PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, announced today that Mojdeh Poul, chief executive officer and Lea Knight, chief financial officer will present at the 35th Annual Oppenheimer Healthcare MedTech & Services Conference on March 17, 2025 at 10:00am ET. A live webcast of the presentation will be available on the Integra LifeSciences investor relations website at https://investor.integralife.co ...

PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, announced today that Mojdeh Poul, chief executive officer and Lea Knight, chief financial officer will present at the 35th Annual Oppenheimer Healthcare MedTech & Services Conference on March 17, 2025 at 10:00am ET. A live webcast of the presentation will be available on the Integra LifeSciences investor relations website at https://investor.integralife.c ...

Core Viewpoint - Integra LifeSciences has faced significant challenges since mid-2023 due to quality control issues at its Boston plant, impacting growth in the Tissue Technologies business [1] Company Summary - The quality control issues have led to a decline in important growth drivers for Integra LifeSciences [1]

Integra LifeSciences Holdings Corporation (IART) delivered adjusted earnings per share (EPS) of 97 cents for the fourth quarter of 2024, which surpassed the Zacks Consensus Estimate by 14.1%. The metric increased 9% year over year.Find the latest EPS estimates and surprises on Zacks Earnings Calendar.The adjustment excludes the impact of certain non-recurring charges like structural optimization charges, divestiture, acquisition and integration-related charges, and EU Medical Device Regulation charges, amon ...

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 ...

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].

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," " ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2024 was $443 million, representing year-over-year reported growth of 11.5% and organic growth of 3.5% [24][35] - Full year 2024 revenues were $1.61 billion, reflecting 4.5% growth on a reported basis and a decline of 1.3% on an organic basis [29][30] - Adjusted EPS for Q4 was $0.97, up 9% compared to 2023, and adjusted EPS for the full year was $2.56, down 17.4% versus 2023 [25][32] Business Line Data and Key Metrics Changes - In the CSS business, Q4 revenues were $314.7 million, an increase of 15.8% on a reported basis and 4.1% on an organic basis [38] - Tissue Technologies grew 2% on both a reported and organic basis in Q4, with the Wound Reconstruction franchise increasing by 8.2% [42] Market Data and Key Metrics Changes - International sales in CSS were down low single digits due to delayed clearance of shipping holds [41] - The company expanded its international commercial footprint in Brazil, India, Korea, and China, enhancing its global presence [20] Company Strategy and Development Direction - The company is focused on operational excellence, executing a compliance master plan, and enhancing manufacturing capacity [68][69] - There is a commitment to invest in innovation and global expansion while addressing operational challenges [53][54] - The company aims to regain market share and drive growth with differentiated products, particularly in the implant-based breast reconstruction market [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged that recent performance has not met expectations and emphasized the need for improvements in quality, manufacturing, and supply chain [11][13] - The company expects Q1 2025 revenues to be between $375 million and $385 million, with organic growth projected to be negative [27][46] - For the full year 2025, revenues are projected to be between $1.65 billion and $1.72 billion, reflecting continued demand for its differentiated portfolio [48] Other Important Information - The company is investing in facility equipment upgrades to enhance quality and capacity, with plans to bring the Braintree facility online in the first half of 2026 [18][22] - The company has established a new standing quality committee to reinforce oversight and accountability [22] Q&A Session Summary Question: Concerns about Integra Skin and shipping holds in 2025 - Management acknowledged the planned maintenance shutdown and lower safety stock levels may prevent meeting demand in Q1, but expects production constraints to diminish throughout the year [61][62] Question: Key strategic initiatives for 2025 - The focus will be on operational excellence, maintaining leadership in core markets, and introducing differentiated new products [68][69] Question: Impact of potential tariffs on manufacturing - The company does not have manufacturing facilities in Mexico or Canada but sources components from those countries and is assessing potential impacts [73][74] Question: Future shipping holds and quality issues - Management indicated that the compliance master plan's assessment phase could lead to potential supply disruptions, although no specific issues are currently known [78][79] Question: Cash flow expectations for 2025 - The company expects operating cash flow and free cash flow to improve in 2025, with a step-up in free cash flow conversion anticipated in Q4 2025 [82][84] Question: Acclarent's growth profile in 2025 - Acclarent is expected to grow at high single digits in 2025, aligning with business expectations and synergies from integration [90][91] Question: Recovery pathway for private label - The private label business is expected to grow at mid-single digit rates, with component supply delays anticipated to be resolved by the second half of 2025 [115][116]

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 ...

Financial Performance - For the quarter ended December 2024, Integra LifeSciences reported revenue of $442.65 million, reflecting an 11.5% increase year-over-year [1] - EPS for the quarter was $0.97, up from $0.89 in the same quarter last year, resulting in a surprise of +14.12% compared to the consensus estimate of $0.85 [1] - The reported revenue was slightly below the Zacks Consensus Estimate of $444.66 million, with a surprise of -0.45% [1] Key Metrics - Organic revenue growth was 3.5%, exceeding the four-analyst average estimate of 2.4% [4] - Revenue from Codman Specialty Surgical totaled $314.66 million, compared to the four-analyst average estimate of $317 million, representing a year-over-year change of +15.8% [4] - Revenue from Tissue Technologies was $127.99 million, slightly above the four-analyst average estimate of $127.54 million, with a year-over-year change of +2.1% [4] - Revenue from Tissue Technologies in Wound Reconstruction and Care was $101.53 million, surpassing the estimated $95.61 million, marking an 8.2% increase year-over-year [4] - Revenue from Tissue Technologies' Private Label was $26.46 million, below the average estimate of $32.20 million, indicating a year-over-year decline of -16.2% [4] Stock Performance - Shares of Integra have returned -16.4% over the past month, contrasting with the Zacks S&P 500 composite's -1.8% change [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]