☒ | 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 | 27-4825712 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||
Common Stock, par value $0.001 per share | GBT | The NASDAQ Global Select Market |
Large accelerated filer | ☒ | Accelerated filer | ||||
☐ | ||||||
Non-accelerated filer | ☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
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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 | $ | 315,525 | $ | 302,237 | ||||
Short-term marketable securities | 215,295 | 307,732 | ||||||
Accounts receivable, net | 4,578 | 2,637 | ||||||
Inventories | 14,927 | 1,277 | ||||||
Prepaid expenses and other current assets | 14,144 | 14,114 | ||||||
Total current assets | 564,469 | 627,997 | ||||||
Property and equipment, net | 37,329 | 27,113 | ||||||
Long-term marketable securities | 84,378 | 85,030 | ||||||
Operating lease right-of-use assets | 52,082 | 52,775 | ||||||
Restricted cash | 2,395 | 2,395 | ||||||
Other assets, noncurrent | 493 | 789 | ||||||
Total assets | $ | 741,146 | $ | 796,099 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 13,696 | $ | 10,621 | ||||
Accrued liabilities | 34,562 | 41,358 | ||||||
Accrued compensation | 11,269 | 17,578 | ||||||
Other liabilities, current | 2,721 | 1,896 | ||||||
Total current liabilities | 62,248 | 71,453 | ||||||
Long-term debt | 73,688 | 73,559 | ||||||
Operating lease liabilities, noncurrent | 81,638 | 72,359 | ||||||
Other liabilities, noncurrent | — | 34 | ||||||
Total liabilities | 217,574 | 217,405 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of March 31, 2020 ( and December 31, 2019; 0 shares issued and outstandingunaudited ) | — | — | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2020 (unaudited) and December 31, 2019, respectively; 60,886,371 and 60,644,380 shares issued and outstanding as of March 31, 2020 (unaudited) and December 31, 2019, respectively | 61 | 61 | ||||||
Additional paid-in capital | 1,334,238 | 1,316,795 | ||||||
Accumulated other comprehensive income | 1,215 | 754 | ||||||
Accumulated deficit | (811,942 | ) | (738,916 | ) | ||||
Total stockholders’ equity | 523,572 | 578,694 | ||||||
Total liabilities and stockholders’ equity | $ | 741,146 | $ | 796,099 | ||||
March 31, 2021 | December 31, 2020 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 445,310 | $ | 494,766 | ||||
Short-term marketable securities | 36,736 | 66,126 | ||||||
Accounts receivable, net | 18,265 | 17,500 | ||||||
Inventories | 42,267 | 40,223 | ||||||
Prepaid expenses and other current assets | 15,554 | 13,548 | ||||||
Total current assets | 558,132 | 632,163 | ||||||
Property and equipment, net | 38,050 | 37,882 | ||||||
Operating lease right-of-use | 50,085 | 50,722 | ||||||
Restricted cash | 2,420 | 2,436 | ||||||
Other assets, noncurrent | 1,211 | 799 | ||||||
Total assets | $ | 649,898 | $ | 724,002 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 10,376 | $ | 19,078 | ||||
Accrued liabilities | 28,845 | 31,133 | ||||||
Accrued compensation | 14,709 | 23,985 | ||||||
Operating lease liabilities, current | 5,037 | 4,836 | ||||||
Total current liabilities | 58,967 | 79,032 | ||||||
Long-term debt | 149,052 | 148,815 | ||||||
Operating lease liabilities, noncurrent | 77,862 | 79,176 | ||||||
Other liabilities, noncurrent | 822 | 822 | ||||||
Total liabilities | 286,703 | 307,845 | ||||||
Commitments and contingencies | 0 | 0 | ||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of March 31, 2021 (unaudited) and December 31, 2020; 0 shares issued and outstanding | 0— | 0— | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of March 31, 2021 (unaudited) and December 31, 2020, respectively; 62,240,050 and 61,898,090 shares issued and outstanding as of March 31, 2021 (unaudited) and December 31, 2020, respectively | 62 | 62 | ||||||
Additional paid-in capital | 1,424,411 | 1,402,262 | ||||||
Accumulated other comprehensive income | 121 | 302 | ||||||
Accumulated deficit | (1,061,399 | ) | (986,469 | ) | ||||
Total stockholders’ equity | 363,195 | 416,157 | ||||||
