Globus Medical (GMED) continues to gain from surging demand for its Musculoskeletal Solutions products. Meanwhile, the company is expanding in the overseas markets through the expansion of direct and distributor sales force. Yet, we are worried about a challenging macroeconomic scenario that continues to plague Globus Medical’s profit margins. It has a Zacks Rank #3 (Hold) at present.GMED is gaining market share in the musculoskeletal solutions space, banking on the strong performance of its implantable dev ...

Financial Data and Key Metrics Changes - The company reported record revenue of $1.569 billion for the full year 2023, representing a 53% increase compared to the prior year, including four months of NuVasive sales [30] - Non-GAAP EPS for Q4 was $0.60, with non-GAAP net income growing 38.9% year-over-year [41] - Full year non-GAAP net income increased by 25.9% over the prior year, with non-GAAP EPS growing 12.6% [41] Business Line Data and Key Metrics Changes - Standalone Globus sales for Q4 were $304 million, an 11% increase year-over-year, while NuVasive standalone sales for Q4 were $312 million, up 2% on a pro forma basis [31] - Musculoskeletal sales for Q4 2023 were $583.8 million, growing 138.3% compared to the prior year quarter [49] - Enabling technologies revenue for Q4 was $32.7 million, growing 10.9% year-over-year [49] Market Data and Key Metrics Changes - U.S. revenue in Q4 2023 was $490.8 million, growing 110.5% over the prior year quarter [42] - International revenue for Q4 was $125.7 million, growing 204.6% compared to the prior year [42] - The company achieved 20% growth internationally and 41% growth in trauma sales [31] Company Strategy and Development Direction - The merger with NuVasive aims to create a leading organization with a comprehensive portfolio in spine, enabling tech, and orthopedics, focusing on long-term sustained growth [36] - The company plans to drive synergy capture and operational improvements while enhancing profitability and cash flow generation [12] - The focus for 2024 includes executing merger integration and driving cross-selling opportunities [12][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving synergy targets and emphasized the importance of listening to customer needs for innovation [12][36] - The company anticipates some sales dissynergies but remains optimistic about growth prospects [66] - Management highlighted the importance of operational improvements and investments in manufacturing to drive future profitability [61] Other Important Information - The company expects adjusted gross profit rates to be in the mid to upper 60s for the full year 2024 [50] - Research and development expenses for Q4 were $52.3 million, reflecting increased spending due to the NuVasive merger [51] - The company has approximately $275.2 million remaining under its authorized share repurchase program [58] Q&A Session Summary Question: What are the expectations regarding NuVasive products registration and improvements? - Management indicated that the readiness of teams to embrace common goals is promising, but common processes and systems need to be established [11] Question: How meaningful are the inbound interests from competitive reps? - Management noted significant interest from competitive sales professionals, indicating a strong recruitment focus [14] Question: What is the strategy for financing arrangements and sales mix? - Management acknowledged a shift towards more volume-based sales due to higher interest rates impacting revenue recognition [21] Question: Can you elaborate on the expected dissynergies and cross-selling opportunities? - Management confirmed that the $150 million in potential dissynergies is a gross number, with expectations to offset it through cross-selling [60] Question: How does the company plan to compete with new robotic systems in the market? - Management expressed confidence in their superior robotic offerings and the merger's strategic advantage in competing effectively [87]

