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INTEGRA ALERT: Bragar Eagel & Squire, P.C. is Investigating Integra LifeSciences Holdings Corp. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-02-26 02:00
NEW YORK, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, is investigating potential claims against Integra LifeSciences Holdings Corp. (NASDAQ: IART) on behalf of long-term stockholders following a class action complaint that was filed against Integra on September 12, 2023 with a Class Period from March 11, 2019 to May 22, 2023. Our investigation concerns whether the board of directors of Integra have breached their fiduciary duties to the ...
Integra LifeSciences(IART) - 2024 Q4 - Annual Report
2025-02-25 22:06
Business Segments and Growth - Integra LifeSciences operates in two reportable segments: Codman Specialty Surgical (CSS) and Tissue Technologies (TT), with CSS accounting for approximately two-thirds of total revenue[19]. - The acquisition of Acclarent in April 2024 positions Integra as a leading provider in ENT products, expanding its market reach and innovation potential[28]. - Integra's international expansion includes new product launches in Europe and Asia, such as MicroMatrix® and Certas Plus® Programmable Valve[26][27]. - The neurosurgical business has seen growth driven by geographic expansion and new product registrations in markets such as China, Japan, and Europe, with expectations for continued growth in the near-to-long term[47]. - The company has significant manufacturing and distribution sites in North America, Europe, China, and Japan, indicating a global operational footprint[138]. Product Development and Innovation - The company anticipates PMA approval for DuraSorb in 2026, following the completion of a clinical study and operationalization of the Braintree facility expected in the first half of 2026[23][45]. - In 2024, Integra launched MicroMatrix® Flex in the U.S., enhancing wound management capabilities[24]. - Integra's R&D strategy focuses on innovative solutions for unmet surgical needs, with significant investments in regenerative technologies and clinical studies[41][42]. - The CUSA® Clarity platform has been updated with new ultrasonic handpiece and electrosurgical capabilities, including a successful commercial launch of a single-sided bone tip in early 2023[48]. - The Aurora Surgiscope, a single-use medical device for cranial surgery, received 510(k) clearance from the FDA in Q4 2023, indicating progress in innovation[50]. Regulatory Environment and Compliance - The regulatory environment is stringent, with extensive FDA regulations governing the introduction and marketing of medical devices, impacting operational timelines and costs[63]. - The FDA requires 510(k) clearance or PMA for medical devices, with Class II and III devices needing pre-market notification or approval[72]. - Compliance with patient and data privacy laws, as well as environmental regulations, is essential for maintaining operational integrity and market access[62]. - The company is subject to various healthcare regulations, including the U.S. federal Anti-Kickback Statute, which prohibits certain remuneration practices that could influence healthcare decisions[94]. - The EU MDR, effective from May 26, 2021, introduces stricter regulations for medical devices in the EEA, replacing the previous EU MDD[80]. Financial Performance and Market Challenges - Revenues typically peak in the fourth quarter due to increased hospital purchases coinciding with budget cycles, with Q1 usually showing lower revenues[59]. - Legislative changes, such as the Budget Control Act of 2011, have resulted in automatic reductions of Medicare payments, affecting revenue[90]. - The company faces potential challenges in market acceptance due to reimbursement policies from government and private payors[87]. - The company faces heightened governmental scrutiny regarding product pricing, which could lead to reduced demand for its products due to potential limitations on coverage and reimbursement[92]. - The company may incur substantial costs to comply with future environmental, health, and safety laws and regulations, impacting its financial condition[100]. Workforce and Corporate Culture - As of December 31, 2024, the company had approximately 4,396 regular full and part-time employees, with 70% located in the United States, 20% in Europe, 9% in Asia Pacific, and 1% in Latin America and Canada[110]. - The company maintained seven employee-led Employee Resource Groups (ERGs) in fiscal year 2024, focusing on career development and networking opportunities[111]. - The company is committed to pay equity and regularly conducts pay equity analyses to adjust compensation as necessary[113]. - The company emphasizes talent development through various learning and development programs, which are critical for employee satisfaction and retention[115]. - The company conducts annual global engagement pulse surveys to gather employee feedback and improve workplace satisfaction[117]. Cybersecurity and Data Privacy - The company is increasingly dependent on sophisticated information technology, and any significant disruptions could have a material adverse effect on its business[204]. - Cybersecurity risks are heightened due to remote work, which may create vulnerabilities for cybercriminals to exploit[206]. - The company maintains a comprehensive cybersecurity program, including regular evaluations and collaboration with third-party cybersecurity services[210]. - Compliance with evolving data privacy laws, such as GDPR and HIPAA, may require significant changes to products and incur additional costs[208]. - The incident response team is generally led by the CIO and includes IT and legal personnel, with escalation protocols to update the Board and senior management on significant incidents[214]. Acquisitions and Strategic Growth - The company has acquired two businesses between January 1, 2022, and December 31, 2024, at a total cost of approximately $329.3 million, including Surgical Innovation Associates, Inc. for $51.5 million and Acclarent, Inc. for $277.8 million[133]. - The company is currently engaged in evaluations of potential acquisitions and is in various stages of discussion regarding possible acquisitions, which could significantly impact future growth[135]. - The company’s future profitability will depend on its ability to develop resources to adapt to new products or business areas acquired through acquisitions[135]. - The company may face impairments or other charges related to goodwill and indefinite-lived intangible assets, which could materially affect its financial statements[147]. - The company may experience difficulties in growing sales in new international markets due to customer acceptance and regulatory restrictions[140]. Supply Chain and Manufacturing - The company maintains long-term supply contracts with suppliers to ensure the availability of raw materials, which is critical for uninterrupted production[55]. - The company faces challenges in replacing sole-source suppliers for key components and raw materials, which could disrupt manufacturing capabilities[154]. - The company anticipates increased costs and potential supply chain disruptions due to global economic factors, including inflation and geopolitical events[158]. - The transition of manufacturing activities to the Braintree facility may not realize anticipated benefits due to unforeseen challenges[173]. - The company is exposed to product liability claims, which may exceed insurance coverage or be excluded from coverage[164].
