Q1 2022 total revenue was $8.7 million, including product sales of
$7.9 million. Core non-COVID-19
product sales were an estimated $7.6
million, and on a constant currency basis were comparable to
core product sales a year ago. Product gross margins were
80%.
MONMOUTH
JUNCTION, N.J., May 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 March 31, 2022.
First Quarter 2022 Financial Results
CytoSorbents Reports First Quarter 2022
Results and Revises 2022 Outlook
- Total revenue, including product sales and grant income, for Q1
2022 was $8.7 million, a decrease of
18% compared to $10.6 million in Q1
2021.
- Q1 2022 product sales were $7.9
million (including an estimated $7.6
million core non-COVID-19 sales and $0.3 million COVID-19 related sales) versus
$10.1 million ($8.3 million core and $1.8
million COVID-related) in Q1 2021, a decrease of 22%. This
decrease was driven primarily by a reduction in German direct
sales, which were hampered by the impact of unprecedented rates of
new COVID-19 infection in the country that persisted throughout Q1
2022, and to a lesser extent a weaker Euro. Germany sales were $3.8
million in Q1 2022 versus $5.9
million a year ago, a decline of 36%. Q1 2022 product sales
were also lower by $0.6 million due
to the stronger dollar compared to the euro.
- On a constant currency basis, core product sales in Q1 2022
would have been $8.2 million, and
were comparable to core product sales of $8.3 million a year ago.
- As expected, COVID-19 related sales during the quarter were
low, reflecting the low severity of current COVID-19 illness
resulting from high rates of vaccination and natural immunity.
- Product gross margins improved to approximately 80% in Q1 2022,
versus 77% in Q1 2021.
- The Company continues to have a solid balance sheet with cash
and cash equivalents of $44.7 million
(which includes $1.7 million in
restricted cash) at March 31, 2022,
and no debt.
Recent Operating Highlights
- More than 170,000 cumulative CytoSorb devices have been
utilized worldwide as of March 31,
2022, an increase of 30% compared to more than 131,000
devices utilized as of the end of the first quarter of 2021.
- CytoSorbents continues to make progress in its
company-sponsored clinical trials, most importantly announcing that
the first patient was enrolled in April
2022 in the U.S. STAR-D (Safe and Timely Antithrombotic
Removal – Direct Oral Anticoagulants) pivotal trial evaluating the
DrugSorb™-ATR Antithrombotic Removal System to remove apixaban and
rivaroxaban during cardiothoracic surgery.
- The first patient was enrolled in February 2022 in the PROCYSS Multicenter
randomized controlled trial evaluating CytoSorb® to restore
hemodynamic stability in patients experiencing refractory septic
shock.
- Buildout of the Company's new manufacturing facility in
Princeton, New Jersey is
approximately 95% complete. In April, the Company successfully
completed its E.U. Notified Body audit of the manufacturing plant,
with no major findings. Based on the positive audit, the Company is
beginning the transition from its existing facility to the new
manufacturing site. Management expects to receive full
certification from its Notified Body in the coming months, which
will allow device manufacturing and product shipments to begin from
the new manufacturing facility.
- CytoSorbents recently appointed Jiny
Kim, MBA to the Board of Directors. She brings an extensive
background in the medical device industry, with significant
experience in U.S. and international commercialization, sales,
marketing and business development to support the Company's growth
initiatives, in particular the eventual commercialization of
DrugSorb™-ATR in the United
States.
- The Company is establishing a direct sales presence in the UK,
the sixth largest medical device market in the world, and
Ireland, part of its strategy to
expand more territories in which CytoSorb is sold directly to
customers.
- Multiple recent scientific publications and presentations
highlighting the use of CytoSorb in critical care and cardiac
surgery (see "Clinical Studies and Data Publications Update"
below). In particular, new data from an expanded analysis of the
U.S. CTC (CytoSorb Therapy in COVID-19) Registry on 56 critically
ill COVID-19 patients with acute respiratory distress syndrome on
life support with ECMO and treated with CytoSorb under FDA
Emergency Use Authorization, continue to demonstrate high survival
and improved clinical benefits with early intervention. These data
were presented in an abstract at the 41st International
Symposium on Intensive Care and Emergency Medicine in Brussels, Belgium, and will be presented this
week at the 10th EuroELSO Congress in London, UK, along with multiple presentations
at the CytoSorbents Lunch Symposium.
