CytoSorbents Reports First Quarter 2026 Financial Results, Recent Business Highlights, and Regulatory Update
First Quarter 2026 Financial Results
- Revenue was
$8.9 million , an increase of 2% over the prior year, from$8.7 million - Gross margin was 69% in the quarter compared to 71% in Q1 2025
- Operating loss was
$3.0 million , compared to$3.9 million in Q1 2025 - Net loss was
$5.1 million or$0.08 per share, compared to a net loss of$1.5 million or$0.02 per share in Q1 2025. The increase was due primarily to the non-cash impact of changes in foreign currency transactions year-over-year - Adjusted net loss, which excludes the impact of non-cash changes in foreign currency transactions and non-cash stock compensation, was
$3.4 million or$0.05 per share, compared to an adjusted net loss of$3.7 million or$0.06 per share in Q1 2025 - Adjusted EBITDA loss, which also excludes the impact of non-cash changes in foreign currency transactions and non-cash stock compensation was
$2.2 million compared to a loss of$2.7 million in Q1 2025 - Total cash, cash equivalents, and restricted cash was approximately
$6.4 million , compared to$7.8 million as ofDecember 31, 2025 - Total cash burn in the quarter, excluding
$0.3 million in restructuring-related payments, was approximately$1.1 million
"First quarter sales were
Distributor sales were flat year-over-year, as progress across several territories was offset by delayed distributor orders of approximately
Gross margin declined marginally to 69% in the first quarter, primarily due to intentionally reduced production volumes aimed at lowering inventory levels and improving working capital.
In the fourth quarter of 2025, we implemented a strategic workforce and cost reduction initiative, reducing headcount by approximately 10% while lowering operating and production expenses. The initial benefits of this program were reflected in lower expenses and improved operating margins in the first quarter. Meanwhile, we have continued to make operational improvements and cost reductions and believe these actions will continue to drive improvements in the coming quarters to support our goal of achieving operating cash flow breakeven in the second half of this year."
DrugSorb-ATR® for Brilinta®
"In
Following the appeal decision and based on feedback from FDA, we announced our intention to submit a new
We are currently evaluating options to generate the additional mechanistic data on an expedited basis and expect to schedule an additional pre-submission meeting with the FDA, if needed, to discuss and align on the proposed approach. Once alignment is achieved, we anticipate completing the required work and submitting a new
Meanwhile, the
DrugSorb-ATR for DOACs: Eliquis® and Xarelto®
"We have previously discussed our intention, following anticipated FDA marketing approval of DrugSorb-ATR for Brilinta®, to pursue an expanded indication for the removal of direct oral anticoagulants (DOACs), such as Eliquis® (apixaban, Pfizer/BMS) and Xarelto® (rivaroxaban, Bayer/Janssen). At the same time, we continue to observe increasing real-world adoption, clinical use, and published evidence supporting the use of our technology for DOAC removal in cardiac surgery, reinforcing the significant unmet medical need globally.
Within the next 30 days, we plan to submit a separate pre-submission request to the Agency to review the data currently available for the DOAC indication that include drug removal data from benchtop testing and data from real-world use and to determine what, if any, additional information may be required to support a parallel
Having this potential second shot on goal is aligned with our other FDA Breakthrough Device Designation for DrugSorb-ATR, to remove DOACs during cardiac surgery. Globally, tens of millions of patients are on chronic or life-long DOAC therapy due to atrial fibrillation, deep vein thrombosis, pulmonary embolism, peripheral vascular disease, or post-surgical prophylaxis. An estimated 5-10% of emergent cardiac surgery cases involve patients who are currently therapeutic on a DOAC and risk serious or life-threatening perioperative bleeding.
In 2025, Eliquis ranked #7 among the top-selling pharmaceuticals globally, generating approximately
New Health Economic Analysis in Septic Shock
"Finally, in our last earnings call update, we highlighted many key publications across critical care and cardiac surgery. Recently, an important study entitled 'Impact of CytoSorb Hemoadsorption Therapy on Cost-Effectiveness and Length of Stay in Critical Care Patients: A Preliminary Study from a Swiss High-Volume Center", was published in the peer-reviewed journal Healthcare. This study provides compelling real-world evidence for the cost-effectiveness of CytoSorb hemoadsorption in a comparative analysis of 246 ICU patients with septic shock. Compared to patients treated with standard of care alone, those additionally treated with CytoSorb showed significant reductions in ICU and hospital length of stay, duration of mechanical ventilation among survivors, and nursing workload, while total hospital treatment costs were not significantly increased. CytoSorb therapy showed a clear advantage in net case profitability (revenue minus costs), with significantly higher earnings per case compared to standard of care. These results highlight the cost-effectiveness of CytoSorb therapy and the ability to achieve clinical, operational, and economic benefits in a resource-intensive critical care setting."
