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Roivant Sciences Ltd.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 6 August 2026: press release. Guidance figures: 3 new, 7 kept. The quarter’s numbers.

Key takeaways

  • Net loss widened to $290.6 million: The company reported a net loss of $290.6 million, or $0.26 per share, against a loss of $273.9 million, or $0.33 per share, a year earlier. Net loss attributable to Roivant Sciences Ltd. was $189.8 million. Source
  • R&D rose on program and bonus costs: R&D expense was $202.0 million, up $49.1 million. Program-specific costs rose $49.4 million, and personnel costs rose $3.8 million, including $4.1 million of Moderna settlement bonuses. Source
  • Dermatomyositis launch set for September: Commercial preparations for brepocitinib in dermatomyositis are described as progressing well, with launch targeted by the end of September 2026. The company describes this as a potential launch. Source
  • Cutaneous sarcoidosis Phase 3 enrolling: First patients were enrolled in BEACON+, a Part B to the Phase 2 BEACON trial. It randomizes patients 3:2 to brepocitinib 45mg or placebo, with a 50% CSAMI-A reduction at Week 16 as primary endpoint. Source
  • Moderna paid $950 million in July: Genevant and Arbutus received $950 million from Moderna in July 2026 under the $2.25 billion settlement. A further $1.3 billion is contingent on a favorable resolution of the Section 1498 appeal. Source
  • Suits filed against Pfizer and BioNTech: In July 2026 Genevant and Arbutus filed three international suits against Pfizer and BioNTech, one in Canada and two before the UPC, covering 21 jurisdictions in total on lipid nanoparticle patents. Source
  • Cash position of $3.9 billion: Cash, cash equivalents, restricted cash and marketable securities were $3.9 billion at June 30, 2026, excluding the July Moderna payment, down from $4.3 billion at March 31, 2026. Management cited cash runway into profitability. Source

“This quarter has been a moment of relative quiet between our incredibly busy last twelve months and our even busier year ahead,”

Matt Gline, CEO of Roivant

Guidance

AreaPeriodFigureAgainst last quarter
Commercial launch (brepocitinib, dermatomyositis) SourceBy end of September 2026by the end of September 2026Kept
Phase 3 topline data (non-infectious uveitis) SourceSecond half of calendar 2026second half of calendar year 2026Kept
Phase 3 topline data (cutaneous sarcoidosis) SourceCalendar 2028calendar year 2028New
Proof-of-concept topline data (cutaneous lupus) SourceSecond half of calendar 2026second half of calendar year 2026Kept
D2T RA program update (IMVT-1402) SourceSecond half of calendar 2026second half of calendar year 2026Kept
Phase 2 topline data (mosliciguat, PH-ILD) SourceSecond half of calendar 2026second half of calendar year 2026Kept
Registrational topline data (GD and MG, IMVT-1402) SourceCalendar 2027calendar year 2027Kept
Registrational topline data (CIDP and SjD, IMVT-1402) SourceCalendar 2028calendar year 2028New
Phase 3 enrollment (BEACON+, cutaneous sarcoidosis) SourcePhase 3 studyapproximately 140 patients across approximately 70 sitesNew
Contingent litigation payment (Moderna) SourceContingent on Section 1498 appeal$1.3 billionKept

What changed from last quarter

  • New guidance: Topline timing for the cutaneous sarcoidosis Phase 3 study is given as calendar 2028; the prior release gave no topline date. Source
  • New guidance: Topline timing for the CIDP and Sjögren's disease registrational trials of IMVT-1402 is given as calendar 2028; the prior release gave no date. Source
  • New: First patients were enrolled in the cutaneous sarcoidosis Phase 3 study; the prior release expected the program to start in the second half of 2026. Source
  • New: Genevant and Arbutus received the $950 million Moderna payment in July 2026, which the prior release had said would be paid in July 2026. Source
  • New: Genevant and Arbutus filed new international lawsuits against Pfizer and BioNTech in July 2026, not reported in the prior release. Source
  • New: The company repurchased 7.3 million common shares in the quarter, a buyback not reported in the prior release. Source

Results and cost drivers

  • Net loss widened to $290.6 million: The company reported a net loss of $290.6 million, or $0.26 per share, against a loss of $273.9 million, or $0.33 per share, a year earlier. Net loss attributable to Roivant Sciences Ltd. was $189.8 million. Source
  • Non-GAAP net loss was $243.7 million: Non-GAAP net loss was $243.7 million, against $170.1 million a year earlier. The measure excludes share-based compensation, depreciation and amortization, and a $36.6 million gain on equity investments. Source
  • R&D rose on program and bonus costs: R&D expense was $202.0 million, up $49.1 million. Program-specific costs rose $49.4 million, and personnel costs rose $3.8 million, including $4.1 million of Moderna settlement bonuses. Source
  • G&A rose on settlement bonuses: G&A expense was $165.5 million, up $31.5 million. The increase included $18.8 million of Moderna-related employee bonuses and $6.3 million of employer payroll taxes on equity awards. Source

Priovant brepocitinib programs

  • Dermatomyositis launch set for September: Commercial preparations for brepocitinib in dermatomyositis are described as progressing well, with launch targeted by the end of September 2026. The company describes this as a potential launch. Source
  • Cutaneous sarcoidosis Phase 3 enrolling: First patients were enrolled in BEACON+, a Part B to the Phase 2 BEACON trial. It randomizes patients 3:2 to brepocitinib 45mg or placebo, with a 50% CSAMI-A reduction at Week 16 as primary endpoint. Source
  • Phase 2 sarcoidosis result cited: In the Phase 2 study, 77% of patients on brepocitinib 45mg reached the 50% CSAMI-A endpoint at Week 16, against 0% on placebo. The FDA granted Breakthrough Therapy Designation for CS on this basis. Source

