Financial Data and Key Metrics Changes - Net sales for Q3 2025 were $15.9 million, reflecting a 44% decrease from $28.3 million in Q3 2024, primarily due to the transition of the largest customer to another supplier [14] - Gross profit for Q3 2025 was $2.3 million, a 64% decrease from $6.2 million in Q3 2024 [14] - Adjusted EBITDA for Q3 2025 was $50,000, an improvement from negative $200,000 in Q2 2025 and negative $400,000 in Q1 2025 [16] - Cash and cash equivalents increased to $23.7 million from $18.4 million at the end of Q2 2025 [17] Business Line Data and Key Metrics Changes - The company reported a gross margin of 14% for Q3 2025, down from 22% in Q3 2024, but excluding restructuring costs, gross margin was 18%, showing improvement over the first two quarters of 2025 [15] - The transition of the largest customer represented 12% of net sales in Q3 2025, indicating reduced dependence on any single customer [10] Market Data and Key Metrics Changes - The company signed several new long-term product purchasing agreements during Q3 2025, including a notable three-year commitment with a dialysis center in Southern Florida, potentially generating approximately $1 million in annualized net sales [8] - Discussions with the formerly largest customer are ongoing, with expectations to continue supplying them through the end of the year [9] Company Strategy and Development Direction - The company is focused on optimizing its organizational structure to align with current scale while enhancing operational efficiency and customer service [5] - Strategic decisions made earlier in the year are translating into tangible results, with over 80% of customers operating under long-term agreements, providing stability and revenue visibility [4] - The company is actively pursuing business development opportunities, including potential acquisitions, leveraging its strong cash position [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year guidance targets and sustainable profitability moving forward [6] - The company anticipates providing forward revenue guidance for 2026 early in the year, with expectations to announce business development impacts shortly [24] Other Important Information - The company is expanding its customer base on the West Coast and is considering establishing a facility there due to growing customer demand [38] - The at-home dialysis market is seen as a significant growth opportunity, with expectations for continued growth in this segment [40] Q&A Session Summary Question: Resolution timeline with former largest customer - Management expects the situation to resolve within the current quarter and is in contract discussions [21] Question: Forward revenue guidance for 2026 - Guidance is typically provided early in the year, with visibility expected during the fourth quarter earnings release [24] Question: Key prospects for bicarbonate disposables business - The introduction of the bicarbonate cartridge is expected to significantly grow this higher margin product opportunity [25] Question: Balancing organizational restructuring with investments - The company is managing resource allocation carefully to focus on growth opportunities while winding down unsupported operations [28] Question: Areas for improving gross margin - Immediate focus is on labor costs, with long-term potential in materials and distribution efficiencies [30] Question: Background on facility closure - A facility was closed as part of consolidation efforts, with expenses being offloaded [32] Question: Update on West Coast expansion and home dialysis business - The West Coast is a focus area for customer acquisition, and the at-home market is expected to grow significantly [38][40]

Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [7][17] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [26] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [27][29] - Operating loss improved by 38% to $43 million compared to the same period last year [28] Business Line Data and Key Metrics Changes - CARVYKTI's U.S. net trade sales were $396 million, growing 53% year-over-year and 11% quarter-over-quarter [18] - International sales reached $128 million, nearly five times the amount from the same period a year ago, representing a 58% increase quarter-over-quarter [18] Market Data and Key Metrics Changes - The company has treated over 9,000 patients with CARVYKTI, marking it as the strongest CAR-T launch to date [7] - The number of authorized treatment centers in the U.S. has increased to 132, with about one-third being community and regional hospitals [22] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [15][16] - Plans include increasing manufacturing capacity to support the treatment of over 10,000 patients annually [19][23] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 [16][29] - The company is optimistic about the long-term growth potential in both the U.S. and international markets, particularly in community settings [15][18] Other