Financial Performance & Guidance - Cerus' annual product revenue has shown consistent growth from 2017 to 2022, with a compound annual growth rate (CAGR) of 30%[10] - In 2022, Cerus achieved product revenues of $162 million[33] - The company projects 2023 product revenue to be in the range of $165 million to $170 million[51] - Cerus anticipates reaching cash flow breakeven during 2023 and expects improvement across margins, cash flow, and operating expense leverage[3, 51] Market Opportunity & Growth Strategy - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential to grow to over $1.5 billion in the next 5-7 years[33] - The U S market represents a $150 million opportunity, expected to exceed $200 million in 5-7 years[33] - Cerus is focused on geographic expansion, including new markets like China, to extend its global reach[3, 53] Technology & Product - The INTERCEPT Blood System targets DNA and RNA to prevent pathogen proliferation in blood products[19, 20] - Over 10 million cumulative kits of INTERCEPT-treated blood products have been sold[40] - Cerus has an FDA-approved product for pathogen-reduced platelets in the U S [20, 58]

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]

Group 1 - Cerus reported a quarterly loss of $0.04 per share, better than the Zacks Consensus Estimate of a loss of $0.05, representing an earnings surprise of 20% [1] - The company posted revenues of $43.24 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 2.95%, and up from $38.37 million a year ago [2] - Cerus has surpassed consensus EPS estimates three times over the last four quarters [2] Group 2 - The stock has underperformed, losing about 14.3% since the beginning of the year, compared to the S&P 500's decline of 5.3% [3] - The current consensus EPS estimate for the coming quarter is -$0.02 on revenues of $49.5 million, and -$0.10 on revenues of $198 million for the current fiscal year [7] - The Zacks Industry Rank for Medical - Products is in the bottom 28% of over 250 Zacks industries, indicating potential challenges for stock performance [8]

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]

