Financial Data and Key Metrics Changes - Total revenue increased by 45% year over year to $111.7 million, with strong organic growth of 9% overall and 12% in strategically important services [13] - Adjusted EBITDA rose more than 70% to $24.8 million, reflecting strong performance and operational efficiency [13] - Service revenue, excluding legacy Fleet Complete, grew 12% organically year over year, with service revenue now representing 80% of total revenue, up from 74% last year [11][13] Business Line Data and Key Metrics Changes - Annual services recurring revenue reached double-digit growth ahead of schedule, indicating strong business momentum [4] - Product margins improved by 640 basis points sequentially to 31.5%, supported by a rebound in higher margin on-site demand [14] - The company reported a 23% expansion in the video pipeline, indicating solid traction with AI video upselling [10] Market Data and Key Metrics Changes - North America experienced double-digit year-over-year revenue performance, with a 26% increase in new logo wins [8] - Global channel bookings increased significantly in Q2, particularly with partners like AT&T and TELUS, showing a 32% sequential increase in quarterly pipeline bill [10] - The company secured major deals with a global industrial manufacturer and a North American logistics company, indicating strong market demand [9] Company Strategy and Development Direction - The company is focused on accelerating sustainable growth following the completion of two major acquisitions and the end of an integration period [4] - A new Chief Revenue Officer has been appointed to drive SaaS growth at scale, indicating a commitment to enhancing revenue expansion [6] - The company plans to embed automation and AI deeper into operations to enhance customer experience and operational efficiency [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting strong momentum and the potential for sustainable double-digit growth into FY2027 [31] - The company is seeing a shift in customer demand towards efficiency, safety, and compliance, which aligns with its value proposition [36] - Management noted that the integration of Fleet Complete has been successful, with no revenue recognition challenges anticipated moving forward [32] Other Important Information - The company achieved over $30 million in annualized synergies from the integration process, marking a significant milestone [17] - PowerFleet received the Frost & Sullivan's 2025 North America Product Leadership Award, recognizing its innovation and market impact [21] Q&A Session Summary Question: Guidance on services and organic SaaS growth into Q3 and Q4 - Management expects to maintain 10% organic growth in Q4, with positive momentum building [25] Question: Update on Fleet Complete's revenue recognition - Management clarified that Fleet Complete's revenue recognition issues are related to invoicing and cash collection, not historical revenue recognition [34] Question: Demand environment and purchasing pauses - Management noted that while there is still caution in the market, demand for efficiency and compliance solutions is increasing [83] Question: Success in cross-sell efforts - Management highlighted traction in cross-selling between warehouse and over-the-road solutions, particularly in video and safety compliance [81] Question: Incremental enterprise opportunities and brand awareness - Management indicated significant improvements in enterprise opportunities and brand recognition compared to one to two years ago [70]

Financial Data and Key Metrics Changes - Total revenues for the first nine months of 2025 were $135.8 million, representing an 11% year-over-year increase [4][10] - Adjusted EBITDA was $34.2 million, up 35% year-over-year, with a 25% margin on revenues [4] - Net income for the first nine months of 2025 was $16.6 million, or $0.29 per diluted share, up 56% compared to the first nine months of 2024 [12] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales of Glassia in ex-U.S. markets, particularly in Latin America and the CIS region [5] - The anti-CMV immunoglobulin Cytogam is undergoing a comprehensive post-marketing research program to demonstrate its advantages [6][31] - The company launched its first biosimilar product in Israel, expected to generate approximately $2.5 million in revenues in 2025, with plans for two additional biosimilars [7] Market Data and Key Metrics Changes - The company has a significant market share in the U.S. for its anti-rabies immunoglobulin Kamrab, with a firm commitment for minimum orders through 2027 [4] - Sales of Cytogam have been below expectations due to inventory management and fewer transplants performed in some hospitals [33] Company Strategy and Development Direction - The company is guided by a four-pillar growth strategy, including organic commercial growth, business development, M&A transactions, plasma collection operations, and advancing its inhaled AAT program [4][39] - Active due