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CytoSorbents Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights

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CytoSorbents (NASDAQ: CTSO) reported strong Q4 2024 results with product revenue of $9.2M, up 25% from Q4 2023. Full-year 2024 product revenue reached $35.6M, a 15% increase year-over-year, with 71% product gross margins.

Q4 operating loss improved 61% to $3.7M, while net loss was $7.6M ($0.14/share). The company strengthened its balance sheet through a successful Rights Offering, raising $7.3M in net proceeds.

Key developments include FDA's acceptance of DrugSorb-ATR De Novo application and submission to Health Canada, with regulatory decisions expected in 2025. The company reported strong international growth with 28% increase in direct sales outside Germany and 22% growth in Distributor/Partner sales, though German sales remained flat.

Management expects Q1 2025 product sales to decline modestly due to German sales team restructuring, but anticipates improved results in H2 2025 as they work toward breakeven in core business.

CytoSorbents (NASDAQ: CTSO) ha riportato risultati solidi per il quarto trimestre del 2024, con entrate da prodotto di 9,2 milioni di dollari, in aumento del 25% rispetto al quarto trimestre del 2023. Le entrate totali da prodotto per l'anno 2024 hanno raggiunto 35,6 milioni di dollari, con un incremento del 15% rispetto all'anno precedente, e margini lordi sui prodotti del 71%.

La perdita operativa del quarto trimestre è migliorata del 61% a 3,7 milioni di dollari, mentre la perdita netta è stata di 7,6 milioni di dollari (0,14 dollari per azione). L'azienda ha rafforzato il proprio bilancio attraverso un'offerta di diritti di successo, raccogliendo 7,3 milioni di dollari in proventi netti.

Tra gli sviluppi chiave, si segnala l'accettazione da parte della FDA della domanda De Novo per DrugSorb-ATR e la presentazione a Salute Canada, con decisioni regolatorie attese nel 2025. L'azienda ha registrato una forte crescita internazionale con un aumento del 28% nelle vendite dirette al di fuori della Germania e del 22% nelle vendite tramite distributori/partner, sebbene le vendite in Germania siano rimaste stabili.

La direzione prevede una leggera diminuzione delle vendite di prodotti nel primo trimestre del 2025 a causa della ristrutturazione del team di vendita in Germania, ma si aspetta risultati migliori nel secondo semestre del 2025 mentre lavorano per raggiungere il pareggio nel business principale.

CytoSorbents (NASDAQ: CTSO) reportó resultados sólidos para el cuarto trimestre de 2024, con ingresos por productos de 9.2 millones de dólares, un incremento del 25% en comparación con el cuarto trimestre de 2023. Los ingresos anuales por productos de 2024 alcanzaron 35.6 millones de dólares, un aumento del 15% interanual, con márgenes brutos de productos del 71%.

La pérdida operativa del cuarto trimestre mejoró un 61% a 3.7 millones de dólares, mientras que la pérdida neta fue de 7.6 millones de dólares (0.14 dólares por acción). La empresa fortaleció su balance a través de una exitosa oferta de derechos, recaudando 7.3 millones de dólares en ingresos netos.

Los desarrollos clave incluyen la aceptación por parte de la FDA de la solicitud De Novo para DrugSorb-ATR y la presentación ante Salud Canadá, con decisiones regulatorias esperadas para 2025. La empresa reportó un fuerte crecimiento internacional con un aumento del 28% en ventas directas fuera de Alemania y un crecimiento del 22% en ventas a través de distribuidores/socios, aunque las ventas en Alemania se mantuvieron estables.

La dirección espera una ligera disminución en las ventas de productos en el primer trimestre de 2025 debido a la reestructuración del equipo de ventas en Alemania, pero anticipa mejores resultados en la segunda mitad de 2025 mientras trabajan para alcanzar el equilibrio en el negocio principal.

CytoSorbents (NASDAQ: CTSO)는 2024년 4분기 강력한 실적을 보고했으며, 제품 매출이 920만 달러로 2023년 4분기 대비 25% 증가했습니다. 2024년 전체 연간 제품 매출은 3560만 달러에 도달했으며, 이는 전년 대비 15% 증가한 수치로, 제품 총 마진은 71%입니다.

4분기 운영 손실은 61% 개선되어 370만 달러에 달했으며, 순손실은 760만 달러(주당 0.14달러)였습니다. 회사는 성공적인 권리 공모를 통해 730만 달러의 순수익을 올리며 재무 상태를 강화했습니다.

주요 개발 사항으로는 FDA의 DrugSorb-ATR De Novo 신청 수락과 캐나다 보건부에 제출이 있으며, 규제 결정은 2025년에 예상됩니다. 회사는 독일 외 지역에서의 직접 판매가 28% 증가하고, 유통업체/파트너 판매가 22% 성장하는 등 국제적인 성장을 보고했지만, 독일 내 판매는 정체 상태를 유지했습니다.

