CytoSorbents Reports Third Quarter 2024 Financial and Operational Results
CytoSorbents reported Q3 2024 financial results with product revenue of $8.6 million, showing 11% growth vs Q3 2023. Total revenue reached $9.4 million, a 7% increase year-over-year. Product gross margins decreased to 61% from 72% due to planned production slowdown. The company reported a net loss of $2.3 million ($0.04 per share), improved from $9.2 million loss in Q3 2023. Cash position stood at $12.2 million. The company submitted DrugSorb-ATR De Novo application to FDA and Medical Device License application to Health Canada, targeting a potential North American market exceeding $300 million.
CytoSorbents ha riportato i risultati finanziari del terzo trimestre 2024 con entrate da prodotto di 8,6 milioni di dollari, mostrando una crescita dell'11% rispetto al terzo trimestre 2023. Le entrate totali hanno raggiunto 9,4 milioni di dollari, un aumento del 7% anno su anno. I margini lordi sui prodotti sono diminuiti al 61% rispetto al 72% a causa di un rallentamento programmato della produzione. La società ha registrato una perdita netta di 2,3 milioni di dollari (0,04 dollari per azione), in miglioramento rispetto a una perdita di 9,2 milioni di dollari nel terzo trimestre 2023. La posizione di cassa era di 12,2 milioni di dollari. L'azienda ha presentato la domanda De Novo per DrugSorb-ATR alla FDA e la domanda per la Licenza di Dispositivo Medico a Salute Canada, puntando a un potenziale mercato nordamericano che supera i 300 milioni di dollari.
CytoSorbents informó los resultados financieros del tercer trimestre de 2024 con ingresos por productos de 8,6 millones de dólares, mostrando un crecimiento del 11% frente al tercer trimestre de 2023. Los ingresos totales alcanzaron 9,4 millones de dólares, un aumento del 7% interanual. Los márgenes brutos de los productos disminuyeron al 61% desde el 72% debido a una desaceleración programada en la producción. La compañía reportó una pérdida neta de 2,3 millones de dólares (0,04 dólares por acción), mejorando desde una pérdida de 9,2 millones de dólares en el tercer trimestre de 2023. La posición de efectivo se situó en 12,2 millones de dólares. La empresa presentó la solicitud De Novo para DrugSorb-ATR a la FDA y la solicitud de licencia de dispositivo médico a Salud Canadá, apuntando a un mercado potencial en América del Norte que supera los 300 millones de dólares.
CytoSorbents는 2024년 3분기 재무 결과를 보고하였으며, 제품 수익이 860만 달러로 2023년 3분기 대비 11% 성장한 것으로 나타났습니다. 총 수익은 940만 달러에 도달했으며, 이는 전년 대비 7% 증가한 것입니다. 제품 총 마진은 계획된 생산 속도의 둔화로 인해 72%에서 61%로 감소했습니다. 회사는 230만 달러의 순손실을 기록했으며(주당 0.04달러), 이는 2023년 3분기의 920만 달러 손실에서 개선된 것입니다. 현금 잔고는 1220만 달러로 나타났습니다. 이 회사는 DrugSorb-ATR의 De Novo 신청을 FDA에 제출하였고, 의료기기 라이센스 신청을 캐나다 보건부에 제출하였으며, 북미 시장의 잠재력이 3억 달러를 초과할 것으로 예상하고 있습니다.
CytoSorbents a rapporté les résultats financiers du troisième trimestre 2024 avec des revenus produits de 8,6 millions de dollars, montrant une croissance de 11 % par rapport au troisième trimestre 2023. Le chiffre d'affaires total a atteint 9,4 millions de dollars, soit une augmentation de 7 % d'une année sur l'autre. Les marges brutes sur les produits ont diminué à 61 % contre 72 % en raison d'un ralentissement de production planifié. L'entreprise a enregistré une perte nette de 2,3 millions de dollars (0,04 dollar par action), s'améliorant par rapport à une perte de 9,2 millions de dollars au troisième trimestre 2023. La position de trésorerie s'élevait à 12,2 millions de dollars. L'entreprise a soumis une demande De Novo pour DrugSorb-ATR à la FDA et une demande de licence de dispositif médical à Santé Canada, visant un marché nord-américain potentiel de plus de 300 millions de dollars.
