Core Insights - Integra LifeSciences Holdings Corporation, a prominent global medical technology company, will have its CEO Mojdeh Poul and CFO Lea Knight present at the Citi 2025 Global Healthcare Conference on December 3, 2025 [1] Company Overview - Integra LifeSciences is focused on restoring patients' lives through innovative treatment pathways that enhance patient outcomes and establish new standards in surgical, neurologic, and regenerative care [2] - The company offers a comprehensive portfolio of high-quality, leading brands in the medical technology sector [2]

Core Insights - Integra LifeSciences Holdings Corporation commends the Centers for Medicare & Medicaid Services (CMS) for its Calendar Year 2026 Medicare Physician Fee Schedule and Outpatient Prospective Payment System rules, which include all of Integra's dermal regenerative templates, decellularized dermal scaffolds, and amniotic tissue membranes classified as skin substitutes [1][2] Group 1: Company Overview - Integra LifeSciences is a global medical technology leader focused on restoring lives through innovation in neurosurgery and tissue reconstruction, with a portfolio of differentiated technologies trusted by healthcare professionals [3] - The company offers a diverse range of products, including Integra matrices, PriMatrix, Cytal, and AmnioExcel, utilizing four unique technology platforms for complex wound reconstruction cases [1][3] Group 2: Industry Impact - The new CMS ruling is seen as a pivotal advancement for the industry, allowing for uniform reimbursement rates across care settings, which will expand access to Integra's product portfolio [2] - The company believes that the new policy will reward innovation, quality, and patient outcomes, areas where it has consistently led [2]

Core Insights - Integra LifeSciences Holdings Corporation has received FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System for use in cardiac surgeries, specifically for debridement of unwanted tissue during valve replacement and repair [1][2][3] Company Overview - Integra LifeSciences is a global leader in medical technology, focusing on restoring lives through innovative solutions in neurosurgery and tissue reconstruction [4] - The company emphasizes its commitment to delivering advanced surgical solutions that enhance patient care [3][4] Product Applications - The CUSA Clarity Ultrasonic Surgical Aspirator System is also indicated for various surgical procedures beyond cardiac surgery, including neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery [2][3] Industry Impact - The expansion of the CUSA Clarity's indications to include cardiac surgery represents a significant milestone for the company, enhancing its position as a leader in the surgical technology industry [3] - The product will be showcased at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, 2025, highlighting its importance in the surgical community [3]

