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Item 1. Business

2025-05-21 compared with 2024-05-20 · 136 added, 124 removed, 364 unchanged (42% of the section changed)

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.

Our technology addresses important medical markets:

blood and plasma component collection, the surgical suite and hospital transfusion services.

Haemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care.

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.

When used in this report, the terms “we,” “us,” “our,” “Haemonetics” and the “Company” mean Haemonetics Corporation.

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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.

“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.

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 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.

We believe that Plasma and Hospital have the greatest growth potential and are well positioned to drive long-term value.

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

Product Lines and Franchises

The following describes our principal products in each of our segments.

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Applicable laws may restrict the sale, distribution or use of these products to, by, or on the order of a licensed healthcare practitioner.

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.

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.

We continue to invest in technology that lowers the overall cost to collect plasma while maintaining high standards of quality and safety.

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The markets for transfusion plasma and source plasma have different participants, product requirements and growth profiles.

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.

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.

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This third method is almost exclusively used for source plasma collection.

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 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.

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.

Over the last 20 years, the collection of source plasma has increasingly been performed by vertically integrated biopharmaceutical companies such as CSL Limited (together with its affiliates, “CSL”), Grifols S.A., Octapharma AG and Takeda’s BioLife Plasma subsidiary.

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Demand for source plasma has continued to grow because of an expanding end user market for plasma-derived biopharmaceuticals.

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.

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.

produced plasma now meeting over half of plasma volume demand worldwide.

regulations are more favorable relative to other markets for plasma collectors.

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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.

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.

Plasma Products — Our automated plasma collection devices, related disposables, software and services are designed to support multiple facets of plasma collector operations.

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Today, nearly all source plasma collections worldwide are performed using automated collection technology at dedicated facilities.

We offer multiple products to support these dedicated source plasma operations, including our NexSys PCS ® and PCS2 ® plasmapheresis equipment, related disposables and solutions.

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.

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.

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.

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.

We have provided automated platforms dedicated to the collection of plasma for over 30 years.

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.

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.

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 (“FDA”) 510(k) clearance for our NexSys PCS with proprietary Persona ® Technology.

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.

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

collection bowl and new Express Plus ® technology engineered to reduce procedure time.

Food and Drug Administration or FDA, 510(k) clearance for our NexSys PCS with proprietary Persona ® technology.

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.

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 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.

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.

We substantially completed conversion of our U.S.

customers to Persona and Express Plus technologies as of the end of fiscal 2025.

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 solutions that improve donor collection centers’ ability to collect and separate blood components for transfusions.

We continue to look for solutions to help our customers improve donor safety, enhance yields and control costs through the existing product portfolio.

Our products and technologies help donor collection centers optimize blood collection capabilities and donor processing management.

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.

Blood Center Market — There are over 100 million blood donations around the world each year that produce blood products for transfusion to surgical, trauma or chronically ill patients.

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Manual whole blood donations are collected from the donor and then transported to a laboratory where the blood is separated into its components.

Automated component blood collections separate the blood component real-time while a person is donating.

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.

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Emerging markets are seeing demand growth with expanded healthcare coverage and greater access to more advanced medical treatments.

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.

Utilizing the MCS automated platelet collection protocols, blood centers collect one or more therapeutic “doses” of platelets during a single donation.

• Our portfolio of disposable whole blood collection and component storage sets offer flexibility in collecting a unit of whole blood and the subsequent production and storage of blood components, including options for in-line or dockable filters for leukoreduction.

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.

Hospitals are called upon to provide the highest standard of patient care while at the same time reduce operating costs.

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.

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.

Blood Center Products — We offer automated blood component systems to blood centers to collect blood products efficiently and cost effectively.

Our MCS ® brand apheresis equipment is designed to collect specific blood components from the donor, with collection options spanning from multi-dose collection of individual components to combinations of different blood components, increasing our customers’ donor management capabilities and reducing the number of donors required to achieve collection targets.

We also market to Blood Center customers our NexSys PCS device for plasma collections as well as our ACP automated cell processor for the preparation and recovery of frozen blood cells.

In the fourth quarter of fiscal 2025, the Company completed the divestiture of its Whole Blood product line within our Blood Center business, allowing us to better align our resources to higher margin, higher growth opportunities.

