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What changed in CERUS CORP's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of CERUS CORP's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+506 added−495 removedSource: 10-K (2026-03-02) vs 10-K (2025-02-26)

Top changes in CERUS CORP's 2025 10-K

506 paragraphs added · 495 removed · 414 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

105 edited+17 added−25 removed190 unchanged
Biggest changePhase 3 acute anemia clinical trial, known as the ReCePI study, completed in 2024 • Additional U.S. studies also planned • European Phase 3 acute anemia clinical trial completed in 2014; European Phase 3 chronic anemia clinical trial completed in 2017 • Resubmission of application for CE Certificate of Conformity under MDR would be required in order to potentially obtain marketing approval in Europe 6 INTERCEPT Blood System—Cryoprecipitation • FDA approval in November 2020 • U.S. agreement with certain blood center manufacturing partners • Limited commercialization in the U.S.
Biggest changePhase 3 acute anemia clinical trial, known as the ReCePI study, completed in 2024 • Additional U.S. studies also planned • European Phase 3 acute anemia clinical trial completed in 2014; European Phase 3 chronic anemia clinical trial completed in 2017 • Application for a conformity assessment to obtain a CE Certificate of Conformity and affix the CE Mark for the EEA was resubmitted in 2025 INTERCEPT Blood System—Cryoprecipitation • Received FDA approval of the premarket approval supplement with respect to IFC in 2020 • U.S. agreement with certain blood center manufacturing partners INTERCEPT Illuminator—LED-based • Commercialized in a number of countries in Europe and selected countries in other regions around the world • Received CE Certificate of Conformity and CE Marked under MDR in 2025 INTERCEPT Blood System for Platelets, Plasma and Cryoprecipitation The platelet system and plasma system are designed to inactivate blood-borne pathogens in platelets and plasma donated for transfusion.
We have also received FDA approval for the INTERCEPT Blood System for Cryoprecipitation, which uses our plasma system to produce IFC for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency and to produce pathogen reduced plasma, cryoprecipitate reduced.
We have also received FDA approval for the INTERCEPT Blood System for Cryoprecipitation, which uses our plasma system to produce IFC for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency and to produce pathogen reduced plasma, cryoprecipitate reduced.
It is also possible that other federal, state, competent authorities of the EU Member States, or foreign authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, or a violation or any other federal or state law that applies to us, such as laws prohibiting false claims for reimbursement.
It is also possible that other federal, state, competent authorities of the EU Member States, or foreign authorities might take action if they consider our promotional or training materials to constitute promotion of an off-label use, or a violation or any other federal, state, or foreign law that applies to us, such as laws prohibiting false claims for reimbursement.
Further discussion of the factors impacting our government contracts revenue and the related impact on our ability to operate our business can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “ A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreement, and if BARDA were to eliminate, reduce, delay, or object to extension for funding of our agreement, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding ” and “Unfavorable provisions in government contracts, including in our contracts with BARDA, FDA and DoD, may harm our business, financial condition and operating results . ” Competition Our products face a wide variety of competition from entities competing directly with alternative pathogen reduction technologies for platelets and/or plasma, as well as from entities developing and selling blood screening products to detect and prevent contaminated products from being transfused, and from process and procedural decisions involving blood banking operations including but not limited to shortened shelf-life of blood components.
Further discussion of the factors impacting our government contracts revenue and the related impact on our ability to operate our business can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “ A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreement, and if BARDA were to eliminate, reduce, delay, or object to extension for funding of our agreement, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding ” and “Unfavorable provisions in government contracts, including in our contracts with BARDA and DoD, may harm our business, financial condition and operating results . ” Competition Our products face a wide variety of competition from entities competing directly with alternative pathogen reduction technologies for platelets and/or plasma, as well as from entities developing and selling blood screening products to detect and prevent contaminated products from being transfused, and from process and procedural decisions involving blood banking operations including but not limited to shortened shelf-life of blood components.
Further discussion of the factors impacting our intellectual property and the related impact on our ability to operate our business can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factor titled “ We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. ” 14 Seasonality Our business is dependent on the marketing and commercialization of the INTERCEPT Blood System to customers such as blood banks, hospitals, distributors and other health care providers that have a need for a pathogen reduction system to treat blood products for transfusion.
Further discussion of the factors impacting our intellectual property and the related impact on our ability to operate our business can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factor titled “ We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. ” Seasonality Our business is dependent on the marketing and commercialization of the INTERCEPT Blood System to customers such as blood banks, hospitals, distributors and other health care providers that have a need for a pathogen reduction system to treat blood products for transfusion.
Further discussion of the health care laws and regulations that may affect our can be found in “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factor titled: “ We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. ” CBER is the center within the FDA principally responsible for regulating the INTERCEPT Blood System.
Further discussion of the health care laws and regulations that may affect us can be found in “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factor titled: “ We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. ” CBER is the center within the FDA principally responsible for regulating the INTERCEPT Blood System.
In the U.S., we expect to incur research and development expenses associated with pursuing a new PMA for both the platelet and plasma systems for use with the new LED-based illuminator and licensure of the red blood cell system including the RedeS study, an additional Phase 3 clinical trial including chronic anemia subjects, in vitro studies, and other activities necessary to pursue FDA approval of our red blood cell system.
In the U.S., we expect to incur research and development expenses associated with pursuing a new PMA for both the platelet and plasma systems for use with the new LED-based illuminator and licensure of the red blood cell system including completion of the RedeS study, an additional Phase 3 clinical trial including chronic anemia subjects, in vitro studies, and other activities necessary to pursue FDA approval of our red blood cell system.
A high level of inactivation has been demonstrated in a broad range of pathogens studied by us and others in laboratory testing. For instance, INTERCEPT has demonstrated inactivation of a number of single stranded nucleic acid-based viruses such as HIV, hepatitis B, hepatitis C (using a model virus), West Nile, chikungunya and certain influenza viruses.
A high level of inactivation has been demonstrated in a broad range of pathogens studied by us and others in laboratory testing. For instance, INTERCEPT has demonstrated 9 inactivation of a number of single stranded nucleic acid-based viruses such as HIV, hepatitis B, hepatitis C (using a model virus), West Nile, chikungunya and certain influenza viruses.
We do not claim, however, that our INTERCEPT Blood System will inactivate all pathogens, including prions or spores, and 9 our inactivation claims are limited to those contained in our product specifications. There can also be no assurance that INTERCEPT will inactivate even those pathogens where claims exist, in every instance or under every processing condition.
We do not claim, however, that our INTERCEPT Blood System will inactivate all pathogens, including prions or spores, and our inactivation claims are limited to those contained in our product specifications. There can also be no assurance that INTERCEPT will inactivate even those pathogens where claims exist, in every instance or under every processing condition.
If we are unable to continue to successfully support EFS’ national adoption of the 11 INTERCEPT Blood System for platelets, EFS’ use of the INTERCEPT Blood System for Plasma or the final commercial terms of any subsequent contract for platelet or plasma disposable kits are less favorable than the terms under our existing contracts, our financial results may be adversely impacted.
If we are unable to continue to successfully support EFS’ national adoption of the INTERCEPT Blood System for platelets, EFS’ use of the INTERCEPT Blood System for Plasma or the final commercial terms of any subsequent contract for platelet or plasma disposable kits are less favorable than the terms under our existing contracts, our financial results may be adversely impacted.
We believe that the INTERCEPT Blood System has certain competitive 13 advantages over competing blood-borne pathogen reduction methods that are either on the market or known to us to be in development. The INTERCEPT Blood System is designed for use in blood centers, which allows for integration with current blood collection, processing and storage procedures.
We believe that the INTERCEPT Blood System has certain competitive advantages over competing blood-borne pathogen reduction methods that are either on the market or known to us to be in development. The INTERCEPT Blood System is designed for use in blood centers, which allows for integration with current blood collection, processing and storage procedures.
Failure to timely resolve and comply to audit findings, if any, may result in enforcement actions and may result in a disruption to the supply of our products. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
Failure to timely resolve and comply to audit findings, if any, may result in enforcement actions and may result in a disruption to the supply of our products. Accordingly, we and others with whom 17 we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control.
Data from human clinical studies must demonstrate the safety of treated blood components and their therapeutic comparability to untreated blood components. In addition, regulatory authorities will weigh INTERCEPT’s safety, including potential toxicities of the inactivation compounds, and other risks against the benefits of using the system in a blood supply that has become safer.
Data from human clinical studies must demonstrate the safety of treated blood components and their therapeutic comparability to untreated blood components. In addition, regulatory authorities will weigh INTERCEPT’s safety, including potential toxicities of the inactivation compounds, and other risks against the benefits of using the 18 system in a blood supply that has become safer.
Under the 2025 Agreement, we and Porex agreed to extend the term of the prior agreement until December 31, 2027. Under the terms of the 2025 Agreement, unit pricing for platelet wafers and plasma disks are set at certain amounts for the first twenty-four months, starting January 1, 2025 with volume based pricing after the first twenty-four months.
Under the 2025 Agreement, we and Porex agreed to extend the term of the prior agreement until December 31, 2027. Under the terms of the 2025 Agreement, unit pricing for platelet wafers and plasma disks are set at certain amounts for the first twenty-four months, starting January 1, 2025 with 10 volume based pricing after the first twenty-four months.
We are currently the only approved pathogen reduction product in the U.S. for platelets and therefore subject to Department of Justice, or DOJ, anti-trust oversight. Terumo BCT’s platelet, plasma or whole blood pathogen reduction product may be viewed as favorable by the Japanese Red Cross.
We are currently the only approved pathogen reduction product in the U.S. for platelets and therefore subject to Department of Justice, or DOJ, anti-trust oversight. Terumo BCT’s platelet, plasma or whole blood pathogen reduction product may be viewed as favorable by the Japanese Red Cross, or JRC.
After unblinding the data from the original Phase 3 clinical trials, we found that we had met the primary endpoint in the 7 clinical trial for acute anemia. We evaluated the antibodies detected and developed process changes to diminish the likelihood of antibody reactivity in RBCs treated with our modified process.
After unblinding the data from the original Phase 3 clinical trials, we found that we had met the primary endpoint in the clinical trial for acute anemia. We evaluated the antibodies detected and developed process changes to diminish the likelihood of antibody reactivity in RBCs treated with our modified process.
As such, establishing additional or replacement 10 suppliers for any of the raw materials, parts and devices, if required, will likely not be accomplished quickly and could involve significant additional costs and potential regulatory reviews that could limit our ability to supply customer demand.
As such, establishing additional or replacement suppliers for any of the raw materials, parts and devices, if required, will likely not be accomplished quickly and could involve significant additional costs and potential regulatory reviews that could limit our ability to supply customer demand.
Our INTERCEPT Blood System for cryoprecipitation competes with traditional cryoprecipitate, a by-product of thawing frozen plasma and with human plasma derived fibrinogen concentrates. While we believe that IFC has many advantages over competitors, conventional cryoprecipitate and fibrinogen concentrates are well established within hospital use.
Our INTERCEPT Blood System for Cryoprecipitation, or IFC, competes with traditional cryoprecipitate, a by-product of thawing frozen plasma and with human plasma derived fibrinogen concentrates. While we believe that IFC has many advantages over competitors, conventional cryoprecipitate and fibrinogen concentrates are well established within hospital use.
However, certain changes to a PMA-approved device do not require submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The 16 FDA requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision.
However, certain changes to a PMA-approved device do not require submission and approval of a new PMA or PMA supplement and may only require notice to FDA in a PMA Annual Report. The FDA requires every supplier to make this determination in the first instance, but the FDA may review any supplier’s decision.
In addition, France, Switzerland, Germany, and Austria require separate approvals for INTERCEPT-treated blood products. The FDA regulates drugs, medical devices and biologics under the Federal Food, Drug, and Cosmetic Act and other laws, including, in the case of biologics, the Public Health Service Act.
In addition, France, Switzerland, Germany, and Austria require separate approvals for INTERCEPT-treated blood products. 16 The FDA regulates drugs, medical devices and biologics under the Federal Food, Drug, and Cosmetic Act and other laws, including, in the case of biologics, the Public Health Service Act.
Accordingly, there may be an extended period during which some potential U.S.-based customers may first choose to validate our technology or run experience studies themselves before deciding to adopt the system for commercial use, which may never occur.
There may be an extended period during which some potential U.S.-based customers may first choose to validate our technology or run experience studies themselves before deciding to adopt the system for commercial use, which may never occur.
Inventory Requirements and Product Return Rights Our platelet and plasma disposable kits have received regulatory approval and certification for shelf lives ranging from 12 to 24 months. Our INTERCEPT Blood System for Cryoprecipitation has received regulatory approval and certification for a shelf life of 12 months.
Inventory Requirements and Product Return Rights Our platelet and plasma disposable kits have received regulatory approval and certification for shelf lives ranging from 18 to 24 months. Our INTERCEPT Blood System for Cryoprecipitation has received regulatory approval and certification for a shelf life of 12 months.
If our forecasts or those of our distributors are inaccurate, we could face backlog situations or conversely, may produce and carry an abundance of inventory that would consume cash faster than we have currently planned.
If our forecasts or those of our distributors are inaccurate, we could face backlog situations or conversely, may produce and carry an abundance of inventory that would 15 consume cash faster than we have currently planned.
We have a small number of employees focused 12 on servicing the markets in Asia-Pacific and Latin American regions and rely primarily on distributors to market and sell our products in those regions.
We have a small number of employees focused on servicing the markets in Asia-Pacific and Latin American regions and rely primarily on distributors to market and sell our products in those regions.
The haemovigilance study was completed, met its endpoint, and results published in a peer-reviewed journal. We have also completed the recovery and survival study of the platelet system and have submitted the data to the FDA.
The haemovigilance study was completed, met its endpoint, and results were published in a peer-reviewed journal. We have also completed the recovery and survival study of the platelet system and have submitted the data to the FDA.
As we look ahead, we anticipate that maintaining compliance with regulatory requirements and obtaining potential PMA supplements for the platelet and plasma systems or post market approval requirements will require substantial continued investment in research and development activities, as will our ongoing clinical, development and chemistry manufacturing and control, or CMC, work for our red blood cell system in Europe as well as our whole-blood initiative in collaboration with the FDA and lyophilized IFC development initiative in collaboration with the DoD.
As we look ahead, we anticipate that maintaining compliance with regulatory requirements and obtaining potential PMA supplements for the platelet and plasma systems or post market approval requirements will require substantial continued investment in research and development activities, as will our ongoing clinical, development and chemistry manufacturing and control, or CMC, work for our red blood cell system in Europe as well as our lyophilized IFC development initiative in collaboration with the DoD.
Generally, government contracts, including our agreements with BARDA, the FDA, and the DoD, contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience.
Generally, government contracts, including our agreements with BARDA and the DoD, contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience.
The largest European markets for our products are in Germany, France, and England. In Germany, decisions on product adoption are made on a regional or blood center-by-blood center basis.
The largest European markets for our products are in Germany, France, and England. 11 In Germany, decisions on product adoption are made on a regional or blood center-by-blood center basis.
Neither party has delivered notice of its intent to terminate the agreement. We and our contract manufacturers purchase certain raw materials for our disposable kits, inactivation compounds, materials and parts associated with compound adsorption devices and UVA illuminators from a limited number of suppliers. Some of those raw material suppliers require minimum annual purchase amounts.
Neither party has delivered notice of its intent to terminate the agreement. We and our contract manufacturers purchase certain raw materials for our disposable kits, inactivation compounds, materials and parts associated with compound adsorption devices, UVA illuminators, and the new LED illuminators from a limited number of suppliers. Some of those raw material suppliers require minimum annual purchase amounts.
The amended supply agreement would have expired in April 2025, however it has automatically renewed for an additional year as neither party has delivered notice of its intent to terminate the agreement. The agreement will continue to automatically renew for one year periods unless either party provides notice not to renew at least two years prior to the expiration.
The amended supply agreement would have expired in April 2026, however it has automatically renewed for an additional year as neither party has delivered notice of its intent to terminate the agreement. The agreement will continue to automatically renew for one year periods unless either party provides notice not to renew at least two years prior to the expiration.
See Note 2 in the Notes to Consolidated Financial Statements under “ Item 15—Exhibits and Financial Statement Schedules—Financial Statements ” of this Annual Report on Form 10-K for information on significant accounting policies related to our government contract revenue and other financial information for the years ended December 31, 2024, 2023 and 2022.
See Note 2 in the Notes to Consolidated Financial Statements under “ Item 15—Exhibits and Financial Statement Schedules—Financial Statements ” of this Annual Report on Form 10-K for information on significant accounting policies related to our government contract revenue and other financial information for the years ended December 31, 2025, 2024 and 2023.
The term of the amended manufacturing and supply agreement with Piramal automatically renewed for two years until December 31, 2025 and will continue to automatically renew for successive two-year periods, unless terminated by either party upon providing at least one year prior written notice, in our case, or at least two years prior written notice, in the case of Piramal.
The term of the amended manufacturing and supply agreement with Piramal automatically renewed for two years until December 31, 2027 and will continue to automatically renew for successive two-year periods, unless terminated by either party upon providing at least one year prior written notice, in our case, or at least two years prior written notice, in the case of Piramal.
While there were not objectionable conditions observed during the audit, the FDA or other regulatory authorities and Notified Bodies may inspect and audit facilities manufacturing or products or components at any time. Complying with and resolving any audit findings may result in additional costs, changes to our manufacturers quality management systems or both.
While there were not objectionable conditions observed during the audit, the FDA or other regulatory authorities and Notified Bodies may inspect and audit facilities manufacturing or products or components at any time. Complying with and resolving any audit findings may result in additional costs, changes to our manufacturers’ quality management systems or both.
