Immunovant, Inc. (IMVT) Q2 2026 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

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%.

Key Financial Performance

Loss from continuing operations net of tax $166 million

Cash and cash equivalents $4.4 billion, with no debt on the balance sheet

Share buybacks Reflective of significant share buybacks over the last 18 months

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Operating Highlights

Brepocitinib in DM: Phase III data for brepocitinib in dermatomyositis (DM) showed success across all 10 ranked endpoints. The NDA filing is planned for the first half of next year, potentially making it the first novel oral therapeutic in DM.

Batoclimab in Graves' Disease: Data from the durable remission portion of the Graves' disease trial demonstrated disease-modifying potential. Patients showed sustained response even after being off the drug for six months.

Graves' Disease Market: Shift away from ablation procedures due to patient preference, with a significant unmet need for new medical therapies. Approximately 330,000 U.S. patients are in the refractory or uncontrolled category.

Dermatomyositis Market: 75% of patients rely on steroids or ISTs, with limited therapeutic options. Only 25% of the market uses other therapies, highlighting a significant unmet need.

Capital Position: Strong financial position with $4.4 billion in cash and cash equivalents, sufficient to support pipeline expansion and profitability.

LNP Litigation: Favorable marketing ruling in the Pfizer case and ongoing progress in the Moderna case, with a jury trial scheduled for March 2026.

Pipeline Expansion: 11 potentially registrational trials in progress, with multiple blockbuster indications targeted, including Graves' disease and dermatomyositis.

Investor Engagement: Investor Day scheduled for December 11, 2025, to discuss future plans and business transformation.

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Risk or Challenges

Regulatory and Legal Risks: The company is involved in ongoing litigation, including the LNP litigation with Moderna and Pfizer. While there have been favorable rulings, the outcomes of these cases remain uncertain and could impact financials and operations.

Pipeline and R&D Risks: The company has a stacked pipeline with multiple registrational trials and launches planned. Delays or failures in these trials, such as the NDA submission for brepocitinib or the TED study, could adversely affect strategic objectives and financial performance.

Market and Competitive Risks: The evolving competitive landscape, particularly in TED and Graves' disease, poses challenges. The company has delayed reporting top-line data for TED due to competitive pressures, which could impact market positioning.

Operational Risks: The company is heavily reliant on its late-stage pipeline and upcoming launches. Any disruptions in these areas, including manufacturing or supply chain issues, could significantly impact operations.

Economic and Financial Risks: While the company has a strong cash position of $4.4 billion, it is operating at a loss of $166 million for the quarter. Sustained losses could impact long-term financial stability.

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Guidance & Outlook

NDA filing for brepocitinib in DM: The NDA filing for brepocitinib in dermatomyositis (DM) is planned for the first half of 2026. If approved, it will be the first novel oral therapeutic in DM.

Future launches and indications for brepocitinib: The company anticipates multiple registrational data sets and launches for brepocitinib, starting with DM and NIU, followed by other indications.

Graves' disease program (batoclimab): The company demonstrated disease-modifying potential for batoclimab in Graves' disease, with plans to advance the 1402 Graves' program. Data from the TED study will be reported in the first half of 2026.

Pipeline expansion and profitability: The company has $4.4 billion in cash and cash equivalents, which is expected to support pipeline expansion and carry the current pipeline to profitability.

LNP litigation updates: The Moderna case is scheduled for trial in March 2026, and the Pfizer case is ongoing in discovery.

Investor Day: The company plans to provide a more detailed outlook on its future during its Investor Day on December 11, 2025.

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Shareholder Return Plan

Dividends: No specific mention of dividends or a dividend program was made during the call.

Share Buyback: The company highlighted a $500 million share buyback program that has been authorized. Additionally, it was noted that the share count reflects significant share buybacks conducted over the last 18 months.

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Key Q&A

Q:What should we watch next with respect to Pfizer litigation, specifically in international markets and the U.S.?

A:Matthew Gline stated that it is tough to comment on ongoing litigation and had nothing to say about the timing of international cases. He mentioned that there should be a scheduling process for the Pfizer case underway, and they should learn more about the timeline, including a potential trial date in the near future.

Q:How does Roivant feel about argenx stepping into Graves' disease, and does it impact their strategy for 1402?

