MONMOUTH JUNCTION, N.J.,
Aug. 3, 2021 /PRNewswire/
-- CytoSorbents Corporation (NASDAQ: CTSO), a leader in
the treatment of life-threatening conditions in intensive care and
cardiac surgery using blood purification via its proprietary
polymer adsorption technology, reports financial and operating
results for the quarter and six months ending June 30, 2021.
38% growth in record core, non-COVID-19 product sales in Q2 2021
drove 23% growth in total quarterly revenue to $12.0M
Second Quarter 2021 Financial Highlights
- Total revenue, including product sales and grant income, for Q2
2021 was $12.0 million, up 23%
compared to $9.8 million in Q2
2020.
- Q2 2021 product sales increased 19% to $11.4 million compared to Q2 2020 product sales
of $9.5 million.
- Core non-COVID-19 product sales for Q2 2021 were a record
$9.7 million, up 38% compared to
approximately $7.0 million in Q2
2020.
- Consolidated gross profit rose to $9.3
million in Q2 2021, compared to $6.5
million in Q2 2020.
- 2Q 2021 product gross margins were approximately 82%, compared
to 70% in 2Q 2020.
- As of June 30, 2021, trailing
twelve months product sales rose 44% to $43.3 million versus $30.0
million for the same period ending June 30, 2020.
- The Company maintains a healthy cash balance of $65.6 million as of June
30, 2021.
Recent Operating Highlights
- In July, CytoSorbents received full FDA approval for its IDE
application to conduct the pivotal STAR-T (Safe and
Timely Antithrombotic Removal –
Ticagrelor) double-blind, randomized, controlled trial in
the United States to support
marketing approval of the DrugSorb-ATR™ antithrombotic removal
system for intraoperative ticagrelor removal during cardiothoracic
surgery.
- More than 143,000 CytoSorb devices have been delivered to date,
an increase of 43% percent compared to more than 100,000 treatments
delivered as of Q2 2020, with an estimated 6,500 COVID-19 patients
treated globally.
- CytoSorb was registered and became commercially available in
Singapore for all equivalent
European Union approved indications, including the reduction of
cytokines , the reduction of bilirubin in liver disease, the
reduction of myoglobin in trauma, and the removal of ticagrelor and
rivaroxaban during urgent or emergent cardiothoracic surgery.
- CytoSorbents appointed Terri Anne
Powers, MBA, IRC as Vice President, Investor Relations and
Corporate Communications.
- The Company successfully completed its MISSION 100,000
international fundraising campaign to raise $100,000 for the global humanitarian organization
CARE. Funds raised will be used to fight the spread of COVID-19 in
the U.S. and abroad.
Second Half and Full Year 2021 Product Revenue
Guidance
- We continue to expect strong growth in core, non-COVID-19
product sales for the remainder of the year, with at least 30% Y-Y
growth in the second half of 2021, as well as at least 30% Y-Y
growth in full year 2021 core, non-COVID-19 product sales.
- To be conservative, we expect COVID-19 product sales for the
remainder of the year to be less than $1
million.
- Overall, we expect second half 2021 product sales to exceed
first half 2021 product sales.
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "We continue to prioritize the U.S.
STAR-T trial as we believe it provides the lowest risk, fastest,
and most likely path to U.S. marketing approval. Following
full FDA approval of our IDE application in July, we are ramping
activities to begin enrollment, with the first patient enrollment
expected this quarter and trial completion targeted next
year. We believe the STAR-T pivotal trial is rigorously
designed to generate the highest level of evidence and capture the
full clinical and economic benefits of intraoperative ticagrelor
removal with our DrugSorb-ATR system in patients undergoing
cardiothoracic surgery. If obtained, FDA marketing approval
of DrugSorb-ATR for this application would be the first step in a
planned multi-phase growth strategy in the United States. We
expect to leverage the STAR-T trial infrastructure and trial design
in future studies to secure other antithrombotic drug removal
indications during cardiothoracic surgery. Eventually, we
plan to pursue the expanded use of DrugSorb-ATR as a pre-operative
measure to reduce the risk of bleeding in patients on
antithrombotic drugs undergoing any type of high-risk surgical
procedure. Overall, we believe the results from these
randomized, controlled trials, combined with real-world evidence
from the STAR registry, will eventually support the use of our
technology as the new global standard of care for the acute
hospital management of patients on antithrombotic drugs."