Products, Product Candidates and Development Activities The following table identifies our products, product candidates and product development activities and their current status: Product or Product Candidate Under Development Product or Development Status INTERCEPT Blood System—Platelets • Commercialized in the U.S., Canada and a number of countries in Europe, the CIS, the Middle East, and selected countries in other regions around the world • Received CE Certificate of Conformity under MDR in December 2023 INTERCEPT Blood System—Plasma • Commercialized in the U.S. and a number of countries in Europe, the CIS, the Middle East, and selected countries in other regions around the world • Received CE Certificate of Conformity under MDR in December 2023 • Received FDA approval of the premarket approval supplement, or PMA, to produce IFC in 2020 INTERCEPT Blood System—Red Blood Cells • U.S.
Products, Product Candidates and Development Activities The following table identifies our products, product candidates and product development activities and their current status: Product or Product Candidate Under Development Product or Development Status 6 INTERCEPT Blood System—Platelets • Commercialized in the U.S., Canada and a number of countries in Europe, the CIS, the Middle East, and selected countries in other regions around the world • Received CE Certificate of Conformity and CE Marked under MDR in 2023 INTERCEPT Blood System—Plasma • Commercialized in the U.S. and a number of countries in Europe, the CIS, the Middle East, and selected countries in other regions around the world • Received CE Certificate of Conformity and CE Marked under MDR in 2023 • Received FDA approval of the premarket approval supplement, or PMA, to produce IFC in 2020 INTERCEPT Blood System—Red Blood Cells • U.S.
Financial Information Our financial information including our consolidated balance sheets, consolidated statements of operations, consolidated statements of comprehensive loss, consolidated statements of stockholders’ equity, consolidated statements of cash flows, and the related footnotes thereto, can be found under “ Financial Statement Schedules ” in Part IV of this Annual Report on Form 10-K. 20
Financial Information Our financial information including our consolidated balance sheets, consolidated statements of operations, consolidated statements of comprehensive loss, consolidated statements of stockholders’ equity, consolidated statements of cash flows, and the related footnotes thereto, can be found under “ Financial Statement Schedules ” in Part IV of this Annual Report on Form 10-K. 21
Similar to our platelet and plasma products, any blood center manufacturing IFC will need to complete their process validations and obtain site-specific licenses from CBER before we or they can sell finished IFC to hospital customers outside of the states producing IFC.
Similar to our platelet and plasma products, any blood center manufacturing IFC will need to complete their process validations and obtain site-specific licenses from CBER before they can sell finished IFC to hospital customers outside of the states producing IFC.
This includes, in the U.S., the California Consumer Privacy Act of 2018, or CCPA, in the European Economic Area, or EEA, the EU General Data Protection Regulation, or GDPR (Regulation 2016/679) and the related national rules of the individual EEA countries, and in the United Kingdom, or UK, the UK GDPR.
This includes, for example, in the U.S., the California Consumer Privacy Act of 2018, or CCPA, in the European Economic Area, or EEA, the EU General Data Protection Regulation, or GDPR (Regulation 2016/679) and the related national rules of the individual EEA countries, and in the United Kingdom, or UK, the UK GDPR.
We have received CE Certificates of Conformity to affix the CE Mark in accordance with the MDR for our INTERCEPT platelet and plasma systems which allows us to continue to place our platelet and plasma systems on the European Union market under the new regulatory requirements of the MDR.
We have received CE Certificates of Conformity to affix the CE Mark in accordance with the MDR for our INTERCEPT platelet and plasma systems which allows us to continue to place our platelet and plasma systems on the European Union market in accordance with the regulatory requirements of the MDR.
The INTERCEPT Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have received a broad range of regulatory approvals and certification, including but not limited to FDA approval in the U.S., CE Certificates of Conformity delivered in accordance with the Medical Devices Directive 93/42/EEC, or MDD, and the Medical Devices Regulation 2017/745, or MDR, permitting us to affix the CE Mark to our products and place them on the market in the European Union and other jurisdictions that recognize the CE Mark, and are being marketed and sold in a number of countries around the world, including the U.S., certain countries in Europe, the Commonwealth of Independent States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world.
The INTERCEPT Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have received a broad range of regulatory approvals and certification, including but not limited to FDA approval in the U.S., CE Certificates of Conformity delivered in accordance with the Medical Devices Regulation 2017/745, or MDR, permitting us to affix the CE Mark to our products and place them on the market in the European Union and other jurisdictions that recognize the CE Mark, and are being marketed and sold in a number of countries around the world, including the U.S., certain countries in Europe, the Commonwealth of Independent States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world.
Both systems received a CE Certificate of Conformity permitting us to affix the CE Mark in the European Economic Area, or EEA, and FDA approval in the U.S. and are currently marketed and sold in a number of countries around the world including the U.S., countries in Europe, the CIS, the Middle East and selected countries in other regions of the world.
Both systems received a CE Certificate of Conformity in accordance with the MDR permitting us to affix the CE Mark in the European Economic Area, or EEA, and FDA approval in the U.S. and are currently marketed and sold in a number of countries around the world including the U.S., countries in Europe, the CIS, the Middle East and selected countries in other regions of the world.
Additional information regarding our interactions with the FDA, our application for a CE Certificate of Conformity in the European Union for the red blood cell system, and potential future clinical development of the INTERCEPT Blood System in Europe and in the U.S. can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “Clinical trials are costly and time consuming, may take longer than we expect or may not be completed at all, and their outcomes are uncertain.
Additional information regarding our interactions with the FDA, our MDR application in the European Union for the red blood cell system, and potential future clinical development of the INTERCEPT Blood System in Europe and in the U.S. can be found under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “Clinical trials are costly and time consuming, may take longer than we expect or may not be completed at all, and their outcomes are uncertain.
See Note 2 in the Notes to Consolidated Financial Statements under “Financial Statement Schedules—Financial 15 Statements” of this Annual Report on Form 10-K for costs and expenses related to research and development, and other financial information for the years ended December 31, 2024, 2023 and 2022.
See Note 2 in the Notes to Consolidated Financial Statements under “Financial Statement Schedules—Financial Statements” of this Annual Report on Form 10-K for costs and expenses related to research and development, and other financial information for the years ended December 31, 2025, 2024 and 2023.
See also the risk factor entitled “The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificate of Conformity” under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K.
See also the risk factor entitled “The red blood system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity” under “Item 1A— Risk Factors ” of this Annual Report on Form 10-K.
In addition, we estimate that the majority of platelets used in the U.S. are collected by apheresis, which is part of our FDA-approved label for the platelet system, though a significant minority are prepared from pooled random donor platelets derived from whole blood collections.
In addition, the majority of platelets used in the U.S. are collected by apheresis, which is part of our FDA-approved label for the platelet system, though a significant minority are prepared from pooled random donor platelets derived from whole blood collections.
We also partnered with LinkedIn to provide unlimited access to LinkedIn Learning, a robust online training platform providing employees with continuous learning opportunities. In 2024, we implemented learning paths within the LinkedIn Learning platform, to drive more specialized and focused development for all employees.
We also partnered with LinkedIn to provide unlimited access to LinkedIn Learning, a robust online training platform providing employees with continuous learning opportunities. We have implemented learning paths within the LinkedIn Learning platform, to drive more specialized and focused development for all employees.
While available in Europe and other regions around the world, in order to gain FDA approval for a pathogen reduction system compatible with triple dose collections and random donor platelets, we will need to perform additional product development and testing, including additional clinical trials, and will need to obtain FDA approval of a PMA supplement.
While available in Europe and other regions around the world, in order to gain FDA approval for a pathogen reduction system compatible with pooled random donor platelets, we will need to perform additional product development and testing, including additional clinical trials, and will need to obtain FDA approval of a PMA supplement.
Additionally, hospital customers of ours or of any of our blood center customers may need to go through the administrative process of generating internal tracking codes to integrate INTERCEPT-treated products into their inventories or may need to amend or adjust those codes in connection with a significant product change that we make, 17 which may adversely impact our ability to sell products in the U.S.
Additionally, hospital customers that purchase INTERCEPT-treated blood products may need to go through the administrative process of generating internal tracking codes to integrate INTERCEPT-treated products into their inventories or may need to amend or adjust those codes in connection with a significant product change that we make, which may adversely impact our ability to sell products in the U.S.
Under the terms of the amended agreement, pricing is volume based and is subject to annual, prospective adjustments based on a Producer Price Index subject to an annual cap. We have completed the manufacturing for the current model of illuminator and maintain an inventory of those final devices.
Under the terms of the amended agreement, pricing is volume based and is subject to annual, prospective adjustments based on a Producer Price Index subject to an annual cap. We have completed the manufacturing for the first generation of the illuminator and maintain an inventory of those final devices.
As of December 31, 2024, we owned 16 issued or allowed U.S. patents and approximately 166 issued or allowed foreign patents related to the INTERCEPT Blood System. Our patents expire at various dates between 2025 and 2042. Recent patent applications will, if granted, result in patents with later expiration dates.
As of December 31, 2025, we owned 21 issued or allowed U.S. patents and approximately 154 issued or allowed foreign patents related to the INTERCEPT Blood System. Our patents expire at various dates between 2027 and 2042. Recent patent applications will, if granted, result in patents with later expiration dates.
We have a small scientific affairs group in the U.S. and the Netherlands that supports our commercialization efforts as well as hospital affairs professionals, to help educate hospitals and physicians on our products, clinical trial history and publications. We have a small group of individuals to market and sell IFC in the U.S.
We have a small scientific affairs group in the U.S. and the Netherlands that supports our commercialization efforts as well as hospital affairs professionals, to help educate hospitals and physicians on our products, clinical trial history and publications.
In order to successfully commercialize all of our products and product candidates, we will be required to conduct significant research, development, preclinical and clinical evaluation, commercialization and regulatory compliance activities for our products and product candidates, which, together with anticipated increased selling, general and administrative expenses, are expected to result in substantial operating losses.
In order to successfully commercialize all of our products and product candidates, we will be required to conduct significant research, development, preclinical and clinical evaluation, commercialization and regulatory compliance activities for our products and product candidates, which, together with selling, general and administrative expenses, may result in operating losses.
As an example, a consultation of additional substances contained within the INTERCEPT RBC Processing Set (Processing Solution and SAG-M Storage Solution) was required and ultimately determined to not support licensure of our application for CE Mark approval.
As an example, a consultation of additional substances contained within the INTERCEPT RBC Processing Set (Processing Solution and SAG-M Storage Solution) was required and ultimately determined to not support licensure of our MDR application.
We have since successfully completed European Phase 3 clinical trials of the red blood cell system for subjects with acute and chronic anemia patients to support an application for a CE Certificate of Conformity.
We have since successfully completed European Phase 3 clinical trials of the red blood cell system for subjects with acute and chronic anemia patients to support an MDR application.
Further discussion of the impact of health care reform and laws governing our business practices on our business can be found in “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “ Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or CE Certificates of Conformity of our products and to produce, market and distribute our products after approval or certification is obtained” and “We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. ” Human Capital As of December 31, 2024, we had 281 employees representing at least 38 nationalities which includes 7 dedicated commercial consultants.
Further discussion of the impact of health care reform and laws governing our business practices on our business can be found in “Item 1A— Risk Factors ” of this Annual Report on Form 10-K, under the risk factors titled “ Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or CE Certificates of Conformity of our products and to produce, market and distribute our products after approval or certification is obtained” and “We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. ” Human Capital As of December 31, 2025, we had 275 employees company-wide.
Revenue from the cost reimbursement provisions under our BARDA and the FDA government contracts varies by year. A portion of our government contract revenue is subject to obtaining approval on audited indirect costs or rates and is subject to termination of the contract at the election of the U.S. government.
Federal Agencies, two with BARDA and one with the DoD. Revenue from the cost reimbursement provisions under our BARDA contracts varies by year. A portion of our government contract revenue is subject to obtaining approval on audited indirect costs or rates and is subject to termination of the contract at the election of the U.S. government.
Such investigations may be difficult for us to assess imputability which may lead to a complete halt of the clinical trial, may irreparably harm our red blood cell product’s reputation and may force us to suspend or terminate development activities related to the red blood cell system in the U.S., which would have a material adverse effect on our business and business prospects.
Such investigations may be difficult for us to assess imputability which may lead to a complete halt of the clinical trial, may irreparably harm our red blood cell product’s reputation and may force us to suspend or terminate development activities related to the red blood cell system in the U.S.
In the past, we have transitioned certain territories to new distribution partners who we felt were capable of improved performance relative to their predecessors as well as transitioned some of these territories to a Cerus direct option, which we believed would provide us with better visibility into and control of sales execution. We may undertake similar changes in the future.
In the past, we have transitioned certain territories to non-exclusive arrangements or to new distribution partners who we felt were capable of improved performance relative to their predecessors as well as transitioned some of these territories to a Cerus direct option, which we believed would provide us with better visibility into and control of sales execution.
While all of our manufacturing partners have received a BLA from CBER, we plan to continue working with any other U.S.-based blood centers producing IFC to support their licensure applications and any delay in obtaining these licenses would adversely impact the nationwide availability of our finished IFC in the U.S.
While all of the blood centers that were manufacturing partners for us have received a BLA from CBER, we plan to continue working with additional U.S.-based blood centers that are onboarding and producing IFC to support their licensure applications and any delay in obtaining these licenses would adversely impact the nationwide availability of finished IFC in the U.S.
Should Terumo BCT’s product be approved for use and commercialized in Japan, our products would likely directly compete against its products and we believe we would likely need to either establish operations in Japan or partner with a local Japanese company.
Should Terumo BCT’s product be approved for use and commercialized in Japan, our products would likely directly compete against its products and we believe we would likely need to either establish operations in Japan or rely on a local partner in the territory.
We initially filed an application for a CE Certificate of Conformity for the red blood cell system in December 2018 under the Medical Device Directive, or MDD, and in June 2021, we completed our application for a CE Certificate of Conformity under the new MDR.
We initially filed an application for conformity assessment to obtain a CE Certificate of Conformity for the red blood cell system in December 2018 under the Medical Device Directive, or MDD, and in June 2021, we submitted an MDR application.
These data from the expanded RedeS study, if positive, are expected to support our chronic use assessment in our planned modular premarket approval, or PMA, application for the red blood cell system that we plan to submit to the FDA.
The preliminary results from the RedeS study are expected in late 2026, and if positive, are expected to support our chronic use assessment in our planned modular premarket approval, or PMA, application for the red blood cell system that we plan to submit to the FDA.
We own 51% of equity in the JV. The JV will need to obtain regulatory approval for the INTERCEPT Blood System for platelets and red blood cells before it can begin commercializing in China. In order to obtain that regulatory approval, the JV may need to run additional clinical studies in China.
We own 51% of equity in the JV. The JV will need to obtain regulatory approval for the INTERCEPT Blood System for platelets and red blood cells before it can begin commercializing in China.
Terumo Corporation is a large Japan-based, multinational corporation with more mature products and relationships than we have. Our ability to commercialize our products in certain markets, particularly in Japan, may be negatively affected by Terumo’s resources and their pre-existing relationships with regulators and customers.
Terumo Corporation is a large Japan-based, multinational corporation with established products and longstanding relationships. 14 Our ability to commercialize our products in certain markets, particularly in Japan, may be negatively affected by Terumo’s resources and their pre-existing relationships with regulators and customers.
In addition, as a result of the failure to obtain approval of our MDR application, our product development costs will be ongoing.
In addition, as a result of the failure to obtain a CE Certificate of Conformity following MDR application, our product development costs will be ongoing.
Cerus Employees 2024 Salaried workforce 267 Managers and above 73 Part-time employees 16 19 Average age 46.6 years Average length of service in years 6.5 years Employee turnover rate December 31, 2023 to 2024 (voluntary) 8.3% Our employees are a key factor in our ability to serve our customers and achieve our mission to establish INTERCEPT as the standard of care for transfused blood components globally and to enable our customers to do everything in their power to deliver safe and effective blood products to patients.
Cerus Employees 2025 Salaried workforce 260 Managers and above 71 Part-time employees 14 Average age 46.5 years Average length of service in years 7.4 years Employee turnover rate December 31, 2024 to 2025 (voluntary) 5.89% Our employees are a key factor in our ability to serve our customers and achieve our mission to establish INTERCEPT as the standard of care for transfused blood components globally and to enable our customers to do everything in their power to deliver safe and effective blood products to patients.
With respect to our MDR application in the European Union, or EU, we announced in October 2024 that the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the red blood cell system, reviewed the active pharmaceutical ingredient module of our MDR application and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating the closure of our MDR application without an approval.
With respect to our application for conformity assessment under the MDR to obtain a CE Certificate of Conformity and affix the CE Mark, or MDR application, in the European Union, or EU, we announced in October 2024 that the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the red blood cell system, reviewed the active pharmaceutical ingredient module of our MDR application and concluded that the data included in the module were insufficient to support the proposed classification of the impurity profile of the final product, necessitating the closure of our MDR application without successful completion of the conformity assessment or issuance of a CE Certificate of Conformity.
If we are unable to gain or maintain widespread commercial adoption in markets where our blood safety products are approved for commercialization, including in the U.S., we will have difficulties achieving and maintaining profitability. 5 The INTERCEPT Blood System for red blood cells, or the red blood cell system, is currently in development.
If we are unable to gain or maintain widespread commercial adoption in markets where our blood safety products are approved for commercialization, including in the U.S., we will have difficulties achieving and maintaining profitability.
We have submitted a new application for conformity assessment to obtain a CE Certificate of Conformity to affix the CE Mark to a new illuminator. In the U.S., we will be required to file a new PMA for our INTERCEPT Blood System for both platelets and plasma for use with our new illuminator.
We submitted an MDR application for a new illuminator and received a CE Certificate of Conformity in 2025. In the U.S., we will be required to file a new PMA for our INTERCEPT Blood System for both platelets and plasma for use with our new illuminator.
For example, such scrutiny has resulted in several recent congressional inquiries, presidential executive orders, and federal and state legislative activity designed to, among other things, bring more transparency to pricing and reform government program reimbursement methodologies for pharmaceutical products.
In addition, there has been heightened governmental scrutiny to control the rising cost of healthcare. For example, such scrutiny has resulted in several recent congressional inquiries, presidential executive orders, and federal and state legislative activity designed to, among other things, bring more transparency to pricing and reform government program reimbursement methodologies for pharmaceutical products.
