CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment
of life-threatening conditions in the intensive care unit and
cardiac surgery using blood purification, today reported unaudited
financial and operating results for the third quarter ended
September 30, 2024.
Third Quarter 2024 Financial Results
- Product revenue of $8.6 million,
11% growth versus $7.8 million in Q3 2023
- Total revenue of $9.4 million
inclusive of product and grant revenue, 7% growth versus $8.8
million in Q3 2023
- Product gross margins decreased to
61%, compared to 72% in Q3 2023, reflecting the impact of a planned
production slowdown to rebalance inventory and a short-term
manufacturing issue that is now resolved
- Net loss of $2.3 million or $0.04
per share, compared to net loss of $9.2 million or $0.21 per share
in Q3 2023
- Adjusted net loss improved to $4.5
million or $0.08 per share, compared to an adjusted net loss of
$6.0 million or $0.14 per share in Q3 2023
- Adjusted EBITDA loss improved to
$3.6 million compared to a loss of $5.6 million in Q3 2023
- Total cash, including cash, cash
equivalents, and restricted cash of $12.2 million, compared to
$14.9 million at the end of Q2 2024, reflecting an improvement of
cash used in the quarter of $2.7 million compared to $5.0 million
used in Q2 2024
“I am pleased with the progress we made this
quarter. Our topline performance is a testament to the improving
strength of our critical care and cardiac surgery businesses,
driven by solid execution from our direct sales team and
distributor network. In addition, our manufacturing is now running
smoothly with an expected return to more normalized production
levels and product gross margins in the fourth quarter of this
year.” stated Dr. Phillip Chan, Chief Executive Officer of
CytoSorbents. “Meanwhile, we believe that we have
significantly improved our operating metrics and continue to
demonstrate a disciplined approach to cash management. We believe
this will enable us to scale our business effectively with improved
operating leverage as we prepare for the commercial launch of
DrugSorb™-ATR in North America, if approved, and position ourselves
for the next phase of growth.”
Advancing Our DrugSorb-ATR Regulatory
and Commercial Strategy
Dr. Chan continued, “The
potential expansion of our markets to the U.S. and Canada with
DrugSorb-ATR could be game-changing. With the steady growth in our
CytoSorb business driving leverage in our operations, we have been
diligently executing on our regulatory strategy for DrugSorb-ATR
with the U.S. Food and Drug Administration (FDA) and Health
Canada.” We have:
- Submitted our DrugSorb-ATR De Novo application to the U.S. FDA
on September 27, 2024, and announced FDA acceptance and initiation
of substantive review of our application on October 22, 2024, which
is also eligible for priority review based on FDA Breakthrough
Device Designation
- Received Medical Device Single Audit Program (MDSAP)
certification on November 1, 2024, a key regulatory milestone that
certifies compliance of our quality management system with the
standard regulatory requirements of Canada, the U.S., Brazil,
Japan, and Australia. Importantly, U.S. FDA accepts MDSAP
certification and audit reports in lieu of their own routine Agency
inspections, if required
- Submitted our Medical Device License (MDL) marketing
application to Health Canada on November 1, 2024, concurrent with
MDSAP certification – a requirement for submission
Dr. Chan continued, “These are
key milestones that give us visibility on regulatory decisions by
FDA and Health Canada expected next year. We are confident that
DrugSorb-ATR has the ability to transform the current standard of
care in patients with acute coronary syndromes (ACS) treated with
the blockbuster blood thinner Brilinta® (ticagrelor, AstraZeneca)
by enabling safe and timely CABG surgery while eliminating
treatment delays that expose patients to additional risk and
consume valuable hospital resources. In doing so, we believe
DrugSorb-ATR represents a winning solution for patients, surgeons,
and hospitals.
The potential North American DrugSorb-ATR total
addressable market (TAM) in patients undergoing CABG surgery on
Brilinta® currently exceeds an estimated $300 million. Brilinta®
already enjoys a dominant market share in Canada due to ACS
treatment guidelines and is growing in dominance in the U.S. The
TAM is expected to grow to well over $600 million once Brilinta®
becomes generic and DrugSorb-ATR makes it the only reversible
orally administered antiplatelet drug; and with potential label
expansion to include other blood thinner categories including
direct oral anticoagulants and direct thrombin inhibitors that
could make DrugSorb-ATR an “all-in-one” countermeasure for these
agents. We further estimate that broadening the use of DrugSorb-ATR
to remove blood thinners in non-CABG cardiac surgeries, off-pump
CABG surgeries, or in other types of non-cardiac surgeries could
expand the total addressable market to $1-2 billion.
