- Commercial launch and market access efforts in
Europe progressing as planned; new multiregional commercialization partnership with Medison Pharma - First patients enrolled into the pivotal
U.S. ConfIdeS study - Agreement established with AskBio to evaluate feasibility of imlifidase as pre-treatment ahead of gene therapy in Pompe disease
- Platform strategy:
Hansa to explore desensitization treatment in allogeneic hematopoietic stem cell transplantation - Year-end cash position of
SEK 889 million ;Hansa financed into 2023, as previously guided
Highlights for the fourth quarter 2021
- Commercial launch and market access efforts for Idefirix® in
Europe are progressing as planned. Reimbursement has been secured inSweden andthe Netherlands , as well as on an individual hospital basis inFinland andGreece . -
Market access procedures are ongoing in 14 countries including
Germany ,France ,Italy and theUnited Kingdom (U.K. ). AHealth Technology Assessment (HTA) dossier forSpain was submitted inJanuary 2022 , which completes HTA filings in all of the five largest markets inEurope . -
In
December 2021 ,Hansa and Medison Pharma announced a multiregional commercialization partnership for Idefirix® for kidney transplantion coveringIsrael and major countries in the Central Eastern European region. -
The first patients in the pivotal
U.S. open-label, randomized, controlled trial "ConfIdeS," were enrolled at theColumbia University Medical Center ,New York duringDecember 2021 . -
Clinical pipeline update: In the Antibody Mediated Rejection (AMR) trial, 23 patients out of a target of 30 patients have been enrolled, and in the Guillain Barré Syndrome (GBS) trial 15 patients out of a target of 30 patients have been enrolled as of
February 2 2022 . The widespread impact of the COVID-19 pandemic and the emergence of the Omicron variant have impacted the availability of staff across a number of trial centers. Additionally, a shortage of IVIg has affected the enrollment rate at a subset of participating hospitals in our GBS program. Given the current difficulty of predicting enrollment due to the direct and indirect effects of the continued pandemic and increased infection rates due to omicron,Hansa expects to update its guidance related to the GBS timelines in April, in connection with the publication of its Q1 report. In the meantime, in order to support mitigating these hurdles,Hansa has simplified the study protocol, is actively supporting the hiring of additional staff at the clinics and is adding two sites for the recruitment of patients in theU.K. andthe Netherlands . -
Plans to initiate a Phase 3 study of imlifidase to treat anti-Glomerular Basement Membrane (anti-GBM) disease were announced in
November 2021 , after a successful pre-IND meeting with theU.S. FDA. The planned pivotal Phase 3 clinical study will enroll approximately 50 patients with anti-GBM disease across theU.S. andEurope . The first patient is expected to be enrolled in 2022. - Partnership with Sarepta and preclinical collaboration with argenx moving forward according to plan.
Events after the reporting period
- On
January 3, 2022 ,Hansa entered into an agreement with AskBio to evaluate the potential use of imlifidase as a pre-treatment prior to the administration of AskBio's investigational gene therapy in Pompe disease in a pre-clinical and clinical feasibility program for patients with pre-existing neutralizing antibodies (Nabs). Upon execution,Hansa receives aUSD 5 million payment, while AskBio has an exclusive option to negotiate a full development and commercialization agreement. -
On
January 9, 2022 ,Hansa announced that it intends to explore the potential development of imlifidase in allogeneic hematopoietic stem cell transplantation (HSCT), also known as "bone-marrow transplantation".
Financial summary
- Cash position of
SEK 889m at the end ofDecember 2021 , expected to fundHansa's operations into 2023. -
Investments in R&D in the fourth quarter amounted to
SEK 68m (Q4'20:SEK 50m ) and toSEK 231m for the full year of 2021 (full year '20:SEK 227m ). SG&A expenses amounted toSEK 103m in Q4 2021 (Q4'20:SEK 63m ) and toSEK 327m for the full year 2021 (full year '20:SEK 203m ), in line with plans. -
Cash flow from operating activities for the fourth quarter of 2021 was
SEK -116m (Q4 '20:SEK -97m ) andSEK -481m for the full year 2021 (full year '20: -290m).
SEKm, unless otherwise stated - unaudited | Q4 2021 | Q4 2020 | 12M 2021 | 12M 2020 |
Revenue | 15.4 | 3.8 | 33.9 | 6.1 |
SG&A expenses | -103.2 | -63.2 | -327.3 | -203.0 |
R&D expenses | -68.2 | -50.4 | -230.8 | -227.2 |
Operating profit/loss | -162.8 | -106.2 | -547.0 | -422.8 |
Net profit/loss | -163.4 | -105.8 | -548.3 | -420.9 |
Cash flow from operating activities | -116.3 | -96.5 | -481.2 | -290.3 |
Cash and short-term investments | 889.0 | 1,377.5 | 889.0 | 1,377.5 |
Shareholders' equity | 757.6 | 1,242.1 | 757.6 | 1,242.1 |
EPS before and after dilution (SEK) | -3.67 | -2.38 | -12.33 | -9.98 |
Number of outstanding shares | 44,473,452 | 44,473,452 | 44,473,452 | 44,473,452 |
Weighted avg. number of shares before and after dilution | 44,473,452 | 44,473,452 | 44,473,452 | 42,176,872 |
Number of employees at the end of the period | 133 | 87 | 133 | 87 |
Søren Tulstrup, President and CEO of
"2021 was, overall, a transformative and successful year for
From a strategic point of view, we have executed throughout the year on our key priorities, including meeting our R&D, commercial and organizational objectives. In addition, I am very encouraged to see the high level of interest from other healthcare companies to partner with
On the operational side, we have seen solid execution in expanding our market access and geographical footprint in
In the
In gene therapy, we were excited to announce an agreement with AskBio, a subsidiary of
Turning to our ongoing Phase 2 programs for GBS and AMR, we have enrolled 23 out of a target of 30 patients in the AMR study while 15 out of a target of 30 patients have been enrolled in the GBS study as of
In regards to our GBS program we see how the impact of the COVID-19 pandemic and the emergence of the Omicron variant have affected the availability of staff across a number of trial centers. Additionally, a shortage of IVIg has affected the enrollment rate in the GBS program at a subset of participating hospitals. Given the current difficulty of predicting enrollment due to the direct and indirect effects of the continued pandemic and increased infection rates due to omicron,
In anti-GBM disease,
As part of
An exciting year lies ahead of us with many potential milestones to be achieved across our platform and many indication areas. I look forward to updating you on our progress."
Upcoming milestones and news flow
H1'22 AMR Phase 2 study: Complete enrollment
Under review GBS Phase 2 study: Complete enrollment (Due to COVID Hansa expects to update its guidance in
2022 NiceR: Completion of GLP tox studies
2022 Anti-GBM: Initiation of phase 3 study
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: First data read out
Under review GBS Phase 2 study: First data read out (Due to COVID Hansa expects to update its guidance in
2023 Long-term follow-up data 5-years out in kidney transplantation
H2 2023 Kidney transplantation US: complete 12 months follow-up
H1 2024 Kidney transplantation US: BLA submission
Conference call details
The presentation will be held in English and be hosted by
To participate in the telephone conference, please use the dial-in details provided below:
The webcast will be available on https://streams.eventcdn.net/hansa/q4-2021/
The interim report and latest investor presentation can be downloaded from our web
Year-end report 2021
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q4, 2021
https://investors.hansabiopharma.com/English/events-and-presentations/presentations/default.aspx
This is information that
For further information, please contact:
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
Head of Corporate Communications
Mobile: +46 (0) 768-198 326
E-mail: katja.margell@hansabiopharma.com
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