☒ | 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 6. | 64 | |||||
65 |
Item 1. | Financial Statements |
June 30, 2019 | December 31, 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 338,454 | $ | 275,357 | ||||
Short-term marketable securities | 320,098 | 202,177 | ||||||
Prepaid expenses and other current assets | 8,207 | 8,246 | ||||||
Total current assets | 666,759 | 485,780 | ||||||
Property and equipment, net | 12,345 | 14,981 | ||||||
Long-term marketable securities | 73,176 | 114,281 | ||||||
Operating lease r ight-of-use assets | 13,964 | — | ||||||
Restricted cash | 2,395 | 2,395 | ||||||
Other assets, noncurrent | 193 | 206 | ||||||
Total assets | $ | 768,832 | $ | 617,643 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 6,755 | $ | 6,046 | ||||
Accrued liabilities | 23,369 | 16,792 | ||||||
Accrued compensation | 8,241 | 10,036 | ||||||
Other liabilities, current | 1,348 | 899 | ||||||
Total current liabilities | 39,713 | 33,773 | ||||||
Operating lease liabilities, noncurrent | 24,048 | — | ||||||
Other liabilities, noncurrent | 881 | 11,071 | ||||||
Total liabilities | 64,642 | 44,844 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2019 (unaudited) and December 31, 2018; no shares issued and outstanding | — | — | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2019 (unaudited) and December 31, 2018, respectively; 59,906,199 and 55,640,299 shares issued and outstanding as of June 30, 2019 (unaudited) and December 31, 2018, respectively | 60 | 56 | ||||||
Additional paid-in capital | 1,281,333 | 1,044,941 | ||||||
Accumulated other comprehensive income (loss) | 1,191 | (48 | ) | |||||
Accumulated deficit | (578,394 | ) | (472,150 | ) | ||||
Total stockholders’ equity | 704,190 | 572,799 | ||||||
Total liabilities and stockholders’ equity | $ | 768,832 | $ | 617,643 | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 36,010 | $ | 31,573 | $ | 70,476 | $ | 61,517 | ||||||||
General and administrative | 24,794 | 10,914 | 42,849 | 23,665 | ||||||||||||
Total operating expenses | 60,804 | 42,487 | 113,325 | 85,182 | ||||||||||||
Loss from operations | (60,804 | ) | (42,487 | ) | (113,325 | ) | (85,182 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income, net | 3,546 | 2,115 | 7,196 | 3,287 | ||||||||||||
Other income (expenses), net | (63 | ) | 4 | (115 | ) | (29 | ) | |||||||||
Total other income, net | 3,483 | 2,119 | 7,081 | 3,258 | ||||||||||||
Net loss | (57,321 | ) | (40,368 | ) | (106,244 | ) | (81,924 | ) | ||||||||
Other comprehensive loss: | ||||||||||||||||
Net unrealized gain on marketable securities, net of tax | 615 | 82 | 1,239 | 94 | ||||||||||||
Comprehensive loss | $ | (56,706 | ) | $ | (40,286 | ) | $ | (105,005 | ) | $ | (81,830 | ) | ||||
Basic and diluted net loss per common share | $ | (1.01 | ) | $ | (0.78 | ) | $ | (1.88 | ) | $ | (1.65 | ) | ||||
Weighted-average number of shares used in computing basic and diluted net loss per common share | 56,539,760 | 51,742,904 | 56,386,560 | 49,767,633 | ||||||||||||
September 30, 2019 | December 31, 2018 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 267,604 | $ | 275,357 | ||||
Short-term marketable securities | 335,500 | 202,177 | ||||||
Prepaid expenses and other current assets | 12,699 | 8,246 | ||||||
Total current assets | 615,803 | 485,780 | ||||||
Property and equipment, net | 14,337 | 14,981 | ||||||
Long-term marketable securities | 80,000 | 114,281 | ||||||
Operating lease right-of-use assets | 13,845 | — | ||||||
Restricted cash | 2,395 | 2,395 | ||||||
Other assets, noncurrent | 968 | 206 | ||||||
Total assets | $ | 727,348 | $ | 617,643 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 7,135 | $ | 6,046 | ||||
Accrued liabilities | 22,198 | 16,792 | ||||||
Accrued compensation | 10,450 | 10,036 | ||||||
Other liabilities, current | 1,410 | 899 | ||||||
Total current liabilities | 41,193 | 33,773 | ||||||
Operating lease liabilities, noncurrent | 23,691 | — | ||||||
Other liabilities, noncurrent | 4,367 | 11,071 | ||||||
Total liabilities | 69,251 | 44,844 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ equity: | ||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of September 30, 2019 (unaudited) and December 31, 2018; 0 shares issued and outstanding | — | — | ||||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of September 30, 2019 (unaudited) and December 31, 2018, respectively; 60,208,293 and 55,640,299 shares issued and outstanding as of September 30, 2019 (unaudited) and December 31, 2018, respectively | 60 | 56 | ||||||
Additional paid-in capital | 1,300,000 | 1,044,941 | ||||||