경영진은 독일 판매팀의 구조 조정으로 인해 2025년 1분기 제품 판매가 다소 감소할 것으로 예상하지만, 핵심 사업에서 손익 분기점을 목표로 하며 2025년 하반기에는 개선된 결과를 예상하고 있습니다.

CytoSorbents (NASDAQ: CTSO) a annoncé des résultats solides pour le quatrième trimestre 2024, avec des revenus produits de 9,2 millions de dollars, en hausse de 25 % par rapport au quatrième trimestre 2023. Les revenus produits pour l'année 2024 ont atteint 35,6 millions de dollars, soit une augmentation de 15 % par rapport à l'année précédente, avec des marges brutes de 71 % sur les produits.

La perte d'exploitation du quatrième trimestre s'est améliorée de 61 % pour atteindre 3,7 millions de dollars, tandis que la perte nette était de 7,6 millions de dollars (0,14 $/action). L'entreprise a renforcé son bilan grâce à une offre de droits réussie, levant 7,3 millions de dollars de produits nets.

Parmi les développements clés, on note l'acceptation par la FDA de la demande De Novo pour DrugSorb-ATR et la soumission à Santé Canada, avec des décisions réglementaires attendues en 2025. L'entreprise a signalé une forte croissance internationale avec une augmentation de 28 % des ventes directes en dehors de l'Allemagne et une croissance de 22 % des ventes via des distributeurs/partenaires, bien que les ventes en Allemagne soient restées stables.

La direction s'attend à une légère baisse des ventes de produits au premier trimestre 2025 en raison de la restructuration de l'équipe de vente en Allemagne, mais anticipe des résultats améliorés au deuxième semestre 2025 alors qu'elle travaille à atteindre le seuil de rentabilité dans son activité principale.

CytoSorbents (NASDAQ: CTSO) hat starke Ergebnisse für das vierte Quartal 2024 berichtet, mit Produktumsätzen von 9,2 Millionen Dollar, was einem Anstieg von 25% im Vergleich zum vierten Quartal 2023 entspricht. Die Produktumsätze für das Gesamtjahr 2024 beliefen sich auf 35,6 Millionen Dollar, ein Anstieg um 15% im Vergleich zum Vorjahr, mit einer Bruttomarge von 71% auf die Produkte.

Der Betriebsverlust im vierten Quartal verbesserte sich um 61% auf 3,7 Millionen Dollar, während der Nettoverlust 7,6 Millionen Dollar (0,14 Dollar/Aktie) betrug. Das Unternehmen stärkte seine Bilanz durch eine erfolgreiche Bezugsangebot und erzielte einen Nettoerlös von 7,3 Millionen Dollar.

Zu den wichtigsten Entwicklungen gehört die Annahme des De Novo-Antrags für DrugSorb-ATR durch die FDA und die Einreichung bei Health Canada, wobei regulatorische Entscheidungen für 2025 erwartet werden. Das Unternehmen berichtete von starkem internationalen Wachstum mit einem Anstieg von 28% bei den Direktverkäufen außerhalb Deutschlands und einem Wachstum von 22% bei den Verkäufen über Distributoren/Partner, während die Verkäufe in Deutschland stabil blieben.

Das Management erwartet, dass die Produktverkäufe im ersten Quartal 2025 aufgrund der Umstrukturierung des Vertriebsteams in Deutschland moderat zurückgehen werden, rechnet jedoch mit verbesserten Ergebnissen im zweiten Halbjahr 2025, während sie auf einen Break-even im Kerngeschäft hinarbeiten.

Positive
  • Product revenue grew 25% YoY to $9.2M in Q4 2024
  • Full-year product revenue increased 15% to $35.6M
  • Strong 71% product gross margins maintained
  • Operating loss improved 61% to $3.7M in Q4
  • Successful rights offering raised $7.3M
  • 28% growth in direct sales outside Germany
  • 22% growth in Distributor/Partner sales
Negative
  • Net loss increased to $7.6M in Q4 2024 vs $6.1M in Q4 2023
  • Flat sales growth in Germany for second consecutive year
  • Expected decline in Q1 2025 product sales
  • Grant income decreased to $1.0M from $1.3M in Q4 2023

Insights

CytoSorbents delivered strong Q4 results with $9.2 million in product revenue, representing 25% year-over-year growth and 6% sequential growth. Full-year product sales reached $35.6 million, up 15% from 2023. The company maintained healthy 71% product gross margins while significantly improving operational efficiency.

The financial progress is evident in the 61% reduction in operating loss to $3.7 million and 78% improvement in adjusted net loss to $1.7 million compared to Q4 2023. This demonstrates management's execution on their cost control initiatives while maintaining growth trajectory.

The successful rights offering strengthened the balance sheet, with pro forma cash increasing to $17 million from $12.2 million at the end of Q3. The $7.3 million in net proceeds plus the release of $5 million in restricted cash provides crucial liquidity for upcoming commercial initiatives.

