Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Q3 2025 Earnings Presentation
26 slides from Hansa Biopharma Ab's earnings presentation, Oct 30, 2025
Slide 1: Interim Results January - September 2025
Interim Results January - September 2025 October 30, 2025
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: Q3 2025 Results Conference Call Agenda
Q3 2025 Results Conference Call Agenda 30 October 2025 CEO Remarks Renée Aguiar-Lucander CEO Operational Update Maria Törnsén COO, President US Pipeline Update Richard Philipson Chief Medical Officer Financial Results Evan Ballantyne Chief Financial Officer Close and Q&A Renée Aguiar-Lucander CEO ©
Slide 4: Key Achievements in Q3 2025
Key Achievements in Q3 2025 Transformation of the Commercial & Pipeline Business Update Successfully addressed the company’s IDEFIRIX sales YTD 102% of 2024 sales YTD 143.6 MSEK, increase of 25.4%. reporting and capital structure Q3 30.1 MSEK vs 39.8 MSEK Q3 24. Initiatives planned to accelerate gro
Slide 5: European Commercial Operations Review
European Commercial Operations Review Challenging Backdrop Large Growth Potential • Organizational structure • Limited clinical data available reviewed for accountability, • Few European sites involved in focus and efficiencies Phase 2 trial – very limited KOL experience • Need for drafting and Acti
Slide 6: USA Market Overview
USA Market Overview Large and robust clinical trial Data read out from PAES data available pre-launch study Significant KOL experience Real world data from Europe Price set by company based Well researched and on research and setting structured launch plan Centralised organ allocation Strong market
Slide 7: Q3 2025 Results Conference Call Agenda
Q3 2025 Results Conference Call Agenda 30 October 2025 CEO Remarks Renée Aguiar-Lucander CEO Operational Update Maria Törnsén COO, President US Pipeline Update Richard Philipson Chief Medical Officer Financial Results Evan Ballantyne Chief Financial Officer Close and Q&A Renée Aguiar-Lucander CEO ©
Slide 8: Q3 Performance impacted by seasonality and Germany pause of prioritized AM program
Q3 Performance impacted by seasonality and Germany pause of prioritized AM* program Performance Market Priority Activities Access Slower than expected due to few Continued P2P education on transplants during summer and National coverage in 21 countries guidelines and delisting practices impact of pa
Slide 9: The US Market Represents a Significant Opportunity
The US Market Represents a Significant Opportunity US Transplant Waitlist ~ 15% of patients are highly sensitized (cPRA > 80%) The US represents a significant market opportunity ~100,000 ~15k highly sensitized on the wait list patients with cPRA >80% ~45,000 new additions to the wait list each year
Slide 10: Following positive ConfIdeS data, US Launch Planning Activities are ongoing
Following positive ConfIdeS data, US Launch Planning Activities are ongoing US Represents a Significant Market Opportunity US and European markets are different US has a National Organ Allocation System where HS ~15,000 Highly Sensitized (HS)* patients on the waitlist – each patients are priorit
Slide 11: Q3 2025 Results Conference Call Agenda
Q3 2025 Results Conference Call Agenda 30 October 2025 CEO Remarks Renée Aguiar-Lucander CEO Operational Update Maria Törnsén COO, President US Pipeline Update Richard Philipson Chief Medical Officer Financial Results Evan Ballantyne Chief Financial Officer Close and Q&A Renée Aguiar-Lucander CEO ©
Slide 12: ConfIdeS
ConfIdeS An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA>99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care Renal function in highly s
Slide 13: Study Design
Study Design Imlifidase Organ offer R Pre-screening Screening Delisting of Eligibility unacceptable assessment antigen(s) Control 12 months Imlifidase arm: accept organ offer; if treatment results in xm-conversion from positive to negative, then proceed to transplant Control arm: EITHER accept organ
