Summary of Roivant Sciences FY Conference Call Company Overview - **Company**: Roivant Sciences (NasdaqGS:ROIV) - **Date**: November 11, 2025 - **Key Personnel**: Richard Pulik, Chief Financial Officer Core Industry Insights - **Industry**: Biotechnology and Pharmaceuticals - **Focus Areas**: Development of innovative therapies for autoimmune diseases and rare conditions Key Points and Arguments Brepocitinib Developments - Brepocitinib is viewed as a significant commercial asset, with plans to file for approval next year and launch in 2027 [3][4] - Strong efficacy demonstrated in clinical trials for dermatomyositis and Graves' disease, with 10 statistically significant endpoints [3][4] - Anticipated readouts for additional indications in 2026, including difficult-to-treat rheumatoid arthritis (RA) and thyroid eye disease (TED) [4] Immunovant and Batoclimab - Batoclimab showed promising results in TED, with a doubling of response rates and significant IgG reduction [6][7] - Two phase three studies for TED are set to read out by mid-2026, with a focus on the competitive landscape [6][7] - The company is prioritizing 1402, a newer molecule, for Graves' disease, with a holistic approach to treatment [9][10] Clinical Data and Patient Population - The Graves' disease population is approximately 330,000 prevalent patients, with a significant unmet need for innovative treatments [11][12] - The company aims to provide disease-modifying treatments without reliance on antithyroid drugs (ATDs), which have not seen innovation in 20 years [12] Future Trials and Registrational Studies - Multiple ongoing trials for 1402, with potential registrational studies for myasthenia gravis (MG), Graves', and chronic inflammatory demyelinating polyneuropathy (CIDP) planned for 2027 [15] - Positive feedback from key opinion leaders (KOLs) regarding the potential of the NIU (non-infectious uveitis) study, which is also set to read out in 2027 [23] BREPO Launch and Market Strategy - The NDA filing for BREPO is expected in the first half of next year, targeting a patient population of approximately 40,000 [16][17] - The launch strategy will focus on niche centers with concentrated prescriber bases, indicating a tailored approach to market entry [19] Financial Position and Cash Deployment - Roivant has a cash balance of $4.4 billion, with plans to allocate funds across internal R&D, business development, and share buybacks [33][34] - The company has successfully reduced its share count by over 14%, indicating a commitment to shareholder value [34] Ongoing Litigation - The company is involved in ongoing litigation with Moderna and Pfizer regarding LNP technology, with a jury trial for the U.S. portion of the Moderna case scheduled for March [28][29] - The potential damages sought in the Moderna case are $5 billion, which could significantly impact the company's cash position [29] Additional Insights - The company is exploring additional indications for BREPO, including cutaneous sarcoidosis, with a small proof-of-concept study reading out next year [24] - The Mosley PH-ILD study is also anticipated to provide data next year, addressing a significant unmet need in pulmonary hypertension [26][27] This summary encapsulates the key insights and developments discussed during the Roivant Sciences FY Conference Call, highlighting the company's strategic direction, clinical advancements, and financial positioning.

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 - The company is experiencing significant growth in the FcRn space, with a focus on expanding its pipeline and product offerings [3][6][30] - The launch of the prefilled syringe (PFS) has expanded the prescriber population, with 150 new prescribers adopting Vivgart [14][36] Business Line Data and Key Metrics Changes - The company has successfully launched Vivgart in multiple indications, including Myasthenia Gravis (MG) and Immune Thrombocytopenia (ITP), and is now pursuing additional indications [3][10][28] - The PFS launch is expected to be a key growth driver, providing patients with independence and ease of use [15][36] Market Data and Key Metrics Changes - The FcRn class currently holds around 10% of the MG market, with expectations for significant growth as more biologics enter the market [25][26] - Japan is identified as a key market with impressive growth, particularly following the CIDP launch [37][38] Company Strategy and Development Direction - The company aims to position Vivgart as a first-line therapy in MG, drawing parallels to the MS market's evolution [11][23] - There is a commitment to developing next-generation molecules to maintain a leadership position in the FcRn space [66][67] Management's Comments on Operating Environment and Future Outlook - Management emphasizes the importance of patient education to drive demand for Vivgart and overcome physician inertia [34][32] - The company is optimistic about upcoming Phase III readouts, which could significantly enhance the product's market potential [56][79] Other Important Information - The company is actively working on expanding its pipeline beyond Vivgart, with multiple indications in development for its complement-targeting molecule, EMPA [71][74] - The