☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Bermuda | 98-1173944 | |||
(State or other jurisdiction of | (I.R.S. Employer |
7th Floor 50 Broadway London SW1H 0DB United Kingdom | Not Applicable | |||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Redeemable Warrants, each whole warrant exercisable for one Common Share at an exercise price of $11.50 per share | ROIVW | The Nasdaq Global Market |
Large accelerated filer | ☐ | Accelerated filer | ☐ | |||||
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |||||
Emerging growth company | ☒ |
Page | |||||
PART I—FINANCIAL INFORMATION | |||||
Item 1. | 6 | ||||
6 | |||||
7 | |||||
8 | |||||
9 | |||||
11 | |||||
12 | |||||
32 | |||||
48 | |||||
49 | |||||
PART II—OTHER INFORMATION | |||||
Item 1. | 49 | ||||
Item 1A. | 49 | ||||
114 | |||||
114 | |||||
114 | |||||
Item 5. | 114 | ||||
115 | |||||
116 |
• | We have limited experience as a commercial company and the marketing and sale of VTAMA® (tapinarof) or any future products may be unsuccessful or less successful than anticipated. |
• | our limited experience as a commercial-stage company and ability to successfully commercialize VTAMA® (tapinarof); |
September 30, 2022 | March 31, 2022 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,599,021 | $ | 2,060,400 | ||||
Restricted cash | 3,993 | 3,903 | ||||||
Other current assets | 111,847 | 82,220 | ||||||
Total current assets | 1,714,861 | 2,146,523 | ||||||
Property and equipment, net | 39,171 | 25,905 | ||||||
Operating lease right-of-use assets | 53,089 | 61,044 | ||||||
Restricted cash, net of current portion | 9,632 | 9,731 | ||||||
Investments measured at fair value | 246,609 | 325,834 | ||||||
Intangible assets, net | 140,298 | — | ||||||
Other assets | 11,874 | 16,092 | ||||||
Total assets | $ | 2,215,534 | $ | 2,585,129 | ||||
Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 41,358 | $ | 34,583 | ||||
Accrued expenses | 128,815 | 127,531 | ||||||
Operating lease liabilities | 11,395 | 11,398 | ||||||
Current portion of long-term debt (includes $27,130 accounted for under the fair value option at September 30, 2022) | 35,754 | — | ||||||
Deferred revenue | 8,373 | 10,147 | ||||||
Other current liabilities | 5,049 | 708 | ||||||
Total current liabilities | 230,744 | 184,367 | ||||||
Liability instruments measured at fair value | 19,486 | 44,912 | ||||||
Operating lease liabilities, noncurrent | 54,092 | 62,468 | ||||||
Long-term debt, net of current portion (includes $188,680 and $177,400 accounted for under the fair value option at September 30, 2022 and March 31, 2022, respectively) | 376,058 | 210,025 | ||||||
Deferred revenue, noncurrent | 11,901 | 13,740 | ||||||
Other liabilities | 9,104 | 8,183 | ||||||
Total liabilities | 701,385 | 523,695 | ||||||
Commitments and contingencies (Note 10) | ||||||||
Redeemable noncontrolling interest | — | 22,491 | ||||||
Shareholders’ equity: | ||||||||
Common shares, par value $0.0000000341740141 per share, 7,000,000,000 shares authorized and 704,386,981 and 694,975,965 shares issued and outstanding at September 30, 2022 and March 31, 2022, respectively | — | — | ||||||
Additional paid-in capital | 4,538,635 | 4,421,614 | ||||||
Accumulated deficit | (3,387,123 | ) | (2,763,724 | ) | ||||
Accumulated other comprehensive income (loss) | 9,089 | (946 | ) | |||||
Shareholders’ equity attributable to Roivant Sciences Ltd. | 1,160,601 | 1,656,944 | ||||||
Noncontrolling interests | 353,548 | 381,999 | ||||||
Total shareholders’ equity | 1,514,149 | 2,038,943 | ||||||
Total liabilities, redeemable noncontrolling interest and shareholders’ equity | $ | 2,215,534 | $ | 2,585,129 |
June 30, 2021 | March 31, 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 1,996,733 | $ | 2,055,044 | ||||
Restricted cash | 2,711 | 77,701 | ||||||
Other current assets | 58,165 | 54,250 | ||||||
Total current assets | 2,057,609 | 2,186,995 | ||||||
Property and equipment, net | 15,550 | 14,749 | ||||||
Operating lease right-of-use | 65,163 | 62,279 | ||||||
Restricted cash, net of current portion | 8,933 | 8,931 | ||||||
Investments measured at fair value | 180,359 | 188,978 | ||||||
Long-term investment | 100,563 | 100,563 | ||||||
Other assets | 26,520 | 27,197 | ||||||
Total assets | $ | 2,454,697 | $ | 2,589,692 | ||||
Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 15,014 | $ | 20,550 | ||||
Accrued expenses | 73,788 | 76,936 | ||||||
Operating lease liabilities | 12,055 | 12,313 | ||||||
Deferred consideration liability | 100,000 | 100,000 | ||||||
Other current liabilities | 8,301 | 9,162 | ||||||
Total current liabilities | 209,158 | 218,961 | ||||||
Liability instruments measured at fair value | 5,906 | 67,893 | ||||||
Operating lease liabilities, noncurrent | 65,263 | 62,384 | ||||||
Long-term debt (includes $155,200 and $150,100 accounted for under the fair value option at June 30, 2021 and March 31, 2021, respectively) | 186,350 | 170,280 | ||||||
Other liabilities | 8,188 | 8,169 | ||||||
Total liabilities | 474,865 | 527,687 | ||||||
Commitments and contingencies (Note 10) | 0 | 0 | ||||||
Redeemable noncontrolling interest | 22,491 | 22,491 | ||||||
Shareholders’ equity: | ||||||||
Common shares, par value $0.0000001 per share, 100,000,000,000 shares authorized and 222,669,799 shares issued and outstanding at June 30, 2021 and March 31, 2021 | 0 | 0 | ||||||
Additional paid-in capital | 3,824,974 | 3,814,805 | ||||||
Subscription receivable | (100,000 | ) | (100,000 | ) | ||||
Accumulated deficit | (2,000,645 | ) | (1,918,462 | ) | ||||
Accumulated other comprehensive (loss) income | (1,207 | ) | 1,445 | |||||
Shareholders’ equity attributable to Roivant Sciences Ltd. | 1,723,122 | 1,797,788 | ||||||
Noncontrolling interests | 234,219 | 241,726 | ||||||
Total shareholders’ equity | 1,957,341 | 2,039,514 | ||||||
Total liabilities, redeemable noncontrolling interest and shareholders’ equity | $ | 2,454,697 | $ | 2,589,692 | ||||
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Revenue, net | $ | 12,533 | $ | 13,987 | $ | 16,852 | $ | 21,722 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of revenues | 3,641 | 6,381 | 5,367 | 7,123 | ||||||||||||
Research and development (includes $7,417 and $28,157 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $19,660 and $29,772 for the six months ended September 30, 2022 and 2021, respectively) | 131,995 | 132,098 | 267,825 | 210,613 | ||||||||||||
Acquired in-process research and development | — | 122,161 | — | 122,272 | ||||||||||||
Selling, general and administrative (includes $54,479 and $369,155 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $115,030 and $386,809 for the six months ended September 30, 2022 and 2021, respectively) | 157,663 | 437,776 | 306,735 | 520,530 | ||||||||||||
Total operating expenses | 293,299 | 698,416 | 579,927 | 860,538 | ||||||||||||
Loss from operations | (280,766 | ) | (684,429 | ) | (563,075 | ) | (838,816 | ) | ||||||||
Change in fair value of investments | 54,678 | (32,273 | ) | 79,225 | (23,654 | ) | ||||||||||
Gain on sale of investment | — | (443,754 | ) | — | (443,754 | ) | ||||||||||
Change in fair value of debt and liability instruments | (13,541 | ) | 13,145 | 27,672 | 17,730 | |||||||||||
Gain on termination of Sumitomo Options | — | — | — | (66,472 | ) | |||||||||||
Gain on deconsolidation of subsidiary | (16,762 | ) | — | (16,762 | ) | — | ||||||||||
Other expense, net | 8,615 | 3,692 | 10,331 | 3,558 | ||||||||||||
Loss before income taxes | (313,756 | ) | (225,239 | ) | (663,541 | ) | (326,224 | ) | ||||||||
Income tax expense | 2,165 | 401 | 6,164 | 494 | ||||||||||||
Net loss | (315,921 | ) | (225,640 | ) | (669,705 | ) | (326,718 | ) | ||||||||
Net loss attributable to noncontrolling interests | (24,331 | ) | (17,159 | ) | (46,306 | ) | (36,054 | ) | ||||||||
Net loss attributable to Roivant Sciences Ltd. | $ | (291,590 | ) | $ | (208,481 | ) | $ | (623,399 | ) | $ | (290,664 | ) | ||||
