CytoSorbents Corporation (NASDAQ: CTSO), a pioneer in critical care
and cardiac surgery blood purification technologies, today reported
unaudited financial and operating results for the quarter ended
June 30, 2024.
Second Quarter 2024 Financial
Results
- Total revenue for Q2 2024,
including product sales and grant income, was $9.9 million, an
increase of 5% compared to $9.4 million in Q2 2023
- Q2 2024 product sales were $8.8
million versus $8.1 million in Q2 2023, a 10% increase
- Product gross margins on devices
and device accessories were approximately 75% in Q2 2024, compared
to 74% in Q2 2023
- Q2 2024 operating loss decreased
48% to $3.4 million from $6.6 million a year ago, reflecting prior
cost cutting efforts and increased sales
- Recently completed additional
cutbacks, expected to save an additional $5 million in annual
expenses going forward. Through attrition and layoffs over the past
5 months, we have decreased our headcount by 17% to 155 full-time
and part-time employees
- Total cash, including cash and cash
equivalents, and restricted cash was $14.9 million as of June 30,
2024
Recent Operating
Highlights:
- Achieved more than a
quarter million CytoSorb® treatments cumulatively
delivered to date across more than 75 countries, helping to save
many lives worldwide – a major company milestone
- Announced the retirement of Chief
Financial Officer Kathleen P. Bloch effective today and the start
of Peter J. Mariani as the new CFO tomorrow (see today’s separate
press release)
- Secured a $20 million credit
facility with Avenue Capital Group, strengthening our financial
position
- Launched a new, redesigned, unified
company and product website highlighting our long-standing
collaboration with the scientific and clinical community in
“Working to Save Lives Together”
- Data from the STAR (Safe and Timely
Antithrombotic Removal) registry was presented at the international
EuroPCR 2024 conference in Paris, France, where it was also
selected as a top 5 finalist in the best scientific abstract
competition
- Launched the PuriFi™ hemoperfusion
pump in the European Union following its E.U. MDR certification in
June, with the first orders of 30 machines already placed
- Completed our Medical Device Single
Audit Program (MDSAP) site audit and are undergoing certification
review – a key requisite to Canadian medical device
commercialization
- Obtained regulatory approval of
CytoSorb in Taiwan
- CytoSorbents’ #DidYouKnow social
media campaign highlighting achievements in the world of medicine
was a Gold Winner at the international 2024 dotCOMM Awards in July
that celebrates excellence in web creativity and digital
communications
Dr. Phillip Chan, Chief Executive Officer of
CytoSorbents, stated, “This year, we have worked diligently to
execute upon a broad turnaround strategy that is dependent on
attaining a number of key objectives. I am pleased to highlight our
achievement or expected achievement of many of these goals.”
1) Submission of
marketing applications to U.S. FDA and Health Canada for
DrugSorb™-ATRWe are rapidly nearing the expected
completion and submission of our marketing applications to the U.S.
Food and Drug Administration (FDA) and Health Canada for
DrugSorb-ATR this quarter, based on the final results of our U.S.
and Canadian pivotal STAR-T trial in patients on the blood thinner
Brilinta® undergoing coronary artery bypass graft (CABG) surgery.
We are leveraging the electronic Submission Template and Resource
(eSTAR) platform used for electronic medical device submissions to
FDA and have completed 75% of our De Novo application to date. For
Canada, we have now completed our MDSAP site audit and are
undergoing certification review by our notified body – a key
requisite to Canadian medical device commercialization. If we
achieve marketing approvals in the U.S. as an FDA Breakthrough
Device and Canada, we will have the potential to unlock an
unprecedented commercial opportunity for the Company, with an
initial $325 million total addressable market estimate for
DrugSorb-ATR in these two countries alone, that could double in
size as Brilinta® goes off patent in 2024.
2) Strengthen our
balance sheetAfter completing our $10.3M equity raise in
December 2023, we further strengthened our balance sheet by
securing a $20M term-loan facility with Avenue Group providing an
initial tranche of $15 million in cash, including $10 million
unrestricted, and $5 million contingent upon FDA acceptance of a De
Novo application for marketing approval of DrugSorb-ATR and certain
liquidity requirements. Another $5 million will become available to
the Company upon U.S. FDA approval of DrugSorb-ATR. The loan
facility is expected to help fund the Company through both Health
Canada and U.S. FDA regulatory decisions. We have also paid back
our previous Bridge Bank debt.
