Cytosorbents : Presentation (ctso q1 2026 earnings presentation 5 13 26 final one final)
CTSO
Published on 05/13/2026 at 11:03 pm EDT
CytoSorbents Corporation
Nasdaq: CTSO
Q1 2026 Earnings Conference Call May 13, 2026
Conference Call Participants
Phillip Chan, MD, PhD Chief Executive Officer
Peter J. Mariani, CPA Chief Financial Officer
Efthymios Deliargyris, MD Chief Medical Officer
Safe Harbor Statement
Statements in this presentation include 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 presentation 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, the impact of geopolitical events including the recent war in Iran, our ability to successfully obtain U.S. FDA and Health Canada regulatory approval and marketing authorization, our ability to complete our strategic workforce and cost reduction plan to reduce costs, optimize operations, and achieve operating cash-flow break-even in the second half of 2026, our ability to appropriately finance the Company, including our ability to meet our financial obligations and comply with the covenants under our existing debt agreement, and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 30, 2026, 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.
Regulatory Disclaimer
CytoSorb
CE Marked in Europe for the following APPROVED Indications for Use:
Cytokine Removal
Bilirubin and Myoglobin Removal
Ticagrelor and Rivaroxaban removal during cardiothoracic surgery
CytoSorb is NOT yet cleared/approved by the FDA or Health Canada
CytoSorb received U.S. FDA Emergency Use Authorization in April 2020 to treat patients 18 years of age or older with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
The CytoSorb device has neither been cleared or approved for the treatment of patients with COVID-19 infection.
The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of the CytoSorb device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
DrugSorb-ATR
INVESTIGATIONAL DEVICE: Limited by U.S. Federal Law to Investigational Use Only
This Investigational Device is NOT yet cleared/approved by FDA, Health Canada, or by any other Global Regulatory Agency, and it is NOT commercially available for sale
Proposed Indication for Use: To reduce the severity of perioperative bleeding in patients undergoing coronary artery bypass rafting (CABG) within 2 days of ticagrelor discontinuation
Dr. Phillip Chan, MD, PhD Chief Executive Officer
CytoSorbents at a Glance
Platform blood purification technology for removing toxins and harmful substances from the blood
High margin "razorblade" that is "plug and play" into existing hospital blood pumps
Two main products leveraging the underlying polymer technology
CytoSorb
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Treatment of life-threatening conditions in the ICU and cardiac surgery Record core product sales of $37.1 million in 2025
E.U. Approved with more than 300,000 CytoSorb devices utilized cumulatively to date in 70+ countries
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Investigational device to reduce the severity of perioperative bleeding during CABG surgery due to blood thinners
Two FDA Breakthrough Device Designations
Actively pursuing regulatory approval in the US with new De Novo submission planned
Core Business Performance Summary
Q1 2026 Revenue was $8.9M, up 2% from $8.7M in Q1 2025
Direct Sales outside Germany: $2.1M vs $1.9M last year (+13% growth)
Direct Germany sales: $2.6M vs $2.8M a year ago (-7% growth)
Excellent productivity gain with a smaller, more focused team
Reflects new leadership, sales execution, account targeting, and customer
engagement
Plan to selectively add back sales reps to improve account coverage and drive new growth opportunities
Distributor partner sales were $4.0M vs $4.0M last year (0% growth)
Unexpected U.S.- Iran war slowed growth of Dubai, UAE subsidiary impacting an estimated $0.5M in expected revenue
Ripple effects in rest of world
Q1 2026 Gross Margins were 69%, down from 71% yoy, reflecting intentional slowing of production to lower inventory and increase working capital. Implemented continued improved operational efficiencies in manufacturing
Continue to Enable Core Messaging
Sepsis, Septic Shock, Other Shock
Infectious diseases (flu, COVID-19, other)
Acute Respiratory Distress Syndrome (ARDS)
Trauma, Rhabdomyolysis
Liver failure
Burn Injury
Right Patient
Cytokine storm/ Cytokine release syndrome
Post-surgical complications Organ transplant
Pancreatitis
Neuroinflammation
Drug overdose
Blood thinner toxicity
High risk surgical procedures, aortic surgery, Infective endocarditis
Highest Chance for Good Cinical Outcome
Right
Timing
Right
Dose
Cost-Effectiveness of CytoSorb in Sepsis
Retrospective, observational study in 246 septic shock patients (104 standard of care (SOC) vs 142 SOC + CytoSorb)
Despite significantly higher initial disease severity at baseline, CytoSorb-treated patients demonstrated significantly:
Shorter ICU length of stay (median 408.5 vs 554 hours, p=0.001)
Shorter hospital length of stay (23.5 vs 30.0 days, p=0.008)
Shorter mechanical ventilation times (164.0 vs 336.0 hours, p=0.014)
Lower nursing workload, (>20% NEMS point reduction, p=0.015)
Each approximately 6-7 days difference
Better net financial result (revenue minus costs) with significantly higher earnings per case compared to SOC alone (+17,125 vs -1,930 Swiss Francs)
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
9 * NEMS: Nine Equivalents of Nursing Manpower Use Score. A concise, 9-item therapeutic index used to measure nursing workload and intensity in intensive care units.
