Hansa Biopharma Reports Fourth Quarter and Full Year 2024 Financial Results
Hansa Biopharma reported strong financial results for Q4 and full year 2024, with IDEFIRIX product sales showing an 83% increase to 189.7 MSEK compared to the previous year (103.7 MSEK), excluding a 49.6 MSEK provision for retroactive price adjustments. Including the provision, 2024 IDEFIRIX sales reached 140.1 MSEK, a 35% increase year-over-year.
The company achieved significant pipeline milestones, including positive Phase 2 results in Guillain-Barré Syndrome, favorable 12-month analysis from the NICE-01 study of HNSA-5487, and completion of enrollment in the GOOD-IDES-02 Phase 3 study. Total revenue for 2024 was 220.9 MSEK (171.3 MSEK after provision), representing a 28% increase from 2023.
Q4 2024 showed IDEFIRIX product sales of 25.6 MSEK, with quarterly fluctuations due to European kidney allocation systems. The company's operating loss improved to -637.4 MSEK for 2024 compared to -788.5 MSEK in 2023.
Hansa Biopharma ha riportato risultati finanziari solidi per il quarto trimestre e per l'intero anno 2024, con le vendite del prodotto IDEFIRIX che hanno mostrato un aumento dell'83%, raggiungendo 189,7 MSEK rispetto all'anno precedente (103,7 MSEK), escludendo una provvista di 49,6 MSEK per adeguamenti retroattivi dei prezzi. Inclusa la provvista, le vendite di IDEFIRIX nel 2024 hanno raggiunto 140,1 MSEK, con un incremento del 35% rispetto all'anno precedente.
L'azienda ha raggiunto traguardi significativi nel suo pipeline, compresi risultati positivi della Fase 2 nella Sindrome di Guillain-Barré, un'analisi favorevole a 12 mesi dello studio NICE-01 su HNSA-5487 e il completamento dell'arruolamento nello studio di Fase 3 GOOD-IDES-02. Il fatturato totale per il 2024 è stato di 220,9 MSEK (171,3 MSEK dopo la provvista), rappresentando un aumento del 28% rispetto al 2023.
Il quarto trimestre del 2024 ha mostrato vendite del prodotto IDEFIRIX di 25,6 MSEK, con fluttuazioni trimestrali dovute ai sistemi di allocazione per i reni in Europa. La perdita operativa dell'azienda è migliorata a -637,4 MSEK per il 2024, rispetto a -788,5 MSEK nel 2023.
Hansa Biopharma reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con las ventas del producto IDEFIRIX mostrando un aumento del 83%, alcanzando 189,7 MSEK en comparación con el año anterior (103,7 MSEK), sin incluir una provisión de 49,6 MSEK para ajustes de precios retroactivos. Incluyendo la provisión, las ventas de IDEFIRIX en 2024 alcanzaron 140,1 MSEK, un incremento del 35% interanual.
La empresa logró hitos significativos en su cartera, incluidos resultados positivos de la Fase 2 en el Síndrome de Guillain-Barré, un análisis favorable a 12 meses del estudio NICE-01 de HNSA-5487, y la finalización de la inscripción en el estudio de Fase 3 GOOD-IDES-02. Los ingresos totales para 2024 fueron de 220,9 MSEK (171,3 MSEK después de la provisión), lo que representa un aumento del 28% con respecto a 2023.
El cuarto trimestre de 2024 mostró ventas del producto IDEFIRIX de 25,6 MSEK, con fluctuaciones trimestrales debido a los sistemas de asignación de riñones en Europa. La pérdida operativa de la empresa mejoró a -637,4 MSEK en 2024 en comparación con -788,5 MSEK en 2023.
한사 바이오파마는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했으며, IDEFIRIX 제품 판매는 전년 대비 83% 증가한 189.7 MSEK에 달했습니다 (전년: 103.7 MSEK), 49.6 MSEK의 가격 조정에 대한 소급적 요금 조정을 제외한 수치입니다. 이 조정을 포함하면 2024년 IDEFIRIX 판매는 140.1 MSEK로, 전년 대비 35% 증가했습니다.
회사는 기이한 바레 증후군에 대한 긍정적인 2상 결과, HNSA-5487에 대한 NICE-01 연구의 12개월 분석 결과가 유리하며, GOOD-IDES-02 3상 연구의 등록이 완료되는 등 중요한 파이프라인 이정표를 달성했습니다. 2024년 총 수익은 220.9 MSEK(조정 후 171.3 MSEK)로서, 2023년 대비 28% 증가했습니다.
2024년 4분기에는 IDEFIRIX 제품 판매가 25.6 MSEK를 기록했으며, 유럽의 신장 할당 시스템으로 인한 분기별 변동이 있었습니다. 회사의 운영 손실은 2024년에 -637.4 MSEK로 개선되었으며, 2023년 -788.5 MSEK에서 개선된 수치입니다.
