Kuros Biosciences Reports First Half of 2024 Results
Kuros Biosciences reported strong financial results for H1 2024, with direct MagnetOs sales increasing 159% to CHF 31.6 million. The Kuros Medical Devices segment saw a 148% increase in total sales to CHF 31.8 million, with EBITDA rising 287% to CHF 8.6 million. The company achieved a positive Group EBITDA of CHF 0.7 million, up from a loss in H1 2023. Adjusted EBITDA excluding Fibrin-PTH costs and share-based compensation reached CHF 4.0 million, representing a 12.5% margin.
Key highlights include FDA clearances for interbody use of various MagnetOs products and the publication of the MAXA Level 1 clinical study demonstrating MagnetOs' effectiveness. The company expects continued growth in H2 2024 and anticipates generating positive EBITDA and reaching operating cash flow break-even for the first time in 2024.
Kuros Biosciences ha riportato risultati finanziari solidi per il primo semestre del 2024, con un aumento del 159% delle vendite dirette di MagnetOs a 31,6 milioni di CHF. Il segmento Dispositivi Medici di Kuros ha visto un incremento del 148% nelle vendite totali, raggiungendo i 31,8 milioni di CHF, con un EBITDA in aumento del 287%, pari a 8,6 milioni di CHF. L'azienda ha registrato un EBITDA positivo per il Gruppo di 0,7 milioni di CHF, in crescita rispetto a una perdita nel primo semestre del 2023. L'EBITDA rettificato, escludendo i costi di Fibrin-PTH e la compensazione basata sulle azioni, ha raggiunto 4,0 milioni di CHF, con un margine del 12,5%.
I punti salienti includono le approvazioni della FDA per l'uso intercorpo di vari prodotti MagnetOs e la pubblicazione dello studio clinico MAXA di livello 1, che dimostra l'efficacia di MagnetOs. L'azienda prevede una continua crescita nel secondo semestre del 2024 e si aspetta di generare un EBITDA positivo, raggiungendo per la prima volta nel 2024 il pareggio di flusso di cassa operativo.
Kuros Biosciences informó resultados financieros sólidos para el primer semestre de 2024, con un aumento del 159% en las ventas directas de MagnetOs, alcanzando 31,6 millones de CHF. El segmento de Dispositivos Médicos de Kuros vio un incremento del 148% en las ventas totales, alcanzando 31,8 millones de CHF, con un EBITDA que creció un 287%, totalizando 8,6 millones de CHF. La compañía logró un EBITDA positivo del Grupo de 0,7 millones de CHF, en comparación con una pérdida en el primer semestre de 2023. El EBITDA ajustado, excluyendo los costos de Fibrin-PTH y la compensación basada en acciones, alcanzó 4,0 millones de CHF, representando un margen del 12,5%.
Los aspectos destacados incluyen las aprobaciones de la FDA para el uso intercorporal de varios productos MagnetOs y la publicación del estudio clínico MAXA de nivel 1 que demuestra la efectividad de MagnetOs. La empresa espera un crecimiento continuo en el segundo semestre de 2024 y anticipa generar EBITDA positivo y alcanzar el punto de equilibrio en el flujo de caja operativo por primera vez en 2024.
쿠로스 바이오사이언스는 2024년 상반기 동안 자체 MagnetOs 판매가 159% 증가하여 3,160만 스위스 프랑으로 증가했다고 보고했습니다. 쿠로스 의료 기기 부문은 총 매출이 148% 증가하여 3,180만 스위스 프랑에 달했으며, EBITDA는 287% 증가한 860만 스위스 프랑에 도달했습니다. 회사는 2023년 상반기 손실에서 벗어나 70만 스위스 프랑의 긍정적인 그룹 EBITDA를 달성했습니다. Fibrin-PTH 비용과 주식 기반 보상을 제외한 조정 EBITDA는 400만 스위스 프랑에 도달하여 12.5%의 마진을 나타냅니다.
주요 하이라이트로는 다양한 MagnetOs 제품의 체내 사용에 대한 FDA의 승인이 포함되며, MagnetOs의 효능을 입증하는 MAXA 1단계 임상 연구의 발표가 있습니다. 회사는 2024년 하반기에도 성장을 지속할 것으로 예상하며, 2024년 처음으로 긍정적인 EBITDA를 창출하고 운영 현금 흐름의 손익 분기점을 달성할 것으로 기대하고 있습니다.
Kuros Biosciences a rapporté de solides résultats financiers pour le premier semestre 2024, avec une augmentation de 159 % des ventes directes de MagnetOs à 31,6 millions de CHF. Le segment des Dispositifs Médicaux de Kuros a connu une augmentation de 148 % des ventes totales, atteignant 31,8 millions de CHF, avec un EBITDA en hausse de 287 % à 8,6 millions de CHF. L'entreprise a réalisé un EBITDA positif de 0,7 million de CHF, par rapport à une perte au premier semestre 2023. L'EBITDA ajusté, hors coûts de Fibrin-PTH et rémunération en actions, s'est élevé à 4,0 millions de CHF, représentant une marge de 12,5 %.
