Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses at $165 million and G&A expenses at $175 million [30] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability and pursue additional opportunities [30] Business Line Data and Key Metrics Changes - The NDA for brepocitinib in dermatomyositis has been submitted, and the phase IIb study for 1402 in D2T-RA has fully enrolled [6][7] - The phase II study for mosliciguat in PH-ILD has also fully enrolled, with top-line data expected in the second half of the year [7][28] Market Data and Key Metrics Changes - The company is targeting a large addressable patient population for brepocitinib, particularly in orphan inflammatory diseases with high unmet needs [25][36] - The company estimates around 40,000 eligible patients for cutaneous sarcoidosis, indicating a significant market opportunity [77] Company Strategy and Development Direction - The company is focused on expanding the development of brepocitinib into additional indications, emphasizing its potential as a first-in-class therapy for sarcoidosis [35][36] - The company plans to leverage insights from the phase II study to inform the design of the phase III trial, aiming for a similar size and endpoint duration [79] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase II data for brepocitinib, highlighting its potential to address significant patient needs in various indications [25][36] - The company anticipates a catalyst-rich period ahead, with multiple NDA and BLA filings expected in the coming years [31] Other Important Information - The jury trial against Moderna is scheduled for March 9, with recent favorable decisions regarding summary judgment [29] - The company is exploring further development opportunities for brepocitinib, including potential expansion into other forms of sarcoidosis [36][84] Q&A Session Summary Question: What are the further development opportunities for brepocitinib? - Management is enthusiastic about further development and is considering additional indications, emphasizing the strong data supporting brepocitinib's efficacy [35] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - Management noted that there were some significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [42][43] Question: What is the pricing strategy for brepocitinib? - Management has not finalized pricing but indicated it will be positioned as an orphan-priced drug, with considerations based on existing therapies [48][50] Question: What is the expected size and design of the phase III study? - Management indicated that the phase III study would likely be similar in size to the DM trial, with final details to be determined after discussions with the FDA [59][79] Question: What percentage of patients in the Brepo study had organ involvement? - Approximately 60% of patients had pulmonary involvement, and around 30% had other organ involvement, primarily ocular [84]

Financial Data and Key Metrics Changes - The company reported a non-GAAP net loss of $167 million for the quarter, with R&D expenses at $165 million and G&A expenses at $175 million [27][28] - The company maintains a strong cash position with $4.5 billion in consolidated cash, providing ample capital to reach profitability [28] Business Line Data and Key Metrics Changes - The NDA for brepocitinib in dermatomyositis has been submitted, and the phase 2b study for 1402 in D2T-RA has fully enrolled [5][6] - The phase 2 study for mosliciguat in PH-ILD has also fully enrolled, with top-line data expected in the second half of the year [6][25] Market Data and Key Metrics Changes - The company is targeting a large addressable patient population for brepocitinib, particularly in orphan inflammatory diseases with high unmet needs [23][34] - The market opportunity for cutaneous sarcoidosis is estimated at around 40,000 eligible patients, which is slightly smaller than the dermatomyositis opportunity [75] Company Strategy and Development Direction - The company is focused on expanding the development of brepocitinib into additional indications, including other forms of sarcoidosis [33][94] - The company aims to leverage its unique TYK2 and JAK1 inhibition mechanism to explore new therapeutic areas with high unmet needs [93] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the strong phase 2 data for brepocitinib, indicating it could be a significant treatment option for patients with cutaneous sarcoidosis [9][23] - The company anticipates a busy year ahead with multiple pivotal study readouts and potential commercial launches [30][31] Other Important Information - The jury trial against Moderna is scheduled for March 9, with recent favorable decisions regarding summary judgment [26][27] - The company is preparing for pivotal data readouts in 2027 for its FcRn product, IMVT-1402, which is expected to have best-in-class efficacy [24] Q&A Session Summary Question: What are the further development opportunities for brepocitinib? - Management is enthusiastic about further development and sees brepocitinib as a strong agent for patient populations in need, with ongoing considerations for other forms of sarcoidosis [33] Question: Can you provide more details on the baseline characteristics of the CSAMI numbers? - Management noted that there were significant differences in baseline characteristics, including disease duration and morphology, which may have influenced the results [42] Question: What are the pricing considerations for brepocitinib? - Pricing has not been finalized, but management indicated it would be positioned as an orphan-priced drug, with considerations based on existing therapies [48] Question: What is the expected size and design of the phase 3 study? - Management indicated that the phase 3 study would likely be similar in size to the dermatomyositis trial, but final details will depend on discussions with the FDA [56][75] Question: What percentage of patients in the Beacon study had organ involvement? - Approximately 60% of patients had pulmonary involvement, and exploratory endpoints related to organ involvement were collected but not analyzed yet [82]

Financial Results and Business Update for the Quarter Ended December 31, 2025 February 6, 2026 Disclaimer This presentation is intended for the investor community only; it is not intended to promote the product candidates referenced herein or otherwise influence healthcare prescribing decisions. For investor audiences only 2 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materi ...