Although these are certainly large markets, be
assured that we have had years of both manufacturing and
commercialization experience in our core international markets and
are actively preparing to leverage this experience for our expected
North American launch.”
Dr. Chan concluded, “We believe
we have a simple and compelling value proposition. Our North
American DrugSorb-ATR opportunity is significant, and leverages the
experience of our international CytoSorb business which continues
to grow across 76 countries and is generating nearly $34 million in
trailing 12-month product sales at approximately 70% gross margins,
and is nearing cash flow breakeven. CytoSorb is generating exciting
clinical data through our STAR (Safe and
Timely Antithrombotic
Removal) and critical care COSMOS
(CytOSorb
TreatMent Of Critically Ill
PatientS) registries with results presented at
major scientific congresses. We are also witnessing a lot of
enthusiasm for our new PuriFi® hemoperfusion pump, launched at the
end of the second quarter 2024, with now many pump placements and
evaluations ongoing. Our global team is executing on our strategy
and positioning us well for this next stage of growth.”
About DrugSorb-ATR The goal of
DrugSorb-ATR, an investigational medical device, is to reduce the
severity of perioperative bleeding in patients on ticagrelor
(Brilinta®, AstraZeneca) undergoing coronary artery bypass graft
(CABG) surgery. Ticagrelor is a blood thinning drug frequently
administered in the hospital to patients suffering a heart attack.
If patients are not eligible for a coronary stent, they will often
require CABG surgery to restore blood flow to heart muscle. Current
guidelines recommend the delay of surgery by three to five days to
allow “washout” or natural elimination of the drug to reduce the
high risk of serious and potentially fatal perioperative bleeding
from the use of the blood thinner. We believe that DrugSorb-ATR
represents a breakthrough solution that will allow patients to
proceed with their much-needed CABG surgery in a safe and timely
manner rather than risking serious, potentially life-threatening
complications and consuming costly hospital resources while waiting
in the hospital for multiple days for ticagrelor to be naturally
eliminated from their system.
Q3 2024 Earnings Conference
CallThe Company will conduct its third quarter 2024
results call today at 4:30 p.m. Eastern time. Investors interested
in participating in the call by phone may do so by dialling (800)
715-987, passcode 9258825. Those interested in listening to the
conference call live via the internet may do so by utilizing the
following link https://edge.media-server.com/mmc/p/e9gv3iaw,
conference ID: 9258825. 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/.
About Non-GAAP Financial
Measures To supplement our condensed consolidated
financial statements, we use the non-GAAP financial measures of
EBITDA, which measures earnings before interest, income taxes,
depreciation and amortization, and Adjusted EBITDA which further
excludes non-cash stock compensation expense, and gain or loss of
foreign exchange translation. We also use the non-GAAP financial
measures of Adjusted Net Income or Loss and Adjusted Net Income or
Loss Per Common Share which excludes non-cash stock compensation
expense and gain or loss of foreign exchange translation from Net
Loss and Net Loss Per Common Share, respectively. These non-GAAP
measures are not based on any comprehensive set of accounting rules
or principles and should not be considered a substitute for, or
superior to, financial measures calculated in accordance with GAAP
and may be different from non-GAAP measures used by other
companies. In addition, these non-GAAP measures should be read in
conjunction with our financial statements prepared in accordance
with GAAP. The reconciliations of the non-GAAP measures to the most
directly comparable financial measures calculated and presented in
accordance with GAAP should be carefully evaluated. We use these
non-GAAP financial measures for financial and operational
decision-making and as a means to evaluate period-to-period
comparisons. We believe that these non-GAAP financial measures
provide meaningful supplemental information regarding our
performance and that both management and investors benefit from
referring to these non-GAAP financial measures in assessing our
performance and when planning, forecasting, and analyzing future
periods. We believe these non-GAAP financial measures are useful to
investors because (1) they allow for greater transparency with
respect to key metrics used by management in its financial and
operational decision-making and (2) they are used by investors and
the analyst community to help them analyze the performance of our
business, the Company’s cash available for operations, and the
Company’s ability to meet future capital expenditure and working
capital requirements.