International Sales and Market Presence - International sales accounted for approximately 18.4% of total sales in 2023[21] - The company launched over 10 new products in 2023 and operates in 64 countries worldwide[18] - The company aims to continue expanding its international presence by commercializing additional products and increasing its sales force in existing and new markets[30] - The company has a direct or distributor sales presence in the U.S. and 64 other countries as of December 31, 2023, with dedicated sales teams for spinal implants, orthopedic trauma, and Enabling Technologies[41] Product Portfolio and Innovation - The company's Musculoskeletal Solutions include implantable devices, biologics, accessories, and neuromonitoring services used in spinal, orthopedic, and neurosurgical procedures[30] - The company's Enabling Technologies focus on advancing surgical procedures through innovative products and software platforms[18] - The company's product portfolio includes solutions for degenerative conditions, deformity, tumors, and trauma, with a focus on both open and minimally invasive surgical techniques[31] - The company's orthopedic trauma products cover four major segments: fracture plates, compression screws, intramedullary nails, and external fixation, with fracture plating including proximal humerus, distal radius, and other specific plates[32] - The company's neuromonitoring services utilize proprietary software with hunting algorithms and graphical user interfaces, providing real-time, surgeon-directed feedback on nerve directionality and proximity during surgery[34] - The company's Enabling Technologies include imaging, navigation, and robotics (INR) solutions, with the ExcelsiusGPS platform supporting minimally invasive and open procedures, and the Excelsius3D™ platform offering 3 imaging modalities[35][36] - The company acquired Nemaris Inc. in 2018, gaining Surgimap, a surgical planning software platform with predictive algorithms and cloud-based infrastructure[36] Regulatory Compliance and Quality Assurance - The company's quality assurance group conducts periodic audits and inspections to ensure compliance with FDA, ISO, and other regulatory standards[51] - The company's facilities and third-party manufacturers are subject to periodic inspections by regulatory authorities, including the FDA and international agencies, to ensure compliance with quality system regulations[52] - The company is subject to FDA postmarket requirements, including compliance with Quality System Regulation (QSR) and labeling restrictions[88] - The company distributes human tissue products regulated under Section 361 of the Public Health Service Act, which do not require premarket FDA authorization[84] - The company resolved a 2018 FDA warning letter related to non-conformities in human tissue product processing by December 31, 2023[93] - The company must comply with international regulatory requirements, including obtaining CE marks for medical devices in the European Economic Area (EEA)[96] - The EU Medical Device Regulation (MDR) imposes stricter requirements for marketing and sale of medical devices, with compliance required by May 2024 for companies like Globus Medical and NuVasive, and extended transitional provisions until December 2027 for Class III and IIb devices[97] - The Japanese PMD Act requires manufacturers to obtain manufacturing or import approval and undergo third-party evaluations for low-risk medical devices, with compliance procedures including Premarket Submission, Certification, and Approval[103] - The UK has introduced the UKCA conformity mark, replacing the CE mark, with rolling requirements for MDD/MDR certified devices through 2027, and mandatory registration with the MHRA as of January 2021[102] - The FDA's 510(k) Program has been strengthened, requiring manufacturers to demonstrate product performance more extensively and promoting the use of best-practice approaches for predicate devices[80] - The GDPR imposes strict data protection obligations, including restrictions on data collection, analysis, and transfer, and mandates prompt notice of data breaches, with substantial fines for non-compliance[106] - The FDA prohibits off-label promotion of medical devices, and violations of federal false claims laws can result in significant civil and criminal sanctions[110] - The company must comply with EU/EEA laws, directives, and regulations, including environmental compliance, product stewardship, and labeling requirements[100] - The company is subject to announced and unannounced inspections by Notified Bodies and other regulatory agencies, which may include supplier facilities[107] - The company must comply with national laws of individual EEA Member States, which may require additional registration efforts before CE-marked products can be distributed[101] - The company is subject to federal anti-kickback laws, which prohibit remuneration in exchange for referrals or purchases of goods or services under federal healthcare programs[108] Financial and Market Risks - The company's sales volumes and prices for Musculoskeletal Solutions products may increasingly depend on third-party payor coverage and reimbursement[62] - The