Bioarctic Ab Class B · OMXSTO:BIOA_B
Bioarctic Ab Class B — Q4 2022 Earnings Presentation
17 slides from Bioarctic Ab Class B's earnings presentation, Feb 3, 2023
Slide 1: Q4 Report October-December 2022
BIOARCTIC AB (PUBL) NASDAQ STOCKHOLM: BIOA B Q4 Report October-December 2022 Stockholm, February 3, 2023 Gunilla Osswald, PhD, CEO Jan Mattsson, 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 High unmet need for disease-modifying treatments for Alzheimer’s and Parkinson’s diseases creates large commercial opportunity World-class research and development driven organization wit
Slide 4: Attractive and well-balanced project portfolio
Attractive and well-balanced project portfolio 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 Preclinical (asymptomatic) Alzheimer’s diseas
Slide 5: Partnership model to de-risk clinical development and optimize commercialization
Partnership model to de-risk clinical development and optimize commercialization opportunity Alzheimer’s disease Partner track record Discovered and developed Used to treat confusion world’s best-selling medicine (dementia) related to for symptoms in Alzheimer’s Alzheimer's disease Industry-leading
Slide 6: Q4 highlights
Q4 highlights Alzheimer’s disease – Lecanemab • Detailed and positive lecanemab data from the Phase 3 study, Clarity AD, were presented by Eisai at the CTAD Alzheimer Congress. The results were simultaneously published in the New England Journal of Medicine • Eisai initiated submission of data for B
Slide 7: Events after the end of the quarter
Events after the end of the quarter • In the U.S., lecanemab (brand name: LEQEMBITM) was granted accelerated approval as a treatment for Alzheimer’s disease by the FDA on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for a full approval under the tra
Slide 8: Clarity AD: lecanemab demonstrates Clinically Meaningful Effect
Clarity AD: lecanemab demonstrates Clinically Meaningful Effect Lecanemab met primary and all key secondary endpoints in Phase 3 Clarity AD study in 1795 early AD subjects with highly statistically significant results, reducing disease progression by 27% as measured by the primary endpoint CDR-SB* w
Slide 9: Disease modeling suggests lecanemab could delay progression to moderate Alzheimer's
Disease modeling suggests that lecanemab could delay progression to moderate Alzheimer´s Dementia by several years Estimated progression time to moderate Alzheimer’s Disease (AD) for patients completing the full lecanemab dosing regime compared with patients subject to standard of care (SOC) only Se
Slide 10: Lecanemab – broad late-stage clinical program
Lecanemab – broad late-stage clinical program Disease stage Early AD Pre-clinical AD MCI Mild AD Moderate AD Severe AD FDA guideline Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6 Clarity AD Phase 3 confirmatory study AHEAD 3-45 Phase 3 Program – ongoing open-label extension study – ongoing • Eisai
Slide 11: Financial Summary
Financial Summary 11 BioArctic AB
Slide 12: Operating expenses 2022 within guidance
Operating expenses 2022 within guidance Net Revenues (MSEK) OPEX by item (MSEK) Operating Profit/Loss (MSEK) 100 133 218 87 80 62 60 48 50 42 42 45 38 40 20 -29 -34 -37 -39 -44 -46 7 7 4 5 4 4 2 -61 0 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2021 2022 2021 2022 Project
Slide 13: BioArctic continues to have a strong financial position
BioArctic continues to have a strong financial position Cash Balance (MSEK) Cash Flow From Operating Net Result (MSEK) Activities (MSEK) 137 112 960 930 892 863 848 801 805 752 -19 -29 -34 -38 -44 -46 -29 -35 -58 -38 -39 -40 -46 -58 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q
Slide 14: Upcoming news and closing remarks
Upcoming news and closing remarks 14 BioArctic AB
Slide 15: Upcoming news flow
Upcoming news flow Alzheimer’s disease Parkinson’s disease Blood-brain barrier Other CNS disorders Lecanemab (Eisai) BAN0805 Brain Transporter (BT) Neurodegeneration • Data to be disclosed at Data presented at technology platform • Data to be disclosed at international congresses, including internat
Slide 16: BioArctic: With Patients in Mind
BioArctic: With Patients in Mind Great science Great projects Great partners Great people 16 BioArctic AB
Slide 17: Contact and next report
GUNILLA OSSWALD, CEO JAN MATTSSON, CFO OSKAR BOSSON, VP NEXT REPORT & IR COMMUNICATIONS & IR CONTACT • Next Report: Q1 Report Jan-Mar 2023 on Apr 27, 2023 • Contact: Oskar Bosson, VP Communications & IR +46 704 10 71 80 [email protected] To subscribe to financial reports/press releases and for more in