Group 1 - The company has experienced significant momentum following the release of data for brepocitinib in dermatomyositis and Graves' disease, indicating strong market potential for the asset [2] - Brepocitinib is expected to be filed next year and launched in 2027, with anticipation from the Key Opinion Leader (KOL) community and patients [2] - The clinical trial for brepocitinib demonstrated strong efficacy across 10 statistically significant endpoints, marking it as one of the cleanest trials in the CFO's 25-year healthcare career [2][3]

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.

Company Performance - Roivant Sciences Ltd. reported a quarterly loss of $0.28 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.27, but an improvement from a loss of $0.29 per share a year ago, indicating a -3.70% earnings surprise [1] - Montes Archimedes Acquisition posted revenues of $1.57 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 75.13%, and down from $4.47 million in the same quarter last year [2] - The current consensus EPS estimate for Montes Archimedes Acquisition is -$0.28 on revenues of $6.32 million for the coming quarter and -$1.18 on revenues of $21.66 million for the current fiscal year [7] Stock Performance - Montes Archimedes Acquisition shares have increased approximately 74.3% since the beginning of the year, significantly outperforming the S&P 500's gain of 14.4% [3] - The company has surpassed consensus EPS estimates two times over the last four quarters [2] Earnings Outlook - The earnings outlook for Montes Archimedes Acquisition is crucial for investors, as it includes current consensus earnings expectations and recent changes in these expectations [4] - The estimate revisions trend for Montes Archimedes Acquisition was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, where Montes Archimedes Acquisition operates, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable industry outlook [8] - Biofrontera Inc., another company in the same industry, is expected to report a quarterly loss of $0.60 per share, reflecting a year-over-year change of +30.2%, with revenues anticipated to be $7 million, down 22.3% from the previous year [9]

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations net of tax of $166 million for the quarter [24] - Cash and cash equivalents stood at $4.4 billion with no debt on the balance sheet, indicating a strong capital position [24][25] Business Line Data and Key Metrics Changes - The company highlighted significant progress in its late-stage pipeline, with 11 potentially registrational trials and indications with blockbuster potential [8][9] - Brepocitinib's data in dermatomyositis (DM) hit all 10 ranked endpoints, with an NDA filing planned for the first half of next year [5][10] - The Graves' disease trial for batoclimab demonstrated disease-modifying potential, with a significant portion of patients achieving remission [19][20] Market Data and Key Metrics Changes - The company noted a large patient population for Graves' disease, with approximately 880,000 diagnosed patients in the U.S., of which 330,000 are uncontrolled or intolerant to current therapies [19] - The unmet medical need in the DM landscape is significant, with 75% of patients currently on only steroids or immunosuppressive therapies [11][12] Company Strategy and Development Direction - The company is focused on expanding its pipeline and achieving profitability, with a strong emphasis on the upcoming investor day to discuss future strategies [8][25] - The management expressed excitement about the potential of their therapies in addressing significant unmet needs in various indications, including Graves' disease and DM [9][19] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the competitive landscape in Graves' disease and expressed confidence in their product's profile and the overall market opportunity [33][60] - The company is optimistic about the upcoming data readouts and the potential for their therapies to transform treatment paradigms in their target indications [16][78] Other Important Information - The company is involved in ongoing litigation related to LNP technology, with a jury trial in the Moderna case scheduled for March 2026 [24] - The company has a favorable marketing ruling in the Pfizer case, which is expected to progress in the near future [24] Q&A Session Summary Question: What should be watched next regarding Pfizer litigation? - Management indicated that the scheduling process for the Pfizer case is underway, and more information about the timeline, including a potential trial date, will be available soon [29] Question: Thoughts on Argenx entering the Graves' market? - Management acknowledged the competitive landscape but expressed confidence in their product's competitive profile and the overall patient population's needs [33][34] Question: What to expect from the investor day? - Management stated that the investor day will provide a comprehensive overview of the company's transformation and future opportunities, with potential new data to be shared [36][38] Question: Insights on remission data for Graves' disease? - Management emphasized that deeper IgG reductions are expected to drive remission rates and that they will learn more from ongoing studies [42][44] Question: Update on the competitive landscape in Graves' disease? - Management noted the increasing competition but expressed confidence in their FcRn mechanism's safety and efficacy, which positions them well in the market [60][62] Question: Status of the overseas study with 1402? - Management confirmed that several large registrational programs are ongoing, and they will share updates as they become available [99]

