Globus Medical Stock

Globus Medical, Inc. and its subsidiaries (Globus) operate as a medical device company that develops and commercializes healthcare solutions whose intention is to improve the quality of life of patients with musculoskeletal disorders.

Globus is committed to medical device innovation and delivering exceptional service to hospitals, ambulatory surgery centers and physicians to advance patient care and improve efficiency. With over 10 product launches in 2023 and operations across 64 countries worldwide, the company offers a comprehensive portfolio of innovative and differentiated technologies that are used to treat a variety of musculoskeletal conditions. Although the company manages its business globally within one reportable segment, the company separates its products and services into two major categories: Musculoskeletal Solutions and Enabling Technologies.

Market

The primary market for the company’s products is the United States (‘U.S.’), where the company sells its products through a combination of direct sales representatives employed by the company and sales representatives employed by the company’s exclusive independent distributors, who distribute the company’s products on its behalf for a commission that is generally based on a percentage of sales.

During the year ended December 31, 2023, international sales accounted for approximately 18.4% of the company’s total sales. Internationally, the company sells its products through a combination of direct sales representatives employed by the company and exclusive international distributors.

Strategy

The company’s business strategies are to leverage its integrated product development engine; increase the size, scope and productivity of the company’s exclusive U.S. sales force; continue to expand into international markets; and pursue strategic acquisitions.

As of December 31, 2023, the company had an existing direct or distributor sales presence in 64 countries outside the U.S.

In 2023, the company acquired NuVasive, a leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. NuVasive’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring (‘IONM’) technology and service offerings. The Merger expanded the company’s global commercial reach, increased operational capabilities and enhanced the company’s comprehensive offerings of Musculoskeletal Solutions and Enabling Technologies.

The Globus Solution

The company’s focus on actively listening and responding to the needs of its customers with high quality solutions separates the company from its industry peers. Since 2003, the company has introduced many products, including 10 products in 2023, designed for the treatment of musculoskeletal disorders.

The company’s Musculoskeletal Solutions products, combined with the company’s ability to provide world-class service through a highly trained and exclusive sales force and corporate account management, create significant value for the company’s customers.

Product & Service Categories

While the company groups its products and services into two categories, Musculoskeletal Solutions and Enabling Technologies, they are not limited to a particular technology, platform or surgical approach.

Musculoskeletal Solutions

The company’s Musculoskeletal Solutions consist primarily of implantable devices, biologics, accessories, unique surgical instruments, and neuromonitoring services, used in an expansive range of spinal, orthopedic and neurosurgical procedures. Musculoskeletal disorders are a leading driver of healthcare costs worldwide. Disorders range in severity from mild pain and loss of feeling to extreme pain and paralysis. These disorders are primarily caused by degenerative and congenital conditions, deformity, tumors and traumatic injuries. Treatment alternatives for musculoskeletal disorders range from non-operative conservative therapies to surgical interventions depending on the pathology. Conservative therapies include bed rest, medication, casting, bracing, and physical therapy. When conservative therapies are not indicated, or fail to provide adequate quality of life improvements, surgical interventions may be used. Surgical treatments for musculoskeletal disorders can be instrumented, which include the use of implants, or non-instrumented, which forego the use of hardware but may include biologics.

The company’s broad spectrum of spine products addresses the vast majority of conditions affecting the spine, including degenerative conditions, deformity, tumors, and trauma. The company provides comprehensive solutions that facilitate both open and minimally invasive surgery (‘MIS’) techniques. This includes traditional fusion implants, such as pedicle screw and rod systems, plating systems, intervertebral spacers and corpectomy devices. The company pioneered expandable solutions for interbody fusion, corpectomy and interspinous fixation that allow intraoperative customization of the company’s devices to the patient’s anatomy, eliminating sequential trialing and potentially saving surgical time. The company has also developed treatment options for motion preservation technologies, such as dynamic stabilization, total disc replacement and interspinous distraction devices, as well as interventional solutions to treat vertebral compression fractures. The company’s biologic solutions include regenerative biologic products such as allografts and synthetic alternatives that are adjunctive treatments typically used in combination with stabilizing implant hardware.

The company’s orthopedic trauma solutions are designed to treat a wide variety of orthopedic fracture patterns and patient anatomies in the upper and lower extremities, as well as the hip. The company’s orthopedic trauma and extremity products, covering four major segments of the orthopedic trauma market: fracture plates, compression screws, intramedullary nails, and external fixation. The company began marketing these products in 2018 and intend to grow the company’s presence in this field. Fracture plating includes proximal humerus, distal radius, proximal tibia, distal tibia, distal fibula, distal femur, small fragment, mini-fragment and clavicle plates. Intramedullary nailing includes tibial, trochanteric, and femoral nail systems. Regenerative biologic products such as bone void fillers and allograft struts are used in orthopedic procedures where applicable.

