MONMOUTH JUNCTION, N.J.,
Nov. 4, 2021 /PRNewswire/
-- 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, reports full
financial and operating results for the quarter ended September 30, 2021.
CytoSorbents Reports Full Third Quarter 2021 Financial and
Operational Results
Third Quarter 2021 Financial Results
- Total revenue, including product sales and grant income, for Q3
2021 was $9.8 million, compared to
$10.5 million in Q3 2020, a decrease
of 7%.
- Q3 2021 CytoSorb product sales were $8.9
million, down 13% compared to $10.2
million in Q3 2020.
- Q3 2021 product sales in Germany were $3.7
million, a decrease of $1.1
million or 24% from product sales of $4.8 million in Germany in Q3 2020.
- Core non-COVID-19 product sales for Q3 2021 were approximately
$7.8 million, up 3% from
approximately $7.5 million in Q3
2020.
- Estimated Q3 2021 COVID-19 related sales were $1.1 million, compared to an estimated
$2.7 million in Q3 2020.
- Q3 2021 product gross margins were 82%, as compared to 74% in
Q3 2020.
- The Company maintains a healthy cash balance of $61.0 million at September
30, 2021 with no debt.
Recent Operating Highlights
- In October, CytoSorbents enrolled the first patient in the
pivotal U.S. STAR-T (Safe and Timely
Antithrombotic Removal – Ticagrelor)
double-blind, randomized controlled trial in the United States to support FDA marketing
approval of the DrugSorb-ATR™ antithrombotic removal system for
intraoperative ticagrelor removal during urgent cardiothoracic
surgery.
- Following receipt of a second Breakthrough Designation
attributed to DrugSorb-ATR for the removal of the market-leading
Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during
urgent cardiothoracic surgery in August, the Company successfully
filed an IDE application and received full FDA approval to begin
the pivotal STAR-D ( Safe and Timely
Antithrombotic Removal – Direct Oral
Anticoagulants) double-blind, randomized controlled trial in
the United States to support
marketing approval for this additional indication.
- In September, CytoSorbents presented topline results from the
U.S. CTC Registry at the International Symposium on Intensive Care
& Emergency Medicine conference in Belgium and hosted a dedicated webinar
highlighting the associated findings.
- Results from two investigator-initiated studies evaluating the
use of CytoSorb in endocarditis, including the randomized,
controlled REMOVE trial were presented at the European Association
for Cardio-Thoracic Surgery conference in Spain in October.
- In August, CytoSorbents and Aferetica announced the commercial
launch in Italy of the PerSorb™
Adsorber (based on CytoSorbents' ECOS-300CY™ sorbent technology) to
remove inflammatory mediators during ex vivo perfusion via
the PerLife™ Organ Perfusion System at the European Society of
Organ Transplantation congress.
- More than 152,000 cumulative CytoSorb devices have been
utilized to date, an increase of 38% compared to more than 110,000
devices utilized as of Q3 2020, with more than 6,900 COVID-19
patients treated globally.
- CytoSorb is now distributed in more than 70 countries, adding
Thailand and the Ukraine during the quarter.
Fourth Quarter and Full Year 2021 Product Revenue
Guidance
- The Company maintains its revised 2021 product revenue guidance
provided on October 12, 2021:
-
- Q4 2021 product revenue is expected to be similar to Q3 2021
product revenue of $8.9 million.
- Full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020
product revenue of $39.5 million.
While difficult to predict, 2021 core non-COVID-19 product sales
are expected to be approximately $33
to $34 million for the year versus
$30.1 million in 2020.
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "As previously communicated in
mid-October, third quarter product sales were negatively affected
by a resurgence in COVID-19 cases in Germany in August and a reversal of initially
encouraging trends that we saw at the beginning of the
quarter. Increased hospital restrictions led to
lower-than-expected core non-COVID-19 sales of CytoSorb with fewer
elective surgical procedures (where complications such as sepsis
are often treated with CytoSorb), fewer ICU patients due to ICU
capacity constraints from COVID-19 allocations and ICU staffing
shortages caused by healthcare worker burnout, as well as decreased
visitor access - impacting the ability of our sales force to
generate sales. Meanwhile, during this historically seasonal
quarter due to European vacation schedules, the severity of illness
and deaths among hospitalized COVID-19 patients was unexpectedly
low, resulting in fewer COVID-related CytoSorb sales."