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations net of tax of $166 million for the quarter [24] - Cash and cash equivalents stood at $4.4 billion with no debt on the balance sheet, indicating a strong capital position [24][25] Business Line Data and Key Metrics Changes - The NDA filing for Brepocitinib in dermatomyositis (DM) is on track for the first half of next year, with significant data showing it hit all 10 ranked endpoints in the VALOR study [5][10] - The Graves' disease trial for Batoclimab demonstrated disease-modifying potential, with a significant portion of patients responding positively to therapy [19][20] Market Data and Key Metrics Changes - The company highlighted a large patient population for Graves' disease, with approximately 880,000 diagnosed patients in the U.S., of which 330,000 are uncontrolled or intolerant to current treatments [19] - The competitive landscape in Graves' disease is evolving, with multiple companies recognizing the importance of this market [33][60] Company Strategy and Development Direction - The company is focused on expanding its late-stage pipeline, with 11 potentially registrational trials and indications with blockbuster potential [8] - The upcoming investor day on December 11, 2025, is expected to provide a comprehensive overview of the company's strategy and future opportunities [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the transformative data from recent trials and the potential for significant market impact [4][9] - The company is optimistic about its competitive positioning in the Graves' disease market, emphasizing the importance of FcRn therapy [60] Other Important Information - The company is involved in ongoing litigation related to LNP technology, with a jury trial in the Moderna case scheduled for March 2026 [24] - The company has a favorable marketing ruling in the Pfizer case, which is expected to influence future developments [7][24] Q&A Session Summary Question: What should be watched next regarding Pfizer litigation? - Management indicated that the scheduling process for the Pfizer case is underway, and more information about the timeline, including a potential trial date, will be available soon [29] Question: Thoughts on Argenx entering the Graves' market? - Management acknowledged the competitive landscape but expressed confidence in their data and the potential for their treatment to stand out [33][34] Question: Expectations for the investor day? - Management stated that the investor day will focus on the transformation of the business and may include new data or strategic directions [36][38] Question: Impact of high-dose Batoclimab on remission rates in Graves' disease? - Management noted that deeper IgG reductions are expected to drive better outcomes, and they are cautious about discussing competitive implications [42][44] Question: Status of LNP litigation and international cases? - Management confirmed ongoing international litigations, with important hearings expected in 2026 [72][73] Question: Insights on Sjögren's disease market opportunity? - Management expressed excitement about the Sjögren's market and the potential for their treatment to be first in class [54][55] Question: Update on overseas studies with 1402? - Management indicated that ongoing studies are being used to inform indication selection and design decisions for larger studies [98]

