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 to 72% 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 $300 million. Brilinta^® already enjoys a dominant market share in Canada due to ACS treatment guidelines and is growing in dominance in the U.S. The TAM is expected to grow to well over $600 million once Brilinta^® becomes generic and DrugSorb-ATR makes it the only reversible orally administered antiplatelet drug; and with potential label expansion to include other blood thinner categories including direct oral anticoagulants and direct thrombin inhibitors that could make DrugSorb-ATR an “all-in-one” countermeasure for these agents. We further estimate that broadening the use of DrugSorb-ATR to remove blood thinners in non-CABG cardiac surgeries, off-pump CABG surgeries, or in other types of non-cardiac surgeries could expand the total addressable market to $1-2 billion.

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 $34 million in trailing 12-month product sales at approximately 70% gross margins, and is nearing cash flow breakeven. CytoSorb is generating exciting clinical data through our STAR (Safe and Timely Antithrombotic Removal) and critical care COSMOS (CytOSorb TreatMent Of Critically Ill PatientS) registries with results presented at major scientific congresses. We are also witnessing a lot of enthusiasm for our new PuriFi^® hemoperfusion pump, launched at the end of the second quarter 2024, with now many pump placements and evaluations ongoing. Our global team is executing on our strategy and positioning us well for this next stage of growth.”

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

See accompanying notes to consolidated financial statements.

See accompanying notes to consolidated financial statements.

See accompanying notes to consolidated financial statements.