3) Cut costs to drive
efficiency, improve product gross margins, and be
self-sustainingWe continue to actively reduce operating
expenses with a focus on improvements in productivity and the
longer-term goal of being self-sustaining. Cost cutting measures
taken in prior periods have helped to reduce our Q2 2024 operating
loss by 48% to $3.4 million, compared to $6.6 million a year ago.
Last month, we enacted additional cost cuts, designed to reduce the
Company’s cash burn by another $5 million on an annualized basis.
Specifically, over the past 5 months, we have streamlined our
operations, and through a combination of attrition and layoffs,
have decreased full-time and part-time headcount by 17% from 186 to
155 as of today. These have been very difficult but
necessary actions for the greater good to ensure that we live
within our means and can fund our critical programs.
Meanwhile, blended product gross margins that
combine higher margin direct sales with lower margin distributor
and partner sales improved year-over-year to 75% with continued
improvements in manufacturing. With greater volumes, we believe we
have direct line of sight to 80% blended product gross margins for
our various therapies. As high margin “razorblades”
that are compatible with industry standard blood pump “razors”,
improvements in product gross margin are expected to reduce our
cash needs and accelerate future profitability.
4) Increase core
CytoSorb sales growth beyond the Quarter Million devices delivered
to dateWe have now achieved a major company milestone with
more than a quarter million CytoSorb devices delivered across 76
countries to date, helping to save many lives worldwide. We thank
everyone who has contributed to this achievement, most importantly
our employees, our customers and supporters around the world, and
our shareholders. This is our success.
Meanwhile, first half 2024 product sales were
$17.8 million, an increase of $1.8 million or approximately 12%
compared to sales of $16.0 million in the same period of 2023.
Although good progress, there is more work we need to do to get
back to historic growth rates, particularly in the post-pandemic
hospital environment. Among our many initiatives to achieve this
objective, here are some quick updates.
- Our newly designed, modern,
integrated corporate and product website is our public face to the
world that now better reflects who we are as a company. An
innovator. A collaborator. A global partner. A leader in acute care
blood purification with more than 12 years of working together with
the international medical and scientific communities to generate
the knowledge of how best to use our therapies to help save
lives
- Our launch of our MDR-certified,
stand-alone hemoperfusion PuriFi® pump is going well, with our
first opening order of 30 PuriFi pumps already placed at customers
or distributors. We expect to take delivery of our second order of
pumps from our OEM (Original Equipment Manufacturer) shortly
- We are actively working with
Fresenius Medical Care (FMC) to co-market CytoSorb as the “featured
solution for cytokine, bilirubin, and myoglobin removal” on their
multiFiltrate® and multiFiltratePRO® machines at the upcoming Asia
Pacific Intensive Care Symposium (APICS) in Singapore this week and
the upcoming European Society of Intensive Care Medicine (ESICM)
conference in Barcelona. There is excellent synergy
between our companies. While FMC is “Shaping the future of
multi-organ support” with its machines and disposables,
CytoSorbents is leading the application front in organ support with
CytoSorb and its ability to help reverse shock and stabilize the
circulatory system, enable “Enhanced Lung Rest” in lung injury,
“Expand the Dimension of Blood Purification®” to extracorporeal
liver support, and protect kidney function in diseases like sepsis
and rhabdomyolysis. In addition, outside of the FMC partnership,
ECOS-300CY® is helping to rehabilitate and recondition sub-standard
hearts, lungs, livers and kidneys for organ transplant during ex
vivo organ perfusion
Dr. Chan concluded, “Finally, we have been
positioning CytoSorbents for the next stage of growth, both our
existing international franchise, as well as the potential to open
the U.S. and Canadian markets. This is why it has taken us so long
to find the right CFO candidate to replace our esteemed retiring
CFO, Kathy Bloch. Kathy has gone above and beyond the call of duty,
selflessly coming back from retirement last August to resume her
former full-time CFO role, and in the intervening 12 months,
helping to secure the future of the Company with two key financings
and orchestrating our cash conservation strategy. With her
retirement, announced today, she caps an outstanding CFO career and
will continue as a consultant to help manage the smooth transition
to our newly appointed CFO, Peter Mariani. On behalf of everyone at
CytoSorbents, we thank Kathy for her more than 11 years of
dedication and leadership at the Company as a trusted colleague and
friend, with so many contributions that have helped us achieve the
success we have today, and wish her an enjoyable, relaxing, and
well-deserved retirement.
