Key Takeaways IMVT posted Q3 loss of 61 cents per share, beating estimates, with no revenues.IMVT ended Q3 with $994.5M in cash after a $550M raise, extending its runway through the IMVT-1402 launch.IMVT advanced IMVT-1402 and batoclimab programs, with multiple top-line readouts expected from 2026 to 2027.Immunovant, Inc. (IMVT) reported third-quarter fiscal 2026 net loss of 61 cents per share, narrower than the Zacks Consensus Estimate of a loss of 72 cents. The company had reported a loss of 76 cents per ...

Immunovant (NasdaqGS:IMVT) Q3 2026 Earnings call February 06, 2026 08:00 AM ET Company ParticipantsAlex Thompson - Managing DirectorBen Zimmer - CEOCorinne Jenkins - Managing DirectorDavid Risinger - Senior Managing DirectorDerek Archila - Managing DirectorDouglas Tsao - Managing DirectorMatt Gline - CEOPrakhar Agrawal - Managing DirectorStephanie Lee - Head of Investor RelationsYatin Suneja - Senior Managing DirectorConference Call ParticipantsAshwani Verma - Research AnalystBrian Cheng - Executive Directo ...

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]

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]

IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) fully enrolled, with topline data expected in the second half of calendar year 2026; topline data from the proof-of-concept trial in cutaneous lupus erythematosus (CLE) expected in the second half of calendar year 2026IMVT-1402 development is progressing with potentially registrational studies in Graves’ disease (GD), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren’s di ...

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 - Immunovant, a biotech company focused on monoclonal antibody therapies for autoimmune diseases, reported a significant insider purchase of 16,666,666 shares by Roivant Sciences Ltd. for approximately $350 million on December 12, 2025 [1][9] Transaction Summary - The transaction involved the purchase of 16,666,666 shares valued at $350 million, with a post-transaction direct ownership of 113,317,007 shares, representing 64.65% of Immunovant's outstanding shares [2][6] - The purchase price of $21.00 per share was approximately 20.4% below the market close of $26.42 on the transaction date [6] Company Overview - As of December 12, 2025, Immunovant had a market capitalization of $5.44 billion and a net income of -$464.69 million, with a 1-year price change of -3.69% [4] - The company specializes in developing monoclonal antibody therapeutics, with its lead candidate, batoclimab, targeting autoimmune diseases such as myasthenia gravis and thyroid eye disease [7][8] Financial Context - The recent purchase by Roivant Sciences is part of an equity offering aimed at providing Immunovant with funds to continue its medical research and advance its key drug candidate, IMVT-1402, towards market introduction [9][11] - Immunovant's operating expenses for the fiscal second quarter ended September 30 were $131.8 million, an increase from $115.7 million the previous year, primarily due to clinical trial activities [10] Strategic Implications - The transaction enhances Roivant Sciences' direct ownership in Immunovant by 17.24%, indicating a strategy of large block acquisitions rather than incremental buying [6] - The additional funds from the stock purchase bolster Immunovant's cash reserves, which stood at $521.9 million, providing a runway for clinical trials and potential FDA approval [11]

December 11, 2025 New York City 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 position, business strategy, potential uses of cash and capital allocat ...

Core Insights - Roivant is at a transformational moment with opportunities for three major product launches, each representing a pipeline-in-a-product opportunity with blockbuster potential [2] - The company is hosting an Investor Day to discuss pipeline updates and long-term value creation strategies [1][9] Program-Specific Highlights and Updates - Brepocitinib is expected to have its NDA filing for dermatomyositis in early 2026, with a commercial launch anticipated in early 2027 [6][7] - The Phase 3 trial for brepocitinib in non-infectious uveitis is fully enrolled, with topline data expected in the second half of 2026 [6][7] - A proof-of-concept trial for brepocitinib in cutaneous sarcoidosis is also fully enrolled, with topline data expected in the first half of 2026 [6][7] - IMVT-1402's potentially registrational trial in difficult-to-treat rheumatoid arthritis is expected to provide topline data in 2026 [6][7] - The ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease is on track, with topline data expected in the second half of 2026 [5][8] Financial and Strategic Developments - Roivant's financing efforts alongside key institutional investors generated approximately $550 million for Immunovant, extending its cash runway to the launch of IMVT-1402 in Graves' disease [6][7] - The company is well-positioned to generate shareholder value through its late-stage pipeline and long-term strategy [2][6]

Core Viewpoint - Immunovant, Inc. has announced an underwritten offering of common stock expected to raise approximately $550 million to support its operations and the potential commercial launch of IMVT-1402 for Graves' Disease [1][2]. Group 1: Offering Details - The company is offering 26.2 million shares at a price of $21.00 per share, with the offering expected to close around December 12, 2025, pending customary closing conditions [3]. - Roivant Sciences Ltd., the controlling stockholder of Immunovant, has agreed to purchase shares in this offering [1]. Group 2: Financial Implications - The proceeds from the offering, combined with existing cash and cash equivalents, are anticipated to be sufficient to fund operating expenses and capital expenditures through the potential commercial launch of IMVT-1402 [2].