** Strong sales performance and solid momentum with the Phase 3 trial in anti-GBM disease
** Cash runway extended into 2026
**
Highlights for the first quarter of 2024
- Strong commercial performance. Total Q1 revenue of
SEK 56m including product sales ofSEK 47m - sales growth during Q1 2024 was driven by product sales in our largest European markets includingFrance ,UK , andGermany , as well as initial sales inBelgium . Represents first time Company has delivered two consecutive quarters of strong growth. -
IDEFIRIX has achieved pricing and reimbursement in 75% of the European kidney transplant market; Ongoing HTA processes in 11 countries including, most recently, in
Ireland . Evan Ballantyne joinedHansa Biopharma as Chief Financial Officer effectiveMarch 1, 2024 . Previously served as CFO ofGain Therapeutics, Inc. , aU.S. based biotech company. Evan brings toHansa more than 30 years of international experience as a senior financial executive in both public and private life science companies.
Clinical pipeline update
- US ConfIdeS trial (kidney transplantation): 122 patients have been enrolled with 49 of 64 targeted patients randomized in this pivotal, Phase 3 U.S. open label, randomized, controlled trial of imlifidase in kidney transplantation.
-
Post Approval Study (kidney transplantation): 36 patients have been treated (72% completion). The study will support full marketing authorization in
Europe and is expected to be completed by 2025. - Phase 3 (anti-GBM disease): 25 of 50 targeted patients enrolled in 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
- Cash runway extended into 2026: Raised SEK ~372m (USD ~34.6m) in a directed share issue targeting mainly high-quality international healthcare specialist investors.
Financial summary
SEKm, unless otherwise stated - unaudited | Q1 2024 | Q1 2023 | FY 2023 |
Revenue | 56.0 | 24.2 | 134.1 |
- thereof: Product sales | 47.4 | 14.3 | 103.7 |
SG&A expenses | (91.3) | (103.3) | (450.5) |
R&D expenses | (103.0) | (92.8) | (411.3) |
Loss from operation | (159.4) | (182.3) | (788.5) |
Loss for the period | (218.6) | (205.4) | (831.7) |
Net cash used in operations | (189.1) | (207.0) | (755.7) |
Cash and short-term investments | 541.5 | 1,286.8 | 732.1 |
EPS before and after dilution (SEK) | (4.15) | (3.92) | (15.83) |
Number of outstanding shares | 52,671,796 | 52,443,962 | 52,671,796 |
Weighted avg. no of shares before and after dilution | 52,671,796 | 52,443,962 | 52,540,089 |
No of employees at the end of the period | 166 | 159 | 168 |
Søren Tulstrup, President and CEO of
"I am very pleased with the strong commercial performance in the first quarter of 2024, the second consecutive quarter with solid product sales and a promising start to 2024. This strong sales performance is a continuation of the traction we saw at the end of last year where key large markets such as
Our clinical programs in kidney transplantation continue to progress at pace. Enrolment and randomization in our pivotal US Phase 3 trial (ConfIdeS) is advancing as expected. During the first quarter of 2024 four new sites have been activated and both screening and randomization of eligible patients have recently accelerated. We expect randomization to complete in mid-2024, as previously guided.
We have also made significant progress in the European post approval study - PAES - with more than a doubling of the number of patients treated in the trial in the last couple of quarters. This post approval study is an obligation under the European conditional marketing authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with IDEFIRIX. The study will also help generate important clinical experience in leading transplant centers in using IDEFIRIX as a new transformative desensitization therapy in highly sensitized patients.
Beyond kidney transplantation, we continue to advance our imlifidase clinical programs in autoimmunity. In the Phase 3 trial in anti-GBM disease, our lead autoimmune indication, we have reached 50% enrolment in the trial and expect completion in 2025 as previously guided. We also expect to share contextualized efficacy data later this year in our 15-HMedIdeS-09 Phase 2 study in Guillain-Barré Syndrome (GBS). This follows promising first high-level data shared in
On
Lastly, I am delighted to welcome
We look forward to keeping you updated on our continued progress, with several upcoming important milestones to be achieved across our platform and franchises as we continue the development of new, transformative medicines for patients suffering from serious, rare immunologic diseases."
Upcoming milestones and news flow
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 (Lead NiceR candidate): Further analysis around endpoints in FIH trial incl. lead indication
2024
2024 First high level data read-out from phase 1b study in DMD with Sarepta
2025
2025 Anti-GBM disease Phase 3: Completion of enrollment
Updated financial calendar 2024
Conference call details
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/interim-report-january-march-2024
For the full financial calendar and list of events in 2024 please visit https://www.hansabiopharma.com/investors/calendar/
This is information that
For more information:
M: +46 (0) 709 298 269
E: klaus.sindahl@hansabiopharma.com
M: +1 (484) 319 2802
E: stephanie.kenney@hansabiopharma.com
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