☒
|
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
|
26-3931704
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer
Identification Number)
|
|
85 Wells Avenue, 2nd Floor
Newton
MA
|
02459
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading
Symbol(s)
|
Name of each exchange
on which registered
|
||
Common Stock
|
KPTI
|
Nasdaq Global Select Market
|
Large accelerated filer
|
☒
|
Accelerated filer
|
☐
|
|||
Non-accelerated filer
|
☐
|
Smaller reporting company
|
☐
|
|||
|
|
Emerging growth company
|
☐
|
|
|
|||||
Item 1.
|
3
|
|||||
|
3
|
|||||
|
4
|
|||||
|
5
|
|||||
|
6
|
|||||
|
7
|
|||||
|
8
|
|||||
Item 2.
|
25
|
|||||
Item 3.
|
31
|
|||||
Item 4.
|
31
|
|||||
|
|
|||||
Item 1.
|
32
|
|||||
Item 1.A.
|
32
|
|||||
Item 6.
|
71
|
|||||
|
72
|
Item 1.
|
Condensed Consolidated Financial Statements (Unaudited).
|
|
June
30,
2019 |
December
31,
2018 |
||||||
Assets
|
|
|
||||||
Current assets:
|
|
|
||||||
Cash and cash equivalents
|
$
|
75,545
|
$
|
118,021
|
||||
Short-term investments
|
141,614
|
210,178
|
||||||
Prepaid expenses and other current assets
|
5,671
|
6,413
|
||||||
Total current assets
|
222,830
|
334,612
|
||||||
Property and equipment, net
|
3,375
|
3,863
|
||||||
Operating lease
right-of-use
assets
|
11,180
|
—
|
||||||
Long-term investments
|
—
|
2,001
|
||||||
Restricted cash
|
715
|
716
|
||||||
Total assets
|
$
|
238,100
|
$
|
341,192
|
||||
Liabilities and stockholders’ equity
|
|
|
||||||
Current liabilities:
|
|
|
||||||
Accounts payable
|
$
|
1,113
|
$
|
4,332
|
||||
Accrued expenses
|
27,799
|
32,493
|
||||||
Deferred revenue
|
1,287
|
9,362
|
||||||
Operating lease liabilities
|
1,522
|
—
|
||||||
Deferred rent
|
—
|
390
|
||||||
Other current liabilities
|
453
|
327
|
||||||
Total current liabilities
|
32,174
|
46,904
|
||||||
Convertible senior notes
|
106,157
|
102,664
|
||||||
Operating lease liabilities, net of current portion
|
14,055
|
—
|
||||||
Deferred revenue, net of current portion
|
3,245
|
4,532
|
||||||
Deferred rent, net of current portion
|
—
|
3,922
|
||||||
Total liabilities
|
155,631
|
158,022
|
||||||
Stockholders’ equity:
|
|
|
||||||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none issued and outstanding
|
—
|
—
|
||||||
Common stock, $0.0001 par value; 200,000,000 shares authorized; 60,965,505 shares issued and outstanding at June 30, 2019;
100,000,000
shares authorized;
60,829,308
shares issued and outstanding at
December 31, 2018
|
6
|
6
|
||||||
Additional
paid-in
capital
|
865,726
|
857,156
|
||||||
Accumulated other comprehensive income (loss)
|
61
|
(244
|
)
|
|||||
Accumulated deficit
|
(783,324
|
)
|
(673,748
|
)
|
||||
Total stockholders’ equity
|
82,469
|
183,170
|
||||||
|
||||||||
Total liabilities and stockholders’ equity
|
$
|
238,100
|
$
|
341,192
|
||||
|
Three Months Ended,
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
License and other revenue
|
$
|
9,493
|
$
|
19,891
|
$
|
9,648
|
$
|
29,891
|
||||||||
Operating expenses:
|
|
|
|
|
||||||||||||
Research and development
|
26,517
|
44,734
|
64,491
|
86,055
|
||||||||||||
General and administrative
|
24,662
|
9,489
|
51,765
|
17,110
|
||||||||||||
|
||||||||||||||||
Total operating expenses
|
51,179
|
54,223
|
116,256
|
103,165
|
||||||||||||
Loss from operations
|
(41,686
|
)
|
(34,332
|
)
|
(106,608
|
)
|
(73,274
|
)
|
||||||||
Other income (expense):
|
|
|
|
|
||||||||||||
Interest income
|
1,412
|
653
|
3,183
|
1,162
|
||||||||||||
Interest expense
|
(3,089
|
)
|
—
|
(6,087
|
)
|
—
|
||||||||||
Other (expense) income
|
(44
|
)
|
7
|
(46
|
)
|
(7
|
)
|
|||||||||
|
||||||||||||||||
Total other (expense) income, net
|
(1,721
|
)
|
660
|
(2,950
|
)
|
1,155
|
||||||||||
Loss before income taxes
|
(43,407
|
)
|
(33,672
|
)
|
(109,558
|
)
|
(72,119
|
)
|
||||||||
Income tax (provision) benefit
|
(8
|
)
|
17
|
(18
|
)
|
5
|
||||||||||
Net loss
|
$
|
(43,415
|
)
|
$
|
(33,655
|
)
|
$
|
(109,576
|
)
|
$
|
(72,114
|
)
|
||||
Net loss per share—basic and diluted
|
$
|
(0.71
|
)
|
$
|
(0.60
|
)
|
$
|
(1.80
|
)
|
$
|
(1.36
|
)
|
||||
Weighted-average number of common shares outstanding used in net loss per share—basic and
diluted |
60,929,024
|
56,089,159
|
60,892,860
|
52,862,194
|
||||||||||||
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Net loss
|
$
|
(43,415
|
)
|
$
|
(33,655
|
)
|
$
|
(109,576
|
)
|
$
|
(72,114
|
)
|
||||
Comprehensive income (loss)
|
|
|
|
|
||||||||||||
Unrealized gain (loss) on investments
|
52
|
104
|
309
|
(5
|
)
|
|||||||||||
Foreign currency translation adjustments
|
37
|
(78
|
)
|
(4
|
)
|
(38
|
)
|
|||||||||
Comprehensive loss
|
$
|
(43,326
|
)
|
$
|
(33,629
|
)
|
$
|
(109,271
|
)
|
$
|
(72,157
|
)
|
||||
|
Six Months Ended
June 30, |
|||||||
|
2019
|
2018
|
||||||
Operating activities
|
|
|
||||||
Net loss
|
$
|
(109,576
|
)
|
$
|
(72,114
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
||||||
Depreciation and amortization
|
487
|
353
|
||||||
Net amortization of premiums and discounts on investments
|
(968
|
)
|
270
|
|||||
Amortization of debt discount and issuance costs
|
3,493
|
—
|
||||||
Stock-based compensation expense
|
8,023
|
8,604
|
||||||
Changes in operating assets and liabilities:
|
|
|
||||||
Prepaid expenses and other current assets
|
742
|
(1,685
|
)
|
|||||
Operating lease
right-of-use
assets
|
531
|
—
|
||||||
Accounts payable
|
(3,171
|
)
|
(1,870
|
)
|
||||
Accrued expenses and other liabilities
|
(4,580
|
)
|
1,624
|
|||||
Operating lease liabilities
|
(446
|
)
|
—
|
|||||
Deferred revenue
|
(9,362
|
)
|
(8,026
|
)
|
||||
Deferred rent
|
—
|
564
|
||||||
Net cash used in operating activities
|
(114,827
|
)
|
(72,280
|
)
|
||||
Investing activities
|
|
|
||||||
Purchases of property and equipment
|
(49
|
)
|
(779
|
)
|
||||
Proceeds from maturities of investments
|
118,511
|
50,602
|
||||||
Purchases of investments
|
(46,668
|
)
|
(74,943
|
)
|
||||
Net cash provided by (used in) investing activities
|
71,794
|
(25,120
|
)
|
|||||
Financing activities
|
|
|
||||||
Proceeds from the issuance of common stock, net of issuance costs
|
—
|
145,720
|
||||||
Proceeds from the exercise of stock options and shares issued under employee stock purchase plan
|
547
|
1,841
|
||||||
Net cash provided by financing activities
|
547
|
147,561
|
||||||
Effect of exchange rate on cash, cash equivalents and restricted cash
|
9
|
(44
|
)
|
|||||
Net (decrease) increase in cash, cash equivalents and restricted cash
|
(42,477
|
)
|
50,117
|
|||||
Cash, cash equivalents and restricted cash at beginning of period
|
118,737
|
69,487
|
||||||
Cash, cash equivalents and restricted cash at end of period
|
$
|
76,260
|
$
|
119,604
|
||||
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
|
|
|
||||||
Cash and cash equivalents
|
$
|
75,545
|
$
|
118,966
|
||||
Short-term restricted cash
|
—
|
—
|
||||||
Long-term restricted cash
|
715
|
638
|
||||||
Total cash, cash equivalents and restricted cash
|
$
|
76,260
|
$
|
119,604
|
||||
Supplemental disclosures:
|
|
|
||||||
Operating lease
right-of-use
assets obtained in exchange for operating lease liabilities
|
$
|
11,711
|
$
|
—
|
||||
Cash paid for amounts included in the measurement of operating lease liabilities
|
$
|
1,319
|
$
|
—
|
|
Common Shares
|
|
|
|
|
||||||||||||||||||||
|
Shares
|
Amount
|
Additional
Paid-In
Capital |
Accumulated
Other Comprehensive Loss |
Accumulated
Deficit |
Total
Stockholders’ Equity (Deficit) |
|||||||||||||||||||
Balance at March 31, 2019
|
60,864,445
|
$
|
6
|
$
|
861,215
|
$
|
(28
|
)
|
$
|
(739,909
|
)
|
$
|
121,284
|
||||||||||||
Vesting of restricted stock
|
—
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan
|
101,060
|
—
|
395
|
—
|
—
|
395
|
|||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
4,116
|
—
|
—
|
4,116
|
|||||||||||||||||||
Unrealized gain on investments
|
—
|
—
|
—
|
52
|
—
|
52
|
|||||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
37
|
—
|
37
|
|||||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(43,415
|
)
|
(43,415
|
)
|
|||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2019
|
|
|
60,965,505
|
|
|
$
|
6 |
|
|
$
|
865,726
|
|
|
$
|
61 |
|
|
$
|
(783,324
|
)
|
|
$
|
82,469
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2018
|
49,670,328
|
$
|
5
|
$
|
629,610
|
$
|
(286
|
)
|
$
|
(533,799
|
)
|
$
|
95,530
|
||||||||||||
Vesting of restricted stock
|
98,800
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan
|
206,708
|
—
|
1,412
|
—
|
—
|
1,412
|
|||||||||||||||||||
Issuance of common stock
|
|
|
10,525,424
|
|
|
|
1
|
|
|
|
145,718
|
|
|
|
—
|
|
|
|
—
|
|
|
|
145,719
|
|
|
Stock-based compensation expense
|
—
|
—
|
4,440
|
—
|
—
|
4,440
|
|||||||||||||||||||
Unrealized gain on investments
|
—
|
—
|
—
|
104
|
—
|
104
|
|||||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(78
|
)
|
—
|
(78
|
)
|
|||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(33,655
|
)
|
(33,655
|
)
|
|||||||||||||||||
Balance at June 30, 2018
|
60,501,260
|
$
|
6
|
$
|
781,180
|
$
|
(260
|
)
|
$
|
(567,454
|
)
|
$
|
213,472
|
||||||||||||
Balance at December 31, 2018
|
60,829,308
|
$
|
6
|
857,156
|
$
|
(244
|
)
|
$
|
(673,748
|
)
|
$
|
183,170
|
|||||||||||||
Vesting of restricted stock
|
5,000
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan
|
131,197
|
—
|
547
|
—
|
—
|
547
|
|||||||||||||||||||
Stock-based compensation expense
|
—
|
—
|
8,023
|
—
|
—
|
8,023
|
|||||||||||||||||||
Unrealized gain on investments
|
—
|
—
|
—
|
309
|
—
|
309
|
|||||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(4
|
)
|
—
|
(4
|