Revenue and Financial Performance - Integra LifeSciences' Codman Specialty Surgical segment accounts for approximately 70% of total revenue, while Tissue Technologies segment generates about 30%[188]. - Total revenues for the three months ended September 30, 2025, were $402.1 million, compared to $380.8 million in 2024, with year-to-date revenues reaching $1.2 billion, up from $1.17 billion in the previous year[219]. - Total revenues for the three months ended September 30, 2025, increased by $21.2 million to $402.1 million, representing mid-single digit growth compared to the same period in 2024[220]. - In the CSS segment, revenues were $292.6 million, an increase of $21.8 million, or 8%, compared to the prior-year period, primarily driven by CSF Management and Dural Access and Repair shipping holds[221]. - In the TT segment, revenues were $109.5 million, a decrease of $0.6 million, or 1%, primarily due to quality and operational issues associated with Medihoney[222]. - For the nine months ended September 30, 2025, total revenues increased by $32.4 million to $1,200.3 million, representing low single digit growth compared to the same period in 2024[238]. - Revenue from the United States for the nine months ended September 30, 2025, was $884.4 million, up 3.2% from $856.6 million in 2024[252]. - The net loss for the three months ended September 30, 2025, was $(5.4) million, a decrease from $(10.7) million in the same period of 2024, while the nine-month net loss increased to $(514.8) million from $(26.4) million year-over-year, primarily due to quality and operational issues and a goodwill impairment of $511.4 million[216]. Product Development and Innovations - The company anticipates PMA approval for SurgiMend in implant-based breast reconstruction by 2026, following the operationalization of the Braintree facility[191]. - In 2024, Integra launched MicroMatrix® Flex, a dual-syringe system for precise delivery in challenging wound areas[192]. - Integra completed the acquisition of Acclarent in April 2024, enhancing its position in the ENT market and enabling future innovations across its technology platforms[195]. - The acquisition of Arkis Biosciences added the CerebroFlo® external ventricular drainage catheter, which has shown a 99% reduction in thrombus accumulation compared to leading products[200]. - The company received FDA 510(k) clearance for the Aurora Surgiscope System in 2025, a single-use medical device for cranial surgery[201]. - The company launched the Durepair Dural Regeneration Matrix for commercial sale in the U.S. in October 2025, complementing its portfolio of dural grafts[204]. - The company completed enrollment in the DuraSorb U.S. IDE clinical trial for two-stage breast reconstruction in 2023, aiming for PMA approval in 2026[207]. - The company acquired Acclarent in 2024, expanding its capabilities in the U.S. ENT market, and launched the AERA Eustachian Tube Dilation System for expanded pediatric indications in 2023[202]. Operational and Compliance Initiatives - The company is implementing a Compliance Master Plan (CMP) to improve its quality management system across manufacturing and supply networks[196]. - The company is in the process of implementing an enterprise-wide quality management system to address quality system gaps and enhance quality culture across its operations[215]. - The company continues to invest in technologies and processes to enhance customer experience and operational excellence[196]. - The company anticipates operationalizing its new tissue manufacturing facility in Braintree, Massachusetts, in 2026, following the transition from its Boston facility[212]. - Total operating expenses decreased by $13.2 million, or 6.3%, to $195.2 million for the three months ended September 30, 2025, compared to $208.4 million in the same period in 2024[224]. - Research and development expenses decreased by $5.0 million for the three months ended September 30, 2025, primarily due to cost management initiatives[225]. Financial Position and Cash Flow - Working capital increased significantly to $779.5 million as of September 30, 2025, compared to $159.6 million at December 31, 2024, primarily due to the repayment of the 2025 Notes[255]. - Cash and cash equivalents decreased to approximately $232.2 million at September 30, 2025, from $246.4 million at December 31, 2024[256]. - Net cash provided by operating activities for the nine months ended September 30, 2025, was $38.6 million, a decrease of $40.1 million compared to $78.6 million in 2024[258]. - Cash flows used in investing activities for the nine months ended September 30, 2025, included $64.2 million for capital expenditures[261]. - The company incurred $12.1 million in tariffs on imported goods during the nine months ended September 30, 2025[271]. - The Consolidated Total Leverage Ratio was 4.35 at September 30, 2025, below the covenant requirement of 5.00[274]. - The effective tax rate for the nine months ended September 30, 2025, was 9.3%, significantly lower than 35.3% in the prior year, primarily due to the goodwill impairment charge[251]. Market and Economic Factors - The company anticipates that tariffs will increase the cost of goods sold, particularly affecting products manufactured in the U.S.[270]. - The company is exposed to foreign currency exchange rate risks primarily with transactions and net assets in Euros, British pounds, Swiss francs, Canadian dollars, Japanese yen, Israeli shekel, Australian dollars, and Chinese yuan[287]. - The results of operations have not been materially affected by inflation[290]. - A hypothetical 100 basis points increase or decrease in interest rates applicable to cash and cash equivalents would impact interest income by approximately $2.3 million annually[291]. - A hypothetical 100 basis points movement in interest rates applicable to short-term investments would increase or decrease interest income by approximately $0.4 million annually[292]. - The total notional amounts related to the company's interest rate swaps were $900.0 million, all effective as of September 30, 2025[293]. - A 100 basis points change in interest rates would impact interest expense on the unhedged portion of the debt by $9.1 million on an annualized basis[293]. - The company manages foreign currency exposure centrally, allowing for netting of exposures and taking advantage of natural offsets[287]. - The company enters into foreign currency forward exchange contracts to manage currency exposures, partially offsetting gains/losses recognized in earnings[288]. - Changes in hedged items are generally expected to be completely offset by changes in the fair value of hedge instruments, minimizing material risk from exchange rate movements[289]. - Interest rate swap derivative instruments are used to manage earnings and cash flow exposure to changes in interest rates[293].

Core Insights - Freddie Mac presented its Third Quarter 2025 Financial Results, indicating a focus on key business drivers and financial performance [1][2]. Group 1 - The presentation was led by Christopher Spina, Vice President of Public Relations and Digital Communications, alongside Jim Whitlinger, Executive Vice President and Chief Financial Officer [1]. - The company highlighted that forward-looking statements may be made during the call, which are based on assumptions about business drivers and other factors that could lead to variations in actual results [2]. - A replay of the call will be available on the company's website, emphasizing the importance of the information shared during the presentation [3].

Core Insights - Integra LifeSciences reported revenue of $402.06 million for Q3 2025, a year-over-year increase of 5.6% and an EPS of $0.54 compared to $0.41 a year ago, indicating positive growth in earnings [1] - The reported revenue fell short of the Zacks Consensus Estimate of $414.8 million, resulting in a surprise of -3.07%, while the EPS exceeded expectations by +25.58% [1] Revenue Breakdown - Organic revenue growth was reported at 5%, below the four-analyst average estimate of 8.5% [4] - Codman Specialty Surgical revenue totaled $292.58 million, compared to the estimated $300.46 million, reflecting an 8.1% year-over-year increase [4] - Tissue Technologies revenue was $109.48 million, below the estimated $114.4 million, showing a slight decline of -0.5% year-over-year [4] - Within Tissue Technologies, Wound Reconstruction and Care generated $83.99 million, slightly below the $84.83 million estimate, marking a +4.4% year-over-year change [4] - Private Label revenue was reported at $25.49 million, significantly lower than the $29.58 million estimate, representing a -13.9% year-over-year decline [4] Stock Performance - Shares of Integra have returned +4.8% over the past month, outperforming the Zacks S&P 500 composite's +3.6% 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]

