Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Date**: February 12, 2026 - **Key Executives**: Marino Garcia (CEO), Ryan Savitz (CFO) Key Industry and Company Insights 1. Transformational Year - 2025 was a pivotal year for Dianthus, marked by the first patient data in myasthenia gravis (MG), which exceeded expectations [2][60] 2. Product Pipeline - **DNTH212**: In-licensed from Leads Biolabs, a bifunctional fusion protein targeting BDCA2 to reduce type I interferon and BAFF/APRIL, showing potential as a best-in-class product [2][3] - **Clasiprubart**: An active C1s inhibitor with promising phase 2 data for MG, with two major catalysts expected in 2026 [3][4] 3. Upcoming Catalysts - **CIDP Phase 3 Study**: Interim responder analysis for the first 40 patients is anticipated in Q2 2026, accelerated from H2 2026 due to strong recruitment [4][16] - **MMN Phase 2 Results**: Expected in the second half of 2026 [4] 4. Competitive Landscape - **Riliprubart**: A competitor from Sanofi, currently in phase 3 studies for CIDP. Dianthus aims to demonstrate at least equal efficacy with a more convenient dosing regimen [10][12] - **Empaciperbart**: Another competitor in MMN, with Dianthus expecting similar efficacy but with advantages in administration and safety [31][39] 5. Efficacy Expectations - For CIDP, Dianthus aims for a responder rate of 40%-50% in the interim analysis, comparable to riliprubart's phase 2 data [12][17] - The company is focusing on a dosing regimen that is more efficient, potentially reducing the number of injections required [12][15] 6. Market Potential - The U.S. market for MG is estimated at $5 billion, with potential growth to $20-$25 billion as biologics penetrate further [60] - Dianthus anticipates capturing 5%-10% of the MG market, translating to $2-$4 billion in sales [60][62] 7. Financial Health - Dianthus ended the year with $514 million in cash, sufficient to fund operations through 2028 and support upcoming milestones [64] 8. Safety and Regulatory Considerations - Concerns about drug-induced lupus (DIL) were addressed, emphasizing the reliability of data from clinical trials versus anecdotal reports [54][56] - The company is confident in the safety profile of its products, with no reported cases of DIL in clinical programs [56] 9. Commercial Strategy - Dianthus plans to leverage the convenience of its auto-injector and the absence of a box warning to differentiate its products in the market [41][44] 10. Recruitment and Trial Design - The company is focusing on efficient recruitment strategies and trial designs that allow for quicker results and better patient outcomes [16][20] Conclusion Dianthus Therapeutics is positioned for significant growth with a strong pipeline and strategic focus on efficacy, safety, and market penetration. The upcoming data releases and competitive advantages in product administration are critical to its success in the evolving biotech landscape.

Summary of Roivant Sciences FY Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Event**: FY Conference Call on January 12, 2026 - **Speaker**: CEO Matt Gline Key Points Company Positioning and Strategy - Roivant is entering a new era with a significantly simplified business model focused on a smaller subset of products, emphasizing clinical execution and pipeline potential [3][4] - The company aims to shape its own destiny with a high priority on delivering results from its clinical programs [3] Financial Strength - Roivant reported a cash balance of **$4.4 billion**, positioning it well for future growth without the need for additional fundraising [5][9] - The company has a strong track record with **12 positive phase III studies** and **8 FDA approvals**, indicating robust past performance and a solid pipeline [9] Clinical Development Highlights - **Brepocitinib**: Positive data for dermatomyositis (DM) with plans to file an NDA by early 2026, marking it as the first novel oral therapeutic for DM [4][5] - **IMVT-1402**: Progressing in pivotal studies for Graves' disease, with expectations for significant disease-modifying benefits [4] - Upcoming data releases include registrational programs for brepocitinib in non-infectious uveitis (NIU) and phase IIb data for mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) [6][7] Market Opportunities - The company sees a potential **$15 billion-plus portfolio** across various indications, with significant opportunities in DM, NIU, and Graves' disease [19][70] - Brepocitinib is expected to capture market share from existing therapies, particularly for patients currently on high-dose steroids or IVIG [41][42] Competitive Landscape - Roivant is positioned to be among the first non-prostacyclin novel mechanisms in PH-ILD, competing against established treatments [6][57] - The company is optimistic about the potential for brepocitinib to outperform existing treatments in DM, especially given the enthusiasm from physicians [41][46] Legal and Regulatory Environment - Ongoing litigation with Moderna regarding lipid nanoparticle technology, with a jury trial scheduled for March 2026 [5][60] - The outcome of this case may have implications for other ongoing litigations and the company's overall strategy [62] Future Outlook - Roivant anticipates a transformative next 36 months with multiple commercial launches and pivotal study readouts [11][19] - The company is focused on executing its clinical programs and expanding its pipeline to drive future value [19][29] Unique Business Model - Roivant's model combines talent from various backgrounds, emphasizing creative clinical development and a focus on delivering value to patients [10][30] - The company aims to differentiate itself by maintaining high standards for partnerships and transactions, driven by a focus on profitability [36] Conclusion - Roivant Sciences is positioned for significant growth with a strong financial foundation, a focused pipeline, and a commitment to innovative clinical development. The upcoming years are expected to be pivotal for the company as it seeks to capitalize on its opportunities in the biotech space [19][70]

