|
|
|
(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))
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
|
|
Item 2.02. |
Results of Operations and Financial Condition.
|
Item 9.01. |
Financial Statements and Exhibits.
|
(d) |
Exhibits.
|
Exhibit No.
|
Description of Exhibit
|
|
Roivant Sciences Ltd. Press Release, dated February 13, 2024
|
||
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: February 13, 2024
|
• |
Roivant completed the sale of Telavant to Roche for $7.1B with an additional $150M in cash payable upon the completion of a near-term milestone
|
• |
Batoclimab produced positive results in Graves’ disease with response rates meaningfully exceeding 50% in the initial cohort of an ongoing 24-week Phase 2 trial
|
• |
VTAMA® (tapinarof) cream, 1% net product revenue was $20.7M for the quarter ended December 31, 2023, with over 300,000 prescriptions written by approximately 14,000 unique prescribers since launch
|
• |
New VTAMA positive long-term efficacy and safety data announced from analyses of the ADORING Phase 3 program in atopic dermatitis. Data from these analyses will be included in sNDA submission expected this
quarter
|
• |
Brepocitinib topline data from the Phase 2 trial in patients with non-infectious uveitis (NIU) is expected this quarter
|
• |
Roivant reported its consolidated cash, cash equivalents and restricted cash of $6.7B at December 31, 2023, supporting cash runway into profitability
|
• |
Roivant: In December 2023,
Roivant announced the completion of the sale of Telavant to Roche for an upfront payment of approximately $7.1 billion with an additional $150 million in cash payable upon the completion of a near-term
milestone. Under the terms of the agreement, Roche gained 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. Prior to
the closing of the transaction, Roivant owned 75% of the issued and outstanding shares of common stock and preferred stock of Telavant and Pfizer owned the remaining 25%, in each case on an as-converted basis. Roivant’s net cash proceeds
from the transaction are approximately $5.2 billion. Approximately $110 million of the additional milestone payment will be payable to Roivant.
|
• |
Immunovant: In November 2023,
Immunovant reported IMVT-1402, a second-generation antibody targeting the neonatal fragment crystallizable receptor (FcRn), continued to show potentially best-in-class profile in a Phase 1 clinical trial in healthy adults. Initial data from
the 600 mg MAD cohort showed that four subcutaneously administered doses of 600 mg IMVT-1402 reduced total immunoglobulin G (IgG) levels by a mean of 74%, very similar to the 76% IgG reduction after four weekly injections of 680 mg
batoclimab, but with no or minimal changes in serum albumin and LDL cholesterol, consistent with observations in placebo.
|
• |
Dermavant: For the third quarter ended December 31, 2023, Roivant reported VTAMA net product revenue of $20.7M, representing a 28.5% gross-to-net
yield for the quarter. As of February 2024, over 300,000 VTAMA prescriptions1 have been written by
approximately 14,000 unique prescribers for psoriasis2, based on IQVIA data. VTAMA is covered for 137 million US commercial lives, including coverage by
all three of the top pharmacy benefit managers.
|
o |
vIGA-AD score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline was observed in 73% (519/711) of patients included
|
o |
80.7% (574/711) of patients achieved at least a 75% improvement in the Eczema Area and Severity Index (EASI75)
|
o |
77.9% (218/280) of patients ≥12 years old with a baseline Peak Pruritus Numeric Rating Scale (PP-NRS) score ≥4 achieved a ≥4-point reduction in PP-NRS
|
o |
92.3% (656/711) of patients achieved at least a 1-grade improvement in vIGA-AD score
|
1
|
IQVIA National Prescription Audit (NPA) for the 3-month period ending 1/26/2024, reflecting estimates of real-world activity. All rights reserved.
|
2
|
NPA for the period 5/20/22 to 1/19/2024, reflecting estimates of real-world activity. All rights reserved.
|
• |
Hemavant: We
have discontinued the development of RVT-2001 after an interim data analysis from the Phase 1/2 study.
