Immunovant, Inc. (IMVT) Q3 2026 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call presents a mixed outlook. Positive aspects include a strong cash position, share buyback authorization, and potential for brepocitinib in high unmet need areas. However, the company reports a non-GAAP net loss, lacks pricing clarity, and faces ongoing litigation. The Q&A reveals management's optimism but also highlights uncertainties, such as unclear timelines and trial designs. Given these factors, the stock price is expected to remain stable, resulting in a neutral sentiment rating.
Key Financial Performance
R&D Expense $165 million, adjusted non-GAAP of $147 million for the quarter.
G&A Expense $175 million, adjusted non-GAAP of $71 million for the quarter.
Non-GAAP Net Loss $167 million for the quarter.
Cash $4.5 billion of consolidated cash in the business.
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Operating Highlights
Phase II results for brepocitinib in cutaneous sarcoidosis: Positive results with a placebo-adjusted 21.6-point delta in CSAMI score, exceeding the clinically meaningful threshold of 5 points. 100% of patients on the high dose achieved at least a 10-point improvement.
Phase III study for brepocitinib in cutaneous sarcoidosis: Planned to start in 2026, aiming to address unmet needs in sarcoidosis with no approved therapies currently available.
Mosliciguat in PH-ILD: Phase II study fully enrolled, with data expected in the second half of 2026. Potential for best-in-class efficacy and tolerability benefits.
IMVT-1402 in D2T RA: Phase IIb study fully enrolled with 170 patients. Data expected in the second half of 2026.
Brepocitinib market potential: Positioned as a first-in-class therapy for orphan inflammatory diseases with high unmet needs, targeting multiple indications including cutaneous sarcoidosis, dermatomyositis, and NIU.
Mosliciguat market potential: Targeting PH-ILD, a disease with limited existing therapies, offering once-daily dosing and potential best-in-class efficacy.
Financial position: Strong cash position of $4.5 billion, sufficient to fund operations to profitability and support additional initiatives.
R&D and G&A expenses: R&D expenses at $165 million and G&A expenses at $175 million for the quarter, with adjusted non-GAAP net loss of $167 million.
Litigation against Moderna: Jury trial scheduled for March 9, 2026, with favorable summary judgment decision on Section 1498, covering most asserted doses.
Pipeline expansion: Focus on advancing brepocitinib and other assets across multiple indications, with 9 or more pivotal study readouts expected in the coming years.
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Risk or Challenges
Regulatory hurdles: The company is preparing for a jury trial against Moderna starting on March 9, which could pose legal and financial risks depending on the outcome. Additionally, the company is navigating regulatory processes for multiple NDA and BLA filings, which inherently carry risks of delays or rejections.
Clinical trial risks: The company is heavily reliant on the success of its clinical trials, including Phase III studies for brepocitinib in cutaneous sarcoidosis and other indications. Any failure or delay in these trials could significantly impact the company's strategic objectives and financial performance.
Market competition: The company faces competitive pressures in the pharmaceutical industry, particularly in developing therapies for high unmet needs. Success in these areas is critical for the company to maintain its market position.
Economic uncertainties: The company reported a non-GAAP net loss of $167 million for the quarter, highlighting ongoing financial challenges. While cash reserves are strong, sustained losses could impact long-term financial stability.
Strategic execution risks: The company has a busy pipeline with multiple pivotal study readouts and potential commercial launches. Effective execution of these plans is critical, and any missteps could adversely affect the company's performance.
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Guidance & Outlook
2026 Key Events: Major events include brepocitinib (brepo) Phase III study in cutaneous sarcoidosis, Phase IIb data for mosliciguat (mosli) in PH-ILD, and D2T RA data expected in the second half of the year. Proof-of-concept data for 1402 in CLE is also anticipated.
Brepocitinib (brepo) Development: Phase III study for brepo in cutaneous sarcoidosis to start in 2026. The drug shows potential for addressing unmet needs in sarcoidosis, with plans to expand its use to other indications like dermatomyositis (DM) and non-infectious uveitis (NIU).
Mosliciguat (mosli) in PH-ILD: Phase IIb data expected in the second half of 2026. The drug targets pulmonary hypertension associated with interstitial lung disease (PH-ILD) and aims to offer best-in-class efficacy and tolerability.
IMVT-1402 Development: Pivotal data for Graves' disease expected in 2027. Data for D2T RA expected in 2026, with the study fully enrolled. The drug aims to be a best-in-class FcRn inhibitor with a favorable safety profile.
Financial Position: Strong cash position of $4.5 billion, sufficient to fund operations to profitability and support additional initiatives. Share buyback authorization remains in place.
Litigation Update: Jury trial against Moderna scheduled for March 9, 2026, with favorable summary judgment decisions setting up a strong case.
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Shareholder Return Plan
Share buyback authorization: The company has share buyback authorization and is happy to have that capability.
Share buyback authorization: The company has share buyback authorization and is happy to have that capability.
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Key Q&A
Q:What are the future development opportunities for brepocitinib and its potential patient population?
A:The management is enthusiastic about further development of brepocitinib, exploring other indications like sarcoidosis and dermatomyositis. They believe brepocitinib aligns well with TYK2/JAK1 inhibition mechanisms and has potential in large orphan markets with tens of thousands of patients and high unmet needs.
Q:Can you explain the baseline characteristics and FDA timeline for brepocitinib?
A:Baseline characteristics showed differences in disease duration and morphology between arms in the study. The FDA timeline for dermatomyositis approval depends on the agency, but the disease's severity and lack of options may influence priority review.