company is focused on innovative delivery methods, including the use of Halozyme technology and Electrify technology for better patient experiences [69][70] Q&A Session Summary Question: How has the launch of Vivgart evolved? - The company has seen a shift in physician questions from "which patients to treat" to "how early to treat," indicating a growing acceptance of Vivgart as a treatment option [10][11] Question: What is the competitive landscape for MG? - The management believes that the MG market is expanding with more innovations, and they aim to be at the forefront by moving upstream in treatment lines [21][23] Question: How is the CIDP launch progressing? - The CIDP launch is in its early stages, focusing on refractory patients, with expectations for increased usage as physicians gain experience [40][41] Question: What are the expectations for the upcoming Phase III trials? - The company anticipates significant data readouts that could enhance the market potential for Vivgart, with a focus on solid clinical execution [56][79] Question: How does the company view the future of the FcRn franchise? - The company is committed to long-term growth through innovation and the development of next-generation molecules to expand its FcRn portfolio [66][67]

Financial Data and Key Metrics Changes - Product net sales for Q4 2024 were $737 million, with full-year sales reaching $2.2 billion, representing a 29% quarter-over-quarter growth and a 98% increase year-over-year [21][22] - Total operating income for Q4 was $761 million, and $2.3 billion for the full year [21] - Gross margin remained at 90%, with cost of sales at $73 million for Q4 and $227 million for the full year [23] - Operating profit for Q4 was $103 million, while the full year showed an operating loss of $22 million [25] - Cash balance at year-end was $3.4 billion, an increase of $200 million in 2024 [27] Business Line Data and Key Metrics Changes - VYVGART has significantly impacted the gMG treatment landscape, with strong early adoption in CIDP patients [10][31] - The company plans to advance 10 Phase III studies and 10 proof-of-concept studies across its pipeline in 2025 [12][18] - The launch of VYVGART Hytrulo in CIDP has seen approximately 1,000 patients on treatment, with 25% of prescribers being first-time users [42][44] Market Data and Key Metrics Changes - Product revenue breakdown: $649 million in the U.S., $27 million in Japan, $49 million in the rest of the world, and $12 million supplied to Zai Lab in China [22] - The company is expanding its market access, now reimbursed in 13 countries in Europe, including 4 out of the 5 major markets [45] Company Strategy and Development Direction - The company aims to maximize growth opportunities through innovation and has set a long-term growth vision influenced by its ability to innovate and stay ahead of competition [19][51] - The introduction of the prefilled syringe for self-administration is expected to drive growth in 2025 [10][36] - The company is committed to addressing unmet needs in the MG community by expanding its label into seronegative and ocular MG [36][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming PDUFA date for the prefilled syringe and the potential for continued growth in both MG and CIDP [58][129] - The company anticipates that 2025 will be a year of significant growth, expanding commercial reach and advancing its late-stage pipeline [53] Other Important Information - The company has nominated 4 new molecules for Phase I development, indicating a robust innovation pipeline [16][17] - The recognition of a deferred tax benefit of $802 million contributed to a profit of $774 million in Q4 [26] Q&A Session Summary Question: Can you talk about the pent-up demand for the prefilled syringe (PFS)? - Management noted that there is no significant pent-up demand but expects the PFS to open up new prescriber bases and maintain consistent growth [58][60] Question: How should we think about pricing for the PFS? - Pricing will be discussed closer to the launch, with a focus on providing broad access and sustainability [61][62] Question: What is the expected growth cadence in MG for 2025? - Continued momentum is expected, with Q1 seasonality considered, but overall dynamics remain strong [70][72] Question: How will the expiration of VBAs affect access? - VBAs will need to be renegotiated, and access is expected to remain stable [75] Question: Are physicians assessing improvement in CIDP patients? - Physicians are generally using simple assessments rather than formal scales like INCAT to evaluate patient responses [77] Question: What is the significance of self-administration for VYVGART? - Self-administration has been beneficial in markets outside the U.S., and similar expectations are held for the U.S. market upon approval [84][86] Question: What are the plans for ARGX-213 and its development timeline? - The company is focused on generating Phase I data for ARGX-213, which is expected to provide insights into its potential [102] Question: What are the expectations for proof-of-concept data in CMS? - The company is looking for strong signals that the treatment can effectively address the condition in CMS patients [140]