☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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27-4825712
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification No.)
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Title of each class
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Trading
Symbol(s)
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Name of each exchange
on which registered
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||
Common Stock, par value $0.001 per share
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GBT
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The NASDAQ Global Select Market
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Large accelerated filer | ☒ | Accelerated filer | ☐ | |||
Non-accelerated
filer
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☐ | Smaller reporting company | ☐ | |||
Emerging growth company | ☐ |
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Page
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3
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Item 1.
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3
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3
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4
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5
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7
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9
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Item 2.
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19
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Item 3.
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28
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Item 4.
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28
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28
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Item 1.
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28
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Item 1A.
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28
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Item 2.
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69
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Item 3.
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69
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Item 4.
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69
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Item 5.
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69
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Item 6.
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69
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71
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Item 1.
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Financial Statements
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June 30, 2021
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|
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December 31, 2020
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(Unaudited)
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Assets
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||||||
Current assets:
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||||||||
Cash and cash equivalents
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$ | 419,311 | $ | 494,766 | ||||
Short-term marketable securities
|
18,085 | 66,126 | ||||||
Accounts receivable, net
|
19,544 | 17,500 | ||||||
Inventories
|
47,991 | 40,223 | ||||||
Prepaid expenses and other current assets
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19,928 | 13,548 | ||||||
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|||||
Total current assets
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524,859 | 632,163 | ||||||
Property and equipment, net
|
36,775 | 37,882 | ||||||
Operating lease
right-of-use
|
49,421 | 50,722 | ||||||
Restricted cash
|
2,395 | 2,436 | ||||||
Other assets, noncurrent
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1,522 | 799 | ||||||
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|||||
Total assets
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$ | 614,972 | $ | 724,002 | ||||
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|||||
Liabilities and Stockholders’ Equity
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||||||||
Current liabilities:
|
||||||||
Accounts payable
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$ | 9,198 | $ | 19,078 | ||||
Accrued liabilities
|
38,904 | 31,133 | ||||||
Accrued compensation
|
19,330 | 23,985 | ||||||
Operating lease liabilities, current
|
5,243 | 4,836 | ||||||
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|
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|||||
Total current liabilities
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72,675 | 79,032 | ||||||
Long-term debt
|
149,268 | 148,815 | ||||||
Operating lease liabilities, noncurrent
|
76,441 | 79,176 | ||||||
Other liabilities, noncurrent
|
822 | 822 | ||||||
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|||||
Total liabilities
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299,206 | 307,845 | ||||||
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|||||
Commitments and contingencies
|
||||||||
Stockholders’ equity:
|
||||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2021 (unaudited) and December 31, 2020; no shares issued and outstanding
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— | — | ||||||
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|||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2021 (unaudited) and December 31, 2020, respectively; 62,379,118 and 61,898,090 shares issued and outstanding as of June 30, 2021 (unaudited) and December 31, 2020, respectively
|
62 | 62 | ||||||
Additional
paid-in
capital
|
1,446,393 | 1,402,262 | ||||||
Accumulated other comprehensive loss
|
302 | 302 | ||||||
Accumulated deficit
|
(1,130,991 | ) | (986,469 | ) | ||||
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|||||
Total stockholders’ equity
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315,766 | 416,157 | ||||||
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|||||
Total liabilities and stockholders’ equity
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$ | 614,972 | $ | 724,002 | ||||
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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||||||||||
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2021
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2020
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2021
|
|
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2020
|
|
||||
Product sales, net
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$ | 47,555 | $ | 31,501 | $ | 86,598 | $ | 45,619 | ||||||||
Costs and operating expenses:
|
||||||||||||||||
Cost of sales
|
748 | 377 | 1,332 | 512 | ||||||||||||
Research and development
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51,784 | 34,085 | 102,641 | 73,858 | ||||||||||||
Selling, general and administrative
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61,093 | 49,075 | 120,059 | 96,736 | ||||||||||||
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|||||||||
Total costs and operating expenses
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113,625 | 83,537 | 224,032 | 171,106 | ||||||||||||
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|||||||||
Loss from operations
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(66,070 | ) | (52,036 | ) | (137,434 | ) | (125,487 | ) | ||||||||
Other income (expense):
|
||||||||||||||||
Interest income
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164 | 1,514 | 493 | 4,370 | ||||||||||||
Interest expense
|
(3,677 | ) | (2,282 | ) | (7,366 | ) | (4,596 | ) | ||||||||
Other expenses, net
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(9 | ) | (36 | ) | (215 | ) | (153 | ) | ||||||||
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|||||||||
Total other income, net
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(3,522 | ) | (804 | ) | (7,088 | ) | (379 | ) | ||||||||
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|||||||||
Net loss
|
