PRINCETON, N.J., Aug. 2, 2022
/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, today
reported unaudited financial and operating results for the quarter
ended June 30, 2022.
Second Quarter 2022 Financial Results
- Total Q2 2022 revenue, including product sales and grant
income, was $8.5 million versus
$12.0 million in Q2 2021, a decrease
of 29%
- Q2 2022 product sales were $7.3
million (negligible COVID-related sales) versus $11.4 million (includes $1.7 million in COVID-related sales) in Q2 2021.
The decrease in the average Euro to U.S. dollar exchange rate
lowered Q2 2022 product sales by approximately $840,000. On a constant currency basis, Q2 2022
core non-COVID sales would have been approximately $8.2 million, which represents a 15% decrease
from approximately $9.7 million in
core non-COVID sales a year ago, but comparable to the average
currency adjusted core non-COVID sales over the prior three
quarters
- As expected, COVID-19 related sales during the quarter were
negligible reflecting the low severity of current COVID-19 illness
resulting from high rates of vaccination and natural immunity
- Product gross margins were approximately 67% in Q2 2022, versus
82% in Q2 2021. The decrease in the gross margin percentage was due
primarily to manufacturing inefficiencies from a scheduled 4-week
production hiatus as we relocated to our new production facility
during the quarter
- The Company maintains a healthy balance sheet with cash and
cash equivalents of $31.9 million
(which includes $1.7 million in
restricted cash) as of June 30, 2022,
and no debt
Recent Operating Highlights:
- More than 179,000 cumulative CytoSorb devices have been
utilized worldwide as of June 30,
2022, compared to more than 143,000 devices utilized
cumulatively a year ago
- Announced today the signing of an expanded global marketing
agreement with Fresenius Medical Care where CytoSorb® will become a
featured blood purification therapy on Fresenius Medical Care
Critical Care platforms
- Entered into a 3-year preferred supplier agreement with
Asklepios Group, one of the largest private hospital operators in
Germany
- Partnered with Nikkiso to distribute the PureAdjust®
hemoperfusion blood pump and supplies in a total of 14 countries, a
key part of CytoSorbents' standalone device and machine strategy to
expand the market for its products
- Hosted the 2022 CytoSorb World Users' Meeting that highlighted
the broad market potential of CytoSorb as an interdisciplinary
therapeutic approach for a wide range of life-threatening
illnesses
- Multiple scientific papers were published on the positive use
of CytoSorb in the areas of antithrombotic drug removal during
acute aortic dissection and in vitro whole blood
removal, Ex vivo lung perfusion for lung
transplantation, Normothermic regional perfusion of Donation
after Circulatory Death (DCD) human liver and kidney donors for
organ transplant, Severe acute pancreatitis (PACIFIC study),
Treatment of hyperbilirubinemia in acute liver dysfunction
patients, A reduction in sepsis-associated mortality in left-sided
acute infective endocarditis, and many others.
- Relocated and established our Company headquarters and state of
the art manufacturing facility in our new Princeton, New Jersey mixed-use facility
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "Our second quarter core non-COVID
product sales on a constant currency basis were $8.2 million and stable to the average currency
adjusted core product sales for the prior three quarters. Although
not the growth we are seeking, we achieved this despite continued
softness in the German market, as the weakened healthcare system
worked to recover from the massive COVID surge in the prior quarter
and grappled with a myriad of problems. These include, for example,
staffing shortages, budget issues, elective procedures
restrictions, and a major 11-week hospital strike in western
Germany that spanned a fifth of
the population, postponing more than 10,000 operations and closing
hospital wards. Year-over-year results were further impacted by a
lack of COVID-19 related revenue due to a lessening in disease
severity globally, and a drop of 12% in the Euro, to near parity
with the U.S. dollar.
