CytoSorbents Postpones Earnings Release to Allow More Time to Complete Annual Audit Following the Passing of Corporate Controller

Rhea-AI Summary

CytoSorbents (NASDAQ: CTSO) has postponed its Q4 and full-year 2024 earnings release from March 6 to March 25, 2025, following the unexpected passing of VP and Corporate Controller James E. Cason, Jr. The company reaffirmed its preliminary financial results, including:

- Q4 2024 product revenue of $9.0-9.2M (22-25% growth vs Q4 2023)
- Full-year 2024 product revenue of $35.4-35.6M (14% growth vs 2023)
- Q4 2024 product gross margin of ~70%

The company raised $7.85M in gross proceeds in Q1 2025 through a Rights Offering and warrant exercises. Pro-forma cash balance as of December 31, 2024, would have been approximately $17.0M, including $15.5M in unrestricted cash. Q4 2024 net cash burn was approximately $2.5M. Regulatory decisions for DrugSorb-ATR are expected from FDA and Health Canada in 2025.

Positive

• 22-25% Q4 product revenue growth year-over-year
• 14% full-year revenue growth
• 70% gross margin in Q4, up from 61% in Q3
• $7.85M new capital raised in Q1 2025
• Reduced cash burn to $2.5M in Q4 2024

Negative

• Earnings release delayed by 19 days
• Loss of key executive (Corporate Controller)
• Additional capital raise indicating cash needs

Insights

Financial Analyst

CytoSorbents' delayed financial reporting presents a mixed scenario for investors. The 22-25% Q4 revenue growth reaching $9.0-9.2 million demonstrates meaningful commercial acceleration from their 14% annual growth rate. This acceleration suggests improving market adoption of their blood purification technology, particularly in critical care settings.

The company's gross margin stabilization at 70% after dipping to 61% in Q3 indicates production efficiency improvements and potentially better product mix. Their burn rate of $2.5 million in Q4 shows disciplined cash management, especially important for smaller medtech companies.

The successful capital raise of $7.85 million in Q1 2025 strengthens their financial position, extending their runway while awaiting regulatory decisions. With pro-forma cash of $17 million, they've secured approximately 6-7 quarters of operations at current burn rates.

The regulatory status update on DrugSorb-ATR is significant, as this represents their most important growth catalyst. The "substantive and interactive review" language suggests active engagement with regulators rather than delays, though approval timelines remain uncertain within the 2025 window.

While the reporting delay due to the controller's passing is unfortunate, the preliminary figures and financial transparency mitigate concerns, allowing investors to maintain visibility into operations during this transition period.

Medical Device Expert

CytoSorbents' blood purification platform represents a important alternative in critical care, where mortality remains high despite conventional treatments. Their technology's ability to remove inflammatory mediators and certain drugs from blood has significant clinical utility in ICU and cardiac surgery settings.

The DrugSorb-ATR application progress is particularly notable for investors. This device is designed to remove anti-thrombotic medications during cardiothoracic surgery, addressing a significant unmet need as bleeding complications remain a serious concern. The "substantive and interactive review" language indicates the regulatory process is progressing, though the broad "decisions expected in 2025" timeframe suggests approval isn't imminent.

The company's 22-25% quarterly revenue growth outpacing their annual rate signals improving clinical adoption of their existing products. This acceleration comes without the potential catalyst of DrugSorb-ATR approval, suggesting their core CytoSorb product line is gaining traction in established markets.

The gross margin recovery to 70% indicates manufacturing consistency and suggests they've overcome earlier production challenges. For medical device companies at this scale, maintaining margins above 65% is typically necessary to eventually achieve profitability while supporting the clinical education and support these complex therapies require.

The leadership continuity despite the controller's passing is reassuring, as specialized medical technology companies depend heavily on institutional knowledge for navigating complex regulatory and reimbursement landscapes.