(69,592 | ) | (52,840 | ) | (144,522 | ) | (125,866 | ) | ||||||||
Other comprehensive loss:
|
||||||||||||||||
Net unrealized gain
(loss)
on marketable securities, net of tax
|
(78 | ) | 12 | (259 | ) | 472 | ||||||||||
Cumulative translation adjustment
|
259 | — | 259 | — | ||||||||||||
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|||||||||
Comprehensive loss
|
$
|
(69,411 | ) |
$
|
(52,828 | ) |
$
|
(144,522 | ) |
$
|
(125,394 | ) | ||||
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|||||||||
Basic and diluted net loss per common share
|
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$
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(1.12
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)
|
$
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(0.86
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)
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$
|
(2.32
|
)
|
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$
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(2.06
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)
|
||
Weighted-average number of shares used in computing basic and diluted net
loss per common share |
62,312,418
|
61,116,707
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62,207,328
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60,952,269
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||||||||||
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Common Stock
|
|
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Additional
Paid-
In Capital
|
|
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Accumulated
Other Comprehensive
Income
|
|
|
Accumulated
Deficit
|
|
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Total
Stockholders’
Equity
|
|
|||||||||
|
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Shares
|
|
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Amount
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|
||||||||||||||||||
Balance at December 31, 2020
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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
loss
on marketable securities
|
— | — | — | (181 | ) | — | (181 | ) | ||||||||||||||||
Net loss
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— | — | — | — | (74,930 | ) | (74,930 | ) | ||||||||||||||||
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Balance at March 31, 2021
|
62,240,050 | $ | 62 | $ | 1,424,411 | $ | 121 | $ | (1,061,399 | ) | $ | 363,195 | ||||||||||||
Issuance of common stock upon exercise of stock options
|
28,575 | — | 403 | — | — | 403 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes
|
110,493 | — | (65 | ) | — | — | (65 | ) | ||||||||||||||||
Stock-based compensation
|
— | — | 21,644 | — | — | 21,644 | ||||||||||||||||||
Net unrealized loss on marketable securities
|
— | — | — | (78 | ) | — | (78 | ) | ||||||||||||||||
Cumulative translation adjustment
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
259
|
|
|
|
—
|
|
|
|
259
|
|
Net loss
|
— | — | — | — | (69,592 | ) | (69,592 | ) | ||||||||||||||||
|
|
|
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|
|
|
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|||||||||||||
Balance at June 30, 2021
|
62,379,118 | $ | 62 | $ | 1,446,393 | $ | 302 | $ | (1,130,991 | ) | $ | 315,766 | ||||||||||||
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Accumulated
|
|
|
|
|
|
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|
||||||
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Additional
|
|
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Other
|
|
|
|
|
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Total
|
|
||||||
|
|
Common Stock
|
|
|
Paid-
In Capital
|
|
|
Comprehensive
Income
|
|
|
Accumulated
Deficit
|
|
|
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 | ) | ||||||||||||||||
|
|
|
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|
|
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|
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|
|||||||||||||
Balance at March 31, 2020
|
60,886,371 | $ | 61 | $ | 1,334,238 | $ | 1,215 | $ | (811,942 | ) | $ | 523,572 | ||||||||||||
Issuance of common stock upon exercise of stock options
|
334,454 | — | 8,018 | — | — | 8,018 | ||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes
|
110,162 | — | (74 | ) | — | — | (74 | ) | ||||||||||||||||
Stock-based compensation
|
— | — | 17,128 | — | — | 17,128 | ||||||||||||||||||
Net unrealized gain on marketable securities
|
— | — | — | 12 | — | 12 | ||||||||||||||||||
Net loss
|
— | — | — | — | (52,840 | ) | (52,840 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance at June 30, 2020
|
61,330,987 | $ | 61 | $ | 1,359,310 | $ | 1,227 | $ | (864,782 | ) | $ | 495,816 | ||||||||||||
|
|
|
|
|
|
|
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|
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Six Months Ended
June 30, |
|
|||||
|
|
2021
|
|
|
2020
|
|
||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
||||||
Net loss
|
$ | (144,522 | ) | $ | (125,866 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
2,908 | 5,577 | ||||||
Amortization (accretion) of premium (discount) on marketable securities
|
112 | (61 | ) | |||||
Non-cash
interest expense
|
476 | 824 | ||||||
Amortization of operating lease
right-of-use
|
1,301 | 580 | ||||||
Stock-based compensation
|
41,184 | 32,938 | ||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
(2,044 | ) | (9,834 | ) | ||||
Inventories
|
(6,841 | ) | (24,926 | ) | ||||
Prepaid expenses and other assets
|
(7,121 | ) | 181 | |||||
Accounts payable
|
(9,730 | ) | (4,918 | ) | ||||
Accrued liabilities
|
7,683 | (1,326 | ) | |||||
Accrued compensation
|
(4,655 | ) | (1,114 | ) | ||||
Other liabilities
|
— | 156 | ||||||
Operating lease liabilities
|
(2,328 | ) | 1,686 | |||||
|
|
|
|
|||||
Net cash used in operating activities
|
(123,577 | ) | (126,103 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of property and equipment
|
(1,920 | ) | (3,918 | ) | ||||
Purchase of marketable securities
|
— | (57,936 | ) | |||||
Maturities of marketable securities
|
47,670 | 261,738 | ||||||
|
|
|
|
|||||
Net cash provided by investing activities
|
45,750 | 199,884 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from issuance of common stock in settlement of employee stock purchase plan and exercise of stock options
|
4,083 | 11,000 | ||||||
Payments of debt issuance costs
|
(49 | ) | (130 | ) | ||||
Tax paid related to net share settlement of equity awards
|
(1,962 | ) | (2,172 | ) | ||||
|
|
|
|
|||||
Net cash provided by financing activities
|
2,072 | 8,698 | ||||||
|
|
|
|
|||||
Effect of exchange rate changes on cash and cash equivalents
|
259 | — | ||||||
Net (decrease)
inc
in cash, cash equivalents and restricted cash
rease
|
(75,496 | ) | 82,479 | |||||
Cash, cash equivalents and restricted cash at beginning of period
|
497,202 | 304,632 | ||||||
|
|
|
|
|||||
Cash, cash equivalents and restricted cash at end of period
|
$ | 421,706 | $ | 387,111 | ||||
|
|
|
|
|||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:
|
||||||||
Cash paid for interest
|
$ | 6,788 | $ | 3,419 |
|
|
June 30, 2021
|
|
|||||||||||||
|
|
Total
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
||||
Financial Assets:
|
||||||||||||||||
Money market funds
|
$ | 358,206 | $ | 358,206 | $ | — | $ | — | ||||||||
Corporate debt securities
|
11,272 | — | 11,272 | — | ||||||||||||
U.S. government agency securities
|
1,800 | — | 1,800 | — | ||||||||||||
U.S. government securities
|
5,013 | — | 5,013 | — | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total financial assets
|
$ | 376,291 | $ | 358,206 | $ | 18,085 | $ | — | ||||||||
|
|
|
|
|
|
|
|
|||||||||
|
|
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 | $ | — | ||||||||
|
|
|
|
|
|
|
|
June 30,2021
|
December 31, 2020
|
|||||||||||||||||||||||||||||||
Amortized
|
Unrealized
|
Unrealized
|
Estimated
Fair |
Amortized
|
Unrealized
|
Unrealized
|
Estimated
Fair |
|||||||||||||||||||||||||
Cost
|
Gains
|
(Losses)
|
Value
|
Cost
|
Gains
|
(Losses)
|
Value
|
|||||||||||||||||||||||||
Financial Assets:
|
||||||||||||||||||||||||||||||||
Money market funds
|
$ | 358,206 | $ | — | $ | — | $ | 358,206 | $ | 486,174 | $ | — | $ | — | $ | 486,174 | ||||||||||||||||
Corporate debt securities
|