Meanwhile, Pete is a seasoned and accomplished
medical device CFO whose many successes at high growth
publicly-traded companies such as Axogen, Hansen Medical, and
Guidant Corporation, speak for themselves. Importantly, at Axogen,
an innovator in peripheral nerve repair, he helped to manage rapid
U.S. growth with a direct sales force and high margin sales from
$27 million to nearly $160 million over the course of his
seven-year tenure as CFO, while raising approximately $250 million
in capital, overseeing a comprehensive investor relations program
with institutional investors, and implementing a financial strategy
to get to near-term profitability. Pete is an
outstanding fit for CytoSorbents and joins at an excellent time
where his deep domestic and international experience and insight is
expected to be vital to our success. We are thrilled to have Pete
join our team and look forward to briefly introducing him to
analysts and investors on today’s earnings call.”
Q2 2024 Earnings Conference
Call
The Company will conduct its second quarter 2024
results call today at 4:30 p.m. Eastern time.
Earnings Call Webcast
Details:Date: Tuesday, August 13, 2024Time: 4:30 PM
Eastern Time
Live Presentation
Webcast:https://edge.media-server.com/mmc/p/smuwcy9aConference
ID: 7567925
Participant Dial-In:Participant
Dial-in toll-free: (888) 596-4144Passcode: 7567925
It is recommended that participants dial in
approximately 10 minutes prior to the start of the call.
An archived recording of the conference call
will be available under the Investor Relations section of the
Company’s website at https://ir.cytosorbents.com/
Results of Operations
Comparison for the three months ended
June 30, 2024 and 2023:
Revenues:
Revenue from product sales was approximately
$8,842,000 in the three months ended June 30, 2024, as compared to
approximately $8,072,000 in the three months ended June 30, 2023,
an increase of approximately $770,000, or 10%. Distributor sales
increased approximately $965,000, or 28%. Direct sales decreased
approximately $196,000, or 4%. In addition, as a result of the
decrease in the average exchange rate of the Euro to the U.S.
dollar, 2024 product sales were negatively impacted by
approximately $104,000. For the three months ended June 30, 2024,
the average exchange rate of the Euro to the U.S. dollar was $1.08
as compared to an average exchange rate of $1.09 for the three
months ended June 30, 2023.
Grant income was approximately $1,053,000 for
the three months ended June 30, 2024 as compared to approximately
$1,348,000 for the three months ended June 30, 2023, a decrease of
approximately $295,000, or 22%. This decrease was due to the
completion of several grants during 2023.
Total revenues were approximately $9,895,000 for
the three months ended June 30, 2024, as compared to total revenues
of approximately $9,421,000 for the three months ended June 30,
2023, an increase of approximately $474,000, or 5%.
Cost of Revenues:
For the three months ended June 30, 2024 and
2023, cost of revenue was approximately $3,392,000 and $3,402,000,
respectively, a decrease of approximately $10,000. Product cost of
revenue was approximately $2,411,000 and $2,093,000, respectively,
for the three months ended June 30, 2024 and 2023, an increase of
approximately $318,000 due to increases in sales in 2024. Gross
margins on devices and device accessories were approximately 75%
for the three months ended June 30, 2024 as compared to
approximately 74% for the three months ended June 30, 2023. This
increase was due to the achievement of greater operating
efficiencies in 2024, which was partially offset by an increase in
the percentage of lower margin distributor sales to total sales
during the three months ended June 30, 2024 as compared to the
three months ended June 30, 2023.
Research and Development
Expenses:
For the three months ended June 30, 2024,
research and development expenses were approximately $1,520,000, as
compared to research and development expenses of approximately
$3,669,000 for the three months ended June 30, 2023, a decrease of
approximately $2,149,000. This decrease was due to a decrease in
our clinical trial activities of approximately $1,842,000 related
to the completion of the STAR-T clinical trial in December 2023.