Les points clés comprennent les approbations de la FDA pour l'utilisation intercorporelle de divers produits MagnetOs et la publication de l'étude clinique MAXA de niveau 1, démontrant l'efficacité de MagnetOs. L'entreprise s'attend à une croissance continue au second semestre 2024 et anticipe de générer un EBITDA positif tout en atteignant le seuil de rentabilité du flux de trésorerie opérationnel pour la première fois en 2024.
Kuros Biosciences hat für das erste Halbjahr 2024 starke Finanzergebnisse gemeldet, mit einem Anstieg der direkten MagnetOs-Verkäufe um 159% auf 31,6 Millionen CHF. Der Bereich Medizinische Geräte von Kuros verzeichnete einen Anstieg der Gesamterlöse um 148% auf 31,8 Millionen CHF, wobei das EBITDA um 287% auf 8,6 Millionen CHF stieg. Das Unternehmen erreichte ein positives Gruppen-EBITDA von 0,7 Millionen CHF, nach einem Verlust im ersten Halbjahr 2023. Das bereinigte EBITDA ohne Fibrin-PTH-Kosten und aktienbasierte Vergütung erreichte 4,0 Millionen CHF, was eine Marge von 12,5% darstellt.
Zu den wichtigsten Höhepunkten gehören FDA-Freigaben für die interkorporelle Anwendung verschiedener MagnetOs-Produkte und die Veröffentlichung der klinischen Studie MAXA Level 1, die die Wirksamkeit von MagnetOs demonstriert. Das Unternehmen erwartet ein weiteres Wachstum im zweiten Halbjahr 2024 und rechnet damit, erstmals im Jahr 2024 ein positives EBITDA zu erzielen und den operativen Cashflow-Breakeven zu erreichen.
- Direct MagnetOs sales increased 159% to CHF 31.6 million
- Kuros Medical Devices segment EBITDA increased 287% to CHF 8.6 million
- Group achieved positive EBITDA of CHF 0.7 million, up from a loss in H1 2023
- Adjusted EBITDA margin of 12.5%
- FDA clearances for interbody use of various MagnetOs products
- MAXA Level 1 study showed MagnetOs superiority over autograft in posterolateral fusions
- Net loss of CHF 0.2 million in H1 2024, though improved from CHF 5.1 million loss in H1 2023
- Increased operating costs to CHF 28.9 million from CHF 15.3 million in H1 2023
Financial Highlights
Direct MagnetOs™ sales increased by
159% to CHF 31.6 million from CHF 12.2 million in H1 2023; this corresponds to a sequential increase of62% or CHF 12.1 million over H2 2023Total Kuros Medical Devices segment sales increased
148% to CHF 31.8 million from CHF 12.9 millionKuros Medical Devices segment EBITDA increased
287% to CHF 8.6 million in H1 2024 compared to CHF 2.2 million in H1 2023, representing an EBITDA margin of27% Kuros Group achieved EBITDA of CHF 0.7 million in H1 2024, increased from EBITDA loss of CHF (3.0) million in H1 2023; adjusted EBITDA excluding the Fibrin-PTH costs, recurring and one-time share-based compensation totaled at CHF 4.0 million, representing an adjusted EBITDA margin of
12.5% Cash and cash equivalents amounted to CHF 14.3 million, compared to CHF 14.2 million as of December 31, 2023; funds available (including trade and other receivables) totaled CHF 25.3 million as of June 30, 2024
Regulatory, Clinical & Commercial Highlights
Peer-reviewed publication of MAXA Level 1 human clinical study outcomes in Spine demonstrates effectiveness of MagnetOs as a standalone alternative to autograft in challenging posterolateral fusions. Noninferiority of Magnetos versus autograft confirmed, with primary analysis even indicating MagnetOs superiority 1
FDA clearances for interbody use of MagnetOs Granules, MagnetOs Putty and MagnetOs Easypack Putty (following MagnetOs Flex Matrix interbody clearance late 2023)
Recent FDA clearance for standalone use of MagnetOs Easypack Putty in PLF and use in pelvis and extremities, supporting the product family expansion outside of spine
Launch of MagnetOs Granules and MagnetOs Putty in New Zealand
Outlook
For the second half of 2024, Kuros expects a similar seasonal sales pattern as in previous years, which corresponds to around
60% of total annual sales. Furthermore, it can be confirmed that the organic growth path is securely financed and that the Group expects to continue generating a positive EBITDA, both unadjusted and adjusted for non-recurring and non-cash items, in the single-digit, and around break even in terms of operating cash flow for the first time.
SCHLIEREN (ZURICH), SWITZERLAND / ACCESSWIRE / August 8, 2024 / Kuros Biosciences ("Kuros" or the "Company") a leader in next generation bone healing technologies, today announced financial results for the first half of 2024.
Revenue from direct MagnetOs product sales were CHF 31.6 million compared to CHF 12.2 million in H1 2023. Total revenue from medical devices product sales reached CHF 31.8 million compared to CHF 12.9 million in H1 2023.
