☒ | 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 |
Delaware | 36-4742850 | ||
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||
430 East 29th Street New York, New York | 10016 | ||
(Address of principal executive offices) | (Zip Code) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock | ITCI | The Nasdaq Global Select Market |
Large accelerated filer | ☒ | Accelerated filer | ☐ | ||||||
☐ | |||||||||
Emerging growth company | ☐ |
1 | ||||||||||
Item 1. | 1 | |||||||||
1 | ||||||||||
2 | ||||||||||
3 | ||||||||||
4 | ||||||||||
5 | ||||||||||
6 | ||||||||||
Item 2. | ||||||||||
Item 3. | ||||||||||
Item 4. | ||||||||||
Item 1. | ||||||||||
Item 1A. | ||||||||||
Item 2. | ||||||||||
Item 3. | ||||||||||
Item 4. | ||||||||||
Item 5. | ||||||||||
Item 6. | ||||||||||
Item 1. | FINANCIAL STATEMENTS |
March 31, 2020 | December 31, 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 179,593,032 | $ | 107,636,849 | ||||
Investment securities, available-for-sale | 269,360,926 | 116,373,335 | ||||||
Restricted cash | 1,400,000 | — | ||||||
Accounts receivable, net | 1,351,013 | — | ||||||
Inventory | 1,391,124 | — | ||||||
Prepaid expenses and other current assets | 7,876,405 | 6,313,785 | ||||||
Total current assets | 460,972,500 | 230,323,969 | ||||||
Property and equipment, net | 2,132,987 | 2,259,740 | ||||||
Right of use assets, net | 18,051,146 | 18,252,074 | ||||||
Deferred tax asset, net | — | 264,609 | ||||||
Other assets | 86,084 | 86,084 | ||||||
Total assets | $ | 481,242,717 | $ | 251,186,476 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 10,994,082 | $ | 7,425,024 | ||||
Accrued and other current liabilities | 10,667,765 | 16,138,909 | ||||||
Lease liabilities, short-term | 3,211,234 | 3,187,435 | ||||||
Accrued employee benefits | 6,203,283 | 9,472,651 | ||||||
Total current liabilities | 31,076,364 | 36,224,019 | ||||||
Lease liabilities | 19,718,023 | 19,955,186 | ||||||
Total liabilities | 50,794,387 | 56,179,205 | ||||||
Stockholders’ equity: | ||||||||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 66,200,761 and 55,507,497 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 6,620 | 5,551 | ||||||
Additional paid-in capital | 1,188,095,880 | 904,971,772 | ||||||
Accumulated deficit | (757,508,971 | ) | (710,098,369 | ) | ||||
Accumulated comprehensive (loss) gain | (145,199 | ) | 128,317 | |||||
Total stockholders’ equity | 430,448,330 | 195,007,271 | ||||||
Total liabilities and stockholders’ equity | $ | 481,242,717 | $ | 251,186,476 | ||||
September 30, 2020 | December 31, 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 300,988,981 | $ | 107,636,849 | ||||
Investment securities, available-for-sale | 420,958,509 | 116,373,335 | ||||||
Restricted cash | 1,400,000 | — | ||||||
Accounts receivable, net | 7,480,604 | — | ||||||
Inventory | 2,947,138 | — | ||||||
Prepaid expenses and other current assets | 11,090,774 | 6,313,785 | ||||||
Total current assets | 744,866,006 | 230,323,969 | ||||||
Property and equipment, net | 2,049,552 | 2,259,740 | ||||||
Right of use assets, net | 24,292,167 | 18,252,074 | ||||||
Deferred tax asset, net | — | 264,609 | ||||||
Other assets | 86,084 | 86,084 | ||||||
Total assets | $ | 771,293,809 | $ | 251,186,476 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 8,569,148 | $ | 7,425,024 | ||||
Accrued and other current liabilities | 12,186,380 | 16,138,909 | ||||||
Lease liabilities, short-term | 5,267,258 | 3,187,435 | ||||||
Accrued employee benefits | 12,005,931 | 9,472,651 | ||||||
Total current liabilities | 38,028,717 | 36,224,019 | ||||||
Lease liabilities | 23,869,557 | 19,955,186 | ||||||
Total liabilities | 61,898,274 | 56,179,205 | ||||||
Stockholders’ equity: | ||||||||
Common stock, $0.0001 par value: 100,000,000 shares authorized; 80,142,797 and 55,507,497 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 8,014 | 5,551 | ||||||
Additional paid-in capital | 1,585,023,637 | 904,971,772 | ||||||
Accumulated deficit | (876,404,854 | ) | (710,098,369 | ) | ||||
Accumulated comprehensive income | 768,738 | 128,317 | ||||||
Total stockholders’ equity | 709,395,535 | 195,007,271 | ||||||
Total liabilities and stockholders’ equity | $ | 771,293,809 | $ | 251,186,476 | ||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Revenues | ||||||||
Product sales, net | $ | 882,516 | $ | — | ||||
Grant revenue | 200,963 | — | ||||||
Total revenues | 1,083,479 | — | ||||||
Operating expenses: | ||||||||
Cost of product sales | 69,311 | — | ||||||
Research and development | 16,003,326 | 24,990,856 | ||||||
Selling, general and administrative | 34,096,366 | 11,704,984 | ||||||
Total operating expenses | 50,169,003 | 36,695,840 | ||||||
Loss from operations | (49,085,524 | ) | (36,695,840 | ) | ||||
Interest income | 1,678,203 | 1,860,077 | ||||||