11,239 | 33 | — | 11,272 | 29,641 | 163 | — | 29,804 | ||||||||||||||||||||||||
U.S. government agency securities
|
1,800 | — | — | 1,800 | 15,906 | 37 | — | 15,943 | ||||||||||||||||||||||||
Certificates of deposits
|
— | — | — | — | 241 | 2 | — | 243 | ||||||||||||||||||||||||
U.S. government securities
|
5,003 | 10 | — | 5,013 | 20,036 | 100 | — | 20,136 | ||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Total
|
$ | 376,248 | $ | 43 | $ | — | $ | 376,291 | $ | 551,998 | $ | 302 | $ | — | $ | 552,300 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2021
|
December 31, 2020
|
|||||||
Cash and cash equivalents
|
$ | 358,206 | $ | 486,174 | ||||
Short-term marketable securities
|
18,085 | 66,126 | ||||||
|
|
|
|
|||||
Total
|
$ | 376,291 | $ | 552,300 | ||||
|
|
|
|
June 30, 2021
|
December 31, 2020
|
|||||||
Raw materials
|
$ | 9,013 | $ | 11,273 | ||||
Work-in-process
|
36,389 | 26,994 | ||||||
Finished goods
|
2,589 | 1,956 | ||||||
|
|
|
|
|||||
Total inventories
|
$ | 47,991 | $ | 40,223 | ||||
|
|
|
|
June 30, 2021
|
December 31, 2020
|
|||||||
Laboratory equipment
|
$ | 13,649 | $ | 11,922 | ||||
Computer equipment
|
3,241 | 3,023 | ||||||
Leasehold improvements
|
32,281 | 32,281 | ||||||
Construction-in-progress
|
456 | 517 | ||||||
|
|
|
|
|||||
Total property and equipment
|
49,627 | 47,743 | ||||||
Less: accumulated depreciation and amortization
|
(12,852 | ) | (9,861 | ) | ||||
|
|
|
|
|||||
Property and equipment, net
|
$ | 36,775 | $ | 37,882 | ||||
|
|
|
|
June 30, 2021
|
December 31, 2020
|
|||||||
Accrued research and development costs
|
$ | 11,976 | $ | 10,677 | ||||
Accrued manufacturing costs
|
13,633 | 9,125 | ||||||
Accrued professional and consulting services
|
4,771 | 4,107 | ||||||
Accrued sales deductions
|
7,635 | 6,405 | ||||||
Other
|
889 | 819 | ||||||
|
|
|
|
|||||
Total accrued liabilities
|
$ | 38,904 | $ | 31,133 | ||||
|
|
|
|
2021 (six months)
|
$ | 6,750 | ||
2022
|
13,500 | |||
2023
|
62,813 | |||
2024
|
58,313 | |||
2025
|
53,813 | |||
Total minimum payments
|
195,189 | |||
|
|
|||
Less amount representing interest
|
(42,189 | ) | ||
Less amount representing Paydown Fee
|
(3,000 | ) | ||
|
|
|||
Long-term debt, gross
|
150,000 | |||
Discount on notes payable
|
(1,501 | ) | ||
Accretion of Paydown Fee
|
769 | |||
|
|
|||
Long-term debt
|
$ | 149,268 | ||
|
|
Six Months Ended
June 30, |
||||||||
2021
|
2020
|
|||||||
ROU assets obtained in exchange for new operating lease
|
$ | — | $ | 205 | ||||
Cash paid for amounts included in the measurement of lease liabilities
|
5,883 | 2,590 | ||||||
Weighted-average remaining lease term of operating leases (in years)
|
8.7 | 9.7 | ||||||
Weighted-average discount rate of operating leases
|
8.7 | % | 8.7 | % |
Year ending December 31,
|
Amount
|
|||
2021 (six months)
|
$ | 5,958 | ||
2022
|
12,222 | |||
2023
|
12,584 | |||
2024
|
12,948 | |||
2025
|
13,368 | |||
Thereafter
|
60,507 | |||
|
|
|||
Total lease payments
|
117,587 | |||
Less: Imputed interest
|
(35,903 | ) | ||
|
|
|||
Present value of operating lease liabilities
|
$ | 81,684 | ||
|
|
|
|
Number of
Options |
|
|
Weighted-
Average Exercise Price |
|
||
Outstanding — December 31, 2020
|
3,327,330 | $ | 42.07 | |||||
Options granted
|
658,480 | 43.57 | ||||||
Options exercised
|
(76,338 | ) | 19.82 | |||||
Options canceled
|
(170,068 | ) | 52.52 | |||||
|
|
|
|
|||||
Outstanding — June 30, 2021
|
3,739,404 | $ | 42.32 | |||||
|
|
|
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
||||
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
Expected term (in years)
|
5.3-6.1
|
5.1-6.1
|
5.3-6.1
|
5.1-6.1
|
||||
Volatility
|
68.1%-72.2%
|
71.0%-71.8%
|
68.1%-72.7%
|
69.6%-71.8%
|
||||
Risk-free interest rate
|
1.0%-1.1%
|
0.4% |
0.9%-1.1%
|
0.4%-1.8%
|
||||
Dividend yield
|
— | — | — | — |
|
|
Number
of RSUs |
|
|
Weighted-
Average Grant Date
Fair Value
|
|
||
Non-vested
units — December 31, 2020
|
2,210,356 | $ | 57.80 | |||||
RSUs granted
|
1,409,417 | 44.28 | ||||||
RSUs vested
|
(379,635 | ) | 55.06 | |||||
RSUs forfeited
|
(302,565 | ) | 53.34 | |||||
|
|
|||||||
Non-vested
units — June 30, 2021
|
2,937,573 | $ | 52.13 | |||||
|
|
Stock Price Targets
|
|
|
Number of Units Allowed
|
|
||
$ 109.20 | 82,940 | |||||
$ 145.60 | 145,145 | |||||
$ 182.00 | 186,615 |
Number
of RSUs |
Weighted-
Average Grant Date Fair Value |
Weighted-
Average Remaining Vesting Period (years) |
Aggregate
Intrinsic Value |
|||||||||||||
Non-vested
market-condition awards — December 31, 2020
|
414,700 | $ | 49.95 | 1.21 | ||||||||||||
Granted
|
42,400 | 13.80 | 2.23 | |||||||||||||
Forfeited
|
(42,400 | ) | 49.95 | 0.71 | ||||||||||||
|
|
|||||||||||||||
Non-vested
market-condition awards — June 30, 2021
|
414,700 | $ | 46.26 | 0.76 | $ | 14,523 | ||||||||||
|
|
|
|
Valuation date stock price
|
$ | 37.20 | ||
Expected term
|
3.1 years | |||
Volatility
|
66.6 | % | ||
Risk-free interest rate
|
0.3 | % | ||
Dividend yield
|
— |
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
||||||||||
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
||||
Research and development
|
$ | 4,906 | $ | 3,430 | $ | 10,216 | $ | 8,780 | ||||||||
Selling, general and administrative
|
15,064 | 13,141 | 30,134 | 24,158 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total stock-based compensation expense
|
$ | 19,970 | $ | 16,571 | $ | 40,350 | $ | 32,938 | ||||||||
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30,
|
|
||||||||||
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
||||
Options to purchase common stock
|
3,739,404 | 3,574,452 | 3,739,404 | 3,574,452 | ||||||||||||
Restricted stock units
|
3,352,273 | 2,866,882 | 3,352,273 | 2,866,882 | ||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total
|
7,091,677 | 6,441,334 | 7,091,677 | 6,441,334 | ||||||||||||
|
|
|
|
|
|
|
|
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
June 30, |
||||||||||||||||
2021
|
2020
|
$ Change
|
% Change
|
|||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Product sales, net
|
$ | 47,555 | $ | 31,501 | $ | 16,054 | 51 | % | ||||||||
Costs and operating expenses:
|
||||||||||||||||
Cost of sales
|
748 | 377 | 371 | 98 | % | |||||||||||
Research and development
|
51,784 | 34,085 | 17,699 | 52 | % | |||||||||||
Selling, general and administrative
|
61,093 | 49,075 | 12,018 | 24 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total costs and operating expenses
|
113,625 | 83,537 | 30,088 | 36 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations
|
(66,070 | ) | (52,036 | ) | (14,034 | ) | 27 | % | ||||||||
Interest income
|
164 | 1,514 | (1,350 | ) | (89 | %) | ||||||||||
Interest expense
|
(3,677 | ) | (2,282 | ) | (1,395 | ) | 61 | % | ||||||||
Other expenses, net
|
(9 | ) | (36 | ) | 27 | (75 | %) | |||||||||
|
|
|
|
|
|
|||||||||||
Total other income, net
|
(3,522 | ) | (804 | ) | (2,718 | ) | 338 | % | ||||||||
|
|
|
|
|
|
|||||||||||
Net loss
|
$ | (69,592 | ) | $ | (52,840 | ) | $ | (16,752 | ) | 32 | % | |||||
|
|
|
|
|
|
Rebates, co-payment
assistance, Medicare Part D coverage gap, product returns and distributor fees |
Prompt payment
discounts and chargebacks |
Total
|
||||||||||
Balances at March 31, 2021
|
$ | 7,010 | $ | 741 | $ | 7,751 | ||||||
Provision related to current period sales
|
5,692 | 2,332 | 8,024 | |||||||||
Credit or payments made during the period
|
(5,067 | ) | (2,327 | ) | (7,394 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at June 30, 2021
|
$
|
7,635
|
|
$
|
746
|
|
$
|
8,381
|
|
|||
|
|
|
|
|
|
• |
employee-related expenses, which include salaries, benefits and stock-based compensation;
|
• |
expenses incurred under agreements with consultants, third-party research and manufacturing organizations, and investigative clinical trial sites that conduct research and development activities on our behalf;
|
• |
the costs related to production of clinical supplies, including fees paid to contract manufacturers;
|
• |
laboratory and vendor expenses related to the execution of nonclinical studies and clinical trials;
|
• |
payments upon achievement of certain clinical development and regulatory milestones pursuant to license agreements; and
|
• |
facilities and other allocated expenses, which include expenses for rent and maintenance of facilities, depreciation and amortization expense and other supplies.
