Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — FY2023 Earnings Presentation
18 slides from Hansa Biopharma Ab's earnings presentation, Feb 2, 2024
Slide 1: Conference Call Presentation
Conference Call Presentation Year-end report January – December 2023 Lund, February 2, 2024
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: Hansa enters 2024 in a strong position to successfully execute on our key priorities
Hansa enters 2024 in a strong position to successfully execute on our key priorities 1 Q4: Strong commercial performance 2 Pipeline: Encouraging read-outs across several indications ü Strong revenue generation in Q4 2023 ü AMR: Full data from AMR phase 2 study • SEK 43m in Idefirix product sales • G
Slide 4: Key strategic priorities
Key strategic priorities Commercialize Idefirix® in Advance our ongoing Expand our IgG-cleaving first indication and markets clinical programs enzyme technology 1 2 3 • Successfully launch • Achieve approval/ • Expand IgG-cleaving Idefirix® in Europe usage of imlifidase in enzyme technology • Secure
Slide 5: Continued progress against our key launch metrics led by in-market growth
Continued progress against our key launch metrics led by in-market growth Market Market Patient Transplant Center Development Access Identification Readiness & Use 7 14 28 ~50 - Medical guidelines 9 6 25 implemented on a national Market access secured in Post Approval Study ~50 clinics are Idefirix
Slide 6: Potential to disrupt transplantation care in the U.S. with imlifidase
Potential to disrupt transplantation care in the U.S. with imlifidase ConfIdeS phase 3 trial will further advance potential for imlifidase to address unmet need in desensitization Involved ConfIdeS sites cover more than 20% of U.S. ConfIdeS total transplantation volumes in the U.S1 Phase 3 463 UW Se
Slide 7: Commercial partnership with NewBridge Pharmaceuticals expands market to MENA
Commercial partnership with NewBridge Pharmaceuticals expands market to Middle East & North Africa (MENA) The MENA region will be the third region outside Europe where Idefirix is commercialized aimed at enabling kidney transplantation in highly sensitized kidney transplant patients GCC Key centers
Slide 8: Advancing HNSA 5487 – a high potential next-gen enzyme for repeat dosing
Advancing HNSA 5487 – a high potential next-gen enzyme for repeat dosing Broaden the IgG free window Rapidly cleaves IgG and could potentially create a HNSA-5487 longer IgG-low period Engineered for lower immunogenicity Address unmet need in autoimmune disease Short and long-term Powerful 5487 IgG c
Slide 9: Potential indication landscape for HNSA-5487 and reasons to believe
Potential indication landscape for HNSA-5487 and reasons to believe First in Human Study Results Long interval Short interval redosing redosing ü Administration was safe and well in combination with humoral inhibitor tolerated AAV Gene therapy Longer-term oncolytic virus ü PD showed a fast and compl
Slide 10: Strong momentum across the pipeline in areas of high unmet need
Strong momentum across the pipeline in areas of high unmet need Phase 1 Phase 2 Phase 3 HNSA-5487 (Lead from NiceR) Antibody Mediated Rejection (AMR) US ConfIdeS Study in kidney • Encouraging first read-out • Primary endpoint met • 104 patients enrolled; Completed • Ongoing collection of Completed •
Slide 11: Strong revenue generation in Q4 2023, including SEK 43m in Idefirix product sales
Strong revenue generation in Q4 2023, including SEK 43m in Idefirix product sales Product sales improved +113% vs Q4 2022 and +163% vs Q3 2023; Growth driven by uptake in U.K., Spain, Germany Revenue (Q/Q) Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 50.4 Product sales SEKm 36.7 30.8 24.2 43.3 22.8 20.3 29.6 14.3
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) Operating loss (Q/Q) Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 -146 -84 -92 -93 -96 -182 -176 -103 -106 -108 -202 -112 -115 -228 SEKm SEKm SEKm -129 SG
Slide 13: With current cash position and projected burn-rate, Hansa's operations are 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) Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 1,496 168 168 -110 -183 -173 -207 -193 1,287 SEKm 162 1,103 Employees 159 SEKm 908 732 O
Slide 14: 2023 achievements and upcoming milestones 2024/25
2023 achievements and upcoming milestones 2024/25 2023 2024 2025 Q4 2023 HNSA-5487 (Lead NiceR candidate): GBS Phase 2: - U.S. ConfIdeS (Kidney tx) Phase 3: ✓ - Outcome of comparative efficacy analysis High-level data readout from Phase 1 BLA submission Long-term follow-up (Kidney tx): Genethon Crig
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, autoimmune diseases, and gene therapy
Broad clinical pipeline in transplantation, autoimmune diseases, and gene therapy 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 reim
Slide 17: Contact our Investor Relations and Corporate Affairs team
Contact our Investor Relations and Corporate Affairs team Contact Calendar and events Feb 6, 2024 Aktiespararna, Falkenberg Klaus Sindahl Feb 8, 2024 Frankfurt MidCap Seminar, Frankfurt VP, Head of Investor Relations Feb 14, 2024 Redeye Cell Therapy & Growth Day, Stockholm Mobile: +46 (0) 709-298 26
Slide 18: HANSAT
MZ HANSAT BIOPHARMA