Integra LifeSciences(IART) - 2024 Q4 - Earnings Call Transcript
2025-02-25 20:58
Integra LifeSciences (IART) Q4 2024 Earnings Call February 25, 2025 04:58 PM ET Company Participants Christopher Ward - Senior Director of Investor RelationsMojdeh Poul - President & Chief Executive OfficerLea Knight - Executive Vice President & Chief Financial OfficerMatthew Taylor - Managing DirectorRichard Newitter - Managing DirectorJoanne Wuensch. - Managing DirectorJayson Bedford - Managing Director, Equity Research Conference Call Participants Vik Chopra - AnalystRobert Marcus - AnalystRyan Zimmerman ...
Integra LifeSciences(IART) - 2024 Q4 - Earnings Call Presentation
2025-02-25 15:51
Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect the Company's judgment as of the date of this presentation. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Some of these forward-looking statements may contain words like "will," "believe," "may," "could," "would," "might," "possible," " ...
Integra LifeSciences(IART) - 2024 Q4 - Earnings Call Transcript
2025-02-25 15:50
Integra LifeSciences Holdings Corporation (NASDAQ:IART) Q4 2024 Earnings Conference Call February 25, 2025 8:30 AM ET Company Participants Chris Ward – Senior Director, Investor Relations Mojdeh Poul - President and Chief Executive Officer Lea Knight - Chief Financial Officer Conference Call Participants Matt Taylor – Jefferies Vik Chopra - Wells Fargo Robbie Marcus - JPMorgan Ryan Zimmerman - BTIG Richard Newitter - Truist Securities Steven Lichtman - Oppenheimer & Company Craig Bijou - Bank of America Sec ...
Integra (IART) Reports Q4 Earnings: What Key Metrics Have to Say
ZACKS· 2025-02-25 15:35
For the quarter ended December 2024, Integra LifeSciences (IART) reported revenue of $442.65 million, up 11.5% over the same period last year. EPS came in at $0.97, compared to $0.89 in the year-ago quarter.The reported revenue represents a surprise of -0.45% over the Zacks Consensus Estimate of $444.66 million. With the consensus EPS estimate being $0.85, the EPS surprise was +14.12%.While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to ...
Integra LifeSciences (IART) Surpasses Q4 Earnings Estimates
ZACKS· 2025-02-25 13:15
Integra LifeSciences (IART) came out with quarterly earnings of $0.97 per share, beating the Zacks Consensus Estimate of $0.85 per share. This compares to earnings of $0.89 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 14.12%. A quarter ago, it was expected that this medical device maker would post earnings of $0.39 per share when it actually produced earnings of $0.41, delivering a surprise of 5.13%.Over the last four quart ...
Integra LifeSciences(IART) - 2024 Q4 - Annual Results
2025-02-25 11:15
News Release Integra LifeSciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides 2025 Financial Guidance Princeton, New Jersey, February 25, 2025 - Integra LifeSciences Holdings Corporation (NASDAQ: IART) today reported financial results for the fourth quarter and full year ended December 31, 2024. Fourth Quarter 2024 Full-Year 2024 2024 Business Highlights "As I step into my role leading Integra, I am inspired by the strength of our portfolio, the dedication of our team, and the t ...
Integra LifeSciences Reports Fourth Quarter and Full-Year 2024 Financial Results and Provides 2025 Financial Guidance
GlobeNewswire· 2025-02-25 11:00
PRINCETON, N.J., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ: IART) today reported financial results for the fourth quarter and full year ended December 31, 2024. Fourth Quarter 2024 Reported revenues were $442.6 million, representing an increase of 11.5% on a reported basis and an increase of 3.5% on an organic basis compared to the fourth quarter 2023. GAAP earnings per diluted share were $0.25, compared to $0.25 in the fourth quarter 2023. Adjusted earnings per dil ...
Jan De Witte joins GHO Capital as Operating Partner
GlobeNewswire News Room· 2025-02-11 09:30
Core Insights - GHO Capital has appointed Jan De Witte as Operating Partner to enhance its portfolio and support transatlantic deal origination [2][6] - Jan De Witte brings extensive experience in leading international growth and transformation in the healthcare and technology sectors [3][4] - GHO Capital aims to leverage Jan's expertise to identify high-growth potential businesses within the healthcare sector [7] Company Overview - GHO Capital Partners LLP is a specialist healthcare investment advisor based in London, focusing on high-growth healthcare opportunities [9] - The firm targets Pan-European and transatlantic internationalization to build market-leading businesses of strategic global value [9] - GHO Capital emphasizes improving healthcare delivery efficiency to enable better, faster, and more accessible healthcare [9] Leadership Background - Jan De Witte previously served as CEO of Integra LifeSciences, where he added $1 billion to the company's total addressable market through strategic acquisitions and innovation [3] - He has also held leadership positions at Barco N.V. and GE Healthcare, focusing on digital transformation and global market expansion [4] - Jan holds an M.B.A. from Harvard Business School and degrees in electromechanical engineering from KU Leuven, Belgium [5]