"Like most international companies, including those in the
medical device and blood purification industries, we are dealing
with not only fallout from the COVID pandemic, but also a storm of
global macroeconomic and geopolitical uncertainty. That said,
although our numbers do not yet reflect it, we are seeing some
early but encouraging signs of improvement in key markets:
- Continued strong and positive feedback from customers in both
our direct and international territories, highlighted by the
success of our recent in-person CytoSorb World User's meeting, with
nearly 300 of the world's leading critical care physicians and
research scientists from 40 countries participating
- Marked improvement in sales representative access to hospitals
in Germany, with 40% more sales
visits during the quarter as compared to the prior quarter, though
still down from pre-pandemic levels
- Increasing levels of activity, interest, and in-person
attendance of healthcare professionals at medical congresses in
Europe and Latin America, and specific countries such as
India, Spain, and Portugal
- Strong pipeline of positive data being submitted and published
by the international user community on CytoSorb use in a wide
variety of areas
- Though early, the Nikkiso expansion has triggered broad
interest by customers in our stand-alone hemoperfusion pump
offering, with initial placements, pump evaluations underway, and
scheduled demonstrations at a number of hospitals
- Growing synergy with our sales and medical affairs teams, and
internal therapy area vertical leadership in critical care, cardiac
surgery, and liver and kidney applications with a prioritization on
sales support and clinical data
- Recent preferred supplier agreement with Asklepios Group, one
of the largest private hospital networks in Germany, making CytoSorb available without
restrictions to all hospitals in the network
- The potential for future sales acceleration, particularly in
Germany, based upon the expansion
of the Fresenius Medical Care global marketing partnership
announced today, as further discussed below
Dr. Chan continued, "As we work to restore sales growth, we
continue to advance our other key initiatives.
- U.S. STAR-T and STAR-D clinical trials – These trials
remain our top clinical priority with each trial now having a
critical mass of more than 20 centers active and screening for
enrollment. As we expand to 30 sites for each trial, recently
approved by the FDA, the majority of our operational plans,
resources, and focus have shifted from study start-up activities
(Phase I) to activities driving enrollment (Phase II). For our lead
study STAR-T, enrollment continues and we are targeting the first
Data Safety Monitoring Board (DSMB) review at 40 patients enrolled,
expected to be achieved with a slight delay in the next few months.
STAR-D is underway also, with the rapid activation of trial
sites
- U.S. Manufacturing - Buildout of our new
Princeton, NJ manufacturing
facility is now complete with production of commercial devices
split between our older production facility and our new facility,
and final certification expected before the end of this year.
Product gross margins dropped from 82% to 67%, driven mainly by
production inefficiencies incurred by a scheduled 4- week
production hiatus as we transitioned from our old to new
manufacturing facilities, and lower sales volumes. We expect gross
margins to return to previous levels as we complete the relocation
to the new facility, eliminate the costs of the Monmouth Junction, NJ facility later this
year, and begin to capture manufacturing efficiencies driven by an
expected improvement in market conditions and increased product
demand
- Partnerships - Today we are pleased to announce an
expanded global marketing agreement with long-time partner,
Fresenius Medical Care ("Fresenius"), the world's leading provider
of products and services for patients with renal diseases with
headquarters and a strong sales and marketing footprint in
Germany. Under the terms of the agreement, CytoSorb will
become a featured blood purification therapy on Fresenius Medical
Care's critical care blood purification platforms for the removal
of cytokines, bilirubin, and myoglobin in critically ill patients,
helping to expand the dimensions of blood purification beyond
hemodialysis. Fresenius will be responsible for the specific
worldwide marketing and combined promotion of CytoSorb with its
critical care products across Fresenius-led in-person, virtual,
social media, and web-based marketing programs and events during
the term of the collaboration. In addition to strengthening and
expanding the global marketing of CytoSorb, we plan to work
together to bring new innovative solutions to the market. To help
support the increased marketing and promotional efforts of the
expanded collaboration, CytoSorbents has agreed to subsidize a
portion of the marketing costs through a royalty payment to
Fresenius Medical Care, with the royalty rate being based on
certain assumptions regarding CytoSorb sales in the intensive care
unit on Fresenius Medical Care platforms, excluding the United States, and subject to further
adjustment should these assumptions change. Additional information
can be found in the Form 8-K filed today.
