go-to-Market structure (unit: Number of vials) (Billions of yen) 30 7000 2.44 6000 25 5000 20 4000 15 3000 1.04 10 2000
Slide 8: Japan – Leqembi launch progressing faster than expected; China preparing
Japan – Leqembi launch progressing faster than expected China – preparing for launch in July Japan Diagnosis and treatment pathway in Japan • Establishment of the pathway has been fast, and the launch is exceeding initial target # of facilities 600 • Diagnosis and treatment for eligible patients are
Slide 9: Continued development of Leqembi increases patient convenience
Continued development of Leqembi increases patient convenience Rolling submission Approved (US, JP, CH) Submitted (US) initiated (US) To be submitted Intravenous Intravenous Subcutaneous Subcutaneous treatment maintenance maintenance initial & 10 mg/kg 10 mg/kg 360 mg maintenance bi-weekly monthly w
Slide 10: Leqembi brings value to patients, caregivers and society
Leqembi brings value to patients, caregivers and society Broad patient Early and ARIA real world population in early continuous clinical practice Alzheimer’s treatment for in line with clinical disease long-term trials as in US (No tau PET patient benefit Package Insert inclusion criteria) Subcutane
Slide 11: Pipeline highlight: Next generation CNS treatments with BrainTransporter
Pipeline highlight Next generation CNS treatments with BrainTransporter Active transport of treatments to the brain highlighted as next big step in CNS at AD/PD Continued development of BioArctic’s proprietary BrainTransporter (BT) technology Alzheimer • BAN2802 (undisclosed target with BT) – resear
Slide 12: Pipeline highlight: Exidavnemab – several different indications
Pipeline highlight Exidavnemab – possibilities in several different indications Development of treatments and biomarkers for neuronal synucleinopathies highlighted at AD/PD Preparing for Phase 2a in Parkinson’s disease (EXIST) • Study focused on safety, tolerability and pharmacokinetics • Will inclu
Slide 13: 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 14: Financial Summary
Financial Summary 14 BioArctic AB
Slide 15: Leqembi royalties are growing fast
Leqembi royalties are growing fast BioArctic royalty including amounts to • Global Leqembi Q1-24 sales were ¥ 2.82 B be passed on to LifeArc (SEK ~200 M), ~170% increase over Q4-23 25 • Royalty rate of 9% on global net sales 21.3 − Recorded royalty includes additional 1% on US sales 20 and 1.5% on e
Slide 16: Eisai forecasts more than tenfold sales increase for Leqembi in FY2024
Eisai forecasts more than tenfold sales increase for Leqembi in their fiscal year 2024 (Q2-24 to Q1-25) FY 2023 FY 2024 (Q2-23 to Q1-24) (Q2-24 to Q1-25) ¥ 4.3 B ¥ 56.5 B (SEK ~300 M) (SEK ~3.9 B) 18% • This corresponds to SEK ~400 M in royalty Q2-24 to Q1-25 9% 77% • Eisai’s mid-term revenue simula
Slide 17: Operating loss of SEK 73 M in the first quarter
Operating loss of SEK 73 M in the first quarter Net Revenues (SEK M) OPEX by function (SEK M) Operating Profit/Loss (SEK M) 104 101 393 88 301 79 78 132 131 Other 218 209 G&A 11 30 M&S -46 -60 4 2 3 -101 -78 -73 R&D Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 2022 2023 2024 2023 2
Slide 18: Strong financial position going forward
Strong financial position going forward Cash Balance (SEK M) Cash Flow From Operating Net Result (SEK M) Activities (SEK M) 1 106 1 112 299 294 1 042 998 991 863 805 112 117 137 752 125 -46 -58 -64 -53 -46 -114 -58 -102 -87 -58 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Slide 19: Upcoming news flow and closing remarks
Upcoming news flow and closing remarks 19 BioArctic AB
Slide 20: Upcoming news flow
Upcoming news flow Q2 2024 Q3 2024 Q4 2024 Q1 2025 Congresses AAIC, Jul 28 - Aug 1 CTAD, Oct 29 - Nov 1 Potential approval of Launch of Leqembi in Planned start of lecanemab China Phase 2a with in Great Britain exidavnemab Potential EU approval US submission of of lecanemab New data on lecanemab SC-
Slide 21: In summary
In summary Leqembi sales in the Early pipeline US and Japan progressing well and Finances remain showing strong first BrainTransporter solid momentum. China agreement signed launching in July 21 BioArctic AB
Slide 22: BioArctic mission statement
” BioArctic will, through world-leading innovative research, create drugs that improve the lives of patients with neurodegenerative diseases. 22 BioArctic AB