Cytosorbents Corporation

Good afternoon and welcome to the CITOSorbents 2020 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode. Following the formal remarks, we will open up the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I'd like to turn the call over to our moderator, Amy Vogel. Please go ahead, Ms. Vogel.

Thank you and good afternoon. Welcome to the CITOSorbents 2020 Financial and Operating Results Conference Call. Joining me today from the company are Dr. Philip Chan, Chief Executive Officer, Vincent Capponi, President and Chief Operating Officer, Kathleen Bloch, Chief Financial Officer, Dr. Efthymios Deliargyris, Chief Medical Officer, Dr. Christian Steiner, Executive Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe, GMBH, Christopher Cramer, VP of Business Development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call, management's prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today. Therefore, the company claims protection under safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, and therefore we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC. As projections as to the company's future performance represented by management include estimates today as of March 9th, 2021 and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for 2020 by Dr. Chan, Dr. Micah Deliargyris, Chris Cramer, and Ms. Bloch. Following the presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. At this time, it's now my pleasure to turn the call over to Dr. Philip Chan.

Thank you very much, Amy, and good afternoon, everyone. Despite the backdrop of COVID-19, we had an outstanding 2020. We announced record 2020 Cytosorb sales of $39.5 million. 22.8 million in 2019, a 73% increase. We also announced record Q4 2020 product sales of 11.5 million versus 6.6 million a year ago, a 74% increase. Our blended product gross margins were a record 82% in the fourth quarter and 76% for the year. We had a solid balance sheet with 71.4 million in cash as of the end of the year and no long-term debt. and we delivered more than 121,000 cumulative cytosorb cartridges to date, which was up 51% from 80,000 a year ago with distribution across 67 countries. In addition, we treated more than 5,000 COVID-19 patients in more than 30 countries, including here in the United States under FDA emergency use authorization granted in 2020. We received EU approval to remove ticagrelor and ribaroxaban during emergent cardiothoracic surgery. and we are also granted FDA breakthrough designation for the removal of ticagrelor for this application. We also received European Union approval for a new product called the ECOS 300CY cartridge to remove inflammatory toxins during ex vivo perfusion of solid organs for organ transplant. And we also were awarded $8.4 million in contracts from the DOD to complete Hemofen BGA preclinical development that will enable universal plasma as well as whole blood transfusions. One of the topics that we wanted to cover today is our sales growth strategy and the new normal. With our strong financial performance and solid cash position, coupled with solid current and anticipated demand for Cytosorb, we're executing a number of key initiatives to drive growth. First, it is to maximize what remains of the COVID-19 opportunity. And then it is to return to our pre-COVID-19 growth strategy where we will be focused on achieving solid growth in product revenue while replacing COVID-19 sales. Prioritizing the path to U.S. regulatory approval of Cytosorb based on Ticagrelor removal and cardiothoracic surgery. Execute on our new clinical strategy in the United States and in Europe. Expand our manufacturing facility to accommodate a peak capacity of $350 to $400 million in sales. begin building out our U.S. commercialization team in anticipation of a potential U.S. approval and also driving to GAAP profitability.