ROIV 8-K Current Reports

Roivant Sciences 8-K Report, Regulation FD Disclosure (Oct 21, 2026)

Roivant Sciences Ltd. (ROIV) reported, via a press release furnished as Exhibit 99.1 to this Form 8-K, positive results from the Phase 3 CLARITY-1 and CLARITY-2 trials evaluating brepocitinib 45 mg once daily in non-infectious uveitis (NIU). The trials were conducted by its subsidiary Priovant Therapeutics, Inc. Brepocitinib achieved statistically significant benefit versus placebo on the primary endpoint (time to treatment failure) and all key secondary endpoints in both studies. Median time to treatment failure was greater than 48 weeks in both studies versus about 12 weeks on placebo (p<0.0001 in both). Pooled across the studies, 62% of brepocitinib patients achieved steroid-free quiescence at Week 48 versus 20% on placebo. The filing reports that 42% of eyes on brepocitinib achieved resolution of macular edema at Week 48 versus 4.8% on placebo (pooled, among patients with macular edema at baseline). Safety was described as consistent with prior brepocitinib trials with no new safety signals, and only 3% of participants discontinued treatment due to an adverse event. Priovant intends to file a supplemental New Drug Application for NIU in the first half of calendar 2027. The company also plans an investor call on October 21, 2026 and an investor day on December 9, 2026. The company describes brepocitinib, already approved as LISRAYA for adult dermatomyositis, as potentially the most effective systemic, non-steroid treatment option for NIU. Management's characterization of the results as a potential new standard of care is company-generated and the filing does not provide regulatory review outcomes or commercial projections.

Oct 21, 2026 8-K

Roivant Sciences 8-K Report, Shareholder Vote Results (Sep 18, 2026)

Roivant Sciences Ltd. held its 2026 Annual General Meeting of Shareholders on September 16, 2026. Holders of record of 652,143,869 common shares, representing approximately 90.3% of the 722,406,273 shares outstanding and entitled to vote as of the July 23, 2026 record date, were present in person or by proxy, which constituted a quorum. The filing states that all proposals on the agenda were approved. The matters are described in more detail in the proxy statement filed with the SEC on July 29, 2026. Shareholders re-elected Daniel Gold and Meghan FitzGerald as Class II directors, each to serve until the annual general meeting following the fiscal year ending March 31, 2029. Shareholders also ratified the appointment of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending March 31, 2027, and as its statutory auditor under the Bermuda Companies Act 1981. The ratification received 651,315,490 votes for, 731,364 against and 97,015 abstentions. On a non-binding advisory basis, shareholders approved the compensation of the company's named executive officers. The vote recorded 316,702,500 for, 269,062,122 against, 230,600 abstentions and 66,148,647 broker non-votes. The filing also lists a Cover Page Interactive Data File (Exhibit 104) as the only exhibit.

Sep 18, 2026 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 8, 2026)

Roivant Sciences Ltd. (ROIV) furnished a Form 8-K under Item 7.01 (Regulation FD Disclosure) announcing positive results from the Phase 2 PHocus clinical trial of mosliciguat, an inhaled sGC activator being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The trial was conducted by its subsidiary, Pulmovant, Inc., and the results were presented at the European Respiratory Society International Congress 2026. The study met its primary endpoint, with a placebo-adjusted reduction in pulmonary vascular resistance (PVR) of -56.3% at Week 16 (p<0.0001), and met its secondary endpoints of a placebo-adjusted improvement in six-minute walk distance (+35.2 meters, p=0.0027) and a placebo-adjusted reduction in NT-proBNP of -357.7 pg/mL (p=0.0002) at Week 16. In a pre-specified exploratory analysis, placebo-adjusted improvements at Week 24 reached +52.7 meters in 6MWD and -487.1 pg/mL (-75.9%) in NT-proBNP, both with nominal p<0.0001. The company reported that mosliciguat was well tolerated, with cough reported in 12.1% of mosliciguat patients versus 18.2% of placebo patients. The company also announced that the Phase 3 PHrontier study, designed to enroll approximately 375 patients, has been initiated and enrollment is underway. The filing is a furnished (not filed) disclosure, and the press release contains forward-looking statement language. Investors should note that the results are from a Phase 2 trial with a relatively small sample of 135 patients across 87 sites in 20 countries, and that the Phase 3 study is ongoing.

Sep 8, 2026 8-K

Roivant Sciences 8-K Report, Corporate Update (Aug 28, 2026)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on August 28, 2026 to report that the U.S. Food and Drug Administration approved LISRAYA (brepocitinib) for the treatment of adults with dermatomyositis (DM). The company posted an investor presentation on its investor relations website, filed as Exhibit 99.1. The filing states a wholesale acquisition cost of $35,000 for a 30-count bottle of 30 mg tablets. According to the presentation, LISRAYA is commercially available immediately upon approval, ahead of prior guidance calling for a launch by the end of September 2026. The presentation cites Phase 3 VALOR results, in which the 30 mg dose reached a mean Total Improvement Score (TIS) of 46.5 versus 31.2 for placebo at Week 52 (p = 0.0006), and TIS40 response rates of 67.9% versus 44.3%. The product carries a JAK-class boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. The presentation also describes a limited specialty pharmacy distribution network and expects adoption to build gradually given long-established prescribing patterns in DM. The presentation states that Priovant, a Roivant subsidiary, holds commercial rights to brepocitinib in the U.S. and Japan, and that Roivant owned 71% of Priovant as of June 30, 2026, with Pfizer owning 24%. Other pipeline indications for brepocitinib, including non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris, remain investigational.

Aug 28, 2026 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Aug 27, 2026)

Roivant Sciences Ltd. (Nasdaq: ROIV) announced in an 8-K filed August 27, 2026 that the U.S. Food and Drug Administration has approved LISRAYA™ (brepocitinib) 30 mg, a once-daily pill, for the treatment of adults with dermatomyositis (DM). The New Drug Application was submitted by the company's subsidiary, Priovant Therapeutics, Inc. The press release states the drug is available immediately in the U.S. through a limited specialty pharmacy distribution network, and that eligible patients may pay as little as $0 per month through the LISRAYA My Compass Support program. The filing cites results from the Phase 3 VALOR trial, which the company describes as the largest DM trial ever conducted. Per the release, 55% of LISRAYA-treated patients achieved moderate or better improvement on the myositis Total Improvement Score and minimal or no steroid use by the end of the 52-week study, compared with 30% on placebo. Among patients taking at least 7.5 mg/day of oral corticosteroids at baseline, 62% tapered to 2.5 mg/day or less, compared with 38% on placebo. The label carries a boxed warning covering serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis. The company also stated that its late-stage programs in non-infectious uveitis, cutaneous sarcoidosis and lichen planopilaris continue, and that it will host an investor conference call at 8:00 a.m. ET on August 28, 2026. The press release is furnished under Item 7.01 and is not deemed filed for purposes of Section 18 of the Exchange Act.

Aug 27, 2026 8-K

Roivant Sciences 8-K Report, Financial Results (Aug 6, 2026)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fiscal quarter ended June 30, 2026, and provided a business update in a press release furnished as Exhibit 99.1 under Item 2.02 of this Form 8-K. Research and development expenses rose $49.1 million to $202.0 million, and general and administrative expenses rose $31.5 million to $165.5 million, compared with the prior-year quarter. Net loss was $290.6 million, or $0.26 per common share, versus $273.9 million, or $0.33 per share, a year earlier. Net loss attributable to Roivant Sciences Ltd. was $189.8 million, compared with $223.4 million. Non-GAAP net loss was $243.7 million, versus $170.1 million. The company reported consolidated cash, cash equivalents, restricted cash and marketable securities of $3.9 billion as of June 30, 2026, excluding the cash payment received from Moderna in July. The update centers on near-term pipeline catalysts. Priovant expects commercial launch of brepocitinib in dermatomyositis by the end of September 2026, with Phase 3 topline data in non-infectious uveitis expected in the second half of calendar 2026. The first patients were enrolled in the Phase 3 BEACON+ study in cutaneous sarcoidosis, with topline data expected in calendar 2028. Immunovant expects proof-of-concept topline data for IMVT-1402 in cutaneous lupus erythematosus in the second half of 2026, and Pulmovant expects Phase 2 topline data for mosliciguat in PH-ILD in the same period. In July 2026, Genevant and Arbutus received $950 million from Moderna, the initial payment under a global $2.25 billion patent settlement, and an additional $1.3 billion is contingent on a favorable resolution of Moderna's Section 1498 appeal. Genevant and Arbutus also filed three international lawsuits against Pfizer and BioNTech covering 21 jurisdictions. Balance sheet data show total assets of $5.31 billion at June 30, 2026, down from $5.71 billion at March 31, 2026, and total shareholders' equity of $4.92 billion, down from $5.29 billion.