About CytoSorbents Corporation (NASDAQ:
CTSO)CytoSorbents Corporation is a leader in the
treatment of life-threatening conditions in the intensive care unit
and cardiac surgery through blood purification. CytoSorbents’
proprietary blood 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. Cartridges filled with these beads can be
used with standard blood pumps already in the hospital (e.g.
dialysis, ECMO, heart-lung machines). CytoSorbents’ technologies
are used in a number of broad applications. Specifically, two
important applications are 1) the removal of blood thinners during
and after cardiothoracic surgery to reduce the risk of severe
bleeding and 2) the removal of inflammatory agents in common
critical illnesses such as sepsis, burn injury, trauma, lung
injury, liver failure, cytokine release syndrome, and pancreatitis
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.
CytoSorbents’ lead product, CytoSorb®, is
approved in the European Union and distributed in 76
countries worldwide, with more than a quarter million devices used
cumulatively to date. 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, to reduce
pro-inflammatory cytokine levels. CytoSorb is not yet approved
in the United States.
In the U.S. and Canada, CytoSorbents is
developing the DrugSorb™-ATR antithrombotic removal system, an
investigational device based on an equivalent polymer technology to
CytoSorb, to reduce the severity of perioperative bleeding in
high-risk surgery due to blood thinning drugs. It 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. In September 2024, the Company submitted
a De Novo medical device application to the U.S. FDA requesting
marketing approval to reduce the severity of perioperative bleeding
in CABG patients on the antithrombotic drug ticagrelor, which was
accepted for substantive review in October 2024. In November 2024,
the Company received its Medical Device Single Audit Program
(MDSAP) certification and submitted its Medical Device License
(MDL) application to Health Canada. DrugSorb-ATR is not yet granted
or approved in the United States and Canada, respectively.
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 website at https://ir.cytosorbents.com/ or follow us
on Facebook and X.
Forward-Looking StatementsThis
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 outcome
of our 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.
Please Click to Follow Us on
Facebook and
X
U.S. Company Contact:Peter J. Mariani, Chief
Financial Officer305 College Road EastPrinceton, NJ
08540pmariani@cytosorbents.com
Investor Relations Contact:Aman Patel, CFA
Investor Relations, ICR-Westwicke (443)
450-4191ir@cytosorbents.com
CYTOSORBENTS CORPORATIONCONSOLIDATED
BALANCE SHEETS |
|
|
September 30, |
|
|
|
|
2024 |
|
|
|
December 31, |
|
|
(Unaudited) |
|
2023 |
|
|
|
|
|
ASSETS |
|
|
|
|
|
Current Assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
5,685,328 |
|
|
$ |
14,131,137 |
|
Grants and accounts
receivable, net of allowance of $160,246 as of September 30, 2024
and $49,663 at December 31, 2023 |
|
6,632,590 |
|
|
|
6,057,072 |
|
Inventories |
|
3,247,756 |
|
|
|
3,680,129 |
|
Prepaid expenses and other
current assets |
|
1,031,694 |
|
|
|
1,834,485 |
|
Total current
assets |
|
16,597,368 |
|
|
|
25,702,823 |
|
|
|
|
|
|
|
Property and equipment,
net |
|
9,269,899 |
|
|
|
10,056,354 |
|
Restricted cash |
|
6,483,958 |
|
|
|
1,483,958 |
|
Right-of-use assets |
|
11,651,563 |
|
|
|
12,058,896 |
|
Other assets |
|
3,801,223 |
|
|
|
3,958,603 |
|
Total
Assets |
$ |
47,804,011 |
|
|
$ |
53,260,634 |
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,338,143 |
|
|
$ |
3,802,170 |
|
Current maturities of
long-term debt |
|
--- |
|
|
|
2,500,000 |
|
Lease liability – current
portion |
|
431,997 |
|
|
|
373,636 |
|
Accrued expenses and other
current liabilities |
|
5,660,051 |
|
|
|
7,870,149 |
|
Total current
liabilities |
|
8,430,191 |
|
|
|
14,545,955 |
|
Lease liability, net of
current portion |
|
12,568,745 |
|
|
|
12,896,659 |
|
Long-term debt |
|
13,805,985 |
|
|
|
2,542,857 |
|
Total
Liabilities |
|
34,804,921 |
|
|
|
29,985,471 |
|
|
|
|
|
|
|
Commitments and Contingencies
(Note 6) |
|
|
|
|
|
Stockholders’
Equity: |
|
|
|
|
|
Preferred Stock, Par Value
$0.001, 5,000,000 shares authorized; no shares issued and
outstanding at September 30, 2024 and December 31, 2023 |
|
— |
|
|
|
— |
|
Common Stock, Par Value
$0.001, 100,000,000 shares authorized; 54,500,613 and 54,240,265
shares issued and outstanding as of September 30, 2024 and December
31, 2023, respectively |
|
54,498 |
|
|
|
54,240 |
|
Additional paid-in
capital |
|
308,441,887 |
|
|
|
305,196,874 |
|
Accumulated other
comprehensive income |
|
(156,925 |
) |
|
|
529,321 |
|
Accumulated deficit |
|
(295,340,370 |
) |
|
|
(282,505,272 |
) |
Total Stockholders’
Equity |
|
12,999,090 |
|
|
|
23,275,163 |
|
Total Liabilities and
Stockholders’ Equity |
$ |
47,804,011 |
|
|
$ |
53,260,634 |
|
See accompanying notes to consolidated financial
statements.
