|
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
94-3134940
|
(State or other jurisdiction of
incorporation or organization)
|
|
(IRS Employer
Identification No.)
|
Securities registered pursuant to Section 12(b) of the Act:
|
||||
|
Title of each class
|
Trading symbol(s)
|
Name of each exchange on which registered
|
|
|
Common Stock, $0.0001 par value
|
NKTR
|
NASDAQ Global Select Market
|
|
Large accelerated filer
|
|
☒
|
|
Accelerated filer
|
|
☐
|
|
|
|
|
|||
Non-accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
|
|
|
|||
Emerging growth company
|
|
☐
|
|
|
|
|
|
||
|
||
|
||
|
6
|
|
|
||
|
||
|
|
|
Item 1.
|
Condensed Consolidated Financial Statements—Unaudited:
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
81,224
|
|
|
$
|
194,905
|
|
Short-term investments
|
1,414,448
|
|
|
1,140,445
|
|
||
Accounts receivable
|
41,205
|
|
|
43,213
|
|
||
Inventory
|
13,720
|
|
|
11,381
|
|
||
Advance payments to contract manufacturers
|
13,015
|
|
|
26,450
|
|
||
Other current assets
|
15,212
|
|
|
21,293
|
|
||
Total current assets
|
1,578,824
|
|
|
1,437,687
|
|
||
Long-term investments
|
231,082
|
|
|
582,889
|
|
||
Property, plant and equipment, net
|
64,614
|
|
|
48,851
|
|
||
Operating lease right-of-use assets
|
134,888
|
|
|
—
|
|
||
Goodwill
|
76,501
|
|
|
76,501
|
|
||
Other assets
|
2,385
|
|
|
4,244
|
|
||
Total assets
|
$
|
2,088,294
|
|
|
$
|
2,150,172
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
21,963
|
|
|
$
|
5,854
|
|
Accrued compensation
|
23,101
|
|
|
9,937
|
|
||
Accrued clinical trial expenses
|
38,338
|
|
|
14,700
|
|
||
Accrued contract manufacturing expenses
|
8,646
|
|
|
23,841
|
|
||
Other accrued expenses
|
11,394
|
|
|
9,580
|
|
||
Interest payable
|
4,198
|
|
|
4,198
|
|
||
Operating lease liabilities, current portion
|
9,318
|
|
|
—
|
|
||
Deferred revenue, current portion
|
8,392
|
|
|
13,892
|
|
||
Total current liabilities
|
125,350
|
|
|
82,002
|
|
||
Senior secured notes, net
|
248,257
|
|
|
246,950
|
|
||
Operating lease liabilities, less current portion
|
145,099
|
|
|
—
|
|
||
Liability related to the sale of future royalties, net
|
73,455
|
|
|
82,911
|
|
||
Deferred revenue, less current portion
|
6,779
|
|
|
10,744
|
|
||
Other long-term liabilities
|
643
|
|
|
9,990
|
|
||
Total liabilities
|
599,583
|
|
|
432,597
|
|
||
Commitments and contingencies
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.0001 par value; 10,000 shares authorized; no shares designated or outstanding at September 30, 2019 or December 31, 2018
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 300,000 shares authorized; 175,786 shares and 173,530 shares outstanding at September 30, 2019 and December 31, 2018, respectively
|
17
|
|
|
17
|
|
||
Capital in excess of par value
|
3,241,160
|
|
|
3,147,925
|
|
||
Accumulated other comprehensive loss
|
(1,186
|
)
|
|
(6,316
|
)
|
||
Accumulated deficit
|
(1,751,280
|
)
|
|
(1,424,051
|
)
|
||
Total stockholders’ equity
|
1,488,711
|
|
|
1,717,575
|
|
||
Total liabilities and stockholders’ equity
|
$
|
2,088,294
|
|
|
$
|
2,150,172
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenue:
|
|
|
|
|
|
|
|
||||||||
Product sales
|
$
|
5,558
|
|
|
$
|
4,256
|
|
|
$
|
14,302
|
|
|
$
|
16,414
|
|
Royalty revenue
|
10,275
|
|
|
10,259
|
|
|
29,008
|
|
|
29,898
|
|
||||
Non-cash royalty revenue related to sale of future royalties
|
10,264
|
|
|
8,372
|
|
|
27,585
|
|
|
24,337
|
|
||||
License, collaboration and other revenue
|
3,121
|
|
|
4,875
|
|
|
9,860
|
|
|
1,082,848
|
|
||||
Total revenue
|
29,218
|
|
|
27,762
|
|
|
80,755
|
|
|
1,153,497
|
|
||||