|
• |
Immunovant expects
initial results from period 1 of the Phase 2b clinical trial of batoclimab in CIDP in the second or third quarter of calendar year 2024, while top-line data from the Phase 3 clinical trials of batoclimab in MG and TED are on track and
expected in the second half of calendar year 2024 and the first half of calendar year 2025, respectively. For IMVT-1402, Immunovant plans to initiate 4-5 potentially registrational programs by March 31, 2025 and plans to initiate trials in
10 indications by March 31, 2026 (inclusive of the 4-5 potentially registrational programs).
|
• |
Priovant 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.
|
• |
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.
|
December 31, 2023
|
March 31, 2023
|
|||||||
Cash, cash equivalents and restricted cash
|
$
|
6,685,458
|
$
|
1,692,115
|
||||
Total assets
|
7,312,679
|
2,389,604
|
||||||
Total liabilities
|
728,097
|
782,017
|
||||||
Total shareholders’ equity
|
6,584,582
|
1,607,587
|
||||||
Total liabilities and shareholders’ equity
|
7,312,679
|
2,389,604
|
|
Three Months Ended
December 31,
|
Nine Months Ended
December 31,
|
||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
||||||||||||
|
||||||||||||||||
Revenues:
|
||||||||||||||||
Product revenue, net
|
$
|
20,666
|
$
|
9,244
|
$
|
55,749
|
$
|
14,354
|
||||||||
License, milestone and other revenue
|
16,474
|
7,808
|
40,116
|
19,550
|
||||||||||||
Revenue, net
|
37,140
|
17,052
|
95,865
|
33,904
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Cost of revenues
|
3,668
|
3,586
|
11,148
|
8,953
|
||||||||||||
Research and development (includes $7,475 and $6,888 of share-based compensation expense for the three months ended December 31, 2023 and 2022 and $24,305
and $26,548 for the nine months ended December 31, 2023 and 2022, respectively)
|
123,717
|
125,533
|
380,834
|
393,358
|
||||||||||||
Acquired in-process research and development
|
—
|
97,749
|
26,450
|
97,749
|
||||||||||||
Selling, general and administrative (includes $46,944 and $50,741 of share-based compensation expense for the three months ended December 31, 2023 and
2022 and $128,445 and $165,771 for the nine months ended December 31, 2023 and 2022, respectively)
|
197,282
|
168,261
|
517,827
|
474,996
|
||||||||||||
Total operating expenses
|
324,667
|
395,129
|
936,259
|
975,056
|
||||||||||||
|
||||||||||||||||
Gain on sale of Telavant net assets
|
5,348,410
|
—
|
5,348,410
|
—
|
||||||||||||
|
||||||||||||||||
Income (loss) from operations
|
5,060,883
|
(378,077
|
)
|
4,508,016
|
(941,152
|
)
|
||||||||||
|
||||||||||||||||
Change in fair value of investments
|
10,467
|
(25,948
|
)
|
63,880
|
53,277
|
|||||||||||
Change in fair value of debt and liability instruments
|
9,331
|
62,360
|
85,376
|
90,032
|
||||||||||||
Gain on deconsolidation of subsidiaries
|
—
|
(12,514
|
)
|
(17,354
|
)
|
(29,276
|
)
|
|||||||||
Interest income
|
(31,953
|
)
|
(10,249
|
)
|
(62,967
|
)
|
(17,900
|
)
|
||||||||
Interest expense
|
9,444
|
8,446
|
27,603
|
19,393
|
||||||||||||
Other income, net
|
(34,743
|
)
|
(18,095
|
)
|
(33,405
|
)
|
(11,060
|
)
|
||||||||
Net income (loss) before income taxes
|
5,098,337
|
(382,077
|
)
|
4,444,883
|
(1,045,618
|
)
|
||||||||||
Income tax expense
|
25,672
|
2,819
|
31,181
|
8,983
|
||||||||||||
Net income (loss)
|
5,072,665
|
(384,896
|
)
|
4,413,702
|
(1,054,601
|
)
|
||||||||||
Net loss attributable to noncontrolling interests
|
(23,519
|
)
|
(32,882
|
)
|
(86,339
|
)
|
(79,188
|
)
|
||||||||
Net income (loss) attributable to Roivant Sciences Ltd.
