Roivant Reports Financial Results for the Second Quarter Ended September 30, 2026, and Provides Business Update
LISRAYA generated its first commercial revenue, while quarterly net loss attributable to Roivant widened from a year earlier.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Roivant (Nasdaq: ROIV) reported second-quarter results with $31.0 million in LISRAYA net product revenue during its first five launch weeks. For the quarter ended September 30, 2026, net loss attributable to Roivant widened to $191.6 million from $113.5 million a year earlier. Cash, cash equivalents and marketable securities totaled $4.2 billion; the company expects this to support operations into profitability.
IMVT-1402 600 mg met its rheumatoid arthritis trial’s primary endpoint in the randomized withdrawal period, but the 300 mg dose did not differ from placebo. Brepocitinib met the primary and all key secondary endpoints in both Phase 3 non-infectious uveitis trials; Priovant plans a supplemental approval application in the first half of 2027. Mosliciguat met Phase 2 endpoints, and its Phase 3 study has started. Immunovant expects further Sjögren’s disease development beyond the ongoing Phase 2 trial is unlikely.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointIMVT-1402 600 mg achieved 92.5% versus 75.6% placebo ACR20 response at Week 28, meeting the primary endpoint (p=0.0139).
- Major pointBrepocitinib met primary and all key secondary endpoints in both Phase 3 non-infectious uveitis trials.
- Major pointMosliciguat met its Phase 2 primary endpoint: 56.3% placebo-adjusted reduction in pulmonary vascular resistance at Week 16.
- Moderate pointLISRAYA generated $31.0 million in its first five launch weeks, versus no product revenue a year earlier.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Roivant expects its $4.2 billion cash, cash equivalents and marketable securities to support operations into profitability.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects potentially registrational IMVT-1402 results in 2027 for Graves’ disease and myasthenia gravis.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects potentially registrational IMVT-1402 results in chronic inflammatory demyelinating polyneuropathy in 2028.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Priovant plans a supplemental brepocitinib application for non-infectious uveitis in the first half of 2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Priovant expects Phase 3 cutaneous sarcoidosis topline data in 2028.
- Moderate pointMosliciguat’s Phase 3 PHrontier study has started, with enrollment underway.
- Moderate pointGenevant and Arbutus received $950 million from Moderna in July under the settlement. 3.4% of market cap
14 minor points
- Minor pointQuarterly net revenue rose to $35.121 million from $1.571 million a year earlier.
- Minor pointQuarterly research and development expenses fell to $145.7 million from $164.6 million a year earlier.
- Minor pointQuarterly continuing-operations loss narrowed to $153.0 million from $166.0 million a year earlier.
- Minor pointIMVT-1402 Period 2 reported no serious adverse events, Grade 3-or-higher treatment-emergent events or adverse-event discontinuations.
- Minor pointBrepocitinib median time to treatment failure exceeded 48 weeks versus approximately 12 weeks on placebo in both trials.
- Minor pointPooled brepocitinib steroid-free disease quiescence reached 62% versus 20% placebo at Week 48.
- Minor pointAmong eyes with baseline macular edema, pooled Week 48 resolution reached 42% versus 4.8% placebo.
- Minor pointBrepocitinib uveitis trials showed no new safety signals, with safety consistent with prior trials.
- Minor pointMosliciguat improved six-minute walking distance by 35.2 meters versus placebo at Week 16.
- Minor pointMosliciguat reduced the heart-strain marker NT-proBNP by 53.2% versus placebo at Week 16.
- Minor pointExploratory Week 24 mosliciguat results showed a 52.7-meter placebo-adjusted improvement in six-minute walking distance.
- Minor pointExploratory Week 24 mosliciguat results showed a 75.9% placebo-adjusted reduction in NT-proBNP.
- Minor pointMosliciguat cough incidence was 12.1% versus 18.2% placebo in Phase 2.
- Minor pointMosliciguat’s Phase 2 PHactor combination study with inhaled treprostinil is ongoing.
Negative
- Moderate pointQuarterly net loss attributable to Roivant widened to $191.6 million from $113.5 million a year earlier.
- Moderate pointIMVT-1402 300 mg showed no difference from placebo: Week 28 ACR20 response was 75.0% versus 75.6%.