Accumulated other comprehensive income (loss) | 978 | (48 | ) | |||||
Accumulated deficit | (642,941 | ) | (472,150 | ) | ||||
Total stockholders’ equity | 658,097 | 572,799 | ||||||
Total liabilities and stockholders’ equity | $ | 727,348 | $ | 617,643 |
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Loss | 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 | |||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 3,375,527 | 3 | 192,294 | — | — | 192,297 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options | 123,513 | 1 | 2,331 | — | — | 2,332 | |||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 47,258 | — | (1,297 | ) | — | — | (1,297 | ) | |||||||||||||||||
Vesting of restricted stock purchases | 22,856 | — | 78 | — | — | 78 | |||||||||||||||||||
Stock-based compensation expense | — | — | 10,948 | — | — | 10,948 | |||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 615 | — | 615 | |||||||||||||||||||
Net loss | — | — | — | — | (57,321 | ) | (57,321 | ) | |||||||||||||||||
Balance at June 30, 2019 | 59,906,199 | $ | 60 | $ | 1,281,333 | $ | 1,191 | $ | (578,394 | ) | $ | 704,190 | |||||||||||||
Common Stock | Additional Paid- In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity | |||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||
Balance at December 31, 2017 | 46,131,723 | $ | 46 | $ | 617,051 | $ | (336 | ) | $ | (297,957 | ) | $ | 318,804 | ||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 4,994,736 | 5 | 255,062 | — | — | 255,067 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options | 259,150 | 1 | 2,168 | — | — | 2,169 | |||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 143,400 | — | (5,404 | ) | — | — | (5,404 | ) | |||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 36,748 | — | 784 | — | — | 784 | |||||||||||||||||||
Vesting of restricted stock purchases | 71,246 | — | 105 | — | — | 105 | |||||||||||||||||||
Stock-based compensation expense | — | — | 7,784 | — | — | 7,784 | |||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 11 | — | 11 | |||||||||||||||||||
Net loss | — | — | — | — | (41,556 | ) | (41,556 | ) | |||||||||||||||||
Balance at March 31, 2018 | 51,637,003 | $ | 52 | $ | 877,550 | $ | (325 | ) | $ | (339,513 | ) | $ | 537,764 | ||||||||||||
Offering cost related to the December 2017 follow-on offerings | — | — | 52 | — | — | 52 | |||||||||||||||||||
Issuance of common stock upon exercise of stock options | 148,954 | — | 1,118 | — | — | 1,118 | |||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 10,123 | — | — | — | — | — | |||||||||||||||||||
Vesting of restricted stock purchases | 71,014 | — | 104 | — | — | 104 | |||||||||||||||||||
Stock-based compensation expense | — | — | 7,800 | — | — | 7,800 | |||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 83 | — | 83 | |||||||||||||||||||
Net loss | — | — | — | — | (40,368 | ) | (40,368 | ) | |||||||||||||||||
Balance at June 30, 2018 | 51,867,094 | $ | 52 | $ | 886,624 | $ | (242 | ) | $ | (379,881 | ) | $ | 506,553 | ||||||||||||
Six Months Ended June 30, | ||||||||
2019 | 2018 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | (106,244 | ) | $ | (81,924 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 4,187 | 1,342 | ||||||
Amortization (accretion) of premium (discount) on marketable securities | (1,204 | ) | 107 | |||||
Amortization of operating lease right-of-use assets | 212 | — | ||||||
Stock-based compensation | 20,401 | 15,584 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | 59 | (2,419 | ) | |||||
Accounts payable | 558 | (3,717 | ) | |||||
Accrued liabilities | 6,136 | 1,894 | ||||||
Accrued compensation | (1,795 | ) | (2,339 | ) | ||||
Operating lease liabilities | (563 | ) | — | |||||
Other liabilities | — | 572 | ||||||
Net cash used in operating activities | (78,253 | ) | (70,900 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | (548 | ) | (3,300 | ) | ||||
Purchase of marketable securities | (195,297 | ) | (112,558 | ) | ||||
Maturities of marketable securities | 120,923 | 76,778 | ||||||
Net cash used in investing activities | (74,922 | ) | (39,080 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from issuance of common stock in public offering, net of issuance costs | 213,989 | 255,119 | ||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 4,266 | 3,896 | ||||||
Tax paid related to net share settlement of equity awards | (1,983 | ) | (5,404 | ) | ||||
Net cash provided by financing activities | 216,272 | 253,611 | ||||||
Net increase in cash, cash equivalents and restricted cash | 63,097 | 143,631 | ||||||
