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

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Paragraph-level year-over-year comparison of HAEMONETICS 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.

+389 added−340 removedSource: 10-K (2025-05-21) vs 10-K (2024-05-20)

Top changes in HAEMONETICS CORP's 2025 10-K

389 paragraphs added · 340 removed · 265 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

77 edited+29 added−18 removed131 unchanged
Biggest changeRisk Factors in this report. • Our ability to achieve our long-term strategic and financial-improvement goals; • Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer; • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete; • Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S. regulatory agencies), reputational damage, declining sales or litigation; • Security breaches of our information technology systems or our products, which could impair our ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers’ patients; • The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of OpSens Inc. and Attune Medical, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected; • Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants; • Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events; • Our ability to obtain th e anticipated benefits of restructuring programs that we have or may undertake, including the Operational Excellence Program and portfolio rationalization initiatives; • The impact of enhanced requirements to obtain regulatory approval in the U.S. and around the world and the associated timing and cost of product approval; 16 Table of Contents • Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including FCPA, EU MDR/EU IVDR and similar laws in other jurisdictions, as well as U.S. and foreign export and import restrictions and tariffs; • The impact of changes in U.S. and international tax laws; • Our ability to meet our debt obligations and raise additional capital when desired on terms reasonably acceptable to us; • The potential impact of our convertible senior notes and related capped call transactions; • Geopolitical and economic conditions in China, Taiwan, Russia, Ukraine, the Middle East and other foreign jurisdictions where we do business; • Our ability to execute and realize anticipated benefits from our investments in emerging economies; • The potential effect of foreign currency fluctuations and interest rate fluctuations on our net sales, expenses and resulting margins; • Our ability to protect intellectual property and the outcome of patent litigation; • Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future; • Our ability to retain and attract key personnel; • Market conditions impacting our stock price and/or our share repurchase program, and the possibility that such share repurchase program may be delayed, suspended or discontinued; • Our ability to achieve against our corporate responsibility initiatives and meet evolving stakeholder expectations concerning corporate responsibility matters; and • The impact of actual or threatened public health crises.
Biggest changeRisk Factors in this report. • Our ability to achieve our long-term strategic and financial-improvement goals; • Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer; • Our ability to develop, manufacture and market new products and technologies successfully and in a timely manner and the ability of our competitors and other third parties to develop products or technologies that render our products or technologies noncompetitive or obsolete; • Product quality or safety concerns, leading to product recalls, withdrawals, regulatory action by the FDA (or similar non-U.S. regulatory agencies), reputational damage, declining sales or litigation; • Security breaches of our products or information technology systems, or those of our customers, suppliers or other business partners, which could impair our ability or our customers’ ability to conduct business or compromise sensitive information of the Company or its customers, suppliers and other business partners, or of customers’ patients; • The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, including the Company’s acquisitions of OpSens Inc. and Attune Medical, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected; • Pricing pressures resulting from trends toward healthcare cost containment, including the continued consolidation among healthcare providers and other market participants; • Disruptions to the continuity, availability and pricing of plastic and other raw materials, finished goods and components used in the manufacturing of our products (including those purchased from sole-source suppliers) and the related continuity of our manufacturing, sterilization, supply chain and distribution operations, including disruptions caused by natural disasters, extreme weather and other conditions caused by or related to climate change, labor strikes, terrorism acts, cyber incidents or other adverse events; • Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including our market and regional alignment and portfolio rationalization initiatives; • The impact of enhanced requirements to obtain regulatory approval in the U.S. and around the world and the associated timing and cost of product approval; 16 Table of Contents • Our ability to comply with established and developing U.S. and foreign legal and regulatory requirements, including the U.S.
In the United States, medical devices, drugs and biological products are subject to extensive regulation by FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and other federal and state statutes and regulations.
In the United States, medical devices, drugs and biological products are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and other federal and state statutes and regulations.
In addition, the Physician Payment Sunshine Act, implemented as the Open Payments program, requires manufacturers of certain products reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to track and report information to the federal government on certain payments or transfers of value that they make to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse midwives and teaching hospitals, as well as ownership 13 Table of Contents and investment interests held by physicians and their immediate family members.
In addition, the Physician Payment Sunshine Act, implemented as the Open Payments program, requires manufacturers of certain products reimbursed by Medicare, Medicaid, or the Children’s Health Insurance Program to track and report information 13 Table of Contents to the federal government on certain payments or transfers of value that they make to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, certified nurse midwives and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.
The federal healthcare program Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federally financed healthcare programs.
The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any healthcare item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federally financed healthcare programs.
This novel design significantly reduces access site complications, increases patient satisfaction and improves hospital workflow metrics that, in turn, drive economic benefits and cost savings. Our Vascular Closure devices address the growing number of catheter-based coronary, structural heart, peripheral and electrophysiology procedures that require vascular access site closure each year.
This novel design significantly reduces access site complications, increases patient satisfaction and improves hospital workflow metrics that, in turn, drive economic benefits and overall cost savings. Our Vascular Closure devices address the growing number of catheter-based coronary, structural heart, peripheral and electrophysiology procedures that require vascular access site closure each year.
NexSys PCS with Persona Technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor’s body composition, and enables a 9% to 12% average increase in plasma volume per donation, based on our PCS2 baseline device, software configuration and donor population.
NexSys PCS with Persona technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor’s body composition and enables a 9% to 12% average increase in plasma volume per donation, based on our baseline device, software configuration and donor population.
Plasma collectors have long sought revisions to plasma collection regulations outside of the U.S. to allow for greater frequency, volume per donation, and remuneration, but updates have been limited and no significant short-term changes are foreseen in the prevalence of U.S. collections.
Plasma collectors have long sought revisions to plasma collection regulations outside of the U.S. to allow for greater frequency, volume per donation, and remuneration, but updates have generally been limited and no significant short-term changes are foreseen in the prevalence of U.S. collections.
We serve the market for plasma that is processed into pharmaceuticals through our Plasma business, and we serve the market for transfusion plasma through our Blood Center business. One of the distinguishing features of the source plasma market is the method of collection. There are three primary ways to collect plasma.
We serve the market for plasma that is processed into pharmaceuticals primarily through our Plasma business, and we serve the market for transfusion plasma through our Blood Center business. One of the distinguishing features of the source plasma market is the method of collection. There are three primary ways to collect plasma.
Additionally, we offer a variety of programs and resources designed to facilitate our employees’ career development, training and networking, including: ◦ Individual development planning by employees, in consultation with their managers, to help define individual development goals and facilitate manager coaching and feedback; ◦ Manager development sessions focused on developing core leadership competencies, including performance management training, coaching and feedback and building trust; ◦ Continuous improvement training for employees, including through our internal learning management platform, to promote individual development, strengthen our culture and drive compliance and quality across our organization; ◦ Tuition reimbursement programs that provide eligible U.S. and Canadian employees with the opportunity to be reimbursed (up to a set dollar limit) for tuition and certain other expenses associated with degree programs, certifications and continuing education courses that relate to their work at the Company; and ◦ Regular recognition of employees across the organization who personify our core values. • We engage regularly with our employees.
Additionally, we offer a variety of programs and resources designed to facilitate our employees’ career development, training and networking, including: ◦ Individual development planning by employees, in consultation with their managers, to help define individual development goals and facilitate manager coaching and feedback; ◦ Manager development sessions focused on developing core leadership competencies, including performance management training, coaching and feedback and building trust; ◦ Continuous improvement training for employees, including through our internal learning management platform, to promote individual development, strengthen our culture and drive compliance and quality across our organization; ◦ Tuition reimbursement programs that provide eligible U.S. and Canadian employees with the opportunity to be reimbursed (up to a set dollar limit) for tuition and certain other expenses associated with degree programs, certifications and continuing education courses that relate to their work at the Company; and ◦ Regular recognition of employees across the organization who personify our core values. 14 Table of Contents • We engage regularly with our employees.
The 510(k) clearance, de novo classification, and PMA processes can be resource intensive, expensive, lengthy and require payment of significant user fees. 10 Table of Contents Postmarket Requirements - U.S. After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply. Generally, establishments that design and/or manufacture devices are required to register with the FDA.
The 510(k) clearance, de novo classification, and PMA processes can be resource intensive, expensive, lengthy and require payment of significant user fees. Postmarket Requirements - U.S. After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply. Generally, establishments that design and/or manufacture devices are required to register with the FDA.
In addition, our 8 Table of Contents value proposition is supported by robust clinical trial evidence and study data, which demonstrate reduced access site complication rates as well as workflow improvements compared to manual compression that lead to cost savings. Sensor Guided Technologies The landscape of sensor-guided technologies is competitive, especially within the mature coronary physiology market.
In addition, our value proposition is supported by robust clinical trial evidence and study data, which demonstrate reduced access site complication rates as well as workflow improvements compared to manual compression that lead to cost savings. Sensor-Guided Technologies The landscape of sensor-guided technologies is competitive, especially within the mature coronary physiology market.
Similarly, the separation of states from participation in the EU, such as through the cessation of the UK’s membership in the EU (commonly known as “Brexit”) and the separation of the Swiss and EU medical product markets with the adoption of the EU MDR (commonly referred to as “Swexit”), may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
Similarly, the separation of states from participation in the EU, such as through the cessation of the United Kingdom’s membership in the EU (commonly known as “Brexit”) and the separation of the Swiss and EU medical product markets with the adoption of the EU MDR (commonly referred to as “Swexit”), may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
For example, the EU has adopted the EU Medical Device Regulation (the “EU MDR”) and the EU In Vitro Diagnostic Regulation (the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and postmarket surveillance, than the medical device directives they replace.
For example, the European Union (“EU”) has adopted the EU Medical Device Regulation (the “EU MDR”) and the EU In Vitro Diagnostic Regulation (the “EU IVDR”), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and postmarket surveillance, than the medical device directives they replace.
Our senior leadership team participates in scheduled meetings with our employees throughout the fiscal year – including quarterly Town Halls with our global workforce – to reiterate strategic priorities, provide business updates, recognize employee contributions and answer employee questions. We 14 Table of Contents also regularly solicit perspectives from our workforce through surveys and other communications channels.
Our senior leadership team participates in scheduled meetings with our employees throughout the fiscal year – including quarterly Town Halls with our global workforce – to reiterate strategic priorities, provide business updates, recognize employee contributions and answer employee questions. We also regularly solicit perspectives from our workforce through surveys and other communications channels.
The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and prepare a patient’s own high-quality blood for reinfusion. 5 Table of Contents Transfusion Management Transfusion Management Market — Hospital transfusion services professionals and clinicians are facing cost restraints in addition to the pressure to enhance patient safety, compliance and operational efficiency.
The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and prepare a patient’s own high-quality blood for reinfusion. Transfusion Management Transfusion Management Market — Hospital transfusion services professionals and clinicians are facing cost restraints in addition to the pressure to enhance patient safety, compliance and operational efficiency.
Applicable laws may restrict the sale, distribution or use of these products to, by, or on the order of a licensed healthcare practitioner. • Plasma Our Plasma business offers automated plasma collection systems, donor management software and supporting software solutions that improve the yield, efficiency, quality, safety and overall donor experience at plasma collection centers.
Applicable laws may restrict the sale, distribution or use of these products to, by, or on the order of a licensed healthcare practitioner. • Plasma Our Plasma business offers automated plasma collection systems, donor management software and supporting software solutions that enable optimization of the yield, efficiency, quality and overall donor experience at plasma collection centers.
Our software products, including our latest NexLynk DMS ® donor management system and Donor360 ® app, automate the donor interview and qualification process, streamline the workflow process in the plasma center, provide the controls necessary to evaluate donor suitability, determine the ability to release units collected and manage unit distribution.
Our software products, including our latest NexLynk DMS ® donor management system and Donor360 ® tools, automate the donor interview and qualification process, streamline the workflow process in the plasma center, provide the controls necessary to evaluate donor suitability, inform the ability to release units collected and manage unit distribution.
With our software solutions, plasma collectors can manage processes across the plasma supply chain, ensure high quality and compliance process support, react quickly to business changes and implement opportunities to reduce costs. With our PCS brand, we have provided an automated platform dedicated to the collection of plasma for over 30 years.
With our software solutions, plasma collectors can manage processes across the plasma supply chain, ensure high quality and compliance process support, react quickly to business changes and implement opportunities to reduce costs. We have provided automated platforms dedicated to the collection of plasma for over 30 years.
In particular, therapies that require a significant quantity of plasma to create have fueled an increase in the number of donations and dedicated source plasma collection centers. A significant portion of this collection growth has occurred in the United States with U.S. produced plasma now meeting an increasing percentage of plasma volume demand worldwide.
Therapies that require a significant quantity of plasma to create have fueled an increase in the number of donations and dedicated source plasma collection centers. A significant portion of this collection growth has occurred in the United States with U.S. produced plasma now meeting over half of plasma volume demand worldwide.
The new, proprietary Persona Technology strengthens the NexSys PCS value proposition and reinforces our commitment to supporting our Plasma customers. In addition, during fiscal 2024, we received FDA clearance for advancements to NexSys PCS including a new plasma 2 Table of Contents collection bowl and new Express Plus ® technology engineered to reduce procedure time.
Our Persona technology strengthens the NexSys PCS value proposition and reinforces our commitment to supporting our Plasma customers. In addition, during fiscal 2024, we received FDA clearance for advancements to NexSys PCS including a new plasma collection bowl and new Express Plus ® technology engineered to reduce procedure time.
We offer multiple products to support these dedicated source plasma operations, including our NexSys PCS ® and PCS2 ® plasmapheresis equipment, related disposables and solutions. We also offer a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain.
We offer multiple products to support these dedicated source plasma operations, including our NexSys PCS ® plasmapheresis collection system and related disposables. We also offer a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain.
Devices deemed by the FDA to pose the greatest risk are placed in Class III. A PMA is required for most Class III devices. The PMA process is more detailed, lengthier and more expensive than the 510(k) and de novo processes. Our VASCADE and VASCADE MVP products are Class III products for which PMAs were previously obtained.
Devices deemed by the FDA to pose the greatest risk are placed in Class III. A PMA is required for most Class III devices. The PMA process is more detailed, lengthier and more expensive than the 510(k) and de novo processes. Our VASCADE portfolio of vascular closure systems are Class III products for which PMAs were previously obtained.
The following provides an overview of the key competitors in each of our three global product enterprises. • Plasma In the automated plasma collection market, we principally compete with Fresenius’ Fenwal Aurora and Aurora Xi device product lines a nd Terumo BCT ’ s Rika device on the basis of procedure and enabled door-to-door time duration, plasma yield per donation, product quality and reliability, ease of use, services and technical features of the collection systems, supply chain reliability and on the long-term cost-effectiveness of equipment and disposables.
The following provides an overview of the key competitors in each of our three global business units. • Plasma In the automated plasma collection market, we principally compete with Fresenius’ Fenwal Aurora and Aurora Xi device product lines a nd Terumo BCT ’ s Rika device on the basis of procedure duration, donor experience, plasma yield per donation, product quality and reliability, ease of use, services and technical features of the collection systems, supply chain reliability and the long-term cost-effectiveness of equipment and disposables.
While we continue to believe we will have access to the raw materials and components that we need, these supply chain dynamics could result in increased costs to us or an inability to fully meet customer demand for certain of our products. Intellectual Property We consider our intellectual property rights to be important to our business.
While we continue to believe we will have access to the raw materials and components that we need, these supply chain dynamics could result in increased costs to us or an inability to fully meet customer demand for certain of our products.
We market our surgical blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, OB-GYN and to anesthesiologists and surgical suite service providers.
We market our surgical 5 Table of Contents blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, OB-GYN and to anesthesiologists and surgical suite service providers.
The conflict minerals include tin, tantalum, tungsten and gold and their derivatives. These requirements could affect the pricing, sourcing and availability of minerals used in the manufacture of our products. There may be material additional costs associated with complying with the disclosure requirements, such as costs related to determining the source of any conflict minerals used in our products.
These requirements could affect the pricing, sourcing and availability of minerals used in the manufacture of our products. There may be material additional costs associated with complying with the disclosure requirements, such as costs related to determining the source of any conflict minerals used in our products.
Vascular closure devices improve upon manual compression by rapidly closing the access site and facilitating more efficient workflow for both the coronary and peripheral markets but also the rapidly growing structural heart and electrophysiology markets. Vascular Closure Products — The VASCADE ® technology platform was developed to address the limitations of manual compression and existing vascular closure devices.
Vascular closure devices improve upon manual compression by rapidly closing the access site and facilitating more efficient workflow for procedures in both the coronary and peripheral markets as well as the rapidly growing structural heart and electrophysiology markets. Vascular Closure Products — Our VASCADE ® technology was developed to address the limitations of manual compression and existing vascular closure devices.
Sensor Guided Technologies Products — The OptoWire® is a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (FFR) and diastolic pressure ratio (dPR) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.
Sensor-Guided Technologies Products — Our OptoWire ® pressure guidewire aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.