Net loss per common share—basic and diluted(1) | $ | (0.42 | ) | $ | (0.32 | ) | $ | (0.89 | ) | $ | (0.45 | ) | ||||
Weighted average shares outstanding—basic and diluted(1) | 699,888,061 | 650,225,764 | 697,894,414 | 650,041,993 |
(1) | Retroactively restated for the stock subdivision as described in Note 7. |
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Revenue, net | $ | 7,735 | $ | 1,576 | ||||
Operating expenses: | ||||||||
Cost of revenues | 742 | 180 | ||||||
Research and development | 78,626 | 58,734 | ||||||
General and administrative | 82,754 | 57,115 | ||||||
Total operating expenses | 162,122 | 116,029 | ||||||
Loss from operations | (154,387 | ) | (114,453 | ) | ||||
Change in fair value of investments | 8,619 | (41,148 | ) | |||||
Change in fair value of debt and liability instruments | 4,585 | 17,125 | ||||||
Gain on termination of Sumitomo Options | (66,472 | ) | 0 | |||||
Gain on deconsolidation of subsidiary | 0 | (86,516 | ) | |||||
Other (income) expense, net | (134 | ) | 2,842 | |||||
Loss before income taxes | (100,985 | ) | (6,756 | ) | ||||
Income tax expense | 93 | 1,221 | ||||||
Net loss | (101,078 | ) | (7,977 | ) | ||||
Net loss attributable to noncontrolling interests | (18,895 | ) | (4,734 | ) | ||||
Net loss attributable to Roivant Sciences Ltd. | $ | (82,183 | ) | $ | (3,243 | ) | ||
Net loss per common share—basic and diluted | $ | (0.37 | ) | $ | (0.02 | ) | ||
Weighted average shares outstanding—basic and diluted | 222,081,975 | 214,879,058 | ||||||
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Net loss | $ | (315,921 | ) | $ | (225,640 | ) | $ | (669,705 | ) | $ | (326,718 | ) | ||||
Other comprehensive income: | ||||||||||||||||
Foreign currency translation adjustment | 3,752 | 2,545 | 9,519 | 106 | ||||||||||||
Total other comprehensive income | 3,752 | 2,545 | 9,519 | 106 | ||||||||||||
Comprehensive loss | (312,169 | ) | (223,095 | ) | (660,186 | ) | (326,612 | ) | ||||||||
Comprehensive loss attributable to noncontrolling interests | (24,648 | ) | (17,102 | ) | (46,822 | ) | (35,784 | ) | ||||||||
Comprehensive loss attributable to Roivant Sciences Ltd. | $ | (287,521 | ) | $ | (205,993 | ) | $ | (613,364 | ) | $ | (290,828 | ) |
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Net loss | $ | (101,078 | ) | $ | (7,977 | ) | ||
Other comprehensive loss: | ||||||||
Foreign currency translation adjustment | (2,439 | ) | (820 | ) | ||||
Total other comprehensive loss | (2,439 | ) | (820 | ) | ||||
Comprehensive loss | (103,517 | ) | (8,797 | ) | ||||
Comprehensive loss attributable to noncontrolling interests | (18,682 | ) | (4,700 | ) | ||||
Comprehensive loss attributable to Roivant Sciences Ltd. | $ | (84,835 | ) | $ | (4,097 | ) | ||
Shareholders’ Equity | ||||||||||||||||||||||||||||||||
Redeemable Noncontrolling Interest | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Noncontrolling Interests | Total Shareholders’ Equity | ||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||
Balance at March 31, 2022 | $ | 22,491 | 694,975,965 | $ | — | $ | 4,421,614 | $ | (946 | ) | $ | (2,763,724 | ) | $ | 381,999 | $ | 2,038,943 | |||||||||||||||
Issuance of subsidiary common shares to the Company | — | — | — | (251 | ) | — | — | 251 | — | |||||||||||||||||||||||
Stock options exercised and equity awards vested and settled, net of tax withholding | — | 4,739,781 | — | (8,329 | ) | — | — | — | (8,329 | ) | ||||||||||||||||||||||
Issuance of the Company’s common shares related to settlement of transaction consideration | — | 1,455,719 | — | — | — | — | — | — | ||||||||||||||||||||||||
Share-based compensation | — | — | — | 61,590 | — | — | 11,204 | 72,794 | ||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | 5,966 | — | (199 | ) | 5,767 | |||||||||||||||||||||||
Net loss | — | — | — | — | — | (331,809 | ) | (21,975 | ) | (353,784 | ) | |||||||||||||||||||||
Balance at June 30, 2022 | $ | 22,491 | 701,171,465 | $ | — | $ | 4,474,624 | $ | 5,020 | $ | (3,095,533 | ) | $ | 371,280 | $ | 1,755,391 | ||||||||||||||||
Issuance of subsidiary common shares to the Company | — | — | — | (1,160 | ) | — | — | 1,160 | — | |||||||||||||||||||||||
Deconsolidation of subsidiary | (22,491 | ) | — | — | — | — | — | — | — | |||||||||||||||||||||||
Equity awards vested and settled | — | 1,185,639 | — | — | — | — | — | — | ||||||||||||||||||||||||
Issuance of the Company’s common shares and other consideration for an acquisition | — | 2,029,877 | — | 8,836 | — | — | 112 | 8,948 | ||||||||||||||||||||||||
Cash contributions to majority-owned subsidiaries | — | — | — | (1,080 | ) | — | — | 1,080 | — | |||||||||||||||||||||||
Share-based compensation | — | — | — | 57,415 | — | — | 4,564 | 61,979 | ||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | 4,069 | — | (317 | ) | 3,752 | |||||||||||||||||||||||
Net loss | — | — | — | — | — | (291,590 | ) | (24,331 | ) | (315,921 | ) | |||||||||||||||||||||
Balance at September 30, 2022 | $ | — | 704,386,981 | $ | — | $ | 4,538,635 | $ | 9,089 | $ | (3,387,123 | ) | $ | 353,548 | $ | 1,514,149 |
Shareholders’ Equity(1) | ||||||||||||||||||||||||||||||||||||
Redeemable Noncontrolling Interest | Common Stock | Additional Paid-in Capital | Subscription Receivable | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Noncontrolling Interests | Total Shareholders’ Equity | |||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | 22,491 | 651,576,293 | $ | — | $ | 3,814,805 | $ | (100,000 | ) | $ | 1,445 | $ | (1,918,462 | ) | $ | 241,726 | $ | 2,039,514 | |||||||||||||||||
Issuance of subsidiary warrants | — | — | — | 2,051 | — | — | — | 24 | 2,075 | |||||||||||||||||||||||||||
Cash contribution to majority-owned subsidiaries | — | — | — | (2,973 | ) | — | — | — | 2,973 | — | ||||||||||||||||||||||||||
Share-based compensation | — | — | — | 11,091 | — | — | — | 8,178 | 19,269 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | (2,652 | ) | — | 213 | (2,439 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (82,183 | ) | (18,895 | ) | (101,078 | ) | ||||||||||||||||||||||||
Balance at June 30, 2021 | $ | 22,491 | 651,576,293 | $ | — | $ | 3,824,974 | $ | (100,000 | ) | $ | (1,207 | ) | $ | (2,000,645 | ) | $ | 234,219 | $ | 1,957,341 | ||||||||||||||||
Issuance of the Company’s common shares upon closing of Business Combination and PIPE Financing, net of issuance costs | — | 32,372,478 | — | 129,097 | — | — | — | — | 129,097 | |||||||||||||||||||||||||||
Issuance of the Company’s common shares related to settlement of transaction consideration | — | 840,398 | — | — | — | — | — | — | — | |||||||||||||||||||||||||||
Issuance of subsidiary preferred shares | — | — | — | — | — | — | — | 70,000 | 70,000 | |||||||||||||||||||||||||||
Issuance of subsidiary common and preferred shares to the Company | — | — | — | (52,189 | ) | — | — | — | 52,189 | — | ||||||||||||||||||||||||||
Payment of subscription receivable | — | — | — | (40,000 | ) | 100,000 | — | — | 40,000 | 100,000 | ||||||||||||||||||||||||||
Cash contribution to majority-owned subsidiaries | — | — | — | (2,590 | ) | — | — | — | 2,590 | — | ||||||||||||||||||||||||||
Share-based compensation | — | — | — | 386,568 | — | — | — | 10,744 | 397,312 | |||||||||||||||||||||||||||
Repurchase of equity awards | — | — | — | — | — | — | — | (2,247 | ) | (2,247 | ) | |||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | 2,488 | — | 57 | 2,545 | |||||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (208,481 | ) | (17,159 | ) | (225,640 | ) | ||||||||||||||||||||||||
Balance at September 30, 2021 | $ | 22,491 | 684,789,169 | $ | — | $ | 4,245,860 | $ | — | $ | 1,281 | $ | (2,209,126 | ) | $ | 390,393 | $ | 2,428,408 |
Shareholders’ Equity | ||||||||||||||||||||||||||||||||||||
