What changed in this filing

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Item 1. Business

2024-05-20 compared with 2023-05-22 · 102 added, 85 removed, 386 unchanged (33% of the section changed)

Company Overview

Haemonetics is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare.

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:

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

Blood is essential to a modern healthcare system.

Blood and its components (plasma, red cells and platelets) have many vital and frequently life-saving clinical applications.

Plasma is used for patients with major blood loss and is manufactured into biopharmaceuticals to treat a variety of illnesses, including immune diseases and coagulation disorders.

Red cells treat trauma patients or patients undergoing surgery with high blood loss, such as open heart surgery or organ transplant.

Platelets have many uses in patient care, including supporting cancer patients undergoing chemotherapy.

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, plasma donor management software, and anticoagulant and saline sold to plasma customers.

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”, which is comprised of Hemostasis Management, Vascular Closure, Cell Salvage and Transfusion Management products, includes devices and methodologies for measuring coagulation characteristics of blood, vascular closure devices, specialized blood cell processing systems and disposables, surgical blood salvage systems and blood transfusion management software.

“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.

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.

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These two methods are mainly used by blood centers to collect plasma for transfusions.

The third method is a dedicated apheresis procedure that only collects plasma and returns the other blood components to the donor.

The third method is a dedicated apheresis procedure that only collects plasma and

returns the other blood components to the donor.

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

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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.

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.

(together with its affiliates, “Grifols”), Octapharma AG and Takeda’s BioLife Plasma subsidiary.

With their global operations and management expertise, these companies are focused on efficient plasma supply chain management and leveraging information technology to manage operations from the point of plasma donation through fractionation to the production of the final pharmaceutical product.

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

The frequency an individual may donate, the volume of plasma that may be donated each time and the ability to remunerate donors are all more favorable to efficient operations and output, leading to approximately 70% of worldwide source plasma collections occurring in the United States.

The frequency an individual may donate, the volume of plasma that may be donated each time and the ability to remunerate donors are all more favorable to efficient operations and output, leading to approximately two-thirds of worldwide source plasma collections occurring in the U.S.

Plasma collectors have long sought revisions to plasma collection regulations outside of the U.S.

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

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.

We expect to pursue further regulatory clearances for additional enhancements to the overall product offering.

We have entered into agreements with all major U.S.

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.

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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 to reduce operating costs.

Haemonetics’ Hospital business has four product lines:

Hemostasis Management, Vascular Closure, Cell Salvage and Transfusion Management.

Vascular Closure became a product line during fiscal 2021 as a result of the March 2021 acquisition of Cardiva Medical, Inc.

(“Cardiva”), a market leader in vascular closure devices.

Each product line has 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.

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.

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.

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.

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.

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.

Blood Management Technologies:

Hemostasis Management

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We have four viscoelastic testing systems that we market to hospitals and laboratories as an alternative to routine blood tests:

the TEG ® 5000 hemostasis analyzer system, the TEG 6s hemostasis analyzer system, the ClotPro ® hemostasis analyzer system and the HAS-100 hemostasis analyzer system.

While the TEG and HAS platforms utilize thromboelastography and the ClotPro system utilizes thromboelastometry, all of the platforms provide a method of testing the efficiency of blood coagulation using whole blood samples.

the TEG ® 5000 hemostasis analyzer system, the TEG 6s hemostasis analyzer system, the HAS-100 hemostasis analyzer system and the HAS-300 hemostasis analyzer system.

The TEG and HAS platforms utilize thromboelastography, providing a method of testing the efficiency of blood coagulation using whole blood samples.

Each hemostasis diagnostic system consists of an analyzer that is used with single-use reagents and disposables.

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We continue to pursue a broader set of indications for TEG 6s in the U.S.

In 2019, we received FDA clearance for the use of TEG 6s in adult trauma settings.

This clearance builds on the previous indication for the TEG 6s system in cardiovascular surgery and cardiology procedures, making it the first cartridge-based system available in the U.S.

to evaluate the hemostasis condition in adult trauma patients.

The ClotPro system is CE marked and is currently available in select European and Asia Pacific markets.

The HAS-100 device is currently commercialized in China.

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.

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.

Vascular closure devices improve upon manual compression by rapidly closing the access site and facilitating more efficient workflow.

Vascular Closure Products — The VASCADE ® technology platform was developed to address the limitations of manual compression and existing vascular closure devices.