Total liabilities and stockholders’ equity | $ | 649,898 | $ | 724,002 | ||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Product sales, net | $ | 14,118 | $ | — | ||||
Costs and operating expenses: | ||||||||
Cost of sales | 135 | — | ||||||
Research and development | 39,773 | 34,468 | ||||||
Selling, general and administrative | 47,662 | 18,055 | ||||||
Total costs and operating expenses | 87,570 | 52,523 | ||||||
Loss from operations | (73,452 | ) | (52,523 | ) | ||||
Other income (expense): | ||||||||
Interest income | 2,856 | 3,831 | ||||||
Interest expenses | (2,314 | ) | (181 | ) | ||||
Other expenses, net | (116 | ) | (50 | ) | ||||
Total other income, net | 426 | 3,600 | ||||||
Net loss | (73,026 | ) | (48,923 | ) | ||||
Other comprehensive income: | ||||||||
Net unrealized gain on marketable securities, net of tax | 461 | 624 | ||||||
Comprehensive loss | $ | (72,565 | ) | $ | (48,299 | ) | ||
Basic and diluted net loss per common share | $ | (1.20 | ) | $ | (0.87 | ) | ||
Weighted-average number of shares used in computing basic and diluted net loss per common share | 60,787,710 | 56,231,587 | ||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Product sales, net | $ | 39,043 | $ | 14,118 | ||||
Costs and operating expenses: | ||||||||
Cost of sales | 584 | 135 | ||||||
Research and development | 50,857 | 39,773 | ||||||
Selling, general and administrative | 58,966 | 47,662 | ||||||
Total costs and operating expenses | 110,407 | 87,570 | ||||||
Loss from operations | (71,364 | ) | (73,452 | ) | ||||
Other income (expense): | ||||||||
Interest income | 329 | 2,856 | ||||||
Interest expenses | (3,689 | ) | (2,314 | ) | ||||
Other expenses, net | (206 | ) | (116 | ) | ||||
Total other income (expense), net | (3,566 | ) | 426 | |||||
Net loss | (74,930 | ) | (73,026 | ) | ||||
Other comprehensive income: | ||||||||
Net unrealized gain (loss) on marketable securities, net of tax | (181 | ) | 461 | |||||
Comprehensive loss | $ | (75,111 | ) | $ | (72,565 | ) | ||
Basic and diluted net loss per common share | $ | (1.21 | ) | $ | (1.20 | ) | ||
Weighted-average number of shares used in computing basic and diluted net loss per common share | 62,101,070 | 60,787,710 | ||||||
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2019 | 60,644,380 | $ | 61 | $ | 1,316,795 | $ | 754 | $ | (738,916 | ) | $ | 578,694 | ||||||||||||
Issuance of common stock upon exercise of stock options | 33,937 | — | 967 | — | — | 967 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 160,594 | — | (2,099 | ) | — | — | (2,099 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 47,460 | — | 1,870 | — | — | 1,870 | ||||||||||||||||||
Stock-based compensation expense | — | — | 16,705 | — | — | 16,705 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 461 | — | 461 | ||||||||||||||||||
Net loss | — | — | — | — | (73,026 | ) | (73,026 | ) | ||||||||||||||||
Balance at March 31, 2020 | 60,886,371 | $ | 61 | $ | 1,334,238 | $ | 1,215 | $ | (811,942 | ) | $ | 523,572 | ||||||||||||
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2020 | 61,898,090 | $ | 62 | $ | 1,402,262 | $ | 302 | $ | (986,469 | ) | $ | 416,157 | ||||||||||||
Issuance of common stock upon exercise of stock options | 47,763 | — | 1,110 | — | — | 1,110 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 229,087 | — | (1,897 | ) | — | — | (1,897 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 65,110 | — | 2,558 | — | — | 2,558 | ||||||||||||||||||
Stock-based compensation | — | — | 20,378 | — | — | 20,378 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | (181 | ) | — | (181 | ) | ||||||||||||||||
Net loss | — | — | — | — | (74,930 | ) | (74,930 | ) | ||||||||||||||||
Balance at March 31, 2021 | 62,240,050 | $ | 62 | $ | 1,424,411 | $ | 121 | $ | (1,061,399 | ) | $ | 363,195 | ||||||||||||
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2018 | 55,640,299 | $ | 56 | $ | 1,044,941 | $ | (48 | ) | $ | (472,150 | ) | $ | 572,799 | |||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 511,363 | — | 21,246 | — | — | 21,246 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 52,288 | — | 817 | — | — | 817 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 78,155 | — | (686 | ) | — | — | (686 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 30,745 | — | 1,128 | — | — | 1,128 | ||||||||||||||||||
