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 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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(d) |
Exhibits.
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Exhibit No.
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Description of Exhibit
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Roivant Sciences Ltd. Press Release, dated November 12, 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:
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Matt Maisak
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Title:
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Authorized Signatory
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Dated: November 12, 2024
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• |
Brepocitinib 52-week data from the Phase 2 NEPTUNE study in non-infectious uveitis (NIU) showed
potential best-in-indication efficacy sustained to one year; first patients enrolled in Phase 3 NIU program
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• |
IMVT-1402 cleared five Investigational New Drug (IND) applications across a range of therapeutic areas
and FDA divisions, including the potentially registrational trial for difficult-to-treat rheumatoid arthritis (D2T RA) expected to initiate by March 31, 2025
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• |
Batoclimab proof of concept data in Graves’ disease (GD) demonstrate potential of deeper IgG reduction with potent FcRn inhibition to transform treatment for GD patients who are not
well controlled on antithyroid drugs (ATDs); initiation of potentially registrational trial to evaluate IMVT-1402 in GD expected by year end
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• |
Mosliciguat, a once-daily inhaled soluble guanylate cyclase (sGC) activator, unveiled as new pipeline program. Mosliciguat Phase 1b data in pulmonary hypertension (PH) patients
demonstrated some of the highest pulmonary vascular resistance (PVR) reductions (~38%) in PH trials to date. The global Phase 2 PHocus trial for mosliciguat has been initiated in patients with pulmonary hypertension associated with
interstitial lung disease (PH-ILD)
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• |
Roivant continued to return capital through share repurchases with $106M purchased for the quarter, resulting in $754M cumulative share repurchases (inclusive of Sumitomo) through
September 30, 2024
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• |
Dermavant transaction with Organon closed on October 28, 2024. At closing, Roivant received $184M in cash, and Organon took on all of Dermavant’s remaining
outstanding long-term debt, which, inclusive of Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon FDA approval for VTAMA
in atopic dermatitis, with a target action date in Q1 2025
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• |
Roivant reported consolidated cash, cash equivalents and marketable securities of approximately $5.4B at September 30, 2024
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• |
Immunovant:
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• |
Priovant: In September 2024, Priovant announced receipt of Fast Track designation from FDA
for brepocitinib in NIU and enrolled the first patients in the Phase 3 program. New 52-week data from the Phase 2 NEPTUNE study of brepocitinib in NIU showed potential best-in-indication efficacy sustained to one year. Treatment failure rate
in the 45 mg dose arm was 35% at week 52 vs. 29% at week 24. Treatment failure rate in the 15 mg dose arm was 56% vs. 44% at week 24. In each treatment arm only one additional patient failed from week 24 to 52. Other important efficacy
measurements at week 52 were consistent with the week 24 data, including measurements of retinal vascular leakage and prevention and treatment of macular edema. Safety and tolerability were consistent with prior clinical studies of
brepocitinib, with no new safety or tolerability signals identified. Brepocitinib has been dosed in over 1,400 subjects and patients with a safety profile that appears consistent with approved and widely prescribed JAK inhibitors.
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• |
Pulmovant: In September 2024, Roivant unveiled mosliciguat, a potential first-in-class and best-in-category inhaled once-daily sGC activator. Mosliciguat is being developed for PH-ILD, which affects ~200,000 patients in the U.S. and Europe with limited or no
treatment options.
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• |
Roivant: In October 2024, Roivant reported the close of Organon’s
acquisition of Dermavant. At closing, Roivant received $184M in cash and Organon took on all of Dermavant’s remaining outstanding long-term debt, which, inclusive of
Dermavant’s senior credit facility repaid at closing, had a carrying value of $336M as of September 30, 2024. In addition, Organon will pay Roivant a $75M milestone upon
FDA approval for VTAMA in atopic dermatitis, with a target action date in the first quarter of calendar year 2025. The transaction also includes payments of up to $950 million
for the achievements of certain commercial milestones, in addition to the tiered royalties on net sales that Organon will pay Dermavant shareholders.
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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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• |
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. In pursuit of this goal, Immunovant now
has active INDs in Graves’ Disease and difficult-to-treat rheumatoid arthritis and expects to initiate potentially registrational trials in these indications by December 31, 2024 and March 31, 2025 respectively. Topline data from the
batoclimab trial in MG is expected by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and the design of the MG program for IMVT-1402, which is expected to initiate by March
31, 2025. Data from the batoclimab trial in CIDP is expected by March 31, 2025 and will be used to inform the trial design for a potentially registrational program for IMVT-1402. Topline data from the current pivotal program evaluating batoclimab in thyroid eye disease (TED) now expected in the second half of calendar year 2025.