Important Information - The FDA has approved an update to include CARVYKTI's overall survival benefit in its label, enhancing its market position [9] - The company is investing in operational efficiency and disciplined expense management to support long-term growth [26] Q&A Session Summary Question: What will be the best way to prioritize cash in terms of pipeline assets? - The company plans to maximize the CARVYKTI franchise and invest significantly in its CAR-T platform [33] Question: Is the Raritan site expansion on track? - The expansion is on track, with the facility expected to support 10,000 doses annually [36] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [40] Question: How will the company mobilize demand to fulfill new supply? - The focus will be on educating physicians about the benefits of early treatment and leveraging community networks [44] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing patient access [95] Question: What are the expectations for international growth? - Strong uptake is noted in Germany, Spain, and Belgium, with TechLane expected to enhance capacity for European launches [88]

Financial Data and Key Metrics Changes - RADCOM achieved record revenue of $18.4 million for Q3 2025, representing a 16.2% year-over-year growth with continued profitability and expanding profit margins [6][19] - Non-GAAP operating income reached $3.8 million, which is 20.9% of revenue, marking the highest since 2017 [6][21] - The company generated a positive cash flow of $5.1 million, ending the quarter with a cash balance of $106.7 million and no debt [7][22] Business Line Data and Key Metrics Changes - The company is deepening deployments with existing customers while developing new opportunities, particularly in 5G standalone networks and AI operations [5][8] - RADCOM's high-capacity user analytics solution, powered by NVIDIA, is currently in field trials and is expected to materialize in 2026 [25] Market Data and Key Metrics Changes - The telecom market is experiencing strong and durable tailwinds, with operators increasing investments in AI-native networks to enhance customer experiences and operational efficiency [7][8] - There is a clear industry shift towards cloud-native platforms leveraging AI, particularly in Europe and other regions [12][13] Company Strategy and Development Direction - RADCOM is focusing on converting a strong pipeline into revenue, deepening strategic partnerships, and investing in AI and automation to maintain leadership [16] - The company is enhancing its technology leadership through partnerships with NVIDIA and ServiceNow, which are expected to contribute initial revenue in 2026 [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving double-digit growth for 2026, supported by new opportunities in the market and ongoing customer transformations [32] - The company anticipates sustained investment across its customer base, driven by improving capital conditions [16] Other Important Information - The company announced a leadership transition, with Hadar Rahav leaving and Hod Kohen joining as the new CFO [17] - RADCOM's agentic AI solution received recognition, winning the Best AI/ML Innovation Award at the Global Connectivity Award [15] Q&A Session Summary Question: Early feedback on the high-capacity user analytics solution - Management is excited about the performance seen in field trials and expects materialization in 2026 [25] Question: Trends in expansion with existing customers - There is a solid pipeline building up, with expectations for double-digit growth and more opportunities in 2026 [28] Question: Visibility into next year and major renewals - Management is confident in maintaining double-digit growth, with new opportunities arising from cloud-native and 5G transformations [32] Question: Earnings leverage and spending plans for next year - Plans include increased spending on sales and marketing, as well as R&D [33] Question: 5G Core deployments in various geographies - There is good momentum in 5G Core deployments across the U.S., Europe, and parts of Asia, driving customer excitement [34]

Summary of Sionna Therapeutics Conference Call Company Overview - **Company**: Sionna Therapeutics (NasdaqGM:SION) - **Focus**: Development of treatments for cystic fibrosis (CF) targeting a differentiated mechanism involving NBD1 - **Market Size**: Current CF market valued at $11 billion, projected to grow to $15 billion, dominated by one player [2][2] Core Points and Arguments - **Unmet Need**: Despite advancements in CF treatment, a significant unmet need remains, particularly in achieving normal CFTR function for patients [1][1] - **Current Treatment Efficacy**: Only one-third of patients on standard care achieve normal CFTR function; Sionna aims to improve this with their combination strategy [2][2] - **Clinical Development**: - Two NBD1 stabilizers (719 and 451) are in development, with 719 advancing to a Phase 2a proof of concept study (PreciSION