The three months ended June 30, 2023 included $70,000 of
non-recurring start-up costs associated with our new facility which
were not incurred in the three months ended June 30, 2024. Cost
savings measures resulted in decreased research and development
salaries of approximately $170,000, and decreased consulting and
other spending of approximately $67,000 in the second quarter of
2024.
Legal, Financial and Other Consulting
Expenses:
Legal, financial, and other consulting expenses
were approximately $821,000 for the three months ended June 30,
2024, as compared to approximately $1,185,000 for the three months
ended June 30, 2023, a decrease of approximately $364,000. This
decrease was due to a decrease in legal fees of approximately
$314,000 due to the settlement of a legal matter in 2023, a
decrease in employment agency fees of approximately $121,000 and a
decrease in accounting fees of approximately $43,000. These
decreases were offset an increase in consulting fees of
approximately $114,000.
Selling, General and Administrative
Expenses:
Selling, general and administrative expenses
were approximately $7,581,000 for the three months ended June 30,
2024, as compared to approximately $7,724,000 for the three months
ending June 30, 2023, a decrease of approximately $143,000. This
decrease was due to a decrease in salaries, commissions, and
related costs of approximately $543,000, a decrease in selling and
distribution costs of approximately $468,000, a decrease in fees,
licenses and permits of approximately $50,000, a decrease in
commercial insurance of approximately $32,000, and a decrease in
travel and entertainment expenses of approximately $20,000. These
decreases were offset by increased non-cash stock compensation
expense of approximately $623,000, a reduction in grant spending
reduced the overhead absorption benefit to selling, general and
administrative expense by approximately $136,000, an increase in
network maintenance costs of approximately $81,000, an increase in
transfer agent fees of approximately $49,000, an increase in
royalty expense of approximately $46,000, and an increase in other
general and administrative expenses of approximately $65,000.
Gain (Loss) on Foreign Currency
Transactions:
For the three months ended June 30, 2024, the
loss on foreign currency transactions was approximately $544,000 as
compared to a gain of approximately $415,000 for the three months
ended June 30, 2023. The 2024 loss was directly related to the
decrease in the spot exchange rate of the Euro to the U.S. dollar
at June 30, 2024 as compared to March 31, 2024. The spot exchange
rate of the Euro to the U.S. dollar was $1.07 per Euro at June 30,
2024, as compared to $1.08 per Euro at March 31, 2024. The 2023
gain was directly related to the increase in the spot exchange rate
of the Euro to the U.S. dollar at June 30, 2023 as compared to
March 31, 2023. The spot exchange rate of the Euro to the U.S.
dollar was $1.09 per Euro at June 30, 2023, as compared to $1.08
per Euro at March 31, 2023.
Comparison for the six months ended June
30, 2024 and 2023:
Revenues:
Revenue from product sales was approximately
$17,831,000 for the six months ended June 30, 2024, as compared to
approximately $15,982,000 for the six months ended June 30, 2023,
an increase of approximately $1,849,000, or 12%. Distributor sales
increased by approximately $1,579,000, or 24%. Overall direct sales
increased by approximately $270,000, or 3%. The change in the
exchange rate of the Euro to U.S. dollar did not have a significant
impact on product sales during the six months ended June 30,
2024.
Grant income was approximately $1,850,000 for
the six months ended June 30, 2024 as compared to approximately
$2,888,000 for the six months ended June 30, 2023, a decrease of
approximately $1,038,000 or 36%. This decrease was due to the
completion of several grants during 2023.
Total revenues were approximately $19,681,000
for the six months ended June 30, 2024, as compared to total
revenues of approximately $18,870,000 for the six months ended June
30, 2023, an increase of approximately $811,000, or 4%.
Cost of Revenues:
For the six months ended June 30, 2024 and 2023,
cost of revenue was approximately $6,607,000 and $7,396,000,
respectively, a decrease of approximately $789,000, primarily due
to a reduction in the cost of revenue related to the Company’s
grant related activities. Product cost of revenue was approximately
$4,759,000 and $4,624,000, respectively, for the six months ended
June 30, 2024 and 2023, an increase of approximately $135,000.
