Roivant Sciences Ltd.

11/09/2026 | Press release | Distributed by Public on 11/09/2026 06:37

Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our (1) unaudited condensed consolidated financial statements and notes to those statements included in this Quarterly Report on Form 10-Q ("Quarterly Report") and (2) audited consolidated financial statements and notes to those statements and management's discussion and analysis of financial condition and results of operations for the fiscal year ended March 31, 2026, included in our Annual Report on Form 10-K, filed with the SEC on May 20, 2026 (the "Annual Report"). Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties. Roivant's actual results may differ materially from those anticipated in these forward-looking statements as a result of many factors. Please see "Cautionary Note Regarding Forward-Looking Statements" in this Quarterly Report. Our fiscal year ends on March 31 and our fiscal quarters end on June 30, September 30 and December 31.
Overview
Roivant is a 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.
Pipeline
The following table summarizes selected commercial and development-stage product candidates from our pipeline:
Product Candidate Indication Vant Modality Phase
Brepocitinib Dermatomyositis Priovant Small Molecule Commercial
Brepocitinib Non-Infectious Uveitis Priovant Small Molecule Phase 3 Completed*
Brepocitinib Cutaneous Sarcoidosis Priovant Small Molecule
Phase 3*
Brepocitinib Lichen Planopilaris Priovant Small Molecule Phase 2b/3*
IMVT-1402 Difficult-to-Treat
Rheumatoid Arthritis 		Immunovant Biologic Phase 2/3*
IMVT-1402 Graves' Disease Immunovant Biologic Phase 2/3*
IMVT-1402 Myasthenia Gravis Immunovant Biologic Phase 2/3*
IMVT-1402 Chronic Inflammatory Demyelinating Polyneuropathy Immunovant Biologic Phase 2/3*
Mosliciguat Pulmonary Hypertension associated with Interstitial Lung Disease Pulmovant Inhaled Phase 3
Note: All clinical stage product candidates in our current pipeline are investigational and subject to health authority approval. References to timing under "Phase" are to calendar years. The "Phase" for a specific product candidate referenced above reflects both ongoing clinical trials and expected upcoming trials.
*Indicates registrational or potentially registrational trials.
Vant Ownership
The following table summarizes our ownership of certain of our subsidiary companies and affiliates as of September 30, 2026.
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Roivant Ownership
Vant
Basic1
Fully Diluted2
Priovant 71 % 65 %
Immunovant 55 %
3
52 %
3
Pulmovant 95 % 90 %
Genevant4
83 % 64 %
Covant 96 % 90 %
Arbutus5
19 %
3
19 %
3
Note: In addition to the subsidiary companies and affiliates listed in the table above, Roivant continues to maintain ownership interests in certain other entities as previously disclosed, including Proxima (formerly VantAI), PsiThera (formerly Psivant) and Datavant, as well as the right to receive future milestones and royalties related to the sale of our subsidiary Dermavant in 2024.
1.Basic ownership refers to Roivant's percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity.
2.Fully diluted ownership refers to Roivant's percentage ownership of all outstanding equity interests of the entity, including unvested RSUs, options and warrants, in each case whether vested or unvested.
3.Denotes entities that are publicly traded.
4.The reference to "Genevant" in the table above is to Genevant Sciences Ltd. Please see Note 5, "Recent Transactions and Developments" for additional detail on the distribution to Genevant's non-Roivant equity holders, including Arbutus, of a portion of the $771.6 million Fixed Payment Genevant received from Moderna in July 2026.
5.In October 2026, following quarter-end, Roivant participated in a modified Dutch auction tender offer by Arbutus. Roivant tendered and had accepted by Arbutus a number of shares proportionate to its ownership interest in Arbutus and therefore continued to own approximately 19% of Arbutus on an issued and outstanding basis following the tender offer.
Upcoming Catalysts
In the upcoming year, we have a robust set of expected near-term catalysts, including the items set forth in the table below. In addition, we plan to in-license multiple potentially category-leading drugs per year.