Dr. Chan continued, "Turning to quarterly results, product sales
in the second quarter of 2021 grew 19% to $11.4 million compared to the prior year, aided
by 38% growth in core non-COVID-19 product sales. These core
sales reached a quarterly record of $9.7
million, or 85% of total product sales. We estimate
that COVID-19 related sales in the second quarter of 2021 were
approximately $1.7 million. We
continue to see improved access of our direct sales force,
distributors and partners to physicians and hospitals, though
access is still significantly less than pre-pandemic levels.
With the increase in global vaccinations, offset by the rise of new
cases and hospitalizations driven by new COVID-19 variants,
including the more contagious Delta variant, we are unable to
predict what impact, if any, the COVID-19 pandemic may have on
sales for the remainder of the year. Overall, we expect
second half 2021 product sales to exceed first half 2021 product
sales, with limited contribution from COVID-19 related sales in the
second half of 2021."
"Our business remains healthy with strong sales growth and 82%
product gross margins achieved in the second quarter of 2021.
We have maintained a robust cash balance, with $65.6M at June 30,
2021, providing us a long runway to support investments in
operations and clinical studies worldwide to drive future
growth. We also continue to expand our clinical team and
other key talent to execute our strategy and believe we are
well-positioned to grow in both the short- and long-term."
Clinical Studies Update
- In July 2021, the U.S. FDA fully
approved the Company's IDE application for the up to 120 patient,
double-blind, randomized, controlled U.S. STAR-T pivotal
trial to remove ticagrelor intraoperatively during cardiothoracic
surgery with the DrugSorb-ATR antithrombotic removal system. We are
working closely with our contract research organization (CRO) and
are advancing operational activities rapidly, including the
successful completion of the first Investigator Meeting and
execution of site initiation visits. We expect to begin enrollment
in the third quarter of 2021, have all study sites activated by end
of the year, and complete the study in 2022.
- The U.S. REFRESH 2-AKI study continues to enroll at
multiple clinical sites and based on our enrollment projections,
notwithstanding potential COVID-19 related delays, we project the
interim analysis milestone will be reached in 2022.
- The CTC Registry: Primary results on observed ICU
mortality of COVID-19 patients with acute respiratory distress
syndrome (ARDS) requiring extracorporeal membrane oxygenation
(ECMO) and treated with CytoSorb according to FDA Emergency Use
Authorization criteria, have been accepted for presentation at the
International Symposium of Intensive Care Medicine conference at
the end of August 2021 in
Brussels, Belgium, and have also
been submitted for journal publication.
- The CYTATION trial in patients on ticagrelor undergoing
emergent cardiothoracic surgery in Germany has enrolled the first patients, but
enrollment has been slower than expected due to the continuing
impact of the COVID-19 pandemic.
- The PROCYSS randomized, controlled, multi-center trial
in Germany to evaluate the ability
of CytoSorb to restore hemodynamic stability in patients with
refractory septic shock recently received Ethics Committee
approval, and notwithstanding any COVID-19 associated delays, is
expected to begin enrollment this year.
- The Hep-On-Fire single-arm, multi-center trial in
Germany in patients suffering from
acute liver failure due to alcoholic hepatitis is also scheduled to
start later this year, pending any COVID-19 related delays.
- The Safe and Timely Antithrombotic
Removal (STAR) Registry was designed to generate real
world evidence on the antithrombotic removal application and will
be ready to receive data entry from Germany and the U.K. this quarter, with plans
to gradually expand to additional E.U. countries. Initial data
release is planned for 2022.
- Finally, we expect the results of the German
government-sponsored and investigator-initiated REMOVE
endocarditis study to be reported before the end of the year.
R&D Update
Our research and development efforts are gaining momentum
despite the disruption brought on by the COVID-19 pandemic.
Since the start of the year, internal and government grant funding
have supported the expansion of our R&D staff by approximately
30%, and we expect to increase headcount further by the end of the
year to support work associated with awarded grants and contracts.
The revenue remaining to be earned on open grant contracts is
$12.1 million. To facilitate
this growth, we have relocated half the team to the new facility in
Princeton, New Jersey where we
were able to occupy existing labs with minimal disruption to
program timelines. Overall, grant funded programs,
HemoDefend-BGA™ (Universal Plasma), HemoDefend-RBC™ and
K+ontrol™, continue to progress and have been the
beneficiary of ~$9.6 million,
$4.7 million and $7.0 million in total funding, respectively,
awarded to date.