Loss before provision for income taxes | (47,407,321 | ) | (34,835,763 | ) | ||||
Income tax expense | 3,281 | — | ||||||
Net loss | $ | (47,410,602 | ) | $ | (34,835,763 | ) | ||
Net loss per common share: | ||||||||
Basic & Diluted | $ | (0.73 | ) | $ | (0.63 | ) | ||
Weighted average number of common shares: | ||||||||
Basic & Diluted | 65,106,103 | 55,113,226 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Revenues | ||||||||||||||||
Product sales, net | $ | 7,368,594 | $ | — | $ | 10,126,999 | $ | — | ||||||||
Grant revenue | — | — | 231,710 | — | ||||||||||||
Total revenues , net | 7,368,594 | — | 10,358,709 | — | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of product sales | 556,107 | — | 753,957 | — | ||||||||||||
Research and development | 10,275,368 | 21,339,792 | 51,483,551 | 70,059,113 | ||||||||||||
Selling, general and administrative | 52,473,573 | 15,036,444 | 128,015,496 | 42,184,078 | ||||||||||||
Total operating expenses | 63,305,048 | 36,376,236 | 180,253,004 | 112,243,191 | ||||||||||||
Loss from operations | (55,936,454 | ) | (36,376,236 | ) | (169,894,295 | ) | (112,243,191 | ) | ||||||||
Interest income | 752,829 | 1,513,837 | 3,591,091 | 5,105,464 | ||||||||||||
Loss before provision for income taxes | (55,183,625 | ) | (34,862,399 | ) | (166,303,204 | ) | (107,137,727 | ) | ||||||||
Income tax expense | — | — | 3,281 | 1,600 | ||||||||||||
Net loss | $ | (55,183,625 | ) | $ | (34,862,399 | ) | $ | (166,306,485 | ) | $ | (107,139,327 | ) | ||||
Net loss per common share: | ||||||||||||||||
Basic & Diluted | $ | (0.79 | ) | $ | (0.63 | ) | $ | (2.48 | ) | $ | (1.94 | ) | ||||
Weighted average number of common shares: | ||||||||||||||||
Basic & Diluted | 69,530,039 | 55,207,400 | 67,030,991 | 55,155,854 |
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Net loss | $ | (47,410,602 | ) | $ | (34,835,763 | ) | ||
Other comprehensive (loss) income : | ||||||||
Unrealized (loss) gain on investment securities | (273,516 | ) | 600,307 | |||||
Comprehensive loss | $ | (47,684,118 | ) | $ | (34,235,456 | ) | ||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Net loss | $ | (55,183,625 | ) | $ | (34,862,399 | ) | $ | (166,306,485 | ) | $ | (107,139,327 | ) | ||||
Other comprehensive income (loss) : | ||||||||||||||||
Unrealized gain ( on investment securitiesloss ) | (399,361 | ) | (33,396 | ) | 640,421 | 866,805 | ||||||||||
Comprehensive loss | $ | (55,582,986 | ) | $ | (34,895,795 | ) | $ | (165,666,064 | ) | $ | (106,272,522 | ) | ||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive Loss | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2018 | 54,895,295 | $ | 5,490 | $ | 880,753,339 | $ | (562,376,191 | ) | $ | (667,757 | ) | $ | 317,714,881 | |||||||||||
Exercise of stock options and issuances of restricted stock | 231,844 | 23 | 31,213 | — | — | 31,236 | ||||||||||||||||||
Stock issued for services | 3,986 | — | 48,549 | — | — | 48,549 | ||||||||||||||||||
Share-based compensation | — | — | 5,055,217 | — | — | 5,055,217 | ||||||||||||||||||
Net loss | — | — | — | (34,835,763 | ) | — | (34,835,763 | ) | ||||||||||||||||
Other comprehensive gain | — | — | — | — | 600,307 | 600,307 | ||||||||||||||||||
Balance at March 31, 2019 | 55,131,125 | $ | 5,513 | $ | 885,888,318 | $ | (597,211,954 | ) | $ | (67,450 | ) | $ | 288,614,427 | |||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive Income (Loss) | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2019 | 55,507,497 | $ | 5,551 | $ | 904,971,772 | $ | (710,098,369 | ) | $ | 128,317 | $ | 195,007,271 | ||||||||||||
Common shares issued January 2020 | 10,000,000 | 1,000 | 276,977,186 | — | — | 276,978,186 | ||||||||||||||||||
Exercise of stock options and issuances of restricted stock | 689,781 | 69 | 589,092 | — | — | 589,161 | ||||||||||||||||||
Stock issued for services | 3,483 | — | 53,533 | — | — | 53,533 | ||||||||||||||||||
Share-based compensation | — | — | 5,504,297 | — | — | 5,504,297 | ||||||||||||||||||
Net loss | — | — | — | (47,410,602 | ) | — | (47,410,602 | ) | ||||||||||||||||
Other comprehensive loss | — | — | — | — | (273,516 | ) | (273,516 | ) | ||||||||||||||||
Balance at March 31, 2020 | 66,200,761 | $ | 6,620 | $ | 1,188,095,880 | $ | (757,508,971 | ) | $ | (145,199 | ) | $ | 430,448,330 | |||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive (Loss) Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at June 30, 2019 | 55,186,745 | $ | 5,519 | $ | 891,183,518 | $ | (634,653,119 | ) | $ | 232,444 | $ | 256,768,362 | ||||||||||||
Exercise of stock options and issuances of restricted stock | 54,332 | 6 | 152,373 | — | — | 152,379 | ||||||||||||||||||
Stock issued for services | 6,502 | — | 48,571 | — | — | 48,571 | ||||||||||||||||||
Share-based compensation | — | — | 4,806,768 | — | — | 4,806,768 | ||||||||||||||||||