In addition, we plan to continue to develop awareness of INTERCEPT’s product profile relative to other platelet and plasma products, including conventional, un-treated components.
We plan to continue to develop and raise 7 awareness of INTERCEPT’s product profile relative to other products, including conventional, un-treated components.
We also have an agreement with EFS for maintenance services for illuminators that will expire in October 2025. We are discussing new contract terms with EFS for the supply of platelet disposable kits, plasma disposable kits, and maintenance services for illuminators.
We also have an agreement with EFS for maintenance services for illuminators that also expired in October 2025, though we have extended this agreement, pending negotiation of a new contract. We are discussing new contract terms with EFS for the supply of platelet disposable kits, plasma disposable kits, and maintenance services for illuminators.
MacoPharma has received a CE Certificate of Conformity for a UVC-based pathogen reduction product for platelets. MacoPharma completed a Phase 3 clinical trial in Germany to generate additional data for possible expanded approvals. We understand that Terumo BCT also developed a pathogen reduction system for whole blood receiving a Class II CE Certificate of Conformity.
MacoPharma is seeking a CE Certificate of Conformity under the MDR for a UVC-based pathogen reduction product for platelets. MacoPharma completed a Phase 3 clinical trial in Germany to generate additional data for possible expanded approvals. Terumo BCT has also received a Class III CE Certificate of Conformity for a pathogen reduction system for whole blood.
We filed our application for a CE Certificate of Conformity of the red blood cell system under the MDR in June 2021.
We filed our MDR application for the red blood cell system under the MDR in June 2021.
We may be subject to diverse laws and regulations relating to data privacy and security as a result of our employee data or other personal information that we may collect. In addition, if we do collect personal data as part of any clinical trials or other testing, we would be subject to regulatory obligations.
We are and may become subject to diverse laws and regulations relating to data privacy and security as a result of our employee data or other personal information that we may collect. In addition, personal data collected as part of any clinical trials, other testing, or other business activities, is and may become subject to additional regulatory obligations.
We completed a series of in vitro and in vivo tests with the red blood cell system, including successfully completing recovery and survival studies measuring red cell recovery twenty-four hours after transfusion.
INTERCEPT Blood System for Red Blood Cells The red blood cell system is designed to inactivate blood-borne pathogens in red blood cells intended for transfusion. We completed a series of in vitro and in vivo tests with the red blood cell system, including successfully completing recovery and survival studies measuring red cell recovery twenty-four hours after transfusion.
Hospitals may not perceive the advantage of IFC over the competing products, may perceive the cost of adopting IFC as prohibitive relative to its advantages or compared to competitive products, we may be ineffective in selling blood components directly to hospitals.
Hospitals may not perceive the advantage of IFC over the competing products, or may perceive the cost of adopting IFC as prohibitive relative to its advantages or compared to competitive products.
To enable broader patient access to IFC in the U.S., U.S.-based blood centers need to complete process validations and obtain site-specific licenses from the FDA Center for Biologics Evaluation and Research, or CBER, before IFC can be made available to hospital customers outside of the state of IFC production.
To distribute blood products, including IFC, to hospitals through interstate commerce, U.S.-based blood centers will need to complete process validations and obtain site-specific licenses from the FDA Center for Biologics Evaluation and Research, or CBER, before those blood products can be made available to hospital customers outside of the state of IFC production.
Accordingly, we may never achieve a profitable level of operations in the future. We were incorporated in California in 1991 and reincorporated in Delaware in 1996. Our wholly-owned subsidiary, Cerus Europe B.V., was formed in the Netherlands in 2006.
While our goal is to achieve and maintain a profitable level of operations, we may be unable to do so. We were incorporated in California in 1991 and reincorporated in Delaware in 1996. Our wholly-owned subsidiary, Cerus Europe B.V., was formed in the Netherlands in 2006.
The primary efficacy endpoint was the proportion of subjects experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels within 48 hours after the 8 surgery.
The primary efficacy endpoint was the proportion of subjects experiencing acute kidney injury as an assessment of RBC efficacy in providing tissue oxygenation, measured as an increase in serum creatinine compared to pre-surgery, baseline levels within 48 hours after the surgery. The ReCePI study was and the RedeS study is being funded as part of our initial agreement with BARDA.
In France, broad product adoption is dependent on a central decision by the Établissement Français du Sang, or EFS, a public organization responsible for all collection, testing preparation and distribution of blood products in France. Our agreements with EFS to supply platelet disposable kits and plasma disposable kits will both expire in October 2025.
In France, broad product adoption is dependent on a central decision by the Établissement Français du Sang, or EFS, a public organization responsible for all collection, testing preparation and distribution of blood products in France.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIn any event, if we are unable to develop and maintain an effective and qualified U.S. based commercial organization, we may fail to realize the full sales potential of our commercial products in the U.S. which would materially and adversely affect our business, financial condition, results of operations and growth prospects. 25 We have very limited experience selling directly to hospitals or expertise complying with regulations governing finished biologics, and our inability to successfully commercialize the INTERCEPT Blood System for cryoprecipitation in the U.S. would have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Biggest changeWe have very limited experience selling directly to hospitals or expertise complying with regulations governing finished biologics, and our inability to successfully commercialize the INTERCEPT Blood System for cryoprecipitation in the U.S. would have a material adverse effect on our business, financial condition, results of operations and growth prospects. 26 We have very limited experience selling directly to hospitals nor do we have prior experience or expertise complying with regulations governing finished biologics.
The advertising and promotion of medical devices in the EU is subject to the national laws of EU Member States applying the MDR, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.
The advertising and promotion of medical devices in the EU is subject to the MDR and national laws of EU Member States applying the MDR, Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other national legislation of individual EU Member States governing the advertising and promotion of medical devices.
If we are unable to generate the required data for new PMAs, use of INTERCEPT in the United States will be limited to continued use with the existing illuminator, which we have a limited number of devices available and for which we have a limited time that we can continue to support and maintain.
If we are unable to generate the required data for new PMAs, use of INTERCEPT in the United States will be limited to continued use with the existing illuminator, of which we have a limited number of devices available for which we have a limited time that we can continue to support and maintain.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for CE Certificates of Conformity in the EU, if costs are higher than anticipated or we encounter further delays.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary to obtain CE Certificates of Conformity in the EU, if costs are higher than anticipated or we encounter further delays.
We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our government contracts, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.
We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our government contracts, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.
Foreign Corrupt Practices Act and anti-corruption laws, and similar laws with a significant anti-corruption intent in foreign countries (as discussed in greater detail above under “ Risks Related to Regulatory Approval, CE Certificates of Conformity and Oversight, and Other Legal Compliance Matters—We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business ” and “ Risks Related to Our Reliance on Third Parties—We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries ”); 52 • differing payor reimbursement regimes, governmental payors and price controls; • changes in the political or economic condition of a specific country or region; • fluctuations in the value of foreign currency versus the U.S. dollar; • adverse tax consequences, including changes in applicable tax laws and regulations; • liabilities for activities of, or related to, our international operations and those of our agents, distributors and joint venture partners; • tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and sanctions (including those administered by the Office of Foreign Assets Control of the U.S.
Foreign Corrupt Practices Act and anti-corruption laws, and similar laws with a significant anti-corruption intent in foreign countries (as discussed in greater detail above under “ Risks Related to Regulatory Approval, CE Certificates of Conformity and Oversight, and Other Legal Compliance Matters—We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business ” and “ Risks Related to Our Reliance on Third Parties—We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries ”); • differing payor reimbursement regimes, governmental payors and price controls; • changes in the political or economic condition of a specific country or region; • fluctuations in the value of foreign currency versus the U.S. dollar; • adverse tax consequences, including changes in applicable tax laws and regulations; • liabilities for activities of, or related to, our international operations and those of our agents, distributors and joint venture partners; • tariffs, trade protection measures, import or export licensing requirements, trade embargoes, and sanctions (including those administered by the Office of Foreign Assets Control of the U.S.
Our failure to comply with applicable regulatory requirements could result in enforcement action by regulatory agencies, which may include any of the following sanctions: • adverse publicity, warning letters, fines, injunctions, seizure, consent decrees and civil penalties; • repair, replacement, recall or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • delaying or refusing our requests for approval of new products, new intended uses or modifications to our existing products and regulatory strategies; • exclusion from participation in government programs, such as Medicare and Medicaid; • refusal to grant export or import approval for our products or refusal to allow us to enter into government contracts; 34 • additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance; • withdrawing, suspension or variation in marketing approvals or CE Certificates of Conformity that have already been granted, resulting in prohibitions on sales of our products; and • criminal prosecution.
Our failure to comply with applicable regulatory requirements could result in enforcement action by regulatory agencies, which may include any of the following sanctions: • adverse publicity, warning letters, fines, injunctions, seizure, consent decrees and civil penalties; • repair, replacement, recall or seizure of our products; • operating restrictions or partial suspension or total shutdown of production; • delaying or refusing our requests for approval of new products, new intended uses or modifications to our existing products and regulatory strategies; • exclusion from participation in government programs, such as Medicare and Medicaid; • refusal to grant export or import approval for our products or refusal to allow us to enter into government contracts; • additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance; • withdrawing, suspension or variation in marketing approvals or CE Certificates of Conformity that have already been granted, resulting in prohibitions on sales of our products; and • criminal prosecution.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension, variation or withdrawal of regulatory clearances, CE Certificates of Conformity or approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
Later discovery of previously unknown problems with our products, including unanticipated adverse events or adverse events of unanticipated severity or frequency, manufacturing problems, or failure to comply with regulatory requirements may result in changes to labeling, restrictions on such products or manufacturing processes, withdrawal of the products from the market, voluntary or 34 mandatory recalls, a requirement to repair, replace or refund the cost of any medical device we manufacture or distribute, fines, suspension, variation or withdrawal of regulatory clearances, CE Certificates of Conformity or approvals, product seizures, injunctions or the imposition of civil or criminal penalties which would adversely affect our business, operating results and prospects.
If we are unable to continue to produce positive operating cash flows or at sufficient levels, meeting our long-term capital requirements will be, in large part, reliant on continued access to funds under our government contracts and the public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash generated from operations, if at all, and interest income earned on the investment of our cash balances.
If we are unable to produce positive operating cash flows or at sufficient levels, meeting our long-term capital requirements will be, in large part, reliant on continued access to funds under our government contracts and the public and private equity and debt capital markets, as well as on collaborative arrangements with partners, augmented by cash generated from operations, if at all, and interest income earned on the investment of our cash balances.
While we believe that our available cash and cash equivalents and short-term investments, as well as cash received from product sales and under our agreements with BARDA, the FDA, and the DoD, will be sufficient to meet our capital requirements for at least the next 12 months, if we are unable to generate sufficient product revenue, or access sufficient funds under our government contracts or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan.
While we believe that our available cash and cash equivalents and short-term investments, as well as cash received from product sales and under our agreements with BARDA and the DoD, will be sufficient to meet our capital requirements for at least the next 12 months, if we are unable to generate sufficient product revenue, or access sufficient funds under our government contracts or the public and private equity and debt capital markets, we may be unable to execute successfully on our operating plan.
We have recently learned of instances where, following treatment with INTERCEPT, mishandling of the treated blood components has introduced environmental bacterium. We must help our blood center customers to remain vigilant or increase their vigilance in adopting best practices regarding blood component handling. Failure to adequately address this risk may call into question the efficacy of using pathogen reduction.
We have learned of instances where, following treatment with INTERCEPT, mishandling of the treated blood components has introduced environmental bacterium. We must help our blood center customers to remain vigilant or increase their vigilance in adopting best practices regarding blood component handling. Failure to adequately address this risk may call into question the efficacy of using pathogen reduction.
While we have entered into agreements with Établissement Français du Sang, or EFS, to supply illuminators, platelet and plasma disposable kits, maintenance services for illuminators and ancillary pooling sets to EFS, we cannot provide any assurance that the national deployment of the platelet system in France will be sustainable or that we will be able to secure any contracts subsequent to our existing contract with EFS.
While we have entered into agreements with Établissement Français du Sang, or EFS, to supply illuminators, platelet and plasma disposable kits, maintenance services for illuminators and ancillary pooling sets to EFS, we cannot provide any assurance that the national deployment of the platelet system in France will be sustainable or that we will be able to secure any contracts subsequent to our existing contract extensions with EFS.
Further, the costs to respond to a security breach and/or to mitigate any security vulnerabilities that may be identified could be significant, our efforts to address these problems may not be successful, and these problems could result in interruptions, delays, cessation of service, negative publicity, loss of customer trust, less use of our products and services as well as other harms to our business and our competitive position.
Further, the costs to respond to a security breach and/or to mitigate any security vulnerabilities that may be identified could be significant, our efforts to address these problems may not be successful, and these problems could result in interruptions, delays, cessation of service, negative publicity, loss of customer trust, less 56 use of our products and services as well as other harms to our business and our competitive position.
In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all.
In addition, widespread investor concerns regarding the U.S. or international financial systems could result in less favorable commercial financing terms, including higher interest 51 rates or costs and tighter financial and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to acquire financing on acceptable terms or at all.
The clinical data we have generated thus far for the red blood cell system does not support multiple configurations of collection processes, storage solutions 30 and kits. If we are required to and are ultimately unable to collect data under each configuration or if we limit our pursuit of certain configurations over others, our market opportunity may be limited.
The clinical data we have generated thus far for the red blood cell system does not support multiple configurations of collection processes, storage solutions and kits. If we are required to and are ultimately unable to collect data under each configuration or if we limit our pursuit of certain configurations over others, our market opportunity may be limited.
Generally, government contracts, including our agreements with BARDA, the FDA and the DoD, contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience. Termination-for-convenience provisions generally enable us to recover only our costs incurred or committed (plus a portion of the agreed fee) and settlement expenses on the work completed prior to termination.
Generally, government contracts, including our agreements with BARDA and the DoD, contain provisions permitting unilateral termination or modification, in whole or in part, at the U.S. government’s convenience. Termination-for-convenience provisions generally enable us to recover only our costs incurred or committed (plus a portion of the agreed fee) and settlement expenses on the work completed prior to termination.
Hiring, training and retaining new personnel is costly, time consuming and distracting to 51 existing employees and management. Currently, we, third-party suppliers and vendors and customers are experiencing an extremely tight labor market exacerbating our ability to attract and retain talent. Furthermore, a significant component of our employee compensation and retention practice involves stock-based compensation.
Hiring, training and retaining new personnel is costly, time consuming and distracting to existing employees and management. Currently, we, third-party suppliers and vendors and customers are experiencing an extremely tight labor market exacerbating our ability to attract and retain talent. Furthermore, a significant component of our employee compensation and retention practice involves stock-based compensation.
Product specifications that receive marketing authorization from the PEI may differ from product specifications that have been adopted in other parts of the EU and other countries where we rely on CE Certificates of Conformity and the CE Mark, thereby 24 necessitating market specific modifications to the commercial product, which may not be economical or technically feasible for us.
Product specifications that receive marketing authorization from the PEI may differ from product specifications that have been adopted in other parts of the EU and other countries where we rely on CE Certificates of Conformity and the CE Mark, thereby necessitating market specific modifications to the commercial product, which may not be economical or technically feasible for us.
Furthermore, if a court were to find the exclusive forum provisions contained in our 57 bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material and adverse impact on our operating results and our financial condition.
Furthermore, if a court were to find the exclusive forum provisions contained in our bylaws to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could have a material and adverse impact on our operating results and our financial condition.
Managing such a dual inventory of blood products may be challenging, and hospitals may need to amend their product labels and inventory management systems before being able to move forward with INTERCEPT. Hospitals may not have adequate staffing levels or may have competing priorities which could delay such system updates, perhaps indefinitely.
Managing such a dual inventory of blood products may be challenging, and hospitals may need to amend their product labels and inventory management systems before being able to move forward with INTERCEPT. Hospitals may not have adequate staffing 24 levels or may have competing priorities which could delay such system updates, perhaps indefinitely.
Under both BARDA agreements, activities covered under the base period and 41 exercised option periods may ultimately take longer than is allowed or cost more than is covered by the respective BARDA agreements, and if we are unable to secure additional funding or allow for additional time for completion, we would have to bear the cost to complete the activities or terminate the activities before completion.
Under both BARDA agreements, activities covered under the base period and exercised option periods may ultimately take longer than is allowed or cost more than is covered by the respective BARDA agreements, and if we are unable to secure additional funding or allow for additional time for completion, we would have to bear the cost to complete the activities or terminate the activities before completion.
Furthermore, contracting with individual hospitals is time consuming and is often a protracted and bespoke process. Our blood center customers may view the sale of biologics directly to hospitals as a competitive threat, which may adversely affect our customer relationships, could negatively impact our business prospects and could result in loss of business and revenue.
Contracting with individual hospitals is time consuming and is often a protracted and bespoke process. Our blood center customers may view the sale of biologics directly to hospitals as a competitive threat, which may adversely affect our customer relationships, could negatively impact our business prospects and could result in loss of business and revenue.
Even if we are able to generate compelling data regarding the use of IFC over other products or traditional cryoprecipitate, hospitals may not perceive the advantage of IFC over the competing products and we may be ineffective in selling biological agents directly to hospitals or be unable to demonstrate the economic or patient advantages to customers relative to 27 the competitors.
Even if we are able to generate compelling data regarding the use of IFC over other products or traditional cryoprecipitate, hospitals may not perceive the advantage of IFC over the competing products and we may be ineffective in selling biological agents directly to hospitals or be unable to demonstrate the economic or patient advantages to customers relative to the competitors.
This may require that we can demonstrate stability of our active compounds manufactured under the FDA’s cGMP regulations and similar requirements outside of the U.S. to meet release specifications. Our contracted manufacturer has had a history of failure in manufacturing the active compound of the red blood cell system.
This may 31 require that we can demonstrate stability of our active compounds manufactured under the FDA’s cGMP regulations and similar requirements outside of the U.S. to meet release specifications. Our contracted manufacturer has had a history of failure in manufacturing the active compound of the red blood cell system.