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $402 million, representing 5.6% reported growth and 5% organic growth year-over-year, but below expectations due to supply interruptions [14][15] - Adjusted EPS for the quarter was $0.54, reflecting a 32% increase compared to Q3 2024 [14] - Gross margin for the quarter was 62.9%, down 10 basis points year-over-year, impacted by remediation costs and tariffs [14][15] - Adjusted EBITDA margin increased to 19.5%, up 330 basis points year-over-year, driven by revenue growth and disciplined cost management [15] Business Line Data and Key Metrics Changes - Codman Specialty Surgical (CSS) segment reported revenues of $292.6 million, reflecting 8.1% reported growth and 7.1% organic growth, with neurosurgery revenues increasing by 13.3% [15][16] - Tissue Technologies revenues were $109.5 million, down 0.5% reported and 0.3% organic, with strong growth in DuraSorb® and Integra Skin offset by declines in MediHoney® [18] Market Data and Key Metrics Changes - International business revenue grew 14.6%, led by a 24% increase in China, reflecting strong demand and improved supply [17] - The ENT business remained flat, impacted by reimbursement pressures and timing of capital equipment purchases [16] Company Strategy and Development Direction - The company is focused on three key priorities: executing a compliance master plan, driving operational excellence, and delivering on financial commitments [6][10] - A portfolio prioritization process has been completed to guide capital and resource allocation towards higher growth, more profitable categories [11] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the need for improved execution consistency and emphasized ongoing efforts to strengthen the supply chain [5][12] - Revised full-year 2025 revenue guidance is set at $1.62 billion to $1.64 billion, reflecting lower than expected Q3 revenue [12][20] Other Important Information - The company has relaunched Primatrix® and DuraPair® ahead of schedule, with expectations to regain market share [9][50] - Operating cash flow for the quarter was $41 million, indicating significant improvement over the first half of the year [15][19] Q&A Session Summary Question: Q4 guidance below street expectations - Management explained that Q4 guidance reflects updated assumptions for ENT and private label, as well as remediation timing and production rates [25] Question: Opportunities for top-line growth in 2026 - Management indicated that there will be both headwinds and tailwinds in 2026, with expectations for modest revenue growth [29] Question: Private label headwinds - Management confirmed that growth in private label will continue to be impacted by the same partner facing market challenges [31] Question: MediHoney® performance - Management stated that MediHoney® is undergoing remediation and has impacted overall performance, but growth in other areas has helped offset this [33] Question: Timeline of supply interruptions - Management clarified that supply interruptions occurred in August, affecting Q3 performance, but have since been resolved [37] Question: Portfolio prioritization and divestment opportunities - Management emphasized that the portfolio review aims to optimize performance, with no predetermined areas for divestment at this time [40] Question: Gross margin sustainability - Management noted that Q3 gross margin performance was better than expected due to efficient cost management, but some headwinds are anticipated moving forward [46] Question: Revenue expectations for Primatrix® and DuraPair® - Management indicated that these products previously generated $25 to $30 million, and regaining market share will take time [49]

Financial Performance - Q3 2025 revenue grew organically by 5% compared to Q3 2024[8, 9] - Adjusted EPS for Q3 2025 was $054, a 317% increase compared to $041 in Q3 2024[7, 10] - Adjusted EBITDA margin for Q3 2025 was 195%, a 330 bps increase compared to 162% in Q3 2024[10] - Q3 2025 operating cash flow was $409 million with a free cash flow conversion of 619%[11] Segment Performance - Codman Specialty Surgical (CSS) Q3 2025 revenue was $2926 million, with organic growth of 71% compared to Q3 2024[13] - Tissue Technologies Q3 2025 revenue was $1095 million, a 03% organic decrease compared to Q3 2024[17] Guidance and Outlook - Q4 2025 reported revenue is projected to be between $420 million and $440 million, with organic growth ranging from -59% to -14%[26] - Full year 2025 reported revenue is projected to be between $162 billion and $164 billion, with organic growth ranging from -16% to -04%[27, 28] - Full year 2025 adjusted EPS is projected to be between $219 and $224[28]

