Globus Medical(GMED)
Search documents
Globus Medical (GMED) Q1 Earnings and Revenues Beat Estimates
Zacks Investment Research· 2024-05-07 22:31
Globus Medical (GMED) came out with quarterly earnings of $0.72 per share, beating the Zacks Consensus Estimate of $0.55 per share. This compares to earnings of $0.53 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 30.91%. A quarter ago, it was expected that this medical device company would post earnings of $0.59 per share when it actually produced earnings of $0.60, delivering a surprise of 1.69%.Over the last four quarters, ...
Globus Medical(GMED) - 2024 Q1 - Quarterly Report
2024-05-07 21:05
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited Q1 2024 consolidated financial statements reflect a net loss and significant changes in financial profile post-NuVasive merger | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total current assets (in thousands) | $1,828,574 | $1,915,374 | | Total assets (in thousands) | $4,943,612 | $5,086,083 | | Total current liabilities (in thousands) | $786,324 | $392,347 | | Total liabilities (in thousands) | $1,021,251 | $1,088,124 | | Total equity (in thousands) | $3,922,361 | $3,997,959 | | Account | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net sales (in thousands) | $606,666 | $276,688 | | Gross profit (in thousands) | $365,179 | $205,863 | | Operating income/(loss) (in thousands) | $7,997 | $56,403 | | Net income/(loss) (in thousands) | $(7,117) | $49,129 | | Diluted EPS | $(0.05) | $0.48 | | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Net cash provided by operating activities (in thousands) | $52,387 | $53,313 | | Net cash provided by/(used in) investing activities (in thousands) | $(46,584) | $10,992 | | Net cash provided by/(used in) financing activities (in thousands) | $(115,721) | $2,940 | | Net increase/(decrease) in cash (in thousands) | $(113,230) | $67,219 | [Note 1. Background](index=7&type=section&id=Note%201.%20Background) Globus Medical, a musculoskeletal medical device company, completed its merger with NuVasive, Inc. on September 1, 2023, becoming the accounting acquirer - The company develops and commercializes healthcare solutions for musculoskeletal disorders, focusing on implants, robotic guidance, and orthopedic trauma products[14](index=14&type=chunk) - On September 1, 2023, Globus Medical merged with NuVasive, Inc., with Globus as the accounting acquirer, impacting prior period comparability[18](index=18&type=chunk)[19](index=19&type=chunk) [Note 3. Asset Acquisitions and Business Combinations](index=12&type=section&id=Note%203.%20Asset%20Acquisitions%20and%20Business%20Combinations) Q1 2024 saw a biotech acquisition with **$12.6 million** in expensed IPR&D, alongside the preliminary **$2.6 billion** NuVasive merger purchase price allocation, including **$1.23 billion** in goodwill - In Q1 2024, the company acquired a biotech company and expensed **$12.6 million** for acquired in-process research and development (IPR&D)[60](index=60&type=chunk) NuVasive Merger Preliminary Purchase Price Allocation (in thousands) | Component | Value | | :--- | :--- | | Total Value Class A Common Stock | $2,153,860 | | Repayment of revolving credit facility | $420,762 | | Fair value of assumed equity awards | $28,635 | | **Total purchase price** | **$2,603,836** | | Fair value of acquired identifiable net assets | $1,369,361 | | **Goodwill** | **$1,234,475** | [Note 4. Net Sales](index=15&type=section&id=Note%204.%20Net%20Sales) Total net sales for Q1 2024 significantly increased to **$606.7 million**, with Musculoskeletal Solutions remaining the largest product category at **$574.7 million** Net Sales by Product Category (in thousands) | Product Category | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Musculoskeletal Solutions | $574,697 | $251,607 | | Enabling Technologies | $31,969 | $25,081 | | **Total net sales** | **$606,666** | **$276,688** | [Note 11. Debt](index=19&type=section&id=Note%2011.%20Debt) The company assumed **$450.0 million** in 0.375% Senior Convertible Notes due 2025 from the NuVasive merger and maintains an undrawn **$400.0 million** revolving credit facility - The company assumed **$450.0 million** in principal of 0.375% Senior Convertible Notes due 2025 from the NuVasive merger[95](index=95&type=chunk) - The 2025 Notes are convertible into Class A Common Stock at a rate equivalent to a conversion price of approximately **$124.38 per share**[96](index=96&type=chunk) - The company has an undrawn **$400.0 million** revolving credit facility as of March 31, 2024[94](index=94&type=chunk) [Note 12. Equity](index=22&type=section&id=Note%2012.