Bermuda
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001-40782
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98-1173944
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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☐ |
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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Common Shares, $0.0000000341740141 par value per share
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ROIV
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The Nasdaq Global Market |
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Redeemable warrants, each whole warrant exercisable for one Common Share |
ROIVW
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The Nasdaq Global Market
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Item 2.02. |
Results of Operations and Financial Condition.
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Item 9.01. |
Financial Statements and Exhibits.
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Exhibit
No.
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Description of Exhibit
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Roivant Sciences Ltd. Press Release, dated February 13, 2023
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104
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Cover Page Interactive Data File (embedded with Inline XBRL document)
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ROIVANT SCIENCES LTD.
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By:
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/s/ Matt Maisak
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Name:
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Matt Maisak
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Title:
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Authorized Signatory
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Dated:
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February 13, 2023
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• |
$9.2M in net product revenue from VTAMA reported for the quarter ended December 31, 2022, with nearly 100,000 VTAMA prescriptions written by approximately 8,600 unique prescribers since launch
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• |
VTAMA payor coverage significantly expanded, with 57% of commercial lives now covered
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• |
ADORING 1 and 2 trials evaluating tapinarof in atopic dermatitis fully enrolled, with topline data expected from the first study in March 2023 and the second study in May 2023
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• |
Partnership established with Pfizer to develop RVT-3101, a potentially first-in-class, fully human monoclonal antibody that blocks tumor necrosis factor-like ligand 1A (TL1A)
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• |
Statistically significant and clinically meaningful efficacy results reported at each dose tested in TUSCANY-2, a 245-patient global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative
colitis
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• |
Data from the chronic therapy period of the TUSCANY-2 study of RVT-3101 for ulcerative colitis expected in 1H 2023
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• |
Primary equity offering upsized to $230M in gross proceeds following strong investor demand with Roivant cash runway into 2H 2025
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• |
Roivant: In February, Roivant completed an
upsized primary equity offering for $230M in gross proceeds, including the exercise in full of the underwriters’ overallotment option following strong investor demand. The company plans to use the net proceeds from the offering principally
to fund additional studies of RVT-3101, including the initiation of Phase 3 development in ulcerative colitis and Phase 2 development in other indications. Roivant had consolidated cash, cash equivalents and restricted cash of $1.5B at
December 31, 2022, or $1.9B after giving effect to the receipt of the anticipated proceeds from the sale of Myovant equity rights to Sumitomo and the net proceeds from the offering, supporting cash runway into the second half of calendar
year 2025.
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• |
Dermavant: Through February 10, 2023, nearly
100,000 VTAMA prescriptions have been written by approximately 8,600 unique prescribers, based on IQVIA data. For the quarter ended December 31, 2022, Roivant reported VTAMA net product revenue of $9.2 million, representing a gross-to-net
yield of approximately 18%. There has been significant progress on payor coverage with the majority of commercial lives, 57%, now covered. Tapinarof Phase 3 trials in atopic dermatitis, ADORING 1 and ADORING 2, are fully enrolled.
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• |
Immunovant: In November 2022, Immunovant initiated a Phase 3 trial to evaluate batoclimab as a treatment for Thyroid Eye Disease (TED). Additionally, in December 2022, IMVT initiated a pivotal Phase 2b trial of batoclimab as a
treatment for chronic inflammatory demyelinating polyneuropathy (CIDP).
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• |
RVT-3101: In December, Roivant announced a
collaboration with Pfizer to develop and commercialize RVT-3101, a potentially first in class, fully human monoclonal antibody that blocks tumor necrosis factor-like ligand 1A (TL1A). In January, Roivant announced data from the induction
period of TUSCANY-2, a large 245-patient global Phase 2b study of RVT-3101 against placebo for the treatment of ulcerative colitis. TUSCANY-2 is a 52-week study, with a 12-week induction period comparing different doses of RVT-3101 against
placebo, and a 40-week chronic therapy period during which all subjects receive RVT-3101. In the induction period of the TUSCANY-2 study, RVT-3101 demonstrated statistically significant and clinically meaningful efficacy at each dose
tested. At the expected Phase 3 dose, 31% of patients achieved clinical remission (modified Mayo) (p=0.01, 20% delta compared to 12% placebo) and 40% of patients achieved endoscopic
improvement (p=0.01, 22% delta compared to 19% placebo). At the expected Phase 3 dose, among patients who were positive for a biomarker that was prospectively defined in TUSCANY-2, clinical remission (modified Mayo) and endoscopic
improvement rates were 40% (p=0.02, 30% delta compared to 10% placebo) and 56% (p=0.0005, 46% delta compared to 10% placebo), respectively. Approximately 60% of patients were identified as positive for this biomarker. Across all doses and
patient groups, RVT-3101 was well tolerated and showed a favorable safety profile.