CytoSorbents berichtete über die Finanzergebnisse des dritten Quartals 2024 mit Produktumsätzen von 8,6 Millionen Dollar, was einem Wachstum von 11% im Vergleich zum dritten Quartal 2023 entspricht. Die Gesamterlöse beliefen sich auf 9,4 Millionen Dollar, was einem Anstieg von 7% im Jahresvergleich entspricht. Die Bruttomargen der Produkte fielen von 72% auf 61% aufgrund einer geplanten Produktionsverlangsamung. Das Unternehmen meldete einen Nettoverlust von 2,3 Millionen Dollar (0,04 Dollar pro Aktie), eine Verbesserung gegenüber dem Verlust von 9,2 Millionen Dollar im dritten Quartal 2023. Die Liquidität betrug 12,2 Millionen Dollar. Das Unternehmen reichte einen De Novo-Antrag für DrugSorb-ATR bei der FDA sowie einen Antrag auf eine Medizinproduktelizenz bei Health Canada ein und zielt auf einen potenziellen nordamerikanischen Markt von über 300 Millionen Dollar ab.
- Product revenue grew 11% YoY to $8.6 million
- Total revenue increased 7% YoY to $9.4 million
- Net loss improved significantly from $9.2M to $2.3M YoY
- FDA accepted DrugSorb-ATR application with priority review status
- Obtained MDSAP certification for quality management system
- Product gross margins declined from 72% to 61% YoY
- Cash position decreased from $14.9M to $12.2M QoQ
- Still operating at a net loss of $2.3 million
- Adjusted EBITDA remains negative at -$3.6 million
Insights
CytoSorbents shows mixed financial performance with some positive trends. Product revenue grew
The potential DrugSorb-ATR market opportunity of
The DrugSorb-ATR regulatory progress is significant, with FDA accepting the De Novo application and granting priority review status. The MDSAP certification strengthens the company's quality management credentials across multiple markets. The technology addresses a critical need in cardiac surgery for patients on blood thinners, particularly Brilinta®.
The STAR and COSMOS registries are generating valuable real-world evidence, while the new PuriFi® pump launch expands the product ecosystem. The potential market expansion beyond CABG surgery to other surgical applications demonstrates strong growth potential, though clinical validation for these additional uses will be needed.
PRINCETON, N.J., Nov. 07, 2024 (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 reported unaudited financial and operating results for the third quarter ended September 30, 2024.
Third Quarter 2024 Financial Results
- Product revenue of
$8.6 million ,11% growth versus$7.8 million in Q3 2023 - Total revenue of
$9.4 million inclusive of product and grant revenue,7% growth versus$8.8 million in Q3 2023 - Product gross margins decreased to
61% , compared to72% in Q3 2023, reflecting the impact of a planned production slowdown to rebalance inventory and a short-term manufacturing issue that is now resolved - Net loss of
$2.3 million or$0.04 per share, compared to net loss of$9.2 million or$0.21 per share in Q3 2023 - Adjusted net loss improved to
$4.5 million or$0.08 per share, compared to an adjusted net loss of$6.0 million or$0.14 per share in Q3 2023 - Adjusted EBITDA loss improved to
$3.6 million compared to a loss of$5.6 million in Q3 2023 - Total cash, including cash, cash equivalents, and restricted cash of
$12.2 million , compared to$14.9 million at the end of Q2 2024, reflecting an improvement of cash used in the quarter of$2.7 million compared to$5.0 million used in Q2 2024
“I am pleased with the progress we made this quarter. Our topline performance is a testament to the improving strength of our critical care and cardiac surgery businesses, driven by solid execution from our direct sales team and distributor network. In addition, our manufacturing is now running smoothly with an expected return to more normalized production levels and product gross margins in the fourth quarter of this year.” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Meanwhile, we believe that we have significantly improved our operating metrics and continue to demonstrate a disciplined approach to cash management. We believe this will enable us to scale our business effectively with improved operating leverage as we prepare for the commercial launch of DrugSorb™-ATR in North America, if approved, and position ourselves for the next phase of growth.”
