Financial Data and Key Metrics Changes - Total revenues for Q2 2025 were $415.6 million, reflecting a decline of approximately 0.6% on a reported basis and 1.4% on an organic basis compared to the prior year [17][18] - Adjusted EPS for the quarter was 45 cents, representing a 29% decline compared to the previous year [18] - Gross margin for the quarter was 60.7%, down 450 basis points year over year, primarily due to higher operational costs associated with remediation efforts [19] - Operating cash flow for the quarter was $9 million, with free cash flow being negative $11.2 million due to continued capital investments [24] Business Line Data and Key Metrics Changes - Specialty Surgical Segment (CSS) reported revenues of $304 million, reflecting growth of 0.7% on a reported basis and a decline of 0.3% on an organic basis [20] - Tissue Technology revenues were $111.6 million, down approximately 4% on both a reported and organic basis compared to the prior year [23] - The ENT business experienced growth below expectations due to reimbursement-driven market pressure, despite double-digit growth in certain product lines [21][62] Market Data and Key Metrics Changes - International performance within CSS declined by low single digits, primarily due to ship holds, which offset strong underlying demand from international markets, including high single-digit growth in China [22] - The company noted a slowdown in private label demand due to competitive pressures, impacting overall market expectations [54] Company Strategy and Development Direction - The company is focused on transforming its quality management system and executing its compliance master plan, which is seen as critical for operational readiness and risk reduction [8][14] - Strategic investments and disciplined cost management are being emphasized to enhance supply chain reliability and drive long-term growth [14][15] - The company is optimistic about the proposed Medicare payment changes favoring evidence-backed, cost-effective wound reconstruction products, positioning it well for future growth [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the leadership positions in neurosurgery and tissue technology, citing sustained demand in attractive markets [14] - The company anticipates a revenue range of $410 million to $420 million for Q3 2025, representing approximately 8% to 10% reported growth [13] - For the full year, the revenue guidance has been updated to a range of $1.655 billion to $1.68 billion, reflecting increased visibility into ship hold and remediation outlook [26][27] Other Important Information - A goodwill impairment charge of approximately $511 million was recorded during the quarter, primarily driven by macroeconomic uncertainties [18] - The company ended the quarter with total liquidity of $1.1 billion, including $254 million in cash and short-term investments [25] Q&A Session Summary Question: Thoughts on CMS' proposed 2026 reimbursement changes - Management indicated that the majority of the business is in the acute care setting, so immediate impacts are not expected, but long-term opportunities are seen as favorable for the wound reconstruction portfolio [35][36] Question: Q3 EPS guidance below street expectations - Management explained that the Q3 guidance is consistent with Q2 performance, with a revenue step-up expected in Q4 driven by seasonal lift and supply recovery [38][39] Question: Impact of ship holds and compliance programs - Management expressed confidence in the progress made and estimated a $100 million impact for the year, with no new material ship holds anticipated [44][45] Question: Ability to win back customers after supply issues - Management noted that once products come off ship holds, they typically see a return to market share, although reintroducing some products may require additional effort [50][51] Question: Revenue growth expectations and guidance adjustments - Management clarified that the updated guidance reflects a more refined view of the full-year impact from ship holds and market demand declines [54] Question: Gross margin softness and future expectations - Management attributed the decline in gross margins to manufacturing variances and operational inefficiencies, projecting a full-year gross margin decline of about 300 basis points [58][59] Question: Expectations for ENT business growth - Management expects mid-single-digit growth for the ENT business moving forward, supported by investments in new products and clinical evidence [63][64]

EARNINGS PRESENTATION Q2 2025 July 31, 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," "ma ...

Core Viewpoint - Integra LifeSciences Holdings Corporation reported an earnings miss for Q1 2025, with adjusted EPS of 41 cents, falling short of estimates and showing a significant year-over-year decline of 25.5% [1][2][11] Financial Performance - Total revenues for Q1 2025 increased by 3.7% year over year to $382.7 million, slightly exceeding consensus estimates by 0.1% [3] - Organic revenue declined by 3.5% year over year, indicating challenges in core operations [3][11] - Gross profit decreased by 6% year over year to $194.4 million, with gross margin contracting by 526 basis points to 50.8% due to a 16.2% rise in the cost of goods sold [6] - Selling, general and administrative expenses rose by 9.5% to $181.5 million, while research and development expenses fell by 8.3% to $24.7 million [6] Segment Performance - Revenues in the Codman Specialty Surgical segment rose by 9.4% year over year to $280.7 million, although organic growth was down by 1.1% [4] - Neurosurgery sales within this segment fell by 4.7% organically, attributed to shipping holds [4] - Tissue Technologies revenues totaled $102 million, down 9.3% year over year, with notable declines in Private Label sales due to supply delays [5] Financial Position - At the end of Q1 2025, the company had approximately $239.1 million in cash and cash equivalents, down from $246.4 million at the end of Q4 2024 [8] - Cumulative net cash outflow from operating activities was $11.26 million, contrasting with cash inflows of $15.76 million a year ago [8] Guidance - For 2025, the company reaffirmed its revenue guidance of $1.650-$1.715 billion, indicating growth of 2.4%-6.5% [9] - Adjusted EPS forecast was reduced to a range of $2.19-$2.29 from a previous range of $2.41-$2.51 [9] - For Q2 2025, expected revenues are projected between $390-$400 million, reflecting a decline of 6.8%-4.4% [10] Strategic Insights - Despite the earnings miss, the company reported positive contributions from the Acclarent acquisition and double-digit growth in several product lines [12] - The company is focusing on advancing its Compliance Master Plan, expanding its international portfolio, and enhancing leadership [12]

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]

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]

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]

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]