Operating costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of goods sold
|
4,927
|
|
|
4,783
|
|
|
15,385
|
|
|
16,951
|
|
||||
Research and development
|
99,048
|
|
|
102,895
|
|
|
324,197
|
|
|
290,653
|
|
||||
General and administrative
|
23,983
|
|
|
18,718
|
|
|
71,570
|
|
|
57,666
|
|
||||
Total operating costs and expenses
|
127,958
|
|
|
126,396
|
|
|
411,152
|
|
|
365,270
|
|
||||
Income (loss) from operations
|
(98,740
|
)
|
|
(98,634
|
)
|
|
(330,397
|
)
|
|
788,227
|
|
||||
Non-operating income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest expense
|
(5,425
|
)
|
|
(5,442
|
)
|
|
(15,882
|
)
|
|
(16,167
|
)
|
||||
Non-cash interest expense on liability related to sale of future royalties
|
(5,813
|
)
|
|
(4,814
|
)
|
|
(17,853
|
)
|
|
(14,808
|
)
|
||||
Interest income and other income (expense), net
|
11,492
|
|
|
11,847
|
|
|
35,964
|
|
|
25,523
|
|
||||
Total non-operating income (expense), net
|
254
|
|
|
1,591
|
|
|
2,229
|
|
|
(5,452
|
)
|
||||
Income (loss) before provision for income taxes
|
(98,486
|
)
|
|
(97,043
|
)
|
|
(328,168
|
)
|
|
782,775
|
|
||||
Provision (benefit) for income taxes
|
322
|
|
|
(900
|
)
|
|
(939
|
)
|
|
3,250
|
|
||||
Net income (loss)
|
$
|
(98,808
|
)
|
|
$
|
(96,143
|
)
|
|
$
|
(327,229
|
)
|
|
$
|
779,525
|
|
|
|
|
|
|
|
|
|
||||||||
Net income (loss) per share
|
|
|
|
|
|
|
|
||||||||
Basic
|
$
|
(0.56
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.87
|
)
|
|
$
|
4.63
|
|
Diluted
|
$
|
(0.56
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.87
|
)
|
|
$
|
4.34
|
|
Weighted average shares outstanding used in computing net income (loss) per share
|
|
|
|
|
|
|
|
||||||||
Basic
|
175,402
|
|
|
172,698
|
|
|
174,609
|
|
|
168,363
|
|
||||
Diluted
|
175,402
|
|
|
172,698
|
|
|
174,609
|
|
|
179,619
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Comprehensive income (loss)
|
$
|
(99,206
|
)
|
|
$
|
(97,519
|
)
|
|
$
|
(322,099
|
)
|
|
$
|
776,258
|
|
|
Three and nine months ended September 30, 2019
|
|||||||||||||||||||||
|
Common
Shares
|
|
Par
Value
|
|
Capital in
Excess of
Par Value
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
|||||||||||
Balance at December 31, 2018
|
173,530
|
|
|
$
|
17
|
|
|
$
|
3,147,925
|
|
|
$
|
(6,316
|
)
|
|
$
|
(1,424,051
|
)
|
|
$
|
1,717,575
|
|
Shares issued under equity compensation plans
|
698
|
|
|
—
|
|
|
5,463
|
|
|
—
|
|
|
—
|
|
|
5,463
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
25,385
|
|
|
—
|
|
|
—
|
|
|
25,385
|
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
3,600
|
|
|
—
|
|
|
3,600
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(118,512
|
)
|
|
(118,512
|
)
|
|||||
Balance at March 31, 2019
|
174,228
|
|
|
$
|
17
|
|
|
$
|
3,178,773
|
|
|
$
|
(2,716
|
)
|
|
$
|
(1,542,563
|
)
|
|
$
|
1,633,511
|
|
Shares issued under equity compensation plans
|
738
|
|
|
—
|
|
|
7,103
|
|
|
—
|
|
|
—
|
|
|
7,103
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
24,522
|
|
|
—
|
|
|
—
|
|
|
24,522
|
|
|||||
Other comprehensive income
|
—
|
|
|
—
|
|
|
—
|
|
|
1,928
|
|
|
—
|
|
|
1,928
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(109,909
|
)
|
|
(109,909
|
)
|
|||||
Balance at June 30, 2019
|
174,966
|
|
|
17
|
|
|
3,210,398
|
|
|
(788
|
)
|
|
(1,652,472
|
)
|
|
1,557,155
|
|
|||||
Shares issued under equity compensation plans
|
820
|
|
|
—
|
|
|
5,882
|
|
|
—
|
|
|
—
|
|
|
5,882
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
24,880
|
|
|
—
|
|
|
—
|
|
|
24,880
|
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(398
|
)
|
|
—
|
|
|
(398
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(98,808
|
)
|
|
(98,808
|
)
|