diligence is being conducted over several potential commercial targets, with expectations to secure transactions in early 2026 [8][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing to generate profitable growth through the remainder of 2025, reiterating annual revenue guidance of $178 million-$182 million [4] - The company is addressing challenges in the Cytogam market and expects resumed growth in the coming months [33] Other Important Information - The Houston plasma collection facility has received FDA approval, with expectations for the San Antonio site to follow in early 2026 [9] - Each plasma collection center is expected to generate annual revenues of $8 million-$10 million at full capacity [9] Q&A Session Summary Question: Details on the Cytogam study and its differences from previous clinical data - The SHILD study will test Cytogam's use in late CMV after antiviral treatment, differing from its current prophylactic use [15][16] Question: Enrollment status for the ATD treatment - Enrollment is at 60-65%, with completion expected by early 2027 and top-line results anticipated in H1 2029 [18][20] Question: Performance of the distribution business - The distribution business has seen actual usage growth, with expectations for continued growth due to a richer product portfolio [24] Question: Plasma collection relative to proprietary product needs - Currently, the majority of plasma collected is normal source plasma, with plans to increase specialty plasma collection over time [25][26] Question: Interim data release for the ATD treatment clinical trial - Results from the interim analysis will be shared through a press release before the end of the year [27][28] Question: Performance of Cytogam and growth drivers - Cytogam sales have been below plan due to inventory management and fewer transplants, but growth is expected to resume [31][33] Question: Future of Glassia royalties - Royalties from Glassia are expected to be above $10 million in 2026, with single-digit growth anticipated thereafter [34][35] Question: Current business development activities - The company is conducting thorough due diligence for potential transactions, with expectations for successful integration of new assets [36][37]

Financial Data and Key Metrics Changes - Total revenue surged 568% year over year to $23.6 million in Q3 2025, driven by IMA's 76% quarter-to-quarter growth [9] - Adjusted EBITDA loss improved from $6.5 million in Q1 to $2.1 million in Q3, indicating operational leverage and a clear path to profitability [12][17] - Cash increased to approximately $82 million and Bitcoin holdings valued at around $40 million, resulting in total liquidity of about $120 million with zero debt [7][18] Business Line Data and Key Metrics Changes - IMA achieved $100 million annual recurring revenue (ARR) in the last 11 months, with projections to reach $300 million ARR by the end of 2026 [6] - Subscription rate for IMA stands at 80%, with an average order value increasing by 36% quarter over quarter to $150 [10][11] - Gross margin improved to 60% from 52%, reflecting enhanced profitability [10] Market Data and Key Metrics Changes - International markets now account for 56.5% of total revenue, with the U.S. being the top market followed by Canada, the U.K., Australia, and Singapore [10] - IMA has achieved over 420,000 customer purchases across 31 countries, indicating strong global demand [9] Company Strategy and Development Direction - The company aims to create a new category at the intersection of health and wealth, targeting $1 billion in annual revenue by 2030 [6] - A strategic divestment of non-core assets is underway to focus resources on IMA, the highest margin growth engine [14] - The company is leveraging partnerships with high-profile individuals to enhance brand visibility and credibility [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving $180-$200 million in revenue for 2026, driven by international expansion and new product launches [18] - The company is strategically choosing to scale aggressively rather than prioritize short-term profitability, aiming to capture maximum market share [18] Other Important Information - The company has initiated a Bitcoin accumulation strategy, purchasing one Bitcoin daily since August 1, which is part of a sustainable framework to build shareholder value [8] - The recent $44 million funding round attracted notable investors, enhancing the company's financial position [6] Q&A Session Summary Question: Impressive payback period of 3.9 months - Management explained that the payback period has improved from four to five months at launch to 3.9 months now, indicating marketing efficiencies and strong unit economics [19][20] Question: Strong growth in international markets - Management noted that the U.S. market share has decreased from 70% to 46.5%, with significant growth observed in Canada, Europe, the Middle East, and Southeast Asia [21] Question: Need for additional capital for expansion - Management stated that with current liquidity, there is no expectation of needing new capital for expansion, emphasizing operational flexibility from recent fundraising [22][24]