The company’s hip and knee joint solutions for the treatment of degenerative conditions or failed previous reconstruction have a long history of clinical use. Over 13 different implants have been marketed to date, including modular hip stems and acetabular cups for total hip arthroplasty, as well as posterior stabilizing and cruciate retaining knee arthroplasty implants.

The company’s neuromonitoring services utilize proprietary software that employs hunting algorithms and graphical user interfaces to provide surgeons with an enhanced and intuitive nerve avoidance system. Through the company’s IONM platforms, the company gives surgeons the option to connect their instruments to a computer system that provides discrete, real-time, surgeon-directed and surgeon-controlled feedback about the directionality and relative proximity of nerves during surgery. The company’s proprietary IONM platforms are a differentiator in the market and are unique in their ability to provide information about the directionality and proximity of nerves. The company’s systems analyze and then translate complex neurophysiologic data into simple, useful information to assist the surgeon’s clinical decision-making process. Surgeons can connect certain instruments to the company’s IONM systems, thus creating an interactive set of instruments that better enable the safe navigation through the body’s nerve anatomy during surgery. The company provides onsite and remote monitoring of the neurological systems of patients undergoing spinal and brain-related surgeries. Monitoring the health of the nervous system during spinal surgery has been a key component of the company’s strategy of product differentiation since early in the company’s development.

Enabling Technologies

The company’s Enabling Technologies are consisted of imaging, navigation and robotics (‘INR’) solutions for assisted surgery which are advanced computer-assisted intelligent systems designed to enhance a surgeon’s capabilities, and ultimately improve patient care and reduce radiation exposure for all involved, by streamlining surgical procedures to be safer, less invasive, and more accurate. The market for the company’s Enabling Technologies in spine, cranial and orthopedic surgery is still in the infancy stage and consists primarily of imaging, navigation and robotic systems. In spine, a majority of these technologies are limited to surgical planning and assistance in implant placement for increased accuracy and time savings with less intraoperative radiation exposure to the patient and surgical staff. As the company’s Enabling Technologies become more fully integrated with the company’s Musculoskeletal Solutions, a continued rise in adoption is expected.

The company’s INR solutions include the ExcelsiusGPS platform, which is a robotic guidance and navigation system that supports minimally invasive and open procedures with screw and interbody spacer placement applications. The ExcelsiusGPS platform has a modular design that the company expect will serve as a foundation for future clinical applications using artificial intelligence and augmented reality. Also, in 2018, the company acquired Nemaris Inc., the company that developed and marketed Surgimap, a leading surgical planning software platform. Surgimap’s intuitive, patient-specific surgical planning and cloud-based infrastructure includes predictive algorithms and visual guides that enable healthcare professionals to plan and simulate surgical treatment of complex deformities. The software also enables medical professionals to share medical imaging technology globally to improve procedural workflow and patient care. In 2022, the company launched Excelsius3D, which when combined with the ExcelsiusGPS robotic navigation system, provides a superior intraoperative, image-guided robotic navigation solution that is designed to improve implant placement accuracy, lower radiation exposure, and shorten operative times. This highly maneuverable and intuitive imaging platform offers 3 imaging modalities, position memory, and a large field of view.

The company’s Enabling Technologies products offer surgeons more information about patient anatomy and surgical options to help them to make well-informed preoperative and intraoperative surgical decisions.

Sales and Marketing

The company markets and sells its products primarily through the company’s exclusive global sales force. As of December 31, 2023, the company had a direct or distributor sales presence in the U.S. and in 64 other countries. The company has dedicated spinal implant, orthopedic trauma and Enabling Technologies sales teams in place. The company sells its hip and knee products primarily through independent sales agents. The company expects to continue to increase the number of the company’s direct and distributor sales representatives in each of these areas, both in the U.S. and internationally, to expand into new geographic territories and to deepen the company’s penetration in existing territories.

The company’s implant sales representatives are present in the operating room during most surgeries in the U.S. and in many, but not all, of the other countries in which the company’s products are sold. These representatives have the responsibility to confirm that all of the items needed in the surgery are available and are provided sterile or are capable of being sterilized at the hospital. An assortment of sizes and quantities of implants are made available to be able to satisfy varying surgical requirements and patient anatomy, along with numerous surgical instruments and cases needed to safely perform the surgery and implantation. As products are used in surgeries, replacement items are shipped to the company’s sales representatives and hospitals to replenish their supply.

