Full Press Release Details
Reports Third Quarter 2024 Financial and Operational Results
N.J., November 7, 2024 - 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 |
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."
Our DrugSorb-ATR Regulatory and Commercial Strategy
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 |
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.
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.
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."
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."
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.
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/.
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.
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, 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.
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