Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][17] - U.S. revenue grew over 21% to $46.4 million, driven by increased adoption of solutions [4][17] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [5][19] - Gross profit was $38.8 million, an increase of $6.9 million or 21.8%, with a gross margin of 79.8% [17][18] - Net loss narrowed to $4.6 million, or $0.11 per diluted share, compared to a net loss of $6.6 million, or $0.16 per diluted share [18][19] Business Line Data and Key Metrics Changes - The flagship solutions continue to perform well in a large, under-penetrated market, with double-digit volume growth across all modalities [5][6] - The interventional case volume doubled compared to Q3 2024, indicating strong adoption of clinically validated solutions [7] - The number of procedures using more than two Granite implants per case grew approximately 40% in the quarter [9] Market Data and Key Metrics Changes - International revenue in Q3 was $2.3 million, representing 10.2% growth, with expectations for acceleration in 2026 due to the launch of iFuse TORQUE [17][18] - The company added 330 physicians in the quarter, marking a 27% year-over-year increase in active physicians [12][48] Company Strategy and Development Direction - The company aims to expand its addressable market by adding new applications of technology and expertise, focusing on compromised bone [22][23] - Plans to launch several innovative solutions over the next five years to address poor bone quality [12][54] - The company is focused on operational excellence, with a disciplined pricing strategy and ongoing supply chain optimization initiatives [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth, expanding margins, and achieving positive free cash flow in 2026 [22][34] - The company anticipates continued physician engagement and adoption trends, with a significant opportunity to increase procedure density [12][15] - Management highlighted the importance of favorable reimbursement changes and the potential for new product launches to drive growth [37][61] Other Important Information - The company achieved its second consecutive quarter of net cash flow breakeven, ending the quarter with $145.7 million in cash and marketable securities [20][21] - The company is actively pursuing regulatory clearance to commercialize additional products across several international markets [17][56] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management emphasized the importance of physician density and the opportunity to grow by increasing the use of technology across different procedure types [24][25] - Operating leverage is expected to range between 1.25-1.75 times, with a focus on delivering strong top-line growth [27][28] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, reflecting continued outperformance and strong momentum heading into Q4 [30][32] Question: Trends in cash burn expectations - Management expects to use some cash in Q4 for building surgical capacity but remains confident in achieving free cash flow in 2026 [34] Question: Insights on TNT and NTAP adoption - Management expressed excitement about the NTAP, which represents a significant reimbursement improvement, and noted strong interest from national distributors for TNT [57][59] Question: Long-term profitability and operating leverage - Management highlighted the unique business model that allows for high ASP and operating leverage, with expectations for margin expansion as new products contribute to revenue [61][62]

Financial Data and Key Metrics Changes - The company reported a 5% increase in sales on an organic, constant currency basis for Q3 2025, with adjusted earnings per share (EPS) of $1.90, up 9.2% year over year [5][20][24] - U.S. business sales grew 5.6% on an organic basis, marking the best revenue growth performance since mid-2023 [5][21] - Adjusted gross margin improved to 72.6%, while adjusted operating margin was 26.5%, reflecting better gross margin and lower manufacturing costs [24] Business Line Data and Key Metrics Changes - The U.S. knee segment saw a growth of 3.5%, driven by the adoption of Persona Osteotide and Oxford partial cementless knee products [6][22] - The robotics and navigation segment increased by 20.3%, with ROSA accounts performing over half of their knee implants robotically [8][21] - The upper extremities business grew in the high single digits, while cranial, maxillofacial, and thoracic (CMFT) business increased over 20% due to new product introductions [10][21] Market Data and Key Metrics Changes - International revenue grew by 4.2%, with emerging markets presenting a headwind to growth [21][22] - The global needs segment grew 5.3%, with U.S. needs increasing by 3.5% and international needs by 7.8% [22] - The company experienced unexpected weakness in Eastern Europe, Latin America, and non-core segments, impacting growth by nearly 120 basis points [6][20] Company Strategy and Development Direction - The company focuses on three strategic priorities: people and culture, operational excellence, and innovation and diversification [11][12] - Recent acquisitions, including Monogram Technologies, aim to enhance the company's robotics capabilities and expand its product offerings [15][17] - The company is committed to maintaining a disciplined approach to capital allocation while pursuing growth opportunities in high-growth markets [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in addressing identified issues and remains optimistic about the market reception of new products [6][19] - The updated guidance for 2025 reflects a more measured outlook due to continued weakness in restorative therapies and challenges in certain international markets [10][26] - Management emphasized the importance of innovation and commercial execution in driving future growth [19][59] Other Important Information - The company updated its full-year organic constant currency revenue growth expectations to a range of 3.5% to 4% [10][26] - Free cash flow for the year is projected to be between $1 billion and $1.2 billion, with operating cash flows of $419 million reported for the quarter [25][26] Q&A Session Summary Question: Guidance philosophy and Q3 performance - Management acknowledged unexpected cancellations and challenges in emerging markets that impacted growth, emphasizing a need for more measured external commentary moving forward [30][34] Question: Future headwinds and capital allocation - Management indicated that the recent challenges are not expected to impact 2025 guidance and highlighted a disciplined approach to capital allocation, focusing on growth markets [38][40] Question: Performance against long-range plan (LRP) targets - Management noted that while current growth is mid-single digits, future acceleration will depend on market dynamics, innovation, and commercial execution [42][44] Question: Product pipeline and innovation - Management discussed the successful rollout of new products and the potential for significant revenue contributions from breakthrough technologies in the coming years [46][55] Question: U.S. knee market share - Management acknowledged potential market share loss but emphasized improved growth rates and the positive impact of new product introductions [60]

Financial Data and Key Metrics Changes - The company reported total revenue of $69.5 million for Q3 2025, including record net product sales of $64.1 million, a 65% year-over-year increase [4][27] - Net income for the third quarter was $27.9 million, compared to $12.4 million for the same period in 2024 [29] - Cash balance increased to $137.1 million, up from $77.3 million at the end of 2024 [29] Business Line Data and Key Metrics Changes - TAVALISSE generated $44.7 million in net product sales, a 70% increase year-over-year [11][27] - GAVRETO achieved $11.1 million in net product sales, reflecting a 56% increase compared to Q3 2024 [12][27] - REZLIDHIA reported $8.3 million in net product sales, a 50% increase year-over-year [12][27] Market Data and Key Metrics Changes - The company has expanded access to TAVALISSE in Japan, Europe, Canada, Israel, and South Korea, with ongoing regulatory approvals in new markets [13] - The commercial portfolio has shown strong year-over-year growth, with net product sales exceeding $200 million on a trailing 12-month basis [11] Company Strategy and Development Direction - The strategic objectives focus on growing the hematology and oncology business through commercial performance and pipeline expansion [4] - The company is pursuing additional in-licensing deals or asset acquisitions to achieve significant growth [7] - The 2025 revenue guidance has been raised to $285-$290 million, reflecting anticipated growth of 55%-59% compared to 2024 [9][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to achieve significant long-term growth through strong commercial execution and financial discipline [9][32] - The company aims to continue driving sales of commercial products while funding key development programs in its internal pipeline [31][32] Other Important Information - The company is advancing its development pipeline, including the ongoing phase 1b study of R289 and collaborations for olutasidenib in various cancer studies [5][16] - The company has received fast-track designation and orphan drug designation from the FDA for R289, indicating a promising regulatory pathway [19] Q&A Session Summary Question: Competitive positioning of R289 in lower-risk MDS versus Rytelo - Management indicated it is too early to speculate on competitive positioning and plans for a registrational study [34] Question: Data needed for potential priority review of R289 - Management noted that the fast-track designation opens potential for priority review, but further data from the dose expansion study is needed [38] Question: Expectations for updated data at ASH for R289 - Management confirmed that updated data will include 16 weeks of follow-up on all patients, providing a robust data set for presentation [40]