company may face pricing pressure from competitors and customers, potentially impacting profit margins[145] - The company's profitability depends on third-party payor coverage and reimbursement for its Musculoskeletal Solutions products[146] - The company is exposed to risks related to currency exchange rate fluctuations in international transactions[138] - The company may incur significant expenses related to the integration of NuVasive, with potential challenges in realizing anticipated synergies[143] - The company is subject to environmental laws and regulations, which could impose significant costs and liabilities[116][138] - The company's products may require new regulatory clearances or approvals for modifications, such as 510(k) or PMA supplements[138] - The company faces risks related to the adoption of its novel Musculoskeletal Solutions and Enabling Technologies products by surgeons and hospitals[141][142] - CMS and private payors may reduce payments for procedures using the company's products, potentially harming sales[147] - Negative coverage policies by third-party payors could impact the company's Musculoskeletal Solutions products[148] - Uncertainty around reimbursement levels for procedures using Musculoskeletal Solutions products under Medicare and private managed care systems[149] - International market acceptance of Musculoskeletal Solutions products depends on coverage and reimbursement approvals[150] - Dependence on direct sales representatives and independent distributors for generating sales[151] - Challenges in managing a geographically dispersed distribution network and retaining key individuals[153] - Need to expand marketing and sales networks to support new product launches and existing products[154] - Intense competition from major medical device companies with greater financial and technical resources[156] - Dependence on a limited number of suppliers for products, materials, and components, exposing the company to supply chain risks[162] - Recent launch of the Excelsius3D™ imaging system and the need to convince surgeons and hospitals of its merits[170] - The company's products lack long-term clinical data, which may limit sales and raise safety concerns[166] - The company relies on FDA's 510(k) clearance process for most products, but future regulatory changes could delay or cancel product launches[193] - The company faces risks from dependence on third-party suppliers, which could disrupt supply chains and harm business operations[161] - The company may pursue acquisitions to grow its business, but integration challenges could negatively impact operations[171][174] - The company maintains high inventory levels, risking obsolescence and potential financial losses[175] - The company's reliance on IT systems exposes it to cybersecurity risks, which could disrupt operations and harm financial performance[176][177] - The company is subject to stringent data privacy laws, including GDPR and CCPA, with potential fines up to €20 million or 4% of global revenue for non-compliance[181] - Consolidation in the healthcare industry may lead to pricing pressures and exclusion from key markets, impacting revenue[183] - The company's SECURE-C device underwent a seven-year clinical study, but most products lack comparable long-term data, potentially slowing adoption[167] - The company's R&D efforts require significant investment, and new products may not generate sufficient sales to offset development costs[169] - Sales of Enabling Technologies products include a 12-month warranty and maintenance obligation, with potential additional costs if warranty claims exceed expectations[185] - Enabling Technologies capital equipment sales cycles are lengthy due to senior management approvals, competitive bidding, and new product evaluations, causing financial result fluctuations[186] - Quarterly operating results may fluctuate, potentially falling below analyst or investor expectations, leading to a decrease in stock price[187] - IONM services expose the company to malpractice risks and operational disruptions due to reliance on technology and internet connectivity[188] - Regulatory changes could restrict operations, increase costs, or reduce sales, with potential delays or denials in FDA approvals for medical devices[191][194] - Modifications to 510(k)-cleared products may require new FDA clearances, potentially leading to marketing halts or recalls if approvals are not obtained[201] - HCT/P products are subject to FDA regulations, and non-compliance could result in enforcement actions such as fines, injunctions, or product