While the core business shows strong momentum with 28% growth in direct sales outside Germany and 22% growth in distributor/partner sales, the flat performance in Germany (their largest market) for a second consecutive year signals a growth bottleneck. The sales team reorganization is a necessary step but will cause temporary disruption, likely resulting in lower Q1 2025 results before improvement in the second half.

The pending regulatory decisions from the FDA and Health Canada for DrugSorb-ATR represent significant near-term catalysts. With a $300 million initial addressable market potentially expanding to $1 billion, approval would transform the company's growth trajectory beyond its current core business.

CytoSorbents' clinical strategy shows impressive momentum with multiple data presentations strengthening the evidence base for their blood purification technologies. The recent presentation at the International Symposium of Intensive Care demonstrated doubled survival rates in septic shock patients with early and intensive CytoSorb treatment—data now accepted for publication in the Journal of Intensive Care Medicine. This reinforces the "Right Patient, Right Time, Right Dose" treatment paradigm that's driving adoption.

The DrugSorb-ATR technology addresses a critical unmet need in cardiac surgery. Current protocols require delaying CABG surgery for 3-5 days when patients are on Brilinta (ticagrelor), placing patients at risk during this waiting period. The ability to remove this blood thinner quickly could revolutionize care protocols while reducing hospital stays and costs.

The upcoming clinical presentations at major cardiovascular conferences will be pivotal in establishing thought leadership. Dr. Michael Gibson's pooled analysis from the STAR-T trial and STAR Registry at the American College of Cardiology Conference provides real-world validation of bleeding reduction benefits. The anticipated presentation by Professor Robert Storey at EuroPCR comparing bleeding rates with and without the device could significantly influence clinical practice if compelling.

The controlled market release strategy for DrugSorb-ATR (pending regulatory approval) is prudent. Starting with clinical trial sites allows for gathering real-world feedback and refining the value proposition before broader commercialization. The focus on both clinical benefits and economic value aligns with healthcare systems' dual priorities.

While the core business continues to generate evidence supporting broader adoption, the potential approval and launch of DrugSorb-ATR represents a step-change opportunity. The technology platform's expansion potential beyond the initial indication into other blood thinners and surgical applications demonstrates significant runway for long-term growth.

  • 2024 marked by strong commercial execution and improved operating leverage
  • Company continues to expect DrugSorb-ATR regulatory decisions from Health Canada and US FDA in 2025
  • Successful Rights Offering and exercise of Series A Right Warrants strengthens balance sheet
  • Strengthening of clinical portfolio across cardiac surgery and critical care in 2025 with new presentations and publications
  • The Company has now adopted the standard accounting convention of reporting Revenue to only include Product Sales. Grant Income is no longer reported as a component of Revenue

PRINCETON, N.J., March 31, 2025 /PRNewswire/ -- 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 reported financial results for the fourth quarter and full year ended December 31, 2024, and recent business highlights. 

Fourth Quarter 2024 Financial Results

  • Product revenue was $9.2 million, an increase of 25% compared to $7.3 million in Q4 2023.
  • Grant income was $1.0 million compared to $1.3 million in Q4 2023. The Company has historically reported grant income as a component of total revenue and cost of revenue, as well as a reduction of related research and development expense. The Company will now report grant income solely as a reduction of related research and development expense. If the Company had continued its historical reporting, total revenue in Q4 2024 would have been $10.1 million, an increase of 17% compared to $8.7 million in Q4 2023. See reclassification of previously reported amounts in the tables below.
  • Product gross margin was 71% compared to 68% in Q4 2023.
  • Operating loss improved by 61% to $3.7 million compared to $9.6 million in Q4 2023, reflecting higher revenue and a 30% reduction in operating expenses.
  • Net loss was $7.6 million or $0.14 per share, compared to net loss of $6.1 million or $0.13 per share in Q4 2023.
  • Adjusted net loss improved by 78% to $1.7 million or $0.03 per share, compared to an adjusted net loss of $7.8 million or $0.17 per share in Q4 2023.
  • Adjusted EBITDA loss improved by 70% to $2.4 million compared to a loss of $8.1 million in Q4 2023.
  • Total cash, cash equivalents, and restricted cash of $9.8 million at December 31, 2024.
  • Pro forma total cash, including cash, cash equivalents, and restricted cash as if the rights offering and exercise of related Series A Right Warrants had occurred on December 31, 2024, of approximately $17.0 million, compared to $12.2 million at the end of Q3 2024, reflecting $7.3 million of net proceeds from the rights offering and exercise of the Series A Right Warrant, and net cash used in the fourth quarter of approximately $2.5 million compared to $2.7 million in Q3 2024.