First Quarter 2026 Earnings Conference Call
Date:
Time:
Live webcast link:
https://app.webinar.net/KbgRLmJk8ow
It is recommended that participants join 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 DrugSorb-ATR
In the
The Company continues to actively pursue regulatory approval of DrugSorb-ATR with the FDA and expects to pursue regulatory approval in
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 Share which excludes non-cash stock compensation expense and gain or loss of foreign exchange translation from Net Loss and Net Loss Per 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. For a reconciliation of non-GAAP financial measures to the most comparable GAAP measure, see the reconciliation included in the financial tables. All non-GAAP adjustments are presented pre-tax.
About
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 surgery. The Company is actively pursuing regulatory approval of DrugSorb-ATR with the
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, PuriFi®, HotSwap®, 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
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CYTOSORBENTS CORPORATION |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands, except share data) |
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March 31, |
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December 31, |
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2026 |
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2025 |
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(unaudited) |
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ASSETS |
|
|
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|
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Current Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,813 |
|
$ |
6,249 |
|
Accounts receivable, net of allowances of |
|
|
7,152 |
|
|
7,550 |
|
Inventories - net |
|
|
4,481 |
|
|
5,281 |
|
Prepaid expenses and other current assets |
|
|
1,311 |
|
|
1,554 |
|
Total current assets |
|
|
17,757 |
|
|
20,634 |
|
|
|
|
|
|
|
|
|
Property and equipment - net |
|
|
7,510 |
|
|
7,823 |
|
Restricted cash |
|
|
1,522 |
|
|
1,522 |
|
Right-of-use asset |
|
|
10,769 |
|
|
10,924 |
|
Patents - net |
|
|
2,952 |
|
|
3,226 |
|
Other assets |
|
|
52 |
|
|
53 |
|
Total assets |
|
$ |
40,562 |
|
$ |
44,182 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,132 |
|
$ |
2,869 |
|
Accrued expenses and other current liabilities |
|
|
5,960 |
|
|
6,299 |
|
Lease liability – current portion |
|
|
565 |
|
|
541 |
|
Current maturities of long-term debt, net of debt discount |
|
|
6,646 |
|
|
— |
|
Total current liabilities |
|
|
16,303 |
|
|
9,709 |
|
Lease liability, net of current portion |
|
|
11,752 |
|
|
11,903 |
|
Long-term debt, net of current portion and debt discount |
|
|
10,313 |
|
|
16,667 |
|
Total liabilities |
|
|
38,368 |
|
|
38,279 |
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|
|
|
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|
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|
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Commitments and Contingencies |
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Stockholders' equity |
|
|
|
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|
|
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Preferred Stock, par value |
|
|
— |
|
|
— |
|
Common Stock, par value |
|
|
63 |
|
|
63 |
|
Additional paid-in capital |
|
|
321,568 |
|
|
321,024 |
|
Accumulated other comprehensive loss |
|
|
(2,101) |
|
|
(2,977) |
|
Accumulated deficit |
|
|
(317,336) |
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|
(312,207) |
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Total stockholders' equity |
|
|
2,194 |
|
|
5,903 |
|
Total liabilities and stockholders' equity |
|
$ |
40,562 |
|
$ |
44,182 |
|
|
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CYTOSORBENTS CORPORATION |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED) |
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(in thousands, except share and per share data) |
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Three Months Ended March 31, |
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|
2026 |
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2025 |
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Revenue, net |
