☒
|
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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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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8
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Item 2.
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18
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Item 3.
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27
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Item 4.
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27
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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.
|
|
|
|
66
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|
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Item 3.
|
|
|
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66
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Item 4.
|
|
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66
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Item 5.
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66
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Item 6.
|
|
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66
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68
|
|
|
June 30, 2020
|
|
December 31, 2019
|
|
||||
|
(Unaudited)
|
|
|
|
||||
Assets
|
|
|
|
|
|
|
||
Current assets:
|
|
|
||||||
Cash and cash equivalents
|
$ |
384,716
|
$ |
302,237
|
||||
Short-term marketable securities
|
156,014
|
307,732
|
||||||
Accounts receivable, net
|
12,471
|
2,637
|
||||||
Inventories
|
27,334
|
1,277
|
||||||
Prepaid expenses and other current assets
|
13,498
|
14,114
|
||||||
Total current assets
|
594,033
|
627,997
|
||||||
Property and equipment, net
|
39,668
|
27,113
|
||||||
Long-term marketable securities
|
33,479
|
85,030
|
||||||
Operating lease
right-of-use
assets
|
51,580
|
52,775
|
||||||
Restricted cash
|
2,395
|
2,395
|
||||||
Other assets, noncurrent
|
512
|
789
|
||||||
Total assets
|
$ |
721,667
|
$ |
796,099
|
||||
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
||||||
Accounts payable
|
$ |
5,690
|
$ |
10,621
|
||||
Accrued liabilities
|
43,733
|
41,358
|
||||||
Accrued compensation
|
16,463
|
17,578
|
||||||
Other liabilities, current
|
3,516
|
1,896
|
||||||
Total current liabilities
|
69,402
|
71,453
|
||||||
Long-term debt
|
73,775
|
73,559
|
||||||
Operating lease liabilities, noncurrent
|
81,903
|
72,359
|
||||||
Other liabilities, noncurrent
|
771
|
34
|
||||||
Total liabilities
|
225,851
|
217,405
|
||||||
Commitments and contingencies
|
|
|
||||||
Stockholders’ equity:
|
|
|
||||||
Preferred stock, $0.001 par value, 5,000,000 shares authorized as of June 30, 2020 (unaudited) and December 31, 2019; no shares issued and outstanding
|
—
|
—
|
||||||
Common stock, $0.001 par value, 150,000,000 shares authorized as of June 30, 2020 (unaudited) and December 31, 2019, respectively; 61,330,987 and 60,644,380 shares issued and outstanding as of June 30, 2020 (unaudited) and December 31, 2019, respectively
|
61
|
61
|
||||||
Additional
paid-in
capital
|
1,359,310
|
1,316,795
|
||||||
Accumulated other comprehensive income
|
1,227
|
754
|
||||||
Accumulated deficit
|
(864,782
|
) |
(738,916
|
) | ||||
Total stockholders’ equity
|
495,816
|
578,694
|
||||||
Total liabilities and stockholders’ equity
|
$ |
721,667
|
$ |
796,099
|
||||
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
||||||||
Product sales, net
|
$ |
31,501
|
$ |
—
|
$ |
45,619
|
$ |
—
|
||||||||
Costs and operating expenses:
|
|
|
|
|
||||||||||||
Cost of sales
|
377
|
—
|
512
|
—
|
||||||||||||
Research and development
|
34,085
|
36,010
|
73,858
|
70,476
|
||||||||||||
Selling, general and administrative
|
49,075
|
24,794
|
96,736
|
42,849
|
||||||||||||
Total costs and operating expenses
|
83,537
|
60,804
|
171,106
|
113,325
|
||||||||||||
Loss from operations
|
(52,036
|
) |
(60,804
|
) |
(125,487
|
) |
(113,325
|
) | ||||||||
Other income (expense):
|
|
|
|
|
||||||||||||
Interest income
|
1,514
|
3,706
|
4,370
|
7,537
|
||||||||||||
Interest expense
|
(2,282
|
) |
(160
|
) |
(4,596
|
) |
(341
|
) | ||||||||
Other expenses, net
|
(36
|
) |
(63
|
) |
(153
|
) |
(115
|
) | ||||||||
Total other income, net
|
(804
|
) |
3,483
|
(379
|
) |
7,081
|
||||||||||
Net loss
|
(52,840
|
) |
(57,321
|
) |
(125,866
|
) |
(106,244
|
) | ||||||||
Other comprehensive loss:
|
|
|
|
|
||||||||||||
Net unrealized gain on marketable securities, net of tax
|
12
|
615
|
472
|
1,239
|
||||||||||||
Comprehensive loss
|
$ |
(52,828
|
) | $ |
(56,706
|
) | $ |
(125,394
|
) | $ |
(105,005
|
) | ||||
Basic and diluted net loss per common share
|
$ |
(0.86
|
) | $ |
(1.01
|
) | $ |
(2.06
|
) | $ |
(1.88
|
) | ||||
Weighted-average number of shares used in computing basic and diluted net loss per common share
|
61,116,707
|
56,539,760
|
60,952,269
|
56,386,560
|
||||||||||||
Common Stock
|
Additional
Paid- In Capital |
Accumulated
Other Comprehensive Income |
Accumulated
Deficit |
Total
Stockholders’ Equity |
||||||||||||||||||||
Shares
|
Amount
|
|||||||||||||||||||||||
Balance at December 31, 2019
|
60,644,380
|
$ |
61
|
$ |
1,316,795
|
$ |
754
|
$ |
(738,916
|
) | $ |
578,694
|
||||||||||||
Issuance of common stock upon exercise of stock options
|
33,937
|
—
|
967
|
—
|
—
|
967
|
||||||||||||||||||
Issuance of common stock upon vesting of restricted share units, net of shares withheld for employee taxes
|
160,594
|
—
|
(2,099
|
) |
—
|
—
|
(2,099
|
) | ||||||||||||||||
Issuance of common stock pursuant to ESPP purchases
|
47,460
|
—
|
1,870
|
—
|
—
|
1,870
|
||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
16,705
|
—
|
—
|
16,705
|
||||||||||||||||||
Net unrealized gain on marketable securities
|
—
|
—
|
—
|
461
|
—
|
461
|
||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(73,026
|
) |
(73,026
|
) | ||||||||||||||||
Balance at March 31, 2020
|
60,886,371
|
$ |
61
|
$ |
1,334,238
|
$ |
1,215
|
$ |
(811,942
|
) | $ |
523,572
|
||||||||||||
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 expense
|
—
|
—
|
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
|
||||||||||||
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
|
||||||||||||
|
June 30, 2020
|
|||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||||||
Financial Assets:
|
|
|
|
|
||||||||||||
Money market funds
|
$ |
384,515
|
$ |
384,515
|
$ |
—
|
$ |
—
|
||||||||
Corporate debt securities
|
84,046
|
—
|
84,046
|
—
|
||||||||||||
U.S. government agency securities
|
43,524
|
—
|
43,524
|
—
|
||||||||||||
Certificates of deposits
|
3,899
|
—
|
3,899
|
—
|
||||||||||||
U.S. government securities
|
58,025
|
—
|
58,025
|
—
|
||||||||||||
Total financial assets
|
$ |
574,009
|
$ |
384,515
|
$ |
189,494
|
$ |
—
|
||||||||
|
December 31, 2019
|
|||||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
||||||||
Financial Assets:
|
|
|
|
|
||||||||||||
Money market funds
|
$ |
250,535
|
$ |
250,535
|
$ |
—
|
$ |
—
|
||||||||
Corporate debt securities
|
152,149
|
—
|
152,149
|
—
|
||||||||||||
U.S. government agency securities
|
95,032
|
—
|
95,032
|
—
|
||||||||||||
Certificates of deposits
|
6,282
|
—
|
6,282
|
—
|
||||||||||||
U.S. government securities
|
140,244
|
—
|
140,244
|
—
|
||||||||||||
Total financial assets
|
$ |
644,242
|
$ |
250,535
|
$ |
393,707
|
$ |
—
|
||||||||
|
June 30, 2020
|
December 31, 2019
|
||||||||||||||||||||||||||||||
|
Amortized
Cost |
|
Unrealized
Gains |
|
Unrealized
(Losses) |
|
Estimated Fair
Value |
|
Amortized
Cost |
|
Unrealized
Gains |
|
Unrealized
(Losses) |
|
Estimated Fair
Value |
|
||||||||||||||||
Financial Assets:
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Money market funds
|
$ |
384,515
|
$ |
—
|
$ |
—
|
$ |
384,515
|
$ |
250,535
|
$ |
—
|
$ |
—
|
$ |
250,535
|
||||||||||||||||
Corporate debt securities
|
83,385
|
661
|
—
|
84,046
|
151,773
|
384
|
(8
|
) |
152,149
|
|||||||||||||||||||||||
U.S. government agency securities
|
43,418
|
108
|
(2
|
) |
43,524
|
94,963
|
73
|
(4
|
) |
95,032
|
||||||||||||||||||||||
Certificates of deposits
|
3,868
|
31
|
—
|
3,899
|
6,239
|
43
|
—
|
6,282
|
||||||||||||||||||||||||
U.S. government securities
|
57,596
|
429
|
—
|
58,025
|
139,978
|
266
|
—
|
140,244
|
||||||||||||||||||||||||
Total
|
$ |
572,782
|
$ |
1,229
|
$ |
(2
|
) | $ |
574,009
|
$ |
643,488
|
$ |
766
|
$ |
(12
|
) | $ |
644,242
|
||||||||||||||
|
June 30, 2020
|
|
December 31, 2019
|
|
||||
Cash and cash equivalents
|
$ |
384,516
|
$ |
251,480
|
||||
Short-term marketable securities
|
156,014
|
307,732
|
||||||
Long-term marketable securities
|
33,479
|
85,030
|
||||||
Total
|
$ |
574,009
|
$ |
644,242
|
||||
|
June 30, 2020
|
|
December 31, 2019
|
|
||||
Raw materials
|
$ |
10,210
|
$ |
700
|
||||
Work-in-process
|
15,617
|
525
|
||||||
Finished goods
|
1,507
|
52
|
||||||
Total inventories
|
$ |
27,334
|
$ |
1,277
|
||||
|
June 30, 2020
|
|
December 31, 2019
|
|
||||
Laboratory equipment
|
$ |
11,612
|
$ |
8,314
|
||||
Computer equipment
|
2,600
|
2,224
|
||||||
Leasehold improvements
|
32,231
|
13,785
|
||||||
Construction-in-progress
|
515
|
19,289
|
||||||
Total property and equipment
|
46,958
|
43,612
|
||||||
Less: accumulated depreciation and amortization
|
(7,290
|
) |
(16,499
|
) | ||||
Property and equipment, net
|
$ |
39,668
|
$ |
27,113
|
||||
|
June 30, 2020
|
|
December 31, 2019
|
|||||
Accrued research and development costs
|
$ |
6,951
|
$ |
26,480
|
||||
Accrued manufacturing costs
|
23,782
|
9,466
|
||||||