Financial Data and Key Metrics Changes - Total GAAP revenue for Q3 2025 was $402 million, representing a 27% year-over-year increase, primarily driven by higher crypto trading activity [26] - Adjusted EBITDA reached $28.7 million, compared to a loss of $20.4 million in Q3 2024, indicating significant improvement in operational efficiency [26] - The company ended the quarter with approximately $64 million in cash and no long-term debt, reflecting a strengthened financial foundation [27][28] Business Line Data and Key Metrics Changes - Bakkt Markets serves as the core business, providing institutional-grade infrastructure for digital assets, with a focus on market making, OTC trading, and regulated custody [15][17] - Bakkt Agent is a programmable finance platform that integrates stablecoins and AI, facilitating seamless money movement and targeting the cross-border remittance market [19] - Bakkt Global focuses on international expansion through minority investments, with initial progress in Japan and plans to extend into South Korea and India [20][43] Market Data and Key Metrics Changes - Stablecoins now settle over $30 trillion annually, surpassing Visa, indicating a growing market for digital asset infrastructure [6] - The total addressable market for digital asset infrastructure is estimated to be enormous, with only a small fraction of global assets currently on blockchain rails [5] Company Strategy and Development Direction - The company aims to transform into a pure-play digital asset infrastructure provider, focusing on compliance, security, and scalability [2][4] - The strategy includes simplifying the capital structure by collapsing the UP-C structure, enhancing transparency and governance [12] - Future growth will be driven by three core verticals: Bakkt Markets, Bakkt Agent, and Bakkt Global, each contributing to a diversified revenue model [15][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in completing the transformation by the end of Q4 2025, with a focus on sustainable growth and profitability [30] - The regulatory environment is seen as favorable, with expectations for the Clarity Act to provide clarity for real-world asset tokenization [41] - The company is positioned to benefit from the increasing participation of large financial institutions in the stablecoin space [42] Other Important Information - The company raised approximately $100 million in new capital between Q2 and Q3 2025, further strengthening its balance sheet [13] - Management emphasized a disciplined approach to future capital raising, focusing on shareholder value [15] Q&A Session Summary Question: Insights on core offerings compared to ZeroHash - Management highlighted that both companies provide regulated infrastructure, but Bakkt aims for sustainable growth without heavy burn [32][33] Question: Key KPIs to monitor progress for 2026 - Key KPIs will include trading volume and spreads for Bakkt Markets, stablecoin transaction volume for Bakkt Agent, and NAV accretion for Bakkt Global [34][35][36] Question: Role of partnerships and M&A in strategy - The focus is on organic growth through distribution partnerships rather than M&A, with updates expected in the coming quarters [38][39] Question: Considerations for macro and policy impacts on growth - The Clarity Act is seen as a potential tailwind, with a positive outlook on stablecoin growth and regulatory clarity [40][41] Question: Competing with major payment networks - Bakkt does not see itself as a direct competitor but rather as a provider of the regulated infrastructure that supports the ecosystem [45][46] Question: Improving shareholder value with new leadership - The new leadership team is focused on restructuring and aligning the company with its core mission to enhance long-term shareholder value [48][49]

Financial Data and Key Metrics Changes - U.S. net product revenue for neffy reached $31.3 million in Q3 2025, a 2.5-fold increase from the prior quarter, exceeding consensus expectations of $28.3 million [3][20] - Total revenue for Q3 2025 was $32.5 million, with $1.1 million recognized in supply revenue and $0.1 million in royalties [20][21] - Net loss for Q3 2025 was $51.2 million or $0.52 per share [23] Business Line Data and Key Metrics Changes - The U.S. net product revenue from neffy was $31.3 million, reflecting strong growth in new patient starts and overall demand [3][20] - Gross-to-net retention improved, with cash prescriptions decreasing from about 20% to approximately 12% of total volume [13][21] - Approximately 19% of neffy patients were lapsed patients who had stopped filling prescriptions, indicating a new patient segment being reached [18] Market Data and Key Metrics Changes - Consumer awareness of neffy increased from 20% pre-campaign to 56% as of September 2025 [14] - The current U.S. epinephrine market is valued at $2 billion annually, growing at 6-8% organically prior to neffy's entry [18] - Market share among new prescribers reached 10.3%, indicating faster uptake compared to existing prescribers [17] Company Strategy and Development Direction - The company is focused on sustaining and accelerating neffy U.S. market share growth and enabling global expansion through multiple launches [25] - The "Get neffy on Us" program aims to simplify access to neffy and drive year-round sales growth [8][16] - The company plans to invest in direct-to-consumer initiatives and real-world evidence generation to support neffy's effectiveness [23][24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a temporary pause in market share growth due to back-to-school seasonality but expects growth to resume in Q4 2025 [6][7] - The company anticipates Q4 sales will decrease from Q3 due to typical seasonality in the epinephrine market [7][19] - Management expressed confidence in the long-term growth and profitability of neffy, supported by a strong balance sheet and cash position [11][24] Other Important Information - The company secured a term loan facility of up to $250 million, drawing down $100 million initially to accelerate commercial growth [11][23] - Neffy received approval in Japan in September 2025, with launches anticipated in Canada and China in 2026 [10] Q&A Session Summary Question: How did Q3 performance stack up against internal expectations? - Management indicated that Q3 performance exceeded analysts' expectations and met internal expectations, despite challenges faced during the summer [32] Question: What is the market share growth among new prescribers? - New prescribers are trialing neffy, and while their market share is increasing, existing prescribers are also expanding their use [37] Question: What percentage of covered lives require prior authorization? - Approximately 50% of prescriptions require prior authorization, with 57% of commercial prescriptions not requiring it [46] Question: What are the inventory levels for neffy? - Distributors maintain inventory levels between 15-20 days, which may fluctuate based on market demand [49] Question: How is the virtual prescriber program expected to impact growth? - The virtual prescriber program is anticipated to streamline the prescription process, making it easier for patients to access neffy and potentially increasing adoption [70]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $28.4 million, up 4% year-over-year from $27.2 million and up 11% sequentially [12] - Non-GAAP EPS for the quarter was $0.11, exceeding expectations [4] - Gross margin improved to 88% on a GAAP basis and 89% on a non-GAAP basis, compared to 85% and 87% respectively a year ago [13] Business Line Data and Key Metrics Changes - Licensing and related revenue totaled $16 million, representing 56% of total revenue, reflecting a 3% year-over-year increase and a 7% sequential increase [12] - AI processor licensing contributed roughly one-third of licensing revenue in both Q2 and Q3 2025, marking a significant impact on the licensing mix [8][12] - Royalty revenue for Q3 was $12.4 million, reflecting 44% of total revenue, a 16% sequential increase, and a 6% year-over-year increase [13] Market Data and Key Metrics Changes - Consumer IoT posted 9% year-over-year growth, supported by record shipments in cellular IoT and Wi-Fi [13] - 5G WAN infrastructure revenues increased by 91% compared to last year [10] - Mobile royalties grew 4% year-over-year and 7% sequentially, driven by recovering low-end smartphone segments [10] Company Strategy and Development Direction - The company is focused on expanding its market-leading position in wireless connectivity and accelerating growth in AI [4] - CEVA aims to lead the transition to NPUs as a foundational technology for AI inference, similar to the licensing model of CPUs and GPUs [5][6] - The strategy includes leveraging a unified software framework and tools to enhance customer differentiation and experience [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in AI-led licensing momentum and wireless connectivity, highlighting a robust pipeline and deal flow [18] - The company expects seasonal momentum in Q4, driven by share gains at a US OEM smartphone customer and strong ramps in Wi-Fi and cellular IoT [18] - The guidance for Q4 total revenue is expected to be in the range of $29-$33 million [19] Other Important Information - CEVA's cash and cash equivalents were approximately $152 million as of September 30, 2025 [17] - The company repurchased approximately 340,000 shares for about $7.2 million in 2025 [17] - Shipped units by CEVA's licensees during Q3 2025 were 559 million units, up 19% sequentially and 11% year-over-year [15] Q&A Session Summary Question: Can you describe the performance of other segments besides smartphones? - Management noted growth momentum in mobile, Wi-Fi shipments, cellular IoT, and automotive ADAS solutions, all contributing to royalty growth [22][24] Question: What is the timeline for Microchip NPU shipments to impact CEVA's royalty revenue? - Typical licensing agreements last a few years, with royalties expected to materialize within two to three years after productization [31] Question: What does the competitive landscape look like for the Microchip deal? - The competitive landscape includes other potential IP vendors, but CEVA's comprehensive NPU portfolio and advanced software stack provided a competitive advantage [44][45]