Product Development and Regulatory Approvals - The INTERCEPT Blood System for red blood cells is currently in development and has not been commercialized anywhere in the world[122]. - The company received FDA approval for the INTERCEPT Blood System for Cryoprecipitation in November 2020, and it is being sold directly to hospitals and through blood centers[126]. - The ReCePI study, which evaluated the efficacy and safety of INTERCEPT-treated red blood cells, met its primary efficacy endpoint, demonstrating non-inferiority compared to conventional red blood cells[124]. - The company has two agreements with BARDA for funding to support the development of the red blood cell system, with the initial agreement expiring in September 2026 and a new agreement expiring in September 2030[125]. - The company plans to initiate a modular PMA application to the FDA upon anticipated completion of the RedeS clinical trial, which is expected in the second half of 2026[124]. - The company is facing challenges with the regulatory approval process for the red blood cell system, including a recent closure of its MDR application due to insufficient data[124]. - The company is required to obtain new PMAs for the INTERCEPT Blood System for Platelets and Plasma with the new LED-based illuminator[131]. Financial Performance - Product revenue for the three months ended March 31, 2025, was $43,239,000, representing a 13% increase from $38,365,000 in the same period of 2024[148]. - Government contract revenue increased to $5,614,000 for the three months ended March 31, 2025, up 12% from $5,030,000 in the prior year[148]. - Total revenue for the three months ended March 31, 2025, reached $48,853,000, a 13% increase compared to $43,395,000 in the same period of 2024[148]. - The increase in product revenue was primarily driven by year-over-year sales volume growth in disposable platelet kit sales to U.S. customers[149]. - The company expects continued growth in product revenue for INTERCEPT disposable kits due to increased market acceptance and adoption of the INTERCEPT Blood System[149]. - The company has a commitment from BARDA to reimburse up to $185.5 million for expenses related to the clinical development of the red blood cell system as of March 31, 2025[140]. - The 2024 BARDA Agreement includes committed funding of up to $32.1 million, with a total funding opportunity of $188.4 million if all options are exercised[142]. Costs and Expenses - Cost of product revenue increased by 4% to $17,815,000 for the three months ended March 31, 2025, compared to $17,093,000 for the same period in 2024[152]. - Gross margin on product sales improved to 59% in Q1 2025 from 55% in Q1 2024, driven by a favorable product mix and capitalization of inventoriable charges[153]. - Research and development expenses rose by 15% to $16,605,000 in Q1 2025, up from $14,482,000 in Q1 2024, mainly due to costs related to a new LED-based illuminator[156]. - Selling, general and administrative expenses increased by 2% to $20,286,000 in Q1 2025, compared to $19,799,000 in Q1 2024, primarily due to higher compensation costs[159]. Cash Flow and Working Capital - Net cash used in operating activities was $(844,000) for Q1 2025, a decrease from $1,959,000 provided in Q1 2024, attributed to increased inventory purchases[169]. - Net cash used in investing activities was $(1,189,000) in Q1 2025, compared to $1,446,000 provided in Q1 2024, primarily due to investment purchases[170]. - Working capital increased to $91,940,000 as of March 31, 2025, from $88,890,000 as of December 31, 2024, mainly due to higher inventory levels[172]. Risks and Financial Position - The company may need to curtail planned development or commercialization activities if unable to raise additional capital due to volatile global financial markets[129]. - The principal amounts under the Term Loan Credit Agreement will begin amortizing on April 1, 2026, which could negatively impact available working capital[128]. - The company expects to meet its capital requirements for at least the next 12 months through available cash, cash equivalents, and short-term investments, alongside revenue from product sales and government contracts[173]. - The company has the potential to borrow additional capital