The EU MDR became fully applicable as of May 26, 2021 and the EU IVDR became fully applicable as of May 26, 2022. 11 Table of Contents There is a conditional transition period after the date of full application, the duration of which is dependent on the classification of the device.
The EU MDR became fully applicable as of May 26, 2021 and the EU IVDR became fully applicable as of May 26, 2022. 11 Table of Contents There is a conditional transition period after the date of full application, the duration of which is dependent on the classification of the device and conditioned upon manufacturers having submitted EU MDR applications by May 26, 2024.
Human Capital We are committed to building a collaborative, performance-driven culture that attracts and retains top talent. As of March 30, 2024, we employed the full-time equivalent of 3,657 persons. Approximately 82% of our employees are located in North America and the remaining 18% are located across 19 other countries.
Human Capital We are committed to building a collaborative, performance-driven culture that attracts and retains top talent. As of March 29, 2025, we employed the full-time equivalent of 3,023 persons. Approximately 78% of our employees are located in North America and the remaining 22% are located across 19 other countries.
This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings. The HAS-100 and HAS-300 devices are currently commercialized in China.
This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings. We continue to pursue a broader set of indications for TEG 6s in the U.S. The HAS-100 and HAS-300 devices are currently commercialized in China.
Our VASCADE family of products consists of two devices, VASCADE and VASCADE MVP ® , which share a common, innovative technology that features a simple, catheter-based delivery system and leverages the natural clot-inducing properties of collagen.
Our VASCADE family of Vascular Closure products consists of four devices, VASCADE ® 5F, VASCADE 6/7F, VASCADE MVP ® and VASCADE MVP ® XL, which share a common, innovative technology that features a simple, catheter-based delivery system and leverages the natural clot-inducing properties of collagen.
In fiscal 2018, we began transitioning customers from our PCS2 equipment to NexSys PCS. NexSys PCS is designed to enable higher plasma yield collections, improve productivity in our customers’ centers, enhance the overall donor experience and provide safe and reliable collections that will become life-changing medicines for patients.
Our NexSys PCS device is designed to enable higher plasma yield collections, improve productivity in our customers’ centers, enhance the overall donor experience and provide safe and reliable collections that will become life-changing medicines for patients.
Our Blood Center business unit represen ted 21.1% , 24.0% and 30.1% of ou r total revenue in fiscal 2024, 2023 and 2022, respectively. 3 Table of Contents • Hospital Hospitals are called upon to provide the highest standard of patient care while at the same time reduce operating costs.
Our Blood Center business represen ted 19.2% , 21.6% and 24.6% of ou r total revenue in fiscal 2025, 2024 and 2023, respectively. • Hospital Hospitals are called upon to provide the highest standard of patient care while at the same time reducing operating costs.
Our Plasma business unit focuses on the collection of source plasma for pharmaceutical manufacturers using apheresis devices that only collect plasma and software solutions that support the efficient operation of dedicated source plasma collection centers.
Our Plasma business focuses on the collection of source plasma for pharmaceutical manufacturers using apheresis devices that only collect plasma and software solutions that support the efficient operation of dedicated source plasma collection centers. Our Blood Center business supports the collection of plasma for blood collectors, such as the American Red Cross, using apheresis collection devices.
In the field of plasma related software, we principally compete with applications developed internally by certain of our customers. • Blood Center Most donations worldwide are traditional manual whole blood collections and approximate ly 25% of th e Blood Center portfolio competes in this space.
In the field of plasma related software, we principally compete with applications developed internally by certain of our customers. • Blood Center Most donations worldwide are manual whole blood collections.
We expect to pursue further regulatory clearances for additional enhancements to the overall product offering. We have entered into agreements with all U.S. customers to adopt NexSys PCS somewhere in their global collection network and we provide ongoing support of NexSys PCS devices and NexLynk DMS donor management software for these Plasma customers.
We expect to pursue further regulatory clearances for additional enhancements to the overall product offering. 2 Table of Contents We have entered into agreements with all U.S. customers to adopt NexSys PCS somewhere in their global collection network and our NexLynk DMS donor management software has been adopted by all U.S. customers except those with internally developed systems.
These guidewires are thin and flexible, allowing surgeons to navigate coronary arteries and can also assist in the diagnosis of certain heart conditions.
Sensor-Guided Technologies Market — Coronary guidewires facilitate the delivery and positioning of interventional devices through the catheters and can also assist in the diagnosis of certain heart conditions. These guidewires are thin and flexible, allowing surgeons to navigate coronary arteries.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, warning letters or untitled letters, injunctions, civil, administrative, or criminal penalties, monetary fines or imprisonment, suspension or withdrawal of regulatory approvals, suspension of ongoing clinical studies, refusal to approve pending applications or supplements to applications filed by us, suspension or the imposition of restrictions on operations, product recalls, the refusal to permit the import or export of our products or the seizure or detention of products. 12 Table of Contents Conflict Minerals The Dodd-Frank Wall Street Reform and Consumer Protection Act imposes disclosure requirements regarding the use of “Conflict Minerals” mined from the Democratic Republic of Congo and adjoining countries in products, whether or not these products are manufactured by third parties.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, warning letters or untitled letters, injunctions, civil, administrative, or criminal penalties, monetary fines or imprisonment, suspension or withdrawal of regulatory approvals, suspension of ongoing clinical studies, refusal to approve pending applications or 12 Table of Contents supplements to applications filed by us, suspension or the imposition of restrictions on operations, product recalls, the refusal to permit the import or export of our products or the seizure or detention of products.
We are engaged in intellectual property litigation as described in Note 15, Commitments & Contingencies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K, and we may be notified in the future of claims that we may be infringing, misappropriating or otherwise violating the intellectual property rights of third parties.
We are engaged in intellectual property litigation as described in Note 15, Commitments & Contingencies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.
Automated component blood collections separate the blood component real-time while a person is donating. In this method, only the specific target blood component is collected and the remaining components are returned to the blood donor. While overall we expect total demand for blood to remain stable to slightly declining, demand in individual markets and for individual components can vary greatly.
Automated component blood collections separate the blood component in real-time while a person is donating. In this method, only the specific target blood component is collected, and the remaining components are returned to the blood donor.
Financial information concerning these segments is provided in Note 18, Segment and Enterprise-Wide Information, to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.
Financial information concerning these segments is provided in Note 18, Segment and Enterprise-Wide Information , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K. We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value.
Our VASCADE family of products serves as an alternative to existing methods of femoral vascular access site closure in interventional procedures, including manual compression and other femoral access closure devices. Our main competitors in femoral access closure for coronary and peripheral procedures include Terumo BCT, Abbott Laboratories and Cardinal Health.
Our VASCADE family of products serves as an alternative to existing methods of vascular access site closure in interventional procedures, generally including manual compression, figure-of-eight sutures and other advanced closure devices.
Haemonetics’ Hospital business has two distinct franchises, Interventional Technologies, which includes Vascular Closure and Sensor Guided Technologies, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management. The Sensor-Guided Technologies product line was acquired as part of the OpSens Inc. transaction in December 2023.
Haemonetics’ Hospital business has two distinct franchises, Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies and Esophageal Protection, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management. The Esophageal Protection products were acquired as part of the Advanced Cooling Therapy, Inc., d/b/a Attune Medical (“Attune Medical”) transaction in April 2024.
These collaborations with customers and transfusion experts provide us with ideas for new products and applications, enhanced protocols and potential test sites as well as objective evaluations and expert opinions regarding technical and performance issues.
These collaborations with customers provide us with ideas for new products and applications, enhanced protocols and potential test sites as well as objective evaluations and expert opinions regarding technical and performance issues. Research and development resources were allocated primarily to support innovation across our Plasma and Hospital product portfolios in fiscal 2025.
At least 90% of global employees participated in our annual engagement surveys conducted between fiscal 2019 and fiscal 2023. Feedback from these surveys was shared across the organization and informed both Company-sponsored initiatives and shared action plans between managers and direct reports.
Nearly 90% of global employees participated in our most recent biennial employee engagement survey conducted in fiscal 2025, with feedback from the survey shared across the organization and used to inform both Company-sponsored initiatives and shared action plans between managers and direct reports.
Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. When used in this report, the terms “we,” “us,” “our,” “Haemonetics” and the “Company” mean Haemonetics Corporation. We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital.
When used in this report, the terms “we,” “us,” “our,” “Haemonetics” and the “Company” mean Haemonetics Corporation. We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital. For that purpose, “Plasma” includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers.
NexSys PCS includes bi-directional connectivity to the NexLynk DMS donor management system to improve operational efficiency within plasma centers, through automated programming of donation procedures and automated data capture of procedure data. Our NexSys PCS with YES ® Technology is a yield-enhancing solution that enables increases in plasma yield per collection by an additional 18-26 mL per donation, on average.
NexSys PCS includes bi-directional connectivity to the NexLynk DMS donor management system to improve operational efficiency within plasma centers, including through automated programming of donation procedures and automated data capture of procedure data.
Similarly, our VASCADE MVP device is the first marketed vascular closure device clinically proven in a prospective, multi-center, randomized clinical trial, to improve workflow relative to manual compression for electrophysiology procedures. Importantly, these improvements drive meaningful cost savings for hospitals, ambulatory surgery centers and other treatment facilities.
Our VASCADE product is proven to have a statistically significant reduction in minor complications compared to manual compression based on a randomized clinical trial. Our VASCADE MVP device is the first marketed vascular closure device clinically proven in a prospective, multi-center, randomized clinical trial, to improve workflow relative to manual compression for electrophysiology procedures.
The development of blood component separation products, hemostasis analyzers and software has required us to maintain technical expertise in various engineering disciplines, including mechanical, electrical, software, biomedical engineering and chemistry. Innovations resulting from these various engineering efforts enable us to develop systems that are faster, smaller and more user-friendly, or that incorporate additional features important to our customer base.
Innovations resulting from these various engineering efforts enable us to develop systems that are faster, smaller and more user-friendly, or that incorporate additional features important to our customer base. Customer collaborations are also an important part of our technical strength and competitive advantage.
Even with the major advances in technology over the last 40 years, the most common complications in coronary and peripheral procedures are still related to the access site. Manual compression, the traditional standard of care, involves the application of pressure in order to facilitate the formation of a blood clot at the access site.
Manual compression, the traditional standard of care, involves the application of pressure in order to facilitate the formation of a blood clot at the access site.
“Hospital” is comprised of Interventional Technologies, which includes vascular closure devices and sensor-guided technologies, and Blood Management Technologies, which includes devices and methodologies for measuring coagulation characteristics of blood, specialized blood cell processing systems and disposables, surgical blood salvage systems and blood transfusion management software.
“Blood Center” includes blood collection and processing devices and disposables for plasma, red cells and platelets. “Hospital” is comprised of Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies and Esophageal Protection product lines, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management product lines.
Beginning in fiscal 2024, we updated our strategic listening approach by transitioning to a biennial annual engagement survey and introducing short pulse surveys throughout the year that allow us to receive more real-time employee feedback and take prompt action as needed to enhance our talent attraction and retention capabilities. • We seek to foster a diverse workforce and an inclusive culture.
Additionally, we conducted short pulse surveys throughout the fiscal year that allowed us to receive more real-time employee feedback and take prompt action as needed to enhance our talent attraction and retention capabilities. • We seek to foster a collaborative, performance-driven culture. We are committed to providing an inclusive environment where the contributions of every individual are valued.
SafeTrace Tx competition primarily consists of stand-alone BBIS including WellSky and some electronic health record software that includes a built-in transfusion management solution including Cerner. Global competition for BloodTrack varies by country including MSoft in Europe and established blood practices in the U.S. such as using standard refrigerators and manual movement of blood products.
SafeTrace Tx competition primarily consists of stand-alone BBIS including WellSky, SSC Soft, and some electronic health record software that includes a built-in transfusion management solution including Cerner and Clinsys.
Additionally, we have continued to make investments related to our next generation plasma collection and software systems, the European Medical Device Regulation and In Vitro Diagnostic Regulation and our Hemostasis Management product line. 6 Table of Contents Manufacturing We endeavor to supply products that are both high quality and cost competitive for our customers by leveraging continuous improvement methodologies, focusing on our core competencies and partnering with strategic suppliers that complement our capabilities.
Also during fiscal 2025, we announced CE mark certification for the SavvyWire pre-shaped pressure guidewire. 6 Table of Contents Manufacturing We endeavor to supply products that are both high quality and cost competitive for our customers by leveraging continuous improvement methodologies, focusing on our core competencies and partnering with strategic suppliers that complement our capabilities.
We also received FDA clearance for a new TEG 6s Global Hemostasis-HN assay cartridge in fiscal 2024, which extends the system’s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.
During fiscal 2025 we announced FDA clearance and our launch of a new TEG 6s Global Hemostasis-HN assay cartridge, which extends the system’s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings, as well as FDA approval and our launch of the VASCADE MVP XL mid-bore venous closure device, which utilizes 58% more collagen and a larger disc than the current VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths such as cryoablation and left atrial appendage closure for atrial fibrillation patients.
We compete primarily on the basis that our products are optimized for the requirements of coronary, structural heart, peripheral and electrophysiology procedures, including procedures that require multiple access sites.
Our main competitors in vascular access closure include Terumo BCT, Abbott Laboratories and Cordis, where we compete primarily based on clinical and economic value, ease of use, workflow improvements and patient satisfaction. Our products are optimized for the 8 Table of Contents requirements of coronary, structural heart, peripheral and electrophysiology procedures, including procedures that require multiple access sites.
Blood Center Products — We offer automated blood component and manual whole blood collection systems to blood collection centers to collect blood products efficiently and cost effectively. • We market the MCS ® brand apheresis equipment which is designed to collect specific blood components from the donor.
Blood Center Products — We offer automated blood component systems to blood centers to collect blood products efficiently and cost effectively.
Both franchises have a leading market position and a mission of helping hospitals and clinicians provide the highest standard of patient care while at the same time reducing operating and procedural costs and helping decision makers in hospitals optimize blood acquisition, storage and usage in critical settings.
Both the Interventional Technologies and Blood Management Technologies franchises have a leading market position and a mission of helping hospitals and clinicians provide the highest standard of patient care while at the same time reducing operating and procedural costs and optimizing resources. 3 Table of Contents Interventional Technologies: Vascular Closure Vascular Closure Market — Catheter-based, minimally invasive alternatives to open surgery have transformed cardiovascular medicine.
They also must provide the FDA with a list of the devices that they design and/or manufacture at their facilities. Other postmarket requirements include compliance with: • The Quality System Regulation, or QSR, which sets forth current good manufacturing practice, or cGMP, requirements for medical devices.
Other postmarket requirements include compliance with: • The Quality System Regulation, or QSR (which will be replaced by the Quality Management System Regulation, or QMSR, beginning in February 2026), which sets forth current good manufacturing practice, or cGMP, requirements for medical devices.
In fiscal 2021, we received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for our NexSys PCS with proprietary Persona ® Technology.
Our NexSys PCS with YES ® technology is a yield-enhancing solution that enables increases in plasma yield per collection by an additional 18-26 mL per donation, on average. In fiscal 2021, we received U.S. Food and Drug Administration or FDA, 510(k) clearance for our NexSys PCS with proprietary Persona ® technology.
Our Plasma business unit represen ted 43.2% , 42.5% and 35.4% of our to tal revenue in fiscal 2024, 2023 and 2022, respectively. • Blood Center Our Blood Center business offers a range of solutions that improve donor collection centers’ ability to collect and separate blood components for transfusions.
Our Plasma business unit represen ted 39.3% , 43.5% and 42.8% of our to tal revenue in fiscal 2025, 2024 and 2023, respectively. • Blood Center Our Blood Center business offers a range of products and technologies to help blood centers optimize their blood collections, improve donor safety, enhance yields and control costs.
We believe that our ability to maintain a competitive advantage will continue to depend on a combination of factors.
“Risk Factors” below. 7 Table of Contents Competition To remain competitive, we continue to develop and acquire new cost-effective products, information technology platforms and business services. We believe that our ability to maintain a competitive advantage will continue to depend on a combination of factors.
The SavvyWire®, which was recently introduced to the medical device market in 2022, is a sensor-guided 3-in-1 guidewire for transcatheter aortic valve replacement (TAVR) procedures, advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients.
Our SavvyWire ® is a sensor-guided 3-in-1 guidewire for transcatheter aortic valve replacement (“TAVR”) procedures, advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients. SavvyWire serves as a guide-wire, delivers accurate hemodynamic measurement and display, and provides left ventricular (“LV”) pacing without the need for adjunct devices or venous access.
Marketing/Sales/Distribution We market and sell our products in approximately 90 countries through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors. Our customers include biopharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations.
Our Hospital business represented 41.5%, 34.9% and 32.7% of our total revenue in fiscal 2025, 2024 and 2023, respectively. Marketing and Sales We market and sell our products in approximately 95 countries through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors in approximately 90 countries.
