Hansa Biopharma AB · OMXSTO:HNSA
Hansa Biopharma AB — Q4 2021 Earnings Presentation
16 slides from Hansa Biopharma AB's earnings presentation, Feb 3, 2022
Slide 1: Conference Call Presentation - Year-end Report 2021
Conference Call Presentation Year-end Report 2021 Lund, February 3, 2022
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: Solid progress across the business as Hansa concludes 2021
Solid progress across the business as Hansa concludes 2021 Highlights for the fourth quarter of 2021 ü Launch and market access efforts in Europe progressing as planned - Market access procedures are ongoing in 14 countries - Health Technology Assessment dossier for Spain submitted during January 20
Slide 4: Progress with commercial metrics; market access procedures ongoing in fourteen countries
Progress with commercial metrics; Market access procedures ongoing in fourteen countries Pricing and Reimbursement processes on track; ESOT workstream formed with leading Completion of HTA filings in EU4+UK experts to advance clinical guidelines in desensitization Pricing and Reimbursement Market ac
Slide 5: New multiregional commercialization partnership with Medison Pharma
New multiregional commercialization partnership with Medison Pharma Partnership will cover Poland, Croatia, Hungary and Slovenia in addition to Israel • Multiregional agreement for Medison to commercialize Idefirix® for kidney transplants in certain countries in Central Eastern Europe and Israel • T
Slide 6: Collaboration with AskBio to evaluate imlifidase in gene therapy targeting Pompe disease
Collaboration with AskBio to evaluate imlifidase in gene therapy targeting Pompe disease Feasibility program to evaluate imlifidase as pre-treatment ahead of gene therapy in Pompe disease for patients with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV) Fully owned subsid
Slide 7: Exploring potential use of imlifidase in allogeneic HSCT
Exploring potential use of imlifidase in allogeneic hematopoietic stem cell transplantation (HSCT) Desensitization treatment of patients with high levels of donor specific antibodies (DSA) prior to allogeneic HSCT transplant is a challenge; Imlifidase may have the potential to inactivate DSAs prior
Slide 8: 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
Slide 9: Ongoing Clinical Programs
Ongoing Clinical Programs Fourth quarter highlights • First patients enrolled in the pivotal U.S. ConfIdeS study in kidney transplant • Alignment with FDA on a Phase 3 study of imlifidase in anti-GBM patients • AMR: Patient enrollment on track for completion first half 2022, as previously guided • G
Slide 10: Revenue amounted to SEK 15m for Q4'21 and SEK 34m for FY'21
Revenue amounted to SEK 15m for Q4’21 and SEK 34m for FY’21 Revenue (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 15 Product sales 9 9 SEKm 4,9 Revenue 6 4,5 3,8 Recognition 2,4 4,4 5,3 Sarepta 2,6 3,6 1,2 0,5 0,9 0,6 1,1 Axis-Shield Revenue (FY/FY) 2019 2020 2021 34 Product sales 15,0 SEKm Revenue 15,7 Recog
Slide 11: Continued investments in our commercialization and pipeline
Continued investments in our commercialization and pipeline SG&A expenses (Q/Q) R&D expenses (Q/Q) Net loss (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 -63 -60 -81 -83 -47 -103 -50 -55 -106 -104 -61 SEKm SEKm SEKm -68 -133 -148 -163 SG&A expenses (
Slide 12: Operations financed into 2023
With current cash position and projected burn-rate, operations is financed into 2023 Operating cash flow (Q/Q) Cash & short-term investments (Q/Q) Shareholders’ equity (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 -39% -35% -97 -121 -113 -116 -132 SEKm SEKm SEKm 1 139 1 007 1 378 1 255 889 1 242 1 031 900 758
Slide 13: Upcoming milestones
Upcoming milestones Milestones subject to potential COVID-19 impact Kidney Long-term follow- AMR Anti-GBM transplantation GBS Phase 2 up data 5-years Kidney Phase 2 complete Initiation of U.S. complete first data read out* out in kidney transplantation enrollment Phase 3 study enrollment (Timeline g
Slide 14: Q&A
Q&A … at Hansa Biopharma we envision a world Visit our web site www.hansabiopharma.com where all patients with rare immunologic diseases can lead long and healthy lives… 14
Slide 15: Corporate Contacts
Corporate Contacts Visit our web site Investor Relations and www.hansabiopharma.com Corporate Communications Calendar and events Feb 3 2022 Year-End report for Jan - Dec 2021 Klaus Sindahl Mar 10 2022 Erik Penser Bolagsdag, Stockholm Head of Investor Relations Mar 10 2022 Redeye Investor Forum, Goth
Slide 16: HANSAT
MZ HANSAT BIOPHARMA