Typically, there is a high rate of failure for product 29 candidates in preclinical studies and clinical trials and products emerging from any successful trial may not reach the market for several years. Enrollment criteria for certain of our clinical trials may be quite narrow, further delaying the clinical trial process.
Typically, there is a high rate of failure for product candidates in preclinical studies and clinical trials and products emerging from any successful trial may not reach the market for several years. Enrollment criteria for certain of our clinical trials may be quite narrow, further delaying the clinical trial process.
Our products must satisfy rigorous standards of safety and efficacy and we must adhere to quality standards regarding manufacturing and customer-facing business processes in order for the FDA and international regulatory authorities and Notified Bodies to approve them for commercial use or issue related CE Certificates of Conformities.
Our products must satisfy rigorous standards of safety and efficacy and we must adhere to quality standards regarding manufacturing and customer-facing business processes in order for the FDA and international regulatory authorities and Notified Bodies to approve them for commercial use or issue 33 related CE Certificates of Conformities.
In addition, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests. In the ordinary course of business, we may transfer personal data from Europe and other jurisdictions to the United States or other countries.
In addition, companies may face private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized by law to represent their interests. In the ordinary course of business, we transfer personal data from Europe and other jurisdictions to the United States or other countries.
These laws 36 are often broadly written, and it is often difficult to determine precisely how these laws will be applied to specific circumstances. For example, within the EU, the control of unlawful marketing activities is largely a matter of national law and regulations in each of the EU Member States.
These laws are often broadly written, and it is often difficult to determine precisely how these laws will be applied to specific circumstances. For example, within the EU, the control of unlawful marketing activities is largely a matter of national law and regulations in each of the EU Member States.
However, the 2016 Agreement with BARDA only reimburses certain specified development and clinical activities that have been authorized by BARDA pursuant to the base period and certain options of the 2016 Agreement and the potential exercise of subsequent option periods. To date, BARDA has exercised approximately $185.5 million under the base period of the 2016 Agreement and associated options.
However, the 2016 Agreement with BARDA only reimburses certain specified development and clinical activities that have been authorized by BARDA pursuant to the base period and certain options of the 2016 42 Agreement and the potential exercise of subsequent option periods. To date, BARDA has exercised approximately $185.5 million under the base period of the 2016 Agreement and associated options.
In particular, it is expensive and time consuming to continually address ever-changing regulatory requirements whether those changes are due to changes in the requirements or changes in our products to expand or maintain our products’ label claims. Furthermore, the cost of complying with increased oversight and changing requirements under U.S.
In particular, it is expensive and time consuming to continually address ever-changing regulatory requirements whether those changes are due to changes in the requirements or changes in our products to expand 50 or maintain our products’ label claims. Furthermore, the cost of complying with increased oversight and changing requirements under U.S.
Risks Related to Our Intellectual Property We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. 55 Our commercial success will depend, in part, on obtaining and maintaining patent protection on our products and successfully defending our products against third-party challenges.
Risks Related to Our Intellectual Property We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. Our commercial success will depend, in part, on obtaining and maintaining patent protection on our products and successfully defending our products against third-party challenges.
EU Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. 33 In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.
EU Member State legislation may also restrict or impose limitations on our ability to advertise our products directly to the general public. In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. General Risk Factors We are obligated to develop and maintain proper and effective internal control over financial reporting.
As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future. General Risk Factors 59 We are obligated to develop and maintain proper and effective internal control over financial reporting.
The review period for a new authorization can be 12 months or longer following submission and we cannot assure that any of the potential German customers submitting a new application for authorization will obtain it. We have invested in substantial commercial resources in Germany.
The review period for a new authorization can be 12 months or longer following submission and we cannot 25 assure that any of the potential German customers submitting a new application for authorization will obtain it. We have invested in substantial commercial resources in Germany.
Risks Related to Managing Our Growth and Other Business Risks We operate a complex global commercial organization, with limited experience in many countries. We have limited resources and experience complying with regulatory, legal, tax and political complexities as we expand into new and increasingly broad geographies.
Risks Related to Managing Our Growth and Other Business Risks 52 We operate a complex global commercial organization, with limited experience in many countries. We have limited resources and experience complying with regulatory, legal, tax and political complexities as we expand into new and increasingly broad geographies.
If we or our products fail to comply with the requirements of MDR, then our products may not be permitted to be sold in the EU or other jurisdictions that recognize CE Certificate of Conformity and our results of operations and financial projections would be adversely affected.
If we or our products fail to comply with the requirements of MDR, then our products may not be permitted to be sold in the EU or other jurisdictions that recognize CE Marking or CE Certificate of Conformity and our results of operations and financial projections would be adversely affected.
We may be unable to identify, select, and qualify such manufacturers or those third parties able to provide support for development and testing activities on a timely basis or enter into contracts with them on reasonable terms, if at all.
We may be unable to identify, select, and qualify such manufacturers or those third 48 parties able to provide support for development and testing activities on a timely basis or enter into contracts with them on reasonable terms, if at all.
We may be unable to make timely filings with regulatory agencies in the event of catastrophic failure of our data storage and backup systems, which may subject us to fines or adverse consequences, up to and including loss of our ability to conduct business.
We 55 may be unable to make timely filings with regulatory agencies in the event of catastrophic failure of our data storage and backup systems, which may subject us to fines or adverse consequences, up to and including loss of our ability to conduct business.
We cannot be certain that our patents or patents that we license from others will be enforceable and afford protection against competitors. Our patents or patent applications, if issued, may be challenged, invalidated or circumvented. Our patent rights may not provide us with proprietary protection or competitive advantages against competitors with similar technologies.
We cannot be certain that our patents or patents that we license from others will be enforceable and afford protection against competitors. Our patents or patent applications, if issued, may be challenged, invalidated or circumvented. Our patent rights may not provide us with 57 proprietary protection or competitive advantages against competitors with similar technologies.
In addition to the other risks described herein, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma and IFC in the U.S. is subject to a number of risks and uncertainties, including those related to: 21 • the impact of macroeconomic developments, such as general political, health and economic conditions, including escalating trade tensions and the Ukraine-Russia conflict, economic slowdowns, recessions, inflation, bank failures, rising interest rates and tightening of credit markets on our business; • staffing shortages at blood centers, hospitals, study sites or suppliers; • the highly concentrated U.S. blood collection market that is dominated by a small number of blood collection organizations; • availability of blood donors; • regulatory and licensing requirements, including the FDA Center for Biologics Evaluation and Research, or CBER, licensing processes and its BLA requirements, that U.S.-based blood centers are required to follow in order to obtain and maintain the required site-specific licenses to engage in interstate transport of blood components processed using the INTERCEPT Blood System; • changed or increased regulatory restrictions or requirements; • our ability to meet regulatory requirements for any changes to our products, including component composition, manufacturing process, and location; • the amount available for reimbursement pursuant to codes we have obtained under the Healthcare Common Procedure Coding System, or HCPCS, and pricing for outpatient use of INTERCEPT-treated blood components; • any supply or manufacturing problems or delays arising with any of our suppliers, many of whom are our sole qualified suppliers for the particular product or component they manufacture, including the ability of our suppliers to maintain FDA approval to manufacture the INTERCEPT Blood System and to comply with FDA-mandated current Good Manufacturing Practice, or cGMP, and Quality System Regulation, or QSR, requirements and foreign equivalents; • our and our suppliers ability to produce sufficient quantity of product to meet the growing demand for our products; • any supply or manufacturing problems or delays arising from our customers third-party suppliers whose products are used in combination and compliance with our products including customers third-party suppliers’ ability to maintain FDA approval to manufacture the INTERCEPT Blood System and to comply with FDA-mandated cGMP and QSR requirements; • ability to contract with, maintain and add additional blood center manufacturers for the production of IFC and for the contracted blood center manufacturing partners to produce IFC at sufficient quantities and at acceptable quality levels or for other blood centers to contract with us for the purchase of kits and to produce IFC for their own sales efforts; • dependency upon any third-party manufacturer that supplies products required by blood centers to process and store blood components consistent with our approved specifications and claims, including but not limited to, apheresis collection devices, disposable blood bags and reagents, and platelet additive solution, or PAS, including those third-party suppliers’ ability to maintain FDA or other regulatory approvals to manufacture their products and to comply with FDA-mandated cGMP and QSR requirements and foreign equivalents; • our ability to obtain patents, protect trade secrets, prevent others from infringing on our proprietary rights, and operate without infringing the proprietary rights of third parties; • existing and potential future competitive threats, including complaints, litigation or other such disruptive practices, regardless of merit; • changes in healthcare laws and policy, including changes in requirements for blood product coverage by U.S. federal healthcare programs; and • acceptance of the INTERCEPT Blood System as safe, effective and economical from the broad constituencies involved in the healthcare system.
In addition to the other risks described herein, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma and IFC in the U.S. is subject to a number of risks and uncertainties, including those related to: 22 • the impact of macroeconomic developments, such as general political, health and economic conditions, including escalating trade tensions and the Ukraine-Russia conflict, economic slowdowns, recessions, inflation, bank failures, rising interest rates, tightening of credit markets on our business and existing and potential new or increased tariffs; • staffing shortages at blood centers, hospitals, study sites or suppliers; • the highly concentrated U.S. blood collection market that is dominated by a small number of blood collection organizations; • availability of blood donors; • regulatory and licensing requirements, including the FDA Center for Biologics Evaluation and Research, or CBER, licensing processes and its BLA requirements, that U.S.-based blood centers are required to follow in order to obtain and maintain the required site-specific licenses to engage in interstate transport of blood components processed using the INTERCEPT Blood System; • changed or increased regulatory restrictions or requirements; • our ability to meet regulatory requirements for any changes to our products, including component composition, manufacturing process, and location; • the amount available for reimbursement pursuant to codes we have obtained under the Healthcare Common Procedure Coding System, or HCPCS, and pricing for outpatient use of INTERCEPT-treated blood components; • any supply or manufacturing problems or delays arising with any of our suppliers, many of whom are our sole qualified suppliers for the particular product or component they manufacture, including the ability of our suppliers to maintain FDA approval to manufacture the INTERCEPT Blood System and to comply with FDA-mandated current Good Manufacturing Practice, or cGMP, and Quality System Regulation, or QSR, requirements and foreign equivalents; • our and our suppliers’ ability to produce sufficient quantities of product to meet the growing demand for our products; • any supply or manufacturing problems or delays arising from our customers’ third-party suppliers whose products are used in combination and compliance with our products; • ability to contract with, maintain and add additional blood center manufacturers for the production of IFC and for the contracted blood center manufacturing partners to produce IFC at sufficient quantities and at acceptable quality levels or for other blood centers to contract with us for the purchase of kits and to produce IFC for their own sales efforts; • dependency upon any third-party manufacturer that supplies products required by blood centers to process and store blood components consistent with our approved specifications and claims, including but not limited to, apheresis collection devices, disposable blood bags and reagents, and platelet additive solution, or PAS, including those third-party suppliers’ ability to maintain FDA or other regulatory approvals to manufacture their products and to comply with FDA-mandated cGMP and QSR requirements and foreign equivalents; • our ability to obtain patents, protect trade secrets, prevent others from infringing on our proprietary rights, and operate without infringing the proprietary rights of third parties; • existing and potential future competitive threats, including complaints, litigation or other such disruptive practices, regardless of merit; • changes in healthcare laws and policy, including changes in requirements for blood product coverage by U.S. federal healthcare programs; and • acceptance of the INTERCEPT Blood System as safe, effective and economical from the broad constituencies involved in the healthcare system.
If we follow such BARDA advice, overall red blood cell program delays and costs associated with additional resources for which we had not planned may result. Also, the costs associated with following such advice may or may not be reimbursed by BARDA under our agreements.
If we 43 follow such BARDA advice, overall red blood cell program delays and costs associated with additional resources for which we had not planned may result. Also, the costs associated with following such advice may or may not be reimbursed by BARDA under our agreements.
Moreover, if treatment emergent 31 antibody reactions associated with hemolysis are observed in any of our Phase 3 trials, the FDA will require us to place a clinical hold and we will need to investigate the underlying cause.
Moreover, if treatment emergent antibody reactions associated with hemolysis are observed in any of our Phase 3 trials, the FDA will require us to place a clinical hold and we will need to investigate the underlying cause.
In any event, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma, and IFC in the U.S. will depend on our ability to: • achieve market acceptance and generate product sales through execution of sales agreements on commercially reasonable terms; • enter into and maintain sufficient manufacturing arrangements for the U.S. market with our third-party suppliers; • support blood center manufacturing partners in obtaining Biologics License Application, or BLAs, for the sale of INTERCEPT-treated products into interstate commerce; • effectively create market demand for the INTERCEPT Blood System through our education, marketing and sales activities; • hire, train, deploy, support and maintain a qualified U.S.-based commercial organization and field sales force; • expand the labeled indications of use for the INTERCEPT Blood System and/or design, develop, test and obtain regulatory approval or certification for new product configurations; • comply with requirements established by the FDA, including post-marketing requirements and label restrictions; and • comply with other U.S. healthcare regulatory requirements.
In any event, our ability to successfully commercialize the INTERCEPT Blood System for platelets, plasma, and IFC in the U.S. will depend on our ability to: • achieve market acceptance and generate product sales through execution of sales agreements on commercially reasonable terms; • enter into and maintain sufficient manufacturing arrangements for the U.S. market with our third-party suppliers; • support blood center manufacturing partners in obtaining BLAs for the sale of INTERCEPT-treated products into interstate commerce; • effectively create market demand for the INTERCEPT Blood System through our education, marketing and sales activities; • hire, train, deploy, support and maintain a qualified U.S.-based commercial organization and field sales force; • expand the labeled indications of use for the INTERCEPT Blood System and/or design, develop, test and obtain regulatory approval or certification for new product configurations; • comply with requirements established by the FDA, including post-marketing requirements and label restrictions; and • comply with other U.S. healthcare regulatory requirements.
Generally, our distribution agreements require distributors to purchase minimum quantities in a given year over the term of the agreement. Failure by our distributors to meet these minimum purchase obligations may adversely 44 affect our financial condition and results of operations.
Generally, our distribution agreements require distributors to purchase minimum quantities in a given year over the term of the agreement. Failure by our distributors to meet these minimum purchase obligations may adversely affect our financial condition and results of operations.
In addition, should other manufacturers of collection devices, compatible assays and blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory approval or a CE Certificate of Conformity necessary for affixing the CE Mark to their products under the MDR, experience unexpected production disruption, or decide to cease distribution of those respective products to customers and prospective customers, or prohibitively increase costs, our ability to sell the INTERCEPT Blood System may be impaired and acceptance within the marketplace could be harmed.
Should other manufacturers of collection devices, compatible assays and blood bags, pooling sets or platelet additive solutions fail to obtain or maintain regulatory approval or a CE Certificate of Conformity necessary for affixing the CE Mark to their products under the MDR, experience unexpected production disruption, or decide to cease distribution of those respective products to customers and prospective customers, or prohibitively increase costs, our ability to sell the INTERCEPT Blood System may be impaired and acceptance within the marketplace could be harmed.
As a result of adverse conditions affecting the global economy and credit and financial markets, disruptions due to political instability, terrorist attacks or war, economies and currencies largely affected by declining commodity prices, inflationary pressures or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement obligations, or may delay payment for the INTERCEPT Blood System, and of which could adversely affect our business, financial condition, results of operations and growth prospects.
As a result of adverse conditions affecting the global economy and credit and financial markets, disruptions due to political instability, terrorist attacks or war, economies and currencies largely affected by declining commodity prices, inflationary pressures, import tariffs, or otherwise, these organizations may defer purchases, may be unable to satisfy their purchasing or reimbursement obligations, or may delay payment for the INTERCEPT Blood System, and of which could adversely affect our business, financial condition, results of operations and growth prospects.
Conversely, we may choose to overstock inventory in order to mitigate any unforeseen potential disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be less efficient.
Conversely, we may choose to overstock inventory in order to mitigate any 49 unforeseen potential disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be less efficient.
Even if we are able to identify and hire qualified personnel commensurate with our growth objectives and opportunities, the process of integrating new employees is time consuming, costly and distracting to existing 53 employees and management.
Even if we are able to identify and hire qualified personnel commensurate with our growth objectives and opportunities, the process of integrating new employees is time consuming, costly and distracting to existing employees and management.
The market price of our common stock is likely to continue to be volatile and 56 subject to significant price and volume fluctuations in response to market, industry and other factors, including the risk factors described in this “Risk Factors” section.
The market price of our common stock is likely to continue to be volatile and subject to significant price and volume fluctuations in response to market, industry and other factors, including the risk factors described in this “Risk Factors” section.
As a result, customers or prospective customers may adopt competing solutions if they perceive that: 22 • the loss of platelets leads to increased costs, or the perception of increased costs for our customers; • the use of our product in any way constrains the availability of platelets due to platelet loss; • our customers or prospective customers believe that the loss of platelets reduces the efficacy of the transfusable unit; • our process requires changes in blood center collection processes or clinical regimens to address platelet loss; or • our products may never receive approval for storage of platelets beyond five days.
As a result, customers or prospective customers may adopt competing solutions if they perceive that: • the loss of platelets leads to increased costs, or the perception of increased costs for our customers; 23 • the use of our product in any way constrains the availability of platelets due to platelet loss; • our customers or prospective customers believe that the loss of platelets reduces the efficacy of the transfusable unit; • our process requires changes in blood center collection processes or clinical regimens to address platelet loss; or • our products may never receive approval for storage of platelets beyond five days.
Risks Related to Government Contracts A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreements, and if BARDA were to eliminate, reduce, delay, or object to extensions for funding of our agreements, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding.
Risks Related to Government Contracts A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreements, and if BARDA were to eliminate, reduce, delay, or object to additional activities or extensions for funding of our agreements, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding.
As a result of economic conditions, general global economic uncertainty, political change, war, the effects of inflationary pressures, including those resulting from new tariffs and escalating trade tensions, and other factors including past and potential future U.S. bank failures, we do not know whether additional capital will be available when needed, or that, if available, whether we will be able to obtain additional capital on reasonable terms.