The TEG 6s system is approved for the same set of indications as the TEG 5000 in Europe, Australia and Japan. We continue to pursue a broader set of indications for TEG 6s in the U.S. In fiscal 2024, we received FDA clearance for a new TEG 6s Global Hemostasis-HN assay cartridge.
The TEG 6s system is approved for the same set of indications as the TEG 5000 in Europe, Australia and Japan. In the U.S., the TEG 6s system is indicated to assess hemorrhage or thrombosis conditions in cardiovascular surgery and cardiology procedures as well as to evaluate the hemostasis condition in adult trauma patients.
We currently hold NDAs and ANDAs for liquid solutions (including anticoagulants, intravenous saline and a red blood cell storage solution), which we sell with our blood component and whole blood collection systems. Post-Approval Regulations After the FDA permits a drug to enter commercial distribution, numerous regulatory requirements continue to apply.
Post-Approval Regulations After the FDA permits a drug to enter commercial distribution, numerous regulatory requirements continue to apply.
ITEM 1. BUSINESS Company Overview Haemonetics is a global healthcare company dedicated to providing a suite of innovative medical technology solutions that improve the quality, effectiveness and efficiency of care. We challenge ourselves to think big and make new possibilities a reality, so that our customers can make it matter for patients, every single day.
ITEM 1. BUSINESS Company Overview Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care.
Interventional Technologies: Vascular Closure Vascular Closure Market — Catheter-based, minimally invasive alternatives to open surgery have transformed cardiovascular medicine. The majority of these procedures gain access to the vascular system through the femoral artery or vein. These access sites in the vessel require closure post procedure.
The majority of these procedures gain access to the vascular system through the femoral artery or vein. These access sites in the vessel require closure post procedure. Even with the major advances in technology over the last 40 years, the most common complications in coronary and peripheral procedures are still related to the access site.
We face intense competition in our whole blood business on the basis of quality and price. Our main competitors are Fresenius, MacoPharma and Terumo BCT.
Our recently divested Whole Blood product line, which historically represented approximate ly 25% of th e Blood Center portfolio, competed in this space and faced intense competition from our main competitors, including Fresenius, MacoPharma and Terumo BCT, based on quality and price.
There are not currently competing, commercially available TAVR guidewires that deliver hemodynamic measurement and on-label LV pacing for TAVR procedures. We differentiate by continually investing in research and development to enhance the features and performance of our products. Furthermore, our commitment to clinical validation, supported by evidence, reinforces the performance and clinical benefits of our sensor-guided technology portfolio.
There are not currently competing, commercially available TAVR guidewires that are indicated to deliver both hemodynamic measurement and LV pacing for TAVR procedures.
In connection with any such claims, we may seek to enter into settlement and/or licensing arrangements. There is a risk in these situations that no license will be available or that a license will not be available on reasonable terms. Alternatively, we may decide or be required to litigate such claims.
Additionally, we have been, and may in the future be, notified of claims that we may be infringing, misappropriating or otherwise violating the intellectual property rights of third parties. In connection with any such claims, we may seek to enter into settlement and/or licensing arrangements or to litigate such claims.
VASCADE MVP is the first vascular closure device to receive a FDA indication for same-day discharge following atrial fibrillation ablation. Sensor Guided Technologies Market — Coronary guidewires facilitate the delivery and positioning of interventional devices through the catheters.
Importantly, these improvements may drive meaningful cost savings for hospitals, ambulatory surgery centers and other treatment facilities. VASCADE MVP was also the first vascular closure device to receive an FDA indication for same-day discharge following atrial fibrillation ablation.
BloodTrack integrates with the hospital’s existing lab or blood bank system allowing for greater market acceptance. 9 Table of Contents Significant Customers In fiscal 2024, 2023 and 2022, our ten largest customers accounted for approximately 48%, 48% and 45% of our net revenues, respectively.
Global competition for BloodTrack varies by country including MSoft, MAK Systems in Europe and established blood 9 Table of Contents practices in the U.S. such as using standard refrigerators and manual movement of blood products. BloodTrack integrates with the hospital’s existing lab or blood bank system allowing for greater market acceptance.
Additionally, we maintain company-sponsored Colleague Resource Groups designed to provide a forum for employees with shared affinities to connect, advance business priorities and drive talent strategies with an inclusive focus. • We offer market-competitive compensation opportunities and benefits that are designed to attract, retain and motivate exceptional employees and drive both individual and company performance .
We advance these efforts through purposeful investments and training, including as described above, and by requiring that employees complete annual training on our Code of Conduct. • We offer market-competitive compensation opportunities and benefits that are designed to attract, retain and motivate exceptional employees and drive both individual and company performance .
We believe that Plasma and Hospital have growth potential, while Blood Center competes in challenging markets that require us to manage the business differently, including reducing costs, shrinking the scope of the current product line, and evaluating opportunities to exit unfavorable customer contracts. Market and Products Product Lines The following describes our principal products in each of our segments.
Blood Center operates in more challenging markets, and we have sharpened our focus accordingly on targeted opportunities – particularly in plasma and platelets – while ensuring continued alignment of this business with the Company’s broader strategic objectives. Market and Products Product Lines and Franchises The following describes our principal products in each of our segments.
A successful claims against us may require us to remove the alleged infringing product from the market or to design around the third party’s patent, potentially resulting in less market demand for the product. 7 Table of Contents Competition To remain competitive, we must continue to develop and acquire new cost-effective products, information technology platforms and business services.
Any such settlements could include cross-licensing of the patents that are the subject of the litigation and/or monetary payments, and a successful claim against us may require the removal of the alleged infringing product from the market or require designing around the third party’s patents, potentially resulting in less market demand for the product. For additional information, see Item 1A.
Removed
For that purpose, “Plasma” includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers. “Blood Center” includes blood collection and processing devices and disposables for red cells, platelets and whole blood.
Added
Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components.
Removed
Our Blood Center business supports the collection of plasma for blood collectors, such as the American Red Cross, using both whole blood collections sets and multi-component apheresis collection devices.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeDue to the high standards and stringent requirements of the FDA and other similar non-U.S. regulatory agencies applicable to manufacturing our products, such as the FDA’s QSR and cGMP regulations, we also may not be able to quickly establish additional or replacement sources for certain raw materials, components or finished goods.
Biggest changeWe are reliant on Tetakawi to provide these services and any disruption in these services or our failure to maintain our contractual relationship with Tetakawi could significantly harm our ability to manufacture our vascular closure devices and maintain sufficient quality standards, which would negatively impact our business and results of operations. 21 Table of Contents Due to the high standards and stringent requirements of the FDA and other similar non-U.S. regulatory agencies applicable to manufacturing our products, such as the FDA’s QSR and cGMP regulations, we also may not be able to quickly establish additional or replacement sources for certain raw materials, components or finished goods.
We also outsource certain elements of our information technology systems to third parties that, as a result of this outsourcing, could have access to certain confidential information and whose systems may also be vulnerable to these types of attacks or disruptions.
We outsource certain elements of our information technology systems to third parties that, as a result of this outsourcing, could have access to certain confidential information and whose systems may also be vulnerable to these types of attacks or disruptions.
Many of these risks are rapidly evolving and subject to an accelerating pace of change. We are continuing to monitor the situation in Ukraine and globally as well as assess its potential impact on our business.
Many of these risks are rapidly evolving and subject to an accelerating pace of change. We are continuing to monitor the situation in Ukraine and globally as well as to assess its potential impact on our business.
Under the share repurchase program, we are authorized to repurchase, from time to time, outstanding shares of common stock in accordance with applicable laws both on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended and in privately negotiated transactions.
Under this share repurchase program, we are authorized to repurchase, from time to time, outstanding shares of common stock in accordance with applicable laws both on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended and in privately negotiated transactions.
The Capped Call Transactions are expected generally to reduce the potential dilution to our common stock upon any conversion of the 2026 Notes and/or offset any potential cash payments we are required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.
The Capped Call Transactions are expected generally to reduce the potential dilution to our common stock upon any conversion of the Notes and/or offset any potential cash payments we are required to make in excess of the principal amount of converted Notes, as the case may be, with such reduction and/or offset subject to a cap.
From time to time, the Option Counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions prior to the maturity of the 2026 Notes.
From time to time, the Option Counterparties and/or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to our common stock and/or purchasing or selling our common stock or other securities of ours in secondary market transactions prior to the maturity of the Notes.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance or reporting requirements in multiple jurisdictions increase the possibility that a healthcare or pharmaceutical company may fail to comply fully with one or more of these requirements.
The shifting commercial compliance environment and the need to build and maintain robust and expandable systems to comply with different compliance or reporting requirements in multiple jurisdictions increase the possibility that a healthcare company may fail to comply fully with one or more of these requirements.
In addition, applicable law, regulatory authorities and the agreements governing our other indebtedness may restrict our ability to repurchase the 2026 Notes or pay the cash amounts due upon conversion. Our failure to repurchase the 2026 Notes or to pay the cash amounts due upon conversion when required will constitute a default under the Indenture.
In addition, applicable law, regulatory authorities and the agreements governing our other indebtedness may restrict our ability to repurchase the Notes or pay the cash amounts due upon conversion. Our failure to repurchase the Notes or to pay the cash amounts due upon conversion when required will constitute a default under the applicable Indenture.
This activity could also cause or avoid an increase or a decrease in the market price of our common stock or the 2026 Notes. We are subject to counterparty risk with respect to the Capped Call Transactions.
This activity could also cause or avoid an increase or a decrease in the market price of our common stock or the Notes. We are subject to counterparty risk with respect to the Capped Call Transactions.
The Capped Call Transactions may affect the value of the 2026 Notes and our common stock. In connection with the 2026 Notes issuance, we entered into privately negotiated capped call transactions (the “Capped Call Transactions”) with certain financial institutions (the “Option Counterparties”).
The Capped Call Transactions may affect the value of the Notes and our common stock. In connection with the issuance of the Notes, we entered into privately negotiated capped call transactions (the “Capped Call Transactions”) with certain financial institutions (the “Option Counterparties”).
Changes in the cost, composition or availability of the plastics and resins we purchase, or of other raw materials and components used in our products, could adversely affect our business, financial condition and results of operations.
Changes in the cost, composition or availability of the plastics we purchase, or of other raw materials and components used in our products, could adversely affect our business, financial condition and results of operations.
Conversion of the 2026 Notes may dilute the ownership interest of existing stockholders. The conversion of some or all of the Notes will dilute the ownership interests of existing stockholders to the extent we deliver shares of our common stock upon conversion of any of the 2026 Notes.
Conversion of the Notes may dilute the ownership interest of existing stockholders. The conversion of some or all of the Notes will dilute the ownership interests of existing stockholders to the extent we deliver shares of our common stock upon conversion of any of the Notes.
If natural disasters, extreme weather and other conditions caused by or related to climate change, strikes, terrorism attacks or other adverse events occur that result in the closure of or damage to one or more of these facilities, we may be unable to supply the relevant products at previous levels or at all for some period.
If natural disasters, extreme weather and other conditions caused by or related to climate change, strikes, terrorism attacks, cyber incidents or other adverse events occur that result in the closure of or damage to one or more of these facilities, we may be unable to supply the relevant products at previous levels or at all for some period.
While we have an active compliance program and various other safeguards to discourage impermissible practices, we have distributors in approximately 80 countries, several of which are considered high risk for corruption. As a result, our global operations carry some risk of unauthorized impermissible activity on the part of one of our distributors, employees, agents or consultants.
While we have an active compliance program and various other safeguards to discourage impermissible practices, we have distributors in approximately 90 countries, several of which are considered high risk for corruption. As a result, our global operations carry some risk of unauthorized impermissible activity on the part of one of our distributors, employees, agents or consultants.
While we conduct security risk assessments prior to engaging third party suppliers and other vendors and business partners to validate that they maintain appropriate safeguards to protect our and their information systems in connection with the services they provide, it is possible that they suffer a cyber-attack that impacts us.
While we conduct security risk assessments prior to engaging third party suppliers and other vendors and business partners to validate that they maintain appropriate safeguards to protect our and their information systems in connection with the services they provide, it is possible that they suffer a cyber-attack that impacts us, our suppliers or our customers.
Although our business in Russia accounted for only about 1% of fiscal 2024 net revenues, a significant escalation or further expansion of the conflict’s current scope or related disruptions to the global markets could have a material adverse effect on our results of operations. Our international operations are governed by the U.S.
Although our business in Russia accounted for only about 1% of fiscal 2025 net revenues, a significant escalation or further expansion of the conflict’s current scope or related disruptions to the global markets could have a material adverse effect on our results of operations. Our international operations are governed by the U.S.
Accordingly, these transactions may not operate as we intend if we are required to adjust their terms as a result of transactions in the future or upon unanticipated developments that may adversely affect the functioning of the Capped Call Transactions. Provisions in the Indenture could delay or prevent an otherwise beneficial takeover of us.
Accordingly, these transactions may not operate as we intend if we are required to adjust their terms as a result of transactions in the future or upon unanticipated developments that may adversely affect the functioning of the Capped Call Transactions. Provisions in the Indentures could delay or prevent an otherwise beneficial takeover of us.
Under certain circumstances, the noteholders may convert their 2026 Notes at their option prior to the scheduled maturities. If one or more noteholders elect to convert their 2026 Notes, we would be required to settle a portion or all of our conversion obligation through the payment of cash, which could adversely affect our liquidity.
Under certain circumstances, the noteholders may convert their Notes at their option prior to their respective scheduled maturities. If one or more noteholders elect to convert their Notes, we would be required to settle a portion or all of our conversion obligation through the payment of cash, which could adversely affect our liquidity.
As previously disclosed, our largest Plasma customer, CSL, informed us in April 2021 of its intent not to renew its supply agreement for the use of PCS2 plasma collection system devices and the purchase of disposable plasmapheresis kits in the U.S. following the expiration of the then current term of its contract, which was subsequently extended on a non-exclusive basis through December 2025.
As previously disclosed, one of our largest Plasma customers, CSL, informed us in April 2021 of its intent not to renew its supply agreement for the use of PCS2 ® plasma collection system devices and the purchase of disposable plasmapheresis kits in the U.S. following the expiration of the then current term of its contract, which was subsequently extended on a non-exclusive basis through December 2025.
Finally, any other significant changes in the competitive, legal, regulatory, reimbursement or economic environments of the jurisdictions in which we conduct our international business could have a material impact on our business. We sell our products in certain emerging economies which exposes us to less mature regulatory systems, more volatile markets for our products and greater credit risks.
Finally, any other significant changes in the competitive, legal, regulatory, reimbursement or economic environments of the jurisdictions in which we conduct our international business could have a material impact on our business. 27 Table of Contents We sell our products in certain emerging economies which exposes us to less mature regulatory systems, more volatile markets for our products and greater credit risks.
While we believe this program is reasonable and adequate, the risk of loss is inherent in litigation as different legal systems offer different levels of protection to intellectual property and it is still possible that even patented technologies may not be protected absolutely from infringement. Pending and future intellectual property litigation could be costly and disruptive to us.
While we believe this program is reasonable and adequate, the risk of loss is inherent in litigation as different legal systems offer different levels of protection to intellectual property and it is still possible that even patented technologies may not be protected absolutely from infringement. 28 Table of Contents Pending and future intellectual property litigation could be costly and disruptive to us.
Similarly, the separation of states from participation in the EU, such as through the cessation of the UK’s membership in the EU (commonly known as “Brexit”) and the separation of the Swiss and EU medical product markets with the adoption of the EU MDR (commonly referred to as “Swexit”), may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
Similarly, the separation of states from participation in the EU, such as through the cessation of the United Kingdom’s membership in the EU (commonly known as “Brexit”) and the separation of the Swiss and EU medical product markets with the adoption of the EU MDR (commonly referred to as “Swexit”), may result in further regulatory risk and complexity as the former EU member or participant state establishes separate laws and regulations governing medical products.
Additionally, for reasons of quality assurance or cost effectiveness, we purchase certain finished goods, components and raw materials from sole suppliers who have their own complex supply chains. We have experienced increased levels of unpredictability in the supply of certain raw materials and components, including semiconductor chips, used in the manufacturing of our products.
Additionally, for reasons of quality assurance or cost effectiveness, we purchase certain finished goods, components and raw materials from sole suppliers who have their own complex supply chains. We have experienced increased levels of unpredictability in the supply of certain raw materials and components used in the manufacturing of our products.
In either case, and in other cases, our obligations under the 2026 Notes and the Indenture could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that noteholders or holders of our common stock may view as favorable.
In either case, and in other cases, our obligations under the Notes and the Indentures could increase the cost of acquiring us or otherwise discourage a third party from acquiring us or removing incumbent management, including in a transaction that noteholders or holders of our common stock may view as favorable.
We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the 2026 Notes or pay the cash amounts due upon conversion.
We may not have enough available cash or be able to obtain financing at the time we are required to repurchase the applicable Notes or pay the cash amounts due upon conversion.
Accordingly, our information systems require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, evolving systems and regulatory standards, the increasing need to protect patient and customer information and changing customer patterns.