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.

Hospitals are called upon to provide the highest standard of patient care while at the same time reducing operating costs.

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.

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.

Interventional Technologies:

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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.

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.

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.

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.

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.

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.

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.

Designed around an easy to use, catheter-based delivery system and the natural clot-inducing properties of collagen, our VASCADE product is the only marketed vascular closure device clinically proven to both increase workflow efficiency and reduce access site complications relative to manual compression for coronary and peripheral procedures.

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.

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.

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 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.

The OptoWire utilizes Fidela™, a patented 2nd generation fiber optic sensor, which is designed to provide the lowest drift in the industry with consistent and repeatable measurements.

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.

Prior to the SavvyWire, innovations in TAVR were generally centered on valves and deliver systems, whereas the SavvyWire is a wire-based solution that serves as a guide-wire, delivers accurate hemodynamic measurement and display, and is designed for efficient left ventricular (LV) pacing without the need for adjunct devices or venous access.

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.

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.

During fiscal 2025, we launched our newest VASCADE product, the VASCADE MVP XL, which utilizes 58% more collagen and a larger disc than the VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths.

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.

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.

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.

Our Sensor-Guided Technologies business also manufactures fiber optic sensor solutions used in medical devices and other industrial applications.

Esophageal Protection Market — Cardiac ablation, which is the primary treatment for atrial fibrillation, is a procedure that uses thermal energy or electrical pulses to cause lesions in certain areas of the heart, with the aim of preventing abnormal electrical signals from triggering irregular heartbeats.

For those cardiac ablation procedures performed using radiofrequency (“RF”) ablation, a risk of thermal injury to the esophagus persists.

Traditionally, the standard of care has been temperature monitoring, which involves placing a temperature probe into the esophagus and pausing the ablation procedure if the esophageal temperature exceeded certain thresholds.

Esophageal protection devices cool or move the esophagus during RF ablation procedures to minimize the risk of thermal injury.

Esophageal Protection Products — Our ensoETM system provides proactive cooling of the esophagus during RF ablation, reducing the likelihood of esophageal injury and enabling potential reductions in procedure times and patient

readmissions and increases in the rate of same-day discharge.

The ensoETM can also be used to cool or warm a patient during other surgical and critical care procedures, particularly in procedures where external cooling or heating may not be available or effective, such as burn surgery.

Blood Management Technologies:

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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 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.

TEG 6s PlateletMapping ® ADP & AA Cartridge can help understand a patient’s platelet function and provide insight into the risk of bleeding and greater confidence in therapeutic decisions.

In fiscal 2024, we received FDA clearance for a new TEG 6s Global Hemostasis-HN assay cartridge.

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.

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This process occurs in a sterile, closed-circuit, single-use consumable set that is fitted into an electromechanical device.

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

blood salvage products to surgical specialists, primarily cardiovascular, orthopedic and trauma surgeons, OB-GYN and to anesthesiologists and surgical suite service providers.

Cell Salvage Products — Our Cell Saver ® Elite ® + autologous blood recovery system is a surgical blood salvage system targeted to medium to high blood loss procedures, such as cardiovascular, orthopedic, trauma, transplant, vascular, obstetrical and gynecological surgeries.

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The software is designed to work with blood storage devices, including the BloodTrack HaemoBank ® .

Our Hospital business unit repr esented 34.0% , 31.8% and 32.5% of our t otal revenue in fiscal 2024, 2023 and 2022, respectively.

The Company also has revenue associated with certain services, maintenance and parts, representing approximately 1.7%, 1.7% and 2.0% of our total revenue in fiscal 2024, 2023 and 2022, respectively.

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 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.

Our customers include biopharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations.

Sales representatives target the primary decision-makers within each of those organizations.

In fiscal 2025, our ten largest customers accounted for approximately 42% of our net reve nues.

We did not have any customers that represented more than 10% of our consolidated revenues in fiscal 2025.

Research and Development

Our research and development centers in North America ensure that protocol variations are incorporated to closely match local customer requirements.

In addition, Haemonetics maintains software development operations in Canada.

Customer collaborations are also an important part of our technical strength and competitive advantage.

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.

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.

Our investment in research and development is critical to driving our future growth.