)
|
|||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(109,576
|
)
|
(109,576
|
)
|
|||||||||||||||||
Balance at June 30, 2019
|
|
|
60,965,505
|
|
|
$
|
6 |
|
|
$
|
865,726
|
|
|
$
|
61 |
|
|
$
|
(783,324
|
)
|
|
$
|
82,469
|
|
|
Balance at December 31, 2017
|
49,533,150
|
$
|
5
|
$
|
625,017
|
$
|
(217
|
)
|
$
|
(495,340
|
)
|
$
|
129,465
|
||||||||||||
Vesting of restricted stock
|
103,800
|
—
|
—
|
—
|
—
|
—
|
|||||||||||||||||||
Exercise of stock options and shares issued under the employee stock purchase plan
|
338,886
|
—
|
1,841
|
—
|
—
|
1,841
|
|||||||||||||||||||
Issuance of common stock
|
|
|
10,525,424
|
|
|
|
1
|
|
|
|
145,718
|
|
|
|
—
|
|
|
|
—
|
|
|
|
145,719
|
|
|
Stock-based compensation expense
|
—
|
—
|
8,604
|
—
|
—
|
8,604
|
|||||||||||||||||||
Unrealized loss on investments
|
—
|
—
|
—
|
(5
|
)
|
—
|
(5
|
)
|
|||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(38
|
)
|
—
|
(38
|
)
|
|||||||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(72,114
|
)
|
(72,114
|
)
|
|||||||||||||||||
Balance at June 30, 2018
|
60,501,260
|
$
|
6
|
$
|
781,180
|
$
|
(260
|
)
|
$
|
(567,454
|
)
|
$
|
213,472
|
||||||||||||
|
January 1, 2019
Prior to ASC
842 Adoption
|
ASC 842
Adjustment
|
January 1, 2019
as Adjusted
|
|||||||||
Consolidated balance sheet data (in thousands):
|
|
|
|
|||||||||
Operating lease and right-of-use assets
(1)
|
$ —
|
$ 11,711
|
$ 11,711
|
|||||||||
Deferred rent
(2)
|
$ 390
|
$ (390)
|
$ —
|
|||||||||
Deferred rent non-current
(2)
|
$ 3,922
|
$ (3,922)
|
$ —
|
|||||||||
Operating lease liabilities
(3)
|
$ —
|
$ 1,175
|
$ 1,175
|
|||||||||
Non-current operating lease liabilities
(3)
|
$ —
|
$ 14,848
|
$ 14,848
|
(1) |
Represents capitalization of operating lease
right-of-use
assets, offset by reclassification of deferred rent and tenant incentives to operating lease
right-of-use
assets.
|
(2) |
Represents reclassification of deferred rent and tenant incentives to operating lease
right-of-use
assets.
|
(3) | Represents recognition of operating lease liabilities. |
Level 1 inputs
|
Quoted prices in active markets for identical assets or liabilities
|
|
Level 2 inputs
|
Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly
|
|
Level 3 inputs
|
Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability
|
Description
|
Total
|
Quoted Prices
in Active Markets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
||||||||||||
Financial assets
|
|
|
|
|
||||||||||||
Cash equivalents:
|
|
|
|
|
||||||||||||
Money market funds
|
$
|
21,211
|
$
|
21,211
|
$
|
—
|
$
|
—
|
||||||||
Commercial paper
|
15,722
|
—
|
15,722
|
—
|
||||||||||||
Investments:
|
|
|
|
|
||||||||||||
Current:
|
|
|
|
—
|
||||||||||||
Corporate debt securities
|
81,086
|
—
|
81,086
|
—
|
||||||||||||
Commercial paper
|
37,246
|
—
|
37,246
|
—
|
||||||||||||
U.S. government and agency securities
|
19,282
|
—
|
19,282
|
—
|
||||||||||||
Certificate of deposit
|
4,000
|
—
|
4,000
|
—
|
||||||||||||
|
$
|
178,547
|
$
|
21,211
|
$
|
157,336
|
$
|
—
|
||||||||
Description
|
Total
|
Quoted Prices
in Active Markets (Level 1) |
Significant
Other Observable Inputs (Level 2) |
Significant
Unobservable Inputs (Level 3) |
||||||||||||
Financial assets
|
|
|
|
|
||||||||||||
Cash equivalents:
|
|
|
|
|
||||||||||||
Money market funds
|
$
|
62,320
|
$
|
62,320
|
$
|
—
|
$
|
—
|
||||||||
Corporate debt securities
|
6,823
|
—
|
6,823
|
—
|
||||||||||||
Commercial paper
|
7,738
|
—
|
7,738
|
—
|
||||||||||||
Investments:
|
|
|
|
|
||||||||||||
Current:
|
|
|
|
|
||||||||||||
Corporate debt securities
|
143,079
|
—
|
143,079
|
—
|
||||||||||||
Commercial paper
|
43,978
|
—
|
43,978
|
—
|
||||||||||||
U.S. government and agency securities
|
19,124
|
—
|
19,124
|
—
|
||||||||||||
Certificate of deposit
|
3,997
|
—
|
3,997
|
—
|
||||||||||||
Non-current:
|
|
|
|
|
||||||||||||
Corporate debt securities (one to two year maturity)
|
2,001
|
—
|
2,001
|
—
|
||||||||||||
|
$
|
289,060
|
$
|
62,320
|
$
|
226,740
|
$
|
—
|
||||||||
|
Amortized Cost
|
Gross Unrealized
Gains |
Gross Unrealized
Loss |
Fair Value
|
||||||||||||
Current:
|
|
|
|
|
||||||||||||
Corporate debt securities
|
$
|
81,037
|
$
|
60
|
$
|
(11
|
)
|
$
|
81,086
|
|||||||
Commercial paper
|
37,219
|
27
|
—
|
37,246
|
||||||||||||
U.S. government and agency securities
|
19,263
|
21
|
(2
|
)
|
19,282
|
|||||||||||
Certificate of deposit
|
4,000
|
—
|
—
|
4,000
|
||||||||||||
|
$
|
141,519
|
$
|
108
|
$
|
(13
|
)
|
$
|
141,614
|
|||||||
|
Amortized Cost
|
Gross Unrealized
Gains |
Gross Unrealized
Loss |
Fair Value
|
||||||||||||
Current:
|
|
|
|
|
||||||||||||
Corporate debt securities
|
$
|
143,254
|
$
|
3
|
$
|
(178
|
)
|
$
|
143,079
|
|||||||
Commercial paper
|
44,001
|
—
|
(23
|
)
|
43,978
|
|||||||||||
U.S. government and agency securities
|
19,131
|
10
|
(17
|
)
|
19,124
|
|||||||||||
Certificate of deposit
|
4,000
|
—
|
(3
|
)
|
3,997
|
|||||||||||
Non-current:
|
|
|
|
|
||||||||||||
Corporate debt securities (one to two year maturity)
|
2,007
|
—
|
(6
|
)
|
2,001
|
|||||||||||
|
$
|
212,393
|
$
|
13
|
$
|
(227
|
)
|
$
|
212,179
|
|||||||
|
|
Three and Six
Months Ended
June 30,
|
|
|||||
|
|
2019
|
|
|
2018
|
|
||
Outstanding stock options
|
|
|
10,410,757
|
|
|
|
8,996,219
|
|
Unvested restricted stock units
|
|
|
903,900
|
|
|
|
123,800
|
|
|
|
Shares
|
|
Weighted-
Average Exercise Price Per Share |
|
|
Weighted-
Average Remaining Contractual Term (years) |
|
|
Aggregate
Intrinsic Value (in thousands) |
||||||
Outstanding at December 31, 2018
|
8,917,084
|
$
|
13.78
|
7.4
|
$
|
8,197
|
||||||||||
Granted
|
2,623,450
|
7.98
|
||||||||||||||
Exercised
|
(30,618
|
)
|
4.72
|
|||||||||||||
Canceled
|
(1,099,159
|
)
|
13.33
|
|||||||||||||
Outstanding at June 30, 2019
|
10,410,757
|
12.40
|
7.17
|
$
|
2,597
|
|||||||||||
Exercisable at June 30, 2019
|
5,315,339
|
$
|
14.79
|
5.71
|
$
|
2,065
|
||||||||||
|
Number of
Shares Underlying RSUs |
Weighted-
Average Grant Date Fair Value |
||||||
Unvested at December
31, 2018
|
25,000
|
$
|
9.87
|
|||||
Granted
|
1,024,750
|
9.18
|
||||||
Forfeited
|
(140,850
|
)
|
9.21
|
|||||
Vested
|
(5,000
|
)
|
10.27
|
|||||
Unvested at June
30, 2019
|
903,900
|
$
|
9.19
|
|||||
Years ended December 31,
|
Future
Minimum Payments |
|
|||
2019
|
$
|
1,571
|
|
||
2020
|
3,200
|
|
|||
2021
|
3,277
|
|
|||
2022
|
3,447
|
|
|||
2023
and thereafter
|
10,453
|
|
|||
|
|||||
Total minimum lease payments
|
$
|
21,948
|
|
||
Less: present value adjustment
|
(6,371
|
)
|
|
||
|
|||||
Present value of minimum lease payments
|
$
|
15,577
|
|
||
|
(1) |
during any calendar quarter commencing after the calendar quarter ending on December 31, 2018 (and only during such calendar quarter), if the last reported sale price of the Company’s common stock for at least
20
trading days (whether or not consecutive) during the period of
30
consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price for the Notes on each applicable trading day;
|
|
|
|
|
(2) |
during the
period (the “Measurement Period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the Measurement Period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day;
five
|
|
|
|
|
(3) | if the Company calls the Notes for redemption, until the close of business on the business day immediately preceding the redemption date; or | |
|
|
|
(4) | upon the occurrence of specified corporate events as described within the indenture governing the Notes. |
Liability component:
|
|
|||
Principal
|
$
|
172,500
|
||
Less: debt discount and issuance costs, net
|
(66,343
|
)
|
||
Net carrying amount
|
$
|
106,157
|
||
Equity component:
|
$
|
70,059
|
||
|
Six
Months Ended June 30, 2019 |
|||
Contractual interest expense
|
$
|
2,594
|
||
Amortization of debt discount
|
3,326
|
|||
Amortization of debt issuance costs
|
167
|
|||
Total interest expense
|
$
|
6,087
|
||
Years ended December 31,
|
Future Minimum
Payments |
|
|||
2019
|
$
|
5,175
|
|
||
2020
|
5,175
|
|
|||
2021
|
5,175
|
|
|||
2022
|
5,175
|
|
|||
2023 and thereafter
|
188,025
|
|
|||
Total minimum payments
|
$
|
208,725
|
|
||
Less: interest
|
(36,225
|
)
|
|
||
Less: unamortized discount
|
(66,343
|
)
|
|
||
Less: current portion
|
—
|
|
|||
Long term debt
|
$
|
106,157
|
|
|
Three Months Ended
June 30,
|
|
|
||||||||||||||
|
2019
|
2018
|
$ Change
|
% Change
|
|||||||||||||
|
(in thousands)
|
|
|
||||||||||||||
License and other revenue
|
$ |
9,493
|
$ |
19,891
|
$ |
(10,398
|
) |
(52.3)%
|
|||||||||
Operating expenses:
|
|
|
|
|
|||||||||||||
Research and development
|
26,517
|
44,734
|
(18,217
|
) |
(40.7)%
|
||||||||||||
General and administrative
|
24,662
|
9,489
|
15,173
|
159.9%
|
|||||||||||||
Loss from operations
|
(41,686
|
) |
(34,332
|
) |
(7,354
|
) |
21.4%
|
||||||||||
Other (expense) income, net
|
(1,721
|
) |
660
|
(2,381
|
) |
(360.8)%
|
|||||||||||
Loss before income taxes
|
(43,407
|
) |
(33,672
|
) |
(9,735
|
) |
28.9%
|
||||||||||
Income tax (provision) benefit
|
(8
|
) |
17
|
(25
|
) |
(147.1)%
|
|||||||||||
Net loss
|
$ |
(43,415
|
) | $ |
(33,655
|
) | $ |
(9,760
|
) |
29.0%
|
|||||||
• | a decrease of $9.4 million in personnel costs and consulting and professional expense; |
• | a decrease of $8.0 million in clinical trial costs, primarily related to the selinexor program; |
• | a decrease of $0.8 million in miscellaneous costs; and |
• | a decrease of $0.3 million in travel costs; offset by |
• | an increase of $0.3 million in facility costs and IT infrastructure costs. |