Financial Performance - AbbVie reported adjusted earnings per share of $1.86, exceeding guidance by $0.10 [4][28] - Total net revenues reached nearly $15.8 billion, reflecting an operational growth of 8.4% [28] - Adjusted gross margin was 83.9% of sales, with adjusted R&D expense at 14.3% and adjusted SG&A expense at 21.6% [28] Business Line Performance - Immunology revenues totaled approximately $7.9 billion, up 11.2% operationally, driven by SKYRIZI and RINVOQ, which saw sales growth of 46% and 34.1% respectively [10][11] - Oncology revenues were nearly $1.7 billion, remaining flat year-over-year, with VENCLEXTA and newer products offsetting declines from IMBRUVICA [13][14] - Neuroscience revenues exceeded $2.8 billion, up 19.6%, with strong performances from Ubrelvy, Qulipta, and Vraylar [17][18] - Aesthetics sales were approximately $1.2 billion, down 4.2%, impacted by challenging market conditions [14][15] Market Dynamics - SKYRIZI and RINVOQ are gaining significant market share in gastroenterology, capturing nearly 50% of newer switching Crohn's patients in the U.S. [10][11] - Humira's global sales declined by 55.7% to $993 million due to biosimilar competition [13] - The aesthetics market is facing low consumer sentiment and inflation concerns, leading to below-expected category growth [16] Strategic Direction - AbbVie is raising its 2025 outlook for the third time this year, indicating strong business performance and pipeline advancement [4][5] - The company plans to invest at least $10 billion in the U.S. over the next decade, with ongoing construction of new manufacturing sites [8] - AbbVie is focusing on expanding its pipeline with approximately 90 programs across various therapeutic areas, including immunology, oncology, and neuroscience [5][6] Management Commentary - Management expressed confidence in the company's ability to adapt to changes in the PBM model and emphasized the importance of differentiated medicines for growth [35][36] - The management highlighted the strong performance of SKYRIZI and RINVOQ, with expectations for continued growth despite challenges from Humira erosion [46][52] Other Important Information - AbbVie announced a 5.5% increase in its quarterly cash dividend, reflecting a commitment to delivering sustainable returns to shareholders [8][31] - The company has executed approximately 30 deals since the beginning of 2024, focusing on external innovation to drive growth [32] Q&A Session Summary Question: Implications of new PBM model and IRA price negotiations - Management indicated that AbbVie's performance is driven by differentiated medicines and strong execution, allowing adaptability to changes in the PBM model [35][36] - The outcomes of IRA price negotiations for Vraylar and Linzess will not impact long-term guidance [38] Question: Competitive dynamics in the IL-23 market - Management expressed confidence in SKYRIZI's growth and its leadership position in IBD, despite competition from Tremfya [42][44] - The IL-23 class is expanding rapidly, benefiting all players in the market [42] Question: 2026 outlook and business dynamics - Management noted strong performance across the neuroscience portfolio and anticipates continued growth despite headwinds from Humira erosion [46][47] Question: Long-term guidance for SKYRIZI and RINVOQ - Management indicated that the combined guidance for SKYRIZI and RINVOQ for 2025 has been raised significantly, suggesting potential for exceeding long-term expectations [51][52] Question: Market conditions for aesthetics products - Management acknowledged challenges in the U.S. aesthetics market but emphasized ongoing investments to revitalize the segment [56][57]

Financial Data and Key Metrics Changes - The company reported record-setting third quarter net sales and earnings results, achieving a year-over-year top-line growth of 10% [4][5] - Consolidated adjusted EBITDA increased by 6%, while adjusted net earnings per share rose by 13% [5][20] - Free cash flow grew significantly, with a double-digit increase both in the quarter and year-to-date [5][20] Business Line Data and Key Metrics Changes - In the Mineral Fiber segment, net sales increased by 6% year-over-year, driven by strong average unit value (AUV) growth and positive sales volume contributions [8][17] - The Architectural Specialties segment saw a net sales increase of 18%, supported by acquisitions and solid organic growth [12][19] Market Data and Key Metrics Changes - The company noted stabilizing market conditions, with no anticipated softening in discretionary renovation activity, contrary to earlier expectations [28][90] - The office market showed signs of improvement, with declining vacancy rates for Class A offices and increased demand for renovations in Class B spaces [30][31] Company Strategy and Development Direction - The company remains focused on operational efficiency, commercial execution, and growth initiatives to navigate a dynamic macroeconomic environment [7][8] - Investments in digital growth initiatives like PROJECTWORKS and Kanopi are expected to drive volume and contribute to margin expansion [15][16] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving strong results for the remainder of 2025, with expectations for continued double-digit growth in net sales and adjusted EBITDA [27][35] - The company anticipates a full-year adjusted EBITDA margin of approximately 43% for the Mineral Fiber segment, the highest since 2019 [10][25] Other Important Information - The company announced a 10% increase in its quarterly dividend, marking the seventh consecutive annual increase since the inception of its dividend program [24] - The acquisition