Core Viewpoint - The leadership transition at argenx SE is aimed at preparing the company for its next phase of growth, with Karen Massey stepping up as CEO and Tim Van Hauwermeiren becoming Chairman of the Board [1][2] Group 1: Leadership Changes - Karen Massey will transition from Chief Operating Officer to Chief Executive Officer and Executive Director [1] - Tim Van Hauwermeiren will move from Chief Executive Officer to Non-Executive Director and Chairman of the Board, succeeding Peter Verhaeghe, who is retiring [1][2] - The leadership changes are subject to shareholder approval at the Annual General Meeting scheduled for May 6, 2026 [1] Group 2: Strategic Vision - The leadership evolution is seen as a natural step towards a long-term future that is patient-focused and sustainable [2] - Tim Van Hauwermeiren expressed confidence in Karen Massey’s ability to lead the company forward, highlighting her impact since joining argenx [2] - Karen Massey emphasized her commitment to executing Vision 2030 and building a future-proof biotech company [2] Group 3: Company Overview - argenx is a global immunology company focused on improving the lives of individuals with severe autoimmune diseases [3] - The company collaborates with leading academic researchers through its Immunology Innovation Program to develop novel antibody-based medicines [3] - argenx is known for commercializing the first approved neonatal Fc receptor blocker and is exploring its potential in various serious autoimmune diseases [3]

Core Insights - Argenx SE has discontinued its Phase 3 UplighTED studies for efgartigimod SC in adults with moderate to severe thyroid eye disease due to futility, as advised by an Independent Data Monitoring Committee [1][2] - The company plans to conduct a comprehensive analysis of the data post-study closure to inform future research in thyroid eye disease [2] - Despite this setback, Argenx remains committed to advancing its portfolio of novel antibody-based medicines and exploring therapies for serious autoimmune conditions [3] Financial Overview - Argenx's stock has experienced fluctuations, with a recent price target set at $1,248 by Stifel Nicolaus, indicating a potential increase of approximately 40.26% from the current price of $849.52 [4] - The stock has seen a decrease of about 3.24% or $28.43 recently, with a trading range between $827.52 and $853.96 during the day [4] - Over the past year, the stock reached a high of $934.62 and a low of $510.06, with a market capitalization of approximately $51.96 billion [5]

Core Viewpoint - argenx SE has announced the discontinuation of the Phase 3 UplighTED studies evaluating efgartigimod for moderate to severe thyroid eye disease (TED) based on an Independent Data Monitoring Committee's recommendation due to futility [1][2] Group 1: Study Discontinuation - The Phase 3 UplighTED studies were halted after an interim analysis indicated that the trials did not meet the desired outcomes [2][3] - The decision reflects a responsible evaluation of the study's future likelihood of success, emphasizing the company's commitment to disciplined resource management [3] Group 2: Study Design and Objectives - The UplighTED studies were randomized, double-masked, placebo-controlled trials designed to assess the efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of efgartigimod in adults with active, moderate-to-severe TED [4] - The primary endpoint was the percentage of participants who were proptosis responders at week 24, with key secondary endpoints including changes in proptosis measurement and quality of life scores [4] Group 3: Background on Thyroid Eye Disease - Thyroid Eye Disease (TED) is an autoimmune condition associated with Graves' disease and characterized by symptoms such as proptosis, diplopia, and potential vision loss, significantly impacting patient quality of life [5] Group 4: About Efgartigimod - Efgartigimod is a human IgG1 antibody fragment that reduces circulating IgG autoantibodies and is the first approved FcRn blocker for various autoimmune diseases [6]