Gross margins on devices and device accessories were approximately
74% for the six months ended June 30, 2024 compared to
approximately 71% for the six months ended June 30, 2023. The
increase in product gross margin is due primarily to greater
efficiencies now being realized at our new manufacturing facility
in Princeton, New Jersey.
Research and Development
Expenses:
For the six months ended June 30, 2024, research
and development expenses were approximately $3,768,000 as compared
to research and development expenses of approximately $7,883,000
for the six months ended June 30, 2023, a decrease of approximately
$4,115,000. This decrease was due to a decrease in costs associated
with our clinical trial activities of approximately $2,753,000
related to the completion of the STAR-T clinical trial in December
2023. The six months ending June 30, 2023 included $919,000 of
non-recurring start-up costs associated with our new facility which
were not incurred in the six months ending June 30, 2024. Cost
savings measures resulted in decreased research and development
salaries of approximately $297,000, and decreased other spending of
approximately $146,000 in 2024.
Legal, Financial and Other Consulting
Expenses:
Legal, financial, and other consulting expenses
were approximately $1,501,000 for the six months ended June 30,
2024, as compared to approximately $1,854,000 for the six months
ended June 30, 2023. The decrease of approximately $353,000 was due
to a decrease in legal fees of approximately $285,000 and a
decrease in employment agency fees of approximately $178,000. These
decreases were offset by an increase in consulting fees of
approximately $108,000 and an increase in accounting and auditing
fees of approximately $2,000.
Selling, General and Administrative
Expenses:
Selling, general and administrative expenses
were approximately $16,148,000 for the six months ended June 30,
2024, as compared to $16,187,000 for the six months ended June 30,
2023, a decrease of approximately $39,000. This decrease was due to
a decrease in salaries, commissions and related costs of
approximately $721,000, a decrease in advertising costs of
approximately $192,000, a decrease in non-recurring facility
start-up costs of approximately $176,000, a decrease in occupancy
costs of approximately $140,000, and a decrease in other general
and administrative expenses of approximately $17,000. These
decreases were offset by an increase in non-cash stock compensation
expense of approximately $467,000, a reduction in grant spending
reduced the overhead absorption benefit to selling, general and
administrative expense by approximately $350,000, an increase in
royalty expense of approximately $134,000, an increase in travel
and entertainment expenses of approximately $112,000, an increase
in network maintenance costs of approximately $95,000, and an
increase in transfer agent fees of approximately $49,000.
Gain (Loss) on Foreign Currency
Transactions:
For the six months ended June 30, 2024, the loss
on foreign currency transactions was approximately $1,970,000 as
compared to a gain of approximately $1,076,000 for the six months
ended June 30, 2023. The 2024 loss was directly related to the
decrease in the spot exchange rate of the Euro to the U.S. dollar
as of June 30, 2024 as compared to December 31, 2023. The spot
exchange rate of the Euro to the U.S. dollar was $1.07 per Euro as
of June 30, 2024, as compared to $1.11 per Euro at December 31,
2023. The 2023 gain was directly related to the increase in the
spot exchange rate of the Euro to the U.S. dollar as of June 30,
2023 as compared to December 31, 2022. The spot exchange rate of
the Euro to the U.S. dollar was $1.09 per Euro as of June 30, 2023,
as compared to $1.07 per Euro at December 31, 2022.
Liquidity and Capital
Resources
Since inception, our operations have been
primarily financed through the issuance of debt and equity
securities. As of June 30, 2024, we had current assets of
approximately $21,955,000 and current liabilities of approximately
$10,336,000. As of June 30, 2024, $25 million of our total shelf
amount was allocated to our ATM facility, of which approximately
$20.3 million is still available. During the six months ended June
30, 2024, the Company sold 53,290 shares pursuant to the Sale
Agreement, at an average selling price of $1.03 per share,
generating net proceeds of approximately $53,200.
In June 2024, we closed on a $20 million
term-loan facility with Avenue Capital Group which provided an
initial tranche of $15 million at the closing of which $10 million
was immediately available at closing and $5 million constitutes
restricted cash subject to release to the Company prior to March
31, 2025, provided certain conditions are met. Another tranche of
$5 million may be disbursed at the Company’s request between July
1, 2025 and December 31, 2025, provided that the Company receives
FDA marketing approval of its DrugSorb-ATR application.