of Geometrik, a Canadian wood ceiling manufacturer, was completed for $7.5 million, enhancing the company's product offerings and geographic diversification [14][23] Q&A Session Summary Question: Can you talk about the benefit that you're seeing from the new products? - Management noted that innovation at the high end of the portfolio is driving double-digit growth in both the Mineral Fiber and Architectural Specialties segments [39][40] Question: What is the outlook for Architectural Specialties margins? - Management expects to maintain organic margins around 20% while continuing to focus on growth opportunities [43][44] Question: Can you elaborate on the timing-related cost headwinds? - Management highlighted that higher SG&A costs were driven by increased incentive compensation and atypical medical claims, which are not expected to persist [50][51] Question: What is the outlook for the education and healthcare segments? - Management indicated that both segments remain stabilized, with positive trends in healthcare and robust opportunities in data centers [54][55] Question: How do you view the potential for Mineral Fiber margins to exceed pre-pandemic levels? - Management emphasized that continued focus on pricing, productivity, and innovation will support margin expansion beyond pre-pandemic levels [92][93]

Core Insights - The company has experienced strong demand for its products, which aligns with initial expectations [1] - The company holds a leadership position in attractive markets, supported by strong brand equity and effective commercial execution [2]

Financial Data and Key Metrics Changes - Worldwide revenue for Q1 2025 reached $47.3 million, representing approximately 25% growth compared to the prior year [6][26] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][26] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7% [27] - Net loss narrowed to $6.5 million or $0.15 per diluted share, compared to a net loss of $10.9 million or $0.27 per diluted share in the prior year [28] - Positive adjusted EBITDA of approximately $5 million compared to an adjusted EBITDA loss of $4 million in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched in 2024 [7][39] - The number of physicians performing procedures using the company's products grew by 27%, with over 1,400 U.S. physicians engaged [19] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [13] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with a cumulative procedure volume growth of 25% over the last three years [9][10] - The company is targeting nearly 100,000 degenerative procedures annually with its Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [13][14] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [9] - The strategy includes diversifying the product platform with unique yet complementary technologies to expand the target modalities and physician footprint [9][10] - The company aims to reach 100 territories over the next 12 to 15 months, leveraging a hybrid commercial model combining territory managers and third-party agents [24][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong results over the long term, supported by resilient business trends and favorable reimbursement conditions [8][9] - The updated full-year revenue guidance is between $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [32] - Management noted that the company is well-positioned to achieve free cash flow in 2026, with a focus on maintaining operational discipline [30][32] Other Important Information - The company has a strong pipeline of novel technologies under development, with plans to launch new products over the next 12 to 18 months [16][18] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [30][31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth and strong demand for current solutions, with impressive adoption of new products launched in 2024 [39] Question: Drivers of gross margin and future expectations - Management highlighted better-than-expected average selling price (ASP) and efficiency initiatives as key drivers of gross margin improvement [42][44] Question: Long-term growth expectations - Management expressed confidence in sustained growth potential, driven by technology leadership and expanding physician engagement [53][56] Question: Expected cadence of new guidance and sequential growth - Management indicated that while they do not think about the business in quarters, they expect to manage seasonality effectively with new product rollouts [66] Question: Operating expenses guidance - Management explained that elevated R&D investments and higher commissions linked to revenue growth are driving the expected increase in operating expenses [70][72] Question: Update on surgeon base and engagement - Management reported a record increase in the physician base, with broad engagement across various specialties [76][78] Question: Updates on reimbursement proposals - Management provided insights on CMS proposals and the potential for increased reimbursement rates, which could accelerate adoption of products [80][81] Question: Traction and adoption of TNT product - Management noted that TNT is seeing rapid adoption and is expected to benefit from upcoming reimbursement changes [97]