Bioarctic Ab Class B · OMXSTO:BIOA_B
Bioarctic Ab Class B — Q3 2023 Earnings Presentation
20 slides from Bioarctic Ab Class B's earnings presentation, Nov 8, 2023
Slide 1: Q3 Report July-September 2023
Q3 Report July-September 2023 Stockholm, November 8, 2023 Gunilla Osswald, PhD, CEO Anders Martin-Löf, CFO BioArctic AB
Slide 2: 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 3: 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 − Disorders with significant unmet needs and large patient populations, creating big commercial opportunity • World-class research and development o
Slide 4: Highlights in and after the quarter
Highlights in and after the quarter • Leqembi approved and launched in the US • Leqembi approved in Japan, milestone of EUR 17 M • Agreed on lecanemab commercialization and co-promotion for the Nordics with Eisai • New data from Clarity AD OLE presented at CTAD supporting subcutaneous, early treatme
Slide 5: Leqembi U.S. launch progressing as planned
Leqembi U.S. launch progressing as planned – Eisai reiterates expectation of 10,000 patients on treatment by end of March 2024 Approx. 800 patients5 • ~2,5001 neurologists or AD (as of October 27) specialists have established diagnostic and infusion pathway • Aim for further growth after Jan. 6 Full
Slide 6: Introduction of Leqembi facilitated by imaging and blood diagnostics
Introduction of Leqembi facilitated by imaging and blood diagnostics 2023 2024 2025 2026 CMS reimbursement ~2024 Blood ~2026 Blood biomarkers of amyloid PET biomarkers for for confirmatory in expanded Oct 13 triaging (potential) clinical praxis (potential) Biomarkers used to identify relevant patien
Slide 7: Lecanemab has the potential to become the first anti-Aβ antibody to receive full approval globally
Lecanemab has the potential to become the first anti-Aβ antibody to receive full approval globally USA Japan EU China Rest of World FDA granted Leqembi Applications submitted in PMDA approval Marketing authorization Initiated Biologics traditional approval and Canada, Great Britain, September 25, 20
Slide 8: Highlights from CTAD – data on subcutaneous, early and maintenance dosing
Highlights from CTAD – data on subcutaneous, early and maintenance dosing further support LEQEMBI • Strong data presented for LEQEMBI Lecanemab • Subcutaneous treatment with Leqembi leads to 14% more reduction of Aβ compared to intravenous with similar ARIA Placebo • Treatment with Leqembi that begi
Slide 9: Alzheimer's disease & Neuronal synucleinopathies: Lecanemab and exidavnemab
Alzheimer’s disease & Neuronal synucleinopathies (NSD) Lecanemab and exidavnemab Lecanemab: Exidavnemab (BAN0805): • Aβ-selective antibody for toxic aggregated • α-syn-selective antibody for toxic aggregated forms forms • First and only fully approved disease • Only symptomatic treatments available,
Slide 10: Exidavnemab (BAN0805)
Exidavnemab (BAN0805) potential disease modifying antibody in Parkinson’s disease towards Phase 2 High unmet medical need Unique profile Pre-clinical proof of concept No existing disease- Unique and targeted binding profile • Reduction of neurotoxic alpha-synuclein oligomers/protofibrils modifying t
Slide 11: Decision to start Phase 2a for Exidavnemab (BAN0805)
Decision to start Phase 2a for Exidavnemab (BAN0805) 2024 Offers opportunities in several neuronal synucleinopathies (NSD) Parkinson’s disease (PD) Ph2a Parkinson’s disease dementia (PDD) in Parkinson’s disease (PD) Lewy body dementia (DLB) Multiple system atrophy (MSA) Biomarkers available to ident
Slide 12: A balanced project portfolio, with a focus on neurodegenerative diseases
A balanced project portfolio, with a focus on neurodegenerative diseases September 30, 2023 Regulatory Project Partner Discovery Preclinical Phase 1 Phase 2 Phase 3 & Market ALZHEIMER’S DSEASE Lecanemab (BAN2401) (Clarity AD) Eisai1 Early Alzheimer’s disease2 Lecanemab (BAN2401) (AHEAD 3-45) Eisai1
Slide 13: Financial Summary
Financial Summary 13 BioArctic AB
Slide 14: Eisai aims to achieve ¥10 B revenue level in fiscal year 2023
Eisai aims to achieve ¥ 10 B revenue level in fiscal year 2023 (Apr-23 to Mar-24) Current rapid US sales growth week over week sets foundation for FY 2023 aim • Leqembi sales in Q3 were ¥ 0.4 B • Recorded Q3 BioArctic royalty was SEK 2.5 M • Eisai aim to reach ¥ 10 B in Apr-23 – Mar-24 (SEK ~700 M)
Slide 15: Operating expenses 2023 within guidance
Operating expenses 2023 within guidance Net Revenues (SEK M) OPEX by item (SEK M) Operating Profit/Loss (SEK M) 120 104 301 393 96 100 86 78 80 132 131 61 218 60 48 50 209 45 40 20 -39 -44 -46 -60 -101 5 4 4 2 3 0 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2021 2022 2023
Slide 16: Strong financial position
Strong financial position Cash Balance (SEK M) Cash Flow From Operating Net Result (SEK M) Activities (SEK M) 294 1 106 299 1 042 998 848 801 863 805 137 125 752 112 -19 -44 -46 -58 -102 -39 -40 -46 -58 -64 -53 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 2021 2022 2023 20
Slide 17: Upcoming news flow and closing remarks
Upcoming news flow and closing remarks 17 BioArctic AB
Slide 18: Upcoming news flow
Upcoming news flow Q4 2023 Q1 2024 Q2 2024 Congresses CTAD, Oct 24-27 AD/PD Mar 5-9 Leqembi price and Lecanemab Potential first sale of reimbursement s.c. and maintenance lecanemab in EU decision in Japan dosing U.S. regulatory filings Lecanemab EU & China regulatory response s.c. – subcutaneous 18
Slide 19: BioArctic will create drugs that improve the lives of patients
” BioArctic will, through world-leading innovative research, create drugs that improve the lives of patients with neurodegenerative diseases. 19 BioArctic AB
Slide 20: IR team
IR team GUNILLA OSSWALD, CEO ANDERS MARTIN-LÖF, OSKAR BOSSON, VP CECILIA LANNEBO, CFO COMMUNICATIONS & IR DIRECTOR IR To subscribe to financial reports/press releases and for more information, please visit www.bioarctic.com Contact: Next Report: Oskar Bosson, Q4 Report VP Communications & IR Oct-Dec