Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Q3 2023 Earnings Presentation
18 slides from Hansa Biopharma Ab's earnings presentation, Oct 26, 2023
Slide 1: Conference Call Presentation
Conference Call Presentation Interim report January – September 2023 Lund, October 26, 2023
Slide 2: Forward-looking statements
Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on our current expectations and beliefs regarding future events and are subject to significant uncertainties and risks since they relate to events and depend on circumstances that will occ
Slide 3: Continued progress with our strategic priorities
Continued progress with our strategic priorities Q3: Continued progress against 1 our key launch metrics 2 Advancing the pipeline • Anticipate sales growth in coming periods as • Anti-GBM: Good momentum in pivotal phase 3 positive first outcomes leads to repeat usage • ANCA: New IIT phase 2 initiate
Slide 4: Long-term market uptake of Idefirix depends on successful early experiences in patients
The long-term market uptake of Idefirix is highly dependent on successful early experiences in patients For decades, medical practice (SoC) in transplantation Idefirix addresses the limitations of these other has been predicated on compatibility as modalities modalities and is the first and only app
Slide 5: Continued progress against key launch metrics; Major markets to support growth
Continued progress against key launch metrics; Major markets to support growth going forward Market Market Patient Transplant Center Development Access Identification Readiness & Use 5 13 16 ~50 - Medical guidelines 9 2 25 issued by ESOT Market access secured Post Approval Study ~50 clinics are Idef
Slide 6: Eurotransplant Desensitization Program set to transform desensitization across eight countries
Eurotransplant Desensitization Program set to transform desensitization across eight European membership countries First patients selected for treatment through the Desensitization Program Eurotransplant zone 8 member countries Eurotransplant Kidney Acceptable Mismatch Allocation System (AM) Program
Slide 7: Potential to disrupt transplantation care in the U.S. with imlifidase
Potential to disrupt transplantation care in the U.S. with imlifidase ~2,500 highly sensitized patients that have not been ConfIdeS phase 3 trial will further advance potential for transplanted despite prioritization points on the waitlist imlifidase to address unmet need in desensitization Increasi
Slide 8: Long term data confirms sustained benefit at five years
Long term data confirms sustained benefit at five years in graft survival and overall patient survival Stable long-term outcomes on graft Results is a continuation of the 3-year data survival and patient survival • After 5 years graft survival (death censored) was 82%, in line with outcomes seen at
Slide 9: Encouraging high-level results for HNSA-5487 first in human trial
Encouraging high-level results for HNSA-5487 first in human trial Lower immunogenicity would potentially allow for repeat dosing in a range of IgG-driven indications High-level results from 36 healthy volunteers Potential indication universe for HNSA-5487 • Study design: Double blind, randomized, pl
Slide 10: Continued momentum with seven clinical programs in areas of high unmet need
Continued momentum with seven clinical programs in areas of high unmet need New clinical program in DMD planned for Q4 Phase 1 Phase 2 Phase 3 HNSA-5487 (Lead from NiceR) Antibody Mediated Rejection (AMR) US ConfIdeS Study in kidney • Positive topline data on primary • 87 patients enrolled; more tha
Slide 11: Q3 2023 Revenue amounted to SEK ~23m
Q3 2023 Revenue amounted to SEK ~23m including SEK ~17m in product sales Revenue (Q/Q) Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 67.1 22.7 36.7 30.8 SEKm 24.2 22.8 43.7 Product sales 20.3 29.6 14.3 16.5 Revenue recognition from 9.2 AskBio and Sarepta 9.0 6.4 5.7 Axis-Shield 0.7 1.3 0.9 0.6 0.6 Revenue (9M/9M) 9
Slide 12: Continued investments in commercialization and R&D activities
Continued investments in commercialization and R&D activities SG&A expenses (Q/Q) R&D expenses (Q/Q) Net loss (Q/Q) Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 -154 -149 -83 -84 -90 -92 -93 -96 -103 -205 -112 -115 SEKm SEKm -251 -251 SEKm -129 SG&A expen
Slide 13: Operations financed into 2025
With current cash position and projected burn-rate, Hansa’s operations are financed into 2025 Operating cash flow (Q/Q) Cash & short-term investments (Q/Q) Number of employees (Q/Q) Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 -110 -129 1,496 -182 -193 -207 SEKm 1,287 1,215 Employees 1,103 168 SEKm 908 162 159 Ope
Slide 14: Achieved and upcoming milestones
Achieved and upcoming milestones 2023 2024 9M 2023 Q4 2023 U.S. ConfIdeS (Kidney tx) Phase 3: HNSA-5487 (Lead NiceR candidate): ✓ ✓ - GBS Phase 2: Continued enrollment beyond 64 patients High-level data readout from Phase 1 Outcome of the comparative efficacy analysis to IGOS data Anti-GBM disease P
Slide 15: Q&A
Q&A Visit our website hansabiopharma.com … at Hansa Biopharma we envision a world where all patients with rare immunologic diseases can lead long and healthy lives… 15
Slide 16: Broad clinical pipeline in transplantation and autoimmune diseases
Broad clinical pipeline in transplantation and autoimmune diseases Research/ Marketing Project Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Partner Next Anticipated Milestone EU: Additional agreements around EU: Kidney transplantation in highly sensitized reimbursement / Pos
Slide 17: Contact our Investor Relations and Corporate Affairs team
Contact our Investor Relations and Corporate Affairs team Contact Calendar and events Klaus Sindahl Oct 26, 2023 Interim Report for January-September 2023 Nov 21, 2023 SEB Healthcare Seminar 2023, Stockholm VP, Head of Investor Relations Nov 23, 2023 Redeye Life Science Day, Stockholm Mobile: +46 (0
Slide 18: HANSAT
MZ HANSAT BIOPHARMA