Dr. Chan concluded, "We are excited about the many opportunities
that we have to drive our business forward, but are proceeding
conservatively, recognizing there is a seasonality to European
business in general in the third quarter, driven by a lull in
business activity as much of Europe takes vacation in July and August.
Because of this, we are focused on executing our game plan, while
controlling costs and conserving cash. We believe the high cash
burn in Q2 2022 was an anomaly with a number of non-recurrent
expenditures. These include, for example, the final $4.8 million payment related to the construction,
capital equipment, and other costs of our new manufacturing
facility (with the exception of approximately $300K in costs for the remainder of 2022), an
approximate $1 million reduction in
gross margin driven mainly by inefficiencies caused by scheduled
production shutdowns associated with the relocation to our new
manufacturing facilities, and lower sales volumes, and a
$0.6 million increase in grant and
accounts receivables during the quarter. Excluding these factors,
our cash burn for Q2 2022 would have been approximately
$6.5 million."
'In addition, we have $5 million
(based on cost of goods) in working capital tied up in CytoSorb
inventory that we have strategically built over several quarters to
buffer against any potential disruption in production with the
transition to the new facility. With fairly good visibility that
the new manufacturing facility will come on-line as expected, we
plan to release and monetize a portion of this inventory, which we
expect could contribute an additional $1
million to our second half 2022 cash flow. Finally, we
retain financial flexibility to add debt from our $15 million term loan with Bridge Bank if
desired."
Results of Operations
Comparison for the three months ended June 30, 2022 and 2021:
Revenues:
Total revenue, including product revenue and grant income, for
the second quarter of 2022 was $8.5
million, down 39% from $12.0
million in the second quarter of 2021. Revenue from product
sales was approximately $7.3 million
in the three months ended June 30,
2022, as compared to approximately $11.4 in the three months ended June 30, 2021, a decrease of approximately
$4.0 million, or 36%. The decrease in
the average exchange rate of the Euro to the U.S. dollar negatively
impacted 2022 product sales by approximately $0.8 million. For the three months ended
June 30, 2022, the average exchange
rate of the Euro to the U.S. dollar was $1.06 as compared to an average exchange rate of
$1.21 for the three months ended
June 30, 2021. We estimate that
demand for CytoSorb to treat COVID-19 patients was de minimis in
the second quarter of 2022 as compared to approximately
$1.7 million in the second quarter of
2021. Overall direct sales declined by approximately $3.4 million resulting primarily from lower sales
in Germany due to COVID-19
pandemic-driven market conditions. COVID-19 restrictions remain in
place at many hospitals throughout Germany and these restrictions continue to
limit our access to hospital personnel, particularly the
physicians.
Cost of Revenues:
For the three months ended June 30,
2022 and 2021, cost of revenue was approximately
$3.6 million and $2.7 million, respectively. Product gross margins
were approximately 67% for the three months ended June 30, 2022 as compared to approximately 82%
for the three months ended June 30,
2021. The decrease in the gross margin percentage in 2022
was due primarily to inefficiencies associated with relocation of
our production activities to our new manufacturing facility during
the second quarter of 2022.
Operating Expenses:
For the three months ended June 30,
2022, operating expenses were approximately $13.3 million, as compared to approximately
$14.2 million for the three months
ended June 30, 2021, a decrease of
approximately $0.9 million or 6%.
Selling, general and administrative (SG&A) expenses decreased
approximately 14% to $8.4 million in
the quarter from $9.8 million in the
prior year. This decrease was due to a decrease in royalty expenses
of approximately $0.4 million due to
the decrease in product sales, a decrease in non-cash restricted
stock expense of approximately $1.5
million related to restricted stock units granted to the
Company's executive officers and a decrease in non-cash stock
compensation expense of approximately $0.8
million. This was offset by increases in salaries,
commissions, and related costs of approximately $0.2 million, an increase in sales and marketing
costs, which include advertising and conference attendance of
approximately $0.4 million, an
increase in travel and entertainment costs of approximately
$0.3 million and an increase in
occupancy costs of approximately $0.4
million related to the rent expense on our new manufacturing
facility. Research and development expenses increased by
approximately $0.5 million primarily
due to costs related to our STAR-T and STAR-D trials in the United
States.