recalls[203][204] - Failure to comply with FDA's QSR and CGTP regulations could impair the company's ability to market products cost-effectively and timely[205] - Product recalls, whether voluntary or mandated, could significantly impact the company's reputation, operations, and financial condition[208] Intellectual Property and Trademarks - The company owns 2,583 issued U.S. patents (2,547 utility patents; 36 design patents) and has 867 U.S. patent applications pending (866 utility patents; 1 design patent) as of December 31, 2023[60] - The company holds 1,744 issued foreign patents and has 502 foreign patent applications pending[60] - The company's trademark portfolio includes 732 registered trademarks and 196 pending trademarks[61] Manufacturing and Supply Chain - The company's manufacturing facilities are located in Eagleville, Limerick, and West Carrollton in the U.S., with regenerative biologic products processed in San Antonio and Audubon, and the ExcelsiusGPS and Excelsius3D™ systems assembled in Methuen[47] - The company relies on a network of third-party suppliers for some implant and instrument products, with a focus on high precision, computer-aided manufacturing and ISO-13485 certification[48][49] - The company's inventory management strategy involves maintaining safety stock levels based on demand, manufacturing lead times, and service level requirements[53] - The company's surgical instrument sets are tailored to meet customer surgery schedules, with instruments often returned post-surgery for reuse[54] Corporate Governance and Workforce - The company's Board of Directors consists of 11 members, with 2 identifying as female and 2 identifying as having a racial and ethnic background other than white[123] - The company has over 5,000 employees worldwide as of December 31, 2023[119] Stock and Market Value - The company's Class A Common Stock is traded on the New York Stock Exchange under the symbol GMED[3] - The aggregate market value of the company's common equity held by non-affiliates was approximately $4.6 billion as of June 30, 2023[5] Strategic Acquisitions and Mergers - The merger with NuVasive expanded the company's global commercial reach and enhanced its Musculoskeletal Solutions and Enabling Technologies offerings[25] - The company has a history of strategic acquisitions, including KB Medical SA, Nemaris Inc., StelKast, Inc., Synoste Oy, Capstone Surgical Technologies, and Harvest Biologics LLC[24]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission File No. 001-35621 GLOBUS MEDICAL, INC. (Exact name of registrant as specified in its charter) DELAWARE 04-3744954 (State or ...

Globus Medical, Inc. (NYSE:GMED) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET Company Participants Brian Kearns - Senior Vice President-Business Development & Investor Relations Dan Scavilla - President & Chief Executive Officer Keith Pfeil - Senior Vice President & Chief Financial Officer Conference Call Participants Matt Miksic - Barclays Caitlin Cronin - Canaccord Genuity Lin Zhang - Truist Securities Operator Welcome to Globus Medical's Second Quarter 2023 Earnings Call. At this time, all ...

OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission File No. 001-35621 GLOBUS MEDICAL, INC. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) (Exact name of registrant as specified in its charter) (State or other jurisdiction of in ...

Globus Medical, Inc. (NYSE:GMED) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Brian Kearns - Senior Vice President of Business Development and Investor Relations Dan Scavilla - President and CEO Keith Pfeil - Senior Vice President and Chief Financial Officer Conference Call Participants Mike Miksic - Barclays Shagun Singh - RBC David Saxon - Needham & Co Sam Dane - BTIG Kyle Rose - Canaccord Vik Chopra - Wells Fargo Operator Welcome to Globus Medical’s First Quarter 2023 Earn ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to _______________ Commission File No. 001-35621 GLOBUS MEDICAL, INC. (Exact name of registrant as specified in its charter) DELAWARE 04-3744954 (State or oth ...

Globus Medical, Inc. (NYSE:GMED) Q4 2022 Earnings Conference Call February 21, 2023 4:30 PM ET Company Participants Brian Kearns - Senior Vice President of Business Development and Investor Relations Dan Scavilla - President and CEO Keith Pfeil - Senior Vice President and Chief Financial Officer Conference Call Participants Shagun Singh - RBC Capital Markets Matt Taylor - Jefferies Matt Miksic - Barclays Vik Chopra - Wells Fargo David Saxon - Needham and Company Steve Lichtman - Oppenheimer Matthew O'Brien ...

