Immunovant's Q2 2026 Earnings Call: Contradictions Emerge on Graves' Disease Strategy, ACPA's Role in RA, FcRn Prioritization, and TED Patient Focus

Guidance:

• NDA filing for brepocitinib (DM) planned in H1 2026.
• NIU study readout guided to H1 2027, with potential brepocitinib registration/launch around that period and an sNDA for NIU shortly thereafter.
• TED topline will be reported together with a second TED study (hold until second study readout in the first half of next year).
• Moderna jury trial (LNP litigation) scheduled for March 2026; Pfizer case scheduling to be clarified soon.
• Cash position $4.4B, no debt, supports pipeline to profitability and potential additional capital return (including $500M authorized).

Business Commentary:

* Transformative Data in Dermatomyositis: - Roivant Sciences presented positive Phase III data for brepocitinib in dermatomyositis, with statistically significant outcomes across primary and secondary endpoints. - The VALOR trial showed a rapid and deep response with a clear dose response, setting the stage for 30 mg as the optimal dose. - The positive results align with a significant unmet need in the dermatomyositis patient population, with 75% on steroids or immunesuppressive therapies.

• Graves' Disease and Immunovant 1402:
• Immunovant's Graves' disease trial demonstrated disease-modifying potential with a 12-week high-dose followed by a 12-week low-dose batoclimab regimen.
• More than 75% of patients achieved TRAb normalization after six months off drug, with nearly half fully off ATDs.

• This success is attributed to the deeper IgG reduction and TRAb lowering effects seen with high-dose FcRn therapy.

• LNP Litigation and Intellectual Property:

• Roivant Sciences made progress in the LNP litigation, with a favorable market ruling in the Pfizer case and ongoing international proceedings.
• The Moderna case is in a pretrial phase, with summary judgment briefings under review by the judge.

• The litigation's resolution remains crucial for Roivant's future, impacting potential licensing and product development.

• Pipeline Expansion and Future Growth:

• Roivant Sciences is advancing multiple registrational trials in various indications, including potential registrational trials in Graves', myasthenia gravis, CIDP, D2T RA, and Sjögren’s.
• The company has a robust late-stage pipeline with 11 potentially registrational trials, setting the stage for multiple product launches and increased revenue streams.
• This expansion is supported by significant capital, with $4.4 billion in cash and cash equivalents, ensuring financial stability for further pipeline development.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management repeatedly described the quarter and data as transformative and positive: "phenomenal quarter," "tremendous moment of transformation," and highlighted strong execution on VALOR and Graves' data. Financial strength cited: "cash and cash equivalents, which will get our current pipeline to profitability" and "$4.4 billion of cash and cash equivalents, which will get our current pipeline to profitability and support pipeline expansion and potential additional capital return."

Q&A:

• Question from David Risinger (Leerink Partners LLC, Research Division): Could you please comment on what we should be watching next with respect to Pfizer litigation, so specifically in international markets and then in the U.S.?
  Response: Limited public comment; key near-term item is the Pfizer case scheduling—watch for a trial date and docket schedule; international timelines are uncertain.

• Question from Lut Ming Cheng (JPMorgan Chase & Co, Research Division): How do you feel about argenx stepping into Graves' and whether that has any impact on your strategy of 1402?
  Response: Competition validates the market; we believe high-dose batoclimab's deeper IgG reductions (above 70%) drove better outcomes and expect a competitive profile based on depth of IgG suppression.

• Question from Lut Ming Cheng (JPMorgan Chase & Co, Research Division): On the Investor Day next month, what do you want investors to get out of it—broader recap or new data/strategic direction?
  Response: Investor Day will present the company's transformed profile and commercial strategy, patient need and blockbuster opportunity; may include additional updates but primarily a forward-looking narrative.

• Question from Samantha Semenkow (Citigroup Inc., Research Division): For Graves', can you tease out the impact of starting on high‑dose batoclimab on remission rates and competitive implications?
  Response: Deeper IgG reductions from high-dose therapy are viewed as a key driver of remission and TRAb normalization; management is confident high‑dose suppression is meaningful.

