Product Development and Launches - Integra LifeSciences anticipates PMA approval for SurgiMend in implant-based breast reconstruction by the first half of 2026, following the operationalization of the Braintree facility[192]. - The company launched MicroMatrix® Flex in the U.S. in 2024, enhancing access to challenging wound areas[193]. - Integra successfully re-launched the CereLink® ICP monitor system in 2024, offering advanced monitoring capabilities for traumatic brain injury patients[194]. - The acquisition of Acclarent in April 2024 positions Integra as a leading provider in ENT products and technologies, enhancing its market presence[196]. - The company has introduced several new products in international markets, including MicroMatrix and Certas Plus® in Europe and CUSA Clarity in Australia and Japan[195]. - The CerebroFlo® EVD catheter, acquired from Arkis Biosciences, shows 99% less thrombus accumulation compared to leading competitors[201]. - The Aurora® Surgiscope, acquired from Rebound Therapeutics, received FDA clearance in 2025, enhancing cranial surgery capabilities[202]. - The company anticipates PMA approval for DuraSorb for use in IBBR in 2026, following the completion of clinical trials and regulatory processes[207]. Financial Performance - In 2025, the company reported a net loss of $25.3 million, or $0.33 per diluted share, compared to a net loss of $3.3 million, or $0.04 per diluted share in 2024[216]. - Total revenues for the three months ended March 31, 2025, increased by $13.8 million to $382.7 million from $368.9 million in the same period in 2024[220]. - The Codman Specialty Surgical segment generated revenues of $280.7 million, an increase of $24.2 million, or 9%, compared to the prior-year period, including $29.1 million from the Acclarent acquisition[221]. - The Tissue Technologies segment reported revenues of $102.0 million, a decrease of $10.4 million, or 9%, primarily due to declines in Integra Skin and private label business[222]. - Gross margin for the three months ended March 31, 2025, was $194.4 million, a decrease of $12.4 million from $206.8 million in 2024, with a gross margin percentage of 50.8% compared to 56.1%[223]. - Special charges for the three months ended March 31, 2025, totaled $42.6 million, up from $30.2 million in 2024, driven by acquisition, integration, and quality remediation costs[217]. - Research and development expenses decreased by $2.2 million in the three months ended March 31, 2025, primarily due to lower spending on EU MDR and other projects[225]. - Selling, general and administrative costs increased by $15.7 million in the same period, primarily due to Acclarent commercial costs[226]. - Total revenue for Q1 2025 was $382.65 million, a 3.2% increase from $368.87 million in Q1 2024, driven by a $26 million increase in domestic revenues[238][239]. Operational Changes and Investments - The company is transitioning manufacturing from the Boston facility to the Braintree facility, with ongoing investments in capacity expansion[197]. - The Braintree facility is expected to be operational with FDA approval in the first half of 2026, which will enhance manufacturing capabilities for several product lines[212]. - The company believes its cash, cash equivalents, and available borrowings under the Senior Credit Facility are sufficient to finance operations and capital expenditures for the next twelve months[262]. Tax and Interest Expenses - The effective tax rate for Q1 2025 was 15.8%, significantly lower than 37.3% in Q1 2024, influenced by operating losses and tax benefits[233]. - Interest income decreased by $0.6 million to $4.42 million in Q1 2025 compared to Q1 2024[229]. - Interest expense increased by $5.2 million to $18.82 million in Q1 2025, attributed to the expiration of interest rate swap derivatives[231]. - The company anticipates a $2.7 million expense related to the new 15% global minimum tax regime for 2025[236]. Cash Flow and Working Capital - Working capital increased to $188.8 million as of March 31, 2025, up from $159.6 million at the end of 2024[241]. - Cash and cash equivalents totaled approximately $239.1 million as of March 31, 2025, down from $246.4 million at the end of 2024[242]. - Net cash used in operating activities was $(11.26) million in Q1 2025, a decrease of $27 million compared to Q1 2024[245]. Debt and Financial Obligations - The Senior Credit Facility's Consolidated Total Leverage Ratio was 4.30 as of March 31, 2025, below the covenant requirement of 5.00[256]. - The company has principal and interest obligations related to its Senior Credit Facility, Securitization Facility, and 2025 Notes, along with future minimum lease payments for manufacturing facilities[265]. - A hypothetical 100 basis points increase in interest rates would impact interest income on cash and cash equivalents by approximately $2.3 million annually[275]. - A 100 basis points change in interest rates would impact interest expense on the unhedged portion of the debt by $8.1 million on an annualized basis[277]. Currency and Derivative Management - The company is exposed to foreign currency exchange rate risks, primarily with transactions in Euros, British pounds, and other currencies[271]. - The company manages foreign currency exposure through derivative financial instruments, including foreign currency exchange forward contracts[272]. - The company has contingent consideration obligations related to prior and current year acquisitions, which are not fixed[266]. Dividend Policy - The company has not paid any cash dividends on its common stock since its formation, and future dividend payments will depend on financial conditions and Board discretion[261].