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, "We delivered a strong fourth quarter, executing on key initiatives that drove solid performance, advanced our regulatory milestones, and fortified our financial position, setting the stage for what we believe will be a transformational year ahead."

  • Strong Sales Growth and Margins: We closed 2024 on a high note, achieving a 25% increase in Q4 sales compared to the prior year, and 6% sequential growth, culminating in $35.6 million in CytoSorb sales for the full year, representing a 15% year-over-year increase with healthy 71% product gross margins. These results were fueled by disciplined execution of our growth strategy in international markets, enhanced operating leverage, and prudent cash management.
  • Regulatory Momentum and Expanding Market Access: We made significant strides in bringing our DrugSorb™-ATR therapy to patients who need them most. Following the FDA's acceptance of our De Novo application for DrugSorb™-ATR, we entered interactive review - a crucial step toward potential U.S. marketing approval this year. In addition, after obtaining Medical Device Single Audit Program ("MDSAP") certification, we submitted our Medical Device License ("MDL") application to Health Canada that is now in advanced review. We believe we remain on track and continue to expect regulatory decisions this year.
  • Strengthened Balance Sheet: With strong support from our shareholders, we successfully executed our Shareholder Rights Offering and have raised total net proceeds of $7.3 million to date from the offering including the exercise of the Series A Right Warrant. This raise, also allowed for the release of $5.0 million of restricted cash on our balance sheet, and combined, has significantly solidified our financial foundation with an increase in liquidity of $12.3 million.

Full Year 2024 Financial Results

  • Product revenue was $35.6 million, an increase of 15% compared to $31.1 million in 2023.
  • Grant income was $3.6 million compared to $5.3 million in 2023. The Company has historically reported grant income as a component of total revenue and cost of revenue, as well as a reduction of related research and development expense. The Company will now report grant income solely as a reduction of related research and development expense. If the company had continued its historical reporting, total revenue would have been $39.2 million, an increase of 8% compared to $36.3 million in 2023. See reclassification of previously reported amounts in the tables below.
  • Product gross margin was 71% compared to 71% in 2023.
  • Operating loss for 2024 improved by 47% to $16.8 million compared to $32 million in 2023 reflecting higher revenue in 2024, and a 22% reduction in operating expenses.
  • Net loss was $20.7 million or $0.38 per share, compared to net loss of $29.2 million or $0.65 per share in 2023.
  • Adjusted net loss for 2024 improved by 53% to $12.7 million or $0.23 per share, compared to an adjusted net loss of $27 million or $0.61 per share in 2023.
  • Adjusted EBITDA loss for 2024 improved by 56% to $11.5 million compared to a loss of $26.2 million in 2023.

Dr. Chan continued, "We believe we have a clear and compelling value proposition.  Our core business grew 15% in 2024 with more than $35 million in high-margin CytoSorb sales, driven by 28% growth in direct sales outside of Germany and 22% growth in Distributor/Partner sales, which was partially offset by flat growth in direct sales in Germany for the year.

Overall, our central messaging of treating the "Right Patient at the Right Time with the Right Dose" of CytoSorb is helping to drive optimized treatment strategies, improve patient outcomes, and accelerate adoption.  For example, at this month's International Symposium of Intensive Care and Emergency Medicine Congress in Brussels, Berlot and colleagues from Italy presented compelling new data from a 175-patient retrospective study on septic shock and multiorgan failure.  They concluded that early and intensive treatment with CytoSorb led to a statistically significant doubling of survival, compared to predicted mortality.  These results, now accepted for publication in the Journal of Intensive Care Medicine, reinforce previously published findings from our CytoSorb Therapy in COVID-19 registry in the journal Critical Care that early and intensive treatment is associated with high survival and shorter time on mechanical support.  With a growing body of clinical data from both investigator- and company-sponsored studies, alongside our STAR-T trial and registries like COSMOS and STAR, the CytoSorb best practices knowledge base in the ICU and cardiac surgery is expanding rapidly worldwide.

Looking forward, we are encouraged by our commercial progress but are prioritizing a return to sales growth in Germany, our largest market, which was flat for the second year in a row.  Entering 2025, we initiated a significant reorganization of our direct sales team and strategy in Germany, including a rebalancing of territories and hospital accounts, with the goal of restoring sales growth through deeper customer engagement, more effective market development, and improved sales representative productivity.  Because of the effect of these changes, we expect a short-term disruption in Germany sales that will result in modestly lower product sales overall in the first quarter compared to a year ago.  However, we expect these actions will yield improved results in the second half of this year with the intent to manage our total core business toward breakeven.

Meanwhile, with the appropriate marketing approvals, we are excited by the potential near-term growth opportunity in the U.S. and Canada of addressing the serious perioperative bleeding problem caused by blood thinners like Brilinta® (ticagrelor, AstraZeneca) in patients undergoing coronary artery bypass graft ("CABG") surgery for which we have received FDA Breakthrough Designation.  Brilinta®, a widely used antiplatelet drug, is given to heart attack patients to prevent further clotting. However, if these patients require CABG surgery, current guidelines recommend delaying the procedure for three to five days to allow the drug to naturally wash out—leading to prolonged hospital stays, increased costs, and a heightened risk of life-threatening complications.

