Haemonetics Stock

Haemonetics Corporation operates as a global healthcare company.

The company provides a suite of innovative medical products and solutions for customers, to help them improve patient care. The company’s technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services.

Segments

The company operates through three segments: Plasma, Blood Center, and Hospital.

Plasma

This segment includes plasma collection devices and disposables, plasma donor management software, and anticoagulant and saline sold to plasma customers.

Blood Center

This segment includes blood collection and processing devices and disposables for red cells, platelets and whole blood.

Hospital

This segment, which consists 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.

Market and Products

Product Lines

The following describes the company’s principal products in each of its segments.

Plasma

The company’s 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.

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. 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 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. The company serves the market for plasma that is processed into pharmaceuticals through its Plasma business, and it serves the market for transfusion plasma through its Blood Center business.

The company’s 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. The company’s 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.

Plasma Products — the company’s automated plasma collection devices, related disposables, software and services are designed to support multiple facets of plasma collector operations. The company has a long-standing commitment to understanding its customers’ collection and manufacturing processes. As a result, the company intends to design equipment that is durable, dependable, and easy to use and to provide comprehensive training and support to help its customers optimize their plasma collections.

Nearly all source plasma collections worldwide are performed using automated collection technology at dedicated facilities. The company offers multiple products to support these dedicated source plasma operations, including its NexSys PCS and PCS2 plasmapheresis equipment, related disposables and solutions. The company also offers a portfolio of integrated information technology platforms for plasma customers to manage their donors, operations and supply chain. The company’s software products, including its 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 the company’s 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.

With its PCS brand, the company has provided an automated platform dedicated to the collection of plasma. In 2018, the company began transitioning customers from its PCS2 equipment to NexSys PCS.

NexSys PCS is designed to enable higher plasma yield collections, improve productivity in the company’s customers’ centers, enhance the overall donor experience and provide safe and reliable collections that will become life-changing medicines for patients. NexSys PCS includes bi-directional connectivity to the NexLynk DMS donor management system to improve operational efficiency within plasma centers, through automated programming of donation procedures and automated data capture of procedure data.

The company’s 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 (year ended April 3, 2021), the company received FDA 510(k) clearance for its 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 the company’s PCS2 baseline device, software configuration and donor population. The new, proprietary Persona Technology strengthens the NexSys PCS value proposition and reinforces the company’s commitment to supporting its Plasma customers. The company expects to pursue further regulatory clearances for additional enhancements to the overall product offering.

The company has entered into agreements with all major U.S. customers to adopt NexSys PCS somewhere in their global collection network and it provides ongoing support of NexSys PCS devices and NexLynk DMS donor management software for these Plasma customers.

The company’s Plasma business unit represented 42.5% of its total revenue in fiscal 2023.

Blood Center

The company’s Blood Center business offers a range of solutions that improve donor collection centers’ ability to collect and separate blood components for transfusions. The company continues to look for solutions to help its customers improve donor safety, enhance yields and control costs through the existing product portfolio. The company’s products and technologies help donor collection centers optimize blood collection capabilities and donor processing management.

Blood Center Products — the company offers automated blood component and manual whole blood collection systems to blood collection centers to collect blood products efficiently.

The company markets the MCS brand apheresis equipment which is designed to collect specific blood components from the donor. Utilizing the MCS automated platelet collection protocols, blood centers collect one or more therapeutic ‘doses’ of platelets during a single donation.

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

The company’s Blood Center business unit represented 24.0% of its total revenue in fiscal 2023.

Hospital

The company’s 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.

Hemostasis Management

Hemostasis Management Products — The company’s portfolio of hemostasis diagnostic systems enables clinicians to assess holistically the coagulation status of a patient at the point-of-care or laboratory setting. The company has four viscoelastic testing systems that it markets 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.

Each hemostasis diagnostic system consists of an analyzer that is used with single-use reagents and disposables. In addition, TEG Manager software connects multiple TEG 5000 and TEG 6S analyzers throughout the hospital, providing clinicians with remote access to both active and historical test results that inform treatment decisions.