Financial Data and Key Metrics Changes - The company reported a loss from continuing operations net of tax of $166 million for the quarter [25] - Cash and cash equivalents stood at $4.4 billion with no debt on the balance sheet, indicating a strong capital position [25][6] - The company has authorized $500 million for potential capital return [6] Business Line Data and Key Metrics Changes - The company highlighted significant progress in its late-stage pipeline, with 11 potentially registrational trials and indications with blockbuster potential [6] - Brepocitinib's data in dermatomyositis (DM) hit all 10 ranked endpoints, with an NDA filing planned for the first half of next year [4][15] - Batoclimab showed disease-modifying potential in Graves' disease, with a significant portion of patients achieving remission [20][21] Market Data and Key Metrics Changes - The company noted a large patient population for Graves' disease, with 880,000 diagnosed patients in the U.S., of which 330,000 are uncontrolled or intolerant to current therapies [19] - The unmet need in DM is underscored by the fact that 75% of patients are on either steroids or immunosuppressive therapies, struggling to achieve well-controlled status [10][11] Company Strategy and Development Direction - The company is focused on expanding its pipeline and achieving profitability through its current projects [6][25] - There is an emphasis on the potential for blockbuster launches across multiple indications, particularly in DM and Graves' disease [7][8] - The management expressed excitement about the upcoming investor day on December 11, 2025, to discuss future strategies and developments [26] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a transformative moment for the business, with significant data releases and upcoming NDA submissions [4][8] - The competitive landscape in Graves' disease is evolving, with other companies entering the space, but management remains confident in their position and strategy [29][42] - The company is optimistic about the upcoming data readouts and their implications for future growth [48][51] Other Important Information - The company is involved in ongoing litigation related to LNP technology, with trials scheduled for March 2026 [25][24] - The TED study is on track to conclude this year, with data expected to be reported in conjunction with other studies [23] Q&A Session Summary Question: What should be watched next regarding Pfizer litigation? - Management indicated that the scheduling process for the Pfizer case is underway, and more information about the timeline, including a potential trial date, will be available soon [28] Question: Thoughts on Argenx entering Graves' disease? - Management acknowledged the competitive landscape but expressed confidence in their data and the potential for their treatment to stand out [29] Question: What to expect from the investor day? - Management stated that the investor day will provide a comprehensive overview of the company's transformation and future opportunities, with potential new data to be shared [32] Question: Impact of high-dose batoclimab on remission rates in Graves' disease? - Management noted that deeper IgG reductions are expected to drive better outcomes, and they are analyzing the data to understand the impact [34][35] Question: Update on the competitive landscape in Graves' disease? - Management highlighted the excitement around increased competition but emphasized their strong data and understanding of the FcRn mechanism as a competitive advantage [42][43] Question: Plans for exploring BREPO in other myositis subtypes? - Management confirmed that they are considering various indications for BREPO and are excited about its potential across multiple areas [56][58]

Business Highlights - Roivant anticipates an NDA filing for brepocitinib in dermatomyositis (DM) in the first half of 2026 [14] - Positive Phase 3 VALOR study results for brepocitinib in DM showed statistically significant benefit on all 10 ranked endpoints [13] - Durable remission data in Graves' disease (GD) and positive Phase 3 batoclimab data in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) were unveiled [13] - A favorable Markman ruling was issued for Genevant in the Pfizer case [13] Pipeline Progress - Registrational trials have been initiated in GD, MG, CIDP, Difficult-to-Treat Rheumatoid Arthritis (D2T RA), and Sjögren's disease (SjD); a Proof of Concept (POC) trial has been initiated in Cutaneous Lupus Erythematosus (CLE) [13] - The company is focusing on clinical trial execution to drive significant potential value, with 11 registrational trials in indications with blockbuster potential [18] - In the VALOR study, brepocitinib 30 mg showed a mean Total Improvement Score (TIS) of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2) [24] - Approximately 50% of responders in the batoclimab Graves' disease study achieved Anti-Thyroid Drug (ATD)-free remission at Week 48 [61] Financial Status - Roivant reported a strong capital position with $4.4 billion in cash balance as of September 30, 2025 [13, 73] - Research and Development (R&D) expense was $165 million, with an adjusted R&D expense of $153 million (non-GAAP) for the three months ended September 30, 2025 [73] - General and Administrative (G&A) expense was $143 million, with an adjusted G&A expense of $72 million (non-GAAP) for the same period [73]