• Question from Yaron Werber (TD Cowen, Research Division): Any thoughts on the Moderna summary judgment issue re: U.S. government involvement in EUA and the 1498 defense?
  Response: Cannot opine in detail; management notes the 1498 issue likely affects only a small fraction of claimed damages and that the judge will decide on the matter.

• Question from Prakhar Agrawal (Cantor Fitzgerald & Co., Research Division): On Sjögren's, how can FcRns differentiate vs ianalumab and could you be first‑in‑class? Also, any plan to apply for FDA priority/rare vouchers for brepo?
  Response: FcRn's deeper IgG suppression could yield best‑in‑class differentiation; they aim to be as close to first‑in‑class as possible but won't promise to beat competitors; priority/voucher options are being evaluated.

• Question from Corinne Jenkins (Goldman Sachs Group, Inc., Research Division): How are you thinking about the evolving competitive clinical landscape in Graves' and any BD update?
  Response: FcRn mechanism is well suited, safe/tolerable and likely to be early‑line; competitive activity is constructive; BD: well capitalized and actively evaluating large, value‑creating pipeline expansion opportunities.

• Question from Yuchen Ding (Jefferies LLC, Research Division): On Pulmovant, how confident about translatability from PH to PH‑ILD and expected PVR delta? And second, what percent of U.S. doses went to federal employees for the LNP litigation?
  Response: Cautiously optimistic—PVR reductions have generally translated and mosliciguat addresses V/Q mismatch risk; expect meaningful PVR reductions but await Phase IIb data. On federal‑employee dosing, estimates aren't in motions but likely a relatively small percentage.

• Question from Yuchen Ding (Jefferies LLC, Research Division): Status of OUS trials in the LNP litigation—how many cases filed, which is furthest along, and potential for initial decisions in 2026?
  Response: Multiple OUS actions filed (Europe UPC, Canada, Japan, others); hearings and proceedings are ongoing with some European jurisdictions capable of delivering outcomes in 2026.

• Question from Dominic (Piper Sandler): What are your expectations for the TED studies reading out soon and what would you need to see to pursue development given the competitive landscape?
  Response: Competitive bar in TED is high (IGF‑1R efficacy); management will assess TED data for efficacy and safety versus competitors and will decide on batoclimab development/launch with partner after reviewing those results.

• Question from Douglas Tsao (H.C. Wainwright & Co, LLC, Research Division): How are you thinking about pursuing TED with 1402 versus using batoclimab—concern about dual‑molecule approach and sequencing?
  Response: Will wait for TED data to inform strategy; different prescribers and disease stages may favor different approaches; Graves' is larger and upstream, which guided initial 1402 focus.

• Question from Douglas Tsao (H.C. Wainwright & Co, LLC, Research Division): Have you considered brepo for other myositis subtypes (e.g., IMM)?
  Response: Yes—management has evaluated many indications; brepo has shown activity broadly and there are multiple attractive opportunities to pursue.

• Question from Hao Shen (Wells Fargo Securities, LLC, Research Division): How do you see the DM treatment paradigm evolving vs VYVGART and CAR‑T, and will brepo be explored in other myositis subtypes?
  Response: Oral therapies like brepo align with most patients' current oral treatment patterns and offer a large opportunity; CAR‑T is a different intervention for different patients; they expect a multiyear head start and intend to define the market while considering other subtypes.

• Question from Thomas Smith (Leerink Partners LLC, Research Division): Comments on recent IL‑6 class TED data and approvability, and any update on overseas 1402 studies and timing for additional indications?
  Response: No comment on others' approvability; noted high placebo in IL‑6 study; overseas small, fast POCs are ongoing to inform registrational designs and indication selection—no new timing disclosed.

• Question from Brandon Frith (Wolfe Research, LLC): Any analogs for DM launch to model cadence out of the gate and longer term expectations?
  Response: Few good analogs for DM; will guide cautiously on launch pace; confident in large unmet need and long‑term upside but timing to peak uptake is uncertain.

