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].

Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving 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). Brepocitinib demonstrated rapid, deep and sustained improvements across all other efficacy endpoints measured with consistent safety profilePriovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indicat ...

PHocus enrollment completed in under 12 months from first patient dosed, representing a rapid enrollment pace in pulmonary hypertension associated with interstitial lung diseaseTopline results on track for second half of calendar year 2026 WALTHAM, Mass., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Pulmovant, a clinical-stage biotechnology company committed to transforming the lives of patients with pulmonary diseases, and a Roivant (Nasdaq: ROIV) company, today announced that it has completed enrollment in the Phase ...

Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ 21.6 P<0.0001)All brepocitinib 45 mg patients achieved a clinically meaningful response, with 100% demonstrating at least a 10-point improvement on CSAMI-AOn the Investigator’s Global Assessment (IGA), 69% percent of brepocitinib 45 mg patients compared to 0% of placebo patients achieved the gold standard two-point improv ...

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]

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]

If You Didn't Buy Roivant in 2025, Now Is the Time J.P. Morgan Healthcare Conference January 12, 2026 Forward-Looking Statements This presentation includes forward-looking statements that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial p ...

Core Insights - Roivant Sciences Ltd. (NASDAQ:ROIV) is highlighted as one of the best stocks under $25 to buy, with an increased price target of $32 from Leerink Partners, maintaining an Outperform rating due to lower estimated operational expenses and anticipated profitability starting in fiscal year 2029 [1] Group 1: Company Projections - By the end of 2028, Roivant's "Next 36 Month vision" includes expectations for at least three commercial launches, four or more NDA/BLA submissions, no less than eight crucial readouts, and at least three proof-of-concept evaluations [2] - The development schedules for Roivant's primary therapeutic candidates have been advanced, including brepocitinib, with a New Drug Application filing for dermatomyositis expected in early 2026 and a potential commercial launch in early 2027 [3] Group 2: Clinical Development - The Phase III trial for brepocitinib in non-infectious uveitis has achieved full enrollment ahead of schedule, with topline results anticipated in the second half of 2026 [3] - Roivant Sciences Ltd. is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing medicines and technologies, with clinical product candidates including IMVT-1402 for Graves' disease and difficult-to-treat rheumatoid arthritis [4]

Core Insights - Jefferies published an in-depth report focusing on the investment prospects of Roivant Sciences (ROIV.US), highlighting three key catalysts and valuation logic that could significantly impact the company's stock price by 2026 [1] Group 1: Key Catalysts - The first catalyst involves a patent lawsuit related to LNP technology with Moderna (MRNA.US) and Pfizer (PFE.US), with a trial set to begin on March 9, 2026. Conservative estimates suggest Roivant could receive $2-4.5 billion in damages based on a 5% royalty from total COVID-19 vaccine revenues of $60-130 billion [1] - The second catalyst is the Phase II clinical trial data for Pulmovant's PH-ILD treatment, which could lead to a Phase III trial if the data shows a reduction in pulmonary vascular resistance (PVR) of over 20%. The Phase III trial is expected to start in the first half of 2027, with results anticipated in 2030 [2] - The third catalyst is the Phase III trial data for Priovant's brepo drug, which has been moved up to the second half of 2026. If brepo captures 30-50% of the market for non-infectious uveitis (NIU) patients, peak sales could reach $1.5-3 billion [2] Group 2: Valuation Analysis - Jefferies utilized a sum-of-the-parts (SOTP) valuation method, estimating the expected compensation from the LNP lawsuit at $2.5-3 billion, with Roivant's share being $1.5-2 billion. The market value of the IMVT subsidiary is estimated at $5.4 billion, adjusted to $5.1 billion after accounting for cash [3] - The brepo drug is valued at $1.75 billion in peak sales, with a 5x price-to-earnings ratio and a 95% success rate, leading to a valuation of $6.25 billion for Roivant's stake [3] - Overall, the valuation framework indicates a clear picture, with current cash of $4.4 billion and projected cash of $3.7 billion, supporting a "buy" rating with a target price of $24, representing a 10.95% upside from the latest closing price of $21.63 [3]