Accrued professional and consulting services
|
3,283
|
4,564
|
||||||
Accrued sales deductions
|
5,302
|
529
|
||||||
Other
|
4,415
|
319
|
||||||
Total accrued liabilities
|
$ |
43,733
|
$ |
41,358
|
||||
|
June 30, 2020
|
|
December 31, 2019
|
|||||
Operating lease liabilities, current
|
$ |
3,486
|
$ |
1,866
|
||||
Other payable
|
30
|
30
|
||||||
Total other liabilities, current
|
$ |
3,516
|
$ |
1,896
|
||||
Year ending December 31,
|
Amount
|
|
||
2020 (six months)
|
$ |
3,375
|
||
2021
|
6,750
|
|||
2022
|
6,750
|
|||
2023
|
31,406
|
|||
2024
|
29,156
|
|||
2025
|
26,906
|
|||
Total minimum payments
|
104,343
|
|||
Less amount representing interest
|
(27,843
|
) | ||
Less amount representing Paydown Fee
|
(1,500
|
) | ||
Long-term debt, gross
|
75,000
|
|||
Discount on notes payable
|
(1,411
|
) | ||
Accretion of Paydown Fee
|
186
|
|||
Long-term debt
|
$ |
73,775
|
||
|
Six Months Ended June 30,
|
|||||||
|
2020
|
|
2019
|
|||||
ROU assets obtained in exchange for new operating lease
|
$ |
205
|
$ |
14,177
|
||||
Cash paid for amounts included in the measurement of lease liabilities
|
2,590
|
2,235
|
||||||
Weighted-average remaining lease term of operating leases (in years)
|
9.7
|
8.4
|
||||||
Weighted-average discount rate of operating leases
|
8.7
|
% |
13.2
|
%
|
Year ending December 31,
|
Amount
|
|
||
2020 (
six
months)
|
$ |
4,837
|
||
2021
|
11,822
|
|||
2022
|
12,202
|
|||
2023
|
12,564
|
|||
2024
|
12,927
|
|||
2025
|
13,347
|
|||
Thereafter
|
61,146
|
|||
Total lease payments
|
128,845
|
|||
Less: Imputed interest
|
(43,456
|
) | ||
Present value of operating lease liabilities
|
$ |
85,389
|
||
|
Number of
Options |
|
Weighted-
Average Exercise Price |
|
||||
Outstanding
|
3,573,860
|
$ |
36.24
|
|||||
Options granted
|
666,633
|
65.91
|
||||||
Options exercised
|
(368,391
|
) |
24.39
|
|||||
Options canceled
|
(297,650
|
) |
52.93
|
|||||
Outstanding
|
3,574,452
|
$ |
41.61
|
|||||
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
||||||||
Expected term (in years)
|
5.1-6.1
|
5.3-6.1
|
5.1-6.1
|
5.3-6.1
|
||||||||||||
Volatility
|
71.0%-71.8%
|
70.5%-71.7%
|
69.6%-71.8%
|
70.5%-72.2%
|
||||||||||||
Risk-free interest rate
|
0.4%
|
1.8%-2.4%
|
0.4%-1.8%
|
1.8%-2.6%
|
||||||||||||
Dividend yield
|
—
|
—
|
—
|
—
|
|
Number
of RSUs |
|
Weighted-
Average Grant Date Fair Value |
|
||||
Non-vested
units
|
1,848,772
|
$ |
49.19
|
|||||
RSUs granted
|
1,183,637
|
66.28
|
||||||
RSUs vested
|
(304,495
|
) |
48.25
|
|||||
RSUs forfeited
|
(275,732
|
) |
54.75
|
|||||
Non-vested
units
|
2,452,182
|
$ |
56.93
|
|||||
Stock Price Targets
|
|
Number of Units Allotted
|
$109.20
|
|
82,940
|
$145.60
|
|
145,145
|
$182.00
|
|
186,615
|
|
Number
of
U
nits
|
|
Weighted-
Average Grant Date Fair Value |
|
Weighted-
Average Remaining Vesting Period (years) |
|
Aggregate
Intrinsic Value |
|
||||||||
Non-vested
market-condition awards
|
—
|
$ |
—
|
—
|
|
|||||||||||
Granted
|
414,700
|
49.95
|
|
|
||||||||||||
Vested
|
—
|
—
|
|
|
||||||||||||
Forfeited
|
—
|
—
|
|
|
||||||||||||
Non-vested
market-condition awards
|
414,700
|
$ |
49.95
|
1.71
|
$ |
26,180
|
||||||||||
Valuation date stock price
|
$ |
68.67
|
||
Volatility
|
68.1
|
%
|
||
Risk-free interest rate
|
0.26
|
% | ||
Dividend yield
|
—
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
||||||||
Research and development
|
$ |
3,430
|
$ |
4,715
|
$ |
8,780
|
$ |
8,738
|
||||||||
Selling, general and administrative
|
13,141
|
6,233
|
24,158
|
11,663
|
||||||||||||
Total stock-based compensation expense
|
$ |
16,571
|
$ |
10,948
|
$ |
32,938
|
$ |
20,401
|
||||||||
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
2020
|
|
2019
|
|
2020
|
|
2019
|
|
||||||||
Options to purchase common stock
|
3,574,452
|
3,758,846
|
3,574,452
|
3,758,846
|
||||||||||||
Restricted stock units
|
2,866,882
|
1,730,348
|
2,866,882
|
1,730,348
|
||||||||||||
Total
|
6,441,334
|
5,489,194
|
6,441,334
|
5,489,194
|
||||||||||||
Item 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
June 30, |
$ Change
|
% Change
|
||||||||||||||
2020
|
2019
|
|||||||||||||||
(in thousands, except percentages)
|
||||||||||||||||
Product sales, net
|
$ | 31,501 | $ | — | $ | 31,501 | * | |||||||||
Costs and operating expenses:
|
||||||||||||||||
Cost of sales
|
377 | — | 377 | * | ||||||||||||
Research and development
|
34,085 | 36,010 | (1,925 | ) | (5 | )% | ||||||||||
Selling, general and administrative
|
49,075 | 24,794 | 24,281 | 98 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total costs and operating expenses
|
83,537 | 60,804 | 22,733 | 37 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations
|
(52,036 | ) | (60,804 | ) | 8,768 | (14 | )% | |||||||||
Interest income
|
1,514 | 3,706 | (2,192 | ) | (59 | )% | ||||||||||
Interest expenses
|
(2,282 | ) | (160 | ) | (2,122 | ) | * | |||||||||
Other expenses, net
|
(36 | ) | (63 | ) | 27 | (43 | )% | |||||||||
|
|
|
|
|
|
|||||||||||
Net loss
|
$ | (52,840 | ) | $ | (57,321 | ) | $ | 4,481 | (8 | )% | ||||||
|
|
|
|
|
|
* |
Change is not meaningful
|
Rebates, co-payment
assistance, Medicare Part D coverage gap, product returns and distributor fees |
Prompt payment
discounts and chargebacks |
Total
|
||||||||||
Balances at March 31, 2020
|
$ | 1,997 | $ | 172 | $ | 2,169 | ||||||
Provision related to current period sales
|
3,865 | 924 | 4,789 | |||||||||
Credit or payments made during the period
|
(560 | ) | (812 | ) | (1,372 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at June 30, 2020
|
$
|
5,302
|
|
$
|
284
|
|
$
|
5,586
|
|
|||
|
|
|
|
|
|
• |
employee-related expenses, which include salaries, benefits and stock-based compensation;
|
• |
expenses incurred under agreements with consultants, third-party research firms, manufacturing organizations for products not approved by the FDA and other regulatory authorities, 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 in relation with license agreement; 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,
|
$ Change
|
% Change
|
||||||||||||||
2020
|
2019
|
|||||||||||||||
Costs incurred by development program:
|
||||||||||||||||
Oxbryta for the treatment of SCD
|
$ | 17,602 | $ | 29,490 | $ | (11,888 | ) | (40 | )% | |||||||
Other preclinical programs
|
10,055 | 5,165 | 4,890 | 95 | % | |||||||||||
Inclacumab for the treatment of SCD
|
6,428 | 1,355 | 5,073 | 374 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expenses
|
$ | 34,085 | $ | 36,010 | $ | (1,925 | ) | (5 | )% | |||||||
|
|
|
|
|
|
• |
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, |
$ Change
|
% Change
|
||||||||||||||
2020
|
2019
|
|||||||||||||||
(in thousands, except percentages)
|
||||||||||||||||
Product sales, net
|
$ | 45,619 | $ | — | $ | 45,619 | * | |||||||||
Costs and operating expenses:
|
||||||||||||||||
Cost of sales
|
512 | — | 512 | * | ||||||||||||
Research and development
|
73,858 | 70,476 | 3,382 | 5 | % | |||||||||||
Selling, general and administrative
|
96,736 | 42,849 | 53,887 | 126 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total costs and operating expenses
|
171,106 | 113,325 | 57,781 | 51 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Loss from operations
|
(125,487 | ) | (113,325 | ) | (12,162 | ) | 11 | % | ||||||||
Interest income
|
4,370 | 7,537 | (3,167 | ) | (42 | )% | ||||||||||
Interest expenses
|
(4,596 | ) | (341 | ) | (4,255 | ) | * | |||||||||
Other expenses, net
|
(153 | ) | (115 | ) | (38 | ) | 33 | % | ||||||||
|
|
|
|
|
|
|||||||||||
Net loss
|
$ | (125,866 | ) | $ | (106,244 | ) | $ | (19,622 | ) | 18 | % | |||||
|
|
|
|
|
|
* |
Change is not meaningful
|
Rebates, co-payment
assistance, Medicare Part D coverage gap, product returns and distributor fees |
Prompt payment
discounts and chargebacks |
Total
|
||||||||||
Balances at December 31, 2019
|
$ | 529 | $ | 113 | $ | 642 | ||||||
Provision related to current period sales
|
5,408 | 1,263 | 6,671 | |||||||||
Credit or payments made during the period
|
(635 | ) | (1,092 | ) | (1,727 | ) | ||||||
|
|
|
|
|
|
|||||||
Balance at June 30, 2020
|
$
|
5,302
|
|
$
|
284
|
|
$
|
5,586
|
|
|||
|
|
|
|
|
|
Six Months Ended June 30,
|
$ Change
|
% Change
|
||||||||||||||
2020
|
2019
|
|||||||||||||||
Costs incurred by development program:
|
||||||||||||||||
Oxbryta for the treatment of SCD
|
$ | 41,082 | $ | 57,214 | $ | (16,132 | ) | (28 | )% | |||||||
Other preclinical programs
|
13,156 | 10,527 | 2,629 | 25 | % | |||||||||||
Inclacumab for the treatment of SCD
|
19,620 | 2,735 | 16,885 | 617 | % | |||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expenses
|
$ | 73,858 | $ | 70,476 | $ | 3,382 | 5 | % | ||||||||
|
|
|
|
|
|
• |
our ability to successfully commercialize Oxbryta, inclacumab and any other product candidates we may identify and develop in any 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, Phase 3 HOPE-KIDS 2 Study, our EAPs in the United States and Europe, and our multi-national open label extension, or OLE, study in Phase 3 HOPE Study countries);
|
• |
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;
|
• |
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, |
||||||||
2020
|
2019
|
|||||||
Cash used in operating activities
|
$ | (126,103 | ) | $ | (78,253 | ) | ||
Cash provided by (used in) investing activities
|
199,884 | (74,922 | ) | |||||
Cash provided by financing activities
|
8,698 | 216,272 | ||||||
|
|
|
|
|||||
Net increase in cash, cash equivalents and restricted cash
|
$ | 82,479 | $ | 63,097 | ||||
|
|
|
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors.