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 Insights - Zai Lab is a global biopharmaceutical company with a focus on oncology, immunology, neuroscience, and infectious diseases, currently having seven products approved in China [1][2] - The company expects significant revenue growth, projecting total revenue to reach US$2.0 billion by 2028, driven by the sales ramp-up of existing products and the approval of new products [1][2] Group 1: Product Portfolio and Revenue Growth - Zai Lab's first commercial product, ZEJULA, was approved in China in 2019, and the company currently has seven commercialized products [1] - In 2024, the company's total revenue is projected to be US$399 million, representing a 50% year-over-year increase, primarily due to the sales ramp-up of new products like VYVGART and NUZYRA [1] - Efgartigimod, an FcRn antagonist, is expected to become a blockbuster product, with domestic sales reaching US$94 million in 2024, an increase of 835% year-over-year [2] Group 2: Pipeline Development and Future Prospects - The company is actively expanding its product pipeline, focusing on areas such as antibody-drug conjugates (ADCs) and bispecific antibodies (biAbs), with several products granted Fast Track Designation by the FDA [2] - ZL-1310 has shown promising results in clinical trials, with plans to initiate a global pivotal trial in the second half of 2025 [2] - The company anticipates filing at least one new IND application annually, indicating a robust pipeline development strategy [2] Group 3: Financial Projections - The company is projected to achieve non-GAAP operating profit in the fourth quarter of 2025, with revenue estimates of US$553 million in 2025, US$802 million in 2026, and US$1.203 billion in 2027 [3] - A net loss of US$134 million is expected in 2025, transitioning to a net profit of US$15 million in 2026 and US$173 million in 2027 [3] - The target price derived from DCF valuation is HK$35.2, indicating a 39% upside potential [3]

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 - The company is hosting a series of R&D Spotlight events, with the first focusing on ARGX-119, a MuSK agonist [1][2] - The initiative to revive these events was driven by requests from analysts and investors, reflecting the company's commitment to being science-based and data-driven [2] Company Developments - The timing for spotlighting ARGX-119 is deemed appropriate, as the company has made a go decision for this molecule into CMS [3]

Financial Data and Key Metrics Changes - The company is experiencing significant growth in the FcRn space, with a focus on expanding its pipeline and product offerings [5][6] - The launch of the prefilled syringe (PFS) in April has been a key growth driver, expanding both the patient and prescriber populations [17][19] - The company reported that over 50% of patients using Vivgart live a life without symptoms, highlighting the drug's efficacy and safety profile [21] Business Line Data and Key Metrics Changes - The company has successfully launched Vivgart in two indications: Myasthenia Gravis (MG) and Immune Thrombocytopenia (ITP), with ongoing expansion into additional indications [5][30] - The PFS has attracted 1,150 prescribers, with 150 being new to Vivgart, indicating a successful expansion into the community [18][20] - The total addressable market (TAM) for MG is projected to be 60,000 patients, with ongoing efforts to expand the label to include seronegative and ocular myasthenia [30][40] Market Data and Key Metrics Changes - The FcRn class currently holds around 10% of the market share for novel biologics in MG, with expectations for significant growth as awareness and adoption increase [27][28] - Japan is identified as a key market, showing impressive growth, particularly following the launch of CIDP [40][41] - The company is focused on disciplined pricing strategies to ensure value proposition while navigating the complexities of pricing and reimbursement in Europe and Canada [42] Company Strategy and Development Direction - The company aims to build a leadership position in the FcRn space by investing in next-generation molecules and expanding its product offerings [69][70] - The strategy includes a focus on patient education to drive demand and adoption of Vivgart, particularly among physicians who may be resistant to change [35][36] - The company is committed to expanding its pipeline beyond Vivgart, with multiple ongoing Phase III trials and a focus on innovative therapies for various indications [56][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the FcRn space, citing historical patterns of market expansion driven by innovation [24][25] - The company acknowledges the challenges of inertia among physicians but emphasizes the importance of patient advocacy in driving change [35][36] - Future data readouts from ongoing trials are expected to significantly enhance the company's growth trajectory and market presence [56][58] Other Important Information - The company is developing multiple presentations of Vivgart, including auto-injectors and hyper-concentrated formulations, to enhance patient experience [72][73] - The upcoming R&D event is expected to showcase advancements in the neuromuscular junction space, highlighting the company's commitment to innovation [82] Q&A Session Summary Question: How has the opportunity set evolved with Vivgart? - Management discussed the initial beachhead strategy and the expansion into multiple indications, emphasizing the growing pipeline and market potential [5][6] Question: How does the PFS fit into the overall strategy? - The PFS is seen as a key growth driver, providing independence to patients and expanding the prescriber base [17][19] Question: What are the competitive dynamics in the MG market? - Management noted that the MG space is becoming increasingly competitive, but innovation is expected to grow the overall market rather than just share among existing players [24][25] Question: What is the outlook for CIDP? - The company is optimistic about CIDP, expecting to build on initial experiences and expand usage beyond refractory patients [44][45] Question: What are the expectations for upcoming Phase III trials? - Management anticipates significant data readouts in the coming year, which could transform the therapeutic landscape for several indications [56][58]

