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 ...

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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, Inc. (NYSE:GMED) Q4 2023 Earnings Conference Call February 20, 2024 4:30 PM ET Company Participants Brian Kearns - Senior Vice President, Business Development and Investor Relations Daniel Scavilla - President and Chief Executive Officer Keith Pfeil - Chief Operating Officer and Chief Financial Officer Conference Call Participants Vikramjeet Chopra - Wells Fargo Securities Steven Lichtman - Oppenheimer Matt Blackman - Stifel Shagun Singh - RBC Capital Markets David Saxon - Needham & Company ...

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, Inc. (NYSE:GMED) Q3 2023 Earnings Conference Call November 7, 2023 4:30 PM ET Company Participants Brian Kearns - SVP, Business Development & IR Daniel Scavilla - President, CEO & Director Keith Pfeil - SVP & CFO Conference Call Participants Matthew Miksic - Barclays Bank Shagun Chadha - RBC Capital Markets Vikramjeet Chopra - Wells Fargo Securities Andrew Ranieri - Morgan Stanley Jason Wittes - ROTH MKM Partners Ryan Zimmerman - BTIG Samuel Brodovsky - Truist Securities Matthew O’Brien - Pi ...

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 ...