IDEFIRIX Product Sales Increased 83% Compared to the Prior Year
LUND, Sweden, Feb. 6, 2025 /PRNewswire/ -- Hansa Biopharma AB, Hansa or the Company (Nasdaq Stockholm: HNSA) today announced its full year and Q4 2024 financial results.
Søren Tulstrup, President and CEO, Hansa Biopharma said, "2024 proved to be a transformative year for Hansa, marked by ongoing commercial success of IDEFIRIX® across Europe and the achievement of key pipeline milestones in our priority therapy areas – Autoimmune, Gene Therapy, and Transplantation. Importantly, 2024 IDEFIRIX product sales, excluding the impact of a 49.6 MSEK provision to account for retroactive price adjustments linked to successful special early access programs following IDEFIRIX's launch in 2020, totaled 189.7 MSEK which represents an 83% increase over the prior year (103.7 MSEK). Including the impact of the provision, 2024 IDEFIRIX product sales totaled 140.1 MSEK which represents a 35% increase over prior year (103.7 MSEK) while total 2024 sales (171.3 MSEK) increased by 28% compared to the prior year (134.1 MSEK). The year-on-year IDEFIRIX growth reflects the continued successful launch execution in Europe and the ongoing momentum we are creating in the clinical community to help drive greater utilization of IDEFIRIX. Q4 2024 IDEFIRIX product sales were 25.6 MSEK and despite strong full year sales, quarterly product sales continue to fluctuate given the unpredictable nature of the European kidney allocation systems and availability of organs."
Tulstrup continued, "Our efforts to advance our exciting pipeline of drug candidates resulted in the achievement of several key milestones, including positive results from a Phase 2 study and indirect treatment comparison of imlifidase in Guillain-Barré Syndrome (GBS), a favorable 12-month analysis from the NICE-01 study of HNSA-5487, completion of enrolment in our GOOD-IDES-02 Phase 3 study of imlifidase in anti-GBM, and the initiation of a Phase 2 trial of imlifidase in Crigler-Najjar for patients with anti-AAV antibodies in collaboration with our gene therapy partner, Genethon."
Financial Performance
Revenue for the full year 2024 totaled 220.9 MSEK excluding the impact of a 49.6 MSEK provision. The provision reflects price adjustments linked to successful early access programs following IDEFIRIX's launch in 2020. Excluding the provision, full year 2024 revenue totaled 171.3 MSEK representing a 28% increase over the prior year (134.1 MSEK). In 2024 IDEFIRIX product sales, excluding the provision, totaled 189.7 MSEK which represents an 83% increase over the prior year (103.7 MSEK). Including the provision, 2024 IDEFIRIX product sales totaled 140.1 MSEK which represents a 35% increase over prior year (103.7 MSEK).
In Q4 2024, Hansa reported total revenue of 32.3 MSEK and IDEFIRIX product sales of 25.6 MSEK. Despite the strong performance of IDEFIRIX in 2024, Hansa product sales continue to fluctuate due to variations in European kidney allocation systems impacting availability of organs to specific patients.
Pipeline Progress
Progress across the company's pipeline continues with a positive read out from the Phase 2 15-HMedIdeS study in Guillain-Barré Syndrome (GBS) and an indirect treatment comparison of imlifidase to the International Guillain-Barré Syndrome Outcome Study (IGOS). In the Phase 2 study, patients treated with imlifidase plus IVIg had rapid overall improvement in functional status - specifically 37% of patients in the study returned to walking independently at one week. In the indirect treatment comparison to the IGOS-IVIg group, patients experienced significantly faster improvement across clinically relevant measures including median time to return to walking independently six weeks sooner than the IVIg-comparator group.
The Company also shared positive results from a 12-month follow-up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential. In the analysis, HNSA-5487 reduced IgG levels by more than 95% in a few hours and achieved lower peak anti-drug antibody (ADA) responses confirming its redosing potential. In the first half of 2025, the Company plans to meet with regulatory agencies to establish a clinical pathway focused on neuro-autoimmune disease.
The Company's Phase 3 GOOD-IDES-02 study in anti-GBM completed enrolment and data read out is expected in the second half of 2025. The Post Authorization Efficacy and Safety (PAES) study in kidney transplantation continued to enroll patients (96%) and is expected to be completed in mid-2025. A Phase 2 trial, GNT-018-IDES, in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated (AAV) vectors was initiated in collaboration with Genethon. Finally, the ConfideS Phase 3 US pivotal trial in kidney transplantation completed enrolment in 2024 and a data read out is expected in the second half of 2025. This will provide the basis for the Company's Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2025.
Financial Summary
MSEK, unless otherwise stated – unaudited
Q4 2024
Q4 2023
12M 2024
12M 2023
Total Revenue
32.3
50.4
220.9
134.1
Provision1
-
-
-49.6
-
Net revenue after provision
32.3
50.4
171.3
134.1
SG&A expenses
-88.5
-106
-343.8
-450.5
R&D expenses
-101.4
-108.3
-375.7
-411.3
Loss from operations
-173.7
-175.5
-637.4
-788.5
Loss for the period
-276.4
-124.5
-806.7
-831.7
Net cash used in operations
-206.8
-172.9
-733.9
-755.7
Cash and short-term investments
405.3
732.1
405.3
732.1
EPS before and after dilution (SEK)
-4.08
-2.36
-12.84
-15.83
Number of outstanding shares
6,78,14,241
5,26,71,796
6,78,14,241
5,26,71,796
Weighted average number of shares before and after dilution
6,78,14,241
5,26,71,796
62.834.848
52,540.09
No of employees at the end of the period
135
168
135
168
1Actual product sales for the full year 2024 totaled 189.7 MSEK. Sales were offset by a provision totaling 49.6 MSEK associated with volume discounts and rebates. Including the provision, year to date product sales totaled 140.1 MSEK.
Conference Call Details
Hansa Biopharma will host a telephone conference today Thursday, February 6, 2025, at 14:00 CET / 8:00 am ET.
The event will be hosted by Søren Tulstrup, President and CEO, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO. The call will include a review of the interim results and a business and pipeline update. It will be held in English.
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.
To participate in the telephone conference, please use the dial-in details provided below: Participant Dial In (Toll Free): 1-833-821-3542 Participant International Dial In: 1-412-652-1248 *Please ask to be joined into the Hansa Biopharma call
This is information that Hansa Biopharma AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 7:00 CET on 2025-02-06.
For more information, please contact: Evan Ballantyne, Chief Financial Officer IR@hansabiopharma.com
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. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients and HNSA-5487, a second-generation IgG cleaving molecule with redosing potential. Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.