A:Matthew Gline expressed that they are aware of the competitive landscape in Graves' disease and view it positively as it validates their strategy. He highlighted the competitive profile of their Phase II study with batoclimab, showing significant benefits in higher doses and IgG reduction. He also emphasized the large patient population and the importance of more treatment options.

Q:What can investors expect from the upcoming Investor Day?

A:Matthew Gline mentioned that the Investor Day will focus on the transformation of their business, their commercial strategy, and the blockbuster opportunities in their indications. He hinted at potential updates or new information but emphasized it as an opportunity to take stock of the business and discuss future opportunities.

Q:Is there any way to tease out the impact of starting on high-dose batoclimab in the Graves' study and its contribution to remission rates?

A:Matthew Gline stated that remission is about TRAbs getting normal for longer and that deeper IgG reductions drive this outcome. He highlighted the speed and depth of responses in the VALOR trial as significant drivers and expressed confidence in their high-dose IgG suppression program.

Q:What are Roivant's thoughts on the ongoing Moderna litigation and the U.S. government’s involvement?

A:Matthew Gline explained that it is difficult to comment in depth on ongoing litigation. He scoped the magnitude of the question, stating that less than half of Moderna's U.S. COVID vaccine sales could be subject to the 1498 question. He emphasized that the judge will ultimately decide.

Q:What is Roivant's perspective on the Sjögren's disease market opportunity and their potential to be first-in-class?

A:Matthew Gline expressed excitement about the Sjögren's market opportunity, highlighting the unmet need and large patient population. He mentioned that FcRns have shown competitive data and that deeper IgG suppression could yield better benefits. He also noted their aim to launch close to first-in-class and differentiate based on their profile.

Q:How does Roivant view the competitive landscape in Graves' disease and their position in it?

A:Matthew Gline acknowledged the competitive intensity in Graves' disease but emphasized their strong position with FcRn as a well-suited mechanism. He highlighted the safety and tolerability of FcRns and their potential as early-line therapy. He also noted that increased activity in the space could benefit everyone by raising awareness.

Q:What is the status of Pulmovant's Phase II PH-ILD data and its translatability from PH to PH-ILD?

A:Matthew Gline expressed cautious optimism about the translatability of PVR reductions from PH to PH-ILD, noting that PVRs have generally translated well. He highlighted the 38% PVR reduction seen in pulmonary hypertension and the potential for significant benefit even if reductions are slightly lower in PH-ILD.

Q:What is the status of Roivant's overseas litigation cases against Moderna?

A:Matthew Gline mentioned that they have filed cases in the UPC in Europe, Canada, Japan, and other places. He noted that important hearings are scheduled for 2026 and that some European jurisdictions could deliver outcomes within that year.

Q:What are Roivant's expectations for the TED data and its impact on their development strategy?

A:Matthew Gline stated that the competitive bar in TED is high but that IGF-1Rs leave room for improvement in safety. He emphasized the importance of the TED data in informing their development strategy and its potential to impact Graves' disease earlier in its course.

Q:How does Roivant view the competitive landscape in DM and their position with brepo?

A:Matthew Gline highlighted the high unmet need in DM and the advantages of brepo as an oral therapy. He noted that brepo's data in DM is likely the best overall and that they aim to define the market. He also mentioned exploring additional indications for brepo.

Q:What is Roivant's perspective on the Graves' disease market opportunity compared to MG for FcRns?

A:Matthew Gline stated that the Graves' disease market is large with many uncontrolled patients, making it an exciting opportunity. He emphasized the importance of being first in the market and learning from their ongoing studies to establish the right product.

Q:Review of Unclear Management Responses

A:Management appeared to avoid giving direct answers or lacked clarity on several questions, including: 1) The timing and specifics of international Pfizer litigation cases. 2) Detailed expectations for the TED data and its impact on their development strategy. 3) Specific updates or data from their overseas study with 1402. 4) The percentage of U.S. doses given to federal employees in the Moderna litigation. 5) Analog comparisons for the DM launch and its expected cadence.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

IMVT Transcript

Immunovant, Inc. (IMVT) Q2 2025 Earnings Call Transcript

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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.

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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.

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