Gain (Loss) on Foreign Currency Transactions:
For the three months ended June 30,
2022, the loss on foreign currency transactions was
approximately $2.5 million as
compared to a gain of approximately $0.2
million for the three months ended June 30, 2021. The 2022 loss was directly related
to the decrease in the spot exchange rate of the Euro to the U.S.
dollar at June 30, 2022 as compared
to March 31, 2022. The spot exchange
rate of the Euro to the U.S. dollar was $1.05 per Euro at June 30,
2022, as compared to $1.11 per
Euro at March 31, 2022.
Comparison for the six months ended June 30, 2022 and 2021:
Revenues:
Total revenues were approximately $17.2
million for the six months ended June
30, 2022, as compared to total revenues of approximately
$22.6 million for the six months
ended June 30, 2021, a decrease of
approximately $5.4 million, or 24%.
Revenue from product sales was approximately $15.3 million in the six months ended
June 30, 2022, as compared to
approximately $21.5 million in the
six months ended June 30, 2021, a
decrease of approximately $6.2
million or 29%. The decrease in the average exchange rate of
the Euro to the U.S. dollar negatively impacted 2022 product sales
by approximately $1.4 million. For
the six months ended June 30, 2022,
the average exchange rate of the Euro to the U.S. dollar was
$1.09 as compared to an average
exchange rate of $1.21 for the six
months ended June 30, 2021. Though
difficult to quantify, we estimate that approximately $0.3 million of total product sales in the six
months ended June 30, 2022 was due to
the demand for CytoSorb to treat COVID-19 patients as compared to
$3.5 million in the six months ended
June 30, 2021. Overall direct sales
declined by of approximately $5.4
million resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market
conditions. COVID-19 restrictions remain in place at many hospitals
throughout Germany and these
restrictions continue to limit our access to hospital personnel,
particularly the physicians.
Cost of Revenues:
For the six months ended June 30,
2022 and 2021, cost of revenue was approximately
$5.8 million and $5.5 million, respectively, an increase of
approximately $0.3 million. Product
gross margins were approximately 74% for the six months ended
June 30, 2022 and approximately 79%
for the six months ended June 30,
2021. The reduction in product gross margin is due primarily
to inefficiencies associated with the relocation of our production
activities to our new manufacturing facility during the second
quarter of 2022.
Operating Expenses:
For the six months ended June 30,
2022, operating expenses were approximately $27.5 million as compared to approximately
$24.9 million for the six months
ended June 30, 2021, an increase of
approximately $2.6 million, or 10%,
for the six months ended June 30,
2022. Research and development expenses were approximately
$8.4 million as compared to
approximately $6.0 million for the
six months ended June 30, 2021, an
increase of approximately $2.4
million or 40%. This increase was due to an increase in
costs associated with our STAR-T and STAR-D trials in the United States. Selling, general and
administrative expenses were approximately $17.6 million for the six months ended
June 30, 2022, as compared to
$17.5 million for the six months
ended June 30, 2021, an increase of
$0.1 million. This increase is
related to an increase in salaries, commissions and related costs
of approximately $1.2 million, an
increase in sales and marketing costs, which include advertising
and conference attendance of approximately $0.7 million, an increase in travel and
entertainment costs of approximately $0.5
million and an increase in occupancy costs of approximately
$0.7 million related to the rent
expense on our new manufacturing facility. These increases were
offset by a decrease in royalty expenses of approximately
$0.5 million, a decrease in non-cash
restricted stock expense of approximately $1.7 million related to restricted stock units
granted to the Company's executive officers, a decrease in non-cash
stock compensation expense of approximately $0.7 million.
