Financial Data and Key Metrics Changes - In Q4 2025, revenue reached $306 million, reflecting a 64% year-over-year growth, with a gross margin of 61% [24][26] - The operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, indicating significant operational leverage [24][26] - Adjusted net income was reported at $2.5 million, a transformation from a $59 million adjusted net loss a year ago [26] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year and a 6% increase from Q3 2025 [7][16] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [16] - Outside the U.S., sales reached $135 million, representing over a threefold increase compared to the same period a year ago [16] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [16][18] - The majority of CARVYKTI utilization is in earlier line settings, with approximately 65% of patients treated in the second to fourth line settings [16][22] - The market for BCMA-directed therapies remains under-penetrated, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [17] Company Strategy and Development Direction - The company aims to achieve company-wide profitability in 2026, following CARVYKTI's profitability in 2025 [7][15] - There is a strategic focus on expanding CARVYKTI's use in earlier treatment lines, supported by clinical evidence showing better outcomes [17][23] - The partnership with Johnson & Johnson is aimed at scaling CARVYKTI to an anticipated peak annual sales potential of over $5 billion [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth from the previous year [31] - The company is optimistic about the long-term growth potential of CARVYKTI, given the significant unmet needs in the multiple myeloma market [17][24] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][22] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [27] - The Tech Lane facility in Belgium began commercial production in September 2025, supporting growth in ex-U.S. markets [16][17] - The company plans to file one to two U.S. INDs by the end of the year, focusing on advancing its R&D pipeline [14] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 - Management expects sequential growth throughout 2026, confident in achieving approximately 50% top-line growth from last year [31] Question: Focused synergistic business development - The company is interested in complementary technologies and potential partnerships to accelerate the development of in vivo CAR T assets [32] Question: Positioning of bispecifics relative to CARVYKTI - Management believes there is a significant unmet need in second and third line settings, with a unique value proposition for CARVYKTI [35] Question: Community setting expansion hurdles - Continued education and training for community physicians are essential for expanding CARVYKTI's adoption in community hospitals [39] Question: Current CAR-T penetration targets - The company sees significant growth potential in both late-line and early-line multiple myeloma treatments, with a focus on improving patient outcomes [44][46] Question: Impact of recent M&A in the space - The acquisition of a competitor validates the market's value, with the company prepared for increased competition [58][59] Question: MRD results and potential filing acceleration - The company is exploring the correlation between MRD activity and clinical outcomes, which could accelerate FDA filing times for future trials [70]

Financial Data and Key Metrics Changes - Total revenues for 2025 were EUR 2.9 billion, a slight increase from the prior year, despite a decrease in COVID-19 vaccine revenues [27] - R&D expenses were approximately EUR 2.1 billion, a slight decrease from the prior year, enabled by cost savings and positive effects from cost-sharing with BMS [27] - The company ended 2025 with EUR 17.2 billion in cash equivalents and security investments, positioning it strongly for future investments [28] - An adjusted non-IFRS net loss of EUR 117 million was reported for 2025 [29] Business Line Data and Key Metrics Changes - The company maintained over 50% market share in the COVID vaccine market, distributing its vaccine in over 180 countries [6] - Significant progress was made in oncology programs, with over 4,000 patients enrolled across phase II and phase III studies [6] - The company executed strategic deals, including acquiring Biotheus and CureVac, to strengthen its oncology pipeline [7] Market Data and Key Metrics Changes - The company anticipates lower COVID-19 vaccine revenues in 2026 compared to 2025, driven by declines in both European and U.S. markets [30] - The U.S. market is expected to be competitive and dynamic, impacting revenue generation [30] - In Germany, direct sales of COVID-19 vaccines will significantly affect the company's top line [31] Company Strategy and Development Direction - The company aims to become a multi-product company by 2030, focusing on oncology and personalized medicine [10] - Key priorities for 2026 include accelerating late-stage development of oncology assets, building momentum in combination-based approaches, and evolving to a tumor-centric clinical development program [8] - The company plans to leverage its diverse clinical assets for combination strategies to address multiple lines of treatment [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and disciplined resource allocation, focusing