Dr. Chan continued, "As a result, product sales in the third
quarter of 2021 were $8.9 million,
reflecting lower sales in Germany
and an expected decline in international COVID-related sales,
taking into account the evolving and migrating pandemic and
increasing global vaccinations. Core non-COVID-19 product
sales accounted for approximately 88% of our overall product sales.
Blended product gross margins were approximately 82% in
the third quarter, a significant improvement from approximately 74%
in the prior year quarter and a strong result driven by
manufacturing efficiencies. Today, the macro environment
remains challenging in Germany,
but we are proactively working within the current constraints to
find creative ways to increase engagement with new and existing
customers and to increase awareness of the benefits of CytoSorb in
both COVID-19 and core applications. We expect the macro
environment to improve over time, though timing is difficult to
predict."
Dr. Chan added, "Meanwhile, we are pleased by the latest
successes of our U.S clinical development program in pursuit of
U.S. commercialization. We recently enrolled our first
patient in the pivotal STAR-T trial evaluating the use of
DrugSorb-ATR for intraoperative ticagrelor removal during urgent
cardiothoracic surgery and are ramping up the number of active
sites. In addition, in the span of approximately three months
we received a second FDA Breakthrough Device Designation for
DrugSorb-ATR, this time to remove the direct oral anticoagulants
apixaban and rivaroxaban during urgent cardiothoracic surgery,
filed an associated IDE, and received full FDA approval to begin
the pivotal STAR-D trial for this application. The successful
execution of these activities in such a short timeline is a
testament to the strength of the clinical and regulatory talent we
have hired over the past 18 months. By the end of this year,
we expect to have seven active Company-sponsored studies underway
that are designed to generate robust clinical data to support our
growth objectives. We continue to have a healthy balance
sheet, with approximately $61 million
in cash and no debt, and we expect to continue funding activities
to drive growth, including clinical development, sales and
marketing infrastructure, and our new, expanded manufacturing
facility, which is on track to come online by the end of 2022."
Dr. Chan concluded, "Despite the complexities of COVID-19 on our
business, we believe we are well-positioned for long-term growth
with an outstanding therapy, CytoSorb, that when used on
the right patients, at the right time, with the right dose, works
to help save lives. We are boldly trying to solve some of the most
complex medical problems in medicine today that claim the lives of
millions each year. It is not simple. But with every
study, we move closer to unlocking the key. In addition, we
believe we have an excellent business model bolstered by strong
product gross margins, broad international physician and
partner support, a growing body of clinical data, and a solid
safety profile with now more than 152,000 treatments utilized
across more than 70 countries. We remain confident in our
core business both in Germany and
internationally and are excited about our pivotal trials in the
U.S. that have the potential to open the significant U.S. market
and make our therapies available to help even more people."
Clinical Studies Update
- In addition to prior commentary provided in this release, the
U.S. STAR-T trial is now actively recruiting at multiple
sites. Pending any COVID-19 related delays, we expect that the
study will complete enrollment in 2022. In addition, study start-up
activities have begun for the U.S. STAR-D trial, with first
patient enrollment expected in the first quarter of 2022.
- The REFRESH 2-AKI study in the
United States has resumed enrollment at multiple trial
centers. The goal of the study is to achieve the milestone of the
interim analysis next year, however, the ongoing COVID-19 pandemic
is causing enrollment delays associated with postponement or
deferral of elective cardiac surgeries and shortage in research
staff.
- Primary results from the CytoSorb Therapy in COVID-19 (CTC)
Registry demonstrating high 90-day survival in critically ill
COVID-19 patients with acute respiratory distress syndrome (ARDS)
treated with both extracorporeal membrane oxygenation (ECMO) and
CytoSorb under FDA Emergency Use Authorization were presented at
the International Symposium of Intensive Care Medicine (ISICEM)
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 is actively recruiting patients at all
three sites plus a recently added clinical site in Luxembourg. Pending any uncertainty introduced
by COVID-19 related delays, we expect that the study will complete
enrollment in 2022.