CYTOSORBENTS CORPORATIONCONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
|
(Unaudited) |
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
CytoSorb sales |
$ |
8,586,274 |
|
|
$ |
7,709,085 |
|
|
$ |
26,381,455 |
|
|
$ |
23,681,183 |
|
Other product sales |
|
26,521 |
|
|
|
44,931 |
|
|
|
62,649 |
|
|
|
55,285 |
|
Total product sales |
|
8,612,795 |
|
|
|
7,754,016 |
|
|
|
26,444,104 |
|
|
|
23,736,468 |
|
Grant income |
|
777,593 |
|
|
|
1,056,831 |
|
|
|
2,627,212 |
|
|
|
3,944,696 |
|
Total revenue |
|
9,390,388 |
|
|
|
8,810,847 |
|
|
|
29,071,316 |
|
|
|
27,681,164 |
|
Cost of revenue |
|
4,108,773 |
|
|
|
3,203,981 |
|
|
|
10,716,394 |
|
|
|
10,600,421 |
|
Gross profit |
|
5,281,615 |
|
|
|
5,606,866 |
|
|
|
18,354,922 |
|
|
|
17,080,743 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
1,851,230 |
|
|
|
3,749,197 |
|
|
|
5,619,040 |
|
|
|
11,632,416 |
|
Legal, financial and other consulting |
|
823,914 |
|
|
|
1,103,475 |
|
|
|
2,325,351 |
|
|
|
2,957,738 |
|
Selling, general and administrative |
|
7,002,718 |
|
|
|
8,104,392 |
|
|
|
23,151,118 |
|
|
|
24,358,417 |
|
Total expenses |
|
9,677,862 |
|
|
|
12,957,064 |
|
|
|
31,095,509 |
|
|
|
38,948,571 |
|
Loss from operations |
|
(4,396,247 |
) |
|
|
(7,350,198 |
) |
|
|
(12,740,587 |
) |
|
|
(21,867,828 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense),
net |
|
(588,153 |
) |
|
|
(33,670 |
) |
|
|
(774,903 |
) |
|
|
(105,662 |
) |
Gain (loss) on foreign
currency transactions |
|
2,650,309 |
|
|
|
(1,809,652 |
) |
|
|
680,392 |
|
|
|
(733,997 |
) |
Miscellaneous income
(expense) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
35,000 |
|
Total other income (expense),
net |
|
2,062,156 |
|
|
|
(1,843,322 |
) |
|
|
(94,511 |
) |
|
|
(804,659 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Loss before benefit from
income taxes |
|
(2,334,091 |
) |
|
|
(9,193,520 |
) |
|
|
(12,835,098 |
) |
|
|
(22,672,487 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders |
$ |
(2,334,091 |
) |
|
$ |
(9,193,520 |
) |
|
$ |
(12,835,098 |
) |
|
$ |
(22,672,487 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per
common share |
$ |
(0.04 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares of common stock outstanding |
|
54,453,006 |
|
|
|
44,373,969 |
|
|
|
54,340,583 |
|
|
|
44,024,483 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(2,334,091 |
) |
|
$ |
(9,193,520 |
) |
|
$ |
(12,835,098 |
) |
|
$ |
(22,672,487 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
(2,330,743 |
) |
|
|
1,655,674 |
|
|
|
(686,246 |
) |
|
|
654,792 |
|
Comprehensive loss |
$ |
(4,664,834 |
) |
|
$ |
(7,537,846 |
) |
|
$ |
(13,521,344 |
) |
|
$ |
(22,017,695 |
) |
See accompanying notes to consolidated financial
statements.