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• |
Priovant plans to report topline data from the ongoing Phase 3 trial of
brepocitinib in DM in the second half of calendar year 2025.
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Genevant Markman hearing in Pfizer / BioNTech action scheduled for December
2024. Summary judgment phase of Moderna action scheduled for second and third quarter of calendar year 2025; Moderna trial scheduled for September 2025.
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September 30, 2024
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March 31, 2024
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|||||||
Cash, cash equivalents and restricted cash
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$
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1,969,914
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$
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6,506,189
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||||
Marketable securities
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3,428,021
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—
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||||||
Total assets
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6,206,028
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7,222,482
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||||||
Total liabilities
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625,986
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773,953
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||||||
Total shareholders’ equity
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5,580,042
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6,448,529
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||||||
Total liabilities and shareholders’ equity
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6,206,028
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7,222,482
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Three Months Ended
September 30,
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Six Months Ended
September 30,
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|||||||||||||||
2024
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2023
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2024
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2023
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|||||||||||||
Revenue, net
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$
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4,475
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$
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3,648
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$
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12,465
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$
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8,131
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||||||||
Operating expenses:
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||||||||||||||||
Cost of revenues
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234
|
223
|
447
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1,206
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||||||||||||
Research and development (includes $9,911 and $8,309 of share-based compensation expense for the three months ended September
30, 2024 and 2023 and $20,443 and $15,726 for the six months ended September 30, 2024 and 2023, respectively)
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143,073
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114,790
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263,580
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224,206
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||||||||||||
Acquired in-process research and development
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—
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13,950
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—
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26,450
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||||||||||||
General and administrative (includes $59,443 and $37,755 of share-based compensation expense for the three months ended
September 30, 2024 and 2023 and $96,284 and $76,472 for the six months ended September 30, 2024 and 2023, respectively)
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202,881
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88,576
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302,773
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179,858
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||||||||||||
Total operating expenses
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346,188
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217,539
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566,800
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431,720
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||||||||||||
Gain on sale of Telavant net assets
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—
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—
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110,387
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—
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||||||||||||
Loss from operations
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(341,713
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)
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(213,891
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)
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(443,948
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)
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(423,589
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)
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||||||||
Change in fair value of investments
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(48,375
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)
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45,849
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(63,601
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)
|
53,413
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||||||||||
Change in fair value of liability instruments
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(635
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)
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11,789
|
515
|
51,967
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|||||||||||
Gain on deconsolidation of subsidiaries
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—
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(17,354
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)
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—
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(17,354
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)
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||||||||||
Interest income
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(69,773
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)
|
(14,299
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)
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(141,900
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)
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(31,014
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)
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||||||||
Other expense, net
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1,453
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1,530
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5,061
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4,357
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||||||||||||
Loss from continuing operations before income taxes
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(224,383
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)
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(241,406
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)
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(244,023
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)
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(484,958
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)
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||||||||
Income tax expense
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12,458
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3,236
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24,421
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4,911
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||||||||||||
Loss from continuing operations, net of tax
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(236,841
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)
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(244,642
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)
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(268,444
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)
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(489,869
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)
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||||||||
(Loss) income from discontinued operations, net of tax
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(43,083
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)
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(86,476
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)
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46,010
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(169,094
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)
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|||||||||
Net loss
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(279,924
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)
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(331,118
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)
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(222,434
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)
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(658,963
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)
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||||||||
Net loss attributable to noncontrolling interests
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(49,740
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)
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(26,791
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)
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(87,547
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)
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(62,820
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)
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||||||||
Net loss attributable to Roivant Sciences Ltd.
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$
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(230,184
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)
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$
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(304,327
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)
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$
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(134,887
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)
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$
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(596,143
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)
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||||
Amounts attributable to Roivant Sciences Ltd.:
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||||||||||||||||
Loss from continuing operations, net of tax
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$
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(187,101
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)
|
$
|
(218,226
|
)
|
$
|
(181,052
|
)
|
$
|
(427,784
|
)
|
||||
(Loss) income from discontinued operations, net of tax
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(43,083
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)
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(86,101
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)
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46,165
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(168,359
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)
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|||||||||
Net loss attributable to Roivant Sciences Ltd.
