Bermuda |
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 | ||
Redeemable warrants, each whole warrant exercisable for one Common Share
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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 August 14, 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: August 14, 2023
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•
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RVT-3101 demonstrated improved efficacy results from the induction to chronic period in the TUSCANY-2 Phase 2b study in ulcerative colitis and was well tolerated with a
favorable safety profile across all doses
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•
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First patient has been dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in Crohn’s disease, with topline data from the induction portion expected in the fourth
quarter of calendar year 2024
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•
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Initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose)
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•
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VTAMA® (tapinarof) net product revenue was $16.7M for the quarter ended June 30, 2023, with nearly 200,000 prescriptions written by approximately 11,500 unique prescribers since
launch
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•
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VTAMA® gross-to-net yield was 26% for the quarter ended June 30, 2023, and as of August 2023, coverage has been expanded to 129 million US commercial lives and 87 million
government lives
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•
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VTAMA® met the primary and all secondary endpoints in ADORING 1, the second of two replicate Phase 3 studies in patients with moderate-to-severe atopic dermatitis – no new
safety or tolerability signals were observed in this population, which included children as young as 2 years old
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•
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Sixth positive Phase 2 study of oral brepocitinib further validates TYK2/JAK1 inhibition activity in highly inflammatory autoimmune diseases
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•
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Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.4B at June 30, 2023, supporting cash runway into the second half of calendar year 2025
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•
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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the
chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy
results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56. In July 2023, Telavant announced the first patient was dosed in the TAHOE study, a global Phase 2 trial of RVT-3101 in patients with
moderate to severe Crohn’s disease.
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•
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Immunovant: In August 2023, Immunovant reported that initial data from the Phase 1 clinical trial of IMVT-1402 remains on track for September 2023 (single-ascending dose) and October / November 2023 (multiple-ascending dose).
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•
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Dermavant: For the first quarter ended June 30, 2023, Roivant reported VTAMA net product revenue of $16.7M, representing a 26% gross-to-net yield for the quarter. As of August 2023, nearly
200,000 VTAMA prescriptions have been written by approximately 11,500 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 129 million US
commercial lives and 87 million government lives and includes coverage by all three of the top pharmacy benefit managers. In May 2023, VTAMA met the primary and all secondary endpoints in ADORING 1, the second of two replicate Phase 3
studies in patients with moderate-to-severe atopic dermatitis. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.
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•
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Priovant: In August 2023, Priovant announced the sixth positive Phase 2 study of oral brepocitinib, out of six conducted, with statistically significant, positive results from the 12-week induction period of Pfizer’s Phase 2 study
of brepocitinib in adult patients with moderate to severe Crohn’s disease. The primary and key secondary endpoints were met with safety and tolerability generally consistent with prior brepocitinib studies, further validating TYK2/JAK1
inhibition activity in highly inflammatory autoimmune diseases.
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•
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Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.4B at June 30, 2023, supporting cash runway into the second half of calendar year 2025.
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•
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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.
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•
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Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in September 2023 and initial data from
multiple-ascending dose cohorts in October or November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the
Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, 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
chronic inflammatory demyelinating polyneuropathy (CIDP) in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in Graves’ disease (GD) are expected in the fourth quarter of calendar year 2023.
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•
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Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data from the induction portion expected in the fourth quarter of calendar year 2024.
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•
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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.
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•
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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 myelodysplastic syndromes (MDS) patients in the second
half of calendar year 2023.
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•
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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 second half of calendar year 2024.
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June 30, 2023
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March 31, 2023
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|||||||
Cash, cash equivalents and restricted cash
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$
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1,449,648
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$
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1,692,115
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Total assets
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2,136,646
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2,389,604
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Total liabilities
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802,507
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782,017
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Total shareholders’ equity
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1,334,139
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1,607,587
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Total liabilities, redeemable noncontrolling interest and shareholders’ equity
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2,136,646
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2,389,604
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Three Months Ended June 30,
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||||||||
2023
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2022
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Revenues:
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||||||||
Product revenue, net
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$
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16,659
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$
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141
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License, milestone and other revenue
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4,965
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4,178
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Revenue, net
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$
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21,624
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$
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4,319
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Operating expenses:
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Cost of revenues
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4,214
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1,726
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Research and development (includes $7,953 and $12,243 of share-based compensation expense for the three months ended June 30, 2023 and 2022, respectively)
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125,133
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135,830
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Acquired in-process research and development
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12,500
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—
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Selling, general and administrative (includes $41,192 and $60,551 of share-based compensation expense for the three months ended June 30, 2023 and 2022,
respectively)
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156,190
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149,072
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Total operating expenses
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298,037
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286,628
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Loss from operations
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(276,413
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)
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(282,309
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)
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Change in fair value of investments
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7,564
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24,547
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Change in fair value of debt and liability instruments
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54,512
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41,213
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Interest income
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(16,715
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)
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(1,981
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)
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Interest expense
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8,912
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2,612
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Other (income) expense, net
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(4,593
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)
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1,085
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Loss before income taxes
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(326,093
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)
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(349,785
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)
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Income tax expense
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1,752
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3,999
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Net loss
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(327,845
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)
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(353,784
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)
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Net loss attributable to noncontrolling interests
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(36,029
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)
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(21,975
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)
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Net loss attributable to Roivant Sciences Ltd.
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$
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(291,816
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)
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$
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(331,809
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)
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Net loss per common share—basic and diluted
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$
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(0.38
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)
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$
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(0.48
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)
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Weighted average shares outstanding—basic and diluted
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759,273,550
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695,878,859
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Three Months Ended June 30,
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|||||||||||
Note
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2023
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2022
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|||||||||
Net loss
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$
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(327,845
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)
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$
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(353,784
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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)
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2,370
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742
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Share-based compensation
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(2)
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38
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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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7,953
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12,243
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Depreciation and amortization
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(3)
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1,489
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1,070
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Selling, general and administrative:
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||||||||||
Share-based compensation
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(2)
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41,192
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60,551
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Depreciation and amortization
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(3)
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1,980
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866
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Other:
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Change in fair value of investments
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(4)
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7,564
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24,547
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Change in fair value of debt and liability instruments
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(5)
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54,512
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41,213
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Estimated income tax impact from adjustments
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(6)
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(732
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)
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1,873
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Adjusted net loss (Non-GAAP)
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$
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(211,479
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)
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$
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(210,679
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)
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Three Months Ended June 30,
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|||||||||||
Note
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2023
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2022
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|||||||||
Research and development expenses
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$
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125,133
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$
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135,830
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Adjustments:
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|||||||||||
Share-based compensation
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(2)
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7,953
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12,243
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Depreciation and amortization
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(3)
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1,489
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1,070
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Adjusted research and development expenses (Non-GAAP)
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$
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115,691
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$
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122,517
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Three Months Ended June 30,
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|||||||||||
Note
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2023
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2022
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|||||||||
Selling, general and administrative expenses
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$
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156,190
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$
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149,072
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Adjustments:
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|||||||||||
Share-based compensation
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(2)
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41,192
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60,551
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|||||||
Depreciation and amortization
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(3)
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1,980
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866
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Adjusted selling, general and administrative expenses (Non-GAAP)
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$
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113,018
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$
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87,655
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