• | an increase of $10.3 million in personnel costs, primarily due to increased headcount and related onboarding costs associated with building our commercial team in preparation for the U.S. commercial launch of XPOVIO; |
• | an increase of $2.4 million in commercial related activities; |
• | an increase of $1.8 million in facility costs and IT infrastructure costs; and |
• | an increase of $1.4 million in costs related to corporate training, travel and corporate events; offset by |
• | a decrease of $0.5 million in consulting and professional costs; and |
• | a decrease of $0.2 million in miscellaneous costs. |
|
Six Months Ended
June 30,
|
|
|
||||||||||||||
|
2019
|
2018
|
$ Change
|
% Change
|
|||||||||||||
|
(in thousands)
|
|
|
||||||||||||||
License and other revenue
|
$ |
9,648
|
$ |
29,891
|
$ |
(20,243
|
) |
(67.7)%
|
|||||||||
Operating expenses:
|
|
|
|
|
|||||||||||||
Research and development
|
64,491
|
86,055
|
(21,564
|
) |
(25.1)%
|
||||||||||||
General and administrative
|
51,765
|
17,110
|
34,655
|
202.5%
|
|||||||||||||
Loss from operations
|
(106,608
|
) |
(73,274
|
) |
(33,334
|
) |
45.5%
|
||||||||||
Other (expense) income, net
|
(2,950
|
) |
1,155
|
(4,105
|
) |
(355.4)%
|
|||||||||||
Loss before income taxes
|
(109,558
|
) |
(72,119
|
) |
(37,439
|
) |
51.9%
|
||||||||||
Income tax (provision) benefit
|
(18
|
) |
5
|
(23
|
) |
(460.0)%
|
|||||||||||
Net loss
|
$ |
(109,576
|
) | $ |
(72,114
|
) | $ |
(37,462
|
) |
51.9%
|
|||||||
• | a decrease of $11.0 million in clinical trial costs, primarily related to the selinexor program; |
• | a decrease of $10.1 million in personnel costs and consulting and professional expense; and |
• | a decrease of $1.2 million in miscellaneous costs; offset by |
• | an increase of $0.7 million in facility costs and IT infrastructure costs. |
• | an increase of $21.3 million in personnel costs, primarily due to increased headcount and related onboarding costs associated with building our commercial team in preparation for the U.S. commercial launch of XPOVIO; |
• | an increase of $6.4 million in commercial related activities; |
• | an increase of $3.9 million in costs related to corporate training, travel and corporate events; |
• | an increase of $3.3 million in facility costs and IT infrastructure costs; and |
• | an increase of $0.7 million in consulting and professional costs; offset by |
• | a decrease of $0.9 million in miscellaneous costs. |
|
Six Months Ended
June 30,
|
|||||||
|
2019
|
2018
|
||||||
|
(in thousands)
|
|||||||
Net cash used in operating activities
|
$ |
(114,827
|
) | $ |
(72,280
|
) | ||
Net cash provided by (used in) investing activities
|
71,794
|
(25,120
|
) | |||||
Net cash provided by financing activities
|
547
|
147,561
|
||||||
Effect of exchange rate changes
|
9
|
(44
|
) | |||||
Net decrease in cash, cash equivalents and restricted cash
|
$ |
42,477
|
$ |
50,117
|
||||
• | revenue generated from commercial sales of XPOVIO; |
• | costs related to the sales and marketing of XPOVIO; |
• | the costs, timing and outcome of regulatory review of our drug candidates; |
• | the costs of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our drug candidates for which we receive marketing approval, to the extent that such sales, marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time; |
• | the amount of revenue received from commercial sales of our drug candidates for which we receive marketing approval; |
• | the progress and results of our current and planned clinical trials of selinexor; |
• | the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our other drug candidates; |
• | our ability to establish and maintain collaborations on favorable terms, if at all; |
• | the success of any collaborations that we may enter into with third parties; |
• |
the extent to which we acquire or
in-license
other drugs and technologies;
|
• | the costs associated with legal activities, including litigation, arising in the course of business activities and our ability to prevail in any such legal disputes; and |
• | the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims. |
• | successful commercialization of XPOVIO in the United States, including establishing sales, marketing and distribution capabilities for XPOVIO; |
• | the consistency of any new data we collect and analyses we conduct with prior results, whether they support a favorable safety, efficacy and effectiveness profile of XPOVIO and any potential impact on our FDA accelerated approval and/or FDA package insert for XPOVIO; |
• | our ability to comply with FDA post-marketing requirements and commitments, including through successfully conducting additional studies that confirm clinical efficacy, effectiveness and safety of XPOVIO and acceptance of the same by the FDA and medical community since continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials; |
• | acceptance of XPOVIO and, if and when approved, our drug candidates by patients, the medical community and third-party payors; |
• | obtaining and maintaining coverage, adequate pricing and adequate reimbursement by third-party payors, including government payors, for XPOVIO and our drug candidates; |
• | successful completion of preclinical studies; |
• | acceptance by the FDA of investigational new drug applications, or INDs, for our drug candidates prior to commencing clinical studies; |
• | successful enrollment in, and completion of, clinical trials, including demonstration of a favorable risk-benefit ratio; |
• | receipt of marketing approvals from applicable regulatory authorities; |
• | establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; |
• | obtaining and maintaining patent and trade secret protection and regulatory exclusivity for our drug candidates; |
• | establishing sales, marketing, manufacturing and distribution capabilities to commercialize any drug candidates for which we may obtain marketing approval, whether alone or in collaboration with others; |
• | launching commercial sales of any drug candidates for which we obtain marketing approval, whether alone or in collaboration with others; |
• | effectively competing with other therapies; |
• | maintaining an acceptable safety profile of the drugs following approval; |
• | enforcing and defending intellectual property rights and claims; and |
• | maintaining and growing an organization of scientists and business people, including collaborators, who can develop and commercialize our drug candidates. |
• | the research methodology used may not be successful in identifying potential drug candidates; |
• | potential drug candidates may, on further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be drugs that will receive marketing approval and/or achieve market acceptance; or |
• | potential drug candidates may not be effective in treating their targeted diseases. |
• | regulatory authorities or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
• | feedback from regulatory authorities that requires us to modify the design of our clinical trials; |
• | we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites or contract research organizations; |
• | clinical trials of our drug candidates may produce negative or inconclusive results, and we may decide, or regulatory authorities may require us, to conduct additional clinical trials, suspend ongoing clinical trials or abandon drug development programs; |
• | the number of patients required for clinical trials of our drug candidates may be larger than we anticipate, enrollment in these clinical trials may be slower than we anticipate or participants may drop out of these clinical trials at a higher rate than we anticipate; |
• | our third-party contractors, including those manufacturing our drug candidates or conducting clinical trials on our behalf, may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all; |
• |
we or our investigators might have to suspend or terminate clinical trials of our drug candidates for various reasons, including
non-compliance
with regulatory requirements, a finding that our drug candidates have undesirable side effects or other unexpected characteristics, or a finding that the participants are being exposed to unacceptable health risks;
|
• | regulators may recommend or require us to perform additional or unanticipated clinical trials to obtain approval; |
• | regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; |
• | the cost of clinical trials of our drug candidates may be greater than we anticipate; |
• | the supply or quality of our drug candidates or other materials necessary to conduct clinical trials of our drug candidates may be insufficient or inadequate; |
• |
regulators may revise the requirements for approving our drug candidates, or such requirements may not be as we anticipate; and
|
• | any partners and collaborators that help conduct clinical trials may face any of the above issues, and may conduct clinical trials in ways they view as advantageous to them but that are suboptimal for us. |
• | be delayed in obtaining marketing approval for our drug candidates; |
• | not obtain marketing approval at all; |
• | obtain marketing approval in some countries and not in others; |
• | obtain approval for indications or patient populations that are not as broad as intended or desired; |
• | obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings; |
• | be subject to additional post-marketing testing requirements; or |
• | have the drug removed from the market after obtaining marketing approval. |