Integra LifeSciences (IART) Q1 2025 Earnings Call May 05, 2025 08:30 AM ET Company Participants Christopher Ward - Senior Director of Investor RelationsMojdeh Poul - President & Chief Executive OfficerLea Knight - Executive VP & CFOYoung Li - Senior VP - Equity ResearchJayson Bedford - Managing Director - Medical Technology Conference Call Participants None - AnalystVik Chopra - AnalystLilia-Celine Lozada - AnalystRavi Misra - Associate Analyst - Medtech Equity ResearchCraig Bijou - Equity Research Analyst ...

Core Insights - Integra LifeSciences reported quarterly earnings of $0.41 per share, missing the Zacks Consensus Estimate of $0.43 per share, and down from $0.55 per share a year ago, representing an earnings surprise of -4.65% [1] - The company posted revenues of $382.65 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 0.13% and up from $368.87 million year-over-year [2] - Integra shares have declined approximately 25.7% since the beginning of the year, compared to a decline of -3.3% for the S&P 500 [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.58 on revenues of $417.75 million, and for the current fiscal year, it is $2.46 on revenues of $1.68 billion [7] - The estimate revisions trend for Integra is mixed, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Instruments industry, to which Integra belongs, is currently in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to the bottom 50% [8] - Another company in the same industry, Neuronetics, is expected to report a quarterly loss of $0.13 per share, reflecting a year-over-year change of +51.9%, with revenues anticipated to be $29.24 million, up 67.8% from the previous year [9][10]

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was approximately $383 million, reflecting a reported growth of 3.7% and an organic decline of 3.5% compared to the previous year [7][23] - Adjusted EPS for the quarter was $0.41, down 25% compared to 2024 [23] - Gross margins were 52.2%, down 220 basis points from 2024, impacted by manufacturing variances and increased network optimization spending [24] - Adjusted EBITDA margins were 16.6%, down 290 basis points compared to 2024 [24] - Operating cash flow for Q1 was negative $11.3 million [24] Business Line Data and Key Metrics Changes - Codman Specialty Surgical (CSS) segment reported revenues of $281 million, with a reported growth of 9.4% and an organic decline of 1.1% [25] - Tissue Technologies revenues were $102 million, down approximately 9% on both a reported and organic basis [28] - The ENT business saw approximately $29 million in revenue from the Aclaren acquisition, with organic growth being flat due to supply constraints [25] Market Data and Key Metrics Changes - Global neurosurgery revenues declined 4.7% organically, primarily due to ship holds affecting several product lines [25] - International performance within CSS declined by high single digits, attributed to the timing and duration of ship holds [27] - Sales in wound reconstruction were down due to Integra Skin and ship holds on other products [28] Company Strategy and Development Direction - The company is focused on a turnaround strategy, emphasizing portfolio prioritization and disciplined program management to enhance operational execution [9][10] - A compliance master plan is in place to address quality system regulations and FDA observations, with significant progress reported in site assessments [12][14] - Investments are being made in manufacturing infrastructure to support long-term sustainable growth [8][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the specialized product portfolio despite current challenges [8] - The anticipated revenue headwinds from ship holds are within the assumptions made when setting guidance [20] - The company expects a revenue range of $390 million to $400 million for Q2 2025, reflecting a decline due to ship holds [19][35] Other Important Information - The company identified additional ship holds for certain products, now expecting total ship holds for the year to be between $55 million and $70 million [13][36] - The impact of recently announced global tariffs has been incorporated into the updated 2025 guidance, estimated at approximately $22 million [20][33] Q&A Session Summary Question: Guidance for Q2 and confidence in the second half of the year - Management acknowledged the impact of newly identified ship holds on Q2 guidance but noted that the guidance reflects improved production and normal seasonality [44][45] Question: Tariff impact and mitigation efforts - Management confirmed that several mitigation strategies are being pursued, including tariff exemptions and sourcing optimization, but did not include their impacts in the current guidance [47][49] Question: Demand for private label products - Management anticipates a step-up in private label demand in the second half of the year, although the forecast has been adjusted to reflect a low single-digit decline for the full year [53] Question: Remediation efforts and FDA compliance - Management is on track to complete assessments and remediation plans by year-end, with ongoing dialogue with the FDA regarding compliance [78][80] Question: Impact of ship holds on revenue guidance - Management indicated that the updated guidance allows for additional supply disruptions while still achieving the high end of the revenue range [71]