Core Viewpoint - Zai Lab Limited (NASDAQ:ZLAB) is identified as a strong investment opportunity with significant upside potential, driven by robust commercial performance and a promising pipeline of products [2][3]. Financial Performance - For Q3 2025, Zai Lab reported a 13.0% year-over-year increase in product revenue, reaching $115.4 million, primarily fueled by sales of NUZYRA and XACDURO, despite a decline in ZEJULA sales [3]. - VYVGART's sales amounted to $27.7 million, benefiting from extended therapy duration and increased market share, even after a voluntary price adjustment of $2.4 million for Hytrulo [3]. - The adjusted loss from operations improved to $28.0 million, while the net loss narrowed to $36.0 million, equating to $0.03 per share [3]. Pipeline Developments - Zai Lab's management highlighted advancements in pivotal studies for Zocilurtatug Pelitecan (zoci) in treating second-line extensive-stage small cell lung cancer and progress in povetacicept trials for IgA nephropathy [4]. - There is optimism regarding VYVGART's adoption in generalized myasthenia gravis, alongside the preparation of KarXT for schizophrenia, which is progressing with favorable new national treatment guidelines [4]. Market Position and Analyst Ratings - Zai Lab is currently rated as a consensus Buy by over 90% of analysts, with a 1-year average price target of $49.49, indicating a potential upside of 147.82% [2]. - UBS reiterated a "Buy" rating for Zai Lab's Hong Kong-listed shares with a price target of HK$33.50 [2]. Revenue Guidance - The company reaffirmed its full-year 2025 revenue guidance of at least $460 million, attributing this to disciplined execution and an expanding commercial presence in China [4].

Third Quarter 2025 Financial Results and Recent Corporate Updates November 2025 Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth ...

Financial Data and Key Metrics Changes - In Q3 2025, the company reported total product net sales of $1.13 billion, marking a historic milestone as it surpassed $1 billion in VYVGART sales for the first time [16] - The quarter saw a growth of 19% or $178 million in product net sales compared to the previous quarter, and a year-over-year growth of 96% or $554 million [16] - Total operating expenses for Q3 were $805 million, representing a 5% increase, with R&D expenses up by 9% and SG&A expenses by 4% [17] - The cash balance at the end of the quarter was $4.3 billion, reflecting a nearly $1 billion increase since the beginning of the year [18] Business Line Data and Key Metrics Changes - VYVGART is delivering significant impact in two indications: generalized Myasthenia Gravis (gMG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [5] - The pre-filled syringe (PFS) has been a major growth driver, with over half of patients starting on PFS being new to VYVGART [21] - The company has three first-in-class molecules in phase III development, including efgartigimod, empasiprubart, and ARGX-119, each representing significant pipeline opportunities [9] Market Data and Key Metrics Changes - Product net sales in the U.S. specifically grew by 20% quarter-over-quarter, reflecting the impact of the PFS launch [17] - The company is seeing strong growth in both gMG and CIDP markets, with VYVGART being the number one prescribed and fastest-growing biologic in gMG [22] - The CIDP market is projected to grow towards a 12,000 addressable patient market not well controlled on current therapy [24] Company Strategy and Development Direction - The company is committed to a long-term growth strategy, Vision 2030, focusing on expanding its pipeline and market leadership [5] - Investments are being made in operations, including a new manufacturing facility in North Carolina to strengthen the global supply chain [15] - The company aims to expand its label to include seronegative gMG patients and ocular gMG, addressing significant unmet needs [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, emphasizing the importance of continuous innovation and patient outcomes [26] - The company is preparing for five registration readouts next year, reflecting a disciplined approach to indication selection and strong commercial potential [12] - Management highlighted the positive feedback from prescribers regarding the CIDP launch and the potential for efgartigimod to become a first-line therapy [34] Other Important Information - The company has made strategic decisions to halt development in certain areas, such as empasiprubart in dermatomyositis, while focusing on high-potential indications [10] - The company is actively engaging with the neurology community to reinforce its commitment to innovation in rare neuromuscular diseases [6] Q&A Session Summary Question: Clarification on the growth drivers for VYVGART - Management confirmed that while the PFS is driving growth, other formulations are still contributing positively to CIDP and gMG [30] Question: Thoughts on Sjögren's disease and competitive landscape - Management expressed optimism about the potential of efgartigimod in Sjögren's disease, highlighting its precision approach compared to broader B cell suppression [31] Question: Feedback on CIDP launch and physician excitement - Positive feedback from prescribers was noted, with a significant portion of patients switching from IVIg, indicating strong market penetration [34] Question: Revenue potential for upcoming indications - Each phase III indication is expected to represent an opportunity similar to that of gMG, with further details to be provided closer to market readiness [39] Question: Enrollment issues in empasiprubart trials - Enrollment challenges were attributed to a highly competitive environment, leading to a decision to reprioritize development efforts [43] Question: Update on pipeline assets - Both ARGX-119 and ARGX-121 are progressing through phase I studies, with expectations for data disclosures soon [55] Question: External innovation opportunities - The company is exploring collaborations with biotech firms and academic labs to enhance its pipeline, leveraging its strong cash position [86]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported total product net sales of $1.13 billion, marking a historic milestone as it surpassed $1 billion in VYVGART sales for the first time [16] - The quarter saw a growth of 19% or $178 million in product net sales compared to the previous quarter, and a year-over-year growth of 96% or $554 million [16] - Operating profit for the quarter was $346 million, with a year-to-date effective tax rate of 13% resulting in a profit after tax of $344 million for the quarter [18] Business Line Data and Key Metrics Changes - VYVGART's product net sales in the U.S. reached $964 million, reflecting a 20% quarter-over-quarter growth driven by the pre-filled syringe (PFS) launch [16][17] - The company achieved a gross margin of 11% year-to-date, with total operating expenses of $805 million, representing a 5% increase [17][18] Market Data and Key Metrics Changes - The pre-filled syringe (PFS) is now approved in most major markets, contributing significantly to the growth in both gMG and CIDP indications [20][21] - The company is seeing consistent growth in patient starts and prescriber engagement in CIDP, with a target of reaching a 12,000 addressable market of patients not well controlled on current therapy [24] Company Strategy and Development Direction - The company is focused on its long-term growth strategy, Vision 2030, which includes advancing its pipeline with three Phase 3 assets and four new molecules in Phase 1 development by year-end [5][6] - Investments are being made to scale operations in the U.S. and enhance manufacturing capabilities, ensuring the ability to meet growing demand for VYVGART and future therapies [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for VYVGART to deliver differentiated efficacy and safety across multiple indications, with five registration readouts expected next year [12][14] - The management highlighted the importance of addressing unmet needs in various patient populations, particularly in seronegative gMG and ocular gMG [23][60] Other Important Information - The company is actively engaging with the neurology community to share new data and reinforce its commitment to innovation in rare neuromuscular diseases [6][7] - The company has made disciplined development decisions, including stopping the development of empasiprubart in dermatomyositis due to operational challenges [10] Q&A Session Summary Question: Clarification on the growth drivers for VYVGART - Management confirmed that while the pre-filled syringe is the major growth driver, other formulations are still contributing positively to the business [30] Question: Thoughts on the CIDP launch and physician feedback - Positive feedback from prescribers indicates a strong real-world experience for CIDP patients, with continued momentum expected in market penetration [34] Question: Revenue potential for upcoming indications - Each Phase 3 indication is expected to represent an opportunity similar to that of MG, with further details to be provided closer to market readiness [39] Question: Enrollment issues in empasiprubart trials - Enrollment challenges were attributed to a highly competitive environment, leading to a decision to reprioritize development efforts [42] Question: Update on external innovation and collaborations - The company is exploring collaborations with young biotech companies and academic labs to enhance its pipeline and innovation efforts [84]

