CytoSorbents Reports Fourth Quarter and Full Year 2023 Results
- Positive financial results for CytoSorbents in 2023 with a 5% increase in total revenue to $36.3 million.
- Product sales grew by 6% to $31.1 million, supported by a 10% increase in core CytoSorb sales.
- Product gross margins improved to 72%, and cumulative CytoSorb treatments exceeded 228,000.
- The STAR-T trial results were chosen for a Breakout Presentation at the AATS Annual Meeting.
- Plans to submit DrugSorb-ATR for regulatory approval to the FDA and Health Canada in 2024.
- Q4 2023 saw a decrease in total revenue by 8% compared to Q4 2022.
- Total product sales in Q4 2023 decreased by 4% compared to Q4 2022.
- Core CytoSorb sales in Q4 2023 dropped by 1% compared to Q4 2022.
- Cost of revenue remained stable at approximately $13.9 million for both 2023 and 2022.
Insights
The detailed financial performance of CytoSorbents Corporation, as outlined, paints a picture of a company navigating the post-pandemic economic landscape with a degree of resilience. The reported 10% year-over-year growth in core sales, excluding COVID-19 related sales, indicates a stable demand for the company's non-pandemic products. This growth, coupled with an increase in product gross margins from 70% to 72%, suggests an improvement in operational efficiency. However, the decrease in total revenue and product sales during Q4 2023 compared to Q4 2022 raises questions about the sustainability of growth and the impact of external factors such as exchange rates on revenue.
Furthermore, the company's strategic focus on submitting DrugSorb-ATR for regulatory approval and the anticipated launch of the PuriFi hemoperfusion pump are strategic moves that could significantly affect future revenues. While the company's cash position, cost-cutting measures and manufacturing optimizations are reassuring, investors should monitor the execution of these initiatives closely, as they are pivotal to the company's growth trajectory.
The selection of the STAR-T trial results for a Breakout Presentation at the prestigious AATS Annual Meeting underscores the scientific community's interest in CytoSorbents' DrugSorb-ATR technology. The focus on the isolated coronary artery bypass graft (CABG) surgery subpopulation, where reduced bleeding complications were observed, highlights a potential niche market for the company's product. However, the primary effectiveness endpoint not being met in the overall patient population warrants a cautious interpretation of the results.
The extended CE Mark under the MDD and the strategic partnership in India are notable developments that could expand the company's international footprint. The potential shift in the market preference towards ticagrelor, especially with its upcoming generic status, may open up new opportunities for DrugSorb-ATR. Nevertheless, the actual impact on sales will depend on regulatory approvals, market adoption rates and the ability to compete with existing therapies.
The company's performance within the context of the broader medical device and blood purification market is of interest. While CytoSorbents has demonstrated a steady increase in product gross margins, the overall modest increase in total revenue suggests that the market for their products is stable but not rapidly expanding. The emphasis on cost control and efficiency improvements is a common strategy in this sector, especially post-COVID, as companies adjust to new market realities.
The upcoming regulatory submissions and product launches are critical strategic steps that could redefine the company's market positioning. The anticipated launch of the PuriFi hemoperfusion pump, in particular, could provide a competitive edge in markets with less developed dialysis capabilities. The potential healthcare reform in Germany may present both challenges and opportunities, as it could lead to an increased focus on therapies for sicker patients and complex operations, aligning well with CytoSorbents' product offerings.
- STAR-T trial results selected for a Breakout Presentation at the American Association of Thoracic Surgery Annual Meeting in late-April 2024
- CytoSorbents intends to submit DrugSorb-ATR for regulatory approval to U.S. Food & Drug Administration (FDA) and Health Canada this year
- CytoSorb core sales increased approximately
10% year-over-year - 2023 Product gross margins increased to
72% - Cumulative CytoSorb treatments surpassed 228,000
PRINCETON, N.J., March 14, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, today reported financial and operating results for the quarter and year ended December 31, 2023 and provides its 2024 outlook.
