Financial Data and Key Metrics Changes - The company achieved a positive non-GAAP adjusted EBITDA for 2024 and is committed to maintaining this for 2025, indicating an improving financial profile [7][42] - Current revenue guidance for 2025 is between $194 million to $200 million, representing a sub-10% penetration of the total addressable market (TAM) of $2.5 billion for existing licensed products [8][11] Business Line Data and Key Metrics Changes - The INTERCEPT Fibrinogen Complex product is projected to generate $12 million to $15 million in revenue for 2025, showing significant growth potential [11][31] - The INTERCEPT technology has been developed to treat all four transfused blood components: platelets, plasma, red cells, and fibrinogen complex, with a strong market presence in the platelet transfusion sector [4][5] Market Data and Key Metrics Changes - The total addressable market for the platelet opportunity is expected to reach at least $1.5 billion by 2030, with organic growth in the platelet market typically ranging from 3% to 5% annually [9][10] - The red cell market opportunity is the largest, estimated at $5 billion globally, highlighting the importance of getting the INTERCEPT Red Cell program approved [10] Company Strategy and Development Direction - The company aims to extend its leadership position in the INTERCEPT blood system for platelets and plasma, targeting additional market share in the U.S. and expanding into markets like China, Brazil, and Germany [42][43] - The focus is on developing real-world outcomes data for the INTERCEPT Fibrinogen Complex and targeting international opportunities [44] Management's Comments on Operating Environment and Future Outlook - Management emphasized the strong and improving financial profile, with sustained revenue growth expected through the end of the decade due to existing and new products [7][42] - The company is well-positioned to leverage its established customer base and recurring revenue model to drive growth [5][6] Other Important Information - The company has a strong cash position, which supports its growth initiatives and operational stability [7] - The INTERCEPT technology addresses significant unmet needs in transfusion medicine, particularly in pathogen reduction and safety [15][18] Q&A Session Summary Question: What is the outlook for the INTERCEPT Red Cell program? - The company is nearing completion of enrollment for the ReCePI study in the U.S., which is required for the PMA submission with the FDA [34] Question: How is the INTERCEPT Fibrinogen Complex performing in the market? - The product is gaining traction in major academic hospitals, with a projected revenue of $12 million to $15 million for 2025 and a significant market opportunity in the U.S. [31][32]

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]