Redeemable Noncontrolling Interest | Common Stock | Additional Paid-in Capital | Subscription Receivable | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Noncontrolling Interests | Total Shareholders’ Equity | |||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||||||
Balance at March 31, 2021 | $ | 22,491 | 222,669,799 | $ | 0 | $ | 3,814,805 | $ | (100,000 | ) | $ | 1,445 | $ | (1,918,462 | ) | $ | 241,726 | $ | 2,039,514 | |||||||||||||||||
Issuance of subsidiary warrants | — | — | — | 2,051 | — | — | — | 24 | 2,075 | |||||||||||||||||||||||||||
Cash contributions to majority-owned subsidiaries | — | — | — | (2,973 | ) | — | — | — | 2,973 | 0 | ||||||||||||||||||||||||||
Share-based compensation | — | — | — | 11,091 | — | — | — | 8,178 | 19,269 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | (2,652 | ) | — | 213 | (2,439 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (82,183 | ) | (18,895 | ) | (101,078 | ) | ||||||||||||||||||||||||
Balance at June 30, 2021 | $ | 22,491 | 222,669,799 | $ | 0 | $ | 3,824,974 | $ | (100,000 | ) | $ | (1,207 | ) | $ | (2,000,645 | ) | $ | 234,219 | $ | 1,957,341 | ||||||||||||||||
(1) | Retroactively restated for the stock subdivision as described in Note 7. |
Shareholders’ Equity | ||||||||||||||||||||||||||||||||||||
Redeemable Noncontrolling Interest | Common Stock | Additional Paid-in Capital | Subscription Receivable | Accumulated Other Comprehensive Loss | Accumulated Deficit | Noncontrolling Interests | Total Shareholders’ Equity | |||||||||||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||||||||||||||
Balance at March 31, 2020 | $ | 22,491 | 214,879,058 | $ | 0 | $ | 3,143,739 | $ | 0 | $ | (2,349 | ) | $ | (1,109,228 | ) | $ | 54,042 | $ | 2,086,204 | |||||||||||||||||
Issuance of subsidiary common shares, net of issuance costs paid | — | — | — | 104,581 | — | — | — | 76,599 | 181,180 | |||||||||||||||||||||||||||
Issuance of subsidiary common shares to the Company | — | — | — | (6,342 | ) | — | — | — | 6,342 | 0 | ||||||||||||||||||||||||||
Exercise of subsidiary stock options | — | — | — | 36 | — | — | — | 27 | 63 | |||||||||||||||||||||||||||
Deconsolidation of subsidiary | — | — | — | — | — | — | — | (3,054 | ) | (3,054 | ) | |||||||||||||||||||||||||
Repurchase of equity awards | — | — | — | (113 | ) | — | — | — | — | (113 | ) | |||||||||||||||||||||||||
Cash contribution to majority-owned subsidiaries | — | — | — | (149 | ) | — | — | — | 149 | 0 | ||||||||||||||||||||||||||
Share-based compensation | — | — | — | 9,285 | — | — | — | 4,993 | 14,278 | |||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | — | (854 | ) | — | 34 | (820 | ) | |||||||||||||||||||||||||
Net loss | — | — | — | — | — | — | (3,243 | ) | (4,734 | ) | (7,977 | ) | ||||||||||||||||||||||||
Balance at June 30, 2020 | $ | 22,491 | 214,879,058 | $ | 0 | $ | 3,251,037 | $ | 0 | $ | (3,203 | ) | $ | (1,112,471 | ) | $ | 134,398 | $ | 2,269,761 | |||||||||||||||||
Six Months Ended September 30, | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (669,705 | ) | $ | (326,718 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Non-cash acquired in-process research and development | — | 72,107 | ||||||
Share-based compensation | 134,773 | 416,581 | ||||||
Change in fair value of investments | 79,225 | (23,654 | ) | |||||
Gain on sale of investment | — | (443,754 | ) | |||||
Change in fair value of debt and liability instruments | 27,672 | 17,730 | ||||||
Gain on deconsolidation of subsidiary | (16,762 | ) | — | |||||
Gain on termination of Sumitomo Options | — | (61,472 | ) | |||||
Depreciation and amortization | 7,753 | 2,856 | ||||||
Non-cash lease expense | 4,194 | 3,660 | ||||||
Other | 8,716 | 758 | ||||||
Changes in assets and liabilities, net of effects from acquisition and divestiture: | ||||||||
Accounts payable | 6,774 | 56,510 | ||||||
Accrued expenses | 1,447 | 18,569 | ||||||
Operating lease liabilities | (4,753 | ) | (2,537 | ) | ||||
Deferred revenue | (3,863 | ) | (1,528 | ) | ||||
Other | (17,183 | ) | 9,126 | |||||
Net cash used in operating activities | (441,712 | ) | (261,766 | ) | ||||
Cash flows from investing activities: | ||||||||
Cash decrease upon deconsolidation of subsidiary | (3,615 | ) | — | |||||
Proceeds from sale of investment | — | 320,170 | ||||||
Milestone payments | (140,136 | ) | — | |||||
Purchase of property and equipment | (10,560 | ) | (5,100 | ) | ||||
Net cash (used in) provided by investing activities | (154,311 | ) | 315,070 | |||||
Cash flows from financing activities: | ||||||||
Proceeds from Business Combination and PIPE Financing | — | 213,424 | ||||||
Proceeds from payment of subscription receivable | — | 100,000 | ||||||
Proceeds from subsidiary debt financings, net of financing costs paid | 159,899 | 36,400 | ||||||
Repayment of debt by subsidiary | (14,685 | ) | (21,590 | ) | ||||
Payment of offering and loan origination costs | (2,250 | ) | (11,843 | ) | ||||
Repurchase of equity awards | — | (2,247 | ) | |||||
Taxes paid related to net settlement of equity awards | (8,329 | ) | — | |||||
Net cash provided by financing activities | 134,635 | 314,144 | ||||||
Net change in cash, cash equivalents and restricted cash | (461,388 | ) | 367,448 | |||||
Cash, cash equivalents and restricted cash at beginning of period | 2,074,034 | 2,141,676 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 1,612,646 | $ | 2,509,124 | ||||
Non-cash investing and financing activities: | ||||||||
Offering costs included in accounts payable and accrued expenses | $ | — | $ | 8,453 | ||||
Issuance of the Company’s common shares and other consideration for an acquisition | $ | 9,694 | $ | — | ||||
Other | $ | 691 | $ | 4,579 |
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (101,078 | ) | $ | (7,977 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Share-based compensation | 19,269 | 14,278 | ||||||
Change in fair value of investments | 8,619 | (41,148 | ) | |||||
Change in fair value of debt and liability instruments | 4,585 | 17,125 | ||||||
Gain on deconsolidation of subsidiary | 0 | (86,516 | ) | |||||
Gain on termination of Sumitomo Options | (61,472 | ) | 0 | |||||
Loss from equity method investment | 0 | 3,750 | ||||||
Other | 838 | 3,307 | ||||||
Changes in assets and liabilities, net of effects from acquisition and divestiture: | ||||||||
Accounts payable | (6,343 | ) | 7,501 | |||||
Accrued expenses | (7,340 | ) | (15,982 | ) | ||||
Operating lease liabilities | (1,957 | ) | (1,769 | ) | ||||
Other | 3,709 | (3,736 | ) | |||||
Net cash used in operating activities | (141,170 | ) | (111,167 | ) | ||||
Cash flows from investing activities: | ||||||||
Cash disposed upon deconsolidation of subsidiary | 0 | (19,085 | ) | |||||
Investments in unconsolidated entities | 0 | (6,250 | ) | |||||
Purchase of property and equipment | (2,339 | ) | (306 | ) | ||||
Net cash used in investing activities | (2,339 | ) | (25,641 | ) | ||||
Cash flows from financing activities: | ||||||||
Proceeds from issuance of subsidiary common shares, net of issuance costs paid | 0 | 181,180 | ||||||
Proceeds from subsidiary debt financings, net of financing costs paid | 36,400 | 0 | ||||||
Repayment of long-term debt by subsidiary | (21,590 | ) | 0 | |||||
Payment of deferred offering and loan origination costs | (4,600 | ) | 0 | |||||
Repurchase of equity awards | 0 | (113 | ) | |||||
Proceeds from exercise of subsidiary stock options | 0 | 63 | ||||||
Net cash provided by financing activities | 10,210 | 181,130 | ||||||
Net change in cash, cash equivalents and restricted cash | (133,299 | ) | 44,322 | |||||
Cash, cash equivalents and restricted cash at beginning of period | 2,141,676 | 2,269,252 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 2,008,377 | $ | 2,313,574 | ||||
Non-cash investing and financing activities: | ||||||||
Operating lease right-of-use | $ | 4,579 | $ | 555 | ||||
Issuance of subsidiary warrant in connection with debt financing | $ | 2,075 | $ | 0 | ||||