|||||
Balance at September 30, 2019
|
175,786
|
|
|
$
|
17
|
|
|
$
|
3,241,160
|
|
|
$
|
(1,186
|
)
|
|
$
|
(1,751,280
|
)
|
|
$
|
1,488,711
|
|
|
Three and nine months ended September 30, 2018
|
|||||||||||||||||||||
|
Common
Shares
|
|
Par
Value
|
|
Capital in
Excess of
Par Value
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Accumulated
Deficit
|
|
Total
Stockholders’
Equity
|
|||||||||||
Balance at December 31, 2017
|
159,524
|
|
|
$
|
15
|
|
|
$
|
2,207,865
|
|
|
$
|
(2,111
|
)
|
|
$
|
(2,117,941
|
)
|
|
$
|
87,828
|
|
Adoption of new accounting standards
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,577
|
|
|
12,577
|
|
|||||
Shares issued under equity compensation plans
|
2,855
|
|
|
1
|
|
|
34,405
|
|
|
—
|
|
|
—
|
|
|
34,406
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
19,949
|
|
|
—
|
|
|
—
|
|
|
19,949
|
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(685
|
)
|
|
—
|
|
|
(685
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(95,792
|
)
|
|
(95,792
|
)
|
|||||
Balance at March 31, 2018
|
162,379
|
|
|
$
|
16
|
|
|
$
|
2,262,219
|
|
|
$
|
(2,796
|
)
|
|
$
|
(2,201,156
|
)
|
|
$
|
58,283
|
|
Sale of stock to Bristol-Myers Squibb
|
8,285
|
|
|
1
|
|
|
790,230
|
|
|
—
|
|
|
—
|
|
|
790,231
|
|
|||||
Shares issued under equity compensation plans
|
1,751
|
|
|
—
|
|
|
20,987
|
|
|
—
|
|
|
—
|
|
|
20,987
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
20,659
|
|
|
—
|
|
|
—
|
|
|
20,659
|
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,206
|
)
|
|
—
|
|
|
(1,206
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
971,460
|
|
|
971,460
|
|
|||||
Balance at June 30, 2018
|
172,415
|
|
|
$
|
17
|
|
|
$
|
3,094,095
|
|
|
$
|
(4,002
|
)
|
|
$
|
(1,229,696
|
)
|
|
$
|
1,860,414
|
|
Shares issued under equity compensation plans
|
642
|
|
|
—
|
|
|
3,940
|
|
|
—
|
|
|
—
|
|
|
3,940
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
23,287
|
|
|
—
|
|
|
—
|
|
|
23,287
|
|
|||||
Other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,376
|
)
|
|
—
|
|
|
(1,376
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(96,143
|
)
|
|
(96,143
|
)
|
|||||
Balance at September 30, 2018
|
173,057
|
|
|
$
|
17
|
|
|
$
|
3,121,322
|
|
|
$
|
(5,378
|
)
|
|
$
|
(1,325,839
|
)
|
|
$
|
1,790,122
|
|
|
Nine months ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net income (loss)
|
$
|
(327,229
|
)
|
|
$
|
779,525
|
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
||||
Non-cash royalty revenue related to sale of future royalties
|
(27,585
|
)
|
|
(24,337
|
)
|
||
Non-cash interest expense on liability related to sale of future royalties
|
17,853
|
|
|
14,808
|
|
||
Stock-based compensation
|
74,787
|
|
|
63,895
|
|
||
Depreciation and amortization
|
9,582
|
|
|
7,799
|
|
||
Accretion of discounts, net and other non-cash transactions
|
(10,421
|
)
|
|
(8,136
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
2,008
|
|
|
(16,179
|
)
|
||
Inventory
|
(2,339
|
)
|
|
(2,570
|
)
|
||
Other assets
|
18,127
|
|
|
(22,087
|
)
|
||
Accounts payable
|
16,109
|
|
|
2,611
|
|
||
Accrued compensation
|
13,164
|
|
|
19,659
|
|
||
Other accrued expenses
|
10,019
|
|
|
26,603
|
|
||
Deferred revenue
|
(9,465
|
)
|
|
(10,931
|
)
|
||
Other liabilities
|
11,932
|
|
|
5,104
|
|
||
Net cash provided by (used in) operating activities
|
$
|
(203,458
|
)
|
|
$
|
835,764
|
|
Cash flows from investing activities:
|
|
|
|
||||
Purchases of investments
|
(1,028,883
|
)
|
|
(1,944,178
|
)
|
||
Maturities of investments
|
1,122,902
|
|
|
467,658
|
|
||
Sales of investments
|
—
|
|
|
11,963
|
|
||
Purchases of property, plant and equipment
|
(22,614
|
