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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
May 9, 2024
CYTOSORBENTS CORPORATION
(Exact name of registrant as specified in
its charter)
Delaware |
|
001-36792 |
|
98-0373793 |
(State or other jurisdiction of
incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
305
College Road East
Princeton, New Jersey |
08540 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (732) 329-8885
Not Applicable
|
(Former name or former address, if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
|
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
common stock, $0.001 par value |
CTSO |
The Nasdaq Stock Market LLC (Nasdaq Capital Market) |
Indicate by check mark whether the registrant
is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2
of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging Growth Company ¨
If an emerging growth company, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Item 2.02 |
Results of Operation and Financial Condition |
On May 9, 2024, CytoSorbents
Corporation (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2024.
A copy of the press release is furnished herewith as Exhibit 99.1.*
(d) Exhibits
* The information in Item 2.02 of this Form 8-K shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or
otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities
Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: May 9, 2024 |
CYTOSORBENTS CORPORATION |
|
|
|
|
By: |
/s/ Dr. Phillip P. Chan |
|
Name: |
Dr. Phillip P. Chan |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
CytoSorbents Reports First Quarter 2024 Results
| · | Product Sales up a robust 14% over prior year, and a significant 22% sequentially |
| · | Enhanced profitability with gross margins that surged an absolute 8% to reach 76%, reflecting stronger operational efficiencies
|
| · | STAR-T data presented at AATS support a favorable benefit-to-risk profile of DrugSorb-ATR in coronary artery bypass graft (CABG)
patients |
| · | On track for U.S. Food and Drug Administration (FDA) De Novo and Health Canada submissions for DrugSorb®-ATR in Q3 2024 |
PRINCETON, N.J., May 9, 2024 — 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 March 31, 2024. The company reported a robust 14% increase in product sales year
over year and a sequential increase of 22%.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents
stated, “We are pleased to announce a strong start to 2024, driven by significant sales growth and operational efficiencies. First
quarter 2024 product sales were $9.0 million, marking the highest quarter for core CytoSorb sales in nearly 3 years. We expanded our product
gross margins to 76%, exclusive of a non-recurring inventory adjustment, up an absolute 8% from Q1 2023, which we believe highlights the
scalability and efficiency of our state-of-the-art manufacturing facility and processes.
Furthermore, Principal Investigator Dr. Michael
Mack presented the results of the U.S. and Canada pivotal STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized controlled
trial at the Annual Meeting of the American Association for Thoracic Surgery (AATS) and at the KOL
and Investor/Analyst Day we hosted earlier this week (replay available)
that we believe support a favorable benefit-to-risk profile of the DrugSorb-ATR system* in the perioperative bleeding risk of patients
undergoing isolated CABG surgery within 2 days of receiving Brilinta® (ticagrelor, AstraZeneca). We received positive and encouraging
feedback on the strength and clinical importance of these data and the continued unmet medical need from cardiothoracic surgeons. Looking
ahead, we expect to submit marketing applications for DrugSorb-ATR, which has an FDA Breakthrough Device Designation, to the FDA under
the De Novo pathway and Health Canada in the third quarter of 2024.
Additionally, we expect to take delivery of and
launch our PuriFi™ hemoperfusion pump in select international countries for which we already have strong interest – a key
2024 growth initiative. We continue to work to strengthen our balance sheet and reduce operating expenses while executing our strategic
plan towards these upcoming milestones.”