CYTOSORBENTS CORPORATIONCONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITYFor
the three and nine months ended September 30, 2024 and 2023
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
|
|
|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders’ |
|
Shares |
|
Par value |
|
Capital |
|
Income (Loss) |
|
Deficit |
|
Equity |
Balance at June 30, 2024 |
54,306,415 |
|
$ |
54,306 |
|
$ |
307,514,758 |
|
|
$ |
2,173,818 |
|
|
$ |
(293,006,279 |
) |
|
$ |
16,736,603 |
|
Stock-based compensation -
employees, consultants and directors |
— |
|
|
— |
|
|
781,881 |
|
|
|
— |
|
|
|
— |
|
|
|
781,881 |
|
Other comprehensive loss: foreign
translation adjustment |
— |
|
|
— |
|
|
— |
|
|
|
(2,330,743 |
) |
|
|
— |
|
|
|
(2,330,743 |
) |
ATM Activation Fees |
— |
|
|
— |
|
|
(41,444 |
) |
|
|
— |
|
|
|
— |
|
|
|
(41,444 |
) |
Issuance of restricted stock
units |
194,198 |
|
|
192 |
|
|
186,692 |
|
|
|
— |
|
|
|
— |
|
|
|
186,884 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(2,334,091 |
) |
|
|
(2,334,091 |
) |
Balance at
September 30, 2024 |
54,500,613 |
|
$ |
54,498 |
|
$ |
308,441,887 |
|
|
$ |
(156,925 |
) |
|
$ |
(295,340,370 |
) |
|
$ |
12,999,090 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2023 |
54,240,265 |
|
$ |
54,240 |
|
$ |
305,196,874 |
|
|
$ |
529,321 |
|
|
$ |
(282,505,272 |
) |
|
$ |
23,275,163 |
|
Stock-based compensation -
employees, consultants and directors |
— |
|
|
— |
|
|
2,344,671 |
|
|
|
— |
|
|
|
— |
|
|
|
2,344,671 |
|
Other comprehensive loss: foreign
translation adjustment |
— |
|
|
— |
|
|
— |
|
|
|
(686,246 |
) |
|
|
— |
|
|
|
(686,246 |
) |
Issuance of common stock
offerings, net of fees |
53,290 |
|
|
53 |
|
|
11,741 |
|
|
|
— |
|
|
|
— |
|
|
|
11,794 |
|
Warrants Issued in connection
with long term debt |
— |
|
|
— |
|
|
690,709 |
|
|
|
— |
|
|
|
— |
|
|
|
690,709 |
|
Issuance of restricted stock
units |
207,058 |
|
|
205 |
|
|
197,892 |
|
|
|
— |
|
|
|
— |
|
|
|
198,097 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(12,835,098 |
) |
|
|
(12,835,098 |
) |
Balance at
September 30, 2024 |
54,500,613 |
|
$ |
54,498 |
|
$ |
308,441,887 |
|
|
$ |
(156,925 |
) |
|
$ |
(295,340,370 |
) |
|
$ |
12,999,090 |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
|
|
|
|
Common Stock |
|
Paid-In |
|
Comprehensive |
|
Accumulated |
|
Stockholders’ |
|
Shares |
|
Par value |
|
Capital |
|
Income (Loss) |
|
Deficit |
|
Equity |
Balance at June 30, 2023 |
44,193,696 |
|
$ |
44,193 |
|
$ |
290,199,035 |
|
|
$ |
1,328,313 |
|
|
$ |
(267,476,845 |
) |
|
$ |
24,094,696 |
|
Stock-based compensation -
employees, consultants and directors |
— |
|
|
— |
|
|
1,086,163 |
|
|
|
— |
|
|
|
— |
|
|
|
1,086,163 |
|
Other comprehensive loss: foreign
