First commercial sales of Idefirix® recorded in Q1; New preclinical collaboration with argenx; Encouraging three-year follow-up data in kidney transplantation
Highlights for the first quarter 2021
- First commercial sales of Idefirix® recorded in Q1 2021 following treatment of the first patients. Commercial launch activities in early launch countries continue to be carried out as planned. National level reimbursement application processes underway and decisions by authorities in the first markets expected from mid-year and onwards.
-
First Healthcare Technology Assessment report published in
Sweden . The Swedish "TLV" assessment is favorable to the use of Idefirix® in highly sensitized patients incompatible with a deceased donor. Hansa Biopharma enters into preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies' IgG-modulating technologies for potential use in both the acute and chronic setting of autoimmune diseases and transplantation.- Encouraging three-year follow-up outcome and safety data in imlifidase treated transplant patents in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data expected to be presented later in the year in a peer-reviewed journal.
Magnus Korsgren , M.D., Ph.D. appointed new Head of R&D.Dr Korsgren will lead research and development activities based onHansa's proprietary enzyme technology platform as the Company expands into new therapeutic areas.- Patient recruitment in the phase 2 studies in AMR and GBS ongoing under a risk-based, site-by-site approach due to the COVID-19 pandemic. In the AMR trial, 9 out of a target of 30 patients have been enrolled, and in the GBS trial 8 out of 30 have been enrolled.
-
US trial:
Hansa continues to be in productive dialogue with the FDA and expects to reach an agreement near-term with the Agency on the protocol for a randomized controlled study in the US. Preparatory work to initiate the trial is ongoing.Hansa expects to initiate the trial over summer and to recruit the first patient in the second half of 2021. -
COVID-19 pandemic: The global COVID-19 pandemic may still adversely impact
Hansa Biopharma's operational business and trial activities.
Events after the end of the reporting period
Hilary Malone , PhD. in Molecular Neuropharmacology (born 1965,U.S. andUK citizen) proposed as new member of the Board of Directors at the next AGM.Dr. Malone is currently COO and EVP atValo Health, Inc. (U.S. ) and has held global executive positions atSanofi ,Reata Pharmaceuticals ,Pfizer , Wyeth andAstraZeneca , among others.Birgit Stattin Norinder has decided not to stand for re-election to the Board of Directors at the next AGM.
Financial summary
- Solid cash position of
SEK 1,255m at the end ofMarch 2021 . -
Investments in SG&A and R&D in the first quarter amounting to
SEK 60m (Q1'20:SEK 39m ) andSEK 47m (Q1'20:SEK 53m ), respectively, in line with plans. -
Cash flow from operating activities for the first quarter ended at
SEK -121m (Q1'20:SEK -121m ).
SEKm, unless otherwise stated - unaudited | Q1 2021 | Q1 2020 | FY 2020 |
Revenue | 9.0 | 0.9 | 6.1 |
Gross profit | 7.3 | 0.5 | 5.1 |
SG&A expenses | -60.1 | -38.7 | -203.0 |
R&D expenses | -47.4 | -52.5 | -227.2 |
Operating profit/loss | -103.7 | -91.4 | -422.8 |
Net profit/loss | -103.9 | -93.4 | -420.9 |
Cash flow from operating activities | -120.9 | -121.2 | -290.3 |
Cash and short-term investments | 1,254.7 | 476.9 | 1,377.5 |
Shareholders' equity | 1,149.8 | 473.9 | 1,242.1 |
EPS before and after dilution (SEK) | -2.34 | -2.33 | -9.98 |
Number of outstanding shares | 44,473,452 | 40,026,107 | 44,473,452 |
Weighted avg. number of shares before and after dilution | 44,473,452 | 40,026,107 | 42,176,872 |
Number of employees | 101 | 78 | 87 |
Søren Tulstrup, President and CEO of
"
Our long-term objective is to build
In
On
In the US,
In our ongoing phase 2 programs, GBS and AMR, we see patient enrollment progressing again following a temporary halt in the recruitment process during large parts of 2020 due to the COVID-19 pandemic. In
Furthermore, I am pleased to announce that our long-term follow-up study in highly sensitized kidney patients continues to show encouraging outcomes after imlifidase treatment and transplantation. We now have three-year data available, demonstrating follow-up outcomes in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. Data is expected to be published later this year following submission of a manuscript to a peer-reviewed journal.
I am also happy to see that we continue to attract the talent and competences needed to build a high-performance organization. In March, we announced the recruitment of
Speaking about attracting highly qualified, international competences, I am also very pleased to see
Upcoming milestones and news flow
H1 2021 NiceR: initiate IND-enabling tox studies
Q2/Q3 2021 First national reimbursement agreement
H2 2021 Kidney transplantation US: First patient dosed
H2 2021 AMR Phase 2 study: Complete enrollment
H2 2021 GBS Phase 2 study: Complete enrollment
H2 2022 Kidney transplantation US: Complete enrollment
H2 2022 AMR Phase 2 study: Data read out
H2 2022 GBS Phase 2 study: Data read out
H2 2023 Kidney transplantation US: 12 months follow-up completed
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/2021q1/
The interim report and latest investor presentation can be downloaded from our web
Interim report January -
https://investors.hansabiopharma.com/English/financial-data/quarterly-report/default.aspx
Investor road show presentation Q1, 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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