Aug 6, 2026 8-K

Earnings & ResultsRegulation FDExhibits & Filings

Roivant Sciences 8-K Report, Financial Results (May 20, 2026)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fourth quarter and fiscal year ended March 31, 2026, and provided a business update. As of March 31, 2026, consolidated cash, cash equivalents and marketable securities were $4.3 billion. For the three months ended March 31, 2026, the company reported income from continuing operations, net of tax, of $355.7 million ($0.43 basic per share), driven mainly by a $770.2 million gain on litigation settlement tied to the Moderna settlement. For the full fiscal year, loss from continuing operations, net of tax, was $397.9 million, compared with $729.8 million a year earlier, and non-GAAP loss from continuing operations was $747.7 million. Revenue for the year was $8.3 million, and R&D expenses rose to $681.8 million, reflecting higher program-specific costs across the anti-FcRn franchise, mosliciguat and brepocitinib. The filing highlights several clinical and regulatory catalysts. Immunovant's IMVT-1402 showed a 72.7% ACR20 response rate at Week 16 in the open-label Period 1 of its difficult-to-treat rheumatoid arthritis trial, and further updates are expected in the second half of calendar 2026. Priovant's brepocitinib received Priority Review for dermatomyositis with a target action date in the third quarter of calendar 2026, with commercial launch expected by the end of September 2026, and it was granted Breakthrough Therapy Designation in cutaneous sarcoidosis. Pulmovant's mosliciguat Phase 2 PHocus study completed enrollment of 135 subjects, with topline data expected in the second half of 2026. The $2.25 billion global settlement with Moderna ends pending patent-infringement litigation brought by Genevant and Arbutus. Moderna is to pay $950 million in July 2026, with an additional $1.3 billion contingent on resolution of Moderna's Section 1498 appeal. The company also discontinued batoclimab after two Phase 3 studies in thyroid eye disease did not meet their primary endpoint in April 2026.

May 20, 2026 8-K

Roivant Sciences 8-K Report, Financial Results (Apr 2, 2026)

Roivant Sciences Ltd. (ROIV) furnished an 8-K on April 2, 2026 reporting preliminary, unaudited consolidated cash, cash equivalents and marketable securities of approximately $4.3 billion as of March 31, 2026. For the three months ended March 31, 2026, the company repurchased 3,956,362 common shares for an aggregate purchase price of approximately $109.7 million (excluding fees and commission). The filing states that the audit of financial statements for the fiscal year ended March 31, 2026 is ongoing and could change this information. The press release furnished under Item 7.01 announces a new seamless Phase 2b/3 potentially registrational trial of brepocitinib (Priovant) in lichen planopilaris (LPP), with first subjects enrolled in March 2026. LPP is described as the fourth late-stage indication for brepocitinib, alongside dermatomyositis (DM), non-infectious uveitis (NIU) and cutaneous sarcoidosis (CS). The FDA granted Priority Review to the brepocitinib NDA for DM with a PDUFA target action date in the third quarter of calendar 2026. The release also reports that Immunovant's two Phase 3 GO studies of batoclimab in active, moderate-to-severe thyroid eye disease failed to meet their primary endpoint of a 2mm proptosis responder rate at Week 24, with consistent safety and no new safety signals. Immunovant will review future batoclimab plans with partner HanAll Biopharma, and it is prioritizing IMVT-1402, with topline Graves' disease data expected in calendar 2027.

Apr 2, 2026 8-K/A

Material AgreementsExhibits & Filings

Roivant Sciences 8-K/A Report, Material Agreement (Mar 23, 2026)

Roivant Sciences Ltd. (ROIV) has filed Amendment No. 1 on Form 8-K/A to its Current Report originally filed March 3, 2026. The sole purpose of this amendment is to file the Settlement Agreement, dated March 3, 2026, as Exhibit 10.1, as the Original 8-K had said a copy would be filed later. No other changes are made to the Original 8-K. The Settlement Agreement is among Genevant Sciences GmbH, a Roivant subsidiary, Arbutus Biopharma Corp., and, solely for certain purposes, Genevant Sciences Ltd., on one side, and Moderna, Inc. and ModernaTx, Inc. on the other. It resolves all patent infringement litigation between Genevant/Arbutus and Moderna, pending in the U.S. and internationally, relating to Moderna's use of Genevant/Arbutus' lipid nanoparticle delivery technology in its vaccines. The filing states that portions of the exhibit have been omitted under Item 601(b)(10)(iv) of Regulation S-K because they are not material and are the type the Company treats as private or confidential, and that certain exhibits and schedules have been omitted under Item 601(a)(5). The filing does not disclose settlement payment terms in the text provided.

Mar 23, 2026 8-K

Material AgreementsRegulation FDOther Events+1

Roivant Sciences 8-K Report, Material Agreement (Mar 3, 2026)

Roivant Sciences Ltd. (ROIV) reported on March 3, 2026 that its subsidiary Genevant Sciences GmbH, together with Arbutus Biopharma Corp., entered into a settlement agreement with Moderna, Inc. and ModernaTx, Inc. resolving all patent infringement litigation over Moderna's use of Genevant/Arbutus lipid nanoparticle (LNP) delivery technology in its vaccines, including Spikevax. The settlement is valued at $2.25 billion in total, consisting of a $950.0 million noncontingent lump sum payable by July 8, 2026, and an additional $1.3 billion contingent payment tied to the outcome of Moderna's appeal on whether 28 U.S.C. §1498 bars the infringement claims for doses sold to the U.S. Government. If the appellate court rules for Genevant/Arbutus, or Moderna does not timely appeal, the full $1.3 billion is payable; if the ruling is partial, the payment is prorated based on the affected doses. Under the settlement, Genevant/Arbutus also grants Moderna a fully paid-up, royalty-free, non-exclusive license and covenant not to sue covering certain products, and the parties exchange customary mutual releases. Separately, Roivant's board authorized an increase in its common share repurchase program to up to $1.0 billion (excluding fees and expenses), inclusive of the previously announced $500 million authorization. The program will be funded with available cash and cash equivalents, has no expiration date, and may be executed through tender offers, open market purchases, privately negotiated transactions, or Rule 10b5-1 trading plans. The company stated that the program may be suspended or discontinued at any time. The press release notes that Pfizer/BioNTech litigation remains ongoing in the United States following a favorable Markman ruling issued in September 2025. The full settlement agreement will be filed as an exhibit to Roivant's Annual Report on Form 10-K for the fiscal year ending March 31, 2026, or earlier.

Mar 3, 2026 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Mar 3, 2026)

Roivant Sciences Ltd. (ROIV) furnished a Form 8-K dated March 3, 2026, under Item 7.01 (Regulation FD Disclosure), attaching a press release issued by its subsidiary Priovant Therapeutics. The release announces that the U.S. Food and Drug Administration has accepted the New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted it Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026, and the company expects to launch the drug in the United States at the end of September 2026. The Priority Review designation was supported by the results of the Phase 3 VALOR study, which enrolled 241 subjects across 90 sites and is described as the longest and largest interventional DM trial to date and the first positive 52-week placebo-controlled study in DM. Brepocitinib 30 mg met the primary endpoint of myositis Total Improvement Score (TIS) at Week 52 versus placebo and improved all nine Key Secondary endpoints. The release notes that serious infections increased on brepocitinib 30 mg compared with placebo, and that these events resolved with medical management in most cases. The information is furnished rather than filed, so it is not subject to the liabilities of Section 18 of the Exchange Act or Sections 11 and 12(a)(2) of the Securities Act. The filing contains no financial statements or financial results.

Mar 3, 2026 8-K

Roivant Sciences 8-K Report, Financial Results (Feb 6, 2026)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on February 6, 2026 to furnish Exhibit 99.1, a press release announcing positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS) and financial results for the fiscal quarter ended December 31, 2025. In the BEACON study (31 patients), the 45 mg arm achieved a 22.3-point mean improvement in CSAMI-A at Week 16 versus a 0.7-point improvement for placebo (Δ21.6, P<0.0001). Priovant plans a Phase 3 CS study starting in calendar 2026, and an NDA for brepocitinib in dermatomyositis has been submitted to the FDA. Financially, the quarter showed a loss from continuing operations, net of tax, of $313.7 million, compared with $208.9 million a year earlier. R&D expenses rose to $165.4 million from $141.6 million, and G&A expenses rose to $175.1 million from $141.5 million, including a $17.1 million impairment tied to the relocation of Roivant Sciences, Inc.'s U.S. headquarters. Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $4.5 billion as of December 31, 2025, which the company says supports cash runway into profitability. Across the pipeline, Immunovant's D2T RA and CLE trials are expected to read out in the second half of 2026, and Immunovant financing generated gross proceeds of approximately $550 million. Pulmovant's mosliciguat PH-ILD Phase 2 trial is fully enrolled with topline data expected in the second half of 2026. In litigation, a favorable summary judgment decision in the U.S. Moderna case was reported, with a jury trial scheduled for March 2026.