Accordingly, our information systems require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace with continuing changes in information processing technology, 19 Table of Contents evolving systems and regulatory standards, the increasing need to protect patient and customer information and changing customer patterns.
If legislation or regulations are enacted in jurisdictions in which we do business that are more stringent than our current obligations, we and companies in our supply chain may experience increased compliance burdens and costs to meet these obligations, which could cause disruption in the sourcing, manufacturing and distribution of our products and adversely affect our business, financial condition or results of operations.
If legislation or regulations are enacted in jurisdictions in which we do business that are more stringent than our current obligations or other stakeholders effectively require more stringent compliance, we and companies in our supply chain may experience increased compliance burdens and costs to meet these obligations, which could cause disruption in the sourcing, manufacturing and distribution of our products and adversely affect our business, financial condition or results of operations.
The share repurchase program may b e suspended, modified or discontinued at any time and we have no obligation to repurchase any amount of our common stock under the programs. Repurchases pursuant to our share repurchase program could affect our stock price and increase its volatility.
The share repurchase program may be suspended, modified or discontinued at any time and we have no obligation to repurchase any amount of our common stock under the programs. Repurchases pursuant to our share repurchase program could affect our stock price and increase its volatility.
Additionally, the impacts of climate change may further include customer preferences and requirements. Failure to meet these preferences or requirements could potentially result in loss of market shares. 30 Table of Contents Actual or threatened public health crises could harm our business.
Additionally, the impacts of climate change may further include customer preferences and requirements. Failure to meet these preferences or requirements could potentially result in loss of market shares. Actual or threatened public health crises could harm our business.
A default under the Indenture or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, including our 2024 Revised Credit Facilities, which may result in that other indebtedness becoming immediately payable in full.
A default under an Indenture or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, including our 2024 Revised Credit Facilities and the other Notes, which may result in that other indebtedness becoming immediately payable in full.
The GDPR imposes stringent EU data protection requirements and provides for significant penalties for noncompliance. HIPAA also imposes stringent data 19 Table of Contents privacy and security requirements and the regulatory authority has imposed significant fines and penalties on organizations found to be out of compliance.
The GDPR imposes stringent EU data protection requirements and provides for significant penalties for noncompliance. HIPAA also imposes stringent data privacy and security requirements and the regulatory authority has imposed significant fines and penalties on organizations found to be out of compliance.
We regularly assess the likely outcomes of these audits in order to determine the appropriateness of our tax provision and have established contingency reserves for material, known tax exposures.
We regularly assess the likely outcomes of these audits in order to determine the appropriateness of our tax provision and have established contingency 24 Table of Contents reserves for material, known tax exposures.
However, the calculation of such tax exposures involves the application of complex 24 Table of Contents tax laws and regulations in many jurisdictions, as well as interpretations as to the legality under various rules in certain jurisdictions.
However, the calculation of such tax exposures involves the application of complex tax laws and regulations in many jurisdictions, as well as interpretations as to the legality under various rules in certain jurisdictions.
The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, effectively use artificial intelligence (AI) and machine learning capabilities, successfully complete clinical trials, obtain regulatory approvals in the United States and abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property protection for our products, and gain and maintain market acceptance of our products.
The results of our product development efforts may be affected by a number of factors, including our ability to anticipate customer needs, innovate and develop new products and technologies, effectively use artificial intelligence (“AI”) and machine learning capabilities, successfully complete clinical trials, obtain regulatory approvals in the United States and abroad, manufacture products in a cost-effective manner, obtain appropriate intellectual property protection for our products, gain and maintain market acceptance of our products, and comply with existing and future regulatory requirements.
Our inability to realize all of the anticipated benefits from the 2020 Pro gram could have a material adverse effect on our business, results of operations, cash flows and financial condition. 22 Table of Contents Risks Related to Government Regulation As a medical device and drug manufacturer, we operate in a highly regulated industry, and non-compliance with applicable laws or regulations could adversely affect our financial condition and results of operations.
Our inability to realize all of the anticipated benefits from the market and regional alignment initiative could have a material adverse effect on our business, results of operations, cash flows and financial condition. 22 Table of Contents Risks Related to Government Regulation As a medical device and drug manufacturer, we operate in a highly regulated industry, and non-compliance with applicable laws or regulations could adversely affect our financial condition and results of operations.
As of April 30, 2024, we were in compliance with the covenants pursuant to our 2024 Revised Credit Facilities, and we currently forecast that we will be in compliance with these covenants through the period ending March 29, 2025. The conditional conversion feature of the 2026 Notes, if triggered, may adversely affect our financial condition and operating results.
As of March 29, 2025, we were in compliance with the covenants pursuant to our 2024 Revised Credit Facilities, and we currently forecast that we will be in compliance with these covenants through the period ending March 28, 2026. 25 Table of Contents The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and operating results.
We make diligent efforts to ensure that the provider of these outsourced services is observing proper internal control practices. However, there are no guarantees that failures will not occur. Accordingly, we are subject to the risks associated with the vendor’s ability to successfully provide the necessary services to meet our needs.
We make diligent efforts to ensure that the provider of these outsourced services is observing proper internal control practices. However, there are no guarantees that failures will not occur, including as a result of cyber-attacks. Accordingly, we are subject to the risks associated with the vendor’s ability to successfully provide the necessary services to meet our needs.
Our vascular closure devices, for example, are often perceived as physician preference devices with a relatively higher price point compared to certain vascular closure alternatives such as sutures or manual compression, and purchases are commonly made by a hospital only after approval by its value analysis committee.
This pressure impacts our Hospital and Blood Center businesses. Our vascular closure devices, for example, are often perceived as physician preference devices with a relatively higher price point compared to certain vascular closure alternatives such as sutures or manual compression, and purchases are commonly made by a hospital only after approval by its value analysis committee.
In the future, the FDA may determine that our products will require more costly, lengthy and uncertain de novo classification or PMA processes. Modifications to Class III devices, like our vascular closure products, may require additional clinical studies or supplemental PMA submissions.
In the future, the FDA may determine that our products, as they currently exist or as they may be changed in the future, will require more costly, lengthy and uncertain de novo classification or PMA processes. Modifications to Class III devices, like our vascular closure products, may require additional clinical studies or supplemental PMA submissions.
In April 2024, subsequent to the fiscal year ended March 30, 2024, the Company entered into a second amended and restated credit agreement with certain lenders to refinance the existing senior unsecured term loan and senior unsecured revolving credit facility and extend their maturity date through April 2029.
In April 2024, the Company entered into a second amended and restated credit agreement with certain lenders to refinance the existing senior unsecured term loan and senior unsecured revolving credit facility and extend their maturity date through April 2029.
These outcomes may in turn result in customers transitioning to available competitive products, loss of market share, negative publicity, reputational damage, loss of customer confidence or other negative consequences (including a decline in stock price). We may not realize the benefits we expect from our Operational Excellence Program.
These outcomes may in turn result in customers transitioning to available competitive products, loss of market share, negative publicity, reputational damage, loss of customer confidence or other negative consequences (including a decline in stock price). We may not realize the benefits we expect from cost reduction initiatives.
Certain provisions in the 2026 Notes and the Indenture could make a third party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then noteholders will have the right to require us to repurchase their 2026 Notes for cash.
Certain provisions in the Notes and the Indentures could make a third party attempt to acquire us more difficult or expensive. For example, if a takeover constitutes a fundamental change, then noteholders will have the right to require us to repurchase 26 Table of Contents their Notes for cash.
The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan and a $750.0 million senior unsecured revolving credit facility (together, the “2024 Revised Credit Facilities”).
The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan and a $750.0 million senior unsecured revolving credit facility, or together, the 2024 Revised Credit Facilities.
Any failure, or perceived failure, to achieve against our corporate responsibility initiatives or to establish goals that align with stakeholder expectations could result in declines in our market share and have an adverse impact on our business, financial condition or results of operations, including as a result of reputational harm, an inability to attract customers, and an inability to attract and retain top talent.
Any failure, or perceived failure, to achieve against our corporate responsibility initiatives or to establish goals that align with stakeholder expectations could result in declines in our market share and have an adverse impact on our business, financial condition or results of operations, including as a result of reputational harm, an inability to attract customers, and an inability to attract and retain top talent. 30 Table of Contents Climate change, or legal, regulatory or market measures to address climate change, could adversely affect our business, results of operations and financial condition.
Wh ile we have implemented cost containment measures, selective price increases and taken other actions to offset these inflationary pressures in our global supply chain, we may not be able to completely offset all the increases in our operational costs.
Wh ile we have implemented cost containment measures, selective price increases and taken other actions to offset these inflationary pressures and potential limitations in our global supply chain, we may not be able to completely offset all the increases in our operational costs and ensure the continued availability of materials we use.
Additionally, our results of operations could be neg atively impacted by volatility in the cost or availability of these and other raw materials and components used in our products that, in turn, increase the costs of producing and distributing our products.
Our results of operations could be materially neg atively impacted by volatility in the cost or availability of plastic raw materials used in our disposable products as well as other raw materials and components used in our products that, in turn, increase the costs of producing and distributing our products.
Consolidation of healthcare providers and blood collectors, healthcare cost containment pressures, government payment and delivery system reforms and changes in private payer policies could decrease demand for our products, the prices which customers are willing to pay for those products and/or the number of procedures performed using our devices, which could have an adverse effect on our business, financial condition and results of operations.
Consolidation of healthcare providers and blood collectors, healthcare cost containment pressures, government payment and delivery system reforms and changes in private payer policies could decrease demand for our products, the prices which customers are willing to pay for those products and/or the number of procedures performed using our devices, which could have an adverse effect on our business, financial condition and results of operations. 20 Table of Contents Political, economic and policy influences are causing the healthcare and blood collection industries to make substantial structural and financial changes that affect our results of operations.
Tariffs and other protectionist measures directed at China and other markets, as well as prolonged uncertainty regarding such measures as administrations change, may have adverse effects on our ability to source, manufacture and distribute products, or receive payments, in a timely and cost effective manner, thereby adversely affecting our business.
Tariffs and other measures directed at China, Mexico, Canada and other markets enacted by the U.S., countervailing measures that may be enacted by various countries, as well as prolonged uncertainty regarding such measures as administrations change, may have adverse effects on our ability to source, manufacture and distribute products, or receive payments, in a timely and cost-effective manner, thereby adversely affecting our business.
We may not have sufficient funds to satisfy all amounts due under the other indebtedness and the Notes. 25 Table of Contents Even if holders do not elect to convert their 2026 Notes, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of the 2026 Notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.
Even if holders do not elect to convert their Notes, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of the Notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.
Personal injuries relating to the use of our products can also result in significant product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in regulatory approval of new products or the imposition of post-market approval requirements.
Personal injuries relating to the use of our products can also result in significant product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in regulatory approval of new products or the imposition of post-market approval requirements. If our business development activities are unsuccessful, we may not realize the intended benefits.
While we have not experienced significant shortages in the past, any interruption in the supply for certain plastics could have a material impact on our business by limiting our ability to manufacture and sell the products that represent a significant portion of our revenues.
While we have not experienced significant shortages in the past, any interruption in the supply for plastics and other raw materials used in our products could have a material impact on our business by limiting our ability to manufacture and sell products.
While we believe that our current product liability insurance coverage is sufficient, there is no assurance that such coverage will be adequate to cover incurred liabilities or that we will be able to obtain acceptable product and professional liability coverage in the future.
Adverse events associated with these products could increase the frequency or cost of such payments. While we believe that our current product liability insurance coverage is sufficient, there is no assurance that such coverage will be adequate to cover incurred liabilities or that we will be able to obtain acceptable product and professional liability coverage in the future.
If our business development activities are unsuccessful, we may not realize the intended benefits. We have sought and in the future may seek to supplement our organic growth through strategic acquisitions, investments and alliances, including our recent acquisitions of OpSens Inc. and Attune Medical.
We have sought and in the future may seek to supplement our organic growth through strategic acquisitions, investments and alliances, including our recent acquisitions of OpSens Inc. and Attune Medical.
We have also sought and in the future may seek to divest certain assets deemed non-core to our long-term strategic objectives. Such transactions are inherently risky and require significant effort and management attention.
We have also sought and in the future may seek to divest certain assets deemed non-core to our long-term strategic objectives, including our recent divestiture of the Whole Blood product line and related assets within our Blood Center business unit. Such transactions are inherently risky and require significant effort and management attention.
Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy, or other significant disruption.
Similar to other large multi-national companies, the size and complexity of our information technology systems makes them vulnerable to a cyber-attack, malicious intrusion, breakdown, destruction, loss of data privacy, or other significant disruption. We also may face operational interruptions as we continue to upgrade our global enterprise resource planning system.
Risks Related to Intellectual Property and Litigation There is a risk that our intellectual property may be subject to misappropriation in some countries. Certain countries, particularly China and Russia, do not enforce compliance with laws that protect intellectual property rights with the same degree of vigor as is available under the U.S. and European systems of justice.
Certain countries, particularly China and Russia, do not enforce compliance with laws that protect intellectual property rights with the same degree of vigor as is available under the U.S. and European systems of justice.
To the extent we or our contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, we may be unable to transition to alternative internal or external resources or methods in a timely or cost effective manner, or at all, which could have a material impact on our results of operations and financial condition. 21 Table of Contents In addition, we manufacture our vascular closure devices under a shelter plan service agreement with Offshore International Incorporated (d/b/a Tetakawi) pursuant to which we lease our manufacturing facility in Guaymas, Mexico.
To the extent we or our contract sterilizers are unable to sterilize our products, whether due to capacity, availability of materials for sterilization, regulatory or other constraints, including federal and state regulations on the use of ethylene oxide, we may be unable to transition to alternative internal or external resources or methods in a timely or cost effective manner, or at all, which could have a material impact on our results of operations and financial condition.
It also puts price pressure on our U.S. Blood Center customers who are also facing reduced demand for red cells. Our Blood Center customers have responded to this pressure by creating their own group purchasing organizations and resorting to single source tenders to create incentives for suppliers, including us, to significantly reduce prices.
Our Blood Center customers have responded to this pressure by creating their own group purchasing organizations and resorting to single source tenders to create incentives for suppliers, including us, to significantly reduce prices.
If this were to occur, we may be subject to an injunction or to payment of royalties, or both, which may adversely affect our ability to market the affected product or otherwise have an adverse effect on our results of operations.
If this were to occur, we may be subject to an injunction or to payment of royalties, or both, which may adversely affect our ability to market the affected product or otherwise have an adverse effect on our results of operations. In addition, competitors may patent technological advances that may give them a competitive advantage or create barriers to entry.
There can be no assurance that any share repurchases will enhance shareholder value because the market price of our common stock may decline below the levels at which we repurchased our common stock. Although our share repurchase program is intended to enhance long-term shareholder value, short-term stock price fluctuations could reduce the program’s effectiveness.
There can be no assurance that any share repurchases will enhance shareholder value because the market price of our common stock may decline below the levels at which we repurchased our common stock.
Refer to Note 7, Earnings per Share , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K for additional information. Our business could be negatively impacted by corporate responsibility matters.
Although our share repurchase program is intended to enhance long-term shareholder value, short-term stock price fluctuations could reduce the program’s effectiveness Refer to Note 7, Earnings per Share , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K for additional information. Our business could be negatively impacted by corporate responsibility matters.
If we are unable to retain qualified representatives or maintain the necessary regulatory approvals, we will not be able to continue to sell products in these markets.
If we are unable to retain qualified representatives or maintain the necessary regulatory approvals, we will not be able to continue to sell products in these markets. We are also exposed to a higher degree of financial risk if we extend credit to customers in these economies.
We are exposed to fluctuations in currency exchange rates, which could adversely affect our cash flows and results of operations. International revenues and expenses account for a substantial portion of our operations. In fiscal 2024, our international revenues accounted for 25.9% of our total revenues. The exposure to fluctuations in currency exchange rates takes different forms.
International revenues and expenses account for a substantial portion of our operations. In fiscal 2025, our international revenues accounted for 25.7% of our total revenues. The exposure to fluctuations in currency exchange rates takes different forms.
Additionally, we do not maintain third-party insurance coverage for all categories of potential liability, which increases our exposure to unanticipated claims and adverse decisions and these losses could have a material adverse effect on our financial condition, results of operations or liquidity.
Additionally, we do not maintain third-party insurance coverage for all categories of potential liability, which increases our exposure to unanticipated claims and adverse decisions and these losses could have a material adverse effect on our financial condition, results of operations or liquidity. 29 Table of Contents General Risk Factors Our success depends on our ability to attract and retain key personnel needed to successfully operate the business and to plan for future executive transitions.
We do business in over 90 countries and have distributors in approximately 80 of these countries. This exposes us to currency fluctuation, geopolitical risk, economic volatility, anti-corruption laws, export and import restrictions, local regulatory authorities and the laws and medical practices in foreign jurisdictions. U.S. legislation aimed at boosting competitiveness of U.S. businesses may have unintended effects on our business.
