Søren Tulstrup, President and CEO, Hansa Biopharma said: “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.”
Financial Performance
The Company delivered strong financial performance for the third consecutive quarter with total revenue of 54.2 MSEK. Of this, 47.1 MSEK is attributed to IDEFIRIX sales. This excludes the impact of an approximate 20 MSEK provision related to potential price adjustments from cumulative sales since the launch of IDEFIRIX in
Sales performance was primarily driven by continued expansion of IDEFIRIX in key European markets. To date, the Company has secured reimbursement in 14 European markets.
In Q2 2024, the Company completed a directed share issue, raising gross proceeds of 372 MSEK (US
Pipeline Progress
Progress across the pipeline included the completed randomization in the ConfIdeS pivotal Phase 3 US trial in kidney transplantation, further enrollment in the European Post Approval Efficacy Study in kidney transplantation (70 percent) with expected completion by 2025, and continued enrollment (70 percent) in the GOOD-IDES-12 Phase 3 trial in anti-GBM disease with data readout in 2025.
Financial Summary
|
MSEK, unless otherwise stated “ unaudited |
Q2 2024 |
Q2 2023 |
H1 2024 |
H1 2023 |
|
Revenue |
34.3 |
36.7 |
90.3 |
60.8 |
|
– thereof: Product sales1(Q2 product sales 47.1 MSEK less provision 19.9 MSEK = 27.2 MSEK) |
27.2 |
29.6 |
74.7 |
43.9 |
|
SG&A expenses |
(88.2) |
(129.5) |
(179.5) |
(232.8) |
|
R&D expenses |
(91.7) |
(114.7) |
(194.6) |
(207.5) |
|
Loss from operations |
(187.4) |
(228.5) |
(346.8) |
(410.8) |
|
Loss for the period |
(207.9) |
(251.2) |
(426.5) |
(456.6) |
|
Net cash used in operations |
(189.2) |
(181.9) |
(378.3) |
(388.9) |
|
Cash and short-term investments |
705.0 |
1,102.5 |
705.0 |
1,102.5 |
|
EPS before and after dilution (SEK) |
(3.30) |
(4.79) |
(7.38) |
(8.71) |
|
Number of outstanding shares |
67,814,241 |
52,443,962 |
67,814,241 |
52,443,962 |
|
Weighted average number of shares before and after dilution |
62,929,675 |
52,443,962 |
57,800,736 |
52,443,962 |
|
No of employees at the end of the period |
146 |
162 |
146 |
162 |
|
1 Product sales in the second quarter 2024 totaled 47.1 MSEK. Sales were offset by a provision totalling 19.9 MSEK for potential credits associated with volume discounts and potential refunds. First half 2024 product sales totaled 94.6 MSEK and were offset by the provision totaling 19.9 MSEK. Net of the provision, first half product sales totaled 74.7 MSEK. |
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Conference Call Details
Hansa Biopharma will host a telephone conference today
The event will be hosted by Søren Tulstrup, President and CEO,
Slides used in the presentation will be live on the company website during the call under “Events & Presentations” and will also be made available online after the call. Link to presentation
To participate in the telephone conference, please use the dial-in details provided below:
Participant access code: 765135
The webcast will be available on https://hansabiopharma.eventcdn.net/events/half-year-january-june-2024
For the full financial calendar and list of events in 2024 please visit https://www.hansabiopharma.com/investors/calendar/
This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act.
For more information:
Evan Ballantyne, CFO
E: ir@hansabiopharma.com
Stephanie Kenney, VP Global Corporate Affairs
E: media@hansabiopharma.com
About Hansa Biopharma
Hansa Biopharma is a pioneering commercial-stage biopharmaceutical company on a mission to develop and commercialize innovative, lifesaving and life altering treatments for patients with rare immunological conditions. Hansa has developed a first-in-class immunoglobulin G (IgG) antibody cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients. Hansa has a rich and expanding research and development program, based on the Company’s proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in transplantation, autoimmune diseases, gene therapy and cancer. Hansa Biopharma is based in
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20240718 HNSA – Q2 2024 Quarterly Report ENG |