What changed in this filing

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Item 1. Business

2023-05-22 compared with 2022-05-25 · 121 added, 119 removed, 350 unchanged (41% of the section changed)

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

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

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.

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“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, Transfusion Management and Cell Salvage products, includes devices and methodologies for measuring coagulation characteristics of blood, surgical blood salvage systems, specialized blood cell processing systems and disposables, blood transfusion management software and vascular closure devices.

Financial information concerning these segments is provided in Note 18 to our audited consolidated financial statements contained in Item 8 of this Annual Report on Form 10-K.

“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.

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.

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

Our Plasma business offers automated plasma collection and donor management software systems that improve the yield, efficiency, quality, safety and overall donor experience at plasma collection centers.

Availability of products may vary from one country or region to another as a result of specific local regulatory approval or clearance requirements.

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.

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

Plasma Collection Market for Fractionation — Human plasma is collected for two purposes.

First, it is used for transfusions in patients, such as trauma victims who need to compensate for extreme blood loss, and second, it is processed into pharmaceuticals that aid in the treatment of immune diseases and coagulation disorders.

First, it is used for transfusions in patients, such as trauma victims who need to compensate for extreme blood loss.

Second, it is processed into pharmaceuticals that aid in the treatment of a broad range of immune system diseases and blood-related disorders.

Plasma for transfusion is almost exclusively collected by blood centers as part of their broader mission to supply blood components.

Plasma that is fractionated and manufactured into pharmaceuticals - frequently referred to as “source plasma” - is mainly collected by vertically integrated biopharmaceutical companies who operate their own collection centers and recruit donors specifically for source plasma donation.

Plasma that is fractionated and manufactured into pharmaceuticals - frequently referred to as “source plasma” - is mainly collected by vertically integrated biopharmaceutical companies that operate their own collection centers and recruit donors specifically for source plasma donation.

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

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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.

Our Plasma business unit focuses on the collection of source plasma by pharmaceutical manufacturers using apheresis devices that only collect plasma and software solutions that support the efficient operation of dedicated source plasma collection centers.

Our Plasma business 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.

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(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 product.

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.

A significant portion of this growth has occurred in the United States with U.S.

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.

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

The frequency with which a donor may donate, the volume of plasma that may be donated each time and the ability to remunerate donors are all optimal in the U.S., leading to approximately 70% of worldwide source plasma collections occurring in the U.S.

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

to allow for greater frequency, volume per donation, and remuneration but achievements have been limited and no significant short-term changes are foreseen in the prevalence of U.S.

Plasma Products — Built around our automated plasma collection devices, related disposables, and software, our portfolio of products and services is designed to support multiple facets of plasma collector operations.

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.

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.

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

We have a long-standing commitment to understanding our customers’ collection and manufacturing processes.

As a result, we aim to design equipment that is durable, dependable, and easy to use and to provide comprehensive training and support to our plasma collection customers.

As a result, we aim to design equipment that is durable, dependable, and easy to use and to provide comprehensive training and support to help our customers optimize their plasma collections.

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 intravenous solutions.

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

We also offer a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain.

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.

With our software solutions, plasma collectors can manage processes across the plasma supply chain, ensure quality and compliance business process support, react quickly to business changes and implement opportunities to reduce costs.

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.

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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.

The NexSys PCS capabilities enable collections with higher plasma yields.

Our YES TM 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 Persona ® technology.

NexSys PCS with Persona technology uses a percent plasma nomogram that customizes plasma collection based on an individual donor's body composition, including an additional 9-12% plasma yield.

The new, proprietary Persona technology strengthens the NexSys PCS value proposition and reinforces our commitment to supporting the plasma

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.

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.

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

We have entered into long-term commercial contracts and are continuing the rollout and support of NexSys PCS devices and NexLynk DMS donor management software for these Plasma customers.

We have entered into agreements with all major 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.

Our Plasma business unit represen ted 42.5%, 35.4% and 38.2% of our to tal revenue in fiscal 2023, 2022 and 2021, respectively.

• Blood Center

Our Blood Center business offers a range of solutions that improve donor collection centers' ability to collect and filter blood and separate blood components.

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

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.

Blood Center Market — There are millions of blood donations throughout the world every year that produce blood products for transfusion to surgical, trauma or chronically ill patients.

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.

