Financial Performance & Guidance - Cerus is raising its full-year 2024 product revenue guidance to $177 - $179 million, anticipating a 12-14% increase compared to full-year 2023 product revenue[13] - The bottom end of the 2024 IFC guidance range has been raised to $9 - $10 million, from the prior $8 - $10 million[13] - In Q3 2024, Non-GAAP Adjusted EBITDA reached $4.4 million[32] Product & Market - The global addressable market for INTERCEPT products is estimated at $1.3 billion, with potential growth to over $1.5 billion in 5-7 years[22] - The U S addressable market is $150 million, with potential growth to over $200 million in 5-7 years[22] - Cerus' preliminary 2023 product revenue was $156 million[22] Strategic Initiatives - Cerus has a new BARDA contract for INTERCEPT RBCs[11] - The company submitted a CE Mark for its LED Illuminator[11] - Cerus is focused on adjusted EBITDA and operating cash flow goals[25]

Financial Performance & Outlook - Cerus achieved positive non-GAAP adjusted EBITDA for Q4 and full year 2024 [9] - The company anticipates product revenue growth of 8% to 11% year-over-year in 2025 [9] - Cerus is committed to sustaining positive adjusted EBITDA for fiscal year 2025 [9] - GAAP net loss attributable to Cerus improved by over 40% in 2024 compared to 2023 [9] - In 2024, Cerus achieved 15% topline growth due to strong team performance and blood center partnerships [10] Market & Product Expansion - Cerus is focused on the continued global expansion of its platelet franchise [9] - The company expects increasing uptake of INTERCEPT Fibrinogen Complex (IFC) in the US [9] - The global addressable market for INTERCEPT products is currently $1.3 billion and is expected to grow to over $1.5 billion in the next 5-7 years [16] - The U S addressable market is $150 million and is expected to grow to over $200 million in the next 5-7 years [16] Technology & Impact - Cumulative kit sales for over 16 million INTERCEPT treated doses of platelets & plasma [5]

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]

Cerus (CERS) FY 2025 Conference June 11, 2025 08:40 AM ET Speaker0 Well, good morning, everyone. My name is Obi Greenman. I am the CEO of Cirrus. I'm here with my colleague, Kevin Green, who's the CFO of Cirrus in the back room there. I just want to thank Goldman Sachs for the opportunity to present our company Cirrus today. Before I start, I will want to acknowledge the forward looking statements that I'll be making today and encourage you all to read the SEC Form 10 Q and 10 ks risk factors just to be awa ...

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]

Cerus (CERS) Q1 2025 Earnings Call May 01, 2025 04:30 PM ET Company Participants Timothy Lee - Head of Investor RelationsObi Greenman - President and CEOVivek Jayaraman - Chief Operating OfficerKevin Green - VP of Finance & CFOJosh Jennings - Managing DirectorCarol Moore - Senior Vice President of Regulatory Affairs, Quality & ClinicalMatthew Park - Equity Research AssociateVidyun Bais - Equity Research - Vice President Conference Call Participants None - Analyst Operator Good day, ladies and gentlemen. Tha ...

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].

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].