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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from: to Commission File Number 000-21937 CERUS CORPORATION (Exact name of registrant as specified in its charter) Delaware 68-0262011 (State or other jurisdiction ...

Cerus (CERS) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Speaker0 Good day, ladies and gentlemen. Thank you for standing by, and welcome to the Seres Corporation First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Tim Lee, Seres' Head of Investor Relations ...

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]

Regulatory Approvals and Product Development - The INTERCEPT Blood System has received regulatory approvals and is marketed in multiple regions, including the U.S., Europe, and Latin America[102]. - The red blood cell system is still in development and has not been commercialized, with a CE application closed due to insufficient data[105]. - The company plans to initiate a modular PMA application for the red blood cell system upon completion of the RedeS clinical trial, previously expected in the second half of 2026[105]. - The company has 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[106]. - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020, with ongoing efforts to support blood centers in obtaining necessary licenses[107]. - The company is assessing strategies for a potential new MDR application for the red blood cell system following the closure of the previous application[105]. - The ReCePI study demonstrated non-inferiority of INTERCEPT RBCs compared to conventional RBCs, meeting its primary efficacy endpoint[105]. Financial Performance - Product revenue for the three months ended September 30, 2024, increased by 16% to $46,017,000 compared to $39,772,000 in the same period of 2023, driven by sales volume growth in disposable platelet kit sales to U.S. customers[123]. - Government contract revenue for the three months ended September 30, 2024, decreased by 38% to $4,639,000 compared to $7,479,000 in the same period of 2023, primarily due to a decrease in revenue from BARDA[123]. - Total revenue for the three months ended September 30, 2024, increased by 7% to $50,656,000 compared to $47,251,000 in the same period of 2023[123]. - The company expects product revenue for INTERCEPT disposable kits to increase in future periods due to growth in the global platelet business and increased market acceptance of the INTERCEPT Blood System[123]. Funding and Capital Requirements - As of September 30, 2024, BARDA has committed to reimburse certain expenses related to the clinical development of the red blood cell system, with a total funding opportunity of up to $188.4 million under the 2024 BARDA Agreement[117]. - The 2024 BARDA Agreement includes a base period with committed funding of up to $32.1 million and subsequent option periods that could increase total funding[117]. - The company may need to curtail planned development or commercialization activities if unable to raise additional capital due to volatile global financial markets[110]. - The company anticipates that government contract revenue will increase in future periods as multiple contracts are active and activities supporting those contracts ramp up[123]. - The company expects to continue seeking access to equity capital markets to support development efforts, which may lead to substantial dilution for existing shareholders[148]. - The company’s near-term capital requirements are heavily reliant on successful commercialization of the INTERCEPT Blood System and ongoing studies, with potential funding from government contracts and equity markets[145]. - The company faces risks related to BARDA funding, which is subject to various uncertainties, including the ability to meet required milestones and potential budget cuts[150]. Expenses and Cash Flow - Cost of product revenue increased by 10% to $19,818,000 for the three months ended September 30, 2024, compared to $17,956,000 for the same period in 2023[124]. - Gross margin on product sales improved to 57% for the three months ended September 30, 2024, up from 55% in the same period of 2023[125]. - Research and development expenses decreased by 17% to $14,013,000 for the three months ended September 30, 2024, compared to $16,783,000 for the same period in 2023[128]. - Selling, general and administrative expenses increased by 10% to $17,786,000 for the three months ended September 30, 2024, compared to $16,155,000 for the same period in 2023[132]. - Total cash and cash equivalents as of September 30, 2024, were $21,575,000, an increase from $11,647,000 as of December 31, 2023[140]. - Total debt increased to $83,368,000 as of September 30, 2024, compared to $79,796,000 as of December 31, 2023[141]. - Net cash provided by operating activities was $6,430,000 for the nine months ended September 30, 2024, compared to net cash used of $27,985,000 during the same period in 2023[142]. - The company expects to incur additional research and development costs due to inflationary pressures and potential regulatory approvals in new geographies[129]. - The restructuring plan initiated in June 2023 resulted in a reduction in force, with restructuring charges of $1,600,000 recorded in the three months ended September 30, 2023[133]. - Foreign exchange losses were reported during the three and nine months ended September 30, 2024, compared to gains in the same periods of 2023, primarily due to variations between the Euro and the U.S. dollar[135]. - Net cash used in investing activities for the nine months ended September 30, 2024, was lower compared to net cash provided during the same period in 2023, primarily due to decreased net proceeds from investments[143]. - Net cash provided by financing activities decreased to $4,218,000 for the nine months ended September 30, 2024, down from $9,490,000 in the same period in 2023, mainly due to payments related to the Revolving Loan Credit Agreement[144]. - Working capital increased to $87,008,000 as of September 30, 2024, compared to $78,392,000 as of December 31, 2023, driven by increased product sales and collections[144]. - The company may experience substantial dilution if additional capital is raised by issuing equity securities[109]. - The principal amounts outstanding under the Term Loan Credit Agreement will begin amortizing by April 1, 2026, which could negatively impact available working capital[109]. - The company has not recorded any credit losses during the three and nine months ended September 30, 2024, and 2023, respectively[154]. - The company may need additional funds to complete development activities for the red blood cell system if costs exceed expectations or delays occur[152].