Cash, cash equivalents and restricted cash at beginning of period | 277,752 | 199,378 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 340,849 | $ | 343,009 | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||||||||
Leasehold improvements paid for by landlord | $ | 851 | $ | — | ||||
Accrued purchase of property and equipment | $ | 147 | $ | (1,401 | ) | |||
Accrued offering costs | $ | 446 | $ | — | ||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 39,088 | $ | 33,026 | $ | 109,564 | $ | 94,543 | ||||||||
General and administrative | 29,654 | 12,450 | 72,503 | 36,115 | ||||||||||||
Total operating expenses | 68,742 | 45,476 | 182,067 | 130,658 | ||||||||||||
Loss from operations | (68,742 | ) | (45,476 | ) | (182,067 | ) | (130,658 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income, net | 4,226 | 2,480 | 11,422 | 5,768 | ||||||||||||
Other expenses, net | (31 | ) | (72 | ) | (146 | ) | (101 | ) | ||||||||
Total other income, net | 4,195 | 2,408 | 11,276 | 5,667 | ||||||||||||
Net loss | (64,547 | ) | (43,068 | ) | (170,791 | ) | (124,991 | ) | ||||||||
Other comprehensive loss: | ||||||||||||||||
Net unrealized gain (loss) on marketable securities, net of tax | (213 | ) | (139 | ) | 1,026 | (45 | ) | |||||||||
Comprehensive loss | $ | (64,760 | ) | $ | (43,207 | ) | $ | (169,765 | ) | $ | (125,036 | ) | ||||
Basic and diluted net loss per common share | $ | (1.07 | ) | $ | (0.83 | ) | $ | (2.96 | ) | $ | (2.47 | ) | ||||
Weighted-average number of shares used in computing basic and diluted net loss per common share | 60,098,093 | 52,050,232 | 57,637,318 | 50,536,860 |
Common Stock | Additional | Accumulated Other | Total | |||||||||||||||||||||
Shares | Amount | Paid- In Capital | Comprehensive Loss | Accumulated Deficit | Stockholders ’ Equity | |||||||||||||||||||
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 | ||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 3,375,527 | 3 | 192,294 | — | — | 192,297 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 123,513 | 1 | 2,331 | — | — | 2,332 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 47,258 | — | (1,297 | ) | — | — | (1,297 | ) | ||||||||||||||||
Vesting of restricted stock purchases | 22,856 | — | 78 | — | — | 78 | ||||||||||||||||||
Stock-based compensation expense | — | — | 10,948 | — | — | 10,948 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 615 | — | 615 | ||||||||||||||||||
Net loss | — | — | — | — | (57,321 | ) | (57,321 | ) | ||||||||||||||||
Balance at June 30, 2019 | 59,906,199 | $ | 60 | $ | 1,281,333 | $ | 1,191 | $ | (578,394 | ) | $ | 704,190 | ||||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 100,000 | — | 6,126 | — | — | 6,126 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 18,439 | — | 386 | — | — | 386 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 151,120 | — | (1,532 | ) | — | — | (1,532 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 32,535 | — | 1,234 | — | — | 1,234 | ||||||||||||||||||
Stock-based compensation expense | — | — | 12,453 | — | — | 12,453 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | (213 | ) | — | (213 | ) | ||||||||||||||||
Net loss | — | — | — | — | (64,547 | ) | (64,547 | ) | ||||||||||||||||
Balance at September 30, 2019 | 60,208,293 | $ | 60 | $ | 1,300,000 | $ | 978 | $ | (642,941 | ) | $ | 658,097 |
Common Stock | Additional | Accumulated Other | Total | |||||||||||||||||||||
Shares | Amount | Paid- In Capital | Comprehensive Loss | Accumulated Deficit | Stockholders ’ Equity | |||||||||||||||||||
Balance at December 31, 2017 | 46,131,723 | $ | 46 | $ | 617,051 | $ | (336 | ) | $ | (297,957 | ) | $ | 318,804 | |||||||||||
Issuance of common stock upon equity offerings, net of issuance costs | 4,994,736 | 5 | 255,062 | — | — | 255,067 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 259,150 | 1 | 2,168 | — | — | 2,169 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 143,400 | — | (5,404 | ) | — | — | (5,404 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 36,748 | — | 784 | — | — | 784 | ||||||||||||||||||
Vesting of restricted stock purchases | 71,246 | — | 105 | — | — | 105 | ||||||||||||||||||
Stock-based compensation expense | — | — | 7,784 | — | — | 7,784 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 11 | — | 11 | ||||||||||||||||||
Net loss | — | — | — | — | (41,556 | ) | (41,556 | ) | ||||||||||||||||
Balance at March 31, 2018 | 51,637,003 | $ | 52 | $ | 877,550 | $ | (325 | ) | $ | (339,513 | ) | $ | 537,764 | |||||||||||
Offering cost related to the December 2017 follow-on offerings | — | — | 52 | — | — | 52 | ||||||||||||||||||
