|
|
|
|
|
(State or Other Jurisdiction of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.)
|
|
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
|
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
|
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
|
|
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
|
Trading
Symbol(s)
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Name of each exchange
on which registered
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||
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| Item 2.02. |
Results of Operations and Financial Condition.
|
| Item 9.01. |
Financial Statements and Exhibits.
|
|
(d)
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Exhibits.
|
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Exhibit No.
|
Description of Exhibit
|
|
|
Roivant Sciences Ltd. Press Release, dated November 13, 2023
|
||
|
104
|
Cover Page Interactive Data File (embedded with Inline XBRL document)
|
|
ROIVANT SCIENCES LTD.
|
||
|
|
||
|
By:
|
/s/ Matt Maisak
|
|
|
Name:
|
Matt Maisak
|
|
|
Title:
|
Authorized Signatory
|
|
|
Dated: November 13, 2023
|
||
| • |
Roivant entered into a definitive agreement with Roche for the sale of Telavant for $7.1B upfront and a milestone payment of $150M payable upon the initiation of a Phase
3 trial in ulcerative colitis
|
| • |
IMVT-1402 subcutaneous (SC) doses achieved peak Immunoglobulin G (IgG) reductions that are similar to those previously observed with batoclimab, based on initial results
from Phase 1 single-ascending dose and 300 mg multiple-ascending dose studies
|
| • |
IMVT-1402 showed no statistically significant dose-related decrease in serum albumin below baseline or increase in low-density lipoprotein cholesterol (LDL-C) above
baseline after 4 weeks of dosing in the 300 mg multiple-ascending dose (MAD) SC cohort
|
| • |
VTAMA® (tapinarof) cream, 1% net product revenue was $18.4M for the quarter ended September 30, 2023, with over 250,000 prescriptions written by approximately 12,800
unique prescribers since launch
|
| • |
Roivant reported cash, cash equivalents and restricted cash of approximately $1.4B at September 30, 2023. Giving effect to Immunovant’s October 2023
follow-on offering and expected cash proceeds from the pending sale of Telavant (including one-time milestone), Roivant’s cash, cash equivalents and restricted cash would have been approximately $7.0B
|
| • |
Roivant appointed President and Chief Investment Officer, Mayukh Sukhatme, M.D., to its Board of Directors
|
| • |
Telavant: In October 2023, Roivant entered into a definitive
agreement with Roche for the sale of Telavant. Roche will gain the rights to develop, manufacture and commercialize RVT-3101 in the US and Japan for the treatment of inflammatory bowel disease and potentially other diseases. Under the terms of
the agreement, Roche will pay a purchase price of $7.1 billion upfront and a milestone payment of $150 million payable upon the initiation of a Phase 3 trial in ulcerative colitis. Roivant owns 75% of the issued and outstanding shares of common
stock and preferred stock of Telavant and Pfizer owns the remaining 25%, in each case on an as-converted basis. Roivant’s net proceeds from the transaction are expected to be approximately $5.2 billion plus $110 million from the milestone
payment. Regulatory filings in connection with the transaction have been submitted and the closing of the transaction remains on track for the fourth quarter of 2023 or the first quarter of 2024.
|
| • |
Immunovant: In September 2023, Immunovant announced initial data
from the Phase 1 clinical trial evaluating the safety, tolerability, and pharmacodynamic profiles of IMVT-1402 in healthy adults showed that subcutaneously administered doses of IMVT-1402 produced dose-dependent reductions in Immunoglobulin G,
with no statistically significant dose-related decrease in serum albumin or increase in LDL cholesterol, strengthening IMVT-1402 as a potential best-in-class neonatal fragment crystallizable receptor (FcRn) inhibitor. In October 2023,
Immunovant announced the closing of an underwritten public offering and concurrent private placement offering of common stock yielding approximately $467 million in net proceeds to Immunovant, after deducting underwriting commissions and
estimated offering expenses. Roivant owns approximately 55.2% of Immunovant as of November 3, 2023.
|
| • |
Dermavant: For the second quarter ended September 30, 2023, Roivant reported VTAMA net
product revenue of $18.4M, representing a 28% gross-to-net yield for the quarter. As of November 2023, over 250,000 VTAMA prescriptions have been written by approximately 12,800 unique prescribers for psoriasis, based on IQVIA data. Coverage
has been expanded to 137 million US commercial lives and includes coverage by all three of the top pharmacy benefit managers.
|
|
|
In October 2023, Dermavant reported that in adult patients, VTAMA showed positive results from a Phase 4 open-label trial for the treatment of
intertriginous plaque psoriasis - 82.8% achieved an intertriginous Physician Global Assessment (iPGA) Score of 0 (clear) or 1 (almost clear) and ≥2-grade improvement from baseline at Week 12, demonstrating compelling efficacy. Additionally,
Dermavant reported in adults and children down to two years of age with atopic dermatitis, VTAMA showed rapid and significant onset of pruritus (itch)
relief as early as 24 hours after initial application.