Chris Fair, Chief Executive Officer of Kuros Biosciences, said: "We are pleased to report first half 2024 results that continue to demonstrate our strong execution and commercialization, with direct MagnetOs revenue growth of
Key developments in H1 2024
Kuros announced the peer-reviewed publication in Spine of the MAXA Level 1 prospective, multi-center, randomized, intra-patient controlled clinical study results. The data indicated superiority of MagnetOs as a standalone alternative to autograft in challenging posterolateral fusions, showing a fusion rate of
Financial position
Cash and cash equivalents (including trade and other receivables) amounted to CHF 25.3 million as of June 30, 2024, compared to CHF 21.8 million as of December 31, 2023.
Revenue from product sales of CHF 31.8 million in H1 2024 increased
Key figures |
|
| H1 2024 |
|
|
| H1 2023 |
|
In TCHF, IFRS |
|
|
|
|
|
|
|
|
Revenue from product sales |
|
| 31,844 |
|
|
| 12,866 |
|
Cost of goods sold |
|
| (3,477 | ) |
|
| (2,142 | ) |
Gross profit |
|
| 28,367 |
|
|
| 10,724 |
|
Sales and marketing costs |
|
| (18,493 | ) |
|
| (9,332 | ) |
Research and development costs |
|
| (3,563 | ) |
|
| (2,291 | ) |
General and administrative costs |
|
| (6,984 | ) |
|
| (3,759 | ) |
Other income |
|
| 114 |
|
|
| 129 |
|
Net operating costs |
|
| (28,926 | ) |
|
| (15,253 | ) |
Operating loss |
|
| (559 | ) |
|
| (4,529 | ) |
Net finance result |
|
| 1,655 |
|
|
| (352 | ) |
Net loss |
|
| (211 | ) |
|
| (5,052 | ) |
Net loss per share (in CHF) |
|
| (0.01 | ) |
|
| (0.14 | ) |
Cash and cash equivalents, trade and other receivables |
| Jun-30, 2024 25,257 |
|
| Dec-31, 2023 21,825 |
| ||
Events after the reporting period
The group has no significant events after the reporting period up to the date of this announcement.
Outlook
Kuros' products are advancing according to plan with MagnetOs continuing to generate strong sales growth in the U.S., Europe, and the rest of the world following a similar seasonal pattern as in previous years. The company is adequately funded along the planned organic growth path and expects to generate positive single-digit unadjusted and adjusted EBITDA and reach around operating cash flow break even for the first time in 2024.
The half year report is available via the following link:
Kuros Biosciences 2024 Interim Report
We will discuss the results of the first half of 2024 and give an update on business and financial strategy in a virtual call on August 15, 2024, at 3pm CET. If you wish to participate, please register in advance for this webinar.
Kuros Biosciences H1 2024 Financial Report Investor Webcast
After registering, you will receive a confirmation email containing information about joining the webinar.
Upcoming Events
October 10, 2024, Trading Update Q3 2024
For further information, please contact:
Kuros Biosciences AG | Investors |
About MagnetOs
MagnetOs is a bone graft like no other: thanks to its NeedleGrip TM surface technology, it enables bone formation without added cells or growth factors. This surface technology provides traction for our body's vitally important ‘pro-healing' immune cells (M2 macrophages). This in turn, unlocks previously untapped potential to stimulate stem cells - and form new bone throughout the graft. The growing body of science behind NeedleGrip is called osteoimmunology. But for surgeons and their patients it means one thing: a more predictable fusion. 2-6†‡§
Indications statement
Please refer to the instructions for use for your local region for a full list of indications, contraindications, warnings, and precautions.
About Kuros Biosciences
Kuros Biosciences is on a mission to discover, develop and deliver innovative biologic fusion technologies. With locations in the United States, Switzerland and the Netherlands, the company is listed on the SIX Swiss Exchange. The company's first commercial product, MagnetOs, is a unique advanced bone graft that has already been used across three continents in 25,000 fusion surgeries. For more information on the company and its products, visit kurosbio.com .
Forward Looking Statements
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words "will" or "expect" or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors. Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.
1. Stempels, H. et al., "Efficacy of biphasic calcium phosphate ceramic with a needle-shaped surface topography versus autograft in instrumented posterolateral spinal fusion: A randomized trial." Spine. June 17, 2024. https://doi.org/10.1097/BRS.0000000000005075
2. Van Dijk, et al. eCM. 2021; 41:756-73.
3. Duan, et al. eCM. 2019; 37:60-73.
4. Van Dijk, et al. Clin Spine Surg. 2020;33(6): E276-E287.
5. Van Dijk, et al. JOR Spine. 2018 ; e1039
6. Van Dijk, et al. J Biomed Mater Res. Part B: Appl Biomater.
*MagnetOs was mixed with venous blood.
†Results from in vivo laboratory testing may not be predictive of clinical experience in humans. For important safety and intended use information please visit kurosbio.com.
‡MagnetOs is not cleared by the FDA or TGA as an osteoinductive bone graft.
§MagnetOs has been proven to generate more predictable fusions than two commercially available alternatives in an ovine model of posterolateral fusion.
SOURCE: Kuros Biosciences AG
View the original press release on accesswire.com
FAQ
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