Surgeon Training and Education

The company devotes significant resources to training and educating surgeons regarding the safety and reproducibility of the company’s surgical techniques and the company’s procedurally integrated solutions. The company’s surgeon education and training program integrates surgical training with professional development and enables the company to introduce surgeons to its comprehensive portfolio and patented approaches to spine surgery. The company offers educational and training courses globally through in-person formats and via virtual content, including virtual conferences and video and social channels, to demonstrate the benefits of the company’s products and procedures.

Competition

Alphatec Holdings, Orthofix, Integra LifeSciences, and ZimVie are competitors of the company.

Manufacturing and Supply

The company, and its third-party manufacturers, is subject to the quality system regulations of the FDA, state regulations (such as the regulations promulgated by the California Department of Health Services), and regulations promulgated by foreign regulatory bodies (such as in the European Union). For tissue products, the company is FDA registered and licensed in the states of California, Delaware, Florida, Illinois, Maryland, New York, and Oregon. For the company’s device implants and instruments, the company is FDA-registered, California-licensed, Conformite Europeenne (‘CE’)-marked and ISO-certified. CE, an acronym for ‘Conformite Europeenne’ or European Conformity, is the registration marking designating that a device can be commercially distributed throughout the European Union (‘EU’). The company’s facilities and the facilities of its third-party manufacturers are subject to periodic announced and unannounced inspections by regulatory authorities, and may undergo compliance inspections conducted by the FDA, state, and/or international regulatory agencies for, among other things, conformance to Quality System Regulations and Current Good Manufacturing Practice requirements, as well as separate foreign or international standards.

Surgical Instrument, Implant Sets and Equipment Sales

For many of the company’s customers, the company provides surgical instrumentation sets, including both implants and instruments, as well as the company’s IONM systems in a manner tailored to fulfill the company’s customer’s obligations to meet surgery schedules.

Intellectual Property

As of December 31, 2023, the company owned 2,583 issued U.S. patents (2,547 utility patents; 36 design patents) and had applications pending for 867 U.S. patents (866 utility patents; 1 design patents), and the company owned 1,744 issued foreign patents and had applications pending for 502 foreign patents. The company’s issued patents expired or will expire between March 2015 and November 2043.

The company’s trademark portfolio contains 732 registered trademarks and 196 pending trademarks. The company’s portfolio includes domestic and foreign trademarks with associated logos and tag lines.

Government Regulation

The company’s products are medical devices and human tissue products subject to extensive regulation by the FDA and other regulatory bodies both inside and outside of the U.S.

The company’s products meet the FDA’s definition of medical devices (per Section 201(h)(1) of the Food, Drug, and Cosmetic Act) and human tissue products (under 21 CFR Parts 1270 and 1271 or Public Health Service Act Section 361), each subject to varying regulation(s) by the FDA and other federal, state, local and foreign regulatory bodies.

The company is subject to both announced and unannounced inspections (device and tissue) by the FDA’s Office of Regulatory Affairs, Office of Compliance, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, and American Association of Tissue Banks, as well as other regulatory agencies overseeing the implementation and adherence of applicable state and federal tissue licensing regulations.

In the EEA, the company’s devices are required to comply with the essential requirements of the EU Medical Device Directive (Council Directive 93/42/EEC) (‘MDD’).

Further, the advertising and promotion of the company’s products in the EEA is subject to limited provisions under Regulation 2017/745 and the laws of individual EEA Member States implementing Directive 2006/114/EC concerning misleading and comparative advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other EEA Member State laws and industry codes governing the advertising and promotion of medical devices.

In addition to the presiding MDD (93/42/EEC; MDD) and MDR (2017/745; MDR) outlined above, the company must also comply with EU / EEA laws, directives, regulations and recognized standards as applicable to the devices the company produces.

Below is a non-exhaustive list of requirements to apply to devices within the company’s portfolio and to which the company must demonstrate some degree of compliance:

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals;

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast);

Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment;

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices;

Directive (EU) 2023/2413 of the European Parliament and of the Council of 18 October 2023 amending Directive (EU) 2018/2001, Regulation (EU) 2018/1999 and Directive 98/70/EC as regards the promotion of energy from renewable sources, and repealing Council Directive (EU) 2015/652;

Directive 2014/30/EU of the European Parliament and the Council of 26 February 2014 on the harmonization of the laws of the Member States relating to electromagnetic compatibility;

Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators and repealing Directive 91/157/EEC; and

Directive 94/62/EC of 20 December 1994 on packaging and packaging waste.

History

Globus Medical, Inc. was founded in 2003. The company was incorporated in Delaware in 2003.