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• |
Roivant plans to announce data from the
chronic therapy period of the ongoing TUSCANY-2 study of RVT-3101 for ulcerative colitis in the first half of calendar year 2023.
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• |
Dermavant expects to report topline data from the first Phase
3 trial of VTAMA for the treatment of atopic dermatitis in March 2023, with topline data from the second Phase 3 trial expected in May 2023.
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• |
Immunovant plans to initiate a Phase 1
clinical trial for IMVT-1402 in early calendar year 2023 contingent on clearance of its Investigational New Drug (“IND”) application, with initial data results from this Phase 1 trial expected to be available in mid-calendar year 2023.
Immunovant expects to have top-line results from the ongoing MG trial in the second half of calendar year 2024 and from the TED program, consisting of two Phase 3 clinical trials, in the first half of calendar year 2025. Immunovant also
expects initial data from period 1 of the Phase 2B trial in CIDP to be available in the first half of calendar year 2024. Immunovant expects to initiate a Phase 2 clinical trial to evaluate batoclimab for the treatment of Graves’ disease in
early calendar year 2023 with initial results expected in the second half of calendar year 2023.
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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the fourth quarter of calendar year 2023. Priovant also expects to announce
topline results from the Phase 3 trial in DM in calendar year 2025.
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Hemavant plans to announce data from the
ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the second half of calendar year 2023.
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Kinevant plans to report topline data from the
ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024.
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December 31, 2022
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March 31, 2022
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|||||||
Cash, cash equivalents and restricted cash
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$
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1,541,037
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$
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2,074,034
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||||
Total assets
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2,202,960
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2,585,129
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||||||
Total liabilities
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775,822
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523,695
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||||||
Total shareholders’ equity
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1,427,138
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2,038,943
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||||||
Total liabilities, redeemable noncontrolling interest and shareholders’ equity
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2,202,960
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2,585,129
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Three Months Ended December 31,
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Nine Months Ended December 31,
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|||||||||||||||
2022
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2021
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2022
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2021
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|||||||||||||
Revenue, net
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$
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17,052
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$
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24,341
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$
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33,904
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$
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46,063
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||||||||
Operating expenses:
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||||||||||||||||
Cost of revenues
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3,586
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1,384
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8,953
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8,507
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||||||||||||
Research and development (includes $6,888 and $17,669 of share-based compensation expense for the three months ended
December 31, 2022 and 2021 and $26,548 and $47,441 for the nine months ended December 31, 2022 and 2021, respectively)
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125,533
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137,345
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393,358
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347,958
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||||||||||||
Acquired in-process research and development
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97,749
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16,105
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97,749
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138,377
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||||||||||||
Selling, general and administrative (includes $50,741 and $53,547 of share-based compensation expense for the three months
ended December 31, 2022 and 2021 and $165,771 and $440,356 for the nine months ended December 31, 2022 and 2021, respectively)
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168,261
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115,530
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474,996
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636,060
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||||||||||||
Total operating expenses
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395,129
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270,364
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975,056
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1,130,902
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||||||||||||
Loss from operations
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(378,077
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)
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(246,023
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)
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(941,152
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)
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(1,084,839
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)
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||||||||
Change in fair value of investments
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(25,948
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)
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38,036
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53,277
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14,382
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|||||||||||
Gain on sale of investment
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—
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—
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—
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(443,754
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)
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|||||||||||
Change in fair value of debt and liability instruments
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62,360
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23,017
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90,032
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40,747
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||||||||||||
Gain on termination of Sumitomo Options
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—
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—
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—
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(66,472
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)
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|||||||||||
Gain on deconsolidation of subsidiaries
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(12,514
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)
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—
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(29,276
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)
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—
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||||||||||
Other (income) expense, net
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(19,898
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)
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(1,029
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)
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(9,567
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)
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2,529
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|||||||||
Loss before income taxes
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(382,077
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)
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(306,047
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)
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(1,045,618
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)
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(632,271
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)
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||||||||
Income tax expense
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2,819
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38
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8,983
|
532
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||||||||||||
Net loss
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(384,896
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)
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(306,085
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)
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(1,054,601
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)
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(632,803
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)
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||||||||
Net loss attributable to noncontrolling interests
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(32,882
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)
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(21,549
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)
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(79,188
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)
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(57,603
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)
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||||||||
Net loss attributable to Roivant Sciences Ltd.