Financial Data and Key Metrics Changes - The company reported an adjusted EBITDA of INR 53.5 billion for the first half of fiscal year 2026, representing a 24% year-on-year growth [6] - Revenue increased by over 50% for the first half of the fiscal year compared to the previous year, driven by an increase in megawatts and contributions from third-party sales in the manufacturing business [12] - The company reaffirmed its fiscal year 2026 adjusted EBITDA guidance of INR 87-93 billion [20] Business Line Data and Key Metrics Changes - The manufacturing business produced over 2 GW of modules and over 900 MW of cells in the first half of fiscal year 2026, contributing INR 3.3 billion to adjusted EBITDA for the quarter [7][8] - The manufacturing EBITDA guidance for fiscal year 2026 was revised upwards to INR 10-12 billion [8] - The company commissioned over 2.1 GW of renewable energy capacity since October of the previous year, marking a 22% growth in its portfolio after adjusting for asset sales [5][12] Market Data and Key Metrics Changes - The Indian government reduced the goods and services tax on renewable energy sector items from 12% to 5%, enhancing the affordability of clean energy [5] - The S&P upgraded India's long-term credit rating, which is expected to positively impact the company's borrowing costs [14] Company Strategy and Development Direction - The company continues to focus on profitable growth, project execution, and capital discipline, aiming to deliver returns significantly above its cost of capital [5] - The company is on track to complete the construction of 1.6-2.4 GW of capacity in fiscal year 2026 [6] - The company is expanding its committed portfolio with signed PPAs for 3.8 GW of installed renewable energy capacity over the past four quarters [6] Management's Comments on Operating Environment and Future Outlook - The management noted that while global macroeconomic conditions remain volatile, the situation in India is relatively stable, with low inflation and expectations of further rate cuts by the Reserve Bank of India [4] - The management expressed confidence in the execution of projects and the potential for future growth despite some cyclical lulls in the bidding environment [10][20] Other Important Information - The company achieved a score of 83 out of 100 in the S&P Global Corporate Sustainability Assessment, marking a 14% year-on-year improvement [16][19] - The company published its inaugural climate risk and biodiversity risk reports aligned with TCFD and TNFD frameworks [18] Q&A Session Summary Question: Progress on contracting side and expectations for additional PPA signings - The company has made good progress on PPA signings, with approximately 6 GW of LOAs expected to convert into PPAs over the next six months [24][25] Question: Update on transmission status for projects in the pipeline - Most transmission connectivity is in place, with efforts ongoing to convert existing connectivity to expedite project timelines [27][28] Question: Decline in solar manufacturing margins - The decline in margins was attributed to a higher mix of captive sales and lower realizations in Q2 compared to Q1 [30] Question: Timelines for cell expansion and plans for wafer ingot - The company expects pre-commissioning of the cell expansion by the same time next year, with full commissioning by the end of fiscal 2027 [38] Question: Experience of curtailment during the last quarter - The company experienced curtailment amounting to about INR 100 crore in the first half, linked to projects where backend lines were not ready [51] Question: Plans for refinancing upcoming bonds - The company is working on refinancing plans and will pursue the market offering the lowest cost of capital [74]