The TEG 5000 system is approved for a broad set of indications in all of the company’s markets. The TEG 6s system is approved for the same set of indications as the TEG 5000 in Europe, Australia and Japan. The company continues to pursue a broader set of indications for TEG 6s in the U.S. In 2019, the company 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 available in select European and Asia Pacific markets. The HAS-100 device is commercialized in China.

Vascular Closure

Vascular Closure Products — The VASCADE technology platform was developed to address the limitations of manual compression and existing vascular closure devices. The company’s 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. The company’s 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, the company’s 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, the company’s VASCADE MVP device is the only marketed vascular closure device clinically proven and labeled to improve workflow relative to manual compression for electrophysiology procedures. 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

Cell Salvage Market — The company market its 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 — The company’s 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

Transfusion Management Products — The company’s Transfusion Management solutions are designed to help provide safety, traceability and compliance from the hospital blood bank to the patient bedside and enable consistent care across the hospital network. The company’s SafeTrace Tx transfusion management software is considered the system of record for all hospital blood bank and transfusion service information. BloodTrack blood management software is a modular suite of blood management and bedside transfusion solutions that combines software with hardware components and acts as an extension of the hospital’s blood bank information system. The software is designed to work with blood storage devices, including the BloodTrack HaemoBank.

The company’s Hospital business unit represented 31.8% of its total revenue in fiscal 2023.

The company also has revenue associated with certain services, maintenance and parts, representing approximately 1.7% of its total revenue in fiscal 2023.

Marketing/Sales/Distribution

The company markets and sells its products in approximately 90 countries through its own direct sales force (including full-time sales representatives and clinical specialists), as well as independent distributors. The company’s customers include biopharmaceutical companies, blood collection groups and independent blood centers, hospitals and hospital service providers, group purchasing organizations and national health organizations.

Competition

Terumo Blood and Cell Technologies (Terumo BCT) and Fresenius SE & Co. KGaA, in particular, have significant financial and other resources and are strong competitors in a number of the company’s businesses. The following provides an overview of the key competitors in each of the company’s three global product enterprises.

Plasma

In the automated plasma collection market, the company principally competes with Fresenius’ Fenwal Aurora and Aurora Xi device product lines and 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 the field of plasma related software, the company principally competes with applications developed internally by certain of its customers, as well as MAK Systems.

Blood Center

The company’s main competitors are Fresenius SE & Co. KGaA (Fresenius), MacoPharma, and Terumo Blood and Cell Technologies (Terumo BCT).

Hospital

Hemostasis Management

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. HemoSonics is owned and offered by Diagnostica Stago SAS.

Vascular Closure

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

Transfusion Management

SafeTrace Tx competition primarily consists of stand-alone blood bank information system (BBIS), including WellSky and some electronic health record software that includes a built-in transfusion management solution, including Cerner. Global competition for BloodTrack varies by country, including MSoft in Europe and established blood practices in the U.S., such as using standard refrigerators and manual movement of blood products.

Cell Salvage

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

Significant Customers

In fiscal 2023 (year ended April 1, 2023), one Plasma customer, CSL Limited (together with its affiliates, ‘CSL’), was greater than 10% of total net revenues and in total accounted for approximately 14% of net revenues.

Government Regulation

Due to the variety of products that the company manufactures, it and its products are subject to a wide range of regulations from numerous government agencies, including the FDA, and similar agencies outside the U.S.

To obtain 510(k) clearance, the company must submit a premarket notification demonstrating that the proposed device is ‘substantially equivalent’ to a previously 510(k)-cleared device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of premarket approval applications (PMAs), or a device that has been the subject of a de novo classification.

Additionally, the company and the manufacturing facilities of some of its suppliers are subject to unannounced inspections by the FDA to determine its compliance with the Quality System Regulation (QSR) and other applicable regulations.

The company’s international sales are subject to regulatory requirements in the countries in which its products are sold. For example, the EU has adopted the EU Medical Device Regulation (the ‘EU MDR’) and the EU In Vitro Diagnostic Regulation (the ‘EU IVDR’), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and postmarket surveillance, than the medical device directives they replace.

The company holds new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for liquid solutions (including anticoagulants, intravenous saline and a red blood cell storage solution), which it sells with its blood component and whole blood collection systems.

History

Haemonetics Corporation was founded in 1971. The company was incorporated in 1985.