- The German PROCYSS multicenter, randomized controlled
trial evaluating the ability of CytoSorb to restore hemodynamic
stability in patients with refractory septic shock is now actively
recruiting. The speed of enrollment remains uncertain due to
COVID-19, however we currently estimate study completion by end of
2023.
- The Hep-On-Fire single-arm, multi-center German trial
evaluating CytoSorb in patients suffering from acute liver failure
due to alcoholic hepatitis received Ethics Committee approval in
October. Study start-up activities are ongoing, and we expect that
the study will begin enrollment in the first quarter of 2022.
- The Safe and Timely Antithrombotic
Removal (STAR) Registry was designed to capture real
world clinical and economic outcomes in the antithrombotic removal
application. The registry is currently actively enrolling patients,
and we estimate that first data readouts from the STAR Registry
will begin in 2022.
- The German government-sponsored and investigator-initiated
REMOVE all-comer endocarditis study presented topline
results at the European Association of Cardio–Thoracic Surgery
(EACTS) annual meeting in Barcelona,
Spain in October 2021.
CytoSorbents is working collaboratively with the REMOVE
investigators to conduct additional exploratory analyses to
potentially identify subgroups that may have benefited from
CytoSorb and to also inform potential future studies in this
application.
Results of Operations for the Quarter ended September 30, 2021
Revenues
Revenue from product sales was
approximately $8,902,000 in the three
months ended September 30, 2021, as
compared to approximately $10,246,000
in the three months ended September 30,
2020, a decrease of approximately $1,344,000, or 13%. This decrease was
driven by a decrease in direct sales of approximately $1,264,000 resulting primarily from lower sales
in Germany due to COVID-19
pandemic-driven market conditions. This was driven by a wave
in new Delta variant-related COVID-19 cases
in Germany, which accelerated through August and has
continued to date. This prompted many hospitals
throughout Germany to reduce elective surgical
procedures, to reserve ICU beds, and to either maintain or
reinstitute restrictions such as visitation rights to
non-essential visitors, in preparation of COVID-19
hospitalizations. However, unlike prior waves
in Germany, the rates of severe COVID-19 illness
requiring ICU care, and death have
been disproportionately 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. Sales to hospitals in the
United States under the EUA granted by the FDA amounted to
approximately $577,000 for the three
months ended September 30,
2021. Though difficult to quantitate, we estimate that
approximately $1.1 million of total
product sales in the third quarter of 2021 was due to the demand
for CytoSorb to treat COVID-19 patients. In addition, the
change in the average exchange rate of the Euro to the U.S. dollar
did not have a significant impact on product sales during the three
months ended September 30, 2021, as
compared to the three months ended September
30, 2020.
Grant income was approximately $859,000 for the three months ended September 30, 2021 as compared to approximately
$301,000 for the three months ended
September 30, 2020, an increase of
approximately $558,000, or
185%. This increase was a result of the easing of the
COVID-19 pandemic in the United
States during the three months ended September 30, 2021 and a corresponding increase
in grant related work. During the three months ended
September 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 $9,760,000 for the three months ended
September 30, 2021, as compared to
total revenues of approximately $10,547,000 for the three months ended
September 30, 2020, a decrease of
approximately $787,000, or 7%.
Cost of Revenues
For the three months ended
September 30, 2021, and 2020, cost of
revenue was approximately $2,463,000
and $2,890,000, respectively, a
decrease of approximately $427,000.
Product cost of revenue was approximately $1,642,000 and $2,622,000, respectively, for the three months
ended September 30, 2021 and 2020, a
decrease of approximately $980,000. This decrease was due to lower
sales and because certain costs associated with the rapid ramp-up
of production during the three months ended September 30, 2020 that did not recur during the
three months ended September 30,
2021. Product gross margins were approximately 82% for the
three months ended September 30, 2021
as compared to approximately 74% for the three months ended
September 30, 2020. The
increase in the gross margin percentage in 2021 was due to
manufacturing efficiencies achieved during the three months ended
September 30, 2021 and the impact of
the ramp-up costs incurred during the three months ended
September 30, 2020 that did not recur
in 2021.
Research and Development Expenses
For the three
months ended September 30, 2021,
research and development expenses were approximately $4,262,000, as compared to approximately
$1,753,000 for the three months ended
September 30, 2020, an increase of
approximately $2,509,000. This
increase was due to an increase in costs associated with our
clinical trial activities, including increased employee costs to
build out our clinical team, as well as higher rent expense, among
other items.
