CytoSorbents Corporation (CTSO)

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Q1 2023 was $9.4 million...

CytoSorbents Reports First Quarter 2023 Results

May 2, 2023 - 4:15 pm
Pivotal U.S. and Canada STAR-T Trial enrollment enters the last third of the study. Strong customer demand from Q4 2022 continued into Q1 2023, with current expectation of overall sales growth in 2023

PRINCETON, N.J., May 02, 2023 (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 unaudited financial and operating results for the quarter ended March 31, 2023.
First Quarter 2023 Financial Results

Total revenue, including product sales and grant income, for Q1 2023 was $9.4 million, an increase of 9% compared to $8.7 million in Q1 2022
Q1 2023 product sales were $7.9 million versus $7.9 million in Q1 2022.

There were no COVID-related sales this quarter, compared to approximately $300K of COVID-related sales in Q1 2022
Currency effects negatively impacted Q1 2023 sales by approximately $349K. Constant currency core product sales in Q1 2023 were $8.3 million, an increase of $635K or 8.3%, over core products sales of $7.6 million in Q1 2022
Q1 2023 represents the second consecutive period of sequential quarterly product sales growth, and the first time that Q1 core product sales sequentially exceeded seasonally strong core Q4 sales in the past five years, which we believe represents a positive indicator of improving business
Q1 2023 product gross margin was approximately 68%, compared to 80% in Q1 2022 due to start-up activities of our new manufacturing facility
We believe the Company remains well-capitalized with cash and cash equivalents of $20.7 million (which includes $1.7 million in restricted cash) as of March 31, 2023
Recent Operating Highlights

We have now surpassed 200,000 cumulative human treatments globally after achieving 100,000 cumulative CytoSorb treatments in August 2020 less than 3 years ago. As of the end of Q1 2023, there have been more than 203,000 CytoSorb cumulative treatments delivered across more than 75 countries worldwide
The pivotal STAR-T randomized controlled trial achieved its second milestone of 80 patients enrolled on schedule in mid-April 2023, following the first milestone of 40 patients enrolled in November 2022, triggering a second pre-specified Data and Safety Monitoring Board (DSMB) review, which is expected to complete in the next few months. The trial continues to enroll well and is now in its last stage of enrollment, which is expected to complete this summer
Our Board Chairman, Al Kraus, announced his intent to retire at the end of his term in June 2023, following 20 years of leadership with the Company at age 78. He will continue to consult for the Company as needed. Pending the results of the 2023 Annual Meeting, current Board Director Michael Bator will succeed Al Kraus as Chairman of the Board
Highlighted a landmark publication in the high impact, peer-reviewed journal, Critical Care, underscoring the power of CytoSorb to reduce cytokine storm during systemic hyperinflammation caused by a very important toxin in half of sepsis cases, in a well-controlled, balanced, and definitive human study
Hosted a successful and highly attended scientific symposium and exhibition at the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) in Brussels, Belgium in March 2023, where data from the latest studies were presented and live-streamed, detailing the effect of CytoSorb in treating cytokine storm and deadly inflammation in diseases such as sepsis, shock, and acute respiratory distress syndrome (ARDS), including the study above which was the centerpiece of the session
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We believe we have started 2023 with favorable momentum and are pleased with the continued execution of three key goals described in the shareholder letter earlier this year.

1. Opening the U.S. and Canadian markets with DrugSorb®-ATR

The STAR-T (Safe and Timely Antithrombotic Removal - Ticagrelor) pivotal, randomized controlled trial is designed to support U.S. FDA and Health Canada marketing approval of DrugSorb-ATR with the goal of demonstrating that DrugSorb-ATR reduces the risk of perioperative bleeding in patients undergoing cardiothoracic surgery on Brilinta® (ticagrelor, AstraZeneca). The STAR-T trial is enrolling well with recruitment by nearly all trial sites, both here in the U.S. and in Canada, and has recently outpaced our own internal projections. Should these trends continue, we expect to enroll the final third of the study this summer and have topline data by year-end that if positive, we believe would support the application for FDA and Health Canada marketing approval of DrugSorb-ATR.

As discussed recently, the rapid pace of enrollment of STAR-T led us to elect to forego a formal interim analysis on the first 80 patients. To fully understand this decision, it is important to clarify that the original intent of this interim analysis was to provide the opportunity to stop the trial early, an important option if enrollment was expected to be slow or delayed. However, the current enrollment pace is brisk and our projections suggest that the trial will likely be completed by the time a formal interim analysis - that requires fully monitored, cleaned, locked, and adjudicated data - would have been completed. Accordingly, a trial that is fully enrolled cannot be stopped early and as such we are now focusing our efforts on the final analysis. We believe it is also important to emphasize that there are no other considerations or information underlying this decision and that the STAR-T study data remain fully-blinded. The next milestone for the STAR-T trial is the second independent Data and Safety Monitoring Board (DSMB) safety evaluation after the first 80 patients which we expect to be completed in the next 2-3 months. As previously disclosed, the DSMB recommendation after the safety evaluation of the first 40 patients was to continue the study as planned without any modifications.

In parallel to the clinical study, Dr. Irina Kulinets, Senior Vice President of Global Regulatory, is leading the execution of the regulatory strategy for DrugSorb-ATR that at this stage includes strengthening her team, planning for future regulatory submissions, and driving interdepartmental alignment and responsibilities to meet our regulatory objectives and timelines.

Finally, we spoke previously of a pending proposal from Centers for Medicare & Medicaid Services (CMS) for Transitional Coverage of Emerging Technology (TCET) that could establish four years of U.S. Medicare coverage to breakthrough medical devices approved by the FDA. This proposal was expected in April 2023, and is still expected imminently. We believe that DrugSorb®-ATR, as an FDA Breakthrough Designated Device that targets many patients in the Medicare population undergoing open heart surgery and at high risk of unwanted bleeding due to blood thinners, could be well-suited for such a program.

2. Return to Sales Growth

We believe the achievement of sequential growth in Q1 2023 product sales from the prior quarter, and 8% quarterly core product sales growth year-over-year on a constant currency basis, represent an encouraging sign towards our goal of returning to sales growth this year. More important than this, however, is the general perception of our employees across each of our business segments of strong customer engagement, excellent feedback on our most recent clinical and scientific data across multiple indications in our therapeutic area verticals, and a trend of improvement in our hospital markets in core countries - though healthcare professional staffing remains a key issue. For example, in Germany, the DIVI Critical Care Society is reporting an increase in regularly operating adult intensive care units, and a concomitant sharp reduction in restricted ICUs – an important, non-quantitative assessment of the supply situation, which is governed by availability of staff, rooms, materials, and other factors. This has correlated with a major drop in COVID-related ICU admissions. If sustained, we believe it is likely that the mandate to have emergency reserve ICU beds for COVID-19 will also likely be lifted, freeing additional ICU capacity throughout the country. We expect this to translate into the ability to accept more non-COVID critically ill patients to the ICU and to do more surgical procedures, such as cardiac surgery, that require ICU postoperative care, which are all drivers of our business. Among our many growth initiatives, we are also seeing good progress in our strategy of expanding into German hospitals within private networks based on our preferred supplier agreements, increasing our accounts in these German networks by 50% last year over 2021.

https://www.stocktitan.net/news/CTSO/cyto-sorbents-reports-first-quarter-2023-qb8krwzat2t2.html


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