)
|
|
(5,552
|
)
|
||
Sales of property, plant and equipment
|
—
|
|
|
2,633
|
|
||
Net cash provided by (used in) investing activities
|
$
|
71,405
|
|
|
$
|
(1,467,476
|
)
|
Cash flows from financing activities:
|
|
|
|
||||
Issuance of common stock
|
—
|
|
|
790,231
|
|
||
Proceeds from shares issued under equity compensation plans
|
18,449
|
|
|
59,067
|
|
||
Net cash provided by financing activities
|
$
|
18,449
|
|
|
$
|
849,298
|
|
Effect of exchange rates on cash and cash equivalents
|
(77
|
)
|
|
(87
|
)
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
(113,681
|
)
|
|
$
|
217,499
|
|
Cash and cash equivalents at beginning of period
|
194,905
|
|
|
4,762
|
|
||
Cash and cash equivalents at end of period
|
$
|
81,224
|
|
|
$
|
222,261
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
||||
Cash paid for interest
|
$
|
14,229
|
|
|
$
|
14,701
|
|
Operating lease right-of-use assets recognized in exchange for lease liabilities
|
$
|
56,025
|
|
|
$
|
—
|
|
|
Estimated Fair Value at
|
||||||
|
September 30, 2019
|
|
December 31, 2018
|
||||
Cash and cash equivalents
|
$
|
81,224
|
|
|
$
|
194,905
|
|
Short-term investments
|
1,414,448
|
|
|
1,140,445
|
|
||
Long-term investments
|
231,082
|
|
|
582,889
|
|
||
Total cash and investments in marketable securities
|
$
|
1,726,754
|
|
|
$
|
1,918,239
|
|
|
|
|
Estimated Fair Value at
|
||||||
|
Fair Value
Hierarchy
Level
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
Corporate notes and bonds
|
2
|
|
$
|
1,163,575
|
|
|
$
|
1,288,986
|
|
Corporate commercial paper
|
2
|
|
482,468
|
|
|
498,048
|
|
||
Obligations of U.S. government agencies
|
2
|
|
—
|
|
|
12,977
|
|
||
Available-for-sale investments
|
|
|
1,646,043
|
|
|
1,800,011
|
|
||
Money market funds
|
1
|
|
45,674
|
|
|
105,656
|
|
||
Certificate of deposit
|
N/A
|
|
6,871
|
|
|
6,760
|
|
||
Cash
|
N/A
|
|
28,166
|
|
|
5,812
|
|
||
Total cash and investments in marketable securities
|
|
|
$
|
1,726,754
|
|
|
$
|
1,918,239
|
|
Level 1 —
|
Quoted prices in active markets for identical assets or liabilities.
|
Level 2 —
|
Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar assets or liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
Level 3 —
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
|
September 30, 2019
|
|
December 31, 2018
|
||||
Raw materials
|
$
|
1,586
|
|
|
$
|
1,846
|
|
Work-in-process
|
7,961
|
|
|
6,403
|
|
||
Finished goods
|
4,173
|
|
|
3,132
|
|
||
Total inventory
|
$
|
13,720
|
|
|
$
|
11,381
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating lease cost
|
$
|
4,116
|
|
|
$
|
1,927
|
|
|
$
|
10,030
|
|
|
$
|
5,651
|
|
Variable lease cost
|
1,485
|
|
|
1,096
|
|
|
4,539
|
|
|
3,371
|
|
||||
Total lease costs
|
$
|
5,601
|
|
|
$
|
3,023
|
|
|
$
|
14,569
|
|
|
$
|
9,022
|
|
Year ended December 31,
|
|
||
2019 (Three months ended)
|
$
|
2,400
|
|
2020
|
15,283
|
|
|
2021
|
19,026
|
|
|
2022
|
19,633
|
|
|
2023
|
20,257
|
|
|
2024
|
20,899
|
|
|
2025 and thereafter
|
116,881
|
|
|
Total lease payments
|
214,379
|
|
|
Less: portion representing interest
|
(56,621
|
)
|
|
Less: lease incentives
|
(3,341
|
)
|
|
Operating lease liabilities
|
154,417
|
|
|
Less: current portion
|
(9,318
|
)
|
|
Operating lease liabilities, less current portion
|
$
|
145,099
|
|
|
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
Partner
|
|
Drug or Drug Candidate
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Bristol-Myers Squibb Company
|
|
NKTR-214
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,059,768
|
|
Eli Lilly and Company
|
|
NKTR-358
|
|
1,500
|
|
|
3,221
|
|
|
5,200
|
|
|
8,627
|
|
||||
Amgen, Inc.