Our research and development efforts are focused on the further development and improvement of our existing products, the design and development of new innovative medical technologies and regulatory compliance across all our business segments.

Our research and development function maintains technical expertise in engineering disciplines critical to our products, 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.

In fiscal 2024, research and development resources were allocated to support innovation across our product portfolio.

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 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.

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.

Customer collaborations are also an important part of our technical strength and competitive advantage.

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.

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.

Also during fiscal 2025, we announced CE mark certification for the SavvyWire pre-shaped pressure guidewire.

Manufacturing

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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.

Additionally, the global macroeconomic environment has continued to present challenging conditions and uncertainty, including around inflation, tariffs, interest rates, monetary policy, exchange rates and geopolitical developments, which could adversely impact the costs associated with our manufacturing operations.

Intellectual Property

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We believe that unpatented know-how and trade secrets relied upon in connection with our business and products are generally as important as patent protection in establishing and maintaining a competitive advantage.

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.

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.

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.

To remain competitive, we must continue to develop and acquire new cost-effective products, information technology platforms and business services.

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.

We have instituted, and may in the future institute, intellectual property litigation to enforce our patent rights, to protect our trade secrets or know-how and to determine the scope and validity of the proprietary rights of others.

Such litigation could be protracted, expensive and subject to significant uncertainty as to outcome.

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.

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.

“Risk Factors” below.

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.

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KGaA, in particular, have significant financial and other resources and are strong competitors in a number of our businesses.

The following provides an overview of the key competitors in each of our three global product enterprises.

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.

In China, the market is populated by local producers, including Nigale and Haier Medical, which offer plasmapheresis device products that are intended to be similar to ours.

In recent years, Nigale has expanded to markets beyond China, competing in European and South American countries.

Scinomed competes in select European countries as well.

The following provides an overview of the key competitors in each of our three global business units.

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.

Outside of the U.S., we also compete with Nigale, a Chinese manufacturer that has expanded beyond China into European and South American markets, and Scinomed, a European company with Chinese manufacturing that competes in select European countries as well.

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.

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 MCS automated component blood collections, which represents approx imately 60% of the Blood Center portfolio, not only compete against the traditional manual whole blood collection market (particularly in red cells) but also compete with products from Terumo BCT and Fresenius.

Most donations worldwide are manual whole blood collections.

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.

In the fourth quarter of fiscal 2025, we completed the divestiture of our Whole Blood product line, including our complete portfolio of proprietary manual whole blood collection, processing and filtration solutions, along with our manufacturing facility in Covina, California where certain of these products were produced, and related equipment and assets located at our manufacturing facility in Tijuana, Mexico.

We believe exiting this product line will help to align our resources to higher margin, higher growth opportunities.

Our MCS brand apheresis equipment competes not only against manual whole blood collections but also with products from Terumo BCT and Fresenius.

Technology is the key differentiator in automated component blood collections, with speed, as measured by the time to collect more than one unit of a specific targeted blood component, quality, reliability, ease of use, service and other technical features being key factors.

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The vascular closure industry is highly competitive and has been evolving rapidly with the introduction of new products, technologies, regulations and activities of industry participants.

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.

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.

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.

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.

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

requirements of coronary, structural heart, peripheral and electrophysiology procedures, including procedures that require multiple access sites.

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

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Competitors such as Abbott Laboratories, Boston Scientific, and Philips pose challenges and opportunities in the coronary physiology segment, each offering their own technologies and solutions.

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.

Through these efforts, we aim to bolster our position as a leader in sensor-guided technologies, delivering exceptional value to healthcare providers and patients alike.

There are not currently competing, commercially available TAVR guidewires that are indicated to deliver both hemodynamic measurement and LV pacing for TAVR procedures.

Esophageal Protection

The ensoETM system competes primarily with temperature monitoring as the current standard of care for esophageal protection during RF ablations, as well as with a small number of other esophageal protection devices that deviate the esophagus.

Additionally, RF ablation technologies are experiencing significant competition from companies advancing pulse field ablation (“PFA”) technologies on the basis of, among other factors, workflow efficiencies and safety profile.

In this context, ensoETM supports the continued use of RF ablation technologies by reducing the likelihood of ablation-related esophageal injury.

The ensoETM system’s utility in temperature regulation during other surgical and critical care procedures also provides additional opportunities for market penetration and differentiation.

