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].

Financial Data and Key Metrics Changes - Total revenue for Q1 2025 was approximately $383 million, reflecting a reported growth of 3.7% but an organic decline of 3.5% primarily due to ship holds [7][23][24] - Adjusted EPS for the quarter was $0.41, down 25% compared to 2024 [8][24] - Gross margins were 52.2%, down 220 basis points from 2024, impacted by manufacturing variances and increased network optimization spend [24] - Adjusted EBITDA margins were 16.6%, down 290 basis points compared to 2024 [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% but 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, while organic growth was flat due to supply constraints [26] Market Data and Key Metrics Changes - Global neurosurgery revenues declined 4.7% organically, largely due to ship holds affecting several product lines [25] - International performance within CSS declined by high single digits, primarily due to the timing and duration of ship holds [27] Company Strategy and Development Direction - The company is focused on a turnaround strategy that includes portfolio prioritization and disciplined program management to enhance operational execution [10][11] - 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 operational excellence, including the Braintree facility to restart production of key products [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 [9] - The anticipated revenue headwinds from ship holds are within the assumptions made when setting guidance ranges [20] - The company expects second quarter revenue to be in the range of $390 million to $400 million, reflecting a reported decline of approximately 6.8% to 4.4% [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 [21][33] Q&A Session Summary Question: Clarification on Q2 guidance and shipment delays - Management acknowledged that the Q2 guidance reflects newly identified ship holds, which impacted expectations, but they had anticipated potential disruptions as part of their compliance plan [42][44] Question: Mitigation efforts related to tariffs - Management is pursuing several mitigation strategies, including tariff exemptions and pricing adjustments, but these impacts have not been built into the current guidance [48][50] Question: Demand visibility for private label products - Management expects a step-up in private label sales in the second half of the year, although the forecast has been adjusted to reflect a low single-digit decline for the full year [54] Question: Impact of tariffs on financials - Approximately half of the estimated $22 million tariff impact is attributed to exposure in China, with the remainder from other international imports [66][86] Question: Ship hold increase and organic growth outlook - The increase in ship holds is projected to have an annual impact of $55 million to $70 million, which has been factored into the organic growth outlook [94][96]

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]

Financial Performance - Total revenue was $382.7 million[37], with a reported growth of 3.7%[7, 40] but an organic growth decline of -3.5%[7, 11, 40] - Adjusted Gross Margin was 62.2%[7, 11, 42], a decrease of (220bps) compared to Q1 2024[7, 11, 40] - Adjusted EPS was $0.41[7, 11, 42], down ($0.14) or (25.5%) compared to Q1 2024[7, 11, 42] - The company is reaffirming full year revenue guidance of $1.650B-$1.715B[7, 38, 40], with reported growth between +2.4% and +6.5%[7, 38] and organic growth between +0.4% and +4.4%[7, 38] - Adjusted EPS guidance is updated to $2.19 - $2.29[7, 31, 38] to account for an estimated $(0.22) impact from recently announced tariffs[9] Segment Performance - Codman Specialty Surgical (CSS) experienced a -1.1% organic growth[7, 40], with US at 3.9% and International at -8.3%[7, 40] - Tissue Technologies (TT) saw a -9.1% decline[7, 40] in organic growth - Neurosurgery declined by -4.7%[13] due to shipping holds, while Instruments grew 15.1%[13, 16] organically - ENT grew 0.4%[13], reflecting only MicroFrance ENT instruments Balance Sheet and Cash Flow - Operating Cash Flow was $(11.3M)[11], with a Free Cash Flow (FCF) conversion of -127.0%[11] - Net Debt was $1,574.4 million as of March 31, 2025[49] compared to $1,535.0 million as of December 31, 2024[49]

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]