|
$ |
8,864 |
|
$ |
8,727 |
|
Cost of goods sold |
|
|
2,734 |
|
|
2,520 |
|
Gross profit |
|
|
6,130 |
|
|
6,207 |
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
Research and development, net of grant income |
|
|
1,025 |
|
|
1,663 |
|
Selling, general and administrative |
|
|
8,149 |
|
|
8,432 |
|
Total operating expenses |
|
|
9,174 |
|
|
10,095 |
|
Loss from operations |
|
|
(3,044) |
|
|
(3,888) |
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
Interest expense, net |
|
|
(857) |
|
|
(605) |
|
Gain (loss) on foreign currency transactions |
|
|
(1,228) |
|
|
3,014 |
|
Total other income (expense), net |
|
|
(2,085) |
|
|
2,409 |
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|
|
|
|
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Net loss |
|
$ |
(5,129) |
|
$ |
(1,479) |
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|
|
|
|
|
|
|
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Basic and diluted net loss per common share |
|
$ |
(0.08) |
|
$ |
(0.02) |
|
|
|
|
|
|
|
|
|
Weighted Average Shares of Common Stock Outstanding |
|
|
|
|
|
|
|
Basic and diluted |
|
|
62,738,827 |
|
|
60,731,929 |
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
Foreign currency translation adjustment, net of tax |
|
|
876 |
|
|
(2,736) |
|
Comprehensive loss |
|
$ |
(4,253) |
|
$ |
(4,215) |
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CYTOSORBENTS CORPORATION |
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CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (UNAUDITED) |
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(in thousands, except share data) |
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Accumulated |
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|
|
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|
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|
|
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Additional |
|
Other |
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|
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||
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|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders' |
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|
|
|
Shares |
|
Par Value |
|
Capital |
|
Income (Loss) |
|
Deficit |
|
Equity |
|||||
|
Balance at |
|
62,804,305 |
|
$ |
63 |
|
$ |
321,024 |
|
$ |
(2,977) |
|
$ |
(312,207) |
|
$ |
5,903 |
|
Stock-based compensation |
|
— |
|
|
— |
|
|
544 |
|
|
— |
|
|
— |
|
|
544 |
|
Reversal of excess RSU shares issued |
|
(71,000) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Foreign currency translation adjustment, net of tax |
|
— |
|
|
— |
|
|
— |
|
|
876 |
|
|
— |
|
|
876 |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(5,129) |
|
|
(5,129) |
|
Balance at March 31, 2026 |
|
62,733,305 |
|
$ |
63 |
|
$ |
321,568 |
|
$ |
(2,101) |
|
$ |
(317,336) |
|
$ |
2,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
|
|
|
||
|
|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders' |
|||||||
|
|
|
Shares |
|
Par Value |
|
Capital |
|
Income |
|
Deficit |
|
Equity |
|||||
|
Balance at |
|
54,830,146 |
|
$ |
55 |
|
$ |
310,809 |
|
$ |
4,252 |
|
$ |
(304,009) |
|
$ |
11,107 |
|
Stock-based compensation |
|
32,321 |
|
|
— |
|
|
818 |
|
|
— |
|
|
— |
|
|
818 |
|
Issuance of common stock from exercise of warrants |
|
1,417,208 |
|
|
2 |
|
|
1,437 |
|
|
— |
|
|
— |
|
|
1,439 |
|
Issuance of common stock and warrants from rights |
|
6,249,791 |
|
|
6 |
|
|
5,386 |
|
|
— |
|
|
— |
|
|
5,392 |
|
Foreign currency translation adjustment, net of tax |
|
— |
|
|
— |
|
|
— |
|
|
(2,736) |
|
|
— |
|
|
(2,736) |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,479) |
|
|
(1,479) |
|
Balance at |
|
62,529,466 |
|
$ |
63 |
|
$ |
318,450 |
|
$ |
1,516 |
|
$ |
(305,488) |
|
$ |
14,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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CYTOSORBENTS CORPORATION |
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|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) |
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(in thousands) |
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|
|
|
|
|
|
|
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|
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Three |
|
Three |