on late-stage programs [8] - The transition to a new independent company for next-generation mRNA innovations is expected to enhance BioNTech's strategic focus [10] - Management anticipates a sustained cadence of event-driven late-stage readouts from 2026 to 2030, with significant potential to improve patient outcomes [9] Other Important Information - The company will supplement its IFRS reporting with adjusted non-IFRS measures to provide better context for business performance [28] - A binding agreement for the new company is expected to be signed by the end of the first half of 2026 [11] Q&A Session Summary Question: How will the mRNA therapeutics be split between BioNTech and the new company? - Management confirmed that all current mRNA capabilities will remain with BioNTech, while the new company will focus on next-generation innovations [38][40] Question: What is the profile for the new CEO search? - The supervisory board is looking for leaders with strong experience in late-stage development and commercial execution [46] Question: Why is the management transition happening now? - The transition is planned for the end of 2026, aligning with key milestones and data readouts [49][50] Question: Will BioNTech contribute capital to the new company? - BioNTech's contribution will relate to certain rights and mRNA technologies, not cash [54] Question: What are the expectations for COVID-19 vaccine revenues in 2026? - Lower revenues are anticipated due to market normalization and seasonal demand [95]

Financial Data and Key Metrics Changes - The company reported record revenue of $19.2 million for Q4 2025, a 35% increase from $14.2 million in the same period last year [6][25] - Gross profit for Q4 2025 increased to $12 million compared to $9 million in the prior year, while gross profit margin slightly decreased to 62.6% from 63% [29] - Net loss attributable to stockholders was $1.3 million or $0.03 per share for Q4 2025, compared to a net loss of $4.6 million or $0.12 per share in the prior year [31] Business Line Data and Key Metrics Changes - Revenue for the surgical aesthetics segment increased 38% to $16.7 million in Q4 2025, driven by sales of the AYON body contouring system [26][27] - OEM segment sales increased 16% to $2.5 million in Q4 2025, attributed to increased sales volume to existing customers [28] Market Data and Key Metrics Changes - Domestic revenue increased 42% year-over-year to $15 million, while international revenue increased 15% year-over-year to $4.2 million [28] - The market for aesthetic surgery is evolving, with a notable increase in demand driven by the adoption of GLP-1 drugs for weight loss, leading to increased interest in body contouring treatments [16][18] Company Strategy and Development Direction - The company is focused on expanding the AYON platform and enhancing its market position by acquiring high-caliber sales talent [21][65] - Plans to submit for regulatory approvals in key international markets, including Europe and Brazil, are underway to expand AYON's reach [71] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong market demand for AYON and the potential for significant growth in the aesthetic surgery market [9][20] - The company anticipates total revenue for 2026 to be in the range of $57.5 million to $58.5 million, reflecting a 9%-11% increase compared to 2025 [35] Other Important Information - Cash used in operating activities decreased to $2.5 million in Q4 2025 from $2.9 million in the prior year, and for the full year, cash used decreased to $8 million from $18.7 million [32][33] - The company expects to achieve cash flow positivity no later than Q4 2026 [80] Q&A Session Summary Question: Can you provide more details on handpiece and capital equipment sales? - Management indicated that growth in Q4 was driven by AYON, with domestic sales growing nearly 50% [47] Question: What is the pricing strategy for AYON? - The list price for AYON is approximately $360,000, which includes the Apyx One generator and complementary components [50] Question: What feedback have you received from customers regarding AYON? - Customers have expressed strong satisfaction with AYON, with requests for the power-assisted handpiece expected in the first half of the year [54] Question: How are new salespeople being integrated into the company? - The company is leveraging the strength of AYON to attract top sales talent and is focusing on expanding market share [62][65] Question: What are the plans for AYON's international expansion? - Currently approved only in the U.S., the company plans to register AYON in key international markets, including Europe and Brazil [71]