Full Year 2023 Financial Results
- 2023 Total Revenue, which includes Product Sales and Grant Income, was
$36.3 million versus$34.7 million in 2022, an increase of approximately$1.7 million or5% - Total product sales were
$31.1 million in 2023 versus$29.4 million in 2022, an increase of approximately$1.7 million or6% . 2022 product sales benefitted from an additional approximately$0.7 million in Other non-CytoSorb product sales and$0.3 million in COVID-19 related sales compared to 2023 - Core (non-COVID-19 related) CytoSorb sales grew
10% to$31.0 million in 2023, versus$28.3 million in 2022 - The increase in the average Euro to U.S. dollar exchange rate positively impacted 2023 product sales by approximately
$0.8 million . The average Euro to dollar exchange rate was 1.08 in 2023 versus 1.05 in 2022 - 2023 Product Gross Margin increased to approximately
72% , from approximately70% in 2022
Fourth Quarter 2023 Financial Results
- Q4 2023 Total Revenue, which includes Product Sales and Grant Income, was
$8.7 million versus$9.4 million in Q4 2022, a decrease of approximately$0.7 million or8% - Total Product Sales were
$7.3 million in 2023 versus$7.6 million in 2022, a decrease of approximately$0.3 million or4% - Core CytoSorb sales in Q4 2023 were
$7.3 million compared to$7.4 million in Q4 2022, a decrease of approximately$0.1 million or1% - The increase in the average Euro to U.S. dollar exchange rate favorably impacted Q4 2023 product sales by approximately
$0.4 million . The average Euro to dollar exchange rate was 1.08 in Q4 2023 versus 1.02 in Q4 2022
Recent Operating Highlights
- Cumulative CytoSorb® treatments delivered exceeded 228,000 at the end of 2023, up
17% from the end of 2022 - The 140-patient, double-blinded, multicenter, pivotal STAR-T randomized, controlled trial was selected for a Breakout Presentation at the American Association of Thoracic Surgery (AATS) Annual Meeting being held April 27-30, 2024 in Toronto, Canada. We expect to follow this event with an Analyst and Investor Day and provide a review of the data by an esteemed thought leader panel
- We plan to submit for regulatory approval of DrugSorb®-ATR to the FDA and Health Canada in the second half of 2024 to reduce the severity of bleeding in patients undergoing isolated coronary artery bypass graft (CABG) surgery on the blood thinner, Brilinta®. This follows the prior discussion of topline study results in December 2023, and subsequent additional data analysis from the STAR-T Trial
- Our European Union CE Mark for CytoSorb was extended under the Medical Devices Directive (MDD) to the earlier of either December 2028 or when we achieve E.U. Medical Device Regulation (MDR) certification, which effort is currently ongoing
- Entered into a new strategic partnership and temporary distribution agreement in India for CytoSorb with the publicly-traded Indian pharmaceutical company, Eris Lifesciences, following its definitive agreement with Biocon Biologics to acquire Biocon’s Nephrology branded formulations business unit, and with it, Biocon’s key leadership and field force of these businesses, including the personnel commercializing CytoSorb in India
- Expecting to launch our new PuriFi stand-alone hemoperfusion pump later this year following the expiration of our previously disclosed distribution agreement with Nikkiso Europe GmbH for its PureAdjust® hemoperfusion pump in September 2023
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “In 2024, we are intent on providing clarity to investors on the key factors that will determine the near-term and future success of this Company. These include visibility on submission of DrugSorb-ATR for regulatory approval to U.S. FDA and Health Canada this year, returning to significant growth in our core existing CytoSorb business outside the U.S. and Canada, continued improvements in product gross margins coupled with a right-sized operating expense structure, and adequately financing CytoSorbents for success.”
STAR-T Update
The pivotal, U.S. and Canadian STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized controlled trial was designed to support FDA and Health Canada marketing approval for DrugSorb®-ATR to reduce the risk of perioperative bleeding in patients undergoing cardiothoracic surgery potentially caused by Brilinta® (ticagrelor, AstraZeneca). Our technology has received FDA Breakthrough Device Designation for this application, highlighting the major unmet medical need and lack of approved or cleared therapies for this problem.