|
|
Neulasta®
|
|
1,250
|
|
|
1,250
|
|
|
3,750
|
|
|
3,750
|
|
||||
Baxalta Inc. / Takeda Pharmaceutical Company Ltd. and other
|
|
ADYNOVATE®
|
|
371
|
|
|
404
|
|
|
910
|
|
|
10,703
|
|
||||
License, collaboration and other revenue
|
|
|
|
$
|
3,121
|
|
|
$
|
4,875
|
|
|
9,860
|
|
|
$
|
1,082,848
|
|
|
Nine months ended
September 30, 2019 |
||
Deferred revenue—December 31, 2018
|
$
|
24,636
|
|
Recognition of previously unearned revenue
|
(9,465
|
)
|
|
Deferred revenue—September 30, 2019
|
$
|
15,171
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Cost of goods sold
|
$
|
1,119
|
|
|
$
|
1,176
|
|
|
$
|
3,208
|
|
|
$
|
3,470
|
|
Research and development
|
15,680
|
|
|
15,365
|
|
|
47,549
|
|
|
40,449
|
|
||||
General and administrative
|
8,081
|
|
|
6,746
|
|
|
24,030
|
|
|
19,976
|
|
||||
Total stock-based compensation
|
$
|
24,880
|
|
|
$
|
23,287
|
|
|
$
|
74,787
|
|
|
$
|
63,895
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Options granted
|
131
|
|
|
190
|
|
|
246
|
|
|
929
|
|
||||
Weighted-average grant-date fair value of options granted
|
$
|
13.43
|
|
|
$
|
30.52
|
|
|
$
|
15.81
|
|
|
$
|
39.28
|
|
RSUs granted
|
316
|
|
|
152
|
|
|
712
|
|
|
558
|
|
||||
Weighted-average grant-date fair value of RSUs granted
|
$
|
28.00
|
|
|
$
|
57.27
|
|
|
$
|
31.80
|
|
|
$
|
54.49
|
|
Shares issued under equity compensation plans
|
820
|
|
|
642
|
|
|
2,256
|
|
|
5,248
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
Three months ended September 30,
|
|
Increase/
(Decrease)
2019 vs. 2018
|
|
Percentage
Increase/
(Decrease)
2019 vs. 2018
|
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Product sales
|
$
|
5,558
|
|
|
$
|
4,256
|
|
|
$
|
1,302
|
|
|
31
|
%
|
Royalty revenue
|
10,275
|
|
|
10,259
|
|
|
16
|
|
|
—
|
%
|
|||
Non-cash royalty revenue related to sale of future royalties
|
10,264
|
|
|
8,372
|
|
|
1,892
|
|
|
23
|
%
|
|||
License, collaboration and other revenue
|
3,121
|
|
|
4,875
|
|
|
(1,754
|
)
|
|
(36
|
)%
|
|||
Total revenue
|
$
|
29,218
|
|
|
$
|
27,762
|
|
|
$
|
1,456
|
|
|
5
|
%
|
|
|
|
|
|
|
|
|
|||||||
|
Nine months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Product sales
|
$
|
14,302
|
|
|
$
|
16,414
|
|
|
$
|
(2,112
|
)
|
|
(13
|
)%
|
Royalty revenue
|
29,008
|
|
|
29,898
|
|
|
(890
|
)
|
|
(3
|
)%
|
|||
Non-cash royalty revenue related to sale of future royalties
|
27,585
|
|
|
24,337
|
|
|
3,248
|
|
|
13
|
%
|
|||
License, collaboration and other revenue
|
9,860
|
|
|
1,082,848
|
|
|
(1,072,988
|
)
|
|
(99
|
)%
|
|||
Total revenue
|
$
|
80,755
|
|
|
$
|
1,153,497
|
|
|
$
|
(1,072,742
|
)
|
|
(93
|
)%
|
|
Three months ended September 30,
|
|
Increase/
(Decrease)
2019 vs. 2018
|
|
Percentage
Increase/
(Decrease)
2019 vs. 2018
|
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Cost of goods sold
|
$
|
4,927
|
|
|
$
|
4,783
|
|
|
$
|
144
|
|
|
3
|
%
|
Product gross profit
|
631
|
|
|
(527
|
)
|
|
1,158
|
|
|
<(100)%
|
|
|||
Product gross margin
|
11
|
%
|
|
(12
|
)%
|
|
|
|
|
|||||
|
|
|
|
|
|
|
|
|||||||
|
Nine months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Cost of goods sold
|
$
|
15,385
|
|
|
$
|
16,951
|
|
|
$
|
(1,566
|
)
|
|
(9
|
)%
|
Product gross profit
|
(1,083
|
)
|
|
(537
|
)
|
|
(546
|
)
|
|
>100%
|
|
|||
Product gross margin
|
(8
|
)%
|
|
(3
|
)%
|
|
|
|
|
|
Three months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Non-cash royalty revenue related to sale of future royalties
|
$
|
10,264
|
|
|
$
|
8,372
|
|
|
$
|
1,892
|
|
|
23
|
%
|
Non-cash interest expense on liability related to sale of future royalties
|
5,813
|
|
|
4,814
|
|
|
999
|
|
|
21
|
%
|
|||
|
|
|
|
|
|
|
|
|||||||
|
Nine months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Non-cash royalty revenue related to sale of future royalties
|
$
|
27,585
|
|
|
$
|
24,337
|
|
|
$
|
3,248
|
|
|
13
|
%
|
Non-cash interest expense on liability related to sale of future royalties
|
17,853
|
|
|
14,808
|
|
|
3,045
|
|
|
21
|
%
|
|
Three months ended September 30,
|
|
Increase/
(Decrease)
2019 vs. 2018
|
|
Percentage
Increase/
(Decrease)
2019 vs. 2018
|
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Interest income and other income (expense), net
|
$
|
11,492
|
|
|
$
|
11,847
|
|
|
$
|
(355
|
)
|
|
(3
|
)%
|
|
|
|
|
|
|
|
|
|||||||
|
Nine months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
|||||||||
|
2019
|
|
2018
|
|
|
|
|
|||||||
Interest income and other income (expense), net
|
$
|
35,964
|
|
|
$
|
25,523
|
|
|
$
|
10,441
|
|
|
41
|
%
|
|
Three months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
||||||||
|
2019
|
|
2018
|
|
|
|
|
||||||
Provision (benefit) for income taxes
|
$
|
322
|
|
|
$
|
(900
|
)
|
|
$
|
1,222
|
|
|
>(100%)
|
|
|
|
|
|
|
|
|
||||||
|
Nine months ended September 30,
|
|
Increase/
(Decrease) 2019 vs. 2018 |
|
Percentage
Increase/ (Decrease) 2019 vs. 2018 |
||||||||
|
2019
|
|
2018
|
|
|
|
|
||||||
Provision (benefit) for income taxes
|
$
|
(939
|
)
|
|
$
|
3,250
|
|
|
$
|
(4,189
|
)
|
|
<(100%)
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 4.