Issuance of common stock upon exercise of stock options | 148,954 | — | 1,118 | — | — | 1,118 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 10,123 | — | — | — | — | — | ||||||||||||||||||
Vesting of restricted stock purchases | 71,014 | — | 104 | — | — | 104 | ||||||||||||||||||
Stock-based compensation expense | — | — | 7,800 | — | — | 7,800 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | 83 | — | 83 | ||||||||||||||||||
Net loss | — | — | — | — | (40,368 | ) | (40,368 | ) | ||||||||||||||||
Balance at June 30, 2018 | 51,867,094 | $ | 52 | $ | 886,624 | $ | (242 | ) | $ | (379,881 | ) | $ | 506,553 | |||||||||||
Issuance of common stock upon exercise of stock options | 119,174 | — | 1,792 | — | — | 1,792 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes | 84,045 | — | (849 | ) | — | — | (849 | ) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases | 24,283 | — | 863 | — | — | 863 | ||||||||||||||||||
Vesting of restricted stock purchases | 25,791 | — | 80 | — | — | 80 | ||||||||||||||||||
Stock-based compensation expense | — | — | 6,968 | — | — | 6,968 | ||||||||||||||||||
Net unrealized gain on marketable securities | — | — | — | (139 | ) | — | (139 | ) | ||||||||||||||||
Net loss | — | — | — | — | (43,068 | ) | (43,068 | ) | ||||||||||||||||
Balance at September 30, 2018 | 52,120,387 | $ | 52 | $ | 895,478 | $ | (381 | ) | $ | (422,949 | ) | $ | 472,200 | |||||||||||
Nine Months Ended September 30, | ||||||||
2019 | 2018 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net loss | $ | (170,791 | ) | $ | (124,991 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 6,294 | 2,509 | ||||||
Accretion of discount on marketable securities | (1,724 | ) | (226 | ) | ||||
Amortization of operating lease right-of-use assets | 332 | — | ||||||
Stock-based compensation | 32,854 | 22,552 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other assets | (5,217 | ) | (4,496 | ) | ||||
Accounts payable | 1,088 | (2,131 | ) | |||||
Accrued liabilities | 5,557 | 5,882 | ||||||
Accrued compensation | 415 | (1,400 | ) | |||||
Other current liabilities | (30 | ) | — | |||||
Operating lease liabilities | (858 | ) | — | |||||
Other liabilities | — | 499 | ||||||
Net cash used in operating activities | (132,080 | ) | (101,802 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | (1,198 | ) | (4,946 | ) | ||||
Purchase of marketable securities | (330,130 | ) | (259,631 | ) | ||||
Maturities of marketable securities | 233,837 | 108,707 | ||||||
Net cash used in investing activities | (97,491 | ) | (155,870 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceeds from issuance of common stock in public offering, net of issuance costs | 219,443 | 255,119 | ||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options | 5,890 | 6,722 | ||||||
Repurchases of unvested restricted stock | — | (8 | ) | |||||
Tax paid related to net share settlement of equity awards | (3,515 | ) | (6,253 | ) | ||||
Net cash provided by financing activities | 221,818 | 255,580 | ||||||
Net decrease in cash, cash equivalents and restricted cash | (7,753 | ) | (2,092 | ) | ||||
Cash, cash equivalents and restricted cash at beginning of period | 277,752 | 199,378 | ||||||
Cash, cash equivalents and restricted cash at end of period | $ | 269,999 | $ | 197,286 | ||||
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING INFORMATION: | ||||||||
Leasehold improvements paid for by landlord | $ | 4,367 | $ | — | ||||
Accrued purchase of property and equipment | $ | 76 | $ | (2,173 | ) | |||
December 31, 2018 | Adjustments Due to our Adoption of Topic 842 | January 1, 2019 | ||||||||||
Assets: | ||||||||||||
Operating lease ROU assets | $ | — | $ | 14,177 | $ | 14,177 | ||||||
Liabilities: | ||||||||||||
Operating lease liabilities, current as included in other liabilities, current | — | 1,176 | 1,176 | |||||||||
Deferred rent, current as included in other liabilities, current | 712 | (712 | ) | — | ||||||||
Operating lease liabilities, noncurrent | — | 24,754 | 24,754 | |||||||||
Deferred rent, noncurrent as included in other liabilities, noncurrent | 11,041 | (11,041 | ) | — |
June 30, 2019 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 333,452 | $ | 333,452 | $ | — | $ | — | ||||||||
Corporate debt securities | 134,311 | — | 134,311 | — | ||||||||||||
U.S. government agency securities | 112,367 | — | 112,367 | — | ||||||||||||
Certificates of deposits | 6,758 | — | 6,758 | — | ||||||||||||
U.S. government securities | 144,838 | — | 144,838 | — | ||||||||||||