Blood Management Technologies:

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Growth drivers for these markets include patient safety, operational efficiencies and compliance.

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.

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.

Global competition for BloodTrack varies by country including MSoft, MAK Systems in Europe and established blood

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.

Significant Customers

In fiscal 2024, 2023 and 2022, our ten largest customers accounted for approximately 48%, 48% and 45% of our net revenues, respectively.

In fiscal 2024, one Plasma customer, CSL, was greater than 10% of total net revenues and accounted for approximately 13% of net revenues.

In addition to CSL, two customers also accounted for greater than 10% of the Plasma segment’s net revenues and two customers accounted for greater than 10% of the Blood Center segment's net revenues, but did not exceed 10% of total net revenues, in fiscal 2024.

Government Regulation

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To varying degrees, each of these agencies requires us to comply with laws and regulations governing the development, testing, manufacturing, labeling, marketing and distribution of our products.

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.

The failure to comply with applicable U.S.

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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.

Our VASCADE portfolio of vascular closure systems are Class III products for which PMAs were previously obtained.

The 510(k) clearance, de novo classification, and PMA processes can be resource intensive, expensive, lengthy and require payment of significant user fees.

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Generally, establishments that design and/or manufacture devices are required to register with the FDA.

They also must provide the FDA with a list of the devices that they design and/or manufacture at their facilities.

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.

• 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.

The QSR applies to manufacturers, including contract manufacturers, of finished medical devices, and governs methods, facilities, and controls used in designing, manufacturing, packaging, labeling, storing, installing and servicing such devices.

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Our international sales are subject to regulatory requirements in the countries in which our products are sold.

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.

The EU MDR became fully applicable as of May 26, 2021 and the EU IVDR became fully applicable as of May 26, 2022.

There is a conditional transition period after the date of full application, the duration of which is dependent on the classification of the device.

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.

A new EU certificate under the applicable regulations must be obtained prior to the end of the transition period if there is to be no interruption in manufacturing and supply of devices to the market.

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Failure to meet these requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.

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.

Regulatory requirements in other jurisdictions also continue to become more stringent, increasing regulatory requirements to register and maintain products in these markets.

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This more limited data set is in lieu of independently demonstrating the proposed product’s safety and effectiveness, which are inferred from the fact that the product is the same as the RLD, which the FDA previously found to be safe and effective.

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.

We hold NDAs and ANDAs for liquid solutions (including anticoagulants, intravenous saline and a red blood cell storage solution) that we are in the process of transferring in connection with the divestiture of our Whole Blood product line in the fourth quarter of fiscal 2025.

Post-Approval Regulations

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The requirements and process governing product licensing vary from country to country.

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.

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.

Conflict Minerals

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We have described below some of the key federal, state and foreign healthcare laws and regulations that apply to our business.

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 statute has been interpreted to apply to arrangements between manufacturers of federally reimbursed products on one hand and prescribers, purchasers and others in a position to recommend, refer, or order federally reimbursed products on the other.

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The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, among other things, imposes criminal and civil liability for knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third party payers and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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

and investment interests held by physicians and their immediate family members.

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.

Manufacturers are also required to collect information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse-midwives for reporting.

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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.

also regularly solicit perspectives from our workforce through surveys and other communications channels.

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.

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.

We recognize that the diversity of our teams and their ideas helps build our collaborative, performance-driven culture, and we are committed to providing an inclusive environment where every individual has the opportunity to thrive.

Accordingly, we focus attention and purposeful investments on developing our diversity, equity and inclusion programs and practices and take steps to ensure consistent and fair pay practices.

We also require that employees complete annual training on our Code of Conduct (which includes specific modules on how to promote an inclusive culture and help identify and prevent unlawful discrimination) as well as standalone anti-harassment and anti-discrimination training.

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 also regularly solicit perspectives from our workforce through surveys and other communications channels.

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.

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.

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 .

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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;

• 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.

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• 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;

• 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.

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• 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 legal and regulatory requirements, including the U.S.

Foreign Corrupt Practices Act, European Union Medical Device Regulation and In Vitro Diagnostic Regulation and similar laws in other jurisdictions, as well as the impact of U.S.

and foreign export and import restrictions and tariffs;

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business