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CytoSorbents Reports First Quarter 2022 Results and Revises 2022 Outlook Q1 2022 total revenue was $8.7 million, including product sales of $7.9 million. Core non-COVID-19 product sales were an estimated $7.6 million, an

Key Takeaway: CytoSorbents Reports First Quarter 2022 Results and Revises 2022 Outlook Q1 2022 total revenue was $8.7 million, including product sales of $7.9 million. Core non-COVID-19 product sales were an estimated $7.6 million, and on a constant currency basis were comparable to core p

Full Press Release Details

CytoSorbents Reports First Quarter 2022 Results
and Revises 2022 Outlook
Q1 2022 total revenue
was $8.7 million, including product sales of $7.9 million. Core non-COVID-19 product sales were an estimated $7.6 million, and on a constant
currency basis were comparable to core product sales a year ago. Product gross margins were 80%.
MONMOUTH JUNCTION, N.J.,
May 3, 2022 - CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening
conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology,
today reported unaudited financial and operating results for the quarter ended March 31, 2022.
First Quarter 2022 Financial Results
Recent Operating Highlights
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents
stated, "A key takeaway from our first quarter results is that our core non-COVID-19 product sales were stable, on par with Q3 and
Q4 2021, and comparable with Q1 2021 product sales on a constant currency basis. We did this despite the many business challenges and
uncertainties created by COVID-19, the Russian-Ukraine war, inflation, currency exchange volatility, and other factors out of our direct
control. As anticipated, COVID-19 related sales were nominal for Q1 2022 due to the low severity of recent COVID-19 infections, and primarily
accounted for the difference in product sales from a year ago."
"During Q1 2022, CytoSorb sales in Germany,
the Company's largest market, lagged as the country experienced its highest rates of COVID infections since the pandemic began.
When we provided our 2022 outlook in early March, the Omicron wave appeared to be peaking, but was supplanted by a massive wave of BA.2
variant infections that drove a new peak of more than a half million new COVID-19 infections a day by the end of Q1 2022 - seven times
higher than in the prior quarter and 21 times the peak seen a year ago. We have previously discussed how these high rates of COVID-19
indirectly reduce CytoSorb sales by impacting hospital budgets, staffing, elective procedure volumes, ICU capacity, and sale representative
access due to visitation restrictions and illness. Fortunately, COVID-19 infection rates have dropped rapidly in the past several weeks.
However, the BA.2 surge, which still accounts for nearly 100,000 new infections a day in the country, will likely delay the expected recovery
in Germany. We are seeing a carryover of Germany Q1 sales trends to the current quarter, and although this may change, it has prompted
us to conservatively revise our 2022 guidance (see "Revision of 2022 Outlook Guidance" below). That said, we are focused on
the more important big picture where current trends portend an end to the global pandemic this year as COVID-19 is expected to morph into
a much less virulent disease like seasonal influenza. When this happens, we want to be well-positioned to capitalize on what we expect
will be a steady improvement and return to growth in our core business."
Dr. Chan continued, "We remain confident
that the slowdown in our growth is mainly driven by reversible COVID-related issues, and expect that these too shall pass. In the meantime,
we have a solid balance sheet anchored by $44.7 million in cash and no debt at the end of Q1 2022 to
weather the current turbulence. We are also managing
our business proactively, continuing to invest in key areas such as our U.S. pivotal STAR-T and STAR-D trials, while instituting tighter
cost controls to reduce our cash burn by an additional $2 million per quarter against budget. Our goal is to end this year with more than
$30M in cash, which exceeds our projected cash need in 2023 and importantly, is expected to provide adequate funds through the anticipated
enrollment completion of both the pivotal U.S. STAR-T and STAR-D trials. We also have the additional financial flexibility from our $15
million Bridge Bank term loan commitment to add debt if desired."
"Meanwhile, we are not just waiting for
conditions to improve. Rather, we are focused on building this company and solidifying our leadership as the treatment pioneer of life-threatening
conditions using blood purification. We are laser-focused on four essential objectives that we believe are the key to driving sustainable,
long-term value for shareholders:
To provide more color on our growth strategy,
we highlight several examples of important initiatives that we have been executing upon during the pandemic that are expected to drive
improved results as the pandemic abates, as well as future, longer-term growth.
Near-term growth drivers
have highlighted the ability of CytoSorb to remove inflammatory mediators and help to stabilize shock, a potentially fatal drop in blood
pressure, in a wide range of patients. A recent 2019 meta-analysis, found that approximately 10% of ICU patients have septic shock at
admission and an additional 8% of patients admitted to the ICU develop septic shock at some point in their hospital stay, with a high