Program Vant Catalyst Expected
Timing
Roivant pipeline growth Roivant New mid/late-stage in-licensing announcements Ongoing
Brepocitinib Priovant Supplemental New Drug Application filing for non-infectious uveitis 1H 2027
IMVT-1402 Immunovant Topline data from potentially registrational trials in Graves' disease 2027
IMVT-1402 Immunovant Topline data from potentially registrational trial in myasthenia gravis 2027
Multiple Programs Roivant Additional indication expansion 2027
IMVT-1402 Immunovant Topline data from potentially registrational trial in chronic inflammatory demyelinating polyneuropathy 2028
Brepocitinib Priovant Topline data from Phase 3 trial in cutaneous sarcoidosis 2028
Brepocitinib Priovant Topline data from Phase 2b/3 trial in lichen planopilaris TBC
Mosliciguat Pulmovant Topline data from Phase 3 trial in pulmonary hypertension associated with interstitial lung disease TBC
Note: References under "Expected Timing" are to calendar years. All catalyst timings are based on current expectations and, where applicable, contingent on FDA feedback, and may be subject to change.
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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 non-infectious uveitis ("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 with 20% 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 with 4.8% 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 difficult-to-treat rheumatoid arthritis ("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, with 75.0% 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 were 80.0% for IMVT-1402 600 mg vs. 56.1% for placebo (nominal p=0.0117), and ACR70 response rates were 52.5% 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 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.
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 pulmonary hypertension associated with interstitial lung disease ("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.
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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.
Components of Results of Operations
Product revenue, net
Following the approval by the FDA in August 2026 of LISRAYA for the treatment of adults with dermatomyositis, we began to recognize product revenue. We record product revenue net of variable consideration, which includes prompt payment discounts, government rebates, chargebacks, product returns and co-pay assistance for patients.
License, milestone and other revenue
License, milestone and other revenue primarily relates to amounts earned in connection with license agreements, as well as revenue generated by subscription and service-based fees.
Cost of revenues
Following the approval by the FDA in August 2026 of LISRAYA for the treatment of adults with dermatomyositis, we began to recognize cost of product revenue associated with sales of LISRAYA, which includes royalties payable on net product revenue. Cost of product revenue will include the cost of inventory sold once zero-cost basis inventory manufactured prior to FDA approval is exhausted.
Our cost of revenues also relates to subscription and service-based revenue recognized for the use of technology developed and consists primarily of employee, hosting and third-party data costs.
Research and development expenses
Research and development expenses consist mainly of costs incurred in connection with the discovery and development of our product candidates. Research and development expenses primarily include the following:
•Program-specific costs, including direct third-party costs, which include expenses incurred under agreements with contract research organizations ("CROs") and contract manufacturing organizations ("CMOs"), manufacturing costs in connection with producing materials for use in conducting nonclinical and clinical studies, the cost of consultants who assist with the development of our product candidates on a program-specific basis, investigator grants, sponsored research and any other third-party expenses directly attributable to the development of our product candidates.
•Unallocated internal costs, including:
•employee-related expenses, such as salaries, share-based compensation and benefits, for research and development personnel; and
•other research and development related expenses that are not allocated to a specific program.
Research and development activities will continue to be central to our business model. We anticipate that our research and development expenses will increase for the foreseeable future as we advance our product candidates with additional studies and our in-licensed assets through preclinical studies and clinical trials, as well as acquire or discover new product candidates.
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The duration, costs and timing of preclinical studies and clinical trials of our product candidates will depend on a variety of factors that include, but are not limited to, the following:
•the scope, rate of progress, expense and results of our preclinical development activities, any future clinical trials of our product candidates and other research and development activities that we may conduct;
•the number and scope of preclinical and clinical programs we decide to pursue;
•the uncertainties in clinical trial design and patient enrollment or drop out or discontinuation rates;
•the number of doses that patients receive;
•the countries in which the trials are conducted;
•our ability to secure and leverage adequate CRO support for the conduct of clinical trials;
•our ability to establish an appropriate safety and efficacy profile for our product candidates;
•the timing, receipt and terms of any approvals from applicable regulatory authorities;
•the potential additional safety monitoring or other studies requested by regulatory agencies;
•the significant and changing government regulation and regulatory guidance;
•our ability to establish clinical and commercial manufacturing capabilities, or make arrangements with third-party manufacturers in order to ensure that we or our third-party manufacturers are able to make product successfully; and
•our ability to maintain a continued acceptable safety profile of our product candidates following regulatory approval of our product candidates.
The successful development of our product candidates is highly uncertain, and we cannot reasonably estimate the costs that will be necessary to complete the remainder of the development of our product candidates. In addition, the probability of success for our product candidates will depend on numerous factors, including competition, manufacturing capability and commercial viability.