|
• |
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 and inclacumab 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;
|
• |
maintain a sales and marketing organization and enter into selected collaborations to commercialize Oxbryta for SCD or any other approved indication;
|
• |
maintain a medical affairs organization to advance our engagement with healthcare providers and stakeholders;
|
• |
advance our other programs, including inclacumab, 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 any 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, Phase 3 HOPE-KIDS 2 Study and our OLE study in Phase 3 HOPE Study countries);
|
• |
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;
|
• |
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 EMA) 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 for conduct of 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;
|
• |
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 General Data Protection Regulation 2016/679, known as GDPR, applicable to the collection and use of personal health data in the European Union;
|
• |
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, including results relating to our launch and 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 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 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 5, 2020 | By: |
/s/ Ted W. Love, M.D.
|
||||
Ted W. Love, M.D.
President and Chief Executive Officer
(Principal Executive Officer)
|
||||||
Date: August 5, 2020 | By: |
/s/ Jeffrey Farrow
|
||||
Jeffrey Farrow
Chief Financial Officer
(Principal Financial Officer)
|
Exhibit 10.1
GLOBAL BLOOD THERAPEUTICS, INC.
AMENDED AND RESTATED 2017 INDUCEMENT EQUITY PLAN
SECTION 1. GENERAL PURPOSE OF THE PLAN; DEFINITIONS
The name of the plan is the Global Blood Therapeutics, Inc. Amended and Restated 2017 Inducement Equity Plan (the Plan). The purpose of the Plan is to enable Global Blood Therapeutics, Inc., a Delaware corporation (the Company), and its Subsidiaries to grant equity awards to induce highly-qualified prospective officers and employees who are not currently employed by the Company or its Subsidiaries to accept employment and to provide them with a proprietary interest in the Company. It is anticipated that providing such persons with a direct stake in the Companys welfare will assure a closer identification of their interests with those of the Company and its stockholders, thereby stimulating their efforts on the Companys behalf and strengthening their desire to remain with the Company. The Company intends that the Plan be reserved for persons to whom the Company may issue securities without stockholder approval as an inducement pursuant to Rule 5635(c)(4) of the Marketplace Rules of the NASDAQ Stock Market, Inc.
The following terms shall be defined as set forth below:
Administrator means either the Board or the compensation committee of the Board or a similar committee performing the functions of the compensation committee and which is comprised of not less than two Non-Employee Directors who are independent.
Award or Awards, except where referring to a particular category of grant under the Plan, shall include Stock Options, Stock Appreciation Rights, Restricted Stock Units, Restricted Stock Awards, Unrestricted Stock Awards and Dividend Equivalent Rights.
Award Certificate means a written or electronic document setting forth the terms and provisions applicable to an Award granted under the Plan. Each Award Certificate is subject to the terms and conditions of the Plan.
Board means the Board of Directors of the Company.
Code means the Internal Revenue Code of 1986, as amended, and any successor Code, and related rules, regulations and interpretations.
Dividend Equivalent Right means an Award entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock specified in the Dividend Equivalent Right (or other award to which it relates) if such shares had been issued to and held by the grantee.
Effective Date means the date on which the Plan is approved by the Board as set forth in Section 18.
Exchange Act means the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder.
Fair Market Value of the Stock on any given date means the fair market value of the Stock determined in good faith by the Administrator; provided, however, that if the Stock is admitted to quotation on the NASDAQ Capital Market, the NASDAQ Global Market, the NASDAQ Global Select Market, the New York Stock Exchange or another national securities exchange, the determination shall be made by reference to the closing price of the Stock as quoted on the applicable exchange. If there is no closing price for such date, the determination shall be made by reference to the last date preceding such date for which there is a closing price.
Non-Employee Director means a member of the Board who is not also an employee of the Company or any Subsidiary.
Option or Stock Option means any option to purchase shares of Stock granted pursuant to Section 5.
Restricted Shares means the shares of Stock underlying a Restricted Stock Award that remain subject to a risk of forfeiture or the Companys right of repurchase.
Restricted Stock Award means an Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time of grant.
Restricted Stock Units means an Award of stock units subject to such restrictions and conditions as the Administrator may determine at the time of grant.
Sale Event shall mean (i) the sale of all or substantially all of the assets of the Company on a consolidated basis to an unrelated person or entity, (ii) a merger, reorganization or consolidation pursuant to which the holders of the Companys outstanding voting power and outstanding stock immediately prior to such transaction do not own a majority of the outstanding voting power and outstanding stock or other equity interests of the resulting or successor entity (or its ultimate parent, if applicable) immediately upon completion of such transaction, (iii) the sale of all of the Stock of the Company to an unrelated person, entity or group thereof acting in concert, or (iv) any other transaction in which the owners of the Companys outstanding voting power immediately prior to such transaction do not own at least a majority of the outstanding voting power of the Company or any successor entity immediately upon completion of the transaction other than as a result of the acquisition of securities directly from the Company.
Sale Price means the value as determined by the Administrator of the consideration payable, or otherwise to be received by stockholders, per share of Stock pursuant to a Sale Event.
Section 409A means Section 409A of the Code and the regulations and other guidance promulgated thereunder.
Stock means the Common Stock, par value $0.001 per share, of the Company, subject to adjustments pursuant to Section 3.
2
Stock Appreciation Right means an Award entitling the recipient to receive shares of Stock having a value equal to the excess of the Fair Market Value of the Stock on the date of exercise over the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock Appreciation Right shall have been exercised.
Subsidiary means any corporation or other entity (other than the Company) in which the Company has at least a 50 percent interest, either directly or indirectly.
Unrestricted Stock Award means an Award of shares of Stock free of any restrictions.
SECTION 2. ADMINISTRATION OF PLAN; ADMINISTRATOR AUTHORITY TO SELECT GRANTEES AND DETERMINE AWARDS
(a) Administration of Plan. The Plan shall be administered by the Administrator.
(b) Powers of Administrator. The Administrator shall have the power and authority to grant Awards consistent with the terms of the Plan, including the power and authority:
(i) to select the individuals to whom Awards may from time to time be granted;
(ii) to determine the time or times of grant, and the extent, if any, of Stock Options, Stock Appreciation Rights, Restricted Stock Awards, Restricted Stock Units, Unrestricted Stock Awards and Dividend Equivalent Rights, or any combination of the foregoing, granted to any one or more grantees;
(iii) to determine the number of shares of Stock to be covered by any Award;
(iv) to determine and modify from time to time the terms and conditions, including restrictions, not inconsistent with the terms of the Plan, of any Award, which terms and conditions may differ among individual Awards and grantees, and to approve the forms of Award Certificates;
(v) to accelerate at any time the exercisability or vesting of all or any portion of any Award;
(vi) subject to the provisions of Section 5(c), to extend at any time the period in which Stock Options may be exercised; and
(vii) at any time to adopt, alter and repeal such rules, guidelines and practices for administration of the Plan and for its own acts and proceedings as it shall deem advisable; to interpret the terms and provisions of the Plan and any Award (including related written instruments); to make all determinations it deems advisable for the administration of the Plan; to decide all disputes arising in connection with the Plan; and to otherwise supervise the administration of the Plan.
All decisions and interpretations of the Administrator shall be binding on all persons, including the Company and Plan grantees.
3
(c) Award Certificate. Awards under the Plan shall be evidenced by Award Certificates that set forth the terms, conditions and limitations for each Award which may include, without limitation, the term of an Award and the provisions applicable in the event employment or service terminates.
(d) Indemnification. Neither the Board nor the Administrator, nor any member of either or any delegate thereof, shall be liable for any act, omission, interpretation, construction or determination made in good faith in connection with the Plan, and the members of the Board and the Administrator (and any delegate thereof) shall be entitled in all cases to indemnification and reimbursement by the Company in respect of any claim, loss, damage or expense (including, without limitation, reasonable attorneys fees) arising or resulting therefrom to the fullest extent permitted by law and/or under the Companys certificate of incorporation or bylaws or any directors and officers liability insurance coverage which may be in effect from time to time and/or any indemnification agreement between such individual and the Company.