We market and sell our products in approximately 95 countries and have distributors in approximately 90 of these countries. This exposes us to currency fluctuation, geopolitical risk, economic volatility, anti-corruption laws, export and import restrictions, local regulatory authorities and the laws and medical practices in foreign jurisdictions.
We are also exposed to a higher degree of financial risk if we extend credit to customers in these economies. 27 Table of Contents In many of the international markets in which we do business, including certain parts of Europe, South America, the Middle East and Asia, our employees, agents or distributors offer to sell our products in response to public tenders issued by various governmental agencies.
In many of the international markets in which we do business, including certain parts of Europe, South America, the Middle East and Asia, our employees, agents or distributors offer to sell our products in response to public tenders issued by various governmental agencies. There is additional risk in selling our products through agents or distributors, particularly in public tenders.
In addition, competitors may patent technological advances that may give them a competitive advantage or create barriers to entry. 28 Table of Contents In order to guard against the risk of infringement of intellectual property rights held by third parties we conduct freedom to operate studies through qualified counsel on all newly developed or acquired technologies.
In order to guard against the risk of infringement of intellectual property rights held by third parties we conduct freedom to operate studies through qualified counsel on all newly developed or acquired technologies.
As described in Note 15, Commitments & Contingencies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K, we are currently party to intellectual property litigation. Our products may be determined to infringe another party’s patent, which could lead to financial losses or adversely affect our ability to market our products.
As described in Note 15, Commitments & Contingencies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K, we are currently party to intellectual property litigation.
While cost savings from the 2020 Program to date have been consistent with our expectations, it is possible that events and circumstances, such as rising interest rates, macroeconomic uncertainty and the related impacts on us, our customers and suppliers could result in our not realizing all of the anticipated benefits or our not realizing the anticipated benefits on our expected timetable.
While cost savings from this initiative to date have been consistent with our expectations, it is possible that events and circumstances, such as financial or strategic difficulties, delays and unexpected costs may occur that could result in our not realizing all of the anticipated benefits or our not realizing the anticipated benefits on our expected timetable.
In recent years, we have experienced inflationary pressures that have significantly increased the cost of raw materials, transportation, construction, services and energy necessary for the production and distribution of our products. Continued uncertainty around inflationary pressures, rising interest rates and macroeconomic conditions have increased the risk of creating new, or exacerbating existing, economic challenges we face.
In recent years, we have experienced inflationary pressures that have significantly increased the cost of raw materials, transportation, construction, services and energy necessary for the production and distribution of our products.
In addition, the existence of the 2026 Notes may encourage short selling by market participants because the conversion of the 2026 Notes could be used to satisfy short positions, or anticipated conversion of the 2026 Notes into shares of our common stock could depress the price of our common stock. 26 Table of Contents Risks Related to Operating Internationally As a substantial amount of our revenue comes from outside the U.S., we are subject to geopolitical events, economic volatility, violations of anti-corruption laws, export and import restrictions and tariffs, decisions by local regulatory authorities and the laws and medical practices in foreign jurisdictions.
Risks Related to Operating Internationally As a substantial amount of our revenue comes from outside the U.S., we are subject to geopolitical events, economic volatility, violations of anti-corruption laws, export and import restrictions and tariffs, decisions by local regulatory authorities and the laws and medical practices in foreign jurisdictions.
Risk Factors, as well as economic and geopolitical conditions in general and to variability in the prevailing sentiment regarding our operations or business prospects, as well as, among other 29 Table of Contents things, changing investment priorities of our shareholders.
Risk Factors, as well as economic and geopolitical conditions in general and to variability in the prevailing sentiment regarding our operations or business prospects, as well as, among other things, changing investment priorities of our shareholders. Because the market price of our common stock fluctuates significantly, shareholders may not be able sell their shares at attractive prices.
Bank National Association, as trustee (the “Trustee”) and us (the “Indenture”)), at a repurchase price equal to the principal amount of the 2026 Notes to be repurchased, plus accrued and unpaid special interest, if any, to but not including, the fundamental change repurchase date.
In addition, holders of our Notes will have the right to require us to repurchase their Notes upon the occurrence of a fundamental change (as defined in the applicable indenture (each, an “Indenture”)), at a repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid special interest, if any, to but not including, the fundamental change repurchase date.
There is additional risk in selling our products through agents or distributors, particularly in public tenders. If they misrepresent our products, do not provide appropriate service and delivery, or commit a violation of local or U.S. law, our reputation could be harmed and we could be subject to fines, sanctions or both.
If they misrepresent our products, do not provide appropriate service and delivery, or commit a violation of local or U.S. law, our reputation could be harmed and we could be subject to fines, sanctions or both. We are exposed to fluctuations in currency exchange rates, which could adversely affect our cash flows and results of operations.
Such changes may also apply retroactively to our historical operations and result in taxes greater than the amounts estimated and recorded in our financial statements.
Such changes may also apply prospectively or retroactively to our historical operations and result in taxes greater than the amounts estimated and recorded in our financial statements, and any such changes could have a material impact on our effective tax rate and on our business, results of operations, financial condition, and cash flows.
There has been increased focus by federal, international, state and local regulatory and legislative bodies to combat and/or limit the effects of climate change.
In addition, access to and pricing of certain natural resources, such as water, could impact our manufacturing operations. There has been increased focus by federal, international, state and local regulatory and legislative bodies and by other stakeholders such as customers and investors to combat and/or limit the effects of climate change.
Extreme weather or other conditions could adversely impact our operations and supply chain, including the variability and cost of raw materials and components required for the operation of our business. In addition, access to and pricing of certain natural resources, such as water, could impact our manufacturing operations.
The long-term effects of climate change are difficult to predict and may be widespread. Extreme weather or other conditions could adversely impact our operations and supply chain, including the variability and cost of raw materials and components required for the operation of our business.
We are also subject to tax audits in various jurisdictions and tax authorities may disagree with certain positions we have taken and assess additional taxes. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could adversely affect our business, results of operations and cash flows.
Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations, which could adversely affect our business, results of operations and cash flows. Risks Related to Intellectual Property and Litigation There is a risk that our intellectual property may be subject to misappropriation in some countries.
For example, we rely on physicians and healthcare providers to properly and correctly use our products on patients. If these physicians or healthcare providers are not properly trained, are negligent in using our products or use our products “off-la bel,” the capabilities of our products may be diminished or the patient may suffer critical injury.
Additionally, if the health care professionals that utilize our products are not properly trained, are negligent in using our products or use our products “off-label,” the capabilities of our products may be diminished or the patient may suffer critical injury.
We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital.
We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital. We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThis risk assessment is heightened with respect to vendors or business partners that have access to personal information that we collect, maintain or use. We evaluate cybersecurity risk as part of our broader enterprise risk framework.
Biggest changeThis risk 31 Table of Contents assessment is heightened with respect to vendors or business partners that have access to personal information that we collect, maintain or use. We evaluate cybersecurity risk as part of our broader enterprise risk framework.
Our Board oversees Haemonetics’ enterprise-wide approach to risk management while our management team is responsible for managing risk on a day-to-day basis and for bringing to the Board’s attention material risks facing the Company, including with respect to cybersecurity threats.
Our Board of Directors oversees Haemonetics’ enterprise-wide approach to risk management while our management team is responsible for managing risk on a day-to-day basis and for bringing to the Board’s attention material risks facing the Company, including with respect to cybersecurity threats.
Our global cybersecurity program is aligned to the National Institute of Standards and Technology (NIST) Cybersecurity Framework and is certified to the ISO 27001 global standard on Information Security Management. Our cybersecurity program is closely integrated with our QMS under the ISO 13485 standard.
Our global cybersecurity program is aligned to the National Institute of Standards and Technology (“NIST”) Cybersecurity Framework and is certified to the ISO 27001 global standard on Information Security Management. Our cybersecurity program is closely integrated with our QMS under the ISO 13485 standard.
Management also reports on these programs to the Audit Committee as 31 Table of Contents needed and periodically reviews with our Technology Committee certain aspects of new and existing products as they relate to quality, safety and cybersecurity.
Management also reports on these programs to the Audit Committee as needed and periodically reviews with our Technology Committee certain aspects of new and existing products as they relate to quality, safety and cybersecurity.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe following is a summary of our facilities as of March 30, 2024 (in approximate square feet): Owned Leased Total U.S. 165,385 638,749 804,134 International 378,000 303,903 681,903 Total 543,385 942,652 1,486,037
Biggest changeThe following is a summary of our facilities as of March 29, 2025 (in approximate square feet): Owned Leased Total U.S. — 433,688 433,688 International 378,000 264,526 642,526 Total 378,000 698,214 1,076,214
ITEM 2. PROPERTIES As of March 30, 2024, our global headquarters are located in Boston, Massachusetts and our principal manufacturing centers are located in Pennsylvania and California within the U.S., as well as internationally in Mexico, M alaysia and Canada. Our products are distributed worldwide from primary distribution centers in Tennessee, Utah and Switzerland, as well as smaller locations globally.
ITEM 2. PROPERTIES As of March 29, 2025, our global headquarters are located in Boston, Massachusetts and our principal manufacturing centers are located in Pennsylvania within the U.S., as well as internationally in Mexico, Malaysia and Canada. Our products are distributed worldwide from our primary distribution centers in Utah and Pennsylvania, as well as smaller locations globally.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeITEM 3. LEGAL PROCEEDINGS Information with respect to this Item may be found in Note 15, Commitments & Contingencies, to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K, which is incorporated herein by reference. ITEM 4. MINE SAFETY DISCLOSURES None. PART II
Biggest changeITEM 3. LEGAL PROCEEDINGS Information with respect to this Item may be found in Note 15, Commitments & Contingencies, to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K, which is incorporated herein by reference.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeUnder the Company’s share repurchase program, shares may be repurchased in accordance with applicable laws both on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Exchange Act, and in privately negotiated transactions.
Biggest changeUnder the share repurchase program, the Company is authorized to repurchase, from time to time, outstanding shares of common stock in accordance with applicable laws on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, and in privately negotiated transactions.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common sto ck is quoted on the New York Stock Exchange under the symbol “HAE.” As of March 30, 2024, we had 101 stockholders of record.
ITEM 5. MARKET FOR THE REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information Our common sto ck is quoted on the New York Stock Exchange under the symbol “HAE.” As of March 29, 2025, we had 96 stockholders of record .
Issuer Purchases of Equity Securities In August 2022, the Company’s Board of Directors approved a three-year share repurchase program authorizing the repurchase of up to $300.0 million of the Company’s common stock from time to time, based on market conditions, through August 2025.
Issuer Purchases of Equity Securities In August 2022, the Company announced that its Board of Directors had approved a three-year share repurchase program authorizing the repurchase of up to $300.0 million of Haemonetics common stock (the “Share Repurchase Authorization”), based on market conditions, through August 2025.
Removed
In November 2022, the Company completed a $75.0 million repurchase of its common stock pursuant to an accelerated share repurchase agreement (“ASR”) entered into with Citibank N.A. in August 2022. As of March 30, 2024, the total remaining authorization for repurchases of the Company’s common stock under the share repurchase program was $225.0 million. ITEM 6.
Added
In February 2025, the Company entered into an accelerated share repurchase agreement (“ASR”) with Goldman Sachs & Co. (“Goldman Sachs”) to repurchase $150.0 million o f the Company’s common stock.
Added
Pursuant to the terms of the ASR, in February 2025, the Company paid Goldman Sachs $150.0 million in cash and received an initial delivery of 2.0 million shares of the Company’s common stock based on the closing market price on the New York Stock Exchange on February 7, 2025 of $59.34.
Added
This initial delivery of shares represented approximately 80% of the notional amount of the ASR. The ASR was completed in April 2025, subsequent to the end of the fourth quarter of fiscal 2025, and 0.4 million additional shares were delivered upon settlement. As of March 29, 2025, we have fully funded the $300.0 million Share Repurchase Authorization.
Added
The following table provides information on the Company’s share repurchases during the fourth quarter of fiscal 2025: Total Number of Shares Purchased Average Price Paid per Share Total Number of Shares Purchased as Part of Publicly Announced Program Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program (in millions) December 29, 2024 – January 25, 2025 — $ — — $ 150.0 January 26, 2025 – February 22, 2025 2,022,245 $ 59.34 2,022,245 $ — February 23, 2025 – March 29, 2025 — $ — — $ — Total 2,022,245 $ 59.34 2,022,245 Share Repurchase Authorization In April 2025 the Company’s Board of Directors approved a new share repurchase authorization of up to $500 million of the Company’s common stock over the next three years.
Added
This new share repurchase program will help to offset the dilutive impact of recent and future employee equity grants. In addition to this share repurchase activity, the Company’s capital allocation strategy continues to prioritize funding of planned internal investments to support the business as well as inorganic opportunities to accelerate its long-term growth plans.
Added
Under the share repurchase program, the Company is authorized to repurchase, from time to time, outstanding shares of common stock in accordance with applicable laws on the open market, including under trading plans established pursuant to Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, and in privately negotiated transactions.
Added
The actual timing, number and value of shares repurchased will be determined by the Company at its discretion and will depend on a number of factors, including market conditions, applicable legal requirements and compliance with the terms of loan covenants.
Added
The share repurchase program may be suspended, modified or discontinued at any time, and the Company has no obligation to repurchase any amount of its common stock under the program. ITEM 6. RESERVED 33 Table of Contents

Item 7. Management's Discussion & Analysis

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

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Biggest changeNet Revenues by Business Unit Fiscal Year (In thousands) 2024 2023 Reported growth Currency impact Constant currency growth (1) Revenues by business unit Plasma 565,944 496,923 13.9 % 0.1 % 13.8 % Apheresis 204,086 200,546 1.8 % (3.1) % 4.9 % Whole Blood 72,058 79,416 (9.3) % (0.6) % (8.7) % Blood Center 276,144 279,962 (1.4) % (2.4) % 1.0 % Interventional Technologies (2) 174,285 126,717 37.5 % (0.2) % 37.7 % Hemostasis Management 159,139 138,854 14.6 % (0.6) % 15.2 % Other (3) 111,938 106,160 5.4 % (0.7) % 6.1 % Hospital 445,362 371,731 19.8 % (0.5) % 20.3 % Net business unit revenues 1,287,450 1,148,616 12.1 % (0.7) % 12.8 % Service 21,605 20,044 7.8 % 0.5 % 7.3 % Total net revenues $ 1,309,055 $ 1,168,660 12.0 % (0.7) % 12.7 % (1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency.
Biggest changePlease see the section entitled “Foreign Exchange” in this discussion for a more complete explanation of how foreign currency affects our business and our strategy for managing this exposure. 39 Table of Contents Net Revenues by Business Unit Fiscal Year (In thousands) 2025 2024 Reported growth Currency impact Constant currency growth (1) Revenues by business unit (2) Plasma (3) 535,431 569,535 (6.0) % (0.1) % (5.9) % Apheresis 213,134 211,173 0.9 % (1.5) % 2.4 % Whole Blood 47,990 72,058 (33.4) % (0.1) % (33.3) % Blood Center 261,124 283,231 (7.8) % (1.1) % (6.7) % Interventional Technologies (4) 255,019 174,285 46.3 % (0.6) % 46.9 % Blood Management Technologies (5) 309,250 282,004 9.7 % (0.2) % 9.9 % Hospital 564,269 456,289 23.7 % (0.3) % 24.0 % Total net revenues $ 1,360,824 $ 1,309,055 4.0 % (0.3) % 4.3 % (1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency.
We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital. For that purpose, “Plasma” includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers. “Blood Center” includes blood collection and processing devices and disposables for red cells, platelets and whole blood.
We view our operations and manage our business in three principal reporting segments: Plasma, Blood Center and Hospital. For that purpose, “Plasma” includes plasma collection devices and disposables, donor management software and supporting software solutions sold to plasma customers. “Blood Center” includes blood collection and processing devices and disposables for plasma, red cells, and platelets.
Future events that could have a negative impact on the levels of excess fair value over carrying value of our reporting units include, but are not limited to, the following: • Decreases in estimated market sizes or market growth rates due to greater-than-expected declines in procedural volumes, pricing pressures, product actions and/or competitive technology developments, • Declines in our market share and penetration assumptions due to increased competition, an inability to develop or launch new and next-generation products and technology features in line with our commercialization strategies and market and/or regulatory conditions that may cause significant launch delays or product recalls, • Decreases in our forecasted profitability due to an inability to implement successfully and achieve timely and sustainable cost improvement measures consistent with our expectations, 44 Table of Contents • Changes in our reporting units or in the structure of our business as a result of future reorganizations, acquisitions or divestitures of assets or businesses and • Increases in our market-participant risk-adjusted weighted average cost of capital and increases in our market-participant tax rate and/or changes in tax laws or macroeconomic conditions.