Financial Data and Key Metrics Changes - In Q3 2025, net product revenues were $15.8 million, down from $18 million in Q3 2024, reflecting variability in customer ordering patterns [17][19] - Total operating expenses were $45 million on a non-GAAP basis, a 12.1% decrease year-over-year, primarily due to lower R&D expenses [18] - The net loss for Q3 2025 was $41 million, or $0.30 per share, compared to a net loss of $44 million, or $0.42 per share, in Q3 2024 [19] - Cash and cash equivalents at the end of Q3 2025 were $234.7 million, down from $250.9 million at the end of 2024, but increased to approximately $292.3 million post a $60 million financing [20] Business Line Data and Key Metrics Changes - Xelanta continues to be positioned as a differentiated treatment option for third-line plus DLBCL patients, with ongoing trials expected to yield additional data [5][6] - The company is advancing its PSMA-targeting ADC, with IND-enabling activities on track for completion by year-end [6] Market Data and Key Metrics Changes - The treatment landscape for DLBCL is evolving, with a 60/40 split between complex therapies and broadly accessible therapies [11] - The company anticipates that Xelanta could achieve peak annual revenues of $600 million to $1 billion in the U.S. by expanding into earlier lines of therapy [9][10] Company Strategy and Development Direction - The company aims to expand Xelanta's use into earlier lines of therapy for DLBCL and into indolent lymphomas, with a focus on maintaining a competitive edge in the market [8][10] - The strategy includes leveraging data from ongoing trials (LOTIS-5 and LOTIS-7) to support regulatory submissions and enhance market penetration [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to invest further in Xelanta, anticipating advancements into earlier lines of therapy and additional indications [8][23] - The management highlighted the potential for Xelanta to transform the treatment paradigm for lymphoma, particularly with promising data from ongoing trials [10][14] Other Important Information - The company secured a $60 million private placement, extending its cash runway to at least 2028, which supports its strategic initiatives [7][20] - The company plans to provide updates on key trials and data catalysts throughout 2025 and 2026 [20][21] Q&A Session Summary Question: Can you frame how many patients we might get later this quarter? - The company is still targeting approximately 100 patients for enrollment, which is expected to occur quicker than originally anticipated [24][25] Question: When should we expect to see an inflection point for Xelanta sales? - The company expects to share interim data for LOTIS-7 later this year and top-line results for LOTIS-5 in the first half of 2026, with revenue ramp-up anticipated post-approval in the first half of 2027 [28][29][30] Question: Would you consider pursuing Xelanta in the front-line DLBCL setting? - The company is monitoring the front-line setting closely but does not plan to fund a phase three study independently [32][33] Question: How do you view the split of community and academic therapies? - The company does not see a strict division between community and academic settings, as both can administer complex therapies depending on patient suitability [36][37][40] Question: How would an increase in penetration in the second or third line setting affect Xelanta revenues? - The company estimates that maintaining a 10% share in the second line could increase revenues from a $70 million run rate to over $200 million [42][44]

Financial Data and Key Metrics Changes - Net revenue for Q3 2025 was $821.5 million, reflecting a 6.6% year-over-year increase [3][15] - Adjusted EBITDA was $136.4 million, up 6.1% year-over-year, with an adjusted EBITDA margin of 16.6% [3][15] - Same facility revenue grew by 6.3%, with same facility case growth of 3.4% and rate growth of 2.8% [15][20] Business Line Data and Key Metrics Changes - Over 166,000 surgical cases were performed in Q3, representing a 2.1% growth [15] - Growth in total joint surgeries was robust, with a 16% increase in Q3 and a 23% increase year-to-date compared to the same period last year [4][15] - Volume growth in gastrointestinal (GI) and musculoskeletal (MSK) procedures was relatively high, while ophthalmology procedures were slightly lower this quarter [4][5] Market Data and Key Metrics Changes - Payer mix showed commercial payers at 50.6% of revenues, down 160 basis points year-over-year, while governmental sources, primarily Medicare, increased by 120 basis points [5] - Same facility revenue growth for the full year is now expected to align with the midpoint of the long-term target range of 4%-6% [12][20] Company Strategy and Development Direction - The company is focused on organic growth, margin improvement, and capital deployment for M&A [3] - A strategic portfolio optimization process is underway to enhance flexibility and streamline operations [9][10] - The company plans to continue investing in DeNovo facilities, with two opened in Q3 and nine under construction [8][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged softer-than-expected same facility volume growth in recent months, prompting adjustments to the fourth quarter outlook [5][12] - The company remains confident in its long-term growth algorithm and the resilience of its business despite near-term challenges [13][21] - Revised full-year guidance expects revenue in the range of $3.275 billion to $3.3 billion and adjusted EBITDA between $535 million and $540 million [11][19] Other Important Information - The company has deployed approximately $71 million in capital for acquisitions