Selling, General and Administrative
Expenses
Selling, general and administrative expenses
were approximately $7,777,000 for the
three months ended September 30,
2021, as compared to approximately $7,282,000 for the three months ending
September 30, 2020, an increase of
$495,000. This increase is
related to an increase in salaries, commissions and sales and
marketing costs, increased travel and entertainment costs and an
increase in non-cash restricted stock expense related to restricted
stock units granted to the Company's executive officers.
These increases were partially offset by a decrease in
non-cash stock option compensation expense, lower royalty expense
due to a decrease in sales, and a decrease in other general and
administrative expenses.
Interest Income/(Expense), net
For the three
months ended September 30, 2021, net
interest income was approximately $13,000, as compared to net interest expense of
approximately $261,000 for the three
months ended September 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.
Liquidity and Capital Resources
Since inception, our
operations have been primarily financed through the issuance of
debt and equity securities. As of September 30, 2021, we had current assets of
approximately $72,752,000 including
cash on hand of approximately $61,043,000 and current liabilities of
approximately $11,070,000. 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 nine months ended September 30, 2021.
We believe that we have sufficient cash to fund our operations
well into the future.
Fourth Quarter and Full Year 2021 Product Revenue
Guidance
The macro environment of the global COVID-19 pandemic continues
to add uncertainty to the Company's sales outlook, especially since
we are unable to predict the course of the pandemic or predict what
impact, if any, the COVID-19 pandemic may have on global sales for
the remainder of the year.
The Company maintains its guidance that Q4 2021 product revenue
will be similar to Q3 2021 product revenue of $8.9 million.
The Company maintains its guidance for expected full year 2021
product revenue of at least $39.3
million, roughly flat compared to 2020 product revenue of
$39.5 million. While difficult
to predict, 2021 core non-COVID-19 product sales are expected to be
approximately $33 to $34 million for the year versus $30.1 million in 2020.
For additional information, please see the Company's Form 10-Q
for the period ended September 30,
2021 filed on November 4, 2021
on http://www.sec.gov.
Conference Call
The company will conduct its third 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:
1-877-521-4127
International: 1- 212-231-2900
Conference ID: 21998483
It is recommended that participants dial in approximately 10
minutes prior to the start of the call. There will be a
simultaneous live webcast of the conference call that can be
accessed through the following audio feed
link: https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2
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/.
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 more than 70 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 152,000 cumulative CytoSorb devices have
been utilized 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 adult critically ill COVID-19 patients with imminent or
confirmed respiratory failure. The DrugSorb-ATR™
Antithrombotic Removal System, which is based on the same polymer
technology as CytoSorb, has also been
granted FDA Breakthrough Designation for the removal
of ticagrelor, as well as FDA Breakthrough
Designation for the removal of the direct oral anticoagulant
(DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass
circuit during urgent cardiothoracic surgery. The Company is
initiating two FDA approved pivotal trials designed to support U.S.
marketing approval of DrugSorb-ATR. The first is the
120-patient, 20 center STAR-T (Safe
and Timely Antithrombotic Removal-Ticagrelor)
randomized, controlled trial evaluating the ability of
intraoperative DrugSorb-ATR use to reduce perioperative bleeding
risk in patients on ticagrelor undergoing cardiothoracic
surgery. The second is the 120-patient, 25
center STAR–D (Safe
and Timely Antithrombotic Removal-Direct
Oral Anticoagulants) randomized, controlled trial, evaluating the
intraoperative use of DrugSorb–ATR to reduce perioperative bleeding
risk in patients undergoing cardiothoracic surgery on direct oral
anticoagulants, including apixaban and rivaroxaban.