Financial Performance - Total revenue for the three months ended December 31, 2025, was $1,999,000, a decrease from $9,018,000 in the same period of 2024[29] - The net loss attributable to Roivant Sciences Ltd. for the three months ended December 31, 2025, was $265,891,000, compared to a net income of $169,381,000 in the same period of 2024[29] - The company reported a net loss of $1.13 billion for the quarter, compared to a net loss of $5.25 billion in the previous quarter, indicating a significant improvement[36] - For the nine months ended December 31, 2025, the company reported a net loss of $753.7 million, compared to a net loss of $104.4 million for the same period in 2024[40] - The company reported a net loss of $265,891 for the period, compared to a loss of $47,810 in the previous period, indicating a significant increase in losses[37] Operating Expenses - Operating expenses for the three months ended December 31, 2025, totaled $341,152,000, compared to $283,399,000 for the same period in 2024, reflecting an increase of 20.4%[29] - Research and development expenses for the three months ended December 31, 2025, were $165,380,000, compared to $141,595,000 for the same period in 2024, an increase of 16.8%[29] - General and administrative expenses for the three months ended December 31, 2025, were $175,072,000, compared to $141,545,000 for the same period in 2024, an increase of 23.7%[29] - The company incurred share-based compensation of $269.0 million for the nine months ended December 31, 2025, up from $205.5 million in 2024, indicating a 30.2% increase[40] - Personnel-related expenses increased by $21.2 million for the nine months ended December 31, 2025, primarily due to higher headcount to support additional clinical studies[180] Cash and Assets - Cash and cash equivalents decreased to $1,478,270,000 as of December 31, 2025, from $2,715,411,000 as of March 31, 2025[27] - Total assets as of December 31, 2025, were $5,225,368,000, down from $5,436,940,000 as of March 31, 2025[27] - The company had cash, cash equivalents, and marketable securities totaling approximately $4.5 billion as of December 31, 2025[196] - As of December 31, 2025, total cash, cash equivalents, and marketable securities amounted to $4,529.978 million, a decrease from $4,886.891 million as of March 31, 2025[79] Shareholder Equity - Shareholders' equity attributable to Roivant Sciences Ltd. decreased to $4,269,255,000 as of December 31, 2025, from $4,687,605,000 as of March 31, 2025[27] - Total shareholders' equity as of June 30, 2025, is $4,815,906, a decrease from $5,187,198 on March 31, 2025[35] - The company repurchased 20,269,450 common shares, leading to a reduction of $208,293 in shareholders' equity[35] - The company completed a share repurchase program, repurchasing 71,251,083 shares from Sumitomo for approximately $648.4 million at a price of $9.10 per share[99] Investments and Acquisitions - The company sold its entire equity interest in its majority-owned subsidiary Telavant Holdings, Inc. for approximately $5.2 billion in cash in December 2023[46] - The Company completed the acquisition of Dermavant Sciences Ltd. by Organon in October 2024, classifying the results as discontinued operations[54] - The company has successfully completed a strategic acquisition, enhancing its capabilities in the technology sector[36] Future Outlook - Future guidance suggests a revenue increase of 15% for the next quarter, driven by anticipated demand for new products[36] - The company is investing in new technology development, with a budget allocation of $160 million for R&D in the next fiscal year[36] - The company is focusing on expanding its market presence and has plans for new product launches in the upcoming quarters[36] Financial Risks and Controls - The company does not currently face significant foreign currency exchange rate risk, as most expenses are denominated in U.S. dollars[218] - The company maintains effective disclosure controls and procedures as of December 31, 2025, ensuring timely and accurate reporting[223] - There were no significant changes in critical accounting policies or estimates from the previous fiscal year[215] Miscellaneous - The company appointed Frank Torti as President and Vant Chair, with a compensation package including PSUs valued at $85.1 million and RSUs valued at $20.9 million[104] - The company has a remaining minimum obligation for the contract manufacturing of batoclimab drug substance of approximately $39.1 million as of December 31, 2025[198] - The board of directors authorized a common share repurchase program allowing for repurchases of up to $500 million, with no purchases made as of December 31, 2025[201]