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$
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(230,184
|
)
|
$
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(304,327
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)
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$
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(134,887
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)
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$
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(596,143
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)
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||||
Basic and diluted net (loss) income per common share:
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||||||||||||||||
Basic and diluted loss from continuing operations
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$
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(0.25
|
)
|
$
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(0.28
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)
|
$
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(0.25
|
)
|
$
|
(0.56
|
)
|
||||
Basic and diluted (loss) income from discontinued operations
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$
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(0.06
|
)
|
$
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(0.11
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)
|
$
|
0.06
|
$
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(0.22
|
)
|
|||||
Basic and diluted net loss per common share
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$
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(0.31
|
)
|
$
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(0.40
|
)
|
$
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(0.18
|
)
|
$
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(0.78
|
)
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||||
Weighted average shares outstanding:
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||||||||||||||||
Basic
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735,470,796
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770,227,849
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735,642,721
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764,780,630
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||||||||||||
Diluted
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735,470,796
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770,227,849
|
735,642,721
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764,780,630
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Three Months Ended
September 30,
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Six Months Ended
September 30,
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|||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
||||||||||||||||
Loss from continuing operations, net of tax
|
$
|
(236,841
|
)
|
$
|
(244,642
|
)
|
$
|
(268,444
|
)
|
$
|
(489,869
|
)
|
||||||||
Adjustments:
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||||||||||||||||||||
Research and development:
|
||||||||||||||||||||
Share-based compensation
|
(1)
|
|
9,911
|
8,309
|
20,443
|
15,726
|
||||||||||||||
Depreciation and amortization
|
(2)
|
|
724
|
1,205
|
1,419
|
2,694
|
||||||||||||||
General and administrative:
|
||||||||||||||||||||
Share-based compensation
|
(1)
|
|
59,443
|
37,755
|
96,284
|
76,472
|
||||||||||||||
Depreciation and amortization
|
(2)
|
|
1,094
|
1,235
|
2,184
|
2,485
|
||||||||||||||
Gain on sale of Telavant net assets
|
(3)
|
|
—
|
—
|
(110,387
|
)
|
—
|
|||||||||||||
Other:
|
||||||||||||||||||||
Change in fair value of investments
|
(4)
|
|
(48,375
|
)
|
45,849
|
(63,601
|
)
|
53,413
|
||||||||||||
Change in fair value of liability instruments
|
(5)
|
|
(635
|
)
|
11,789
|
515
|
51,967
|
|||||||||||||
Gain on deconsolidation of subsidiaries
|
(6)
|
|
—
|
(17,354
|
)
|
—
|
(17,354
|
)
|
||||||||||||
Estimated income tax impact from adjustments
|
(7)
|
|
(3,986
|
)
|
1,100
|
(4,190
|
)
|
369
|
||||||||||||
Adjusted loss from continuing operations, net of tax (Non-GAAP)
|
$
|
(218,665
|
)
|
$
|
(154,754
|
)
|
$
|
(325,777
|
)
|
$
|
(304,097
|
)
|
Three Months Ended
September 30,
|
Six Months Ended
September 30,
|
|||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
||||||||||||||||
Research and development expenses
|
$
|
143,073
|
$
|
114,790
|
$
|
263,580
|
$
|
224,206
|
||||||||||||
Adjustments:
|
||||||||||||||||||||
Share-based compensation
|
(1)
|
|
9,911
|
8,309
|
20,443
|
15,726
|
||||||||||||||
Depreciation and amortization
|
(2)
|
|
724
|
1,205
|
1,419
|
2,694
|
||||||||||||||
Adjusted research and development expenses (Non-GAAP)
|
$
|
132,438
|
$
|
105,276
|
$
|
241,718
|
$
|
205,786
|
Three Months Ended
September 30,
|
Six Months Ended
September 30,
|
|||||||||||||||||||
Note
|
2024
|
2023
|
2024
|
2023
|
||||||||||||||||
General and administrative expenses
|
$
|
202,881
|
$
|
88,576
|
$
|
302,773
|
$
|
179,858
|
||||||||||||
Adjustments:
|
||||||||||||||||||||
Share-based compensation
|
(1)
|
|
59,443
|
37,755
|
96,284
|
76,472
|
||||||||||||||
Depreciation and amortization
|
(2)
|
|
1,094
|
1,235
|
2,184
|
2,485
|
||||||||||||||
Adjusted general and administrative expenses (Non-GAAP)
|
$
|
142,344
|
$
|
49,586
|
$
|
204,305
|
$
|
100,901
|