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, peripheral and electrophysiology procedures that require vascular access site closure each year.

Similarly, our VASCADE MVP device is the only marketed vascular closure device clinically proven and labeled 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 and only vascular closure device to receive a U.S.

Food and Drug Administration (“FDA”) indication for same-day discharge following atrial fibrillation ablation.

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.

The HAS-100 and HAS-300 devices are currently commercialized in China.

Cell Salvage Market — The Cell Salvage market is mainly comprised of devices designed to collect, wash and prepare a patient’s own blood for reinfusion during or after surgery.

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Research and Development

Our research and development centers in the U.S.

ensure that protocol variations are incorporated to closely match local customer requirements.

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.

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

In fiscal 2023, the VASCADE and VASCADE MVP systems received CE mark clearance, providing a pathway for country-specific introduction of these products in the European Union (“EU”).

We also received 510(k) clearance from the FDA on Intelligent Control, the next-generation software for the Cell Saver Elite+ Autotransfusion System, which offers customers key enhancements to help simplify operations, supporting enhanced efficiency and an improved user experience.

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.

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We rely on a combination of patent, trademark, copyright and trade secret laws, as well as provisions in our agreements with third parties, to protect our intellectual property rights.

We hold numerous patents in the United States and have applied for numerous additional U.S.

W e hold numerous patents in North America and have applied for numerous additional U.S.

patents relating to our products and related technologies.

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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.

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Scinomed 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 as well as MAK Systems.

In the field of plasma related software, we principally compete with applications developed internally by certain of our customers.

• Blood Center

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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.

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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This is particularly relevant in platelet donations and can drive market share shifts in certain markets.

Interventional Technologies:

Vascular Closure

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.

Sensor Guided Technologies

The landscape of sensor-guided technologies is competitive, especially within the mature coronary physiology market.

Our OptoWire and SavvyWire products stand out as leading offerings in their respective segments, providing real-time feedback and precise guidance during coronary physiology and structural heart procedures.

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.

Blood Management Technologies:

Hemostasis Management

Our hemostasis analyzer systems are used primarily in surgical applications.

Competition includes routine coagulation tests, such as prothrombin time, partial thromboplastin time and platelet count marketed by various manufacturers, such as Instrumentation Laboratory, Diagnostica Stago SAS and Sysmex.

Competition includes routine coagulation tests, such as prothrombin time, partial thromboplastin time and platelet count marketed by various manufacturers, such as Werfen, Diagnostica Stago SAS and Sysmex.

The TEG ® analyzer competes with these routine laboratory tests based on its ability to provide a more complete picture of a patient’s hemostasis at a single point in time and to measure the clinically relevant platelet function for an individual patient.

In addition, TEG and ClotPro systems compete more directly with other viscoelastic testing systems, including ROTEM ® analyzers, the VerifyNow™ System and HemoSonics Quantra ® .

ROTEM and VerifyNow instruments are marketed by Instrumentation Laboratory, a subsidiary of Werfen.

In addition, TEG competes more directly with other viscoelastic testing systems, including ROTEM ® analyzers, the VerifyNow™ System and HemoSonics Quantra ® .

ROTEM and VerifyNow instruments are marketed by Werfen.

HemoSonics is owned and offered by Diagnostica Stago.

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In the advanced viscoelastic testing segment, Haemonetics is the global market leader.

Vascular Closure

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 main competitors in femoral access closure for coronary and peripheral procedures include Terumo BCT, Abbott Laboratories and Cardinal Health.

There are not currently any competing vascular access site closure devices that are labeled for electrophysiology procedures that require multiple access sites.

We compete primarily on the basis that our products are optimized for the requirements of coronary, 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.

In the intraoperative autotransfusion market, competition is based on reliability, ease of use, service, support and price.

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

In fiscal 2023, one Plasma customer, CSL, was greater than 10% of total net revenues and in total accounted for approximately 14% of net revenues.

In addition to CSL, two customers also accounted for greater than 10% of the Plasma segment’s net revenues and one customer accounted for greater than 10% of the Blood Center segment's net revenues, but did not exceed 10% of total net revenues, in fiscal 2023.

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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A PMA is required for most Class III devices.

The PMA process is generally more detailed, lengthier and more expensive than the 510(k) and de novo processes.

