CytoSorbents expects to achieve first
milestone of the U.S. pivotal STAR-T Trial this month
PRINCETON, N.J., Nov. 3, 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 September 30, 2022.
Third Quarter 2022 Financial Results
- Total revenue, including product sales and grant income, for Q3
2022 was $8.1 million, a decrease of
17% compared to $9.8 million in Q3
2021
- Q3 2022 product sales were $6.5
million (negligible COVID-related sales) versus $8.9 million (includes $1.1 million in COVID-related sales) in Q3 2021.
The decrease in the average Euro to U.S. dollar exchange rate
lowered Q3 2022 product sales by approximately $771,000. On a constant currency basis, Q3 2022
core non-COVID sales would have been approximately $7.2 million, which represents a 7% decrease from
approximately $7.8 million in core
non-COVID sales a year ago
- 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 55% in Q3 2022, versus
82% in Q3 2021. The decrease in the gross margin percentage was due
primarily to an inventory write-off related to an equipment failure
and to inefficiencies associated with lower production due to a
decrease in sales and the process of relocating our production
activities to the new facility. Excluding the inventory write-off,
product gross margin in Q3 2022 would have been 64%
- The Company maintains a healthy balance sheet with cash and
cash equivalents of $24.2 million
(which includes $1.7 million in
restricted cash) as of September 30,
2022, and no debt
Recent Operating Highlights:
- More than 186,000 cumulative CytoSorb devices have been
utilized worldwide as of September 30,
2022, compared to more than 152,000 devices utilized
cumulatively a year ago
- The U.S. STAR-T Trial is enrolling well with the expectation of
achieving the first milestone with 40 patients enrolled this
month
- Presented final data from the U.S. CytoSorb Therapy in COVID-19
(CTC) Registry at the European Society of Intensive Care Medicine
conference last week, highlighting the early use of CytoSorb with
ECMO (extracorporeal membrane oxygenation) to achieve "enhanced
lung rest" and high survival in 100 critically ill COVID-19
patients with refractory lung failure treated at 5 U.S. academic
centers
- Achieved ISO 13485 certification of our new Princeton, New Jersey manufacturing
facility
- The Israeli Ministry of Health assigned national reimbursement
coverage to CytoSorb for key intraoperative cardiac surgery
indications such as antithrombotic drug removal, infective
endocarditis, and aortic dissection
- The Turkish Ministry of Health granted national reimbursement
to CytoSorb, which is now a reimbursed catalog product in the State
Supply of Turkey (DMO) portal and
can be purchased directly by hospitals and physicians without
restrictions
- CytoSorbents received funding for HemoDefend-BGA™, a
development stage product designed to enable life-saving universal
plasma, under two separate Department of Defense contracts. This
includes a two year contract valued at $1,977,024 to develop a fully-finished,
commercial device that will be evaluated in a pre-clinical porcine
study and a three-year Phase III contract valued at $4,292,641 to customize the design of the
HemoDefend-BGA™ filter to enable freeze-dried universal plasma
- Released new cardiac surgery data at the European Association
for Cardio-Thoracic Surgery (EACTS) highlighting the benefits of
CytoSorb when used intraoperatively during cardiothoracic surgery
in Staphylococcus aureus infective endocarditis, heart
transplantation, and to remove antithrombotic agents
- The National Institute of General Medical Sciences (NIGMS), a
division of the U.S. National Institutes of Health, granted a Phase
I SBIR award, valued at $281,835, to
CytoSorbents to test novel polymers for cytokine and endotoxin
removal from septic porcine plasma, with the goal of advancing new
blood purification technologies to treat Gram negative sepsis, a
deadly global killer
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "Based upon the increased pace of
enrollment, we are excited to be very close to achieving the first
of three milestones of the U.S. STAR-T pivotal randomized,
controlled study, where we expect to have 40 patients enrolled this
month. Should the pace of the study continue, we expect to achieve
the second milestone of 80 patients enrolled this Spring 2023,
which would trigger a formal interim analysis, and if needed,
expected potential completion of enrollment of all 120 patients by
Summer 2023. We expect that if the STAR-T study is successful, we
would be in a position to submit for U.S. FDA marketing approval
for DrugSorb-ATR® in the second half of 2023.
Based upon these projections, and based upon the current
macroenvironment, market conditions, and cash conservation
imperative, we are taking a number of proactive steps as we work
towards the expected achievement of this key objective.