Vesting of restricted stock purchases | 24,195 | — | 80 | — | — | 80 | ||||||||||||||||||
Stock-based compensation expense | — | — | 9,453 | — | — | 9,453 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 624 | — | 624 | ||||||||||||||||||
Net loss | — | — | — | — | (48,923 | ) | (48,923 | ) | ||||||||||||||||
Balance at March 31, 2019 | 56,337,045 | $ | 56 | $ | 1,076,979 | $ | 576 | $ | (521,073 | ) | $ | 556,538 | ||||||||||||
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||
Shares | Amount | |||||||||||||||||||||||
Balance at December 31, 2019 | 60,644,380 | $ | 61 | $ | 1,316,795 | $ | 754 | $ | (738,916 | ) | $ | 578,694 | ||||||||||||
Issuance of common stock upon exercise of stock options | 33,937 | — | 967 | — | — | 967 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 160,594 | — | (2,099 | ) | — | — | (2,099 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 47,460 | — | 1,870 | — | — | 1,870 | ||||||||||||||||||
Stock-based compensation | — | — | 16,705 | — | — | 16,705 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 461 | — | 461 | ||||||||||||||||||
Net loss | — | — | — | — | (73,026 | ) | (73,026 | ) | ||||||||||||||||
Balance at March 31, 2020 | 60,886,371 | $ | 61 | $ | 1,334,238 | $ | 1,215 | $ | (811,942 | ) | $ | 523,572 | ||||||||||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | (73,026 | ) | $ | (48,923 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 2,238 | 2,094 | ||||||
Amortization (accretion) of premium (discount) on marketable securities | (101 | ) | (565 | ) | ||||
Non-cash interest expense | 412 | — | ||||||
Amortization of operating lease right-of-use assets | 693 | 100 | ||||||
Stock-based compensation | 16,367 | 9,453 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivables | (1,941 | ) | — | |||||
Inventories | (13,218 | ) | — | |||||
Prepaid expenses and other assets | (147 | ) | 49 | |||||
Accounts payable | 2,567 | 1,272 | ||||||
Accrued liabilities | (6,766 | ) | 887 | |||||
Accrued compensation | (6,309 | ) | (4,407 | ) | ||||
Operating lease liabilities | 1,762 | (276 | ) | |||||
Other liabilities | (1,153 | ) | — | |||||
Net cash used in operating activities | (78,622 | ) | (40,316 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | (2,524 | ) | (56 | ) | ||||
Purchase of marketable securities | (57,936 | ) | (164,177 | ) | ||||
Maturities of marketable securities | 151,586 | 63,582 | ||||||
Net cash provided by (used in) investing activities | 91,126 | (100,651 | ) | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from issuance of common stock in public offering, net | — | 21,207 | ||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 2,968 | 1,925 | ||||||
Payments of debt issuance costs | (85 | ) | — | |||||
Tax paid related to net share settlement of equity awards | (2,099 | ) | (686 | ) | ||||
Net cash provided by financing activities | 784 | 22,446 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 13,288 | (118,521 | ) | |||||
Cash, cash equivalents and restricted cash at beginning of period | 304,632 | 277,752 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 317,920 | $ | 159,231 | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||||||||
Leasehold improvements paid for by landlord | $ | 9,461 | $ | — | ||||
Accrued purchase of property and equipment | $ | 563 | $ | 146 | ||||
Accrued issuance costs | $ | (85 | ) | $ | (41 | ) | ||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | (74,930 | ) | $ | (73,026 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 1,404 | 2,238 | ||||||
Amortization (accretion) of premium (discount) on marketable securities | 75 | (101 | ) | |||||
Non-cash interest expense | 237 | 412 | ||||||
Amortization of operating lease right-of-use | 637 | 693 | ||||||
Stock-based compensation | 19,948 | 16,367 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivables | (765 | ) | (1,941 | ) | ||||