Deferred offering and financing costs included in accounts payable and accrued expenses | $ | 4,999 | $ | 0 |
September 30, 2022 | March 31, 2022 | |||||||
Cash and cash equivalents | $ | 1,599,021 | $ | 2,060,400 | ||||
Restricted cash | 13,625 | 13,634 | ||||||
Cash, cash equivalents and restricted cash | $ | 1,612,646 | $ | 2,074,034 |
June 30, 2021 | March 31, 2021 | |||||||
Cash and cash equivalents | $ | 1,996,733 | $ | 2,055,044 | ||||
Restricted cash | 11,644 | 86,632 | ||||||
Cash, cash equivalents and restricted cash | $ | 2,008,377 | $ | 2,141,676 | ||||
• | Licenses of intellectual property: If the licenses to intellectual property are determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are not distinct from other promises, the Company applies judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the related revenue recognition accordingly. |
• | Milestone payments: At the inception of each arrangement that includes research, development or regulatory milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative standalone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price on a cumulative catch-up basis in earnings in the period of the adjustment. |
• | Royalties and commercial milestone payments: For arrangements that include sales-based royalties, including commercial milestone payments based on a pre-specified level of sales, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Achievement of these royalties and commercial milestones may solely depend upon performance of the licensee. |
a. | Prompt Pay and Cash Pay Discounts: The Company generally provides invoice discounts on product sales to its customers for prompt payment and/or cash payment. The Company estimates the amount of such discounts that will be utilized and deducts the amount from its gross product revenues and accounts receivable at the time such revenues are recognized. |
b. | Customer Fees: The Company pays fees to its customers for account management, data management, and other administrative services. To the extent the services received are distinct from sales of products to the customer, the Company records these payments in selling, general and administrative expenses. |
c. | Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a wholesaler or specialty distributor. Contracted customers, which currently consist primarily of public health service institutions, federal government entities, pharmaceutical benefit managers, and health maintenance organizations, generally purchase the product at a discounted price. The wholesaler or specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the wholesaler or specialty distributor and the discounted price paid to the wholesaler or specialty distributor by the contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales to contracted customers. |
d. | Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program and the Medicare Part D prescription drug benefit as well as contracted discounts with pharmaceutical benefit managers and health maintenance organizations. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements with payers or statutory requirements pertaining to Medicaid and Medicare benefit providers. The allowance for rebates is based on contractual or statutory discount rates, estimated payer mix, and expected utilization. The Company’s estimates for expected utilization of rebates are based on historical data received from wholesalers, specialty distributors, and pharmacies since launch, as well as analog data from similar products. The Company monitors sales trends and adjusts the allowance on a regular basis to reflect the most recent rebate experience. The Company’s liability for these rebates consists of invoices received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. |
e. | Co-payment Assistance: The Company offers co-payment assistance to patients. Co-payment assistance is accrued based on an estimate of the number of co-payment assistance claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. |
f. | Product Returns: Consistent with industry practice, the Company offers its customers limited product return rights for damages, shipment errors, and expiring product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual distribution or customer agreement. The Company does not allow product returns for product that has been dispensed to a patient. In arriving at its estimate for product returns, the Company considers historical product returns, the underlying product demand, and industry specific data. |
Remaining Weighted Average Estimated Useful Lives | September 30, 2022 | ||||
Gross amount | 16.1 years | $ | 143,206 | ||
Less: accumulated amortization | (2,908 | ) | |||
Net book value | $ | 140,298 |
September 30, 2022 | March 31, 2022 | |||||||
Prepaid expenses | $ | 70,300 | $ | 53,370 | ||||
Trade receivables, net | 25,036 | 3,878 | ||||||
Income tax receivable | 2,331 | 2,854 | ||||||
Other | 14,180 | 22,118 | ||||||
Total other current assets | $ | 111,847 | $ | 82,220 |
June 30, 2021 | March 31, 2021 | |||||||
Prepaid expenses | $ | 44,941 | $ | 39,544 | ||||
Trade receivables, net | 3,416 | 11,222 | ||||||
Income tax receivable | 1,993 | 1,803 | ||||||
Other | 7,815 | 1,681 | ||||||
Total other current assets | $ | 58,165 | $ | 54,250 | ||||
September 30, 2022 | March 31, 2022 | |||||||
Research and development expenses | $ | 66,920 | $ | 66,188 | ||||
Compensation-related expenses | 27,839 | 44,262 | ||||||
Other expenses | 34,056 | 17,081 | ||||||
Total accrued expenses | $ | 128,815 | $ | 127,531 |
June 30, 2021 | March 31, 2021 | |||||||
Research and development expenses | $ | 28,347 | $ | 20,755 | ||||
Compensation-related expenses | 15,242 | 38,552 | ||||||
Professional services expenses | 16,489 | 10,267 | ||||||
Other general and administrative expenses | 13,710 | 7,362 | ||||||
Total accrued expenses | $ | 73,788 | $ | 76,936 | ||||
June 30, 2021 | March 31, 2021 | |||||||
Deferred revenue | $ | 3,777 | $ | 5,918 | ||||
Income tax payable | 199 | 207 | ||||||
Other | 4,325 | 3,037 | ||||||
Total other current liabilities | $ | 8,301 | $ | 9,162 | ||||
June 30, 2021 | March 31, 2021 | |||||||
Principal amount | $ | 195,200 | $ | 170,100 | ||||
Exit fee / end of term charge | 5,000 | 1,390 | ||||||
Less: unamortized debt discount and issuance costs | (13,850 | ) | (1,210 | ) | ||||
Total debt, net | 186,350 | 170,280 | ||||||
Less: current portion | 0 | 0 | ||||||
Total long-term debt, net | $ | 186,350 | $ | 170,280 | ||||
September 30, 2022 | March 31, 2022 | |||||||
Fair value of long-term debt | $ | 215,810 | $ | 177,400 | ||||
Less: current portion | (27,130 | ) | — | |||||
Total long-term debt, net | $ | 188,680 | $ | 177,400 |
September 30, 2022 | March 31, 2022 | |||||||
Principal amount | $ | 40,000 | $ | 40,000 | ||||
Exit fee | 5,000 | 5,000 | ||||||
Less: unamortized discount and debt issuance costs | (11,322 | ) | (12,375 | ) | ||||
Total debt, net | 33,678 | 32,625 | ||||||
Less: current portion | — | — | ||||||
Total long-term debt, net | $ | 33,678 | $ | 32,625 |
September 30, 2022 | ||||
Carrying balance | $ | 167,206 | ||
Less: unamortized issuance costs | (4,882 | ) | ||
Total debt, net | 162,324 | |||
Less: current portion | (8,624 | ) | ||
Total long-term debt, net | $ | 153,700 |
Number of Options | ||||
Options outstanding at March 31, 2022 | 80,364,904 | |||
Granted | 74,708,623 | |||
Forfeited/Canceled | (237,470 | ) | ||
Options outstanding at September 30, 2022 | 154,836,057 | |||
Options exercisable at September 30, 2022 | 51,611,787 |
Number of Shares | ||||
Non-vested balance at March 31, 2022 | 21,956,749 | |||
Granted | 9,666,571 | |||
Vested | (3,880,500 | ) | ||
Forfeited | (2,528,054 | ) | ||
Non-vested balance at September 30, 2022 | 25,214,766 |
Number of Stock Options | Weighted Average Exercise Price | |||||||
Stock options outstanding at March 31, 2021 | 9,389,371 | $ | 26.61 | |||||