Net loss | — | — | — | (34,862,399 | ) | — | (34,862,399 | ) | ||||||||||||||||
Other comprehensive loss | — | — | — | — | (33,396 | ) | (33,396 | ) | ||||||||||||||||
Balance at September 30, 2019 | 55,247,579 | $ | 5,525 | $ | 896,191,230 | $ | (669,515,518 | ) | $ | 199,048 | $ | 226,880,285 | ||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive (Loss) Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2018 | 54,895,295 | $ | 5,490 | $ | 880,753,339 | $ | (562,376,191 | ) | $ | (667,757 | ) | $ | 317,714,881 | |||||||||||
Exercise of stock options and issuances of restricted stock | 338,054 | 34 | 442,792 | — | — | 442,826 | ||||||||||||||||||
Stock issued for services | 14,230 | 1 | 145,690 | — | — | 145,691 | ||||||||||||||||||
Share-based compensation | — | — | 14,849,409 | — | — | 14,849,409 | ||||||||||||||||||
Net loss | — | — | — | (107,139,327 | ) | — | (107,139,327 | ) | ||||||||||||||||
Other comprehensive gain | — | — | — | — | 866,805 | 866,805 | ||||||||||||||||||
Balance at September 30, 2019 | 55,247,579 | $ | 5,525 | $ | 896,191,230 | $ | (669,515,518 | ) | $ | 199,048 | $ | 226,880,285 | ||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive (Loss) Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at June 3 0 , 2020 | 66,777,737 | $ | 6,678 | $ | 1,199,576,320 | $ | (821,221,229 | ) | $ | 1,168,099 | $ | 379,529,868 | ||||||||||||
Common shares issued | 13,179,458 | 1,318 | 370,137,298 | — | — | 370,138,616 | ||||||||||||||||||
Common shares coll ected | — | — | 5,705,186 | — | — | 5,705,186 | ||||||||||||||||||
Exercise of stock options and issuances of restricted stock | 183,516 | 18 | 2,650,587 | — | — | 2,650,605 | ||||||||||||||||||
Stock issued for services | 2,086 | 0 | 53,527 | — | — | 53,527 | ||||||||||||||||||
Share-based compensation | — | — | 6,900,719 | — | — | 6,900,719 | ||||||||||||||||||
Net loss | — | — | — | (55,183,625 | ) | — | (55,183,625 | ) | ||||||||||||||||
Other comprehensive loss | — | — | — | — | (399,361 | ) | (399,361 | ) | ||||||||||||||||
Balance at September 30, 2020 | 80,142,797 | $ | 8,014 | $ | 1,585,023,637 | $ | (876,404,854 | ) | $ | 768,738 | $ | 709,395,535 | ||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Comprehensive (Loss) Income | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2019 | 55,507,497 | $ | 5,551 | $ | 904,971,772 | $ | (710,098,369 | ) | $ | 128,317 | $ | 195,007,271 | ||||||||||||
Common shares issued | 23,409,458 | 2,341 | 652,709,670 | — | — | 652,712,011 | ||||||||||||||||||
Exercise of stock options and issuances of restricted stock | 1,218,188 | 121 | 7,829,463 | — | — | 7,829,584 | ||||||||||||||||||
Stock issued for services | 7,654 | 1 | 160,582 | — | — | 160,583 | ||||||||||||||||||
Share-based compensation | — | — | 19,352,150 | — | — | 19,352,150 | ||||||||||||||||||
Net loss | — | — | — | (166,306,485 | ) | — | (166,306,485 | ) | ||||||||||||||||
Other comprehensive gain | — | — | — | — | 640,421 | 640,421 | ||||||||||||||||||
Balance at September 30, 2020 | 80,142,797 | $ | 8,014 | $ | 1,585,023,637 | $ | (876,404,854 | ) | $ | 768,738 | $ | 709,395,535 | ||||||||||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Cash flows used in operating activities | ||||||||
Net loss | $ | (47,410,602 | ) | $ | (34,835,763 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 148,802 | 101,353 | ||||||
Share-based compensation | 5,504,297 | 5,055,217 | ||||||
Stock issued for services | 53,533 | 48,549 | ||||||
Amortization of premiums and discounts on investment securities, net | (298,210 | ) | (356,798 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (1,351,013 | ) | — | |||||
Inventory | (1,391,124 | ) | — | |||||
Prepaid expenses and other assets | (1,562,620 | ) | (526,089 | ) | ||||
Long term deferred tax asset, net | 264,609 | — | ||||||
Accounts payable | 3,569,058 | (5,386,627 | ) | |||||
Accrued liabilities and other | (8,740,512 | ) | 270,833 | |||||
Lease liabilities, net | (12,436 | ) | — | |||||
Net cash used in operating activities | (51,226,218 | ) | (35,629,325 | ) | ||||
Cash flows (used in) provided by investing activities | ||||||||
Purchases of investments | (210,466,633 | ) | (14,327,684 | ) | ||||
Maturities of investments | 57,503,736 | 59,136,544 | ||||||
Purchases of property and equipment | (22,049 | ) | (67,193 | ) | ||||
Net cash (used in) provided by investing activities | (152,984,946 | ) | 44,741,667 | |||||
Cash flows provided by financing activities | ||||||||
Proceeds from exercise of stock options | 589,161 | 31,236 | ||||||
Proceeds of public offering, net | 276,978,186 | — | ||||||
Net cash provided by financing activities | 277,567,347 | 31,236 | ||||||
Net increase in cash, cash equivalents, and restricted cash | 73,356,183 | 9,143,578 | ||||||