EARNINGS PRESENTATION Q1 2025 May 5, 2025 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, ...

Financial Performance - Total reported revenues for Q1 2025 were $382.7 million, an increase of 3.7% on a reported basis but a decline of 3.5% on an organic basis compared to the prior year[4] - GAAP gross margin was 50.8%, down from 56.1% in Q1 2024; adjusted gross margin was 62.2%, compared to 64.4% in the prior year[5] - Adjusted EBITDA for Q1 2025 was $63.6 million, or 16.6% of revenue, down from $71.8 million, or 19.5% of revenue, in the prior year[5] - The company reported a GAAP net loss of $(25.3) million, or $(0.33) per diluted share, compared to a net loss of $(3.3) million, or $(0.04) per diluted share, in the prior year[6] - Total revenues for Q1 2025 increased by 3.7% to $382,653,000 compared to $368,872,000 in Q1 2024[27] - Net loss for Q1 2025 was $25,293,000, compared to a net loss of $3,281,000 in Q1 2024, resulting in a diluted net loss per share of $(0.33) versus $(0.04) in the prior year[27][33] - Adjusted EBITDA for Q1 2025 was $63,609,000, down from $71,837,000 in Q1 2024[32] - Total organic revenues decreased by 3.5% to $355,798,000, excluding the impact of acquisitions and currency changes[28] - Adjusted net income for Q1 2025 was $31,654,000, with adjusted diluted net income per share at $0.41, down from $42,950,000 and $0.55 in Q1 2024[33] - Total costs and expenses increased to $398,150,000 in Q1 2025 from $364,908,000 in Q1 2024, primarily driven by higher cost of goods sold[27] Future Guidance - For Q2 2025, the company expects reported revenues in the range of $390 million to $400 million, representing a decline of (6.8)% to (4.4)%[11] - The full-year 2025 revenue guidance is reaffirmed at $1.650 billion to $1.715 billion, indicating reported growth of 2.4% to 6.5%[12] Cash Flow and Debt - Cash flow from operations was $(11.3) million in the quarter, with total balance sheet debt at $1.85 billion and net debt at $1.58 billion[9] - Total liquidity at the end of the quarter was approximately $1.16 billion, including $273 million in cash and short-term investments[10] - Cash and cash equivalents as of March 31, 2025, were $239,104,000, down from $246,375,000 at the end of 2024[35] - Free cash flow for Q1 2025 was $(40,177,000), compared to $291,000 in Q1 2024, indicating a significant decline in cash generation[38] - Net debt as of March 31, 2025, was $1,574,431,000, compared to $1,535,001,000 at the end of 2024, reflecting an increase in leverage[40] Segment Performance - Segment performance showed Codman Specialty Surgical revenues at $280.7 million, a reported growth of 9.4%, while Tissue Technologies revenues were $102.0 million, a decline of 9.3%[8] - Neurosurgery segment revenues decreased by 5.6% to $190,912,000, while ENT revenues surged by 296.2% to $38,802,000[28] Operational Initiatives - The company is advancing its Compliance Master Plan and investing in supply reliability, with new leadership appointments to enhance operational execution[3]