Advancing Our DrugSorb-ATR Regulatory and Commercial Strategy
Dr. Chan continued, “The potential expansion of our markets to the U.S. and Canada with DrugSorb-ATR could be game-changing. With the steady growth in our CytoSorb business driving leverage in our operations, we have been diligently executing on our regulatory strategy for DrugSorb-ATR with the U.S. Food and Drug Administration (FDA) and Health Canada.” We have:
- Submitted our DrugSorb-ATR De Novo application to the U.S. FDA on September 27, 2024, and announced FDA acceptance and initiation of substantive review of our application on October 22, 2024, which is also eligible for priority review based on FDA Breakthrough Device Designation
- Received Medical Device Single Audit Program (MDSAP) certification on November 1, 2024, a key regulatory milestone that certifies compliance of our quality management system with the standard regulatory requirements of Canada, the U.S., Brazil, Japan, and Australia. Importantly, U.S. FDA accepts MDSAP certification and audit reports in lieu of their own routine Agency inspections, if required
- Submitted our Medical Device License (MDL) marketing application to Health Canada on November 1, 2024, concurrent with MDSAP certification – a requirement for submission
Dr. Chan continued, “These are key milestones that give us visibility on regulatory decisions by FDA and Health Canada expected next year. We are confident that DrugSorb-ATR has the ability to transform the current standard of care in patients with acute coronary syndromes (ACS) treated with the blockbuster blood thinner Brilinta® (ticagrelor, AstraZeneca) by enabling safe and timely CABG surgery while eliminating treatment delays that expose patients to additional risk and consume valuable hospital resources. In doing so, we believe DrugSorb-ATR represents a winning solution for patients, surgeons, and hospitals.
The potential North American DrugSorb-ATR total addressable market (TAM) in patients undergoing CABG surgery on Brilinta® currently exceeds an estimated
Although these are certainly large markets, be assured that we have had years of both manufacturing and commercialization experience in our core international markets and are actively preparing to leverage this experience for our expected North American launch.”
Dr. Chan concluded, “We believe we have a simple and compelling value proposition. Our North American DrugSorb-ATR opportunity is significant, and leverages the experience of our international CytoSorb business which continues to grow across 76 countries and is generating nearly
About DrugSorb-ATR
The goal of DrugSorb-ATR, an investigational medical device, is to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering a heart attack. If patients are not eligible for a coronary stent, they will often require CABG surgery to restore blood flow to heart muscle. Current guidelines recommend the delay of surgery by three to five days to allow “washout” or natural elimination of the drug to reduce the high risk of serious and potentially fatal perioperative bleeding from the use of the blood thinner. We believe that DrugSorb-ATR represents a breakthrough solution that will allow patients to proceed with their much-needed CABG surgery in a safe and timely manner rather than risking serious, potentially life-threatening complications and consuming costly hospital resources while waiting in the hospital for multiple days for ticagrelor to be naturally eliminated from their system.