“Our teams are deep in preparation for the potential launch of brepocitinib in dermatomyositis,”

Matt Gline, CEO of Roivant

Immunovant and Pulmovant programs

  • IMVT-1402 timelines held on track: Timelines remain on track for IMVT-1402 across announced indications, including potentially registrational trials in GD, MG, CIDP, D2T RA and SjD, and a proof-of-concept trial in CLE. Source
  • Registrational readouts run to 2028: Potentially registrational topline data for IMVT-1402 are expected in 2027 for GD and MG, and in 2028 for CIDP and SjD. Source
  • CLE readout and D2T RA update due: Topline data from the CLE proof-of-concept trial are expected in the second half of calendar 2026. An update on the D2T RA potentially registrational program is also expected then. Source
  • Anti-FcRn costs drove program spend: Program-specific costs rose mainly because of the anti-FcRn franchise, which accounted for $44.8 million of the increase, reflecting the progression of the programs. Source
  • Mosliciguat PH-ILD on track: The Phase 2 study of mosliciguat in PH-ILD remains on track, with topline data expected in the second half of calendar 2026. Mosliciguat program costs rose $4.7 million in the quarter. Source

Genevant and Moderna settlement

  • Moderna paid $950 million in July: Genevant and Arbutus received $950 million from Moderna in July 2026 under the $2.25 billion settlement. A further $1.3 billion is contingent on a favorable resolution of the Section 1498 appeal. Source
  • Suits filed against Pfizer and BioNTech: In July 2026 Genevant and Arbutus filed three international suits against Pfizer and BioNTech, one in Canada and two before the UPC, covering 21 jurisdictions in total on lipid nanoparticle patents. Source
  • U.S. Pfizer case still in discovery: The discovery phase of the U.S. case against Pfizer and BioNTech is ongoing, the company said. Source

“if we are successful across even some of these endeavors, we will look radically different on the other side.”

Matt Gline, CEO of Roivant

Cash and share repurchases

  • Cash position of $3.9 billion: Cash, cash equivalents, restricted cash and marketable securities were $3.9 billion at June 30, 2026, excluding the July Moderna payment, down from $4.3 billion at March 31, 2026. Management cited cash runway into profitability. Source
  • Buybacks of 7.3 million shares: The company repurchased 7.3 million common shares for an aggregate price of approximately $208.7 million in the three months ended June 30, 2026. Source
  • Weighted share count rose: Weighted average basic and diluted shares were 720.8 million, against 680.3 million a year earlier. Source

Pipeline breadth and subsidiary model

  • Non-infectious uveitis readout pending: Topline data from the Phase 3 study of brepocitinib in non-infectious uveitis are expected in the second half of calendar 2026. Source
  • Lichen planopilaris enrollment progressing: Enrollment in Part 1 of the Phase 2b/3 study of brepocitinib in lichen planopilaris is progressing well. Source
  • Other brepocitinib indications explored: The company continues to actively explore other indications for brepocitinib beyond the programs listed. Source
  • Vant subsidiary model: Roivant says it advances its pipeline by creating nimble subsidiaries, called Vants, to develop and commercialize its medicines and technologies. Source

Coming up, as management said on 6 August 2026

  • Dermatomyositis launch by September end: Launch of brepocitinib in dermatomyositis is expected by the end of September 2026. Source
  • Uveitis Phase 3 topline data: Topline data from the Phase 3 study in non-infectious uveitis are expected in the second half of calendar 2026. Source
  • CLE readout and D2T RA update: Immunovant expects to report topline data from the proof-of-concept trial of IMVT-1402 in CLE in the second half of calendar 2026, with a D2T RA update in the same period. Source
  • Mosliciguat PH-ILD topline data: Topline data from the ongoing Phase 2 trial of mosliciguat in PH-ILD are expected in the second half of calendar 2026. Source
  • Moderna appeal decides further payment: The additional $1.3 billion depends on the outcome of Moderna's Section 1498 appeal. Source
  • Registrational readouts in 2027: Topline data across potentially registrational IMVT-1402 trials in GD and MG are expected in calendar 2027. Source
  • Brepocitinib indication work continues: The company continues to explore other brepocitinib indications. Source

Figures management reported

FigureReported
GAAP R&D expense Source$202.0 million, three months ended June 30, 2026
Non-GAAP R&D expense Source$192.9 million
Brepocitinib dermatomyositis launch Sourceby end of September 2026
Regulatory status, brepocitinib DM Sourceunder FDA review
Phase 3 cutaneous sarcoidosis enrollment Sourceapproximately 140 patients, approximately 70 sites
Phase 2 cutaneous sarcoidosis response Source77% vs 0% placebo
Trial readouts, second half 2026 SourceNIU Phase 3, CLE proof-of-concept, PH-ILD Phase 2
Patent litigation settlement (Moderna) Source$2.25 billion

Risks management discussed

  • Regulatory: Brepocitinib is described as under FDA review for dermatomyositis, so the launch is described as potential rather than confirmed. Source
  • Financial: A further $1.3 billion from the Moderna settlement depends on a favorable outcome of Moderna's Section 1498 appeal. Source
  • External: The U.S. Pfizer and BioNTech patent case remains in its discovery phase. Source

Earlier plans management reported on

  • On track: Management said launch preparations are on track for launch by the end of September 2026. Source
  • On track: Management said timelines remain on track across announced IMVT-1402 indications. Source
  • On track: Management said the mosliciguat Phase 2 study remains on track for topline data in the second half of 2026. Source
  • Met: The prior release said Moderna would pay $950 million in July 2026; the current release reports receipt in July. Source
  • Not stated: The prior release expected the Phase 3 program to start in the second half of 2026; first patients are now enrolled. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.