Feb 6, 2026 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Dec 11, 2025)

Roivant Sciences Ltd. (Nasdaq: ROIV) furnished this Form 8-K under Item 7.01 (Regulation FD) on December 11, 2025, in connection with its 2025 Investor Day. The filing attaches a press release (Exhibit 99.1) and the Investor Day presentation (Exhibit 99.2). Both exhibits are furnished, not filed, for Section 18 purposes. The headline update is a set of accelerated timing guidance across four programs. The brepocitinib NDA filing in dermatomyositis (DM) is now expected in early calendar 2026, with commercial launch expected early in calendar 2027. The Phase 3 CLARITY trial in non-infectious uveitis (NIU) is fully enrolled, with topline data now expected in the second half of calendar 2026, versus prior guidance of the first half of 2027. The brepocitinib proof-of-concept trial in cutaneous sarcoidosis (CS) is fully enrolled, with topline data now expected in the first half of 2026, versus prior guidance of the second half of 2026. The IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) now has topline data expected in calendar 2026, previously expected as Period 1 data in 2026 and topline in 2027. Management also highlighted financial and strategic points. A Roivant-led financing at Immunovant generated gross proceeds to Immunovant of approximately $550 million, which the company says extends Immunovant's cash runway to the launch of IMVT-1402 in Graves' disease. The presentation cites $4.4 billion of cash, cash equivalents, restricted cash and marketable securities as of September 30, 2025, and a $1.5 billion share repurchase with an additional $500 million authorized. Management states that its cash balance supports runway into profitability and that all other pipeline programs remain on track.

Dec 11, 2025 8-K

Roivant Sciences 8-K Report, Financial Results (Nov 10, 2025)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the quarter ended September 30, 2025, and provided a business update. The company's headline clinical news is that brepocitinib 30 mg met the primary endpoint and all nine key secondary endpoints versus placebo in the Phase 3 VALOR study in dermatomyositis, with an NDA filing planned for the first half of calendar year 2026. CEO Matt Gline described the quarter as "a moment of transformation" for the company. Immunovant's 24-week uncontrolled Graves' disease study also showed what the filing calls a first-ever potentially disease-modifying outcome, based on six-month off-treatment data. On financials, research and development expenses rose to $164.6 million from $143.1 million, driven mainly by program-specific costs and personnel-related expenses tied to the anti-FcRn franchise and brepocitinib. General and administrative expenses fell to $143.1 million from $202.9 million, mainly because the prior-year quarter included one-time cash retention awards. Loss from continuing operations, net of tax, was $166.0 million, or $0.17 per share, compared with $236.8 million, or $0.25 per share, a year earlier. The company reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.4 billion as of September 30, 2025, which it says supports cash runway into profitability. The filing also outlines a dense set of milestones. These include a brepocitinib proof-of-concept readout in cutaneous sarcoidosis in the second half of calendar year 2026, a Phase 3 non-infectious uveitis readout in the first half of 2027, and two batoclimab thyroid eye disease Phase 3 studies now expected to read out concurrently in the first half of 2026. Genevant's LNP litigation continues, with a jury trial in the U.S. Moderna case scheduled for March 2026. Roivant will hold an Investor Day on December 11, 2025.

Nov 10, 2025 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 17, 2025)

Roivant Sciences Ltd. (ROIV) furnished an 8-K on September 17, 2025 announcing positive results from the Phase 3 VALOR study of brepocitinib in dermatomyositis (DM), conducted at its subsidiary Priovant Therapeutics. On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 versus 31.2 for placebo (p=0.0006). The company states the result is the first positive outcome for a 52-week placebo-controlled trial in DM and the first positive registrational trial for a targeted therapy in DM. Brepocitinib 30 mg also showed statistically significant improvement over placebo on all nine key secondary endpoints, and the 15 mg and 30 mg arms showed a consistent dose response. The filing reports that 62% of brepocitinib 30 mg patients on background steroids reached a steroid dose of 2.5 mg/day or less by the end of the study, versus 34% on placebo, and 42% came off steroids altogether versus 23% on placebo. Adverse events of special interest, including malignancy, cardiovascular events and thromboembolic events, did not occur more frequently on 30 mg than on placebo. Priovant plans to file a New Drug Application (NDA) in the first half of 2026. Roivant also posted a presentation for an 8:00 a.m. EDT investor call on September 17, 2025, and attached it as Exhibit 99.2. The presentation notes an upcoming Roivant investor day on December 11, 2025, and ties the DM readout to a planned FDA filing in 1H 2026.

Sep 17, 2025 8-K

Roivant Sciences 8-K Report, Shareholder Vote Results (Sep 11, 2025)

Roivant Sciences Ltd. (ROIV) reported on Form 8-K that it held its 2025 Annual General Meeting of Shareholders on September 10, 2025. Of 682,519,374 common shares outstanding and entitled to vote as of the July 17, 2025 record date, holders of 628,673,675 common shares were present in person or by proxy. Shareholders approved all three proposals described in the Company's Proxy Statement. Shareholders re-elected Matthew Gline, Keith Manchester, and Melissa Epperly as Class I directors, each to serve until the annual general meeting following the fiscal year ending March 31, 2028. Shareholders also ratified Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending March 31, 2026, and as statutory auditor under the Bermuda Companies Act 1981. On a non-binding advisory basis, shareholders approved the compensation of the named executive officers, though the vote against was substantial relative to the vote for. The filing contains no financial statements, operating results, or guidance. Its investor relevance is governance-related: board composition, auditor continuity, and shareholder sentiment on executive pay, with further detail deferred to the Proxy Statement.

Sep 11, 2025 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 3, 2025)

Roivant Sciences Ltd. (ROIV) reported on September 3, 2025 an update on the Graves' disease proof-of-concept study of batoclimab at its subsidiary Immunovant, Inc. (Nasdaq: IMVT). Of 21 patients who entered the 24-week off-treatment follow-up, ~80% (17/21) maintained T3/T4 values at or below the upper limit of normal at Week 48. Of those 17 responders, ~50% (8/17) were in anti-thyroid drug (ATD)-free remission, and an incremental ~30% (5/17) were on ATD doses of 2.5 mg/day. The company states that safety and tolerability were consistent with prior batoclimab studies. The company describes these results as the first-ever potentially disease-modifying therapy for uncontrolled Graves' disease patients, though the study enrolled 25 patients and the filing presents the data as an abstract to be presented at the 2025 American Thyroid Association Annual Meeting on September 11, 2025. The filing also highlights the lead compound IMVT-1402, for which two potentially registrational trials in Graves' disease are enrolling, with topline readouts expected in 2027. The trials will evaluate a 600 mg dose for up to 52 weeks without a step-down in dose, which the company says is designed to potentially improve efficacy relative to batoclimab's step-down regimen. Roivant hosted an investor conference call and webcast at 4:30 p.m. EDT on September 3, 2025, and posted a presentation on its investor relations website. The Item 7.01 and Item 8.01 disclosures are furnished rather than filed under the Exchange Act, and the filing's forward-looking statements warn that early trial results may not predict later outcomes and that Immunovant will require additional capital.

Sep 3, 2025 8-K

Roivant Sciences 8-K Report, Financial Results (Aug 11, 2025)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the quarter ended June 30, 2025, in a press release attached as Exhibit 99.1 to this Form 8-K. The company reported revenue of $2.2 million, compared with $8.0 million a year earlier, and a loss from continuing operations, net of tax, of $273.9 million, or $0.33 per share, versus income of $31.6 million in the prior-year period. Research and development expenses rose to $152.9 million from $120.5 million, and general and administrative expenses rose to $134.0 million from $99.9 million. The filing attributes the G&A increase mainly to a $34.2 million rise in share-based compensation tied to long-term equity incentive awards. Non-GAAP loss from continuing operations was $170.1 million, compared with $107.1 million a year earlier. Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of $4.5 billion at June 30, 2025, which it says supports cash runway into profitability. The company completed its $1.5 billion share repurchase program, including $208 million of repurchases in the quarter, and reduced outstanding shares by over 15% from March 31, 2024. The board approved a new $500 million repurchase program in June 2025. The filing highlights several clinical and legal catalysts. The Phase 3 VALOR study of brepocitinib in dermatomyositis is expected to read out topline data in the second half of calendar 2025, with last patient last visit completed in July. Other expected readouts include brepocitinib in cutaneous sarcoidosis in the second half of 2026 and in non-infectious uveitis in the first half of 2027. In the LNP litigation, a jury trial in the U.S. Moderna case is scheduled for March 2026.