Q3 2024 Earnings Conference Call
The Company will conduct its third quarter 2024 results call today at 4:30 p.m. Eastern time. Investors interested in participating in the call by phone may do so by dialling (800) 715-987, passcode 9258825. Those interested in listening to the conference call live via the internet may do so by utilizing the following link https://edge.media-server.com/mmc/p/e9gv3iaw, conference ID: 9258825. 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. 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, 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
305 College Road East
Princeton, NJ 08540
pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA
Investor Relations, ICR-Westwicke
(443) 450-4191
ir@cytosorbents.com
| CYTOSORBENTS CORPORATION CONSOLIDATED BALANCE SHEETS | |||||||
| September 30, | |||||||
| 2024 | December 31, | ||||||
| (Unaudited) | 2023 | ||||||
| ASSETS | |||||||
| Current Assets: | |||||||
| Cash and cash equivalents | $ | 5,685,328 | $ | 14,131,137 | |||
| Grants and accounts receivable, net of allowance of | 6,632,590 | 6,057,072 | |||||
| Inventories | 3,247,756 | 3,680,129 | |||||
| Prepaid expenses and other current assets | 1,031,694 | 1,834,485 | |||||
| Total current assets | 16,597,368 | 25,702,823 | |||||
| Property and equipment, net | 9,269,899 | 10,056,354 | |||||
| Restricted cash | 6,483,958 | 1,483,958 | |||||
| Right-of-use assets | 11,651,563 | 12,058,896 | |||||
| Other assets | 3,801,223 | 3,958,603 | |||||
| Total Assets | $ | 47,804,011 | $ | 53,260,634 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current Liabilities: | |||||||
| Accounts payable | $ | 2,338,143 | $ | 3,802,170 | |||
| Current maturities of long-term debt | --- | 2,500,000 | |||||
| Lease liability – current portion | 431,997 | 373,636 | |||||
| Accrued expenses and other current liabilities | 5,660,051 | 7,870,149 | |||||
| Total current liabilities | 8,430,191 | 14,545,955 | |||||
| Lease liability, net of current portion | 12,568,745 | 12,896,659 | |||||
| Long-term debt | 13,805,985 | 2,542,857 | |||||
| Total Liabilities | 34,804,921 | 29,985,471 | |||||
| Commitments and Contingencies (Note 6) | |||||||
| Stockholders’ Equity: | |||||||
| Preferred Stock, Par Value | — | — | |||||
| Common Stock, Par Value | 54,498 | 54,240 | |||||
| Additional paid-in capital | 308,441,887 | 305,196,874 | |||||
| Accumulated other comprehensive income | (156,925 | ) | 529,321 | ||||
| Accumulated deficit | (295,340,370 | ) | (282,505,272 | ) | |||
| Total Stockholders’ Equity | 12,999,090 | 23,275,163 | |||||
| Total Liabilities and Stockholders’ Equity | $ | 47,804,011 | $ | 53,260,634 | |||
See accompanying notes to consolidated financial statements.
| CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||
| Revenue: | |||||||||||||||
| CytoSorb sales | $ | 8,586,274 | $ | 7,709,085 | $ | 26,381,455 | $ | 23,681,183 | |||||||
| Other product sales | 26,521 | 44,931 | 62,649 | 55,285 | |||||||||||
| Total product sales | 8,612,795 | 7,754,016 | 26,444,104 | 23,736,468 | |||||||||||
| Grant income | 777,593 | 1,056,831 | 2,627,212 | 3,944,696 | |||||||||||
| Total revenue | 9,390,388 | 8,810,847 | 29,071,316 | 27,681,164 | |||||||||||