First Quarter 2024 Financial Results
| · | Q1 2024 product sales were $9.0 million versus $7.9 million in Q1 2023, an increase of 14%, and up 22%
sequentially from $7.3 million in Q4 2023 |
| · | Total revenue, including product sales and grant income, for Q1 2024 was $9.8 million, an increase of
4% compared to $9.4 million in Q1 2023 |
| · | Q1 2024 product gross margins increased to approximately 76%, (excluding the impact of a one-time, non-recurring
inventory adjustment of approximately $304,000 which was recorded in the first quarter of 2024) compared to 68% in Q1 2023 due primarily
to greater efficiencies now being realized at our new manufacturing facility in Princeton, New Jersey |
Recent Operating Highlights
| • | Cumulative
CytoSorb® treatments delivered exceeded 237,000 at the end of Q1 2024, up 19% from a year ago |
| • | Pivotal
U.S. and Canada STAR-T Trial |
| ○ | Results
from the pivotal STAR-T randomized controlled trial were presented by Principal Investigator
Dr. Michael Mack at a Breakout Oral Presentation at the American Association for Thoracic
Surgery (AATS) Annual
Meeting in Toronto, Canada on April 28, 2024. We believe the data support a favorable benefit-to-risk
profile for the DrugSorb-ATR system in reducing the risk of severe perioperative bleeding
in patients undergoing isolated CABG surgery on Brilinta® |
| ○ | Hosted
a KOL and Analyst/Investor webcast on May 6, 2024 reviewing the
results of the pivotal STAR-T randomized trial, featuring presentations by all three study Principal Investigators: Drs. Michael Mack,
Michael Gibson, and Richard Whitlock. Additional insights into real-world usage in Europe for blood thinners removal including data from
the International STAR Registry were presented by Dr. Michael Schmoeckel |
Upcoming Milestones
| • | Based on the guidance of internal and external regulatory experts, we
are planning submissions of our DrugSorb®-ATR system for marketing approval to the FDA under the De Novo pathway leveraging our Breakthrough
Device Designation, and to Health Canada in Q3 2024. Based on standard and published FDA timelines, and that FDA Breakthrough Devices
receive priority review, a decision on FDA De Novo clearance could potentially range between 6-12 months following submission |
| • | Expect
to commercially launch the new PuriFi® stand-alone hemoperfusion pump in Q2 2024 in select international countries |
| • | We
are in active discussions with a number of debt providers to obtain non-dilutive debt financing to strengthen our balance sheet and plan
to provide an update when appropriate |
*Disclaimer: The DrugSorb-ATR system is
an investigational device that is not yet cleared/approved by FDA, Health Canada, or by any other Global Regulatory Agency and is not
commercially available for sale.
Earnings Call Webcast Details:
Date: Thursday, May 9th, 2024
Time: 4:30 PM EDT
Live webcast link: https://edge.media-server.com/mmc/p/yv8wd3bs
Conference ID: 5517203
Participant Dial-In:
Participant Dial-in toll-free: (888) 596-4144
Passcode: 5517203
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/
For additional information, please see the Company’s Form 10-Q
for the period ended March 31, 2024, filed on May 9, 2024, on http://www.sec.gov.
Results of Operations
Comparison of the three months ended March
31, 2024, and March 31, 2023
Revenues:
Revenue from product sales was approximately $8,990,000
in the three months ended March 31, 2024, as compared to approximately $7,910,000 in the three months ended March 31, 2023, an increase
of approximately $1,080,000, or 14%. Distributor sales increased approximately $614,000, or 20%. Direct sales increased approximately
$466,000, or 10%. As a result of the increase in the average exchange rate of the Euro to the U.S. dollar, 2024 product sales were positively
impacted by approximately $98,000. For the three months ended March 31, 2024, the average exchange rate of the Euro to the U.S. dollar
was $1.09 as compared to an average exchange rate of $1.07 for the three months ended March 31, 2023.
Grant income was approximately $797,000 for the
three months ended March 31, 2024 as compared to approximately $1,539,000 for the three months ended March 31, 2023, a decrease of approximately
$742,000, or 48%. This decrease was due to the completion of several grants during 2023.
Total revenues were approximately $9,786,000 for
the three months ended March 31, 2024, as compared to total revenues of approximately $9,449,000 for the three months ended March 31,
2023, an increase of approximately $337,000, or 4%.