Aug 11, 2025 8-K

Roivant Sciences 8-K Report, Corporate Update (Jun 25, 2025)

Roivant Sciences Ltd. (ROIV) disclosed in this Form 8-K, filed June 25, 2025, that its board of directors authorized on June 24, 2025 a new common share repurchase program of up to $500 million (excluding fees and expenses). The authorization is in addition to the $1.5 billion repurchase program announced in April 2024, which had approximately $205 million of remaining capacity as of March 31, 2025 and has since been fully exhausted. The new program will be funded with available cash and cash equivalents on hand and has no expiration date. The timing and total amount of repurchases will depend on factors including the market price of the common shares, general business, macroeconomic and market conditions, and other investment opportunities. Purchases may be made through open market transactions, tender offers, or privately negotiated transactions, including Rule 10b5-1 trading plans. The company may suspend or discontinue the program at any time, and it gives no assurance as to how many shares will be repurchased or at what prices. The filing's only other item is Item 9.01, which lists a Cover Page Interactive Data File (Inline XBRL) as the exhibit.

Jun 25, 2025 8-K

Roivant Sciences 8-K Report, Financial Results (May 29, 2025)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fourth quarter and fiscal year ended March 31, 2025, and provided a business update in this Form 8-K furnished under Item 2.02 (Exhibit 99.1 press release). For the fiscal year, the company reported a loss from continuing operations, net of tax, of $729.8 million, compared with income from continuing operations of approximately $4.5 billion in the prior year, which included the Telavant sale gain. Income from discontinued operations, net of tax, was $373.0 million, reflecting the gain on the sale of its Dermavant interest to Organon in October 2024. Research and development expenses rose to $550.4 million and general and administrative expenses rose to $591.4 million for the year, driven largely by Immunovant personnel costs and share-based compensation. Consolidated cash, cash equivalents, restricted cash and marketable securities totaled approximately $4.9 billion at March 31, 2025. Capital allocation was a notable theme: Roivant repurchased $1.3 billion of its shares as of March 31, 2025, reducing outstanding shares by 14% from March 31, 2024. Management said the cash position supports cash runway into profitability. On the pipeline, the company highlighted the brepocitinib VALOR Phase 3 study in dermatomyositis, which is fully enrolled with topline data expected in the second half of calendar 2025, and an investor event on June 17, 2025. Immunovant is advancing IMVT-1402 across six indications under a new leadership team, and Genevant and Arbutus have expanded LNP patent litigation against Moderna internationally.

May 29, 2025 8-K

Leadership ChangesExhibits & Filings

Roivant Sciences 8-K Report, Regulation FD Disclosure (Apr 21, 2025)

Roivant Sciences Ltd. furnished a press release announcing leadership changes at its subsidiary Immunovant, Inc. and the expansion of IMVT-1402 into two new indications. Eric Venker, M.D., Roivant's President and an Immunovant director, was appointed CEO of Immunovant, and Tiago Girao, formerly Telavant CFO, succeeded Renee Barnett as CFO. Pete Salzmann, M.D. retired as CEO and director. The company describes the changes as part of a broader strategic transition, in which development activities for batoclimab are concluding and activity on IMVT-1402 is ramping up, with increased Roivant operational involvement and strategic oversight. On the pipeline, the filing states that an IND has been cleared for a potentially registrational program for IMVT-1402 in Sjögren's disease (SjD), its fifth indication, with the study expected to initiate in summer 2025. A proof-of-concept study in cutaneous lupus erythematosus (CLE), its sixth indication, has also been initiated. The company states that its current cash balance provides runway for the announced indications through a Graves' Disease readout expected in 2027. Board and governance changes include George Migausky stepping down from the Immunovant board, and Robert Susman and Jacob Bauer joining, effective April 18, 2025. Roivant will also take over all Immunovant investor relations activity, and it hosted an investor call on April 21, 2025 at 8:00 a.m. EDT.

Apr 21, 2025 8-K

Roivant Sciences 8-K Report, Executive Changes (Mar 20, 2025)

Roivant Sciences Ltd. (ROIV) filed this Current Report on Form 8-K on March 20, 2025 to disclose a change in its accounting leadership. Under Item 5.02, on March 16, 2025, its wholly-owned subsidiary Roivant Sciences, Inc. ("RSI") entered into a consulting agreement with Rakhi Kumar, its former Chief Accounting Officer. The filing notes that Ms. Kumar had stepped down from that role effective February 20, 2025, as previously disclosed in a Form 8-K filed on February 21, 2025. The consulting agreement has an 18-month term during which Ms. Kumar will provide advisory and transition services as reasonably requested by RSI. In consideration, she will remain eligible to continue vesting in her outstanding Company equity incentive awards during that term. At the end of the term, provided she has complied with her obligations and the agreement has not been earlier terminated, any outstanding and unvested equity awards will fully vest. The filing contains no financial statements and no financial figures. Its only exhibit is the cover page Interactive Data File embedded in the Inline XBRL document. For investors, the filing is a routine executive transition disclosure that documents continuity of transition support and a retention-style equity arrangement for a departing officer.

Mar 20, 2025 8-K

Leadership ChangesExhibits & Filings

Roivant Sciences 8-K Report, Regulation FD Disclosure (Mar 19, 2025)

Roivant Sciences Ltd. (ROIV) furnished this Form 8-K on March 19, 2025 to report an update on the myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) programs at its subsidiary, Immunovant, Inc. (Nasdaq: IMVT). The press release (Exhibit 99.1) states that the Phase 3 MG study of batoclimab met its primary endpoint of mean change from baseline in MG-ADL in AChR+ participants at Week 12: a 5.6-point improvement at the 680mg weekly dose (74% mean IgG reduction), a 4.7-point improvement at 340mg weekly (64% mean IgG reduction), and a 3.6-point improvement with placebo. Initial pooled Period 1 data from the Phase 2b CIDP study, covering 73 patients, showed a 1.8-point mean improvement in adjusted INCAT at Week 12 and an 84% responder rate among patients with IgG reduction of at least 70%. Immunovant stated that it does not currently intend to seek regulatory approval for batoclimab in MG or CIDP. It will instead focus on its lead asset, IMVT-1402, and plans to begin potentially registrational studies in both indications, with INDs cleared for both. The final decision on batoclimab regulatory submissions will wait for results from the ongoing Phase 3 thyroid eye disease studies. The CIDP study has not been unblinded, so no primary endpoint data from Period 2 are available yet. The filing also includes a presentation (Exhibit 99.2) that describes safety as consistent with prior batoclimab studies, reports treatment-related serious TEAEs in 2 of 57 patients on 680mg (3.5%) and one death in the placebo arm, and includes cross-trial comparisons with other FcRn inhibitors. The company itself cautions that these comparisons are not head-to-head.

Mar 19, 2025 8-K

Roivant Sciences 8-K Report, Executive Changes (Feb 21, 2025)

Roivant Sciences Ltd. (ROIV) filed this Current Report on Form 8-K under Item 5.02, reporting a leadership change in its finance function. Rakhi Kumar stepped down as Principal Accounting Officer of Roivant Sciences Ltd. and as Chief Accounting Officer of its subsidiary, Roivant Sciences, Inc. (RSI), effective February 20, 2025. The company thanked Ms. Kumar for her many years of service. Jennifer Humes was appointed to succeed her as Principal Accounting Officer of the Company and Chief Accounting Officer of RSI, effective the same date. Ms. Humes most recently served as a Managing Director at JPMorgan Chase from September 2016 to December 2024, where she led a team of more than 80 controllers covering the global investment banking businesses. Earlier roles include Senior Vice President at Citigroup (2013 to 2016) and various audit positions at Deloitte (2005 to 2013) and PricewaterhouseCoopers (2003 to 2005). She holds a BA in Accounting from the University of St. Thomas and is a Certified Public Accountant. The filing also sets out the material terms of Ms. Humes's offer letter with RSI: an annual base salary of $380,000, a sign-on bonus of $261,500 subject to repayment if she leaves on or before the second anniversary of the payment date, a target annual cash bonus of $190,000, RSU grants with an estimated grant-date value of approximately $1.2 million, and option grants with an estimated Black-Scholes value of approximately $800,000. The filing states there are no family relationships or related-person transactions involving Ms. Humes.

Feb 21, 2025 8-K

Roivant Sciences 8-K Report, Financial Results (Feb 10, 2025)

Roivant Sciences Ltd. (Nasdaq: ROIV) furnished a press release under Item 2.02 reporting financial results for the fiscal third quarter ended December 31, 2024, and providing a business update. The company reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024. Net loss from continuing operations was $208.9 million for the quarter, compared with income from continuing operations of $5.1 billion a year earlier, which included a gain on the Telavant sale. Quarterly income from discontinued operations of $327.0 million reflected the gain on the sale of the entire equity interest in Dermavant to Organon in October 2024. Operating expenses rose year over year. R&D expenses increased to $141.6 million from $108.1 million, driven mainly by anti-FcRn franchise program costs, and G&A expenses increased to $141.5 million from $128.2 million, largely due to share-based compensation tied to July 2024 long-term equity awards. Revenue, net was $9.0 million for the quarter versus $15.6 million a year earlier. The update centers on pipeline milestones. Immunovant expects topline batoclimab results in myasthenia gravis and initial CIDP period 1 results by March 31, 2025, and initiated pivotal IMVT-1402 studies in Graves' disease and difficult-to-treat rheumatoid arthritis. Priovant added cutaneous sarcoidosis as a third brepocitinib indication, with a Phase 2 start expected in Q2 calendar 2025. Kinevant discontinued namilumab for sarcoidosis after a Phase 2 study failed to show treatment benefit. The Genevant litigation against Moderna continues, with a jury trial scheduled for September 2025.