Dr. Phillip Chan, Chief Executive
Officer of CytoSorbents stated, "A key takeaway from our first
quarter results is that our core non-COVID-19 product sales were
stable, on par with Q3 and Q4 2021, and comparable with Q1 2021
product sales on a constant currency basis. We did this
despite the many business challenges and uncertainties created by
COVID-19, the Russian-Ukraine war, inflation, currency exchange
volatility, and other factors out of our direct control. As
anticipated, COVID-19 related sales were nominal for Q1 2022 due to
the low severity of recent COVID-19 infections, and primarily
accounted for the difference in product sales from a year ago."
"During Q1 2022, CytoSorb sales in Germany, the Company's largest market, lagged
as the country experienced its highest rates of COVID infections
since the pandemic began. When we provided our 2022 outlook
in early March, the Omicron wave appeared to be peaking, but was
supplanted by a massive wave of BA.2 variant infections that drove
a new peak of more than a half million new COVID-19 infections a
day by the end of Q1 2022 - seven times higher than in the prior
quarter and 21 times the peak seen a year ago. We have
previously discussed how these high rates of COVID-19 indirectly
reduce CytoSorb sales by impacting hospital budgets, staffing,
elective procedure volumes, ICU capacity, and sale representative
access due to visitation restrictions and illness.
Fortunately, COVID-19 infection rates have dropped rapidly in the
past several weeks. However, the BA.2 surge, which still
accounts for nearly 100,000 new infections a day in the country,
will likely delay the expected recovery in Germany. We are seeing a carryover of
Germany Q1 sales trends to the
current quarter, and although this may change, it has prompted us
to conservatively revise our 2022 guidance (see "Revision of 2022
Outlook Guidance" below). That said, we are focused on the
more important big picture where current trends portend an end to
the global pandemic this year as COVID-19 is expected to morph into
a much less virulent disease like seasonal influenza. When
this happens, we want to be well-positioned to capitalize on what
we expect will be a steady improvement and return to growth in our
core business."
Dr. Chan continued, "We remain confident that the slowdown in
our growth is mainly driven by reversible COVID-related issues, and
expect that these too shall pass. In the meantime, we have a
solid balance sheet anchored by $44.7
million in cash and no debt at the end of Q1 2022 to weather
the current turbulence. We are also managing our business
proactively, continuing to invest in key areas such as our U.S.
pivotal STAR-T and STAR-D trials, while instituting tighter cost
controls to reduce our cash burn by an additional $2 million per quarter against budget. Our
goal is to end this year with more than $30M in cash, which exceeds our projected cash
need in 2023 and importantly, is expected to provide adequate funds
through the anticipated enrollment completion of both the pivotal
U.S. STAR-T and STAR-D trials. We also have the additional
financial flexibility from our $15
million Bridge Bank term loan commitment to add debt if
desired."
"Meanwhile, we are not just waiting for conditions to
improve. Rather, we are focused on building this company and
solidifying our leadership as the treatment pioneer of
life-threatening conditions using blood purification. We are
laser-focused on four essential objectives that we believe are the
key to driving sustainable, long-term value for shareholders:
- Open the U.S. market by obtaining FDA Marketing approval for
DrugSorb™-ATR to remove blood thinning drugs during cardiothoracic
surgery (see "Clinical update" below)
- Restore growth of core CytoSorb sales, driven by numerous
initiatives (see below).
- Transition CytoSorb production to our new manufacturing
facility and headquarters in Princeton,
New Jersey this year (See "Operational Update" above)
- Forge and expand new and existing strategic partnerships to
maximize the synergy between our technology and those of our
partners, while creating new global opportunities for growth.
To provide more color on our growth strategy, we highlight
several examples of important initiatives that we have been
executing upon during the pandemic that are expected to drive
improved results as the pandemic abates, as well as future,
longer-term growth.
Near-term growth drivers
- Resume in-person sales from a strong customer
base: Our active customer base accounts for
the majority of our direct sales and grew by 20-25% at the start of
the pandemic and has remained stable since. We are in
close contact with these accounts and have confirmed that COVID-19
related issues, including its effect on staffing and numbers of ICU
patients, are the primary issue for volatility in ordering.