|
Controls and Procedures
|
Item 1.
|
Legal Proceedings
|
Item 1A.
|
Risk Factors
|
•
|
delays in obtaining regulatory authorization to commence a clinical study;
|
•
|
delays in reaching agreement with applicable regulatory authorities on a clinical study design;
|
•
|
for product candidates (such as NKTR-214) partnered with other companies, delays caused by our partner;
|
•
|
imposition of a clinical hold by the FDA or other health authorities, which may occur at any time including after any inspection of clinical trial operations or trial sites;
|
•
|
suspension or termination of a clinical study by us, our partners, the FDA or foreign regulatory authorities due to adverse side effects of a drug on subjects in the trial;
|
•
|
delays in recruiting suitable patients to participate in a trial;
|
•
|
delays in having patients complete participation in a trial or return for post-treatment follow-up;
|
•
|
clinical sites dropping out of a trial to the detriment of enrollment rates;
|
•
|
delays in manufacturing and delivery of sufficient supply of clinical trial materials;
|
•
|
changes in regulatory authorities policies or guidance applicable to our drug candidates; and
|
•
|
delays caused by changing standards of care or new treatment options.
|
•
|
designing and conducting large scale clinical studies;
|
•
|
preparing and filing documents necessary to obtain government approvals to sell a given drug candidate; and/or
|
•
|
marketing and selling the drugs when and if they are approved.
|
•
|
we have very little control over the timing and level of resources that our collaboration partners dedicate to commercial marketing efforts such as the amount of investment in sales and marketing personnel, general marketing campaigns, direct-to-consumer advertising, product sampling, pricing agreements and rebate strategies with government and private payers, manufacturing and supply of drug product, and other marketing and selling activities that need to be undertaken and well executed for a drug to have the potential to achieve commercial success;
|
•
|
collaboration partners with commercial rights may choose to devote fewer resources to the marketing of our partnered drugs than they devote to their own drugs or other drugs that they have in-licensed;
|
•
|
we have very little control over the timing and amount of resources our partners devote to development programs in one or more major markets;
|
•
|
disagreements with partners could lead to delays in, or termination of, the research, development or commercialization of product candidates or to litigation or arbitration proceedings;
|
•
|
disputes may arise or escalate in the future with respect to the ownership of rights to technology or intellectual property developed with partners;
|
•
|
we do not have the ability to unilaterally terminate agreements (or partners may have extension or renewal rights) that we believe are not on commercially reasonable terms or consistent with our current business strategy;
|
•
|
partners may be unable to pay us as expected; and
|
•
|
partners may terminate their agreements with us unilaterally for any or no reason, in some cases with the payment of a termination fee penalty and in other cases with no termination fee penalty.
|
•
|
the cost, timing and outcomes of clinical studies and regulatory reviews of our proprietary drug candidates that we have licensed to our collaboration partners —important examples include NKTR-214 in collaboration with BMS and NKTR-358 licensed to Lilly;
|
•
|
the commercial launch and sales levels of products marketed by our collaboration partners for which we are entitled to royalties and sales milestones—importantly, the level of success in marketing and selling MOVANTIK® by AstraZeneca in the U.S. and ADYNOVATE® by Baxalta (a wholly-owned subsidiary of Takeda) globally, as well as MOVENTIG® (the naloxegol brand name in the EU) by Kirin in the EU;
|
•
|
if and when we receive potential milestone payments and royalties from our existing collaborations if the drug candidates subject to those collaborations achieve clinical, regulatory or commercial success;
|
•
|
the progress, timing, cost and results of our clinical development programs;
|
•
|
the success, progress, timing and costs of our efforts to implement new collaborations, licenses and other transactions that increase our current net cash, such as the sale of additional royalty interests held by us, term loan or other debt arrangements, and the issuance of securities;
|
•
|
the number of patients, enrollment criteria, primary and secondary endpoints, and the number of clinical studies required by the regulatory authorities in order to consider for approval our drug candidates and those of our collaboration partners;
|
•
|
our general and administrative expenses, capital expenditures and other uses of cash; and
|
•
|
disputes concerning patents, proprietary rights, or license and collaboration agreements that negatively impact our receipt of milestone payments or royalties or require us to make significant payments arising from licenses, settlements, adverse judgments or ongoing royalties.
