First Quarter Product Revenue Increased 24% from Prior Year Quarter Three Months Ended March 31, 2024 2023 Product Revenue $38,365 $30,974 Government Contract Revenue 5,030 7,502 Total Revenue $43,395 $38,476 • The Company is reiterating its full-year 2024 annual product revenue guidance range of $172 million to $175 million. Included in this range is full-year 2024 guidance for INTERCEPT Fibrinogen Complex, which is expected to be between $8 million to $10 million. • The Company expects to report GAAP net ...

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced positive topline results for ReCePI, a pivotal Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells (INTERCEPT RBCs) transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury (AKI) following transfusion of study RBCs. AKI is a sensitive transfusio ...

Financial Data and Key Metrics Changes - In Q4 2023, product gross profit was $26 million, a 6% increase from $24.5 million in the prior year period, with product gross margins at 55.5%, stable compared to the previous year and slightly up from Q3 [3][14][21] - The net loss attributable to Cerus for Q4 2023 was $1.3 million, significantly improved from $13.6 million in the same period last year [63] - Non-GAAP adjusted EBITDA was positive for the first time, reaching almost $5 million, an improvement of over $8 million compared to Q4 2022 [21][60] Business Line Data and Key Metrics Changes - The U.S. product revenues in Q4 2023 exceeded prior year levels, increasing sequentially by 22% from Q3 [18][20] - The INTERCEPT Fibrinogen Complex (IFC) is expected to generate annual revenue of $8 million to $10 million in 2024, marking a significant growth opportunity [4][68] - The platelet franchise showed strong growth globally, with Canadian Blood Services implementing INTERCEPT for whole blood derived platelets, achieving over 85% of platelet units issued to hospitals being INTERCEPT treated [16][59] Market Data and Key Metrics Changes - In EMEA, Q4 product revenues were up 3% year-over-year and around 2% compared to Q3 2023, with foreign exchange rates providing a benefit of approximately 430 basis points [18] - The company anticipates continued growth in the U.S. platelet franchise and IFC business, with significant opportunities in international markets such as Germany and the Middle East [72][74] Company Strategy and Development Direction - The company is focused on international expansion of INTERCEPT platelets and growth of IFC in the U.S., with a commitment to maintaining pricing discipline amid inflation [2][74] - The strategic emphasis is on deepening relationships with existing customers and activating new accounts, particularly in the IFC business [70][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for 2024, expecting double-digit growth in product revenues and improved bottom-line results [14][41] - The company is optimistic about the ReCePI trial results and anticipates providing updates on its progress throughout the year [43][91] Other Important Information - Operating expenses in Q4 2023 totaled $31.6 million, a 24% decline from $41.8 million in the prior year, reflecting the impact of a restructuring initiative [37][38] - The cash position at the end of Q4 2023 was $65.9 million, with cash used from operations at $15.2 million, compared to $1.8 million in the prior year [40][65] Q&A Session Summary Question: What is the expected revenue for IFC in 2024 and its potential market size? - The company expects IFC revenue to be in the range of $8 million to $10 million for 2024, with a total addressable market estimated between $200 million to $300 million [68][44] Question: Can you provide insights on international growth, particularly in Germany and China? - The company anticipates continued progress in Germany and sees growth opportunities in the Middle East, while the regulatory process in China is ongoing with no indication of needing a clinical trial [72][73] Question: What are the expectations for positive EBITDA in 2024? - Management indicated that positive EBITDA is a reasonable assumption for the entire year, with expectations for stability and potential improvement from Q4 levels [70][64]

