Full Press Release Details
CytoSorbents Reports Fourth Quarter and Full
Year 2021 Results and
Provides 2022 Outlook
was $43.2 million, including product sales of $40.1 million. Core
non-COVID-19 product sales increased approximately 13% Y-Y to $33.8
anniversary of CytoSorb commercialization
JUNCTION, N.J., March 8, 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 audited financial and operating results for the quarter and year ended December 31, 2021 and provides its 2022 outlook.
Full Year 2021 Financial Results
Fourth Quarter 2021 Financial Results
2021 Operating Highlights
a more detailed discussion of 2021 and our 2022 strategy, please refer to our annual stockholder letter, issued January 18,
Chan, Chief Executive Officer of CytoSorbents stated, "CytoSorbents is the pioneer and leader in acute care hemoadsorption.
This year, we celebrate the 10th anniversary of CytoSorb commercialization, during which time we
have grown our business substantially, with more than 162,000 cumulative CytoSorb devices delivered to more than 70 countries worldwide.
Our blood purification technologies help to treat patients who suffer from many of the most difficult and deadly medical conditions that
physicians face on a daily basis. These are illnesses for which few, if any, therapies are effective, leading to millions of deaths each
year. This is no easy task, but when used in the right patient, at the right time, with the right dose, our CytoSorb therapy is associated
with exciting and often dramatic positive outcomes, which has driven adoption and usage around the globe. In fact, the scientific body
of knowledge regarding CytoSorb use continues to grow with Company-sponsored and investigator-initiated studies, making CytoSorb the most
published cytokine adsorption therapy worldwide. With every study - positive, neutral, or negative - we continue to learn who we can treat
and how to achieve the best possible outcomes for these critically ill patients. And now with DrugSorb -ATR in U.S. clinical trials
for antithrombotic drug removal during cardiothoracic surgery to reduce perioperative bleeding, and the ECOS-300CY cartridge approved
in the E.U. for cytokine removal during ex vivo organ perfusion with the goal of improving the function of organs destined for
transplant, we have even greater opportunities to impact human health."
continued, "In 2021, as discussed in detail in our annual stockholder letter in January, we had a good year despite
a challenging operational environment with the ebbs and flows caused by the COVID-19 pandemic. Total revenue and product sales were slightly
ahead of our record results in 2020, highlighted by an approximate 13% increase in core non-COVID-19 product sales as we worked to offset
the anticipated decline in COVID-19 related sales. Product gross margins remained strong at approximately 80% and we ended the year with
a solid cash balance of nearly $54 million that is intended to fuel our future growth initiatives, fund the opening of the critical U.S.
market, and propel us to profitability."
added, "Looking forward in 2022, it is too early to predict how our business may be impacted by the ongoing effects of COVID-19
and the new geopolitical uncertainty caused by the Russia-Ukraine war. However, as it relates to COVID-19, we believe that 2022
will bring a near normalization of our operating environment with the most severe impacts of COVID in the rearview mirror. While the pace
and timing are difficult to predict, we believe the trajectory of COVID-19 has followed other major viral pandemics, including the devastating
1918-1919 Spanish influenza epidemic almost a century ago to the year, that lasted roughly 2 years without the benefit of a flu vaccine.
Mass immunity to COVID-19 from widespread vaccinations and natural infections have led to plummeting new infections from the Omicron variant
in many countries, though note that infection rates are still near all-time highs in Germany and Austria and have only recently just peaked.
However, taking other major E.U. countries as a guide, COVID-19 infections should rapidly fall in Germany and Austria over the next month
or two, and Germany has already declared its intent to lift social restrictions by late-March. Turning to the Russia-Ukraine war, we are
saddened for the people affected by this tragic turn of events and are unable to predict how it may evolve. With the current turmoil and
economic and trade sanctions, we have assumed little to no sales from this region in 2022, which in 2021 only represented less than 4%
of our product sales. Regardless, we remain focused on factors that are within our control and at the end of the day our priority is to
Dr. Chan continued, "In 2022, we will
continue to remain disciplined in our focus, execution, investment, and control of expenses to drive progress in 4 major areas.
