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 per share
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ROIV
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The Nasdaq Global Select 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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Press Release dated May 30, 2024
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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: Matt Maisak
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||
Title: Authorized Signatory
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• |
Once-daily brepocitinib produced the best Treatment Failure rates observed to date among studies in active non-infectious uveitis (NIU), supporting initiation of a pivotal
program in NIU in the second half of calendar year 2024
|
|
• |
Brepocitinib is well positioned to support a potential multi-blockbuster franchise in rare and orphan autoimmune disease with an ongoing pivotal study in dermatomyositis on
track to read out in calendar year 2025
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• |
Following a recently completed Type B meeting with the FDA, Immunovant is on track to initiate 4-5 potentially registrational studies with IMVT-1402 over the fiscal year ending
March 31, 2025
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|
• |
Immunovant expects to announce detailed results from the study of batoclimab in Graves’ disease (GD) as well as an overview of the development plan of IMVT-1402 in GD in the
fall of 2024
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• |
VTAMA® sNDA submission for atopic dermatitis was accepted by the FDA; PDUFA action is expected in the fourth quarter of calendar year 2024, potentially enabling a four-fold
market expansion
|
|
• |
VTAMA, approved for psoriasis, net product revenue was $75.1M for the fiscal year ended March 31, 2024, with over 385,000 prescriptions written by over 15,300 unique
prescribers since launch
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|
• |
Roivant renegotiated Dermavant’s debt obligations, reducing potential cash payments due by over $300M in the aggregate. Approximately $225M of this reduction is expected to be
achieved over the next three fiscal years
|
|
• |
Roivant has $852M in share repurchase authorization available following the repurchase of Sumitomo’s entire stake at $9.10 per share for $648M, which reduced outstanding shares
by 9%
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|
• |
Net cash used in operating activities for the quarter was $108M
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• |
Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.6B at March 31, 2024, supporting cash runway into profitability
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• |
Priovant: In April 2024, Priovant announced positive results from the Phase 2 study (NEPTUNE) evaluating brepocitinib in non-anterior non-infectious uveitis. On the pre-specified primary efficacy endpoint of Treatment Failure
at week 24, 29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met Treatment Failure criteria (lower failure rates reflect greater treatment benefit). The brepocitinib 45 mg results represent
the best Treatment Failure rates observed to date among studies in active NIU measuring this registrational endpoint. All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit
on prevention and treatment of uveitic macular edema. NEPTUNE represents the seventh positive Phase 2 study for brepocitinib with over 1,400 subjects and patients treated with brepocitinib in clinical trials. Brepocitinib was generally
safe and well-tolerated in the study, with no new safety or tolerability signals identified.
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|
• |
Immunovant: Following a recently completed Type B meeting with the FDA, 4-5 potentially registrational programs for IMVT-1402 are on track to be initiated by March 31, 2025. Immunovant is prioritizing the development of
IMVT-1402 as the lead asset going forward.
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|
• |
Dermavant: For the fourth quarter and fiscal year ended March 31, 2024, Roivant reported VTAMA net product revenue of $19.3M, and
$75.1M, respectively. As of May 2024, over 385,000 VTAMA prescriptions have been written by over 15,300 unique prescribers for psoriasis. VTAMA is covered for over 138M US commercial lives, including
coverage by all three of the top pharmacy benefit managers.
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• |
Genevant: In April 2024,
the U.S. District Court for the District of Delaware issued its claim construction (Markman) ruling in the lawsuit brought by Genevant and Arbutus against Moderna. The court agreed with Genevant and Arbutus’ proposed constructions for
three of the four disputed terms.
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|
• |
Kinevant: In April 2024,
Kinevant completed enrollment in RESOLVE-LUNG, a Phase 2 study evaluating namilumab for chronic pulmonary sarcoidosis.
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• |
Roivant: In April 2024, Roivant announced that its board of
directors had authorized a share repurchase program for up to $1.5B of the company’s common shares. Pursuant to that program, the company completed the repurchase of all 71.3M shares held by Sumitomo Pharma at a purchase price of $9.10
per share. The aggregate purchase price for Sumitomo Pharma’s stake was approximately $648.4M, reducing Roivant’s shares outstanding by approximately 9%.
|
|
• |
Dermavant expects PDUFA action for VTAMA in atopic
dermatitis in the fourth quarter of calendar year 2024.
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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 fourth quarter of calendar year 2024.
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|
• |
Priovant expects topline results from the
ongoing Phase 3 trial of brepocitinib in dermatomyositis (DM) in calendar year 2025 and to initiate a Phase 3 pivotal trial of brepocitinib in the second half of calendar year 2024.
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|
• |
Immunovant plans to have initiated 4-5 potentially registrational programs by March 31, 2025, and plans to have initiated studies in a total of 10 indications by March 31, 2026 for IMVT-1402. Detailed results from the
batoclimab study in Graves’ Disease (GD) and an overview of the development plan of IMVT-1402 in GD are expected in the fall of 2024. Immunovant expects to report topline data from the study of batoclimab in MG over this fiscal year with
further potentially registrational development of IMVT-1402 in MG expected to begin in the same timeframe. Immunovant has decided to run the study of batoclimab in CIDP longer prior to unblinding period 1 in order to better ensure that
the data from the batoclimab study can be used to optimize development of IMVT-1402 in CIDP. Top-line data from the ongoing Phase 3
clinical trial in thyroid eye disease (TED) is expected in the first half of calendar year 2025.