Granted | 3,798,605 | $ | 29.26 | |||||
Forfeited | (106,428 | ) | $ | 30.27 | ||||
Stock options outstanding at June 30, 2021 | 13,081,548 | $ | 27.35 | |||||
Restricted Stock Units | ||||
Number of Performance Options | Weighted Average Exercise Price | |||||||
Performance Options outstanding at March 31, 2021 | 14,425,663 | $ | 38.93 | |||||
Granted | 0 | $ | 0 | |||||
Forfeited | 0 | $ | 0 | |||||
Performance Options outstanding at June 30, 2021 | 14,425,663 | $ | 38.93 | |||||
Number of CVARs | ||||
Non-vested balance at March 31, | 6,285,250 | |||
(1,928,472 | ) | |||
Forfeited | ||||
(296,650 | ) | |||
Non-vested balance at | ||||
4,060,128 |
Performance RSUs | ||||
Restricted Common Stock | ||||
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Share-based compensation expense recognized as: | ||||||||
R&D expenses | $ | 1,615 | $ | 1,119 | ||||
G&A expenses | 17,654 | 13,159 | ||||||
Total | $ | 19,269 | $ | 14,278 | ||||
a. | 2,033,591 common shares to Patient Square Capital LLC (the “MAAC Sponsor”) and 10,000 common shares issued to each of MAAC’s independent directors (collectively, the “20% Earn-Out Shares”), which will vest if the closing price of the Company’s common shares is greater than or equal to $15.00 over any twenty out of thirty trading day period during the Vesting Period (defined below). |
b. | 1,016,796 common shares issued to the MAAC Sponsor and 5,000 common shares issued to each of MAAC’s independent directors (collectively, the “10% Earn-Out Shares” and, together with the 20% Earn-Out Shares, the “Earn-Out Shares”), each in respect of its MAAC Class B Shares, will vest if the closing price of the Company’s common shares is greater than or equal to $20.00 over any twenty out of thirty trading day period during the Vesting Period (as defined below). |
c. | The remaining number of common shares issued to the MAAC Sponsor and each of MAAC’s independent director are not subject to the vesting conditions described above (the “Retained Shares”). |
As of September 30, 2022 | As of March 31, 2022 | |||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance as of September 30, 2022 | Level 1 | Level 2 | Level 3 | Balance as of March 31, 2022 | |||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 1,222,901 | $ | — | $ | — | $ | 1,222,901 | $ | 1,297,844 | $ | — | $ | — | $ | 1,297,844 | ||||||||||||||||
Investment in Datavant Class A units | — | — | 165,021 | 165,021 | — | — | 193,963 | 193,963 | ||||||||||||||||||||||||
Investment in Sio common shares | 5,202 | — | — | 5,202 | 12,447 | — | — | 12,447 | ||||||||||||||||||||||||
Investment in Arbutus common shares | 74,198 | — | — | 74,198 | 115,765 | — | — | 115,765 | ||||||||||||||||||||||||
Other investment | 2,188 | — | — | 2,188 | 3,659 | — | — | 3,659 | ||||||||||||||||||||||||
Total assets at fair value | $ | 1,304,489 | $ | — | $ | 165,021 | $ | 1,469,510 | $ | 1,429,715 | $ | — | $ | 193,963 | $ | 1,623,678 | ||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||||||||
Debt issued by Dermavant to NovaQuest | $ | — | $ | — | $ | 215,810 | $ | 215,810 | $ | — | $ | — | $ | 177,400 | $ | 177,400 | ||||||||||||||||
Liability instruments measured at fair value(1) | 7,985 | — | 11,501 | 19,486 | 18,019 | — | 26,893 | 44,912 | ||||||||||||||||||||||||
Total liabilities at fair value | $ | 7,985 | $ | — | $ | 227,311 | $ | 235,296 | $ | 18,019 | $ | — | $ | 204,293 | $ | 222,312 |
(1) | At September 30, 2022, Level 1 includes the fair value of the Public Warrants of $8.0 million, and Level 3 includes the fair value of the Earn-Out Shares of $4.7 million, Private Placement Warrants of $4.1 million, and other liability instruments issued of $2.7 million. At March 31, 2022, Level 1 includes the fair value of the Public Warrants of $18.0 million, and Level 3 includes the fair value of the Earn-Out Shares of $9.2 million, Private Placement Warrants of $9.1 million, and other liability instruments issued of $8.6 million. |
As of June 30, 2021 | As of March 31, 2021 | |||||||||||||||||||||||||||||||
Level 1 | Level 2 | Level 3 | Balance as of June 30, 2021 | Level 1 | Level 2 | Level 3 | Balance as of March 31, 2021 | |||||||||||||||||||||||||
Assets: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 1,340,662 | $ | — | $ | — | $ | 1,340,662 | $ | 1,420,597 | $ | — | $ | — | $ | 1,420,597 | ||||||||||||||||
Investment in Sio common shares | 50,716 | — | — | 50,716 | 48,487 | — | — | 48,487 | ||||||||||||||||||||||||
Investment in Arbutus common shares | 48,521 | — | — | 48,521 | 53,325 | — | — | 53,325 | ||||||||||||||||||||||||
Investment in Arbutus convertible preferred shares | — | 69,187 | — | 69,187 | — | 76,037 | — | 76,037 | ||||||||||||||||||||||||
Other investment | 11,935 | — | — | 11,935 | 11,129 | — | — | 11,129 | ||||||||||||||||||||||||
Total assets at fair value | $ | 1,451,834 | $ | 69,187 | $ | — | $ | 1,521,021 | $ | 1,533,538 | $ | 76,037 | $ | — | $ | 1,609,575 | ||||||||||||||||
Liabilities: | ||||||||||||||||||||||||||||||||
Debt issued by Dermavant to NovaQuest | $ | — | $ | — | $ | 155,200 | $ | 155,200 | $ | — | $ | — | $ | 150,100 | $ | 150,100 | ||||||||||||||||
Liability instruments measured at fair value | — | — | 5,906 | 5,906 | — | — | 67,893 | 67,893 | ||||||||||||||||||||||||
Total liabilities at fair value | $ | — | $ | — | $ | 161,106 | $ | 161,106 | $ | — | $ | — | $ | 217,993 | $ | 217,993 | ||||||||||||||||
Balance at March 31, 2021 | $ | — | ||
Fair value of investment in Datavant at recognition date | 224,147 | |||
Changes in fair value of investment in Datavant, included in net loss | (4,172 | ) | ||
Balance at September 30, 2021 | $ | 219,975 | ||
Balance at March 31, 2022 | $ | 193,963 | ||
Changes in fair value of investment in Datavant, included in net loss | (28,942 | ) | ||
Balance at September 30, 2022 | $ | 165,021 |
Balance at March 31, 2021 | $ | 217,993 | ||
Fair value of liability instrument issued | 38,634 | |||
Changes in fair value of debt and liability instruments, included in net loss | 17,730 | |||
Termination of Sumitomo Options | (61,472 | ) | ||
Balance at September 30, 2021 | $ | 212,885 | ||
Balance at March 31, 2022 | $ | 204,293 | ||
Payments related to long-term debt | (14,687 | ) | ||
Changes in fair value of debt and liability instruments, included in net loss | 37,705 | |||
Balance at September 30, 2022 | $ | 227,311 |
Balance at March 31, 2020 | $ | 191,473 | ||
Changes in fair value of debt and liability instruments, included in net loss | 17,125 | |||
Liability instruments disposed due to deconsolidation of subsidiary | (3,325 | ) | ||
Balance at June 30, 2020 | $ | 205,273 | ||
Balance at March 31, 2021 | $ | 217,993 | ||
Changes in fair value of debt and liability instruments, included in net loss | 4,585 | |||
Termination of DSP Options | (61,472 | ) | ||
Balance at June 30, 2021 | $ | 161,106 | ||
Point Estimate Used | ||||||||
Input | As of September 30, 2022 | As of March 31, 2022 | ||||||
Volatility | 100.0% | 110.0% | ||||||
Risk-free rate | 4.18% | 1.62% |
Point Estimate Used | ||||||||
Input | As of September 30, 2022 | As of March 31, 2022 | ||||||
Volatility | 78.2% | 82.3% | ||||||
Risk-free rate | 4.16% | 2.43% |
Point Estimate Used | ||||||||
Input | As of September 30, 2022 | As of March 31, 2022 | ||||||
Volatility | 58.8% | 56.5% | ||||||
Risk-free rate | 4.16% | 2.43% | ||||||
Term (in years) | 4.00 | 4.50 |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Interest income | $ | (5,670 | ) | $ | (62 | ) | $ | (7,651 | ) | $ | (133 | ) | ||||
Interest expense | 8,335 | 1,552 | 10,947 | 4,065 | ||||||||||||
Other expense (income) | 5,950 | 2,202 | 7,035 | (374 | ) | |||||||||||
Total | $ | 8,615 | $ | 3,692 | $ | 10,331 | $ | 3,558 |
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
Loss from equity method investment | $ | 0 | $ | 3,750 | ||||