• Question from Gaurav Maini (LifeSci Capital, LLC, Research Division): How do you size uncontrolled Graves' opportunity versus the MG FcRn market?
  Response: Hard to directly compare; management emphasizes a very large uncontrolled Graves' population (hundreds of thousands) and significant opportunity—more commercial detail to come at Investor Day.

Contradiction Point 1

Competitive Landscape and Strategy in Graves' Disease

It reflects a shift in the company's perspective on the competitive landscape in the Graves' disease market and its strategy in response to new competition.

What is your view on Argenx entering Graves' and its potential impact on your 1402 strategy? - Lut Ming Cheng (JPMorgan)

2026Q2: Welcome to competition in Graves' space, validates our strategy. We have high-dose data showing benefit and will continue to study in Graves' and other indications. - Matthew Gline(CEO)

Can you provide an update on the additional benefits and timeline for TED trial results from the ATA meeting? - Miriam (JPMorgan)

2025Q2: In terms of competition, we believe that the thyroid eye disease space is relatively empty at the moment... There is no approved therapies for thyroid eye disease. - Peter Salzmann(CEO)

Contradiction Point 2

Importance and Impact of ACPA Antibodies in RA Pathogenesis

It highlights a discrepancy in the company's understanding and emphasis on the role of ACPA antibodies in RA pathogenesis and their relevance to potential therapies.

Can you discuss the market potential for Sjögren’s syndrome and the opportunities with FcRn technology? - Prakhar Agrawal (Cantor Fitzgerald)

2026Q2: We believe that the ACPA positive cohort is a more homogeneous and clinically relevant cohort. - Matthew Gline(CEO)

What is the significance of ACPA antibodies in RA pathogenesis compared to other pathways like TH17 cells? - Andy Chan (Wolfe Research)

2025Q2: The heterogeneity and contribution of ACPA to RA pathogenesis are still largely unknown. - Peter Taylor(CSO)

Contradiction Point 3

FcRn Indication Prioritization and Strategy

It highlights changes in the company's approach towards indication prioritization and strategic focus, which are critical for resource allocation and market positioning.

How do you view Argenx entering Graves' and whether this impacts your 1402 strategy? - Lut Ming Cheng (JPMorgan)

2026Q2: We have high-dose data showing benefit and will continue to study in Graves' and other indications. - Matthew Gline(CEO)

What is the rationale for selecting development indications, and will either of the two upcoming pivotal trials target indications beyond MG, TED, and WAIHA? - Trepan (Robyn Karnauskas with Truist Securities)

2022Q1: We select indications based on the probability of technical success and unmet need. One of our indications beyond MG will begin with a pivotal trial in 2022. - Pete Salzmann(CEO)

Contradiction Point 4

TED Indication and Patient Population Focus

It involves differing views on the focus of the patient population for TED indication, which could impact drug development and commercialization strategies.

How are you evaluating TED's development between 1402 and batoclimab, considering argenx's dual-market approach? - Douglas Tsao(H.C. Wainwright)

2026Q2: We'll consider the different patient populations and physician bases. - Matthew Gline(CEO)

Can you discuss regulatory discussions with the FDA regarding TED and the enrollment criteria for Phase 3 trials? - Thomas Smith(SVB Securities)

2022Q4: Enrollment criteria will be the same as in previous pivotal programs, focusing on the moderate to severe spectrum, with no specific adjustments to attract a more moderate patient population. - Pete Salzmann(CEO)

Contradiction Point 5

TED Indication and Market Evolution

It involves changes in the company's perspective on the TED indication and market evolution, which are crucial for competitive positioning and market strategy.

How do you view Argenx's entry into Graves' and its impact on your 1402 strategy? - Lut Ming Cheng (JPMorgan)

2026Q2: We have high-dose data showing benefit and will continue to study in Graves' and other indications. - Matthew Gline(CEO)

Can you explain the rationale for selecting indications and whether one of the two upcoming pivotal trials will be beyond MG, TED, and WAIHA? - Trepan (Robyn Karnauskas with Truist Securities)

2022Q1: Regarding TED, the market is evolving with new medical therapies and potential combination treatments. 1401's unique profile and efficacy could lead to sequential treatment strategies, impacting the market's evolution. - Pete Salzmann(CEO)