CF) [3][3] - The study aims to demonstrate the efficacy of NBD1 in improving CFTR function when added to standard care [6][6] - Data from the study is expected by mid-2026 [3][3] Study Design and Expectations - **Phase 2a Study**: - A two-way crossover design to assess safety, tolerability, and efficacy based on sweat chloride levels [5][5] - Targeting a minimum reduction of 10 millimoles in sweat chloride, which is expected to correlate with a 3% improvement in FEV1 [10][10] - **Patient Selection**: Focus on patients who do not achieve normal CFTR function on Trikafta but are not outliers in sweat chloride levels [19][19] Mechanism and Assay Validation - **Assay Confidence**: - The assay used for predicting clinical outcomes has been validated through historical data and comparisons with Vertex's methodologies [33][33] - Sionna's assay has shown predictive power, replicating clinical results of Vertex compounds [37][37] - **NBD1 Mechanism**: NBD1 is expected to provide significant improvements in CFTR function, potentially achieving wild-type levels when combined with other correctors [41][41] Future Development Path - **Regulatory Engagement**: Anticipated discussions with regulators regarding the development path, with FEV1 expected to be the primary registration endpoint [42][42] - **Combination Strategy**: The dual combination of 451 with either Sion-2222 or Sion-109 is prioritized for its potential to normalize CFTR function [31][31] Financial Position - **Cash Reserves**: As of Q3, Sionna has $325 million in cash, extending its runway into 2028, allowing for continued development of its clinical programs [51][51] Additional Insights - **Community Needs**: There is a strong demand for more treatment options in the CF community, emphasizing the importance of differentiated mechanisms [47][47] - **Capital Considerations**: Future advancements will depend on the ability to raise capital to support multiple development paths [27][27] This summary encapsulates the key points discussed during the Sionna Therapeutics conference call, highlighting the company's strategic focus, clinical development plans, and financial outlook.

Financial Data and Key Metrics Changes - Retail sales volume increased by 36% to over 44,000 cars in the first nine months of 2025 [9] - Revenue grew by 49% to approximately $2.2 billion in the first nine months of 2025 [10] - Adjusted EBITDA loss improved by 8% to $561 million, reflecting fixed cost reductions and carbon credit income [13] - Net loss for the third quarter was $365 million, with a gross margin of negative 6%, a deterioration of 5 percentage points [15] Business Line Data and Key Metrics Changes - Retail sales in the third quarter grew by 13% year-on-year, with revenue increasing by 36% to $748 million [14] - The Polestar 3 and Polestar 4 accounted for 65% of retail sales [9] - Carbon credit sales amounted to $104 million under the new EU pooling agreement, a significant increase from below $1 million in the same period in 2024 [11] Market Data and Key Metrics Changes - Europe remains the main market, representing over 75% of global deliveries, with notable growth in Belgium (40%), Netherlands (37%), Germany (46%), Norway (63%), Sweden (41%), and the U.K. (100%) [6] - Korea showed exceptional growth of 430% [7] - The U.S. market represented only 8% of retail sales for the first nine months of 2025, down from 16% in 2024, due to tariff and policy challenges [10] Company Strategy and Development Direction - The company is focusing on transforming commercial operations, increasing retail footprint, and improving operational efficiency [4] - A shift in platform strategy was announced, utilizing group technology platforms for future models [7] - The company plans to continue optimizing its operations and expects to end the year with approximately 2,000 employees, down from 2,500 [7] Management's Comments on Operating Environment and Future Outlook - Management acknowledged significant external headwinds, including tariff and pricing pressures impacting profitability [9] - The company aims to drive growth through an active selling model and leverage its attractive model lineup [16] - Management expressed optimism about the prospects for the Polestar 4 in North America, highlighting positive media reception [8] Other Important Information - The company raised $200 million in new equity from PSD Investment Limited, controlled by Mr. Li Shufu, founder and chairman of GD Group [16] - A reverse stock split is planned to change the ratio of American depositary shares to ordinary shares [16] Q&A Session Summary Question: Can you help us bridge the walk for gross margin? - Management noted that Q3 gross margin was disappointing due to pricing pressure and higher production costs, with an adverse mix effect from selling more Polestar 2 and 3 [19][20] Question: Can you comment on OPEX spending trends? - Management indicated a significant decrease in fixed costs, driven by optimized