Patients typically receive only the blood components necessary to treat a particular clinical condition.

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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 blood.

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

In this method, only the specific target blood component is collected and the remaining components are returned to the blood donor.

While overall we expect total demand for blood to remain stable to slightly declining, demand in individual markets can vary greatly.

While overall we expect total demand for blood to remain stable to slightly declining, demand in individual markets and for individual components can vary greatly.

The development in mature markets of more minimally invasive procedures with lower associated blood loss, as well as hospitals’ improved blood management techniques and protocols have more than offset the increasing demand for blood from aging populations.

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Our Blood Center business unit represen ted 24.0%, 30.1% and 35.3% of ou r total revenue in fiscal 2023, 2022 and 2021, respectively.

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

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, Transfusion Management and Cell Salvage.

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.

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

We received FDA clearance for the use of TEG 6s in adult trauma settings.

This clearance builds on the current indication for the TEG 6s system in cardiovascular surgery and cardiology procedures, making it the first cartridge-based system available 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 received CE mark clearance and is currently available in select European and Asia Pacific markets.

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.

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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.

Our Vascular Closure devices address the growing number of

catheter-based coronary, 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.

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Importantly, these improvements drive meaningful cost savings for hospitals, ambulatory surgery centers and other treatment facilities.

During fiscal 2022, the VASCADE MVP Venous Vascular Closure System became the first and only vascular closure device to receive FDA indication for same-day discharge following atrial fibrillation ablation.

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.

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.

Loss of blood is common in many surgical procedures, including open heart, trauma, transplant, vascular and orthopedic procedures, and the need for transfusion of oxygen-carrying red cells to make up for lost blood volume is routine.

Patients commonly receive donor (or allogeneic) blood which carries various risks for transfusion reactions including chills, fevers or other side effects that can prolong a patient’s recovery.

An alternative to allogeneic blood is surgical cell salvage, also known as autotransfusion, which reduces or eliminates a patient’s need for blood donated from others and ensures that the patient receives the freshest and safest blood possible - his or her own.

Surgical cell salvage involves the collection of a patient’s own blood during or after surgery with the intent of reinfusion of red cells to that patient.

Blood is suctioned from the surgical site or collected from a wound or chest drain, processed and washed through a centrifuge-based system that yields concentrated red cells, available in a reinfusion bag, for transfusion back to the patient at the physician’s discretion.

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.

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.

The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and prepare a patient’s own high-quality blood for reinfusion.

Transfusion Management

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

Cell Salvage Market — The Cell Salvage market is mainly comprised of devices designed to transfuse back a patient’s own blood during or after surgery.

Patients commonly receive donor (or allogeneic) blood which carries various risks for transfusion reactions including chills, fevers or other side effects that can prolong a patient’s recovery.

Surgical cell salvage involves the collection of a patient’s own blood during or after surgery for reinfusion of red cells to that patient.

Blood is suctioned from the surgical site or collected from a wound or chest drain, processed and washed through a centrifuge-based system that yields concentrated red cells available for transfusion back to the patient.

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, and to anesthesiologists and surgical suite service providers.

The Cell Saver Elite + is designed to minimize allogeneic blood use and reliably recover and transfuse a patient’s own high-quality blood.

Our Hospital business unit repr esented 31.8%, 32.5% and 24.2% of our t otal revenue in fiscal 2023, 2022 and 2021, respectively.

The Company also has revenue associated with certain services, maintenance and parts, representing approximately 1.7%, 2.0% and 2.3% of our total revenue in fiscal 2023, 2022 and 2021, respectively.

Marketing/Sales/Distribution

We market and sell our products to biopharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors.

We market and sell our products in approximately 90 countries through our own direct sales force (including full-time sales representatives and clinical specialists) as well as independent distributors.

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

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

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In fiscal 2023, research and development resources were allocated to support innovation across our product portfolio.

In October 2020, we announced FDA clearance for our NexSys PCS ® with Persona ® technology.

In April 2020, we also announced the commercial availability of the next generation of SafeTrace Tx Transfusion Management Software in the United Kingdom.

This software version features significant improvements to the user experience and workflow efficiency.

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, our Hemostasis Management product line, and our recent product acquisitions in Hospital.

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.

Manufacturing

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Our primary consumable manufacturing operations are located in North America and Malaysia.