We believe these initiatives will lead to sustainable
and significant value creation for our Company and our shareholders."
concluded, "Over the past decade, we have been working tirelessly to help save the lives of patients all over the world with our
CytoSorb blood purification technology and to "Change Medicine" for the better. During the pandemic, under FDA Emergency Use
Authorization, we have had the opportunity here in the United States to personally train and guide U.S. clinicians on how to use CytoSorb
in the most critically ill COVID-19 patients with acute respiratory distress syndrome and refractory respiratory failure on ECMO. We were
tremendously gratified to learn that in 52 such patients from 5 major U.S. ECMO centers, using CytoSorb helped roughly 7 out of 10 patients
survive their life-threatening ordeal and make it back home to their families. What we are doing is meaningful and important and we are
proud to work with all of our healthcare worker, hospital, and distributor/strategic partners
to bring this vital therapy to patients in need. We have accomplished a lot over the last 10 years, but we are even more excited about
Clinical Studies Update
Results of Operations for the year ended December 31,
Total revenue, including product revenue and grant
income, for the year ended December 31, 2021 was $43.2 million, a 5% increase from $41.0 million for the year ended December 31,
2020. Product sales in 2021 were $40.1 million in 2021, a 2% increase from $39.5 million in 2020. COVID-19 relates sales in 2021 were
estimated to be $6.3 million compared to $9.4 million in 2020. Core non-COVID-19 sales grew approximately 13% from $30.1 million in 2020
to $33.8 million in 2021.
Cost of revenue for the year ended December 31,
2021 was $11.0 million compared to $11.1 million for the year ended December 31, 2020. Product gross margins were approximately 80%
for the year ended December 31, 2021, compared to 76% for the year ended December 31, 2020, due to certain costs associated
with the rapid ramp-up of production during 2020 that did not recur during 2021.
Operating expenses for the year ended December 31,
2021 amounted to $54.9 million, a 36% increase from $40.3 million for the year ended December 31, 2020. Research and development
expenses increased from $8.8 million in 2020 to $16.4 million in 2021 due primarily to an increase in clinical trial and related costs
associated with the start of our STAR-T and STAR-D clinical trials in the U.S. and our PROCYSS and Hep-on-Fire clinical trials in Germany.
Selling, General & Administrative (SG&A) expenses increased 26% to $35.8 million in 2021 from $28.5 million in 2020 due primarily
to an increase in salaries, commissions, and related costs of $4.5 million, an increase in non-cash restricted stock expense of $1.0 million
related to restricted stock units granted to the Company's executive officers and an increase of $0.5 million in non-cash stock
option compensation expense, among other items. Legal, financial, and other consulting expense decreased 10% in 2021 to $2.7 million compared
to $3.0 million in 2020.
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 December 31, 2021, we had current assets
of approximately $64.3 million including cash, cash equivalents and restricted cash on hand of approximately $53.8 million and had current
liabilities of approximately $13.7 million. As of December 31, 2021, $25 million of our total shelf amount was allocated to our ATM
facility, all of which is still available. Also, we expect to receive approximately $736,000 in cash from the approved sale of our 2020
net operating losses and research and development credits from the State of New Jersey in the first half of 2022.
We believe that we have sufficient cash to fund
our operations and clinical trial activities well into the future.
Results of Operations for the Quarter ended
Total revenue, including product revenue and grant
income, for the fourth quarter of 2021 was $10.8 million, down 10% from $12.0 million in the fourth quarter of 2020. Product sales in
the fourth quarter of 2021 were $9.7 million, down 16% from $11.5 million in the fourth quarter of 2020. COVID-19 relates sales in the
fourth quarter of 2021 were estimated to be $1.7 million compared to $2.6 million in the fourth quarter of 2021. Core, Non-COVID-19 sales
declined 10% from $8.9 million in the fourth quarter of 2020 to $8.0 million in the fourth quarter of 2021.
Cost of revenue for the fourth quarter of 2021
was $3.1 million compared to $2.5 million for the fourth quarter of 2020. Product gross margin was approximately 78% for the fourth quarter
of 2021, compared to approximately 81% for the fourth quarter of 2020, due mainly to a scheduled manufacturing plant shut down for planned
maintenance and year-end inventory count.
expenses for the fourth quarter of 2021 amounted to $17.2 million, a 43% increase from $12.1 million for the fourth quarter of 2020. Research
and development expenses increased from $2.7 million in the fourth quarter of 2020 to $6.1 million in the fourth quarter of 2021 due primarily
to an increase in clinical trial and related costs associated with the start of our STAR-T and STAR-D clinical trials in the U.S. and
our PROCYSS and Hep-on-Fire clinical trials in Germany. Selling, General & Administrative (SG&A) expenses increased 26% to
$10.4 million in the fourth quarter of 2021 from $8.3 million in the fourth quarter of 2020 due primarily to an increase in salaries,