translation adjustment |
— |
|
|
— |
|
|
— |
|
|
|
1,655,674 |
|
|
|
— |
|
|
|
1,655,674 |
|
Issuance of common stock
offerings, net of fees |
162,078 |
|
|
162 |
|
|
632,232 |
|
|
|
— |
|
|
|
— |
|
|
|
632,394 |
|
Proceeds from exercise of stock
options for cash |
7,962 |
|
|
9 |
|
|
15,920 |
|
|
|
— |
|
|
|
— |
|
|
|
15,929 |
|
Issuance of restricted stock
units |
74,773 |
|
|
75 |
|
|
220,211 |
|
|
|
— |
|
|
|
— |
|
|
|
220,286 |
|
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(9,193,520 |
) |
|
|
(9,193,520 |
) |
Balance at September 30,
2023 |
44,438,509 |
|
$ |
44,439 |
|
$ |
292,153,561 |
|
|
$ |
2,983,987 |
|
|
$ |
(276,670,365 |
) |
|
$ |
18,511,622 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2022 |
43,635,715 |
|
$ |
43,635 |
|
$ |
287,000,021 |
|
|
$ |
2,329,195 |
|
|
$ |
(253,997,878 |
) |
|
$ |
35,374,973 |
|
Stock-based compensation -
employees, consultants and directors |
— |
|
|
— |
|
|
2,486,679 |
|
|
|
— |
|
|
|
— |
|
|
|
2,486,679 |
|
Other comprehensive income:
foreign translation adjustment |
— |
|
|
— |
|
|
— |
|
|
|
654,792 |
|
|
|
— |
|
|
|
654,792 |
|
Issuance of common stock
offerings, net of fees |
590,348 |
|
|
591 |
|
|
2,106,528 |
|
|
|
— |
|
|
|
— |
|
|
|
2,107,119 |
|
Proceeds from exercise of stock
options for cash |
82,355 |
|
|
83 |
|
|
213,224 |
|
|
|
— |
|
|
|
— |
|
|
|
213,307 |
|
Issuance of restricted stock
units |
130,091 |
|
|
130 |
|
|
403,811 |
|
|
|
— |
|
|
|
— |
|
|
|
403,941 |
|
Legal/audit fees related to ATM
offering |
— |
|
|
— |
|
|
(56,702 |
) |
|
|
— |
|
|
|
— |
|
|
|
(56,702 |
) |
Net loss |
— |
|
|
— |
|
|
— |
|
|
|
— |
|
|
|
(22,672,487 |
) |
|
|
(22,672,487 |
) |
Balance at September 30,
2023 |
44,438,509 |
|
$ |
44,439 |
|
$ |
292,153,561 |
|
|
$ |
2,983,987 |
|
|
$ |
(276,670,365 |
) |
|
$ |
18,511,622 |
|
See accompanying notes to consolidated financial
statements.
CYTOSORBENTS CORPORATIONRECONCILIATION OF
GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL
MEASURESFor the three and nine months ended
September 30, 2024 and 2023 (Unaudited) |
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
Sep 30, |
|
Sep 30, |
|
Sep 30, |
|
Sep 30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
Net
loss |
$ |
(2,334 |
) |
|
$ |
(9,194 |
) |
|
$ |
(12,835 |
) |
|
$ |
(22,672 |
) |
Depreciation and amortization
expense |
|
381 |
|
|
|
402 |
|
|
|
1,180 |
|
|
|
1,062 |
|
Income tax expense (benefit) |
|
-- |
|
|
|
-- |
|
|
|
-- |
|
|
|
-- |
|
Interest expense (income) |
|
588 |
|
|
|
34 |
|
|
|
775 |
|
|
|
106 |
|
EBITDA
- non GAAP |
$ |
(1,365 |
) |
|
$ |
(8,758 |
) |
|
$ |
(10,880 |
) |
|
$ |
(21,505 |
) |
Non cash stock-based compensation
expense |
|
458 |
|
|
|
1,372 |
|
|
|
2,220 |
|
|
|
2,667 |