(e) Foreign Award Recipients. Notwithstanding any provision of the Plan to the contrary, in order to comply with the laws in other countries in which the Company and its Subsidiaries operate or have employees or other individuals eligible for Awards, the Administrator, in its sole discretion, shall have the power and authority to: (i) determine which Subsidiaries shall be covered by the Plan; (ii) determine which individuals outside the United States are eligible to participate in the Plan; (iii) modify the terms and conditions of any Award granted to individuals outside the United States to comply with applicable foreign laws; (iv) establish subplans and modify exercise procedures and other terms and procedures, to the extent the Administrator determines such actions to be necessary or advisable (and such subplans and/or modifications shall be attached to this Plan as appendices); provided, however, that no such subplans and/or modifications shall increase the share limitation contained in Section 3(a) hereof; and (v) take any action, before or after an Award is made, that the Administrator determines to be necessary or advisable to obtain approval or comply with any local governmental regulatory exemptions or approvals. Notwithstanding the foregoing, the Administrator may not take any actions hereunder, and no Awards shall be granted, that would violate the Exchange Act or any other applicable United States securities law, the Code, or any other applicable United States governing statute or law.
SECTION 3. STOCK ISSUABLE UNDER THE PLAN; MERGERS; SUBSTITUTION
(a) Stock Issuable. The maximum number of shares of Stock reserved and available for issuance under the Plan shall be 3,400,000 shares, subject to adjustment as provided in Section 3(c). For purposes of this limitation, the shares of Stock underlying any Awards under the Plan that are forfeited, canceled, held back upon exercise of an Option or settlement of an Award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of Stock or otherwise terminated (other than by exercise or settlement) shall be added back to the shares of Stock available for issuance under the Plan. In the event the Company repurchases shares of Stock on the open market, such shares shall not be added to the shares of Stock available for issuance under the Plan. Subject to such overall limitation, shares of Stock may be issued up to such maximum number pursuant to any type or types of Award. The shares available for issuance under the Plan may be authorized but unissued shares of Stock or shares of Stock reacquired by the Company.
4
(b) [Reserved].
(c) Changes in Stock. Subject to Section 3(d) hereof, if, as a result of any reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Companys capital stock, the outstanding shares of Stock are increased or decreased or are exchanged for a different number or kind of shares or other securities of the Company, or additional shares or new or different shares or other securities of the Company or other non-cash assets are distributed with respect to such shares of Stock or other securities, or, if, as a result of any merger or consolidation, sale of all or substantially all of the assets of the Company, the outstanding shares of Stock are converted into or exchanged for securities of the Company or any successor entity (or a parent or subsidiary thereof), the Administrator shall make an appropriate or proportionate adjustment in (i) the maximum number of shares reserved for issuance under the Plan, (ii) the number and kind of shares or other securities subject to any then outstanding Awards under the Plan, (iii) the repurchase price, if any, per share subject to each outstanding Restricted Stock Award, and (iv) the exercise price for each share subject to any then outstanding Stock Options and Stock Appreciation Rights under the Plan, without changing the aggregate exercise price (i.e., the exercise price multiplied by the number of Stock Options and Stock Appreciation Rights) as to which such Stock Options and Stock Appreciation Rights remain exercisable. The Administrator shall also make equitable or proportionate adjustments in the number of shares subject to outstanding Awards and the exercise price and the terms of outstanding Awards to take into consideration cash dividends paid other than in the ordinary course or any other extraordinary corporate event. The adjustment by the Administrator shall be final, binding and conclusive. No fractional shares of Stock shall be issued under the Plan resulting from any such adjustment, but the Administrator in its discretion may make a cash payment in lieu of fractional shares.
(d) Mergers and Other Transactions. Except as the Administrator may otherwise specify with respect to particular Awards in the applicable Award Certificate, in the case of and subject to the consummation of a Sale Event, the parties thereto may cause the assumption or continuation of Awards theretofore granted by the successor entity, or the substitution of such Awards with new Awards of the successor entity or parent thereof, with appropriate adjustment as to the number and kind of shares and, if appropriate, the per share exercise prices, as such parties shall agree. To the extent the parties to such Sale Event do not provide for the assumption, continuation or substitution of Awards, the Plan and all outstanding Awards hereunder will terminate upon the effective time of the Sale Event. Notwithstanding the foregoing, the Administrator may, in its discretion or to the extent provided in the relevant Award Certificate, cause certain Awards to become vested and/or exercisable immediately prior to such Sale Event. In the event of such termination, (i) the Company shall have the right, but not the obligation, to make or provide for a cash payment to the grantees holding Options and Stock Appreciation Rights, in exchange for the cancellation thereof, in an amount equal to the difference between (A) the Sale Price multiplied by the number of shares of Stock subject to outstanding Options and Stock Appreciation Rights (to the extent then exercisable after taking into account any acceleration thereunder at prices not in excess of the Sale Price) and (B) the aggregate exercise price of all such outstanding Options and Stock Appreciation Rights; or (ii) each grantee shall be permitted, within a specified period of time prior to the consummation of the Sale Event as determined by the Administrator, to exercise all outstanding Options and Stock Appreciation Rights (to the extent then exercisable) held by such grantee, including those that
5
will become exercisable upon the consummation of the Sale Event (provided that such exercise shall be subject to the consummation of the Sale Event). The Company shall also have the right, but not the obligation, to make or provide a cash payment to the grantees holding other Awards, in exchange for cancellation thereof an amount equal to the Sale Price multiplied by the number of shares subject to such Awards, to be paid at the time of the Sale Event or upon the later vesting of such Awards.
Notwithstanding anything to the contrary herein, in the event a grantees service relationship is terminated by the Company or any successor without Cause within one year following the consummation of a Sale Event, any Awards assumed or substituted in a Sale Event which are subject to vesting conditions, the lapse or achievement of any conditions and/or a right of repurchase in favor of the Company or a successor entity, shall accelerate in full, and any Awards accelerated in such manner with conditions and restrictions relating to the attainment of performance goals will be deemed achieved at one hundred percent (100%) of target levels. As used in this subsection (d) only, Cause shall mean dismissal as a result of (i) any material breach by the grantee of any agreement between the grantee and the Company; (ii) the conviction of, indictment for or plea of nolo contendere by the grantee to a felony or a crime involving moral turpitude; or (iii) any material misconduct or willful and deliberate non-performance (other than by reason of disability) by the grantee of the grantees duties to the Company.
SECTION 4. ELIGIBILITY
Grantees under the Plan will be such full or part-time officers and other employees of the Company and its Subsidiaries to whom the Company may issue securities without stockholder approval in accordance with Rule 5635(c)(4) of the Marketplace Rules of the NASDAQ Stock Market, Inc., as selected from time to time by the Administrator in its sole discretion.
SECTION 5. STOCK OPTIONS
(a) Award of Stock Options. The Administrator may grant Stock Options under the Plan. Any Stock Option granted under the Plan shall be in such form as the Administrator may from time to time approve. All Stock Options granted under the Plan shall be non-qualified stock options.
Stock Options granted pursuant to this Section 5 shall be subject to the following terms and conditions and shall contain such additional terms and conditions, not inconsistent with the terms of the Plan, as the Administrator shall deem desirable.
(b) Exercise Price. The exercise price per share for the Stock covered by a Stock Option granted pursuant to this Section 5 shall be determined by the Administrator at the time of grant but shall not be less than one hundred percent (100%) of the Fair Market Value on the date of grant.
(c) Option Term. The term of each Stock Option shall be fixed by the Administrator, but no Stock Option shall be exercisable more than ten years after the date the Stock Option is granted.
6
(d) Exercisability; Rights of a Stockholder. Stock Options shall become exercisable at such time or times, whether or not in installments, as shall be determined by the Administrator at or after the grant date. The Administrator may at any time accelerate the exercisability of all or any portion of any Stock Option. An optionee shall have the rights of a stockholder only as to shares acquired upon the exercise of a Stock Option and not as to unexercised Stock Options.
(e) Method of Exercise. Stock Options may be exercised in whole or in part, by giving written or electronic notice of exercise to the Company, specifying the number of shares to be purchased. Payment of the purchase price may be made by one or more of the following methods except to the extent otherwise provided in the Option Award Certificate:
(i) In cash, by certified or bank check or other instrument acceptable to the Administrator;
(ii) Through the delivery (or attestation to the ownership following such procedures as the Company may prescribe) of shares of Stock that are not then subject to restrictions under any Company plan. Such surrendered shares shall be valued at Fair Market Value on the exercise date;
(iii) By the optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company for the purchase price; provided that in the event the optionee chooses to pay the purchase price as so provided, the optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a condition of such payment procedure; or
(iv) By a net exercise arrangement pursuant to which the Company will reduce the number of shares of Stock issuable upon exercise by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price.
Payment instruments will be received subject to collection. The transfer to the optionee on the records of the Company or of the transfer agent of the shares of Stock to be purchased pursuant to the exercise of a Stock Option will be contingent upon receipt from the optionee (or a purchaser acting in his stead in accordance with the provisions of the Stock Option) by the Company of the full purchase price for such shares and the fulfillment of any other requirements contained in the Option Award Certificate or applicable provisions of laws (including the satisfaction of any withholding taxes that the Company is obligated to withhold with respect to the optionee). In the event an optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the optionee upon the exercise of the Stock Option shall be net of the number of attested shares. In the event that the Company establishes, for itself or using the services of a third party, an automated system for the exercise of Stock Options, such as a system using an internet website or interactive voice response, then the paperless exercise of Stock Options may be permitted through the use of such an automated system.
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SECTION 6. STOCK APPRECIATION RIGHTS
(a) Award of Stock Appreciation Rights. The Administrator may grant Stock Appreciation Rights under the Plan. A Stock Appreciation Right is an Award entitling the recipient to receive shares of Stock having a value equal to the excess of the Fair Market Value of a share of Stock on the date of exercise over the exercise price of the Stock Appreciation Right multiplied by the number of shares of Stock with respect to which the Stock Appreciation Right shall have been exercised.