Future events that could have a negative impact on the levels of excess fair value over carrying value of our reporting units include, but are not limited to, the following: • Decreases in estimated market sizes or market growth rates due to greater-than-expected declines in procedural volumes, pricing pressures, product actions and/or competitive technology developments, • Declines in our market share and penetration assumptions due to increased competition, an inability to develop or launch new and next-generation products and technology features in line with our commercialization strategies and market and/or regulatory conditions that may cause significant launch delays or product recalls, • Decreases in our forecasted profitability due to an inability to implement successfully and achieve timely and sustainable cost improvement measures consistent with our expectations, • Changes in our reporting units or in the structure of our business as a result of future reorganizations, acquisitions or divestitures of assets or businesses and • Increases in our market-participant risk-adjusted weighted average cost of capital and increases in our market-participant tax rate and/or changes in tax laws or macroeconomic conditions.
Each quarter until such contingent amounts are earned, the fair value of the liability is remeasured at each reporting period and adjusted as a component of operating expenses based on changes to the underlying assumptions.
At each reporting period until such contingent amounts are earned, the fair value of the liability is remeasured and adjusted as a component of operating expenses based on changes to the underlying assumptions.
(“OpSens”), a medical device cardiology-focused company delivering solutions based on its proprietary optical technology, pursuant to which, among other things, the Company agreed to acquire all of the issued and outstanding common shares of OpSens. On December 12, 2023, the Company completed its acquisition of OpSens for total consideration of approximately $254.5 million, or $243.9 million, net of cash acquired.
(“OpSens”), a medical device cardiology-focused company delivering solutions based on its proprietary optical technology, pursuant to which, among other things, we agreed to acquire all of the issued and outstanding common shares of OpSens. On December 12, 2023, we completed our acquisition of OpSens for total consideration of approximately $254.5 million, or $243.9 million, net of cash acquired.
However, certain jurisdictions such as Egypt and the United Kingdom have begun to collect or are considering collection of plasma for fractionation for their local needs, which could expand the Plasma market. Blood Center Market In the Blood Center market, we sell automated blood component and manual whole blood collection systems.
However, certain jurisdictions such as Egypt and the United Kingdom have begun to collect or are considering collection of plasma for fractionation for their local needs, which could expand the Plasma market. Blood Center Market In the Blood Center market, we sell automated blood component collection systems.
Conversely, in the more mature percutaneous coronary intervention (PCI) market, the steady demand for sensor-guided technologies such as OptoWire remains driven by persistent prevalence of coronary artery disease, emphasizing the need for advanced diagnostic and therapeutic interventions.
Conversely, in the more mature percutaneous coronary intervention (“PCI”) market, the steady demand for sensor-guided technologies such as OptoWire remains driven by persistent prevalence of coronary artery disease, emphasizing the need for advanced diagnostic and therapeutic interventions.
OpSens’ core products include the SavvyWire ® , a sensor-guided 3-in-1 guidewire for TAVR procedures, advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients; and the OptoWire ® , a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (FFR) and diastolic pressure ratio (dPR) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.
OpSens’ core products include the SavvyWire ® , a sensor-guided 3-in-1 guidewire for TAVR procedures, advancing the workflow of the procedure and enabling potentially shorter hospital stays for patients; and the OptoWire ® , a pressure guidewire that aims to improve clinical outcomes by accurately and consistently measuring Fractional Flow Reserve (“FFR”) and diastolic pressure ratio (“dPR”) to aid clinicians in the diagnosis and treatment of patients with coronary artery disease.
Conditions indicating that an impairment exists include but are not limited to a change in the competitive landscape, internal decisions to pursue new or different technology strategies, a loss of a significant customer or a significant change in the marketplace including prices paid for our products or the size of the market for our products.
Conditions indicating that an impairment exists include 47 Table of Contents but are not limited to a change in the competitive landscape, internal decisions to pursue new or different technology strategies, a loss of a significant customer or a significant change in the marketplace including prices paid for our products or the size of the market for our products.
Loans under the 2024 Revised Credit Facilities will initially bear interest at an annual rate equal to the Adjusted Term SOFR Rate (as specified in the second amended and restated credit agreement), which is subject to a floor of 0.0%, plus an applicable rate ranging from 1.125% to 1.750% based on the Company’s consolidated net leverage ratio (as specified in the second amended and restated credit agreement) at the applicable measurement date.
Loans under the 2024 Revised Credit Facilities bear interest at an annual rate equal to the Adjusted Term SOFR Rate (as specified in the second amended and restated credit agreement), which is subject to a floor of 0%, plus an applicable rate ranging from 1.125% to 1.750% based on the our consolidated net leverage ratio (as specified in the second amended and restated credit agreement) at the applicable measurement date.
Foreign Exchange During fiscal 2024, 25.9% of our sales were generated outside the U.S., generally in foreign currencies, yet our reporting currency is the U.S. Dollar. We also incur certain manufacturing, marketing and selling costs in international markets in local currency. Our primary foreign currency exposures relate to sales denominated in Japanese Yen, Euro and Chinese Yuan.
Foreign Exchange During fiscal 2025, 25.7% of our sales were generated outside the U.S., generally in foreign currencies, yet our reporting currency is the U.S. Dollar. We also incur certain manufacturing, marketing and selling costs in international markets in local currency. Our primary foreign currency exposures relate to sales denominated in Japanese Yen, Euro and Chinese Yuan.
Concentration of Credit Risk While approximately 48% of our revenue during fiscal 2024 was generated by our ten largest customers, concentrations of credit risk with respect to trade accounts receivable are generally limited due to our large number of customers and their diversity across many geographic areas. Certain markets and industries, however, can expose us to concentrations of credit risk.
Concentration of Credit Risk While approximately 42% of our revenue during fiscal 2025 was generated by our ten largest customers, concentrations of credit risk with respect to trade accounts receivable are generally limited due to our large number of customers and their diversity across many geographic areas. Certain markets and industries, however, can expose us to concentrations of credit risk.
The percentage of revenue generated in our principal operating regions is summarized below: Fiscal Year 2024 2023 United States 74.1 % 72.1 % Japan 4.5 % 5.2 % Europe 12.2 % 13.4 % Rest of Asia 8.2 % 8.9 % Other 1.0 % 0.4 % Total 100.0 % 100.0 % International sales are generally conducted in local currencies, primarily Japanese Yen, Euro and Chinese Yuan.
The percentage of revenue generated in our principal operating regions is summarized below: Fiscal Year 2025 2024 United States 74.3 % 74.1 % Japan 4.6 % 4.5 % Europe 12.9 % 12.2 % Rest of Asia 6.8 % 8.2 % Other 1.4 % 1.0 % Total 100.0 % 100.0 % International sales are generally conducted in local currencies, primarily Japanese Yen, Euro and Chinese Yuan.
The Company financed the acquisition through a combination of cash on hand and borrowings under its senior unsecured revolving credit facility. OpSens offers commercially and clinically validated optical technology for use primarily in interventional cardiology.
We financed the acquisition through a combination of cash on hand and borrowings under our senior unsecured revolving credit facility. OpSens offers commercially and clinically validated optical technology for use primarily in interventional cardiology.
Our products also address many of the vascular closure needs for the structural heart (contralateral access sites) and electrophysiology procedures. Our Vascular Closure market continues to grow with the VASCADE MVP launch in Japan in September 2023.
Our products also address many of the vascular closure needs for the structural heart (“contralateral access sites”) and electrophysiology procedures. Our Vascular Closure market continues to grow with the VASCADE MVP launch in Japan in September 2023.
The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan, the proceeds of which, along with $12.5 million of cash on hand, have been used to retire the balance of the term loan under the 2022 Revised Credit Facilities, and a $750.0 million senior unsecured revolving credit facility (together, the “2024 Revised Credit Facilities”), which constitutes a $330.0 million increase from the revolving credit facility under the 2022 Revised Credit Facilities.
The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan, the proceeds of which, along with $12.5 million of cash on hand, were used to retire the balance of the term loan under the 2022 Revised Credit Facilities, and a $750.0 million senior unsecured revolving credit facility (together, the “2024 Revised Credit Facilities”).
Our strategic investment in sensor-guided technologies positions us to capitalize on these trends, leveraging innovation to address evolving needs in both high-growth and mature markets while expanding our global market presence through initiatives like obtaining CE mark clearance for our vascular closure systems.
Our strategic investment in sensor-guided technologies positions us to capitalize on these trends, leveraging innovation to address evolving needs in both high-growth and mature markets while expanding our global market presence through initiatives such as obtaining CE mark clearance for our Savvywire.
We utilize forward foreign currency contracts to hedge the anticipated cash flows from transactions denominated in foreign currencies, primarily Japanese Yen and Euro, and to a lesser extent Swiss 43 Table of Contents Franc and Mexican Peso.
We utilize forward foreign currency contracts to hedge the anticipated cash flows from transactions denominated in foreign currencies, primarily Japanese Yen, Mexican Peso and Euro, and to a lesser extent Canadian Dollar and Swiss Franc.
Our reported tax rate is impacted by the jurisdictional mix of earnings in any given period as the foreign jurisdictions in which we operate have tax rates that differ from the U.S. statutory tax rate.
Our reported tax rate differs from the statutory tax rate due to the jurisdictional mix of earnings in any given period as the foreign jurisdictions in which we operate have tax rates that differ from the U.S. statutory tax rate.
Fiscal years 2024 and 2023 included 52 weeks with each quarter having 13 weeks. Net revenues for fiscal 2024 increased 12.0% compared with fiscal 2023. Without the effects of foreign exchange, net revenues increased 12.7% compared with fiscal 2023.
Fiscal years 2025 and 2024 included 52 weeks with each quarter having 13 weeks. Net revenues for fiscal 2025 increased 4.0% compared with fiscal 2024. Without the effects of foreign exchange, net revenues increased 4.3% compared with fiscal 2024.
Geographically, TEG systems have achieved the highest market penetration in North America, Europe and China. However, there are considerable growth opportunities in these as well as other markets, as TEG systems become more established as the standard of care around the wor ld. The HAS-100 and HAS-300 are currently commercialized in China.
Geographically, TEG systems have achieved the highest market penetration in North America and Europe. However, there are considerable growth opportunities in these as well as other markets, as TEG systems become more established as the standard 37 Table of Contents of care around the wor ld.
Management’s Use of Non-GAAP Measures Management uses non-GAAP financial measures, in addition to financial measures in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results.
This information is incorporated by reference herein. 38 Table of Contents Management’s Use of Non-GAAP Measures Management uses non-GAAP financial measures, in addition to financial measures in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”), to monitor the financial performance of the business, make informed business decisions, establish budgets and forecast future results.
Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and/or estimates. Actual results may differ from those estimates.
While all of these significant accounting policies impact our financial condition and results of operations, we view certain of these policies as critical. Policies determined to be critical are those policies that have the most significant impact on our financial statements and require management to use a greater degree of judgment and/or estimates. Actual results may differ from those estimates.
See “Management’s Use of Non-GAAP Measures.” 36 Table of Contents International Operations and the Impact of Foreign Exchange Our principal operations are in the United States, Europe, Japan and other parts of Asia. Our products are marketed in approximately 90 countries around the world through a combination of our direct sales force and independent distributors and agents.
See “Management’s Use of Non-GAAP Measures.” International Operations and the Impact of Foreign Exchange Our principal operations are in the United States, Europe, Japan and other parts of Asia. We market and sell our products in approximately 95 countries through a combination of our direct sales force and independent distributors.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our Business Haemonetics is a global healthcare company dedicated to providing a suite of innovative medical technology solutions that improve the quality, effectiveness and efficiency of care.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our Business Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care.
In April 2024, subsequent to the fiscal year ended March 30, 2024, the Company entered into a second amended and restated credit agreement with certain lenders to refinance the 2022 Revised Credit Facilities and extend their maturity date through April 2029.
On April 30, 2024, we entered into a second amended and restated credit agreement with certain lenders to refinance the 2022 Revised Credit Facilities and extend their maturity date through April 2029.
All tax reserves are analyzed quarterly and adjustments are made as events occur that result in changes in judgment. Contingencies We may become involved in various legal proceedings that arise in the ordinary course of business, including, without limitation, patent infringement, product liability and environmental matters.
All tax reserves are analyzed quarterly and adjustments are made as events occur that result in changes in judgment. Contingencies We are currently involved in or may become involved in various legal proceedings and claims, including, without limitation, patent infringement, product liability, breach of contract and employee-related matters.
RESULTS OF OPERATIONS Net Revenues by Geography Fiscal Year (In thousands) 2024 2023 Reported growth Currency impact Constant currency growth (1) United States $ 970,007 $ 842,897 15.1 % — % 15.1 % International 339,048 325,763 4.1 % (2.4) % 6.5 % Net revenues $ 1,309,055 $ 1,168,660 12.0 % (0.7) % 12.7 % (1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency.
RESULTS OF OPERATIONS Net Revenues by Geography Fiscal Year (In thousands) 2025 2024 Reported growth Currency impact Constant currency growth (1) United States $ 1,010,918 $ 970,007 4.2 % — % 4.2 % International 349,906 339,048 3.2 % (1.5) % 4.7 % Net revenues $ 1,360,824 $ 1,309,055 4.0 % (0.3) % 4.3 % (1) Constant currency growth, a non-GAAP financial measure, measures the change in revenue between the current and prior year periods using a constant currency.
In accordance with U.S. GAAP, we have eliminated the effect of foreign currency throughout our cash flow statement, except for its effect on our cash and cash equivalents. Operating Activities Net ca sh provided by operating activities was $181.8 million during fiscal 2024, a de crease o f $91.3 million as compared with fiscal 2023.
In accordance with U.S. GAAP, we have eliminated the effect of foreign currency throughout our cash flow statement, except for its effect on our cash and cash equivalents. 44 Table of Contents Operating Activities Net ca sh provided by operating activities was $181.7 million during fiscal 2025, relatively flat as compared with fiscal 2024.
Without the effects of foreign exchange, selling, general and administrative expenses increased 14.5% during fiscal 2024.
Without the effects of foreign exchange, selling, general and administrative expenses increased 1.4% during fiscal 2025.
Income Taxes Fiscal Year 2024 2023 % Increase/(Decrease) Reported income tax rate 22.6 % 18.4 % 4.2 % Reported Tax Rate We conduct business globally and report our results of operations in a number of foreign jurisdictions in addition to the U.S.
Income Taxes Fiscal Year 2025 2024 % Increase/(Decrease) Reported income tax rate 20.9 % 22.6 % (1.7) % Reported Tax Rate We conduct business globally and report our results of operations in a number of foreign jurisdictions in addition to the United States.
Adjusted Term SOFR Rate loans are also subject to a credit spread adjustment of 0% per annum. The revolving credit facility carries an unused fee that ranges from 0.125% to 0.250% annually based on the Company’s consolidated net leverage ratio at the applicable measurement date. The 2024 Revised Credit Facilities mature on April 30, 2029.
The revolving credit facility carries an unused fee that ranges from 0.125% to 0.250% a annually based on our consolidated net leverage ratio at the applicable measurement date. The 2024 Revised Credit Facilities mature on April 30, 2029.
In the transcatheter aortic valve replacement (TAVR) market, characterized by high growth, the demand for innovative solutions like SavvyWire is driven by an aging population and increasing prevalence of aortic valve diseases globally.
Sensor-Guided Technologies Market - The market for sensor-guided technologies reflects varying dynamics across different interventional cardiology procedures. In the transcatheter aortic valve replacement (“TAVR”) market, characterized by high growth, the demand for innovative solutions like SavvyWire is driven by an aging population and increasing prevalence of aortic valve diseases globally.
There can be no assurance that the settlement, resolution, or other outcome of one or more matters, including the matters set forth below, during any subsequent reporting period will not 45 Table of Contents have a material adverse effect on the Company’s results of operations or cash flows for that period or on the Company’s financial condition.
There can be no assurance that the settlement, resolution, or other outcome of one or more matters, including the matters set forth below, during any subsequent reporting period will not have a material adverse effect on our results of operations or cash flows for that period or on the our financial condition. 48 Table of Contents Business Combinations We record tangible and intangible assets acquired and liabilities assumed in business combinations under the purchase method of accounting.
Our primary sources of liquidity are cash and cash equivalents, internally generated cash flow from operations and our senior unsecured revolving credit facility. We believe these sources are sufficient to fund our cash requirements over at least the next twelve months and to meet our known long-term cash requirements, including our convertible senior notes due March 1, 2026.
We believe these sources are sufficient to fund our cash requirements over at least the next twelve months and to meet our known long-term cash requirements, including our convertible senior notes due March 1, 2026 and June 1, 2029.
We continually evaluate all receivables for potential collection risks associated with the availability of government funding and reimbursement practices. If the financial condition of customers or the countries’ healthcare systems deteriorate such that their ability to make payments is uncertain, allowances may be required in future periods. Legal Proceedings In accordance with U.S.
If the financial condition of customers or the countries’ healthcare systems deteriorate such that their ability to make payments is uncertain, allowances may be required in future periods. Legal Proceedings In accordance with U.S.