Gain (Loss) on Foreign Currency Transactions:
For the six months ended June 30,
2022, the loss on foreign currency transactions was
approximately $3.7 million as
compared to a loss of approximately $1.1
million for the six months ended June
30, 2021. The 2022 loss was directly related to the decrease
in the spot exchange rate of the Euro to the U.S. dollar as of
June 30, 2022 as compared to
December 31, 2021. The spot exchange
rate of the Euro to the U.S. dollar was $1.05 per Euro as of June
30, 2022, as compared to $1.14
per Euro at December 31,
2021.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed
through the issuance of debt and equity securities. As of
June 30, 2022, we had current assets
of approximately $41.6 million
including unrestricted cash on hand of approximately $30.2 million and current liabilities of
approximately $10.6 million. As of
June 30, 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 2022, we received approximately
$0.7 million in cash from the
approved sale of our net operating losses and research and
development credits from the State of New
Jersey.
We are also managing our resources proactively, continuing to
invest in key areas such as our U.S. pivotal STAR-T and STAR-D
trials. In April 2022, we began
instituting tighter cost controls which are expected to reduce our
planned cash burn by an additional $2
million per quarter. We are currently actively engaged in
making further reductions to our operating costs to reduce our
future cash burn.
We believe that we have sufficient cash to fund the Company's
operations beyond twelve months from the issuance of these
financial statements.
2022 Outlook Guidance
The macro environment in which we operate remains difficult to
predict given the complex drivers of our business, the global
nature of our operations, and external factors such as the COVID-19
pandemic, the Russia-Ukraine war, inflation, foreign currency
exchange rate volatility, and other factors that are not under our
direct control. Because of this, we expect that our business, and
in particular product sales, may continue to see challenges for the
remainder of 2022. However, we expect a gradual recovery of
normalized hospital activity and sales access in Germany and other key countries in the coming
quarters. With improved access and other growth initiatives, we
expect a resumption of growth in our core non-COVID-19 product
sales.
For additional information, please see the Company's Form 10-Q
for the period ended June 30, 2022
filed on August 2, 2022 on
http://www.sec.gov.
Conference Call
The Company will conduct its second quarter 2022 results call
today at 4:30 p.m. Eastern time.
Conference Call Details:
Date: Tuesday, August 2, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-877-451-6152
International: 1-201-389-0879
Conference ID: 13731826
Live Presentation Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
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:
https://viavid.webcasts.com/starthere.jsp?ei=1561029&tp_key=ddc6a4af76
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 179,000
cumulative CytoSorb devices have been utilized as of June 30,
2022. 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 has initiated two FDA approved pivotal trials
designed to support U.S. marketing approval of DrugSorb-ATR. The
first is the 120-patient, 30 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, 30 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, future targets and outlooks
for our business, expectations regarding the future impacts of
COVID-19 or the ongoing conflict between Russia and
the Ukraine or other macroeconomic factors, 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 10, 2022, 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
(amounts in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
Three months ended June
30,
|
|
|
Six months ended June
30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