Cash, cash equivalents, and restricted cash at beginning of period | 107,636,849 | 54,947,502 | ||||||
Cash, cash equivalents, and restricted cash at end of period | $ | 180,993,032 | $ | 64,091,080 | ||||
Non-cash investing and financing activities | ||||||||
Right of use assets under operating leases | $ | 97,234 | $ | 219,703 | ||||
Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
Cash flows used in operating activities | ||||||||
Net loss | $ | (166,306,485 | ) | $ | (107,139,327 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 402,146 | 335,461 | ||||||
Share-based compensation | 19,352,150 | 14,849,409 | ||||||
Stock issued for services | 160,583 | 145,691 | ||||||
Amortization of premiums and discounts on investment securities, net | (177,374 | ) | (871,412 | ) | ||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable, net | (7,480,604 | ) | — | |||||
Inventory | (2,947,138 | ) | — | |||||
Prepaid expenses and other assets | (4,776,989 | ) | 4,020,430 | |||||
Long term deferred tax asset, net | 264,609 | — | ||||||
Accounts payable | 1,144,124 | (7,730,137 | ) | |||||
Accrued liabilities and other | (1,419,249 | ) | 3,462,560 | |||||
Lease liabilities, net | (45,899 | ) | — | |||||
Net cash used in operating activities | (161,830,126 | ) | (92,927,325 | ) | ||||
Cash flows (used in) provided by investing activities | ||||||||
Purchases of investments | (488,524,539 | ) | (58,332,886 | ) | ||||
Maturities of investments | 184,757,160 | 199,383,553 | ||||||
Purchases of property and equipment | (191,958 | ) | (1,350,688 | ) | ||||
Net cash (used in) provided by investing activities | (303,959,337 | ) | 139,699,979 | |||||
Cash flows provided by financing activities | ||||||||
Proceeds from exercise of stock options | 7,829,584 | 442,826 | ||||||
Proceeds of public offerings, net | 652,712,011 | — | ||||||
Net cash provided by financing activities | 660,541,595 | 442,826 | ||||||
Net increase in cash, cash equivalents, and restricted cash | 194,752,132 | 47,215,480 | ||||||
Cash, cash equivalents, and restricted cash at beginning of period | 107,636,849 | 54,947,502 | ||||||
Cash, cash equivalents, and restricted cash at end of period | $ | 302,388,981 | $ | 102,162,982 | ||||
Non-cash investing and financing activities | ||||||||
Right of use assets under operating vehicle fleet leases | $ | 7,750,959 | $ | — | ||||
Right of use assets under operating real estate leases | $ | — | $ | 219,703 | ||||
March 31, | ||||||||
2020 | 2019 | |||||||
Cash and cash equivalents | $ | 179,593,032 | $ | 64,091,080 | ||||
Restricted cash | 1,400,000 | — | ||||||
Total cash, cash equivalents and restricted cash | $ | 180,993,032 | $ | 64,091,080 | ||||
September 30, | ||||||||
2020 | 2019 | |||||||
Cash and cash equivalents | $ | 300,988,981 | | $ | 102,162,982 | |||
Restricted cash | 1,400,000 | — | ||||||
Total cash, cash equivalents and restricted cash | $ | 302,388,981 | $ | 102,162,982 | ||||
September 30, 2020 | ||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||
(Unaudited) | ||||||||||||||||
U.S. Government Agency Securities | $ | 159,237 | $ | 12 | $ | (32 | ) | $ | 159,217 | |||||||
Certificates of Deposit | 10,500 | — | — | 10,500 | ||||||||||||
Commercial Paper | 78,788 | 138 | (2 | ) | 78,924 | |||||||||||
Corporate Notes/Bonds | 171,665 | 782 | (129 | ) | 172,318 | |||||||||||
$ | 420,190 | $ | 932 | $ | (163 | ) | $ | 420,959 | ||||||||
December 31, 2019 | ||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||
U.S. Government Agency Securities | $ | 35,462 | $ | 35 | $ | (3 | ) | $ | 35,494 | |||||||
Certificates of Deposit | 3,000 | — | — | 3,000 | ||||||||||||
Commercial Paper | 39,013 | 10 | (5 | ) | 39,018 | |||||||||||
Corporate Notes/Bonds | 38,770 | 91 | — | 38,861 | ||||||||||||
$ | 116,245 | $ | 136 | $ | (8 | ) | $ | 116,373 | ||||||||
• | Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. |
• | Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. |
• | Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. |
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
September 30, 2020 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 224,239 | $ | 224,239 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 159,217 | — | 159,217 | — | ||||||||||||
Certificates of Deposit | 10,500 | — | 10,500 | — | ||||||||||||
Commercial Paper | 78,924 | — | 78,924 | — | ||||||||||||
Corporate Notes/Bonds | 172,318 | — | 172,318 | — | ||||||||||||
$ | 645,198 | $ | 224,239 | $ | 420,959 | $ | — | |||||||||
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
December 31, 2019 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 49,882 | $ | 49,882 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 35,494 | — | 35,494 | — | ||||||||||||
Certificates of Deposit | 50,622 | — | 50,622 | — | ||||||||||||