We are pleased to report acceleration of our HemoDefend-RBC™
filter development, which is designed to remove non-infectious
contaminants in transfused packed red blood cells that can cause
transfusion reactions. We are currently producing devices for
the required preclinical testing that is expected to start this
quarter, to support an investigational device exemption (IDE)
application to run a small (<30 patient) human study to support
FDA marketing approval.
Results of Operations for the Quarter ended June 30, 2021
Comparison for the three months ended June 30, 2021, and 2020
Revenues
Revenue from product sales was
approximately $11,365,000 in the
three months ended June 30, 2021, as
compared to approximately $9,520,000
in the three months ended June 30,
2020, an increase of approximately $1,845,000, or 19%. This increase was driven by
an increase in direct sales of approximately $1,492,000 resulting from sales to both new
customers and repeat orders from existing customers and an increase
in distributor sales of approximately $353,000. Sales to hospitals in the United States under the EUA granted by the
FDA amounted to approximately $362,000 for the three months ended June 30, 2021. Though difficult to
quantitate, we estimate that approximately $1.7 million of total product sales in the second
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
$819,000. For the three months
ended June 30, 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
June 30, 2020.
Grant income was approximately $659,000 for the three months ended June 30, 2021 as compared to approximately
$275,000 for the three months ended
June 30, 2020, an increase of
approximately $384,000, or
140%. This increase was a result of the easing of the
COVID-19 pandemic during the three months ended June 30, 2021 and a corresponding increase in
grant related work. During the three months ended
June 30, 2020, 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 CytoSorb.
Total revenues were approximately $12,024,000 for the three months ended
June 30, 2021, as compared to total
revenues of approximately $9,795,000
for the three months ended June 30,
2020, an increase of approximately $2,229,000, or 23%.
Cost of Revenues
For the three months ended
June 30, 2021 and 2020, cost of
revenue was approximately $2,710,000
and $3,250,000, respectively, a
decrease of approximately $540,000.
Product cost of revenue was approximately $2,094,000 and $2,901,000, respectively, for the three months
ended June 30, 2021 and 2020, a
decrease of approximately $807,000. This decrease was due to certain
costs associated with the rapid ramp-up of production during the
three months ended June 30, 2020 that
did not recur during the three months ended June 30, 2021. Product gross margins were
approximately 82% for the three months ended June 30, 2021 as compared to approximately 70%
for the three months ended June 30,
2020. The increase in the gross margin percentage in 2021 was
due manufacturing efficiencies achieved during the three months
ended June 30, 2021 and the impact of
the ramp-up costs incurred during the three months ended
June 30, 2020 that did not recur in
2021.
Research and Development Expenses
For the three
months ended June 30, 2021, research
and development expenses were approximately $3,699,000, as compared to research and
development expenses of approximately $2,406,000 for the three months ended
June 30, 2020, an increase of
approximately $1,293,000. This
increase was due to an increase in our clinical trial activities of
approximately $452,000 due to
pre-enrollment activities related to our STAR-T trial in
the United States, an increase in
salaries related to our clinical trial activities of approximately
$506,000 due to the hiring of
clinical expertise, an increase in rent expense of approximately
$181,000 related to rent expense on
our new facility and an increase in non-grant related research and
development labor and other costs of approximately $154,000.
Legal, Financial and Other Consulting
Expenses
Legal, financial and other consulting expenses
were approximately $718,000 for the
three months ended June 30, 2021, as
compared to approximately $846,000
for the three months ended June 30,
2020. The decrease of approximately $128,000 was due to a decrease in legal fees of
approximately $98,000, a decrease in
employment agency fees of approximately $46,000, and a decrease in accounting and
auditing fees of approximately $23,000. The decreases were offset by an
increase in consulting fees of approximately $39,000.
Selling, General and Administrative
Expenses
Selling, general and administrative expenses
were approximately $9,821,000 for the
three months ended June 30, 2021, as
compared to approximately $6,591,000
for the three months ending June 30,
2020, an increase of $3,231,000. Approximately $1,396,000, or 43%, of this increase was
associated with non-cash related expenses including restricted
stock expense of approximately $884,000 related to restricted stock units
granted to the Company's executive officers and an increase in
stock compensation expense of approximately $512,000. The remaining increases in selling,
general and administrative expense are related to an increase in
salaries, commissions and related costs of approximately
$1,127,000, an increase in royalty
expenses of approximately $156,000
due to the increase in product sales, an increase in
commercial insurance of approximately $194,000 and an increase in sales and
marketing costs, which include advertising and conference
attendance of approximately $229,000 and an increase in other general
and administrative expenses of approximately $129,000.