As a result of economic conditions, general global economic uncertainty, political change, war, the effects of inflationary pressures, including those resulting from tariffs and the threat of potential new or increased tariffs and escalating trade tensions, and other factors including past and potential future U.S. bank failures, we do not know whether additional capital will be available when needed, or that, if available, whether we will be able to obtain additional capital on reasonable terms.
In addition, it may take longer for us to be paid if payment timing and terms in these new arrangements are less favorable to us than those in our existing distributor arrangements.
In addition, it may take longer for us to be 46 paid if payment timing and terms in these new arrangements are less favorable to us than those in our existing distributor arrangements.
Even a temporary failure to supply adequate numbers of INTERCEPT Blood System components may cause an irreparable loss of customer goodwill and potentially irreversible loss of momentum in the marketplace.
Even a temporary failure to supply adequate numbers of INTERCEPT Blood System components may cause an irreparable loss of customer goodwill and 47 potentially irreversible loss of momentum in the marketplace.
In addition, some hospitals may decide to purchase and transfuse both INTERCEPT-treated blood components and conventional blood components, including IFC which we have very limited experience selling directly to 23 hospitals.
In addition, some hospitals may decide to purchase and transfuse both INTERCEPT-treated blood components and conventional blood components, including IFC which we have very limited experience selling directly to hospitals.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or qualify for and exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital beyond the next 12 months.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital beyond the next 12 months.
We may also need to demonstrate the safety and efficacy of our platelet system using a variety of configurations before our platelet system would be approved 28 for such configurations.
We may also need to demonstrate the safety and efficacy of our platelet system using a variety of configurations before our platelet system would be approved for such configurations.
The current conflict in the Middle East and impact on shipping routes may result in increased costs to ship our products via ocean and meet our supply chain requirements.
Conflict in the Middle East and impact on shipping routes may result in increased costs to ship our products via ocean and meet our supply chain requirements.
The Physician Payments Sunshine Act, imposes annual reporting requirements on device and biologics manufacturers and distributors for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to the Centers for Medicare & Medicaid Services, or CMS, for payments and other transfers of value provided by them, directly or indirectly, to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as ownership and investment interests held by physicians and their family members.
The Physician Payments Sunshine Act, imposes annual reporting requirements on device and biologics manufacturers and distributors for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, with specific exceptions, to track and annually report to the Centers for Medicare & Medicaid Services (“CMS”), for payments 38 and other transfers of value provided by them, directly or indirectly, to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as ownership and investment interests held by physicians and their family members.
Our ability to use our federal and state net operating loss, or NOL, carryforwards to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the NOL carryforwards (if any), and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our NOL carryforwards.
Our ability to use our federal and state net operating loss, or NOL, carryforwards to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the NOL carryforwards (if any), and we cannot predict when, or whether, we will generate sufficient taxable income to use all of our NOL carryforwards.
If we are unable to access funds contemplated under our BARDA contract for this purpose, for any reason, the development of a more operationally scalable version may require capital investment which may be beyond our means. Additionally, the use of the red blood cell system may result in some processing loss of red blood cells.
If we are unable to access funds contemplated under our BARDA contracts for this purpose, for any reason, the development of a more operationally scalable version may require capital investment which may be beyond our means. Additionally, the use of the red blood cell system may result in some processing loss of red blood cells.
We know that certain of our suppliers have been successfully attacked by certain malware aimed at extracting a ransom. Should such ransomware breaches occur in the future, production may be impacted, information exfiltrated or other records and information compromised or lost.
For example, we know that certain of our suppliers have been successfully attacked by certain malware aimed at extracting a ransom. Should such ransomware breaches occur in the future, production may be impacted, information exfiltrated or other records and information compromised or lost.
In addition, assuming approval or certification, we will be required to develop a registry of patients receiving INTERCEPT-treated red blood cells for future data collection and evaluation. To commence, enroll and complete such a registry, we may incur significant costs.
In addition, assuming approval or certification, we anticipate that we will be required to develop a registry of patients receiving INTERCEPT-treated red blood cells for future data collection and evaluation. To commence, enroll and complete such a registry, we may incur significant costs.
We do not know if data from the ReCePI Phase 3 clinical trial will be accepted by TÜV or whether such data would be supportive of expanding the target patient population beyond chronic anemia patients or whether such data will be accepted at all.
We do not know if data from the ReCePI Phase 3 clinical trial will be accepted by TÜV-SÜD or whether such data would be supportive of expanding the target patient population beyond chronic anemia patients or whether such data will be accepted at all.
Given the logistical challenges of producing the products in Europe before shipping to the U.S., we may incur elevated air freight costs, may receive requests by customers to return expired product or we may not be able to supply product to customers in the U.S. timely.
Given the logistical challenges of producing the products in Europe before shipping to the U.S., we may incur elevated air freight costs and tariffs, may receive requests by customers to return expired product or we may not be able to supply product to customers in the U.S. timely.
In the EEA, the General Data Protection Regulation, or EU GDPR, and in the UK the United Kingdom’s implementation of the EU GDPR, the UK GDPR, which are wide-ranging in scope, imposes detailed requirements, in particular, in relation to the control over personal data by individuals to whom the personal data relates, the information that we must provide to the individuals, the documentation we must maintain, the security and confidentiality of the personal data, data breach notification, the legal bases for processing personal data, the exceptions that allow us to process special categories of personal data and the use of third-party processors in connection with the processing of personal data.
In the EEA, the General Data Protection Regulation, or EU GDPR, and in the UK the United Kingdom’s implementation of the EU GDPR, the UK GDPR, which are wide-ranging in scope, impose detailed requirements, for example, in relation to the control over personal data by individuals to whom the personal data relates, the information that we must provide to the individuals, the documentation we must maintain, the security and confidentiality of the personal data, data breach notification, the legal bases for processing personal data, the exceptions that allow us to process special categories of personal data and the use of third-party processors in connection with the processing of personal data.
Any failure to, or delays in, receiving regulatory approvals for the redesigned illuminator, or increased costs associated with mitigating any such delays, could materially and adversely affect our business, financial condition, results of operations and growth prospects and impair our sales and ability to penetrate new markets.
Any failure to, or delays in, receiving regulatory approvals for the new LED-based illuminator, or increased costs associated with mitigating any such delays, could materially and adversely affect our business, financial condition, results of operations and growth prospects and impair our sales and ability to penetrate new markets.
We are also required to provide clinical data in the form of a clinical evaluation report. Fulfilment of the obligations imposed by the MDR may cause us to incur substantial costs.
We are also required to provide clinical data in the form of a clinical evaluation report. Fulfillment of the obligations imposed by the MDR may cause us to incur substantial costs.
We are uncertain how future U.S. government budgets, executive actions, and debt ceiling negotiations will affect BARDA funding. We have hired and maintain staffing, as well as having entered into agreements with third parties to perform activities associated with our BARDA agreements.
We are uncertain how future U.S. government budgets, executive actions, and debt ceiling negotiations will affect BARDA funding, nor are we certain how future U.S. government shutdowns will affect BARDA funding. We have hired and maintain staffing, as well as having entered into agreements with third parties to perform activities associated with our BARDA agreements.
In addition, our illuminators contain embedded proprietary software that runs on software code we have developed and that we own. Changes to certain components due to obsolescence, illuminator redesign or market demand, may require us to modify the existing software code or to develop new illuminator software.
In addition, our illuminators contain embedded proprietary software that runs on software code we have developed and that we own. Changes to certain components due to obsolescence, software bugs or performance issues, illuminator redesign or market demand, may require us to modify the existing software code or to develop new illuminator software.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for CE Certificates of Conformity in the EU, if costs are higher than anticipated or we encounter further delays.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary to obtain CE Certificates of Conformity and affix the CE Mark in the EU, if costs are higher than anticipated or we encounter further delays.
In the ordinary course of business, we collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, processing) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, and sensitive third-party data.
In the ordinary course of business, we (and the third parties with whom we work) collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) personal data and other sensitive information, including proprietary and confidential business data, trade secrets, intellectual property, data we collect about trial participants in connection with clinical trials, and sensitive third-party data.
Until such time as we obtain approval for the new LED-based 46 illuminator, if ever, the demand for illuminators may be higher than the remaining number of illuminators in inventory, resulting in possible customer allocations or loss of sales.
Until such time as we obtain wide-spread approval for the new LED-based illuminator, if ever, the demand for illuminators may be higher than the remaining number of illuminators in inventory, resulting in possible customer allocations or loss of sales.
Weakness and/or instability in worldwide oil demand and/or prices, civil, political and economic disturbances and any potential spillover effect may have a negative impact on markets that we service. Moreover, the new Trump administration has recently imposed tariffs on certain imports, and Canada, China and other countries have responded with retaliatory tariffs on certain U.S. exports.
Weakness and/or instability in worldwide oil demand and/or prices, civil, political and economic disturbances and any potential spillover effect may have a negative impact on markets that we service. Moreover, the Trump administration has imposed tariffs on imports, and other countries have responded with retaliatory tariffs on certain U.S. exports.
Under current law, U.S. federal NOL carryforwards incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOL carryforwards in a taxable year is limited to 80% of taxable income in such year.
U.S. federal NOL carryforwards incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOL carryforwards in a taxable year is limited to 80% of taxable income in such year.
Our inability to efficiently and timely convert the existing illuminators in the field to the new illuminator, if approved, could negatively impact our ability to maintain the existing installed base.
Our inability to efficiently and timely convert the existing illuminators in the field to the new illuminator, could negatively impact our ability to maintain the existing installed base.
While we successfully completed the European Phase 3 acute anemia clinical trial and the European Phase 3 chronic anemia clinical trial, we cannot assure you that the adverse events observed in the terminated 2003 Phase 3 clinical trials of our earlier red blood cell system will not be observed in current and potential future clinical trials using our modified process.
While we successfully completed the European Phase 3 acute anemia clinical trial and the European Phase 3 chronic anemia clinical trial, we cannot provide assurance that the adverse events observed in the terminated 2003 Phase 3 clinical trials of our earlier red blood cell system will not be observed in current and potential future clinical trials using our modified process.
Conversely, we may also sell the disposable kits directly to blood centers for the manufacture of IFC for their own account or for hospitals with whom they already have contracts in place. As a result, we may be directly competing with these blood centers for the sale of IFC.
As such, we have begun to sell the disposable kits directly to blood centers for the manufacture of IFC for their own account or for hospitals with whom they already have contracts in place. As a result, we may be directly competing with these blood centers for the sale of IFC.
Unless we prepay the principal amount due or meet the requirements for and choose to extend the interest only period of the Term Loan we will be required to make principal payments beginning in April 2026 until March 1, 2028 if not repaid sooner.
Unless we prepay the principal amount due or choose to extend the interest only period of the Term Loan we will be required to make principal payments beginning in April 2026 until March 1, 2028 if not repaid sooner.
Until the American Red Cross can produce IFC for their own accounts, they will be dependent on us or other blood centers to supply IFC for sale to their accounts and our ability to source and produce sufficient IFC for the American Red Cross is limited.
Until the American Red Cross can produce IFC for their own accounts, they will be dependent on us or other blood centers to supply IFC for sale to their accounts and our ability to source and produce sufficient IFC for the American Red Cross is limited and may not be cost effective.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThe board of directors also has access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation. Item 3. Legal Proceedings None. Item 4. Mine Saf ety Disclosures Not applicable. 60 PART II
Biggest changeThe board of directors also has access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation. Item 3. Legal Proceedings None.
Our information security function identifies and assesses risks from cybersecurity threats by monitoring and evaluating our threat environment using various methods and resources including, for example automated tools, internal and external audits, external intelligence feeds and third-party threat assessments; conducting scans of the threat environment, threat assessments for internal and external risk and vulnerability assessments to identify vulnerabilities; evaluating our and our industry’s risk profile and threats reported to us; subscribing to reports and services that identify cybersecurity threats; analyzing reports of threat and threat actors and coordinating with law enforcement concerning threats; and internal tabletop incident response exercises.
Our information security function identifies and assesses risks 60 from cybersecurity threats by monitoring and evaluating our threat environment using various methods and resources including, for example automated tools, internal and external audits, external intelligence feeds and third-party threat assessments; conducting scans of the threat environment, threat assessments for internal and external risk and vulnerability assessments to identify vulnerabilities; evaluating our and our industry’s risk profile and threats reported to us; subscribing to reports and services that identify cybersecurity threats; analyzing reports of threat and threat actors and coordinating with law enforcement concerning threats; and internal tabletop incident response exercises.
Our cybersecurity incident response plan is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including Senior Director, IT & Facilities, Chief Legal Officer, Chief Financial Officer, Chief Executive Officer and others. Those individuals work with our incident response team to help us mitigate and remediate cybersecurity incidents of which 59 they are notified.
Our cybersecurity incident response plan is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including Senior Director, IT & Facilities, Chief Legal Officer, Chief Financial Officer, Chief Executive Officer and others. Those individuals work with our incident response team to help us mitigate and remediate cybersecurity incidents of which they are notified.
We use third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats, including for example professional service firms, threat intelligence service providers, cybersecurity software providers, managed cybersecurity service providers, penetration testing firms and forensic investigators.
We use third-party service providers to assist us from time to time in our effort to identify, assess, and manage material risks from cybersecurity threats, including for example professional service firms, threat intelligence service providers, cybersecurity software providers, managed cybersecurity service providers, penetration testing firms and forensic investigators.
Our Senior Director, IT & Facilities has over 26 years of experience in systems engineering, network design and security and is a Certified Information Systems Security Professional, or CISSP. Our Senior Manager, IT Infrastructure and Operations has over 24 years of experience in network administration, security administration and incident response and remediation.
Our Senior Director, IT & Facilities has over 27 years of experience in systems engineering, network design and security and is a Certified Information Systems Security Professional, or CISSP. Our Senior Manager, IT Infrastructure and Operations has over 25 years of experience in network administration, security administration and incident response and remediation.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see our risk factors under “Item 1A— Risk Factors ” in Part I of this Annual Report on Form 10-K, including the risk factor captioned, “ Significant disruptions of information technology systems or actual or alleged breaches of data security could adversely affect our business .” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.
For a description of the risks from cybersecurity threats that may materially affect us and how they may do so, see our risk factors under “Item 1A— Risk Factors ” in Part I of this Annual Report on Form 10-K, including the risk factor captioned, “D isruptions or other compromises of information technology systems or actual or perceived breaches of data security could adversely affect our business .” Governance Our board of directors addresses our cybersecurity risk management as part of its general oversight function.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeOf the 84,631 square feet, we sublease 14,908 square feet to a subtenant under a three-year lease ending March 31, 2025 and ceased using approximately 15,000 square feet of rentable area of corporate office building in the third quarter of 2023. We are currently marketing our vacant space and subleased space for lease after March 31, 2025.
Biggest changeOf the 84,631 square feet, we ceased using approximately 15,000 square feet of rentable area of corporate office building in the third quarter of 2023. We are currently marketing our vacant space, though there continues to be more supply than demand for office space in the San Francisco Bay Area.
We also lease an office facility 58 in Amersfoort, the Netherlands, which is used for selling and administrative functions. We believe that our current and future facilities will be adequate for the foreseeable future.
We also lease an office facility in Amersfoort, the Netherlands, which is used for selling and administrative functions. We believe that our current and future facilities will be adequate for the foreseeable future.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeComparison of 5-year Cumulative Total Return on Investment December 31, 2019 2020 2021 2022 2023 2024 Cerus Corporation $ 100.00 $ 163.98 $ 161.37 $ 86.49 $ 51.18 $ 36.49 Nasdaq US Benchmark Medical Supplies TR 100.00 125.26 151.98 99.65 105.43 95.87 Nasdaq 100.00 135.23 194.24 235.78 226.24 291.03 (1) The graph and the other information furnished in this section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by references to any filing of Cerus Corporation under the Securities Act of 1933, as amended or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in such filing.
Biggest changeComparison of 5-year Cumulative Total Return on Investment December 31, 2020 2021 2022 2023 2024 2025 Cerus Corporation $ 100.00 $ 98.41 $ 52.75 $ 31.21 $ 22.25 $ 29.77 Nasdaq US Benchmark Medical Supplies TR 100.00 121.33 79.56 84.17 76.54 68.69 Nasdaq 100.00 143.64 174.36 167.30 215.22 259.03 (1) The graph and the other information furnished in this section is not “soliciting material,” is not deemed “filed” with the SEC and is not to be incorporated by references to any filing of Cerus Corporation under the Securities Act of 1933, as amended or the Exchange Act, whether made before or after the date hereof and irrespective of any general incorporation language in such filing.
Stock Performance Graph (1) The following graph shows the total stockholder return of an investment of $100 in cash (and the reinvestment of any dividends thereafter) on December 31, 2019, and tracked the performance through December 31, 2024, for (i) our common stock, (ii) the US Benchmark Medical Suppliers TR, and (iii) the Nasdaq Stock Market (United States) Index.
Stock Performance Graph (1) The following graph shows the total stockholder return of an investment of $100 in cash (and the reinvestment of any dividends thereafter) on December 31, 2020, and tracked the performance through December 31, 2025, for (i) our common stock, (ii) the US Benchmark Medical Suppliers TR, and (iii) the Nasdaq Stock Market (United States) Index.
Item 5. Market for Registrant’s Common Equity, Related Sto ckholder Matters and Issuer Purchases of Equity Securities Our common stock is traded on the Nasdaq Global Market under the symbol “CERS”. On February 6, 2025, we had 115 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Sto ckholder Matters and Issuer Purchases of Equity Securities Our common stock is traded on the Nasdaq Global Market under the symbol “CERS”. On February 5, 2026, we had 113 holders of record of our common stock.

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Biggest changeRestructuring In June 2023, we began implementing a restructuring plan to pursue greater efficiency and to realign our business and strategic priorities, which included a reduction in force of our employee base during the second quarter of 2023.