Feb 10, 2025 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Dec 3, 2024)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on December 3, 2024 under Item 7.01 (Regulation FD Disclosure) to furnish a press release announcing topline results from the Phase 2 RESOLVE-Lung study of namilumab in chronic active pulmonary sarcoidosis. The study, conducted by Kinevant Sciences, failed to meet its primary endpoint, defined as the proportion of subjects with a Rescue Event during the double-blind period. Secondary endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the King's Sarcoidosis Questionnaire, also failed to show a treatment benefit consistent with the primary endpoint. As a result, Kinevant will discontinue further development of namilumab for sarcoidosis, and the company states the safety profile remained similar to previous studies. Kinevant plans to publish the RESOLVE-Lung results to inform future sarcoidosis research. The study enrolled 107 patients in a randomized, double-blind, placebo-controlled design at sites in the U.S. and Europe. For investors, the filing reports a clinical failure and the end of one program in sarcoidosis, with management emphasizing that the study was well designed and that Roivant will continue pursuing calculated risks in other programs. The filing itself does not quantify any financial impact of this discontinuation.

Dec 3, 2024 8-K

Material AgreementsRegulation FDExhibits & Filings

Roivant Sciences 8-K Report, Financial Results (Nov 12, 2024)

Roivant Sciences Ltd. (ROIV) furnished a press release under Item 2.02 reporting financial results for the fiscal quarter ended September 30, 2024, along with a business update. The filing states that the information is furnished, not filed, under Section 18 of the Exchange Act. For the three months ended September 30, 2024, the company reported revenue, net of $4,475 thousand, research and development expenses of $143.1 million, and general and administrative expenses of $202.9 million, which the filing attributes in part to $79.1 million of one-time cash retention awards for senior executives. Loss from continuing operations, net of tax, was $236.8 million, or $0.25 per share, compared with $244.6 million, or $0.28 per share, a year earlier. Non-GAAP loss from continuing operations was $218.7 million. Consolidated cash, cash equivalents, restricted cash and marketable securities were approximately $5.4 billion at September 30, 2024. The business update highlights clinical progress across subsidiaries, including 52-week Phase 2 NEPTUNE data for brepocitinib in non-infectious uveitis, initiation of the Phase 2 PHocus trial for mosliciguat in PH-ILD, and positive batoclimab proof-of-concept data in Graves' disease at Immunovant. The company also closed the Dermavant sale to Organon on October 28, 2024, receiving $184 million in cash, with a further $75 million milestone tied to FDA approval of VTAMA in atopic dermatitis. Share repurchases totaled $106 million in the quarter and $754 million cumulatively through September 30, 2024, inclusive of the repurchase of Sumitomo's stake in April 2024. The filing lists several upcoming milestones, including topline data from Kinevant's namilumab sarcoidosis trial in the fourth quarter of calendar 2024, Immunovant's planned potentially registrational trials for IMVT-1402, topline batoclimab data in MG and CIDP by March 31, 2025, and Priovant's Phase 3 brepocitinib data in dermatomyositis in the second half of calendar 2025.

Nov 12, 2024 8-K

Roivant Sciences 8-K Report, Agreement Terminated (Oct 28, 2024)

Roivant Sciences Ltd. (ROIV) reported that the previously announced acquisition of its subsidiary Dermavant Sciences Ltd. by Organon & Co. closed on October 28, 2024. Under the Merger Agreement dated September 17, 2024, Organon Bermuda Ltd., an indirect wholly owned subsidiary of Organon, merged into Dermavant, which continues as the surviving company and a wholly owned subsidiary of Organon. Roivant acted as representative of Dermavant's securityholders under the agreement. In connection with the closing, Dermavant repaid all amounts outstanding under its Credit Agreement dated May 14, 2021 (amended May 24, 2024), including accrued interest, premiums and exit fees, and the Credit Agreement was terminated in accordance with its terms. The filing also furnishes a joint Organon and Roivant press release announcing the closing, which highlights VTAMA (tapinarof) cream, 1%, approved by the FDA for plaque psoriasis, with an sNDA for atopic dermatitis under FDA review and PDUFA action expected in the fourth quarter of calendar 2024. The filing does not state the purchase price or other deal economics. The press release refers to Roivant continuing to share in the success of VTAMA, and it notes that Organon's prior announcement summarized the transaction terms.

Oct 28, 2024 8-K

Material AgreementsExhibits & Filings

Roivant Sciences 8-K Report, Material Agreement (Sep 23, 2024)

On September 17, 2024, Dermavant Sciences Ltd., a subsidiary of Roivant Sciences Ltd. (ROIV), entered into an Agreement and Plan of Merger with Organon & Co. and Organon Bermuda Ltd., under which Organon will acquire Dermavant. Roivant owns approximately 87% of Dermavant's issued and outstanding common and preference shares. Merger Sub will merge into Dermavant, which will continue as a wholly owned subsidiary of Organon. The aggregate cash consideration is up to approximately $1.2 billion, consisting of a $175 million payment at closing (subject to certain adjustments), a $75 million milestone payable upon FDA approval of VTAMA for atopic dermatitis, and up to $950 million in additional milestones tied to tiered net sales. Organon will also pay tiered royalties of low-to-mid single digit percentages on annual net sales up to $1 billion and 30% on annual net sales above $1 billion. Payments are distributed pro rata to all Dermavant equity holders after the liquidation preference of preference shares, all of which are held by Roivant. Outstanding amounts under the Dermavant credit agreement will be paid at closing, and Organon will assume the revenue interest purchase agreement and funding agreement with NovaQuest entities. The boards of Roivant and Dermavant approved the transaction, and shareholders holding at least 75% of Dermavant's voting rights approved it by written consent. The merger is expected to close in the fourth quarter of calendar 2024, subject to customary conditions including expiration of the HSR waiting period. The agreement may be terminated if not consummated by March 17, 2025, extendable to June 17, 2025 for antitrust-related delays, and either Roivant or Organon may terminate if the merger is not consummated by January 5, 2025 due to failure to satisfy certain antitrust-related conditions.

Sep 23, 2024 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 18, 2024)

On September 18, 2024, Roivant Sciences Ltd. (ROIV) and Organon & Co. (NYSE: OGN) announced a definitive Agreement and Plan of Merger under which Organon will acquire Dermavant Sciences Ltd., Roivant's majority-owned subsidiary that owns the rights to VTAMA (tapinarof) cream, 1%, globally excluding China and with Japan rights out-licensed. Aggregate consideration is up to approximately $1.2 billion, consisting of a $175 million upfront payment, a $75 million milestone upon regulatory approval in atopic dermatitis (AD), and up to $950 million in commercial sales milestones, plus tiered royalties on net sales. Organon will also assume Dermavant liabilities with an approximate value of $286 million as of June 30, 2024. The filing states that the transaction is subject to Hart-Scott-Rodino review and other customary conditions, with closing expected in the fourth quarter of 2024. Organon expects the deal to be modestly dilutive to Adjusted EBITDA in 2025 and accretive in 2026, with net leverage expected to be elevated above 4.0x. Roivant's investor presentation states that the deal removes all debt (about $324 million) from Roivant's consolidated balance sheet and includes a 30% royalty on net sales above $1 billion, in addition to tiered royalties below that level, with royalties beginning in 2027. VTAMA is approved for plaque psoriasis in adults, and an sNDA for atopic dermatitis is under FDA review with a PDUFA action expected in the fourth quarter of 2024. The deal's value to investors depends heavily on this regulatory milestone and on future commercial sales, since most of the consideration is contingent.

Sep 18, 2024 8-K

Roivant Sciences 8-K Report, Shareholder Vote Results (Sep 16, 2024)

Roivant Sciences Ltd. (ROIV) held its 2024 Annual General Meeting of Shareholders on September 10, 2024, and reported the voting results in this Form 8-K. Holders of record of 680,116,302 common shares, out of 739,183,842 outstanding and entitled to vote as of the July 17, 2024 record date, attended in person or by proxy. Shareholders approved all four proposals on the agenda, as described in more detail in the Company's Proxy Statement. Shareholders re-elected Ilan Oren, James C. Momtazee and Dr. Mayukh Sukhatme as Class III directors, each to hold office until the annual general meeting following the fiscal year ending March 31, 2027. Shareholders also ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending March 31, 2025, and as statutory auditor under the Bermuda Companies Act 1981, as amended. The auditor ratification received 679,096,310 votes for, 759,669 against and 260,323 abstentions. On a non-binding advisory basis, shareholders approved the compensation of the named executive officers, with 540,184,951 votes for, 64,461,892 against and 587,930 abstentions. Shareholders also favored holding this say-on-pay vote every year, with 600,744,457 votes for one year, and the Company has decided to hold the advisory vote annually. The filing also includes the Cover Page Interactive Data File as an exhibit.