%20Equity) In Q1 2024, the company repurchased **1.6 million** Class A common shares for **$83.3 million**, with **$191.7 million** remaining under the repurchase authorization - In Q1 2024, the company repurchased **1.6 million** shares of Class A common stock for **$83.3 million**[107](index=107&type=chunk) - As of March 31, 2024, **$191.7 million** was remaining under the share repurchase authorization[107](index=107&type=chunk) [Note 15. Restructuring and Other Costs](index=26&type=section&id=Note%2015.%20Restructuring%20and%20Other%20Costs) The company incurred **$24.0 million** in pre-tax costs in Q1 2024 for its '2024 Synergy Plan' post-merger, with **$19.1 million** recorded as restructuring costs - The company incurred **$24.0 million** in pre-tax costs in Q1 2024 related to its '2024 Synergy Plan' to optimize the post-merger organization[129](index=129&type=chunk)[130](index=130&type=chunk) - Of the total costs, **$19.1 million** was classified as 'Restructuring Costs' on the income statement, mainly for employee termination benefits[130](index=130&type=chunk) [Note 18. Segment and Geographic Information](index=29&type=section&id=Note%2018.%20Segment%20and%20Geographic%20Information) The company aggregates its two operating segments into one reportable segment, with the United States accounting for **$482.9 million** of Q1 2024 net sales Net Sales by Geographic Area (in thousands) | Region | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | United States | $482,927 | $234,120 | | International | $123,739 | $42,568 | | **Total** | **$606,666** | **$276,688** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2024 financial results, highlighting a **119.3% surge in net sales** to **$606.7 million** due to the NuVasive merger, offset by significantly higher operating costs leading to a net loss Net Sales Change by Geography (in thousands) | Geography | Q1 2024 | Q1 2023 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | United States | $482,927 | $234,120 | $248,807 | 106.3% | | International | $123,739 | $42,568 | $81,171 | 190.7% | | **Total net sales** | **$606,666** | **$276,688** | **$329,978** | **119.3%** | - The increase in net sales was primarily due to the addition of NuVasive[153](index=153&type=chunk)[154](index=154&type=chunk) - Cost of sales increased by **241.0%** to **$241.5 million**, driven by the NuVasive addition, amortization of inventory fair value step-up, and increased volume[155](index=155&type=chunk) - Operating expenses increased significantly: R&D rose **171.6%** to **$57.3 million**, SG&A rose **103.2%** to **$248.7 million**, and Amortization of Intangibles rose **545.0%** to **$29.7 million**, all primarily due to the NuVasive merger[156](index=156&type=chunk)[157](index=157&type=chunk)[158](index=158&type=chunk) - The company recorded **$19.1 million** in restructuring costs in Q1 2024 related to the 2024 Synergy Plan, primarily for employee termination benefits[161](index=161&type=chunk) - Cash used in financing activities increased to **$115.7 million**, primarily due to **$83.3 million** in common stock repurchases and payments for business acquisition liabilities[171](index=171&type=chunk)[107](index=107&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) No significant changes to quantitative and qualitative market risk disclosures were reported compared to the 2023 Annual Report on Form 10-K - There have been no significant changes to the market risk information disclosed in the 2023 Annual Report on Form 10-K[178](index=178&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded the company's disclosure controls and procedures were effective as of March 31, 2024, with no material changes to internal controls - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2024[180](index=180&type=chunk) - There were no material changes in the company's internal control over financial reporting during the first quarter of 2024[181](index=181&type=chunk) [PART II. OTHER INFORMATION](index=37&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in ordinary course legal proceedings, including a favorable defense verdict in the Moskowitz Family LLC patent infringement case in December 2023 - The company is subject to legal proceedings arising in the ordinary course of