CytoSorbents, Inc. Reports Record Quarterly And Full-Year 2015 Revenue

MONMOUTH JUNCTION, N.J., March 9, 2016 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in critical care immunotherapy commercializing its CytoSorb® blood filtration technology to reduce deadly uncontrolled inflammation in critically-ill and cardiac surgery patients around the world with the goal of preventing or treating organ failure, reports operational and financial results for the fiscal year ending December 31, 2015.

2015 Financial Highlights:

• CytoSorb® product sales for 2015 were $4.0 million, record results propelled by an acceleration in sales in the second half of 2015
• Product sales for Q4 2015 were also a record $1.5 million, representing a 72% increase over Q4 2014, driven by a tripling of direct sales and a doubling of new direct customers
• Adjusted for the decline in the Euro in 2015, CytoSorb® product sales would have been approximately $1.7 million for Q4 2015 and approximately $4.7 million for 2015, representing a 98% and 49% increase, respectively, in the comparable year-ago periods
• Total revenue for 2015 was approximately $4.7 million, which includes both product sales and grant income
• Product gross margins expanded to approximately 64% in Q4 2015 and were 62% for full-year 2015
• Achieved continued year-over-year growth on a quarterly basis since commercialization of CytoSorb®

2015 Operational Highlights:

• More than 10,000 human CytoSorb® treatments have now been administered
• Increased geographic distribution of CytoSorb® to a total of 32 countries, with the addition of Italy, Israel, Australia, New Zealand, and Vietnam
• Achieved Saudi Food and Drug Authority approval for CytoSorb®
• Fresenius Medical Care AG & Co KGaA (Fresenius), the world’s largest dialysis company and our strategic partner, began pre-marketing CytoSorb® in France, Poland, Denmark, Norway, Sweden and Finland
• Initiated 40-patient, 8-center, U.S. REFRESH I cardiac surgery feasibility and safety trial in complex cardiac surgery patients at major cardiac surgery centers
• Announced $1.5 million Phase II SBIR contract from the National Heart, Lung, And Blood Institute, a division of the National Institutes of Health, to advance HemoDefend towards commercialization to improve the quality and safety of the blood supply
• Appointed Dr. Joerg Scheier, an experienced critical care physician and anesthesiologist with significant clinical trial experience, as European Medical Director
• Added Michael G. Bator, former Managing Director of Healthcare Research at Jennison Associates, to the Board of Directors
• Conducted the 1^st and 2^nd International CytoSorb® Users Meetings in Brussels, Belgium (March 2015) and Berlin, Germany (October 2015), respectively
• Added to the Russell Microcap® Index in June 2015
• Celebrated the one-year anniversary of our up-listing to NASDAQ with ringing the opening bell in Times Square, New York City on December 23, 2015

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “2015 was a solid year for CytoSorbents, and as discussed at length in our January 2016 Letter to Stockholders, we expect an even stronger 2016 as we approach an anticipated inflection point in our business. These results are expected to be driven by increased usage of CytoSorb® in key markets, continued geographic expansion, completion of product registrations in major countries, new clinical data, and new or expanded partnerships.”

“Specifically, in the upcoming months, we plan to provide greater detail on a number of significant events.

• Next week, we will host our 3^rd International CytoSorb Users Meeting in Brussels, Belgium, featuring many presentations on new CytoSorb® clinical data from colleagues from around the world. We also will host a research symposium and exhibit at the 36^thInternational Symposium for Intensive Care and Emergency Medicine (ISICEM), one of the most prominent critical care conferences worldwide
• We continue to progress on our U.S. REFRESH I study, a 40-patient, 8-center randomized, controlled safety and feasibility study using CytoSorb® intraoperatively during complex cardiac surgery. The study is currently 35% enrolled with several additional patients already consented for the study, and is expected to complete enrollment by mid-2016. Pending a timely and successful study, we plan to submit an Investigational Device Exemption application to the U.S. Food and Drug Administration (FDA) shortly thereafter, to conduct a pivotal REFRESH 2 registration trial, intended to support application for U.S. approval of CytoSorb® for cardiac surgery
• Fresenius has indicated that it plans to initiate the marketing push of CytoSorb® at the ISICEM conference next week in Brussels in anticipation of its forthcoming market launch. Fresenius has indicated that it will feature CytoSorb® on the multiFiltrate Acute Therapy System in its exhibition booth and will introduce the technology broadly to its customers
• More publications are expected in peer-reviewed journals, including data from a number of investigator initiated studies in sepsis, including the recently discussed data from University of Greifswald in refractory septic shock, and cardiac surgery from studies completed at University of Hamburg-Eppendorf and Medical University of Vienna
• We also expect to discuss the analysis of data from our International CytoSorb Registry, where 103 clinical sites are now registered to submit data.”

Dr. Chan continued, “We are excited by the increasing number of CytoSorb® treatment successes within our 32-country network. Today, CytoSorb® is being used to prevent or treat organ dysfunction and organ failure in a broad range of life-threatening conditions, by controlling deadly inflammation. To maximize treatment effect, patients need to exhibit not only severe inflammation, but also evidence of organ injury and organ dysfunction. This matches well with the new guidelines and definitions of sepsis, proposed by the Third International Consensus Definitions Task Force and published in a recent issue of the Journal of the American Medical Association (JAMA). In the new guidelines, they define sepsis as ‘life-threatening organ dysfunction due to a dysregulated host response to infection’ and highlight organ dysfunction as one of the defining and most predictive characteristics in sepsis outcomes. As one of the only therapies designed to try to address the underlying causes of organ dysfunction and failure, we believe that we are extremely well-positioned to save lives and change the way critically-ill patients are treated today.

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