|
$
|
5,096,184
|
$
|
(352,014
|
)
|
$
|
4,500,041
|
$
|
(975,413
|
)
|
||||||
|
||||||||||||||||
Net income (loss) per common share:
|
||||||||||||||||
Basic
|
$
|
6.37
|
$
|
(0.49
|
)
|
$
|
5.79
|
$
|
(1.39
|
)
|
||||||
Diluted
|
$
|
6.03
|
$
|
(0.49
|
)
|
$
|
5.46
|
$
|
(1.39
|
)
|
||||||
|
||||||||||||||||
Weighted average shares outstanding:
|
||||||||||||||||
Basic
|
800,587,716
|
713,319,399
|
776,759,728
|
703,054,773
|
||||||||||||
Diluted
|
844,461,685
|
713,319,399
|
824,310,013
|
703,054,773
|
|
Three Months Ended
December 31,
|
Nine Months Ended
December 31,
|
|||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||
|
|||||||||||||||||||
Net income (loss)
|
$
|
5,072,665
|
$
|
(384,896
|
)
|
$
|
4,413,702
|
$
|
(1,054,601
|
)
|
|||||||||
Adjustments:
|
|||||||||||||||||||
Cost of revenues
|
|||||||||||||||||||
Amortization of intangible assets
|
(1)
|
|
2,442
|
2,228
|
7,211
|
5,170
|
|||||||||||||
Share-based compensation
|
(2)
|
|
55
|
—
|
153
|
—
|
|||||||||||||
Research and development:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
7,475
|
6,888
|
24,305
|
26,548
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,023
|
1,258
|
3,717
|
3,558
|
|||||||||||||
Selling, general and administrative:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
46,944
|
50,741
|
128,445
|
165,771
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,956
|
1,664
|
5,902
|
4,176
|
|||||||||||||
Gain on sale of Telavant net assets
|
(4)
|
(5,348,410
|
)
|
—
|
(5,348,410
|
)
|
—
|
||||||||||||
Other:
|
|||||||||||||||||||
Change in fair value of investments
|
(5)
|
10,467
|
(25,948
|
)
|
63,880
|
53,277
|
|||||||||||||
Change in fair value of debt and liability instruments
|
(6)
|
|
9,331
|
62,360
|
85,376
|
90,032
|
|||||||||||||
Gain on deconsolidation of subsidiaries
|
(7)
|
|
—
|
(12,514
|
)
|
(17,354
|
)
|
(29,276
|
)
|
||||||||||
Estimated income tax impact from adjustments
|
(8)
|
21,199
|
756
|
21,351
|
410
|
||||||||||||||
|
|||||||||||||||||||
Adjusted net loss (Non-GAAP)
|
$
|
(174,853
|
)
|
$
|
(297,463
|
)
|
$
|
(611,722
|
)
|
$
|
(734,935
|
)
|
|
Three Months Ended
December 31,
|
Nine Months Ended
December 31,
|
|||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||
|
|||||||||||||||||||
Research and development expenses
|
$
|
123,717
|
$
|
125,533
|
$
|
380,834
|
$
|
393,358
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
7,475
|
6,888
|
24,305
|
26,548
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,023
|
1,258
|
3,717
|
3,558
|
|||||||||||||
|
|||||||||||||||||||
Adjusted research and development expenses (Non-GAAP)
|
$
|
115,219
|
$
|
117,387
|
$
|
352,812
|
$
|
363,252
|
|
Three Months Ended
December 31,
|
Nine Months Ended
December 31,
|
|||||||||||||||||
|
Note
|
2023
|
2022
|
2023
|
2022
|
||||||||||||||
|
|||||||||||||||||||
Selling, general and administrative expenses
|
$
|
197,282
|
$
|
168,261
|
$
|
517,827
|
$
|
474,996
|
|||||||||||
Adjustments:
|
|||||||||||||||||||
Share-based compensation
|
(2)
|
|
46,944
|
50,741
|
128,445
|
165,771
|
|||||||||||||
Depreciation and amortization
|
(3)
|
|
1,956
|
1,664
|
5,902
|
4,176
|
|||||||||||||
|
|||||||||||||||||||
Adjusted selling, general and administrative expenses (Non-GAAP)
|
$
|
148,382
|
$
|
115,856
|
$
|
383,480
|
$
|
305,049
|