mortality of 38%. CytoSorb is being used around the world as a treatment of shock and we are conducting the PROCYSS RCT to formally evaluate
CytoSorb as a treatment of this common and major unmet medical need.
In the treatment of acute liver disease, CytoSorb outperforms the market leading MARS platform (Baxter) in the in vitro removal
of many liver toxins, but has the added benefit of removing cytokines and inflammatory mediators, while being much easier to use. In real-world
practice, CytoSorb has replaced MARS at many accounts. One in 11 people worldwide have chronic liver disease that may deteriorate and
require hospitalization and blood purification. Through our Liver/Kidney division, we aim to drive CytoSorb as a therapy of choice in
U.S. CTC registry highlights the high survival of critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) treated
with CytoSorb and ECMO under FDA Emergency Use Authorization. We believe these data demonstrate a therapeutic strategy of "enhanced
lung rest" using the combined therapies that can be extrapolated to the treatment of ARDS in non-COVID patients, a very large market.
Longer-term growth drivers
Dr. Chan concluded, "We firmly believe we
are a solidly financed company with a robust strategic and tactical plan that positions us well for both near-term and long-term success
once the effects of the pandemic abate. Although we know it has been challenging, we thank you for your understanding and continued support."
Clinical Studies and Data Publications Update
Results of Operations for the quarter ended
March 31, 2022 compared to the quarter ended March 31, 2021
Total revenue, including product revenue and grant
income, for the first quarter of 2022 was $8.7 million, down 18% from $10.6 million in the first quarter of 2021. Product sales in the
first quarter of 2022 were $7.9 million, down 22% from $10.1 million in the first quarter of 2021 due to a decrease in direct sales, primarily
from lower sales in Germany due to COVID-19 pandemic market conditions, as well as the impact of the decrease in the average exchange
rate of the Euro to the U.S. dollar, which negatively impacted first quarter 2022 product sales by approximately $0.6 million. Due to
a surge in COVID-19 case in the first quarter of 2022, many hospitals throughout Germany either maintained or reinstituted restrictions
such as visitation rights to non-essential visitors. However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring
ICU care, and death have been comparatively very low. This is being partly attributed to high rates of vaccinations that are associated
with reduced severity of illness, reduced need for hospitalization, and risk of death. These factors led to a decrease in both COVID-19
and core non-COVID-19 CytoSorb sales in Germany. In aggregate, COVID-19 related sales in the first quarter of 2021 were estimated to be
$0.3 million, compared to $1.8 million in the first quarter of 2021. Core, non-COVID-19 sales declined 9% from $8.3 million in the first
quarter of 2021 to $7.6 million in the first quarter of 2022.
Cost of revenue for the first quarter of 2022
was $2.3 million compared to $2.8 million for the first quarter of 2021. Product gross margins were approximately 80% for the first quarter
of 2022, compared to approximately 77% for the first quarter of 2021, due mainly to the impact of non-recurring costs of approximately
$0.7 million in the first quarter of 2021 related to prior year tariffs following an audit by the German Customs Authorities that did
Operating expenses for the first quarter of 2022
amounted to $14.2 million, a 33% increase from $10.7 million for the first quarter of 2021. Research and development expenses increased
from $2.3 million in the first quarter of 2021 to $4.2 million in the first quarter of 2022 due primarily to an increase in clinical
trial and related costs, rent expense on our new facility and other R&D costs. Selling, General & Administrative (SG&A) expenses
increased 19% to $9.2 million in the first quarter of 2022 from $7.7 million in the prior year period due primarily to an increase in
salaries, commissions, and related costs of $0.9 million, an increase in occupancy costs related to rent on our new facility in Princeton,
NJ of $0.4 million, and an increase in sales and marketing costs, which include advertising and conference attendance of approximately
$0.3 million, among other items. These SG&A expense increases were partially offset by lower non-cash restricted stock expense of
$0.3 million, among other decreased expenses included within SG&A. Legal, financial, and other consulting expense increased from
$0.7 million in the first quarter of 2021 to $0.8 million in the first quarter of 2022.
Liquidity and Capital Resources
Since inception, our operations have been primarily
financed through the private and public placement of our debt and equity securities. At March 31, 2022, we had current assets of approximately
$55.9 million including unrestricted cash on hand of approximately $43.0 million and had current liabilities of approximately $14.7 million.
As of March 31, 2022, $25 million of our total shelf amount was allocated to our ATM facility, all of which is still available. In addition,
we have $15 million of debt availability, providing financial flexibility, if needed. In April of 2022, we received approximately $740,000
in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey.
We believe that we have sufficient cash to fund
Last updated: May 3, 2022