Full Press Release Details
CytoSorbents Reports Fourth Quarter and Full
Results and Recent Business Highlights
N.J., March 31, 2025 -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 financial results for the fourth quarter and full year ended December 31, 2024, and recent
business highlights.
Fourth Quarter 2024 Financial Results
Dr. Phillip Chan, Chief Executive Officer
of CytoSorbents, stated, "We delivered a strong fourth quarter, executing on key initiatives that drove solid performance, advanced
our regulatory milestones, and fortified our financial position, setting the stage for what we believe will be a transformational year
Full Year 2024 Financial Results
Dr. Chan continued, "We believe we
have a clear and compelling value proposition. Our core business grew 15% in 2024 with more than $35 million in high-margin CytoSorb sales,
driven by 28% growth in direct sales outside of Germany and 22% growth in Distributor/Partner sales, which was partially offset by flat
growth in direct sales in Germany for the year.
Overall, our central
messaging of treating the "Right Patient at the Right Time with the Right Dose" of CytoSorb is helping to drive optimized
treatment strategies, improve patient outcomes, and accelerate adoption. For example, at this month's International Symposium of
Intensive Care and Emergency Medicine Congress in Brussels, Berlot and colleagues from Italy presented compelling new data from a
175-patient retrospective study on septic shock and multiorgan failure. They concluded that early and intensive treatment
with CytoSorb led to a statistically significant doubling of survival, compared to predicted mortality. These results, now accepted for
publication in the Journal of Intensive Care Medicine, reinforce previously published findings
from our CytoSorb Therapy in COVID-19 registry in the journal Critical Care that early and intensive treatment is associated
with high survival and shorter time on mechanical support. With a growing body of clinical data from both investigator- and company-sponsored
studies, alongside our STAR-T trial and registries like COSMOS and STAR, the CytoSorb best practices knowledge base in the ICU and cardiac
surgery is expanding rapidly worldwide.
Looking forward, we are encouraged by our commercial
progress but are prioritizing a return to sales growth in Germany, our largest market, which was flat for the second year in a row. Entering
2025, we initiated a significant reorganization of our direct sales team and strategy in Germany, including a rebalancing of territories
and hospital accounts, with the goal of restoring sales growth through deeper customer engagement, more effective market development,
and improved sales representative productivity. Because of the effect of these changes, we expect a short-term disruption in Germany sales
that will result in modestly lower product sales overall in the first quarter compared to a year ago. However, we expect these actions
will yield improved results in the second half of this year with the intent to manage our total core business toward breakeven.
the appropriate marketing approvals, we are excited by the potential near-term growth opportunity in the U.S. and Canada of addressing
the serious perioperative bleeding problem caused by blood thinners like Brilinta (ticagrelor, AstraZeneca) in patients undergoing
coronary artery bypass graft ("CABG") surgery for which we have received FDA Breakthrough Designation. Brilinta ,
a widely used antiplatelet drug, is given to heart attack patients to prevent further clotting. However, if these patients require CABG
surgery, current guidelines recommend delaying the procedure for three to five days to allow the drug to naturally wash out-leading
to prolonged hospital stays, increased costs, and a heightened risk of life-threatening complications.
Blood purification with DrugSorb-ATR represents
a unique solution that can enable patients to undergo CABG surgery safely and quickly, without having to wait at risk. The intent is to
both reduce serious bleeding complications while reducing the burden on hospital resources. We estimate the total addressable market for
DrugSorb-ATR in the U.S. and Canada will grow from $300 million today to over $1 billion as Brilinta becomes generic, DrugSorb-ATR establishes
Brilinta as the only reversible oral antiplatelet, and we expand into other blood thinners and surgical applications.
As we await decisions from the FDA and Health
Canada, we are preparing to execute a controlled market release at key clinical trial sites if approved. This initial stage is expected
to last a few months and will allow us to gather real-world feedback, validate assumptions, and refine our commercialization strategy
for a broader national launch. Our DrugSorb-ATR launch team leverages years of commercial expertise and has initiated pre-market
launch planning, including engaging with leading U.S. and Canadian key opinion leaders, recruiting essential talent, managing numerous
market access activities, and developing a clear value proposition for patients, surgeons, and hospitals.
Visibility and thought leadership are key pillars
of our DrugSorb-ATR launch strategy. Over the next several months, impactful new data will be presented at major cardiovascular conferences
that underscore the clinical benefits of antithrombotic removal in cardiac surgery.
Dr. Chan concluded, "With an established
foundation of commercial sales, strong regulatory progress, and enhanced financial stability, we believe we are very well-positioned to
take advantage of a host of new opportunities this year. As we advance our global commercialization strategy and prepare for the potential
launch of DrugSorb-ATR, we remain committed to delivering life-saving solutions that improve patient outcomes and drive long-term value
for our shareholders."
anticipate a multitude of opportunities to potentially expand our business both internationally and in the United States and Canada this
year. To address flat product sales in our largest market of Germany, we restructured the direct sales team and strategy, including a
realignment of sales territories and accounts, to drive a return to sales growth in this key country. Because of the impact of these changes,
we expect a short-term disruption in German sales and a modest decline in overall product sales for Q1 2025, both sequentially and compared
to Q1 2024. However, we expect these actions will help to improve results in the second half of this year with the intent to manage
our core business toward breakeven.
Q4 and Full Year 2024 Earnings Conference Call
CytoSorbents' management will host a live conference call, presentation
webcast, and a question-and-answer session with the following information:
Date: Monday, March 31, 2025
North American toll-free: 1-800-836-8184
International toll: 1-646-357-8785
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 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.
Additionally, we have provided a Proforma Cash balance as of December 31, 2024, reflecting the proceeds, net of related fees, for
the Rights Offering and Exercise of the Series A Warrant which were received in the first quarter of 2025 as if the net proceeds
had been received as of December 31, 2024. 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)
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, continuous renal replacement therapy