CytoSorb
sales
|
|
$
|
7,038
|
|
|
$
|
11,360
|
|
|
$
|
14,905
|
|
|
$
|
21,504
|
|
Other
sales
|
|
|
293
|
|
|
|
5
|
|
|
|
350
|
|
|
|
5
|
|
Total
product sales
|
|
|
7,331
|
|
|
|
11,365
|
|
|
|
15,255
|
|
|
|
21,509
|
|
Grant
income
|
|
|
1,165
|
|
|
|
659
|
|
|
|
1,932
|
|
|
|
1,114
|
|
Total
revenue
|
|
|
8,496
|
|
|
|
12,024
|
|
|
|
17,187
|
|
|
|
22,623
|
|
Cost of
revenue
|
|
|
3,551
|
|
|
|
2,710
|
|
|
|
5,828
|
|
|
|
5,462
|
|
Gross profit
|
|
|
4,945
|
|
|
|
9,314
|
|
|
|
11,359
|
|
|
|
17,161
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
4,184
|
|
|
|
3,699
|
|
|
|
8,427
|
|
|
|
5,981
|
|
Legal,
financial and other consulting
|
|
|
679
|
|
|
|
718
|
|
|
|
1,480
|
|
|
|
1,426
|
|
Selling,
general and administrative
|
|
|
8,439
|
|
|
|
9,822
|
|
|
|
17,600
|
|
|
|
17,531
|
|
Total
expenses
|
|
|
13,302
|
|
|
|
14,239
|
|
|
|
27,507
|
|
|
|
24,938
|
|
Loss from
operations
|
|
|
(8,357)
|
|
|
|
(4,925)
|
|
|
|
(16,148)
|
|
|
|
(7,777)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
|
|
24
|
|
|
|
13
|
|
|
|
32
|
|
|
|
3
|
|
Gain (loss) on foreign
currency transactions
|
|
|
(2,523)
|
|
|
|
234
|
|
|
|
(3,736)
|
|
|
|
(1,071)
|
|
Miscellaneous Income
(Expense)
|
|
|
(23)
|
|
|
|
---
|
|
|
|
6
|
|
|
|
|
|
Total other income
(expense), net
|
|
|
(2,522)
|
|
|
|
247
|
|
|
|
(3,698)
|
|
|
|
(1,068)
|
|
Loss before benefit
from income taxes
|
|
|
(10,879)
|
|
|
|
(4,678)
|
|
|
|
(19,846)
|
|
|
|
(8,845)
|
|
Benefit from income
taxes
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
|
|
--
|
|
Net loss
|
|
$
|
(10,879)
|
|
|
$
|
(4,678)
|
|
|
$
|
(19,846)
|
|
|
$
|
(8,845)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.25)
|
|
|
$
|
(0.11)
|
|
|
$
|
(0.46)
|
|
|
$
|
(0.20)
|
|
Weighted average number
of shares of
common stock outstanding
|
|
|
43,560,481
|
|
|
|
43,317,578
|
|
|
|
43,524,414
|
|
|
|
43,280,266
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,879)
|
|
|
$
|
(4,678)
|
|
|
$
|
(19,846)
|
|
|
$
|
(8,845)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
2,053
|
|
|
|
(264)
|
|
|
|
3,016
|
|
|
|
893
|
|
Comprehensive
loss
|
|
$
|
(8,826)
|
|
|
$
|
(4,942)
|
|
|
$
|
(16,830)
|
|
|
$
|
(7,952)
|
|
CYTOSORBENTS
CORPORATION
CONDENSED CONSOLIDATED
BALANCE SHEETS
(amounts in
thousands)
|
|
|
|
|
June 30,
2022
|
|
|
December 31,
2021
|
|
|
ASSETS:
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
30,164
|
|
$
|
52,138
|
|
|
Grants and accounts
receivable, net
|
|
5,171
|
|
|
4,523
|
|
|
Inventories
|
|
4,980
|
|
|
4,766
|
|
|
Prepaid expenses and
other current assets
|
|
1,331
|
|
|
2,872
|
|
|
Total current assets
|
|
41,646
|
|
|
64,299
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
10,220
|
|
|
5,151
|
|
|
Restricted
Cash
|
|
1,687
|
|
|
1,687
|
|
|
Right of use
asset
|
|
12,982
|
|
|
13,423
|
|
|
Other assets
|
|
4,670
|
|
|
4,959
|
|
|
TOTAL ASSETS
|
$
|
71,205
|
|
$
|
89,519
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
2,129
|
|
$
|
2,805
|
|
|
Lease liability -
current portion
|
|
417
|
|
|
571
|
|
|
Accrued expenses and
other current liabilities
|
|
8,007
|
|
|
10,314
|
|
|
Total current
liabilities
|
|
10,553
|
|
|
13,690
|
|
|
Lease liability, net of
current portion
|
|
13,092
|
|
|
13,251
|
|
|
TOTAL LIABILITIES
|
|
23,645
|
|
|
26,941
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
47,560
|
|
|
62,578
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
71,205
|
|
$
|
89,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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U.S. Company Contact:
Amy
Vogel
305 College Road East
Princeton, NJ 08540
+1 (732) 329-8885
avogel@cytosorbents.com
European Company Contact:
Josephine Kraus
+49 30 765 84 66 23
josephine.kraus@cytosorbents.com
Public Relations Europe:
Marcus Schult
commponists
+49 69 13823 ext. 960
+49 172 4238938
marcus.schult@die-kommponisten.com
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SOURCE CytoSorbents Corporation