1. Prioritize completion
of the U.S. STAR-T Trial
The STAR-T randomized, controlled trial is a
120-patient, 30 center pivotal study designed to evaluate the
ability of DrugSorb-ATR to reduce perioperative bleeding by
removing the antithrombotic agent, Brilinta® (ticagrelor, Astra
Zeneca) in patients undergoing cardiothoracic surgery. Today,
Brilinta usage is being fueled by the fact that, according to the
U.S. Centers of Disease Control and Prevention (CDC), heart disease
is the leading cause of mortality in the U.S., accounting for 1 in
every 5 deaths. Coronary artery disease is the most common
form of heart disease, killing nearly 400,000 people from heart
attacks each year. The CDC states that someone in the U.S.
has a heart attack every 40 seconds, or more than 800,000 people
annually. This is relevant for Brilinta because when patients
have signs and symptoms of having a heart attack and cannot get a
stent placed or coronary artery bypass graft (CABG) surgery right
away, they are often placed on dual antiplatelet therapy (DAPT) in
the hospital consisting of aspirin and a "super-asprin" like
Brilinta, to thin the blood and reduce the risk of a worsening
heart attack and death. If they are not candidates for a
stent, they may require surgery but now face the risk of severe or
uncontrolled bleeding because of DAPT intervention. The risk
of bleeding depends on when the surgery takes place, but the risk
of major fatal or life-threatening CABG-related bleeding can be
higher than 50% if the surgery happens that day.
The goal of DrugSorb-ATR® is to allow
patients to get the critical surgery that they need without delay,
while reducing or preventing this bleeding risk by actively
removing the drug during the surgery.
This indication has received FDA Breakthrough
Device Designation, and is already approved in the European Union,
with very positive published data on a reduction in bleeding risk,
which is the primary endpoint of the STAR-T trial. In
addition to this, there are a number of other reasons why we are
excited about this study and believe it is the right time to
primarily focus our resources on this trial.
a. STAR-T has
overcome the typical inertia of new studies and is enrolling well
with many centers participating
b. FDA has given
approval to expand the study to Canadian hospitals, who are high
users of ticagrelor and have been historically top enrollers in
cardiac surgery trials. Expansion to Canada has the potential to accelerate
enrollment and completion of the trial. We also believe inclusion
of Canadian centers in the STAR-T study may support Health Canada
marketing approval for DrugSorb-ATR, potentially helping to expand
our commercial sales opportunities in North America
c.
Ticagrelor will become generic globally in 2024, likely eliminating
cost as the current barrier to usage, and should we stay on
schedule, may be ideal timing for the expected commercial
availability of DrugSorb-ATR in the U.S. and Canada
d. Ticagrelor
monotherapy is now increasingly considered by the cardiology
community as a more effective approach than aspirin to reduce
cardio-thrombotic events, strokes, and ischemia in patients at high
risk. As this treatment paradigm shift evolves, it may
potentially change the recommendations on ticagrelor usage from 1
year, to lifelong therapy
e. Based on recent
events and certain competitive dynamics, we believe we have the
potential to have first-mover advantage in the U.S. market
f. And
finally, we have received strong cardiothoracic surgeon feedback
for this application internationally, highlighted by the rapidly
enrolling STAR registry, which is ahead of schedule and has now
enrolled 125 patients
2. Pause the U.S. STAR-D
Trial
The U.S. STAR-D randomized, controlled trial is
a 120-patient, 30 center pivotal study designed to evaluate the
ability of DrugSorb-ATR to reduce perioperative bleeding by
removing the direct oral anticoagulants (DOACs), Xarelto®
(rivaroxaban, Janssen/Bayer) and Eliquis® (apixaban, Bristol-Myers
Squibb/Pfizer), in patients undergoing cardiothoracic surgery.
DOACs are used as chronic therapy to thin the blood to reduce
the risk of stroke and heart attack in patients with atrial
fibrillation, or a history of stroke, heart attack, or vascular
disease, but uses a different mechanism of action than ticagrelor
and are not directly interchangeable. However, like ticagrelor,
patients on DOACs who require urgent cardiothoracic surgery have a
particularly high risk of perioperative bleeding. The goal of
DrugSorb-ATR in this population is identical to that for ticagrelor
– remove the drug and reduce or prevent perioperative bleeding.
