Slide 1: Q2 Report April – June 2024
Q2 Report April – June 2024 Stockholm, August 29, 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: Q3 Report July - September 2024 on November 14, 2024 To subscribe to financial reports/press releases and for more information, please visit www.
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: Important events in and after Q2 2024
Important events in and after Q2 2024 Lecanemab • The FDA accepted Eisai’s sBLA for less frequent monthly IV maintenance dosing of Leqembi • Eisai received Fast Track designation and initiated a rolling BLA to the FDA for subcutaneous maintenance dosing of Leqembi • Leqembi was approved in South Kor
Slide 5: Lecanemab is the first disease-modifying Alzheimer disease treatment to receive 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 Approvals: FDA granted Leqembi PMDA approval Marketing authorization NMPA approval South Korea, Israel, (lecanemab) traditional S
Slide 6: Regulatory update for the EU
Regulatory update for the EU 6 BioArctic AB
Slide 7: Leqembi authorised in Great Britain on August 22, 2024
Leqembi authorised in Great Britain on August 22, 2024 • Leqembi authorised in Great Britain, for the treatment Clinical decline as measured by of early AD in adult patients that are ApoE4 CDR-SB for the indicated population heterozygotes or non-carriers • In the indicated population, Leqembi reduce
Slide 8: AAIC highlights – Long-term lecanemab data show increased patient benefit
AAIC highlights – Long-term lecanemab data show increased patient benefit with maintained safety profile 36-month data showed increasing clear and >50% of patients in the earliest stage of AD meaningful long-term treatment effect continued to show improvement after 36 months No new safety findings w
Slide 9: Clinical Dementia Rating (CDR) – 0.5 points matter
Clinical Dementia Rating (CDR) – 0.5 points matter Lecanemab prolongs time in the earlier stages of disease where individuals are still independent CDR-SB score 0.5 – 4.0 MCI 4.5 – 9.0 Mild AD 9.5 – 15.5 Moderate AD 16 – 18 Severe AD Clarity AD baseline: 3.2 9 BioArctic AB Source: https://knightadrc
Slide 10: Simplified diagnosis and continued development of Leqembi could increase patient population and convenience
Simplified diagnosis and continued development of Leqembi could increase patient population and convenience Approved Rolling submission (8 geographies) Submitted (US) initiated (US) To be submitted Intravenous Intravenous Subcutaneous Subcutaneous Convenient treatment maintenance maintenance initial
Slide 11: 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 12: Preparation for Phase 2a for exidavnemab 2024
Preparation for Phase 2a for exidavnemab 2024 Offers opportunities in several neuronal synucleinopathies (NSD) Biomarkers available to identify patients with pathological α-syn 12 BioArctic AB
Slide 13: Exidavnemab Phase 2a study EXIST in Parkinson's disease
Exidavnemab Phase 2a study “EXIST” in Parkinson's disease 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 & tolerability Inclusion criteria: • I
Slide 14: Financial Summary
Financial Summary 14 BioArctic AB
Slide 15: Leqembi royalties are growing fast
Leqembi royalties are growing fast BioArctic royalty • Global Q2-24 sales were ¥ 6,3 B ($ ~40 M), ~120% increase over Q1-24 45 42.6 40 • US expansion started picking up speed Monthly US in May Leqembi sales 35 − Eisai/Biogen increase in commercial 3 structure completed, ~450 positions in place 2.1 2
Slide 16: Eisai forecast reiterated with more than tenfold sales increase for Leqembi
Eisai forecast reiterated with 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
Slide 17: Operating loss of SEK 76 M in the second quarter
Operating loss of SEK 76 M in the second quarter Net Revenues (SEK M) OPEX by function (SEK M) Operating Profit/Loss (SEK M) 121 301 393 104 101 88 Other 132 131 78 218 209 G&A 50 M&S 2 3 11 30 -60 -78 -73 -76 R&D -101 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q2 Q3 Q4 Q1 Q2 2022 2023 2024 202
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 1 042 1 112 299 294 998 991 863 805 890 112 117 137 125 -58 -64 -53 -114 -94 -58 -87 -58 -68 -102 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2
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 Q3 2024 Q4 2024 Q1 2025 Q2 2025 Congresses AAIC, Jul 28 - Aug 1 CTAD, Oct 29 - Nov 1 AD/PD, Apr 1 - Apr 5 Leqembi launched Planned start of Potential approval of in China Phase 2a with IV maintenance exidavnemab dosing Leqembi authorized in Great Britain New data on Potential EU a
Slide 21: In summary
In summary Leqembi sales growing fast. Early pipeline Finances remain Now launched in the progressing well solid US, Japan and China 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