Cost of Revenues:
For the three months ended March 31, 2024, and
2023, cost of revenue was approximately $3,216,000 and $3,994,000, respectively, a decrease of approximately $778,000. This decrease was
primarily due to the decrease in cost of revenue related to the Company’s grant related activities following the completion of several
grants in 2023. Product cost of revenue was approximately $2,420,000 and $2,531,000, respectively, for the three months ended March 31,
2024 and 2023, a decrease of approximately $111,000. This decrease is due primarily to greater efficiencies now being realized at our
new manufacturing facility in Princeton, New Jersey. Product gross margins were approximately 76% during the three months ended March
31, 2024 (which excludes the impact of a one-time, non-recurring inventory adjustment of approximately $304,000 recorded in the first
quarter of 2024), as compared to 68% during the three months ended March 31, 2023.
Research and Development Expenses:
For the three months ended March 31, 2024, research
and development expenses were approximately $2,248,000 as compared to research and development expenses of approximately $4,214,000 for
the three months ended March 31, 2023, a decrease of approximately $1,966,000. This decrease was due to a decrease in clinical trial costs
of approximately $911,000 related to completion of the STAR-T trial in 2023, a decrease of approximately $850,000 in start-up expenses
related to the new facility that were incurred in the first quarter of 2023 that did not recur in the first quarter of 2024, a decrease
in non-grant related salaries of approximately $127,000 and a decrease in other non-grant related research and development activities
of approximately $78,000.
Legal, Financial and Other Consulting Expenses:
Legal, financial and other consulting expenses
were approximately $681,000 for the three months ended March 31, 2024, as compared to approximately $669,000 for the three months ended
March 31, 2023, an increase of approximately $12,000. This increase was due to an increase in accounting and auditing fees of approximately
$46,000 and an increase in legal fees of approximately $30,000. These increases were offset by a decrease in employment agency fees of
approximately $58,000 and a decrease in consulting fees of approximately $6,000.
Selling, General and Administrative Expenses:
Selling, general and administrative expenses were
approximately $8,567,000 for the three months ended March 31, 2024, as compared to approximately $8,463,000 for the three months ending
March 31, 2023, an increase of approximately $104,000. This increase was due to an increase in travel and entertainment expenses of approximately
$132,000, an increase in royalty expense of $88,000, an increase in sales and marketing costs, which include advertising and conference
attendance, of approximately $80,000. These increases were offset by decreases in non-cash stock compensation expense (which includes
both stock options and restricted stock units) of approximately $156,000, and a decrease in salaries, commissions and related costs of
approximately $40,000.
Gain (Loss) on Foreign Currency Transactions:
For the three months ended March 31, 2024, the
loss on foreign currency transactions was approximately $1,426,000 as compared to a gain of approximately $661,000 for the three months
ended March 31, 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
March 31, 2024 as compared to December 31, 2023. The spot exchange rate of the Euro to the U.S. dollar was $1.08 per Euro as of March
31, 2024, as compared to $1.11 per Euro as of December 31, 2023.
Liquidity and Capital Resources
Since inception, our operations have been primarily
financed through the issuance of debt and equity securities. As of March 31, 2024, we had current assets of approximately $19,993,000
and current liabilities of approximately $13,424,000. As of March 31, 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 three months ended March 31, 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 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 U.S. pivotal STAR-T trial, which includes the detailed analysis of trial data and the preparation
of our application for marketing approval to the U.S. FDA. We have also instituted and continue to maintain tight control over expenditures.
As of March 31, 2024, we have approximately $10.1
million in cash, including approximately $8.6 million and $1.5 million in unrestricted and restricted cash, respectively. We believe this
is sufficient to fund the Company’s operations into the fourth quarter of 2024. We are actively pursuing financing sources, including
less or non-dilutive debt financing, royalty financing, strategic or direct investments, equity, 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 75 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 March 31, 2024, more than 237,000 CytoSorb devices have been
used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE
mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively,
and for ticagrelor and rivaroxaban
removal in cardiothoracic surgery procedures. CytoSorb has also received FDA
Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed
respiratory failure.