Selling, general and administrative expenses
Selling, general and administrative ("SG&A") expenses consist primarily of employee-related expenses, such as salaries, share-based compensation, sales incentive compensation and benefits, for employees engaged in SG&A activities. SG&A employees include those responsible for the identification and acquisition or in-license of new product candidates, as well as for managing Vant operations and facilitating the use of our platform and technologies at the Vants. SG&A expenses also consist of commercial and marketing activities, advertising, legal and accounting fees, consulting services and other operating costs relating to corporate matters and daily operations.
We expect SG&A expenses to increase in future periods as we continue to expand our sales and marketing infrastructure and general administrative functions. These increases will likely include salaries, sales incentive compensation, share-based compensation and travel expenses associated with our sales force, which began promoting LISRAYA in the U.S. following approval by the FDA in August 2026, as well as expected costs associated with the further build out of our commercial operations functions. We anticipate these expenses to further increase if any of our current or future product candidates receives regulatory approval in the U.S. or another jurisdiction.
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Additionally, in July 2024, the Compensation Committee of the board of directors approved a multi-year incentive compensation program for each of Matthew Gline, Chief Executive Officer; Mayukh Sukhatme, President and Chief Investment Officer; and Eric Venker, President and Immunovant CEO. In July 2025, the Compensation Committee also approved a multi-year incentive compensation program for Frank Torti, President and Vant Chair, in connection with his appointment as an executive officer of the Company. Collectively, these compensation arrangements are referred to herein as the "Senior Executive Compensation Program." The long-term equity incentive awards granted pursuant to this program will continue to result in significant share-based compensation expense over the vesting period of the awards. Refer to Note 9, "Share-Based Compensation" of our financial statements for further details.
Change in fair value of investments
Change in fair value of investments includes the unrealized gains on equity investments, including Arbutus Biopharma Corporation ("Arbutus") and Heracles Parent, L.L.C. ("Datavant"). We have elected the fair value option to account for these investments.
Interest income
Interest income consists of interest earned on our cash, cash equivalents and marketable securities.
Income tax (benefit) expense
Income tax (benefit) expense is recorded for the jurisdictions in which we do business. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and the respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded when, after consideration of all positive and negative evidence, it is not more likely than not that our deferred tax assets will be realizable. When uncertain tax positions exist, we recognize the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position and consideration of the available facts and circumstances.
Income from discontinued operations, net of tax
Income from discontinued operations, net of tax includes a gain resulting from the resolution of post-closing adjustments in July 2026 related to the sale of our entire equity interest in our majority-owned subsidiary, Dermavant Sciences Ltd., to Organon & Co. ("Organon") in October 2024.
Net income (loss) attributable to noncontrolling interests
Net income (loss) attributable to noncontrolling interests consists of the portion of net income (loss) of those consolidated entities that is not allocated to us. We record net income (loss) attributable to noncontrolling interests equal to the noncontrolling interest's proportionate share of the respective operations based on shareholders' rights. Refer to Note 13, "Net Loss per Common Share" of our financial statements for further details.
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Results of Operations
Comparison of the three and six months ended September 30, 2026 and 2025
The following table sets forth our results of operations for the three months ended September 30, 2026 and 2025:
Three Months Ended September 30,
2026 2025 Change
(in thousands)
Revenues:
Product revenue, net $ 30,969 $ - $ 30,969
License, milestone and other revenue 4,152 1,571 2,581
Revenues, net 35,121 1,571 33,550
Operating expenses:
Cost of revenues 3,347 111 3,236
Research and development 145,747 164,568 (18,821)
Selling, general and administrative 154,076 143,125 10,951