Commercial Paper | 42,015 | — | 42,015 | — | ||||||||||||
Corporate Notes/Bonds | 38,861 | — | 38,861 | — | ||||||||||||
$ | 216,874 | $ | 49,882 | $ | 166,992 | $ | — | |||||||||
• | Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. |
• | Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. |
• | Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. |
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
September 30, 2020 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 224,239 | $ | 224,239 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 159,217 | — | 159,217 | — | ||||||||||||
Certificates of Deposit | 10,500 | — | 10,500 | — | ||||||||||||
Commercial Paper | 78,924 | — | 78,924 | — | ||||||||||||
Corporate Notes/Bonds | 172,318 | — | 172,318 | — | ||||||||||||
$ | 645,198 | $ | 224,239 | $ | 420,959 | $ | — | |||||||||
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
December 31, 2019 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 49,882 | $ | 49,882 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 35,494 | — | 35,494 | — | ||||||||||||
Certificates of Deposit | 50,622 | — | 50,622 | — | ||||||||||||
Commercial Paper | 42,015 | — | 42,015 | — | ||||||||||||
Corporate Notes/Bonds | 38,861 | — | 38,861 | — | ||||||||||||
$ | 216,874 | $ | 49,882 | $ | 166,992 | $ | — | |||||||||
March 31, 2020 | ||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||
(Unaudited) | ||||||||||||||||
U.S. Government Agency Securities | $ | 86,053 | $ | 187 | $ | (4 | ) | $ | 86,236 | |||||||
Commercial Paper | 89,361 | 53 | (22 | ) | 89,392 | |||||||||||
Corporate Notes/Bonds | 94,092 | 120 | (479 | ) | 93,733 | |||||||||||
$ | 269,506 | $ | 360 | $ | (505 | ) | $ | 269,361 | ||||||||
December 31, 2019 | ||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||
U.S. Government Agency Securities | $ | 35,462 | $ | 35 | $ | (3 | ) | $ | 35,494 | |||||||
Certificates of Deposit | 3,000 | — | — | 3,000 | ||||||||||||
Commercial Paper | 39,013 | 10 | (5 | ) | 39,018 | |||||||||||
Corporate Notes/Bonds | 38,770 | 91 | — | 38,861 | ||||||||||||
$ | 116,245 | $ | 136 | $ | (8 | ) | $ | 116,373 | ||||||||
• | Level 1—Fair value is determined by using unadjusted quoted prices that are available in active markets for identical assets and liabilities. |
• | Level 2—Fair value is determined by using inputs other than Level 1 quoted prices that are directly or indirectly observable. Inputs can include quoted prices for similar assets and liabilities in active markets or quoted prices for identical assets and liabilities in inactive markets. Related inputs can also include those used in valuation or other pricing models, such as interest rates and yield curves that can be corroborated by observable market data. |
• | Level 3—Fair value is determined by inputs that are unobservable and not corroborated by market data. Use of these inputs involves significant and subjective judgments to be made by a reporting entity—e.g., determining an appropriate adjustment to a discount factor for illiquidity associated with a given security. |
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
March 31, 2020 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 84,966 | $ | 84,966 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 106,235 | — | 106,235 | — | ||||||||||||
Certificates of Deposit | 58,254 | — | 58,254 | — | ||||||||||||
Commercial Paper | 101,387 | — | 101,387 | — | ||||||||||||
Corporate Notes/Bonds | 93,733 | — | 93,733 | — | ||||||||||||
Restricted Cash | 1,400 | 1,400 | — | — | ||||||||||||
$ | 445,975 | $ | 86,366 | $ | 359,609 | $ | — | |||||||||
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
September 30, 2020 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 224,239 | $ | 224,239 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 159,217 | — | 159,217 | — | ||||||||||||
Certificates of Deposit | 10,500 | — | 10,500 | — | ||||||||||||
Commercial Paper | 78,924 | — | 78,924 | — | ||||||||||||
Corporate Notes/Bonds | 172,318 | — | 172,318 | — | ||||||||||||
$ | 645,198 | $ | 224,239 | $ | 420,959 | $ | — | |||||||||
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
December 31, 2019 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 49,882 | $ | 49,882 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 35,494 | — | 35,494 | — | ||||||||||||
Certificates of Deposit | 50,622 | — | 50,622 | — | ||||||||||||
Commercial Paper | 42,015 | — | 42,015 | — | ||||||||||||
Corporate Bonds/Notes | 38,861 | — | 38,861 | — | ||||||||||||
$ | 216,874 | $ | 49,882 | $ | 166,992 | $ | — | |||||||||
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
December 31, 2019 | Quoted Prices in Active Markets for Identical Assets (Level 1) | Significant Other Observable Inputs (Level 2) | Significant Unobservable Inputs (Level 3) | |||||||||||||