Interest income | (71 | ) | (621 | ) | ||||
Interest expense | 2,513 | 791 | ||||||
Other income | (2,576 | ) | (1,078 | ) | ||||
Total | $ | (134 | ) | $ | 2,842 | |||
September 30, 2022 | September 30, 2021 | |||||||
Stock options and performance stock options | 154,836,057 | 79,901,448 | ||||||
Restricted stock units and performance stock units (non-vested) | 25,214,766 | 22,124,997 | ||||||
March 2020 CVARs(1) | 32,011,996 | 32,447,626 | ||||||
November 2021 CVARs | 4,060,128 | — | ||||||
Restricted common stock (non-vested) | 772,018 | 1,720,090 | ||||||
Earn-Out Shares (non-vested) | 3,080,387 | 3,080,387 | ||||||
Private Placement Warrants | 10,214,365 | 10,214,365 | ||||||
Public Warrants | 20,475,875 | 20,535,896 | ||||||
Other stock based awards and instruments issued | 6,209,162 | 5,164,558 |
(1) | Refer to Note 8, “Share-Based Compensation” for details regarding settlement of CVARs. |
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
• | commercially launched VTAMA® (tapinarof) cream 1% for the treatment of plaque psoriasis in adults; |
Product/Product Candidate | Indication | |||||||
VTAMA® (tapinarof) | Psoriasis | Dermavant | Commercial | |||||
VTAMA® (tapinarof) | Atopic Dermatitis | Dermavant | Topical | Phase 3 | ||||
Brepocitinib | Dermatomyositis | Priovant | Small Molecule | Phase 3 | ||||
Brepocitinib | Systemic Lupus Erythematosus | Priovant | Small Molecule | Phase | ||||
Brepocitinib | Other Indications | Priovant | Small Molecule | Phase 2 | ||||
Batoclimab | Myasthenia Gravis | Immunovant | Biologic | Phase 3 | ||||
Batoclimab | Thyroid Eye Disease | Immunovant | Biologic | Phase 3 | ||||
Batoclimab | Chronic Inflammatory Demyelinating Polyneuropathy | Immunovant | Biologic | Phase 2† | ||||
Batoclimab | Graves’ Disease | Immunovant | Biologic | Phase 2 | ||||
Batoclimab | Warm Autoimmune Hemolytic Anemia | |||||||
Immunovant | Biologic | Phase 2 | ||||||
IMVT-1402 | Numerous Indications | Immunovant | Biologic | Preclinical | ||||
Namilumab | Sarcoidosis | Kinevant | Biologic | |||||
RVT-2001 | Transfusion-Dependent Anemia in | Hemavant | Small Molecule | Phase 1/2 |
Roivant Ownership | ||||||||
Vant | Basic 1 | Fully Diluted 2 | ||||||
Dermavant | 100 | % | 84 | % | ||||
Immunovant 3 | 58 | % 4 | 53 | % 4 | ||||
Aruvant | 88 | % | 79 | % | ||||
Proteovant | 60 | % | 60 | % | ||||
Lysovant | 100 | % | 99 | % | ||||
Kinevant | 88 | % | 88 | % | ||||
Affivant | 100 | % | 100 | % | ||||
Cytovant | 72 | % | 68 | % | ||||
Arbutus | 32 | % 4 | 29 | % 4 | ||||
Sio Gene Therapies | 27 | % 4 | 24 | % 4 | ||||
Genevant | 83 | % | 69 | % | ||||
Silicon Therapeutics | 100 | % | 100 | % | ||||
VantAI | 100 | % | 100 | % | ||||
Lokavant | 90 | % | 85 | % | ||||
Datavant 5 | 52 | % | 48 | % | ||||
Alyvant | 97 | % | 95 | % |
† | Indicates potentially registrational trials. |
Roivant Ownership | ||||||||
Vant | Basic1 | Fully Diluted2 | ||||||
Dermavant | 100 | % | 85 | % | ||||
Immunovant | 63 | %3† | 55 | %3† | ||||
Priovant | 75 | % | 70 | % | ||||
Proteovant | 60 | % | 54 | % | ||||
Genevant | 83 | % | 65 | % | ||||
Kinevant | 88 | % | 82 | % | ||||
Hemavant | 100 | % | 100 | % | ||||
Affivant | 100 | % | 98 | % | ||||
Covant | 100 | % | 100 | % | ||||
Psivant | 100 | % | 100 | % | ||||
Arbutus | 25 | %3 | 23 | %3 | ||||
Lokavant | 87 | % | 71 | % | ||||
Datavant | * | * |
1. | Basic ownership refers to Roivant’s percentage ownership of the issued and outstanding common and preferred shares (if applicable) of the entity. |
2. | Fully diluted ownership refers to Roivant’s percentage ownership of all outstanding equity interests of the entity, including unvested RSUs as well as options and warrants, in each case whether vested or |
3. |
Denotes entities that are publicly traded. |
As of September 30, 2022, the Company’s minority equity interest in Datavant |
† | In October 2022, Immunovant completed an offering of 12.5 million shares of common stock for total gross proceeds of $75.0 million. Giving effect to this offering, Roivant has |
Program | Vant | Catalyst | Expected Timing | |||
Roivant pipeline growth | ||||||
New mid/late-stage in-licensing announcements | ||||||
LNP platform | Genevant | |||||
Updates to LNP patent litigation | Ongoing | |||||
Roivant Discovery | Roivant | Updates on discovery programs and technology | Ongoing | |||
VTAMA® (tapinarof) | Dermavant | Topline data from | 1H 2023 | |||
IMVT-1402 | Immunovant | Initial data from Phase 1 trial | Mid 2023 | |||
Brepocitinib | Priovant | Topline data from potentially registrational Phase 2 trial in systemic lupus erythematosus | 2H 2023 | |||
Batoclimab | Immunovant | Initial data from Phase 2 trial in Graves’ disease | 2H 2023 | |||
RVT-2001 | Hemavant | Data from RVT-2001 Phase 1/2 trial in lower-risk MDS | 2H 2023 | |||
Batoclimab | Immunovant | Initial data from pivotal Phase 2B trial in chronic inflammatory demyelinating polyneuropathy | 1H 2024 | |||
Namilumab | Kinevant | Topline data from Phase 2 trial in sarcoidosis | 1H 2024 | |||
Batoclimab | Immunovant | Topline data from Phase 3 | ||||
Batoclimab | ||||||
Immunovant | ||||||
1H | ||||||
• | Roivant: On November 8, priced $150 million total gross primary and secondary offering, consisting of gross primary proceeds to Roivant of $100 million. Roivant continued its cost optimization and pipeline reprioritization initiatives initially announced in June 2022 in order to focus capital on the most valuable and meaningful opportunities in the pipeline, while maintaining the financial flexibility to opportunistically in-license assets. Roivant expects that its consolidated cash, cash equivalents and restricted cash of $1.6 billion at September 30, 2022, or $1.9 billion after giving effect to subsequent Roivant and Immunovant follow-on offerings and anticipated proceeds from the sale of Myovant equity rights to Sumitomo Pharma, along with continued cost savings initiatives, support cash runway into second half of calendar year 2025. |
• | Dermavant: Through November 4, VTAMA has had over 54,000 prescriptions written by approximately 6,400 unique prescribers, based on IQVIA data. For the quarter ended September 30, 2022, Roivant reported VTAMA net product revenue of $5.0 million, representing a gross-to-net yield of approximately 12%. Dermavant also entered into a reimbursement contract with one of the three largest PBMs, effective October 1, 2022. Finally, Dermavant announced results from its maximal use pharmacokinetic study of VTAMA in atopic dermatitis, which showed minimal to no systemic absorption and favorable tolerability when used in pediatric patients down to age two. |
• | Priovant: Completed enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. With over 1,000 patients exposed in these studies, brepocitinib showed a safety and tolerability profile in line with other class agents. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single potentially registrational Phase 3 trial. |
• | Immunovant: At Roivant’s Investor Day on September 28, Immunovant unveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL levels in a head-to-head animal study with batoclimab and placebo. Additionally, on September 7 Immunovant unveiled two new development programs for batoclimab in Graves’ disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Immunovant also completed a $75.0 million follow-on offering in October, with leading life sciences investors including Logos Capital, Deep Track Capital, Frazier Life Sciences, TCGX, BVF Partners, and Commodore Capital participating. |
• | Genevant: On November 2, the federal district court in Delaware issued an opinion and order in the patent infringement suit brought by Genevant and Arbutus against Moderna. The court denied Moderna’s partial motion to dismiss the suit based on the government-contractor defense under 28 U.S.C. Section 1498, which was an attempt by Moderna to shift liability for an unspecified portion its alleged infringement to the US government and taxpayers. The case is now expected to proceed to the pre-trial discovery phase. |