Following the completion of the STAR-T trial last year, we announced topline data from the study in December 2023 as follows:
- The independent STAR-T Data and Safety Monitoring Board (DSMB) conducted a review of unblinded data on all 140 patients in the trial and concluded there were no issues with device safety, meeting the primary safety endpoint of the study
- Following initial data analysis from STAR-T, the primary effectiveness endpoint in the overall patient population that underwent different types of cardiac surgeries was not met. However, in the pre-specified subpopulation of patients undergoing isolated coronary artery bypass graft (CABG) surgery that accounted for more than
90% of patients enrolled in the STAR-T trial and also represent the main use case for DrugSorb®-ATR, we observed evidence of reduced bleeding complications, including serious bleeding events.
We have since performed additional analyses of our trial data in the isolated CABG population and believe the results further support the favorable benefit-to-risk profile of DrugSorb-ATR in these patients who represent the overwhelming majority facing this clinical unmet need.
We are pleased at the selection of the STAR-T trial for a breakout presentation at the 104th Annual Meeting of the American Association of Thoracic Surgery, described as the world’s most prestigious cardiothoracic surgery event. This year, the meeting will be in collaboration with the Society of Cardiovascular Anesthesiologists (SCA), who are often managing blood product usage due to intraoperative bleeding during surgical procedures. In general, this conference is targeted towards cardiothoracic surgeons and physicians in related specialties; perfusionists; non-physician health care providers involved in the care of cardiothoracic surgical patients; as well as fellows, residents, and medical students in cardiothoracic surgery. These are the stakeholders who directly witness and need to manage the perioperative bleeding complications of their patients on blood thinners and who would use DrugSorb-ATR in clinical practice.
Shortly after AATS, we plan to host an Analyst and Investor Day to share these data with participants, who will then be able to evaluate the benefit-risk proposition of DrugSorb-ATR. Our data give us confidence in our decision to submit for regulatory approval to U.S. FDA and Health Canada, estimated in the second-half of 2024. For an interesting discussion on therapies seeking FDA approval in our situation, see page 3 of this report from Zacks Research.
Although we cannot predict the outcome of a regulatory submission, should DrugSorb-ATR be approved in both the U.S. and Canada only for patients undergoing isolated CABG, we believe the initial total addressable market opportunity remains relatively intact at approximately
2023 Sales Highlights
2023 was a reasonable recovery year of progress and growth, where core (non-COVID-19) CytoSorb sales grew roughly
- Strong performance from our International Direct sales division (representing 14 countries, excluding Germany) resulted in
27% sales growth year-over-year to approximately$6.0 million , or19% of 2023 product sales - Distributor and Partner sales (representing more than 60 countries) grew
18% (excluding U.S. dsitributor sales in 2022) in the first three quarters of 2023 over the prior year. Based on our stand-alone pump initiative that is expected to catalyze sales of CytoSorb in countries with less developed dialysis capabilities, we had budgeted higher growth in Q4 for this division. For a number of different reasons, it became clear that Nikkiso’s PureAdjust® hemoperfusion machine was not the long-term solution for our stand-alone pump initiative and we mutually agreed to not renew our distributor agreement in September 2023. We pivoted to an alternative strategy, focused on the launch of our own hemoperfusion machine called Purifi that we expect to launch later this year. Anticipation of this machine, however, led to some order slippage from distributors to the new year, resulting in lower than expected Q4 2023 sales overall. For the year, Distributor and Partner sales grew9% (excluding U.S. distributor sales in 2022) to$12.1 million , or39% of 2023 product sales - Direct Sales Germany was flat at
3% growth to$13.0 million for the year, or42% of 2023 product sales. German hospitals are still working through the aftermath of the COVID-19 pandemic with staff shortages, decreased hospital beds, fewer patients, and fewer revenue generating procedures, and economic stressors such as inflation, labor, energy, and other unexpected costs. Notwithstanding this market backdrop, the costs and challenges that physicians and healthcare workers continue to face in the management of critical illness and cardiac surgery are real. Given the numerous applications, both old and new, that our products can help to address, and other initiatives such as our preferred supplier agreement with the largest private hospital networks in Germany, we believe there are many opportunities to return to significant growth in the country.