The Company reaffirms previously provided preliminary financial results for the quarter and full year ended December 31, 2024, and continues to expect regulatory decisions on DrugSorb™-ATR marketing applications in 2025

PRINCETON, N.J., March 04, 2025 (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 announced that it is postponing its previously announced earnings call scheduled for March 6, 2025 to allow more time to complete the annual financial audit following the recent passing of the Company’s Vice President and Corporate Controller from natural causes.

The Company now expects to report fourth quarter and full year 2024 financial results after the market close on Tuesday, March 25, 2025. Management will host a live conference call, presentation webcast, and a question-and-answer session starting at 4:30PM ET the same day, and expects to file its Form 10-K in that timeframe.

The delay follows the unexpected passing of the Company’s Vice President and Corporate Controller, James E. Cason, Jr. Mr. Cason had a long and successful career and worked with the Company for the past 10 years.

“We are deeply saddened by the loss of our dear colleague, Jim,” said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Over the past decade, Jim was an exceptional leader, talented colleague, and trusted friend who contributed greatly to the growth and success of CytoSorbents, and was dedicated to our mission to help save lives around the world. We extend our deepest condolences to his family and many friends.”

Dr. Chan continued, “Though we will miss Jim, we are fortunate to have a strong financial team whose immediate focus has been to support one another and to ensure an effective transition of Jim’s important responsibilities during this difficult time. We believe this extension of time is a prudent decision to ensure the thorough completion of the year-end audit.”

The Company reiterates previously provided preliminary expectations, including:

• Fourth quarter product revenue (excluding grant income) in the range of $9.0 million to $9.2 million, representing 22% to 25% growth versus $7.35 million in the fourth quarter of 2023
• Full-year product revenue (excluding grant income) in the range of $35.4 million to $35.6 million, representing approximately 14% growth versus $31.1 million for the full-year 2023
• Fourth quarter product gross margin of approximately 70%, compared to 61% in the prior quarter and 72% in the fourth quarter of 2023
  

DrugSorb-ATR Marketing Applications
The Company’s marketing applications for DrugSorb-ATR continue to be in substantive and interactive review with the U.S. FDA and Health Canada, and the Company continues to expect regulatory decisions from both agencies in 2025.

Estimated Pro-Forma December 31, 2024, Cash Balance and Q4 2024 Cash Burn
As previously disclosed, the Company has raised a total of $7.85 million of aggregate gross proceeds in the first quarter of 2025 inclusive of $6.25 million from the January 10, 2025, Rights Offering, and $1.6 million from the related February 24, 2025, exercise of Series A Right Warrants. Proceeds net of related fees is approximately $7.3 million. The pro forma balance of cash, cash equivalents, and restricted cash on December 31, 2024, after giving effect to the Rights Offering and the exercise of Series A Right Warrants as if they had occurred on December 31, 2024, would have been approximately $17.0 million, including unrestricted cash of approximately $15.5 million. These amounts reflect $7.3 million in net proceeds raised and net cash used in the fourth quarter of 2024 of approximately $2.5 million.

The estimated financial results, proforma cash balance and estimate of cash utilized in the fourth quarter remain preliminary and unaudited.

Conference Call and Webcast Details:
Date: Tuesday, March 25, 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 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. Two important ones 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 250,000 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 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 www.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.

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

FAQ

What are CytoSorbents' (CTSO) Q4 2024 revenue expectations?

CTSO expects Q4 2024 product revenue between $9.0-9.2M, representing 22-25% growth compared to Q4 2023's $7.35M.

What is CTSO's gross margin for Q4 2024?

CytoSorbents reported a preliminary Q4 2024 product gross margin of approximately 70%, compared to 61% in Q3 2024.

How much capital did CTSO raise in Q1 2025?

CTSO raised $7.85M in gross proceeds ($7.3M net) through a $6.25M Rights Offering and $1.6M from Series A Right Warrants exercise.

When does CTSO expect regulatory decisions for DrugSorb-ATR?

The company expects regulatory decisions from both the U.S. FDA and Health Canada in 2025.

What is CytoSorbents' cash position as of December 31, 2024?

Pro-forma cash balance would be approximately $17.0M, including $15.5M unrestricted cash, after including Q1 2025 fundraising.