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CytoSorbents Reports First Quarter 2021 Financial and Operational Results Total revenue increased to $10.6M. Q1 2021 CytoSorb product sales grew 24% to $10.1M versus $8.2M a year ago

Key Takeaway: CytoSorbents Reports First Quarter 2021 Financial and Operational Results Total revenue increased to $10.6M. Q1 2021 CytoSorb product sales grew 24% to $10.1M versus $8.2M a year ago MONMOUTH JUNCTION, N.J., May 4, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a critical c

Full Press Release Details

CytoSorbents Reports First Quarter 2021 Financial
and Operational Results
Total revenue increased
to $10.6M. Q1 2021 CytoSorb product sales grew 24% to $10.1M versus $8.2M a year ago
MONMOUTH JUNCTION, N.J.,
May 4, 2021 - CytoSorbents Corporation (NASDAQ: CTSO), a critical care leader using its CytoSorb
blood purification technology to treat life-threatening conditions in critically-ill and cardiac surgery patients around the world, reports
financial and operating results for the quarter ended March 31, 2021.
First Quarter 2021 Financial Results:
Q1 2021 Operating Highlights:
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents
stated, "Product sales grew by a healthy 24% in Q1 2021 compared to a year ago, aided by 27% growth in our core non-COVID-19 business
and 79% growth in distributor and partner sales overall. We believe that Q1 2021 sales would have been even higher, but were hampered
for most of the quarter by restrictions and lockdowns throughout Europe in many of our core markets, coupled with rapidly declining new
COVID-19 infections and hospitalizations globally throughout the first two months of the quarter. COVID-19 related sales for Q1 2021 were
approximately $1.8M, down from an average of $2.6M in the prior three quarters. However, March brought another dreaded COVID-19 wave to
Europe, Latin America, the Middle East, and India, resulting in a massive spike in new worldwide infections and a strengthening of COVID-19
related orders of CytoSorb, despite a continuation of lockdowns and restrictions."
"Once the COVID-19 pandemic
diminishes, we believe we will continue our multi-year cycle of sales growth based on the breadth and strength of our core
non-COVID-19 businesses in critical care and cardiac surgery and the growing body of evidence generated by our clinical programs.
The accelerated adoption of CytoSorb around the world that we are seeing due to COVID-19 and new exciting applications, such as liver
dialysis therapy and anti-thrombotic drug removal during cardiac surgery, are expected to accelerate this growth phase. Because of
this, we continue to invest in our commercialization team, new manufacturing facilities, and importantly, Company-sponsored clinical
studies designed to support inclusion of our therapy into global standard treatment guidelines."
"To this end, we have made excellent progress
in our clinical programs. The U.S. STAR-T trial is our current clinical priority, as we believe it provides the shortest, lowest risk,
and most visible path to potential U.S. regulatory approval. Our FDA conditional IDE approval gave us the green light to complete our
operational readiness activities and begin anticipated enrollment of the study in Q3 2021. We have already evaluated and received verbal
agreement from all of our clinical trial centers to participate in the study, selected a contract research organization, and established
a Data and Safety Monitoring Board (DSMB) and Clinical Evaluation Committee (CEC). We are now proceeding with clinical trial agreements
and ethics committee review at these trial sites. Most importantly, today we are pleased to announce STAR-T trial leadership by two seminal
figures in cardiovascular clinical research, Dr. Michael Mack and Dr. C. Michael Gibson. Their guidance and involvement in the study design
has already proven invaluable. We look forward to sharing more detail of the study once the IDE is fully approved."
"Meanwhile, we continue to make progress
on our other studies:
Dr. Chan concluded, "Finally, we recently
added a new warehouse and product distribution center in Berlin, Germany to help manage our increased international product volumes and
logistics. We are also excited to move forward with construction of our manufacturing facility and building improvements of our new corporate
headquarters in Princeton, New Jersey. With a modest capital expenditure of $6-7M, this new production plant is expected to quintuple
our capacity to support $350-400M in sales, while helping to significantly improve our product gross margins and potential future profitability.
Pending COVID-19 restrictions, most of our non-manufacturing staff are expected to move into the new building during the summer, with
a staged transition of our manufacturing teams to the new building by the end of 2022 as the Princeton manufacturing facility is expected
to be completed, validated, and comes on line."
"Please join us on our earnings conference
call today, details for which are below."