- Moderate pointIMVT-1402 rheumatoid arthritis registration plans await FDA discussions later in 2026 to determine the path forward.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Immunovant expects further IMVT-1402 Sjögren’s development beyond the ongoing Phase 2 trial is unlikely.
- Moderate pointThe IMVT-1402 cutaneous lupus erythematosus study was discontinued in September 2026.
- Moderate point. Forward-looking: it has not happened yet and may not happen.An additional $1.3 billion Moderna settlement payment depends on an appeal outcome favorable to Genevant and Arbutus. 4.6% of market cap
5 minor points
- Minor pointQuarterly net loss attributable to Roivant per share widened to $0.27 from $0.17 a year earlier.
- Minor pointQuarterly selling, general and administrative expenses rose to $154.1 million from $143.1 million a year earlier.
- Minor pointContinuing-operations loss per share widened to $0.29 from $0.17 a year earlier.
- Minor pointGenevant equity-award distributions added $95.9 million to quarterly net loss attributable to Roivant.
- Minor pointIMVT-1402 600 mg secondary disease-activity endpoints only numerically favored treatment: p=0.1096 and p=0.1299.
Key Figures
- Net product revenue
- $31.0 million
- First 5 weeks of LISRAYA launch
- Cash, cash equivalents and marketable securities
- $4.2 billion
- As of September 30, 2026
- Net loss attributable to Roivant
- $191.6 million vs. $113.5 million
- Three months ended September 30, 2026 vs. 2025
- Moderna settlement initial payment
- $950 million
- Received by Genevant and Arbutus in July 2026 under the global settlement
- ACR20 response
- 92.5% vs. 75.6% placebo; p=0.0139
- IMVT-1402 600 mg, Week 28
- Steroid-free quiescence
- 62% vs. 20% placebo; p<0.0001
- Pooled CLARITY studies, Week 48
- Placebo-adjusted PVR reduction
- -56.3%; p<0.0001
- Mosliciguat Phase 2 PHocus study, Week 16
- sNDA submission timing
- First half of calendar year 2027
- Brepocitinib for non-infectious uveitis
Key Terms
acr20 medical
snda regulatory
pulmonary vascular resistance medical
6mwd medical
nt-probnp medical
non-gaap financial
AI-generated analysis. How Rhea-AI works. Not financial advice.
- LISRAYA™ (brepocitinib) generated net product revenue of
$31.0 million in its first 5 weeks of launch following FDA approval in August 2026 - IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (
92.5% vs.75.6% placebo, p=0.0139) in Period 2 (randomized withdrawal design following open-label lead-in) of the potentially registrational trial in patients with difficult-to-treat rheumatoid arthritis (D2T RA); FDA discussions planned for later this year to determine the path forward regarding the registrational program for IMVT-1402 in D2T RA - Brepocitinib met the primary and all key secondary endpoints in the Phase 3 CLARITY-1 and CLARITY-2 trials in non-infectious uveitis (NIU); sNDA submission for NIU expected in the first half of calendar year 2027
- Mosliciguat demonstrated positive topline data in the Phase 2 PHocus study in pulmonary hypertension associated with interstitial lung disease (PH-ILD); Phase 3 PHrontier study initiated
- In light of the evolving Sjögren’s disease (SjD) landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial
- Roivant reported consolidated cash, cash equivalents and marketable securities of
$4.2 billion as of September 30, 2026, including the cash payment received from Moderna in July, supporting cash runway into profitability - Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026, to report its financial results for the second quarter ended September 30, 2026, and provide a business update
- Roivant will also host an Investor Day in New York City and virtually on December 9, 2026
BASEL, Switzerland and LONDON and NEW YORK, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2026, and provided a business update.
“This quarter has marked a major transition for Roivant. LISRAYA is now commercially available to patients and we are off to a strong start, with
Recent Developments
- Priovant: LISRAYA became commercially available in the U.S. in August 2026 and generated net product revenue of
$31.0 million in its first 5 weeks of launch.