under existing credit agreements, which may include restrictive covenants that could impact operational flexibility[174]. - Funding from BARDA is subject to risks, including potential termination of agreements and the need to achieve specific milestones, which could significantly impact revenues and cash flows[179]. - The company does not currently hedge against foreign exchange fluctuations, which could materially affect future results[180]. - Economic uncertainties, including inflation and trade tensions, may limit the company's access to capital and negatively impact liquidity[181]. - Additional funding may be required to complete development activities for the red blood cell system, especially if costs exceed expectations or delays occur[182]. - The company has no off-balance sheet arrangements as of March 31, 2025, indicating a straightforward financial position[184]. Investment and Market Risk - The investment policy focuses on preserving principal and liquidity while maximizing returns, with no recorded credit losses during the three months ended March 31, 2025[185]. - There were no material changes to market risk disclosures during the three months ended March 31, 2025, indicating stability in risk management practices[186].

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]

Revenue Performance - First quarter 2025 product revenue was $43.2 million, a 13% increase from $38.4 million in the prior year[4] - Total revenue for the first quarter 2025 was $48.9 million, including government contract revenue of $5.6 million, reflecting a 13% growth year-over-year[4] - The company reiterated its full-year 2025 product revenue guidance of $194 million to $200 million, indicating an expected growth of 8% to 11% from 2024[16] - Adoption of INTERCEPT Fibrinogen Complex (IFC) increased, with first quarter 2025 revenue of $3.0 million compared to $1.9 million in the prior year[4] - Cerus Corporation reported product revenue of $43,239,000 for the three months ended March 31, 2025, representing a 13% increase from $38,365,000 in the same period of 2024[29] - North America saw a 22% increase in revenue, totaling $30,601,000, while international revenue decreased by 9% to $12,211,000[29] Profitability - First quarter 2025 product gross profit was $25.4 million, a 20% increase from $21.3 million in the prior year, with a gross margin of 58.8%[7] - The gross profit on product revenue for the same period was $25,424,000, up from $21,272,000, indicating a positive trend in profitability[31] - The company reported a net loss of $7.7 million for the first quarter 2025, an improvement from a net loss of $9.7 million in the same period last year[12] - The net loss attributable to Cerus Corporation decreased to $7,717,000 in Q1 2025 from $9,688,000 in Q1 2024, reflecting improved financial performance[31] - Non-GAAP adjusted EBITDA for the first quarter 2025 was positive $0.2 million, compared to negative $2.7 million in the prior year[13] - Adjusted EBITDA for Q1 2025 was $157,000, a significant recovery from a loss of $2,709,000 in Q1 2024[35] Expenses and Investments - R&D expenses for the first quarter 2025 were $16.6 million, up 15% from $14.5 million in the prior year, driven by development costs for the INT200 device[9] - Research and development expenses rose to $16,605,000 in Q1 2025, compared to $14,482,000 in Q1 2024, indicating ongoing investment in innovation[31] - Total operating expenses increased to $36,891,000 in Q1 2025 from $34,281,000 in Q1 2024, reflecting higher costs associated with growth initiatives[31] Cash and Assets - Cash, cash equivalents, and short-term investments totaled $80.9 million as of March 31, 2025, slightly up from $80.5 million at the end of 2024[14] - Cash and cash equivalents decreased slightly to $19,476,000 from $20,266,000, indicating a need for careful cash management[33] - The company’s total assets as of March 31, 2025, were $206,776,000, up from $200,917,000 at the end of 2024[33] Market Trends - The number of treatable platelet doses in North America increased by 17%, while the international market saw a decline of 10%[27] - The company submitted an updated CE Mark application for the INTERCEPT red blood cell system, with the review process underway[11]