Inventories | (1,569 | ) | (13,218 | ) | ||||
Prepaid expenses and other assets, current | (2,041 | ) | (147 | ) | ||||
Other assets, non-current | (415 | ) | — | |||||
Accounts payable | (8,544 | ) | 2,567 | |||||
Accrued liabilities | (2,904 | ) | (6,766 | ) | ||||
Accrued compensation | (9,276 | ) | (6,309 | ) | ||||
Operating lease liabilities | (1,113 | ) | 1,762 | |||||
Other liabilities | — | (1,153 | ) | |||||
Net cash used in operating activities | (79,256 | ) | (78,622 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | (1,130 | ) | (2,524 | ) | ||||
Purchase of marketable securities | — | (57,936 | ) | |||||
Maturities of marketable securities | 29,134 | 151,586 | ||||||
Net cash provided by investing activities | 28,004 | 91,126 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 3,703 | 2,968 | ||||||
Payments of debt issuance costs | (26 | ) | (85 | ) | ||||
Tax paid related to net share settlement of equity awards | (1,897 | ) | (2,099 | ) | ||||
Net cash provided by financing activities | 1,780 | 784 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | (49,472 | ) | 13,288 | |||||
Cash, cash equivalents and restricted cash at beginning of period | 497,202 | 304,632 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 447,730 | $ | 317,920 | ||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | ||||||||
Cash paid for interest | $ | 3,375 | $ | 1,706 | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||||||||
Leasehold improvements paid for by landlord | $ | — | $ | 9,461 | ||||
Accrued purchase of property and equipment | $ | 484 | $ | 563 | ||||
Accrued issuance costs | $ | (26 | ) | $ | (85 | ) | ||
RECONCILIATION OF CASH, CASH EQUIVALENTS, AND RESTRICTED CASH TO THE CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
Cash, cash equivalents | $ | 445,310 | $ | 315,525 | ||||
Restricted cash | 2,420 | 2,395 | ||||||
Total cash and cash equivalents and restricted cash | $ | 447,730 | $ | 317,920 | ||||
March 31, 2020 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 294,863 | $ | 294,863 | $ | — | $ | |||||||||
Corporate debt securities | 118,390 | — | 118,390 | — | ||||||||||||
U.S. government agency securities | 79,579 | — | 79,579 | — | ||||||||||||
Certificates of deposits | 5,808 | — | 5,808 | — | ||||||||||||
U.S. government securities | 95,896 | — | 95,896 | — | ||||||||||||
Total financial assets | $ | 594,536 | $ | 294,863 | $ | 299,673 | $ | — | ||||||||
March 31, 2021 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 389,448 | $ | 389,448 | $ | — | $ | — | ||||||||
Corporate debt securities | 19,639 | — | 19,639 | — | ||||||||||||
U.S. government agency securities | 6,802 | — | 6,802 | — | ||||||||||||
Certificates of deposits | 241 | — | 241 | — | ||||||||||||
U.S. government securities | 10,054 | — | 10,054 | — | ||||||||||||
Total financial assets | $ | 426,184 | $ | 389,448 | $ | 36,736 | $ | — | ||||||||
December 31, 2019 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 250,535 | $ | 250,535 | $ | — | $ | |||||||||
Corporate debt securities | 152,149 | — | 152,149 | — | ||||||||||||
U.S. government agency securities | 95,032 | — | 95,032 | — | ||||||||||||
Certificates of deposits | 6,282 | — | 6,282 | — | ||||||||||||
U.S. government securities | 140,244 | — | 140,244 | — | ||||||||||||
Total financial assets | $ | 644,242 | $ | 250,535 | $ | 393,707 | $ | — | ||||||||
December 31, 2020 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 486,174 | $ | 486,174 | $ | — | $ | — | ||||||||
Corporate debt securities | 29,804 | — | 29,804 | — | ||||||||||||
U.S. government agency securities | 15,943 | — | 15,943 | — | ||||||||||||
Certificates of deposits | 243 | — | 243 | — | ||||||||||||
U.S. government securities | 20,136 | — | 20,136 | — | ||||||||||||
Total financial assets | $ | 552,300 | $ | 486,174 | $ | 66,126 | $ | — | ||||||||
March 31, 2020 | December 31, 2019 | |||||||||||||||||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 294,863 | $ | — | $ | — | $ | 294,863 | $ | 250,535 | $ | — | $ | — | $ | 250,535 | ||||||||||||||||