| Cost of revenue | 4,108,773 | 3,203,981 | 10,716,394 | 10,600,421 | |||||||||||
| Gross profit | 5,281,615 | 5,606,866 | 18,354,922 | 17,080,743 | |||||||||||
| Other expenses: | |||||||||||||||
| Research and development | 1,851,230 | 3,749,197 | 5,619,040 | 11,632,416 | |||||||||||
| Legal, financial and other consulting | 823,914 | 1,103,475 | 2,325,351 | 2,957,738 | |||||||||||
| Selling, general and administrative | 7,002,718 | 8,104,392 | 23,151,118 | 24,358,417 | |||||||||||
| Total expenses | 9,677,862 | 12,957,064 | 31,095,509 | 38,948,571 | |||||||||||
| Loss from operations | (4,396,247 | ) | (7,350,198 | ) | (12,740,587 | ) | (21,867,828 | ) | |||||||
| Other income (expense): | |||||||||||||||
| Interest income (expense), net | (588,153 | ) | (33,670 | ) | (774,903 | ) | (105,662 | ) | |||||||
| Gain (loss) on foreign currency transactions | 2,650,309 | (1,809,652 | ) | 680,392 | (733,997 | ) | |||||||||
| Miscellaneous income (expense) | — | — | — | 35,000 | |||||||||||
| Total other income (expense), net | 2,062,156 | (1,843,322 | ) | (94,511 | ) | (804,659 | ) | ||||||||
| Loss before benefit from income taxes | (2,334,091 | ) | (9,193,520 | ) | (12,835,098 | ) | (22,672,487 | ) | |||||||
| Benefit from income taxes | — | — | — | — | |||||||||||
| Net loss attributable to common stockholders | $ | (2,334,091 | ) | $ | (9,193,520 | ) | $ | (12,835,098 | ) | $ | (22,672,487 | ) | |||
| Basic and diluted net loss per common share | $ | (0.04 | ) | $ | (0.21 | ) | $ | (0.24 | ) | $ | (0.52 | ) | |||
| Weighted average number of shares of common stock outstanding | 54,453,006 | 44,373,969 | 54,340,583 | 44,024,483 | |||||||||||
| Net loss | $ | (2,334,091 | ) | $ | (9,193,520 | ) | $ | (12,835,098 | ) | $ | (22,672,487 | ) | |||
| Other comprehensive income (loss): | |||||||||||||||
| Foreign currency translation adjustment | (2,330,743 | ) | 1,655,674 | (686,246 | ) | 654,792 | |||||||||
| Comprehensive loss | $ | (4,664,834 | ) | $ | (7,537,846 | ) | $ | (13,521,344 | ) | $ | (22,017,695 | ) | |||
See accompanying notes to consolidated financial statements.
| CYTOSORBENTS CORPORATION CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY For the three and nine months ended September 30, 2024 and 2023 (Unaudited) | ||||||||||||||||||||
| Accumulated | ||||||||||||||||||||
| Additional | Other | |||||||||||||||||||
| Common Stock | Paid-In | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||
| Shares | Par value | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||
| Balance at June 30, 2024 | 54,306,415 | $ | 54,306 | $ | 307,514,758 | $ | 2,173,818 | $ | (293,006,279 | ) | $ | 16,736,603 | ||||||||
| Stock-based compensation - employees, consultants and directors | — | — | 781,881 | — | — | 781,881 | ||||||||||||||
| Other comprehensive loss: foreign translation adjustment | — | — | — | (2,330,743 | ) | — | (2,330,743 | ) | ||||||||||||
| ATM Activation Fees | — | — | (41,444 | ) | — | — | (41,444 | ) | ||||||||||||
| Issuance of restricted stock units | 194,198 | 192 | 186,692 | — | — | 186,884 | ||||||||||||||
| Net loss | — | — | — | — | (2,334,091 | ) | (2,334,091 | ) | ||||||||||||