Blood purification with DrugSorb-ATR represents a unique solution that can enable patients to undergo CABG surgery safely and quickly, without having to wait at risk.  The intent is to both reduce serious bleeding complications while reducing the burden on hospital resources.  We estimate the total addressable market for DrugSorb-ATR in the U.S. and Canada will grow from $300 million today to over $1 billion as Brilinta becomes generic, DrugSorb-ATR establishes Brilinta as the only reversible oral antiplatelet, and we expand into other blood thinners and surgical applications.

As we await decisions from the FDA and Health Canada, we are preparing to execute a controlled market release at key clinical trial sites if approved. This initial stage is expected to last a few months and will allow us to gather real-world feedback, validate assumptions, and refine our commercialization strategy for a broader national launch.  Our DrugSorb-ATR launch team leverages years of commercial expertise and has initiated pre-market launch planning, including engaging with leading U.S. and Canadian key opinion leaders, recruiting essential talent, managing numerous market access activities, and developing a clear value proposition for patients, surgeons, and hospitals.

Visibility and thought leadership are key pillars of our DrugSorb-ATR launch strategy. Over the next several months, impactful new data will be presented at major cardiovascular conferences that underscore the clinical benefits of antithrombotic removal in cardiac surgery.

  • At the American College of Cardiology Conference in Chicago, the largest cardiovascular event in North America, STAR-T Principal Investigator, Dr. Michael Gibson, just presented an important pooled data analysis from the STAR-T trial and the international STAR Registry demonstrating that the bleeding reductions after CABG surgery observed in the controlled STAR-T trial also extend into real-world clinical practice.
  • At the Society of Cardiovascular Anesthesiologists 47th Annual Meeting in Montreal in April, Dr. David Mazer, a pioneer in perioperative blood conservation and a STAR-T Executive Committee member, will lead a roundtable discussion on the integration of DrugSorb-ATR into perioperative blood management protocols.
  • At EuroPCR in Paris this May, Professor Robert Storey will present what we believe to be some of the most compelling blood thinner removal evidence to date, comparing bleeding rates after CABG in Brilinta® patients operated with or without our device. This latest analysis with updated data from the STAR Registry clearly demonstrates the significant bleeding reductions associated with the use of our device in contemporary real-world practice.
  • At the Canadian Society of Cardiac Surgery conference in Montreal in May, Dr. Richard Whitlock, the STAR-T Canadian Principal Investigator, will host a symposium on the STAR-T study results, outlining DrugSorb-ATR's clinical and economic value proposition in Canadian hospital practice.
  • Finally, at the European Society of Cardiology Heart Failure meeting in Belgrade in May, a new study will be presented demonstrating how DrugSorb-ATR successfully prevented bleeding complications in patients on Brilinta® or other direct oral anticoagulants undergoing emergency, complex heart transplantation surgery."

Dr. Chan concluded, "With an established foundation of commercial sales, strong regulatory progress, and enhanced financial stability, we believe we are very well-positioned to take advantage of a host of new opportunities this year. As we advance our global commercialization strategy and prepare for the potential launch of DrugSorb-ATR, we remain committed to delivering life-saving solutions that improve patient outcomes and drive long-term value for our shareholders."

Business Outlook

As discussed, we anticipate a multitude of opportunities to potentially expand our business both internationally and in the United States and Canada this year.  To address flat product sales in our largest market of Germany, we restructured the direct sales team and strategy, including a realignment of sales territories and accounts, to drive a return to sales growth in this key country.  Because of the impact of these changes, we expect a short-term disruption in German sales and a modest decline in overall product sales for Q1 2025, both sequentially and compared to Q1 2024.  However, we expect these actions will help to improve results in the second half of this year with the intent to manage our core business toward breakeven. 

Q4 and Full Year 2024 Earnings Conference Call
CytoSorbents' management will host a live conference call, presentation webcast, and a question-and-answer session with the following information:

Date: Monday, March 31, 2025
Time: 4:30 PM ET
North American toll-free: 1-800-836-8184
International toll: 1-646-357-8785
Live webcast link: https://app.webinar.net/KGyNpgaYZgQ

It is recommended that participants dial in approximately 10 minutes prior to the start of the call.