marketing expenses and headcount reduction, aiming to reach 2,000 employees by year-end [23][24] Question: How is the bilateral trade agreement affecting business plans? - Management discussed local production in the U.S. and the introduction of Polestar 4 from South Korea, which has lower duties, as a positive setup for optimizing the U.S. business model [28] Question: What is the new effective rate of interest on Polestar's debt portfolio? - Management confirmed that most of the interest rate is floating, with no significant change to the previous rate [31] Question: Can you provide an update on capital needs and liquidity? - Management reported a monthly cash burn of around $136 million, with expectations for an increase due to legacy CapEx, while actively working on improving working capital [36][38] Question: What are the opportunities in autonomy for Polestar? - Management highlighted partnerships with Mobileye and the importance of balancing performance with higher levels of autonomy as a focus area for the future [41][42]

Financial Data and Key Metrics Changes - The company reported net sales of CHF 794.4 million, representing a year-over-year growth of 24.9% on a reported basis and 34.5% at constant currency [17][30] - Gross profit margin reached 65.7%, an increase of 510 basis points year-over-year, while adjusted EBITDA margin was 22.6%, up 370 basis points year-over-year [25][31] - Adjusted EBITDA grew nearly 50% year-over-year, amounting to CHF 179.9 million [17][25] Business Line Data and Key Metrics Changes - Performance footwear net sales reached CHF 731.3 million, growing 21.1% year-over-year on a reported basis and 30.4% at constant currency [22] - Apparel category net sales surged to CHF 50.1 million, an increase of 86.9% year-over-year on a reported basis and 100.2% at constant currency, with over 1 million apparel units sold in a single quarter for the first time [23][30] - Direct-to-consumer (D2C) channel net sales reached CHF 314.7 million, up 27.6% year-over-year on a reported basis and 37.5% at constant currency [17][30] Market Data and Key Metrics Changes - Asia Pacific region net sales grew to CHF 144.9 million, a remarkable increase of 94.2% year-over-year on a reported basis and 109.2% at constant currency [21] - The Americas reported net sales of CHF 436.2 million, growing 10.3% year-over-year on a reported basis and 21% at constant currency [19] - Europe, Middle East, and Africa (EMEA) saw net sales of CHF 213.3 million, up 28.6% year-over-year on a reported basis and 33% at constant currency [20] Company Strategy and Development Direction - The company aims to maintain its position as the most premium global sportswear brand, focusing on brand awareness and premium positioning [12][30] - The strategy includes expanding the apparel business as a standalone growth pillar, with a focus on D2C sales and enhancing the customer experience [15][44] - The company plans to continue investing in innovation and technology, with a strong product pipeline set to launch in 2026 [9][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the brand's momentum and the effectiveness of its premium strategy, particularly in the face of price increases and tariff impacts [19][66] - The company anticipates strong growth across all regions, with a focus on maintaining full-price sales and avoiding discounting strategies [67][74] - The outlook for 2026 includes a constant currency growth expectation of at least 23%, supported by a robust product pipeline and strategic investments [33][56] Other Important Information - The company opened new flagship stores in key markets, including Tokyo and Zurich, which contributed to record sales [13][18] - The successful launch of collaborations with cultural icons like Zendaya and Burna Boy is enhancing brand appeal among younger consumers [10][84] - The company is leveraging operational efficiencies to improve its cash conversion cycle and maintain a strong cash balance of CHF 961.8 million [28] Q&A Session Summary Question: Can you discuss the traction in apparel and its regional performance? - Management highlighted strong traction in apparel, accounting for about 8% of total business, with significant growth in running, training, and tennis categories [38][39] Question: How does the company balance top-line growth with margin protection? - Management emphasized the importance of disciplined inventory management and maintaining a premium business model to protect margins while driving growth [47][49] Question: What is the outlook for U.S. growth compared to other regions? - Management indicated that U.S. growth remains strong, supported by effective price increases and brand awareness, while also noting significant growth opportunities in Asia and EMEA [66][70] Question: Can you elaborate on the younger consumer segment? - Management noted that the younger consumer segment is becoming increasingly important, with successful collaborations and a growing kids line contributing to this trend [84][86]