Total operating expenses 303,170 307,804 (4,634)
Loss from operations (268,049) (306,233) 38,184
Change in fair value of investments (60,292) (128,501) 68,209
Change in fair value of liability instruments - 20,959 (20,959)
Interest income (41,612) (45,341) 3,729
Other expense, net 200 5,694 (5,494)
Loss from continuing operations before income taxes (166,345) (159,044) (7,301)
Income tax (benefit) expense (13,371) 6,995 (20,366)
Loss from continuing operations, net of tax (152,974) (166,039) 13,065
Income from discontinued operations, net of tax 15,763 - 15,763
Net loss (137,211) (166,039) 28,828
Net income (loss) attributable to noncontrolling interests 54,408 (52,520) 106,928
Net loss attributable to Roivant Sciences Ltd. $ (191,619) $ (113,519) $ (78,100)
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The following table sets forth our results of operations for the six months ended September 30, 2026 and 2025:
Six Months Ended September 30,
2026 2025 Change
(in thousands)
Revenues:
Product revenue, net $ 30,969 $ - $ 30,969
License, milestone and other revenue 5,594 3,741 1,853
Revenues, net 36,563 3,741 32,822
Operating expenses:
Cost of revenues 3,631 265 3,366
Research and development 347,763 317,487 30,276
Selling, general and administrative 319,603 277,144 42,459
Total operating expenses 670,997 594,896 76,101
Gain on litigation settlement 392 - 392
Loss from operations (634,042) (591,155) (42,887)
Change in fair value of investments (96,929) (109,376) 12,447
Change in fair value of liability instruments - 23,288 (23,288)
Interest income (78,534) (93,663) 15,129
Other expense, net 2,330 16,902 (14,572)
Loss from continuing operations before income taxes (460,909) (428,306) (32,603)
Income tax (benefit) expense (17,329) 11,644 (28,973)
Loss from continuing operations, net of tax (443,580) (439,950) (3,630)
Income from discontinued operations, net of tax 15,763 - 15,763
Net loss (427,817) (439,950) 12,133
Net loss attributable to noncontrolling interests (46,361) (103,076) 56,715
Net loss attributable to Roivant Sciences Ltd. $ (381,456) $ (336,874) $ (44,582)
Variance analysis for the three and six months ended September 30, 2026 and 2025
Product revenue, net
Three Months Ended September 30, Six Months Ended September 30,
2026 2025 Change 2026 2025 Change
(in thousands) (in thousands)
Product revenue, net $ 30,969 $ - $ 30,969 $ 30,969 $ - $ 30,969
Product revenue, net was $31.0 million for the three and six months ended September 30, 2026, consisting of net product revenue from sales of LISRAYA in its first 5 weeks of launch following FDA approval in August 2026. We did not have product revenue for the three and six months ended September 30, 2025.
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Research and development expenses
For the three months ended September 30, 2026 and 2025, our research and development expenses consisted of the following:
Three Months Ended September 30,
2026 2025 Change
(in thousands)
Program-specific costs:
Anti-FcRn franchise-endocrine diseases $ 22,461 $ 24,895 $ (2,434)
Anti-FcRn franchise-neurological diseases 18,274 23,087 (4,813)
Anti-FcRn franchise-rheumatology diseases 9,864 13,611 (3,747)
Anti-FcRn franchise-dermatology diseases 648 7,952 (7,304)
Anti-FcRn franchise-other clinical and nonclinical 268 319 (51)
Brepocitinib 14,436 14,715 (279)
Mosliciguat 19,051 7,467 11,584
Other development and discovery programs 11,815 11,184 631
Total program-specific costs 96,817 103,230 (6,413)
Unallocated internal costs:
Share-based compensation 7,965 10,996 (3,031)
Personnel-related expenses 33,267 40,658 (7,391)
Other expenses 7,698 9,684 (1,986)
Total research and development expenses $ 145,747 $ 164,568 $ (18,821)
Research and development expenses decreased by $18.8 million to $145.7 million for the three months ended September 30, 2026, compared to $164.6 million for the three months ended September 30, 2025. This decrease was primarily driven by decreases in personnel-related expense of $7.4 million, program-specific costs of $6.4 million and share-based compensation of $3.0 million.
The decrease of $6.4 million in program-specific costs was primarily driven by a decrease of $18.3 million related to the anti-FcRn franchise. This decrease reflected lower costs for the IMVT-1402 study in cutaneous lupus erythematosus, which was discontinued in September 2026, the wind-down of batoclimab clinical trials and the timing of contract manufacturing costs. These decreases were partially offset by higher costs for ongoing clinical trials of IMVT-1402 in Graves' disease, and further offset by an increase of $11.6 million related to mosliciguat, reflecting the progression of the program.
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.