Critical Accounting Policies and Estimates Our significant accounting policies are summarized in Note 2, Summary of Significant Accounting Policies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K. While all of these significant accounting policies impact our financial condition and results of operations, we view certain of these policies as critical.
Critical Accounting Policies and Estimates 46 Table of Contents Our significant accounting policies are summarized in Note 2, Summary of Significant Accounting Policies , to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.
The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions including forecasted cash flows, revenues attributable to existing technology and discount rates.
Amounts paid for each acquisition are allocated to the assets acquired and liabilities assumed based on their fair values at the dates of acquisition. The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions including forecasted cash flows, revenues attributable to existing technology and discount rates.
Interest payments are projected using interest rates in effect as of April 30, 2024, the date the term loan was refinanced. Certain of these projected interest payments may differ in the future based on changes in market interest rates.
Interest payments are projected using interest rates in effect as of March 29, 2025. Certain of these projected interest payments may differ in the future based on changes in market interest rates.
In addition, a portion of our trade accounts receivable outside the U.S. include sales to government-owned or supported healthcare systems in several countries, which are subject to payment delays and local economic conditions. Payment is dependent upon the financial stability and creditworthiness of those countries’ national economies. We have not incurred significant losses on trade accounts or other receivables.
In addition, a portion of our trade accounts receivable outside the U.S. include sales to government-owned or supported healthcare systems in several countries, which are subject to payment delays and local economic conditions.
For a discussion of our material legal proceedings refer to Note 15, Commitments & Contingencies, to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K. Inflation We continue to monitor inflationary pressures generally and raw materials indices that may affect our procurement and production costs.
For a discussion of our material legal proceedings refer to Note 15, Commitments & Contingencies, to the Consolidated Financial Statements in Item 8 of this Annual Report on Form 10-K.
For the year ended March 30, 2024, we recorded income tax expense of $34.3 million on our worldwide pre-tax income of $151.9 million, resulting in a reported tax rate of 22.6%.
For the year ended March 29, 2025, we recorded income tax expense of $44.4 million on our worldwide pre-tax income of $212.1 million, resulting in a reported tax rate of 20.9%.
The Company acquired Attune Medical for total upfront consideration of $160.0 million. The agreement also provides for additional contingent consideration based on sales growth over the next three years and the achievement of certain other milestones. The Company financed the acquisition through a combination of cash on hand and borrowings under its senior unsecured revolving credit facility.
The contingent consideration is based on sales growth over the next three years, which is uncapped, and the achievement of certain other milestones. We financed the acquisition through a combination of cash on hand and borrowings under our senior unsecured revolving credit facility.
The Company incurred charges of $13.9 million in fiscal 2024 related to these initiatives. Market Trends Plasma Market There are two key aspects to the market for our plasma products - the growth in demand for plasma-derived biopharmaceuticals and the limited number of significant biopharmaceutical companies in this market.
Market Trends Plasma Market There are two key aspects to the market for our plasma products - the growth in demand for plasma-derived biopharmaceuticals and the limited number of significant biopharmaceutical companies in this market. Changes in demand for plasma-derived biopharmaceuticals, particularly immunoglobulin, are the key driver of plasma collection volumes in the biopharmaceutical market.
The addition of Attune Medical expands the Hospital business unit’s presence in electrophysiology and complements its Vascular Closure product line. OpSens Inc. On October 10, 2023, the Company entered into an Arrangement Agreement with OpSens Inc.
The addition of our Esophageal Protection product line through this acquisition expands our Hospital business unit’s presence in electrophysiology and complements our Vascular Closure product line within Interventional Technologies, which is included in the Hospital reportable segment. OpSens Inc. On October 10, 2023, we entered into an Arrangement Agreement with OpSens Inc.
The 2026 Notes have an effective interest rate of 0.5% as of March 30, 2024. 40 Table of Contents As of March 30, 2024, we had $178.8 million in cash and cash equivalents, the majority of which is held in the U.S. or in countries from which it can be repatriated to the U.S.
As of March 29, 2025, we had $306.8 million in cash and cash equivalents, the majority of which is held in the U.S. or in countries from which it can be repatriated to the U.S.
Without the effects of foreign exchange, research and development expenses increased 8.1% during fiscal 2024. The increase in fiscal 2024 was primarily due to increased investments into product innovation as well as increased costs associated with the acquisition of OpSens. Selling, General and Administrative Selling, general and administrative expenses increased 14.6% during fiscal 2024 as compared with fiscal 2023.
Without the effects of foreign exchange, research and development expenses increased 15.6% during fiscal 2025. The increase in fiscal 2025 was primarily due to increased headcount as a result of recent acquisitions. Selling, General and Administrative Selling, general and administrative expenses increased 1.2% during fiscal 2025 as compared with fiscal 2024.
The principal amount of the term loan under the 2024 Revised Credit Facilities amortizes quarterly through the maturity date at a rate of 2.5% for the first three years following the closing date, 5.0% for the fourth year following the closing date and 7.5% for the fifth year following the closing date, with the unpaid balance due at maturity.
The principal amount of the term loan under the 2024 Revised Credit Facilities amortizes quarterly through the maturity date at a rate of 2.5% for the first three years following the closing date, 5.0% for the fourth year following the closing date and 7.5% for the fifth year following the closing date, with the unpaid balance due at maturity. 43 Table of Contents At March 29, 2025, $245.3 million was outstanding under the term loan with an effective interest rate of 5.7%, which was netted down by the $5.3 million of remaining debt discount, resulting in a net note payable of $240.0 million.
OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications. The addition of OpSens expands the Hospital business unit portfolio in the interventional cardiology market and is included in the Hospital reportable segment.
OpSens also manufactures a range of fiber optic sensor solutions used in medical devices and other critical industrial applications.
Impairment of Intangible Assets We recognized a $10.4 million impairment of intangible assets in fiscal 2024 related to the enicor GmbH acquisition completed in fiscal 2021 within our Hospital business unit. Interest and Other Expense, Net Interest and other expenses de creased 11.0% during fiscal 2024 as compared with fiscal 2023.
Impairment of Intangible Assets We recognized impairment of intangible assets of $2.4 million and $10.4 million during fiscal 2025 and fiscal 2024, respectively. Impairment of intangible assets in fiscal 2025 related to internally developed software assets. Impairment of intangible assets in fiscal 2024 related to the enicor GmbH acquisition completed in fiscal 2021 within our Hospital business unit.
We continue to explore opportunities to expand the portfolio internationally. 35 Table of Contents Financial Summary Fiscal Year (In thousands, except per share data) 2024 2023 % Increase/(Decrease) Net revenues $ 1,309,055 $ 1,168,660 12.0 % Gross profit $ 691,548 $ 615,097 12.4 % % of net revenues 52.8 % 52.6 % Operating expenses $ 526,665 $ 459,064 14.7 % Operating income $ 164,883 $ 156,033 5.7 % % of net revenues 12.6 % 13.4 % Interest and other expense, net $ (13,018) $ (14,630) (11.0) % Income before provision for income taxes $ 151,865 $ 141,403 7.4 % Provision for income taxes $ 34,307 $ 26,002 31.9 % % of pre-tax income 22.6 % 18.4 % Net income $ 117,558 $ 115,401 1.9 % % of net revenues 9.0 % 9.9 % Net income per share - basic $ 2.32 $ 2.27 2.2 % Net income per share - diluted $ 2.29 $ 2.24 2.2 % Our fiscal year ends on the Saturday closest to the last day of March.
Financial Summary Fiscal Year (In thousands, except per share data) 2025 2024 % Increase/(Decrease) Net revenues $ 1,360,824 $ 1,309,055 4.0 % Gross profit $ 748,958 $ 691,548 8.3 % % of net revenues 55.0 % 52.8 % Operating expenses $ 527,141 $ 526,665 0.1 % Operating income $ 221,817 $ 164,883 34.5 % % of net revenues 16.3 % 12.6 % Interest and other expense, net $ (9,746) $ (13,018) (25.1) % Income before provision for income taxes $ 212,071 $ 151,865 39.6 % Provision for income taxes $ 44,392 $ 34,307 29.4 % % of pre-tax income 20.9 % 22.6 % Net income $ 167,679 $ 117,558 42.6 % % of net revenues 12.3 % 9.0 % Net income per share - basic $ 3.33 $ 2.32 43.5 % Net income per share - diluted $ 3.31 $ 2.29 44.5 % Our fiscal year ends on the Saturday closest to the last day of March.
Overall, we expect a flat to low single-digit decline in this business. • Declining transfusion rates in mature markets due to the development of more minimally invasive procedures with lower associated blood loss, as well as better blood management. • Competition in multi-unit collection technology for automated blood component collection systems has intensified and has negatively impacted our sales in markets where these collections are prevalent. ▪ Industry consolidation through group purchasing organizations has intensified pricing competition particularly in the manual whole blood collection systems.
Within the Blood Center market, we have seen two trends that have negatively impacted growth of the overall marketplace despite the overall increase in aging populations. • Declining transfusion rates in mature markets due to the development of more minimally invasive procedures with lower associated blood loss, as well as better blood management. 36 Table of Contents • Competition in multi-unit collection technology for automated blood component collection systems has intensified and has negatively impacted our sales in markets where these collections are prevalent.
While we sell products around the world, a significant portion of our sales are to a limited number of customers due to relatively limited number of blood collectors. Within the Blood Center market, we have seen three trends that have negatively impacted growth of the overall marketplace despite the overall increase in aging populations.
While we sell products around the world, a significant portion of our sales are to a limited number of customers due to relatively limited number of blood collectors.
During the fiscal years ended March 30, 2024 and April 1, 2023, the Company incurr ed $9.8 million and $11.5 million, respectively, of restructuring and restructuring related costs under this program. 41 Table of Contents Cash Flows Fiscal Year (In thousands) 2024 2023 Net cash provided by (used in): Operating activities $ 181,751 $ 273,058 Investing activities (322,389) (143,788) Financing activities 38,157 (100,364) Effect of exchange rate changes on cash and cash equivalents (1) (3,185) (3,936) Net change in cash and cash equivalents $ (105,666) $ 24,970 (1) The balance sheet is affected by spot exchange rates used to translate local currency amounts into U.S. dollars.
Cash Flows Fiscal Year (In thousands) 2025 2024 Net cash provided by (used in): Operating activities $ 181,725 $ 181,751 Investing activities (161,895) (322,389) Financing activities 108,818 38,157 Effect of exchange rate changes on cash and cash equivalents (1) (685) (3,185) Net change in cash and cash equivalents $ 127,963 $ (105,666) (1) The balance sheet is affected by spot exchange rates used to translate local currency amounts into U.S. dollars.
The amended and restated credit agreement includes a $280.0 million senior unsecured term loan, the proceeds of which have been used to retire the balance of the term loan under the 2018 Credit Facilities, and a $420.0 million senior unsecured revolving credit facility (together, the “2022 Revised Credit Facilities”).
The second amended and restated credit agreement provides for a $250.0 million senior unsecured term loan, the proceeds of which, along with $12.5 million of cash on hand, have been used to retire the balance of the term loan under our prior credit facilities, and a $750.0 million senior unsecured revolving credit facility.
Without the effect of foreign exchange, Blood Center revenue increased 1.0% during fiscal 2024. The decrease in Blood Center’s reported revenue was primarily driven by declines in whole blood disposables and the impact of foreign exchange, partially offset by an increase in apheresis disposables. Hospital Hospital revenue increased 19.8% during fiscal 2024 as compared with fiscal 2023.
Blood Center Blood Center revenue decreased 7.8% during fiscal 2025 as compared with fiscal 2024. Without the effect of foreign exchange, Blood Center revenue decreased 6.7% during fiscal 2025. The decrease in Blood Center’s reported revenue was primarily driven by declines in our Whole Blood business, which was divested in the fourth quarter of fiscal 2025.
The above table does not reflect our long-term liabilities associated with unrecognized tax benefits of $2.9 million recorded in accordance with ASC Topic 740, Income Taxes.
The above table does not reflect our long-term liabilities associated with unrecognized tax benefits of $1.8 million recorded in accordance with ASC Topic 740, Income Taxes. We cannot reasonably make a reliable estimate of the period in which we expect to settle these long-term liabilities due to factors outside of our control, such as tax examinations.
Loans under the 2022 Revised Credit Facilities bear interest at an annual rate equal to the Adjusted Term SOFR Rate (as specified in the amended and restated credit agreement), which is subject to a floor of 0%, plus an applicable rate ranging from 1.125% to 1.750% based on the Company’s consolidated net leverage ratio (as specified in the amended and restated credit agreement) at the applicable measurement date.
The amended and restated credit agreement provided for a $750.0 million senior unsecured term loan and a $420.0 million senior unsecured revolving credit facility (together, the “2022 Revised Credit Facilities”) with applicable interest rates during the period established using an annual rate equal to the Adjusted Term SOFR Rate plus an applicable rate ranging from 1.125% to 1.750% based on our consolidated net leverage ratio, as specified in the agreement.
See “Management's Use of Non-GAAP Measures.” (2) Interventional Technologies includes Vascular Closure and Sensor Guided Technologies product lines of the Hospital business unit. (3) Other includes the Cell Salvage and Transfusion Management product lines of the Hospital business unit. 37 Table of Contents Plasma Plasma revenue increased 13.9% during fiscal 2024 as compared with fiscal 2023.
(4) Interventional Technologies includes Vascular Closure, Sensor -Guided Technologies and Esophageal Protection product lines of the Hospital business. (5) Blood Management Technologies includes Hemostasis Management, Cell Salvage and Transfusion Management product lines of the Hospital business unit. Plasma Plasma revenue decreased 6.0% during fiscal 2025 as compared with fiscal 2024.
This does not eliminate the volatility of foreign exchange rates, but because we generally enter into forward contracts one year out, rates are fixed for a one-year period, thereby facilitating financial planning and resource allocation. These contracts are designated as cash flow hedges.
This does not eliminate the volatility of foreign exchange rates, but because we generally enter into forward contracts into the future, rates are fixed at the time of execution; thereby facilitating financial planning and resource allocation. Hedges are executed on a rolling basis over an 18-month horizon, informed by forecasted net income exposures.
The increase was primarily driven by volume, product mix and productivity savings from the 2020 Program, partially offset by spend on portfolio rationalization initiatives and amortization of inventory fair value step-up related to the OpSens acquisition. 38 Table of Contents Operating Expenses Fiscal Year (In thousands) 2024 2023 % Increase/(Decrease) Research and development $ 54,435 $ 50,131 8.6 % % of net revenues 4.2 % 4.3 % Selling, general and administrative $ 431,780 $ 376,675 14.6 % % of net revenues 33.0 % 32.2 % Amortization of acquired intangible assets $ 32,031 $ 32,640 (1.9) % % of net revenues 2.4 % 2.8 % Gains on divestiture and sale of assets $ (2,000) $ (382) n/m % of net revenues (0.2) % — % Impairment of intangible assets $ 10,419 $ — n/m % of net revenues 0.8 % — % Total operating expenses $ 526,665 $ 459,064 14.7 % % of net revenues 40.2 % 39.3 % Research and Development Research and development expenses increased 8.6% during fiscal 2024 as compared with fiscal 2023.
Operating Expenses Fiscal Year (In thousands) 2025 2024 % Increase/(Decrease) Research and development $ 62,722 $ 54,435 15.2 % % of net revenues 4.6 % 4.2 % Selling, general and administrative $ 436,789 $ 431,780 1.2 % % of net revenues 32.1 % 33.0 % Amortization of acquired intangible assets $ 48,261 $ 32,031 50.7 % % of net revenues 3.5 % 2.4 % Remeasurement of contingent consideration $ (23,022) $ — n/m % of net revenues (1.7) % — % Gains on divestiture and sale of assets $ — $ (2,000) n/m % of net revenues — % (0.2) % Impairment of intangible assets $ 2,391 $ 10,419 (77.1) % % of net revenues 0.2 % 0.8 % Total operating expenses $ 527,141 $ 526,665 0.1 % % of net revenues 38.7 % 40.2 % Research and Development Research and development expenses increased 15.2% during fiscal 2025 as compared with fiscal 2024.
Liquidity and Capital Resources The following table contains certain key performance indicators we believe depict our liquidity and cash flow position: (Dollars in thousands) March 30, 2024 April 1, 2023 Cash and cash equivalents $ 178,800 $ 284,466 Working capital $ 468,520 $ 517,906 Current ratio 2.6 3.1 Net debt position (1) $ (628,993) $ (481,420) Days sales outstanding (DSO) 54 53 Inventory turnover 1.7 1.8 (1) Net debt position is the sum of cash and cash equivalents less total debt.
Our effective tax rate for the year ended March 29, 2025 is lower than our effective tax rate of 22.6% for fiscal 2024, primarily due to the favorable impact of contingent consideration remeasurement and the expiration of the statute of limitations associated with uncertain tax position reserves, partially offset by the impact of the jurisdictional mix of earnings. 42 Table of Contents Liquidity and Capital Resources The following table contains certain key performance indicators we believe depict our liquidity and cash flow position: (Dollars in thousands) March 29, 2025 March 30, 2024 Cash and cash equivalents $ 306,763 $ 178,800 Working capital $ 356,862 $ 468,520 Current ratio 1.6 2.6 Net debt position (1) $ (918,025) $ (628,993) Days sales outstanding ("DSO") 55 54 Inventory turnover 1.4 1.7 (1) Net debt position is the sum of cash and cash equivalents less total debt.