Financial Data and Key Metrics Changes - System-wide sales for Q3 2025 were $238.2 million, a decrease of 0.8% year-over-year, primarily due to closed centers [20][22] - Same-store sales grew by 20 basis points year-over-year [20] - Adjusted EBITDA increased by 9.6% to $20.2 million from $18.4 million in the prior year, with an adjusted EBITDA margin improvement of 400 basis points to 37.2% [23] - Total revenue decreased by approximately $1.2 million, or 2.2%, primarily due to lower contributions from wholesale product and retail revenue [22] - Net interest expense increased to $6.5 million from $6.3 million in the prior year [23] Business Line Data and Key Metrics Changes - The company opened three growth centers during the quarter and closed nine, resulting in six net closures, which was better than the expected closure range of 15-16 [22] - Wax Pass sales saw a slight year-over-year uptick, indicating stability in core guest engagement [39] Market Data and Key Metrics Changes - Com trends were strong through July and mid-August before softening in the latter half of August and September [21] - Regional performance showed improvement in California, while areas like New York, Philadelphia, and DC experienced more weakness [39] Company Strategy and Development Direction - The company is focused on three strategic priorities: driving sales through traffic growth, improving four-wall profitability for franchisees, and pursuing disciplined, profitable expansion [7][12] - A new brand agency has been brought on to refine brand identity and connect with high-value audiences, with initiatives expected to scale meaningfully in 2026 [12][54] - The company expects to return to positive net center growth by year-end 2026, with a focus on new centers and markets with strong demand [17][40] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed full-year financial guidance, expecting system-wide sales of $940-$950 million and same-store sales to be flat to up 1% for the full year [26][27] - The company is optimistic about the strategic groundwork established, which is beginning to take hold and position the company for sustainable long-term growth [28][29] - Management acknowledged that new guest acquisition remains pressured but expects improvement in 2026 [26][27] Other Important Information - The company narrowed its closure range for the year to between 35 and 40, reflecting timing shifts in anticipated closures and progress made on initiatives with franchisees [25][26] - The company ended the quarter with $73.6 million in cash and a net leverage ratio of 3.9 times [24] Q&A Session Summary Question: Can you quantify the lift from revamped marketing efforts? - Management noted that they have improved contactability from 38% to 60% of guests, which has enhanced engagement and driven frequency improvements [32][33] Question: What trends are observed in Wax Pass sales and regional performance? - Wax Pass sales have seen a slight uptick year-over-year, with stability in the core guest base, while California has shown improvement compared to weaker performance in New York, Philadelphia, and DC [39] Question: What are the expectations for center openings and closures moving forward? - Management indicated that closures are primarily low-volume units due to various factors, and they expect to return to net positive growth by the end of 2026 [40][46] Question: What is the outlook for new guest acquisition? - Management highlighted that robust data analytics and a refreshed brand identity are expected to enhance new guest acquisition efforts moving forward [54][55] Question: Can you provide insights on guest count versus ticket growth? - Management emphasized a balanced approach to driving traffic and ticket growth, focusing on both increasing guest count and smart pricing strategies [56][58]

Financial Data and Key Metrics Changes - The company's total revenues and income increased to $165 million, up from $113 million last year, representing a growth rate of 46.7% year over year [26] - Adjusted EBITDA grew by 23% to $112 million compared to $91 million for the same period in 2024 [28] - Net income amounted to $32 million compared to $24 million last year, an increase of 33% year over year [27] Business Line Data and Key Metrics Changes - Revenues from the sale of electricity rose 27% to $139 million compared to $109 million in the same period of 2024, driven by newly operational projects [26] - New projects contributed $22 million to the revenues from the sale of electricity, with significant contributions from Atwisko, Reyes Project, Pupin, and Tapolca [26][27] - The energy storage segment is projected to deliver an average project-level return of 22% [11] Market Data and Key Metrics Changes - Revenues and income were distributed between MENA, Europe, and the U.S., with 47% from Israel, 27% from Europe, and 26% from the U.S. [27] - The company anticipates annual revenue and income