Financial Performance - Total revenue for the three months ended September 30, 2025, was $1,571,000, a decrease of 64.8% compared to $4,475,000 for the same period in 2024[27]. - The net loss attributable to Roivant Sciences Ltd. for the three months ended September 30, 2025, was $113,519,000, compared to a net loss of $230,184,000 for the same period in 2024, indicating a 50.7% improvement[27]. - The company reported a comprehensive loss of $163,721,000 for the three months ended September 30, 2025, compared to a comprehensive loss of $279,718,000 for the same period in 2024[31]. - For the six months ended September 30, 2025, the company reported a net loss of $439.95 million, compared to a net loss of $222.43 million for the same period in 2024, indicating a significant increase in losses[39]. - The net loss for the three months ended September 30, 2025, was $166.039 million, compared to a net loss of $279.924 million for the same period in 2024[135]. - Net loss attributable to Roivant Sciences Ltd. was $336.87 million for the six months ended September 30, 2025, compared to $134.89 million for the same period in 2024[166]. Expenses - Operating expenses for the three months ended September 30, 2025, totaled $307,804,000, down from $346,188,000 in the prior year, representing a decrease of 11.1%[27]. - Research and development expenses for the three months ended September 30, 2025, were $164,568,000, an increase of 15.0% from $143,073,000 in the same period of 2024[27]. - Total operating expenses increased by $28.1 million to $594.9 million for the six months ended September 30, 2025, compared to $566.8 million for the same period in 2024[166]. - Personnel-related expenses increased by $18.1 million for the six months ended September 30, 2025, primarily due to higher headcount for clinical studies[174]. - The company incurred share-based compensation of $163.99 million for the six months ended September 30, 2025, up from $121.86 million in the prior year[39]. Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $1,237,010,000, down from $2,715,411,000 as of March 31, 2025[25]. - Total assets decreased to $5,062,598,000 as of September 30, 2025, from $5,436,940,000 as of March 31, 2025, reflecting a decline of 6.9%[25]. - Cash, cash equivalents, and marketable securities totaled approximately $4.4 billion as of September 30, 2025, following the sale of its subsidiary Telavant for approximately $5.2 billion in December 2023[44]. - The company’s cash, cash equivalents, and restricted cash decreased from $2.73 billion at the beginning of the period to $1.25 billion at the end of the period[39]. - As of September 30, 2025, total shareholders' equity was $4,805,458, with a net loss of $166,039 for the quarter[35]. Shareholder Equity - Shareholders' equity attributable to Roivant Sciences Ltd. decreased to $4,362,331,000 as of September 30, 2025, from $4,687,605,000 as of March 31, 2025, a decline of 6.9%[25]. - The company repurchased 20,269,450 common shares, leading to a reduction of $208,293 in shareholders' equity[34]. - The company issued 6,560,959 common shares related to equity incentive plans, resulting in an increase of $16,912 in additional paid-in capital[34]. - The company has $400 million remaining under its at-the-market equity offering program as of September 30, 2025[92][93]. - A new share repurchase program was authorized for up to $500 million, with no purchases made as of September 30, 2025[94]. Investments - The fair value of the Company's investment in Arbutus was $176.4 million as of September 30, 2025, up from $135.6 million as of March 31, 2025, with unrealized gains of $56.3 million recognized during the three months ended September 30, 2025[80]. - The fair value of the Company's investment in Datavant was $235.9 million as of September 30, 2025, compared to $167.4 million as of March 31, 2025, with unrealized gains of $72.2 million recognized during the three months ended September 30, 2025[82]. - The Company recognized unrealized gains of $40.8 million on its investment in Arbutus for the six months ended September 30, 2025[80]. - For the six months ended September 30, 2025, unrealized gains from investments were $109.4 million, up from $63.6 million in 2024, reflecting an increase of $45.8 million[180]. Future Outlook - The company expects to incur additional losses in the future to fund operations and conduct product research and development[45]. - The company plans to in-license multiple potentially category-leading drugs per year in the upcoming year[143]. - The NDA filing for brepocitinib in dermatomyositis is planned for the first half of calendar year 2026[146]. - The company anticipates an increase in general and administrative expenses to support potential commercialization efforts[155]. - The company expects to enter into additional collaborative research and contract agreements, which may require upfront payments and long-term capital commitments[112]. Market Risks - The company is exposed to market risks related to interest rate and foreign currency sensitivities[208]. - The company maintains a portfolio of investments in high credit quality and short-term duration securities to preserve capital[209]. - Drug development involves significant upfront investments and a substantial degree of risk, impacting the company's ability to execute its business model[222].