| Balance at September 30, 2024 | 54,500,613 | $ | 54,498 | $ | 308,441,887 | $ | (156,925 | ) | $ | (295,340,370 | ) | $ | 12,999,090 | |||||||
| Balance at December 31, 2023 | 54,240,265 | $ | 54,240 | $ | 305,196,874 | $ | 529,321 | $ | (282,505,272 | ) | $ | 23,275,163 | ||||||||
| Stock-based compensation - employees, consultants and directors | — | — | 2,344,671 | — | — | 2,344,671 | ||||||||||||||
| Other comprehensive loss: foreign translation adjustment | — | — | — | (686,246 | ) | — | (686,246 | ) | ||||||||||||
| Issuance of common stock offerings, net of fees | 53,290 | 53 | 11,741 | — | — | 11,794 | ||||||||||||||
| Warrants Issued in connection with long term debt | — | — | 690,709 | — | — | 690,709 | ||||||||||||||
| Issuance of restricted stock units | 207,058 | 205 | 197,892 | — | — | 198,097 | ||||||||||||||
| Net loss | — | — | — | — | (12,835,098 | ) | (12,835,098 | ) | ||||||||||||
| Balance at September 30, 2024 | 54,500,613 | $ | 54,498 | $ | 308,441,887 | $ | (156,925 | ) | $ | (295,340,370 | ) | $ | 12,999,090 | |||||||
| Accumulated | ||||||||||||||||||||
| Additional | Other | |||||||||||||||||||
| Common Stock | Paid-In | Comprehensive | Accumulated | Stockholders’ | ||||||||||||||||
| Shares | Par value | Capital | Income (Loss) | Deficit | Equity | |||||||||||||||
| Balance at June 30, 2023 | 44,193,696 | $ | 44,193 | $ | 290,199,035 | $ | 1,328,313 | $ | (267,476,845 | ) | $ | 24,094,696 | ||||||||
| Stock-based compensation - employees, consultants and directors | — | — | 1,086,163 | — | — | 1,086,163 | ||||||||||||||
| Other comprehensive loss: foreign translation adjustment | — | — | — | 1,655,674 | — | 1,655,674 | ||||||||||||||
| Issuance of common stock offerings, net of fees | 162,078 | 162 | 632,232 | — | — | 632,394 | ||||||||||||||
| Proceeds from exercise of stock options for cash | 7,962 | 9 | 15,920 | — | — | 15,929 | ||||||||||||||
| Issuance of restricted stock units | 74,773 | 75 | 220,211 | — | — | 220,286 | ||||||||||||||
| Net loss | — | — | — | — | (9,193,520 | ) | (9,193,520 | ) | ||||||||||||
| Balance at September 30, 2023 | 44,438,509 | $ | 44,439 | $ | 292,153,561 | $ | 2,983,987 | $ | (276,670,365 | ) | $ | 18,511,622 | ||||||||
| Balance at December 31, 2022 | 43,635,715 | $ | 43,635 | $ | 287,000,021 | $ | 2,329,195 | $ | (253,997,878 | ) | $ | 35,374,973 | ||||||||
| Stock-based compensation - employees, consultants and directors | — | — | 2,486,679 | — | — | 2,486,679 | ||||||||||||||
| Other comprehensive income: foreign translation adjustment | — | — | — | 654,792 | — | 654,792 | ||||||||||||||
| Issuance of common stock offerings, net of fees | 590,348 | 591 | 2,106,528 | — | — | 2,107,119 | ||||||||||||||
| Proceeds from exercise of stock options for cash | 82,355 | 83 | 213,224 | — | — | 213,307 | ||||||||||||||
| Issuance of restricted stock units | 130,091 | 130 | 403,811 | — | — | 403,941 | ||||||||||||||
| Legal/audit fees related to ATM offering | — | — | (56,702 | ) | — | — | (56,702 | ) | ||||||||||||
| Net loss | — | — | — | — | (22,672,487 | ) | (22,672,487 | ) | ||||||||||||
| Balance at September 30, 2023 | 44,438,509 | $ | 44,439 | $ | 292,153,561 | $ | 2,983,987 | $ | (276,670,365 | ) | $ | 18,511,622 | ||||||||
See accompanying notes to consolidated financial statements.