Biggest changeYear Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Selling, general and administrative $ 80,914 $ 75,891 $ 75,516 7 % 0 % Selling, general, and administrative expenses increased during the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily driven by increased workforce costs, partially offset by the Employee Retention Credit refund received in 2025. 70 Restructuring In June 2023, we began implementing a restructuring plan to pursue greater efficiency and to realign our business and strategic priorities, which included a reduction in force of our employee base during the second quarter of 2023.
The six-year agreement with BARDA includes a base period, or the 2024 Base Period, with committed funding of up to $32.1 million, and subsequent option periods, or 2024 Option Periods, that, if exercised by BARDA and completed, would bring the total funding opportunity of $188.4 million as of September 30, 2024.
The six-year agreement with BARDA includes a base period, or the 2024 Base Period, with committed funding of up to $32.1 million, and subsequent option periods, or 2024 Option Periods, that, if exercised by BARDA and completed, would bring the total funding opportunity to $188.4 million as of September 30, 2024.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for CE Certificates of Conformity in the EU, if costs are higher than anticipated or we encounter further delays.
In addition, we may need to obtain additional funds to complete development activities for the red blood cell system necessary for CE Certificates of Conformity in the EU, if costs are higher than anticipated or we encounter further delays.
We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our government contracts, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.
We may need to obtain additional funding to conduct additional randomized controlled clinical trials for existing or new products, particularly if we are unable to access any additional portions of the funding contemplated by our government contracts, and we may choose to defer such activities until we can obtain sufficient additional funding or, at such time, our existing operations provide sufficient cash flow to conduct these trials.
Capital Requirements 70 Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments associated with developing and commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. commercialization of our platelet, plasma systems and IFC, costs to develop different configurations of existing product candidates and products, costs associated with the development of new products, including our illuminator, costs associated with planning, enrolling and completing ongoing clinical and non-clinical studies, including the post-approval studies or registry studies we are and may be required to conduct in connection with the approvals of the platelet system, costs associated with pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs associated with planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., costs associated with performing the agreed-upon activities under our government agreements, costs related to legal compliance, and costs related to creating, maintaining and defending our intellectual property.
Capital Requirements Our near-term capital requirements are dependent on various factors, including operating costs and working capital investments associated with developing and commercializing the INTERCEPT Blood System, including in connection with the continuing U.S. 72 commercialization of our platelet, plasma systems and IFC, costs to develop different configurations of existing product candidates and products, costs associated with the development of new products, including our illuminator, costs associated with planning, enrolling and completing ongoing clinical and non-clinical studies, including the post-approval studies or registry studies we are and may be required to conduct in connection with the approvals of the platelet system, costs associated with pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, costs associated with planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., costs associated with performing the agreed-upon activities under our government agreements, costs related to legal compliance, and costs related to creating, maintaining and defending our intellectual property.
We continue to believe that we will need to conduct and complete, and generate acceptable data from an additional Phase 3 clinical trial in chronic anemia patients in the U.S., in vitro studies, and other necessary activities before the FDA will consider our red blood cell system for potential approval.
We continue to believe that we will need to conduct, complete and generate acceptable data from an additional Phase 3 clinical trial in chronic anemia patients in the U.S., in vitro studies, and other necessary activities before the FDA will consider our red blood cell system for potential 64 approval.
We have borrowed and may in the future borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
We have borrowed and may 65 in the future borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates, financial performance covenants and repayment provisions that reduce cash resources and limit future access to capital markets.
Our commercial efforts outside the U.S. are focused on increasing market adoption with our existing customer relationships and building demand in new geographies. Generally, we enter into customer agreements for a specified term and varying options or extensions beyond the initial term.
Our commercial efforts outside the U.S. are focused on increasing market adoption with our existing customer relationships and building demand in new geographies. 66 Generally, we enter into customer agreements for a specified term and varying options or extensions beyond the initial term.
We could be responsible for cost sharing of up to $60.1 million which we would satisfy by agreeing to utilize lower fringe, overhead, and G&A rates for select options than we are otherwise allowed to use as supported by audited indirect cost submissions.
We could be responsible for cost sharing of up to $60.1 million which we would satisfy by agreeing to utilize lower fringe, overhead, and G&A rates for select 67 options than we are otherwise allowed to use as supported by audited indirect cost submissions.
Accordingly, we may never achieve a profitable level of operations in the future. 64 In addition to the anticipated product revenues from sales of our platelet and plasma systems and sales of IFC, we anticipate that we will continue to recognize revenue from our government contracts.
Accordingly, we may never achieve a profitable level of operations in the future. In addition to the anticipated product revenues from sales of our platelet and plasma systems and sales of IFC, we anticipate that we will continue to recognize revenue from our government contracts.
A summary of our restructuring charges is as follows (in thousands): Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Restructuring $ — $ 3,728 $ — N/A N/A See Note 7, Restructuring to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and Financial Statement Schedules” of this Annual Report on Form 10-K for further information regarding the restructuring charges related to one-time termination benefits.
A summary of our restructuring charges is as follows (in thousands): Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Restructuring $ — $ — $ 3,728 N/A N/A See Note 7, Restructuring to our audited consolidated financial statements included in Part IV, Item 15, “Exhibits and Financial Statement Schedules” of this Annual Report on Form 10-K for further information regarding the restructuring charges related to one-time termination benefits.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or qualify for and exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital beyond the next 12 months.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital in and beyond the next 12 months.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or qualify for and exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital.
In addition, unless we restructure our credit agreements prior to April 1, 2026, or exercise our option to delay amortization to April 1, 2027, the principal amounts outstanding under our Term Loan Credit Agreement will begin amortizing on April 1, 2026 and will require us to pay amounts as they come due in cash, which would negatively impact our available working capital.
Accordingly, substantially all of our U.S. deferred tax assets continue to be subject to a valuation allowance as of December 31, 2024. Liquidity and Capital Resources In recent years, our sources of capital have primarily consisted of public issuance of common stock, debt arrangements and, to a lesser extent, cash from product sales and reimbursements under our government agreements.
Accordingly, substantially all of our U.S. deferred tax assets continue to be subject to a valuation allowance as of December 31, 2025. Liquidity and Capital Resources In recent years, our sources of capital have primarily consisted of public issuance of common stock, debt arrangements and, to a lesser extent, cash from product sales and reimbursements under our government agreements.
The standardized rates are significantly lower than our current audited indirect rates. While our contracts with BARDA are not currently impacted by these orders, should the U.S. Federal Government impose similar restrictions, we would have to absorb many of our indirect costs which would adversely affect our operating results.
The standardized rates are significantly lower than our current audited indirect rates. While our contracts with BARDA are not currently impacted by these standardized indirect rates, should the U.S. Federal Government impose similar rate restrictions, we would have to absorb many of our indirect costs which would adversely affect our operating results.
Furthermore, our vendors and suppliers may raise prices in an inflationary environment, including as a result of new tariffs imposed by the new Trump administration and retaliatory tariffs imposed by China and other countries, costs to transport our products may increase and access to timely shipping may be limited.
Furthermore, our vendors and suppliers may raise prices in an inflationary environment, including as a result of tariffs imposed by the Trump administration and retaliatory tariffs imposed by China and other countries. Additionally, costs to transport our products may increase and access to timely shipping may be limited.
Changes in our gross margin on product sales are affected by various factors, including prices of products sold, the volume of product manufactured, pricing with suppliers, the timing of inventory purchases related to the underlying exchange rate of the Euro relative to the U.S. dollar, manufacturing and supply chain costs, including transportation costs, the mix of product sold, the mix of customers to which products are sold, and the reserves for excess and obsolete inventory.
Changes in our gross margin on product sales are affected by various factors, including 69 prices of products sold, the volume of product manufactured, pricing with suppliers, the timing of inventory purchases related to the underlying exchange rate of the Euro relative to the U.S. dollar, manufacturing and supply chain costs, including transportation costs, import tariffs, the mix of product sold, the mix of customers to which products are sold, and the reserves for excess and obsolete inventory.
Due to our history of cumulative operating losses, management has concluded that, after considering all of the available objective evidence, it is not likely that all our net deferred tax assets as of December 31, 2024, will be realized.
Due to our history of cumulative operating losses, management has concluded that, after considering all of the available objective evidence, it is not likely that all our net deferred tax assets as of December 31, 2025, will be realized.
Operating results for the year ended December 31, 2024, are not necessarily indicative of results that may occur in future periods. This discussion contains forward-looking statements that involve risks and uncertainties.
Operating results for the year ended December 31, 2025, are not necessarily indicative of results that may occur in future periods. This discussion contains forward-looking statements that involve risks and uncertainties.
In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.
In addition, we may opportunistically seek access to the equity capital markets to support our development efforts and operations. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution.
Department of Defense, or DoD, for the development of pathogen reduced, lyophilized cryoprecipitate to treat bleeding due to trauma. In May 2023, we entered into an amendment to the agreement with the DoD to extend the agreement to February 2027 and increased the total contract value from $9.1 million to $17.8 million.
Department of Defense, or DoD, for the development of pathogen reduced, lyophilized cryoprecipitate (“Lyo-Cryo”) to treat bleeding due to trauma. In May 2023, we entered into an amendment to extend the agreement to February 2027 and increased the total contract value from $9.1 million to $17.8 million.
We expect product revenue for INTERCEPT disposable kits to increase in future periods driven by growth in our platelet business due in part to increased market acceptance of the INTERCEPT Blood System and adoption of the INTERCEPT Blood System in geographies where commercialization efforts are underway.
We expect product revenue for INTERCEPT disposable kits to increase in future periods driven by growth in our platelet business and from sales of our IFC product due in part to increased market acceptance of the INTERCEPT Blood System and adoption of the INTERCEPT Blood System in geographies where commercialization efforts are underway.
Specifically, monetary policies of many countries, as well as recent bank failures, have significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. As a result of stimulus programs and global events over the past few years, the U.S. and many countries are currently experiencing an inflationary environment.
Specifically, monetary policies of many countries, as well as recent bank failures, have significantly disrupted global financial markets, and may limit our ability to access capital, which could in the future negatively affect our liquidity. As a result of stimulus programs and global events over the past few years, the U.S. and many countries experienced an inflationary environment.
We maintain portfolio liquidity by ensuring that the securities have active secondary or resale markets. We did not record any credit losses during the years ended December 31, 2024, 2023 and 2022. Adverse global economic conditions have had, and may continue to have, a negative impact on the market values of potential investments. 73
We maintain portfolio liquidity by ensuring that the securities have active secondary or resale markets. We did not record any credit losses during the years ended December 31, 2025, 2024 and 2023. Adverse global economic conditions have had, and may continue to have, a negative impact on the market values of potential investments. 75
Comparability This Management’s Discussion and Analysis of Financial Condition and Results of Operations generally discusses December 31, 2024 and December 31, 2023 items and year-to-year comparisons between 2024 and 2023, respectively.
Comparability This Management’s Discussion and Analysis of Financial Condition and Results of Operations generally discusses December 31, 2025 and December 31, 2024 items and year-to-year comparisons between 2025 and 2024, respectively.
Item 6. R e served It em 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 61 This discussion and analysis should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in this Annual Report on Form 10-K for the year ended December 31, 2024.
Item 6. R e served 63 It em 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations This discussion and analysis should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in this Annual Report on Form 10-K for the year ended December 31, 2025.
We did not have any off-balance sheet arrangements as of December 31, 2024. 72 Financial Instruments Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return on the investment portfolio to assist us in funding our operations.
We did not have any off-balance sheet arrangements as of December 31, 2025. 74 Financial Instruments Our investment policy is to manage our marketable securities portfolio to preserve principal and liquidity while maximizing the return on the investment portfolio to assist us in funding our operations.
Due to the inherent uncertainties and risks associated with developing biomedical products, including, but not limited to, intense and changing government regulation, the impact of macroeconomic developments, including escalating trade tensions and the ongoing conflict between Ukraine and Russia, the uncertainty of future preclinical studies and clinical trial results and the uncertainty associated with manufacturing, it is not possible to reasonably estimate the costs to complete these research and development projects.
Due to the inherent uncertainties and risks associated with developing biomedical products, including, but not limited to, intense and changing government regulation, the impact of macroeconomic developments, including escalating trade tensions and existing and potential new or increased tariffs and the ongoing conflict between Ukraine and Russia, the uncertainty of future preclinical studies and clinical trial results and the uncertainty associated with manufacturing, it is not possible to reasonably estimate the costs to complete these research and development projects.
We expect cost of product revenue for INTERCEPT disposable kits to increase in future periods as our product revenue grows. 67 Our gross margin on product sales was 55% during both the years ended December 31, 2024 and December 31, 2023.
We expect cost of product revenue for INTERCEPT disposable kits to increase in future periods as our product revenue grows. Our gross margin on product sales was approximately 55% during both the years ended December 31, 2025 and December 31, 2024.
Should interest rates increase, the rates that we are obligated to pay under our credit agreements would increase, leading to higher interest expense. In addition, we expect to continue to opportunistically seek access to the equity capital markets to support our development efforts and operations, including through the Controlled Equity Offering SM Sales Agreement, as mended, or the Sales Agreement.
Should interest rates increase, the rates that we are obligated to pay under our credit agreements would increase, leading to higher interest expense. In addition, we may opportunistically seek access to the equity capital markets to support our development efforts and operations, including through the Controlled Equity Offering SM Sales Agreement, as amended, or the Sales Agreement.
Discussions of 2022 items and year-to-year comparisons between 2023 and 2022 that are not included in this Annual Report on Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 5, 2024.
Discussions of 2023 items and year-to-year comparisons between 2024 and 2023 that are not included in this Annual Report on Form 10-K can be found in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part II Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on February 26, 2025.
We understand that we will be required to obtain new PMAs for our INTERCEPT Blood System for Platelets and for Plasma with our new LED-based illuminator. We are currently working with the FDA to understand the data requirements for those PMAs.
We understand that we will be required to obtain new PMAs and certain in-country approvals for our INTERCEPT Blood System for Platelets and for Plasma with our new LED-based illuminator. We are currently working with the FDA to understand the data requirements for those PMAs.
We expect to incur additional research and development costs associated with inflationary pressures on labor and study costs, pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., any activities in support of any potential new MDR application for our red blood cell system in the EU, new product development and product enhancements, including potential new label claims, design efforts on our new illuminator, and costs associated with performing the activities under our government contracts.
We expect to incur additional research and development costs associated with inflationary pressures on labor and study costs, pursuing potential regulatory approvals in other geographies where we do not currently sell our platelet and plasma systems, pursuing potential regulatory approvals for the LED illuminator in territories where the platelet and plasma systems are approved, planning and conducting in vitro studies and clinical development of our red blood cell system in Europe and the U.S., any activities in support of the new MDR application for our red blood cell system in the EU, new product development and product enhancements, including potential new label claims, further design efforts on our new LED-based illuminator for the U.S. market and ongoing software development, and costs associated with performing the activities under our government contracts.
We also recently announced positive topline results from a Phase 3 clinical trial in the U.S., known as the ReCePI study, that was designed to evaluate the efficacy and safety of INTERCEPT-treated red blood cells in patients requiring transfusion for acute blood loss during surgery.
In addition, in the first quarter of 2024, we announced positive topline results from a Phase 3 clinical trial in the U.S., known as the ReCePI study, that was designed to evaluate the efficacy and safety of INTERCEPT-treated red blood cells in patients requiring transfusion for acute blood loss during surgery.
In any event, for our planned modular PMA application, we will seek to introduce supplemental clinical data we 62 obtained from European clinical trials, though we cannot assure you that we will be able to demonstrate comparability or that the FDA will allow supplemental clinical European data.
In any event, for our planned modular PMA application, we will seek to introduce supplemental clinical data we obtained from European clinical trials, though we cannot provide assurance that we will be able to demonstrate comparability or that the FDA will allow supplemental clinical European data.
Provision for Income Taxes Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Provision for income taxes $ 205 $ 325 $ 488 (37 %) (33 %) The tax expenses were primarily a result of our Cerus Europe B.V. subsidiary’s activities.
Provision for Income Taxes Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Provision for income taxes $ 354 $ 205 $ 325 73 % (37 %) The tax expenses were primarily a result of our Cerus Europe B.V. subsidiary’s activities.
We believe the following critical accounting policies require us to make significant judgments and estimates used in the preparation of our financial statements: • Revenue —Revenue is recognized in accordance with Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers”, by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
Actual results may differ from those estimates under different assumptions or conditions. 68 We believe the following critical accounting policies require us to make significant judgments and estimates used in the preparation of our financial statements: Revenue —Revenue is recognized in accordance with Accounting Standards Codification Topic 606, “Revenue from Contracts with Customers”, by applying the following five steps: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from those estimates under different assumptions or conditions.
We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form our basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.
Should those amounts be inaccessible and should we be unable to self-fund the remaining initiatives, successful completion of the development of the red blood cell system may require us to obtain additional capital in order to obtain any regulatory approvals for and commercialize this product.
See the discussion under “Government contracts” below for more information. Should those amounts be inaccessible and should we be unable to self-fund the remaining initiatives, successful completion of the development of the red blood cell system may require us to obtain additional capital in order to obtain any regulatory approvals for and commercialize this product.
In October 2024, we announced that TÜV-SÜD’s, our Notified Body for the red blood cell system, in consultation with the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the red blood cell system, reviewed information regarding the medicinal product or active pharmaceutical ingredient of our MDR application and concluded that the data provided were insufficient to support the proposed classification of the impurity profile of the final product, necessitating the closure of our MDR application without an approval.
In October 2024, we announced that TÜV-SÜD, our Notified Body for the red blood cell system, in consultation with the Dutch Medicines Evaluation Board, or CBG, the Competent Authority for the red blood cell system, reviewed information regarding the medicinal product or active pharmaceutical ingredient of our MDR application and concluded that the data provided were insufficient to support the proposed classification of the impurity profile of the final product, necessitating the closure of our MDR application without successful completion of the conformity assessment and issuance of a CE Certificate of Conformity.