We believe a return to in-person selling will reinvigorate
growth.
- New therapeutic area divisions: We have
established three distinct therapy divisions within our commercial
operations including Critical Care, Cardiovascular, and
Liver/Kidney/other to develop these markets internationally under
the leadership of dedicated medical and commercial subject matter
experts, who will work closely with our sales teams and best serve
the needs and interests of our customers. We have already
seen our efforts bear fruit with now more than 150 cardiac surgery
centers internationally who have begun to use CytoSorb to remove
antithrombotic drugs during cardiac surgery, for example. We
believe this infrastructure will yield many more similar successes
across a broad array of applications.
- New exclusive private hospital chain
partnerships: We are now the preferred supplier
of hemoadsorption technology to the three largest hospital chains
in Germany, including, as
announced yesterday, Asklepios Group. A number of these
hospitals are already current customers and our agreements
facilitate access and sales of CytoSorb to these and all other
relevant institutions within these hospital networks.
- Rise of Existing and New Applications:
Among the many applications, we highlight:
Shock: Many studies have highlighted the
ability of CytoSorb to remove inflammatory mediators and help to
stabilize shock, a potentially fatal drop in blood pressure, in a
wide range of patients. A recent 2019
meta-analysis, found that approximately 10% of ICU patients
have septic shock at admission and an additional 8% of patients
admitted to the ICU develop septic shock at some point in their
hospital stay, with a high mortality of 38%. CytoSorb is
being used around the world as a treatment of shock and we are
conducting the PROCYSS RCT to formally evaluate CytoSorb as a
treatment of this common and major unmet medical
need.
Liver disease: In the
treatment of acute liver disease, CytoSorb outperforms the
market leading MARS® platform (Baxter) in the in
vitro removal of many liver toxins, but has the added
benefit of removing cytokines and inflammatory mediators, while
being much easier to use. In real-world practice, CytoSorb has
replaced MARS at many accounts. One in 11 people worldwide
have chronic liver disease that may deteriorate and require
hospitalization and blood purification. Through our Liver/Kidney
division, we aim to drive CytoSorb as a therapy of choice in these
patients.
Lung injury: Our U.S.
CTC registry highlights the high survival of critically ill
COVID-19 patients with acute respiratory distress syndrome (ARDS)
treated with CytoSorb and ECMO under FDA Emergency Use
Authorization. We believe these data demonstrate a therapeutic
strategy of "enhanced lung rest" using the combined therapies that
can be extrapolated to the treatment of ARDS in non-COVID patients,
a very large market.
Longer-term growth drivers
- Stand-alone blood pump business
model: There are many applications where a
simple-to-use, low-cost hemoperfusion pump is adequate to implement
our CytoSorb blood purification technology. This approach
enables our customers to deliver CytoSorb without the complexity of
a full-scale dialysis or continuous renal replacement therapy
(CRRT) machine, without the need for a dialysis technician, and in
clinical situations where the patient has not developed kidney
failure. By improving access to care and simplifying
treatment with CytoSorb in the ICU, we are potentially enabling
more frequent and earlier use on more patients while supporting new
"hospital-wide" applications in the emergency room, surgery suites,
and elsewhere. CytoSorbents has partnered with a major
international dialysis company to distribute a high-quality
hemoperfusion machine and accessories, and to provide field support
to customers in Germany,
Austria, and Luxembourg, and are currently in the midst of
a pilot launch. While early, the initial results and feedback
from this pilot have been promising. Pending continued
success, we plan a broader rollout in these countries, and may
pursue expansion of the program to more countries in the
future. We believe this can be a potentially important
supplementary business model going forward that can significantly
expand our total addressable markets and contribute meaningfully to
CytoSorb sales growth.
- Expansion of direct sales territories:
Although opening new countries with a direct sales force
requires time, cost, and resources, it also allows us to directly
lead the effort, drive results, and benefit from more profitable
sales. With the announcement of expansion of direct sales
into the U.K. and Ireland, we now
sell direct in two of the E.U.'s Big 5 Economies - Germany and the U.K. – and a total of 15
countries direct overall, while working with distributors or
partners in the other three Big 5 Economies: France, Italy, and Spain.