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|
Months Ended |
|
Months Ended |
||
|
|
|
March 31, |
|
March 31, |
||
|
|
|
2026 |
|
2025 |
||
|
Cash flows from operating activities |
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,129) |
|
$ |
(1,479) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Amortization of debt discount |
|
|
291 |
|
|
190 |
|
Amortization of patents |
|
|
61 |
|
|
63 |
|
Depreciation |
|
|
289 |
|
|
306 |
|
Amortization of right-of-use asset |
|
|
26 |
|
|
36 |
|
Loss on abandoned patents |
|
|
274 |
|
|
8 |
|
Bad debt expense (recovery) |
|
|
(1) |
|
|
2 |
|
Stock-based compensation |
|
|
544 |
|
|
818 |
|
Foreign currency transaction (gains) losses |
|
|
1,228 |
|
|
(3,014) |
|
Changes in operating assets and liabilities |
|
|
|
|
|
|
|
Accounts receivable |
|
|
310 |
|
|
(80) |
|
Inventories |
|
|
723 |
|
|
(199) |
|
Prepaid expenses and other current assets |
|
|
129 |
|
|
250 |
|
Other assets |
|
|
1 |
|
|
— |
|
Accounts payable and accrued expenses |
|
|
92 |
|
|
(367) |
|
Net cash used in operating activities |
|
|
(1,162) |
|
|
(3,466) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(11) |
|
|
(2) |
|
Disposals of property and equipment |
|
|
26 |
|
|
— |
|
Payments for patent costs |
|
|
(61) |
|
|
(45) |
|
Net cash used in investing activities |
|
|
(46) |
|
|
(47) |
|
Cash flows from financing activities |
|
|
|
|
|
|
|
Cash for exercise of warrants, net |
|
|
— |
|
|
1,439 |
|
Proceeds from rights offering, net |
|
|
— |
|
|
5,392 |
|
Net cash provided by financing activities |
|
|
— |
|
|
6,831 |
|
Effect of exchange rates on cash |
|
|
(228) |
|
|
28 |
|
Net change in cash, cash equivalents, and restricted cash |
|
|
(1,436) |
|
|
3,346 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and restricted cash at beginning of year |
|
|
7,771 |
|
|
9,764 |
|
Cash, cash equivalents, and restricted cash – end of period |
|
$ |
6,335 |
|
$ |
13,110 |
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
591 |
|
$ |
506 |
|
|
|
|
|
|
|
|
|
Supplemental disclosure of non-cash financing activities |
|
|
|
|
|
|
|
Fair value of common stock warrants issued in connection with the rights offering |
|
|
— |
|
|
556 |
|
Offering fees included in accounts payable |
|
$ |
— |
|
$ |
253 |
|
|
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RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL MEASURES |
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|
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|
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Three Months Ended |
||||
|
|
|
|
||||
|
|
|
2026 |
|
2025 |
||
|
|
|
(amounts, in thousands) |
||||
|
Net income (loss) |
|
$ |
(5,129) |
|
$ |
(1,479) |
|
Depreciation and amortization expense |
|
$ |
350 |
|
$ |
369 |
|
Income tax expense (benefit) |
|
$ |
- |
|
$ |
- |
|
Interest expense (income) |
|
$ |
857 |
|
$ |
605 |
|
EBITDA – non-GAAP measure |
|
$ |
(3,922) |
|
$ |
(505) |
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense |
|
$ |
544 |
|
$ |
818 |
|
(Gain)/Loss on foreign currency transactions |
|
|
1,228 |
|
|
(3,014) |
|
Adjusted EBITDA – non-GAAP measure |
|
$ |
(2,150) |
|
$ |
(2,701) |
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(5,129) |
|
$ |
(1,479) |
|
Non-cash stock-based compensation expense |
|
|
544 |
|
|
818 |
|
(Gain)/Loss on foreign currency transactions |
|
$ |
1,228 |
|
$ |
(3,014) |
|
Adjusted net loss – non-GAAP measure |
|
$ |
(3,357) |
|
$ |
(3,675) |
|
Weighted average common shares outstanding |
|
|
|
|
|
|
|
Basic |
|
|
62,738,827 |
|
|
60,731,929 |
|
Diluted |
|
|
62,738,827 |
|
|
60,731,929 |
|
Basic net income (loss) per common share |
|
$ |
(0.08) |
|
$ |
(0.02) |
|
Diluted net income (loss) per common share |
|
$ |
(0.08) |
|
$ |
(0.02) |
|
|
|
|
|
|
|
|
|
Non-cash stock-based compensation expense - basic |
|
$ |
0.01 |
|
$ |
0.01 |
|
Non-cash stock-based compensation expense - diluted |
|
$ |
0.01 |
|
$ |
0.01 |
|
(Gain)/Loss on foreign currency transactions - basic |
|
$ |
0.02 |
|
$ |
(0.05) |
|
(Gain)/Loss on foreign currency transactions - diluted |
|
$ |
0.02 |
|
$ |
(0.05) |
|
Adjusted net income (loss) per common share – basic – non- |
|
$ |
(0.05) |
|
$ |
(0.06) |
|
Adjusted net income (loss) per common share – diluted – |
|
$ |
(0.05) |
|
$ |
(0.06) |
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