Question-and-Answer SessionOne of the first questions when we were putting these together that came to me is that both of you are relatively new. And I'd love if you could just sort of give us a state of the union of what you've learned since you've arrived, what surprised you positively and what you're like, "Hey, I didn't expect that."Mojdeh PoulPresident, CEO & Director Yes. Thank you so much for having us, Joanne, first of all, and I get started, and then I'll pass it on to Lea, but I would say one of t ...

Integra LifeSciences (NasdaqGS:IART) FY 2025 Conference December 03, 2025 10:30 AM ET Company ParticipantsMojdeh Poul - CEOLea Knight - CFOConference Call ParticipantsNone - AnalystNoneOf Integra LifeSciences, join us. One of the first questions, when we were putting these together, that came to me is that both of you are relatively new, and I'd love if you could just sort of give us a state of the union of what you've learned since you've arrived, what surprised you positively, and what you, like, didn't e ...

Financial Data and Key Metrics Changes - The company is focused on improving operational cash flow and expects to see momentum in cash flow management throughout Q4 and into 2026, driven by better supply reliability and improved EBITDA [21][39] - The company has identified $25-$30 million in savings for 2026, targeting enhanced productivity and stronger procurement management to mitigate inflationary pressures [35][36] Business Line Data and Key Metrics Changes - The relaunch of PriMatrix and Durepair has been successful, exceeding expectations since their launch in early October, indicating strong demand for these products [12][16] - The ENT franchise is experiencing growth in the high single-digit to low double-digit range, particularly in the ERA Eustachian tube dilation products, while Balloon Sinuplasty is facing challenges due to reimbursement issues [18][19] Market Data and Key Metrics Changes - The implant-based breast reconstruction market is estimated at $800 million, growing at high single-digit to low double-digit rates, presenting significant opportunities for the company [32] - The company is leveraging its broad portfolio in tissue technologies, which includes products for wound care and surgical reconstruction, to capture market share [29][30] Company Strategy and Development Direction - The company is prioritizing quality management system transformation and supply chain optimization as part of its Compliance Master Plan initiated in mid-2024 [7][20] - Future M&A activities are on hold until the company improves its leverage and operational stability, with a focus on cash flow improvements and debt reduction through 2026 [21][41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to a growth trajectory and stabilizing operations, with a focus on leveraging the strengths of their product portfolio [41][44] - The company aims to establish a culture of continuous improvement in supply chain and operations to enhance profitability moving forward [39][40] Other Important Information - The Boston facility is set to be operational by June 2026, with ongoing work on equipment and process validations [5][10] - The company is committed to dual sourcing in its supply chain to build resiliency and ensure product availability [11] Q&A Session Summary Question: What is the status of the Boston facility remediation? - The Boston facility is on track to be operational by June 2026, with the older facility already closed and employees transitioned to the new site [5][6] Question: How is the company addressing operational challenges? - The company is implementing a harmonized quality management system across its global operations to systematically address issues [7][8] Question: What are the growth prospects for the ENT franchise? - The high-growth segment of the ENT portfolio is performing well, while the Balloon Sinuplasty segment faces reimbursement challenges [17][18] Question: When will the company return to M&A activities? - M&A activities are not expected until after 2026, focusing first on improving operational cash flow and reducing leverage [20][21] Question: What are the expected savings from the margin expansion program? - The company has identified savings in cost of goods sold and operational expenses, targeting $25-$30 million for 2026 [35][36]

PRINCETON, N.J., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, today announced that chief executive officer Mojdeh Poul and chief financial officer Lea Knight will present at the Citi 2025 Global Healthcare Conference on December 3, 2025 at 10:30 a.m ET A live webcast of the presentation will be available on the Integra LifeSciences investor relations website under EVENTS & PRESENTATIONS. About Integra LifeSciencesAt ...

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]