Total financial assets | $ | 731,726 | $ | 333,452 | $ | 398,274 | $ | — | ||||||||
September 30, 2019 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 237,318 | $ | 237,318 | $ | — | $ | — | ||||||||
Corporate debt securities | 117,188 | — | 117,188 | — | ||||||||||||
U.S. government agency securities | 146,933 | — | 146,933 | — | ||||||||||||
Certificates of deposits | 6,530 | — | 6,530 | — | ||||||||||||
U.S. government securities | 144,849 | — | 144,849 | — | ||||||||||||
Total financial assets | $ | 652,818 | $ | 237,318 | $ | 415,500 | $ | — | ||||||||
December 31, 2018 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 275,234 | $ | 275,234 | $ | — | $ | — | ||||||||
Corporate debt securities | 110,027 | — | 110,027 | — | ||||||||||||
U.S. government agency securities | 88,028 | — | 88,028 | — | ||||||||||||
Certificates of deposits | 6,675 | — | 6,675 | — | ||||||||||||
U.S. government securities | 111,728 | — | 111,728 | — | ||||||||||||
Total financial assets | $ | 591,692 | $ | 275,234 | $ | 316,458 | $ | — | ||||||||
December 31, 2018 | ||||||||||||||||
Total | Level 1 | Level 2 | Level 3 | |||||||||||||
Financial Assets: | ||||||||||||||||
Money market funds | $ | 275,234 | $ | 275,234 | $ | — | $ | — | ||||||||
Corporate debt securities | 110,027 | — | 110,027 | — | ||||||||||||
U.S. government agency securities | 88,028 | — | 88,028 | — | ||||||||||||
Certificates of deposits | 6,675 | — | 6,675 | — | ||||||||||||
U.S. government securities | 111,728 | — | 111,728 | — | ||||||||||||
Total financial assets | $ | 591,692 | $ | 275,234 | $ | 316,458 | $ | — | ||||||||
June 30, 2019 | December 31, 2018 | September 30, 2019 | December 31, 2018 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | Amortized Cost | Unrealized Gains | Unrealized (Losses) | Estimated Fair Value | |||||||||||||||||||||||||||||||||||||||||||||||||
Financial Assets: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Money market funds | $ | 333,452 | $ | — | $ | — | $ | 333,452 | $ | 275,234 | $ | — | $ | — | $ | 275,234 | $ | 237,318 | $ | — | $ | — | $ | 237,318 | $ | 275,234 | $ | — | $ | — | $ | 275,234 | ||||||||||||||||||||||||||||||||
Corporate debt securities | 133,775 | 536 | — | 134,311 | 110,053 | 69 | (95 | ) | 110,027 | 116,660 | 528 | — | 117,188 | 110,053 | 69 | (95 | ) | 110,027 | ||||||||||||||||||||||||||||||||||||||||||||||
U.S. government agency securities | 112,169 | 200 | (2 | ) | 112,367 | 88,042 | 40 | (54 | ) | 88,028 | 146,856 | 131 | (54 | ) | 146,933 | 88,042 | 40 | (54 | ) | 88,028 | ||||||||||||||||||||||||||||||||||||||||||||
Certificates of deposits | 6,714 | 44 | — | 6,758 | 6,681 | 1 | (7 | ) | 6,675 | 6,478 | 52 | — | 6,530 | 6,681 | 1 | (7 | ) | 6,675 | ||||||||||||||||||||||||||||||||||||||||||||||
U.S. government securities | 144,425 | 413 | — | 144,838 | 111,730 | 60 | (62 | ) | 111,728 | 144,528 | 321 | — | 144,849 | 111,730 | 60 | (62 | ) | 111,728 | ||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 730,535 | $ | 1,193 | $ | (2 | ) | $ | 731,726 | $ | 591,740 | $ | 170 | $ | (218 | ) | $ | 591,692 | $ | 651,840 | $ | 1,032 | $ | (54 | ) | $ | 652,818 | $ | 591,740 | $ | 170 | $ | (218 | ) | $ | 591,692 | ||||||||||||||||||||||||||||
June 30, 2019 | December 31, 2018 | |||||||
Cash and cash equivalents | $ | 338,452 | $ | 275,234 | ||||
Short-term marketable securities | 320,098 | 202,177 | ||||||
Long-term marketable securities | 73,176 | 114,281 | ||||||
Total | $ | 731,726 | $ | 591,692 | ||||
September 30, 2019 | December 31, 2018 | |||||||
Cash and cash equivalents | $ | 237,318 | $ | 275,234 | ||||
Short-term marketable securities | 335,500 | 202,177 | ||||||
Long-term marketable securities | 80,000 | 114,281 | ||||||
Total | $ | 652,818 | $ | 591,692 | ||||
June 30, 2019 | December 31, 2018 | September 30, 2019 | December 31, 2018 | |||||||||||||
Laboratory equipment | $ | 7,935 | $ | 7,363 | $ | 8,191 | $ | 7,363 | ||||||||
Computer equipment | 1,501 | 1,501 | 1,979 | 1,501 | ||||||||||||
Leasehold improvements | 13,785 | 13,785 | 13,785 | 13,785 | ||||||||||||
Construction-in-progress | 1,213 | 239 | 4,575 | 239 | ||||||||||||
Total property and equipment | 24,434 | 22,888 | 28,530 | 22,888 | ||||||||||||
Less: accumulated depreciation and amortization | (12,089 | ) | (7,907 | ) | (14,193 | ) | (7,907 | ) | ||||||||
Property and equipment, net | $ | 12,345 | $ | 14,981 | $ | 14,337 | $ | 14,981 | ||||||||
June 30, 2019 | December 31, 2018 | September 30, 2019 | December 31, 2018 | |||||||||||||
Accrued clinical and manufacturing expenses | $ | 18,602 | $ | 15,121 | $ | 17,843 | $ | 15,121 | ||||||||