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$
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(352,014
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)
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$
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(284,536
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)
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$
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(975,413
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)
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$
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(575,200
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)
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Net loss per common share—basic and diluted
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$
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(0.49
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)
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$
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(0.41
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)
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$
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(1.39
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)
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$
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(0.87
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)
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Weighted average shares outstanding—basic and diluted
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713,319,399
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686,589,478
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703,054,773
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662,268,788
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Three Months Ended December 31,
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Nine Months Ended December 31,
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||||||||||||||||||
Note
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2022
|
2021
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2022
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2021
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|||||||||||||||
Net loss
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$
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(384,896
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)
|
$
|
(306,085
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)
|
$
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(1,054,601
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)
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$
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(632,803
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)
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|||||||
Adjustments:
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|||||||||||||||||||
Cost of revenues
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|||||||||||||||||||
Amortization of intangible assets
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(1)
|
|
2,228
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—
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5,170
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—
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|||||||||||||
Research and development:
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|||||||||||||||||||
Share-based compensation
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(2)
|
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6,888
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17,669
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26,548
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47,441
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|||||||||||||
Depreciation and amortization
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(3)
|
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1,258
|
778
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3,558
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2,301
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|||||||||||||
Selling, general and administrative:
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|||||||||||||||||||
Share-based compensation
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(2)
|
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50,741
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53,547
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165,771
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440,356
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|||||||||||||
Depreciation and amortization
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(3)
|
|
1,664
|
592
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4,176
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1,925
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|||||||||||||
Other:
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|||||||||||||||||||
Change in fair value of investments
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(4)
|
|
(25,948
|
)
|
38,036
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53,277
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14,382
|
||||||||||||
Gain on sale of investment
|
(5)
|
|
—
|
—
|
—
|
(443,754
|
)
|
||||||||||||
Change in fair value of debt and liability instruments
|
(6)
|
|
62,360
|
23,017
|
90,032
|
40,747
|
|||||||||||||
Gain on termination of Sumitomo Options
|
(7)
|
|
—
|
—
|
—
|
(66,472
|
)
|
||||||||||||
Gain on deconsolidation of subsidiaries
|
(8)
|
|
(12,514
|
)
|
—
|
(29,276
|
)
|
—
|
|||||||||||
Estimated income tax impact from adjustments
|
(9)
|
|
756
|
(689
|
)
|
410
|
(629
|
)
|
|||||||||||
Adjusted net loss (Non-GAAP)
|
$
|
(297,463
|
)
|
$
|
(173,135
|
)
|
$
|
(734,935
|
)
|
$
|
(596,506
|
)
|
Three Months Ended December 31,
|
Nine Months Ended December 31,
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||||||||||||||||||
Note
|
2022
|
2021
|
2022
|
2021
|
|||||||||||||||
Research and development expenses
|
$
|
125,533
|
$
|
137,345
|
$
|
393,358
|
$
|
347,958
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
6,888
|
17,669
|
26,548
|
47,441
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,258
|
778
|
3,558
|
2,301
|
|||||||||||||
Adjusted research and development expenses (Non-GAAP)
|
$
|
117,387
|
$
|
118,898
|
$
|
363,252
|
$
|
298,216
|
Three Months Ended December 31,
|
Nine Months Ended December 31,
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||||||||||||||||||
Note
|
2022
|
2021
|
2022
|
2021
|
|||||||||||||||
Selling, general and administrative expenses
|
$
|
168,261
|
$
|
115,530
|
$
|
474,996
|
$
|
636,060
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
50,741
|
53,547
|
165,771
|
440,356
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,664
|
592
|
4,176
|
1,925
|
|||||||||||||
Adjusted selling, general and administrative expenses (Non-GAAP)
|
$
|
115,856
|
$
|
61,391
|
$
|
305,049
|
$
|
193,779
|
|
• |
SVB Securities Global Biopharma Conference on Tuesday, February 14 including a fireside chat at 12:00 p.m. EST
|
|
• |
Cowen 43rd Annual Health Care Conference on Tuesday, March 7 including a fireside chat at 11:10 a.m. EST and a panel discussion at 12:50 p.m. EST
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