• | Proteovant: Disclosed today data from its preclinical estrogen receptor (ER) degrader demonstrating equal or better tumor reduction in an in vivo modelin a head-to-head comparison with the most advanced degrader in its class. |
• | Affivant: Affivant and Affimed jointly unveiled AFVT-2101 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston on November 8. AFVT-2101 is a tetravalent, bispecific ICE® (innate cell engager) that selectively targets folate receptor alpha (FRα) and CD16A (FcγR3A). AFVT-2101 directs innate immune cells to kill tumor cells selectively and potently with a wide range of FRα expression. Due to the high avidity for CD16A, AFVT-2101 is more efficacious and potent in both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays than farletuzumab, a monoclonal antibody targeting FRα. |
◦ | employee-related expenses, such as salaries, share-based compensation, and benefits, for research and development personnel; and |
◦ | other expenses that are not allocated to a specific program. |
Three Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
Revenue, net | $ | 12,533 | $ | 13,987 | $ | (1,454 | ) | |||||
Operating expenses: | ||||||||||||
Cost of revenues | 3,641 | 6,381 | (2,740 | ) | ||||||||
Research and development | 131,995 | 132,098 | (103 | ) | ||||||||
Acquired in-process research and development | — | 122,161 | (122,161 | ) | ||||||||
Selling, general and administrative | 157,663 | 437,776 | (280,113 | ) | ||||||||
Total operating expenses | 293,299 | 698,416 | (405,117 | ) | ||||||||
Loss from operations | (280,766 | ) | (684,429 | ) | 403,663 | |||||||
Change in fair value of investments | 54,678 | (32,273 | ) | 86,951 | ||||||||
Gain on sale of investment | — | (443,754 | ) | 443,754 | ||||||||
Change in fair value of debt and liability instruments | (13,541 | ) | 13,145 | (26,686 | ) | |||||||
Gain on deconsolidation of subsidiary | (16,762 | ) | — | (16,762 | ) | |||||||
Other expense, net | 8,615 | 3,692 | 4,923 | |||||||||
Loss before income taxes | (313,756 | ) | (225,239 | ) | (88,517 | ) | ||||||
Income tax expense | 2,165 | 401 | 1,764 | |||||||||
Net loss | (315,921 | ) | (225,640 | ) | (90,281 | ) | ||||||
Net loss attributable to noncontrolling interests | (24,331 | ) | (17,159 | ) | (7,172 | ) | ||||||
Net loss attributable to Roivant Sciences Ltd. | $ | (291,590 | ) | $ | (208,481 | ) | $ | (83,109 | ) |
Six Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
Revenue, net | $ | 16,852 | $ | 21,722 | $ | (4,870 | ) | |||||
Operating expenses: | ||||||||||||
Cost of revenues | 5,367 | 7,123 | (1,756 | ) | ||||||||
Research and development | 267,825 | 210,613 | 57,212 | |||||||||
Acquired in-process research and development | — | 122,272 | (122,272 | ) | ||||||||
Selling, general and administrative | 306,735 | 520,530 | (213,795 | ) | ||||||||
Total operating expenses | 579,927 | 860,538 | (280,611 | ) | ||||||||
Loss from operations | (563,075 | ) | (838,816 | ) | 275,741 | |||||||
Change in fair value of investments | 79,225 | (23,654 | ) | 102,879 | ||||||||
Gain on sale of investment | — | (443,754 | ) | 443,754 | ||||||||
Change in fair value of debt and liability instruments | 27,672 | 17,730 | 9,942 | |||||||||
Gain on termination of Sumitomo Options | — | (66,472 | ) | 66,472 | ||||||||
Gain on deconsolidation of subsidiary | (16,762 | ) | — | (16,762 | ) | |||||||
Other expense, net | 10,331 | 3,558 | 6,773 | |||||||||
Loss before income taxes | (663,541 | ) | (326,224 | ) | (337,317 | ) | ||||||
Income tax expense | 6,164 | 494 | 5,670 | |||||||||
Net loss | (669,705 | ) | (326,718 | ) | (342,987 | ) | ||||||
Net loss attributable to noncontrolling interests | (46,306 | ) | (36,054 | ) | (10,252 | ) | ||||||
Net loss attributable to Roivant Sciences Ltd. | $ | (623,399 | ) | $ | (290,664 | ) | $ | (332,735 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Revenue, net | $ | 7,735 | $ | 1,576 | $ | 6,159 | ||||||
Operating expenses: | ||||||||||||
Cost of revenues | 742 | 180 | 562 | |||||||||
Research and development | 78,626 | 58,734 | 19,892 | |||||||||
General and administrative | 82,754 | 57,115 | 25,639 | |||||||||
Total operating expenses | 162,122 | 116,029 | 46,093 | |||||||||
Loss from operations | (154,387 | ) | (114,453 | ) | (39,934 | ) | ||||||
Change in fair value of investments | 8,619 | (41,148 | ) | 49,767 | ||||||||
Change in fair value of debt and liability instruments | 4,585 | 17,125 | (12,540 | ) | ||||||||
Gain on termination of Sumitomo Options | (66,472 | ) | — | (66,472 | ) | |||||||
Gain on deconsolidation of subsidiary | — | (86,516 | ) | 86,516 | ||||||||
Other (income) expense, net | (134 | ) | 2,842 | (2,976 | ) | |||||||
Loss before income taxes | (100,985 | ) | (6,756 | ) | (94,229 | ) | ||||||
Income tax expense | 93 | 1,221 | (1,128 | ) | ||||||||
Net loss | (101,078 | ) | (7,977 | ) | (93,101 | ) | ||||||
Net loss attributable to noncontrolling interests | (18,895 | ) | (4,734 | ) | (14,161 | ) | ||||||
Net loss attributable to Roivant Sciences Ltd. | $ | (82,183 | ) | $ | (3,243 | ) | $ | (78,940 | ) | |||
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Revenue, net | $ | 7,735 | $ | 1,576 | $ | 6,159 |
Three Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
VTAMA revenues, net | $ | 4,969 | $ | — | $ | 4,969 | ||||||
License, milestone, and other revenue | 7,564 | 13,987 | (6,423 | ) | ||||||||
Total revenue, net | $ | 12,533 | $ | 13,987 | $ | (1,454 | ) |
Six Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
VTAMA revenues, net | $ | 5,110 | $ | — | $ | 5,110 | ||||||
License, milestone, and other revenue | 11,742 | 21,722 | (9,980 | ) | ||||||||
Total revenue, net | $ | 16,852 | $ | 21,722 | $ | (4,870 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Cost of revenues | $ | 742 | $ | 180 | $ | 562 |
Three Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
Cost of product and other revenues | $ | 1,441 | $ | 6,381 | $ | (4,940 | ) | |||||
Amortization of intangible assets | 2,200 | — | 2,200 | |||||||||
Cost of revenues | $ | 3,641 | $ | 6,381 | $ | (2,740 | ) |
Six Months Ended September 30, | ||||||||||||
2022 | 2021 | Change | ||||||||||
(in thousands) | ||||||||||||
Cost of product and other revenues | $ | 2,425 | $ | 7,123 | $ | (4,698 | ) | |||||
Amortization of intangible assets | 2,942 | — | 2,942 | |||||||||
Cost of revenues | $ | 5,367 | $ | 7,123 | $ | (1,756 | ) |
Three Months Ended September 30, | ||||||||||||
2022 | 2021(1) | Change | ||||||||||
(in thousands) | ||||||||||||
Program-specific costs: | ||||||||||||
FcRn programs(2) | $ | 19,502 | $ | 9,781 | $ | 9,721 | ||||||
Tapinarof | 12,543 | 28,566 | (16,023 | ) | ||||||||
Brepocitinib | 8,592 | 41 | 8,551 | |||||||||
Namilumab | 5,091 | 795 | 4,296 | |||||||||
RVT-2001 | 4,646 | — | 4,646 | |||||||||
AFVT-2101 | 3,350 | 1,353 | 1,997 | |||||||||
ARU-1801(3) | 1,917 | 7,197 | (5,280 | ) | ||||||||
LSVT-1701(3) | 1,085 | 4,454 | (3,369 | ) | ||||||||
ARU-2801 | — | 3,334 | (3,334 | ) | ||||||||
Other program-specific costs | 24,631 | 16,971 | 7,660 | |||||||||
Total program-specific costs | 81,357 | 72,492 | 8,865 | |||||||||
Unallocated internal costs: | ||||||||||||
Share-based compensation | 7,417 | 28,157 | (20,740 | ) | ||||||||
Personnel-related expenses | 35,268 | 23,760 | 11,508 | |||||||||
Other expenses | 7,953 | 7,689 | 264 | |||||||||
Total research and development expenses | $ | 131,995 | $ | 132,098 | $ | (103 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Program-specific costs: | ||||||||||||
IMVT-1401 (Immunovant, Inc.) | $ | 13,688 | $ | 14,393 | $ | (705 | ) | |||||
Tapinarof (Dermavant Sciences Ltd.) | 9,757 | 8,414 | 1,343 | |||||||||
ARU-1801 (Aruvant Sciences Ltd.) | 2,389 | 3,353 | (964 | ) | ||||||||