Regulatory Approvals and Compliance - The INTERCEPT Blood System for platelets and plasma has received CE Certificates of Conformity under MDR in December 2023 and is commercialized in the U.S. and several countries worldwide[24]. - The company has received FDA approval for the INTERCEPT Blood System for Cryoprecipitation in November 2020, which is used for treating bleeding associated with fibrinogen deficiency[26]. - The company anticipates ongoing product development costs due to the failure to obtain approval for the red blood cell system's MDR application, which was closed in October 2024[20][29]. - The company faces significant risks related to regulatory compliance, manufacturing supply chain, and potential inability to achieve profitability[19][21]. - The company must continue to comply with FDA and other regulatory requirements related to labeling, packaging, and quality control for its products[93]. - The company is required to report adverse events and production problems to regulatory authorities, which could lead to product recalls[94]. - The company must comply with extensive FDA and foreign regulatory requirements, including quality control and manufacturing procedures conforming to cGMP and current QSR requirements[191]. - Non-compliance with regulatory requirements could result in sanctions such as fines, product recalls, and operational restrictions[193]. - The company is required to notify its Notified Body of significant changes to products sold in the EU, which can delay the introduction of new products[205]. - Non-compliance with the Medical Device Regulation (MDR) could prevent the sale of products in the EU, adversely affecting financial projections[217]. Clinical Trials and Product Development - The red blood cell system is currently in Phase 3 clinical trials in the U.S. and has completed European Phase 3 trials for acute and chronic anemia[20][29]. - The company has completed two post-approval studies required by the FDA for the platelet system, evaluating the incidence of acute lung injury and recovery of treated platelets[25]. - The European Phase 3 clinical trial of INTERCEPT-treated RBCs for acute anemia met its primary endpoint, showing a mean hemoglobin content of 53.1g compared to 55.8g for conventional RBCs, within the inferiority margin of 5g[30]. - A total of 581 patients were enrolled in the U.S. ReCePI study, which demonstrated non-inferiority of INTERCEPT RBCs compared to conventional RBCs in preventing acute kidney injury following transfusion[32]. - The RedeS study has been expanded to include up to 800 subjects, assessing the safety and efficacy of INTERCEPT-treated RBCs in regions affected by the Zika virus, with a primary endpoint of hemoglobin increment following transfusion[31]. - The company plans to submit a modular premarket approval application to the FDA based on positive data from the expanded RedeS study[31]. - The company must demonstrate compliance with good clinical practices to avoid regulatory complications that could hinder the approval of the red blood cell system[172]. - The company anticipates the final PMA module submission upon completion of the RedeS study, previously expected in the second half of 2026, but delays in clinical trial enrollment may impact this timeline[175]. - The company reported positive topline results from the ReCePI study in Q1 2024, but this does not guarantee success in other clinical trials, including the RedeS study[177]. - The company may need to conduct additional successful Phase 3 clinical trials to obtain regulatory approval in certain countries, which could complicate market acceptance[178]. Market Adoption and Sales Strategy - The company plans to focus on increasing the production of platelet and plasma units in 2025 and selling IFC to hospital customers[27]. - The INTERCEPT Blood System is one of the options available for U.S. blood centers to comply with FDA guidance, but adoption levels remain uncertain[52]. - Market adoption is influenced by blood center budgets and reimbursement availability, with HCPCS codes established for reimbursement in 2015 and 2021[61][62]. - The American Red Cross is a key customer, but the volume and timing of their purchases cannot be guaranteed[53]. - The German blood banking market has seen several blood centers receive necessary approvals for the INTERCEPT system, but pricing remains low compared to other markets[55]. - In France, the national adoption of the INTERCEPT system is dependent on the Établissement Français du Sang, with current contracts expiring in October 2025[56][57]. - The Japanese Red Cross has not yet made a formal decision on adopting pathogen reduction measures, which may require additional product configuration changes[59]. - The company is currently working with the FDA to understand data requirements for new PMAs related to the redesign of the illuminators used in its systems[202]. - The company has limited experience selling directly to hospitals, which may hinder the commercialization of INTERCEPT Blood System for cryoprecipitation[141]. - Customers may delay or refrain from purchasing INTERCEPT Blood System products due to operational or technical problems, which could impact market acceptance[129]. Financial Risks and Funding - The company relies on BARDA agreements for funding the development of the red blood cell system, and any reduction or delay in funding could significantly impact revenues[19]. - The company faces significant risks in commercializing the INTERCEPT Blood System in the U.S., including the need to demonstrate the products' safety, efficacy, and economic viability[121]. - The company is exposed to potential liability risks from product harm, which may lead to substantial liabilities or limit commercialization if product liability claims arise[144]. - The company maintains product liability insurance, but it is uncertain whether this coverage will be adequate against potential liabilities[146]. - Significant costs were incurred in connection with the CID, which may impact the company's financial performance objectives[211]. - The company faces challenges in educating hospitals and clinicians about the value of pathogen reduction, impacting U.S. market commercialization[140]. - Budgetary constraints and reimbursement issues from healthcare facilities may limit the adoption of INTERCEPT products[132]. Research and Development - The company anticipates substantial continued investment in research and development activities, particularly for the platelet and plasma systems, and expects to incur expenses associated with pursuing a new PMA for these systems[82]. - The company is assessing strategies for a potential new MDR application for the red blood cell system after its previous application was closed without approval[85]. - The company must develop additional configurations of the platelet system to address the entire U.S. market, which may delay product revenues[92]. - The company is stockpiling pooling sets to mitigate potential disruptions, which diverts capital from core products[158]. - The company may need to conduct additional toxicology studies if there are major changes to product components, which could delay regulatory approval[167]. Employee and Organizational Information - As of December 31, 2024, the company had 281 employees, with approximately 62% being women and 50% of U.S. employees identifying as non-white[110]. - The average age of employees is 46.6 years, with an average length of service of 6.5 years and a voluntary employee turnover rate of 8.3% from December 31, 2023, to 2024[112]. - The company has implemented a hybrid workplace policy to support employee well-being and productivity, allowing for flexible schedules and remote work[115]. - The company provides competitive compensation packages, including market-competitive pay, stock grants, and health benefits, to attract and retain talent[113]. - The company encourages community involvement through a Volunteer Paid Time Off Program, allowing employees to volunteer while being compensated[114].