|
•
|
clinical development and commercialization obligations that are based on certain commercial reasonableness performance standards that can often be difficult to enforce if disputes arise as to adequacy of our partner’s performance;
|
•
|
research and development performance and reimbursement obligations for our personnel and other resources allocated to partnered drug candidate development programs;
|
•
|
clinical and commercial manufacturing agreements, some of which are priced on an actual cost basis for products supplied by us to our partners with complicated cost allocation formulas and methodologies;
|
•
|
intellectual property ownership allocation between us and our partners for improvements and new inventions developed during the course of the collaboration;
|
•
|
royalties on drug sales based on a number of complex variables, including net sales calculations, geography, scope of patent claim coverage, patent life, generic competitors, bundled pricing and other factors; and
|
•
|
indemnity obligations for intellectual property infringement, product liability and certain other claims.
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
•
|
the inability of sales personnel to obtain access to or successfully educate adequate numbers of physicians about the potential benefits associated with the use of, and to subsequently prescribe, our products;
|
•
|
the lack of complementary products or multiple product pricing arrangements may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
•
|
unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
|
•
|
develop drugs utilizing our technologies, either independently or in collaboration with other pharmaceutical or biotechnology companies;
|
•
|
effectively estimate and manage clinical development costs, particularly the cost of the clinical studies for NKTR-214, NKTR-358, NKTR-262, NKTR-255, and ONZEALD®;
|
•
|
receive necessary regulatory and marketing approvals;
|
•
|
maintain or expand manufacturing at necessary levels;
|
•
|
achieve market acceptance of our partnered products;
|
•
|
receive royalties on products that have been approved, marketed or submitted for marketing approval with regulatory authorities; and
|
•
|
maintain sufficient funds to finance our activities.
|
•
|
announcements of data from, or material developments in, our clinical studies and those of our collaboration partners, including data regarding efficacy and safety, delays in clinical development, regulatory approval or commercial launch – in particular, data from clinical studies of NKTR-214 has had a significant impact on our stock price;
|
•
|
announcements by collaboration partners as to their plans or expectations related to drug candidates and approved drugs in which we have a substantial economic interest;
|
•
|
announcements regarding terminations or disputes under our collaboration agreements;
|
•
|
fluctuations in our results of operations;
|
•
|
developments in patent or other proprietary rights, including intellectual property litigation or entering into intellectual property license agreements and the costs associated with those arrangements;
|
•
|
announcements of technological innovations or new therapeutic products that may compete with our approved products or products under development;
|
•
|
announcements of changes in governmental regulation affecting us or our competitors;
|
•
|
litigation brought against us or third parties to whom we have indemnification obligations;
|
•
|
public concern as to the safety of drug formulations developed by us or others;
|
•
|
our financing needs and activities; and
|
•
|
general market conditions.
|
•
|
establishment of a classified board of directors such that not all members of the board may be elected at one time;
|
•
|
lack of a provision for cumulative voting in the election of directors, which would otherwise allow less than a majority of stockholders to elect director candidates;
|
•
|
the ability of our board to authorize the issuance of “blank check” preferred stock to increase the number of outstanding shares and thwart a takeover attempt;
|
•
|
prohibition on stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of stockholders;
|
•
|
establishment of advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings; and
|
•
|
limitations on who may call a special meeting of stockholders.
|
•
|
incur or guarantee additional indebtedness or issue disqualified capital stock or cause certain of our subsidiaries to issue preferred stock;
|
•
|
pay dividends or distributions, redeem equity interests or subordinated indebtedness or make certain types of investments;
|
•
|
create or incur liens;
|
•
|
transfer, sell, lease or otherwise dispose of assets and issue or sell equity interests in certain of our subsidiaries;
|
•
|
incur restrictions on certain of our subsidiaries’ ability to pay dividends or other distributions to the Company or to make intercompany loans, advances or asset transfers;
|
•
|
enter into transactions with affiliates;
|
•
|
engage in any business other than businesses which are the same, similar, ancillary or reasonably related to our business as of the date of the indenture; and
|
•
|
consummate a merger, consolidation, reorganization or business combination, sell, lease, convey or otherwise dispose of all or substantially all of our assets or other change of control transaction.
|
•
|
the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration (a term interpreted broadly to include anything of value, including, for example, gifts, discounts, and credits), directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order, or recommendation of, an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
|
•
|
federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment to Medicare, Medicaid, or other third-party payers that are false or fraudulent, or making a false statement or record material to payment of a false claim or avoiding, decreasing, or concealing an obligation to pay money owed to the federal government;
|
•
|
provisions of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which created new federal criminal statutes, referred to as the “HIPAA All-Payer Fraud Prohibition,” that prohibit knowingly and willfully executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters;
|
•
|
federal transparency laws, including the federal Physician Payment Sunshine Act, which require manufacturers of certain drugs and biologics to track and disclose payments and other transfers of value they make to U.S. physicians and teaching hospitals as well as physician ownership and investment interests in the manufacturer, and that such information is subsequently made publicly available in a searchable format on a CMS website;
|
•
|
provisions of HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which imposes certain requirements relating to the privacy, security and transmission of individually identifiable health information; and
|
•
|
state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, state transparency reporting and compliance laws; and state laws governing the privacy and security of health information in certain
|
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
Item 3.
