
Financial Data and Key Metrics Changes - In Q3 2019, total revenue was approximately $6.1 million, a 6% increase from $5.7 million in Q3 2018 [13] - Product sales for Q3 2019 were $5.7 million, a 12.3% increase from $5.1 million in Q3 2018 [11] - Gross profit for Q3 2019 grew to approximately $4.4 million, an increase of over 19% from $3.7 million in Q3 2018 [14] - Blended product gross margins expanded to 77% in Q3 2019, up from 72% in Q3 2018 [14][19] - Cash as of September 30, 2019, was approximately $16 million, providing a solid operating foundation [20] Business Line Data and Key Metrics Changes - Cytosorbents delivered 73,000 treatments in Q3 2019, up from 51,000 a year ago [7] - Direct sales accounted for approximately 75% of product sales, with efforts to double the number of direct sales countries from five to ten in 2019 [22] - Product sales for the first nine months of 2019 were approximately $16.2 million, a 9% increase over $14.8 million for the same period in 2018 [15] Market Data and Key Metrics Changes - The Euro to dollar exchange rate declined from an average of $1.16 in Q3 2018 to $1.11 in Q3 2019, impacting reported sales [12] - Expansion into 58 countries, with new registrations pending in Brazil, Mexico, South Korea, and Colombia, potentially adding over 440 million people to the market [24] Company Strategy and Development Direction - The company aims for significant growth in 2020, driven by increased direct sales and expanded market presence [22] - A focus on strengthening the commercial organization by increasing headcount and enhancing sales strategies [25][27] - Continued clinical progress with trials aimed at expanding the use of CytoSorb in various medical applications [9][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a strong finish to 2019 and anticipates faster growth in 2020 [22] - The company is optimistic about the demand for CytoSorb, with 85% of invoices coming from repeat customers [28] - Clinical data generation is robust, with over 120 publications supporting the efficacy of CytoSorb in treating various conditions [29] Other Important Information - The company received renewal of its CytoSorb CE Mark through May 2024 and ISO 13485 certification through September 2023 [8] - The company has an at-the-market facility allowing it to raise up to $25 million in equity if needed [20] Q&A Session Summary Question: Update on the outlook for direct sales and distributor revenue - Management acknowledged challenges with distributor revenue due to inventory issues but noted that two of three distributors are now ordering again [50] - Direct sales outside Germany are expected to grow, with Poland showing promising early results [56] Question: Potential for label expansion and future clinical trials - Management confirmed that they are actively pursuing label expansion based on compelling data from recent studies [76] Question: Details on the REFRESH 2 study interim analysis - The interim analysis will assess whether the study needs rebalancing or if there are any safety concerns, but results will not be publicly disclosed to maintain trial integrity [102][104]