from its mature portfolio to reach $1.6 billion upon commencement of operations in the 2027 to 2028 timeframe [16] Company Strategy and Development Direction - The company is committed to becoming a leading global energy developer and IPP, focusing on renewable energy as the fastest-growing segment within the energy industry [7][8] - The strategy includes expanding the energy storage segment in Europe and strengthening its presence in Germany and Poland through acquisitions [10][11] - The company aims to triple its business size every three years, with a projected revenue growth rate of 40% [56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing strong market fundamentals and a favorable regulatory environment [18] - The anticipated growth in AI investments is expected to drive unprecedented demand for processing capacity and electricity, positioning renewable energy as a key solution [17] - The company raised its full-year 2025 guidance, expecting revenues and income to be between $555 million and $565 million [31] Other Important Information - The company secured $4.8 billion in project finance, corporate debt, and asset sales in the past 12 months, enhancing its financial flexibility [30] - The financial close for the Snowflake A project, totaling approximately $1.5 billion, marks a significant milestone for the company [24] Q&A Session Summary Question: How did solar and wind resource availability compare to typical seasonal assumptions? - Management noted additional wind in some Israeli assets and that solar performance was in line with expectations, with battery storage projects contributing additional revenues [33] Question: What enabled the acceleration in safe harboring projects? - The safe harbor strategy included significant physical work both onsite and offsite, allowing the company to complete 9 FGW already this year [34][35] Question: What are the growth rates of operating capacity moving into 2028 and beyond? - The company expects continued growth rates similar to past performance, with a focus on mitigating risks related to interconnection and other project aspects [36][37] Question: Can you discuss the current India tariff exposure and mitigation strategies? - The company is focused on sourcing PV cells from countries not subject to ongoing investigations and has flexibility in module assembly to mitigate country-specific risks [48][49] Question: Are the new projects in Europe part of a new strategy? - The projects in Europe are part of a diversified strategy that allows the company to grow consistently across different geographies and technologies [54][55]

Financial Data and Key Metrics Changes - Consolidated revenue for the quarter was $1.24 billion, a 9% increase compared to the same quarter last year [10] - Adjusted segment operating income rose to $155.3 million, up 4% from $149 million in the previous year [10] - Adjusted EPS decreased to $0.23 from $0.24 year-over-year [10] - Net finance expense increased to $56.9 million from $52.9 million, primarily due to additional financing costs related to acquisitions and lease expenses [10] - Net cash from operating activities increased to $214 million from $162.1 million [11] - Free cash flow rose by 44% to $201 million compared to $140 million in the same quarter last year [11] - Capital expenditures totaled $87.6 million, with approximately 85% allocated to growth initiatives [12] Business Line Data and Key Metrics Changes - Civil segment revenue grew 5% year-over-year to $670 million, but adjusted segment operating income decreased 6% to $108.7 million, resulting in a margin of 16.2% [14] - Defense segment revenue increased 14% year-over-year to $566.6 million, with adjusted segment operating income rising 41% to $46.6 million, achieving an 8.2% margin [15] Market Data and Key Metrics Changes - Civil training center utilization dropped to 64% from 70% in the prior year [14] - The civil adjusted backlog increased by 27% year-over-year to $8.5 billion, indicating a strong foundation for future growth [37] - The defense adjusted backlog reached $11.2 billion, with a robust pipeline of $6.1 billion in pending orders [39] Company Strategy and Development Direction - The company is focusing on a transformation plan that includes sharpening its portfolio, disciplined capital management, and operational excellence [5][8] - The defense business is highlighted as a key growth area, especially with increased government spending on defense [7] - The company aims to leverage its technology and customer relationships to improve cash flow and return on assets [17] - Organizational changes have been made to streamline operations and enhance performance [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategic advantages and the potential for growth in both civil aviation and defense markets [16][43] - The outlook remains strong, with expectations for improved performance as market conditions normalize [43] - The company is committed to disciplined