Slide 14: Disposition and Demographics
Disposition and Demographics Imlifidase Control Total Disposition n (%) (N=32) (N=32) (N=64) Randomized 32 (100) 32 (100) 64 (100) Treated with imlifidase 30 (93.8) 0 (0) 30 (46.9) Completed study 30 (93.8) 28 (87.5) 58 (90.6) Sex, n (%) Female 18 (56.3) 15 (46.9) 33 (51.6) Male 14 (43.8) 17 (53.1)
Slide 15: Efficacy Outcomes
Efficacy Outcomes Imlifidase Control Imlifidase eGFR Control p-value n n (mean) eGFR (mean) Primary endpoint 32 32 51.5 19.3 <0.0001 eGFR at 12 months in FAS Rank-based non-parametric analysis 32 32 50.0* 0* 0.0001 of eGFR at 12 months eGFR at 12 months in patients transplanted based on organ offer
Slide 16: Safety Outcomes in Imlifidase-Treated Patients
Safety Outcomes in Imlifidase-Treated Patients • Tolerability of imlifidase was good • There was a low incidence of infusion reactions, and no infusions were interrupted due to an infusion reaction • Infections observed in imlifidase-treated patients were typically not related to treatment • The AE
Slide 17: ConfIdeS - Conclusions
ConfIdeS - Conclusions • The treatment arms were well-balanced at baseline, and the demographic characteristics reflected a highly sensitised, dialysis-dependent population wait-listed for transplantation • Retention in the study was excellent; 58/64 patients (90.6%) completed the study • The primar
Slide 18: GOOD-IDES-02 Phase 3 Trial Top Line Data Expected in Q4 2025
GOOD-IDES-02 Phase 3 Trial Top Line Data Expected in Q4 2025 Results from Phase 2 Study GOOD-IDES-03 Open Label Results Published in JASN (2022) Phase 3 Trial Fully enrolled 50 patients from 30+ centers in US, UK and EU Primary endpoint: eGFR at 6 months Imlifidase granted orphan drug Key seco
Slide 19: Q3 2025 Results Conference Call Agenda
Q3 2025 Results Conference Call Agenda 30 October 2025 CEO Remarks Renée Aguiar-Lucander CEO Operational Update Maria Törnsén COO, President US Pipeline Update Richard Philipson Chief Medical Officer Financial Results Evan Ballantyne Chief Financial Officer Close and Q&A Renée Aguiar-Lucander CEO ©
Slide 20: Q3 & YTD 2025 IDEFIRIX Sales Performance
Q3 & YTD 2025 IDEFIRIX Sales Performance Revenue (Q/Q) Product Sales(Q/Q) Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 66.3 48.7 49.1 MSEK MSEK 32.3 30.8 65,7 Product 65,7 39,8 Sales 47,8 47,8 25,6 39,8 30,1 30,1 25,6 8,9 Contract 6,7 Revenue* 0,7 1,4 0,7 Revenue (FY/YTD Q3 2025) Prod
Slide 21: Continued investments in R&D and commercialization
Continued investments in R&D and commercialization SG&A Expenses (Q/Q) R&D Expenses (Q/Q) Operating Loss (Q/Q) Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 -76 -76 -64 -93 MSEK -70 MSEK MSEK -88 -91 -88 -80 -117 -101 -96 -155 -148 -174 SG&A Expenses (FY/F
Slide 22: Summary of Cash & Headcount
Summary of Cash & Headcount Operating Cash Flow (Q/Q) Cash & Cash Equivalents (Q/Q) 888 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 636 MSEK 554 MSEK -99 -112 405 354 -149 -148 -152 250 252 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25* * Pro-forma cash is 888 MSEK including net proceeds from the October 1st capital raise Operat
Slide 23: Q3 2025 Results Conference Call Agenda
Q3 2025 Results Conference Call Agenda 30 October 2025 CEO Remarks Renée Aguiar-Lucander CEO Operational Update Maria Törnsén COO, President US Pipeline Update Richard Philipson Chief Medical Officer Financial Results Evan Ballantyne Chief Financial Officer Close and Q&A Renée Aguiar-Lucander CEO ©
Slide 24: Highly experienced leadership team
Highly experienced leadership team Proven track record delivering growth, approvals, and launches across renal, rare disease, and immunology Renée Aguiar-Lucander Maria Törnsén CEO COO, President US 20+ yrs rare disease leader and former investor, took Successfully launched multiple orphan drugs in
Slide 25: Q&A
Q&A © 2025, Hansa Biopharma AB 25
Slide 26: Hansa Biopharma
MZ HANSAT BIOPHARMA