An archived recording of the conference call will be available under the Investor Relations section of the Company's website at https://ir.cytosorbents.com/

About Non-GAAP Financial Measures
To supplement our condensed consolidated financial statements, we use the non-GAAP financial measures of EBITDA, which measures earnings before interest, income taxes, depreciation and amortization, and Adjusted EBITDA which further excludes non-cash stock compensation expense, and gain or loss of foreign exchange translation. We also use the non-GAAP financial measures of Adjusted Net Income or Loss and Adjusted Net Income or Loss Per Common Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per Common Share, respectively. Additionally, we have provided a Proforma Cash balance as of December 31, 2024, reflecting the proceeds, net of related fees, for the Rights Offering and Exercise of the Series A Warrant which were received in the first quarter of 2025 as if the net proceeds had been received as of December 31, 2024.  These non-GAAP measures are not based on any comprehensive set of accounting rules or principles and should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP and may be different from non-GAAP measures used by other companies. In addition, these non-GAAP measures should be read in conjunction with our financial statements prepared in accordance with GAAP. The reconciliations of the non-GAAP measures to the most directly comparable financial measures calculated and presented in accordance with GAAP should be carefully evaluated. We use these non-GAAP financial measures for financial and operational decision-making and as a means to evaluate period-to-period comparisons. We believe that these non-GAAP financial measures provide meaningful supplemental information regarding our performance and that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP financial measures are useful to investors because (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and (2) they are used by investors and the analyst community to help them analyze the performance of our business, the Company's cash available for operations, and the Company's ability to meet future capital expenditure and working capital requirements.

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, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. 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 and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. 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 over 70 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.  CytoSorb is not yet approved or cleared 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 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, our restructuring of our direct sales team and strategy in Germany and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com 

Investor Relations Contact:
Aman Patel, CFA & Adanna G. Alexander, PhD
ICR Healthcare
ir@cytosorbents.com 

 

CYTOSORBENTS CORPORATION

CONSOLIDATED BALANCE SHEETS











At December 31,



2024


2023, as Restated

ASSETS







Current Assets:







Cash and cash equivalents


$

3,279,926


$

14,131,137

Restricted cash, current



5,000,000



Grants and accounts receivable, net of allowances of $157,701 and
     $49,663 at December 31, 2024 and 2023, respectively



7,319,597



6,057,072

Inventories



2,732,907



3,375,817

Prepaid expenses and other current assets



3,270,812



1,834,485

Total current assets



21,603,242



25,398,511








Property and equipment – net



9,002,383



10,056,354

Restricted cash



1,483,958



1,483,958

Right-of-use asset



11,511,236



12,058,896

Other assets



3,770,680



3,958,603

Total Assets


$

47,371,500


$

52,956,322








LIABILITIES AND STOCKHOLDERS' EQUITY







Current Liabilities:







Accounts payable


$

3,339,885


$

3,802,170

Accrued expenses and other current liabilities



6,031,670



7,359,786

Lease liability – current portion



452,688



373,636

Current maturities of long-term debt





2,500,000

Total current liabilities



9,824,243



14,035,592

Lease liability, net of current portion



12,443,971



12,896,659

Long-term debt, net of current maturities



13,996,350



2,542,857

Total Liabilities



36,264,564



29,475,108








Commitments and Contingencies







Stockholders' Equity:







Preferred Stock, Par Value $0.001, 5,000,000 shares authorized; no
     shares issued and outstanding at December 31, 2024 and 2023





Common Stock, Par Value $0.001, 100,000,000 shares authorized at
     December 31, 2024 and 2023; and 54,830,146 and 54,240,265
     shares issued and outstanding at December 31, 2024 and 2023,
     respectively



54,830



54,240

Additional paid-in capital



310,808,711



306,187,314

Accumulated other comprehensive income



4,252,013



529,321

Accumulated deficit



(304,008,618)



(283,289,661)

Total stockholders' equity



11,106,936



23,481,214

Total Liabilities and Stockholders' Equity


$

47,371,500


$

52,956,322

 

CYTOSORBENTS CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS













Three months
ended

Three months ended


Year ended


Year ended



December 31, 

December 31, 


December 31, 


December 31, 



2024
(unaudited)

2023, as Restated
(unaudited)


2024


2023, as Restated

Product revenue



$9,150,416

$ 7,348,486


$ 35,594,520


$

31,084,953

Cost of goods sold



2,656,446

2,346,618


10,468,529



9,131,716

Gross profit



6,493,970

5,001,868


25,125,991



21,953,237

Operating expenses:










Research and development, net of
grant income



 

1,324,353

 

4,091,400


6,916,181



 

15,594,442

Selling, general and administrative



8,898,722

10,551,838


34,995,749



38,307,415

Total operating expenses



10,223,076

14,643,238


41,911,930



53,901,857

Loss from operations



 

(3,729,107)

 

(9,641,369)


 

(16,785,940)



 

(31,948,620)

Other income (expense):










Interest expense, net



(624,180)

(52,229)


(1,399,092)



(157,891)

Gain (loss) on foreign currency
transactions



 

(4,905,114)

 

2,683,254


 

(4,224,721)



 

1,949,257

Miscellaneous income (expense)



(29)

61,754


(29)



