Cytosorbents Corporation

Good afternoon and welcome to the Cytosorbents Second Quarter 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 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, Jeremy Pfeffer. Please go ahead, sir.

Good afternoon, everyone. Welcome to Cytosorbents' second quarter 2020 financial and operating results conference call. Joining me today are Dr. Philip Chan, Chief Executive Officer, Vincent Capponi, Chief Marketing Officer, Kathleen Bloch, Chief Financial Officer, Dr. Efthymios Deliargyris, Chief Medical Officer, Dr. Christian Steiner, Senior Vitals and Marketing from Germany, and Christopher Cramer, Vice President of Business Development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that management's prepared remarks may contain forward-looking statements which are subject to risks. Management may make additional forward-looking statements to your questions today. Therefore, the company claims protection under safe harbor for phones contained in the Private Securities Litigation Reform Act of 1995. Notes may differ from results discussed today, and therefore, we refer you to a more detailed disclaimer on certainties and the company's filings with the SEC. To the company's future performance represented by management include estimates today as of August 4th, 2020, and we assume no obligation to update these projections in the few that should change. During today's call, we will have an overview presentation covering the operating and financial highlights for the second quarter by Dr. Chan and Ms. Bloch. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. This time, it's my pleasure to turn the call over to Dr. Philip Chan. Phil?

Thank you very much, Jeremy, and good afternoon, everyone. We had a very busy and productive record second quarter. First, second quarter 2020 total revenue grew 58% to $9.8 million, and product sales grew 61% to $9.5 million over the second quarter of 2019, trailing 12-month product sales for a record $30 million. Blended product gross margins were 70% in the second quarter, lower than 76% a year ago due to a higher percent of distributor sales over direct sales and higher costs of ramped COVID-19 production. One of the hallmarks of the second quarter was that the U.S. FDA granted Emergency Use Authorization, or EUA, to Cytosorb for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure, enabling sales to all U.S. hospitals and generating approximately $667,000 in U.S. revenues. We also achieved FEA breakthrough designation for cytosorb during the quarter to remove ticagrelor during on-pump urgent or emergent cardiothoracic surgery. We also received EU approval for cytosorb to remove rivaroxaban during on-pump cardiothoracic surgery as well. In May, Dr. Efthymios Deliargyris, better known as Micus, started as Chief Medical Officer and has done a fantastic job in a short time at the company. We've also treated now more than 1,200 COVID-19 patients in more than 30 countries, including here in the United States. We received $1.1 million in non-dilutive funds from the New Jersey Technology Business Tax Certificate Transfer Program, and we were also awarded a $2.9 million Phase III STTR contract to advance HemaDefend BGA, for clinical trials for universal plasma and for whole blood treatment. Finally, we expanded distribution to 65 countries, adding nine Latin American countries to our distribution network. One of our most gratifying milestones was announced yesterday. Cytosorbents is now celebrating the delivery of more than 100,000 cytosurge treatments cumulatively to date, with tens of thousands of patients treated in a wide variety of applications, with many publications documenting The Joint Statement that we made in a press release yesterday sums up my thoughts well, but I wanted to say that I've been blessed with outstanding colleagues at the company, particularly on my management team with whom I've had the pleasure of working closely with over the years to build this company. And I thought it would be fitting to turn it over to each of them to say a few words upon this very significant occasion before we continue. To lead it off, I'd like to invite Dr. Christian Steiner, Senior Vice President of Sales and Marketing and Managing Director of Cytosorbents Europe, whose passion for the therapy rivals my own, to start. Christian?