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March 31, 2024
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March 31, 2023
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|||||||
Cash, cash equivalents and restricted cash
|
$
|
6,550,450
|
$
|
1,692,115
|
||||
Total assets
|
7,222,482
|
2,389,604
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||||||
Total liabilities
|
773,953
|
782,017
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||||||
Total shareholders’ equity
|
6,448,529
|
1,607,587
|
||||||
Total liabilities and shareholders’ equity
|
7,222,482
|
2,389,604
|
Three Months Ended March 31,
|
Years Ended March 31,
|
|||||||||||||||
2024
|
2023
|
2024
|
2023
|
|||||||||||||
(Unaudited)
|
(Unaudited)
|
|||||||||||||||
Revenues:
|
||||||||||||||||
Product revenue, net
|
$
|
19,308
|
$
|
13,657
|
$
|
75,057
|
$
|
28,011
|
||||||||
License, milestone and other revenue
|
9,622
|
13,719
|
49,738
|
33,269
|
||||||||||||
Revenue, net
|
28,930
|
27,376
|
124,795
|
61,280
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of revenues
|
4,412
|
4,175
|
15,560
|
13,128
|
||||||||||||
Research and development (includes $10,290 and $4,366 of share-based compensation expense for the three months ended March 31, 2024 and
2023, respectively, and $34,595 and $30,914 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively)
|
120,902
|
131,857
|
501,736
|
525,215
|
||||||||||||
Acquired in-process research and development
|
—
|
—
|
26,450
|
97,749
|
||||||||||||
Selling, general and administrative (includes $36,396 and $20,832 of share-based compensation expense for the three months ended March 31,
2024 and 2023, respectively, and $164,841 and $186,603 of share-based compensation expense for the years ended March 31, 2024 and 2023, respectively)
|
169,616
|
125,510
|
687,443
|
600,506
|
||||||||||||
Total operating expenses
|
294,930
|
261,542
|
1,231,189
|
1,236,598
|
||||||||||||
Gain on sale of Telavant net assets
|
—
|
—
|
5,348,410
|
—
|
||||||||||||
(Loss) income from operations
|
(266,000
|
)
|
(234,166
|
)
|
4,242,016
|
(1,175,318
|
)
|
|||||||||
Change in fair value of investments
|
(15,907
|
)
|
(32,462
|
)
|
47,973
|
20,815
|
||||||||||
Change in fair value of debt and liability instruments
|
(6,433
|
)
|
(12,031
|
)
|
78,943
|
78,001
|
||||||||||
Gain on deconsolidation of subsidiaries
|
(15,418
|
)
|
—
|
(32,772
|
)
|
(29,276
|
)
|
|||||||||
Interest income
|
(83,458
|
)
|
(14,284
|
)
|
(146,425
|
)
|
(32,184
|
)
|
||||||||
Interest expense
|
7,175
|
8,575
|
34,778
|
27,968
|
||||||||||||
Other expense (income), net
|
39,494
|
(4,748
|
)
|
6,089
|
(15,808
|
)
|
||||||||||
(Loss) income from continuing operations before income taxes
|
(191,453
|
)
|
(179,216
|
)
|
4,253,430
|
(1,224,834
|
)
|
|||||||||
Income tax (benefit) expense
|
(8,957
|
)
|
(3,793
|
)
|
22,224
|
5,190
|
||||||||||
(Loss) income from continuing operations, net of tax
|
(182,496
|
)
|
(175,423
|
)
|
4,231,206
|
(1,230,024
|
)
|
|||||||||
Income from discontinued operations, net of tax
|
—
|
114,561
|
—
|
114,561
|
||||||||||||
Net (loss) income
|
(182,496
|
)
|
(60,862
|
)
|
4,231,206
|
(1,115,463
|
)
|
|||||||||
Net loss attributable to noncontrolling interests
|
(31,381
|
)
|
(27,245
|
)
|
(117,720
|
)
|
(106,433
|
)
|
||||||||
Net (loss) income attributable to Roivant Sciences Ltd.
|
$
|
(151,115
|
)
|
$
|
(33,617
|
)
|
$
|
4,348,926
|
$
|
(1,009,030
|
)
|
|||||
Amounts attributable to Roivant Sciences Ltd.:
|
||||||||||||||||
(Loss) income from continuing operations, net of tax
|
$
|
(151,115
|
)
|
$
|
(148,178
|
)
|
$
|
4,348,926
|
$
|
(1,123,591
|
)
|
|||||
Income from discontinued operations, net of tax
|
—
|
114,561
|
—
|
114,561
|
||||||||||||
Net (loss) income attributable to Roivant Sciences Ltd.