Money Market Funds | $ | 49,882 | $ | 49,882 | $ | — | $ | — | ||||||||
U.S. Government Agency Securities | 35,494 | — | 35,494 | — | ||||||||||||
Certificates of Deposit | 50,622 | — | 50,622 | — | ||||||||||||
Commercial Paper | 42,015 | — | 42,015 | — | ||||||||||||
Corporate Notes/Bonds | 38,861 | — | 38,861 | — | ||||||||||||
$ | 216,874 | $ | 49,882 | $ | 166,992 | $ | — | |||||||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Stock Options | 6,408,389 | 6,012,069 | ||||||
RSUs | 1,695,397 | 1,296,634 | ||||||
TSR RSUs | 86,044 | 269,129 |
Three and Nine Months Ended September 30, | ||||||||
2020 | 2019 | |||||||
Stock options | 5,964,135 | 6,330,914 | ||||||
RSUs | 1,702,538 | 1,425,459 | ||||||
TSR RSUs | 43,022 | 134,170 |
March 31, 2020 | ||||
Raw materials | $ | — | ||
Work in process | 1,250,025 | |||
Finished goods | 141,099 | |||
Total inventories | $ | 1,391,124 | ||
September 30, 2020 | ||||
Raw materials | $ | 0 | ||
Work in process | 1,597,413 | |||
Finished goods | 1,349,725 | |||
$ | 2,947,138 | |||
March 31, 2020 | December 31, 2019 | |||||||
Computer equipment | $ | 243,532 | $ | 243,532 | ||||
Furniture and fixtures | 423,097 | 423,097 | ||||||
Scientific equipment | 3,883,276 | 3,861,227 | ||||||
Leasehold improvements | 1,240,315 | 1,240,315 | ||||||
5,790,220 | 5,768,171 | |||||||
Less accumulated depreciation | (3,657,233 | ) | (3,508,431 | ) | ||||
$ | 2,132,987 | $ | 2,259,740 | |||||
September 30, 2020 | December 31, 2019 | |||||||
Computer equipment | $ | 243,532 | $ | 243,532 | ||||
Furniture and fixtures | 423,097 | 423,097 | ||||||
Scientific equipment | 4,053,185 | 3,861,227 | ||||||
Leasehold improvements | 1,240,315 | 1,240,315 | ||||||
5,960,129 | 5,768,171 | |||||||
Less accumulated depreciation | (3,910,577 | ) | (3,508,431 | ) | ||||
$ | 2,049,552 | $ | 2,259,740 | |||||
Nine months ending December 31, 2020 | $ | 2,515,636 | ||
Year ending December 31, 2021 | 3,448,323 | |||
Year ending December 31, 2022 | 3,491,166 | |||
Year ending December 31, 2023 | 3,566,466 | |||
Year ending December 31, 2024 | 3,675,196 | |||
Thereafter | 17,627,041 | |||
Total | 34,323,828 | |||
Less: Present value discount | (11,488,613 | ) | ||
Total Lease liability | $ | 22,835,215 | ||
Less: Current portion | (3,211,234 | ) | ||
Long-term lease liabilities | $ | 19,623,981 | ||
Three months ending December 31, 2020 | $ | 845,566 | ||
Year ending December 31, 2021 | 3,448,323 | |||
Year ending December 31, 2022 | 3,491,166 | |||
Year ending December 31, 2023 | 3,566,466 | |||
Year ending December 31, 2024 | 3,675,196 | |||
Thereafter | 17,627,040 | |||
Total | 32,653,757 | |||
Less: Present value discount | (10,463,196 | ) | ||
Total Lease liability | 22,190,561 | |||
Less: Current portion | (3,259,966 | ) | ||
Long-term lease liabilities | $ | 18,930,595 | ||
Lease Assets and Liabilities – Fleet | Classification | March 31, 2020 | ||||||
Assets | ||||||||
Right of use assets, net | Operating lease right of use assets | $ | 94,042 | |||||
$ | 94,042 | |||||||
Liabilities | ||||||||
Current | ||||||||
Lease liabilities, short-term | Operating lease liabilities | $ | — | |||||
Non-Current | ||||||||
Lease liabilities | Non-current operating lease liabilities | 94,042 | ||||||
Total lease liabilities | $ | 94,042 | ||||||
Weighted average remaining lease term | 2.4 years | |||||||
Weighted average discount rate | 1.80 | % |
Lease Assets and Liabilities – Fleet | Classification | September 30, 2020 | ||||||
Assets | ||||||||
Right of use assets, net | Operating lease right of use assets | $ | 6,946,254 | |||||
$ | 6,946,254 | |||||||
Liabilities | ||||||||
Current | ||||||||
Lease liabilities, short-term | Operating lease liabilities | $ | 2,007,292 | |||||
Non-Current | ||||||||
Lease liabilities | Non-current operating lease liabilities | 4,938,962 | ||||||
Total lease liabilities | $ | 6,946,254 | ||||||
Weighted average remaining lease term | 2.2 years | |||||||
Weighted average discount rate | 1.85 | % |
Nine months ending December 31, 2020 | $ | 20,555 | ||
Year ending December 31, 2021 | 27,407 | |||
Year ending December 31, 2022 | 49,797 | |||
Year ending December 31, 2023 | — | |||
Year ending December 31, 2024 | — | |||
Thereafter | — | |||
Total | 97,759 | |||
Less: Present value discount | (3,717 | ) | ||
Total operating lease liabilities | $ | 94,042 | ||
Less: Current portion | — | |||
Long-term lease liabilities | $ | |||
Time | Period |
Three months ending December 31, 2020 | $ | 530,799 | ||
Year ending December 31, 2021 | 2,112,506 | |||
Year ending December 31, 2022 | 3,207,898 | |||
Year ending December 31, 2023 | 1,273,867 | |||
Thereafter | 0 | |||
Total | 7,125,070 | |||
Less: Present value discount | (178,816 | ) | ||
Total operating lease liabilities | 6,946,254 | |||