execution and operational efficiency as it advances its transformation [43] Other Important Information - The company is reducing capital expenditures by approximately 10% year-over-year, reflecting a disciplined approach to capital allocation [12][61] - The leadership team is focused on aligning the organization for better performance and accountability [31][34] Q&A Session Summary Question: Changes in capital approval thresholds - Management indicated that the threshold for capital approval has become more disciplined, reflecting current market conditions and performance expectations [51][52] Question: Surprises encountered during the transition - Management noted positive surprises in organizational energy and customer relevancy, emphasizing the depth of technology available [56] Question: CapEx reduction drivers - The reduction in CapEx is driven by market conditions and a disciplined approach, with a significant portion allocated to maintenance and growth [61] Question: Return on invested capital outlook - Management is focused on maximizing returns on current investments and is evaluating how to improve future capital allocation [62][80] Question: Timeline for margin and free cash flow improvement - Management stated that some initiatives will yield immediate results while others may take longer, with guidance expected at the end of the year [84]

Financial Data and Key Metrics Changes - In Q3 2025, CARVYKTI net trade sales reached approximately $524 million, representing an 84% year-over-year increase [7][17] - Total revenues for the quarter were $272 million, driven by collaboration revenue growth of 84% year-over-year [26] - The company reported a net loss of $40 million, with an adjusted net loss of $19 million after excluding non-core items [27][29] - Operating loss improved by 38% to $43 million compared to the same period last year [28] Business Line Data and Key Metrics Changes - CARVYKTI's U.S. net trade sales were $396 million, growing 53% year-over-year and 11% quarter-over-quarter [18] - International sales reached $128 million, nearly five times the amount from the same period last year, representing a 58% quarter-over-quarter increase [18] - The company has treated over 9,000 patients with CARVYKTI, marking it as the strongest CAR-T launch to date [7][15] Market Data and Key Metrics Changes - The U.S. market saw 60% utilization of CARVYKTI in earlier line settings [18] - The number of authorized treatment centers in the U.S. increased to 132, with about one-third being community and regional hospitals [22] - The company launched in 14 markets globally, with strong uptake in Germany, Spain, and Belgium [87] Company Strategy and Development Direction - The company aims to solidify its leadership in cell therapy and expand CARVYKTI into frontline settings [15][16] - Plans include increasing manufacturing capacity to support demand, targeting 10,000 annualized doses [19][41] - The company is focused on educating physicians about CARVYKTI's overall survival benefits and the importance of early treatment [21][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability for CARVYKTI by the end of 2025 and company-wide profitability in 2026 [16][29] - The company is optimistic about the long-term growth potential in both the U.S. and international markets [15][87] - Management highlighted the importance of effective bridging therapies to mitigate adverse events and improve patient outcomes [66] Other Important Information - The FDA approved an update to CARVYKTI's label to include overall survival benefits [9] - The company is investing in operational efficiency and disciplined expense management to support long-term growth [25][29] Q&A Session Summary Question: How will the company prioritize cash allocation in 2026? - The company plans to maximize the CARVYKTI franchise and invest in manufacturing and CAR-T platform growth [33] Question: What is the status of the Raritan site expansion? - The expansion is on track for completion, with the facility expected to support 10,000 doses annually [36] Question: What are the expectations for authorized treatment centers in 2026? - The company aims to expand coverage to match competitors, targeting over 160 sites [40] Question: How will the company mobilize demand in a supply-constrained environment? - The focus will be on educating physicians about the benefits of early treatment and leveraging community networks [44] Question: What is the impact of loosening REMS requirements? - The changes are expected to facilitate quicker patient transitions back home, enhancing overall patient experience [93] Question: How is the company addressing delayed neurotoxicity? - The company emphasizes the need for effective bridging therapies to manage tumor burden and reduce adverse events [66] Question: What is the outlook for outpatient administration? - Approximately 50% of patients are currently treated in outpatient settings, with expectations for growth [76]