Brepocitinib 45 mg once-daily achieved statistically significant benefit compared to placebo on the primary and all key secondary endpoints for each of CLARITY-1 and CLARITY-2, the two identical Phase 3 trials comprising the CLARITY program in NIU. Median time to treatment failure for brepocitinib patients was greater than 48 weeks in both studies, compared with ~12 weeks on placebo in each study (p<0.0001 in both studies), including 40 weeks of steroid-free treatment, setting a new bar for time to failure and steroid-sparing benefit in NIU. Pooled across the CLARITY studies,62% of patients on brepocitinib achieved steroid-free quiescence at Week 48, compared with20% on placebo (p<0.0001), with similar results in each study. Of patients that entered the CLARITY studies (pooled) with macular edema,42% of eyes on brepocitinib achieved resolution of macular edema at Week 48, compared with4.8% on placebo (p<0.0001), with similar results in each study. The magnitude and breadth of benefit observed across every ranked endpoint, compared with results reported in registrational trials of existing NIU therapies, suggest brepocitinib has the potential to be the most effective systemic, non-steroid treatment option for NIU. Safety data consistent with prior brepocitinib clinical trials; no new safety signals or findings. Priovant intends to file a supplemental New Drug Application (sNDA) for brepocitinib for the treatment of NIU in the first half of calendar year 2027.
Additionally, the Phase 3 study in cutaneous sarcoidosis (CS) and Phase 2b/3 study in lichen planopilaris (LPP) are progressing well.
- Immunovant: Following the open-label lead-in in Period 1 of the potentially registrational trial in patients with D2T RA, where a total of 170 participants were enrolled to receive IMVT-1402 600 mg for 16 weeks, study participants meeting the criteria for an ACR20 response at Weeks 14 and 16 were eligible to advance to Period 2 of the trial. A total of 117 participants were included in the Period 2 efficacy analysis and randomized to IMVT-1402 600 mg (n=40), IMVT-1402 300 mg (n=36), or placebo (n=41). IMVT-1402 600 mg met the primary endpoint of ACR20 response at Week 28 (
92.5% vs.75.6% placebo, p=0.0139). Participants randomized to IMVT-1402 300 mg did not show a difference from placebo, with75.0% maintaining an ACR20 response at Week 28 (p=0.9426). The secondary endpoints, change in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) from Period 2 baseline to Week 28, numerically favored IMVT-1402 600 mg over placebo (p=0.1096 and p=0.1299, respectively). In exploratory analyses, ACR50 response rates at Week 28 were80.0% for IMVT-1402 600 mg vs.56.1% for placebo (nominal p=0.0117), and ACR70 response rates were52.5% vs.36.6% (nominal p=0.1674); the trial was not powered to detect differences in these measures. IMVT-1402 was generally well tolerated in Period 2, with no serious adverse events, Grade 3 or higher treatment-emergent adverse events, or adverse events leading to treatment discontinuation reported in any arm. FDA discussions are planned for later this year to determine the path forward for the registrational program of IMVT-1402 in D2T RA.
In light of the evolving SjD landscape and recent data in the field, we expect it is unlikely that we will advance IMVT-1402 further in SjD beyond the ongoing, fully enrolled Phase 2 trial.
IMVT-1402 clinical development timelines remain on track across the potentially registrational trials in Graves’ disease (GD), myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP).
- Pulmovant: Mosliciguat demonstrated positive topline data in the Phase 2 PHocus study in PH-ILD; the study met its primary endpoint, demonstrating a clinically meaningful and statistically significant placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -
56.3% (p<0.0001) at Week 16, the highest ever reported PVR reduction in any randomized controlled PH trial. The study also met its secondary endpoints at Week 16 with a +35.2-meter placebo-adjusted improvement in six-minute walk distance (6MWD, p=0.0027) and a -53.2% (-357.7 pg/mL) placebo-adjusted reduction in N-terminal pro–B-type natriuretic peptide (NT-proBNP, p=0.0002), both clinically meaningful and statistically significant. Pre-specified exploratory Week 24 results showed continued placebo-adjusted improvements in 6MWD to +52.7m (nominal p<0.0001) and NT-proBNP to -75.9% (-487.1 pg/mL, nominal p<0.0001). Mosliciguat was observed to be well tolerated with a favorable safety profile, and compared with placebo, a lower proportion of patients experienced cough (12.1% mosliciguat vs.18.2% placebo), a common tolerability challenge with inhaled prostacyclins.
The Phase 3 PHrontier study of mosliciguat in patients with PH-ILD has been initiated, with enrollment underway.