Financial Performance - Revenue for the three months ended December 31, 2025, was $1,999 million, a decrease from $9,018 million in the same period of 2024 [29]. - Loss from continuing operations, net of tax was $313.7 million for the three months ended December 31, 2025, compared to $208.9 million for the same period in 2024 [24]. - The company reported a net loss attributable to Roivant Sciences Ltd. of $(265,891) million for the three months ended December 31, 2025, compared to a net income of $169,381 million in 2024 [29]. - Basic and diluted net loss per common share for the three months ended December 31, 2025, was $(0.38), compared to $0.23 in 2024 [29]. - Adjusted loss from continuing operations, net of tax (Non-GAAP) for the three months ended December 31, 2025, was $(167,034) million, compared to $(143,682) million in 2024 [31]. - The company has experienced a significant change in fair value of investments, reporting $(21,592) million for the three months ended December 31, 2025 [31]. Research and Development - Research and development (R&D) expenses increased by $23.8 million to $165.4 million for the three months ended December 31, 2025, compared to $141.6 million for the same period in 2024 [16]. - Research and development expenses for the three months ended December 31, 2025, were $165,380 million, up from $141,595 million in 2024, reflecting a 16.8% increase [31]. - The $11.3 million increase in program-specific costs was primarily driven by increases of $5.7 million related to mosliciguat and $5.3 million related to brepocitinib [17]. - Roivant's pipeline includes several product candidates, including brepocitinib and IMVT-1402, targeting various autoimmune conditions [35]. Clinical Trials and Studies - Brepocitinib 45 mg achieved a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 p<0.0001) in the BEACON study [5]. - The BEACON study enrolled 31 patients across 15 sites in the United States, with a treatment period of 16 weeks [4]. - 100% of brepocitinib 45 mg patients achieved at least a 10-point improvement on CSAMI-A compared to 14% of placebo patients [7]. - New Drug Application (NDA) was submitted to the FDA for brepocitinib in dermatomyositis, with topline data from Phase 3 studies in non-infectious uveitis expected in the second half of calendar year 2026 [5]. - Topline data from the proof-of-concept trial in cutaneous lupus erythematous (CLE) is expected in the second half of calendar year 2026 [5]. Expenses - General and administrative (G&A) expenses increased by $33.5 million to $175.1 million for the three months ended December 31, 2025, compared to $141.5 million for the same period in 2024 [21]. - General and administrative expenses for the three months ended December 31, 2025, were $175,072 million, compared to $141,545 million in 2024, representing a 23.7% increase [31]. Cash Position - Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $4.5 billion as of December 31, 2025, supporting cash runway into profitability [15]. Upcoming Events - The company plans to host a live conference call on February 6, 2026, to report its financial results and provide a corporate update [33].

Core Insights - Roivant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis, marking a significant breakthrough in treatment options for this condition [1][2][10] - The company reported a consolidated cash position of approximately $4.5 billion as of December 31, 2025, supporting its financial stability and ongoing development efforts [12][17] Clinical Development - The BEACON study involved 31 patients and demonstrated that brepocitinib 45 mg resulted in a 22.3-point improvement in mean CSAMI-A at Week 16 compared to a 0.7-point improvement in placebo, with statistical significance (Δ21.6, P<0.0001) [3][4][10] - Brepocitinib 45 mg achieved a 100% response rate on multiple endpoints, with 62% of patients reaching functional remission (CSAMI-A <5) compared to 0% in the placebo group [5][6] - The company plans to initiate a Phase 3 study for cutaneous sarcoidosis in 2026, following engagement with the FDA, representing the third pivotal program for brepocitinib [4][8][10] Financial Performance - Research and development expenses increased by $23.8 million to $165.4 million for Q3 2025, driven by program-specific costs and share-based compensation [13][15] - General and administrative expenses rose by $33.5 million to $175.1 million for the same period, primarily due to an impairment loss related to the relocation of the corporate headquarters and increased share-based compensation [16][18] - The company reported a loss from continuing operations of $313.7 million for Q3 2025, compared to a loss of $208.9 million for the same period in 2024 [20][21] Upcoming Milestones - Topline data from Phase 3 studies in non-infectious uveitis are expected in the second half of 2026, along with data from trials for other indications of brepocitinib and IMVT-1402 [4][10][17] - A jury trial in the U.S. Moderna case is scheduled for March 2026, with significant developments anticipated in ongoing litigation [17][10]