(b) Exercise Price of Stock Appreciation Rights. The exercise price of a Stock Appreciation Right shall not be less than one hundred percent (100%) of the Fair Market Value of the Stock on the date of grant.
(c) Grant and Exercise of Stock Appreciation Rights. Stock Appreciation Rights may be granted by the Administrator independently of any Stock Option granted pursuant to Section 5 of the Plan.
(d) Terms and Conditions of Stock Appreciation Rights. Stock Appreciation Rights shall be subject to such terms and conditions as shall be determined from time to time by the Administrator. The term of a Stock Appreciation Right may not exceed ten years.
SECTION 7. RESTRICTED STOCK AWARDS
(a) Nature of Restricted Stock Awards. The Administrator may grant Restricted Stock Awards under the Plan. A Restricted Stock Award is any Award of Restricted Shares subject to such restrictions and conditions as the Administrator may determine at the time of grant. Conditions may be based on continuing employment (or other service relationship) and/or achievement of pre-established performance goals and objectives. The terms and conditions of each such Award Certificate shall be determined by the Administrator, and such terms and conditions may differ among individual Awards and grantees.
(b) Rights as a Stockholder. Upon the grant of the Restricted Stock Award and payment of any applicable purchase price, a grantee shall have the rights of a stockholder with respect to the voting of the Restricted Shares and receipt of dividends; provided that if the lapse of restrictions with respect to the Restricted Stock Award is tied to the attainment of performance goals, any dividends paid by the Company during the performance period shall accrue and shall not be paid to the grantee until and to the extent the performance goals are met with respect to the Restricted Stock Award. Unless the Administrator shall otherwise determine, (i) uncertificated Restricted Shares shall be accompanied by a notation on the records of the Company or the transfer agent to the effect that they are subject to forfeiture until such Restricted Shares are vested as provided in Section 7(d) below, and (ii) certificated Restricted Shares shall remain in the possession of the Company until such Restricted Shares are vested as provided in Section 7(d) below, and the grantee shall be required, as a condition of the grant, to deliver to the Company such instruments of transfer as the Administrator may prescribe.
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(c) Restrictions. Restricted Shares may not be sold, assigned, transferred, pledged or otherwise encumbered or disposed of except as specifically provided herein or in the Restricted Stock Award Certificate. Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 15 below, in writing after the Award is issued, if a grantees employment (or other service relationship) with the Company and its Subsidiaries terminates for any reason, any Restricted Shares that have not vested at the time of termination shall automatically and without any requirement of notice to such grantee from or other action by or on behalf of, the Company be deemed to have been reacquired by the Company at its original purchase price (if any) from such grantee or such grantees legal representative simultaneously with such termination of employment (or other service relationship), and thereafter shall cease to represent any ownership of the Company by the grantee or rights of the grantee as a stockholder. Following such deemed reacquisition of Restricted Shares that are represented by physical certificates, a grantee shall surrender such certificates to the Company upon request without consideration.
(d) Vesting of Restricted Shares. The Administrator at the time of grant shall specify the date or dates and/or the attainment of pre-established performance goals, objectives and other conditions on which the non-transferability of the Restricted Shares and the Companys right of repurchase or forfeiture shall lapse. Subsequent to such date or dates and/or the attainment of such pre-established performance goals, objectives and other conditions, the shares on which all restrictions have lapsed shall no longer be Restricted Shares and shall be deemed vested.
SECTION 8. RESTRICTED STOCK UNITS
(a) Nature of Restricted Stock Units. The Administrator may grant Restricted Stock Units under the Plan. A Restricted Stock Unit is an Award of stock units that may be settled in shares of Stock upon the satisfaction of such restrictions and conditions at the time of grant. Conditions may be based on continuing employment (or other service relationship) and/or achievement of pre-established performance goals and objectives. The terms and conditions of each such Award Certificate shall be determined by the Administrator, and such terms and conditions may differ among individual Awards and grantees. Except in the case of Restricted Stock Units with a deferred settlement date that complies with Section 409A, at the end of the vesting period, the Restricted Stock Units, to the extent vested, shall be settled in the form of shares of Stock. Restricted Stock Units with deferred settlement dates are subject to Section 409A and shall contain such additional terms and conditions as the Administrator shall determine in its sole discretion in order to comply with the requirements of Section 409A.
(b) Rights as a Stockholder. A grantee shall have the rights as a stockholder only as to shares of Stock acquired by the grantee upon settlement of Restricted Stock Units; provided, however, that the grantee may be credited with Dividend Equivalent Rights with respect to the stock units underlying his Restricted Stock Units, subject to the provisions of Section 10 and such other terms and conditions as the Administrator may determine.
(c) Termination. Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 13 below, in writing after the Award is issued, a grantees right in all Restricted Stock Units that have not vested shall automatically terminate upon the grantees termination of employment (or cessation of service relationship) with the Company and its Subsidiaries for any reason.
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SECTION 9. UNRESTRICTED STOCK AWARDS
Grant or Sale of Unrestricted Stock. The Administrator may grant (or sell at par value or such higher purchase price determined by the Administrator) an Unrestricted Stock Award under the Plan. An Unrestricted Stock Award is an Award pursuant to which the grantee may receive shares of Stock free of any restrictions under the Plan. Unrestricted Stock Awards may be granted in respect of past services or other valid consideration, or in lieu of cash compensation due to such grantee.
SECTION 10. DIVIDEND EQUIVALENT RIGHTS
(a) Dividend Equivalent Rights. The Administrator may grant Dividend Equivalent Rights under the Plan. A Dividend Equivalent Right is an Award entitling the grantee to receive credits based on cash dividends that would have been paid on the shares of Stock specified in the Dividend Equivalent Right (or other Award to which it relates) if such shares had been issued to the grantee. A Dividend Equivalent Right may be granted hereunder to any grantee as a component of an award of Restricted Stock Units or Restricted Stock Award or as a freestanding award. The terms and conditions of Dividend Equivalent Rights shall be specified in the Award Certificate. Dividend equivalents credited to the holder of a Dividend Equivalent Right may be paid currently or may be deemed to be reinvested in additional shares of Stock, which may thereafter accrue additional equivalents. Any such reinvestment shall be at Fair Market Value on the date of reinvestment or such other price as may then apply under a dividend reinvestment plan sponsored by the Company, if any. Dividend Equivalent Rights may be settled in cash or shares of Stock or a combination thereof, in a single installment or installments. A Dividend Equivalent Right granted as a component of an Award of Restricted Stock Units or a Restricted Stock Award with performance vesting shall provide that such Dividend Equivalent Right shall be settled only upon settlement or payment of, or lapse of restrictions on, such other Award, and that such Dividend Equivalent Right shall expire or be forfeited or annulled under the same conditions as such other Award.
(b) Termination. Except as may otherwise be provided by the Administrator either in the Award Certificate or, subject to Section 15 below, in writing after the Award is issued, a grantees rights in all Dividend Equivalent Rights or equivalent interest granted as a component of any award of Restricted Stock Units or Restricted Stock Award that has not yet vested shall automatically terminate upon the grantees termination of employment (or cessation of service relationship) with the Company and its Subsidiaries for any reason.
SECTION 11. TRANSFERABILITY OF AWARDS
(a) Transferability. Except as provided in Section 11(b) below, during a grantees lifetime, his or her Awards shall be exercisable only by the grantee, or by the grantees legal representative or guardian in the event of the grantees incapacity. No Awards shall be sold, assigned, transferred or otherwise encumbered or disposed of by a grantee other than by will or by the laws of descent and distribution or pursuant to a domestic relations order. No Awards shall be subject, in whole or in part, to attachment, execution, or levy of any kind, and any purported transfer in violation hereof shall be null and void.
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(b) Administrator Action. Notwithstanding Section 11(a), the Administrator, in its discretion, may provide either in the Award Certificate regarding a given Award or by subsequent written approval that the grantee (who is an employee) may transfer his or her Stock Options to his or her immediate family members, to trusts for the benefit of such family members, or to partnerships in which such family members are the only partners, provided that the transferee agrees in writing with the Company to be bound by all of the terms and conditions of this Plan and the applicable Award. In no event may an Award be transferred by a grantee for value.
(c) Family Member. For purposes of Section 11(b), family member shall mean a grantees child, stepchild, grandchild, parent, stepparent, grandparent, spouse, former spouse, sibling, niece, nephew, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships, any person sharing the grantees household (other than a tenant of the grantee), a trust in which these persons (or the grantee) have more than fifty percent (50%) of the beneficial interest, a foundation in which these persons (or the grantee) control the management of assets, and any other entity in which these persons (or the grantee) own more than fifty percent (50%) of the voting interests.
(d) Designation of Beneficiary. To the extent permitted by the Administrator, each grantee to whom an Award has been made under the Plan may designate a beneficiary or beneficiaries to exercise any Award or receive any payment under any Award payable on or after the grantees death. Any such designation shall be on a form provided for that purpose by the Administrator and shall not be effective until received by the Administrator. If no beneficiary has been designated by a deceased grantee, or if the designated beneficiaries have predeceased the grantee, the beneficiary shall be the grantees estate.
SECTION 12. TAX WITHHOLDING
(a) Payment by Grantee. Each grantee shall, no later than the date as of which the value of an Award or of any Stock or other amounts received thereunder first becomes includable in the gross income of the grantee for Federal income tax purposes, pay to the Company, or make arrangements satisfactory to the Administrator regarding payment of, any Federal, state, or local taxes of any kind required by law to be withheld by the Company with respect to such income. The Company and its Subsidiaries shall, to the extent permitted by law, have the right to deduct any such taxes from any payment of any kind otherwise due to the grantee. The Companys obligation to deliver evidence of book entry (or stock certificates) to any grantee is subject to and conditioned on tax withholding obligations being satisfied by the grantee.