- Investment in important clinical studies in shock, liver
failure, cardiac surgery, ATR, etc: We are committed
to funding Company-sponsored studies, such as the STAR-T, STAR-D,
and PROCYSS RCTs, in key areas that we believe will drive
international adoption and usage of our technologies, with the goal
of becoming a standard of care for those applications (See
"Clinical Studies and Data Publications Update" below).
Dr. Chan concluded, "We firmly believe we are a solidly financed
company with a robust strategic and tactical plan that positions us
well for both near-term and long-term success once the effects of
the pandemic abate. Although we know it has been challenging,
we thank you for your understanding and continued support."
Clinical Studies and Data Publications Update
Cardiac Surgery
- U.S. STAR-T pivotal RCT: Enrollment and site activation
continues to progress. Barring the potential of another surge in
U.S. COVID cases, we expect the study to reach its first scheduled
milestone of 33% patient enrollment that will trigger the first
Data Safety Monitoring Board (DSMB) meeting this summer, with
overall study enrollment to be complete in the first quarter of
2023.
- U.S. STAR-D pivotal RCT: Site activation is ongoing with
the first patient enrolled in April
2022. Pending the continuing uncertainty from the ongoing
COVID-19 pandemic, we expect the study to complete enrollment in
12-18 months.
- International Safe and Timely Antithrombotic Removal (STAR)
Registry continues to actively enroll patients in the U.K.,
Germany, and Austria, with expansion into additional EU
countries before the end of 2022.
- Recent scientific publications highlight CytoSorb use in
cardiac surgery for antithrombotic removal include in the Annals
of Thoracic and Cardiovascular Surgery, Expert Review of
Cardiovascular Therapy, Journal of Cardiothoracic and
Vascular Anesthesia, and in endocarditis in the Journal of
Cardiothoracic and Vascular Anesthesia.
Critical Care
- CytoSorb Therapy in COVID-19 (CTC) Registry: New data
will be presented at the EuroELSO conference this week (see
"Operational Highlights" above). The CTC Registry has completed
enrollment at 100 patients and the final results will be presented
at an upcoming international conference and submitted for
publication.
- The German PROCYSS Refractory Septic Shock RCT: The
study continues to actively enroll at multiple sites. The speed of
enrollment remains uncertain due to COVID-19, however, we still
expect to achieve the next important milestone of the interim
analysis after 50% enrollment in 2023.
- The German Hep-On-Fire multicenter, single-arm trial in
acute liver failure due to alcoholic hepatitis: We continue to
expect that the first patient will be enrolled this quarter and
that the study will complete enrollment in 2023.
- The International COSMOS Registry: Designed to capture
ongoing, real-world outcomes using CytoSorb in critical care, the
Registry is undergoing start-up activities and remains scheduled to
begin enrollment this quarter with the goal of being active in
multiple countries in 2023.
- Many peer-reviewed publications of new studies on sepsis
in The International Journal of Artificial Organs and in
sepsis-associated acute kidney injury in Blood Purification,
as well as in acute pancreatitis in Artificial
Organs, and wound healing following severe burn injury
in Frontiers in Surgery. Finally, cytokine reduction
using CytoSorb and the successful transplant of donated kidneys and
livers from deceased donors was detailed in the International
Journal of Artificial Organs.
Results of Operations for the quarter ended March 31, 2022 compared to the quarter ended
March 31, 2021
Revenues
Total revenue, including product
revenue and grant income, for the first quarter of 2022 was
$8.7 million, down 18% from
$10.6 million in the first quarter of
2021. Product sales in the first quarter of 2022 were
$7.9 million, down 22% from
$10.1 million in the first quarter of
2021 due to a decrease in direct sales, primarily from lower sales
in Germany due to COVID-19
pandemic market conditions, as well as the impact of the decrease
in the average exchange rate of the Euro to the U.S. dollar, which
negatively impacted first quarter 2022 product sales by
approximately $0.6 million. Due
to a surge in COVID-19 case in the first quarter of 2022, many
hospitals throughout Germany
either maintained or reinstituted restrictions such as visitation
rights to non-essential visitors. However, unlike prior waves
in Germany, the rates of severe
COVID-19 illness requiring ICU care, and death have been
comparatively 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. In aggregate, COVID-19 related
sales in the first quarter of 2021 were estimated to be
$0.3 million, compared to
$1.8 million in the first quarter of
2021. Core, non-COVID-19 sales declined 9% from $8.3 million in the first quarter of 2021 to
$7.6 million in the first quarter of
2022.