- Genevant: In July 2026, Genevant Sciences GmbH (Genevant) and Arbutus received
$950 million from Moderna, the initial payment under the global$2.25 billion patent infringement settlement. Oral arguments on Moderna’s Section 1498 appeal took place on November 5, 2026. - Roivant: Roivant reported consolidated cash, cash equivalents and marketable securities of
$4.2 billion as of September 30, 2026, including the cash payment received from Moderna in July, supporting cash runway into profitability. For the three months ended September 30, 2026, Roivant repurchased 2.1 million common shares for an aggregate repurchase price of approximately$72.5 million .
Major Upcoming Milestones
- Priovant intends to file an sNDA for brepocitinib for the treatment of NIU in the first half of calendar year 2027 and expects topline data from the Phase 3 study in CS in calendar year 2028. Roivant continues to actively explore other indications for brepocitinib.
- Immunovant plans to meet with the FDA later this year to determine the path forward for the registrational program of IMVT-1402 in D2T RA. Immunovant expects to report topline data across potentially registrational trials of IMVT-1402 in GD and MG in calendar year 2027. In calendar year 2028, topline data are expected for the potentially registrational trial of IMVT-1402 in CIDP.
- Pulmovant Phase 3 PHrontier study of mosliciguat and Phase 2 PHactor study of mosliciguat in combination with inhaled treprostinil in PH-ILD are ongoing. Roivant continues to actively explore other indications for mosliciguat.
- Genevant LNP litigation continues to progress. An additional
$1.3 billion payment under the Moderna settlement is contingent upon a resolution of Moderna’s Section 1498 appeal favorable to Genevant and Arbutus. The Pfizer/BioNTech case is ongoing.
Second Quarter Ended September 30, 2026 Financial Summary
Cash Position and Marketable Securities
As of September 30, 2026, the Company had consolidated cash, cash equivalents, and marketable securities of
Product Revenue, Net
Product revenue, net was
Research and Development Expenses
Research and development (R&D) expenses decreased by
The decrease of
The majority of share-based compensation and personnel-related expenses, which are unallocated internal costs, were related to the anti-FcRn franchise activities at Immunovant during the three months ended September 30, 2026 and 2025. The decreases in Immunovant’s share-based compensation and personnel-related expenses compared to the same period in 2025 primarily resulted from lower headcount.
Adjusted R&D expenses (Non-GAAP) were
Selling, General and Administrative Expenses
Selling, general and administrative (SG&A) expenses increased by
Adjusted SG&A expenses (Non-GAAP) were
Loss from continuing operations, net of tax
Loss from continuing operations, net of tax was
Net loss attributable to Roivant Sciences Ltd.
Net loss attributable to Roivant was
| ROIVANT SCIENCES LTD. Selected Balance Sheet Data (unaudited, in thousands) | |||||
| September 30, 2026 | March 31, 2026 | ||||
| Cash and cash equivalents | $ | 1,642,266 | $ | 1,419,232 | |
| Marketable securities | 2,565,320 | 2,872,601 | |||
| Litigation settlement receivable | — | 770,235 | |||
| Total assets | 4,975,824 | 5,708,687 | |||
| Total liabilities | 380,104 | 416,275 | |||
| Total shareholders’ equity | 4,595,720 | 5,292,412 | |||
| Total liabilities and shareholders’ equity | 4,975,824 | 5,708,687 | |||
| ROIVANT SCIENCES LTD. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended September 30, | Six Months Ended September 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Revenues: | |||||||||||||||
| Product revenue, net | $ | 30,969 | $ | — | $ | 30,969 | $ | — | |||||||
| License, milestone and other revenue | 4,152 | 1,571 | 5,594 | 3,741 | |||||||||||
| Revenues, net | 35,121 | 1,571 | 36,563 | 3,741 | |||||||||||
| Operating expenses: | |||||||||||||||
| Cost of revenues | 3,347 | 111 | 3,631 | 265 | |||||||||||
| Research and development (includes | 145,747 | 164,568 | 347,763 | 317,487 | |||||||||||
| Selling, general and administrative (includes | 154,076 | 143,125 | 319,603 | 277,144 | |||||||||||
| Total operating expenses | 303,170 | 307,804 | 670,997 | 594,896 | |||||||||||