Concurrently with the closing of the first tranche, the Company
paid off our existing debt with Bridge Bank.
In March of 2024, we received approximately
$880,000 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 planned regulatory
submission of DrugSorb-ATR to U.S. FDA and Health Canada. We have
also instituted and continue to maintain tight control over
expenditures.
As of June 30, 2024 we have approximately $14.9
million in cash, including approximately $8.4 million and $6.5
million in unrestricted and restricted cash, respectively. With our
cost cutting efforts, we believe this is sufficient to fund the
Company’s operations into the second quarter of 2025. The Company
continues to pursue additional milestones related to its recently
announced Avenue debt facility that would increase its unrestricted
cash position by up to $10 million. If these milestones are not
achieved, we will need to raise additional capital to support our
ongoing operations in the future. Meanwhile the Company continues
to evaluate other traditional and alternative sources of capital,
including additional less or non-dilutive debt financing, royalty
financing, strategic or direct investments, equity financing,
and/or combinations thereof. There can be no assurance that
management will be successful in these endeavors.
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 76 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 antithrombotic drugs and
inflammatory mediators that can lead to postoperative
complications, including severe bleeding and multiple organ
failure. As of June 30, 2024, more than 248,000 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. CytoSorb
is not yet approved in the United States.
The DrugSorb™-ATR antithrombotic removal system,
an investigational device based on the same polymer technology as
CytoSorb, has 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
completed the FDA-approved, randomized, controlled STAR-T (Safe and
Timely Antithrombotic Removal-Ticagrelor) study of 140 patients at
approximately 30 centers in U.S. and Canada to
evaluate whether intraoperative use of DrugSorb-ATR can reduce the
perioperative risk of bleeding in patients receiving ticagrelor and
undergoing cardiothoracic surgery. This pivotal study is intended
to support U.S. FDA and Health Canada marketing
approval for DrugSorb-ATR in this application.
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
approximately $50 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™, 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 X.
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, representations and contentions, and the
timing of our expected regulatory submissions, 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 14, 2024, 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 CORPORATIONCONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS(amounts in thousands, except per share data) |
| |
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
| |
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
| Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
CytoSorb sales |
|
$ |
8,831 |
|
|
$ |
8,066 |
|
|
$ |
17,795 |
|
|
$ |
15,972 |
|
|
|
Other sales |
|
|
11 |
|
|
|
6 |
|
|
|
36 |
|
|
|
10 |
|
|
|
Total product sales |
|
|
8,842 |
|
|
|
8,072 |
|
|
|
17,831 |
|
|
|
15,982 |
|
|
|
Grant income |
|
|
1,053 |
|
|
|
1,349 |
|
|
|
1,850 |
|
|
|
2,888 |
|
|
| Total revenue |
|
|
9,895 |
|
|
|
9,421 |
|
|
|
19,681 |
|
|
|
18,870 |
|
|
| Cost of revenue |
|
|
3,392 |
|
|
|
3,402 |
|
|
|
6,608 |
|
|
|
7,396 |
|
|
| Gross profit |
|
|
6,503 |
|
|
|
6,019 |
|
|
|
13,073 |
|
|
|
11,474 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
1,520 |
|
|
|
3,669 |
|