• | severity of the disease under investigation; |
• | availability and efficacy of approved drugs for the disease under investigation; |
• | patient eligibility criteria for the study in question; |
• | competing drugs in clinical development; |
• | perceived risks and benefits of the drug candidate under study; |
• | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials; |
• | efforts to facilitate timely enrollment in clinical trials; |
• | patient referral practices of physicians; |
• | the ability to monitor patients adequately during and after treatment; and |
• | proximity and availability of clinical trial sites for prospective patients. |
• | regulatory authorities may withdraw the approval of such drug; |
• | regulatory authorities may require additional warnings on the label or impose distribution or use restrictions; |
• | regulatory authorities may require one or more postmarketing studies; |
• | regulatory authorities may withdraw the approval of such drug; |
• | we may be required to create a medication guide outlining the risks of such side effects for distribution to patients; |
• | we could be sued and held liable for harm caused to patients; and |
• | our reputation may suffer. |
• | efficacy and potential advantages compared to alternative treatments; |
• | the ability to offer our drugs for sale at competitive prices; |
• | convenience and ease of administration compared to alternative treatments; |
• | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
• | the strength of marketing and distribution support; |
• | the timing of market introduction of competitive products; |
• | sufficient third-party coverage or reimbursement; |
• | effectiveness of our sales and marketing efforts; |
• | adverse publicity about our drugs or favorable publicity about competitive products; |
• | the prevalence and severity of any side effects; |
• | any restrictions on the use of our drugs together with other medications; and |
• | inability of certain types of patients to take our drugs. |
• | our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel; |
• | the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future drugs; |
• | the lack of complementary drugs to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive drug lines; |
• | unforeseen costs and expenses associated with creating an independent sales, marketing and distribution organization; and |
• | inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies. |
• | decreased demand for XPOVIO and any other drugs that we may develop; |
• | injury to our reputation and significant negative media attention; |
• | withdrawal of clinical trial participants; |
• | initiation of investigations by regulators; |
• | product recalls, withdrawals or labeling, marketing or promotional restrictions; |
• | significant costs to defend the related litigation; |
• | substantial monetary awards to trial participants or patients; |
• | loss of revenue; |
• | reduced resources of our management to pursue our business strategy; and |
• | the inability to successfully commercialize XPOVIO and any other drugs that we may develop. |
• | potentially reduced protection for intellectual property rights; |
• |
the potential for
so-called
parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market (with low or lower prices) rather than buying them locally;
|
• | unexpected changes in tariffs, trade barriers and regulatory requirements; |
• | economic weakness, including inflation, volatility in currency exchange rates or political instability in particular foreign economies and markets; |
• | workforce uncertainty in countries where labor unrest is more common than in the United States; |
• | production shortages resulting from any events affecting a product candidate and/or finished drug product supply or manufacturing capabilities abroad; |
• |
business interruptions resulting from
geo-political
actions, including war and terrorism, or natural disasters, including earthquakes, hurricanes, typhoons, floods and fires; and
|
• | failure to comply with Office of Foreign Asset Control rules and regulations and the Foreign Corrupt Practices Act, or FCPA. |
• | continue to commercialize XPOVIO in the United States and seek regulatory approval for XPOVIO outside of the United States; |
• | continue to grow our sales, marketing and distribution infrastructure during the commercialization of XPOVIO and any drug candidates for which we may obtain marketing approval, prior to or upon receiving marketing approval; |
• | continue our research and preclinical and clinical development of our drug candidates; |
• | initiate additional clinical trials for our drug candidates; |
• | seek marketing approvals for any of our drug candidates that successfully complete clinical trials; |
• | maintain, expand and protect our intellectual property portfolio; |
• | manufacture our drug candidates; |
• | hire additional clinical, quality control, scientific, commercial and management personnel; |
• | identify additional drug candidates; |
• |
acquire or
in-license
other drugs and technologies;
|
• | add operational, financial and management information systems and personnel, including personnel to support our drug development, any commercialization efforts and our other operations as a public company; and |
• | increase our product liability insurance coverage as we initiate and expand our commercialization efforts. |
• | successful launching of XPOVIO, including by further developing our sales force, marketing and distribution capabilities; |
• | achieving an adequate level of market acceptance and obtaining and maintaining coverage and adequate reimbursement from third-party payors for XPOVIO and any other drugs we commercialize; |
• | completing preclinical studies and clinical trials of our drug candidates; |
• | obtaining marketing approval for these drug candidates; |
• | manufacturing at commercial scale, marketing, selling and distributing XPOVIO or any drug candidates for which we may obtain marketing approval; |
• | maintaining regulatory and marketing approvals for XPOVIO and for any drug candidates for which we obtain marketing approval; |
• | establishing and managing any collaborations for the development, marketing and/or commercialization of our drug candidates; |
• | hiring and building a full commercial organization required for the marketing, selling and distribution for those drugs for which we obtain marketing approval; and |
• | obtaining, maintaining and protecting our intellectual property rights. |
• | our ability to successfully commercialize and sell XPOVIO in the United States; |
• | the cost of, and our ability to expand and maintain, the commercial infrastructure required to support the commercialization of XPOVIO and any other drug for which we receive marketing approval, including product sales, medical affairs, marketing and distribution; |
• | the progress and results of our current and planned clinical trials of selinexor; |
• | the scope, progress, results and costs of drug discovery, preclinical development, laboratory testing and clinical trials for our other drug candidates; |
• | the costs, timing and outcome of regulatory review of our drug candidates, including whether any additional clinical trials or other activities are required for approval or label expansion; |
• | our ability to establish and maintain collaborations on favorable terms; |
• | the success of any collaborations that we have entered into and may enter into with third parties; |
• |
the extent to which we acquire or
in-license
other drugs and technologies;
|
• |
the costs of commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our drug candidates for which we receive marketing approval, and
pre-commercialization
costs for our drug candidates incurred prior to receiving any such marketing approval, including the costs and timing of establishing product sales, marketing, manufacturing and distribution capabilities that are not the responsibility of any collaborator that we may have at such time;
|
• | the amount of revenue, if any, received from commercial sales of our drug candidates, assuming receipt of marketing approval; |
• | the terms and timing of any future collaborations, partnerships, licensing, marketing, distribution or other arrangements that we may establish; and |
• | the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims. |
• | increasing our vulnerability to adverse economic and industry conditions; |
• | limiting our ability to obtain additional financing; |
• | requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for other purposes; |
• | limiting our flexibility to plan for, or react to, changes in our business; |
• | diluting the interests of our existing stockholders as a result of issuing shares of our common stock upon conversion of the Notes; and |
• | placing us at a possible competitive disadvantage with competitors that are less leveraged than us or have better access to capital. |
• | collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations; |
• | collaborators may not perform their obligations as expected or in compliance with applicable regulatory requirements; |
• | collaborators may not pursue development, marketing and/or commercialization of our drug candidates or may elect not to continue or renew development, marketing or commercialization programs based on clinical trial results, changes in the |
collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities; |
• | collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing; |
• | collaborators could independently develop, or develop with third parties, drugs that compete directly or indirectly with our drugs or drug candidates if the collaborators believe that competitive drugs are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours; |
• | a collaborator with marketing and distribution rights to one or more drugs may not commit sufficient resources to the marketing and distribution of such drug or drugs; |
• | disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of drug candidates, might lead to additional responsibilities for us with respect to drug candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive; |
• | collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation; |
• | collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; |
• | disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our drugs or drug candidates or that result in costly litigation or arbitration that diverts management’s attention and resources of our company; |
• | we may lose certain valuable rights under circumstances identified in any collaboration arrangement that we enter into, such as if we undergo a change of control; |
• | collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development, marketing and/or commercialization of the applicable drug candidates; |
• | collaborators may learn about our discoveries and use this knowledge to compete with us in the future; and |
• | the number and type of our collaborations could adversely affect our attractiveness to collaborators or acquirers. |
• | reliance on the third party for regulatory compliance and quality assurance; |
• | the possible breach of the manufacturing agreement by the third party; |
• | the possible failure of the third party to manufacture our drugs or drug candidates according to our schedule, or at all, including if the third-party manufacturer gives greater priority to the supply of other drugs over our drugs and drug candidates, or otherwise does not satisfactorily perform according to the terms of the manufacturing agreement; |
• | equipment malfunctions, power outages or other general disruptions experienced by our third-party manufacturers to their respective operations and other general problems with a multi-step manufacturing process; |
• |
the possible misappropriation or disclosure by the third party or others of our proprietary information, including our trade secrets and
know-how;
and
|
• | the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us. |
• | litigation involving patients taking our drug; |
• | restrictions on such drugs, manufacturers or manufacturing processes; |
• | restrictions on the labeling or marketing of a drug; |
• | restrictions on drug distribution or use; |
• | requirements to conduct post-marketing studies or clinical trials; |
• | warning letters or untitled letters; |
• | withdrawal of the drugs from the market; |
• | refusal to approve pending applications or supplements to approved applications that we submit; |
• | recall of drugs; |
• | fines, restitution or disgorgement of profits or revenues; |
• | suspension or withdrawal of marketing approvals; |
• | damage to relationships with any potential collaborators; |
• | unfavorable press coverage and damage to our reputation; |
• | refusal to permit the import or export of drugs; |
• | drug seizure; or |
• | injunctions or the imposition of civil or criminal penalties. |
• |
an annual,
non-deductible
fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents;
|
• | an increase in the statutory minimum rebates a manufacturer must pay under the Medicaid Drug Rebate Program; |
• | expansion of healthcare fraud and abuse laws, including the civil False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for noncompliance; |
• |
a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% (and 70% starting January 1, 2019)
point-of-sale
discounts off negotiated prices to eligible beneficiaries during their coverage gap period, as a condition for a manufacturer’s outpatient drugs to be covered under Medicare Part D;
|
• | extension of manufacturers’ Medicaid rebate liability; |
• | expansion of eligibility criteria for Medicaid programs; |
• | expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; |
• | new requirements to report certain financial arrangements with physicians and teaching hospitals; |
• | a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and |
• | a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research. |
• |
Anti-Kickback Statute
|
• |
False Claims Act
per-claim
penalties, currently set at $5,500 to $11,000 per false claim;
|
• |
HIPAA
|
• |
Transparency Requirements
|
• |
Analogous State and Foreign Laws
|
• | establish a classified board of directors such that not all members of the board are elected at one time; |
• | allow the authorized number of our directors to be changed only by resolution of our board of directors; |
• | limit the manner in which stockholders can remove directors from the board; |
• | establish advance notice requirements for stockholder proposals that can be acted on at stockholder meetings and nominations to our board of directors; |
• | require that stockholder actions must be effected at a duly called stockholder meeting and prohibit actions by our stockholders by written consent; |
• | limit who may call stockholder meetings; |
• | authorize our board of directors to issue preferred stock without stockholder approval, which could be used to institute a “poison pill” that would work to dilute the stock ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by our board of directors; and |
• | require the approval of the holders of at least 75% of the votes that all our stockholders would be entitled to cast to amend or repeal certain provisions of our charter or bylaws. |
• | our success in launching and commercializing XPOVIO; |
• | the success of competitive drugs or technologies; |
• | results of clinical trials of our drug candidates or those of our competitors; |
• | our success in commercializing our drug candidates, if and when approved; |
• | regulatory or legal developments in the United States and other countries; |
• | developments or disputes concerning patent applications, issued patents or other proprietary rights; |
• | the recruitment or departure of key personnel; |
• | the level of expenses related to the commercial launch of XPOVIO and clinical development programs for any of our drug candidates; |
• |
the results of our efforts to discover, develop, acquire or
in-license
additional drug candidates or drugs;
|
• | actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts; |
• | variations in our financial results or those of companies that are perceived to be similar to us; |
• | changes in the structure of healthcare payment systems; |
• | market conditions in the pharmaceutical and biotechnology sectors; |
• | general economic, industry and market conditions; and |
• | the other factors described in this “Risk Factors” section. |
Exhibit
Number
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Form
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Incorporated by Reference
|
Provided
Herewith
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Description of Exhibit
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File Number
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Date of Filing
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Exhibit Number
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3.1
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X
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31.1
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X
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31.2
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X
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32.1
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X
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32.2
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X
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101.INS
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Inline XBRL Instance Document
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101.SCH
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Inline XBRL Schema Document
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X
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101.CAL
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Inline XBRL Calculation Linkbase Document
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X
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101.DEF
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Inline XBRL Definition Linkbase Document
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X
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101.LAB
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Inline XBRL Label Linkbase Document
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101.PRE
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Inline XBRL Presentation Linkbase Document
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104
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Cover Page Interactive Data File
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Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101)
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KARYOPHARM THERAPEUTICS INC.