business[186](index=186&type=chunk) - In the Moskowitz Family LLC patent infringement lawsuit, a jury returned a defense verdict in favor of Globus in December 2023. No liability has been recorded for this matter as of March 31, 2024[137](index=137&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's 2023 Annual Report on Form 10-K were reported - There have been no material changes to the risk factors set forth in the company's 2023 Annual Report on Form 10-K[188](index=188&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased **1.6 million** Class A common shares for **$83.3 million** in Q1 2024, with **$191.7 million** remaining under the authorization Share Repurchases in Q1 2024 (in thousands, except per share prices) | Period | Total Shares Purchased | Average Price Paid per Share | Dollar Value Remaining in Program | | :--- | :--- | :--- | :--- | | Jan 2024 | 717 | $52.80 | $237,367 | | Feb 2024 | 464 | $51.94 | $213,291 | | Mar 2024 | 416 | $51.84 | $191,732 | | **Total** | **1,597** | **-** | **-** | - The share repurchase program was expanded in September 2023 by an additional **$350.0 million**[189](index=189&type=chunk) [Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - Not applicable[192](index=192&type=chunk) [Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[193](index=193&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) Not applicable - Not applicable[194](index=194&type=chunk) [Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including CEO/CFO certifications and XBRL data files - The report includes a list of filed exhibits, such as CEO/CFO certifications under Sarbanes-Oxley Sections 302 and 906, and XBRL documents[196](index=196&type=chunk)
Globus Medical(GMED) - 2024 Q1 - Quarterly Results
2024-05-07 20:21
Globus Medical Reports First Quarter 2024 Results AUDUBON, PA, May 7, 2024: Globus Medical, Inc. (NYSE: GMED), a leading musculoskeletal solutions company, today announced its financial results for the quarter ended March 31, 2024. "Since the NuVasive merger closed in September of last year, we worked aggressively to execute our integration strategy and are making significant progress towards rapidly reaching steady state. I am pleased with the first quarter results delivered by strong teamwork and partners ...
Wall Street's Insights Into Key Metrics Ahead of Globus Medical (GMED) Q1 Earnings
Zacks Investment Research· 2024-05-06 14:22
Wall Street analysts expect Globus Medical (GMED) to post quarterly earnings of $0.55 per share in its upcoming report, which indicates a year-over-year increase of 3.8%. Revenues are expected to be $586.66 million, up 112% from the year-ago quarter.Over the past 30 days, the consensus EPS estimate for the quarter has remained unchanged. This demonstrates the covering analysts' collective reassessment of their initial projections during this period.Before a company announces its earnings, it is essential to ...
GMED vs. PEN: Which Stock Is the Better Value Option?
Zacks Investment Research· 2024-04-23 16:41
Investors with an interest in Medical - Instruments stocks have likely encountered both Globus Medical (GMED) and Penumbra (PEN) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.We have found that the best way to discover great value opportunities is to pair a strong Zacks Rank with a great grade in the Value category of our Style Scores system. The Zacks Rank favors stocks with strong earnings estimate revision trends, and our Style Sc ...
Why Globus Medical (GMED) is a Top Momentum Stock for the Long-Term
Zacks Investment Research· 2024-04-15 14:51
It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.The popular research service can help you become a smarter, more self-assured investor, giving you access to daily updates of the Zacks Rank and Zacks Industry Rank, the Zacks #1 Rank List, Equity Research reports, and Premium stock screens.Zacks Premium includes access to the Zacks Style Scores a ...
Globus Medical (GMED) Gains From New Launches Amid Macro Issues
Zacks Investment Research· 2024-04-04 13:47
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 ...
Globus Medical(GMED) - 2023 Q4 - Earnings Call Transcript
2024-02-21 04:01
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]
Globus Medical(GMED) - 2023 Q4 - Annual Report
2024-02-20 23:32
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]
Globus Medical(GMED) - 2023 Q3 - Quarterly Report
2023-11-07 22:30
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 ...