| Gain on litigation settlement | — | — | 392 | — | |||||||||||
| Loss from operations | (268,049 | ) | (306,233 | ) | (634,042 | ) | (591,155 | ) | |||||||
| Change in fair value of investments | (60,292 | ) | (128,501 | ) | (96,929 | ) | (109,376 | ) | |||||||
| Change in fair value of liability instruments | — | 20,959 | — | 23,288 | |||||||||||
| Interest income | (41,612 | ) | (45,341 | ) | (78,534 | ) | (93,663 | ) | |||||||
| Other expense, net | 200 | 5,694 | 2,330 | 16,902 | |||||||||||
| Loss from continuing operations before income taxes | (166,345 | ) | (159,044 | ) | (460,909 | ) | (428,306 | ) | |||||||
| Income tax (benefit) expense | (13,371 | ) | 6,995 | (17,329 | ) | 11,644 | |||||||||
| Loss from continuing operations, net of tax | (152,974 | ) | (166,039 | ) | (443,580 | ) | (439,950 | ) | |||||||
| Income from discontinued operations, net of tax | 15,763 | — | 15,763 | — | |||||||||||
| Net loss | (137,211 | ) | (166,039 | ) | (427,817 | ) | (439,950 | ) | |||||||
| Net income (loss) attributable to noncontrolling interests | 54,408 | (52,520 | ) | (46,361 | ) | (103,076 | ) | ||||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (191,619 | ) | $ | (113,519 | ) | $ | (381,456 | ) | $ | (336,874 | ) | |||
| Amounts attributable to Roivant Sciences Ltd.: | |||||||||||||||
| Loss from continuing operations, net of tax | $ | (207,382 | ) | $ | (113,519 | ) | $ | (397,219 | ) | $ | (336,874 | ) | |||
| Income from discontinued operations, net of tax | 15,763 | — | 15,763 | — | |||||||||||
| Net loss attributable to Roivant Sciences Ltd. | $ | (191,619 | ) | $ | (113,519 | ) | $ | (381,456 | ) | $ | (336,874 | ) | |||
| Basic and diluted net loss per common share: | |||||||||||||||
| Loss from continuing operations, net of tax | $ | (0.29 | ) | $ | (0.17 | ) | $ | (0.55 | ) | $ | (0.49 | ) | |||
| Income from discontinued operations, net of tax | $ | 0.02 | $ | — | $ | 0.02 | $ | — | |||||||
| Net loss per common share—basic and diluted | $ | (0.27 | ) | $ | (0.17 | ) | $ | (0.53 | ) | $ | (0.49 | ) | |||
| Weighted average shares outstanding—basic and diluted | 722,751,617 | 680,947,866 | 721,769,574 | 680,619,200 | |||||||||||
| ROIVANT SCIENCES LTD. Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in thousands) | ||||||||||||||||||
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||
| Note | 2026 | 2025 | 2026 | 2025 | ||||||||||||||
| Loss from continuing operations, net of tax | $ | (152,974 | ) | $ | (166,039 | ) | $ | (443,580 | ) | $ | (439,950 | ) | ||||||
| Adjustments: | ||||||||||||||||||
| Research and development: | ||||||||||||||||||
| Share-based compensation | (1 | ) | 7,965 | 10,996 | 16,686 | 22,095 | ||||||||||||
| Depreciation and amortization | (2 | ) | 347 | 676 | 693 | 1,462 | ||||||||||||
| Selling, general and administrative: | ||||||||||||||||||
| Share-based compensation | (1 | ) | 71,332 | 70,825 | 145,953 | 141,904 | ||||||||||||
| Depreciation and amortization | (2 | ) | 257 | 246 | 511 | 558 | ||||||||||||
| Gain on litigation settlement | (3 | ) | — | — | (392 | ) | — | |||||||||||
| Other: | ||||||||||||||||||
| Change in fair value of investments | (4 | ) | (60,292 | ) | (128,501 | ) | (96,929 | ) | (109,376 | ) | ||||||||
| Change in fair value of liability instruments | (5 | ) | — | 20,959 | — | 23,288 | ||||||||||||
| Estimated income tax impact from adjustments | (6 | ) | — | 3,059 | — | 2,116 | ||||||||||||
| Adjusted loss from continuing operations, net of tax (Non-GAAP) | $ | (133,365 | ) | $ | (187,779 | ) | $ | (377,058 | ) | $ | (357,903 | ) | ||||||
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||
| Note | 2026 | 2025 | 2026 | 2025 | ||||||||||
| Research and development expenses | $ | 145,747 | $ | 164,568 | $ | 347,763 | $ | 317,487 | ||||||
| Adjustments: | ||||||||||||||
| Share-based compensation | (1 | ) | 7,965 | 10,996 | 16,686 | 22,095 | ||||||||
| Depreciation and amortization | (2 | ) | 347 | 676 | 693 | 1,462 | ||||||||
| Adjusted research and development expenses (Non-GAAP) | $ | 137,435 | $ | 152,896 | $ | 330,384 | $ | 293,930 | ||||||
| Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||
| Note | 2026 | 2025 | 2026 | 2025 | ||||||||||
| Selling, general and administrative expenses | $ | 154,076 | $ | 143,125 | $ | 319,603 | $ | 277,144 | ||||||