Dr. Efthymios "Makis" Deliargyris, MD, FACC, FESC, FSCAI
Chief Medical Officer
Tens of millions of patients globally take Direct Oral Anticoagulants (e.g, DOACs like Eliquis® and Xarelto®) and antiplatelet agents (e.g, Brilinta®) either chronically or acutely to reduce risk of heart attack, stroke, and other serious thrombotic complications
Each year, an estimated 1-2% will require emergent or urgent surgery, particularly cardiac surgery
~5-10% of emergency cardiac surgeries involve patients on chronic DOAC therapy
~5-10% of heart attack patients on antiplatelet agents are not eligible for a stent and require CABG surgery
Blood thinners significantly increase the risk of perioperative bleeding in cardiac surgery.
Delay of surgery for multiple days for drug clearance is typically recommended to reduce this risk
There is a major unmet need in patients awaiting urgent cardiothoracic surgery
Many patients cannot wait due to the need for emergency surgery
Waiting for drug washout may increase the risk of poor patient outcomes (e.g. thrombotic events, clinical instability, and sudden death) and wastes valuable hospital resources
DrugSorb-ATR is an FDA Breakthrough Designated Device with the potential to address this pervasive and serious unmet medical need
DrugSorb-ATR is an investigational medical device in the U.S. and Canada and is not yet cleared or approved.
FDA Appeal Decision of the original De Novo submission (August 20, 2025)
Upheld the prior denial decision, and required additional information primarily based on real-world evidence (RWE) and clinical
outcomes to support the Company's desired label claim that would require a new De Novo submission
However, there were two important positive outcomes of the appeal decision
FDA did not identify any issues with with device safety - key to the benefit-to-risk ratio that FDA uses to judge De Novo devices
Based on our understanding, FDA agreed to a focused review of a new De Novo submission on the remaining open items
In January 2026, we held a formal Pre-Submission meeting with FDA and have since been in continued discussions to clarify and confirm requirements for a new De Novo submission, including whether all information would be required within the submission or as a post-marketing requirement. Based on these discussions, FDA requested that additional mechanistic data be included alongside RWE within the new De Novo submission
Currently we are evaluating options to generate the additional mechanistic data which we plan to discuss with FDA and incorporate their feedback before completing the required work. Though this will likely delay a new De Novo application submission to late 2026 or early 2027, we now have a clearer direction from FDA and plan to file as soon as possible
Following submission, a regulatory decision is typically expected within a 150-day review period, although timelines may be accelerated or extended based on the nature and scope of FDA interactions during the review process
We have previously discussed our intention to pursue an expanded label for DrugSorb-ATR to include removal of DOACs following an initial marketing approval. Meanwhile, real-world evidence and publications continue to grow for this indication
Within the next 30 days, we plan to submit a separate pre-submission request to FDA to review the data currently available for the DOAC indication and determine what, if any, additional information may be required to support a parallel De Novo submission for DOAC removal
This strategy is consistent with our second FDA Breakthrough Device Designation for DrugSorb-ATR to remove DOACs during cardiac surgery
Tens of millions of patients are on chronic or lifelong DOAC therapy for diseases such as atrial fibrillation,
DVT, pulmonary embolism, and peripheral vascular disease. Eliquis® (#7 pharmaceutical in the world with
$14.4B in global 2025 sales) and Xarelto® ($5.1B global 2025 sales) are the market leaders
Potential FDA Marketing approval for both Brilinta® and DOAC removal in cardiac surgery could
