Financial Data and Key Metrics Changes - The company reported product revenue of $52.4 million for Q2 2025, representing a 16% year-over-year increase [22][28] - For the first half of 2025, product revenue increased 15% to $95.7 million compared to the same period in 2024 [22] - Non-GAAP adjusted EBITDA for Q2 2025 was $935,000, marking the fifth consecutive quarter of positive adjusted EBITDA [28] Business Line Data and Key Metrics Changes - IFC revenue for Q2 2025 was $5.6 million, up from $2 million in the prior year period, with strong demand driving growth [24] - The core platelet franchise continues to be a key revenue driver, with increasing adoption of pathogen-reduced platelets in the U.S. and international markets [9][14] - The INT-two 100 illuminator was launched, receiving positive feedback and contributing to product growth [10][15] Market Data and Key Metrics Changes - North American product revenues increased 17% year-over-year in Q2 2025, while EMEA product revenues rose 21% [23] - Canadian Blood Services transitioned to 100% routine use of INTERCEPT platelets, and growth was noted in the Middle East [15] - The company is addressing regulatory requirements in China to strengthen its market position [16][17] Company Strategy and Development Direction - The company aims to transform blood safety and availability through its INTERCEPT product portfolio, with a focus on expanding its market presence [6][31] - The anticipated regulatory approval of the INTERCEPT red blood cell program in Europe is expected to enhance customer relationships [32] - The company is committed to achieving positive non-GAAP adjusted EBITDA for the full year 2025 [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in exceeding the full-year 2025 product revenue guidance due to strong customer demand [7][31] - The company remains mindful of macroeconomic and geopolitical factors but believes its value proposition and pipeline position it well for future growth [20] - The strong commercial results and product development progress indicate a sustainable growth trajectory [20][31] Other Important Information - The company received a $7.2 million award from the U.S. Defense Department for a study evaluating the utility of early IFC in trauma patients [12] - The company ended Q2 2025 with $78 million in cash and equivalents, slightly down from $80.5 million in the prior year [29] Q&A Session Summary Question: Revenue guidance for the year and expected cadence - Management expects continued growth in the back half of the year, with a flattening from Q2 to Q3 due to seasonal factors and deferred revenue recognized in Q2 [35][36] Question: EU red blood cell opportunity and TAM - The expanded CE Mark submission allows access to all patient populations, reducing initial limitations and opening up new opportunities [37][38] Question: Key drivers for IFC guidance and quarterly cadence - The strong pipeline of new hospital customers and increased supply position are expected to drive growth, despite some backlog being cleared in the first half [42][44] Question: Operating expenses and investment growth - The increase in operating expenses is primarily due to government contract activity and cost of living adjustments, with no significant one-time expenses [45]

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 [21][22] - North American product revenues increased by 22% compared to the same period last year, driven by higher platelet sales and increasing demand for IFC [22][23] - First quarter product gross profit was $25.4 million, up from $21.3 million for the same period last 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 period, 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 [18][22] - U.S. IFC sales totaled $3 million in Q1 2025, compared to $1.9 million in Q1 2024, reflecting strong customer demand [23] - EMEA product revenue declined by 4% year-over-year, with a 1% decline on a non-GAAP basis when excluding foreign exchange impacts [22] Market Data and Key Metrics Changes - The INTERCEPT system is now used in over 40 countries, with a significant presence in North America and Europe [8] - The company anticipates continued growth in international markets, particularly in regions with emerging demand for pathogen-reduced blood products [18][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][20] - 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 [16][17] - The company is optimistic about achieving positive non-GAAP adjusted EBITDA for the full year 2025, despite potential impacts from tariffs [29][30] - Management highlighted the importance of customer feedback and real-world experience in driving growth and validating the technology [72][75] 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 investments in working capital [30] Q&A Session Summary Question: Can you provide details on the 22% growth in North American product revenue in Q1? - Management noted that growth was driven by underlying demand in the U.S. franchise, with significant contributions from both platelet and IFC sales [35][38] Question: What are the next steps regarding the CE Mark application for the INTERCEPT red blood cell system? - Management indicated that TUV is conducting a clinical review, and they are optimistic about the application due to strong prior communications and a solid submission [43][45] Question: How is the EMEA business performing, particularly in France? - Management confirmed that the French platelet market remains stable, contributing positively to overall growth, with plans to initiate activity on the plasma side [48][50] Question: What are the plans to increase production capacity for IFC? - Management explained that several blood center production partners have received biologic license application approvals, allowing them to ramp up manufacturing to meet growing demand [51][53] Question: Can you discuss the assumptions in your guidance for the year? - Management clarified that the guidance includes anticipated revenue from the INT200 device and assumes a ramp-up in IFC production throughout the year [56][60]