Sep 16, 2024 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 10, 2024)

Roivant Sciences Ltd. (ROIV) disclosed on September 10, 2024 that it is advancing a previously undisclosed pipeline program, mosliciguat, developed at its subsidiary Pulmovant. The company issued a press release (Exhibit 99.1) furnished under Item 7.01 of Form 8-K, presenting data from the Phase 1b ATMOS study at the European Respiratory Society Congress. Mosliciguat is described as an inhaled, once-daily soluble guanylate cyclase (sGC) activator delivered via dry powder inhaler, being developed for pulmonary hypertension associated with interstitial lung disease (PH-ILD), which the company says affects about 200,000 patients in the U.S. and Europe. In the ATMOS study of 38 patients, the company reported mean-max peak reductions in pulmonary vascular resistance (PVR) from baseline of -25.9%, -38.1% and -36.3% for the 1.0, 2.0 and 4.0 mg doses, respectively, in the per-protocol set (N=20). The company stated that once-daily dosing was generally well tolerated with low rates of treatment-emergent adverse events. A global Phase 2 PHocus study in about 120 PH-ILD patients is expected to begin imminently. Roivant states that Pulmovant in-licensed exclusive worldwide rights from Bayer, which received an upfront cash payment of about $14.0 million, with up to an additional $280 million in development, regulatory and commercial milestones, plus tiered high-single-digit sales-based royalties.

Sep 10, 2024 8-K

Roivant Sciences 8-K Report, Regulation FD Disclosure (Sep 9, 2024)

Roivant Sciences Ltd. furnished this Form 8-K under Item 7.01 (Regulation FD Disclosure) to attach a September 9, 2024 press release, Exhibit 99.1, providing an update on the Graves' disease development program at Immunovant, Inc. (Nasdaq: IMVT). The release reports Phase 2a trial results for batoclimab in patients who were hyperthyroid despite antithyroid drug (ATD) therapy. Participants first received 12 weeks of high-dose batoclimab (680 mg weekly, subcutaneous), with a mean IgG reduction of 77%, a 76% response rate, and a 56% ATD-free response rate. During weeks 13 to 24 on the lower 340 mg dose, mean IgG reduction was 65%, with a 68% responder rate and a 36% ATD-free response rate. Patients who achieved at least a 70% IgG reduction had a 60% ATD-free response rate, compared with 23% for those who did not. The company also cited real-world claims data indicating that 25-30% of Graves' disease patients per year are uncontrolled on ATDs, with minimal to no existing therapeutic options. Immunovant said it has aligned with the U.S. Food and Drug Administration on a pivotal trial design and that the Investigational New Drug application for IMVT-1402 has been cleared. It expects to initiate the pivotal trial of IMVT-1402 in Graves' disease by December 31, 2024. Management described the IgG-lowering correlation with clinical outcomes as supporting a potential first-in-class and best-in-class opportunity for IMVT-1402. Under the filing's terms, the information in Item 7.01 and Exhibit 99.1 is furnished and not deemed filed for purposes of Section 18 of the Exchange Act.

Sep 9, 2024 8-K

Roivant Sciences 8-K Report, Financial Results (Aug 8, 2024)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fiscal quarter ended June 30, 2024, in a press release furnished as Exhibit 99.1 under Item 2.02 of this Form 8-K. Total revenue, net was $55.1 million, comprising product revenue, net of $18.4 million (VTAMA) and license, milestone and other revenue of $36.8 million. The company reported net income of $57.5 million, compared with a net loss of $327.8 million in the prior-year quarter, and net income attributable to Roivant Sciences Ltd. of $95.3 million. Non-GAAP net loss was $131.2 million. The filing notes that a $110.4 million gain on the sale of Telavant net assets to Roche was recognized in the quarter, and that changes in fair value of debt and liability instruments of $118.2 million also contributed to the result. Consolidated cash, cash equivalents and restricted cash was approximately $5.7 billion at June 30, 2024, down from $6.55 billion at March 31, 2024. The company cited a $648 million share repurchase announced in April 2024 and excluded a $110 million milestone payment received in August 2024 related to the Telavant sale. Total shareholders' equity was $5.90 billion at June 30, 2024. R&D expenses rose to $133.2 million and SG&A expenses fell to $148.5 million year over year. The business update highlights the Phase 3 VALOR trial of brepocitinib in dermatomyositis, which completed enrollment with 241 subjects, with topline data expected in the second half of calendar 2025. Immunovant completed enrollment in the batoclimab pivotal myasthenia gravis trial, and the VTAMA atopic dermatitis PDUFA action is expected in the fourth quarter of calendar 2024. The filing also notes the Genevant/Arbutus lawsuit against Moderna, with trial timing potentially moving to September 2025.

Aug 8, 2024 8-K

Material Agreements

Roivant Sciences 8-K Report, Material Agreement (May 30, 2024)

On May 24, 2024, Dermavant Sciences Ltd. (DSL), a subsidiary of Roivant Sciences Ltd., entered into a series of agreements to renegotiate its existing debt obligations (the "Debt Renegotiation"). The company states the renegotiation is expected to reduce DSL's potential cash payments under these obligations by over $300 million in aggregate, of which approximately $225 million would be achieved over the next three fiscal years. The renegotiation involves amendments to the Revenue Interest Purchase and Sale Agreement (RIPSA), the Credit Agreement, and the NovaQuest Funding Agreement. As part of the transaction, Roivant agreed under an Equity Commitment Letter to contribute $195 million to DSL in exchange for convertible preferred shares with a liquidation preference of 1.5 times its invested capital. DSL also issued common shares to the RIPSA Purchasers and NovaQuest, each in an amount equal to approximately 13.2% of DSL's issued and outstanding common and preferred shares on an as-converted basis. At closing, and after full funding of the $195 million commitment, Roivant will own approximately 87% of DSL's issued and outstanding common and preferred shares and approximately 82% on a fully-diluted basis. The amendments include a cap of $6 million per fiscal year on RIPSA royalties for fiscal years ended March 31, 2025, 2026 and 2027; an extension of the Credit Agreement maturity from May 2026 to May 2028, with the interest rate rising from 10% to 12.25% per annum; and elimination of $176.3 million in fixed quarterly payments tied to tapinarof approval for atopic dermatitis, elimination of up to $141.0 million in commercial milestone payments, and restructuring of remaining NovaQuest payments totaling $122.5 million through fiscal 2029. The full amendments will be filed as exhibits to Roivant's next Form 10-Q.

May 30, 2024 8-K

Roivant Sciences 8-K Report, Financial Results (May 30, 2024)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fourth quarter and fiscal year ended March 31, 2024, in a press release furnished as Exhibit 99.1 to this Form 8-K dated May 30, 2024. For the fiscal year, the company reported income from continuing operations of $4.23 billion (net of tax), driven by a $5.35 billion gain on the sale of its Telavant net assets to Roche in December 2023, compared with a loss from continuing operations of $1.23 billion in the prior year. Total revenue, net, was $124.8 million for the year, of which VTAMA product revenue was $75.1 million. Operating expenses were $1.23 billion, including R&D of $501.7 million and SG&A of $687.4 million. Non-GAAP loss from continuing operations was $799.9 million for the year. Cash, cash equivalents and restricted cash was $6.55 billion at March 31, 2024. Capital allocation was a major theme. The board authorized a share repurchase program of up to $1.5 billion, and the company used $648.4 million to repurchase Sumitomo Pharma's entire stake of 71.3 million shares at $9.10 per share, reducing shares outstanding by approximately 9%. The filing states that $852 million remains available under the authorization. Pro forma for the Sumitomo repurchase, cash would have been approximately $5.9 billion. Dermavant also renegotiated its debt obligations, reducing potential cash payments by over $300 million in the aggregate, with approximately $225 million of that reduction expected over the next three fiscal years. Pipeline updates include positive Phase 2 NEPTUNE data for brepocitinib in non-infectious uveitis, with a 29% Treatment Failure rate at 45 mg at week 24, supporting a pivotal NIU program planned for the second half of calendar 2024. The FDA accepted the VTAMA sNDA for atopic dermatitis, with PDUFA action expected in the fourth quarter of calendar 2024. Immunovant is advancing IMVT-1402 with 4-5 potentially registrational studies planned by March 31, 2025.