Conference Call Details:
Date: Tuesday, May 4, 2021
Time: 4:45 PM Eastern Time
Participant Dial-In: 1-877-451-6152
Conference ID: 13718834
It is recommended that participants dial in approximately 10 minutes
prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the
An archived recording of the conference call
will be available under the Investor Relations section of the Company's website at http://cytosorbents.com/investor-relations/financial-results/.
Results of Operations
Comparison for the three months ended March
Revenue from product sales was approximately $10,143,000
in the three months ended March 31, 2021, as compared to approximately $8,156,000 in the three months ended March 31, 2020, an increase
of approximately $1,987,000, or 24%. This increase was driven by an increase in direct sales of approximately $608,000 resulting from
sales to both new customers and repeat orders from existing customers and an increase in distributor sales of approximately $1,379,000.
Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $304,000 for the three months ended
March 31, 2021. Though difficult to quantitate, we estimate that approximately $1.8 million of total product sales in the first quarter
of 2021 was due to the demand for CytoSorb to treat COVID-19 patients. In addition, as a result of the increase in the average exchange
rate of the Euro to the U.S. dollar, 2021 product sales were positively impacted by approximately $790,000. For the three months ended
March 31, 2021, the average exchange rate of the Euro to the U.S. dollar was $1.21 as compared to an average exchange rate of $1.10 for
the three months ended March 31, 2020.
Grant income was approximately $455,000 for the
three months ended March 31, 2021 as compared to approximately $551,000 for the three months ended March 31, 2020, a decrease of approximately
$96,000 or 17%. This decrease was a result of delays in grant related work caused by the COVID-19 pandemic as our research and development
employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of
Total revenues were approximately $10,599,000
for the three months ended March 31, 2021, as compared to total revenues of approximately $8,707,000 for the three months ended March
31, 2020, an increase of approximately $1,892,000, or 22%.
For the three months ended March 30, 2021 and
2020, cost of revenue was approximately $2,751,000 and $2,385,000, respectively, an increase of approximately $366,000. Product cost of
revenues increased approximately $354,000 during the three months ended March 31, 2021 as compared to the three months ended March 31,
2020 primarily as a result of increased sales. Product gross margins were approximately 77% for the three months ended March 31, 2021
and approximately 76% for the three months ended March 31, 2020. The increase in the gross margin percentage in 2021 was due manufacturing
efficiencies achieved during the three months ended March 31, 2021 and the receipt of approximately $388,000 related to the Employee Retention
Tax Credit under the Coronavirus Aid, Relief and Economic Security Act (the "CARES Act"). These increases were offset by the
impact of costs related to prior years tariffs as a result of an audit by the German Customs Authorities. Excluding the non-recurring
negative impact of the 2018, 2019 and 2020 tariff adjustments of approximately $732,000 and the offsetting non-recurring positive impact
of the Employee Retention Tax Credit which were recorded in the first quarter of 2021, product gross margins were approximately 81% for
the three months ended March 31, 2021. Please see Note 6 to the financial statements for details related to this matter.
Research and Development Expenses:
For the three months ended March 31, 2021, research
and development expenses were approximately $2,282,000 as compared to research and development expenses of approximately $1,965,000 for
the three months ended March 31, 2021, an increase of approximately $317,000. This increase was due to an increase in salaries related
to our clinical trial activities of approximately $333,000 due to the hiring of additional personnel dedicated to the design of protocol
and the anticipated start of a clinical trial in the United States for the removal of ticagrelor in emergent and urgent cardiac surgery
patients and an increase in non-grant related research and development costs of approximately $65,000. These increases were offset by
a decrease in new product development costs of approximately $81,000.
Legal, Financial and Other Consulting Expenses:
Legal, financial and other consulting expenses
were approximately $708,000 for the three months ended March 31, 2021, as compared to approximately $519,000 for the three months ended
March 31, 2020. The increase of approximately $189,000 was due to an increase in hiring fees of approximately $151,000 due to the hiring
of certain senior level personnel and an increase in consulting fees of approximately $111,000 primarily related to certain financial
Last updated: May 4, 2021