Prior to the acquisition of Cardiva in March 2021, we had not been required to obtain a PMA for any of our products and did not have any Class III products in our product pipeline.

Our VASCADE and VASCADE MVP products are both Class III products for which PMAs were previously obtained.

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.

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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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.

Among other requirements, manufacturers of medical devices must establish a quality system appropriate for the devices they manufacture.

Manufacturers of medical devices must establish a quality system appropriate for the devices they manufacture.

For example, devices containing certain types of software must implement comprehensive cybersecurity risk management programs and documentation consistent with the QSR;

• Labeling regulations, including unique device identification;

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Additionally, we and the manufacturing facilities of some of our suppliers are subject to unannounced inspections by the FDA to determine our compliance with the QSR and other applicable regulations described above.

The FDA can issue Form 483 Notices of Observation, warning letters or untitled letters, seek a court order detaining or seizing certain devices, seek an injunction, suspend regulatory clearance or approvals, ban certain medical devices, order repair, replacement or refund of those devices and require notification of health professionals and others with regard to medical devices that present risks of substantial harm to the public health.

If a company fails to comply with regulatory requirements, the FDA can issue Form 483 Notices of Observation, warning letters or untitled letters, recommend or require product recalls, issue safety communications, seek a court order detaining or seizing certain devices, seek an injunction, suspend or withdraw regulatory clearance or approvals, ban certain medical devices, order repair, replacement or refund of medical devices or require notification of health professionals and others with regard to medical devices that present risks of substantial harm to the public health.

The FDA may also initiate action for criminal prosecution of violations.

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The FDA may place conditions on a PMA-approved device that could restrict the distribution or use of the product.

In addition, quality control, manufacture, cybersecurity, packaging and labeling procedures must continue to conform to QSRs after approval and clearance, and manufacturers are subject to periodic inspections by the FDA.

In addition, manufacturers are subject to periodic inspections by the FDA.

Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with QSRs.

The FDA may withdraw product approvals or recommend or require product recalls if a company fails to comply with regulatory requirements.

Advertising, marketing and promotional activities for devices are also subject to FDA oversight.

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Promotion of products for uses not described in the approved or cleared labeling (“off-label” uses) has resulted in enforcement actions against manufacturers, including actions alleging violation of the Federal False Claims Act, federal and state healthcare fraud and abuse laws, and state consumer protection laws.

The failure to comply with prohibitions on “off-label” promotion can result in significant monetary penalties, suspension of sales of certain products, product recalls, civil or criminal sanctions, exclusion from participating in federal healthcare programs, or other enforcement actions.

In the United States, allegations of such wrongful conduct could also result in a corporate integrity agreement with the U.S.

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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) and teaching hospitals, as well as ownership 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 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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We are committed to building a collaborative, performance-driven culture that attracts and retains top talent.

As of April 1, 2023, we employed the full-time equivalent of 3,034 persons.

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.

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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.

We also conduct an annual employee engagement survey, with at least 90% global participation since 2018.

Feedback from these surveys is shared across the organization and informs both Company-sponsored initiatives and shared action plans between managers and direct reports.

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.

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This includes eliminating unsafe work practices and workplace injuries and illnesses and promoting the health, safety and well-being of all employees, contractors and visitors.

Important objectives in achieving our vision include:

creating a positive safety culture, maintaining an effective safety management system and reducing risk in the workplace.

Important objectives in achieving our vision include creating a positive safety culture, maintaining an effective safety management system and reducing risk in the workplace.

Among other things, we utilize a third-party enterprise compliance and risk management solution at all of our locations to track incidents.

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• 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;

• 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 and distribution;

• Our ability to obtain the anticipated benefits of restructuring programs that we have or may undertake, including the Operational Excellence Program;

• The potential that the expected strategic benefits and opportunities from completed or planned acquisitions, divestitures or other strategic investments by the Company may not be realized or may take longer to realize than expected;

• 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.

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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, Russia and other foreign jurisdictions where we do business;

• 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;

• The impact of changes in U.S.

and international tax laws;

• 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;

• The impact of actual or threatened public health emergencies;

• Our ability to retain and attract key personnel;

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• Our ability to achieve against our corporate responsibility initiatives and meet evolving stakeholder expectations concerning corporate responsibility matters;

• The impact of actual or threatened public health crises.

Investors should understand that it is not possible to predict or identify all such factors and should not consider the risks described above and in Item 1A.

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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