Corporate debt securities | 118,187 | 287 | (84 | ) | 118,390 | 151,773 | 384 | (8 | ) | 152,149 | ||||||||||||||||||||||
U.S. government agency securities | 79,417 | 181 | (19 | ) | 79,579 | 94,963 | 73 | (4 | ) | 95,032 | ||||||||||||||||||||||
Certificates of deposits | 5,766 | 42 | — | 5,808 | 6,239 | 43 | — | 6,282 | ||||||||||||||||||||||||
U.S. government securities | 95,088 | 808 | — | 95,896 | 139,978 | 266 | — | 140,244 | ||||||||||||||||||||||||
Total | $ | 593,321 | $ | 1,318 | $ | (103 | ) | $ | 594,536 | $ | 643,488 | $ | 766 | $ | (12 | ) | $ | 644,242 | ||||||||||||||
March 31, 2021 | December 31, 2020 | |||||||||||||||||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||||||||||||
Money market funds | $ | 389,448 | $ | — | $ | — | $ | 389,448 | $ | 486,174 | $ | — | $ | — | $ | 486,174 | ||||||||||||||||
Corporate debt securities | 19,563 | 76 | — | 19,639 | 29,641 | 163 | — | 29,804 | ||||||||||||||||||||||||
U.S. government agency securities | 6,800 | 2 | — | 6,802 | 15,906 | 37 | — | 15,943 | ||||||||||||||||||||||||
Certificates of deposits | 240 | 1 | — | 241 | 241 | 2 | — | 243 | ||||||||||||||||||||||||
U.S. government securities | 10,012 | 42 | — | 10,054 | 20,036 | 100 | — | 20,136 | ||||||||||||||||||||||||
Total | $ | 426,063 | $ | 121 | $ | — | $ | 426,184 | $ | 551,998 | $ | 302 | $ | — | $ | 552,300 | ||||||||||||||||
March 31, 2020 | December 31, 2019 | |||||||
Cash and cash equivalents | $ | 294,863 | $ | 251,480 | ||||
Short-term marketable securities | 215,295 | 307,732 | ||||||
Long-term marketable securities | 84,378 | 85,030 | ||||||
Total | $ | 594,536 | $ | 644,242 | ||||
March 31, 2021 | December 31, 2020 | |||||||
Cash and cash equivalents | $ | 389,448 | $ | 486,174 | ||||
Short-term marketable securities | 36,736 | 66,126 | ||||||
Total | $ | 426,184 | $ | 552,300 | ||||
March 31, 2020 | December 31, 2019 | |||||||
Raw materials | $ | 7,141 | $ | 700 | ||||
Work-in-process | 7,217 | 525 | ||||||
Finished goods | 569 | 52 | ||||||
Total inventories | $ | 14,927 | $ | 1,277 | ||||
March 31, 2021 | December 31, 2020 | |||||||
Raw materials | $ | 10,632 | $ | 11,273 | ||||
Work-in-process | 28,656 | 26,994 | ||||||
Finished goods | 2,979 | 1,956 | ||||||
Total inventories | $ | 42,267 | $ | 40,223 | ||||
March 31, 2020 | December 31, 2019 | |||||||
Laboratory equipment | $ | 8,472 | $ | 8,314 | ||||
Computer equipment | 2,224 | 2,224 | ||||||
Leasehold improvements | 13,785 | 13,785 | ||||||
Construction-in-progress | 31,679 | 19,289 | ||||||
Total property and equipment | 56,160 | 43,612 | ||||||
Less: accumulated depreciation and amortization | (18,831 | ) | (16,499 | ) | ||||
Property and equipment, net | $ | 37,329 | $ | 27,113 | ||||
March 31, 2021 | December 31, 2020 | |||||||
Laboratory equipment | $ | 12,264 | $ | 11,922 | ||||
Computer equipment | 3,024 | 3,023 | ||||||
Leasehold improvements | 32,281 | 32,281 | ||||||
Construction-in-progress | 1,788 | 517 | ||||||
Total property and equipment | 49,357 | 47,743 | ||||||
Less: accumulated depreciation and amortization | (11,307 | ) | (9,861 | ) | ||||
Property and equipment, net | $ | 38,050 | $ | 37,882 | ||||
March 31, 2020 | December 31, 2019 | |||||||
Accrued research and development costs | $ | 9,659 | $ | 26,480 | ||||
Accrued manufacturing costs | 18,160 | 9,466 | ||||||
Accrued professional and consulting services | 4,262 | 4,564 | ||||||
Accrued sales deductions | 1,998 | 529 | ||||||
Other | 483 | 319 | ||||||
Total accrued liabilities | $ | 34,562 | $ | 41,358 | ||||
March 31, 2020 | December 31, 2019 | |||||||
Operating lease liabilities, current | $ | 2,691 | $ | 1,866 | ||||
Other payable | 30 | 30 | ||||||
Total other liabilities, current | $ | 2,721 | $ | 1,896 | ||||
March 31, 2021 | December 31, 2020 | |||||||
Accrued research and development costs | $ | 8,121 | $ | 10,677 | ||||
Accrued manufacturing costs | 7,631 | 9,125 | ||||||
Accrued professional and consulting services | 5,199 | 4,107 | ||||||
Accrued sales deductions | 7,010 | 6,405 | ||||||
Other | 884 | 819 | ||||||