| CYTOSORBENTS CORPORATION RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES For the three and nine months ended September 30, 2024 and 2023 (Unaudited) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| Sep 30, | Sep 30, | Sep 30, | Sep 30, | ||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (In thousands, except per share amounts) | |||||||||||||||
Net loss | $ | (2,334 | ) | $ | (9,194 | ) | $ | (12,835 | ) | $ | (22,672 | ) | |||
| Depreciation and amortization expense | 381 | 402 | 1,180 | 1,062 | |||||||||||
| Income tax expense (benefit) | -- | -- | -- | -- | |||||||||||
| Interest expense (income) | 588 | 34 | 775 | 106 | |||||||||||
| EBITDA - non GAAP | $ | (1,365 | ) | $ | (8,758 | ) | $ | (10,880 | ) | $ | (21,505 | ) | |||
Non cash stock-based compensation expense | 458 | 1,372 | 2,220 | 2,667 | |||||||||||
| (Gain)/Loss on foreign currency translation | (2,650 | ) | 1,810 | (680 | ) | 734 | |||||||||
| Adjusted EBITDA - non GAAP | $ | (3,557 | ) | $ | (5,576 | ) | $ | (9,341 | ) | $ | (18,103 | ) | |||
Net loss | $ | (2,334 | ) | $ | (9,194 | ) | $ | (12,835 | ) | $ | (22,672 | ) | |||
| Non cash stock-based compensation expense | 458 | 1,372 | 2,220 | 2,667 | |||||||||||
| (Gain)/Loss on foreign currency translation | (2,650 | ) | 1,810 | (680 | ) | 734 | |||||||||
| Adjusted net income (loss) - non GAAP | $ | (4,526 | ) | $ | (6,012 | ) | $ | (11,296 | ) | $ | (19,271 | ) | |||
Weighted average common shares outstanding basic and diluted | 54,453,006 | 44,373,969 | 54,340,583 | 44,024,483 | |||||||||||
Loss per common share — basic and diluted | $ | (0.04 | ) | $ | (0.21 | ) | $ | (0.24 | ) | $ | (0.52 | ) | |||
| Non cash stock-based compensation expense | $ | 0.01 | $ | 0.03 | $ | 0.04 | $ | 0.06 | |||||||
| (Gain)/Loss on foreign currency translation | $ | (0.05 | ) | $ | 0.04 | $ | (0.01 | ) | $ | 0.02 | |||||
| Adjusted net income (loss) per common share - basic and | |||||||||||||||
| diluted - non GAAP | $ | (0.08 | ) | $ | (0.14 | ) | $ | (0.21 | ) | $ | (0.45 | ) | |||
| CYTOSORBENTS CORPORATION HISTORICAL RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES For Year-ended Dec 31, 2023 | |||||||||||||||
| Mar 31, | June 30, | Sep 30, | Dec 31, | Full Year | |||||||||||
| 2023 | 2023 | 2023 | 2023 | 2023 | |||||||||||
| (In thousands, except per share amounts) | |||||||||||||||
Net loss | $ | (7,326 | ) | $ | (6,153 | ) | $ | (9,194 | ) | $ | (5,835 | ) | $ | (28,507 | ) |
| Depreciation and amortization expense | 258 | 402 | 402 | 397 | 1,459 | ||||||||||
| Income tax expense (benefit) | -- | -- | -- | (814 | ) | (814 | ) | ||||||||
| Interest expense (income) | 63 | 9 | 34 | 52 | 158 | ||||||||||
| EBITDA - non GAAP | $ | (7,005 | ) | $ | (5,742 | ) | $ | (8,758 | ) | $ | (6,200 | ) | $ | (27,704 | ) |
Non cash stock-based compensation expense | 1,080 | 215 | 1,372 | 1,053 | 3,720 | ||||||||||
| (Gain)/Loss on foreign currency translation | (661 | ) | (415 | ) | 1,810 | (2,683 | ) | (1,949 | ) | ||||||
| Adjusted EBITDA - non GAAP | $ | (6,585 | ) | $ | (5,942 | ) | $ | (5,576 | ) | $ | (7,830 | ) | $ | (25,933 | ) |
Net loss | $ | (7,326 | ) | $ | (6,153 | ) | $ | (9,194 | ) | $ | (5,835 | ) | $ | (28,507 | ) |