96,755

Total other income (expense), net



(5,529,332)

2,692,779


(5,623,842)



1,888,121











Loss before benefit from income taxes



 

(9,258,438)

 

(6,948,590)


(22,409,782)



 

(30,060,499)











Benefit from income taxes



1,690,825

813,739


1,690,825



813,739











Net loss attributable to common
stockholders


$

 

(7,567,613)

 

$ (6,134,851)


 

$ (20,718,957)


$

 

(29,246,760)











Basic and diluted net loss per
common share



 

$ (0.14)

 

$ (0.13)


$ (0.38)



$ (0.65)











Weighted average number of shares
of common stock outstanding



 

54,714,642

 

46,531,510


54,434,609



44,656,391











Comprehensive loss:










Net loss


$

 

(7,567,613)

 

$ (6,134,851)


$ (20,718,957)


$

(29,246,760)

Other comprehensive income (loss):










Foreign currency translation adjustment



 

4,713,249

 

(2,454,666)


4,027,003



(1,799,874)

Comprehensive loss


$

(2,854,364)

$ (8,589,517)


$ (16,691,953)


$

(31,046,634)


The Notes to Consolidated Financial Statements are an integral part of these statements.

 

CYTOSORBENTS CORPORATION

CONSOLIDATED STATEMENTS OF CHANGES IN

STOCKHOLDERS' EQUITY

FOR THE YEARS ENDED DECEMBER 31, 2024 and 2023






























Accumulated














Additional


Other









Common Stock


Paid-In


Comprehensive


Accumulated


Stockholders'



Shares


Par value


Capital


Income (Loss)


Deficit


Equity



















Balance at December 31, 2022


43,635,715


$

43,635


$

287,000,021


$

2,329,195


$

(253,997,878)


$

35,374,973

Cumulative effect of adjustments to
     beginning balance






777,310





(45,023)



732,287

Stock-based compensation (as restated)






4,155,342







4,155,342

Proceeds from the exercise of stock options
     for cash, net of fees incurred


84,905



85



218,193







218,278

Issuance of common stock offerings, net of
     fees incurred


10,389,554



10,390



14,245,542







14,255,932

Common stock issued upon vesting of
     restricted stock units, less shares withheld
     to cover taxes


130,091



130



(209,094)







(208,964)

Other comprehensive loss, foreign currency
     translation adjustment








(1,799,874)





(1,799,874)

Net loss (as restated)










(29,246,760)



(29,246,760)

Balance at December 31, 2023 (as restated)


54,240,265


$

54,240


$

306,187,314


$

529,321


$

(283,289,661)


$

23,481,214

Stock-based compensation






3,759,534







3,759,534

Issuance of common stock offerings, net of
     fees incurred


382,823



385



178,269







178,654

Common stock issued upon vesting of
     restricted stock units, less shares withheld
     to cover taxes


207,058



205



(7,115)







(6,910)

Issuance of warrants






690,709







690,709

Other comprehensive loss, foreign currency
     translation adjustment








3,722,692





3,722,692

Net loss










(20,718,957)



(20,718,957)

Balance at December 31, 2024


54,830,146


$

54,830


$

310,808,711


$

4,252,013


$

(304,008,618)


$

11,106,936

 

CYTOSORBENTS CORPORATION

RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES

For the three and twelve months ended December 31, 2024 and 2023 (Unaudited)



Three Months Ended 


Twelve Months Ended


Dec 31,


Dec 31,


Dec 31,


Dec 31,


2024


2023, as
Restated


2024


2023, as
Restated

(In thousands, except per share amounts)








 

Net loss

 

$            (7,568)


 

$            (6,135)


 

$           (20,719)


 

$          (29,247)

Depreciation and amortization expense

391


397


1,570


1,459

Income tax expense (benefit)

(1,691)


(814)


(1,691)


(814)

Interest expense (income)

624


52


1,399


158

EBITDA - non GAAP

$(8,244)


$            (6,500)


$           (19,441)


$          (28,444)

 

Non cash stock-based compensation expense

 

919


 

1,048


 

3,760


 

4,155

 (Gain)/Loss on foreign currency translation

4,905


(2,683)


4,225


(1,949)

Adjusted EBITDA - non GAAP

$              (2,420)


$             (8,134)


$            (11,456)


$          (26,237)

 

Net loss

 

$              (7,568)


 

$             (6,135)


 

$           (20,719)


 

$          (29,247)

Non cash stock-based compensation expense

919


1,048


3,760


4,155

 (Gain)/Loss on foreign currency translation

4,905


(2,683)


4,225


(1,949)

Adjusted net income (loss) - non GAAP

$(1,743)


$            (7,769)


$           (12,735)


$         (27,041)

 

Weighted average common shares outstanding basic and
diluted

 

 

54,714,642


 

 

46,531,510


 

 

54,434,609


 

 

44,656,391

 