Financial Performance - Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $4.4 billion as of September 30, 2025, supporting cash runway into profitability[3] - Loss from continuing operations, net of tax was $166.0 million for the three months ended September 30, 2025, compared to $236.8 million for the same period in 2024[13] - Non-GAAP loss from continuing operations, net of tax was $187.8 million for the three months ended September 30, 2025, compared to $218.7 million for the same period in 2024[14] - Basic and diluted loss from continuing operations was $0.17 per share for the three months ended September 30, 2025, compared to $0.25 per share for the same period in 2024[13] - Loss from continuing operations for Q2 2025 was $166,039,000, a decrease from $236,841,000 in Q2 2024, representing a 29.8% improvement[20] - The adjusted loss from continuing operations (Non-GAAP) was $187,779,000 in Q2 2025, compared to $218,665,000 in Q2 2024, a 14.1% improvement[20] Research and Development - Research and development (R&D) expenses increased by $21.5 million to $164.6 million for the three months ended September 30, 2025, compared to $143.1 million for the same period in 2024[6] - Research and development expenses increased to $164,568,000 in Q2 2025 from $143,073,000 in Q2 2024, reflecting a 15.0% rise[20] - Adjusted research and development expenses (Non-GAAP) were $152,896,000 in Q2 2025, up from $132,438,000 in Q2 2024, indicating a 15.5% increase[20] General and Administrative Expenses - General and administrative (G&A) expenses decreased by $59.8 million to $143.1 million for the three months ended September 30, 2025, compared to $202.9 million for the same period in 2024[9] - General and administrative expenses decreased to $143,125,000 in Q2 2025 from $202,881,000 in Q2 2024, a reduction of 29.4%[20] - Adjusted general and administrative expenses (Non-GAAP) were $72,054,000 in Q2 2025, down from $142,344,000 in Q2 2024, a decrease of 49.3%[20] Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $307.8 million, compared to $346.2 million for the same period in 2024[18] - The increase of $13.2 million in program-specific costs was primarily driven by an increase of $10.2 million related to the anti-FcRn franchise and $4.2 million related to brepocitinib[7] Pipeline and Future Plans - Brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints in Phase 3 VALOR study in dermatomyositis (DM), with NDA filing planned for the first half of calendar year 2026[3] - Immunovant's study in uncontrolled Graves' disease patients showed a potentially disease-modifying outcome with six-month off-treatment data, with results from the first of two batoclimab Phase 3 thyroid eye disease studies expected before the end of calendar year 2025[3] - The company plans to host an investor day on December 11, 2025, to provide further updates on its strategies and pipeline[24] - Roivant's pipeline includes several product candidates targeting various autoimmune indications and pulmonary hypertension, indicating ongoing market expansion efforts[25] Investment and Tax Impact - The company reported a change in fair value of investments resulting in a loss of $128,501,000 in Q2 2025 compared to a loss of $48,375,000 in Q2 2024[20] - The estimated income tax impact from adjustments was $3,059,000 in Q2 2025, compared to a tax impact of $(3,986,000) in Q2 2024[20]

Core Insights - Roivant is experiencing a transformative quarter, highlighted by positive data from brepocitinib in dermatomyositis and Immunovant's remission data in Graves' disease, indicating a promising trajectory for the company [2][3] Recent Developments - Brepocitinib 30 mg showed significant improvement in the Phase 3 VALOR study for dermatomyositis, with an NDA filing planned for the first half of 2026 [3][4] - The brepocitinib program is advancing with rapid enrollment in studies for non-infectious uveitis and cutaneous sarcoidosis, with readouts expected in 2027 and late 2026, respectively [3][4] - Immunovant's study in uncontrolled Graves' disease patients indicated a potentially disease-modifying outcome, with results from Phase 3 thyroid eye disease studies expected in early 2026 [3][4] - Roivant reported consolidated cash and marketable securities of $4.4 billion as of September 30, 2025, providing a strong cash runway [3][4] Financial Summary - Research and development expenses increased by $21.5 million to $164.6 million for Q2 2025, driven by program-specific costs and personnel-related expenses [7][9] - General and administrative expenses decreased by $59.8 million to $143.1 million for Q2 2025, primarily due to reduced personnel-related expenses [10][11] - Loss from continuing operations for Q2 2025 was $166.0 million, an improvement from $236.8 million in Q2 2024 [15][16] Upcoming Milestones - NDA filing for brepocitinib in dermatomyositis is planned for the first half of 2026, with topline data from ongoing trials expected in 2026 and 2027 [13][14] - Immunovant anticipates reporting results from several trials in 2026, including potentially registrational trials for IMVT-1402 [13][14] - Genevant's litigation continues with significant hearings expected in early 2026 [13][14]