Hansa Biopharma a publié des résultats financiers solides pour le quatrième trimestre et pour l'année complète 2024, avec des ventes du produit IDEFIRIX montrant une augmentation de 83 % pour atteindre 189,7 MSEK par rapport à l'année précédente (103,7 MSEK), à l'exclusion d'une provision de 49,6 MSEK pour des ajustements de prix rétroactifs. En y incluant la provision, les ventes d'IDEFIRIX en 2024 ont atteint 140,1 MSEK, soit une augmentation de 35 % par rapport à l'année précédente.
L'entreprise a atteint des jalons significatifs dans son pipeline, y compris des résultats positifs de phase 2 dans le syndrome de Guillain-Barré, une analyse favorable à 12 mois de l'étude NICE-01 sur HNSA-5487, et l'achèvement de l'inscriptions dans l'étude de phase 3 GOOD-IDES-02. Le chiffre d'affaires total pour 2024 était de 220,9 MSEK (171,3 MSEK après provision), représentant une augmentation de 28 % par rapport à 2023.
Le quatrième trimestre 2024 a montré des ventes du produit IDEFIRIX de 25,6 MSEK, avec des fluctuations trimestrielles dues aux systèmes d'allocation des reins en Europe. La perte opérationnelle de l'entreprise s'est améliorée, s'établissant à -637,4 MSEK pour 2024, contre -788,5 MSEK en 2023.
Hansa Biopharma berichtete von soliden finanziellen Ergebnissen für das vierte Quartal und das gesamte Jahr 2024, wobei die Verkäufe des Produkts IDEFIRIX um 83 % auf 189,7 MSEK im Vergleich zum Vorjahr (103,7 MSEK) gestiegen sind, ohne eine Rückstellung von 49,6 MSEK für nachträgliche Preisänderungen. Einschließlich der Rückstellung erreichten die IDEFIRIX-Verkäufe im Jahr 2024 140,1 MSEK, was einem Anstieg von 35 % im Vergleich zum Vorjahr entspricht.
Das Unternehmen erreichte bedeutende Meilensteine in seiner Produktpipeline, einschließlich positiver Ergebnisse der Phase 2 bei Guillain-Barré-Syndrom, einer positiven 12-Monats-Analyse der NICE-01-Studie von HNSA-5487 und dem Abschluss der Rekrutierung im GOOD-IDES-02-Studie der Phase 3. Der Gesamtumsatz für 2024 betrug 220,9 MSEK (171,3 MSEK nach Rückstellung) und stellt einen Anstieg von 28 % im Vergleich zu 2023 dar.
Im vierten Quartal 2024 lagen die IDEFIRIX-Verkäufe bei 25,6 MSEK, wobei es aufgrund der europäischen Nierenzuweisungssysteme zu quartalsweise Schwankungen kam. Der operative Verlust des Unternehmens verbesserte sich auf -637,4 MSEK für 2024 im Vergleich zu -788,5 MSEK im Jahr 2023.
- IDEFIRIX product sales grew 83% year-over-year to 189.7 MSEK (pre-provision)
- Total revenue increased 28% to 171.3 MSEK (post-provision)
- Operating loss improved from -788.5 MSEK in 2023 to -637.4 MSEK in 2024
- Positive Phase 2 results in Guillain-Barré Syndrome treatment
- 49.6 MSEK provision required for retroactive price adjustments
- Cash position decreased from 732.1 MSEK to 405.3 MSEK
- Quarterly product sales continue to show significant fluctuations
- Net loss of 806.7 MSEK for 2024
Insights
Hansa Biopharma's FY2024 results demonstrate robust commercial execution with IDEFIRIX product sales reaching 189.7 MSEK, representing an impressive
The revenue performance is particularly noteworthy given the inherent challenges in European kidney allocation systems. Q4 product sales of
Critical near-term catalysts include:
- ConfideS Phase 3 US pivotal trial readout (H2 2025)
- Planned BLA submission to FDA (H2 2025)
- GOOD-IDES-02 Phase 3 anti-GBM study results (H2 2025)
The positive Phase 2 GBS results and HNSA-5487's promising 12-month data strengthen the company's pipeline value proposition, potentially opening new revenue streams beyond transplantation. The planned regulatory discussions for neuro-autoimmune applications in H1 2025 could significantly expand the addressable market.
IDEFIRIX Product Sales Increased
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
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
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
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
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 (
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 | |
1 Actual 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
Join the webcast here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=8Ylnk0T5
For the full financial calendar and list of events in 2025 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. 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
Stephanie Kenney, VP Global Corporate Affairs
media@hansabiopharma.com
Notes to editors
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. 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
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
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SOURCE Hansa Biopharma AB
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