That said, we are currently tracking a proposal for healthcare reform of Germany’s hospital system. In July 2023, Germany’s federal and state governments issued a consensus white paper that could result in new laws that change how hospitals are funded. Government payments to hospitals would de-emphasize the DRG (diagnosis-related group) “lump sum” payment system that incentivizes revenue generation through more patients treated and procedures performed, and instead emphasize base payments focused on quality measures and appropriate patient care. This is expected to favor a shift of routine operations and procedures to outpatient centers, consolidation of smaller hospitals into larger ones, and importantly, an increased focus of remaining hospitals on sicker patients, more complex operations such as cardiothoracic surgery and organ transplant, and on therapies that help reduce the severity of illness and help patients recover faster. Given that the goal of our therapies is to improve clinical outcomes while reducing the costs of critical care and cardiac surgery by controlling deadly inflammation and other life-threatening conditions, while reducing the need for expensive life support measures that keep patients in the hospital, we believe such reform may favor our business in the longer-term. Hospital administrators expect such change will take careful planning and time, potentially years, to implement. We continue to track these developments with interest.
As we discussed in the last earnings release, we believe we can return to and potentially even exceed our historic compound annual growth rate (CAGR) of approximately
Reduced Cash Burn with Tight Control Over Expenses
Following our equity financing in December, we ended the year with
Dr. Chan concluded, “We believe the successful execution of our strategy will form the basis of a strong turnaround of our business and position us well for strong growth and profitability in the next several years. We thank you for your continued support.”
Conference Call Details:
Date: Thursday, March 14th, 2024
Time: 4:30 PM Eastern Time
Participant Dial-In: (888) 596-4144
Conference ID: 5329219
Live Presentation Webcast: https://edge.media-server.com/mmc/p/tgivev9a
Participants are recommended to 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 http://cytosorbents.com/investor-relations/financial-results/.
For additional information, please see the Company’s Form 10-K for the period ended December 31, 2023, filed on March 14, 2024, on http://www.sec.gov.
Results of Operations
Comparison of the year ended December 31, 2023 and 2022
Revenues:
For the year ended December 31, 2023, we generated total revenue, which includes product revenue and grant income, of approximately
Grant income was approximately
Cost of Revenue:
For the years ended December 31, 2023 and 2022, cost of revenue was approximately
Gross Profit:
Gross profit was approximately
Research and Development Expenses:
Our research and development costs were approximately
Legal, Financial and Other Consulting Expenses:
Our legal, financial and other consulting costs were approximately
Selling, General and Administrative Expenses:
Our selling, general and administrative expenses were approximately
Gain (Loss) on Foreign Currency Transactions:
For the year ended December 31, 2023, the gain on foreign currency transactions was approximately
Benefit from Income Taxes:
Our benefit from income taxes was approximately
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities. As of December 31, 2023, we had current assets of approximately
In April of 2023, we received approximately
On December 13, 2023, the Company closed on a registered direct offering for the sale, directly to investors, of 7,733,090 shares of registered common stock and warrants to purchase up to 2,706,561 shares of common stock (the “Offering”). Each share of common stock and accompanying warrant to purchase up to 0.35 shares of common stock, were sold together for a combined purchase price of
We are also managing our resources proactively, continuing to invest in key areas such as our U.S. and Canadian 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 and Health Canada. We have also instituted and continue to maintain tight control over expenditures.