|
|||
Date: August 7, 2019
|
By:
|
/s/ MICHAEL KAUFFMAN
|
||
|
|
Michael Kauffman, M.D., Ph.D.
|
||
|
|
Chief Executive Officer
|
||
|
|
(Principal executive officer)
|
||
Date: August 7, 2019
|
By:
|
/s/ MICHAEL MASON
|
||
|
|
Michael Mason
|
||
|
|
Senior Vice President,
Chief Financial Officer and Treasurer
|
||
|
|
(Principal financial and accounting officer)
|
Exhibit 3.1
RESTATED CERTIFICATE OF INCORPORATION
OF
KARYOPHARM THERAPEUTICS INC.
(originally incorporated on December 22, 2008)
FIRST: The name of the Corporation is Karyopharm Therapeutics Inc. (the Corporation).
SECOND: The address of the Corporations registered office in the State of Delaware is Corporation Trust Center, 1209 Orange Street, in the City of Wilmington, County of New Castle, 19801. The name of its registered agent at that address is The Corporation Trust Company.
THIRD: The nature of the business or purposes to be conducted or promoted by the Corporation is to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of the State of Delaware.
FOURTH: The total number of shares of all classes of stock which the Corporation shall have authority to issue is 105,000,000 shares, consisting of (i) 100,000,000 shares of Common Stock, $0.0001 par value per share (Common Stock), and (ii) 5,000,000 shares of Preferred Stock, $0.0001 par value per share (Preferred Stock).
The following is a statement of the designations and the powers, privileges and rights, and the qualifications, limitations or restrictions thereof in respect of each class of capital stock of the Corporation.
A COMMON STOCK.
1. General. The voting, dividend and liquidation rights of the holders of the Common Stock are subject to and qualified by the rights of the holders of the Preferred Stock of any series as may be designated by the Board of Directors of the Corporation (the Board of Directors) upon any issuance of the Preferred Stock of any series.
2. Voting. The holders of the Common Stock shall have voting rights at all meetings of stockholders, each such holder being entitled to one vote for each share thereof held by such holder; provided, however, that, except as otherwise required by law, holders of Common Stock shall not be entitled to vote on any amendment to this Certificate of Incorporation (which, as used herein, shall mean the certificate of incorporation of the Corporation, as amended from time to time, including the terms of any certificate of designations of any series of Preferred Stock) that relates solely to the terms of one or more outstanding series of Preferred Stock if the holders of such affected series are entitled, either separately or together as a class with the holders of one or more other such series, to vote thereon pursuant to this Certificate of Incorporation. There shall be no cumulative voting.
The number of authorized shares of Common Stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the stock of the Corporation entitled to vote, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of the State of Delaware.
3. Dividends. Dividends may be declared and paid on the Common Stock from funds lawfully available therefor as and when determined by the Board of Directors and subject to any preferential dividend or other rights of any then outstanding Preferred Stock.
4. Liquidation. Upon the dissolution or liquidation of the Corporation, whether voluntary or involuntary, holders of Common Stock will be entitled to receive all assets of the Corporation available for distribution to its stockholders, subject to any preferential or other rights of any then outstanding Preferred Stock.
B PREFERRED STOCK.
Preferred Stock may be issued from time to time in one or more series, each of such series to have such terms as stated or expressed herein and in the resolution or resolutions providing for the issue of such series adopted by the Board of Directors as hereinafter provided. Any shares of Preferred Stock which may be redeemed, purchased or acquired by the Corporation may be reissued except as otherwise provided by law.
Authority is hereby expressly granted to the Board of Directors from time to time to issue the Preferred Stock in one or more series, and in connection with the creation of any such series, by adopting a resolution or resolutions providing for the issuance of the shares thereof and by filing a certificate of designations relating thereto in accordance with the General Corporation Law of the State of Delaware, to determine and fix the number of shares of such series and such voting powers, full or limited, or no voting powers, and such designations, preferences and relative participating, optional or other special rights, and qualifications, limitations or restrictions thereof, including without limitation thereof, dividend rights, conversion rights, redemption privileges and liquidation preferences, as shall be stated and expressed in such resolutions, all to the full extent now or hereafter permitted by the General Corporation Law of the State of Delaware. Without limiting the generality of the foregoing, the resolutions providing for issuance of any series of Preferred Stock may provide that such series shall be superior or rank equally or be junior to any other series of Preferred Stock to the extent permitted by law.
The number of authorized shares of Preferred Stock may be increased or decreased (but not below the number of shares then outstanding) by the affirmative vote of the holders of a majority of the voting power of the capital stock of the Corporation entitled to vote thereon, voting as a single class, irrespective of the provisions of Section 242(b)(2) of the General Corporation Law of the State of Delaware.
FIFTH: Except as otherwise provided herein, the Corporation reserves the right to amend, alter, change or repeal any provision contained in this Certificate of Incorporation, in the manner now or hereafter prescribed by statute and this Certificate of Incorporation, and all rights conferred upon stockholders herein are granted subject to this reservation.
2
SIXTH: In furtherance and not in limitation of the powers conferred upon it by the General Corporation Law of the State of Delaware, and subject to the terms of any series of Preferred Stock, the Board of Directors shall have the power to adopt, amend, alter or repeal the By-laws of the Corporation by the affirmative vote of a majority of the directors present at any regular or special meeting of the Board of Directors at which a quorum is present. The stockholders may not adopt, amend, alter or repeal the By-laws of the Corporation, or adopt any provision inconsistent therewith, unless such action is approved, in addition to any other vote required by this Certificate of Incorporation, by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes that all the stockholders would be entitled to cast in any annual election of directors or class of directors. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article SIXTH.
SEVENTH: Except to the extent that the General Corporation Law of the State of Delaware prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty, no director of the Corporation shall be personally liable to the Corporation or its stockholders for monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability. No amendment to or repeal of this provision shall apply to or have any effect on the liability or alleged liability of any director of the Corporation for or with respect to any acts or omissions of such director occurring prior to such amendment or repeal. If the General Corporation Law of the State of Delaware is amended to permit further elimination or limitation of the personal liability of directors, then the liability of a director of the Corporation shall be eliminated or limited to the fullest extent permitted by the General Corporation Law of the State of Delaware as so amended.
EIGHTH: The Corporation shall provide indemnification as follows:
1. Actions, Suits and Proceedings Other than by or in the Right of the Corporation. The Corporation shall indemnify each person who was or is a party or threatened to be made a party to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or in the right of the Corporation) by reason of the fact that he or she is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) (all such persons being referred to hereafter as an Indemnitee), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974), and amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The termination of any action, suit or proceeding by judgment, order,
3
settlement, conviction or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that Indemnitee did not act in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, and, with respect to any criminal action or proceeding, had reasonable cause to believe that his or her conduct was unlawful.
2. Actions or Suits by or in the Right of the Corporation. The Corporation shall indemnify any Indemnitee who was or is a party to or threatened to be made a party to any threatened, pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that Indemnitee is or was, or has agreed to become, a director or officer of the Corporation, or is or was serving, or has agreed to serve, at the request of the Corporation, as a director, officer, partner, employee or trustee of, or in a similar capacity with, another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan), or by reason of any action alleged to have been taken or omitted in such capacity, against all expenses (including attorneys fees) and, to the extent permitted by law, amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with such action, suit or proceeding and any appeal therefrom, if Indemnitee acted in good faith and in a manner which Indemnitee reasonably believed to be in, or not opposed to, the best interests of the Corporation, except that no indemnification shall be made under this Section 2 in respect of any claim, issue or matter as to which Indemnitee shall have been adjudged to be liable to the Corporation, unless, and only to the extent, that the Court of Chancery of Delaware or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of such liability but in view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to indemnity for such expenses (including attorneys fees) which the Court of Chancery of Delaware or such other court shall deem proper.