These charges, the majority of which will result in cash outlays, including severance and other employee costs, will be incurred as the specific actions required to execute these initiatives are identified and approved and are expected to be substantially completed by the end of fiscal 2025.
These charges, substantially all of which will result in cash outlays, will be incurred as the specific actions required to execute on the initiative are identified and approved and are expected to continue through the end of fiscal 2027. We expect savings from this initiative of approximately $30 million on an annualized basis once the initiative is completed .
We also had $18.7 million of uncommitted operating lines of credit to fund our global operations under which there were no outstanding borrowings a s of March 30, 2024. Additionally, the Company was in compliance with the leverage and interest coverage ratios specified in the credit agreement as well as all other bank covenants as of March 30, 2024.
There were no outstanding borrowings under the revolving credit facilities at March 29, 2025. We also had $18.9 million of uncommitted operating lines of credit to fund our global operations under which there were no outstanding borrowings as of March 29, 2025.
In addition, our VASCADE and VASCADE MVP 34 Table of Contents vascular closure systems received CE mark clearance in fiscal 2023, providing a pathway for country-specific introduction of these products in the EU. Sensor Guided Technologies Market - The market for sensor-guided technologies reflects varying dynamics across different interventional cardiology procedures.
In addition, our VASCADE and VASCADE MVP vascular closure systems received CE mark clearance in fiscal 2023, providing a pathway for country-specific introduction of these products in the EU. In August 2024, we successfully launched the VASCADE MVP XL, which allowed us to capitalize more broadly in procedures as part of electrophysiology, coronary and peripheral markets.
“Hospital” is comprised of Interventional Technologies, which includes Vascular Closure and Sensor Guided Technologies products, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management products.
“Hospital” is comprised of Interventional Technologies, which includes Vascular Closure, Sensor-Guided Technologies and Esophageal Protection product lines, and Blood Management Technologies, which includes Hemostasis Management, Cell Salvage and Transfusion Management product lines. We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value.
The decrease in cash provided by operating activities was primarily the result of replenishment of NexSys PCS devices during fiscal 2024. Investing Activities Net cash used in investing activities was $322.4 million during fiscal 2024, an increase of $178.6 million as compared with fiscal 2023.
Investing Activities Net cash used in investing activities was $161.9 million during fiscal 2025, an increase of $160.5 million as compared with fiscal 2024.
Our expected cash outlays relate primarily to acquisitions, investments, capital expenditures, including enhancements to our North American manufacturing facilities, share repurchases, portfolio rationalization initiatives and cash principal and interest payments under our revised credit agreements. The Company has $500.0 million aggregate principal amount of 0% convertible senior notes due in 2026, or the 2026 Notes.
Our expected cash outlays relate primarily to acquisitions, investments, capital expenditures, share repurchases, the market and regional alignment initiative and cash principal and interest payments under our revised credit agreements.
The increase in fiscal 2024 was primarily driven by spend on portfolio rationalization initiatives, continuous growth investments, digital transformation costs incurred as part of the upgrade of our enterprise resource planning system and transaction and integration costs related to the acquisition of OpSens, partially offset by operating leverage.
The increase in fiscal 2025 was primarily driven by transaction, integration and operating costs related to recent acquisitions and increased headcount and digital transformation costs incurred as part of the upgrade of our enterprise resource planning system, partially offset by gains realized on the sale of a manufacturing facility in the first quarter of fiscal 2025. 41 Table of Contents Amortization of Acquired Intangible Assets We recognized amortization expense related to our acquired intangible assets of $48.3 million and $32.0 million during fiscal 2025 and fiscal 2024, respectively.
Without the effect of foreign exchange, Plas ma revenue increased 13.8% during fiscal 2024 as compared with fiscal 2023. This revenue increase was primarily driven by volume and price.
Without the effect of foreign exchange, Plas ma revenue decreased 5.9% during fiscal 2025 as compared with fiscal 2024. This revenue decrease was primarily driven by lower sales volumes in North America, entirely relating to the previously announced customer transition of CSL Plasma.
On July 26, 2022, we entered into an amended and restated credit agreement with certain lenders to refinance our prior credit agreement entered into on June 15, 2018, which consisted of a $350.0 million term loan and a $350.0 million revolving credit facility (together, as amended from time to time, the “2018 Credit Facilities”), and extend the maturity date through June 2025.
Interest expense related to the 2029 Notes was $17.3 million for fiscal 2025 , which includes nominal interest expense and the amortization of the debt issuance costs. On July 26, 2022, we entered into an amended and restated credit agreement to refinance our credit facilities initially entered into in 2018 and extend their maturity date through June 2025.
Contractual Obligations A summary of our contractual and commercial commitments as of March 30, 2024, which includes the impact of the April 2024 refinancing of the term loan under our 2024 Revised Credit Facilities, is as follows: Payments Due by Period (In thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Convertible senior notes $ 500,000 $ — $ 500,000 $ — $ — Debt 493,509 17,341 14,249 31,400 430,519 Interest payments (1) 80,255 17,032 32,780 30,172 271 Operating leases 82,321 11,041 21,785 17,075 32,420 Purchase commitments (2) 334,626 334,626 — — — Expected retirement plan benefit payments 21,313 1,598 3,088 4,272 12,355 Total contractual obligations $ 1,512,024 $ 381,638 $ 571,902 $ 82,919 $ 475,565 (1) Interest payments reflect the contractual interest payments on outstanding debt related to the term loan under our 2024 Revised Credit Facilities and exclude the impact of interest rate swap agreements.
Contractual Obligations A summary of our contractual and commercial commitments as of March 29, 2025 is as follows: Payments Due by Period (In thousands) Total Less than 1 year 1-3 years 3-5 years More than 5 years Convertible senior notes $ 1,000,000 $ 300,000 $ — $ 700,000 $ — Contingent consideration 2,278 44 2,234 — — Debt 246,120 6,349 17,307 222,010 454 Interest payments (1) 54,137 14,218 27,201 12,718 — Operating leases 71,536 10,835 20,869 15,056 24,776 Purchase commitments (2) 287,923 287,923 — — — Expected retirement plan benefit payments 19,906 1,553 3,149 4,030 11,174 Total contractual obligations $ 1,681,900 $ 620,922 $ 70,760 $ 953,814 $ 36,404 (1) Interest payments reflect the contractual interest payments on outstanding debt related to the term loan under our 2024 Revised Credit Facilities and exclude the impact of interest rate swap agreements.
Financing Activities Net cas h provided by financing activities was $38.2 million during fiscal 2024, an increase of $138.5 million as compared with fiscal 2023, primarily due to the borrowings under the revolving credit facility in fiscal 2024 in connection with the OpSens acquisition as well as cash outflows in fiscal 2023 for share repurchases and higher contingent consideration payments.
Financing Activities Net cas h provided by financing activities was $108.8 million during fiscal 2025, an increase of $70.7 million as compared with fiscal 2024, primarily du e to the issuance of the 2029 Notes, partially offset by the repurchase of a portion of the 2026 Notes, proceeds on the revolving credit facility in the previous year, capped call transactions, share repurchases, payments on the revolving credit facility in the current year and debt issuance costs.
The increase in cash used in investing activities was primarily the result of the acquisition of OpSens in fiscal 2024, partially offset by lower capital expenditures driven by NexSys PCS device placements that occurred during fiscal 2023 and decreased cash outflows for other investments compared to fiscal 2023.
The increase in cash used in investing activities in fiscal 2025 as compared to fiscal 2024 was primarily the result of decreased cash outflows for acquisitions and the proceeds from divestitures and the sales of property, plant and equipment.
The final impact of currency fluctuations on the results of operations is dependent on the local currency amounts hedged and the actual local currency results.
Both forecasted exposures and active hedges are reviewed periodically throughout the year to ensure effective and efficient mitigation of foreign currency exchange rate risk. These contracts are designated as cash flow hedges. The final impact of currency fluctuations on the results of operations is dependent on the local currency amounts hedged and the actual local currency results.
Gains on Divestiture and sale of assets We recognized gains on divestiture and sale of assets of $2.0 million and $0.4 million during fiscal 2024 and fiscal 2023, respectively.
There was no contingent consideration obligation outstanding prior to April 1, 2025. Gains on Divestiture and sale of assets There were no gains on divestiture and sales of assets recorded in operating expenses in fiscal 2025. We recognized gains on divestiture and sale of assets of $2.0 million during fiscal 2024 related to the sale of certain licenses.
Revenue increases in our Plasma and Hospital businesses, primarily related to volume and price, drove the overall increase in revenue during the fiscal year ended March 30, 2024.
The increase in revenue as compared to fiscal 2024 was driven by Hospital, primarily related to recent acquisitions as well as volume and price benefits, partially offset by declines in both Plasma and Blood Center.
Without the effect of foreign exchange, Hospital revenue increased 20.3% during fiscal 2024. The increase was primarily attributable to Vascular Closure revenue and Hemostasis Management disposables revenue, as well as increases in Transfusion Management revenue.
Hospital Hospital revenue increased 23.7% during fiscal 2025 as compared with fiscal 2024. Without the effect of foreign exchange, Hospital revenue increased 24.0% during fiscal 2025.
Removed
We challenge ourselves to think big and make new possibilities a reality, so that our customers can make it matter for patients, every single day. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services.
Added
Our innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

15 edited+1 added−3 removed7 unchanged
Biggest changeHow We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for the business combination. We tested controls over the valuation of intangible assets, including the valuation models and underlying assumptions used to develop such estimates.
Biggest changeWhen estimating the significant assumptions, the Company considered current industry information and trends, historical results of the acquired business, and other relevant factors. How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of the controls over the Company’s accounting for the business combination.
Our testing procedures over the significant assumptions included, among others, comparing them to current industry, market and economic trends, historical results of the acquired business and to other relevant factors. We also performed sensitivity analyses of the significant assumptions to evaluate the change in the fair value resulting from changes in the assumptions.
Our testing procedures over the significant assumptions included, among others, comparing them to current industry, market and economic trends and to historical results of the acquired business. We also performed sensitivity analyses of the significant assumptions to evaluate the change in the fair value resulting from changes in the assumptions.
These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges. 46 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and Board of Directors of Haemonetics Corporation Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Haemonetics Corporation and subsidiaries (the Company) as of March 30, 2024 and April 1, 2023, the related consolidated statements of income, comprehensive income, stockholders' equity and cash flows for each of the three years in the period ended March 30, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
These interest rate swaps are intended to mitigate the exposure to fluctuations in interest rates and qualify for hedge accounting treatment as cash flow hedges. 49 Table of Contents Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of Haemonetics Corporation Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Haemonetics Corporation and subsidiaries (the Company) as of March 29, 2025 and March 30, 2024, the related consolidated statements of income, comprehensive income, stockholders' equity and cash flows for each of the three years in the period ended March 29, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
The significant estimation was primarily due to the judgmental nature of the inputs to the valuation model used to measure the fair value of the developed technology intangible asset, as well as the sensitivity of the respective fair value to the underlying significant assumptions. The Company used the income approach to measure the fair value of the intangible asset.
The significant estimation was primarily due to the judgmental nature of the inputs to the valuation model used to measure the fair value of the developed technology intangible asset, as well as the sensitivity of the respective fair value to the underlying significant assumptions.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at March 30, 2024 and April 1, 2023, and the results of its operations and its cash flows for each of the three years in the period ended March 30, 2024, in conformity with U.S. generally accepted accounting principles.
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at March 29, 2025 and March 30, 2024, and the results of its operations and its cash flows for each of the three years in the period ended March 29, 2025, in conformity with U.S. generally accepted accounting principles.
Dollar, the change in fair value of all forward contracts would result in a $4.4 million increase in the fair value of the forward contracts, whereas a 10% weakening of the U.S. Dollar would result in a $5.4 million decrease in the fair value of the forward contracts.
Dollar, the change in fair value of all forward contracts would result in a $5.6 million increase in the fair value of the forward contracts, whereas a 10% weakening of the U.S. Dollar would result in a $6.8 million decrease in the fair value of the forward contracts.
We estimate the change in the fair value of all forward contracts assuming both a 10% strengthening and weakening of the U.S. Dollar relative to all other major currencies. As of March 30, 2024, in the event of a 10% strengthening of the U.S.
We estimate the change in the fair value of all forward contracts assuming both a 10% strengthening and weakening of the U.S. Dollar relative to all other major currencies. As of March 29, 2025, in the event of a 10% strengthening of the U.S.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of March 30, 2024, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated May 20, 2024 expressed an unqualified opinion thereon.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company's internal control over financial reporting as of March 29, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated May 21, 2025 expressed an unqualified opinion thereon.
Auditing the Company’s accounting for the business combination was complex due to the significant estimation required by management to determine the fair value of certain identified intangible assets, which totaled $172 million and principally consisted of developed technology.
The acquisition was accounted for as a business combination. Auditing the Company’s accounting for the business combination was complex due to the significant estimation required by management to determine the fair value of certain identified intangible assets, which totaled $105.8 million and principally consisted of developed technology.
To test the fair value of the acquired intangible assets, our audit procedures included, among others, evaluating the significant assumptions used, and the testing of the completeness and accuracy of underlying data. We tested the valuation models used to value the acquired intangible assets.
We tested controls over the valuation of intangible assets, including the valuation models and underlying assumptions used to develop such estimates. To test the fair value of the acquired intangible assets, our audit procedures included, among others, evaluating the significant assumptions used, and the testing of the completeness and accuracy of underlying data. We also tested the valuation models used.
Interest Rate Risk Our exposure to changes in interest rates is associated with borrowings under our credit facilities, all of which is variable rate debt. Total outstanding debt under our senior unsecured term loan as of March 30, 2024 was $262.5 million with an effective interest rate of 6.9% based on prevailing Term SOFR rates.
Interest Rate Risk Our exposure to changes in interest rates is associated with borrowings under our credit facilities, all of which is variable rate debt. Total outstanding debt under our senior unsecured term loan as of March 29, 2025 was $245.3 million with an effective interest rate of 5.7% based on prevailing Term SOFR rates.
The significant assumptions used to estimate the fair value of the intangible asset included discount rates and certain assumptions that form the basis of the forecasted results, specifically certain revenue growth rates and EBITDA margin.
The Company used the income approach to measure the fair value of the developed technology intangible asset. The significant assumptions used to estimate the fair value of the intangible asset included the discount rate and certain assumptions that form the basis of the forecasted results, specifically certain revenue growth rates and EBITDA margin.
The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. 47 Table of Contents Business combination Description of the Matter As described in Note 3 to the consolidated financial statements, during fiscal year 2024, the Company completed the acquisition of OpSens Inc. for a purchase price of $254.5 million.
The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. 50 Table of Contents Business combination Description of the Matter As described in Note 3 to the consolidated financial statements, during fiscal year 2025, the Company completed the acquisition of Attune Medical for a purchase price of $187.7 million, inclusive of contingent consideration with an initial fair value of $25.3 million.
In addition, we involved valuation professionals to assist in our evaluation of the methodology, computations, and certain significant assumptions used by the Company within the valuation. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2002. Boston, Massachusetts May 20, 2024 48 Table of Contents
In addition, we involved valuation professionals to assist in our evaluation of the methodology, computations, and certain significant assumptions included in the fair value estimates. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2002. Boston, Massachusetts May 21, 2025 51 Table of Contents
As of March 30, 2024 , the notional amount on our two active interest rate swap agreements to effectively convert borrowings under our 2022 Revised Credit Facilities from a variable rate to a fixed rate were $211.4 million .
An increase of 100 basis points in Term SOFR rates would result in additional annual interest expense of $0.4 million. As of March 29, 2025 , the notional amount on our two active interest rate swap agreements to effectively convert borrowings under our 2022 Revised Credit Facilities from a variable rate to a fixed rate were $204.5 million .
Removed
An increase of 100 basis points in Term SOFR rates would result in additional annual interest expense of $0.5 million . In addition, as of March 30, 2024 , there was $50.0 million outstanding on our senior unsecured revolving credit facility with an effective interest rate of 6.8%, also based on prevailing Term SOFR rates.
Added
A significant emphasis is placed on the appropriateness of the estimates used by management to determine the fair value of acquired intangible assets due to the sensitivity of the respective fair values to the underlying assumptions.
Removed
The acquisition was accounted for as a business combination. The financial statement accounts primarily affected by this transaction were intangible assets and goodwill.
Removed
When estimating the significant assumptions to be used in the valuation the Company considered current industry information, market and economic trends, historical results of the acquired business, and other relevant factors. These significant assumptions are forward-looking and could be affected by future economic and market conditions.

Other HAE 10-K year-over-year comparisons