Contract manufacturers also supply component sets and liquid solutions according to our specifications and manufacture in Japan, Singapore, Thailand and the Philippines.

Contract manufacturers also supply component sets and liquid solutions according to our specifications, with component sets manufactured in Japan, Singapore, Thailand, Indonesia and the Philippines and liquid solutions manufactured in Europe.

Our capital equipment is principally manufactured in Malaysia, Australia and the U.S.

Plastics and other petroleum-based products are the principal components of our disposable products and can be affected by oil and gas prices.

Contracts with our suppliers help to mitigate some of the short term effects of price volatility in this market.

However, increases in the price of petroleum derivatives could result in corresponding increases in our costs to procure plastic raw materials.

We have experienced increased levels of unpredictability in the supply of certain raw materials and components used in the manufacturing of our products.

While we continue to believe we will have access to the raw materials and components that we need, these supply chain dynamics could result in increased costs to us or an inability to fully meet customer demand for certain of our products.

Intellectual Property

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However, the standards for international protection of intellectual property vary widely.

We cannot assure that pending patent and trademark applications will result in issued patents and registered

trademarks, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that our patents will not be determined invalid.

We cannot assure that pending patent and trademark applications will result in issued patents and registered trademarks, that patents issued to or licensed by us will not be challenged or circumvented by competitors, or that our patents will not be determined invalid.

To maintain our competitive position, we also rely on the technical expertise and know-how of our personnel.

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Terumo Blood and Cell Technologies (“Terumo BCT”) and Fresenius SE & Co.

KGaA, in particular, have significantly greater financial and other resources than we do and are strong competitors in a number of our businesses.

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 product lines a nd Terumo BCT's Rika device on the basis of speed, plasma yield per donation, quality, reliability, ease of use, services and technical features of the collection systems and on the long-term cost-effectiveness of equipment and disposables.

In China, the market is populated by local producers of a product that is intended to be similar to ours.

Recently, those competitors have expanded to markets beyond China, including European and South American countries.

In the field of plasma related software, MAK Systems is the primary competitor along with applications developed internally by our customers.

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.

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

• 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, as measured by the time to collect more than one unit of a specific targeted blood component.

While not all donors are eligible to donate more than one unit, it continues to become more prevalent in markets with a significant number of eligible donors.

Therefore, both Haemonetics and our competitors continue to experience downward pressure on collection through single platelet collection procedures.

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.

In markets with a significant number of people eligible to donate more than one unit in a single donation, the processing speed can be a significant competitive differentiator.

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

Hemostasis Management

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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.

For high-volume platforms, each manufacturer's technology is similar and our Cell Saver ® technology competes principally with products offered by LivaNova PLC, Medtronic and Fresenius.

Transfusion Management

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BloodTrack integrates with the hospital’s existing lab or blood bank system allowing for greater market acceptance.

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

For high-volume platforms, each manufacturer's technology is similar and our Cell Saver technology competes principally with products offered by LivaNova PLC, Medtronic and Fresenius.

Significant Customers

In fiscal 2023, 2022 and 2021, our ten largest customers accounted for approximately 48%, 45% and 49% of our net revenues, respectively.

In fiscal 2022, one Plasma customer, CSL, was greater than 10% of total net revenue and in total accounted for approximately 12% 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 revenue, but did not exceed 10% of total net revenues, in fiscal 2022.

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.

Government Regulation

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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.

With the acquisition of Cardiva, we have acquired VASCADE and VASCADE MVP, which are both Class III products for which PMAs were previously obtained.

Our VASCADE and VASCADE MVP products are both 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 FDA may place conditions on a PMA-approved device that could restrict the distribution or use of the product.

In addition, quality control, manufacture, 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, 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.

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

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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.

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

There is a transition period for devices with a notified body certificate with an expiry date after the date of full application.

However, a new EU certificate under the applicable Regulations must be obtained before that expiry date if there is to be no interruption in manufacturing and supply of devices to the market.

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.

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.

There are nevertheless a number of provisions that need to be complied with from the date of application, including updating the postmarket surveillance process, appointing an importer for the EU, appointing a person responsible for regulatory compliance, and updating economic operator agreements.

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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.

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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NDAs require extensive studies and submission of a large amount of data by the applicant.

A generic version of an approved drug is approved by means of an abbreviated new drug application, or ANDA, by which the sponsor demonstrates that the proposed product is the same as the approved, brand-name drug, which is referred to as the

“reference listed drug,” or RLD.

Generally, an ANDA must contain data and information showing that the proposed generic product and RLD have the same active ingredient, in the same strength and dosage form, to be delivered via the same route of administration, are intended for the same uses and are bioequivalent.

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These include the FDA's current cGMPs, which include a series of requirements relating to organization and training of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, quality control and quality assurance, packaging and labeling controls, holding and distribution, and laboratory controls and records and reports.

The FDA has also established labeling regulations, advertising and promotion requirements and restrictions;

regulations regarding conducting recalls of product;

and requirements relating to the reporting of adverse events.

The FDA has also established labeling regulations, advertising and promotion requirements and restrictions, regulations regarding conducting recalls of product and requirements relating to the reporting of adverse events.

Failure to comply with applicable FDA requirements and restrictions in this area may subject a company to adverse publicity, such as warning letters, and enforcement action by the FDA, the Department of Justice, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities.

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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.

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.

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.

Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration to those who prescribe, purchase, or recommend medical devices or pharmaceutical and biological products, including certain discounts, or engaging consultants as speakers or consultants, may be subject to scrutiny if they do not fit squarely within the exemption or safe harbor.

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Human Capital

Our employees are the foundation of our organization, each with their own talents, backgrounds and abilities.

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.

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In our industry, there is substantial competition for key personnel in the regions in which we operate.

Recruiting, developing and retaining talented employees is critical to both our strategy and our ability to compete effectively in the markets we serve.

We are committed to building a collaborative, performance-driven culture that attracts and retains the best talent.

We strive to do this by soliciting employee perspectives, investing in their development, promoting employee health and safety, providing competitive pay and benefits and recognizing that the diversity of our teams and their ideas helps build our culture and strengthens our ability to make our work matter for the customers, patients, donors and healthcare providers who depend on us.

These efforts include:

• Employee Engagement .

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

Recruiting, developing, engaging and retaining talented employees is critical to both our strategy and our ability to compete effectively in the markets we serve.

Our human capital strategy focuses on a complementary set of initiatives designed to support our corporate strategy and secure top talent, including the following:

• We dedicate meaningful time and resources to employee development, training and succession planning.

Pursuant to our Principles of Corporate Governance, our Board of Directors plans for succession to the position of Chief Executive Officer as well as other senior leadership positions and reviews potential successors to these roles at least annually.

We maintain a robust performance management review process for our permanent employees below the senior leadership level to help develop talent and ensure alignment of performance goals at every level of the organization throughout the fiscal year.

Additionally, we offer a variety of programs and resources designed to facilitate our employees’ career development, training and networking, including:

◦ Individual development planning by employees, in consultation with their managers, to help define individual development goals and facilitate manager coaching and feedback;

◦ Manager development sessions focused on developing core leadership competencies, including performance management training, coaching and feedback and building trust;

◦ Continuous improvement training for employees, including through our internal learning management platform, to promote individual development, strengthen our culture and drive compliance and quality across our organization;

◦ Tuition reimbursement programs that provide eligible U.S.

and Canadian employees with the opportunity to be reimbursed (up to a set dollar limit) for tuition and certain other expenses associated with degree programs, certifications and continuing education courses that relate to their work at the Company;

◦ Regular recognition of employees across the organization who personify our core values.

• We engage regularly with our employees.

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.

• Employee Development .

We offer a variety of programs and resources designed to facilitate our employees’ career development, training and networking, including:

◦ Manager development sessions focused on leadership skills, such as performance management training, coaching and feedback;

◦ Continuous improvement training for employees in functions that can best leverage and utilize process improvement practices;

◦ Best-in-class learning management system and dynamic content libraries aimed to meet the individual needs of employees’ current roles as well as future goals and aspirations;

◦ Tuition reimbursement to support degree programs and certifications.

• Competitive Pay and Benefits .

We offer market-competitive base pay and benefits to our employees around the world.

Most of our employees also have variable components to their compensation that are tied to achievement of corporate and individual performance goals, the fluctuations of our stock price, or a combination of both.

We also offer an Employee Stock Purchase Plan to eligible employees, consistent with our philosophy that compensation should align the interests of employees and shareholders and promote a long-term shareholder perspective.