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For the six months ended September 30, 2026 and 2025, our research and development expenses consisted of the following:
Six Months Ended September 30,
2026 2025 Change
(in thousands)
Program-specific costs:
Anti-FcRn franchise-endocrine diseases $ 65,346 $ 44,224 $ 21,122
Anti-FcRn franchise-neurological diseases 43,729 44,024 (295)
Anti-FcRn franchise-rheumatology diseases 32,204 21,820 10,384
Anti-FcRn franchise-dermatology diseases 8,190 13,097 (4,907)
Anti-FcRn franchise-other clinical and nonclinical 2,877 2,711 166
Brepocitinib 28,528 29,735 (1,207)
Mosliciguat 32,092 15,852 16,240
Other development and discovery programs 22,933 21,420 1,513
Total program-specific costs 235,899 192,883 43,016
Unallocated internal costs:
Share-based compensation 16,686 22,095 (5,409)
Personnel-related expenses 79,621 83,188 (3,567)
Other expenses 15,557 19,321 (3,764)
Total research and development expenses $ 347,763 $ 317,487 $ 30,276
Research and development expenses increased by $30.3 million to $347.8 million for the six months ended September 30, 2026, compared to $317.5 million for the six months ended September 30, 2025. This increase was primarily driven by an increase in program-specific costs of $43.0 million, partially offset by decreases in share-based compensation of $5.4 million, other expenses of $3.8 million and personnel-related expenses of $3.6 million.
The increase of $43.0 million in program-specific costs was primarily driven by increases of $26.5 million related to the anti-FcRn franchise and $16.2 million related to mosliciguat, reflecting the progression of the IMVT-1402 and mosliciguat programs, partially offset by lower costs related to the wind-down of batoclimab clinical trials.
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 six 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.
Selling, general and administrative expenses
Three Months Ended September 30, Six Months Ended September 30,
2026 2025 Change 2026 2025 Change
(in thousands) (in thousands)
Selling, general and administrative expenses $ 154,076 $ 143,125 $ 10,951 $ 319,603 $ 277,144 $ 42,459
Selling, general and administrative expenses increased by $11.0 million to $154.1 million for the three months ended September 30, 2026, compared to $143.1 million for the three months ended September 30, 2025. This increase was primarily due to higher selling, general and administrative expenses as a result of the commercial launch of LISRAYA. This was partially offset by a decrease of $11.2 million due to expense recognized for one-time cash retention awards from the Senior Executive Compensation Program during the three months ended September 30, 2025.
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Selling, general and administrative expenses increased by $42.5 million to $319.6 million for the six months ended September 30, 2026, compared to $277.1 million for the six months ended September 30, 2025. This increase was primarily due to higher selling, general and administrative expenses as a result of the commercial launch of LISRAYA, along with other increased personnel-related expenses, including $18.8 million in employee bonuses related to the global settlement reached with Moderna in March 2026. These increases were partially offset by a decrease of $14.8 million due to expense recognized for one-time cash retention awards from the Senior Executive Compensation Program during the six months ended September 30, 2025.
A summary of selling, general and administrative expense relating to the one-time cash retention bonus award to its employees awarded during the year ended March 31, 2024 (the "Cash Bonus Program") and Senior Executive Compensation Program is as follows (in thousands):
Three Months Ended September 30, Six Months Ended September 30,
Remaining Expense as of September 30, 2026
2026 2025 2026 2025
(in thousands)
Cash Bonus Program $ - $ 2,399 $ - $ 4,510 $ -
Senior Executive Compensation Program:
Cash awards - 11,159 - 14,819 -
Performance restricted stock units(1)
40,796 36,404 79,073 66,561 62,700
Restricted stock units 3,384 3,401 6,745 5,708 46,114
Stock options 183 183 365 357 1,202
Total $ 44,363 $ 53,546 $ 86,183 $ 91,955 $ 110,016
(1) As of September 30, 2026, all performance restricted stock units have satisfied the Performance Condition and remain subject to the Service Condition and an additional two-year holding period, measured from their vesting date, before such common shares may be sold by the executive (subject to certain customary exceptions). Refer to Note 9, "Share-Based Compensation" of our financial statements for further details. The remaining expense of $62.7 million as of September 30, 2026 will be recognized through June 2027.
Change in fair value of investments
Three Months Ended September 30, Six Months Ended September 30,
2026 2025 Change 2026 2025 Change
(in thousands) (in thousands)
Change in fair value of investments $ (60,292) $ (128,501) $ 68,209 $ (96,929) $ (109,376) $ 12,447
Changes in fair value of investments were unrealized gains of $60.3 million and $128.5 million for the three months ended September 30, 2026 and 2025, respectively, which were driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant, due in part to growth in forecasted financial performance.
Changes in fair value of investments were unrealized gains of $96.9 million and $109.4 million for the six months ended September 30, 2026 and 2025, respectively, which were driven by changes in the public share price of Arbutus, as well as the change in the fair value of our investment in Datavant, due in part to growth in forecasted financial performance.
