Financial Data and Key Metrics Changes - For Q3 2025, the company reported record product revenue of $52.7 million, a 15% year-over-year increase [20] - Year-to-date product revenue for the first nine months of 2025 reached $148.4 million, also reflecting a 15% increase compared to the same period in 2024 [20] - Product gross profit for Q3 was $28.1 million, a 7% increase from $26.2 million in the prior year, while product gross margins decreased to 53.4% from 56.9% due to inflationary pressures and higher production costs [25][26] Business Line Data and Key Metrics Changes - The Intercept platelet franchise remains the foundation of the business, with US market penetration estimated at mid-60%, up from low 60% a year ago [6] - IFC sales in Q3 were $3.9 million, a significant increase from $2.3 million in Q3 2024, with a year-over-year revenue increase of approximately 70% and volume demand up about 110% [22][24] - The shift from direct sales to hospitals to IFC kit sales to blood centers is expected to continue, with approximately 70% of dose-equivalent unit sales tied to kits in Q3 compared to less than 25% the previous year [15][24] Market Data and Key Metrics Changes - AMEA product revenues increased by 21% year-over-year, driven by strong Middle Eastern platelet sales and initial shipments to Germany [21] - North American product revenues increased by 11% year-over-year, led by gains in the United States [21] Company Strategy and Development Direction - The company aims to establish a complete portfolio of pathogen-inactivated blood components worldwide, with ongoing regulatory reviews and clinical trials [32] - The transition to a kit-based model for IFC sales is designed to leverage existing blood center sales channels and reduce contract cycle times, enhancing market access [42][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued momentum across franchises, raising the full-year 2025 product revenue guidance to $202-$204 million [24][31] - The company anticipates a strong finish to 2025, with expectations for record revenue in Q4 and positive growth projections for 2026 [19][31] Other Important Information - The company achieved its sixth consecutive quarter of positive non-GAAP adjusted EBITDA, totaling $5 million for Q3 2025 [28] - Cash generated from operations during Q3 was $1.9 million, with a stable cash balance of $78.5 million at the end of the quarter [28][30] Q&A Session Summary Question: What are the expectations for gross margin headwinds in 2026? - Management indicated that some headwinds, such as foreign exchange rates and tariffs, are out of their control, but they can focus on growing the business and improving product mix to drive margin expansion [35] Question: How will the company meet growing demand for IFC? - Management stated that production and supply capabilities have improved significantly, and they do not foresee supply constraints in the near future [36] Question: What drove the decision to shift towards a kit-based model for IFC? - The shift was primarily driven by the ability to leverage existing blood center sales channels and contracts, which reduces cycle time and improves gross margins [41][42]

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]