| Adjustments: | ||||||||||||||
| Share-based compensation | (1 | ) | 71,332 | 70,825 | 145,953 | 141,904 | ||||||||
| Depreciation and amortization | (2 | ) | 257 | 246 | 511 | 558 | ||||||||
| Adjusted selling, general and administrative expenses (Non-GAAP) | $ | 82,487 | $ | 72,054 | $ | 173,139 | $ | 134,682 | ||||||
Notes to non-GAAP financial measures:
(1) Represents non-cash share-based compensation expense.
(2) Represents non-cash depreciation and amortization expense.
(3) As a result of the global settlement with Moderna entered in March 2026, the Company recognized a gain during the year ended March 31, 2026 for Genevant’s expected portion of a non-contingent, non-creditable and non-refundable payment. The Company recognized an additional gain during the six months ended September 30, 2026, reflecting the final determination of actual litigation costs incurred.
(4) Represents the unrealized gains on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings.
(5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.
(6) Represents the estimated tax effect of the adjustments.
Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, November 9, 2026, to report its financial results for the second quarter ended September 30, 2026, and provide a business update.
To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.
Roivant will also host an investor day on Wednesday, December 9, 2026. To attend the event in person or by webcast, please register online using this registration link.
About Roivant
Roivant (Nasdaq: ROIV) is a commercial-stage biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes LISRAYA™ (brepocitinib), a potent small molecule inhibitor of JAK1 and TYK2 FDA-approved for the treatment of dermatomyositis in adult patients and also in late-stage development for the treatment of non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris; IMVT-1402, a fully human monoclonal antibody targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. For more information, visit www.roivant.com.
Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.
Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product and product candidates, the availability and success of topline results from our ongoing clinical trials, the timing of potential regulatory approvals for our product and product candidates, any commercial potential of our product and product candidates following applicable regulatory approvals and the outcome of any pending litigation. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.
Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts:
Investors
Keyur Parekh
keyur.parekh@roivant.com
Media
Stephanie Lee
stephanie.lee@roivant.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much revenue did Roivant’s LISRAYA generate after launch?
LISRAYA generated $31.0 million in net product revenue during its first five weeks of launch. It became commercially available in the United States in August 2026 following FDA approval that month. Roivant had no product revenue in the comparable quarter of 2025.
What did Roivant’s IMVT-1402 rheumatoid arthritis trial show?
IMVT-1402 600 mg met the primary endpoint, with 92.5% maintaining an ACR20 response versus 75.6% on placebo at Week 28 (p=0.0139). ACR20 measures at least 20% improvement in rheumatoid arthritis symptoms and related measures. The 300 mg group did not differ from placebo.
How was the IMVT-1402 rheumatoid arthritis trial’s randomized period designed?
Only participants meeting the ACR20 response criteria at Weeks 14 and 16 after open-label treatment could advance to the randomized withdrawal period. Initially, 170 participants received 600 mg for 16 weeks. The Period 2 efficacy analysis included 117 participants: 40 assigned to 600 mg, 36 to 300 mg and 41 to placebo.
How did Genevant equity-award distributions affect Roivant’s quarterly loss?
Distributions on Genevant restricted stock units and options added $95.9 million to Roivant’s quarterly net loss attributable to shareholders. The awards participated through dividend-equivalent rights in the distribution of Moderna settlement proceeds. These distributions increased both basic and diluted net loss per common share by $0.13.