|
Three Months Ended
June 30, |
||||||||||||||||
2021
|
2020
|
$ Change
|
% Change
|
|||||||||||||
Costs incurred by development program:
|
||||||||||||||||
Oxbryta for the treatment of SCD
|
$ | 23,623 | $ | 17,602 | $ | 6,021 | 34 | % | ||||||||
Other preclinical programs
|
16,714 | 10,055 | 6,659 | 66 | % | |||||||||||
Inclacumab for the treatment of SCD
|
11,447 | 6,428 | 5,019 | 78 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expenses
|
$ | 51,784 | $ | 34,085 | 17,699 | 52 | % | |||||||||
|
|
|
|
|
|
• |
employee-related expenses, which include salaries, benefits and stock-based compensation;
|
• |
fees to third-party vendors providing customer support services;
|
• |
expenses incurred under agreements with consultants; and
|
• |
facilities and other allocated expenses, which include expenses for rent and maintenance of facilities, depreciation and amortization expense and other supplies.
|
Six Months Ended
June 30,
|
||||||||||||||||
2021
|
2020
|
$ Change
|
% Change
|
|||||||||||||
(in thousands, except percentages) | ||||||||||||||||
Product sales, net
|
$ | 86,598 | $ | 45,619 | $ | 40,979 | 90 | % | ||||||||
Costs and operating expenses:
|
||||||||||||||||
Cost of sales
|
1,332 | 512 | 820 | 160 | % | |||||||||||
Research and development
|
102,641 | 73,858 | 28,783 | 39 | % | |||||||||||
Selling, general and administrative
|
120,059 | 96,736 | 23,323 | 24 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total costs and operating expenses
|
224,032 | 171,106 | 52,926 | 31 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations
|
(137,434 | ) | (125,487 | ) | (11,947 | ) | 10 | % | ||||||||
Interest income
|
493 | 4,370 | (3,877 | ) | (89 | %) | ||||||||||
Interest expense
|
(7,366 | ) | (4,596 | ) | (2,770 | ) | 60 | % | ||||||||
Other expenses, net
|
(215 | ) | (153 | ) | (62 | ) | 41 | % | ||||||||
|
|
|
|
|
|
|||||||||||
Total other income, net
|
(7,088 | ) | (379 | ) | (6,709 | ) | 1770 | % | ||||||||
|
|
|
|
|
|
|||||||||||
Net loss
|
$ | (144,522 | ) | $ | (125,866 | ) | $ | (18,656 | ) | 15 | % | |||||
|
|
|
|
|
|
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
|
10,928 | 3,809 | 14,737 | |||||||||
Credit or payments made during the period
|
(9,698 | ) | (3,814 | ) | (13,512 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at June 30, 2021
|
$
|
7,635
|
|
$
|
746
|
|
$
|
8,381
|
|
|||
|
|
|
|
|
|
Six Months Ended
June 30, |
||||||||||||||||
2021
|
2020
|
$ Change
|
% Change
|
|||||||||||||
Costs incurred by development program:
|
||||||||||||||||
Oxbryta for the treatment of SCD
|
$ | 47,704 | $ | 41,082 | $ | 6,622 | 16 | % | ||||||||
Other preclinical programs
|
33,361 | 13,156 | 20,205 | 154 | % | |||||||||||
Inclacumab for the treatment of SCD
|
21,576 | 19,620 | 1,956 | 10 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expenses
|
$ | 102,641 | $ | 73,858 | 28,783 | 39 | % | |||||||||
|
|
|
|
|
|
• |
our ability to successfully commercialize Oxbryta, inclacumab and any other product candidates we may identify and develop in the United States or any other territories;
|
• |
the manufacturing, selling, and marketing costs associated with the commercialization of Oxbryta and the potential commercialization of inclacumab and any other product candidates we may identify and develop, including the cost and timing of establishing or maintaining our sales and marketing capabilities in any territory(ies);
|
• |
the amount and timing of sales and other revenues from Oxbryta, inclacumab and any other product candidates we may identify and develop, including the sales price and the availability of adequate third-party reimbursement;
|
• |
the time and cost necessary to conduct and complete multiple ongoing studies (including our HOPE-KIDS 1 Study, our Phase 3 HOPE-KIDS 2 Study, and other studies);
|
• |
the time and cost necessary to conduct and complete any additional clinical studies required to pursue additional regulatory approvals for Oxbryta for SCD, including our Phase 3 HOPE-KIDS 2 Study (which is intended as our required confirmatory study to move from our current Subpart H approval to a full approval of Oxbryta) and any studies to support potential label expansions into younger SCD pediatric populations, or any other post-marketing studies for Oxbryta for SCD;
|
• |
the progress, data and results of clinical trials of Oxbryta and our product candidates;
|
• |
the progress, timing, scope and costs of our nonclinical studies, our clinical trials and other related activities, including our ability to enroll subjects in a timely manner for our ongoing and future clinical trials of Oxbryta, inclacumab or any other product candidate that we may identify and develop;
|
• |
the costs of obtaining clinical and commercial supplies of Oxbryta, inclacumab and any other product candidates we may identify and develop;
|
• |
our ability to advance our development programs, including for Oxbryta, inclacumab and any other potential product candidate programs we may identify and pursue, the timing and scope of these development activities, and the availability of approval for any of our other product candidates;
|
• |
our ability to successfully obtain any additional regulatory approvals from any regulatory authorities, and the scope of any such regulatory approvals, to market and sell Oxbryta, inclacumab and any other product candidates we may identify and develop in any territory(ies);
|
• |
the cash requirements of any future acquisitions or discovery of product candidates;
|
• |
the time and cost necessary to respond to technological and market developments;
|
• |
the extent to which we may acquire or
in-license
other product candidates and technologies, and the costs and timing associated with any such acquisitions or
in-licenses;
|
• |
our ability to attract, hire, and retain qualified personnel; and
|
• |
the costs of maintaining, expanding, and protecting our intellectual property portfolio.
|
Six Months Ended June 30,
|
||||||||
2021
|
2020
|
|||||||
Cash used in operating activities
|
$ | (123,577 | ) | $ | (126,103 | ) | ||
Cash provided by investing activities
|
$ | 45,750 | $ | 199,884 | ||||
Cash provided by financing activities
|
$ | 2,072 | $ | 8,698 | ||||
Effect of exchange rate changes on cash and cash equivalents
|
$ | 259 | $ | — | ||||
|
|
|
|
|||||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
$ | (75,496 | ) | $ | 82,479 | |||
|
|
|
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
• |
Our business is substantially dependent on our ability to successfully commercialize our first approved product, Oxbryta, which will depend upon the degree of market acceptance by the medical community and marketplace.
|
• |
If our sales and marketing capabilities for Oxbryta or any product candidate for which we receive regulatory approval are not effective, we may not succeed in our commercialization efforts.
|
• |
Our profitability depends on our ability to sell sufficient amounts of product at competitive prices and on the availability of adequate coverage and reimbursement through governmental or private third-party payors, the status of which is subject to significant uncertainty.
|
• |
Our future growth may depend on our ability to penetrate foreign markets, which would subject us to additional regulatory burdens and other risks and uncertainties.
|
• |
We will be subject to ongoing regulatory obligations and scrutiny for Oxbryta and any other product candidate for which we receive approval, which may include restrictions on product labeling, distribution or other post-marketing activities.
|
• |
Our business operations and relationships with third parties are subject to various laws and regulations, and any failure to comply with such laws and regulations could adversely affect our business.
|
• |
We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that render our only approved product, Oxbryta, or product candidates uneconomical or obsolete, which could adversely affect our development programs, commercialization activities and financial condition.
|
• |
If the market for Oxbryta or our product candidates is smaller than expected, our business and financial condition may be adversely affected.
|
• |
We have a limited operating history, with only one drug approved for marketing, and expect to continue to incur losses for the foreseeable future.
|
• |
We may require substantial additional funds to achieve our business goals, and any inability to obtain such funds may force us to delay, limit or terminate our commercialization of Oxbryta or our other product development efforts and operations.
|
• |
We are party to a loan and security agreement that contains operating covenants and obligations that may restrict our business and financing activities.
|
• |
If we are unable to obtain regulatory approval in additional jurisdictions for Oxbryta or in any jurisdictions for other product candidates, our business will be substantially harmed.
