Financial Data and Key Metrics Changes - For Q1 2025, the company reported product revenue of $43.2 million, a 13% increase year-over-year, aligning with the guidance of 10% to 15% growth [20][21] - North American product revenues increased by 22% compared to the same period last year, driven by higher platelet sales and increasing demand for IFC [21][22] - Product gross profit for Q1 was $25.4 million, up from $21.3 million in the prior year, representing a 20% increase [24] - The net loss attributable to the company was $7.7 million, or $0.04 per share, compared to a net loss of $9.7 million, or $0.05 per share, for the prior year, indicating a 20% improvement [28] Business Line Data and Key Metrics Changes - The growth in product revenue was primarily led by robust North American platelet kit sales, with increasing demand in both the U.S. and Canada [17][21] - U.S. IFC sales totaled $3 million in Q1 2025, compared to $1.9 million in Q1 2024, reflecting strong customer demand [22] - EMEA product revenue declined by 4% year-over-year, with a 1% decline on a non-GAAP basis when excluding foreign exchange impacts [21] Market Data and Key Metrics Changes - The INTERCEPT system is now used in over 40 countries, with a standard of care established in approximately one-third of those countries [7] - The company anticipates continued growth in international markets, particularly in regions with increasing adoption of INTERCEPT technology [17][72] Company Strategy and Development Direction - The company aims to expand its platelet market share in the U.S. and improve IFC supply to meet growing customer demand [9][19] - The phased global launch of the INT200 device is expected to enhance the usability and efficiency of the system, supporting future geographic expansion [8][9] - The company remains focused on securing global regulatory approvals for its INTERCEPT product portfolio to improve blood safety and availability [32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating geopolitical and macroeconomic uncertainties, emphasizing the compelling value proposition of INTERCEPT technology [15][16] - The company expects to achieve positive adjusted EBITDA for the full year, assuming existing tariffs remain in place [29] Other Important Information - The company ended Q1 2025 with $80.9 million in cash and cash equivalents, a slight increase from $80.5 million at the end of 2024 [29] - Cash used from operations was minimal at $800,000, primarily tied to working capital investments in anticipation of expected commercial growth [29] Q&A Session Summary Question: Can you elaborate on the 22% growth in North American product revenue? - Management indicated that growth was driven by underlying demand in the U.S. franchise, with significant contributions from both platelet and IFC sides [35][39] Question: What are the next steps regarding the CE Mark application for the INTERCEPT red blood cell system? - Management confirmed that TUV is conducting a clinical review, and they are optimistic about the application based on previous submissions [43][45] Question: How is the EMEA business performing, particularly in France? - Management reported stability in the French platelet market, with positive experiences from INTERCEPT and plans to initiate plasma activities [48][49] Question: What are the plans to increase production capacity for IFC? - Management noted that several production partners have received biologic license application approvals, enabling them to ramp up manufacturing to meet growing demand [51][53] Question: Can you discuss the assumptions in your guidance for the year? - Management indicated that the guidance includes anticipated revenue from the INT200 device and assumes a ramp-up in IFC production throughout the year [56][59]