International Sales and Market Presence - In the year ended December 31, 2022, international sales accounted for approximately 14.8% of total sales[19] - As of December 31, 2022, Globus had a direct or distributor sales presence in 53 countries outside the United States[35] - The company expects to continue expanding its international presence through the commercialization of additional products[20] - International operations account for approximately 14.8% of total net sales, with significant revenues generated in Japan, the Euro zone, United Kingdom, and Australia[185] Product Development and Innovation - Globus launched 8 new products in 2022 and has a range of new products in various stages of development[20] - Globus has introduced over 230 products designed for the treatment of musculoskeletal disorders since its inception[22] - The ExcelsiusGPS platform, a robotic guidance and navigation system, supports minimally invasive and open procedures[30] - The company employs an integrated team approach to product development, allowing for rapid product conception to launch[32] - The company has launched the Excelsius3D™ imaging system and continues to introduce new products related to the ExcelsiusGPS platform and orthopedic trauma products, but faces challenges in convincing surgeons and hospitals of their merits[119] Regulatory Compliance and Risks - The company is subject to extensive FDA regulations, requiring pre-market clearance or approval for medical devices, which can impact time to market[57] - The company has received a warning letter from the FDA regarding non-conformities related to human tissue products, which remains open as of December 31, 2022[64] - The company must comply with the EU Medical Device Regulation (MDR) by May 2027, which includes stricter technical documentation requirements[67] - The company is subject to extensive governmental regulations, including the FDA's good manufacturing practice regulations, which could impact operations[91] - The company must comply with international laws and regulations to market products outside the U.S., with potential adverse actions from foreign regulatory bodies if standards are not met[156] - Non-compliance with FDA regulations could result in sanctions such as fines, recalls, or even criminal penalties, adversely affecting the company's reputation and financial condition[147] Financial Performance and Growth Strategies - Net sales increased to $1,022.8 million in 2022, reflecting rapid growth since inception[187] - The company anticipates substantial increases in operating expenses to support growth strategies, including adding sales representatives and conducting clinical trials[186] - Future growth will depend on the success of growth strategies, brand strength, and market success of current and future products[188] - The existing revolving credit facility contains restrictive covenants that may limit operational flexibility and ability to engage in certain transactions[194] Supply Chain and Manufacturing - The company has expanded its in-house manufacturing capabilities, with significant portions of implant products manufactured in Pennsylvania and regenerative biologics processed in Texas[41] - The company maintains a small number of carefully selected suppliers for key products to ensure reliability and quality compliance[43] - The company relies on less than five third-party suppliers for allograft implants and products, which poses risks related to pricing, availability, quality, and delivery schedules[162] Competition and Market Challenges - The musculoskeletal devices industry is facing intense competition, with established companies increasing pricing pressure due to new entrants and technologies[95] - Surgeons and hospitals are critical in the adoption of new products, and their acceptance depends on education regarding the benefits and safety of the products[92] - The proliferation of physician-owned distributorships (PODs) may increase pricing pressure and impact the company's ability to compete effectively[113] Management and Organizational Structure - The company is highly dependent on key members of senior management, particularly Executive Chairman David C. Paul and CEO Daniel T. Scavilla, and their loss could disrupt operations and strategic plans[115] - As of December 31, 2022, executive officers and directors beneficially owned approximately 74.5% of the voting power of the outstanding capital stock[207] - David C. Paul, the Executive Chairman, controlled approximately 22.4% of the Class A and Class B common stock, representing about 74.3% of the voting power[208] Legal and Liability Risks - The company faces potential product liability claims due to the inherent risks in the medical device industry, which could result in significant financial liabilities[204] - Product liability claims could increase insurance costs or lead to inadequate coverage, adversely affecting the company's financial condition[206] - The company faces scrutiny under healthcare fraud and abuse laws, which could result in criminal and civil sanctions if violated[167] Economic and Market Conditions - Negative trends in the general economy, including inflation and financial market volatility, may adversely affect business performance[190] - The company faces risks from currency exchange rate fluctuations that could adversely affect profitability due to international operations[185] Intellectual Property and Patent Issues - As of December 31, 2022, the company owned 1,527 issued U.S. patents and had applications pending for 518 U.S. patents, indicating a strong intellectual property portfolio[46] - The company relies on patent, copyright, and trademark laws to protect proprietary technologies, but faces uncertainties regarding the effectiveness of these protections[195] - The medical device industry is characterized by patent litigation, which could divert management's attention and incur substantial costs[199]