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,
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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(amounts in thousands, except per share data)
|
|
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
CytoSorb
sales
|
|
$
|
8,901
|
|
|
$
|
10,246
|
|
|
$
|
30,405
|
|
|
$
|
27,853
|
|
Other
sales
|
|
|
1
|
|
|
|
--
|
|
|
|
6
|
|
|
|
69
|
|
Total
product sales
|
|
|
8,902
|
|
|
|
10,246
|
|
|
|
30,411
|
|
|
|
27,922
|
|
Grant
income
|
|
|
858
|
|
|
|
301
|
|
|
|
1,972
|
|
|
|
1,127
|
|
Total
revenue
|
|
|
9,760
|
|
|
|
10,547
|
|
|
|
32,383
|
|
|
|
29,049
|
|
Cost of
revenue
|
|
|
2,463
|
|
|
|
2,891
|
|
|
|
7,924
|
|
|
|
8,525
|
|
Gross
profit
|
|
|
7,297
|
|
|
|
7,656
|
|
|
|
24,459
|
|
|
|
20,524
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,262
|
|
|
|
1,754
|
|
|
|
10,244
|
|
|
|
6,125
|
|
Legal,
financial and other consulting
|
|
|
665
|
|
|
|
580
|
|
|
|
2,090
|
|
|
|
1,945
|
|
Selling,
general and administrative
|
|
|
7,776
|
|
|
|
7,282
|
|
|
|
25,308
|
|
|
|
20,190
|
|
Total
expenses
|
|
|
12,703
|
|
|
|
9,616
|
|
|
|
37,642
|
|
|
|
28,260
|
|
Loss from
operations
|
|
|
(5,406)
|
|
|
|
(1,960)
|
|
|
|
(13,183)
|
|
|
|
(7,736)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
|
|
13
|
|
|
|
(261)
|
|
|
|
16
|
|
|
|
(840)
|
|
Gain (loss) on
foreign currency transactions
|
|
|
(1,013)
|
|
|
|
1,381
|
|
|
|
(2,085)
|
|
|
|
1,417
|
|
Total other income
(expense), net
|
|
|
(1,000)
|
|
|
|
1,120
|
|
|
|
(2,069)
|
|
|
|
577
|
|
Loss before benefit
from income taxes
|
|
|
(6,406)
|
|
|
|
(840)
|
|
|
|
(15,252)
|
|
|
|
(7,159)
|
|
Benefit from income
taxes
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
Net loss
|
|
$
|
(6,406)
|
|
|
$
|
(840)
|
|
|
$
|
(15,252)
|
|
|
$
|
(7,159)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.15)
|
|
|
$
|
(0.02)
|
|
|
$
|
(0.35)
|
|
|
$
|
(0.19)
|
|
Weighted average
number of shares of common stock outstanding
|
|
|
43,396,464
|
|
|
|
41,593,218
|
|
|
|
43,319,507
|
|
|
|
37,350,564
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,406)
|
|
|
$
|
(840)
|
|
|
$
|
(15,252)
|
|
|
$
|
(7,159)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
808
|
|
|
|
(1,047)
|
|
|
|
1,701
|
|
|
|
(1,044)
|
|
Comprehensive
loss
|
|
$
|
(5,598)
|
|
|
$
|
(1,887)
|
|
|
$
|
(13,551)
|
|
|
$
|
(8,203)
|
|
CYTOSORBENTS
CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands)
|
|
|
|
September 30,
2021
|
|
|
December 31,
2020
|
|
|
|
(unaudited)
|
|
|
|
|
ASSETS:
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
61,043
|
|
$
|
71,422
|
|
Grants and accounts
receivable, net
|
|
5,241
|
|
|
5,159
|
|
Inventories
|
|
4,528
|
|
|
2,674
|
|
Prepaid expenses and
other current assets
|
|
1,940
|
|
|
3,198
|
|
Total current assets
|
|
72,752
|
|
|
82,453
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
3,799
|
|
|
2,120
|
|
Right of use
asset
|
|
13,651
|
|
|
1,029
|
|
Other
assets
|
|
4,865
|
|
|
4,348
|
|
TOTAL ASSETS
|
$
|
95,067
|
|
$
|
89,950
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
$
|
3,358
|
|
$
|
1,835
|
|
Lease liability -
current portion
|
|
265
|
|
|
447
|
|
Accrued expenses and
other current liabilities
|
|
7,447
|
|
|
7,871
|
|
Total current
liabilities
|
|
11,070
|
|
|
10,153
|
|
Lease liability, net
of current portion
|
|
13,386
|
|
|
582
|
|
TOTAL LIABILITIES
|
|
24,456
|
|
|
10,735
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
70,611
|
|
|
79,215
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
95,067
|
|
$
|
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