Less: Current portion | (2,007,292 | ) | ||
Long-term lease liabilities | $ | 4,938,962 | ||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Inventoriable costs | $ | 293,384 | $ | — | ||||
Research and development | 2,006,855 | 2,407,644 | ||||||
General and administrative | 3,204,058 | 2,647,573 | ||||||
Total share-based compensation expense | $ | 5,504,297 | $ | 5,055,217 | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Inventoriable costs | $ | 345,460 | $ | — | $ | 996,802 | $ | — | ||||||||
Research and development | 2,402,865 | 2,023,700 | 6,792,498 | $ | 6,785,280 | |||||||||||
General and administrative | 4,152,394 | 2,783,068 | 11,562,850 | 8,064,129 | ||||||||||||
Total share-based compensation expense | $ | 6,900,719 | $ | 4,806,768 | $ | 19,352,150 | $ | 14,849,409 | ||||||||
2020 | 2019 | |||||||
Dividend yield | 0 | % | 0 | % | ||||
Expected volatility | 91.6-92.5 | % | 85.7 | % | ||||
Weighted-average risk-free interest rate | 1.42 | % | 2.52 | % | ||||
Expected term (in years) | 6.0 | 6.0 |
2020 | 2019 | |||
Dividend yield | 0% | 0% | ||
Expected volatility | 91.6%-92.7% | 83.7%-85.7% | ||
Weighted-average risk-free interest rate | 1.31% | 2.32% | ||
Expected term (in years) | 6.0 | 6.0 |
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | — | $ | — | |||||||||
Options granted in 2020 | 39,728 | $ | 17.18 | 10.0 years | ||||||||
Outstanding at March 31, 2020 | 39,728 | $ | 17.18 | 10.0 years | ||||||||
Vested or expected to vest at March 31, 2020 | 39,728 | $ | 17.18 | |||||||||
Exercisable at March 31, 2020 | — | $ | — | |||||||||
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 0 | $ | 0 | |||||||||
Options granted in 2020 | 39,728 | $ | 17.18 | 9.5 years | ||||||||
Outstanding at September 30, 2020 | 39,728 | $ | 17.18 | 9.5 years | ||||||||
Vested or expected to vest at September 30, 2020 | 39,728 | $ | 17.18 | |||||||||
Exercisable at September 30, 2020 | 0 | $ | 0 | |||||||||
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | — | $ | — | |||||||||
Time based RSUs granted in 2020 | 274,410 | $ | 16.01 | 10.0 years | ||||||||
Outstanding at March 31, 2020 | 274,410 | $ | 16.01 | 10.0 years | ||||||||
Vested or expected to vest at March 31, 2020 | 274,410 | $ | 16.01 | |||||||||
Exercisable at March 31, 2020 | — | $ | — | |||||||||
Number of Shares | Weighted- Average Grant Fair | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 0 | $ | 0 | |||||||||
Time based RSUs granted in 2020 | 274,410 | $ | 16.01 | 2.6 years | ||||||||
Time based RSUs cancelled in 2020 | (15,064 | ) | $ | 15.81 | 2.5 years | |||||||
Outstanding at September 30, 2020 | 259,346 | $ | 16.01 | 2.6 years | ||||||||
Vested or expected to vest at September 30, 2020 | 259,346 | $ | 16.01 | |||||||||
Exercisable at September 30, 2020 | 0 | $ | 0 | |||||||||
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 6,039,945 | $ | 16.81 | 7.0 years | ||||||||
Options granted | 656,433 | $ | 23.94 | 9.9 years | ||||||||
Options exercised | (211,961 | ) | $ | 7.81 | 4.0 years | |||||||
Options canceled or expired | (115,756 | ) | $ | 16.01 | 8.8 years | |||||||
Outstanding at March 31, 2020 | 6,368,661 | $ | 17.86 | 7.1 years | ||||||||
Vested or expected to vest at March 31, 2020 | 6,368,661 | $ | 17.86 | |||||||||
Exercisable at March 31, 2020 | 3,869,771 | $ | 18.95 | 6.0 years | ||||||||
Number of Shares | Weighted- Average Exercise Price | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 6,039,945 | $ | 16.81 | 7.0 years | ||||||||
Options granted | 742,509 | $ | 23.85 | 9.4 years | ||||||||
Options exercised | (696,936 | ) | $ | 12.79 | 4.8 years | |||||||
Options canceled or expired | (161,111 | ) | $ | 21.70 | 7.9 years | |||||||
Outstanding at September 30, 2020 | 5,924,407 | $ | 18.03 | 6.8 years | ||||||||
Vested or expected to vest at September 30, 2020 | 5,924,407 | $ | 18.03 | |||||||||
Exercisable at September 30, 2020 | 3,620,984 | $ | 18.85 | 5.7 years | ||||||||
Number of Shares | Weighted-Average Grant Date Fair Value Per Share | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 1,268,679 | $ | 13.60 | 1.7 years | ||||||||
Time based RSUs granted in 2020 | 698,336 | $ | 23.94 | 2.9 years | ||||||||
Time based RSUs vested in 2020 | (466,657 | ) | $ | 13.82 | 1.3 years | |||||||
Time based RSUs cancelled in 2020 | (79,371 | ) | $ | 16.25 | 1.9 years | |||||||
Outstanding at March 31, 2020 | 1,420,987 | $ | 18.46 | 2.4 years | ||||||||
Number of Shares | Weighted-Average Grant Date Fair Value Per Share | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 1,268,679 | $ | 13.60 | 1.7 years | ||||||||
Time based RSUs granted in 2020 | 728,596 | $ | 23.05 | 2.7 years | ||||||||
Time based RSUs vested in 2020 | (506,546 | ) | $ | 13.78 | 0.9 years | |||||||