|
• |
All of our programs other than Oxbryta are still in earlier development stages, so we remain very reliant on the potential success of Oxbryta in the clinic and in the marketplace.
|
• |
Expedited development and regulatory approval programs for Oxbryta or other product candidates may not lead to a faster development or regulatory review or approval process, or to a timely approval, if at all.
|
• |
The development of Oxbryta represents a novel therapeutic approach, and the outcomes of our clinical trials may not support any label expansion or any decision to seek, grant or maintain any regulatory approval.
|
• |
Results of earlier studies may not be predictive of future clinical trial results, and initial studies may not establish or maintain an adequate safety or efficacy profile for Oxbryta or a product candidate to justify proceeding to advanced clinical trials or an application for regulatory approval.
|
• |
We may encounter substantial delays in conducting or completing our clinical trials, including due to difficulties in enrolling patients or maintaining compliance with trial protocols, or the occurrence of serious adverse events or unacceptable side effects.
|
• |
We may not realize the expected benefits of the orphan drug designations we have received for Oxbryta, and we may not receive orphan drug designation for any product candidate.
|
• |
If the third parties upon which we rely to conduct our clinical trials, nonclinical studies, manufacturing and other activities related to the development and commercialization of Oxbryta and our product candidates fail to meet regulatory requirements or otherwise do not perform in a satisfactory manner, our business will be harmed.
|
• |
If we or our licensors are unable to obtain and maintain intellectual property protection that is adequate in scope and duration for Oxbryta or our product candidates, our ability to successfully commercialize Oxbryta and other product candidates will be impaired.
|
• |
We may become subject to litigation, claims and investigations, including healthcare compliance claims, product liability claims or claims alleging infringement of third parties’ proprietary rights and/or seeking to invalidate our patents, which would be costly and could impair our development and commercialization efforts.
|
• |
If we are unable to protect the confidentiality of our trade secrets or other confidential information, our business would be harmed.
|
• |
The
COVID-19
pandemic has adversely impacted, and may continue to adversely impact, our business, including our commercialization activities, clinical trials and preclinical studies.
|
• |
Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel, including an adequate sales force, as well as managing our growth.
|
• |
If we are not successful in discovering, developing, acquiring or commercializing additional product candidates, our ability to expand our business and achieve our strategic objectives could be impaired.
|
• |
Any collaboration, license, distribution or other arrangements that we are a party to or may enter into in the future may not be successful.
|
• |
Our operating results may fluctuate significantly, which makes our future operating results difficult to predict.
|
• |
We do not currently intend to pay dividends on our common stock, and, consequently, our stockholders’ ability to achieve a return on their investment will depend on appreciation in the price of our common stock.
|
• |
the demonstrated efficacy and potential advantages of our drugs compared to alternative treatments;
|
• |
our ability to offer our drugs for sale at competitive prices;
|
• |
the availability of third-party coverage and adequate reimbursement;
|
• |
the convenience and ease of administration of our drugs compared to alternative current and future treatments;
|
• |
the willingness of the SCD or other target patient populations to try new therapies and of physicians to prescribe these therapies;
|
• |
the availability of our drugs and our ability to meet market demand, including a reliable supply for long-term chronic treatment;
|
• |
the strength of labeling, marketing and distribution support;
|
• |
the clinical indications and approved labeling for which the drug is approved, including labeling restrictions for drugs approved under Subpart H, such as Oxbryta;
|
• |
the prevalence and severity of any side effects and overall safety profile of the drug; and
|
• |
any restrictions on the use of the drug, including together with other medications.
|
• |
the burden of complying with complex and changing foreign regulatory, tax, accounting, compliance and legal requirements;
|
• |
different medical practices and customs in foreign countries affecting acceptance in the marketplace;
|
• |
import or export licensing requirements;
|
• |
longer accounts receivable collection times;
|
• |
longer lead times for shipping;
|
• |
language barriers for technical training;
|
• |
reduced protection of intellectual property rights in some foreign countries, and related prevalence of bioequivalent or generic alternatives to therapeutics;
|
• |
foreign currency exchange rate fluctuations;
|
• |
potential resource constraints, including with respect to patients’ ability to obtain reimbursement for our products in foreign markets; and
|
• |
the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.
|
• |
issue untitled or warning letters;
|
• |
impose civil or criminal penalties;
|
• |
impose injunctions;
|
• |
impose fines;
|
• |
impose additional specialized restrictions on the company’s activities and practices;
|
• |
suspend regulatory approval;
|
• |
suspend ongoing clinical trials;
|
• |
seek voluntary product recalls and impose publicity requirements;
|
• |
refuse to approve pending applications or supplements to approved applications submitted by us;
|
• |
impose restrictions on our operations, including closing our contract manufacturers’ facilities; or
|
• |
seize or detain products.
|
• |
commercialize Oxbryta and continue related clinical development, including conducting (i) our Phase 2a HOPE-KIDS 1 Study of Oxbryta, (ii) our Phase 3 HOPE-KIDS 2 Study, which we intend to serve as our post-confirmatory study of Oxbryta in SCD (and any other post-marketing studies that may be required by regulatory authorities, if any), and (iii) any additional clinical trials of Oxbryta we may conduct now or in the future in SCD patients or for any other indications for Oxbryta, inclacumab or any other product candidates, if any;
|
• |
establish and maintain manufacturing and supply relationships with third parties that can provide adequate supplies (in amount and quality) of Oxbryta, inclacumab or any other product candidates to support commercialization and further clinical development;
|
• |
seek and obtain additional regulatory and marketing approvals for Oxbryta for SCD, including for younger pediatric patient populations, or any potential approvals we may pursue for other product candidates;
|
• |
maintain a sales and marketing organization and enter into selected collaborations to commercialize Oxbryta for SCD or any other approved indication, as well as for any other product candidates;
|
• |
maintain a medical affairs organization to advance our engagement with healthcare providers and stakeholders;
|
• |
advance our other programs, including inclacumab and any other product candidates, through nonclinical and clinical development and commence development activities for any additional product candidates we may identify and pursue; and
|
• |
expand our organization to support our commercialization, research, development and medical activities and our operations as a public company.
|
• |
our ability to successfully commercialize Oxbryta, inclacumab and any other product candidates we may identify and develop in the United States or any other territories;
|
• |
the manufacturing, selling, and marketing costs associated with the commercialization of Oxbryta and the potential commercialization of inclacumab and any other product candidates we may identify and develop, including the cost and timing of establishing or maintaining our sales and marketing capabilities in any territory(ies);
|
• |
the amount and timing of sales and other revenues from Oxbryta, inclacumab and any other product candidates we may identify and develop, including the sales price and the availability of adequate third-party reimbursement;
|
• |
the time and cost necessary to conduct and complete multiple ongoing studies (including our HOPE-KIDS 1 Study, our Phase 3 HOPE-KIDS 2 Study and other studies);
|
• |
the time and cost necessary to conduct and complete any additional clinical studies required to pursue additional regulatory approvals for Oxbryta for SCD, including our Phase 3 HOPE-KIDS 2 Study (which is necessary to move from our current Subpart H approval to a full approval) and any studies to support potential label expansions into younger SCD pediatric populations, or any other post-marketing studies for Oxbryta for SCD;
|
• |
the progress, data and results of clinical trials of Oxbryta and product candidates;
|
• |
the progress, timing, scope and costs of our nonclinical studies, our clinical trials and other related activities, including our ability to enroll subjects in a timely manner for our ongoing and future clinical trials of Oxbryta, inclacumab or any other product candidate that we may identify and develop;
|
• |
the costs of obtaining clinical and commercial supplies of Oxbryta, inclacumab and any other product candidates we may identify and develop;
|
• |
our ability to advance our development programs, including for Oxbryta, inclacumab and any other potential product candidate programs we may identify and pursue, the timing and scope of these development activities, and the availability of approval for any of our other product candidates;
|
• |
our ability to successfully obtain any additional regulatory approvals from any regulatory authorities, and the scope of any such regulatory approvals, to market and sell Oxbryta, inclacumab and any other product candidates we may identify and develop in any territory(ies);
|
• |
the cash requirements of any future acquisitions or discovery of product candidates;
|
• |
the time and cost necessary to respond to technological and market developments;
|
• |
the extent to which we may acquire or
in-license
other product candidates and technologies, and the costs and timing associated with any such acquisitions or
in-licenses;
|
• |
our ability to attract, hire, and retain qualified personnel; and
|
• |
the costs of maintaining, expanding, and protecting our intellectual property portfolio.