Regulatory Approvals and Compliance - The INTERCEPT Blood System has received FDA approval and CE Certificates of Conformity for its platelet and plasma systems, allowing commercialization in multiple countries, including the U.S. and several European nations[19][27]. - The INTERCEPT Blood System for Cryoprecipitation received FDA approval in November 2020 and is intended for treating bleeding associated with fibrinogen deficiency[28]. - The red blood cell system's CE Certificate of Conformity application is under review, with a decision expected in the second half of 2024[26][33]. - The FDA has granted Breakthrough Device Designation for the INTERCEPT Blood System for Cryoprecipitation, but commercial use data is needed for market influence[61]. - The FDA has required the completion of two post-approval studies for the platelet system, including a haemovigilance study that has met its endpoint and published results[90]. - Compliance with FDA and other regulatory requirements is mandatory, including adherence to Good Manufacturing Practice (cGMP) and Quality System Regulation (QSR) standards[92]. - The EU's Medical Device Regulation (MDR) has introduced stricter requirements for clinical evidence and pre-market assessments, which may incur substantial costs for compliance[93]. - The company must report adverse events and production problems to regulatory authorities, which could lead to product recalls if deemed necessary[94]. - The company must demonstrate compliance with stringent manufacturing and quality standards to secure regulatory approvals, which is a costly and time-consuming process[186]. - The company is required to conduct costly post-market testing and surveillance to monitor the safety or effectiveness of its products in the EU, which may adversely affect financial condition and results of operations[192]. - The FDA has requested information on bacterial contamination of INTERCEPT-treated products, indicating potential regulatory scrutiny that could impact product sales[195]. - The company must notify its Notified Body of significant changes to products, which can be a time-consuming process affecting product introduction timelines[206]. - Regulatory authorities may impose sanctions for non-compliance, including fines, product recalls, and operational restrictions, adversely affecting business[196]. - The company is currently under investigation by the U.S. Department of Justice regarding contracting and information exchange practices, which may lead to fines or changes in business practices[211]. - Compliance with various state and federal laws regarding data privacy and security is complex and rapidly changing, increasing operational risks[215]. - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose additional obligations on the company regarding personal information management[216]. - The EU General Data Protection Regulation (GDPR) and UK GDPR impose strict requirements on personal data control and processing, with potential fines of up to €20 million or 4% of annual global revenue for noncompliance[217]. Clinical Trials and Research - The company is conducting two Phase 3 clinical trials for the red blood cell system in the U.S., with top-line data expected in Q1 2024[21][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 on day 35 of storage, compared to 55.8g for conventional RBCs[34]. - The U.S. Phase 2 recovery and lifespan study was successfully completed, leading to the initiation of the double-blind Phase 3 RedeS study, which will include up to 800 subjects[35]. - The RedeS study has been expanded to include a chronic phase for subjects requiring repeat transfusions and will assess the safety and efficacy of INTERCEPT-treated RBCs compared to conventional RBCs[35]. - The ReCePI study, designed to evaluate INTERCEPT-treated RBCs for acute blood loss during surgery, has completed enrollment with up to 600 subjects expected to be transfused[35]. - The primary efficacy endpoint for the ReCePI study is the proportion of subjects experiencing acute kidney injury within 48 hours post-surgery[35]. - The company plans to conduct additional in vitro studies required for FDA approval of the red blood cell product[36]. - The company may need to conduct additional Phase 3 clinical trials to demonstrate non-inferiority of INTERCEPT red blood cells compared to conventional red blood cells, which could further delay approvals[181]. - The company has faced historical manufacturing failures with its contracted manufacturer, impacting the ability to meet regulatory requirements for the red blood cell system[177]. Financial Outlook and Investment - The company anticipates continued operating losses due to significant research, development, and regulatory compliance costs, with no guarantee of achieving profitability[22]. - The company is dependent on the commercial success of the INTERCEPT Blood System, and failure to successfully commercialize it in the U.S. could materially adversely affect its financial condition and growth prospects[128]. - Successful commercialization of the INTERCEPT Blood System in the U.S. depends on obtaining adequate coverage and reimbursement from third-party payors, which can vary significantly[107]. - The company faces potential impacts on profitability due to legislative changes in the U.S. healthcare system, particularly from the ACA, which may exert downward pressure on medical product pricing[108]. - Significant costs are expected to continue due to the ongoing investigation, potentially impacting financial performance objectives[212]. Market Dynamics and Competition - The company faces competition from established products in the market, including traditional cryoprecipitate and human plasma-derived fibrinogen concentrates, which may affect sales to hospitals[73]. - The U.S. blood banking market is consolidating, which may further concentrate the customer base[56]. - The current shortage of platelets in the U.S. may lead hospitals to prioritize conventional platelet products over INTERCEPT-treated products[133]. - The perception of increased costs due to platelet loss during processing may deter customers from adopting the INTERCEPT Blood System[137]. - The company faces challenges in developing an effective U.S.-based commercial organization, which may hinder the education of blood centers and clinicians on pathogen reduction[146]. - Competitors developing superior products or receiving regulatory approval first could reduce the company's commercial opportunities[158]. Supply Chain and Manufacturing - The company relies on third-party suppliers and blood centers for marketing and distribution, which poses risks to its operations[19]. - The company relies on a limited number of suppliers for raw materials, which may pose risks to supply continuity and regulatory compliance[51]. - The company is in the process of identifying potential alternate manufacturers for several components to mitigate supply chain risks[46]. - The manufacturing agreement with Fresenius Kabi AG for disposable kits is effective until December 31, 2031, with provisions for volume-based pricing adjustments[46]. - The company is stockpiling pooling sets to mitigate potential disruptions from third-party manufacturers discontinuing production due to new EU regulations, which has required capital investment[164]. Employee Engagement and Diversity - As of December 31, 2023, the company employed 288 individuals from at least 33 nationalities, with approximately 60% being women and 49% of U.S. employees identifying as non-white[113]. - The average employee age is 45.7 years, with an average length of service of 5.9 years, and a voluntary turnover rate of 4.8% from December 31, 2022, to 2023[115]. - The company has implemented an Employee Value Proposition and updated its website to reflect its commitment to employee engagement and diversity[116]. - The company is focused on pay equity globally and aims to close the pay gap among similar roles within the organization[118]. - The company has introduced a Volunteer Paid Time Off Program to encourage community involvement among employees[119]. - The company is committed to achieving zero serious injuries through safety programs and provides various health and wellness tools to its employees[123].