Interest Expense, net
For the three months
ended June 30, 2021, net interest
income was approximately $13,000, as
compared to net interest expense of approximately $274,000 for the three months ended June 30, 2020. This decrease in net interest
expense was the result of the payoff of our outstanding term loans
with Bridge Bank in December of 2020.
Gain (Loss) on Foreign Currency
Transactions
For the three months ended June 30, 2021, the gain on foreign currency
transactions was approximately $234,000 as compared to a gain of approximately
$705,000 for the three months ended
June 30, 2020. The 2021 gain was
directly related to the increase in the spot exchange rate of the
Euro to the U.S. dollar at June 30,
2021 as compared to March 31,
2021. The spot exchange rate of the Euro to the U.S. dollar
was $1.18 per Euro at June 30, 2021, as compared to $1.17 per Euro at March
31, 2021. The 2020 gain was directly related to the
increase in the spot exchange rate of the Euro at June 30, 2020 as compared to March 31, 2020. The spot exchange rate of
the Euro to the U.S. dollar was $1.12
per Euro at June 30, 2020, as
compared to $1.10 per Euro at
March 31, 2020.
Comparison for the six months ended June 30, 2021, and 2020
Revenues
Revenue from product sales was
approximately $21,509,000 in the six
months ended June 30, 2021, as
compared to approximately $17,676,000
in the six months ended June 30,
2020, an increase of approximately $3,833,000, or 22%. This increase was driven by
an increase in direct sales of approximately $2,100,000 resulting from sales to both new
customers and repeat orders from existing customers and an increase
in distributor sales of approximately $1,733,000. Sales to hospitals in the United States under the EUA granted by the
FDA amounted to approximately $666,000 for the six months ended June 30, 2021. Though difficult to
quantitate, we estimate that approximately $3.5 million of total product sales in the six
months ended June 30, 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 $1,608,000. For the six months ended
June 30, 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 six months ended
June 30, 2020.
Grant income was approximately $1,114,000 for the six months ended June 30, 2021 as compared to approximately
$826,000 for the six months ended
June 30, 2020, an increase of
approximately $288,000 or 35%.
This increase was a result of the easing of the COVID-19 pandemic
during the three months ended June 30,
2021 and a corresponding increase in grant related
work. During the six months ended June
30, 2020, 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 CytoSorb.
Total revenues were approximately $22,623,000 for the six months ended June 30, 2021, as compared to total revenues of
approximately $18,502,000 for the six
months ended June 30, 2020, an
increase of approximately $4,121,000,
or 22%.
Cost of Revenues
For the six months ended
June 30, 2021 and 2020, cost of
revenue was approximately $5,462,000
and $5,635,000, respectively, a
decrease of approximately $173,000.
Product cost of revenue was approximately $4,426,000 and $4,878,000, respectively, for the six months
ended June 30, 2021 and 2020, a
decrease of approximately $452,000. This decrease was related to
certain costs associated with the rapid ramp-up of production of
approximately $884,000 during the
period ended June 30, 2020 that did
not recur during the period ended June 30,
2021. These decreases were offset by the negative impact of
non-recurring costs related to prior years tariffs as a result of
an audit by the German Customs Authorities of approximately
$732,000 and the offsetting
non-recurring positive impact of the Employee Retention Tax Credit
of approximately $388,000, both of
which were recorded in the first quarter of 2021. Product gross
margins were approximately 79% for the six months ended
June 30, 2021, and approximately 72%
for the six months ended June 30,
2020. Excluding the impact of the non-recurring costs
outlined above, product gross margins were approximately 81% for
the six months ended June 30,
2021.
Research and Development Expenses
For the six
months ended June 30, 2021, research
and development expenses were approximately $5,981,000 as compared to research and
development expenses of approximately $4,371,000 for the six months ended June 30, 2020, an increase of approximately
$1,610,000. This increase was
due to an increase in costs associated with our clinical trial
activities of approximately $839,000,
an increase in salaries related to our clinical trial activities of
approximately $457,000 due to the
hiring of clinical expertise, an increase in rent expense of
approximately $181,000 related to
rent expense on our new facility and an increase in non-grant
related research and development labor and other costs of
approximately $133,000.