In fact, we believe DrugSorb-ATR will eventually become the
"one-stop-shop" for the removal of all classes of antithrombotic
agents during cardiothoracic surgery, and potentially other
surgeries such as orthopedic and neurosurgery, in the future.
We view STAR-D as the sister trial to STAR-T,
that leverages many of the same study centers, trial design and
user training, but trails STAR-T by at least 6 months.
Rather than run this study in parallel, we have decided
to pause STAR-D to focus our internal resources on our lead
program, STAR-T, including opening new Canadian trial sites to
potentially accelerate enrollment and drive STAR-T to
completion. This will save an estimated $4 million in expenses in 2023. We
fully intend to return to STAR-D when either STAR-T nears, or is
at, completion or when we have the financial resources to do
so.
3. Restore sales growth
and product gross margins
We strongly believe that our commercial markets
will recover, but it will take some time. To this point, 2022
continues to be a work-in-progress as hospitals in our core markets
continue to struggle to recover from the worst of the COVID
pandemic, while grappling with macroeconomic issues such as
inflation and high energy costs. Internationally, many
hospitals are operating in the red, with rising costs and decreased
revenue from issues such as healthcare workforce shortages that
negatively impact bed capacity, scheduled operations and
procedures, and patient volume. Given our focus on critical
care, cardiac surgery, and the hospital market, we are witnessing
these issues firsthand. That said, we recorded approximately
$6.5 million in core non-COVID
product sales in a historically weak seasonal quarter, which on a
constant currency basis, was approximately $7.2 million. Adjusting for currency
effects, core sales were down 7% year over year, which we view as a
modest decline.
As we wait for these global headwinds to clear,
we are actively pursuing new exciting growth initiatives and sales
optimization strategies to drive sales, despite the challenging
environment. We have previously detailed a number of
important programs that we are executing upon, such as our
standalone blood pump initiative with Nikkiso, our global marketing
agreement with Fresenius Medical Care, our therapy area focus in
critical care, cardiac surgery, and liver & kidney, and our
preferred supplier agreements with the top two largest private
hospital networks in Germany,
Asklepios and Helios. We believe each of these initiatives
has the potential for a tangible return on investment and the
ability to add significantly to our growth prospects. We also
believe there are some exciting areas of growth in the treatment of
acute respiratory distress syndrome (ECMO and CytoSorb), liver
dysfunction and failure (CytoSorb), blood thinner removal
(DrugSorb-ATR and CytoSorb), and ex vivo organ perfusion for
transplant (e.g., ECOS-300CY® and PerSorb®), some of which we will
discuss in more detail in the earnings call. In the meantime,
we currently expect to return our product gross margins to historic
levels (≥ 80%) in 2023, once we consolidate manufacturing
completely to the new Princeton, New
Jersey facility and close the old facility, and upon an
expected resumption in CytoSorb sales growth, pending an
improvement in market conditions.
4. Strengthen our cash
balance with debt
We currently expect to bolster our balance sheet
and current cash position by drawing down a portion of the
$15 million in debt under our
existing term loan facility before year-end. We believe this
amount of debt is very manageable and will provide a suitable
financial cushion for us as we drive our clinical and commercial
initiatives.
5. Control
expenses
Cash conservation is a priority and we continue
to focus on controlling expenses. During 2022, we have
already reduced our headcount by approximately 10% across our
company, including full and part-time employees, and consultants,
and shifted our R&D headcount to funded grant programs, where
we have an extensive $13.2 million
backlog as of the end of Q3 2022. Some of the cost savings of
our headcount reduction are not yet visible in our results due to
notice periods and labor laws in Europe, but will be reflected in our 2023
operating budget. Meanwhile, we are working diligently to
prioritize activities that we believe have a near-term return on
investment and advance our strategic priorities, while cutting
non-core or non-essential activities and spend. Our goal is,
through a combination of driving an increase in sales and gross
margin, and cutting costs, to significantly reduce our cash burn
and to extend our operating runway with the resources we have.
Dr. Chan concluded, "We are excited to rally around the progress
of our U.S. STAR-T program and if successful, strongly believe this
has the potential to unlock significant value in our Company and
open up a very important commercial growth opportunity for years to
come."