Total accrued liabilities | $ | 28,845 | $ | 31,133 | ||||
Year ending December 31, | Amount | |||
2020 (nine months) | $ | 5,063 | ||
2021 | 6,750 | |||
2022 | 6,750 | |||
2023 | 31,406 | |||
2024 | 29,156 | |||
2025 | 26,906 | |||
Total minimum payments | 106,031 | |||
Less amount representing interest | (29,531 | ) | ||
Less amount representing Paydown Fee | (1,500 | ) | ||
Long-term debt, gross | 75,000 | |||
Discount on notes payable | (1,418 | ) | ||
Accretion of Paydown Fee | 106 | |||
Long-term debt | $ | 73,688 | ||
2021 (nine months) | 10,125 | |||
2022 | 13,500 | |||
2023 | 62,813 | |||
2024 | 58,313 | |||
2025 | 53,812 | |||
Total minimum payments | 198,563 | |||
Less amount representing interest | (45,563 | ) | ||
Less amount representing Paydown Fee | (3,000 | ) | ||
Long-term debt, gross | 150,000 | |||
Discount on notes payable | (1,539 | ) | ||
Accretion of Paydown Fee | 591 | |||
Long-term debt | $ | 149,052 | ||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
ROU assets obtained in exchange for new operating lease upon adoption of ASC 842 | $ | — | $ | 14,177 | ||||
Cash paid for amounts included in the measurement of lease liabilities | 1,153 | 1,117 | ||||||
Weighted-average remaining lease term of operating leases (in years) | 10 | 8.7 | ||||||
Weighted-average discount rate of operating leases | 8.7 | % | 13.2 | % |
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Cash paid for amounts included in the measurement of lease liabilities | 2,904 | 1,153 | ||||||
Weighted-average remaining lease term of operating leases (in years) | 9.0 | 10 | ||||||
Weighted-average discount rate of operating leases | 8.66 | % | 8.66 | % |
Year ending December 31, | Amount | |||
2020 (nine months) | $ | 5,878 | (a) | |
2021 | 11,736 | |||
2022 | 12,116 | |||
2023 | 12,508 | |||
2024 | 12,913 | |||
2025 | 13,333 | |||
Thereafter | 61,035 | |||
Total lease payments | 129,519 | |||
Less: Imputed interest (b) | (45,190 | ) | ||
Present value of operating lease liabilities | $ | 84,329 | ||
Year ending December 31, | Amount | |||
2021 (nine months) | 8,937 | |||
2022 | 12,222 | |||
2023 | 12,584 | |||
2024 | 12,948 | |||
2025 | 13,368 | |||
Thereafter | 60,507 | |||
Total lease payments | 120,566 | |||
Less: Imputed interest | (37,667 | ) | ||
Present value of operating lease liabilities | $ | 82,899 | ||
Number of Options | Weighted- Average Exercise Price | |||||||
Outstanding — December 31, 2019 | 3,573,860 | $ | 36.24 | |||||
Options granted | 621,703 | 66.05 | ||||||
Options exercised | (33,937 | ) | 28.50 | |||||
Options canceled | (27,905 | ) | 47.16 | |||||
Outstanding — March 31, 2020 | 4,133,721 | $ | 40.72 | |||||
Number of Options | Weighted- Average Exercise Price | |||||||
Outstanding — December 31, 2020 | 3,327,330 | $ | 42.07 | |||||
Options granted | 576,768 | 44.48 | ||||||
Options exercised | (47,763 | ) | 23.24 | |||||
Options canceled | (41,493 | ) | 57.37 | |||||
Outstanding — March 31, 2021 | 3,814,842 | $ | 42.51 | |||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Expected term (in years) | 6.1 | 6.1 | ||||||
Volatility | 69.6%-69.9% | 71.6%-72.2% | ||||||
Risk-free interest rate | 1.4%-1.8% | 2.5%-2.6% | ||||||
Dividend yield | — | — |
Three Months Ended March 31, | ||||
2021 | 2020 | |||
Expected term (in years) | 5.8-6.1 | 6.1 | ||
Volatility | 72.6%-72.7% | 69.6%-69.9% | ||
Risk-free interest rate | 0.9%-1.0% | 1.4%-1.8% | ||
Dividend yield | 0 | 0 |
Number of RSUs | Weighted- Average Grant Date Fair Value | |||||||
Non-vested units — December 31, 2019 | 1,848,772 | $ | 49.19 | |||||
RSUs granted | 1,073,766 | 66.16 | ||||||
RSUs vested | (192,966 | ) | 45.68 | |||||
RSUs forfeited | (38,413 | ) | 48.18 | |||||
Non-vested units — March 31, 2020 | 2,691,159 | $ | 56.23 | |||||
Number of RSUs | Weighted- Average Grant Date Fair Value | |||||||
Non-vested units — December 31, 2020 | 2,210,356 | $ | 57.80 | |||||
RSUs granted | 1,255,399 | 44.87 | ||||||
RSUs vested | (267,629 | ) | 54.41 | |||||
RSUs forfeited | (94,999 | ) | 56.87 | |||||
Non-vested units — March 31, 2021 | 3,103,127 | $ | 52.89 | |||||