3. Indemnification for Expenses of Successful Party. Notwithstanding any other provisions of this Article EIGHTH, to the extent that an Indemnitee has been successful, on the merits or otherwise, in defense of any action, suit or proceeding referred to in Sections 1 and 2 of this Article EIGHTH, or in defense of any claim, issue or matter therein, or on appeal from any such action, suit or proceeding, Indemnitee shall be indemnified against all expenses (including attorneys fees) actually and reasonably incurred by or on behalf of Indemnitee in connection therewith. Without limiting the foregoing, if any action, suit or proceeding is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to Indemnitee, (ii) an adjudication that Indemnitee was liable to the Corporation, (iii) a plea of guilty or nolo contendere by Indemnitee, (iv) an adjudication that Indemnitee did not act in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the Corporation, and (v) with respect to any criminal proceeding, an adjudication that Indemnitee had reasonable cause to believe his or her conduct was unlawful, Indemnitee shall be considered for the purposes hereof to have been wholly successful with respect thereto.
4. Notification and Defense of Claim. As a condition precedent to an Indemnitees right to be indemnified, such Indemnitee must notify the Corporation in writing as soon as practicable of any action, suit, proceeding or investigation involving such Indemnitee for which indemnity will or could be sought. With respect to any action, suit, proceeding or investigation of which the Corporation is so notified, the Corporation will be entitled to participate therein at its own expense and/or to assume the defense thereof at its own expense, with legal counsel
4
reasonably acceptable to Indemnitee. After notice from the Corporation to Indemnitee of its election so to assume such defense, the Corporation shall not be liable to Indemnitee for any legal or other expenses subsequently incurred by Indemnitee in connection with such action, suit, proceeding or investigation, other than as provided below in this Section 4. Indemnitee shall have the right to employ his or her own counsel in connection with such action, suit, proceeding or investigation, but the fees and expenses of such counsel incurred after notice from the Corporation of its assumption of the defense thereof shall be at the expense of Indemnitee unless (i) the employment of counsel by Indemnitee has been authorized by the Corporation, (ii) counsel to Indemnitee shall have reasonably concluded that there may be a conflict of interest or position on any significant issue between the Corporation and Indemnitee in the conduct of the defense of such action, suit, proceeding or investigation or (iii) the Corporation shall not in fact have employed counsel to assume the defense of such action, suit, proceeding or investigation, in each of which cases the fees and expenses of counsel for Indemnitee shall be at the expense of the Corporation, except as otherwise expressly provided by this Article EIGHTH. The Corporation shall not be entitled, without the consent of Indemnitee, to assume the defense of any claim brought by or in the right of the Corporation or as to which counsel for Indemnitee shall have reasonably made the conclusion provided for in clause (ii) above. The Corporation shall not be required to indemnify Indemnitee under this Article EIGHTH for any amounts paid in settlement of any action, suit, proceeding or investigation effected without its written consent. The Corporation shall not settle any action, suit, proceeding or investigation in any manner which would impose any penalty or limitation on Indemnitee without Indemnitees written consent. Neither the Corporation nor Indemnitee will unreasonably withhold or delay its consent to any proposed settlement.
5. Advance of Expenses. Subject to the provisions of Section 6 of this Article EIGHTH, in the event of any threatened or pending action, suit, proceeding or investigation of which the Corporation receives notice under this Article EIGHTH, any expenses (including attorneys fees) incurred by or on behalf of an Indemnitee in defending an action, suit, proceeding or investigation or any appeal therefrom shall be paid by the Corporation in advance of the final disposition of such matter; provided, however, that the payment of such expenses incurred by or on behalf of Indemnitee in advance of the final disposition of such matter shall be made only upon receipt of an undertaking by or on behalf of Indemnitee to repay all amounts so advanced in the event that it shall ultimately be determined by final judicial decision from which there is no further right to appeal that Indemnitee is not entitled to be indemnified by the Corporation as authorized in this Article EIGHTH; and provided further that no such advancement of expenses shall be made under this Article EIGHTH if it is determined (in the manner described in Section 6 of this Article EIGHTH) that (i) Indemnitee did not act in good faith and in a manner he or she reasonably believed to be in, or not opposed to, the best interests of the Corporation, or (ii) with respect to any criminal action or proceeding, Indemnitee had reasonable cause to believe his or her conduct was unlawful. Such undertaking shall be accepted without reference to the financial ability of Indemnitee to make such repayment.
6. Procedure for Indemnification and Advancement of Expenses. In order to obtain indemnification or advancement of expenses pursuant to Section 1, 2, 3 or 5 of this Article EIGHTH, an Indemnitee shall submit to the Corporation a written request. Any such advancement of expenses shall be made promptly, and in any event within 60 days after receipt by the Corporation of the written request of Indemnitee, unless (i) the Corporation has assumed
5
the defense pursuant to Section 4 of this Article EIGHTH (and none of the circumstances described in Section 4 of this Article EIGHTH that would nonetheless entitle the Indemnitee to indemnification for the fees and expenses of separate counsel have occurred) or (ii) the Corporation determines within such 60-day period that Indemnitee did not meet the applicable standard of conduct set forth in Section 1, 2 or 5 of this Article EIGHTH, as the case may be. Any such indemnification, unless ordered by a court, shall be made with respect to requests under Section 1 or 2 of this Article EIGHTH only as authorized in the specific case upon a determination by the Corporation that the indemnification of Indemnitee is proper because Indemnitee has met the applicable standard of conduct set forth in Section 1 or 2 of this Article EIGHTH, as the case may be. Such determination shall be made in each instance (a) by a majority vote of the directors of the Corporation consisting of persons who are not at that time parties to the action, suit or proceeding in question (disinterested directors), whether or not a quorum, (b) by a committee of disinterested directors designated by majority vote of disinterested directors, whether or not a quorum, (c) if there are no disinterested directors, or if the disinterested directors so direct, by independent legal counsel (who may, to the extent permitted by law, be regular legal counsel to the Corporation) in a written opinion, or (d) by the stockholders of the Corporation.
7. Remedies. The right to indemnification or advancement of expenses as granted by this Article EIGHTH shall be enforceable by Indemnitee in any court of competent jurisdiction. Neither the failure of the Corporation to have made a determination prior to the commencement of such action that indemnification is proper in the circumstances because Indemnitee has met the applicable standard of conduct, nor an actual determination by the Corporation pursuant to Section 6 of this Article EIGHTH that Indemnitee has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that Indemnitee has not met the applicable standard of conduct. In any suit brought by Indemnitee to enforce a right to indemnification, or brought by the Corporation to recover an advancement of expenses pursuant to the terms of an undertaking, the Corporation shall have the burden of proving that Indemnitee is not entitled to be indemnified, or to such advancement of expenses, under this Article EIGHTH. Indemnitees expenses (including attorneys fees) reasonably incurred in connection with successfully establishing Indemnitees right to indemnification, in whole or in part, in any such proceeding shall also be indemnified by the Corporation. Notwithstanding the foregoing, in any suit brought by Indemnitee to enforce a right to indemnification hereunder it shall be a defense that the Indemnitee has not met any applicable standard for indemnification set forth in the General Corporation Law of the State of Delaware.
8. Limitations. Notwithstanding anything to the contrary in this Article EIGHTH, except as set forth in Section 7 of this Article EIGHTH, the Corporation shall not indemnify an Indemnitee pursuant to this Article EIGHTH in connection with a proceeding (or part thereof) initiated by such Indemnitee unless the initiation thereof was approved by the Board of Directors. Notwithstanding anything to the contrary in this Article EIGHTH, the Corporation shall not indemnify an Indemnitee to the extent such Indemnitee is reimbursed from the proceeds of insurance, and in the event the Corporation makes any indemnification payments to an Indemnitee and such Indemnitee is subsequently reimbursed from the proceeds of insurance, such Indemnitee shall promptly refund indemnification payments to the Corporation to the extent of such insurance reimbursement.
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9. Subsequent Amendment. No amendment, termination or repeal of this Article EIGHTH or of the relevant provisions of the General Corporation Law of the State of Delaware or any other applicable laws shall adversely affect or diminish in any way the rights of any Indemnitee to indemnification under the provisions hereof with respect to any action, suit, proceeding or investigation arising out of or relating to any actions, transactions or facts occurring prior to the final adoption of such amendment, termination or repeal.
10. Other Rights. The indemnification and advancement of expenses provided by this Article EIGHTH shall not be deemed exclusive of any other rights to which an Indemnitee seeking indemnification or advancement of expenses may be entitled under any law (common or statutory), agreement or vote of stockholders or disinterested directors or otherwise, both as to action in Indemnitees official capacity and as to action in any other capacity while holding office for the Corporation, and shall continue as to an Indemnitee who has ceased to be a director or officer, and shall inure to the benefit of the estate, heirs, executors and administrators of Indemnitee. Nothing contained in this Article EIGHTH shall be deemed to prohibit, and the Corporation is specifically authorized to enter into, agreements with officers and directors providing indemnification rights and procedures different from those set forth in this Article EIGHTH. In addition, the Corporation may, to the extent authorized from time to time by its Board of Directors, grant indemnification rights to other employees or agents of the Corporation or other persons serving the Corporation and such rights may be equivalent to, or greater or less than, those set forth in this Article EIGHTH.