|
Defaults Upon Senior Securities
|
Item 4.
|
Mine Safety Disclosures
|
Item 5.
|
Other Information
|
Item 6.
|
Exhibits
|
Exhibit
Number
|
|
Description of Documents
|
|
|
|
|
|
|
3.1(1)
|
|
|
|
|
|
3.2(2)
|
|
|
|
|
|
3.3(3)
|
|
|
|
|
|
3.4(4)
|
|
|
|
|
|
3.5(5)
|
|
|
|
|
|
10.1(6)
|
|
|
|
|
|
31.1(6)
|
|
|
|
|
|
31.2(6)
|
|
|
|
|
|
32.1*
|
|
|
|
|
|
101.SCH(6)
|
|
Inline XBRL Taxonomy Extension Schema Document.
|
|
|
|
101.CAL(6)
|
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
101.LAB(6)
|
|
Inline XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
101.PRE(6)
|
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
101.DEF(6)
|
|
Inline XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
104(6)
|
|
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101).
|
(1)
|
Incorporated by reference to Exhibit 3.1 to Nektar Therapeutics’ Quarterly Report on Form 10-Q, for the quarter ended June 30, 1998.
|
(2)
|
Incorporated by reference to Exhibit 3.3 to Nektar Therapeutics’ Quarterly Report on Form 10-Q, for the quarter ended June 30, 2000.
|
(3)
|
Incorporated by reference to Exhibit 3.1 to Nektar Therapeutics’ Current Report on Form 8-K, filed with the SEC on January 23, 2003.
|
(4)
|
Incorporated by reference to Exhibit 3.6 to Nektar Therapeutics’ Annual Report on Form 10-K, for the year ended December 31, 2009.
|
(5)
|
Incorporated by reference to Exhibit 3.1 to Nektar Therapeutics’ Current Report on Form 8-K, filed with the SEC on February 6, 2019.
|
(6)
|
Filed herewith.
|
*
|
Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as otherwise stated in such filing.
|
++
|
Management contract or compensatory plan or arrangement.
|
|
By:
|
/s/ GIL M. LABRUCHERIE
|
|
|
Gil M. Labrucherie
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
|
|
Date: November 6, 2019
|
|
|
|
|
By:
|
/s/ JILLIAN B. THOMSEN
|
|
|
Jillian B. Thomsen
Senior Vice President, Finance and Chief Accounting Officer
|
|
|
Date: November 6, 2019
|
Period
|
Compensation
|
October 16-31, 2019
|
19,134.14
|
November 1-30, 2019
|
38,268.58
|
December 1-31, 2019
|
38,268.58
|
January 1-31, 2020
|
38,268.58
|
February 1-29, 2020
|
38,268.58
|
March 1-31, 2020
|
38,268.58
|
April 1-30, 2020
|
38,268.58
|
May 1-31, 2020
|
38,268.58
|
June 1-30, 2020
|
38,268.58
|
July 1-31, 2020
|
38,268.58
|
August 1-31, 2020
|
38,268.58
|
September 1-30, 2020
|
38,268.58
|
October 1-31, 2020
|
38,268.58
|
November 1-30, 2020
|
38,268.58
|
December 1-31, 2020
|
38,268.58
|
January 1-31, 2021
|
38,268.58
|
February 1-28 2021
|
38,268.58
|
March 1-31, 2021
|
38,268.58
|
Total
|
669,700.00
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2019 of Nektar Therapeutics;
|
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 registrant’s 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 registrant’s 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 registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s 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 registrant’s 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 registrant’s internal control over financial reporting.
|
Date: November 6, 2019
|
|
/s/ HOWARD W. ROBIN
|
|
|
Howard W. Robin
Chief Executive Officer, President and Director
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q for the period ended September 30, 2019 of Nektar Therapeutics;
|
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 registrant’s 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 registrant’s 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 registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s 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 registrant’s 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 registrant’s internal control over financial reporting.
|
Date: November 6, 2019
|
|
/s/ GIL M. LABRUCHERIE
|
|
|
Gil M. Labrucherie
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
1.
|
The Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2019, to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
|
2.
|
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: November 6, 2019
|
|
|
|
|
|
/s/ HOWARD W. ROBIN
|
|
/s/ GIL M. LABRUCHERIE
|
Howard W. Robin
Chief Executive Officer, President and Director
|
|
Gil M. Labrucherie
Senior Vice President, Chief Operating Officer, and Chief Financial Officer
|
*
|
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 the Company 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.
|