| Non cash stock-based compensation expense | 1,080 | 215 | 1,372 | 1,053 | 3,720 | ||||||||||
| (Gain)/Loss on foreign currency translation | (661 | ) | (415 | ) | 1,810 | (2,683 | ) | (1,949 | ) | ||||||
| Adjusted net income (loss) - non GAAP | $ | (6,906 | ) | $ | (6,354 | ) | $ | (6,012 | ) | $ | (7,465 | ) | $ | (26,736 | ) |
Weighted average common shares outstanding basic and diluted | 43,676,435 | 44,015,380 | 44,373,969 | 46,531,510 | 44,656,391 | ||||||||||
Loss per common share — basic and diluted | $ | (0.17 | ) | $ | (0.14 | ) | $ | (0.21 | ) | $ | (0.13 | ) | $ | (0.64 | ) |
| Non cash stock-based compensation expense | $ | 0.02 | $ | 0.00 | $ | 0.03 | $ | 0.02 | $ | 0.08 | |||||
| (Gain)/Loss on foreign currency translation | $ | (0.02 | ) | $ | (0.01 | ) | $ | 0.04 | $ | (0.06 | ) | $ | (0.04 | ) | |
| Adjusted net income (loss) per common share - basic and | |||||||||||||||
| diluted - non GAAP | $ | (0.16 | ) | $ | (0.14 | ) | $ | (0.14 | ) | $ | (0.16 | ) | $ | (0.60 | ) |
| CYTOSORBENTS CORPORATION HISORICAL RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES For year to date, 2024 (Unaudited) | ||||||||||||
| QTD ENDED | YTD ENDED | |||||||||||
| Mar 31, | Jun 30, | Sep 30, | Sep 30, | |||||||||
| 2024 | 2024 | 2024 | 2024 | |||||||||
| (In thousands, except per share amounts) | ||||||||||||
Net loss | $ | (6,358 | ) | $ | (4,143 | ) | $ | (2,334 | ) | $ | (12,835 | ) |
| Depreciation and amortization expense | 396 | 403 | 381 | 1,180 | ||||||||
| Income tax expense (benefit) | -- | -- | -- | -- | ||||||||
| Interest expense (income) | 7 | 180 | 588 | 775 | ||||||||
| EBITDA - non GAAP | $ | (5,955 | ) | $ | (3,560 | ) | $ | (1,365 | ) | $ | (10,880 | ) |
Non cash stock-based compensation expense | 924 | 838 | 458 | 2,220 | ||||||||
| (Gain)/Loss on foreign currency translation | 1,426 | 544 | (2,650 | ) | (680 | ) | ||||||
| Adjusted EBITDA - non GAAP | $ | (3,605 | ) | $ | (2,179 | ) | $ | (3,557 | ) | $ | (9,341 | ) |
Net loss | $ | (6,358 | ) | $ | (4,143 | ) | $ | (2,334 | ) | $ | (12,835 | ) |
| Non cash stock-based compensation expense | 924 | 838 | 458 | 2,220 | ||||||||
| (Gain)/Loss on foreign currency translation | 1,426 | 544 | (2,650 | ) | (680 | ) | ||||||
| Adjusted net income (loss) - non GAAP | $ | (4,008 | ) | $ | (2,761 | ) | $ | (4,526 | ) | $ | (11,296 | ) |
Weighted average common shares outstanding basic and diluted | 54,262,790 | 54,306,041 | 54,453,006 | 54,340,583 | ||||||||
Loss per common share — basic and diluted | $ | (0.12 | ) | $ | (0.08 | ) | $ | (0.04 | ) | $ | (0.24 | ) |
| Non cash stock-based compensation expense | $ | 0.02 | $ | 0.02 | $ | 0.01 | $ | 0.04 | ||||
| (Gain)/Loss on foreign currency translation | $ | 0.03 | $ | 0.01 | $ | (0.05 | ) | $ | (0.01 | ) | ||
| Adjusted net income (loss) per common share - basic and | ||||||||||||
| diluted - non GAAP | $ | (0.07 | ) | $ | (0.05 | ) | $ | (0.08 | ) | $ | (0.21 | ) |
FAQ
What was CytoSorbents (CTSO) revenue growth in Q3 2024?
What caused CTSO's gross margin decline in Q3 2024?
What is the market potential for CTSO's DrugSorb-ATR in North America?