|
| • |
Roivant: In September 2023, Roivant raised
approximately $200 million in a follow-on offering. Roivant reported cash, cash equivalents and restricted cash of approximately $1.4 billion at September 30, 2023. Giving effect to Immunovant’s October 2023 follow-on offering and expected cash
proceeds from the pending sale of Telavant (including one-time milestone), Roivant’s cash, cash equivalents and restricted cash would have been approximately $7.0 billion. The acquisition of Telavant is subject to customary closing conditions
and is expected to close in the fourth quarter of 2023 or the first quarter of 2024.
|
| • |
Immunovant expects additional IMVT-1402 data from
the 600 mg multiple-ascending dose cohort in November 2023. Additionally, for batoclimab: Top-line data from the Phase 3 clinical trial in MG are expected in the second half of calendar year 2024. For the Phase 3 program in TED, top-line data
are expected in the first half of calendar year 2025. Immunovant also expects to have initial results from period 1 of the Phase 2B clinical trial in CIDP in the first half of calendar year 2024, and initial Phase 2 proof-of-concept data in
Graves’ disease by the end of calendar year 2023.
|
| • |
Priovant plans to announce topline results from
the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 2
POC study in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.
|
| • |
Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis
to the FDA in the first quarter of calendar year 2024.
|
| • |
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 myelodysplastic syndromes (MDS) patients in the first quarter of calendar year 2024.
|
| • |
Kinevant plans to report topline data from the
ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.
|
|
September 30, 2023
|
March 31, 2023
|
|||||||
|
Cash, cash equivalents and restricted cash
|
$
|
1,423,188
|
$
|
1,692,115
|
||||
|
Total assets
|
2,065,543
|
2,389,604
|
||||||
|
Total liabilities
|
739,910
|
782,017
|
||||||
|
Total shareholders’ equity
|
1,325,633
|
1,607,587
|
||||||
|
Total liabilities and shareholders’ equity
|
2,065,543
|
2,389,604
|
||||||
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
|||||||||||||
|
Revenues:
|
||||||||||||||||
|
Product revenue, net
|
$
|
18,424
|
$
|
4,969
|
$
|
35,083
|
$
|
5,110
|
||||||||
|
License, milestone and other revenue
|
18,677
|
7,564
|
23,642
|
11,742
|
||||||||||||
|
Revenue, net
|
37,101
|
12,533
|
58,725
|
16,852
|
||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Cost of revenues
|
3,266
|
3,641
|
7,480
|
5,367
|
||||||||||||
|
Research and development (includes $8,877 and $7,417 of share-based compensation expense for the three months ended
September 30, 2023 and 2022 and $16,830 and $19,660 for the six months ended September 30, 2023 and 2022, respectively)
|
131,984
|
131,995
|
257,117
|
267,825
|
||||||||||||
|
Acquired in-process research and development
|
13,950
|
—
|
26,450
|
—
|
||||||||||||
|
Selling, general and administrative (includes $40,309 and $54,479 of share-based compensation expense for the three
months ended September 30, 2023 and 2022 and $81,501 and $115,030 for the six months ended September 30, 2023 and 2022, respectively)
|
164,355
|
157,663
|
320,545
|
306,735
|
||||||||||||
|
Total operating expenses
|
313,555
|
293,299
|
611,592
|
579,927
|
||||||||||||
|
Loss from operations
|
(276,454
|
)
|
(280,766
|
)
|
(552,867
|
)
|
(563,075
|
)
|
||||||||
|
Change in fair value of investments
|
45,849
|
54,678
|
53,413
|
79,225
|
||||||||||||
|
Change in fair value of debt and liability instruments
|
21,533
|
(13,541
|
)
|
76,045
|
27,672
|
|||||||||||
|
Gain on deconsolidation of subsidiaries
|
(17,354
|
)
|
(16,762
|
)
|
(17,354
|
)
|
(16,762
|
)
|
||||||||
|
Interest income
|
(14,299
|
)
|
(5,670
|
)
|
(31,014
|
)
|
(7,651
|
)
|
||||||||
|
Interest expense
|
9,247
|
8,335
|
18,159
|
10,947
|
||||||||||||
|
Other expense, net
|
5,931
|
5,950
|
1,338
|
7,035
|
||||||||||||
|
Loss before income taxes
|
(327,361
|
)
|
(313,756
|
)
|
(653,454
|
)
|
(663,541
|
)
|
||||||||
|
Income tax expense
|
3,757
|
2,165
|
5,509
|
6,164
|
||||||||||||
|
Net loss
|
(331,118
|
)
|
(315,921
|
)
|
(658,963
|
)
|
(669,705
|
)
|
||||||||
|
Net loss attributable to noncontrolling interests
|
(26,791
|
)
|
(24,331
|
)
|
(62,820
|
)
|
(46,306
|
)
|
||||||||
|
Net loss attributable to Roivant Sciences Ltd.