in 2025, with a robust M&A pipeline of over $300 million under evaluation [6][8] - The company completed divestitures of three ASCs, generating cash proceeds of $45 million [18][40] - The inaugural investor day has been shifted to spring 2026 to provide a comprehensive update on portfolio optimization efforts [11] Q&A Session Summary Question: What is causing the weakness in demand or procedure volumes as you think through Q4? - Management noted broad-based weakness in volumes and payer mix, with higher government payer mix than expected [23][24] Question: Is the low level of spend on acquisitions due to deal timing or evaluation? - Management confirmed strong deal flow but emphasized a disciplined approach to acquisitions [25] Question: Can you clarify the payer mix commentary regarding commercial volumes being weaker? - Management indicated that while there is always pressure from payers, the current issue is more about the growth trend not being as strong as expected [29][30] Question: Can you break down the $20 million pressure on EBITDA guidance? - Management stated that approximately 60% of the pressure is related to development or capital timing, with the rest due to recent trend changes [31][32] Question: What are the expectations for free cash flow in Q4 and the year ahead? - Management does not provide specific guidance on free cash flow but noted strong operating cash flow and improvements in working capital [75][78]

Financial Data and Key Metrics Changes - Third quarter revenue was $1.6 billion, with adjusted EBITDA of $518 million, representing an adjusted EBITDA margin of 32.3% [13][30] - The company is lowering its full-year revenue guidance to $6.2 billion-$6.25 billion, reflecting a year-over-year nominal decline of 3.2%-2.4% [33] - Adjusted gross margin for the third quarter was 60.3%, down from 61.7% in the same quarter of 2024, primarily due to pricing pressure and unfavorable product mix [29][30] Business Line Data and Key Metrics Changes - Women's health franchise revenue declined 4% in the third quarter compared to the same period in 2024, with a 9% decline in Nexplanon sales [17] - Global Nexplanon sales were $223 million in the third quarter, with a 50% decline in the U.S. and a 7% growth internationally [17][18] - The fertility business was flat in the third quarter but up 13% year-to-date, with expectations of high single-digit growth for the full year [19] - Hadlima, a biosimilar, saw a 63% increase in sales year-to-date, contributing significantly to the biosimilars segment [21] Market Data and Key Metrics Changes - The U.S. market for Nexplanon faced challenges due to unfavorable policy changes impacting budget-constrained public segments [17][18] - The respiratory business is experiencing declines, particularly in Singulair and Dulera, due to competitive pressures and mandatory price reductions [24][25] Company Strategy and Development Direction - The company remains focused on deleveraging, driving cost savings, and achieving revenue growth [12][38] - A definitive agreement was made to divest the JADA system for $440 million, which will help in faster deleveraging [20] - The company is committed to enhancing operational performance and aligning resources to strategic priorities [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating current headwinds and emphasized the importance of operational excellence [10][38] - The company anticipates that the discontinuation of certain sales practices will have a significant impact on future revenue [15][19] - Management expects Nexplanon sales to be down mid to high single digits for the full year in the U.S. but anticipates international growth [18][19] Other Important Information - The independent internal investigation regarding improper sales practices has concluded, and remediation efforts are underway [9][48] - The company is not planning any additional divestitures at this time but will continue to evaluate its portfolio strategically [40] Q&A Session Summary Question: Are there opportunities for additional divestitures within the portfolio? - The company is constantly evaluating its assets but has no definitive plans for further divestitures at this time [40] Question: When should growth inflection for Vtama be expected? - Significant strides have been made to improve access, and 2026 is seen as a key year for evaluating growth trajectory [41] Question: Can you elaborate on the pressure on the respiratory business? - The respiratory business is expected to continue facing challenges due to competitive pressures and mandatory price reductions [42][43] Question: What are the expectations for Denosumab and its impact on future revenue? - The company is excited about Denosumab's launch and anticipates it will contribute positively to the biosimilars segment [54] Question: How is the CEO search progressing? - The search committee is actively working to find a permanent CEO, with no strategic changes anticipated in the interim [51]