May 30, 2024 8-K

Roivant Sciences 8-K Report, Corporate Update (Apr 2, 2024)

Roivant Sciences Ltd. (ROIV) reported on April 2, 2024, in a Form 8-K (Item 8.01) that it announced positive results from the Phase 2 NEPTUNE study of brepocitinib in non-anterior non-infectious uveitis (NIU), and that its board authorized a share repurchase program of up to $1.5 billion of common shares, funded with available cash and cash equivalents and without an expiration date. As part of this program, Roivant entered into an agreement to repurchase all 71,251,083 common shares held by Sumitomo Pharma Co., Ltd. at $9.10 per share, for an aggregate of approximately $648.4 million, with closing expected on or about April 4, 2024. The company states this repurchase will reduce shares outstanding as of February 9, 2024 by approximately 9%. On the clinical side, the press release states that at week 24, 29% (5 of 17) of subjects in the brepocitinib 45 mg arm and 44% (4 of 9) in the 15 mg arm met the primary Treatment Failure endpoint, with lower rates indicating greater benefit. The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the 45 mg arm. All secondary endpoints were reported as positive and dose responsive, and no new safety or tolerability signals were identified. The study enrolled 26 subjects, and the company plans to begin a Phase 3 NIU program in the second half of calendar year 2024, while the ongoing Phase 3 dermatomyositis study is expected to read out in calendar year 2025. The filing also indicates that the repurchase program may be suspended or discontinued at any time, and that there can be no assurance of how many shares will be repurchased or at what prices. Roivant plans an investor call and webcast at 8:00 a.m. EDT on April 2, 2024 to discuss the results and the repurchase program.

Apr 2, 2024 8-K

Roivant Sciences 8-K Report, Financial Results (Feb 13, 2024)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported financial results for the fiscal third quarter ended December 31, 2023, in a press release furnished as Exhibit 99.1 under Item 2.02. The headline driver was the closing of the sale of Telavant to Roche in December 2023. The company recorded a gain on sale of Telavant net assets of $5,348,410 thousand (about $5.3 billion) and reported net income of approximately $5.1 billion for the quarter, compared with a net loss of $384.9 million a year earlier. Net income per diluted share was $6.03. Excluding the one-time gain and other non-GAAP adjustments, the company reported a non-GAAP net loss of $174.9 million, compared with $297.5 million in the prior-year quarter. Operationally, VTAMA cream 1% generated net product revenue of $20.7 million for the quarter, up from $9.2 million a year earlier, and cumulative prescriptions passed 300,000. Research and development expenses were $123.7 million and selling, general and administrative expenses were $197.3 million, the latter including a special one-time cash retention bonus that the filing cites as a driver of higher personnel costs. Consolidated cash, cash equivalents and restricted cash was $6.7 billion at December 31, 2023, which management said supports cash runway into profitability. The release also outlined near-term catalysts, including the planned VTAMA atopic dermatitis sNDA submission, brepocitinib topline Phase 2 data in non-infectious uveitis, batoclimab readouts in Graves' disease and other indications, and the discontinuation of the RVT-2001 program at Hemavant.

Feb 13, 2024 8-K

Acquisitions & DispositionsOther EventsExhibits & Filings

Roivant Sciences 8-K Report, Regulation FD Disclosure (Dec 20, 2023)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on December 20, 2023 to furnish a press release from its subsidiary Immunovant, Inc. reporting initial data from an ongoing 24-week Phase 2 proof-of-concept trial of batoclimab in patients with Graves' disease. The filing states that results from the initial cohort meaningfully exceeded 50% response rates. Response is defined as normalization of T3 and T4 hormone levels without increasing anti-thyroid medication (ATD) dose. The trial is open-label and gives patients 680 mg batoclimab weekly for 12 weeks, followed by 340 mg weekly for 12 weeks. In the initial cohort, the 680 mg dose produced IgG reductions of up to 87% and a mean IgG reduction of 81% after 12 weeks, with lower reductions at 340 mg. Anti-TSHR autoantibody reductions showed a similar dose response. The 680 mg regimen also produced numerically higher responses on clinical parameters, including the percentage of patients whose ATD dose was reduced or discontinued. The company reported batoclimab was generally well tolerated with no new safety signals in the initial data set. Immunovant's CEO said the company intends to focus future Graves' development on IMVT-1402, with plans expected to be announced later in 2024. The filing describes these results as preliminary and early, and includes standard forward-looking statement cautions regarding early trial data, the need for additional capital, and dependence on batoclimab and IMVT-1402.

Dec 20, 2023 8-K/A

Exhibits & Filings

Roivant Sciences 8-K/A Report, Exhibit Filing (Dec 20, 2023)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K/A on December 20, 2023 to amend its initial 8-K of December 14, 2023, which reported the completion of the sale of Telavant Holdings, Inc. to Roche Holdings, Inc. This amendment adds unaudited pro forma condensed consolidated financial information giving effect to the transaction. Roivant owned 75% of Telavant and Pfizer owned the remaining 25%. The Sellers received approximately $7.1 billion in cash at closing, and will receive a $150 million milestone payment upon initiation of a Phase 3 trial in ulcerative colitis. The filing states that the milestone is not reflected in the pro forma statements because it was not probable at closing. The pro forma balance sheet as of September 30, 2023 shows cash and cash equivalents rising from $1,408.2 million historically to $6,626.4 million pro forma, reflecting $5.2 billion of cash recognized by Roivant at closing. The filing reports a $5.3 billion gain on the sale allocated to Roivant. Pro forma net loss attributable to Roivant for the six months ended September 30, 2023 is $(552.3) million, compared with $(596.1) million historically. For the year ended March 31, 2023, pro forma net income from continuing operations attributable to Roivant is $4,296.6 million, compared with a historical loss of $(1,123.6) million, driven by the gain on sale. The filing states that the pro forma figures are illustrative only and do not indicate actual results or future performance. They exclude corporate cost allocations, potential dis-synergies, and any earnings from use of the sale proceeds.

Dec 20, 2023 8-K

Roivant Sciences 8-K Report, Acquisition Completed (Dec 14, 2023)

Roivant Sciences Ltd. (ROIV) reported in this Form 8-K, filed December 14, 2023, that it completed the sale of its subsidiary Telavant Holdings, Inc. to Roche (the Buyer, named in the filing as Roche Holdings, Inc., together with Pfizer Inc. as parties to the Stock Purchase Agreement dated October 22, 2023). The Buyer paid total consideration of approximately $7.1 billion in cash at closing, distributed pro rata to all Telavant equity holders, including restricted stock unit holders. Prior to closing, the Company owned 75% of Telavant's common and preferred stock on an as-converted basis. Telavant holds the US and Japan rights to RVT-3101, a therapy in development for inflammatory bowel disease, including ulcerative colitis and Crohn's disease. The transaction also includes an additional milestone payment of $150 million in cash, payable upon initiation of a Phase 3 trial in ulcerative colitis. The filing states that pro forma financial information will be filed by amendment within four business days of December 14, 2023. The press release (Exhibit 99.1) quotes Mayukh Sukhatme, President and Chief Investment Officer, saying the company will continue working with partners on programs for high unmet need areas.

Dec 14, 2023 8-K

Roivant Sciences 8-K Report, Corporate Update (Nov 28, 2023)

Roivant Sciences Ltd. furnished an 8-K reporting initial data from the 600 mg multiple-ascending dose (MAD) cohort of a Phase 1 trial of IMVT-1402, an anti-FcRn antibody being developed by Immunovant for IgG-mediated autoimmune diseases. The press release (Exhibit 99.1) states that four once-weekly subcutaneous 600 mg doses reduced total IgG by a mean of 74%, which the company describes as similar to batoclimab at 680 mg, which reduced IgG by 76% after four weekly doses. The company states that in disease settings where batoclimab was given continuously, a 80% reduction was observed at steady state after about 6-8 weeks, and it believes IMVT-1402 will match this result and timing. The filing reports that serum albumin and LDL-C at Day 29, the peak pharmacodynamic point, showed no significant decrease or increase from baseline (p-values above 0.05), which the company describes as placebo-like. Across all doses evaluated, treatment-emergent adverse events were reported as mild or moderate, with no serious treatment-emergent adverse events and no deaths in the presentation's safety table. The company characterizes IMVT-1402 as a potential best-in-class anti-FcRn antibody and says it may enable self-administration by subcutaneous injection. The accompanying investor presentation (Exhibit 99.2) describes the 600 mg data as consistent with the 300 mg MAD data and identifies potential first-in-class and best-in-class indications, including Graves' disease, refractory rheumatoid arthritis, myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy. The presentation's closing slide states that 2024 will be a big year for IMVT-1402 as the company announces a broad portfolio of pivotal trials and proof-of-concept studies. The presentation notes that cross-trial and post-hoc comparisons are hypothesis-generating only.