Results of Operations
Comparison for the three months ended September 30, 2022 and 2021:
Revenues:
Total revenues were approximately $8.1
million for the three months ended September 30, 2022, as compared to total revenues
of approximately $9.8 million for the
three months ended September 30,
2021, a decrease of approximately $1.6 million, or 17%. Revenue from product sales
was approximately $6.5 million in the
three months ended September 30,
2022, as compared to approximately $8.9 million in the three months ended
September 30, 2021, a decrease of
approximately $2.4 million or 27%.
The decrease in the average exchange rate of the Euro to the U.S.
dollar negatively impacted 2022 product sales by approximately
$.7 million. For the three months
ended September 30, 2022, the average
exchange rate of the Euro to the U.S. dollar was $1.01 as compared to an average exchange rate of
$1.18 for the three months ended
September 30, 2021. We estimate that
demand for CytoSorb to treat COVID-19 patients was de minimis in
the third quarter of 2022 as compared to approximately $1.1 million in the third quarter of 2021.
Overall direct sales declined by approximately $1,407,000 resulting primarily from lower sales
in Germany due to COVID-19
pandemic-driven market conditions, and unfavorable currency
conversions. Although improved, continued staffing shortages,
reduction in ICU bed capacity, decreased elective surgical
procedures, hospital budgets, and hospital restrictions which at
some hospitals continue to limit our access to hospital personnel,
continue to impact the hospital market.
Grant income was approximately $1.6
million for the three months ended September 30, 2022, as compared to approximately
$859,000 for the three months ended
September 30, 2021, an increase of
approximately $790,000, or 92%.
During the three months ended September 30,
2021, 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. In
2022, research and development employees were assigned exclusively
to grant and other research and development activities.
Cost of Revenues:
For the three months ended September 30,
2022 and 2021, cost of revenue was approximately
$4.5 million and $2.5 million, respectively. Product gross margins
were approximately 55% for the three months ended September 30, 2022 as compared to approximately
82% for the three months ended September 30,
2021. The decrease in the gross margin percentage was due to
an equipment failure of a refrigeration unit at our new
manufacturing facility that caused a write-off of approximately
$0.6 million of work-in-process
inventory and to inefficiencies associated with lower production
due to a decrease in sales and the process of relocating our
production activities to the new facility. Excluding the write-off
of inventory related to the equipment failure, product gross margin
would have been 64% in Q3 2022.
Operating Expenses:
For the three months ended September 30,
2022, operating expenses were approximately $12.6 million, as compared to approximately
$12.7 million for the three months
ended September 30, 2021, a decrease
of approximately $0.1 million.
Selling, general and administrative (SG&A) expenses increased
approximately $0.9 million to
$8.7 million in the quarter from
$7.8 million in the prior year. This
increase was due to an increase in sales and marketing costs, which
include advertising and conference attendance of approximately
$0.4 million, an increase in
occupancy costs of approximately $0.4
million related to the rent expense on our new manufacturing
facility, increases in salaries, severance, commissions, and
related costs of approximately $0.1
million and an increase in other general and administrative
expenses of approximately $0.2
million. This was offset by a decrease in royalty
expenses of approximately $0.2
million due to the decrease in product sales. Research and
development expenses decreased approximately $1.0 million due to a decrease of approximately
$0.7 million in clinical trial
expenditures and a decrease in non-grant R&D activities of
approximately $0.3 million.
Loss on Foreign Currency Transactions:
For the three months ended September 30,
2022, the loss on foreign currency transactions was
approximately $3.2 million as
compared to a loss of approximately $1.0
million for the three months ended September 30, 2021. The 2022 loss was directly
related to the decrease in the spot exchange rate of the Euro to
the U.S. dollar, which was $0.98 as
of September 30, 2022 as compared to
$1.05 at June
30, 2022.
Comparison for the nine months ended September 30, 2022 and 2021:
Revenues:
Total revenues were approximately $25.3
million for the nine months ended September 30, 2022, as compared to total revenues
of approximately $32.4 million for
the nine months ended September 30,
2021, a decrease of approximately $7.1 million, or 22%. Revenue from product sales
was approximately $21.1 million in
the nine months ended September 30,
2022, as compared to approximately $30.4 million in the nine months ended
September 30, 2021, a decrease of
approximately $8.7 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
$2.3 million. For the nine months
ended September 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
$1.20 for the nine months ended
September 30, 2021. Though difficult
to quantify, we estimate that approximately $0.3 million of total product sales in the nine
months ended September 30, 2022 was
due to the demand for CytoSorb to treat COVID-19 patients as
compared to $4.6 million in the nine
months ended September 30, 2021.