Core Insights - Integra LifeSciences (IART) reported quarterly earnings of $0.54 per share, exceeding the Zacks Consensus Estimate of $0.43 per share, and showing an increase from $0.41 per share a year ago, resulting in an earnings surprise of +25.58% [1] - The company posted revenues of $402.06 million for the quarter ended September 2025, which was 3.07% below the Zacks Consensus Estimate, but an increase from $380.83 million year-over-year [2] - Integra shares have declined approximately 32% year-to-date, contrasting with the S&P 500's gain of 17.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.93 on revenues of $457.68 million, and for the current fiscal year, it is $2.21 on revenues of $1.67 billion [7] - The estimate revisions trend for Integra was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Instruments industry, to which Integra belongs, is currently ranked in the top 39% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8] - Another company in the same industry, ClearPoint Neuro, Inc. (CLPT), is expected to report a quarterly loss of $0.20 per share, reflecting a year-over-year change of -11.1%, with revenues anticipated to be $9.9 million, up 21.9% from the previous year [9]

Financial Performance - Total reported revenues for Q3 2025 were $402.1 million, an increase of 5.6% on a reported basis and 5.0% on an organic basis compared to the prior year[4] - Adjusted EBITDA for Q3 2025 was $78.5 million, or 19.5% of revenue, compared to $61.8 million, or 16.2% of revenue, in the prior year[4] - Revenues from Codman Specialty Surgical segment were $292.6 million, representing reported growth of 8.1% and organic growth of 7.1% compared to Q3 2024[7] - Total revenue for the three months ended September 30, 2025, was $402,062,000, representing a 5.6% increase from $380,834,000 in the same period of 2024[26] - Neurosurgery revenue increased by 14.6% to $201,563,000, while total reported revenues from Codman Specialty Surgical rose by 8.1% to $292,583,000[27] - Total revenues for Q3 2025 reached $402.062 million, an increase from $380.834 million in Q3 2024, representing a growth of 5.3%[41] Profitability Metrics - GAAP gross margin for Q3 2025 was 51.5%, down from 52.6% in Q3 2024; adjusted gross margin was 62.9%, compared to 63.0% in the prior year[4] - Adjusted net income for Q3 2025 was $41.6 million, or $0.54 per diluted share, compared to $31.7 million, or $0.41 per diluted share, in the prior year[5] - The company reported a GAAP net loss of $(5.4) million, or $(0.07) per diluted share, improving from a net loss of $(10.7) million, or $(0.14) per diluted share, in the prior year[5] - The net loss for the three months ended September 30, 2025, was $5,404,000, an improvement from a net loss of $10,695,000 in 2024[26] - Adjusted EBITDA for the three months ended September 30, 2025, was $78,453,000, compared to $61,758,000 in 2024, reflecting a significant increase[32] - The company reported an adjusted net income of $41,621,000 for the three months ended September 30, 2025, compared to $31,736,000 in 2024, with adjusted diluted net income per share increasing to $0.54 from $0.41[33] Cash Flow and Debt - The company generated cash flow from operations of $40.9 million in the quarter, with total balance sheet debt of $1.8 billion and net debt of $1.6 billion[8] - Free cash flow for the three months ended September 30, 2025, was $25,751,000, a turnaround from a negative free cash flow of $(7,166,000) in 2024[38] - The company’s cash and cash equivalents as of September 30, 2025, were $232,186,000, down from $246,375,000 at the end of 2024[35] - Net debt as of September 30, 2025, was $1,566,871,000, compared to $1,535,001,000 at the end of 2024, indicating a slight increase in leverage[40] - The company’s adjusted free cash flow conversion rate for the three months ended September 30, 2025, was 61.9%, a significant improvement from (22.6)% in 2024[38] Guidance and Future Expectations - For Q4 2025, the company expects reported revenues in the range of $420 million to $440 million, representing reported growth of (5.1%) to (0.6%) and organic growth of (5.9%) to (1.4%)[11] - The full year 2025 revenue guidance is updated to a range of $1.620 billion to $1.640 billion, with reported growth of 0.6% to 1.8% and organic growth of (1.6%) to (0.4%)[12] Cost and Expense Analysis - Total costs and expenses for the three months ended September 30, 2025, were $390,301,000, slightly up from $388,984,000 in 2024[26] - Structural optimization charges for Q3 2025 totaled $8.413 million, compared to $3.737 million in Q3 2024, showing an increase of 125.4%[41] - Acquisition, divestiture, and integration-related charges were $177 thousand in Q3 2025, down from $3.643 million in Q3 2024[41] - Boston Recall/Braintree Transition costs amounted to $13.447 million in Q3 2025, up from $9.601 million in Q3 2024, representing an increase of 40.5%[41] - Intangible asset amortization expense for Q3 2025 was $23.145 million, compared to $21.854 million in Q3 2024, reflecting an increase of 5.9%[41] - Cost of goods sold for Q3 2025 was $195.071 million, an increase from $180.596 million in Q3 2024, representing a growth of 8.0%[41]