|
$
|
(151,115
|
)
|
$
|
(33,617
|
)
|
$
|
4,348,926
|
$
|
(1,009,030
|
)
|
|||||
Net (loss) income per common share, basic:
|
||||||||||||||||
(Loss) income from continuing operations
|
$
|
(0.19
|
)
|
$
|
(0.20
|
)
|
$
|
5.55
|
$
|
(1.58
|
)
|
|||||
Income from discontinued operations, net of tax
|
$
|
—
|
$
|
0.15
|
$
|
—
|
$
|
0.16
|
||||||||
Net (loss) income
|
$
|
(0.19
|
)
|
$
|
(0.05
|
)
|
$
|
5.55
|
$
|
(1.42
|
)
|
|||||
Net (loss) income per common share, diluted:
|
||||||||||||||||
(Loss) income from continuing operations
|
$
|
(0.19
|
)
|
$
|
(0.20
|
)
|
$
|
5.23
|
$
|
(1.58
|
)
|
|||||
Income from discontinued operations, net of tax
|
$
|
—
|
$
|
0.15
|
$
|
—
|
$
|
0.16
|
||||||||
Net (loss) income
|
$
|
(0.19
|
)
|
$
|
(0.05
|
)
|
$
|
5.23
|
$
|
(1.42
|
)
|
|||||
Weighted average shares outstanding:
|
||||||||||||||||
Basic
|
802,859,062
|
742,541,052
|
783,248,906
|
712,791,115
|
||||||||||||
Diluted
|
802,859,062
|
742,541,052
|
831,049,444
|
712,791,115
|
Three Months Ended March 31,
|
Years Ended March 31,
|
||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
|||||||||||||||
(Loss) income from continuing operations, net of tax
|
$
|
(182,496
|
)
|
$
|
(175,423
|
)
|
$
|
4,231,206
|
$
|
(1,230,024
|
)
|
||||||||
Adjustments:
|
|||||||||||||||||||
Cost of revenues:
|
|||||||||||||||||||
Amortization of intangibles
|
(1)
|
2,421
|
2,298
|
9,632
|
7,468
|
||||||||||||||
Share-based compensation
|
(2)
|
|
38
|
37
|
191
|
95
|
|||||||||||||
Research and development:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
10,290
|
4,366
|
34,595
|
30,914
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
873
|
1,539
|
4,590
|
5,097
|
|||||||||||||
Selling, general and administrative:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
36,396
|
20,832
|
164,841
|
186,603
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,912
|
2,116
|
7,814
|
6,292
|
|||||||||||||
Gain on sale of Telavant net assets
|
(4)
|
|
—
|
—
|
(5,348,410
|
)
|
—
|
||||||||||||
Other:
|
|||||||||||||||||||
Change in fair value of investments
|
(5)
|
|
(15,907
|
)
|
(32,462
|
)
|
47,973
|
20,815
|
|||||||||||
Change in fair value of debt and liability instruments
|
(6)
|
|
(6,433
|
)
|
(12,031
|
)
|
78,943
|
78,001
|
|||||||||||
Gain on deconsolidation of subsidiaries
|
(7)
|
|
(15,418
|
)
|
—
|
(32,772
|
)
|
(29,276
|
)
|
||||||||||
Estimated income tax impact from adjustments
|
(8)
|
|
(19,813
|
)
|
(704
|
)
|
1,538
|
(294
|
)
|
||||||||||
Adjusted loss from continuing operations, net of tax (Non-GAAP)
|
$
|
(188,137
|
)
|
$
|
(189,432
|
)
|
$
|
(799,859
|
)
|
$
|
(924,309
|
)
|
Three Months Ended March 31,
|
Years Ended March 31,
|
||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
|||||||||||||||
Research and development expenses
|
$
|
120,902
|
$
|
131,857
|
$
|
501,736
|
$
|
525,215
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
10,290
|
4,366
|
34,595
|
30,914
|
||||||||||||||
Depreciation and amortization
|
(3)
|
|
873
|
1,539
|
4,590
|
5,097
|
|||||||||||||
Adjusted research and development expenses (Non-GAAP)
|
$
|
109,739
|
$
|
125,952
|
$
|
462,551
|
$
|
489,204
|
Three Months Ended March 31,
|
Years Ended March 31,
|
||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
|||||||||||||||
Selling, general and administrative expenses
|
$
|
169,616
|
$
|
125,510
|
$
|
687,443
|
$
|
600,506
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
36,396
|
20,832
|
164,841
|
186,603
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,912
|
2,116
|
7,814
|
6,292
|
|||||||||||||
Adjusted selling, general and administrative expenses (Non-GAAP)
|
$
|
131,308
|
$
|
102,562
|
$
|
514,788
|
$
|
407,611
|
|
• |
Fireside Chat at Jefferies Global Healthcare Conference in New York at 11:30 a.m. ET on June 5, 2024
|
|
• |
Fireside Chat at Goldman Sachs 45th Annual Global Healthcare Conference in Miami at 8:40 a.m. ET on June 10, 2024
|