Loss per common share — basic and diluted

 

$              (0.14)


 

$              (0.13)


 

$              (0.38)


 

$              (0.65)

Non cash stock-based compensation expense

$               0.02


$               0.02


$               0.07


$               0.09

(Gain)/Loss on foreign currency translation

$               0.09


$              (0.06)


$               0.08


$             (0.04)

Adjusted net income (loss) per common share - basis and








diluted - non GAAP

$              (0.03)


$              (0.17)


$              (0.23)


$              (0.61)

 

CYTOSORBENTS CORPORATION

RECLASSIFICATION AND RESTATEMENT OF INCOME STATEMENT



For the Year-ended Dec 31, 2023


For the Year-ended Dec 31, 2024














Mar 31, 2023

Jun 30, 2023

Sep 30, 2023

Dec 31, 2023

2023


Mar 31, 2024

Jun 30, 2024

Sep 30, 2024

Dec 31, 2024

2024

As Previously Reported












Grant Income

$1,539

$1,348

$1,057

$1,320

$5,264


$797

$1,053

$778

$                -

$   -

Total Revenue

9,449

9,421

8,811

8,668

36,349


9,786

9,895

9,390

-

-

Cost of revenue

3,994

3,402

3,204

3,357

13,957


3,216

3,392

4,109

-

-

Gross profit

5,455

6,019

5,607

5,311

22,392


6,571

6,503

5,282

-

-

Gross margin %

58 %

64 %

64 %

61 %

62 %


67 %

66 %

56 %



Research and development

4,214

3,669

3,749

4,097

15,729


2,248

1,520

1,851

-

-

Legal, financial, and other consulting

669

1,185

1,103

1,315

4,272


681

821

824

-

-

Selling, general and administrative

8,463

7,724

8,104

9,242

33,600


8,567

7,581

7,003

-

-













Impact of Reclassification












Grant Income

($1,539)

($1,348)

($1,057)

($1,320)

($5,264)


($797)

($1,053)

($778)

$                -

$   -

Total Revenue

(1,539)

(1,348)

(1,057)

(1,320)

(5,264)


(797)

(1,053)

(778)

-

-

Cost of revenue

(1,463)

(1,309)

(1,043)

(1,315)

(5,130)


(795)

(1,053)

(752)

-

-

Gross profit

(76)

(39)

(14)

(5)

(134)


(2)

-

(26)

-

-

Research and development

(76)

(39)

(14)

(5)

(134)


(2)

-

(26)

-

-

Legal, financial, and other consulting

(669)

(1,185)

(1,103)

(1,315)

(4,272)


(681)

(821)

(824)

-

-

Selling, general and administrative

669

1,185

1,103

1,315

4,272


681

821

824

-

-













Impact of Restatement












Cost of goods sold

-

-

-

304

304


(304)

-

-

-

-

Gross profit

-

-

-

304

304


(304)

-

-

-

-

Selling, general and administrative

(3)

448

(5)

435

435


35

152

433

-

-













As Reclassfied and Restated












Grant Income

-

-

-

-

-


-

-

-

-

-

Total Revenue

7,910

8,073

7,754

7,348

31,085


8,990

8,842

8,612

-

-

Cost of goods sold

2,531

2,093

2,161

2,346

9,131


2,117

2,339

3,357

-

-

Gross profit

5,379

5,980

5,593

5,002

21,954


6,873

6,503

5,256

-

-

Gross margin %

68 %

74 %

72 %

68 %

71 %


76 %

74 %

61 %



Research and development

4,138

3,630

3,735

4,092

15,595


2,246

1,520

1,825

-

-

Legal, financial, and other consulting

-

-

-

-

-


-

-

-

-

-

Selling, general and administrative

9,129

9,357

9,202

10,553

38,307


9,283

8,554

8,260



 

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SOURCE Cytosorbents Corp

FAQ

What were CytoSorbents' (CTSO) Q4 2024 financial results?

CTSO reported Q4 2024 product revenue of $9.2M (up 25% YoY), with 71% gross margins. Operating loss improved 61% to $3.7M, while net loss was $7.6M ($0.14/share).

How much did CytoSorbents (CTSO) raise in their Rights Offering?

CTSO raised $7.3M in net proceeds from the Rights Offering and exercise of Series A Right Warrants, strengthening their balance sheet.

What is the status of DrugSorb-ATR regulatory approval for CTSO?

DrugSorb-ATR is under FDA De Novo review and Health Canada MDL application review, with regulatory decisions expected in 2025.

What are CTSO's sales expectations for Q1 2025?

CTSO expects modest decline in Q1 2025 product sales due to German sales team restructuring, with improvements anticipated in H2 2025.

What was CytoSorbents' (CTSO) full-year 2024 revenue?

CTSO achieved $35.6M in CytoSorb product sales for full-year 2024, representing 15% growth year-over-year.
Cytosorbents Corp

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