(b) Payment in Stock. Subject to approval by the Administrator, a grantee may elect to have the Companys minimum required tax withholding obligation satisfied, in whole or in part, by authorizing the Company to withhold from shares of Stock to be issued pursuant to any Award a number of shares with an aggregate Fair Market Value (as of the date the withholding is effected) that would satisfy the withholding amount due. For purposes of share withholding, the Fair Market Value of withheld shares shall be determined in the same manner as the value of Stock includible in income of the Participants. The Administrator may also require Awards to be subject to mandatory share withholding up to the required withholding amount. For purposes of share withholding, the Fair Market Value of withheld shares shall be determined in the same manner as the value of Stock includible in income of the Participants.
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SECTION 13. SECTION 409A AWARDS
To the extent that any Award is determined to constitute nonqualified deferred compensation within the meaning of Section 409A (a 409A Award), the Award shall be subject to such additional rules and requirements as specified by the Administrator from time to time in order to comply with Section 409A. In this regard, if any amount under a 409A Award is payable upon a separation from service (within the meaning of Section 409A) to a grantee who is then considered a specified employee (within the meaning of Section 409A), then no such payment shall be made prior to the date that is the earlier of (i) six months and one day after the grantees separation from service, or (ii) the grantees death, but only to the extent such delay is necessary to prevent such payment from being subject to interest, penalties and/or additional tax imposed pursuant to Section 409A. Further, the settlement of any such Award may not be accelerated except to the extent permitted by Section 409A.
SECTION 14. TERMINATION OF EMPLOYMENT, TRANSFER, LEAVE OF ABSENCE, ETC.
(a) Termination of Employment. If the grantees employer ceases to be a Subsidiary, the grantee shall be deemed to have terminated employment for purposes of the Plan.
(b) For purposes of the Plan, the following events shall not be deemed a termination of employment:
(i) a transfer to the employment of the Company from a Subsidiary or from the Company to a Subsidiary, or from one Subsidiary to another; or
(ii) an approved leave of absence for military service or sickness, or for any other purpose approved by the Company, if the employees right to re-employment is guaranteed either by a statute or by contract or under the policy pursuant to which the leave of absence was granted or if the Administrator otherwise so provides in writing.
SECTION 15. AMENDMENTS AND TERMINATION
The Board may, at any time, amend (including to increase the number of shares of Stock reserved and available for issuance hereunder) or discontinue the Plan and the Administrator may, at any time, amend or cancel any outstanding Award for the purpose of satisfying changes in law or for any other lawful purpose, but no such action shall adversely affect rights under any outstanding Award without the holders consent. Except as provided in Section 3(c) or 3(d), without prior stockholder approval, in no event may the Administrator exercise its discretion to reduce the exercise price of outstanding Stock Options or Stock Appreciation Rights or effect repricing through cancellation and re-grants or cancellation of Stock Options or Stock Appreciation Rights in exchange for cash. Nothing in this Section 15 shall limit the Administrators authority to take any action permitted pursuant to Section 3(c) or 3(d).
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SECTION 16. STATUS OF PLAN
With respect to the portion of any Award that has not been settled or exercised and any payments in cash, Stock or other consideration not received by a grantee, a grantee shall have no rights greater than those of a general creditor of the Company unless the Administrator shall otherwise expressly determine in connection with any Award or Awards. In its sole discretion, the Administrator may authorize the creation of trusts or other arrangements to meet the Companys obligations to deliver Stock or make payments with respect to Awards hereunder, provided that the existence of such trusts or other arrangements is consistent with the foregoing sentence.
SECTION 17. GENERAL PROVISIONS
(a) No Distribution. The Administrator may require each person acquiring Stock pursuant to an Award to represent to and agree with the Company in writing that such person is acquiring the shares without a view to distribution thereof.
(b) Delivery of Stock Certificates. Stock certificates to grantees under this Plan shall be deemed delivered for all purposes when the Company or a stock transfer agent of the Company shall have mailed such certificates in the United States mail, addressed to the grantee, at the grantees last known address on file with the Company. Uncertificated Stock shall be deemed delivered for all purposes when the Company or a Stock transfer agent of the Company shall have given to the grantee by electronic mail (with proof of receipt) or by United States mail, addressed to the grantee, at the grantees last known address on file with the Company, notice of issuance and recorded the issuance in its records (which may include electronic book entry records). Notwithstanding anything herein to the contrary, the Company shall not be required to issue or deliver any certificates evidencing shares of Stock pursuant to the exercise of any Award, unless and until the Administrator has determined, with advice of counsel (to the extent the Administrator deems such advice necessary or advisable), that the issuance and delivery of such certificates is in compliance with all applicable laws, regulations of governmental authorities and, if applicable, the requirements of any exchange on which the shares of Stock are listed, quoted or traded. All Stock certificates delivered pursuant to the Plan shall be subject to any stop-transfer orders and other restrictions as the Administrator deems necessary or advisable to comply with federal, state or foreign jurisdiction, securities or other laws, rules and quotation system on which the Stock is listed, quoted or traded. The Administrator may place legends on any Stock certificate to reference restrictions applicable to the Stock. In addition to the terms and conditions provided herein, the Administrator may require that an individual make such reasonable covenants, agreements, and representations as the Administrator, in its discretion, deems necessary or advisable in order to comply with any such laws, regulations, or requirements. The Administrator shall have the right to require any individual to comply with any timing or other restrictions with respect to the settlement or exercise of any Award, including a window-period limitation, as may be imposed in the discretion of the Administrator.
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(c) Stockholder Rights. Until Stock is deemed delivered in accordance with Section 17(b), no right to vote or receive dividends or any other rights of a stockholder will exist with respect to shares of Stock to be issued in connection with an Award, notwithstanding the exercise of a Stock Option or any other action by the grantee with respect to an Award.
(d) Other Compensation Arrangements; No Employment Rights. Nothing contained in this Plan shall prevent the Board from adopting other or additional compensation arrangements, including trusts, and such arrangements may be either generally applicable or applicable only in specific cases. The adoption of this Plan and the grant of Awards do not confer upon any employee any right to continued employment with the Company or any Subsidiary.
(e) Trading Policy Restrictions. Option exercises and other Awards under the Plan shall be subject to the Companys insider trading policies and procedures, as in effect from time to time.
(f) Clawback Policy. Awards under the Plan shall be subject to the Companys clawback policy, as in effect from time to time.
SECTION 18. EFFECTIVE DATE OF PLAN
This Plan shall become effective immediately upon approval by the Board.
SECTION 19. GOVERNING LAW
This Plan and all Awards and actions taken thereunder shall be governed by, and construed in accordance with, the laws of the State of Delaware, applied without regard to conflict of law principles.
Approved by the Board of Directors: June 17, 2020
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NON-QUALIFIED STOCK OPTION AGREEMENT
FOR COMPANY EMPLOYEES
UNDER GLOBAL BLOOD THERAPEUTICS, INC.
2017 INDUCEMENT EQUITY PLAN
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Pursuant to the Global Blood Therapeutics, Inc. 2017 Inducement Equity Plan as amended through the date hereof (the Plan), Global Blood Therapeutics, Inc., a Delaware corporation (the Company), hereby grants to the Optionee named above an option (the Stock Option) to purchase on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.001 per share (the Stock) of the Company specified above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan. For the avoidance of doubt, this Stock Option is not issued under the Companys 2015 Stock Option and Incentive Plan, and does not reduce the share reserve under such equity plan. This Stock Option has been granted as an inducement pursuant to Rule 5635(c)(4) of the Marketplace Rules of the Nasdaq Stock Market, Inc. This Stock Option is not intended to be an incentive stock option under Section 422 of the Internal Revenue Code of 1986, as amended.
1. Exercisability Schedule. No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability schedule hereunder, this Stock Option shall be exercisable as follows: , so long as Optionee remains an employee or other service provider (including a consultant) of the Company or a Subsidiary on such dates. Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions hereof and of the Plan.
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Note to Form: FMV on Grant Date |
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Note to Form: No more than 10 years |
2. Manner of Exercise.
(a) The Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the Expiration Date of this Stock Option, the Optionee may give written notice to the Administrator of his or her election to purchase some or all of the Option Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.
Payment of the purchase price for the Option Shares may be made by one or more of the following methods: (i) in cash, by certified or bank check or other instrument acceptable to the Administrator; (ii) through the delivery (or attestation to the ownership) of shares of Stock that have been purchased by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions under any Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; (iii) by the Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Administrator shall prescribe as a condition of such payment procedure; (iv) by a net exercise arrangement pursuant to which the Company will reduce the number of shares of Stock issuable upon exercise by the largest whole number of shares with a Fair Market Value that does not exceed the aggregate exercise price; or (v) a combination of (i), (ii), (iii) and (iv) above. Payment instruments will be received subject to collection.
The transfer to the Optionee on the records of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the Companys receipt from the Optionee of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements contained herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and regulations. In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares attested to.
(b) The shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the records of the Company or of the transfer agent upon compliance to the satisfaction of the Administrator with all requirements under applicable laws or regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Administrator as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option shall have been exercised pursuant to the terms hereof, the Company or the transfer agent shall have transferred the shares to the Optionee, and the Optionees name shall have been entered as the stockholder of record on the books of the Company. Thereupon, the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.
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(c) The minimum number of shares with respect to which this Stock Option may be exercised at any one time shall be 100 shares, unless the number of shares with respect to which this Stock Option is being exercised is the total number of shares subject to exercise under this Stock Option at the time.
(d) Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.
3. Termination of Employment or Service Relationship. If the Optionees employment by or other service relationship with the Company or a Subsidiary (as defined in the Plan) is terminated, the period within which to exercise the Stock Option may be subject to earlier termination as set forth below.
(a) Termination Due to Death. If the Optionees employment or other service relationship terminates by reason of the Optionees death, any portion of this Stock Option outstanding on such date, to the extent exercisable on the date of death, may thereafter be exercised by the Optionees legal representative or legatee for a period of 12 months from the date of death or until the Expiration Date, if earlier.
(b) Termination Due to Disability. If the Optionees employment or other service relationship terminates by reason of the Optionees disability (as determined by the Administrator), any portion of this Stock Option outstanding on such date, to the extent exercisable on the date of such termination of employment, may thereafter be exercised by the Optionee for a period of 12 months from the date of disability or until the Expiration Date, if earlier.