|
(Gain)/Loss on foreign currency translation |
|
(2,650 |
) |
|
|
1,810 |
|
|
|
(680 |
) |
|
|
734 |
|
Adjusted
EBITDA - non
GAAP |
$ |
(3,557 |
) |
|
$ |
(5,576 |
) |
|
$ |
(9,341 |
) |
|
$ |
(18,103 |
) |
Net
loss |
$ |
(2,334 |
) |
|
$ |
(9,194 |
) |
|
$ |
(12,835 |
) |
|
$ |
(22,672 |
) |
Non cash stock-based compensation
expense |
|
458 |
|
|
|
1,372 |
|
|
|
2,220 |
|
|
|
2,667 |
|
(Gain)/Loss on foreign currency
translation |
|
(2,650 |
) |
|
|
1,810 |
|
|
|
(680 |
) |
|
|
734 |
|
Adjusted
net income
(loss) - non
GAAP |
$ |
(4,526 |
) |
|
$ |
(6,012 |
) |
|
$ |
(11,296 |
) |
|
$ |
(19,271 |
) |
Weighted
average common
shares outstanding
basic and diluted |
|
54,453,006 |
|
|
|
44,373,969 |
|
|
|
54,340,583 |
|
|
|
44,024,483 |
|
Loss
per common share
— basic and
diluted |
$ |
(0.04 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.52 |
) |
Non cash stock-based compensation
expense |
$ |
0.01 |
|
|
$ |
0.03 |
|
|
$ |
0.04 |
|
|
$ |
0.06 |
|
(Gain)/Loss on foreign currency
translation |
$ |
(0.05 |
) |
|
$ |
0.04 |
|
|
$ |
(0.01 |
) |
|
$ |
0.02 |
|
Adjusted
net income (loss) per
common share - basic
and |
|
|
|
|
|
|
|
diluted
- non GAAP |
$ |
(0.08 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.45 |
) |
CYTOSORBENTS CORPORATIONHISTORICAL
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL
MEASURESFor Year-ended Dec 31, 2023 |
|
|
Mar 31, |
June 30, |
Sep 30, |
Dec 31, |
Full Year |
|
|
2023 |
|
|
2023 |
|
|
2023 |
|
|
2023 |
|
|
2023 |
|
(In thousands, except per share
amounts) |
|
|
|
|
|
Net
loss |
$ |
(7,326 |
) |
$ |
(6,153 |
) |
$ |
(9,194 |
) |
$ |
(5,835 |
) |
$ |
(28,507 |
) |
Depreciation and amortization
expense |
|
258 |
|
|
402 |
|
|
402 |
|
|
397 |
|
|
1,459 |
|
Income tax expense (benefit) |
|
-- |
|
|
-- |
|
|
-- |
|
|
(814 |
) |
|
(814 |
) |
Interest expense (income) |
|
63 |
|
|
9 |
|
|
34 |
|
|
52 |
|
|
158 |
|
EBITDA
- non GAAP |
$ |
(7,005 |
) |
$ |
(5,742 |
) |
$ |
(8,758 |
) |
$ |
(6,200 |
) |
$ |
(27,704 |
) |
Non cash stock-based compensation
expense |
|
1,080 |
|
|
215 |
|
|
1,372 |
|
|
1,053 |
|
|
3,720 |
|
(Gain)/Loss on foreign currency translation |
|
(661 |
) |
|
(415 |
) |
|
1,810 |
|
|
(2,683 |
) |
|
(1,949 |
) |
Adjusted
EBITDA - non
GAAP |
$ |
(6,585 |
) |
$ |
(5,942 |
) |
$ |
(5,576 |
) |
$ |
(7,830 |
) |
$ |
(25,933 |
) |
Net
loss |
$ |
(7,326 |
) |
$ |
(6,153 |
) |
$ |
(9,194 |
) |
$ |
(5,835 |
) |
$ |
(28,507 |
) |
Non cash stock-based compensation
expense |
|
1,080 |
|
|
215 |
|
|
1,372 |
|
|
1,053 |
|
|
3,720 |
|
(Gain)/Loss on foreign currency
translation |
|
(661 |
) |
|
(415 |
) |
|
1,810 |
|
|
(2,683 |
) |
|
(1,949 |
) |
Adjusted
net income
(loss) - non
GAAP |
$ |
(6,906 |
) |
$ |
(6,354 |
) |
$ |
(6,012 |
) |