Gimsilumab (Kinevant Sciences Ltd.) | 2,069 | 12,325 | (10,256 | ) | ||||||||
Other program-specific costs | 20,112 | 9,097 | 11,015 | |||||||||
Total program-specific costs | 48,015 | 47,582 | 433 | |||||||||
Unallocated internal costs: | ||||||||||||
Share-based compensation | 1,615 | 1,119 | 496 | |||||||||
Personnel-related expenses | 22,092 | 8,767 | 13,325 | |||||||||
Other expenses | 6,904 | 1,266 | 5,638 | |||||||||
Total research and development expenses | $ | 78,626 | $ | 58,734 | $ | 19,892 | ||||||
Six Months Ended September 30, | ||||||||||||
2022 | 2021(1) | Change | ||||||||||
(in thousands) | ||||||||||||
Program-specific costs: | ||||||||||||
FcRn programs(2) | $ | 30,097 | $ | 20,309 | $ | 9,788 | ||||||
Tapinarof | 22,983 | 38,323 | (15,340 | ) | ||||||||
Brepocitinib | 20,894 | 41 | 20,853 | |||||||||
ARU-1801(3) | 11,764 | 9,475 | 2,289 | |||||||||
LSVT-1701(3) | 7,173 | 5,820 | 1,353 | |||||||||
RVT-2001 | 6,769 | — | 6,769 | |||||||||
AFVT-2101 | 6,662 | 6,104 | 558 | |||||||||
Namilumab | 6,109 | 1,605 | 4,504 | |||||||||
ARU-2801 | 3,456 | 4,636 | (1,180 | ) | ||||||||
Other program-specific costs | 45,953 | 34,083 | 11,870 | |||||||||
Total program-specific costs | 161,860 | 120,396 | 41,464 | |||||||||
Unallocated internal costs: | ||||||||||||
Share-based compensation | 19,660 | 29,772 | (10,112 | ) | ||||||||
Personnel-related expenses | 69,715 | 45,852 | 23,863 | |||||||||
Other expenses | 16,590 | 14,593 | 1,997 | |||||||||
Total research and development expenses | $ | 267,825 | $ | 210,613 | $ | 57,212 |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Acquired in-process research and development expenses | $ | — | $ | 122,161 | $ | (122,161 | ) | $ | — | $ | 122,272 | $ | (122,272 | ) |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Selling, general and administrative | $ | 157,663 | $ | 437,776 | $ | (280,113 | ) | $ | 306,735 | $ | 520,530 | $ | (213,795 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
General and administrative | $ | 82,754 | $ | 57,115 | $ | 25,639 |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Change in fair value of investments | $ | 8,619 | $ | (41,148 | ) | $ | 49,767 |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Change in fair value of investments | $ | 54,678 | $ | (32,273 | ) | $ | 86,951 | $ | 79,225 | $ | (23,654 | ) | $ | 102,879 |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Gain on sale of investment | $ | — | $ | (443,754 | ) | $ | 443,754 | $ | — | $ | (443,754 | ) | $ | 443,754 |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Change in fair value of debt and liability instruments | $ | (13,541 | ) | $ | 13,145 | $ | (26,686 | ) | $ | 27,672 | $ | 17,730 | $ | 9,942 |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Change in fair value of debt and liability instruments | $ | 4,585 | $ | 17,125 | $ | (12,540 | ) |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Gain on termination of Sumitomo Options | $ | — | $ | — | $ | — | $ | — | $ | (66,472 | ) | $ | 66,472 |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Gain on termination of Sumitomo Options | $ | (66,472 | ) | $ | — | $ | (66,472 | ) |
Three Months Ended September 30, | Six Months Ended September 30, | |||||||||||||||||||||||
2022 | 2021 | Change | 2022 | 2021 | Change | |||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||
Gain on deconsolidation of subsidiary | $ | (16,762 | ) | $ | — | $ | (16,762 | ) | $ | (16,762 | ) | $ | — | $ | (16,762 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Gain on deconsolidation of subsidiary | $ | — | $ | (86,516 | ) | $ | 86,516 |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Other (income) expense, net | $ | (134 | ) | $ | 2,842 | $ | (2,976 | ) |
Three Months Ended June 30, | ||||||||||||
2021 | 2020 | Change | ||||||||||
(in thousands) | ||||||||||||
Income tax expense | $ | 93 | $ | 1,221 | $ | (1,128 | ) |
Six Months Ended September 30, | ||||||||
2022 | 2021 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (441,712 | ) | $ | (261,766 | ) | ||
Net cash (used in) provided by investing activities | $ | (154,311 | ) | $ | 315,070 | |||
Net cash provided by financing activities | $ | 134,635 | $ | 314,144 |
Three Months Ended June 30, | ||||||||
2021 | 2020 | |||||||
(in thousands) | ||||||||
Net cash used in operating activities | $ | (141,170 | ) | $ | (111,167 | ) | ||
Net cash used in investing activities | $ | (2,339 | ) | $ | (25,641 | ) | ||
Net cash provided by financing activities | $ | 10,210 | $ | 181,130 |
Item 3. | Quantitative and Qualitative Disclosures About Market Risk. |
Item 4. | Controls and Procedures. |
Item 1. | Legal Proceedings. |
Item 1A. | Risk Factors. |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds. |
Item 3. | Defaults Upon Senior Securities. |
Item 4. | Mine Safety Disclosures. |
Item 5. | Other Information. |
Item 6. | Exhibits. |
Incorporated by Reference | |||||||
Exhibit Number | Description | Form | File No. | Exhibit | Filing Date | ||
Partial Termination and Supplementary Fee Agreement relating to the Clinical Supply Agreement and Commercial Supply Agreement, dated as of July 25, 2022, by and between GlaxoSmithKline Trading Services Limited and Dermavant Sciences GmbH | — | — | — | Filed herewith | |||
Master Commercial Manufacturing Supply Agreement, dated as of July 1, 2022, by and between Dermavant Sciences GmbH and Thermo Fisher Scientific Cork Limited | — | — | — | Filed herewith | |||
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||
101.INS | Inline XBRL Instance Document | — | — | — | Filed herewith | ||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | — | — | — | Filed herewith | ||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | — | — | — | Filed herewith | ||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | — | — | — | Filed herewith | ||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | — | — | — | Filed herewith | ||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | — | — | — | Filed herewith | ||
104 | Cover Page Interactive Data (formatted as Inline XBRL and contained in Exhibit 101) | — | — | — | Filed herewith |
# | Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to Roivant Sciences Ltd. if publicly disclosed. |
Incorporated by Reference | ||||||||||||||||||
Exhibit Number | Description | Form | File No. | Exhibit | Filing Date | |||||||||||||
3.1 | Memorandum of Association of Roivant Sciences Ltd. | S-4/A | — | 3.1 | June 30, 2021 | |||||||||||||
3.2 | Form of Amended and Restated Bye-Laws of Roivant Sciences Ltd. | S-4/A | — | 3.2 | June 30, 2021 | |||||||||||||
31.1 | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||||||||||||
31.2 | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||||||||||||
32.1 | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | — | — | — | Filed herewith | |||||||||||||
32.2 | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | — | — | — | Filed herewith | |||||||||||||
101.INS | Inline XBRL Instance Document | — | — | — | Filed herewith | |||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | — | — | — | Filed herewith | |||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | — | — | — | Filed herewith | |||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | — | — | — | Filed herewith | |||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | — | — | — | Filed herewith | |||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | — | — | — | Filed herewith | |||||||||||||
104 | Cover Page Interactive Data (formatted as Inline XBRL and contained in Exhibit 101) | — | — | — | Filed herewith |
ROIVANT SCIENCES LTD. | |||
By: | /s/ Matthew Gline | ||
Name: Matthew Gline | |||
Title: Principal Executive Officer | |||
By: | /s/ Richard Pulik | ||
Name: Richard Pulik | |||
Title: Principal Financial Officer | |||
By: | /s/ Matt Maisak | ||
Name: Matt Maisak | |||
Title: Authorized Signatory |