|
|
3,768 |
|
|
|
7,883 |
|
|
|
Legal, financial and other consulting |
|
|
821 |
|
|
|
1,185 |
|
|
|
1,501 |
|
|
|
1,854 |
|
|
|
Selling, general and administrative |
|
|
7,581 |
|
|
|
7,724 |
|
|
|
16,148 |
|
|
|
16,188 |
|
|
| Total expenses |
|
|
9,922 |
|
|
|
12,578 |
|
|
|
21,417 |
|
|
|
25,925 |
|
|
| Loss from operations |
|
|
(3,419 |
) |
|
|
(6,559 |
) |
|
|
(8,344 |
) |
|
|
(14,451 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Interest income (expense),
net |
|
|
(180 |
) |
|
|
(9 |
) |
|
|
(187 |
) |
|
|
(72 |
) |
|
| Gain (loss) on foreign
currency transactions |
|
|
(544 |
) |
|
|
415 |
|
|
|
(1,970 |
) |
|
|
1,076 |
|
|
| Miscellaneous Income
(Expense) |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
(32 |
) |
|
| Total other income (expense),
net |
|
|
(724 |
) |
|
|
406 |
|
|
|
(2,157 |
) |
|
|
972 |
|
|
| Loss before benefit
from income taxes |
|
|
(4,143 |
) |
|
|
(6,153 |
) |
|
|
(10,501 |
) |
|
|
(13,479 |
) |
|
| Benefit from income taxes |
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
| Net loss |
|
$ |
(4,143 |
) |
|
$ |
(6,153 |
) |
|
$ |
(10,501 |
) |
|
$ |
(13,479 |
) |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Basic and diluted net loss per
common share |
|
$ |
(0.08 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.31 |
) |
|
| Weighted average number of
shares of common stock outstanding |
|
|
54,306,041 |
|
|
|
44,015,380 |
|
|
|
54,284,416 |
|
|
|
43,758,888 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Net loss |
|
$ |
(4,143 |
) |
|
$ |
(6,153 |
) |
|
$ |
(10,501 |
) |
|
$ |
(13,479 |
) |
|
| Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Currency translation adjustment |
|
|
421 |
|
|
|
(393 |
) |
|
|
1,644 |
|
|
|
(1,001 |
) |
|
| Comprehensive loss |
|
$ |
(3,722 |
) |
|
$ |
(6,546 |
) |
|
$ |
(8,857 |
) |
|
$ |
(14,480 |
) |
|
|
CYTOSORBENTS CORPORATIONCONDENSED CONSOLIDATED BALANCE
SHEETS(amounts in thousands) |
|
|
|
June 30, 2024 |
|
|
December 31, 2023 |
|
| ASSETS: |
|
|
|
|
|
|
| Current Assets: |
|
|
|
|
|
|
| Cash and cash
equivalents |
$ |
8,458 |
|
$ |
14,131 |
|
| Grants and accounts
receivable, net |
|
7,823 |
|
|
6,057 |
|
| Inventories |
|
4,317 |
|
|
3,680 |
|
| Prepaid expenses and
other current assets |
|
1,357 |
|
|
1,835 |
|
|
Total current assets |
|
21,955 |
|
|
25,703 |
|
| |
|
|
|
|
|
|
| Property and
equipment, net |
|
9,424 |
|
|
10,056 |
|
| Restricted Cash |
|
6,484 |
|
|
1,484 |
|
| Right of use
asset |
|
11,790 |
|
|
12,059 |
|
| Other assets |
|
3,774 |
|
|
3,959 |
|
|
TOTAL ASSETS |
$ |
53,427 |
|
$ |
53,261 |
|
| |
|
|
|
|
|
|
| LIABILITIES AND
STOCKHOLDERS’ EQUITY: |
|
|
|
|
|
|
| Current
Liabilities: |
|
|
|
|
|
|
| Accounts payable |
$ |
3,047 |
|
$ |
3,802 |
|
| Lease liability -
current portion |
|
412 |
|
|
374 |
|
| Accrued expenses and
other current liabilities |
|
6,877 |
|
|
7,870 |
|
| Current maturities of
long-term debt |
|
--- |
|
|
2,500 |
|
|
Total current liabilities |
|
10,336 |
|
|
14,546 |
|
| Lease liability, net
of current portion |
|
12,681 |
|
|
12,897 |
|
| Long-term debt |
|
13,673 |
|
|
2,543 |
|
|
TOTAL LIABILITIES |
|
36,690 |
|
|
29,986 |
|
| |
|
|
|
|
|
|
| Total stockholders’
equity |
|
16,737 |
|
|
23,275 |
|
| |
|
|
|
|
|
|
| TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
$ |
53,427 |
|
$ |
53,261 |
|
|
|
|
|
|
|
|
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U.S. Company Contact:Dr. Phillip Chan, CEO305
College Road EastPrinceton, NJ 08540pchan@cytosorbents.com
Investor Relations Contact:Eric RibnerLifeSci
Advisors, LLC250 W 55th St, #3401New York,
NY 10019ir@cytosorbents.com
CytoSorbents (NASDAQ:CTSO)
過去 株価チャート
から 10 2024 まで 11 2024
CytoSorbents (NASDAQ:CTSO)
過去 株価チャート
から 11 2023 まで 11 2024