Legal, Financial and Other Consulting
Expenses
Legal, financial and other consulting expenses
were approximately $1,426,000 for the
six months ended June 30, 2021, as
compared to approximately $1,365,000
for the six months ending June 30,
2020. The increase of approximately $61,000 was due to an increase in hiring fees of
approximately $105,000 due to the
hiring of certain senior level personnel and an increase in
consulting fees of approximately $150,000 primarily related to certain financial
advisory and information systems consulting fees. These
increases were offset by decreases in legal fees of approximately
$157,000 and accounting fees of
approximately $37,000.
Selling, General and Administrative
Expenses
Selling, general and administrative expenses
were approximately $17,531,000 for
the six months ended June 30, 2021,
as compared to $12,908,000 for the
six months ended June 30, 2020, an
increase of $4,623,000.
This increase is related to an increase in salaries, commissions
and related costs of approximately $2,699,000, an increase in royalty expenses of
approximately $312,000 due to the
increase in product sales, and an increase in non-cash restricted
stock expense of approximately $849,000 related to restricted stock units
granted to the Company's executive officers, an increase in
non-cash stock compensation expense of approximately $450,000, an increase in commercial insurance of
approximately $260,000 and an
increase in sales and marketing costs, which include
advertising and conference attendance and other general and
administrative expenses of approximately $243,000. These increases were offset by a
decrease in travel and entertainment costs of approximately
$190,000 due primarily to travel
restrictions related to the COVID-19 pandemic.
Interest Expense, net
For the six months ended
June 30, 2021, interest income was
approximately $3,000, as compared to
interest expense of approximately $579,000 for the six months ended June 30, 2020. This decrease in net interest
expense of approximately $582,000 was
the result of the payoff of our outstanding term loans with Bridge
Bank in December of 2020.
Gain (Loss) on Foreign Currency
Transactions
For the six months ended June 30, 2021, the loss on foreign currency
transactions was approximately $1,071,000 as compared to a gain of approximately
$36,000 for the six months ended
June 30, 2020. The 2021 loss was
directly related to the decrease in the spot exchange rate of the
Euro to the U.S. dollar at June 30,
2021 as compared to December
31, 2020. The spot exchange rate of the Euro to the
U.S. dollar was $1.18 per Euro at
June 30, 2021, as compared to
$1.22 per Euro at December 31, 2020. The 2020 gain was
directly related to the increase in the spot exchange rate of the
Euro at June 30, 2020 as compared to
December 31, 2019.
Liquidity and Capital Resources
Since inception, our
operations have been primarily financed through the issuance of
debt and equity securities. At June 30,
2021, we had current assets of approximately $77,085,000 including cash on hand of
approximately $65,609,000 and current
liabilities of approximately $10,796,000. During the period from January 1, 2020 through July 15, 2020, we raised approximately
$26,427,000 by utilizing our ATM
facility with co-agents Jefferies LLC and B. Riley FBR. In
addition, we received net proceeds of approximately $53,800,000 from our underwritten public offering
that closed on July 24, 2020.
Also, we received approximately $1,127,000 in cash from the approved sale of our
net operating losses and research and development credits from the
State of New Jersey during the
three months ended June 30, 2021.
We believe that we have sufficient cash to fund our operations
well into the future.
Second Half and Full Year 2021 Product Revenue
Guidance
We continue to see underlying strength in our core
markets and therefore continue to expect strong growth of at least
30% Y-Y in core, non-COVID-19 product sales for the remainder of
the year, as well as at least 30% Y-Y growth in full year 2021
core, non-COVID-19 product sales. Overall, we expect second
half 2021 product sales to exceed first half 2021 product
sales.
We believe the COVID-19 pandemic has increased awareness and
usage of CytoSorb as a treatment to reduce cytokine storm in many
countries worldwide. However, the COVID-19 pandemic continues
to add uncertainty to the sales outlook, especially since we are
unable to predict the course of the pandemic. Vaccinations
have increased globally, but new cases and hospitalizations are
being driven by additional COVID-19 variants and we are unable to
predict what impact, if any, the COVID-19 pandemic may have on
sales for the remainder of the year. Given this uncertainty,
and to be conservative, we expect product sales associated with
COVID-19 treatments to be less than $1
million in the second half of 2021, compared to
approximately $3.5 million in the
first half of 2021.