Financial Data and Key Metrics Changes - In Q4 2025, total revenues reached RMB 34.7 billion, up 75.9% year-over-year and 59% quarter-over-quarter [24] - Vehicle sales were RMB 31.6 billion, representing an increase of 80.9% year-over-year and 64.6% quarter-over-quarter [24] - Non-GAAP operating profit reached RMB 1.25 billion, while GAAP operating profit was RMB 810 million [7] - The vehicle margin improved to 18.1% compared to 13.1% in Q4 last year and 14.7% last quarter [25] - Overall gross margin increased to 17.5% from 11.7% in Q4 last year and 13.9% last quarter [27] - Net profit was RMB 0.3 billion, compared to a net loss of RMB 7.1 billion in Q4 last year [28] Business Line Data and Key Metrics Changes - The NIO, Onvo, and Firefly brands delivered a total of 326,028 vehicles in 2025, up 46.9% year-over-year [5] - The NIO brand's all-new ES8 reached 70,000 deliveries in just 160 days, setting a monthly delivery record among vehicles priced above CNY 400,000 [9] - The Onvo brand's L90 became the best-selling large battery electric SUV in 2025 [10] - The Firefly brand ranked number one in the high-end small car market for seven consecutive months in 2025 [11] Market Data and Key Metrics Changes - The penetration rate of battery electric vehicles (BEVs) in the premium segment increased from 14% in Q4 2024 to 27% in Q4 2025 [35] - The overall BEV penetration in the premium segment saw an increase driven by strong demand for large three-row and five-seater battery electric SUVs [36] Company Strategy and Development Direction - The company plans to launch three new models in 2026, further strengthening its product portfolio and expanding its share in the premium large vehicle segment [22] - Continued investments in charging and swapping infrastructure are planned, with a target of installing 1,000 new Power Swap stations annually [91] - The company aims to maintain a balance between sales volume and vehicle gross margin, focusing on long-term competitiveness [102] Management's Comments on Operating Environment and Future Outlook - The management acknowledged challenges in the auto industry but remains confident in achieving a year-over-year volume growth target of 40%-50% for 2026 [38] - The company expects to maintain vehicle gross margin at a similar level as Q4 2025 despite rising raw material costs [50] - The management emphasized the importance of the Power Swap system as a systematic solution to address mismatched life cycles of vehicles and batteries [79] Other Important Information - The company achieved positive operating cash flow and free cash flow for two consecutive quarters, ending Q4 2025 with total cash and cash equivalents of RMB 45.9 billion [29] - Shenji, the company's smart driving chip subsidiary, raised CNY 2.257 billion in its first round of equity financing, enhancing its R&D capabilities [20] Q&A Session Summary Question: What is the plan for product and volume sales growth target in the second half of the year? - Management acknowledged industry challenges but remains confident in achieving a year-over-year growth target of 40%-50% for 2026, supported by new model launches [33][38] Question: What feedback has been received regarding user experience with autonomous driving? - The share of smart driving time increased by over 80% month-over-month after the rollout of the new model, indicating positive user experience [42] Question: Can the company pass on raw material cost inflation to customers? - Management indicated that while there are pressures on vehicle cost structure, larger models with higher margins are expected to help mitigate these impacts [55][56] Question: What is the outlook for R&D and SG&A expenses? - R&D expenses are expected to be maintained at around CNY 2-2.5 billion per quarter, while SG&A expenses will grow but remain controlled within 10% of sales revenue [97][98] Question: What is the expected gross margin for the service business in 2026? - The service revenue gross margin is expected to continue improving as the user base grows and operational efficiency increases [90][92]

Financial Data and Key Metrics Changes - In Q4 2025, revenue reached $306 million, representing a 64% year-over-year growth [23] - Gross margin remained strong at 61%, with CARVYKTI net product sales gross margin at 57% [23] - Operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, reflecting operational leverage [23][24] - Adjusted net income was reported at $2.5 million, a significant improvement from a $59 million adjusted net loss a year ago [25] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year [7] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [16] - Outside the U.S., sales reached $135 million, representing over a 3x increase compared to the same period a year ago [16] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [16] - The majority of CARVYKTI utilization is in earlier line settings, with approximately 65% of patients from the second to fourth line [16] - BCMA-directed therapies remain under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [17] Company Strategy and Development Direction - The company aims to become a fully scaled CAR-T leader and achieve company-wide profitability in 2026 [7] - There is a strategic focus on expanding CARVYKTI's use in earlier lines, supported by evidence showing better outcomes with earlier intervention [17][22] - The partnership with Johnson & Johnson is aimed at scaling CARVYKTI to an anticipated potential of over $5 billion in peak annual sales [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth from the previous year [31] - The company is optimistic about the long-term growth potential of CARVYKTI, given the significant unmet needs in the multiple myeloma market [17][22] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][88] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [26] - The company plans to file one to two U.S. INDs by the end of the year, focusing on advancing its R&D pipeline [14] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 and business development focus - Management expects sequential growth throughout 2026, confident in delivering approximately 50% top-line growth [31] - Business development efforts will focus on complementary technologies and potential partnerships to accelerate global development [32] Question: Positioning of bispecifics in early lines relative to CARVYKTI - Management believes there is a significant unmet need in second and third lines, with a unique value proposition for CARVYKTI as a one-time infusion [35] Question: Hurdles for community setting expansion - Continued education and training for community physicians are crucial for expanding CARVYKTI's adoption in community hospitals [40] Question: Current CAR-T penetration and growth opportunities - Management sees significant growth opportunities across all segments, including academic centers and community hospitals, with a focus on early line use [48] Question: Impact of recent M&A in the space - The acquisition of a competitor validates the market's value, with management confident in CARVYKTI's unmatched efficacy and durability [60] Question: Pipeline strategy and long-term data confidence - Management is particularly excited about in vivo CAR-T approaches, leveraging their experience with lentiviral vectors while remaining open to exploring other technologies [82]

Financial Data and Key Metrics Changes - The company reported total revenue of $168.4 million for Q4 2025, an increase of 144% year-over-year [16] - U.S. net product revenue reached $43.7 million, up approximately 38% from $31.6 million in Q4 2024 [16] - Collaboration revenue surged to $124.7 million, a 232% increase compared to $37.6 million in Q4 2024, driven by a one-time payment of $90 million from Otsuka [16] - The company ended 2025 with $167.9 million in cash and reduced debt by $55 million [15] Business Line Data and Key Metrics Changes - The U.S. bempedoic acid franchise saw strong prescription growth, with Q4 year-over-year sales increasing by 38% and retail prescription equivalents rising by 34% [7] - The number of unique healthcare practitioners prescribing NEXLETOL and NEXLIZET increased by nearly 25% [7] Market Data and Key Metrics Changes - Daiichi Sankyo Europe reported a 51% increase in fourth quarter royalty revenue compared to Q4 2024, expanding access to 30 countries [9] - The Japanese partner, Otsuka, successfully launched NEXLETOL in Japan, exceeding early market expectations [9] Company Strategy and Development Direction - The company introduced its Vision 2040 strategy, aiming for long-term growth and the acquisition of Corstasis Therapeutics to enhance its portfolio [5] - The acquisition of Corstasis is expected to provide global rights to Enbumyst, a first-in-class intranasal diuretic, expanding the company's presence in the cardiometabolic market [11][12] - The company plans to leverage its commercial team's cardiovascular sales presence to scale adoption of Enbumyst and accelerate revenue contribution [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continuing momentum into 2026, driven by strong reimbursement and favorable positioning in U.S. dyslipidemia guidelines [8] - The American College of Cardiology's recognition of the link between inflammation and cardiovascular disease is expected to positively impact the company's products [8] - Management emphasized the importance of the upcoming U.S. guidelines and their potential to enhance awareness and prescribing of bempedoic acid [35][44] Other Important Information - The company anticipates completing clinical and regulatory requirements for its triple combination programs by 2027 [8] - The planned acquisition of Corstasis is expected to close in Q2 2026, further strengthening the company's market position [14] Q&A Session Summary Question: Capacity and next steps for Corstasis - Management confirmed they are prepared for the launch and have sufficient capacity for the product [23] Question: Updates on ACC guidelines - Management expects the guidelines to be released a week before the ACC conference and is preparing a comprehensive plan for the medical community [29][32] Question: Impact of EU guidelines on U.S. prescribing - Management noted that the sentiment from U.S. physicians is positive regarding the European guidelines, which could lead to increased awareness and prescribing [42][44] Question: Triple combination product label expectations - Management indicated that the label for the triple combination will not carry outcomes data but will still be well-received by physicians [49] Question: Collaboration revenue guidance for 2026 - Management highlighted that collaboration revenue will be influenced by ongoing partnerships and the ramp-up of manufacturing [51] Question: Risks of additional concessions in 2026 - Management stated they do not foresee the need for concessions, as they have strong coverage and outcomes data to support their products [56]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 reached $306 million, representing a 64% year-over-year growth [22] - Gross margin remained strong at 61%, with CARVYKTI net product sales gross margin at 57% [22] - Operating margin improved from -142% in Q2 2023 to -6% in Q4 2025, reflecting operational leverage [22][24] - Adjusted net income was reported at $2.5 