|
$
|
(304,327
|
)
|
$
|
(291,590
|
)
|
$
|
(596,143
|
)
|
$
|
(623,399
|
)
|
||||
|
Net loss per common share—basic and diluted
|
$
|
(0.40
|
)
|
$
|
(0.42
|
)
|
$
|
(0.78
|
)
|
$
|
(0.89
|
)
|
||||
|
Weighted average shares outstanding—basic and diluted
|
770,227,849
|
699,888,061
|
764,780,630
|
697,894,414
|
||||||||||||
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||||
|
Net loss
|
$
|
(331,118
|
)
|
$
|
(315,921
|
)
|
$
|
(658,963
|
)
|
$
|
(669,705
|
)
|
||||||||
|
Adjustments:
|
||||||||||||||||||||
|
Cost of revenues
|
||||||||||||||||||||
|
Amortization of intangible assets
|
(1
|
)
|
2,399
|
2,200
|
4,769
|
2,942
|
||||||||||||||
|
Share-based compensation
|
(2
|
)
|
60
|
—
|
98
|
—
|
||||||||||||||
|
Research and development:
|
||||||||||||||||||||
|
Share-based compensation
|
(2
|
)
|
8,877
|
7,417
|
16,830
|
19,660
|
||||||||||||||
|
Depreciation and amortization
|
(3
|
)
|
1,205
|
1,230
|
2,694
|
2,300
|
||||||||||||||
|
Selling, general and administrative:
|
||||||||||||||||||||
|
Share-based compensation
|
(2
|
)
|
40,309
|
54,479
|
81,501
|
115,030
|
||||||||||||||
|
Depreciation and amortization
|
(3
|
)
|
1,966
|
1,646
|
3,946
|
2,512
|
||||||||||||||
|
Other:
|
||||||||||||||||||||
|
Change in fair value of investments
|
(4
|
)
|
45,849
|
54,678
|
53,413
|
79,225
|
||||||||||||||
|
Change in fair value of debt and liability instruments
|
(5
|
)
|
21,533
|
(13,541
|
)
|
76,045
|
27,672
|
|||||||||||||
|
Gain on deconsolidation of subsidiaries
|
(6
|
)
|
(17,354
|
)
|
(16,762
|
)
|
(17,354
|
)
|
(16,762
|
)
|
||||||||||
|
Estimated income tax impact from adjustments
|
(7
|
)
|
884
|
(2,219
|
)
|
152
|
(346
|
)
|
||||||||||||
|
Adjusted net loss (Non-GAAP)
|
$
|
(225,390
|
)
|
$
|
(226,793
|
)
|
$
|
(436,869
|
)
|
$
|
(437,472
|
)
|
||||||||
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||||
|
Research and development expenses
|
$
|
131,984
|
$
|
131,995
|
$
|
257,117
|
$
|
267,825
|
||||||||||||
|
Adjustments:
|
||||||||||||||||||||
|
Share-based compensation
|
(2
|
)
|
8,877
|
7,417
|
16,830
|
19,660
|
||||||||||||||
|
Depreciation and amortization
|
(3
|
)
|
1,205
|
1,230
|
2,694
|
2,300
|
||||||||||||||
|
Adjusted research and development expenses (Non-GAAP)
|
$
|
121,902
|
$
|
123,348
|
$
|
237,593
|
$
|
245,865
|
||||||||||||
|
Three Months Ended September 30,
|
Six Months Ended September 30,
|
|||||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||||
|
Selling, general and administrative expenses
|
$
|
164,355
|
$
|
157,663
|
$
|
320,545
|
$
|
306,735
|
||||||||||||
|
Adjustments:
|
||||||||||||||||||||
|
Share-based compensation
|
(2
|
)
|
40,309
|
54,479
|
81,501
|
115,030
|
||||||||||||||
|
Depreciation and amortization
|
(3
|
)
|
1,966
|
1,646
|
3,946
|
2,512
|
||||||||||||||
|
Adjusted selling, general and administrative expenses (Non-GAAP)
|
$
|
122,080
|
$
|
101,538
|
$
|
235,098
|
$
|
189,193
|
||||||||||||
Document and Entity Information |
Nov. 13, 2023 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Nov. 13, 2023 |
| Entity File Number | 001-40782 |
| Entity Registrant Name | Roivant Sciences Ltd. |
| Entity Central Index Key | 0001635088 |
| Entity Incorporation, State or Country Code | D0 |
| Entity Tax Identification Number | 98-1173944 |
| Entity Address, Address Line One | 7th Floor |
| Entity Address, Address Line Two | 50 Broadway |
| Entity Address, City or Town | London |
| Entity Address, Country | GB |
| Entity Address, Postal Zip Code | SW1H 0DB |
| City Area Code | 207 |
| Local Phone Number | 400-3347 |
| Title of 12(b) Security | Common Shares, $0.0000000341740141 par value per share |
| Trading Symbol | ROIV |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Entity Ex Transition Period | true |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |