Søren Tulstrup, President and CEO, Hansa Biopharma stated: “For the third consecutive quarter, Hansa Biopharma delivered solid IDEFIRIX ® sales performance driven by continued utilization of IDEFIRIX in key transplant centers across all major European markets. Additionally, we continued to progress key trials across the pipeline. Notably, we completed randomization of all patients in ConfIdeS, our pivotal Phase 3 US trial in kidney transplantation, and look forward to communicating data in the second half of 2025 with an expected Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA). Also, our Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease and the European Post Authorization Efficacy Study (PAES) in kidney transplant have both increased enrollment and remain on track. Looking ahead, the Company has several important milestones in the second half, including further analysis of data from the Phase 1 study of HNSA-5487, the Company’s second-generation IgG cleaving enzyme designed to be re-dosed.”
Monetary Efficiency
The Firm delivered robust monetary efficiency for the third consecutive quarter with whole income of 54.2 MSEK. Of this, 47.1 MSEK is attributed to IDEFIRIX gross sales. This excludes the influence of an approximate 20 MSEK provision associated to potential worth changes from cumulative gross sales for the reason that launch of IDEFIRIX in
Gross sales efficiency was primarily pushed by continued enlargement of IDEFIRIX in key European markets. So far, the Firm has secured reimbursement in 14 European markets.
In Q2 2024, the Firm accomplished a directed share problem, elevating gross proceeds of 372 MSEK (US
Pipeline Progress
Progress throughout the pipeline included the finished randomization within the ConfIdeS pivotal Part 3 US trial in kidney transplantation, additional enrollment within the European Put up Approval Efficacy Research in kidney transplantation (70 %) with anticipated completion by 2025, and continued enrollment (70 %) within the GOOD-IDES-12 Part 3 trial in anti-GBM illness with knowledge readout in 2025.
Monetary Abstract
|
MSEK, until in any other case acknowledged “ unaudited |
Q2 2024 |
Q2 2023 |
H1 2024 |
H1 2023 |
|
Income |
34.3 |
36.7 |
90.3 |
60.8 |
|
– thereof: Product gross sales1(Q2 product gross sales 47.1 MSEK much less provision 19.9 MSEK = 27.2 MSEK) |
27.2 |
29.6 |
74.7 |
43.9 |
|
SG&A bills |
(88.2) |
(129.5) |
(179.5) |
(232.8) |
|
R&D bills |
(91.7) |
(114.7) |
(194.6) |
(207.5) |
|
Loss from operations |
(187.4) |
(228.5) |
(346.8) |
(410.8) |
|
Loss for the interval |
(207.9) |
(251.2) |
(426.5) |
(456.6) |
|
Web money utilized in operations |
(189.2) |
(181.9) |
(378.3) |
(388.9) |
|
Money and short-term investments |
705.0 |
1,102.5 |
705.0 |
1,102.5 |
|
EPS earlier than and after dilution (SEK) |
(3.30) |
(4.79) |
(7.38) |
(8.71) |
|
Variety of excellent shares |
67,814,241 |
52,443,962 |
67,814,241 |
52,443,962 |
|
Weighted common variety of shares earlier than and after dilution |
62,929,675 |
52,443,962 |
57,800,736 |
52,443,962 |
|
No of staff on the finish of the interval |
146 |
162 |
146 |
162 |
|
1 Â Product gross sales within the second quarter 2024 totaled 47.1 MSEK. Gross sales had been offset by a provision totalling 19.9 MSEK for potential credit related to quantity reductions and potential refunds. First half 2024 product gross sales totaled 94.6 MSEK and had been offset by the supply totaling 19.9 MSEK. Web of the supply, first half product gross sales totaled 74.7 MSEK. |
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Convention Name Particulars
Hansa Biopharma will host a phone convention at the moment
The occasion can be hosted by Søren Tulstrup, President and CEO,
Slides used within the presentation can be stay on the corporate web site in the course of the name underneath “Events & Presentations” and also will be made accessible on-line after the decision. Hyperlink to presentation
To take part within the phone convention, please use the dial-in particulars offered under:
Participant entry code: 765135
The webcast can be accessible on https://hansabiopharma.eventcdn.web/occasions/half-year-january-june-2024 Â
For the total monetary calendar and checklist of occasions in 2024 please go to https://www.hansabiopharma.com/buyers/calendar/
That is data that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.
For extra data:
Evan Ballantyne, Â CFO
E: Â ir@hansabiopharma.com
Stephanie Kenney, Â VP World Company Affairs
E: Â media@hansabiopharma.com
About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical firm on a mission to develop and commercialize progressive, lifesaving and life altering therapies for sufferers with uncommon immunological situations. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme remedy, which has been proven to allow kidney transplantation in extremely sensitized sufferers. Hansa has a wealthy and increasing analysis and growth program, based mostly on the Firm’s proprietary IgG-cleaving enzyme expertise platform, to handle severe unmet medical wants in transplantation, autoimmune illnesses, gene remedy and most cancers. Hansa Biopharma relies in
This data was dropped at you by Cision http://information.cision.com
https://information.cision.com/hansa-biopharma-ab/r/hansa-biopharma-reports-second-quarter-2024-financial-results-and-business-update,c4016231
The next recordsdata can be found for obtain:
|
https://mb.cision.com/Important/1219/4016231/2919974.pdf |
20240718 HNSA – Q2 2024 Quarterly Report ENG |