Q:What is the pricing strategy for brepocitinib and Pfizer's 25% ownership impact?
A:Pricing has not been decided but will likely fall within the range of IVIG and VYVGART prices. Pfizer's 25% ownership will be reflected as a below-the-line minority interest in financials, and Pfizer will receive its share of distributed cash.
Q:What are the plans for Phase III trials for brepocitinib in cutaneous sarcoidosis?
A:The Phase III trial will likely have a similar size to the dermatomyositis trial. The management is confident in the data's robustness and plans to finalize the design after discussions with the FDA.
Q:What is the market opportunity for brepocitinib in cutaneous sarcoidosis?
A:The market opportunity is slightly smaller than dermatomyositis, with around 40,000 eligible patients. The management is optimistic about the drug's potential based on Phase II data.
Q:What are the upcoming catalysts for brepocitinib and PH-ILD?
A:The management is evaluating further indications for brepocitinib and sees potential in PH-ILD. They acknowledge competition from sotatercept but believe brepocitinib has a favorable profile.
Q:What are the expectations for the RA readout and Phase III plans for brepocitinib?
A:The management is optimistic about the RA readout, noting the high unmet need in the patient population. They plan to finalize Phase III designs after engaging with the FDA.
Q:What is the significance of Dr. Mitchell's testimony in the Genevant case?
A:The management cannot comment on ongoing litigation but hopes for favorable outcomes in the Daubert motions.
Q:What are the plans for expanding brepocitinib into other forms of sarcoidosis?
A:The management is evaluating further opportunities for brepocitinib in other forms of sarcoidosis and other indications.
Q:What are the commercial synergies between brepocitinib and 1402?
A:The management plans to leverage contracting and other commercial strategies to maximize benefits across the portfolio, rather than focusing solely on shared sales forces.
Q:What is the competitive landscape for brepocitinib and 1402?
A:The management is confident in their lead in Graves' disease and other indications, despite competition from argenx and others. They believe their deeper IgG suppression will be a significant advantage.
Q:What are the expectations for TED and Graves' disease data?
A:The management is optimistic about the potential efficacy of FcRns in Graves' disease and does not see much read-through from TED data. They plan to optimize their Graves' program based on upcoming data.
Q:What are the plans for Phase III trials in Graves' disease and MG?
A:The management expects to launch Graves' disease by 2028 and is evaluating the timeline for MG, which may also launch in 2028.
Q:What is the scope of brepocitinib's opportunity?
A:The management sees significant potential for brepocitinib in high unmet need areas, particularly where TYK2/JAK1 inhibition is effective. They are exploring both derisked and higher-risk opportunities.
Q:Review of Unclear Management Responses
A:Management avoided providing specific details on pricing for brepocitinib, the exact design and size of Phase III trials, and the timeline for TED and Graves' disease data. They also did not clarify the impact of Dr. Mitchell's testimony in the Genevant case or provide detailed plans for expanding brepocitinib into other forms of sarcoidosis.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
CS
CSAMI
IGAs
JAK
Phase III
Skindex
TYK
achievement
arm Slide
assessment
bar placebo
brepo milligram
brepo sarcoidosis
brepocitinib
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difference brepo
domain
dose arm
duration disease
efficacy
end trial
endpoint patient
evidence benefit
form sarcoidosis
imbalance
improvement point
improvement week
involvement
milligram arm
milligram patient
milligram placebo
morphology
outcome
patient milligram
patient placebo
patient skin
placebo group
point improvement
response rate
skin disease
worsening
IMVT Transcript
Immunovant, Inc. (IMVT) Q3 2026 Earnings Call Transcript
Unknown2-6
The earnings call presents a mixed outlook. Positive aspects include a strong cash position, share buyback authorization, and potential for brepocitinib in high unmet need areas. However, the company reports a non-GAAP net loss, lacks pricing clarity, and faces ongoing litigation. The Q&A reveals management's optimism but also highlights uncertainties, such as unclear timelines and trial designs. Given these factors, the stock price is expected to remain stable, resulting in a neutral sentiment rating.
Immunovant, Inc. (IMVT) Q2 2025 Earnings Call Transcript
Unknown11-12
The earnings call summary indicates a mixed sentiment. While there are positive aspects like potential market opportunities and a strong capitalization, concerns arise from litigation uncertainties, lack of clear guidance, and competitive pressures. The Q&A reveals cautious optimism but lacks concrete data to support strong positive sentiment. Given the market cap, the overall sentiment is neutral, suggesting limited short-term stock price movement.
Immunovant, Inc. (IMVT) Q2 2026 Earnings Call Transcript
Positive11-10
The earnings call summary indicates a positive outlook with strong financial performance, optimistic product development updates, a solid market strategy, and shareholder return plans. The Q&A section reveals management's confidence in their competitive positioning and strategic initiatives, despite some litigation uncertainties. Considering the company's market cap and the overall positive sentiment, the stock is likely to see a positive movement of 2% to 8%.
Immunovant, Inc. (IMVT) CEO Pete Salzmann on Q4 2022 Results - Earnings Call Transcript
Positive6-9
The earnings call highlights strong market research favoring batoclimab for TED, a dose-dependent efficacy in trials, and a strategic regulatory approach. The Q&A reveals confidence in batoclimab's potential despite previous mixed results, with a clear enrolment strategy and safety measures. The market cap suggests moderate volatility, supporting a positive outlook for stock price movement.
IMVT Report
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