|
• |
sell, transfer or otherwise dispose of any of our business or property, subject to limited exceptions;
|
• |
make certain changes to our organizational structure;
|
• |
consolidate or merge with other entities or acquire other entities;
|
• |
incur additional indebtedness or create encumbrances on our assets;
|
• |
pay dividends, other than dividends paid solely in shares of our common stock, or make distributions on and, in certain cases, repurchase our stock;
|
• |
repay subordinated indebtedness; or
|
• |
make certain investments.
|
• |
we may not be able to demonstrate to the satisfaction of regulatory authorities (including the FDA and comparable foreign regulatory authorities) that Oxbryta, inclacumab or any other product candidates we may develop are safe and effective for any proposed indications;
|
• |
the FDA or comparable foreign regulatory authorities may disagree with our plans or expectations regarding the pathways and endpoints for approval, including the availability of accelerated approval, or the design or implementation of our nonclinical studies or clinical trials;
|
• |
the populations studied in our clinical programs may not be sufficiently broad or representative to assure safety or demonstrate efficacy in the full population for which we seek approval;
|
• |
the FDA or comparable foreign regulatory authorities may require additional nonclinical studies or clinical trials beyond those we anticipate;
|
• |
the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data and results from our nonclinical studies or clinical trials;
|
• |
the data and results collected from nonclinical studies or clinical trials of Oxbryta, inclacumab and any other product candidates that we may identify and pursue may not be sufficient to support the submission for regulatory approval;
|
• |
we may be unable to demonstrate to the FDA or comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
|
• |
the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we contract and rely on for all clinical and commercial supplies of Oxbryta, inclacumab and any other product candidates (if any); and
|
• |
the approval policies or regulations of the FDA or comparable foreign regulatory authorities may change in a manner that renders our development or manufacturing efforts insufficient for approval.
|
• |
delays or failures in reaching a consensus with regulatory agencies on study design, including clinical endpoints sufficient to support an approval decision;
|
• |
delays or failures to receive approval to conduct clinical studies in one or more geographies, which could result in delays in enrollment and availability of data and results;
|
• |
delays or failures in reaching agreement on acceptable terms with a sufficient number of prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
|
• |
delays in obtaining required Institutional Review Board, or IRB, or ethics committee approval for each clinical trial site;
|
• |
delays in recruiting a sufficient number of suitable patients to participate in our clinical trials, which could be due to, among other things, competition for such patients as a result of other clinical trials we are conducting, as well as sickle cell-related clinical trials of other entities, that target the same or similar patient populations;
|
• |
imposition of a clinical hold by any regulatory authority, including if imposed due to safety concerns after an inspection of our clinical trial operations or study sites;
|
• |
failure by our CROs, clinical sites, participating clinicians or patients, other third parties or us to adhere to clinical trial, regulatory or legal requirements;
|
• |
failure to perform in accordance with the FDA’s good clinical practices, or GCPs, or applicable regulatory requirements in other countries;
|
• |
delays in the testing, validation, manufacturing and delivery of sufficient quantities of Oxbryta or our product candidates or study related devices to the clinical sites and patients;
|
• |
delays in having patients enroll or complete participation in a study in accordance with applicable protocols or protocol amendments or return for post-treatment
follow-up;
|
• |
reduction in the number of participating clinical trial sites or patients, including by dropping out of a trial;
|
• |
failure to address in an adequate or timely manner any patient safety concerns that arise during the course of a trial;
|
• |
unanticipated costs or increases in costs of clinical trials of Oxbryta or our product candidates;
|
• |
the occurrence of serious adverse events or other safety concerns associated with Oxbryta or our product candidates; or
|
• |
changes in regulatory requirements and guidance that require amending or submitting new clinical protocols or obtaining additional IRB or other approvals to conduct or complete clinical studies of Oxbryta or our product candidates.
|
• |
reliance on the third party for regulatory compliance and quality assurance;
|
• |
the possible breach or termination of the manufacturing agreement by the third party or by us, including at a time that is costly or inconvenient for us;
|
• |
the inability of the third party to satisfy our ordering requirements as to quality, quantity and/or price, including, without limitation, potential impact on supply chain due to the impact of public health risks, such as the
COVID-19
pandemic;
|
• |
the possible misappropriation of our proprietary information, including our trade secrets and
know-how;
and
|
• |
the unwillingness of the third party to extend or renew terms with us when desired.
|
• |
the research methodology used may not be successful in identifying potential product candidates;
|
• |
competitors may develop alternatives that render our product candidates obsolete or less attractive;
|
• |
product candidates we develop may nevertheless be covered by third parties’ patents or other exclusive rights;
|
• |
the market for a product candidate may change during our program so that such a product may become unreasonable to continue to develop;
|
• |
a product candidate may on further study be shown to have harmful side effects, lack of potential efficacy or other characteristics that indicate it is unlikely to meet applicable regulatory criteria or remain reasonable to continue to develop;
|
• |
a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and
|
• |
a product candidate may not be accepted as safe and effective by patients, the medical community or third-party payors, if applicable.
|
• |
impairment of our business reputation;
|
• |
withdrawal of clinical trial participants;
|
• |
costs due to related litigation;
|
• |
distraction of management’s attention from our primary business;
|
• |
substantial monetary awards to patients or other claimants;
|
• |
increased warnings on product labels or additional restrictions imposed by regulatory authorities;
|
• |
the recall of Oxbryta or our product candidates;
|
• |
the inability to commercialize Oxbryta or our product candidates; and
|
• |
decreased demand for Oxbryta or our product candidates, if approved for commercial sale.
|
• |
restrictions and obligations imposed by privacy regulations, such as provisions under the GDPR, applicable to the collection and use of personal health data in the EU;
|
• |
multiple, conflicting, and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements, and any requirements to obtain other governmental approvals, permits, and licenses;
|
• |
failure by us to obtain and maintain regulatory approvals for the sale or use of our products in various countries;
|
• |
additional potentially relevant third-party patent rights;
|
• |
complexities and difficulties in obtaining protection for and enforcing our intellectual property;
|
• |
difficulties in staffing and managing our current and potential foreign operations;
|
• |
complexities associated with managing multiple payor reimbursement regimes, government payors, or patient
self-pay
systems;
|
• |
limits in our ability to penetrate international markets;
|
• |
financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our products, and exposure to foreign currency exchange rate fluctuations;
|
• |
natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions;
|
• |
certain expenses including, among others, expenses for travel, translation, and insurance; and
|
• |
regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the FCPA, its books and records provisions, or its anti-bribery provisions.
|
• |
comply with EMA or FDA regulations or similar regulations of comparable foreign regulatory authorities;
|
• |
provide accurate information to the FDA or EMA or comparable foreign regulatory authorities;
|
• |
comply with cGMP regulations and manufacturing standards that we have established and comply with applicable healthcare fraud and abuse regulations in the jurisdictions in which we operate;
|
• |
report financial information or data accurately; or
|
• |
disclose unauthorized activities to us.