Accrued professional and consulting services | 4,336 | 1,016 | 3,850 | 1,016 | ||||||||||||
Other | 431 | 655 | 505 | 655 | ||||||||||||
Total accrued liabilities | $ | 23,369 | $ | 16,792 | $ | 22,198 | $ | 16,792 | ||||||||
June 30, 2019 | December 31, 2018 | September 30, 2019 | December 31, 2018 | |||||||||||||
Operating lease liabilities, current | $ | 1,318 | $ | — | $ | 1,380 | | $ | — | |||||||
Restricted shares subject to repurchase, current | — | 157 | — | 157 | ||||||||||||
Deferred rent, current | — | 712 | — | 712 | ||||||||||||
Other payable | 30 | 30 | 30 | 30 | ||||||||||||
Total other liabilities, current | $ | 1,348 | $ | 899 | $ | 1,410 | $ | 899 | ||||||||
Deferred rent, noncurrent | $ | — | $ | 11,041 | $ | — | $ | 11,041 | ||||||||
Accrued lease liabilities | 851 | — | 4,367 | — | ||||||||||||
Other liabilities, noncurrent | 30 | 30 | — | 30 | ||||||||||||
Total other liabilities, noncurrent | $ | 881 | $ | 11,071 | $ | 4,367 | $ | 11,071 | ||||||||
Number of Options | Weighted- Average Exercise Price | Number of Options | Weighted- Average Exercise Price | |||||||||||||
Outstanding — December 31, 2018 | 3,243,551 | $ | 29.74 | 3,243,551 | $ | 29.74 | ||||||||||
Options granted | 807,965 | 50.15 | 885,765 | 50.06 | ||||||||||||
Options exercised | (175,801 | ) | 17.91 | (194,239 | ) | 18.20 | ||||||||||
Options canceled | (116,869 | ) | 41.01 | (142,577 | ) | 41.92 | ||||||||||
Outstanding — June 30, 2019 | 3,758,846 | $ | 34.33 | |||||||||||||
Outstanding — September 30, 2019 | 3,792,500 | $ | 34.62 | |||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | 2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||
Expected term (in years) | 5.3-6.1 | 5.3-6.1 | 5.3-6.1 | 5.3-6.1 | 6.1 | 6.1 | 5.3-6.1 | 5.3-6.1 | ||||||||||||||||||||||||
Volatility | 70.5%-71.7% | 68.7%-70.8% | 70.5%-72.2% | 68.7%-70.8% | 70.4%-71.2% | 69.7%-70.3% | 70.4%-72.2% | 68.7%-70.8% | ||||||||||||||||||||||||
Risk-free interest rate | 1.8%-2.4% | 2.6%-2.9% | 1.8%-2.6% | 2.6%-2.9% | 1.4%-1.9% | 2.8%-2.9% | 1.4%-2.6% | 2.6%-2.9% | ||||||||||||||||||||||||
Dividend yield | — | — | — | — | — | — | — | — |
Number of RSUs | Weighted- Average Grant Date Fair Value | |||||||
Non-vested units — December 31, 2018 | 816,169 | $ | 43.34 | |||||
RSUs granted | 995,385 | 50.77 | ||||||
RSUs vested | (116,389 | ) | 41.74 | |||||
RSUs forfeited | (75,317 | ) | 46.01 | |||||
Non-vested units — June 30, 2019 | 1,619,848 | $ | 47.90 | |||||
Number of RSUs | Weighted- Average Grant Date Fair Value | |||||||
Non-vested units — December 31, 2018 | 816,169 | $ | 43.34 | |||||
RSUs granted | 1,150,960 | 50.84 | ||||||
RSUs vested | (295,764 | ) | 43.67 | |||||
RSUs forfeited | (96,088 | ) | 46.57 | |||||
Non-vested units — September 30, 2019 | 1,575,277 | $ | 48.56 | |||||
Three Months Ended June 30, | Six Months Ended June 30, | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | 2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||
Research and development | $ | 4,715 | $ | 3,784 | $ | 8,738 | $ | 6,752 | $ | 5,109 | $ | 2,835 | $ | 13,847 | $ | 9,587 | ||||||||||||||||
General and administrative | 6,233 | 4,016 | 11,663 | 8,832 | 7,344 | 4,133 | 19,007 | 12,965 | ||||||||||||||||||||||||
Total stock-based compensation expense | $ | 10,948 | $ | 7,800 | $ | 20,401 | $ | 15,584 | $ | 12,453 | $ | 6,968 | $ | 32,854 | $ | 22,552 | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | 2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||
Options to purchase common stock | 3,758,846 | 3,297,839 | 3,758,846 | 3,297,839 | 3,792,500 | 3,200,529 | 3,792,500 | 3,200,529 | ||||||||||||||||||||||||
Restricted stock subject to future vesting | — | 97,037 | — | 97,037 | — | 71,246 | — | 71,246 | ||||||||||||||||||||||||
Restricted stock units | 1,730,348 | 1,002,766 | 1,730,348 | 1,002,766 | 1,685,777 | 926,244 | 1,685,777 | 926,244 | ||||||||||||||||||||||||
Total | 5,489,194 | 4,397,642 | 5,489,194 | 4,397,642 | 5,478,277 | 4,198,019 | 5,478,277 | 4,198,019 | ||||||||||||||||||||||||
Year ending December 31, | Amount (a) | Amount (a) | ||||||
2019 (six months) | $ | 2,247 | ||||||
2019 (three months) | $ | 1,129 | ||||||
2020 | 4,576 | 4,576 | ||||||
2021 | 4,701 | 4,701 | ||||||
2022 | 4,856 | 4,856 | ||||||
2023 | 5,017 | 5,017 | ||||||
2024 | 5,183 | 5,183 | ||||||
Thereafter | 16,114 | 16,114 | ||||||
Total lease payments | 42,694 | 41,576 | ||||||
Less: Imputed interest (b) | (17,328 | ) | (16,505 | ) | ||||
Present value of operating lease liabilities | $ | 25,366 | $ | 25,071 | ||||
