MONMOUTH JUNCTION, N.J., May 4, 2021 /PRNewswire/ --CytoSorbents Corporation(NASDAQ:CTSO), a critical care leader using its CytoSorb® blood purification technology to treat life-threatening conditions in critically-ill and cardiac surgery patients around the world,reports financial and operating results for the quarter ended March 31, 2021.
CytoSorbents Continues Healthy Sales Growth in Q1 2021
First Quarter 2021 Financial Results:
- Total revenue for Q1 2021 was $10.6 million, including both product sales and grant income, compared to $8.7 million in Q1 2020, an increase of 22%
- Q1 2021 CytoSorb product sales was $10.1 million, an increase of approximately $2.0 million over Q1 2020 product sales of $8.2 million, an increase of 24%. Estimated COVID-19 related sales for Q1 2021 were approximately $1.8 million, compared to $1.6 million in Q1 2020
- Gross profit margin rose to $7.8 million in Q1 2021, as compared to $6.3 million in Q1 2020
- Q1 2021 Product gross margins were 77%. Excluding the non-recurring negative impact of 2018, 2019 and 2020 tariff adjustments of approximately $732K and the offsetting non-recurring positive impact of the Employee Retention Tax Credit of $388K, product gross profit margins were 81% in Q1 2021, as compared to 76% in Q1 2020
- Trailing twelve months product sales rose to $41.4M at March 31, 2021, an increase of $15.1M or 57% over trailing twelve months product sales of $26.3M at March 31, 2020
- Healthy cash balance of $68.5M at March 31, 2021
Q1 2021 Operating Highlights:
- Exceeded 131,000 cumulative CytoSorb treatments delivered, up from 88,000 in Q1 2020, an increase of 49%, with an estimated 5,750 COVID-19 patients treated across 30+ countries to date
- Filed and later received U.S. FDA conditional approval of an Investigational Device Exemption (IDE) protocol to conduct the U.S. STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized controlled trial. This trial was designed to support U.S. FDA approval under Breakthrough Designation
- We are pleased to announce that the U.S. STAR-T trial will be led by two luminaries in the field of cardiovascular medicine who will serve as Co-Principal Investigators:
- Dr. Michael Mack, MD Medical Director of Cardiothoracic Surgery for Baylor Scott & White Health and the chairman of BSW The Heart Hospital Plano Research Center. He is a pioneer in the field of cardiothoracic surgery and a world-renowned clinical researcher and physician who has performed more than 7,000 cardiac surgeries and authored over 400 publications, and has been instrumental in key advances in the treatment of cardiovascular disease.
- Dr. C. Michael Gibson, MS, MD President and CEO of the combined non-profit Baim and PERFUSE research institutes at Harvard Medical School that has led over 1,000 studies, published 3,000 manuscripts, and led 60 FDA submissions from their worldwide network. Dr. Gibson is an interventional cardiologist and an internationally recognized thought leader in cardiovascular clinical trials and the regulatory process and has led Phase I-4 clinical trials, and cardiology megatrials totaling more than 180,000 patients which eventuated in international approval of drugs like prasugrel (Effient®, Daiichi Sankyo, Eli Lilly) and rivaroxaban (Xarelto®, Bayer, Jannsen), and betrixaban (Bevyxxa®, AstraZeneca)
- Announced a global co-marketing agreement with B. Braun Avitum AG, the third largest dialysis company in the world with 7.5 billion in worldwide revenue, to promote CytoSorb® with their OMNI® Continuous Blood purification platform
- Appointed two key hires:
- Mr. James Komsa as Vice President U.S. Sales and Marketing to manage U.S. sales of CytoSorb under the FDA Emergency Use Authorization for COVID-19 patients, and potential U.S. approval of the technology for antithrombotic removal during cardiothoracic surgery. Formerly a VP at Medtronic
- Dr. David D. Cox, PhD, MBA as Vice President Global Regulatory Affairs to help drive regulatory approval in the U.S. and lead CytoSorbents global regulatory initiatives. Formerly VP of Regulatory Affairs at Integra LifeSciences
- The Korean Ministry of Food and Drug Safety (KMFDS) approved CytoSorb for all equivalent European Union (E.U.) approved indications, in collaboration with partner, Fresenius Medical Care
- Health Canada authorized CytoSorb for the importation, sale, and use in hospitalized COVID-19 patients, with CytoSorb distributed by ebbtides medical
- United Kingdom's National Institute of Health and Care Excellence (NICE) issued a Medtech Innovation Briefing on CytoSorb for reducing the risk of bleeding during cardiac surgery
- Executed the lease on our new 48,500 sq ft. U.S. corporate headquarters and future manufacturing center at 305 College Road East, Princeton, New Jersey, intended to support volume production capacity of $350-400 million in CytoSorb sales and product gross margins in excess of 85%
- Opened the new CytoSorbents Logistics Hub Europe, an expanded warehouse and distribution facility
- Conducted multiple webinars using CytoSorb in:
- Liver dialysis therapy and how it surpasses other technologies
- Removal of anti-thrombotic or blood thinner medications and the reduction in bleeding complication and costs, the potential to reduce re-thoracotomies (re-operations), and why this application is relevant
- Post-cardiac surgery to control post-operative complications such as shock
- Multiple separate applications in septic shock, in COVID-19 patients, in muscle injury and rhabdomyolysis, valve replacement for infective endocarditis, in major aortic surgery, and extracorporeal membrane oxygenation (ECMO) here and here.
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, Product sales grew by a healthy 24% in Q1 2021 compared to a year ago, aided by 27% growth in our core non-COVID-19 business and 79% growth in distributor and partner sales overall. We believe that Q1 2021 sales would have been even higher, but were hampered for most of the quarter by restrictions and lockdowns throughout Europe in many of our core markets, coupled with rapidly declining new COVID-19 infections and hospitalizations globally throughout the first two months of the quarter. COVID-19 related sales for Q1 2021 were approximately $1.8M, down from an average of $2.6M in the prior three quarters. However, March brought another dreaded COVID-19 wave to Europe, Latin America, the Middle East, and India, resulting in a massive spike in new worldwide infections and a strengthening of COVID-19 related orders of CytoSorb, despite a continuation of lockdowns and restrictions.