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Interest income
Three Months Ended September 30, Six Months Ended September 30,
2026 2025 Change 2026 2025 Change
(in thousands) (in thousands)
Interest income
$ (41,612) $ (45,341) $ 3,729 $ (78,534) $ (93,663) $ 15,129
Interest income decreased by $3.7 million to $41.6 million for the three months ended September 30, 2026, compared to $45.3 million for the three months ended September 30, 2025. The decrease was primarily due to lower interest rates, partially offset by higher average cash, cash equivalents and marketable securities balances in our interest-bearing accounts.
Interest income decreased by $15.1 million to $78.5 million for the six months ended September 30, 2026, compared to $93.7 million for the six months ended September 30, 2025. The decrease was primarily due to lower interest rates as well as lower average cash, cash equivalents and marketable securities balances in our interest-bearing accounts.
Income tax (benefit) expense
Three Months Ended September 30, Six Months Ended September 30,
2026 2025 Change 2026 2025 Change
(in thousands) (in thousands)
Income tax (benefit) expense $ (13,371) $ 6,995 $ (20,366) $ (17,329) $ 11,644 $ (28,973)
We recognized an income tax benefit of $13.4 million for the three months ended September 30, 2026, compared to income tax expense of $7.0 million for the three months ended September 30, 2025. The favorable change of $20.4 million was primarily due to the discrete tax consequences of the Fixed Payment Distribution (as defined below), as well as our fluctuating earnings by legal entity in various jurisdictions over the periods.
We recognized an income tax benefit of $17.3 million for the six months ended September 30, 2026, compared to income tax expense of $11.6 million for the six months ended September 30, 2025. The favorable change of $29.0 million was primarily due to the discrete tax consequences of the Fixed Payment Distribution (as defined below), as well as our fluctuating earnings by legal entity in various jurisdictions over the periods.
Liquidity and Capital Resources
For the six months ended September 30, 2026 and 2025, we incurred net losses from continuing operations of $443.6 million and $440.0 million, respectively. As of September 30, 2026, we had cash, cash equivalents and marketable securities of approximately $4.2 billion and our accumulated deficit was approximately $1.2 billion. Through our subsidiary Priovant, we launched our commercial product LISRAYA, following approval by the FDA in August 2026 and began generating product revenue, net from sales of LISRAYA in the U.S. We believe our existing cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital expenditures for the foreseeable future. However, projections of future cash flows and operating expenses are inherently uncertain and subject to changes, as described under "Risk Factors" in Part I, Item 1A. in our Annual Report for the year ended March 31, 2026. As a result, our existing cash, cash equivalents and marketable securities may not be sufficient to fund our operating expenses as anticipated, and we may need to raise additional capital to fund our operations.
Our short-term and long-term liquidity requirements as of September 30, 2026 included:
•obligations under our leases (refer to Note 11, "Leases" in our Annual Report for the year ended March 31, 2026 for further information regarding our lease commitments);
•certain non-cancelable contractual costs accrued as a result of the discontinuation of batoclimab of $42.5 million, which were recognized as research and development expense in prior fiscal years; and
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•certain commitments pursuant to an agreement entered by Immunovant in April 2026 that includes provisions for minimum obligations for the contract manufacturing of IMVT-1402 drug substance. As of September 30, 2026, the minimum commitment was approximately $22.8 million, of which $4.2 million and $18.6 million are expected to be paid during the fiscal years ending March 31, 2027 and 2028, respectively. The agreement includes a variable component whereby service prices may be adjusted based on related commitments for raw materials and other costs, and annual inflationary changes in an applicable price index.
Beyond this, we do not currently have any other material contractually obligated minimum purchases or firm non-cancelable purchase commitments. We anticipate other purchases in the ordinary course of business and have other payment obligations as discussed below.
Additionally, we have certain payment obligations under various asset acquisition and license agreements. Under these agreements we are required to make milestone payments upon successful completion and achievement of certain development, regulatory and commercial milestones. The payment obligations under the asset acquisition and license agreements are contingent upon future events, such as the achievement of specified development, regulatory and commercial milestones, and the amount, timing and likelihood of such payments are not known. We will also be required to make milestone payments and royalty payments in connection with the sale of products developed under these agreements.