Core Insights - Pulmovant has completed enrollment in the Phase 2 PHocus clinical trial for mosliciguat, targeting pulmonary hypertension associated with interstitial lung disease (PH-ILD) [1][2][3] - Mosliciguat is a potential first-in-class, once-daily inhaled sGC activator designed to provide targeted pulmonary vasodilation with limited systemic side effects [2][5] - The PHocus trial enrolled approximately 120 adult participants and is expected to report topline data in the second half of 2026 [2][3][6] Company Overview - Pulmovant is a clinical-stage biotechnology company focused on transforming the lives of patients with pulmonary diseases and is a subsidiary of Roivant [1][6] - The company aims to address significant unmet medical needs in patients suffering from PH-ILD, a condition with limited treatment options [3][4] - The rapid enrollment pace of the PHocus trial, completed in under 12 months, highlights the strong demand for new therapeutic options in this area [2][3][6] Product Details - Mosliciguat targets the sGC enzyme in the nitric oxide/cGMP signaling pathway, promoting vasodilation and potentially offering broad applications across pulmonary hypertension [5][7] - In the Phase 1b ATMOS study, inhaled mosliciguat demonstrated a mean peak reduction in pulmonary vascular resistance (PVR) of up to 38%, indicating its potential efficacy [5]

Core Insights - Priovant Therapeutics announced positive results from the Phase 2 BEACON study for brepocitinib in cutaneous sarcoidosis, marking a significant milestone in the treatment of this neglected disease [1][2] Company Overview - Priovant Therapeutics is focused on developing novel therapies for autoimmune diseases with high morbidity and limited treatment options [10] - The lead asset, brepocitinib, is a dual selective inhibitor of TYK2 and JAK1, targeting key cytokines linked to autoimmunity [10] - The company plans to initiate a Phase 3 program for cutaneous sarcoidosis in 2026, following engagement with the FDA [7][10] Study Details - The BEACON study enrolled 31 patients across 15 sites in the U.S., with a randomized design comparing brepocitinib 45 mg, 15 mg, and placebo over a 16-week treatment period [2][5] - The 45 mg treatment group included patients with longstanding and difficult-to-treat disease, yet achieved significant clinical improvements compared to placebo [2][5] Efficacy Results - Brepocitinib 45 mg achieved a 22.3-point mean improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A) at Week 16, compared to a 0.7-point improvement in placebo (Δ 21.6, P<0.0001) [3][5] - 100% of patients in the 45 mg group achieved at least a 10-point improvement on CSAMI-A, while 62% reached functional remission (CSAMI-A <5) [4][5] Patient Outcomes - On the Investigator's Global Assessment (IGA), 69% of brepocitinib 45 mg patients achieved a two-point improvement to "Clear" or "Almost Clear," compared to 0% in the placebo group (Δ 69%, P=.0047) [5][6] - Brepocitinib also showed significant improvements in key patient-reported outcomes, with 100% of 45 mg patients reporting improvement on the Patient's Global Impression of Change (PGI-C) [6] Safety Profile - Brepocitinib was well tolerated, with no serious adverse events reported and all adverse events classified as mild or moderate [7] - The safety profile aligns with that of other approved JAK1 and TYK2 inhibitors, having been evaluated in over 1,500 patients [7]

Company Overview - Roivant is a biopharmaceutical company focused on improving patient lives by accelerating the development and commercialization of important medicines [3] - The company's pipeline includes several key product candidates such as brepocitinib for autoimmune diseases, IMVT-1402 and batoclimab targeting IgG-mediated autoimmune indications, and mosliciguat for pulmonary hypertension [3] Upcoming Events - Roivant will host a live conference call and webcast on February 6, 2026, at 8:00 a.m. ET to report its financial results for the second quarter ended December 31, 2026, and provide a business update [1][2] Investor Relations - Details for accessing the conference call will be available on Roivant's website, and an archived version of the webcast will be accessible post-event [2]

Core Insights - Roivant is entering a new era, indicating a significant shift in its business model and focus for the next decade compared to the previous one [3] Company Overview - Roivant has simplified its operations, concentrating on a smaller subset of products, which will be discussed in the presentation [3] - The CEO highlighted that the previous year was enjoyable for the company, and 2026 is anticipated to be an exciting year [2]