|
• |
failure to successfully develop and commercialize Oxbryta, inclacumab or any other product candidates, especially results relating to our commercialization of Oxbryta in the United States;
|
• |
adverse results or delays in, or the halting of, our nonclinical studies or clinical trials, especially in our ongoing or future clinical program for Oxbryta for the treatment of SCD;
|
• |
reports of adverse events from our commercialization or clinical trials of Oxbryta, or from clinical trials of any other product candidates that we may develop;
|
• |
any delay in the review of, or potential action with respect to, our previous or planned filing of any IND, NDA or MAA for Oxbryta, inclacumab or for any other product candidates that we may develop and any adverse development or perceived adverse development with respect to the FDA’s or any other regulatory agency’s review of such filing;
|
• |
adverse regulatory decisions affecting Oxbryta, inclacumab or any other product candidates we may develop, including any delay in or denial of potential approval in accordance with our plans and expectations;
|
• |
inability to obtain additional funding;
|
• |
failure to prosecute, maintain or enforce our intellectual property rights;
|
• |
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;
|
• |
changes in laws or regulations applicable to Oxbryta or future products;
|
• |
inability to obtain adequate product supply for Oxbryta or our product candidates or the inability to do so at acceptable prices;
|
• |
introduction of new products, services or technologies by our competitors;
|
• |
failure to enter into or perform under strategic collaborations;
|
• |
failure to meet or exceed any financial projections that we or the investment community may provide;
|
• |
the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
|
• |
announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
|
• |
additions or departures of key scientific or management personnel;
|
• |
significant lawsuits, including patent or stockholder litigation;
|
• |
changes in the market valuations of similar companies;
|
• |
sales of our common stock by us or our stockholders in the future;
|
• |
trading volume of our common stock; and
|
• |
the other risks described in this “Risk Factors” section.
|
• |
our ability to successfully commercialize Oxbryta in the United States or any other jurisdictions, or any of our product candidates, if approved, and the timing and costs of our commercialization activities;
|
• |
the timing and cost of, and level of investment in, research and development activities relating to Oxbryta and our product candidates, which may change from time to time;
|
• |
the timing and success or failure of clinical trials for Oxbryta and our product candidates or competing product candidates, or any other change in the competitive landscape of our industry, including consolidation among our competitors or partners;
|
• |
our ability to obtain and maintain full regulatory approval for Oxbryta in the United States (including potential pediatric approval) and to obtain regulatory approval of Oxbryta outside of the United States (including potential European approval) as well as regulatory approval for our product candidates, and the timing and scope of any such approvals we may receive;
|
• |
the cost of manufacturing Oxbryta and our product candidates, which may vary depending on the quantity of production and the terms of our agreements with manufacturers;
|
• |
our ability to attract, hire, train and retain qualified personnel;
|
• |
expenditures that we will or may incur to acquire or develop additional product candidates and technologies;
|
• |
the level of demand for Oxbryta and our product candidates, if approved, which may vary significantly;
|
• |
future accounting pronouncements or changes in our accounting policies;
|
• |
the risk/benefit profile, cost and reimbursement policies with respect to Oxbryta and our products candidates, if approved, and existing and potential future drugs that compete with Oxbryta and our product candidates;
|
• |
whether Oxbryta or any of our product candidates are subject to any compliance-related challenges or sanctions, or any intellectual-property related challenges; and
|
• |
the changing and volatile U.S., European and global economic environments, including economic volatility as a result of the
COVID-19
pandemic.
|
• |
authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock;
|
• |
create a classified board of directors whose members serve staggered three-year terms;
|
• |
specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, our chief executive officer or our president;
|
• |
prohibit stockholder action by written consent;
|
• |
establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;
|
• |
provide that our directors may be removed only for cause;
|
• |
provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even though less than a quorum;
|
• |
specify that no stockholder is permitted to cumulate votes at any election of directors;
|
• |
expressly authorize our board of directors to modify, alter or repeal our amended and restated bylaws; and
|
• |
require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated bylaws.
|
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
|
* |
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 Form
10-Q,
irrespective of any general incorporation language contained in such filing.
|
# |
Represents management compensation plan, contract or arrangement.
|
Global Blood Therapeutics, Inc.
|
||||||
Date: August 3, 2021 | By: |
/s/ Ted W. Love, M.D.
|
||||
Ted W. Love, M.D.
President and Chief Executive Officer
(Principal Executive Officer)
|
||||||
Date: August 3, 2021 | By: |
/s/ Jeffrey Farrow
|
||||
Jeffrey Farrow
Chief Financial Officer
(Principal Financial Officer)
|
Exhibit 10.1
November 23, 2020
Kim M. Smith-Whitley, MD
Dear Kim,
Global Blood Therapeutics, Inc. (the Company) is pleased to offer you employment on the following terms:
1. Position. Your title will be EVP, Head of Research & Development, and you will report to Ted Love, President and CEO. This is a full-time position. While you render services to the Company, you will not engage in any other employment, consulting or other business activity (whether full-time or part-time) that would create a conflict of interest with the Company. By signing this letter agreement, you confirm to the Company that you have no contractual commitments or other legal obligations that would prohibit you from performing your duties for the Company.
2. Cash Compensation. The Company will pay you a starting salary at the rate of $510,000 per year, payable in accordance with the Companys standard payroll schedule. This salary will be subject to adjustment pursuant to the Companys employee compensation policies in effect from time to time. In addition to your base salary, you will be eligible to participate in the annual performance-based Cash Incentive Bonus Plan, which is based on the achievement of Company performance goals and your personal goals to be set with your manager. Your initial bonus target for the Companys fiscal year (January 1 through December 31) shall be 50% of your base salary and will be paid according to the terms of the Bonus Plan, which is subject to change at the Companys discretion, and prorated accordingly for any fiscal year in which you do not work a full twelve months. If your employment start date is before October 1st, you will be eligible for a bonus payment for the applicable fiscal year, otherwise you will participate in the following fiscal year.
3. Employee Benefits. As a regular employee of the Company, you will be eligible to participate in a number of Company-sponsored benefits. Should you decide to participate in the Company health benefits program, your coverage will begin the first day of the month following your start date. In addition, you will be entitled to accrue up to 20 days of paid time off per year in accordance with the Companys policy.
4. Equity. Subject to the approval of the Companys Board of Directors or its designee, you will be granted equity awards as described in this section, consisting of a stock option award, an award of restricted stock units with time-based vesting, and an award of restricted stock units with performance-based vesting. Specifically, you will be granted an option to purchase 35,500 shares of the Companys Common Stock. The option will be subject to the terms and conditions applicable to options granted under the Companys Amended and Restated 2017 Inducement Equity Plan (the 2017 Plan), as described in the 2017 Plan and the applicable stock option agreement. The exercise price per share will be determined when the option is granted. You will vest in 25% of the option shares 12 months after your employment start date, and the balance will vest in equal quarterly installments of 6.25% per quarter over the next 36 months, in each case subject to your continuous service, as described in the applicable stock option agreement. In addition, you will be granted 24,160 time-based Restricted Stock Units (RSUs) of the Companys Common Stock. This award of RSUs will be subject to the terms and conditions applicable to RSU awards granted under the 2017 Plan, as described in the 2017 Plan and the applicable RSU award agreement. You will vest in 25% of the RSU shares after 12 months of continuous service from the vesting start date specified in the RSU award agreement (with vesting to commence after your employment start date), and the balance will vest in equal six-month installments (of 12.5% per installment) over the next 36 months of continuous service, as described in the applicable RSU award agreement. In addition, you will be granted 42,400 performance-based RSUs of the Companys Common Stock. This award of RSUs will be subject to the terms and conditions applicable to performance-based RSU awards granted under the Companys Amended and Restated 2015 Stock Option and Incentive Plan (the 2015 Plan), as described in the 2015 Plan and the applicable RSU award agreement. You will vest in the performance-based RSUs as follows:
Upon the first instance of the Companys achievement, on or before June 30, 2024, of the applicable Stock Price Hurdles set forth below, subject to your continued employment or other service relationship with the Company through such vesting date (the Hurdle Achievement Date), 50% of the corresponding number of RSUs shall vest on such Hurdle Achievement Date and the remaining 50% of the corresponding number of RSUs shall vest on the first anniversary of such Hurdle Achievement Date, subject to the your continued employment or other service relationship with the Company through such date.