Following the approval of LISRAYA by the FDA in August 2026, we began incurring a tiered, sub-teens royalty payable to Pfizer on net sales of LISRAYA pursuant to the terms of the license and collaboration agreement entered into between Priovant and Pfizer in September 2021. We are also obligated to pay Pfizer a one-time mid-tens-of-million dollars sales milestone payment if net sales of LISRAYA in a given year exceed a mid-hundreds-of-millions dollars amount. We expect to enter into additional asset acquisition and license agreements in the future, which may require upfront payments and long-term commitments of capital resources.
We enter into agreements with contract service providers to assist in the performance of our research and development activities. Expenditures to contract research organizations and contract manufacturing organizations represent significant costs in the clinical development of our product candidates. Subject to required notice periods and certain obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. We expect to enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require upfront payments and long-term commitments of capital resources.
Our board of directors has authorized various share repurchase programs, including a $1.5 billion (excluding fees and expenses) program that was completed in June 2025 and a subsequent program authorized in June 2025 and subsequently increased in March 2026, allowing for aggregate repurchases up to $1.0 billion (excluding fees and expenses). During the six months ended September 30, 2026, we repurchased 9,359,498 shares for an aggregate purchase price of approximately $281.2 million (including fees and expenses). Following these repurchases, approximately $609.3 million remains available for share repurchases. During the six months ended September 30, 2025, we repurchased 20,269,450 shares for an aggregate purchase price of approximately $208.3 million (including fees and expenses).
We have historically financed our operations primarily through the sale of equity securities, sale of subsidiary interests, debt financings and revenue generated from licensing and collaboration arrangements.
Pursuant to the Settlement Agreement with Moderna as described in Note 5, "Recent Transactions and Developments," of our financial statements, our subsidiary, Genevant Sciences GmbH ("Genevant"), received $771.6 million for its portion of the Fixed Payment on July 8, 2026. In July 2026, Genevant's parent, Genevant Sciences Ltd. ("GSL"), declared a dividend to GSL's shareholders. Holders of equity awards granted under the GSL 2018 Equity Incentive Plan, as amended, with dividend equivalent rights also participated pro rata in the dividend (the dividend and dividend equivalent rights, together, the "Fixed Payment Distribution"). The portion of the Fixed Payment Distribution attributable to non-RSL common shareholders and other equity award holders was $186.6 million (including $67.3 million to Arbutus), of which $179.1 million was paid as of September 30, 2026.
Additionally, as described in Note 7, "Certain Balance Sheet Components" of our financial statements, as of September 30, 2026, accrued compensation-related expenses included $22.9 million for employee bonuses related to the global settlement reached with Moderna.
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Funding Requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we advance the discovery efforts, preclinical activities, clinical trials and potential commercialization of our product candidates. Our operating results, including our net losses, may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our planned clinical trials, our expenditures on other research and development activities and our commercialization efforts. We anticipate our expenses will increase substantially as we:
•fund preclinical studies and clinical trials for our product candidates, which we are pursuing or may choose to pursue in the future;
•fund the manufacturing of drug substance and drug product of our product candidates in development;
•seek to identify, acquire, develop and commercialize additional product candidates;
•invest in activities related to the discovery of novel drugs and advancement of our internal programs;
•integrate acquired product candidates or technologies into a comprehensive regulatory and product development strategy;
•maintain, expand and protect our intellectual property portfolio;
•hire scientific, clinical, quality control and administrative personnel;
•add operational, financial and management information systems and personnel, including personnel to support our drug development efforts;
•achieve milestones under our agreements with third parties that will require us to make substantial payments to those parties;
•seek regulatory approvals for any product candidates that successfully complete clinical trials;
•build out our sales, marketing and distribution infrastructure and scale up external manufacturing capabilities to commercialize LISRAYA and any drug candidates for which we may obtain regulatory approval; and
•operate as a public company.
While we do not have a need for additional capital to continue our current operations as a result of our current liquidity position, we may in the future require additional capital to fund our operations, pursue business opportunities or strategic transactions or respond to challenges, competition or unforeseen circumstances. In that case, until such time, if ever, that we can generate substantial revenues, we may finance future cash needs through a combination of equity offerings, debt financings, strategic alliances and license and development agreements or other collaborations at Roivant and the Vants. To the extent that we raise additional capital by issuing equity securities at Roivant or the Vants, our existing shareholders' ownership, or our ownership in the Vants, may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that could harm the rights of our shareholders. Additionally, any agreements for future debt or preferred equity financings, if available, may involve covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations or strategic alliances or through marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our product and product candidates, future revenue streams, research programs or technologies or grant licenses on terms that may not be favorable to us. The foregoing restrictions associated with potential sources of additional capital may make it more difficult for us to raise additional capital, if needed, or to pursue business opportunities, including potential acquisitions.