(a) | Operating lease payments exclude $121.5 million of legally - binding minimum lease payments for the Lease Amendment, which has been signed by us but has not yet commenced. |
(b) | Imputed interest is calculated using the interest rate for each lease. |
Year ending December 31, | Amount (c) | |||
2019 | $ | 4,406 | ||
2020 | 6,513 | |||
2021 | 11,642 | |||
2022 | 12,020 | |||
2023 | 12,409 | |||
Thereafter | 90,367 | |||
Total | $ | 137,357 | ||
(c) | The table above is prepared under the assumption that the Substitute Premises Commencement Date at the Substitute Premises starts on June 30 , 2020. |
Item 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
Three Months Ended June 30, | $ Change | % Change | Three Months Ended September 30, | $ Change | % Change | |||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||||||
(in thousands, except percentages) | (in thousands, except percentages) | |||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||
Research and development | $ | 36,010 | $ | 31,573 | $ | 4,437 | 14 | % | $ | 39,088 | $ | 33,026 | $ | 6,062 | 18 | % | ||||||||||||||||
General and administrative | 24,794 | 10,914 | 13,880 | 127 | % | 29,654 | 12,450 | 17,204 | 138 | % | ||||||||||||||||||||||
Total operating expenses | 60,804 | 42,487 | 18,317 | 43 | % | 68,742 | 45,476 | 23,266 | 51 | % | ||||||||||||||||||||||
Loss from operations | (60,804 | ) | (42,487 | ) | (18,317 | ) | 43 | % | (68,742 | ) | (45,476 | ) | (23,266 | ) | 51 | % | ||||||||||||||||
Interest income, net | 3,546 | 2,115 | 1,431 | 68 | % | 4,226 | 2,480 | 1,746 | 70 | % | ||||||||||||||||||||||
Other income (expenses), net | (63 | ) | 4 | (67 | ) | * | ||||||||||||||||||||||||||
Other expenses, net | (31 | ) | (72 | ) | 41 | (57 | )% | |||||||||||||||||||||||||
Net loss | $ | (57,321 | ) | $ | (40,368 | ) | $ | (16,953 | ) | 42 | % | $ | (64,547 | ) | $ | (43,068 | ) | $ | (21,479 | ) | 50 | % | ||||||||||
Three Months Ended June 30, | $ Change | % Change | Three Months Ended September 30, | $ Change | % Change | |||||||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||||||||||||||||
Costs incurred by development program: | ||||||||||||||||||||||||||||||||
Voxelotor for the treatment of SCD | $ | 29,490 | $ | 24,888 | $ | 4,602 | 18 | % | $ | 29,294 | $ | 24,656 | $ | 4,638 | 19 | % | ||||||||||||||||
Other preclinical programs and voxelotor for the treatment of hypoxemic pulmonary disorders | 5,165 | 6,127 | (962 | ) | (16 | )% | ||||||||||||||||||||||||||
Other preclinical programs | 7,664 | 5,901 | 1,763 | 30 | % | |||||||||||||||||||||||||||
Inclacumab for the treatment of SCD | 1,355 | 558 | 797 | 143 | % | 2,130 | 2,469 | (339 | ) | (14 | )% | |||||||||||||||||||||
Total research and development expenses | $ | 36,010 | $ | 31,573 | $ | 4,437 | 14 | % | $ | 39,088 | $ | 33,026 | $ | 6,062 | 18 | % | ||||||||||||||||
Nine Months Ended September 30, | $ Change | % Change | ||||||||||||||
2019 | 2018 | |||||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 109,564 | $ | 94,543 | $ | 15,021 | 16 | % | ||||||||
General and administrative | 72,503 | 36,115 | 36,388 | 101 | % | |||||||||||
Total operating expenses | 182,067 | 130,658 | 51,409 | 39 | % | |||||||||||
Loss from operations | (182,067 | ) | (130,658 | ) | (51,409 | ) | 39 | % | ||||||||
Interest income, net | 11,422 | 5,768 | 5,654 | 98 | % | |||||||||||
Other expenses, net | (146 | ) | (101 | ) | (45 | ) | 45 | % | ||||||||
Net loss | $ | (170,791 | ) | $ | (124,991 | ) | $ | (45,800 | ) | 37 | % | |||||
Six Months Ended June 30, | $ Change | % Change | ||||||||||||||
2019 | 2018 | |||||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 70,476 | $ | 61,517 | $ | 8,959 | 15 | % | ||||||||
General and administrative | 42,849 | 23,665 | 19,184 | 81 | % | |||||||||||
Total operating expenses | 113,325 | 85,182 | 28,143 | 33 | % | |||||||||||
Loss from operations | (113,325 | ) | (85,182 | ) | (28,143 | ) | 33 | % | ||||||||
Interest income, net | 7,196 | 3,287 | 3,909 | 119 | % | |||||||||||
Other expenses, net | (115 | ) | (29 | ) | (86 | ) | 297 | % | ||||||||
Net loss | $ | (106,244 | ) | $ | (81,924 | ) | $ | (24,320 | ) | 30 | % | |||||
Six Months Ended June 30, | $ Change | % Change | ||||||||||||||
2019 | 2018 | |||||||||||||||
Costs incurred by development program: | ||||||||||||||||
Voxelotor for the treatment of SCD | $ | 57,214 | $ | 48,019 | $ | 9,195 | 19 | % | ||||||||
Other preclinical programs and voxelotor for the treatment of hypoxemic pulmonary disorders | 10,527 | 12,940 | (2,413 | ) | (19 | )% | ||||||||||