• Health and Safety .

As a Company, we are also committed to making our workplaces safe and secure.

• 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 offer market-competitive compensation opportunities and benefits that are designed to attract, retain and motivate exceptional employees and drive both individual and company performance .

In addition to base salary, most of our employees have variable components to their compensation that are tied to achievement of corporate and individual performance goals, the fluctuations of our stock price, or a combination of both.

We also offer a comprehensive package of global benefits to support the health and well-being of our employees and their families and continually introduce new and enhanced benefit offerings to meet the evolving needs of our workforce and to remain competitive in local markets, including a hybrid work offering for our corporate offices in the U.S.

and certain other jurisdictions.

• We maintain policies and practices to promote employee health and safety .

As a Company, we are committed to making our workplaces safe and secure.

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.

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

Our response to the COVID-19 pandemic has focused on business continuity and the safety of our employees.

This includes prioritizing employee safety with remote work for employees in our administrative functions, implementing extensive cleaning and sanitation processes for all Haemonetics facilities, and instituting various safety protocols to limit exposur e for our manufacturing and customer facing employees, including field service and sales teams, to ensure supplies and support for our customers.

We have also instituted protocols to ensure compliance with vaccine mandates applicable to our employees.

Beginning in March 2022, we executed plans to return employees to offices in jurisdictions where safe and feasible and introduced a new hybrid work model for administrative functions in the U.S.

and certain other jurisdictions.

• Diversity, Equity and Inclusion .

The diversity of our teams and their ideas helps build our collaborative, performance driven culture.

We understand the value that each individual brings to our workplace, and we are committed to providing an inclusive e nvironment where every individual has the opportunity to thrive.

Additionally, we encourage colleagues with shared interests and affinities to connect and learn from one another.

For example, in 2020 we formed the Women’s Initiative Network under the sponsorship of executive leaders that meets regularly, provides development opportunities and participates in external networking events.

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

We also require tailored health and safety compliance training for all site employees as well as annual training for all employees on our Code of Conduct, which includes a specific module on health and safety.

Availability of Reports and Other Information

All of our corporate governance materials, including the Principles of Corporate Governance, Code of Conduct and the charters of the Audit, Compensation, Governance and Compliance and Technology Committees are published on the Investor Relations section of our website at www.haemonetics.com .

Our Principles of Corporate Governance, Code of Conduct and the charters of the Audit, Compensation, Governance and Compliance and Technology Committees of our Board of Directors are published on the Investor Relations section of our website at www.haemonetics.com .

On this website the public can also access, free of charge, our annual, quarterly and current reports and other documents filed or furnished to the Securities and Exchange Commission, or SEC, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the SEC.

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expected operating results and financial performance;

impacts of the COVID-19 pandemic;

the Company’s strategy for growth;

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impacts of acquisitions or dispositions;

market position and expenditures.

and market position and expenditures.

Because forward-looking statements are based on current beliefs, expectations and assumptions regarding future events, they are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of the Company’s control.

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Risk Factors in this report.

• The effect o f the ongoing COVID-19 pandemic, or outbreaks of communicable diseases, on our business, financial conditions and results of operations, including the time it will take for vaccines to be broadly distributed and a dministered worldwide, and the effectiveness of such vaccines in slowing or stopping the spread of COVID-19 and its variants and mitigating the economic effects of the pandemic, including inflationary pressures and higher freight costs in our global supply chain;

• Failure to achieve our long-term strategic and financial-improvement goals;

• Our ability to achieve our long-term strategic and financial-improvement goals;

• Demand for and market acceptance risks for new and existing products, including material reductions in purchasing from or loss of a significant customer;

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regulatory agencies), reputational damage, declining sales or litigation;

• Our ability to retain and attract key personnel;

• 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;

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• Costs and risks associated with product liability and other litigation claims we may be subject to now or in the future;

• Market conditions impacting our stock price and/or share repurchase programs we may enter into from time to time, and the possibility that such share repurchase programs may be delayed, suspended or discontinued.

• The impact of actual or threatened public health emergencies;

• Our ability to retain and attract key personnel;

• Market conditions impacting our stock price and/or our share repurchase program, and the possibility that such share repurchase program may be delayed, suspended or discontinued;

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

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