While we do not have a near-term need for additional capital as a result of our current liquidity position, we may in the future require additional capital, and if adequate funds are not available to us, in that case, we may be required to forego potential in-licensing or acquisition opportunities, delay, limit or terminate one or more development or discovery programs, or be unable to expand operations or otherwise capitalize on business opportunities, which could materially affect our business, prospects, financial condition and results of operations.
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Finally, as part of our ongoing business strategy we regularly evaluate new acquisition and in-licensing opportunities, as well as our capital structure. We may from time to time use our existing cash to fund such opportunities or to return capital to shareholders through share repurchases or the issuance of cash dividends on our common shares to optimize our capital structure. See "Risk Factors-Risks Related to Our Business and Industry-We face risks associated with acquisitions, divestitures and other strategic transactions." in Part I, Item 1A. of our Annual Report for more information.
Cash Flows
The following table sets forth a summary of our cash flows for the six months ended September 30, 2026 and 2025:
Six Months Ended September 30,
2026 2025
(in thousands)
Net cash provided by (used in) operating activities $ 323,914 $ (390,047)
Net cash provided by (used in) investing activities $ 323,799 $ (965,294)
Net cash used in financing activities $ (430,724) $ (125,181)
Operating Activities
Cash flow from operating activities represents the cash receipts and disbursements related to all of our activities other than investing and financing activities. Cash flow from operating activities is derived from adjusting our net loss for non-cash items and changes in working capital.
For the six months ended September 30, 2026, cash flow from operating activities changed by $714.0 million to net cash provided by operating activities of $323.9 million for the six months ended September 30, 2026 from net cash used in operating activities of $390.0 million for the six months ended September 30, 2025. This change was primarily due to the receipt of Genevant's portion of the upfront litigation settlement payment from Moderna in July 2026, partially offset by increased spending to support commercialization activities for LISRAYA and to advance our research and development program for mosliciguat during the six months ended September 30, 2026.
Investing Activities
For the six months ended September 30, 2026, cash flow from investing activities changed by approximately $1.3 billion to net cash provided by investing activities of $323.8 million from net cash used in investing activities of $965.3 million for the six months ended September 30, 2025. This change was primarily due to a decrease in purchases of marketable securities, partially offset by a decrease in maturities of marketable securities during the six months ended September 30, 2026.
Financing Activities
For the six months ended September 30, 2026, cash used in financing activities increased by $305.5 million to $430.7 million compared to $125.2 million for the six months ended September 30, 2025. This increase was primarily due to a distribution made by Genevant Sciences Ltd. to common shareholders and other equity award holders in September 2026, an increase in repurchases of the Company's common shares and higher taxes paid related to net settlement of equity awards during the six months ended September 30, 2026.
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Critical Accounting Policies and Significant Judgments and Estimates
Our management's discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles ("U.S. GAAP"). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosures of contingencies as of the dates of the unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts or experience. Changes in estimates and assumptions are reflected in reported results in the period in which they become known.
We define our critical accounting policies as those under U.S. GAAP that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles.
Aside from the addition of estimates related to revenue recognition as discussed below, there have been no significant changes to our critical accounting policies and use of estimates from those disclosed under Management's Discussion and Analysis of Financial Condition and Results of Operations for the year ended March 31, 2026 in our Annual Report.
Revenue Recognition
Our accounting policy over revenue recognition for product revenue, net involves judgment and estimation. The amount of net product revenue we recognize is impacted by variable consideration, as described in Note 2, "Summary of Significant Accounting Policies" of our financial statements, including prompt payment discounts, government rebates, chargebacks, product returns and co-pay assistance for patients. Our gross-to-net estimates are based on contracts with our customers, contractual and statutory requirements under Medicaid, Medicare and other government programs, available industry data and, as our commercial experience with LISRAYA develops, our own sales information, including dispense data from our customers. The judgments and estimates involved in determining these variable consideration reserves are reviewed each reporting period, as all are subject to adjustment as new information becomes available.
Roivant Sciences Ltd. published this content on November 09, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on November 09, 2026 at 12:37 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]