Stock Price Hurdle |
Number of RSUs |
Aggregate
% of Target Award |
||||||
$72.80 |
| | ||||||
$109.20 |
8,480 | (20%) | 20 | % | ||||
$145.60 |
14,840 | (35%) | 55 | % | ||||
$182.00 |
19,080 | (45%) | 100 | % |
The performance-based RSUs shall be subject to additional terms and conditions, including with respect to their treatment upon a Sale Event (as defined in the 2015 Plan), consistent with those applicable to the performance-based RSUs previously approved by the Compensation Committee of the Board and granted to selected employees at the EVP level. This grant of performance based-RSUs is contingent upon the Companys stock price not exceeding $80.00 per share, which is 10% above the base price provided above (with the stock price per share to be calculated based on the 20-trading day average stock price immediately preceding your start of employment).
5. Relocation Bonus. The Company will pay you a one-time bonus of $75,000 (the Relocation Bonus), subject to applicable payroll deductions and tax withholdings if relocation of your primary residence to the Bay Area in Northern California occurs prior to June 30, 2022. If you voluntarily leave the Company or your employment with the Company is terminated by the Company with Cause (as defined in the Change in Control Policy, defined below), on or before the first anniversary of the date the Relocation Bonus is paid, then you agree to repay the total gross amount of the Relocation Bonus within 30 days of your last date of employment.
6. Change in Control. You will be eligible to participate in the Companys Amended and Restated Severance and Change in Control Policy (the Change in Control Policy). In accordance with the policys terms, which the Company retains the right to amend, revise, change or end at any time, if your employment is terminated without Cause (as defined in the Change in Control Policy) within one year after the closing of a Sale Event, you will receive certain benefits provided that you first execute and not revoke a severance agreement including a general release of claims. Currently those benefits are: (a) full acceleration of vesting of your outstanding equity awards under the Companys equity plan applicable to your equity awards (as set forth in the applicable plan); (b) a lump sum equal to twelve months of your base salary; (c) a lump sum equal to your then-current target bonus; and (d) if you are participating in the Company group health plan immediately prior to termination and you elect COBRA, a monthly cash payment for twelve months equal to the Companys monthly premium contribution. This section is not intended to modify the Change in Control Policy and is provided merely as an introductory summary of the policys current terms. A copy of the Change in Control Policy will be available from Human Resources upon request after your start date.
7. Employee Confidentiality and Assignment Agreement. Like all Company employees, you will be required, as a condition of your employment with the Company, to sign the Companys standard Employee Confidentiality and Assignment Agreement, a copy of which is attached hereto as Exhibit A.
8. Background Check. The Company may conduct a background or reference check (or both). If so, then you agree to cooperate fully in those procedures, and this offer is subject to the Companys approving the outcome of those checks, in the discretion of the Company.
9. Employment Relationship. Employment with the Company is for no specific period of time. Your employment with the Company will be at will, meaning that either you or the Company may terminate your employment at any time and for any reason, with or without cause. Any contrary representations that may have been made to you are superseded by this letter agreement. This is the full and complete agreement between you and the Company on this term. Although your job duties, title, reporting relationship, compensation and benefits, as well as the Companys personnel policies and procedures, may change from time to time, the at will nature of your employment may only be changed in an express written agreement signed by both you and a duly authorized officer of the Company.
10. Taxes. All forms of compensation referred to in this letter agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law. You agree that the Company does not have a duty to design its compensation policies in a manner that minimizes your tax liabilities, and you will not make any claim against the Company or its Board of Directors related to tax liabilities arising from your compensation.
11. Interpretation, Amendment and Enforcement. This letter agreement and Exhibit A constitute the complete agreement between you and the Company, contain all of the terms of your employment with the Company and supersede any prior agreements, representations or understandings (whether written, oral or implied) between you and the Company. This letter agreement may not be amended or modified, except by an express written agreement signed by both you and a duly authorized officer of the Company. The terms of this letter agreement and the resolution of any disputes as to the meaning, effect, performance or validity of this letter agreement or arising out of, related to, or in any way connected with, this letter agreement, your employment with the Company or any other relationship between you and the Company will be governed by California law, excluding laws relating to conflicts or choice of law. Prior to your start of employment with the Company, you and the Company intend to enter into a consulting arrangement, in terms and conditions separate from this letter agreement. You understand and agree that none of the terms and conditions of this agreement will apply during the period of your consultancy, which will be governed by a separate contract to be entered into no later than December 18, 2020 (or such other date as you and I (as an authorized party on behalf of the Company) may agree to in writing (without the need to formally amend this offer letter).
* * * * *
We hope that you will accept our offer to join the Company. You may indicate your agreement with these terms and accept this offer by signing this employment agreement and the enclosed Employee Confidentiality and Assignment Agreement and returning them to me. This offer, if not accepted, will expire at 5:00pm on Friday, November 27, 2020. As required by law, your employment with the Company is contingent upon your providing legal proof of your identity and authorization to work in the United States. Your employment is also contingent upon your starting work with the Company on May 3, 2021, or such other date as you and I (as an authorized party of the Company) may agree to in writing (without the need to formally amend this offer letter).
If you have any questions, please call me at [***].
Very truly yours, |
/s/ Eric Fink |
Eric Fink Chief Human Resources Officer GLOBAL BLOOD THERAPEUTICS, INC. |
I have read and accept this employment offer:
/s/ Kim Smith-Whitley |
Kim Smith-Whitley |
Date: 11/14/2020
Attachment
Exhibit A: Employee Confidentiality and Assignment Agreement
Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULES 13a-14(a) AND 15d-14(a) OF THE SECURITIES EXCHANGE ACT, AS ADOPTED
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Ted W. Love, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Global Blood Therapeutics, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
a) |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) |
evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) |
disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: August 3, 2021 |
/s/ Ted W. Love, M.D. |
Ted W. Love, M.D. President and Chief Executive Officer (Principal Executive Officer) |
Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULES 13a-14(a) AND 15d-14(a) OF THE SECURITIES EXCHANGE ACT, AS ADOPTED PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Jeffrey Farrow, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Global Blood Therapeutics, Inc.; |
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. |
The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have: |
a) |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b) |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c) |
evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d) |
disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. |
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and |
b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
Date: August 3, 2021 |
/s/ Jeffrey Farrow |
Jeffrey Farrow |
Chief Financial Officer (Principal Financial Officer) |
Exhibit 32.1
GLOBAL BLOOD THERAPEUTICS, INC.
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Global Blood Therapeutics, Inc. (the Company) on Form 10-Q for the quarter ended June 30, 2021, as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Ted W. Love, President and Chief Executive Officer of the Company, and Jeffrey Farrow, Chief Financial Officer, do each hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
1. |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Ted W. Love, M.D. |
Ted W. Love, M.D. President and Chief Executive Officer (Principal Executive Officer) |
August 3, 2021 |
/s/ Jeffrey Farrow |
Jeffrey Farrow Chief Financial Officer (Principal Financial Officer) |
August 3, 2021
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission 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 the Form 10-Q), irrespective of any general incorporation language contained in such filing.