Financial Data and Key Metrics Changes - In Q3 2025, the company reported total product net sales of $1.13 billion, marking a historic milestone as it surpassed $1 billion in VYVGART sales for the first time in a single quarter [17] - The quarter saw a growth of 19% or $178 million in product net sales compared to the previous quarter, and a year-over-year growth of 96% or $554 million [17] - Total operating expenses for Q3 were $805 million, representing a 5% increase, with R&D expenses up by 9% and SG&A expenses by 4% [18] - The operating profit for the quarter was $346 million, with a year-to-date effective tax rate of 13% [19] Business Line Data and Key Metrics Changes - VYVGART's product net sales in the U.S. were $964 million, with a quarter-over-quarter growth of 20% driven by the pre-filled syringe (PFS) launch [17][18] - The company has three first-in-class molecules in Phase 3 development, including efgartigimod, empasiprubart, and ARGX-119, which represent significant pipeline opportunities [10] Market Data and Key Metrics Changes - The U.S. market saw a significant contribution to sales, with $964 million in product net sales, while Japan contributed $60 million and other markets contributed $94 million [17] - The company is actively expanding its operations in the U.S. with a new manufacturing facility in North Carolina to support growing demand [15] Company Strategy and Development Direction - The company is focused on its long-term growth strategy, Vision 2030, which includes advancing its pipeline and expanding its market presence in neurology and immunology [6][15] - The strategy includes investments in new molecules and expanding the label for VYVGART to address unmet needs in seronegative and ocular gMG [12][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory, highlighting the strong performance of VYVGART and the positive feedback from prescribers regarding its efficacy and safety [26][37] - The company anticipates five registration readouts next year, reflecting a disciplined approach to indication selection and strong commercial potential [13] Other Important Information - The company has made strategic decisions to halt development in certain areas, such as empasiprubart in dermatomyositis, while continuing to focus on high-potential indications [11] - The cash balance at the end of the quarter was $4.3 billion, indicating strong financial health and capacity for future investments [19] Q&A Session Summary Question: Clarification on the growth drivers for VYVGART - Management confirmed that while the pre-filled syringe is a major growth driver, other formulations are still contributing positively to sales [32][33] Question: Insights on CIDP launch and physician feedback - Positive feedback from prescribers indicates a strong interest in moving efgartigimod to frontline therapy, with ongoing efforts to expand market penetration [36][37] Question: Revenue potential for upcoming indications - Each Phase 3 indication is expected to represent an opportunity similar to that of MG, with further details to be provided closer to market readiness [40] Question: Update on empasiprubart and enrollment issues - Enrollment challenges in dermatomyositis were attributed to competitive environments, while CIDP trials are still in early stages [45][48] Question: Thoughts on competitive landscape and operating expenses - Management remains confident in their competitive positioning despite new trials and anticipates continued growth in operating expenses aligned with strategic investments [84][91]