Financial Data and Key Metrics Changes - Total operating income for Q2 2025 was $967 million, reflecting a 97% year-over-year growth, driven by significant unmet needs in MG and CIDP [14][20] - Product net sales were $949 million, with a quarter-over-quarter growth of 19% or $158 million compared to Q1 2025 [14][15] - Gross to net increased from 12% at the end of 2024 to approximately 20% by the end of Q2 2025, with net revenue per patient remaining consistent [17][76] Business Line Data and Key Metrics Changes - Plinab achieved a year-over-year growth of 97% across all approved indications, with 15,000 patients globally treated with Vipcart [6][7] - The introduction of the prefilled syringe (PFS) has driven new patient starts, with 50% of PFS patients being new to the product [25][49] - In the U.S., product net sales reached $802 million, with 18% quarter-over-quarter growth driven by strong performance in gMG and CIDP [15][16] Market Data and Key Metrics Changes - The contribution of non-U.S. markets now represents over 15% of global product net sales, with growth seen across all regions except for supply to China [15][16] - The U.S. market specifically saw strong growth across all three presentations of the product, indicating a robust demand [16][17] Company Strategy and Development Direction - The company is focused on long-term value creation through its Vision 2030 roadmap, aiming to expand its pipeline and market reach [6][8] - There is a commitment to innovation, with multiple registrational trials initiated in large market opportunities and a robust late-stage pipeline [6][8] - The company is expanding its immunology innovation platform, with four new molecules in Phase I studies targeting high unmet needs [12][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential within MG and CIDP, emphasizing the transformative impact of their treatments [31][32] - The company anticipates data from six Phase III and six Phase II trials over the next eighteen months, which could unlock new patient populations [32][33] - Management acknowledged the competitive landscape but believes their innovative approach positions them well for continued leadership [58][59] Other Important Information - The company has a strong cash position of $3.9 billion, up from $3.4 billion at the beginning of the year, driven by operating cash flow [20][88] - Total operating expenses for Q2 were $766 million, reflecting a disciplined investment in innovation [18][19] Q&A Session Summary Question: How have your cycles per year in MG evolved? - Management confirmed that they continue to guide for five cycles per year on average for an MG patient, with high utilization and adherence expected due to the convenience of PFS [38][39] Question: Can you provide a breakdown of the PFS switches between Hytrula and IV? - Management indicated that 50% of PFS patients are new to Vivgut, with the strategy focused on market expansion rather than just switching existing patients [44][45] Question: How much of the gMG patient adds were due to the prefilled syringe? - Management noted that the prefilled syringe significantly contributed to the strong quarter in MG, expanding the prescriber base and allowing for earlier lines of treatment [49][50] Question: What are your thoughts on increasing competition? - Management acknowledged the competitive dynamics but emphasized their commitment to raising treatment expectations and maintaining leadership in the market [58][59] Question: Can you comment on the CIDP launch and patient dynamics? - Management reported strong growth in CIDP, with 85-90% of patients coming from IVIG switches, indicating a long growth trajectory ahead [69][72] Question: What is the outlook for gross margin? - Management expects gross margin to remain around 11%, with decreasing costs offset by increasing royalties [67][68]