Nov 28, 2023 8-K

Roivant Sciences 8-K Report, Corporate Update (Nov 27, 2023)

Roivant Sciences Ltd. (Nasdaq: ROIV) reported in a Form 8-K dated November 27, 2023 that its subsidiary Priovant's Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint, which was a Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) at Week 52. The company disclosed the results in a press release furnished as Exhibit 99.1 and stated that Priovant plans to disclose the study data at a future date. In the press release, Roivant's CEO Matt Gline said the active arm showed some of the highest SRI-4 responder rates ever observed in a lupus study, along with a favorable safety and tolerability profile, but the study also recorded the highest placebo response rate observed in any significant SLE study. As a result, the company said it could not truly assess the drug's impact or establish sufficient differentiation from other therapies in lupus. Roivant does not plan to progress the program in SLE. Roivant and Priovant still plan to pursue brepocitinib in indications outside lupus, citing its safety profile, six other positive Phase 2 studies, and active arm performance in this trial. Priovant expects topline results from the Phase 2 proof-of-concept study in non-infectious uveitis in the first quarter of calendar 2024 and from the Phase 3 trial in dermatomyositis in calendar 2025.

Nov 27, 2023 8-K

Material AgreementsOther EventsExhibits & Filings

Roivant Sciences 8-K Report, Financial Results (Nov 13, 2023)

Roivant Sciences Ltd. (ROIV) furnished this Form 8-K under Item 2.02 to report financial results for the fiscal quarter ended September 30, 2023, attaching a press release as Exhibit 99.1. The company reported revenue, net of $37.1 million for the three months ended September 30, 2023, up from $12.5 million a year earlier, with net loss of $331.1 million ($0.40 per share) compared with $315.9 million ($0.42 per share) in the prior-year quarter. Non-GAAP net loss was $225.4 million. Cash, cash equivalents and restricted cash were $1.4 billion at September 30, 2023. The most significant development is the pending sale of Telavant to Roche for a $7.1 billion upfront payment plus a $150 million milestone payable upon initiation of a Phase 3 ulcerative colitis trial. Roivant's expected net proceeds are approximately $5.2 billion plus $110 million from the milestone, and closing is expected in the fourth quarter of 2023 or first quarter of 2024. Management stated that, giving effect to Immunovant's October 2023 offering and the Telavant proceeds, cash would have been approximately $7.0 billion. Operationally, VTAMA (tapinarof) cream 1% generated net product revenue of $18.4 million in the quarter, and Immunovant reported Phase 1 data for IMVT-1402 with IgG reductions similar to batoclimab. Selling, general and administrative expenses were $164.4 million and research and development expenses were $132.0 million for the quarter, with several clinical readouts guided for the remainder of 2023 and 2024.

Nov 13, 2023 8-K

Roivant Sciences 8-K Report, Material Agreement (Oct 23, 2023)

Roivant Sciences Ltd. (ROIV) and its subsidiary Telavant Holdings, Inc. entered into a Stock Purchase Agreement on October 22, 2023 with Pfizer Inc. and Roche Holdings, Inc. (the Buyer), under which Roche agreed to acquire all outstanding shares of Telavant. Telavant holds the rights to RVT-3101, an anti-TL1A antibody in development for ulcerative colitis and Crohn's disease. Roivant owns 75% of Telavant's common and preferred stock on an as-converted basis and Pfizer owns the remaining 25%. The total consideration is $7.1 billion in cash at closing, subject to customary adjustments, plus a $150 million cash milestone payable upon initiation of a Phase 3 trial in ulcerative colitis. Proceeds are to be shared pro rata among all Telavant equity holders, including restricted stock unit holders. The Transaction was approved by the boards of both Roivant and Telavant. Closing is expected in the fourth quarter of 2023 or the first quarter of 2024, subject to customary conditions including certain regulatory approvals, and either party may terminate if the deal has not closed by July 23, 2024. Roivant issued a press release on October 23, 2023 announcing the transaction, which states that Roche will gain development, manufacturing and commercialization rights to RVT-3101 in the US and Japan, with Pfizer retaining commercialization rights elsewhere. Roche will also obtain an option to enter a global collaboration with Pfizer on a next-generation p40/TL1A bispecific antibody currently in Phase 1.

Oct 23, 2023 8-K

Material AgreementsExhibits & Filings

Roivant Sciences 8-K Report, Material Agreement (Sep 29, 2023)

Roivant Sciences Ltd. (ROIV) reported on Form 8-K filed September 29, 2023 that on September 26, 2023 it entered into common share purchase and sale agreements with certain institutional investors. Under these agreements the company agreed to issue and sell an aggregate of 19,600,685 common shares at $10.21 per share, for aggregate gross proceeds of approximately $200.1 million, in a registered direct offering. The offering was made under a prospectus supplement to the company's effective shelf registration statement on Form S-3 (Registration No. 333-267503). The company expects to use the net proceeds to make an investment in its subsidiary, Immunovant, Inc., and for working capital and other general corporate purposes. The filing includes a legal opinion from Conyers Dill & Pearman Limited on the legality of the issued shares. The form of purchase and sale agreement is filed as Exhibit 1.1, with certain portions redacted under Item 601(b)(10) of Regulation S-K.

Sep 29, 2023 8-K

Roivant Sciences 8-K Report, Corporate Update (Sep 26, 2023)

Roivant Sciences Ltd. reported in this Form 8-K that its subsidiary, Immunovant, Inc., issued a press release and corporate update on September 26, 2023, with initial data from a Phase 1 trial of IMVT-1402, an anti-FcRn antibody being developed as a subcutaneous injection. The trial is randomized, double-blind and placebo-controlled, and enrolls healthy adults. In the single-ascending dose portion, subcutaneous IMVT-1402 produced dose-dependent reductions in IgG, with potency described as similar to or greater than that of batoclimab. All adverse events were mild or moderate, and no significant reduction in serum albumin or increase in LDL-C from baseline was observed at any timepoint measured. In the multiple-ascending dose portion, the 300 mg subcutaneous cohort received four weekly doses. The mean total IgG reduction from baseline was 63%, with no decrease in serum albumin below baseline and no increase in LDL-C above baseline. Dosing in the 600 mg cohort has recently begun, and the company said it expects to share additional multiple-dose data in November 2023. The filing states that the comparisons with batoclimab come from separate trials and are not head-to-head. For investors, the key points are the strength of the pharmacodynamic data at this early stage, the favorable analyte profile through four weeks at 300 mg, and the dependence of the program on results still to come. The filing itself notes that early-trial results may not predict later outcomes, and that Immunovant will require additional capital to advance IMVT-1402 and batoclimab.

Sep 26, 2023 8-K

Roivant Sciences 8-K Report, Shareholder Vote Results (Sep 15, 2023)

At its 2023 Annual General Meeting of Shareholders, held on September 12, 2023, Roivant Sciences Ltd. shareholders approved both proposals on the agenda. Holders of record of 710,264,272 common shares were present in person or by proxy, out of 768,357,739 common shares outstanding and entitled to vote as of the July 17, 2023 record date. The filing describes the proposals in more detail in the Company's Proxy Statement. Shareholders re-elected Daniel Gold and Meghan FitzGerald, DrPH as Class II directors. Each will hold office until the annual general meeting following the fiscal year ending March 31, 2026, or until a successor is elected or the director dies, resigns or is removed. Election required a plurality of votes cast. Mr. Gold received 480,335,783 votes for and 189,651,604 withheld, and Dr. FitzGerald received 668,955,006 votes for and 1,032,381 withheld. Each nominee had 40,276,885 broker non-votes for Mr. Gold, and the filing reports the same broker non-vote figure for Dr. FitzGerald. Shareholders also ratified Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending March 31, 2024. The same firm was appointed as statutory auditor under the Bermuda Companies Act 1981, as amended, for that year. The ratification received 709,944,901 votes for, 65,948 against and 253,423 abstentions. The filing also includes the cover page interactive data file for the report.

Sep 15, 2023 8-K

Roivant Sciences 8-K Report, Corporate Update (Sep 11, 2023)

Roivant Sciences Ltd. (ROIV) filed this Form 8-K on September 11, 2023 under Item 8.01 (Other Events) to report that it completed the redemption of its outstanding public warrants and private placement warrants. The redemption followed 5:00 p.m. New York City Time on September 1, 2023 (the Redemption Date), with a redemption price of $0.10 per Warrant, as previously announced in an August 2, 2023 press release. According to the attached press release (Exhibit 99.1), of the 20,475,875 Public Warrants outstanding as of June 30, 2023, 397 were exercised for cash at $11.50 per Common Share, yielding 397 Common Shares, and 20,061,507 were exercised on a cashless basis for an aggregate of 5,005,531 Common Shares. The filing states this represents approximately 98% of the outstanding Public Warrants. All Private Warrants were exercised on a cashless basis for an aggregate of 2,548,621 Common Shares. The Public Warrants ceased trading on The Nasdaq Global Market and were delisted, with the trading halt announced after market close on September 1, 2023. The Common Shares continue to trade on Nasdaq under the symbol "ROIV."

Sep 11, 2023 8-K