Should we be unable to manufacture INTERCEPT in sufficient quantities in a timely manner, or have adequate resources to assist customers with implementing the INTERCEPT Blood System, U.S. blood centers may be forced to use alternate options allowed by the guidance document, which could permanently impact our ability to convert those blood centers to INTERCEPT users.
Should we be unable to manufacture INTERCEPT in sufficient quantities in a timely manner, have adequate resources to assist customers with implementing the INTERCEPT Blood System, or need to increase prices to address existing and potential new or increased tariffs, U.S. blood centers may be forced to use alternate options allowed by the guidance document, which could permanently impact our ability to convert those blood centers to INTERCEPT users.
If we are unable to generate the required data for new PMAs, use of INTERCEPT in the United States will be limited to continued use with the existing illuminator, which we have a limited number of devices available and for which we have a limited time that we can continue to support and maintain.
If we are unable to generate the required data for new PMAs, use of INTERCEPT in the United States will be limited to continued use with the existing illuminator, of which we have a limited number of devices available.
Under the agreement, we are reimbursed and will recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses. The total contract value is $11.1 million.
Under this agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses.
Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Cost of product revenue $ 80,748 $ 69,967 $ 74,954 15 % (7 %) Cost of product revenue increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, consistent with the increase in product revenue for the same comparative periods.
Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Cost of product revenue $ 93,845 $ 80,748 $ 69,967 16 % 15 % Cost of product revenue increased during the year ended December 31, 2025, compared to the year ended December 31, 2024, approximately consistent with the increase in product revenue for the same comparative periods.
In this regard, our product development costs will be ongoing in connection with our failure to obtain approval of our MDR application and the potential submission of a new MDR application and would also increase if existing clinical data is insufficient for us to either submit or potentially obtain approval of any such new application.
In this regard, our product development costs will be ongoing in connection with our failure to obtain a CE Certificate of Conformity following successful completion of our MDR application and the submission of a new MDR application and would also increase if existing clinical data is insufficient for us to potentially obtain approval of such new application.
The initial agreement currently expires in September 2026 and the new agreement currently expires in September 2030. The ReCePI study was funded and the RedeS and other studies are being funded as part of our initial BARDA agreement and BARDA reimburses us for allowable direct contract costs, as such costs are incurred, and for allowable indirect costs under both agreements.
The ReCePI study was funded and the RedeS and other studies are being funded as part of our 2016 BARDA Agreement and BARDA reimburses us for allowable direct contract costs, as such costs are incurred, and for allowable indirect costs under both agreements.
Contract liabilities related to DoD of $0.5 million and $1.5 million as of December 31, 2024 and December 31, 2023, respectively, are excluded from working capital.
Contract assets related to DoD of $0.4 million and zero as of December 31, 2025 and December 31, 2024, respectively, are excluded from working capital. Contract liabilities related to DoD of zero and $0.5 million as of December 31, 2025 and December 31, 2024, respectively, are excluded from working capital.
Should interest rates increase, the rates that we are obligated to pay under our credit agreements would increase, leading to higher interest expense. Other Income (Expense), Net Other income, net increased during the year ended December 31, 2024, compared to the year ended December 31, 2023.
Should interest rates increase, the rates that we are obligated to pay under our credit agreements would increase, leading to higher interest expense. Other Income, Net Other income, net increased during the year ended December 31, 2025, compared to the year ended December 31, 2024 primarily due to the increase of interest income from our investments in marketable securities.
Results of Operations Years Ended December 31, 2024, 2023 and 2022 Revenue Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Product revenue $ 180,270 $ 156,367 $ 162,048 15 % (4 %) Government contract revenue 21,051 30,430 26,267 (31 %) 16 % Total revenue $ 201,321 $ 186,797 $ 188,315 8 % (1 %) Product revenue increased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to year-over-year sales volume increase of disposable platelet kit sales to U.S. customers.
Results of Operations Years Ended December 31, 2025, 2024 and 2023 Revenue Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Product revenue $ 206,133 $ 180,270 $ 156,367 14 % 15 % Government contract revenue 27,665 21,051 30,430 31 % (31 %) Total revenue $ 233,798 $ 201,321 $ 186,797 16 % 8 % Product revenue increased during the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to year-over-year sales volume increase of disposable platelet kit sales and IFC sales to U.S. customers.
Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Foreign exchange gain (loss) $ 370 $ (648 ) $ (690 ) (157 %) (6 %) Interest expense (8,877 ) (8,386 ) (5,831 ) 6 % 44 % Other income (expense), net 1,976 1,765 (1,735 ) 12 % (202 %) Total non-operating expense, net $ (6,531 ) $ (7,269 ) $ (8,256 ) (10 %) (12 %) Foreign Exchange Gain (Loss) We had foreign exchange gain during the year ended December 31, 2024, compared to foreign exchange loss during the year ended December 31, 2023.
Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Foreign exchange (loss) gain $ (1,275 ) $ 370 $ (648 ) (445 %) (157 %) Interest expense (8,343 ) (8,877 ) (8,386 ) (6 %) 6 % Other income, net 3,016 1,976 1,765 53 % 12 % Total non-operating expense, net $ (6,602 ) $ (6,531 ) $ (7,269 ) 1 % (10 %) Foreign Exchange (Loss) Gain We had foreign exchange loss during the year ended December 31, 2025, compared to foreign exchange gain during the year ended December 31, 2024.
As of December 31, 2024 and December 31, 2023, we had the following cash and cash equivalents, short-term investments and restricted cash (in thousands): 69 December 31, 2024 December 31, 2023 Cash and cash equivalents $ 20,266 $ 11,647 Short-term investments 60,186 54,205 Restricted cash 1,095 1,712 Total $ 81,547 $ 67,564 Cash is typically invested in highly liquid instruments of short-term investments with high-quality credit rated corporate and government agency fixed-income securities in accordance with our investment policy.
As of December 31, 2025 and December 31, 2024, we had the following cash and cash equivalents, short-term investments and restricted cash (in thousands): 71 December 31, 2025 December 31, 2024 Cash and cash equivalents $ 19,961 $ 20,266 Short-term investments 62,918 60,186 Restricted cash 639 1,095 Total $ 83,518 $ 81,547 Cash is typically invested in highly liquid instruments of short-term investments with high-quality credit rated corporate and government agency fixed-income securities in accordance with our investment policy.
While we expect to receive significant funding under our agreements with BARDA, our ability to obtain the funding we expect to receive under both agreements is subject to various risks and uncertainties, including with respect to BARDA’s ability to terminate the agreements for convenience at any time and our ability to achieve the required milestones under the agreements, including the completion of the RedeS study.
During the year ended December 31, 2025, we did not sell shares of our common stock under the Sales Agreement. 73 While we expect to receive significant funding under our agreements with BARDA, our ability to obtain the funding we expect to receive under both agreements is subject to various risks and uncertainties, including with respect to BARDA’s ability to terminate the agreements for convenience at any time and our ability to achieve the required milestones under the agreements, including the completion of the RedeS study.
As of September 30, 2024, BARDA has committed to reimburse certain of our expenses related to the clinical development of the red blood cell system during a base period, or the 2016 Base Period, and under exercised option periods, or 2016 Option Periods, in an aggregate amount of up to $185.5 million.
As of December 31, 2025, BARDA has committed to reimburse certain of our expenses related to the clinical development of the red blood cell system during a base period and under exercised option periods, in an aggregate amount of up to $185.5 million. BARDA will no longer exercise any unexercised options under the 2016 BARDA Agreement.
We do not know whether or not the FDA will have a similar perspective on the information regarding the medicinal product as CBG, or that we will be able to answer such questions satisfactorily, should they arise. We have agreements with Biomedical Advanced Research and Development Authority, or BARDA, part of the U.S.
We do not know whether or not the FDA will have a similar perspective on the information regarding the medicinal product as CBG, or that we will be able to answer such questions satisfactorily, should they arise.
Financing Activities Year Ended (in thousands) December 31, 2024 December 31, 2023 Net cash provided by financing activities $ 4,964 $ 10,673 The decrease in net cash provided by financing activities for the twelve months ended December 31, 2024 was primarily due to payments related to the Revolving Loan Credit Agreement during the twelve months ended December 31, 2024 compared to proceeds from the Revolving Loan Credit Agreement during the twelve months ended December 31, 2023.
Financing Activities Year Ended (in thousands) December 31, 2025 December 31, 2024 Net cash provided by financing activities $ 231 $ 4,964 The decrease in net cash provided by financing activities for the year ended December 31, 2025 was primarily due to proceeds from the Term Loan Credit Agreement during the year ended December 31, 2024.
See Note 14, Development and License Agreements , to our audited consolidated financial statements included in Part IV, Item 15, “ Exhibits and Financial Statement Schedules ” of this Annual Report on Form 10-K for further information regarding our agreements with BARDA. 65 In September 2020, we entered into a five-year agreement with the FDA for the development of next-generation compounds to optimize pathogen reduction treatment of whole blood to reduce the risk of transfusion-transmitted infections.
See Note 14, Development and License Agreements , to our audited consolidated financial statements included in Part IV, Item 15, “ Exhibits and Financial Statement Schedules ” of this Annual Report on Form 10-K for further information regarding our agreements with BARDA. In September 2024, we entered into the 2024 BARDA Agreement.
If we are unable to access all of the activities and associated reimbursement amounts for the remaining options available under our new BARDA agreement, we will need to fund the activities required to satisfy the requirements for PMA licensure in the U.S. See the discussion under “Government contracts” below for more information.
If we are unable to access all of the activities and associated reimbursement amounts for the remaining options available under our 2024 BARDA Agreement or if we are unable to add additional options and respective reimbursement amounts to fund further activities that may be required to meet licensure requirements, we will need to self-fund the activities required to satisfy the requirements for PMA licensure in the U.S.
To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies, grant licenses on terms that are not favorable to us, or issue equity that may be substantially dilutive to our stockholders. 63 As a result of economic conditions, general global economic uncertainty, political change, war, the effects of inflationary pressures, including those resulting from new tariffs and escalating trade tensions, and other factors including past and potential future U.S. bank failures, we do not know whether additional capital will be available when needed, or that, if available, whether we will be able to obtain additional capital on reasonable terms.
As a result of economic conditions, general global economic uncertainty, political change, war, the effects of inflationary pressures, including those resulting from tariffs and escalating trade tensions, and other factors including past and potential future U.S. bank failures, we do not know whether additional capital will be available when needed, or that, if available, whether we will be able to obtain additional capital on reasonable terms.
Margins were impacted by the mix of geographies into which products were sold, with higher U.S. kit sales over sales in other regions and, to a lesser extent product mix.
Margins were impacted by the mix of geographies into which products were sold, with higher U.S. kit sales over sales in other regions and, to a lesser extent product mix. Geographic mix and by extension foreign exchange rates along with the impact of enacted import tariffs had an adverse effect on our gross margins.
In addition, if we are unable to enroll a sufficient number of patients for the RedeS study to generate the data needed for licensure, we will need to reach agreement with the FDA on sufficiency of fewer patients, or a new pathway to generate sufficient data for the red blood cell system, including the potential for additional Phase 3 clinical trials beyond what we are currently contemplating.
In addition, if we are unable to generate the additional data needed for licensure, we will need to reach agreement with the FDA on a new pathway to generate sufficient data for the red blood cell system.
If the amount of consideration in a contract is variable, we estimate the amount of variable consideration that should be included in the transaction price. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration that we expect to receive in exchange for those products or services.
The contracts with customers can include various combinations of products, and to a much lesser extent, services. Product revenue is recognized upon transfer of control of promised products or services to customers in an amount that reflects the consideration that we expect to receive in exchange for those products or services.
Any of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above, could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and results of operations. 71 In March 2023, we entered into an amendment to our Sales Agreement under which we may issue and sell up to $96.8 million of our common stock through or to Cantor Fitzgerald & Co. or Stifel, Nicolaus & Company, Incorporated, as sales agent or principal.
In March 2023, we entered into an amendment to our Sales Agreement under which we may issue and sell up to $96.8 million of our common stock through or to Cantor Fitzgerald & Co. or Stifel, Nicolaus & Company, Incorporated, as sales agent or principal.
As of December 31, 2024 and December 31, 2023, we had the following indebtedness (in thousands): December 31, 2024 December 31, 2023 Debt – current $ 19,297 $ 20,000 Debt – non-current 64,862 59,796 Total $ 84,159 $ 79,796 Operating Activities Year Ended (in thousands) December 31, 2024 December 31, 2023 Net cash provided by (used in) operating activities $ 11,359 $ (43,168 ) We had net cash provided by operating activities for the twelve months ended December 31, 2024 compared to net cash used in operating activities during the same period in 2023.
As of December 31, 2025 and December 31, 2024, we had the following indebtedness (in thousands): December 31, 2025 December 31, 2024 Debt – current $ 43,343 $ 19,297 Debt – non-current 40,545 64,862 Total $ 83,888 $ 84,159 Operating Activities Year Ended (in thousands) December 31, 2025 December 31, 2024 Net cash provided by operating activities $ 4,837 $ 11,359 The decrease in net cash provided by operating activities for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily related to the increase in inventory related purchases partially offset by the reduction in our net loss and a net increase in cash related to the timing of cash collections and payments compared to the same period in 2024.
BARDA will no longer exercise any unexercised options under the 2016 BARDA Agreement. In September 2024, we entered into a new agreement with BARDA, or the 2024 BARDA Agreement. The 2024 BARDA Agreement builds on the 2016 BARDA Agreement and aims to further advance the development of the red blood cell system.
The 2024 BARDA Agreement builds on the 2016 BARDA Agreement and aims to further advance the development of the red blood cell system.
Cost of Product Revenue Our cost of product revenue consists of the cost of the INTERCEPT Blood System sold, provisions for obsolete, slow-moving and unsaleable product, certain order fulfillment costs, to the extent applicable and costs for idle facilities. Inventory is accounted for on a first-in, first-out basis.
We anticipate that government contract revenue will decrease in future periods due to the 2016 BARDA Agreement ending in September 2026. Cost of Product Revenue Our cost of product revenue consists of the cost of the INTERCEPT Blood System sold, provisions for obsolete, slow-moving and unsaleable product, and certain order fulfillment costs, to the extent applicable.
The change was primarily due to higher purchases of investments offset by higher proceeds from the maturity and sale of our investments during the twelve months ended December 31, 2024, compared to the same period in 2023.
Investing Activities Year Ended (in thousands) December 31, 2025 December 31, 2024 Net cash used in investing activities $ (6,165 ) $ (8,130 ) The decrease in net cash used in investing activities for the year ended December 31, 2025 compared to the year ended December 31, 2024 was primarily due to higher proceeds from the maturity and sale of our investments offset by increased investment in capital expenditures compared to the same period in 2024.
Freight costs charged to customers are recorded as a component of product revenue.
Freight costs charged to customers are recorded as a component of product revenue. Taxes invoiced to our customers and remitted to governments are recorded on a net basis, which excludes such tax from product revenue.
In collaboration with TÜV-SÜD, we are assessing strategies for a potential new MDR application, including data to address the classification questions raised by CBG.
In collaboration with TÜV-SÜD, we developed a plan for resubmission of our application and identified a new Competent Authority. We revised our MDR application to address the questions raised by CBG and submitted a new MDR application for the red blood cell system to TÜV-SÜD.
While we previously anticipated that the completion of the RedeS clinical trial and the planned final PMA module submission would occur in the second half of 2026, clinical trial enrollment at additional RedeS clinical trial sites recently commenced later than previously anticipated and we are continuing to assess the potential impact of that delay on the anticipated timing for completion of the RedeS clinical trial and the planned final PMA module submission.
While we previously anticipated that the completion of the RedeS clinical trial and the planned final PMA module submission would occur in the second half of 2026, we anticipate that additional clinical trial data will be required to supplement our two Phase 3 clinical trials, ReCePI and RedeS.
Government contract revenue decreased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the completion of the ReCePI study in the first quarter of 2024.
Government contract revenue increased during the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to an increase in revenue from BARDA in 2025 relative to the same period in the prior year. The increase in revenue from BARDA is primarily due to the 2024 BARDA Agreement executed in the fourth quarter of 2024.
Working Capital (in thousands) December 31, 2024 December 31, 2023 Working capital $ 88,890 $ 78,392 Working capital increased as of December 31, 2024, compared to December 31, 2023, primarily due to proceeds from increased product sales, collections, and increase in short-term investments and decrease in our accounts payable as a result of the timing of payments to our vendors.
Working Capital (in thousands) December 31, 2025 December 31, 2024 Working capital $ 73,214 $ 88,890 Working capital decreased as of December 31, 2025, compared to December 31, 2024, primarily due to net increases in accounts payable and accrued liabilities as a result of the timing of payments to our vendors offset by an increase in inventory and due to the reclassification of $24.3 million of long-term debt to short-term due to our amended Term Loan Credit agreement.
These were primarily due to foreign exchange variations between the Euro and the U.S. dollar.
These were primarily due to foreign exchange variations between the Euro and the U.S. dollar. Interest Expense Interest expense decreased during the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily due to the decrease in interest rates on our Term Loan.
The 2016 BARDA Agreement provides for the reimbursement of certain amounts incurred by us in connection with our satisfaction of certain contractual milestones. Under the 2016 BARDA Agreement, we are reimbursed and recognize revenue as qualified direct contract costs are incurred plus capped indirect costs, which permit partial recovery of fringe benefits, overhead and general and administrative expenses.
The 2016 BARDA Agreement provides for the reimbursement of certain amounts incurred by us in connection with our satisfaction of certain contractual milestones.
In addition, as a result of the failure to obtain approval of our MDR application, our product development costs will be ongoing.
In this regard, our product development costs will be ongoing in connection with our resubmission of our MDR application and, as discussed above, transferring the review of the API from SÚKL to ANSM.
Taxes invoiced to our customers and remitted to governments are recorded on a net basis, which excludes such tax from product revenue. • Government contract revenue —Revenue related to the cost reimbursement provisions under our government contract agreements is recognized as the allowable direct contract costs plus allowable indirect costs are incurred based on approved provisional indirect billing rates, which permit recovery of fringe benefits, overhead and general and administrative expenses.