Core Insights - Argenx SE (ARGX) is a global leader in immunology, focusing on innovative therapies for severe autoimmune diseases, competing with firms like Alexion Pharmaceuticals and Horizon Therapeutics [1] Financial Performance - On October 30, 2025, ARGX reported earnings per share of $4.40, surpassing the estimated $4.37 [2][6] - The company achieved revenue of approximately $1.12 billion, exceeding the estimated $1.07 billion [2][6] - Global product net sales for the third quarter of 2025 reached $1.13 billion [2] Pipeline and Development - Argenx is set to submit a supplemental Biologics License Application (sBLA) for seronegative generalized myasthenia gravis (gMG) by the end of the year [3] - The company plans to report results from the ADAPT-OCULUS study in the first half of 2026, aiming for the broadest myasthenia gravis label of any biologic [3] - Five registrational study readouts are anticipated in 2026 from its leading immunology pipeline [4] Growth Strategy - The expansion of VYVGART in two blockbuster indications and the advancement of five registrational programs demonstrate the company's growth strategy [4] - The management will host a conference call to discuss updates, reflecting proactive communication with stakeholders [4] Financial Ratios - ARGX has a price-to-earnings (P/E) ratio of approximately 36.57, indicating investor confidence [5] - The price-to-sales ratio is about 13.74, and the enterprise value to sales ratio is around 13.19, reflecting strong market valuation [5] - The company maintains a strong financial position with a debt-to-equity ratio of 0.007 and a current ratio of approximately 5.60 [5]

Financial Performance - Product net sales for Q3 2025 reached $1.127 billion, a 96% increase compared to $573 million in Q3 2024[19, 22] - Q3 2025 sales grew by 19% compared to Q2 2025[23] - U.S sales in Q3 2025 were $964 million, a 96% increase from $492 million in Q3 2024, and a 20% increase from $802 million in Q2 2025[22, 24] - Japan sales in Q3 2025 were $60 million, a 148% increase from $24 million in Q3 2024, and a 19% increase from $52 million in Q2 2025[22, 24] - Cash, cash equivalents, and current financial assets totaled $4.3 billion as of September 30, 2025, compared to $3.4 billion as of December 31, 2024[41] Strategic Priorities and Pipeline - The company is focused on reaching more patients with VYVGART, fueling pipeline growth with 10 Phase 3 and 10 Phase 2 programs, and expanding the next wave of innovation with 4 new molecules in Phase 1[4, 9] - The company is advancing a late-stage pipeline with transformative potential, including Efgartigimod in 15+ indications, Empasiprubart in 4+ indications, and ARGX-119 in 3+ indications[4, 13] - Five registrational readouts are expected in 2026 across Ocular MG, MMN, TED, IMM, and ITP[4, 15] VYVGART Growth and Market Expansion - The company aims to maximize the VYVGART opportunity and globally expand with commercial growth drivers including pre-filled syringe, CIDP, gMG, and ITP[4] - The company is growing VYVGART leadership in MG, including a path to 60,000 addressable patients, with a seronegative sBLA submission planned by the end of 2025 and pre-filled syringe launched in all major markets[4, 31, 32] - First-time VYVGART prescribers have increased since the pre-filled syringe (PFS) launch, with 97% year-over-year revenue growth[30]