expand the total addressable market for DrugSorb-ATR to $500M- $1B in the U.S. alone
14 DrugSorb-ATR is an investigational medical device in the U.S. and Canada and is not yet cleared or approved. Eliquis® and Xarelto® are trademarks of Bristol-Myers Squibb and Bayer, respectively
At EuroPCR 2026 (May 19-22), the world-leading course in interventional cardiovascular medicine, next week in Paris, two key presentations will be made on antithrombotic removal:
Urgent CABG in ACS: Impact of P2Y12 Choice and Intraoperative Hemoadsorption on Perioperative Bleeding -PSM Analysis of Real-World Data
Intraoperative DOAC Removal During CABG: An Interim Report From the STAR registry
Later this year in Munich at ESC 2026 (Aug 28-31), the world's largest cardiovascular conference, two
additional analyses on antithrombotic removal in cardiac surgery will be presented:
Intraoperative ticagrelor removal to reduce bleeding after urgent CABG: Matched comparison of patient level observational data
Intraoperative antithrombotic removal during urgent CABG: Early German experience with a novel hemoadsorption device
These analyses highlight the increasing adoption of our technology by leading heart centers in Europe and their enthusiasm around the reductions in bleeding they are experiencing with the use of our device as part of their operative protocols for patients on blood thinners.
Peter J. Mariani
Chief Financial Officer
Q1 2026 Revenue
Q1 2026
YoY Change
Revenue:
$8.9m
+2%
Germany
$2.6m
-7%
Direct Intl
$2.1m
+13%
Distributors
$4.0m
+0%
Revenue led by double digit growth in our direct international markets
Although German revenue is below last year, we are encouraged by improved leadership and sales process of our smaller more focused team and plan to selectively add reps over the coming quarters
Distributor revenues were flat, but negatively impacted by order delays of approximately $500k primarily in the Middle East and broader EMEA regions due to disruptions resulting from the war in Iran
2026
2025
YoY Change
Product revenue
$8.9m
$8.7m
+2%
Gross margin
69%
71%
Margins negatively impacted by lower unit production levels to reduce inventory balance
Total operating expenses
$9.2m
$10.1m
Reduction in R&D/clinical projects and compensation costs
Operating loss
$3.0m
$3.9m
~22% improvement
Net loss
$5.1m / $0.08/sh
$1.5m / $0.02/sh
Adjusted net loss
$3.4m / $0.05/sh
$3.7m / $0.06/sh
Adjusted EBITDA loss
$2.2m
$2.7m
~20% improvement
Q1 2026 Performance
(12/31/25)
$1.1 million cash burn, net of $0.3 million of restructuring-related payments in the quarter
$1.3 million improvement in net working capital including sequentially lower inventory and accounts receivable
Continuing to cut costs and drive improvements which we believe will support our goal of
achieving operating cash flow breakeven in the second half of the year
Workforce and cost reduction program has lowered our cash burn, and we
are continuing to lower operating and production spend in 2026
$6.4 million in cash, cash equivalents and restricted cash* (3/31/26) compared to $7.8 million
Phillip Chan, MD, PhD Chief Executive Officer
A Clear and Compelling Value Proposition
We believe we have a sound plan to build and maximize shareholder value
Significant critical care and cardiac surgery market opportunity worldwide, targeting major unmet medical needs, with new products helping to drive usage and the value proposition
A commitment to bringing DrugSorb-ATR to the North American market with a potential dual path to FDA marketing approval based on two FDA Breakthrough Device Designations for Brilinta® and Direct Oral Anticoagulants
Active measures to restore Germany back to growth
NASDAQ: CTSO
Company Contacts:
Dr. Phillip Chan - CEO
Peter Mariani - CFO [email protected]
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Disclaimer
CytoSorbents Corporation published this content on May 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2026 at 03:02 UTC.