Under the agreement, we were reimbursed and would recognize revenue as qualified direct contract costs were incurred plus allowable indirect costs, based on approved provisional indirect billing rates, which permitted recovery of fringe benefits, overhead and general and administrative expenses. The agreement, which ended in September 2025, had a total contract value of $11.1 million.
Year Ended December 31, % Change (in thousands, except percentages) 2024 2023 2022 2024 to 2023 2023 to 2022 Research and development $ 58,907 $ 67,639 $ 64,107 (13 %) 6 % Research and development expenses decreased during the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily driven by decreased headcount due to our reduction in force implemented in the second quarter of 2023 and the completion of the ReCePI study in the first quarter of 2024.
Year Ended December 31, % Change (in thousands, except percentages) 2025 2024 2023 2025 to 2024 2024 to 2023 Research and development $ 67,720 $ 58,907 $ 67,639 15 % (13 %) Research and development expenses increased during the year ended December 31, 2025, compared to the year ended December 31, 2024, primarily driven by costs related to red blood cells for work performed under our BARDA agreements, workforce related costs, and costs to support our new LED-based illuminator, partially offset by the Employee Retention Credit refund received in 2025.
Removed
We cannot predict with certainty when, if ever, we will be able to satisfactorily address CBG’s conclusions and as such cannot predict if or when we will submit a new MDR application for the red blood cell system and, if submitted, when a decision concerning certification would occur.
Added
In July 2025, we announced that TÜV-SÜD completed their clinical assessment of our new MDR application and transferred information regarding the active substances, or API, to the identified competent authority, the State Institute for Drug Control, or SÚKL.
Removed
We anticipate initiating a modular PMA application to the FDA upon the anticipated completion of the RedeS clinical trial.
Added
After discussions with TÜV-SÜD, we decided to transfer the review of the API from SÚKL to the French National Agency for Medicines and Health Products Safety, or ANSM. We cannot predict if or when a decision concerning certification would occur. In addition, as a result of the resubmission of our MDR application, our product development costs will be ongoing.

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Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeThese forward-looking statements may include, but are not limited to, statements about: • the impact of macroeconomic developments, including escalating trade tensions and the ongoing conflict between Ukraine and Russia on our business and operations as well as the business or operations of our customers, manufacturers, research partners, and other third parties with whom we conduct business; • future sales of and anticipated demand for, and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT™ Blood System, including our ability to comply with applicable United States, or U.S., and foreign laws, regulations and regulatory requirements; • our ability to successfully complete the development of, receive regulatory approvals for and commercialize the red blood cell system; • our strategy and the potential therapeutic applications for the INTERCEPT Blood System; • our ability to manage the growth of our business and attendant cost increases, including in connection with the commercialization of the INTERCEPT Blood System in the U.S., as well as our ability to manage the risks attendant to our international operations; • the timing or likelihood of regulatory submissions and approvals and other regulatory actions or interactions, including whether we will submit a new application for conformity assessment to obtain a CE Certificate of Conformity to affix the CE Mark to the red blood cell system, whether data exist to support a classification of compounds for approval, whether existing clinical data would be sufficient to either submit or potentially obtain approval of any such new application, and whether our planned modular premarket approval, or PMA, application for the red blood cell system will be submitted to the U.S.
Biggest changeThese forward-looking statements may include, but are not limited to, statements about: • the impact of macroeconomic developments, including escalating trade tensions and existing tariffs and potential new or increased tariffs and the ongoing conflict between Ukraine and Russia as well as the risk of a global conflict on our business and operations as well as the business or operations of our customers, manufacturers, research partners, and other third parties with whom we conduct business; • future sales of and anticipated demand for, and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT™ Blood System, including our ability to comply with applicable United States, or U.S., and foreign laws, regulations and regulatory requirements; • our ability to successfully complete the development of, receive regulatory approvals for and commercialize the red blood cell system; • our strategy and the potential therapeutic applications for the INTERCEPT Blood System; • our ability to manage the growth of our business and attendant cost increases, including in connection with the commercialization of the INTERCEPT Blood System in the U.S., as well as our ability to manage the risks attendant to our international operations; • the timing or likelihood of regulatory submissions and approvals and other regulatory actions or interactions, including whether existing clinical data will be sufficient in order to obtain a CE Certificate of Conformity and affix a CE Mark to the red blood cell system and whether our planned modular premarket approval, or PMA, application for the red blood cell system will be submitted to the U.S.
Food and Drug Administration, or FDA, on the timeline we anticipate or at all; • our ability to obtain and maintain regulatory approvals of the INTERCEPT Blood System; • our ability to obtain adequate clinical and commercial supplies of the INTERCEPT Blood System from our sole source suppliers for a particular product or component they manufacture; • the initiation, scope, rate of progress, results and timing of our ongoing and proposed preclinical and clinical trials of the INTERCEPT Blood System; • the successful completion of our research, development and clinical programs and our ability to manage cost increases associated with preclinical and clinical development of the INTERCEPT Blood System; • the amount and availability of funding we may receive under our government contracts with the Biomedical Advanced Research and Development Authority, or BARDA, the U.S.
Food and Drug Administration, or FDA, on the timeline we anticipate or at all; • our ability to obtain and maintain regulatory approvals of the INTERCEPT Blood System; • our ability to obtain adequate clinical and commercial supplies of the INTERCEPT Blood System from our sole source suppliers for a particular product or component they manufacture; • the initiation, scope, rate of progress, results and timing of our ongoing and proposed preclinical and clinical trials of the INTERCEPT Blood System; • the successful completion of our research, development and clinical programs and our ability to manage cost increases associated with preclinical and clinical development of the INTERCEPT Blood System; • the amount and availability of funding we may receive under our government contracts with the Biomedical Advanced Research and Development Authority, or BARDA, and the U.S.
A failure to generate data in clinical trials to support expanded label claims or to support marketing approvals or certification for our product candidates could materially and adversely affect our business, financial condition, results of operations and growth prospects. • The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity. • Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive regulation by domestic authorities, foreign authorities and Notified Bodies. 4 • If we or our third-party suppliers fail to comply with the U.S.
A failure to generate data in clinical trials to support expanded label claims or to support marketing approvals or certification for our product candidates could materially and adversely affect our business, financial condition, results of operations and growth prospects. 4 • The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity. • Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive regulation by domestic authorities, foreign authorities and Notified Bodies. • If we or our third-party suppliers fail to comply with the U.S.
Certain important factors could cause actual results to differ materially from those discussed in such statements, including the rate of customer adoption in the U.S. and our ability to achieve market acceptance of our products in the U.S. and international markets, whether our preclinical and clinical data or data from commercial use will be considered sufficient by regulatory authorities or Notified Bodies to grant marketing approval or receive CE Certificates of Conformity for our products or for product extensions or additional claims for our products, our ability to obtain reimbursement approval for our products, changes in regulatory approval or certification requirements for our products, our ability to complete the development and testing of additional configurations or redesigns of our products, our need for additional financing and our ability to access funding under our agreements with BARDA, the DoD, and the FDA, the impacts of regulation of our products by domestic and foreign regulatory authorities, our limited experience in sales, marketing and regulatory support for the INTERCEPT Blood System, our reliance on Fresenius Kabi AG and other third parties to manufacture and supply certain components of the INTERCEPT Blood System, incompatibility of our platelet system with some commercial platelet collection methods, our need to complete our red blood cell system’s commercial design, more effective product offerings by, or clinical setbacks of, our competitors, product liability, our use of hazardous materials in the development of our products, business interruption due to earthquake, our expectation of continuing losses, protection of our intellectual property rights, volatility in our stock price, on-going compliance with the requirements of the Sarbanes-Oxley Act of 2002, adverse market and economic conditions, including those resulting from the effects of macroeconomic conditions, and other factors discussed below and under the caption “Risk Factors,” in Item 1A of this Annual Report on Form 10-K.
Certain important factors could cause actual results to differ materially from those discussed in such statements, including the rate of customer adoption in the U.S. and our ability to achieve market acceptance of our products in the U.S. and international markets, whether our preclinical and clinical data or data from commercial use will be considered sufficient by regulatory authorities or Notified Bodies to grant marketing approval or receive CE Certificates of Conformity for our products or for product extensions or additional claims for our products, our ability to obtain reimbursement approval for our products, changes in regulatory approval or certification requirements for our products, our ability to complete the development and testing of additional configurations or redesigns of our products, our need for additional financing and our ability to access funding under our agreements with BARDA and the DoD, the impacts of regulation of our products by domestic and foreign regulatory authorities, our limited experience in sales, marketing and regulatory support for the INTERCEPT Blood System, our reliance on Fresenius Kabi AG and other third parties to manufacture and supply certain components of the INTERCEPT Blood System, incompatibility of our platelet system with some commercial platelet collection methods, our need to complete our red blood cell system’s commercial design, more effective product offerings by, or clinical setbacks of, our competitors, product liability, our use of hazardous materials in the development of our products, business interruption due to earthquake, our expectation of continuing losses, protection of our intellectual property rights, volatility in our stock price, on-going compliance with the requirements of the Sarbanes-Oxley Act of 2002, adverse market and economic conditions, including those resulting from the effects of macroeconomic conditions, and other factors discussed below and under the caption “Risk Factors,” in Item 1A of this Annual Report on Form 10-K.
Food and Drug Administration’s, or FDA’s, or other regulatory authorities’ good manufacturing practice regulations, it could impair our ability to market our products in a cost-effective and timely manner. • If we modify our FDA-approved or CE Marked products, we may need to seek additional approvals or certification, which, if not granted, would prevent us from selling our modified products. • We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. • A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreements, and if BARDA were to eliminate, reduce or delay, or object to extensions for funding of our agreements, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding.
Food and Drug Administration’s, or FDA’s, or other regulatory authorities’ good manufacturing practice regulations, it could impair our ability to market our products in a cost-effective and timely manner. • If we modify our FDA-approved or CE Marked products, we may need to seek additional approvals or certification, which, if not granted, would prevent us from selling our modified products. • We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business. • A significant portion of the funding for the development of the red blood cell system has come and is expected to continue to come from our BARDA agreements, and if BARDA were to eliminate, reduce or delay, or object to additional activities or extensions for funding of our agreements, it would have a significant, negative impact on our government contract revenues and cash flows, and we may be forced to suspend or terminate our U.S. red blood cell development program or obtain alternative sources of funding.
Our ability to be paid by the DoD is predicated on our ability to achieve the stated milestones in the agreement and for the DoD to agree with the successful completion of each. • We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries. • Our manufacturing supply chain exposes us to significant risks. • We may continue to generate losses and never achieve a profitable level of operations. • If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate continued positive cash flows from our operations, we will need to curtail planned development or sales and commercialization activities. • We operate a complex global commercial organization, with limited experience in many countries.
Our ability to be paid by the DoD is predicated on our ability to achieve the stated milestones in the agreement and for the DoD to agree with the successful completion of each. • We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries. • Our manufacturing supply chain exposes us to significant risks. • We may continue to generate losses and never achieve a profitable level of operations. • We may not be able to achieve, or sustain, profitability. • If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate continued positive cash flows from our operations, we will need to curtail planned development or sales and commercialization activities. • We operate a complex global commercial organization, with limited experience in many countries.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 77 PART III Item 10. Directors, Executive Officers and Corporate Governance 78 Item 11. Executive Compensation 78 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 78 Item 13. Certain Relationships and Related Transactions, and Director Independence 79 Item 14.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 79 PART III Item 10. Directors, Executive Officers and Corporate Governance 80 Item 11. Executive Compensation 80 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 80 Item 13. Certain Relationships and Related Transactions, and Director Independence 81 Item 14.
Form 10-K Summary 85 SIGNATURES 114 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties.
Form 10-K Summary 87 SIGNATURES 118 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 61 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 74 Item 8. Financial Statements and Supplementary Data 74 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 74 Item 9A. Controls and Procedures 75 Item 9B. Other Information 77 Item 9C.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 64 Item 7A. Quantitative and Qualitative Disclosures About Market Risk 76 Item 8. Financial Statements and Supplementary Data 76 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 76 Item 9A. Controls and Procedures 77 Item 9B. Other Information 79 Item 9C.
We may be distracted by expansion into new geographies where we do not have experience and we may be unsuccessful in monetizing such opportunities for the benefit of our organization at large. • Adverse market and economic conditions may exacerbate certain risks affecting our business. • Risks associated with our operations outside of the United States could adversely affect our business. • We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others. • Our stock price is volatile and your investment may suffer a decline in value.
We may be distracted by expansion into new geographies where we do not have experience and we may be unsuccessful in monetizing such opportunities for the benefit of our organization at large. • Adverse market and economic conditions as well as tariffs and escalating international trade tensions may exacerbate certain risks affecting our business. • Risks associated with our operations outside of the United States could adversely affect our business. • We may not be able to protect our intellectual property or operate our business value. • Our stock price is volatile and your investment may suffer a decline in value.
Principal Accountant Fees and Services 79 PART IV Item 15. Exhibits and Financial Statement Schedules 80 Item 16.
Principal Accountant Fees and Services 81 PART IV Item 15. Exhibits and Financial Statement Schedules 82 Item 16.
As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize our products. • We have very limited experience selling directly to hospitals or expertise complying with regulations governing finished biologics, and our inability to successfully commercialize the INTERCEPT Blood System for cryoprecipitation in the U.S. would have a material adverse effect on our business, financial condition, results of operations and growth prospects. • If our competitors develop products superior to ours, market their products more effectively, or receive regulatory approval or certification before our products, our commercial opportunities could be reduced or be eliminated.
As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize our products. • An inability to successfully transition from a direct selling model to a kit model, as well as an inability to successfully commercialize the INTERCEPT Blood System for Cryoprecipitation in the U.S. would have a material adverse effect on our business, financial condition, results of operations and growth prospects. • If our competitors develop products superior to ours, market their products more effectively, or receive regulatory approval or certification before our products, our commercial opportunities could be reduced or be eliminated.
There can be no assurance that any of the events anticipated by 3 forward-looking statements will occur or, if any of them do occur, what impact they will have on our business, results of operations and financial condition.
Forward-looking statements reflect our current views with respect to future events, are based on assumptions, and are subject to risks and uncertainties. There can be no assurance that any of the events anticipated by forward-looking statements will occur or, if any of them do occur, what impact they will have on our business, results of operations and financial condition.
Department of Defense, or DoD, and the FDA; • our ability to transition distribution of the INTERCEPT Blood System from third parties to a direct sales model in certain international markets; • the ability of our products to inactivate the emerging viruses and other pathogens that we may target in the future; • our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; • our estimates regarding the sufficiency of our cash resources, our ability to continue as a going concern and our need for additional funding; and • our plans, objectives, expectations and intentions and any other statements that are not historical facts.
Department of Defense, or DoD, due to executive orders impacting government contract funding and personnel, previous and potential future U.S. government shutdown or otherwise; • our ability to transition distribution of the INTERCEPT Blood System from third parties to a direct sales model in certain international markets; • the ability of our products to inactivate the emerging viruses and other pathogens that we may target in the future; • our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; • our estimates regarding the sufficiency of our cash resources, our ability to continue as a going concern and our need for additional funding; and • our plans, objectives, expectations and intentions and any other statements that are not historical facts. 3 In some cases, you can identify forward-looking statements by terms such as “anticipate,” “will,” “believe,” “estimate,” “expect,” “plan,” “may,” “should,” “could,” “would,” “project,” “predict,” “potential,” and similar expressions intended to identify such forward-looking statements.
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In some cases, you can identify forward-looking statements by terms such as “anticipate,” “will,” “believe,” “estimate,” “expect,” “plan,” “may,” “should,” “could,” “would,” “project,” “predict,” “potential,” and similar expressions intended to identify such forward-looking statements. Forward-looking statements reflect our current views with respect to future events, are based on assumptions, and are subject to risks and uncertainties.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeItem 7A. Quantitative and Qualitat ive Disclosures about Market Risk Interest Rate Risk At December 31, 2024, we held cash, cash equivalents, short-term investments and investments in marketable equity securities of $80.5 million.
Biggest changeItem 7A. Quantitative and Qualitat ive Disclosures about Market Risk Interest Rate Risk At December 31, 2025, we held cash, cash equivalents, and short-term investments of $82.9 million.
Based on our indebtedness under the Term Loan Credit Agreement of $65.0 million and Revolving Loan Credit Agreement of $19.3 million as of December 31, 2024, and the interest rate on such borrowings then in effect, a hypothetical 100 basis point increase in interest rates could increase our net interest expense in 2024 by approximately $0.8 million subject to certain limitations in each agreement.
Based on our indebtedness under the Term Loan Credit Agreement of $65.0 million and Revolving Loan Credit Agreement of $19.0 million as of December 31, 2025, and the interest rate on such borrowings then in effect, a hypothetical 100 basis point increase in interest rates could increase our net interest expense in 2025 by approximately $0.8 million subject to certain limitations in each agreement.
The weighted average interest rate of our cash and cash equivalents at December 31, 2024, was 4.4%. Our exposure to market rate risk for changes in interest rates relates primarily to our money market instruments, corporate debt securities and the amounts borrowed pursuant to the Term Loan Credit Agreement and Revolving Loan Credit Agreement.
The weighted average interest rate of our cash and cash equivalents at December 31, 2025, was 4.2%. Our exposure to market rate risk for changes in interest rates relates primarily to our money market instruments, corporate debt securities and the amounts borrowed pursuant to the Term Loan Credit Agreement and Revolving Loan Credit Agreement.
An unfavorable 10% change in foreign currency exchange rates for our cash, accounts receivable, accounts payable and accrued liabilities that are denominated in foreign currencies at December 31, 2024, would have negatively impacted our annual financial results by $1.0 million.
An unfavorable 10% change in foreign currency exchange rates for our cash, accounts receivable, accounts payable and accrued liabilities that are denominated in foreign currencies at December 31, 2025, would have negatively impacted our annual financial results by $1.2 million.

Other CERS 10-K year-over-year comparisons