For additional information, please see the Company's Form 10-Q
for the period ended June 30, 2021,
filed on August 3, 2021 on
http://www.sec.gov.
Conference Call
The company will conduct its second
quarter operating and financial results call today at 4:30 p.m. Eastern time. It will be archived
for replay following the conference call.
Conference Call Details:
Toll free:
1-877-451-6152
International: 1-201-389-0879
Conference ID: 13721110
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 following audio feed
link: http://public.viavid.com/index.php?id=145516
About CytoSorbents Corporation (NASDAQ:
CTSO)
CytoSorbents Corporation is a leader
in the treatment of life-threatening conditions in intensive care
and cardiac surgery using blood purification. Its flagship
product, CytoSorb® is approved in the European Union with
distribution in 68 countries around the world, as an extracorporeal
cytokine adsorber designed to reduce the "cytokine storm" or
"cytokine release syndrome" seen in common critical illnesses that
may result in massive inflammation, organ failure and patient
death. These are conditions where the risk of death can be
extremely high, yet few to no effective treatments exist.
CytoSorb is also being used during and after cardiothoracic surgery
to remove inflammatory mediators that can lead to post-operative
complications, including multiple organ failure. More than
143,000 CytoSorb devices have been delivered to date.
CytoSorb was originally introduced into the European Union under
CE-Mark as a first-in-kind cytokine adsorber. Additional
CE-Mark label expansions were received for the removal of bilirubin
and myoglobin in clinical conditions such as liver disease and
trauma, respectively, and both ticagrelor and rivaroxaban during
cardiothoracic surgery. CytoSorb has also received FDA
Emergency Use Authorization in the United
States for use in critically ill COVID-19 patients with
imminent or confirmed respiratory failure. CytoSorbents'
technology has also been granted FDA Breakthrough Designation
for the removal of ticagrelor in a cardiopulmonary bypass circuit
during emergent and urgent cardiothoracic surgery, and if FDA
clearance is obtained, would be marketed as DrugSorb-ATR™ in
the United States.
CytoSorbents' 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. Its technologies have received
non-dilutive grant, contract, and other funding of more than
$39.5 million from DARPA, the U.S.
Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), National Heart, Lung, and Blood
Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special
Operations Command (SOCOM), Air Force Material Command (USAF/AFMC),
and others. 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 patents and registered trademarks, and multiple
patent applications pending, including ECOS-300CY®, CytoSorb-XL™,
HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™,
DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others. For
more information, please visit the Company's websites at
www.cytosorbents.com and www.cytosorb.com or follow us on Facebook
and Twitter.
Forward-Looking Statements
This press release includes
forward-looking statements intended to qualify for the safe harbor
from liability established by the Private Securities Litigation
Reform Act of 1995. These forward-looking statements include,
but are not limited to, statements about our plans, objectives,
anticipated future results and performance, representations and
contentions and are not historical facts and typically are
identified by use of terms such as "may," "should," "could,"
"expect," "plan," "anticipate," "believe," "estimate," "predict,"
"potential," "continue" and similar words, although some
forward-looking statements are expressed differently. You
should be aware that the forward-looking statements in this press
release represent management's current judgment and expectations,
but our actual results, events and performance could differ
materially from those in the forward-looking statements. Factors
which could cause or contribute to such differences include, but
are not limited to, the risks discussed in our Annual Report on
Form 10-K, filed with the SEC on March 9,
2021, as updated by the risks reported in our Quarterly
Reports on Form 10-Q, and in the press releases and other
communications to shareholders issued by us from time to time which
attempt to advise interested parties of the risks and factors which
may affect our business. We caution you not to place undue
reliance upon any such forward-looking statements. We
undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise, other than as required under the
Federal securities laws.