Cost of Revenues
Cost of revenue for the first
quarter of 2022 was $2.3 million
compared to $2.8 million for the
first quarter of 2021. Product gross margins were
approximately 80% for the first quarter of 2022, compared to
approximately 77% for the first quarter of 2021, due mainly to the
impact of non-recurring costs of approximately $0.7 million in the first quarter of 2021 related
to prior year tariffs following an audit by the German Customs
Authorities that did not recur in 2022.
Operating Expenses
Operating expenses for the
first quarter of 2022 amounted to $14.2
million, a 33% increase from $10.7
million for the first quarter of 2021. Research and
development expenses increased from $2.3
million in the first quarter of 2021 to $4.2 million in the first quarter of 2022 due
primarily to an increase in clinical trial and related costs, rent
expense on our new facility and other R&D costs. Selling,
General & Administrative (SG&A) expenses increased 19% to
$9.2 million in the first quarter of
2022 from $7.7 million in the prior
year period due primarily to an increase in salaries, commissions,
and related costs of $0.9 million, an
increase in occupancy costs related to rent on our new facility in
Princeton, NJ of $0.4 million, and an increase in sales and
marketing costs, which include advertising and conference
attendance of approximately $0.3
million, among other items. These SG&A
expense increases were partially offset by lower non-cash
restricted stock expense of $0.3
million, among other decreased expenses included within
SG&A. Legal, financial, and other consulting expense
increased from $0.7 million in the
first quarter of 2021 to $0.8 million
in the first quarter of 2022.
Liquidity and Capital Resources
Since
inception, our operations have been primarily financed through the
private and public placement of our debt and equity securities.
At March 31, 2022, we had
current assets of approximately $55.9
million including unrestricted cash on hand of approximately
$43.0 million and had current
liabilities of approximately $14.7
million. As of March 31,
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 of 2022, we
received approximately $740,000 in
cash from the approved sale of our net operating losses and
research and development credits from the State of New Jersey.
We believe that we have sufficient cash to fund the Company's
operations beyond twelve months from issuance of the financial
statements for the quarter ending March 31,
2022.
Revision of 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, currency exchange
volatility, and other factors that are not in our direct
control.
As evidence of this, since our prior guidance on March 8, 2022, where we anticipated growth of 20%
or more in 2022 core product sales, Germany has since suffered a major surge in
new COVID-19 cases, driven by the Omicron BA.2 variant.
Although infection rates are now falling, we believe this has
delayed the recovery of German hospitals and our German
business. Given the importance of Germany to our financial results, and given
that we see some Q1 sales trends carrying over to Q2 2022 (although
this may change), we are revising our guidance to the
following:
We expect COVID-19 cases and hospitalizations worldwide to
continue to decline and expect to reach a more normalized operating
environment as the year progresses. Because of this, we expect
continued and progressive improvement in our underlying core
non-COVID-19 business and expect growth in 2022 of core product
sales on a constant currency basis. However, due to our
limited visibility, we are removing specific growth targets with
plans to revisit this later in the year. This expectation
assumes:
- A gradual recovery of normalized hospital activity and sales
access in Germany and other key
countries
- No major economic slowdowns or major surges in COVID-19
infections caused by new COVID-19 variants
- Little to no contribution to sales from Russia and neighboring countries that might be
impacted by the war. In 2021, sales from these geographies
represented less than 4% of total product sales
- No escalation of the Russia-Ukraine war to other countries
- Limited COVID-19 related product sales in 2022 due to high
rates of vaccination and natural immunity that have reduced the
severity of COVID-19 illness and need for hospitalization and ICU
care, and with it the use of CytoSorb in these patients.
For additional information, please see the Company's Form 10-Q
for the period ended March 31, 2022,
filed today with the SEC on http://www.sec.gov.
Conference Call
The company will conduct its first quarter 2022 results call
today at 4:30 p.m. Eastern time.