(c) Termination for Cause. If the Optionees employment or other service relationship terminates for Cause, any portion of this Stock Option outstanding on such date shall terminate immediately and be of no further force and effect. For purposes hereof, Cause shall mean, unless otherwise provided in an employment agreement between the Company and the Optionee, a determination by the Administrator that the Optionee shall be dismissed as a result of (i) any material breach by the Optionee of any agreement between the Optionee and the Company; (ii) the conviction of, indictment for or plea of nolo contendere by the Optionee to a felony or a crime involving moral turpitude; or (iii) any material misconduct or willful and deliberate non-performance (other than by reason of disability) by the Optionee of the Optionees duties to the Company.
(d) Other Termination. If the Optionees employment or other service relationship terminates for any reason other than the Optionees death, the Optionees disability or Cause, and unless otherwise determined by the Administrator, any portion of this Stock Option outstanding on such date may be exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination or until the Expiration Date, if earlier.
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Any portion of this Stock Option that is not exercisable on the date of termination shall terminate and be of no further force or effect on the date that is three months following the date of termination, or the Expiration Date if earlier; provided that if the Administrator determines to accelerate the exercisability of any such portion of the Stock Option during such period, such Stock Option shall remain exercisable for the applicable period set forth in this Section 3. The Administrators determination of the reason for termination of the Optionees employment or other service relationship shall be conclusive and binding on the Optionee and his or her representatives or legatees.
4. Incorporation of Plan. Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
5. Transferability. This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise, other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionees lifetime, only by the Optionee, and thereafter, only by the Optionees legal representative or legatee.
6. Tax Withholding. The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to cause the minimum required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued to the Optionee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the minimum withholding amount due.
7. No Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this Agreement to continue the Optionee in employment and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or any Subsidiary to terminate the employment of the Optionee at any time.
8. Integration. This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior agreements and discussions between the parties concerning such subject matter.
9. Data Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the Relevant Companies) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the Relevant Information). By entering into this Agreement, the Optionee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy
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rights the Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.
10. Notices. Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.
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The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Companys instructions to the Optionee (including through an online acceptance process) is acceptable.
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5
RESTRICTED STOCK UNIT AWARD AGREEMENT
FOR COMPANY EMPLOYEES
UNDER GLOBAL BLOOD THERAPEUTICS, INC.
2017 INDUCEMENT EQUITY PLAN
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Pursuant to the Global Blood Therapeutics, Inc. 2017 Inducement Equity Plan as amended through the date hereof (the Plan), Global Blood Therapeutics, Inc., a Delaware corporation (the Company), hereby grants an award of the number of Restricted Stock Units listed above (an Award) to the Grantee named above. Each Restricted Stock Unit shall relate to one share of Common Stock, par value $0.001 per share (the Stock) of the Company. For the avoidance of doubt, the Award is not issued under the Companys 2015 Stock Option and Incentive Plan, and does not reduce the share reserve under such equity plan. This Award is granted as an employment inducement award pursuant to the exemption provided by Rule 5635(c)(4) of the Marketplace Rules of the NASDAQ Stock Market, Inc.
1. Restrictions on Transfer of Award. This Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of by the Grantee, and any shares of Stock issuable with respect to the Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of until (i) the Restricted Stock Units have vested as provided in Paragraph 2 of this Agreement and (ii) shares of Stock have been issued to the Grantee in accordance with the terms of the Plan and this Agreement.
2. Vesting of Restricted Stock Units. The restrictions and conditions of Paragraph 1 of this Agreement shall lapse as follows: ________________________ (each such date, a Vesting Date), so long as the Grantee remains an employee or other service provider (including a consultant) of the Company or a Subsidiary on such Dates. The Administrator may at any time accelerate the vesting schedule specified in this Paragraph 2.
3. Termination of Employment or Service Relationship. If the Grantees employment by or other service relationship with the Company and its Subsidiaries terminates for any reason (including death or disability) prior to the satisfaction of the vesting conditions set forth in Paragraph 2 above, any Restricted Stock Units that have not vested as of such date shall automatically and without notice terminate and be forfeited unless the Administrator otherwise determines, in its sole discretion, within three months following the date of termination, to accelerate all or any portion of such unvested Restricted Stock Units, and neither the Grantee nor any of his or her successors, heirs, assigns, or personal representatives will thereafter have any further rights or interests in such unvested Restricted Stock Units.
4. Issuance of Shares of Stock. As soon as practicable following each Vesting Date (but in no event later than two and one-half months after the end of the year in which the Vesting Date occurs), the Company shall issue to the Grantee the number of shares of Stock equal to the aggregate number of Restricted Stock Units that have vested pursuant to Paragraph 2 of this Agreement on such date and the Grantee shall thereafter have all the rights of a stockholder of the Company with respect to such shares.
5. Incorporation of Plan. Notwithstanding anything herein to the contrary, this Agreement shall be subject to and governed by all the terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.
6. Tax Withholding. The Grantee shall, not later than the date as of which the receipt of this Award becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Administrator for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event. The Company may, in its sole discretion, satisfy all or any portion of such withholding obligations relating to this Award by any of the means or by a combination of such means described in this Paragraph 6, subject to the other terms set forth herein. Provided that the Grantee makes an advance election, in accordance with procedures established by the Company (including its applicable insider trading policies), prior to the date upon which any portion of the Award vests to satisfy withholding obligations, as to which means or combination of means permitted hereunder Grantee elects, the Company shall allow the Grantee to irrevocably elect any of the following means or a combination of such means to satisfy such withholding obligations through, as applicable, a mandatory arrangement at a brokerage firm designated by the Company that is a member of the Financial Industry Regulatory Authority (a FINRA Dealer): (i) withholding from a same day sale commitment with the FINRA Dealer whereby the Grantee irrevocably elects to sell a portion of the shares of Stock to be delivered in connection with the settlement of this Award to satisfy such withholding obligation and the Grantee also elects to sell the remaining shares of Stock, and whereby the FINRA Dealer irrevocably commits to forward the proceeds necessary to satisfy the withholding obligation directly to the Company and to forward the remaining cash proceeds to the Grantee; (ii) causing the Grantee to tender a cash payment; (iii) permitting the Grantee to enter into a same day sale to cover commitment with the FINRA Dealer whereby the Grantee irrevocably elects to sell a portion of the shares of Stock to be delivered in connection with the settlement of this Award to satisfy such withholding obligation and whereby the FINRA Dealer irrevocably commits to forward the proceeds necessary to satisfy the withholding obligation directly to the Company; or (iv) if authorized or required by the Compensation Committee of the Board, by withholding a number of shares of Stock with an aggregate Fair Market Value equal to such minimum tax withholding obligation. If the Grantee fails to make an election in advance as required by the Companys procedures, or if the Companys insider trading compliance officer determines that the Companys insider trading policies and procedures would prohibit or prevent the Grantee from making any such election, the Grantee shall be deemed to have elected the same day sale to cover commitment method under clause (iii) of this Paragraph 6 to satisfy Grantees withholding obligations.
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7. Section 409A of the Code. This Agreement shall be interpreted in such a manner that all provisions relating to the settlement of the Award are exempt from the requirements of Section 409A of the Code as short-term deferrals as described in Section 409A of the Code.
8. No Obligation to Continue Employment. Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this Agreement to continue the Grantee in employment and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or any Subsidiary to terminate the employment of the Grantee at any time.
9. Integration. This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements and discussions between the parties concerning such subject matter.
10. Data Privacy Consent. In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the Relevant Companies) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the Relevant Information). By entering into this Agreement, the Grantee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.
11. Notices. Notices hereunder shall be mailed or delivered to the Company at its principal place of business and shall be mailed or delivered to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.
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GLOBAL BLOOD THERAPEUTICS, INC. | ||
By: | ||
Name: | ||
Title: |
The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned. Electronic acceptance of this Agreement pursuant to the Companys instructions to the Grantee (including through an online acceptance process) is acceptable.
Dated: |
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Grantees Signature | ||||||
Grantees name and address: | ||||||
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Exhibit 10.2
Global Blood Therapeutics, Inc.
Amended and Restated Severance and Change in Control Policy
Adopted on July 23, 2015
(amended and restated on January 6, 2016, July 5, 2017, July 26, 2017,
December 13, 2017, March 13, 2018, July 23, 2019, October 16, 2019, January 7, 2020 and
May 26, 2020)
Benefits in Connection with a Sale Event.
In connection with a Sale Event (as defined in the Global Blood Therapeutics, Inc. 2015 Stock Option and Incentive Plan (as may be amended or restated, the 2015 Plan)), employees of Global Blood Therapeutics, Inc. and its subsidiaries and affiliates (collectively, the Company) will be entitled to receive the following benefits in the event of a termination of their employment or other service relationship with the Company (or its successor or acquirer) without Cause (as defined below) or for Good Reason (as defined below) within one (1) year after the closing of the Sale Event (the Change in Control Period), subject to each such employees execution and non-revocation of a severance agreement within sixty (60) days following the date of such termination, including a general release of claims acceptable to the Company or its successor or acquirer:
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Full acceleration of vesting of all outstanding equity-based awards, including stock options and restricted stock units, under the 2015 Plan, the Companys 2017 Inducement Equity Plan, and such additional equity incentive plans, arrangements and agreements (as each may be further amended or restated) covering employees of the Company as the Companys Board of Directors may adopt and approve from time to time (collectively, Awards), and for the sake of clarity, for any Awards accelerated in such manner that contain conditions and restrictions relating to the attainment of performance goals, such performance goals will be deemed achieved at one hundred percent (100%) of target levels; and |
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Payment of (a) severance in a lump sum in the amounts set forth below, (b) target incentive bonus payouts in the amounts set forth below, equal to (i) a percentage, as set forth below, of the employees incentive bonus target for the year in which the closing of the Sale Event occurred plus (ii) a prorated incentive bonus payout for the portion of the year in which the closing of the Sale Event occurred, prorated based on employees incentive bonus target and the date of termination of their employment or other service relationship with the Company and (c) if the employee was participating in the Companys group health plan immediately prior to the date of termination of his or her employment and elects COBRA health continuation, payment of a monthly cash payment for the period set forth below or the employees COBRA health continuation period, whichever ends earlier, in an amount equal to the monthly employer contribution that the Company would have made to provide health insurance to the employee if the employee had remained employed by the Company, including, if applicable, the monthly employer contribution to a health savings account: |
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Position |
Severance (Amount of Base Salary) |
Incentive Bonus |
Benefits Continuation |
|||
Chief Executive Officer | 18 months |
150% bonus target
and prorated payout |
18 months | |||
Senior Management Team
(SMT) members |
12 months |
100% bonus target
and prorated payout |
12 months | |||
Senior Vice Presidents and
Vice Presidents (other than SMT members) |
9 months |
100% bonus target
and prorated payout |
9 months | |||
All Other Employees | 6 months |
100% bonus target
and prorated payout |
6 months |
Benefits Not in Connection with a Sale Event.