CYTOSORBENTS
CORPORATION
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CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
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(amounts in
thousands, except per share data)
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Three months ended
June 30,
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Six months ended June
30,
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|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
CytoSorb
sales
|
|
$
|
11,360
|
|
|
$
|
9,451
|
|
|
$
|
21,504
|
|
|
$
|
17,607
|
|
Other
sales
|
|
|
5
|
|
|
|
69
|
|
|
|
5
|
|
|
|
69
|
|
Total
product sales
|
|
|
11,365
|
|
|
|
9,520
|
|
|
|
21,509
|
|
|
|
17,676
|
|
Grant
income
|
|
|
659
|
|
|
|
275
|
|
|
|
1,114
|
|
|
|
826
|
|
Total
revenue
|
|
|
12,024
|
|
|
|
9,795
|
|
|
|
22,623
|
|
|
|
18,502
|
|
Cost of
revenue
|
|
|
2,710
|
|
|
|
3,250
|
|
|
|
5,462
|
|
|
|
5,635
|
|
Gross
profit
|
|
|
9,314
|
|
|
|
6,545
|
|
|
|
17,161
|
|
|
|
12,867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
3,699
|
|
|
|
2,406
|
|
|
|
5,981
|
|
|
|
4,371
|
|
Legal,
financial and other consulting
|
|
|
718
|
|
|
|
846
|
|
|
|
1,426
|
|
|
|
1,365
|
|
Selling,
general and administrative
|
|
|
9,822
|
|
|
|
6,591
|
|
|
|
17,531
|
|
|
|
12,908
|
|
Total
expenses
|
|
|
14,239
|
|
|
|
9,843
|
|
|
|
24,938
|
|
|
|
18,644
|
|
Loss from
operations
|
|
|
(4,925)
|
|
|
|
(3,298)
|
|
|
|
(7,777)
|
|
|
|
(5,777)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
|
|
13
|
|
|
|
(274)
|
|
|
|
3
|
|
|
|
(579)
|
|
Gain (loss) on
foreign currency transactions
|
|
|
234
|
|
|
|
705
|
|
|
|
(1,071)
|
|
|
|
36
|
|
Total other income
(expense), net
|
|
|
247
|
|
|
|
431
|
|
|
|
(1,068)
|
|
|
|
(543)
|
|
Loss before benefit
from income taxes
|
|
|
(4,678)
|
|
|
|
(2,867)
|
|
|
|
(8,845)
|
|
|
|
(6,320)
|
|
Benefit from income
taxes
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
Net loss
|
|
$
|
(4,678)
|
|
|
$
|
(2,867)
|
|
|
$
|
(8,845)
|
|
|
$
|
(6,320)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.11)
|
|
|
$
|
(0.08)
|
|
|
$
|
(0.20)
|
|
|
$
|
(0.18)
|
|
Weighted average
number of shares of
common stock outstanding
|
|
|
43,317,578
|
|
|
|
36,483,355
|
|
|
|
43,280,266
|
|
|
|
35,232,308
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(4,678)
|
|
|
$
|
(2 ,867)
|
|
|
$
|
(8,845)
|
|
|
$
|
(6,320)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
(264)
|
|
|
|
(605)
|
|
|
|
893
|
|
|
|
5
|
|
Comprehensive
loss
|
|
$
|
(4,942)
|
|
|
$
|
(3,472)
|
|
|
$
|
(7,952)
|
|
|
$
|
(6,315)
|
|
CYTOSORBENTS
CORPORATION
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(amounts in
thousands)
|
|
|
|
June 30,
2021
|
|
|
December 31,
2020
|
|
ASSETS:
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
65,609
|
|
$
|
71,422
|
|
Grants and accounts
receivable, net
|
|
5,755
|
|
|
5,159
|
|
Inventories
|
|
3,689
|
|
|
2,674
|
|
Prepaid expenses and
other current assets
|
|
2,032
|
|
|
3,198
|
|
Total current assets
|
|
77,085
|
|
|
82,453
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
3,058
|
|
|
2,120
|
|
Right of use
asset
|
|
13,264
|
|
|
1,029
|
|
Other
assets
|
|
4,786
|
|
|
4,348
|
|
TOTAL ASSETS
|
$
|
98,193
|
|
$
|
89,950
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
$
|
2,166
|
|
$
|
1,835
|
|
Lease liability -
current portion
|
|
252
|
|
|
447
|
|
Accrued expenses and
other current liabilities
|
|
8,378
|
|
|
7,871
|
|
Total current
liabilities
|
|
10,796
|
|
|
10,153
|
|
Lease liability, net
of current portion
|
|
13,012
|
|
|
582
|
|
TOTAL LIABILITIES
|
|
23,808
|
|
|
10,735
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
74,385
|
|
|
79,215
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
98,193
|
|
$
|
89,950
|
|
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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com
U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com
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SOURCE CytoSorbents Corporation