$ |
(7,465 |
) |
$ |
(26,736 |
) |
Weighted
average common
shares outstanding
basic and diluted |
|
43,676,435 |
|
|
44,015,380 |
|
|
44,373,969 |
|
|
46,531,510 |
|
|
44,656,391 |
|
Loss
per common share
— basic and
diluted |
$ |
(0.17 |
) |
$ |
(0.14 |
) |
$ |
(0.21 |
) |
$ |
(0.13 |
) |
$ |
(0.64 |
) |
Non cash stock-based compensation
expense |
$ |
0.02 |
|
$ |
0.00 |
|
$ |
0.03 |
|
$ |
0.02 |
|
$ |
0.08 |
|
(Gain)/Loss on foreign currency
translation |
$ |
(0.02 |
) |
$ |
(0.01 |
) |
$ |
0.04 |
|
$ |
(0.06 |
) |
$ |
(0.04 |
) |
Adjusted
net income (loss) per
common share - basic
and |
|
|
|
|
|
diluted
- non GAAP |
$ |
(0.16 |
) |
$ |
(0.14 |
) |
$ |
(0.14 |
) |
$ |
(0.16 |
) |
$ |
(0.60 |
) |
CYTOSORBENTS CORPORATIONHISORICAL
RECONCILIATION OF GAAP FINANCIAL MEASURES TO NON-GAAP FINANCIAL
MEASURESFor year to date, 2024
(Unaudited) |
|
|
QTD ENDED |
YTD ENDED |
|
Mar 31, |
Jun 30, |
Sep 30, |
Sep 30, |
|
|
2024 |
|
|
2024 |
|
|
2024 |
|
|
2024 |
|
(In thousands, except per share
amounts) |
|
|
|
|
Net
loss |
$ |
(6,358 |
) |
$ |
(4,143 |
) |
$ |
(2,334 |
) |
$ |
(12,835 |
) |
Depreciation and amortization
expense |
|
396 |
|
|
403 |
|
|
381 |
|
|
1,180 |
|
Income tax expense (benefit) |
|
-- |
|
|
-- |
|
|
-- |
|
|
-- |
|
Interest expense (income) |
|
7 |
|
|
180 |
|
|
588 |
|
|
775 |
|
EBITDA
- non GAAP |
$ |
(5,955 |
) |
$ |
(3,560 |
) |
$ |
(1,365 |
) |
$ |
(10,880 |
) |
Non cash stock-based compensation
expense |
|
924 |
|
|
838 |
|
|
458 |
|
|
2,220 |
|
(Gain)/Loss on foreign currency
translation |
|
1,426 |
|
|
544 |
|
|
(2,650 |
) |
|
(680 |
) |
Adjusted
EBITDA - non
GAAP |
$ |
(3,605 |
) |
$ |
(2,179 |
) |
$ |
(3,557 |
) |
$ |
(9,341 |
) |
Net
loss |
$ |
(6,358 |
) |
$ |
(4,143 |
) |
$ |
(2,334 |
) |
$ |
(12,835 |
) |
Non cash stock-based compensation
expense |
|
924 |
|
|
838 |
|
|
458 |
|
|
2,220 |
|
(Gain)/Loss on foreign currency translation |
|
1,426 |
|
|
544 |
|
|
(2,650 |
) |
|
(680 |
) |
Adjusted
net income
(loss) - non
GAAP |
$ |
(4,008 |
) |
$ |
(2,761 |
) |
$ |
(4,526 |
) |
$ |
(11,296 |
) |
Weighted
average common
shares outstanding
basic and diluted |
|
54,262,790 |
|
|
54,306,041 |
|
|
54,453,006 |
|
|
54,340,583 |
|
Loss
per common share
— basic and
diluted |
$ |
(0.12 |
) |
$ |
(0.08 |
) |
$ |
(0.04 |
) |
$ |
(0.24 |
) |
Non cash stock-based compensation
expense |
$ |
0.02 |
|
$ |
0.02 |
|
$ |
0.01 |
|
$ |
0.04 |
|
(Gain)/Loss on foreign currency
translation |
$ |
0.03 |
|
$ |
0.01 |
|
$ |
(0.05 |
) |
$ |
(0.01 |
) |
Adjusted
net income (loss) per
common share - basic
and |
|
|
|
|
diluted
- non GAAP |
$ |
(0.07 |
) |
$ |
(0.05 |
) |
$ |
(0.08 |
) |
$ |
(0.21 |
) |
CytoSorbents (NASDAQ:CTSO)
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