Financial Data and Key Metrics Changes - Full year 2024 product revenues were $180.3 million, representing 15% growth year-over-year [23] - Fourth quarter 2024 product revenue was $50.8 million, reflecting year-over-year growth of 9% [23] - Reported net loss attributable to Cerus for 2024 improved by 44% to $20.9 million from $37.5 million for 2023 [34] - Positive adjusted EBITDA of $5.7 million for the year, a significant improvement over the negative $10.7 million for the prior year [35] - Fourth quarter 2024 generated positive operating cash flows of $4.9 million, compared to cash used for operations of $15.2 million in Q4 2023 [36] Business Line Data and Key Metrics Changes - The IFC business was up almost 30% in Q4 2024 compared to the prior year [24] - Full year 2024 North American product revenues increased by 23% over 2023 levels [24] - EMEA fourth quarter product revenues were up 16% year-over-year [25] - Government contract revenue totaled $21.1 million for 2024 compared to $30.4 million for 2023 [26] Market Data and Key Metrics Changes - Canadian Blood Services achieved 100% PR adoption for platelet production [15] - The company is seeing strong platelet traction across its global franchise as it enters 2025 [19] - The total addressable market for blood safety and availability is estimated to exceed $7 billion annually [39] Company Strategy and Development Direction - The company aims to establish the INTERCEPT blood system as a standard of care in transfusion medicine [9] - Plans for a new and enhanced CE Mark submission for INTERCEPT red blood cells are underway [12] - The company is focused on expanding its global platelet franchise and capturing market share in the U.S. [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in 2025, driven by strong demand for both platelet and IFC products [39] - The company anticipates year-over-year growth of 8% to 11% in product revenue for 2025 [11] - Management highlighted the importance of balancing demand and supply to unlock market potential [48] Other Important Information - The company ended Q4 2024 with $80.5 million in cash, cash equivalents, and short-term investments [36] - Operating expenses for 2024 were down more than 8% to $134.8 million compared to $146.9 million for 2023 [30] Q&A Session Summary Question: Steps to full U.S. market access for IFC - Management highlighted the importance of balancing demand and supply, with recent BLA approvals enabling transportation across state lines [48] Question: Outlook for China market opportunity - NMPA approval is expected in 2025, followed by a reimbursement process that may take about a year [51] Question: Dynamics of additional supply for IFC - Management confirmed that sufficient manufacturing supply is anticipated to meet demand, with ongoing efforts to increase supply [58] Question: Product gross margins outlook - Management indicated that most issues affecting Q4 margins were episodic, with FX rates being a key factor to monitor [62] Question: SG&A guidance for 2025 - SG&A expenses are expected to rise slightly due to inflationary pressures, but significant new investments are not planned [70] Question: Penetration levels at major U.S. blood centers - Management noted continued inbound inquiries from blood centers to adopt INTERCEPT, indicating ongoing share capture [97] Question: Government contract revenue run-rate for 2025 - Management suggested that Q4 revenue may not be a good baseline for 2025, expecting overall government contract revenue to increase as initiatives ramp up [101]

Revenue Growth - Preliminary full-year 2024 product revenues totaled $180.3 million, representing a 15% increase over 2023 results and exceeding the prior guidance of $177-$179 million[1][2] - The IFC revenue for full-year 2024 was $9.2 million, reflecting a significant growth of 42% compared to 2023[2] - For full-year 2025, product revenues are expected to be between $194 million and $200 million, indicating a year-over-year growth of 8% to 11%[1][3] - The first quarter of 2025 is projected to see product revenue growth of approximately 10% to 15% compared to the first quarter of 2024[3] - Total product revenue for the fourth quarter of 2024 was $50.8 million, a 9% increase from $46.8 million in the fourth quarter of 2023[6] - The platelet revenue for the full year 2024 was $171.1 million, up 14% from $149.9 million in 2023[6] Product Launch and Expansion - The company plans to launch the LED Illuminator in Europe and anticipates further geographic expansion[3] - The INTERCEPT Blood System remains the only pathogen reduction system with both CE mark and FDA approval for platelets and plasma[7] Financial Position - The company continues to strengthen its financial position to support future growth initiatives[4] - Cerus is currently finalizing its full financial results for the year ended December 31, 2024, with preliminary results subject to change[12]