Core Insights - Integra LifeSciences Holdings Corporation reported total revenues of $382.7 million for Q1 2025, reflecting a 3.7% increase on a reported basis but a 3.5% decline on an organic basis compared to the previous year [3][13] - The company experienced a GAAP net loss of $(25.3) million, or $(0.33) per diluted share, compared to a net loss of $(3.3) million, or $(0.04) per diluted share, in Q1 2024 [5][13] - Adjusted EBITDA for Q1 2025 was $63.6 million, representing 16.6% of revenue, down from $71.8 million, or 19.5% of revenue, in the prior year [4][29] Financial Performance - Total revenues for the Codman Specialty Surgical segment were $280.7 million, showing reported growth of 9.4% but an organic decline of 1.1% compared to Q1 2024 [6] - The Tissue Technologies segment reported revenues of $102.0 million, a decline of 9.3% on a reported basis and 9.1% organically compared to the same quarter last year [7] - The company generated cash flow from operations of $(11.3) million in the quarter, with total balance sheet debt at $1.85 billion and net debt at $1.58 billion, resulting in a consolidated total leverage ratio of 4.3x [7][8] Outlook - For Q2 2025, the company expects reported revenues between $390 million and $400 million, indicating a decline of 6.8% to 4.4% on a reported basis and 7.5% to 5.1% organically [9] - The full-year 2025 revenue guidance remains at $1.650 billion to $1.715 billion, representing reported growth of 2.4% to 6.5% and organic growth of 0.4% to 4.4% [10] - Adjusted EPS guidance for 2025 has been reduced to a range of $2.19 to $2.29 per share, accounting for an estimated impact of $(0.22) per share due to new tariffs [10] Segment Insights - Sales in the Neurosurgery segment declined by 4.7% on an organic basis, attributed to shipping holds across several product lines [14] - Instruments sales grew by 15.1% on an organic basis due to strong demand and favorable prior year comparisons [14] - The ENT segment reported significant revenue growth driven by the Acclarent acquisition, while private label sales decreased by 13.3% due to component supply delays [14]

Core Viewpoint - Integra LifeSciences Holdings Corporation is set to release its first quarter 2025 financial results on May 5, 2025, before the market opens, indicating a significant upcoming event for investors [1]. Group 1: Financial Results Announcement - The financial results will be released prior to market opening on May 5, 2025 [1]. - A conference call hosted by Integra's management team will take place at 8:30 a.m. ET on the same day [1]. Group 2: Participation Details - A live webcast of the conference call will be available on the Investors section of the company's website [2]. - Participants are encouraged to register for dial-in details and an individual pin, with a recommendation to join 10 minutes early [2]. - A replay of the conference call will be accessible on the company's website following the event [2]. Group 3: Company Overview - Integra LifeSciences is focused on restoring patients' lives through innovative treatment pathways and aims to advance patient outcomes in surgical, neurologic, and regenerative care [3]. - The company offers a comprehensive portfolio of high-quality, leading brands in the medical technology sector [3].

Integra LifeSciences Holdings Corporation (IART) is successfully broadening its international footprint through certain key developments on the overseas front. The company also sees healthy demand for its industry-leading products within the Codman Specialty Surgical (CSS) segment. A strong emphasis on portfolio optimization has steadily ramped up its research and development (R&D) spend, which is highly promising. Meanwhile, macroeconomic headwinds and a negative solvency remain concerns for Integra’s oper ...

Core Viewpoint - Grabar Law Office is investigating potential breaches of fiduciary duties by the Board of Directors of Integra LifeSciences Holdings Corp. [1] Group 1: Shareholder Actions - Current shareholders who held Integra LifeSciences shares since on or before March 11, 2019, can seek corporate reforms and the return of funds spent on litigation [2][4] - Shareholders can also pursue a court-approved incentive award at no cost [2][4] Group 2: Securities Fraud Allegations - A securities fraud class action complaint alleges that Integra's officers and directors misrepresented the company's growth prospects for SurgiMend, claiming FDA approval for post-mastectomy reconstruction [3] - On May 23, 2023, Integra announced a recall of all products manufactured at its Boston Facility from March 1, 2018, to May 22, 2023, due to deviations from good manufacturing practices [3] - The recall was attributed to unsafe levels of bacterial endotoxins in products, leading to a revised revenue guidance for Q2 2023 and an expected $22 million impairment from inventory write-off [3]