Conference Call Details:
Toll free:
1-877-451-6152
International: 1-201-389-0879
Conference ID: 13728663
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=1541445&tp_key=979468cd12
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 170,000 cumulative CytoSorb devices have
been utilized as of March 31,
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, 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)
|
|
|
For the Three Months
Ended
|
|
|
March 31,
2022
|
|
|
March 31,
2021
|
|
Revenue:
|
|
|
|
|
|
|
CytoSorb
sales
|
$
|
7,867
|
|
$
|
10,143
|
|
Other sales
|
|
58
|
|
|
---
|
|
Total product sales
|
|
7,925
|
|
|
10,143
|
|
Grant income
|
|
767
|
|
|
456
|
|
Total
revenue
|
|
8,692
|
|
|
10,599
|
|
Cost of
revenue
|
|
2,278
|
|
|
2,751
|
|
Gross profit
|
|
6,414
|
|
|
7,848
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
Research and development
|
|
4,243
|
|
|
2,282
|
|
Legal, financial and other
consulting
|
|
801
|
|
|
708
|
|
Selling, general and administrative
|
|
9,161
|
|
|
7,710
|
|
Total operating expenses
|
|
14,205
|
|
|
10,700
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(7,791)
|
|
|
(2,852)
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest income (expense), net
|
|
8
|
|
|
(10)
|
|
Loss on foreign currency transactions
|
|
(1,213)
|
|
|
(1,306)
|
|
Miscellaneous Income
|
|
30
|
|
|
---
|
|
Total other expense,
net
|
|
(1,175)
|
|
|
(1,316)
|
|
Loss before benefit
from income taxes
|
|
(8,966)
|
|
|
(4,168)
|
|
Benefit from income
taxes
|
|
---
|
|
|
---
|
|
Net loss
|
|
(8,966)
|
|
|
(4,168)
|
|
|
|
|
|
|
|
|
Earnings per
share:
|
|
|
|
|
|
|
Basic and diluted loss per share
|
$
|
(0.21)
|
|
$
|
(0.10)
|
|
Weighted average share outstanding
|
|
43,487,946
|
|
|
43,242,791
|
|
|
|
|
|
|
|
|
Net Loss
|
$
|
(8,966)
|
|
$
|
(4,168)
|
|
Other comprehensive
income:
|
|
|
|
|
|
|
Currency translation adjustment
|
|
963
|
|
|
1,158
|
|
Comprehensive
loss
|
$
|
(8,003)
|
|
$
|
(3,010)
|
|
CYTOSORBENTS
CORPORATION
|
CONDENSED CONSOLIDATED
BALANCE SHEETS
|
(amounts in
thousands)
|
|
|
|
March 31,
2022
|
|
|
December 31,
2021
|
|
ASSETS:
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
43,023
|
|
$
|
52,138
|
|
Grants and accounts
receivable, net
|
|
4,577
|
|
|
4,523
|
|
Inventories
|
|
5,445
|
|
|
4,766
|
|
Prepaid expenses and
other current assets
|
|
2,809
|
|
|
2,872
|
|
Total current assets
|
|
55,854
|
|
|
64,299
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
7,849
|
|
|
5,151
|
|
Right of use
asset
|
|
13,197
|
|
|
13,423
|
|
Restricted
cash
|
|
1,687
|
|
|
1,687
|
|
Other assets
|
|
4,685
|
|
|
4,959
|
|
TOTAL ASSETS
|
$
|
83,272
|
|
$
|
89,519
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
Accounts
payable
|
$
|
4,826
|
|
$
|
2,805
|
|
Lease liability -
current portion
|
|
487
|
|
|
571
|
|
Accrued expenses and
other current liabilities
|
|
9,359
|
|
|
10,314
|
|
Total current
liabilities
|
|
14,672
|
|
|
13,690
|
|
Lease liability, net of
current portion
|
|
13,172
|
|
|
13,251
|
|
TOTAL LIABILITIES
|
|
27,844
|
|
|
26,941
|
|
|
|
|
|
|
|
|
Total stockholders'
equity
|
|
55,428
|
|
|
62,578
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY
|
$
|
83,272
|
|
$
|
89,519
|
|
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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