Overall direct sales declined by of approximately $6.8 million resulting primarily from lower sales
in Germany due to COVID-19
pandemic-driven market conditions and unfavorable currency exchange
conversions. Although improved, continued staffing shortages,
reduction in ICU bed capacity, decreased elective surgical
procedures, hospital budgets, and hospital restrictions which at
some hospitals continue to limit our access to hospital personnel,
continue to impact the hospital market.
Grant income was approximately $3.6
million for the nine months ended September 30, 2022 as compared to approximately
$2.0 million for the nine months
ended September 30, 2021, an increase
of approximately $1.6 million or 81%.
During the nine months ended September 30,
2021, 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. In
2022, research and development employees were assigned exclusively
to grant and other research and development activities.
Cost of Revenues:
For the nine months ended September 30,
2022 and 2021, cost of revenue was approximately
$10.3 million and $7.9 million, respectively, an increase of
approximately $2.4 million. Product
gross margins were approximately 68% for the nine months ended
September 30, 2022 and approximately
80% for the nine months ended September 30,
2021. The decrease in the gross margin percentage in 2022
was primarily due to an equipment failure of a refrigeration unit
at our new manufacturing facility that caused a write-off of
approximately $0.6 million of
work-in-process inventory and to inefficiencies associated with
lower production due to a decrease in sales and the process of
relocating our production activities to the new facility, including
a scheduled four-week production hiatus in Q2 2022.
Operating Expenses:
For the nine months ended September 30,
2022, operating expenses were approximately $40.1 million as compared to approximately
$37.6 million for the nine months
ended September 30, 2021, an increase
of approximately $2.5 million, or 7%,
for the nine months ended September 30,
2022. Research and development expenses were approximately
$11.7 million as compared to
approximately $10.2 million for nine
months ended September 30, 2021, an
increase of approximately $1.5
million or 14%. This increase was primarily 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 $26.3
million for the nine months ended September 30, 2022, as compared to $25.3 million for the nine months ended
September 30, 2021, an increase of
$1.0 million. This increase is
related to an increase in sales and marketing costs, which include
advertising and conference attendance of approximately $1.1 million, an increase in salaries, severance,
commissions, and related costs of approximately $1.3 million, an increase in travel and
entertainment costs of approximately $0.5
million and an increase in occupancy costs of approximately
$1.1 million related to the rent
expense on our new manufacturing facility. These increases were
offset by a decrease in royalty expenses of approximately
$0.7 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.
Loss on Foreign Currency Transactions:
For the nine months ended September 30,
2022, the loss on foreign currency transactions was
approximately $7.0 million as
compared to a loss of approximately $2.1
million for the nine months ended September 30, 2021. The 2022 loss was directly
related to the decrease in the spot exchange rate of the Euro to
the U.S. dollar which was $0.98 as of
September 30, 2022 as compared to
$1.14 as of 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
September 30, 2022, we had current
assets of approximately $32.4 million
including unrestricted cash on hand of approximately $22.6 million and current liabilities of
approximately $10.1 million. As of
September 30, 2022, $25 million of our total shelf amount was
allocated to our ATM facility, all of which remains available. In
addition, we have $15 million of debt
availability, providing financial flexibility, if needed. In April
of 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. clinical program. while
driving cost-cutting throughout our Company. At the beginning of Q2
2022, we began instituting tighter cost controls and have reduced
our headcount internationally by 10%, with the goal of reducing our
cash burn. A reduction in product sales and product gross
margins, as well as a delay in realizing headcount reduction cost
savings in Europe, have offset
these cost cutting efforts. We are currently actively engaged in
making further reductions to our operating costs to reduce our
future cash burn.
Including cash related to the use of a portion of our available
debt facility, we believe that we have sufficient cash to fund the
Company's operations beyond twelve months from the issuance of
these consolidated financial statements.
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.
We expect that our business, and in particular product sales,
will continue to be challenging for the remainder of 2022 and into
2023. 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, we expect a resumption of
growth in our core non-COVID-19 product sales.
Meanwhile, we remain focused on completing enrollment of our
U.S. STAR-T randomized, controlled trial for ticagrelor removal
during cardiothoracic surgery, estimated for Summer 2023, and if
successful, being in a position to apply for U.S. FDA marketing
approval in the second half of 2023.