Time based RSUs cancelled in 2020 | (90,559 | ) | $ | 17.03 | 1.5 years | |||||||
Outstanding at September 30, 2020 | 1,400,170 | $ | 18.69 | 1.9 years | ||||||||
Number of Shares | Weighted-Average Grant Date Fair Value Per Share | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 67,080 | $ | 17.08 | 0.2 years | ||||||||
Milestone RSUs and TSR RSUs granted in 2020 | 86,044 | $ | 33.47 | 2.9 years | ||||||||
Milestone RSUs and TSR RSUs vested in 2020 | (67,080 | ) | $ | 17.08 | 0.2 years | |||||||
Outstanding at March 31, 2020 | 86,044 | $ | 33.47 | 2.9 years | ||||||||
Number of Shares | Weighted-Average Grant Date Fair Value Per Share | Weighted- Average Contractual Life | ||||||||||
Outstanding at December 31, 2019 | 67,080 | $ | 17.08 | 0.2 years | ||||||||
Milestone RSUs and TSR RSUs granted in 2020 | 86,044 | $ | 32.56 | 2.4 years | ||||||||
Milestone RSUs and TSR RSUs vested in 2020 | (67,080 | ) | $ | 17.08 | 0.2 years | |||||||
Outstanding at September 30, 2020 | 86,044 | $ | 32.56 | 2.4 years | ||||||||
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
For the Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
(Unaudited) | ||||||||
Revenues | ||||||||
Product sales, net | $ | 882 | $ | — | ||||
Grant revenue | 201 | — | ||||||
Total revenues, net | 1,083 | — | ||||||
Expenses | ||||||||
Cost of product sales | 69 | — | ||||||
Research and development | 16,003 | 24,991 | ||||||
General and administrative | 34,097 | 11,705 | ||||||
Total costs and expenses | 50,169 | 36,696 | ||||||
Loss from operations | (49,086 | ) | (36,696 | ) | ||||
Interest income | 1,678 | 1,860 | ||||||
Income tax expense | (3 | ) | — | |||||
Net loss | $ | (47,411 | ) | $ | (34,836 | ) | ||
For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Revenues | ||||||||||||||||
Product sales, net | $ | 7,368 | $ | — | $ | 10,127 | $ | — | ||||||||
Grant revenue | — | — | 232 | — | ||||||||||||
Total revenues, net | 7,368 | — | 10,359 | — | ||||||||||||
Expenses | ||||||||||||||||
Cost of product sales | 556 | — | 754 | — | ||||||||||||
Research and development | 10,275 | 21,340 | 51,484 | 70,059 | ||||||||||||
Selling, general and administrative | 52,474 | 15,036 | 128,015 | 42,184 | ||||||||||||
Total costs and expenses | 63,305 | 36,376 | 180,253 | 112,243 | ||||||||||||
Loss from operations | (55,937 | ) | (36,376 | ) | (169,894 | ) | (112,243 | ) | ||||||||
Interest income | 753 | 1,514 | 3,591 | 5,106 | ||||||||||||
Income tax expense | — | — | (3 | ) | (2 | ) | ||||||||||
Net loss | $ | (55,184 | ) | $ | (34,862 | ) | $ | (166,306 | ) | $ | (107,139 | ) | ||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
External costs | $ | 9,007 | $ | 17,809 | ||||
Internal costs | 6,996 | 7,182 | ||||||
Total research and development expenses | $ | 16,003 | $ | 24,991 | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
External costs | 2,815 | 14,372 | 29,897 | 48,302 | ||||||||||||
Internal costs | 7,460 | 6,968 | 21,587 | 21,757 | ||||||||||||
Total research and development expenses | $ | 10,275 | $ | 21,340 | $ | 51,484 | $ | 70,059 | ||||||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Lumateperone costs | $ | 7,046 | $ | 14,489 | ||||
Manufacturing costs | 2,673 | 5,860 | ||||||
Stock based compensation | 2,300 | 2,408 | ||||||
Other projects and overhead | 3,984 | 2,234 | ||||||
Total research and development expenses | $ | 16,003 | $ | 24,991 | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Lumateperone costs | 4,360 | 10,515 | 30,402 | 32,282 | ||||||||||||
Manufacturing costs | 160 | 3,061 | 3,455 | 14,920 | ||||||||||||
Share-based compensation | 2,748 | 2,024 | 7,789 | 6,785 | ||||||||||||
Other projects and overhead | 3,007 | 5,740 | 9,838 | 16,072 | ||||||||||||
Total research and development expenses | $ | 10,275 | $ | 21,340 | $ | 51,484 | $ | 70,059 | ||||||||
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 |
Exhibit Number | Exhibit Description | Filed Herewith | Incorporated by Reference herein from Form or | Filing Date | SEC File/ Reg. Number | ||||||||||||||
Master Services Agreement, effective as of January 10, 2017, by and between ITI Limited and Lonza Ltd. | X | ||||||||||||||||||
31.1 | X | ||||||||||||||||||
31.2 | X | ||||||||||||||||||
32 | X | ||||||||||||||||||
101 | The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended | X | |||||||||||||||||
104 | Cover Page Interactive | X |
* | Certain confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. |
INTRA-CELLULAR THERAPIES, INC. | ||||||||
Date: November 9, 2020 | ||||||||
By: | /s/ Sharon Mates, Ph.D. | |||||||
Sharon Mates, Ph.D. | ||||||||
Chairman, President and Chief Executive Officer | ||||||||
Date: November 9, 2020 | ||||||||
By: | /s/ Lawrence J. Hineline | |||||||
Lawrence J. Hineline | ||||||||
Senior Vice President of Finance and Chief Financial Officer |