million, a significant improvement from a $59 million adjusted net loss a year ago [24] Business Line Data and Key Metrics Changes - CARVYKTI net trade sales were approximately $555 million in Q4 2025, a 66% increase year-over-year [5][14] - U.S. net trade sales of CARVYKTI were $420 million, growing 38% year-over-year [14] - Outside the U.S., sales reached $135 million, representing over a threefold increase compared to the same period last year [14] Market Data and Key Metrics Changes - CARVYKTI is now offered in 14 global markets, with 294 treatment sites worldwide [14] - The majority of CARVYKTI patients (approximately 65%) are from the second to fourth line settings [14][76] - BCMA-directed therapies remain under-penetrated in earlier lines, with less than 5% of patients in the second through fourth line treated with a BCMA targeting agent in 2025 [15] Company Strategy and Development Direction - The company aims to achieve company-wide profitability in 2026, following CARVYKTI's profitability in 2025 [5][13] - Focus on expanding CARVYKTI's use in earlier treatment lines, supported by clinical evidence showing better outcomes [15][20] - Plans to file one to two U.S. INDs by the end of the year and to explore synergistic business development opportunities [12][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sequential growth throughout 2026, targeting approximately 50% top-line growth for CARVYKTI [30] - The company is optimistic about capturing a significant market share in the under-penetrated multiple myeloma market [15][45] - Management highlighted the importance of effective bridging therapy in improving patient outcomes and safety [19][90] Other Important Information - The company ended the year with $949 million in cash equivalents, providing flexibility for future investments [25] - Manufacturing capacity has been expanded to support annual production of 10,000 doses, with plans to increase to 20,000 doses [11][52] Q&A Session Summary Question: Expectations for CARVYKTI growth in 2026 and business development focus - Management expects sequential growth throughout 2026, confident in achieving approximately 50% top-line growth [30] - Business development efforts will focus on complementary technologies and potential partnerships to accelerate global development [31] Question: Positioning of bispecifics in early lines relative to CARVYKTI - Management noted a significant unmet need in second and third lines, with CARVYKTI's unique value proposition supporting its growth in these settings [34] Question: Community setting expansion hurdles - Continued education and training for community physicians are essential for expanding CARVYKTI's adoption in community hospitals [39][40] Question: Current CAR-T penetration targets - Management believes there is significant growth potential in both late and early lines, with plans to increase annual supply to meet demand [45][47] Question: Competitive dynamics following recent M&A in the space - The acquisition of a competitor validates the market's value, with management confident in CARVYKTI's unmatched efficacy and durability [59][61] Question: Pipeline strategy and in vivo programs - The company is particularly excited about in vivo CAR T approaches due to their convenience and potential for broader applications [82]

Financial Data and Key Metrics Changes - In Q4 2025, total revenues reached RMB 34.7 billion, up 75.9% year-over-year and 59% quarter-over-quarter [24] - Vehicle sales were RMB 31.6 billion, representing an increase of 80.9% year-over-year and 64.6% quarter-over-quarter [24] - Non-GAAP operating profit reached RMB 1.25 billion, while GAAP operating profit was RMB 810 million [6] - The company achieved its first-ever quarterly profit with a net profit of RMB 0.3 billion, compared to a net loss of RMB 7.1 billion in Q4 last year [27] Business Line Data and Key Metrics Changes - In Q4 2025, vehicle margin reached 18.1%, up from 13.1% in Q4 last year and 14.7% last quarter [25] - Other sales margin reached a record high of 11.9%, reflecting improvements in profitability from services and community-related businesses [25] - The company delivered a total of 326,028 vehicles for the full year 2025, marking a 46.9% year-over-year increase [4] Market Data and Key Metrics Changes - The penetration rate of battery electric vehicles (BEVs) in the premium segment increased from 14% in Q4 2024 to 27% in Q4 2025 [34] - The large three-row battery electric SUV model led the segment across all powertrain types for five consecutive months [36] Company Strategy and Development Direction - The company plans to launch three new models in 2026, further strengthening its product portfolio in the premium large vehicle segment [23] - The company is committed to investing in 12 full-stack technology domains for smart EVs to ensure leadership in products and technology [23] - The Power Swap network is seen as a unique competitive advantage, with over 3,800 stations installed and plans to expand by 1,000 new stations annually [18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in the auto industry but remains confident in achieving a year-over-year volume growth target of 40%-50% for 2026 [40] - The company expects to maintain vehicle gross margin at a similar level as in Q4 2025 despite rising raw material costs [49] - Management highlighted the importance of the Power Swap system as a systematic solution to address mismatched life cycles of vehicles and batteries [81] Other Important Information - The company achieved positive free cash flow for two consecutive quarters and positive operating cash flow for the full year of 2025 [7] - The smart driving chip subsidiary, GeniTech, raised CNY 2.257 billion in its first round of equity financing, enhancing its R&D capabilities [20][21] Q&A Session Summary Question: What is the plan for product and volume sales growth target in the second half of the year? - Management confirmed that despite industry challenges, they maintain a target of 40%-50% annual volume growth, supported by new model launches [32][40] Question: What feedback has been received regarding user experience with autonomous driving? - The usage of smart driving functionality increased by over 80% month-over-month after the rollout of the new version, indicating positive user feedback [42] Question: Can the company pass on raw material cost inflation to customers? - Management indicated that while there are pressures from rising material costs, they believe larger vehicle models will help mitigate these impacts [56][57] Question: What is the outlook for SG&A expenses in 2026? - SG&A expenses are expected to grow in absolute terms but will be controlled to remain within 10% of sales revenue [97] Question: What is the expected gross margin for the service business in 2026? - The company anticipates continued improvement in service gross margin, supported by the growth of the user base and operational efficiency [92]

Financial Data and Key Metrics Changes - Total revenues for 2025 were EUR 2.9 billion, a slight increase from the prior year despite a decrease in COVID-19 vaccine revenues [26] - The company ended 2025 with EUR 17.2 billion in cash equivalents and securities, positioning itself strongly for future investments [27] - Adjusted non-IFRS net loss for 2025 was EUR 117 million, reflecting the impact of various expenses [28] Business Line Data and Key Metrics Changes - The company maintained over 50% market share in the COVID vaccine market, distributing its vaccine in over 180 countries [5] - Revenue from the BMS collaboration contributed EUR 613 million, offsetting declines in COVID-19 vaccine revenues [26] - R&D expenses were approximately EUR 2.1 billion, slightly decreasing from the prior year due to cost savings and collaboration benefits [26] Market Data and Key Metrics Changes - The company anticipates lower COVID-19 vaccine revenues in 2026, particularly in the U.S. and Europe, as the market normalizes [30] - The U.S. market is expected to be competitive, leading to lower revenues, while Germany's direct sales will significantly impact overall top line [30][96] Company Strategy and Development Direction - The company aims to accelerate late-stage development of oncology assets and focus on combination-based approaches [6] - A new independent company will be established to pursue next-generation mRNA innovations, allowing BioNTech to sharpen its strategic focus on its late-stage pipeline [9][10] - The company plans to transition from a platform-centric to a tumor-centric clinical development program, targeting high-incidence cancers [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and disciplined resource allocation, focusing on late-stage programs [6][27] - The company expects a sustained cadence of late-stage readouts from 2026 to 2030, with multiple pivotal trials planned [8] - Management emphasized the importance of maintaining a strong balance sheet while advancing key programs [33] Other Important Information - The company is transitioning leadership, with Ugur Sahin and Özlem Türeci remaining through the transition period [44] - The company is preparing for potential launches in oncology, including endometrial cancer, while building commercial capabilities [44] Q&A Session Summary Question: How will the mRNA therapeutics be split between BioNTech and the new company? - Management confirmed that all current mRNA capabilities will remain with BioNTech, while the new company will focus on next-generation innovations [36][39] Question: What is the profile for the new CEO? - The supervisory board is looking for leaders with strong experience in late-stage development and commercial execution [42][44] Question: Why is the leadership transition happening now? - The transition is planned for the end of 2026, aligning with key milestones and data readouts [46][47] Question: Will BioNTech contribute capital to the new company? - BioNTech will not contribute cash but will provide certain rights and mRNA technologies [51][53] Question: What are the expectations for COVID-19 vaccine revenues in 2026? - Lower revenues are anticipated due to market normalization, particularly in the U.S. and Europe [30][96]

Apyx Medical (NasdaqGS:APYX) Q4 2025 Earnings call March 10, 2026 08:00 AM ET Speaker6Good morning, ladies and gentlemen, and welcome to the Apyx Medical Fourth Quarter and Full Year 2025 Earnings Conference Call. At this time, all lines are in a listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call require immediate assistance, please press star zero for the operator. I would now like to turn the conference call over to Jeremy Feffer, L ...