CytoSorbents Reports Preliminary Unaudited Fourth Quarter and Full-Year 2024 Product Revenue
CytoSorbents (NASDAQ: CTSO) has announced preliminary Q4 and full-year 2024 financial results. The company estimates Q4 product revenue between $9.0-9.2 million, representing 22-25% growth compared to Q4 2023. Full-year 2024 product revenue is expected to reach $35.4-35.6 million, a 14% increase from 2023.
Q4 product gross margin improved to approximately 70%, up from 61% in Q3 2024, following the resolution of production slowdown and manufacturing issues. The company has initiated a rights offering ending January 10, 2025. FDA and Health Canada reviews are ongoing for DrugSorb™-ATR, their device aimed at reducing perioperative bleeding in CABG surgery patients on Brilinta®, with regulatory decisions expected in 2025.
CytoSorbents (NASDAQ: CTSO) ha annunciato i risultati finanziari preliminari per il quarto trimestre e per l'intero anno 2024. L'azienda stima che i ricavi da prodotto nel quarto trimestre saranno compresi tra $9,0-9,2 milioni, rappresentando una crescita del 22-25% rispetto al quarto trimestre del 2023. I ricavi da prodotto per l'intero anno 2024 dovrebbero raggiungere $35,4-35,6 milioni, con un aumento del 14% rispetto al 2023.
Il margine lordo sui prodotti del quarto trimestre è migliorato, raggiungendo circa 70%, rispetto al 61% del terzo trimestre 2024, a seguito della risoluzione dei rallentamenti nella produzione e dei problemi di fabbricazione. L'azienda ha avviato un'offerta di diritti che terminerà il 10 gennaio 2025. Le revisioni da parte della FDA e di Health Canada sono in corso per DrugSorb™-ATR, il loro dispositivo progettato per ridurre il sanguinamento perioperatorio nei pazienti sottoposti a intervento di CABG in terapia con Brilinta®, con decisioni regolatorie previste per il 2025.
CytoSorbents (NASDAQ: CTSO) ha anunciado los resultados financieros preliminares para el cuarto trimestre y el año completo 2024. La empresa estima que los ingresos por productos en el cuarto trimestre estarán entre $9,0-9,2 millones, lo que representa un crecimiento del 22-25% en comparación con el cuarto trimestre de 2023. Se espera que los ingresos por productos del año completo 2024 alcancen $35,4-35,6 millones, un aumento del 14% respecto a 2023.
El margen bruto de productos del cuarto trimestre mejoró a aproximadamente 70%, aumentando desde el 61% en el tercer trimestre de 2024, después de la solución de los problemas de ralentización de producción y fabricación. La empresa ha iniciado una oferta de derechos que finalizará el 10 de enero de 2025. Las revisiones de la FDA y Health Canada están en curso para DrugSorb™-ATR, su dispositivo destinado a reducir el sangrado perioperatorio en pacientes de cirugía de CABG que reciben Brilinta®, con decisiones regulatorias esperadas en 2025.
CytoSorbents (NASDAQ: CTSO)는 2024년 4분기 및 전체 연도의 예비 재무 결과를 발표했습니다. 회사는 4분기 제품 수익이 $9.0-9.2 백만 사이일 것으로 추정하며, 이는 2023년 4분기와 비교하여 22-25% 성장한 수치입니다. 2024년 전체 연도 제품 수익은 $35.4-35.6 백만에 도달할 것으로 예상되며, 이는 2023년 대비 14% 증가한 것입니다.
4분기 제품 총 이익률은 약 70%로 개선되었으며, 이는 2024년 3분기 61%에서 상승한 수치입니다. 이는 생산 지연 및 제조 문제 해결 이후의 결과입니다. 회사는 2025년 1월 10일에 종료되는 권리 공모를 시작했습니다. DrugSorb™-ATR에 대한 FDA 및 캐나다 보건부 검토가 진행 중이며, 이는 Brilinta®를 투여받는 CABG 수술 환자의 수술 전후 출혈을 줄이기 위한 장치입니다. 규제 결정은 2025년에 내려질 것으로 예상됩니다.
CytoSorbents (NASDAQ: CTSO) a annoncé les résultats financiers préliminaires pour le quatrième trimestre et l'année complète 2024. L'entreprise estime que les revenus des produits pour le quatrième trimestre seront compris entre $9,0-9,2 millions, représentant une croissance de 22-25% par rapport au quatrième trimestre 2023. Les revenus des produits pour l'année entière 2024 devraient atteindre $35,4-35,6 millions, soit une augmentation de 14% par rapport à 2023.
La marge brute des produits du quatrième trimestre a augmenté pour atteindre environ 70%, contre 61% au troisième trimestre 2024, suite à la résolution des ralentissements de production et des problèmes de fabrication. L'entreprise a lancé une offre de droits qui se terminera le 10 janvier 2025. Les examens de la FDA et de Santé Canada sont en cours pour DrugSorb™-ATR, leur dispositif destiné à réduire les saignements périopératoires chez les patients ayant subi une chirurgie de CABG sous Brilinta®, avec des décisions réglementaires attendues pour 2025.
CytoSorbents (NASDAQ: CTSO) hat vorläufige Finanzzahlen für das vierte Quartal und das gesamte Jahr 2024 bekannt gegeben. Das Unternehmen schätzt, dass die Produktumsätze im vierten Quartal zwischen $9,0-9,2 Millionen liegen werden, was einem Wachstum von 22-25% im Vergleich zum vierten Quartal 2023 entspricht. Die Produktumsätze für das gesamte Jahr 2024 werden voraussichtlich $35,4-35,6 Millionen erreichen, ein Anstieg von 14% im Vergleich zu 2023.