Stock Price Targets | Number of Units Allotted | |||
$109.20 | 82,940 | |||
$145.60 | 145,145 | |||
$182.00 | 186,615 |
Three Months Ended March 31, | ||||||||
20 20 | 2019 | |||||||
Research and development | $ | 5,350 | $ | 4,023 | ||||
Selling, general and administrative | 11,017 | 5,430 | ||||||
Total stock-based compensation expense | $ | 16,367 | $ | 9,453 | ||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Research and development | $ | 4,879 | $ | 5,350 | ||||
Selling, general and administrative | 15,069 | 11,017 | ||||||
Total stock-based compensation expense | $ | 19,948 | $ | 16,367 | ||||
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Options to purchase common stock | 4,133,721 | 3,813,995 | ||||||
Restricted stock subject to future vesting | — | 22,856 | ||||||
Restricted stock units | 2,691,159 | 1,626,127 | ||||||
Total | 6,824,880 | 5,462,978 | ||||||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Options to purchase common stock | 3,814,842 | 4,133,721 | ||||||
Restricted stock units | 3,517,827 | 2,691,159 | ||||||
Total | 7,332,669 | 6,824,880 | ||||||
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Three Months Ended March 31, | $ Change | % Change | ||||||||||||||
2020 | 2019 | |||||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Product sales, net | $ | 14,118 | $ | — | $ | 14,118 | * | |||||||||
Costs and operating expenses: | ||||||||||||||||
Cost of sales | 135 | — | 135 | * | ||||||||||||
Research and development | 39,773 | 34,468 | 5,305 | 15 | % | |||||||||||
Selling, general and administrative | 47,662 | 18,055 | 29,607 | 164 | % | |||||||||||
Total costs and operating expenses | 87,570 | 52,523 | 35,047 | 67 | % | |||||||||||
Loss from operations | (73,452 | ) | (52,523 | ) | (20,929 | ) | 40 | % | ||||||||
Interest income | 2,856 | 3,831 | (975 | ) | (25 | )% | ||||||||||
Interest expenses | (2,314 | ) | (181 | ) | (2,133 | ) | * | |||||||||
Other expenses, net | (116 | ) | (50 | ) | (66 | ) | 132 | % | ||||||||
Net loss | $ | (73,026 | ) | $ | (48,923 | ) | $ | (24,103 | ) | 49 | % | |||||
Three Months Ended March 31, | $ Change | % Change | ||||||||||||||
2021 | 2020 | |||||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Product sales, net | $ | 39,043 | $ | 14,118 | $ | 24,925 | 177 | % | ||||||||
Costs and operating expenses: | ||||||||||||||||
Cost of sales | 584 | 135 | 449 | 333 | % | |||||||||||
Research and development | 50,857 | 39,773 | 11,084 | 28 | % | |||||||||||
Selling, general and administrative | 58,966 | 47,662 | 11,304 | 24 | % | |||||||||||
Total costs and operating expenses | 110,407 | 87,570 | 22,837 | 26 | % | |||||||||||
Loss from operations | (71,364 | ) | (73,452 | ) | 2,088 | (3 | )% | |||||||||
Interest income | 329 | 2,856 | (2,527 | ) | (88 | )% | ||||||||||
Interest expenses | (3,689 | ) | (2,314 | ) | (1,375 | ) | 59 | % | ||||||||
Other expenses, net | (206 | ) | (116 | ) | (90 | ) | 78 | % | ||||||||
Net loss | $ | (74,930 | ) | $ | (73,026 | ) | $ | (1,904 | ) | 3 | % | |||||
Rebates, co-payment assistance, Medicare Part D coverage gap, product returns and distributor fees | Prompt payment discounts and chargebacks | Total | ||||||||||
Balances at December 31, 2019 | $ | 529 | $ | 113 | $ | 642 | ||||||
Provision related to current period sales | 1,543 | 339 | 1,882 | |||||||||
Credit or payments made during the period | (75 | ) | (280 | ) | (355 | ) | ||||||
Balance at March 31, 2020 | $ | 1,997 | $ | 172 | $ | 2,169 | ||||||
Rebates, co-payment assistance, Medicare Part D coverage gap, product returns and distributor fees | Prompt payment discounts and chargebacks | Total | ||||||||||
Balances at December 31, 2020 | $ | 6,405 | $ | 751 | $ | 7,156 | ||||||
Provision related to current period sales | 5,236 | 1,477 | 6,713 | |||||||||
Credit or payments made during the period | (4,631 | ) | (1,487 | ) | (6,118 | ) | ||||||
Balance at March 31, 2021 | $ | 7,010 | $ | 741 | $ | 7,751 | ||||||
Three Months Ended March 31, | $ Change | % Change | ||||||||||||||
2020 | 2019 | |||||||||||||||