11. Partial Indemnification. If an Indemnitee is entitled under any provision of this Article EIGHTH to indemnification by the Corporation for some or a portion of the expenses (including attorneys fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) or amounts paid in settlement actually and reasonably incurred by or on behalf of Indemnitee in connection with any action, suit, proceeding or investigation and any appeal therefrom but not, however, for the total amount thereof, the Corporation shall nevertheless indemnify Indemnitee for the portion of such expenses (including attorneys fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) or amounts paid in settlement to which Indemnitee is entitled.
12. Insurance. The Corporation may purchase and maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise (including any employee benefit plan) against any expense, liability or loss incurred by him or her in any such capacity, or arising out of his or her status as such, whether or not the Corporation would have the power to indemnify such person against such expense, liability or loss under the General Corporation Law of the State of Delaware.
13. Savings Clause. If this Article EIGHTH or any portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall nevertheless indemnify each Indemnitee as to any expenses (including attorneys fees), liabilities, losses, judgments, fines (including excise taxes and penalties arising under the Employee Retirement Income Security Act of 1974) and amounts paid in settlement in connection with any action, suit, proceeding or investigation, whether civil, criminal or administrative, including an action by or
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in the right of the Corporation, to the fullest extent permitted by any applicable portion of this Article EIGHTH that shall not have been invalidated and to the fullest extent permitted by applicable law.
14. Definitions. Terms used herein and defined in Section 145(h) and Section 145(i) of the General Corporation Law of the State of Delaware shall have the respective meanings assigned to such terms in such Section 145(h) and Section 145(i).
NINTH: This Article NINTH is inserted for the management of the business and for the conduct of the affairs of the Corporation.
1. General Powers. The business and affairs of the Corporation shall be managed by or under the direction of the Board of Directors.
2. Number of Directors; Election of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the number of directors of the Corporation shall be established by the Board of Directors. Election of directors need not be by written ballot, except as and to the extent provided in the By-laws of the Corporation.
3. Classes of Directors. Subject to the rights of holders of any series of Preferred Stock to elect directors, the Board of Directors shall be and is divided into three classes, designated Class I, Class II and Class III. Each class shall consist, as nearly as may be possible, of one-third of the total number of directors constituting the entire Board of Directors. The Board of Directors is authorized to assign members of the Board of Directors already in office to Class I, Class II or Class III at the time such classification becomes effective.
4. Terms of Office. Subject to the rights of holders of any series of Preferred Stock to elect directors, each director shall serve for a term ending on the date of the third annual meeting of stockholders following the annual meeting of stockholders at which such director was elected; provided that each director initially assigned to Class I shall serve for a term expiring at the Corporations first annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; each director initially assigned to Class II shall serve for a term expiring at the Corporations second annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; and each director initially assigned to Class III shall serve for a term expiring at the Corporations third annual meeting of stockholders held after the effectiveness of this Restated Certificate of Incorporation; provided further, that the term of each director shall continue until the election and qualification of his or her successor and be subject to his or her earlier death, resignation or removal.
5. Quorum. The greater of (a) a majority of the directors at any time in office and (b) one-third of the number of directors fixed pursuant to Section 2 of this Article NINTH shall constitute a quorum of the Board of Directors. If at any meeting of the Board of Directors there shall be less than such a quorum, a majority of the directors present may adjourn the meeting from time to time without further notice other than announcement at the meeting, until a quorum shall be present.
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6. Action at Meeting. Every act or decision done or made by a majority of the directors present at a meeting duly held at which a quorum is present shall be regarded as the act of the Board of Directors unless a greater number is required by law or by this Certificate of Incorporation.
7. Removal. Subject to the rights of holders of any series of Preferred Stock, directors of the Corporation may be removed only for cause and only by the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors.
8. Vacancies. Subject to the rights of holders of any series of Preferred Stock, any vacancy or newly created directorship in the Board of Directors, however occurring, shall be filled only by vote of a majority of the directors then in office, although less than a quorum, or by a sole remaining director and shall not be filled by the stockholders. A director elected to fill a vacancy shall hold office until the next election of the class for which such director shall have been chosen, subject to the election and qualification of a successor and to such directors earlier death, resignation or removal.
9. Stockholder Nominations and Introduction of Business, Etc. Advance notice of stockholder nominations for election of directors and other business to be brought by stockholders before a meeting of stockholders shall be given in the manner provided by the By-laws of the Corporation.
10. Amendments to Article. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article NINTH.
TENTH: Stockholders of the Corporation may not take any action by written consent in lieu of a meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article TENTH.
ELEVENTH: Special meetings of stockholders for any purpose or purposes may be called at any time by only the Board of Directors, the Chairman of the Board of Directors or the Chief Executive Officer of the Corporation, and may not be called by any other person or persons. Business transacted at any special meeting of stockholders shall be limited to matters relating to the purpose or purposes stated in the notice of meeting. Notwithstanding any other provisions of law, this Certificate of Incorporation or the By-laws of the Corporation, and notwithstanding the fact that a lesser percentage may be specified by law, the affirmative vote of the holders of at least seventy-five percent (75%) of the votes which all the stockholders would
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be entitled to cast in any annual election of directors or class of directors shall be required to amend or repeal, or to adopt any provision inconsistent with, this Article ELEVENTH.
IN WITNESS WHEREOF, this Restated Certificate of Incorporation, which restates, integrates and amends the certificate of incorporation of the Corporation, and which has been duly adopted in accordance with Sections 228, 242 and 245 of the General Corporation Law of the State of Delaware, has been executed by its duly authorized officer this 12th day of November, 2013.
KARYOPHARM THERAPEUTICS INC. | ||
By: |
/s/ Michael Kauffman |
|
Name: Michael Kauffman, M.D., Ph.D. | ||
Title: President and Chief Executive Officer |
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CERTIFICATE OF AMENDMENT OF
RESTATED CERTIFICATE OF INCORPORATION
OF
KARYOPHARM THERAPEUTICS INC.
(Pursuant to Section 242 of the
General Corporation Law of the State of Delaware)
Karyopharm Therapeutics Inc. (the Corporation), a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware, does hereby certify as follows:
A resolution was duly adopted by the Board of Directors of the Corporation pursuant to Section 242 of the General Corporation Law of the State of Delaware setting forth a proposed amendment to the Restated Certificate of Incorporation of the Corporation and declaring said amendment to be advisable. The stockholders of the Corporation duly approved said proposed amendment in accordance with Section 242 of the General Corporation Law of the State of Delaware. The resolution setting forth the amendment is as follows:
RESOLVED: |
That the first sentence of Article FOURTH of the Restated Certificate of Incorporation of the Corporation be and hereby is deleted in its entirety and the following is inserted in lieu thereof: |
FOURTH: The total number of shares of all classes of stock which the Corporation shall have the authority to issue is 205,000,000 shares, consisting of (i) 200,000,000 shares of Common Stock, $0.0001 par value per share (Common Stock), and (ii) 5,000,000 shares of Preferred Stock, $0.0001 par value per share (Preferred Stock).
***
IN WITNESS WHEREOF, this Certificate of Amendment has been executed by a duly authorized officer of the Corporation on this 6th day of June, 2019.
KARYOPHARM THERAPEUTICS INC. | ||
By: /s/ Michael Kauffman | ||
Michael Kauffman, M.D., Ph.D. | ||
Chief Executive Officer |
Exhibit 31.1
CERTIFICATIONS
I, Michael Kauffman, M.D., Ph.D., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Karyopharm 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 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 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.
/s/ MICHAEL KAUFFMAN |
Michael Kauffman, M.D., Ph.D. |
Chief Executive Officer |
(Principal executive officer) |
Date: August 7, 2019
Exhibit 31.2
CERTIFICATIONS
I, Michael Mason, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Karyopharm 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 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 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.
/s/ MICHAEL MASON |
Michael Mason |
Senior Vice President, Chief Financial Officer and Treasurer |
(Principal financial and accounting officer) |
Date: August 7, 2019
Exhibit 32.1
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 on Form 10-Q of Karyopharm Therapeutics Inc. (the Company) for the period ended June 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Michael Kauffman, M.D., Ph.D., Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
(1) |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; 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/ MICHAEL KAUFFMAN |
Michael Kauffman, M.D., Ph.D. |
Chief Executive Officer |
(Principal executive officer) |
Date: August 7, 2019
Exhibit 32.2
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 on Form 10-Q of Karyopharm Therapeutics Inc. (the Company) for the period ended June 30, 2019, as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Michael Mason, Senior Vice President, Chief Financial Officer and Treasurer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:
(1) |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; 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/ MICHAEL MASON |
Michael Mason |
Senior Vice President, Chief Financial Officer and Treasurer |
(Principal financial and accounting officer) |
Date: August 7, 2019