Die Bruttomarge für Produkte im vierten Quartal verbesserte sich auf etwa 70%, gegenüber 61% im dritten Quartal 2024, nachdem Produktionsverzögerungen und Fertigungsprobleme behoben werden konnten. Das Unternehmen hat ein Bezugsangebot initiiert, das am 10. Januar 2025 endet. Die Überprüfungen durch die FDA und Health Canada für DrugSorb™-ATR, das Gerät, das darauf abzielt, perioperative Blutungen bei CABG-Patienten unter Brilinta® zu reduzieren, sind im Gange, mit erwarteten regulatorischen Entscheidungen im Jahr 2025.
- Q4 product revenue growth of 22-25% year-over-year
- Full-year 2024 revenue growth of 14%
- Gross margin recovery to 70% in Q4 from 61% in Q3
- Resolution of manufacturing issues from Q3 2024
- Ongoing rights offering potentially indicating need for additional capital
- Regulatory approval for DrugSorb-ATR still pending
Insights
The preliminary Q4 results demonstrate meaningful operational progress for CytoSorbents. Product revenue growth of
With an estimated
The sequential improvement in gross margins to
The FDA and Health Canada reviews of DrugSorb-ATR represent transformational opportunities. The device addresses an unmet need in managing perioperative bleeding risk for patients on Brilinta undergoing CABG surgery - a significant concern given that newer antiplatelet medications have no approved reversal agents. Positive regulatory decisions in 2025 would open access to the lucrative North American market and could accelerate adoption given the strong clinical data package from the STAR-T trial.
Fourth quarter product revenue growth estimated at
Fourth quarter gross margin estimated to improve to approximately
Management will host in-person investor meetings in San Francisco during J.P. Morgan Healthcare Conference week
PRINCETON, N.J., Jan. 03, 2025 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today announced preliminary, selected, unaudited fourth quarter and full-year 2024 financial results and business updates.
Preliminary, Selected Fourth Quarter and Full-Year 2024 Financial Results and Business Updates
- Fourth quarter product revenue (excluding grant income) is estimated to be in the range of
$9.0 million to$9.2 million , representing22% to25% growth versus$7.35 million in the fourth quarter of 2023 - Full-year product revenue (excluding grant income) is estimated to be in the range of
$35.4 million to$35.6 million , representing approximately14% growth versus$31.1 million for the full-year 2023 - Fourth quarter product gross margin is estimated to be approximately
70% , compared to61% in the prior quarter and72% in the fourth quarter of 2023. This sequential improvement reflects the successful resolution of both a planned production slowdown to rebalance inventory and a short-term manufacturing issue which reduced product gross margins in the third quarter of 2024 - On December 23, 2024, the Company commenced a rights offering with a subscription period that ends on January 10, 2025
- U.S. Food and Drug Administration (FDA) and Health Canada substantive and interactive reviews are underway for the marketing application for DrugSorb™-ATR, the Company’s investigational medical device to reduce the severity of perioperative bleeding in patients on Brilinta® (ticagrelor, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The Company continues to expect regulatory decisions for DrugSorb-ATR in the U.S. and Canada in 2025.
“We are pleased with our topline performance in the quarter. Our strong year-over-year growth represents solid execution in our core international business, and underscores the importance of CytoSorb®, our flagship product, in addressing a diverse range of critical care and cardiac surgery indications,” commented Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “This strong top-line close to 2024, as well as our return to more normalized product gross margins, positions us well to drive improved efficiencies in our core business as we prepare to enter the North American market with DrugSorb-ATR to reduce the severity of perioperative bleeding in CABG surgery due to Brilinta®, pending FDA and Health Canada approvals.”
The results disclosed in this press release are preliminary and unaudited. The Company expects to report full, audited results for the fourth quarter and year ended December 31, 2024, on March 6, 2025.
Management will host in-person investor meetings in San Francisco alongside the 43rd Annual J.P. Morgan Healthcare Conference being held January 13-16, 2025, in San Francisco, CA. ICR Healthcare is coordinating meetings on the Company’s behalf. To schedule a meeting with Dr. Phillip Chan, Chief Executive Officer, and Peter J. Mariani, Chief Financial Officer, please send requests to ICR Healthcare at ir@cytosorbents.com.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents’ proprietary blood purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, ECMO, heart-lung machines). CytoSorbents’ technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding and 2) the removal of inflammatory agents in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments.
CytoSorbents’ lead product, CytoSorb®, is approved in the European Union and distributed in 76 countries worldwide, with more than a quarter million devices used cumulatively to date. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.
In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has received two FDA Breakthrough Device Designations: one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively.
The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, ContrastSorb, and others. For more information, please visit the Company’s website at https://ir.cytosorbents.com/ or follow us on Facebook and X.
Forward-Looking Statements
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements about our plans, objectives, future targets and outlooks for our business, representations and contentions, and the outcome of our regulatory submissions, and are not historical facts and typically are identified by use of terms such as “may,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management’s current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 14, 2024, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
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U.S. Company Contact:
Peter J. Mariani
Chief Financial Officer
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA
Investor Relations, ICR Healthcare
(443) 450-4191
ir@cytosorbents.com
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