Costs incurred by development program: | ||||||||||||||||
Oxbryta for the treatment of SCD | $ | 23,460 | $ | 27,725 | $ | (4,265 | ) | (15 | )% | |||||||
Other preclinical programs | 9,316 | 5,363 | 3,953 | 74 | % | |||||||||||
Inclacumab for the treatment of SCD | 6,997 | 1,380 | 5,617 | 407 | % | |||||||||||
Total research and development expenses | $ | 39,773 | $ | 34,468 | $ | 5,305 | 15 | % | ||||||||
Three Months Ended March 31, | $ Change | % Change | ||||||||||||||
2021 | 2020 | |||||||||||||||
Costs incurred by development program: | ||||||||||||||||
Oxbryta for the treatment of SCD | $ | 23,462 | $ | 23,460 | $ | 2 | * | |||||||||
Other preclinical programs | 17,274 | 9,316 | 7,958 | 85 | % | |||||||||||
Inclacumab for the treatment of SCD | 10,120 | 6,997 | 3,123 | 45 | % | |||||||||||
Total research and development expenses | $ | 50,857 | $ | 39,773 | $ | 11,084 | 28 | % | ||||||||
* | Change is not meaningful |
Three Months Ended March 31, | ||||||||
2020 | 2019 | |||||||
Cash used in operating activities | $ | (78,622 | ) | $ | (40,316 | ) | ||
Cash provided by (used in) investing activities | 91,126 | (100,651 | ) | |||||
Cash provided by financing activities | 784 | 22,446 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | 13,288 | $ | (118,521 | ) | |||
Three Months Ended March 31, | ||||||||
2021 | 2020 | |||||||
Cash used in operating activities | $ | (79,256 | ) | $ | (78,622 | ) | ||
Cash provided by investing activities | 28,004 | 91,126 | ||||||
Cash provided by financing activities | 1,780 | 784 | ||||||
Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (49,472 | ) | $ | 13,288 | |||
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Item 4. | Controls and Procedures |
Item 1. | Legal Proceedings |
Item 1A. | Risk |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
a) | Sales of Unregistered Securities |
b) | Use of Proceeds from our Initial Public Offering of Common Stock |
c) | Repurchases of Shares or of Company Equity Securities |
Item 3. | Defaults Upon Senior Securities |
Item 4. | Mine Safety Disclosures |
Item 5. | Other Information |
Item 6. | Exhibits |
Exhibit Number | Incorporated by Reference | Filed Herewith | ||||||||||||||||||
Exhibit Description | Form | Date | Number | |||||||||||||||||
3.1 | S-1/A | 7/31/2015 | 3.2 | |||||||||||||||||
3.2 | S-1/A | 7/31/2015 | 3.4 | |||||||||||||||||
4.1 | S-1/A | 7/31/2015 | 4.1 | |||||||||||||||||
10.1# | 8-K | 1/9/2020 | 10.1 | |||||||||||||||||
10.2# | 8-K | 1/9/2020 | 10.2 | |||||||||||||||||
10.3# | S-8 | 1/23/2020 | 99.1 | |||||||||||||||||
10.4# | S-8 | 1/23/2020 | 99.3 | |||||||||||||||||
10.5# | — | — | — | X | ||||||||||||||||
10.6# | — | — | — | X | ||||||||||||||||
31.1 | — | — | — | X | ||||||||||||||||
31.2 | — | — | — | X | ||||||||||||||||
32.1* | — | — | — | X | ||||||||||||||||
101.SCH | Inline XBRL Taxonomy Extension Schema Document | — | — | — | X | |||||||||||||||
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | — | — | — | X | |||||||||||||||
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | — | — | — | X | |||||||||||||||
101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document | — | — | — | X | |||||||||||||||
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | — | — | — | X | |||||||||||||||
104 | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.) | — | — | — | X |
* | The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the SEC and is not to be incorporated by reference into any filing of Global Blood Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form10-Q, irrespective of any general incorporation language contained in such filing. |
+ | Portions of this exhibit have been omitted as confidential information. |
# | Represents management compensation plan, contract or arrangement. |
Global Blood Therapeutics, Inc. |
Date: May | By: | /s/ Ted W. Love, M.D. | |||||||
Ted W. Love, M.D. President and Chief Executive Officer (Principal Executive Officer) | |||||||||
Date: May | By: | /s/ Jeffrey Farrow | |||||||
Jeffrey Farrow Chief Financial Officer (Principal Financial Officer) |