Inclacumab for the treatment of SCD | 2,735 | 558 | 2,177 | 390 | % | |||||||||||
Total research and development expenses | $ | 70,476 | $ | 61,517 | $ | 8,959 | 15 | % | ||||||||
Nine Months Ended September 30, | $ Change | % Change | ||||||||||||||
2019 | 2018 | |||||||||||||||
Costs incurred by development program: | ||||||||||||||||
Voxelotor for the treatment of SCD | $ | 86,516 | $ | 72,940 | $ | 12,576 | 17 | % | ||||||||
Other preclinical programs | 18,183 | 18,575 | (392 | ) | (2 | )% | ||||||||||
Inclacumab for the treatment of SCD | 4,865 | 3,028 | 1,837 | 61 | % | |||||||||||
Total research and development expenses | $ | 109,564 | $ | 94,543 | $ | 15,021 | 16 | % | ||||||||
�� | the costs of obtaining clinical and commercial supplies of voxelotor, inclacumab and any other product candidates we may identify and develop; |
Six Months Ended June 30, | Nine Months Ended September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Cash used in operating activities | $ | (78,253 | ) | $ | (70,900 | ) | $ | (132,080 | ) | $ | (101,802 | ) | ||||
Cash used in investing activities | (74,922 | ) | (39,080 | ) | (97,491 | ) | (155,870 | ) | ||||||||
Cash provided by financing activities | 216,272 | 253,611 | 221,818 | 255,580 | ||||||||||||
Net increase in cash, cash equivalents and restricted cash | $ | 63,097 | $ | 143,631 | ||||||||||||
Net decrease in cash, cash equivalents and restricted cash | $ | (7,753 | ) | $ | (2,092 | ) | ||||||||||
December 31, 2018 | Adjustments Due to our Adoption of Topic 842 | January 1, 2019 | ||||||||||
Assets: | ||||||||||||
Operating lease ROU assets | $ | — | $ | 14,177 | $ | 14,177 | ||||||
Liabilities: | ||||||||||||
Operating lease liabilities, current as included in other liabilities, current | — | 1,176 | 1,176 | |||||||||
Deferred rent, current as included in other liabilities, current | 712 | (712 | ) | — | ||||||||
Operating lease liabilities, noncurrent | — | 24,754 | 24,754 | |||||||||
Deferred rent, noncurrent as included in other liabilities, noncurrent | 11,041 | (11,041 | ) | — |
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Item 4. | Controls and Procedures |
Item 1. | Legal Proceedings |
Item 1A. | Risk Factors. |
retail prices, the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party product reimbursement are subject to scrutiny under this law. The civil False Claims Act has been used to assert liability on the basis of, among other things, kickbacks and other improper referrals, improperly reported government pricing metrics such as Best Price or Average Manufacturer Price causing underpayment of rebates, improper use of Medicare provider or supplier numbers when detailing a provider of services, improper promotion (e.g. of off-label uses not expressly approved by the FDA in a product’s label), and allegations as to misrepresentations with respect to the services rendered. Intent to deceive is not required to establish liability under the civil False Claims Act. Over time, False Claims Act lawsuits against biopharmaceutical companies have increased significantly in volume and breadth, leading to multiple substantial civil and criminal settlements regarding sales practices and promoting off label uses. Further, the government may further prosecute conduct constituting a false claim under the criminal False Claims Act; |
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 | Exhibit Description | Incorporated by Reference | Filed Herewith | |||||||||||||||||
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# | 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 |
Exhibit Number | Exhibit Description | Incorporated by Reference | Filed Herewith | |||||||||||||||||
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# | 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 |
# | Represents a management compensation plan, contract or arrangement. Senior Management Team Members have been designated by the Compensation Committee of the Company’s Board of Directors and include all of the Company’s executive officers (other than the Chief Executive Officer), who shall each continue to be considered Senior Management Team Members for purposes of Change in Control Benefits so long as they are employed with the Company in any capacity. |
* | 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. |
Global Blood Therapeutics, Inc. | ||||||
Date: | By: | /s/ Ted W. Love, M.D. | ||||
Ted W. Love, M.D. President and Chief Executive Officer (Principal Executive Officer) | ||||||
Date: | By: | /s/ Jeffrey Farrow | ||||
Jeffrey Farrow Chief Financial Officer (Principal Financial Officer) |