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced today that its fourth quarter and full-year 2023 financial results will be released on Tuesday, March 5, 2024, after the close of the stock market. The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast and view the presentation slides, please visit the ...

CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) announced management participation in two upcoming investor conferences. Management plans to attend the BTIG 11th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Tuesday, February 13th and will participate in TD Cowen’s 44th Annual Health Care Conference on Wednesday, March 6th at 11:10 AM EST. A live webcast of the TD Cowen presentation will be available here and the replay will be available on the Company’s ...

Cerus Corporation (NASDAQ:CERS) Q3 2023 Earnings Conference Call November 2, 2023 4:30 PM ET Company Participants Jessica Hanover - Vice President of Corporate Affairs Obi Greenman - President & Chief Executive Officer Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Conference Call Participants Operator Good day and thank you for standing by. Welcome to Cerus Corporation Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. Af ...

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, with the CE Certificate of Conformity application resubmitted in June 2021[116] - The company received FDA approval for the INTERCEPT Blood System for Cryoprecipitation in November 2020, and began supplying it to select blood centers in 2021[118] - The company must demonstrate compliance with Good Manufacturing Practice and ISO standards before seeking regulatory approval for the red blood cell system[117] - The introduction of new products may face delays due to regulatory approval processes, affecting market entry timelines[234] Financial Performance and Revenue - The total potential contract value for the agreement with the FDA for the development of next-generation compounds is $11.1 million[125] - The agreement with the U.S. Department of Defense was extended to February 2027, increasing the total contract value from $9.1 million to $17.8 million[125] - The company anticipates continued revenue from government contracts as qualified costs are incurred for reimbursement over the performance period[122] - Product revenue decreased during the nine months ended September 30, 2023, primarily due to a year-over-year sales volume decrease of disposable platelet system kit sales[128] - The company expects product revenue for INTERCEPT disposable kits to increase in future periods driven by growth in the platelet business and increased market acceptance[128] - The American Red Cross accounted for 35% of product revenue for the three months ended September 30, 2023, down from 39% in the same period last year[140] Market and Competitive Landscape - The company is focused on increasing market adoption of its platelet and plasma systems in international markets, utilizing both direct sales and regional distributors[121] - The market for the INTERCEPT Blood System is highly concentrated, with the American Red Cross being a significant customer, impacting revenue predictability[227] - The company anticipates ongoing competition in the pathogen reduction market, which could affect market share and sales[229] Operational Challenges and Risks - Economic conditions and global uncertainties may limit the company's ability to access additional capital, potentially impacting liquidity and planned development activities[120] - The company has experienced overall supply chain challenges that may necessitate carrying lower inventory levels, impacting operations[128] - The company is facing potential liabilities from product liability claims, which could significantly impact financial results[229] - Regulatory scrutiny has increased, with a civil investigative demand from the U.S. Department of Justice regarding contracting practices, potentially leading to fines or changes in business practices[235] - Compliance with data localization and privacy laws has become more complex, potentially increasing operational costs and legal risks[236] - The company is expanding into higher-risk markets, such as China, India, and Russia, which may expose it to greater scrutiny and compliance costs[236] - There is a risk of product recalls or regulatory actions that could harm the company's reputation and financial performance[229] - The company may incur significant costs related to ongoing investigations, impacting its ability to achieve financial performance objectives[235] - The company must navigate complex healthcare regulations, which could lead to increased costs and operational challenges[236] Shareholder and Stock Information - The company had approximately 40.0 million shares of common stock subject to outstanding options or unvested RSUs as of September 30, 2023[133] - The Amended 2008 Plan allows for the issuance of up to 7.0 million additional shares of common stock as approved in June 2023[133] - The company maintains a performance-based stock award limit of 500,000 shares per calendar year and performance-based cash awards limited to $1.0 million per recipient[133]

Cerus Corporation (NASDAQ:CERS) Q2 2023 Earnings Conference Call August 2, 2023 4:30 PM ET Company Participants Jessica Hanover - Vice President-Corporate Affairs Obi Greenman - president and Chief Executive Officer Vivek Jayaraman - Chief Operating Officer Kevin Green - Chief Financial Officer Laurence Corash - Chief Scientific Officer Conference Call Participants Jacob Johnson - Stephens Mathew Blackman - Stifel Joshua Jennings - TD Cohen Operator Good day, ladies and gentlemen. Thank you for standing by ...

• comply with requirements established by the FDA, including post-marketing requirements and label restrictions; and • comply with other U.S. healthcare regulatory requirements. 36 We are exposed to risks associated with the highly concentrated market for the INTERCEPT Blood System. 37 Our research and development activities involve the controlled use of hazardous materials, including certain hazardous chemicals, radioactive materials and infectious pathogens, such as HIV and hepatitis viruses. Although we ...