Hansa Biopharma AB · OMXSTO:HNSA
Hansa Biopharma AB — Redeye Conference, Stockholm 2022
17 slides from Hansa Biopharma AB's conference presentation, Aug 31, 2022
Slide 1: Investor Presentation
Investor Presentation Redeye Conference, Stockholm August 31, 2022 Klaus Sindahl Head of Investor RelationsPresident & CEO
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 Biopharma today
Hansa Biopharma today Successful track record... A validated Idefirix® is our first Broad pipeline in Strong momentum... technology approved drug in transplantation and Europe* autoimmunity Promising future... VALIDATION ACROSS EUROPE KIDNEY THREE AREAS TRANSPLANTS PROGRAMS IN CLINICAL DEVELOPMENT A
Slide 4: Many milestones achieved during the last 15 months
Many milestones achieved during the last 15 months Pricing and Marketing ESOT guidelines published in reimbursement authorization in Transplant International achieved for Israel for Idefirix® First patient enrolled in Idefirix® in Germany (imlifidase) the U.S. pivotal First national market access ra
Slide 5: Imlifidase
Imlifidase A novel approach to eliminate pathogenic IgG Origins from a bacteria A unique IgG antibody-cleaving enzyme Inactivates IgG in 2-6 hours Streptococcus pyogenes • Species of Gram-positive, • Interacts with Fc-part of IgG with extremely high specificity • Rapid onset of action that inactivat
Slide 6: Potential indication universe
Gene therapy pre-treatment Potential indication universe (partnership opportunities) Transplantation and post transplantation (Own commercial infrastructure in EU/US) … … … Limb- Transplantation and Pompe post transplantation Girdle … Lung Heart disease (LGMD) Other areas Lung Duchenne First generat
Slide 7: Our Business model
Our Business model Leveraging our technology platform to develop new therapies targeting rare diseases with unmet medical need across a range of indications Growth engine Value chain Commercialization Leveraging our We are controlling Build-up of Indications Multiple proprietary antibody the full va
Slide 8: Idefirix (imlifidase) has received conditional approval in the European Union
Idefirix® (imlifidase) has received conditional approval in the European Union Low Higher complexity complexity transplants transplants ~70% of patients1,2 15-20% of patients1,2 10-15% of patients1,2 Non or less sensitized Moderately sensitized Highly sensitized (cPRA < 20%) (20% < cPRA < 80%) (cPRA
Slide 9: The kidney transplantation landscape in Europe and the U.S.
The kidney transplantation landscape in Europe and the U.S. Up to 15% of patients waiting for a new kidney are highly sensitized ~50,000 transplants done annually in the U.S. and Europe Breakdown of the kidney transplant U.S. annual transplantations 5Y avg 22 083 Total YoY waitlist in U.S. and EU 20
Slide 10: Commercial sales uptake
Our center focused and sequenced launch process will help build the foundation for Idefirix® to become a new Standard of Care in transplantation Idefirix® is the first and only approved treatment in Europe for desensitization treatment of highly sensitized kidney transplant patients. The long-term m
Slide 11: Recommendation by NICE is an important step forward
Recommendation by NICE is an important step forward for our commercialization efforts and for patients in England, Wales & Northern Ireland NICE considers Idefirix® to be a clinically- and cost-effective treatment; Market access has now been secured in 7 European countries and procedures are ongoing
Slide 12: Broad clinical pipeline in transplantation and auto-immune diseases
Broad clinical pipeline in transplantation and auto-immune diseases Candidate/ Research/ Marketing Program Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Next Anticipated Milestone EU: Additional agreements EU: Kidney transplantation in highly sensitized patients 1,2 around re
Slide 13: Our unique antibody cleaving enzyme technology may have relevance across a range of indications
Our unique antibody cleaving enzyme technology may have relevance across a range of indications Expanding our commercial franchises Targeting rare IgG mediated diseases Regulatory approval (conditional) Clinical development Partnership (preclinical development) Preclinical development Potential indi
Slide 14: Hansa Biopharma is financed through 2024
Hansa Biopharma is financed through 2024 $70 million non-dilutive financing transaction announced in July 2022 to support the continued development of Hansa’s antibody-cleaving enzyme technology platform 1,600 1,476 1,378 ~1.3bn 1,400 Financing 1,255 SEK ~750m Raised Capital Raised Cash position 1,2
Slide 15: Upcoming milestones
Upcoming milestones Milestones subject to potential COVID-19 impact Anti-GBM Kidney transplantation GBS Kidney Initiation of U.S. complete Phase 2 complete GBS Phase 2 transplantation Phase 3 study enrollment enrollment first data read out U.S. BLA submission (2022) (H2 2022) (H2 2022) (H1 2023) (H1
Slide 16: Hansa Biopharma
MZ HANSAT BIOPHARMA
Slide 17: Investor Relations
Investor Relations Visit our web site www.hansabiopharma.com Calendar and events Klaus Sindahl Aug 31, 2022 Redeye Late-stage Life Science conference, Stockholm Head of Investor Relations Sept 7, 2022 Pareto annual Healthcare Conference 2022, Stockholm Sept 8, 2022 Citi's 17th Annual BioPharma Confe