The DrugSorb™-ATR antithrombotic removal
system, based on the same polymer technology as CytoSorb, 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, statements about potential exposures resulting from our cash positions, 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 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 CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(amounts in thousands, except per share data)
| |
For the Three Months Ended | |
| |
| 3/31/24 | | |
| 3/31/23 | |
Revenue: | |
| | | |
| | |
CytoSorb sales | |
$ | 8,965 | | |
$ | 7,906 | |
Other sales | |
| 25 | | |
| 4 | |
Total product sales | |
| 8,990 | | |
| 7,910 | |
Grant income | |
| 797 | | |
| 1,539 | |
Total revenue | |
| 9,787 | | |
| 9,449 | |
Cost of revenue | |
| 3,216 | | |
| 3,994 | |
Gross profit | |
| 6,571 | | |
| 5,455 | |
| |
| | | |
| | |
Operating Expenses: | |
| | | |
| | |
Research and development | |
| 2,248 | | |
| 4,215 | |
Legal, financial and other consulting | |
| 681 | | |
| 669 | |
Selling, general and administrative | |
| 8,567 | | |
| 8,463 | |
Total operating expenses | |
| 11,496 | | |
| 13,347 | |
| |
| | | |
| | |
Loss from operations | |
| (4,925 | ) | |
| (7,892 | ) |
Other income (expense): | |
| | | |
| | |
Interest income (expense), net | |
| (7 | ) | |
| (63 | ) |
Gain (Loss) on foreign currency transactions | |
| (1,426 | ) | |
| 661 | |
Miscellaneous income (expense) | |
| --- | | |
| (32 | ) |
Total other income (expense), net | |
| (1,433 | ) | |
| 566 | |
Loss before benefit from income taxes | |
| (6,358 | ) | |
| (7,326 | ) |
Benefit from income taxes | |
| --- | | |
| --- | |
Net loss | |
| (6,358 | ) | |
| (7,326 | ) |
| |
| | | |
| | |
Earnings per share: | |
| | | |
| | |
Basic and diluted loss per share | |
$ | (0.12 | ) | |
$ | (0.17 | ) |
Weighted average share outstanding | |
| 54,262,790 | | |
| 43,676,435 | |
| |
| | | |
| | |
Net Loss | |
$ | (6,358 | ) | |
$ | (7,326 | ) |
Other comprehensive income (loss): | |
| | | |
| | |
Foreign currency translation adjustment | |
| 1,223 | | |
| (608 | ) |
Comprehensive loss | |
$ | (5,135 | ) | |
$ | (7,934 | ) |
CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands)
| |
March 31, 2024 | | |
December 31, 2023 | |
ASSETS: | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 8,608 | | |
$ | 14,131 | |
Grants and accounts receivable, net | |
| 6,766 | | |
| 6,057 | |
Inventories | |
| 3,739 | | |
| 3,680 | |
Prepaid expenses and other current assets | |
| 880 | | |
| 1,835 | |
Total current assets | |
| 19,993 | | |
| 25,703 | |
| |
| | | |
| | |
Property and equipment, net | |
| 9,749 | | |
| 10,056 | |
Restricted Cash | |
| 1,484 | | |
| 1,484 | |
Right of use asset | |
| 11,925 | | |
| 12,059 | |
Other assets | |
| 3,920 | | |
| 3,959 | |
TOTAL ASSETS | |
$ | 47,071 | | |
$ | 53,261 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY: | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,399 | | |
$ | 3,802 | |
Lease liability - current portion | |
| 393 | | |
| 374 | |
Accrued expenses and other current liabilities | |
| 8,132 | | |
| 7,870 | |
Current maturities of long-term debt | |
| 2,500 | | |
| 2,500 | |
Total current liabilities | |
| 13,424 | | |
| 14,546 | |
Lease liability, net of current portion | |
| 12,790 | | |
| 12,897 | |
Long-term debt | |
| 1,929 | | |
| 2,543 | |
TOTAL LIABILITIES | |
| 28,143 | | |
| 29,986 | |
| |
| | | |
| | |
Total stockholders’ equity | |
| 18,928 | | |
| 23,275 | |
| |
| | | |
| | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 47,071 | | |
$ | 53,261 | |
| |
| | | |
| | |
| |
| | | |
| | |
Please Click to Follow Us on Facebook and
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U.S. Company
Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com
Investor
Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
ir@cytosorbents.com
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