- Strong revenue generation in Q4 2023 including
SEK 43m in Idefirix® product sales supported by growth in new markets such asU.K. ,Germany , andSpain - Encouraging results from first-in-human trial of HNSA-5487
- Initiation of phase 1b trial of imlifidase as pre-treatment to Sarepta's SRP-9001 in DMD
Highlights for the fourth quarter of 2023
- Strong commercial performance. Total Q4 revenue of
SEK 50m includingSEK 43m in product sales andSEK 7m under our agreement mainly with Sarepta. Idefirix® sales were driven by growth in new markets such asU.K. ,Germany , andSpain . -
Medical guidelines and recommendations including use of Idefirix® implemented on a national level in
Italy andGermany . - NICE-01 phase 1 (HNSA-5487): Following positive results from the first-in-human trial of HNSA-5487, the lead candidate from the NiceR program for repeat dosing, an analysis of additional exploratory endpoints on IgG recovery and immunogenicity is being conducted for completion in 2024.
-
AMR (antibody-mediated transplant rejection) phase 2: Full data published in
December 2023 . Imlifidase met the primary endpoint; explorative secondary outcome measures were not designed nor sufficiently powered to show statistical significance versus the control arm. -
GBS (Guillain-Barré Syndrome) phase 2: Positive high-level data announced in
December 2023 as imlifidase demonstrated positive safety, tolerability, and early efficacy outcomes. Further analysis will contextualize the efficacy data. -
SRP-9001-104 phase 1b trial (Duchenne Muscular Dystrophy, DMD): The first clinical study with imlifidase as a pre-treatment to Sarepta's SRP-9001 gene therapy in DMD was initiated
mid-December 2023 . First patient is expected to be dosed in early 2024. -
On
October 17, 2023 ,Hansa announced 5-year data from the long-term follow-up study of imlifidase, demonstrating 90% patient survival and 82% graft survival in extended pooled analysis with data from the 17-HMedIdeS-14 study. -
On
December 5, 2023 ,Hansa announced plans to restructure the organization to better align and focus on key clinical development and commercial priorities. The planned restructuring should result in an approximately 20-25% reduction in the current workforce and will provide approximatelySEK 75-85 million in annual savings, when fully implemented.
Clinical pipeline update
- US ConfIdeS phase 3 trial (kidney transplantation): 104 patients have been enrolled with 40 of 64 targeted patients randomized in this pivotal
U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation. - GOOD-IDES-02 phase 3 (anti-GBM disease): 18 of 50 targeted patients enrolled in this global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Completion of enrollment is expected in 2025.
- Investigator-initiated phase 2 trial (ANCA-associated vasculitis): 3 of 10 targeted patients enrolled.
Events after closing period
- On
January 6, 2024 ,Hansa andNewBridge Pharmaceuticals announced their partnership to enable supply of Idefirix® to kidney transplant patients in theMiddle East andNorth Africa (MENA). -
On
February 1, 2024 ,Hansa Biopharma and Medison Pharma announced positive reimbursement decision inSlovenia for Idefirix® in highly sensitized kidney transplant patients. With this, commercial access to Idefirix® has now been obtained in 14 European countries. -
First patient treated in the new Eurotransplant Desensitization Program, under the Acceptable Mismatch Program, which is intended to transform desensitization across eight European member countries including
Germany , the Benelux and select Eastern European countries.
Financial summary
SEKm, unless otherwise stated - unaudited | Q4 2023 | Q4 2022 | 12M 2023 | 12M 2022 |
Revenue | 50.4 | 30.8 | 134.1 | 154.5 |
- thereof: Product sales | 43.3 | 20.3 | 103.7 | 86.7 |
SG&A expenses | (107.8) | (83.7) | (452.3) | (337.9) |
R&D expenses | (108.3) | (92.3) | (411.3) | (346.2) |
Loss from operation | (177.3) | (146.2) | (790.3) | (588.6) |
Loss for the period | (126.2) | (148.7) | (833.5) | (611.1) |
Net cash used in operations | (172.9) | (110.1) | (755.7) | (502.7) |
Cash and short-term investments | 732.1 | 1,496.2 | 732.1 | 1,496.2 |
EPS before and after dilution (SEK) | (2.40) | (3.22) | (15.86) | (13.60) |
Number of outstanding shares | 52,671,796 | 52,443,962 | 52,671,796 | 52,443,962 |
Weighted avg. no of shares before and after dilution | 52,671,796 | 46,128,829 | 52,540,089 | 44,923,998 |
No of employees at the end of the period | 168 | 150 | 168 | 150 |
Søren Tulstrup, President and CEO of
"
I am particularly excited about the encouraging first results from the first-in-human trial of HNSA-5487,
In kidney transplantation, we continue to see good commercial progress in
During the fourth quarter, we also saw increased patient identification through organ allocation systems such as Eurotransplant where both a first and second wave patient assessment took place with the new Desensitization Program. This new pilot program, under the Acceptable Mismatch Program, is intended to transform desensitization across eight European member countries including
In the
Beyond our core markets, we continue to expand access to imlifidase for highly sensitized kidney transplant patients through a new commercial partnership with
Further, I am also pleased to see positive data from our long-term follow-up study further supporting the clinical benefit of imlifidase in kidney transplantation out to year five. The five-year data demonstrate graft survival in line with outcomes seen at 3-years post-transplant.
Beyond kidney transplantation, we shared data read-outs from two phase 2 programs in AMR and GBS. In the AMR phase 2 trial (16-HMedIdes-12), imlifidase met the primary endpoint demonstrating statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to plasma exchange which is a common part of a standard of care treatment. While we are encouraged to have met the primary endpoint, it is important to note that the secondary endpoints were not met as the trial was not designed nor sufficiently powered to show a statistically significant difference between the two arms given the heterogeneity of patients, involving many patients with an additional cellular component of the immune rejection, and the small number of patients enrolled. Patients with an acute AMR may be best placed to benefit from a rapid and significant reduction in DSA levels.
In the GBS phase 2 study (15-HMedIdeS-09), high level data was announced in
In our pivotal phase 3 program in anti-glomerular basement membrane (anti-GBM) disease (GOOD-IDES-02), we continue to see good progress, with 18 of 50 targeted patients enrolled as of
Further, I am happy to report that the first clinical study with imlifidase in gene therapy was recently commenced by our partners from
Lastly, we recently announced plans to restructure the organisation to better align and focus on key clinical development and commercial priorities. This is expected to result in an approximate 20-25% reduction in the current workforce and will yield approximately
While we firmly believe this initiative is a necessary action to help us deliver on our important mission, it was obviously a difficult decision to take as it impacts our most valuable asset - our people. We are grateful for the commitment and relentless efforts of our colleagues who have worked tirelessly to advance potentially lifesaving medicines for people suffering from serious immunological diseases and conditions and we remain committed to supporting those colleagues impacted by the restructure.
I look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises in 2024."
Upcoming milestones and news flow
2024 First high level data read-out from phase 1b study in DMD with Sarepta (NEW)
2024 GBS Phase 2: Outcome of the comparative efficacy analysis
2024 Genethon Crigler-Najjar Phase 1/2: Initiate clinical study with imlifidase prior to GNT-0003
2024 HNSA-5487: Further analysis around endpoints in FIH trial
2024
2025
2025 Anti-GBM disease Phase 3: Completion of enrollment (NEW)
Updated financial calendar 2024
Conference call details
The event will be hosted by
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The year-end report and latest investor presentation can be downloaded from our web:
Interim report January to
Investor road show presentation Q4, 2023 https://www.hansabiopharma.com/investors/presentations/
This is information that
For more information:
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