As of December 31, 2023, we have approximately
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. At the end of 2023, more than 228,000 CytoSorb devices had been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company has 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
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, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the results of our STAR-T clinical trial and regulatory submissions relating thereto, 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) | ||||||||||
| Year ended December 31, | ||||||||||
| 2023 | 2022 | 2021 | ||||||||
| Revenue: | ||||||||||
| CytoSorb sales | $ | 31,015 | $ | 28,573 | $ | 39,997 | ||||
| Other sales | 70 | 787 | 112 | |||||||
| Total product sales | 31,085 | 29,360 | 40,109 | |||||||
| Grant income | 5,264 | 5,329 | 3,057 | |||||||
| Total revenue | 36,349 | 34,689 | 43,166 | |||||||
| Cost of revenue | 13,957 | 13,956 | 11,048 | |||||||
| Gross profit | 22,392 | 20,733 | 32,118 | |||||||
| Other Expenses: | ||||||||||
| Research and development | 15,729 | 15,119 | 16,381 | |||||||
| Legal, financial and other consulting | 4,272 | 2,848 | 2,732 | |||||||
| Selling, general and administrative | 33,600 | 34,288 | 35,750 | |||||||
| Total expenses | 53,601 | 52,255 | 54,863 | |||||||
| Loss from operations | (31,209 | ) | (31,522 | ) | (22,745 | ) | ||||
| Other income (expense): | ||||||||||
| Interest income (expense), net | (158 | ) | 133 | 28 | ||||||
| Gain (loss) on foreign currency transactions | 1,949 | (2,449 | ) | (2,578 | ) | |||||
| Miscellaneous income | 97 | (67 | ) | --- | ||||||
| Total other income (expense), net | 1,888 | (2,383 | ) | (2,550 | ) | |||||
| Loss before benefit from income taxes | (29,321 | ) | (33,905 | ) | (25,295 | ) | ||||
| Benefit from income taxes | 814 | 1,092 | 736 | |||||||
| Net loss | $ | (28,507 | ) | $ | (32,813 | ) | $ | (24,559 | ) | |
| Basic and diluted net loss per common share | $ | (0.64 | ) | $ | (0.75 | ) | $ | (0.57 | ) | |
| Weighted average number of shares of common stock outstanding | 44,656,391 | 43,573,215 | 43,359,186 | |||||||
| Net loss | $ | (28,507 | ) | $ | (32,813 | ) | $ | (24,559 | ) | |
| Other comprehensive income (loss): | ||||||||||
| Currency translation adjustment | (1,800 | ) | 1,804 | 2,260 | ||||||
| Comprehensive loss | $ | (30,307 | ) | $ | (31,009 | ) | $ | (22,299 | ) | |
| CYTOSORBENTS CORPORATION | |||||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||||
| (amounts in thousands) | |||||||||||
| December 31, 2023 | December 31, 2022 | ||||||||||
| ASSETS: | |||||||||||
| Current Assets: | |||||||||||
| Cash and cash equivalents | $ | 14,131 | $ | 22,145 | |||||||
| Grants and accounts receivable, net | 6,057 | 5,665 | |||||||||
| Inventories | 3,680 | 3,461 | |||||||||
| Prepaid expenses and other current assets | 1,835 | 2,489 | |||||||||
| Total current assets | 25,703 | 33,760 | |||||||||
| Property and equipment, net | 10,056 | 10,743 | |||||||||
| Restricted Cash | 1,484 | 1,687 | |||||||||
| Right of use asset | 12,059 | 12,604 | |||||||||
| Other assets | 3,959 | 4,438 | |||||||||
| TOTAL ASSETS | $ | 53,261 | $ | 63,232 | |||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY: | |||||||||||
| Current Liabilities: | |||||||||||
| Accounts payable | $ | 3,802 | $ | 1,655 | |||||||
| Lease liability - current portion | 374 | 109 | |||||||||
| Accrued expenses and other current liabilities | 7,870 | 7,951 | |||||||||
| Current maturities of long-term debt | 2,500 | --- | |||||||||
| Total current liabilities | 14,546 | 9,715 | |||||||||
| Lease liability, net of current portion | 12,897 | 13,142 | |||||||||
| Long-term debt | 2,543 | 5,000 | |||||||||
| TOTAL LIABILITIES | 29,986 | 27,857 | |||||||||
| Total stockholders’ equity | 23,275 | 35,375 | |||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 53,261 | $ | 63,232 | |||||||
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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
FAQ
What was the total revenue for CytoSorbents in 2023?
How much did product sales increase in 2023 compared to 2022?
What was the core CytoSorb sales growth in 2023?
What was the product gross margin in 2023?
How many CytoSorb treatments were delivered by the end of 2023?
What event selected the STAR-T trial results for a Breakout Presentation?
What regulatory approvals are planned for DrugSorb-ATR in 2024?