For additional information, please see the Company's Form 10-Q
for the period ended September 30,
2022, filed on November 3,
2022, on http://www.sec.gov.
Conference Call
The Company will conduct its third quarter 2022 results call
today at 4:30 p.m. Eastern time.
Conference Call Details:
Date: Thursday, November 3rd, 2022
Time: 4:30 PM Eastern Time
Toll free: 1-800-458-4121
International: 1-929-477-0402
Conference ID: 1375266
Live Presentation
Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1576192&tp_key=7e23c8c13c
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=1576192&tp_key=7e23c8c13c
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 the intensive care unit and in cardiac surgery
through blood purification. Its lead product, CytoSorb®,
is approved in the European Union and distributed in more than 70
countries worldwide. It is an extracorporeal cytokine adsorber that
reduces "cytokine storm" or "cytokine release syndrome" in common
critical illnesses that can lead to massive inflammation, organ
failure and patient death. In these diseases, the risk of
death can be extremely high, and there are few, if any, effective
treatments. CytoSorb is also used during and after
cardiothoracic surgery to remove inflammatory mediators that can
lead to postoperative complications, including multiple organ
failure. As of September 30, 2022, more than 186,000
CytoSorb devices have been used cumulatively. CytoSorb was
originally launched in the European Union under CE mark as the
first cytokine adsorber. Additional CE mark extensions were
granted for bilirubin and myoglobin removal in clinical conditions
such as liver disease and trauma, respectively, and
for ticagrelor and rivaroxaban removal in
cardiothoracic surgery procedures. CytoSorb has also
received FDA Emergency Use Authorization in the
United States for use in adult critically ill COVID-19
patients with impending or confirmed respiratory failure. The
DrugSorb™-ATR antithrombotic removal system, based on the same
polymer technology as CytoSorb, also received two FDA
Breakthrough Device Designations, one for the removal
of ticagrelor and another for the removal of
the direct oral anticoagulants (DOAC) apixaban and
rivaroxaban in a cardiopulmonary bypass circuit during urgent
cardiothoracic procedures. The company has initiated two
FDA-approved pivotal studies to support FDA marketing approval of
DrugSorb-ATR in the United States. The first is the
randomized, controlled STAR-T (Safe and Timely Antithrombotic
Removal-Ticagrelor) study of 120 patients at 30 centers to evaluate
whether intraoperative use of DrugSorb-ATR can reduce the
perioperative risk of bleeding in patients receiving ticagrelor and
undergoing cardiothoracic surgery. The second study is the
STAR‑D (Safe and Timely Antithrombotic Removal-Direct Oral
Anticoagulants) randomized, controlled trial of 120 patients at 30
centers evaluating the intraoperative use of DrugSorb-ATR to reduce
perioperative bleeding risk in patients undergoing cardiothoracic
surgery and taking 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 body fluids through pore
entrapment and surface adsorption. The company's technologies
have received more than $41.5 million in non-dilutive
grants, contracts and other non-dilutive funding from DARPA, the
U.S. Department of Health and Human Services (HHS), the National
Institutes of Health (NIH), the 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 and
in-development products based on this unique blood purification
technology protected by numerous issued U.S. and international
patents and registered trademarks, as well as several pending
patent applications, 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, 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
September 30,
|
|
|
Nine months ended
September 30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
|
(Unaudited)
|
|
Revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
CytoSorb
sales
|
|
$
|
6,271
|
|
|
$
|
8,901
|
|
|
$
|
21,176
|
|
|
$
|
30,405
|
|
Other
sales
|
|
|
191
|
|
|
|
1
|
|
|
|
542
|
|
|
|
6
|
|
Total
product sales
|
|
|
6,462
|
|
|
|
8,902
|
|
|
|
21,718
|
|
|
|
30,411
|
|
Grant
income
|
|
|
1,649
|
|
|
|
858
|
|
|
|
3,580
|
|
|
|
1,972
|
|
Total
revenue
|
|
|
8,111
|
|
|
|
9,760
|
|
|
|
25,298
|
|
|
|
32,383
|
|
Cost of
revenue
|
|
|
4,494
|
|
|
|
2,463
|
|
|
|
10,322
|
|
|
|
7,924
|
|
Gross profit
|
|
|
3,617
|
|
|
|
7,297
|
|
|
|
14,976
|
|
|
|
24,459
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
3,290
|
|
|
|
4,262
|
|
|
|
11,717
|
|
|
|
10,244
|
|
Legal,
financial and other consulting
|
|
|
609
|
|
|
|
665
|
|
|
|
2,089
|
|
|
|
2,090
|
|
Selling,
general and administrative
|
|
|
8,735
|
|
|
|
7,776
|
|
|
|
26,335
|
|
|
|
25,308
|
|
Total
expenses
|
|
|
12,634
|
|
|
|
12,703
|
|
|
|
40,141
|
|
|
|
37,642
|
|
Loss from
operations
|
|
|
(9,017)
|
|
|
|
(5,406)
|
|
|
|
(25,165)
|
|
|
|
(13,183)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other
income/(expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
(expense), net
|
|
|
47
|
|
|
|
13
|
|
|
|
79
|
|
|
|
16
|
|
Loss on foreign
currency transactions
|
|
|
(3,231)
|
|
|
|
(1,013)
|
|
|
|
(6,967)
|
|
|
|
(2,085)
|
|
Miscellaneous
Income
|
|
|
-----
|
|
|
|
-----
|
|
|
|
7
|
|
|
|
-----
|
|
Total other expense),
net
|
|
|
(3,184)
|
|
|
|
(1,000)
|
|
|
|
(6,881)
|
|
|
|
(2,069)
|
|
Loss before benefit
from income taxes
|
|
|
(12,201)
|
|
|
|
(6,406)
|
|
|
|
(32,046)
|
|
|
|
(15,252)
|
|
Benefit from income
taxes
|
|
|
-----
|
|
|
|
-----
|
|
|
|
-----
|
|
|
|
-----
|
|
Net loss
|
|
$
|
(12,201)
|
|
|
$
|
(6,406)
|
|
|
$
|
(32,046)
|
|
|
$
|
(15,252)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.28)
|
|
|
$
|
(0.15)
|
|
|
$
|
(0.74)
|
|
|
$
|
(0.35)
|
|
Weighted average number
of shares of
common stock outstanding
|
|
|
43,606,980
|
|
|
|
43,396,464
|
|
|
|
43,552,238
|
|
|
|
43,319,507
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,201)
|
|
|
$
|
(6,406)
|
|
|
$
|
(32,046)
|
|
|
$
|
(15,252)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive
income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency
translation adjustment
|
|
|
2,659
|
|
|
|
808
|
|
|
|
5,675
|
|
|
|
1,701
|
|
Total Comprehensive
loss
|
|
$
|
(9,542)
|
|
|
$
|
(5,598)
|
|
|
$
|
(26,371)
|
|
|
$
|
(13,551)
|
|
CYTOSORBENTS
CORPORATION
CONDENSED CONSOLIDATED
BALANCE SHEETS
(amounts in
thousands)
|
|
|
|
|
|
|
|
September 30,
2022
|
|
|
December 31,
2021
|
|
|
ASSETS:
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
22,552
|
|
$
|
52,138
|
|
|
Grants and accounts
receivable, net
|
|
4,961
|
|
|
4,523
|
|
|
Inventories
|
|
3,542
|
|
|
4,766
|
|
|
Prepaid expenses and
other current assets
|
|
1,326
|
|
|
2,872
|
|
|
Total current assets
|
|
32,381
|
|
|
64,299
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
10,712
|
|
|
5,151
|
|
|
Restricted
Cash
|
|
1,687
|
|
|
1,687
|
|
|
Right of use
asset
|
|
12,794
|
|
|
13,423
|
|
|
Other assets
|
|
4,696
|
|
|
4,959
|
|
|
TOTAL ASSETS
|
$
|
62,270
|
|
$
|
89,519
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
2,348
|
|
$
|
2,805
|
|
|
Lease liability -
current portion
|
|
377
|
|
|
571
|
|
|
Accrued expenses and
other current liabilities
|
|
7,394
|
|
|
10,314
|
|
|
Total current
liabilities
|
|
10,119
|
|
|
13,690
|
|
|
Lease liability, net of
current portion
|
|
13,009
|
|
|
13,251
|
|
|
TOTAL LIABILITIES
|
|
23,128
|
|
|
26,941
|
|
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
39,142
|
|
|
62,578
|
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
62,270
|
|
$
|
89,519
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Please Click to Follow Us on Facebook and Twitter
U.S. Company Contact:
Kathleen
Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@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