Financial Data and Key Metrics Changes - The company reported product revenue of $46 million for Q3 2024, representing a year-over-year growth of 16% [28] - For the first nine months of 2024, product revenue reached $129.5 million, up 18% from the prior year [29] - The net loss attributable to the company narrowed by 60% to $2.9 million for Q3 2024, compared to $7.3 million in the prior year [39] - Non-GAAP adjusted EBITDA for Q3 2024 was positive at $4.4 million, compared to a loss of nearly $1 million for the prior year [39] Business Line Data and Key Metrics Changes - North American platelet sales were the major contributor to product revenue growth during the quarter [29] - The U.S. platelet business saw product revenues exceed prior year levels by 17% [30] - ISC product revenue increased to $2.3 million in Q3 2024, up from $1.7 million in the prior year [31] Market Data and Key Metrics Changes - EMEA product revenues were stable to slightly higher compared to the prior year and the second quarter of 2024 [30] - FX rates provided a slight tailwind for the EMEA business, benefiting the top-line results by approximately 40 basis points [30] Company Strategy and Development Direction - The company is raising its full-year 2024 product revenue guidance to a range of $177 to $179 million, up from the previous range of $175 to $178 million [43] - The company is focused on expanding its manufacturing capacity to meet growing demand for IFC products [48] - The company is collaborating with BARDA to fund further development and regulatory activities for INTERCEPT RBCs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the positive outlook for the full year 2024, driven by strong commercial performance [9] - The company noted the ongoing need for pathogen inactivation due to rising incidences of emerging viruses [13] - Management highlighted the importance of customer confidence in the INTERCEPT technology as a key driver for growth [46] Other Important Information - The company ended Q3 2024 with a cash position of $75.6 million [41] - Operating cash flows for Q3 were positive at $4.1 million, compared to cash used for operations of $10.5 million during the same period in 2023 [42] Q&A Session Summary Question: Anticipation of additional manufacturing capacity for IFC - Management indicated that they are working with blood centers to add manufacturers for IFC and anticipate continued growth in supply as demand increases [48][49] Question: Timeline for LED illuminator approval - The company is targeting a launch for the LED illuminator in Europe in 2025, with a PMA submission in the U.S. likely in 2026 [51] Question: Growth drivers for IFC - Growth is coming from both new customer acquisition and deeper penetration within existing accounts, with approximately 55-60% of customers added this year being new [56] Question: Sustainability of cash flow - Management noted that they expect to generate operating cash flows due to growth in the top line and effective management of margins and operating expenses [90] Question: Government contract revenue expectations - The company expects government contract revenue to increase in 2025 as new BARDA contract activities ramp up alongside ongoing initiatives [84]

Company Performance - Cerus reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, and an improvement from a loss of $0.03 per share a year ago, representing an earnings surprise of 33.33% [1] - The company posted revenues of $46.02 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 4.35% and up from $39.77 million in the same quarter last year [2] - Over the last four quarters, Cerus has surpassed consensus EPS estimates two times and topped consensus revenue estimates three times [2] Stock Outlook - Cerus shares have declined approximately 21.3% since the beginning of the year, contrasting with the S&P 500's gain of 22.3% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $49.2 million, and for the current fiscal year, it is -$0.13 on revenues of $176.7 million [7] Industry Context - The Medical - Products industry, to which Cerus belongs, is currently ranked in the top 25% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Cerus's stock performance [5]