Certain designated employees of the Company who execute a participation letter in substantially the form attached hereto as Exhibit A will be entitled to receive the following benefits in the event of a termination of their employment or other service relationship with the Company (or its successor or acquirer) without Cause or for Good Reason outside of the Change in Control Period, subject to each such employees execution and non-revocation of a severance agreement within sixty (60) days following the date of such termination, including a general release of claims acceptable to the Company or its successor or acquirer:
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Payment of (a) severance in a lump sum in the amounts set forth below, (b) target incentive bonus payouts in the amounts set forth below, equal to (i) a percentage, as set forth below, of the employees incentive bonus target for the year in which such termination of employment or other service relationship occurred plus (ii) a prorated incentive bonus payout for the portion of the year in which such termination of employment or other service relationship occurred, prorated based on employees incentive bonus target and the date of termination of their employment or other service relationship with the Company and (c) if the employee was participating in the Companys group health plan immediately prior to the date of termination of his or her employment and elects COBRA health continuation, payment of a monthly cash payment for the period set forth below or the employees COBRA health continuation period, whichever ends earlier, in an amount equal to the monthly employer contribution that the Company would have made to provide health insurance to the employee if the employee had remained employed by the Company, including, if applicable, the monthly employer contribution to a health savings account: |
Position |
Severance (Amount of Base Salary) |
Incentive Bonus |
Benefits Continuation |
|||
Chief Executive Officer | 12 months |
100% bonus target
and prorated payout |
12 months | |||
SMT members | 12 months | N/A | 12 months |
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General Provisions.
For purposes of this Amended and Restated Severance and Change in Control Policy (this Policy), SMT members shall include (i) each individual who is then employed by the Company as an executive officer and (ii) such other employees of the Company as may be designated by the Compensation Committee of the Board as SMT members for purposes of this Policy from time to time, which individuals specified in clauses (i) and (ii) shall each continue to be considered SMT members for purposes of general severance and change in control severance benefits so long as they are employed with the Company as SMT members; provided that (a) if any such individual is employed by the Company in any other capacity (other than serving as a SMT member), such individual will be eligible for benefits under this Policy in accordance with their then-applicable level of service as provided above; (b) any individual employed as the Companys Chief Executive Officer shall be eligible for the general severance and change in control severance benefits applicable to the Chief Executive Officer only so long as such individual is employed with the Company as the Chief Executive Officer (and if at any time such individual remains employed by the Company but is not serving as the Chief Executive Officer, e.g., serving as a non-CEO SMT member, such individual will be eligible for benefits under this Policy in accordance with his or her then-applicable level of service as provided above) and (c) any SMT member shall cease to be considered an SMT member for purposes of this Policy upon the termination of such individuals employment with the Company (except to the extent such termination triggers such individuals entitlement to general severance or change in control severance benefits in accordance with this Policy).
The amounts payable pursuant to this Policy shall be paid or commence to be paid within 60 days following the date of termination of employment, provided that if the 60-day period begins in one calendar year and ends in a second calendar year, such payments shall be paid or commence to be paid in the second calendar year by the last day of such 60-day period.
Upon the consummation of a Sale Event, to the extent Section 280G of the Internal Revenue Code is applicable to an employee, such employee shall be entitled to receive either: (a) payment of the full amounts set forth above to which the employee is entitled or (b) payment of such lesser amount that does not trigger excise taxes under Section 280G, whichever results in the employee receiving a higher amount after taking into account all federal, state, and local income, excise and employment taxes.
For purposes of this Policy, Cause shall mean (i) the employees dishonest statements or acts with respect to the Company, or any current or prospective customers, suppliers, vendors or other third parties with which such entity does business, including without limitation, the employee engaging in misappropriation of funds or financial accounting improprieties; (ii) the employees commission of (A) a felony or (B) any misdemeanor involving moral turpitude, deceit, dishonesty or fraud; (iii) the employees continued non-performance of his or her duties to the Company which has continued for thirty (30) or more days following written notice of such non-performance by the Company; (iv) the employees material violation of the Companys Code of Business Conduct and Ethics or of any of the Companys other written employment, compliance or other policies as in effect from time to time; (v) the employees material violation of any provision of any agreement(s) between the employee and the Company relating to noncompetition, nonsolicitation, confidentiality, nondisclosure and/or assignment of inventions; or (vi) the employees failure to cooperate with a bona fide internal investigation or an investigation by regulatory or law enforcement authorities, after being instructed by the Company to cooperate, or the willful destruction or failure to preserve documents or other materials known to be relevant to such investigation or the inducement of others to fail to cooperate or to produce documents or other materials in connection with such investigation.
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For purposes of this Policy, Good Reason shall mean that the employee followed the Good Reason Process following the occurrence of (a) a material diminution in the employees job responsibilities (provided that a change in the employees job title or reporting relationship shall not be deemed a material diminution in the employees job responsibilities), (b) a material diminution in the employees base salary or (c) the relocation of the employees principal place of business to a location that is more than twenty-five (25) miles from the employees then-current location of employment. Good Reason Process shall mean that (i) the employee reasonably determines in good faith that a Good Reason condition has occurred; (ii) the employee notifies the Company (or its successor) in writing of the first occurrence of the Good Reason condition within 60 days of the first occurrence of such condition; (iii) the employee cooperates in good faith with the Companys (or its successors) efforts, for a period not less than 30 days following such notice (the Cure Period), to remedy the condition; (iv) notwithstanding such efforts, the Good Reason condition continues to exist; and (v) the employee terminates his employment within 60 days after the end of the Cure Period. If the Company or its successor cures the Good Reason condition during the Cure Period, Good Reason shall be deemed not to have occurred.
This Policy shall be administered by the Company, and the Company shall have the power and authority to interpret the terms and provisions of this Policy, to make all determinations it deems advisable for the administration of this Policy, to decide all disputes arising in connection with this Policy and to otherwise supervise administration of this Policy. The Company retains the right to amend, revise, change or end this Policy at any point in the future; provided that this Policy may not be amended or terminated during the period commencing on the date that it enters into a definitive agreement that if consummated, would result in a Sale Event and ending on the earlier of (i) one (1) year after a Sale Event and (ii) the termination of the definitive agreement without the consummation of a Sale Event. This Policy does not change the at-will employment status of any employee.
In the event an employee of the Company is party to an agreement or other arrangement with the Company that provides greater benefits than set forth in this Policy, such employee shall be entitled to receive the payments or benefits under such other agreement or arrangement and shall not be eligible to receive any payments or benefits under this Policy, provided that the definition of Cause set forth herein shall continue to apply to the eligibility to receive such other benefits.
The payments under this Policy are intended either to be exempt from Section 409A of the Internal Revenue Code of 1986, as amended (Section 409A) under the short-term deferral, separation pay, or other applicable exception, or to otherwise comply with Section 409A. This Policy shall be administered in a manner consistent with such intent. For purposes of Section 409A, all payments under this Policy shall be considered separate payments. To the extent that any payment or benefit described in this Policy constitutes non-qualified deferred compensation under Section 409A, and to the extent that such payment or benefit is payable upon an employees termination of employment, then such payments or benefits shall be payable only upon such employees separation from service (determined in accordance with the presumptions set forth in Treasury Regulation Section 1.409A 1(h)). Notwithstanding any
4
provision to the contrary, to the extent an employee is considered a specified employee under Section 409A and would be entitled during the six-month period beginning on such employees separation from service to a payment that is not otherwise excluded under Section 409A, such payment will not be made until the earlier of (i) the date six months and one day after the employees separation from service or (ii) the employees death. This Policy may be amended as may be necessary to fully comply with Section 409A and all related rules and regulations in order to preserve the payments and benefits provided hereunder. The Company makes no representation or warranty and shall have no liability to any employee or any other person if any provisions of this Policy are determined to constitute deferred compensation subject to Section 409A but do not satisfy an exemption from, or the conditions of, such Section.
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EXHIBIT A
PARTICIPATION LETTER
[DATE]
[PARTICIPANT NAME]
[ADDRESS]
Dear [PARTICIPANT]:
The Board of Directors of Global Blood Therapeutics, Inc. (the Company) has designated you as eligible for benefits not in connection with a Sale Event (the Non-Sale Benefits) as set forth in the Companys Amended and Restated Severance and Change in Control Policy as may be amended from time to time (the Policy). As set forth in the Policy, there are certain eligibility requirements for such Non-Sale Benefits including, but not limited to, your execution of a participation letter as set forth herein.
You agree that to the extent any benefits to which you may be eligible under the Policy are contingent on the termination of your employment or other service relationship by the Company (or a successor or acquirer) without cause, such term shall mean Cause as defined in the Policy. For the avoidance of doubt, the Cause definition in the Policy supersedes any other definition of such term which may apply to you.
This letter and the Policy constitute the entire agreement between you and the Company with respect to the subject matter hereof and supersede in all respects any and all prior agreements (oral or written) between you and the Company concerning such subject matter. In the event of a conflict between the terms of this letter and the terms of the Policy, the terms of the Policy shall apply.
Congratulations on being selected to be eligible for Non-Sale Benefits under the Policy.
GLOBAL BLOOD THERAPEUTICS, INC. | ||
By: | ||
Name: | ||
Title: |
AGREED TO AND ACCEPTED | ||
[Participant Name] |
1
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 5, 2020 |
/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 5, 2020 |
/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, 2020, 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 5, 2020 |
/s/ Jeffrey Farrow |
Jeffrey Farrow Chief Financial Officer (Principal Financial Officer) |
August 5, 2020
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.