We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Spectrum Pharmaceuticals Inc | NASDAQ:SPPI | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 1.03 | 1.14 | 0.9785 | 0 | 01:00:00 |
|
|
☒
|
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
|
|
93-0979187
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification No.)
|
11500 South Eastern Avenue
|
Suite 240
|
Henderson
|
Nevada
|
89052
|
(Address of principal executive offices)
|
|
|
|
(Zip Code)
|
|
Large accelerated filer
|
|
☒
|
|
Accelerated filer
|
|
☐
|
Non-accelerated filer
|
|
☐
|
|
Smaller reporting company
|
|
☐
|
|
|
|
|
Emerging growth company
|
|
☐
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, $0.001 par value
|
SPPI
|
The NASDAQ Global Select Market
|
Item
|
|
Page
|
|
PART I. FINANCIAL INFORMATION
|
|
Item 1.
|
Financial Statements (unaudited):
|
|
|
||
|
||
|
||
|
||
|
||
|
||
|
|
|
Item 2.
|
||
Item 3.
|
||
Item 4.
|
||
|
|
|
|
PART II. OTHER INFORMATION
|
|
Item 1.
|
||
Item 1A.
|
||
Item 6.
|
||
|
|
June 30,
2019 |
|
December 31,
2018 |
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
118,251
|
|
|
$
|
157,480
|
|
Restricted cash
|
4,020
|
|
|
—
|
|
||
Marketable securities
|
160,134
|
|
|
46,508
|
|
||
Accounts receivable, net of allowance for doubtful accounts of $67 and $67, respectively
|
2,542
|
|
|
29,873
|
|
||
Other receivables
|
10,229
|
|
|
3,698
|
|
||
Prepaid expenses and other assets
|
10,839
|
|
|
7,574
|
|
||
Discontinued operations, current assets (
Note 11
)
|
—
|
|
|
5,555
|
|
||
Total current assets
|
306,015
|
|
|
250,688
|
|
||
Property and equipment, net of accumulated depreciation
|
4,534
|
|
|
385
|
|
||
Other assets
|
8,277
|
|
|
7,188
|
|
||
Facility and equipment under lease
|
3,842
|
|
|
—
|
|
||
Discontinued operations, non-current assets (
Note 11
)
|
—
|
|
|
132,625
|
|
||
Total assets
|
$
|
322,668
|
|
|
$
|
390,886
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable and other accrued liabilities
|
$
|
44,455
|
|
|
$
|
69,460
|
|
Accrued payroll and benefits
|
5,262
|
|
|
9,853
|
|
||
Contract liabilities
|
7,245
|
|
|
4,850
|
|
||
Discontinued operations, current liabilities (
Note 11
)
|
—
|
|
|
2,311
|
|
||
Total current liabilities
|
56,962
|
|
|
86,474
|
|
||
Deferred tax liabilities
|
—
|
|
|
1,469
|
|
||
Other long-term liabilities
|
10,923
|
|
|
5,650
|
|
||
Discontinued operations, non-current liabilities (
Note 11
)
|
—
|
|
|
14,031
|
|
||
Total liabilities
|
67,885
|
|
|
107,624
|
|
||
Commitments and contingencies (
Note 9
)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 300,000,000 shares authorized; 112,684,387 and 110,525,141 issued and outstanding at June 30, 2019 and December 31, 2018, respectively
|
112
|
|
|
110
|
|
||
Additional paid-in capital
|
905,871
|
|
|
886,740
|
|
||
Accumulated other comprehensive loss
|
(3,764
|
)
|
|
(3,702
|
)
|
||
Accumulated deficit
|
(647,436
|
)
|
|
(599,886
|
)
|
||
Total stockholders’ equity
|
254,783
|
|
|
283,262
|
|
||
Total liabilities and stockholders’ equity
|
$
|
322,668
|
|
|
$
|
390,886
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Revenues (
Note 1(b)
)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative
|
17,230
|
|
|
16,391
|
|
|
33,182
|
|
|
33,007
|
|
||||
Research and development
|
16,982
|
|
|
16,595
|
|
|
38,868
|
|
|
29,960
|
|
||||
Total operating costs and expenses
|
34,212
|
|
|
32,986
|
|
|
72,050
|
|
|
62,967
|
|
||||
Loss from continuing operations
|
(34,212
|
)
|
|
(32,986
|
)
|
|
(72,050
|
)
|
|
(62,967
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
||||||||
Interest income (expense), net
|
1,495
|
|
|
(242
|
)
|
|
2,556
|
|
|
(473
|
)
|
||||
Other income (expense), net
|
3,722
|
|
|
48,492
|
|
|
(7,563
|
)
|
|
58,463
|
|
||||
Total other income (expense)
|
5,217
|
|
|
48,250
|
|
|
(5,007
|
)
|
|
57,990
|
|
||||
(Loss) income from continuing operations before income taxes
|
(28,995
|
)
|
|
15,264
|
|
|
(77,057
|
)
|
|
(4,977
|
)
|
||||
Benefit (provision) for income taxes from continuing operations
|
212
|
|
|
(370
|
)
|
|
8,454
|
|
|
698
|
|
||||
(Loss) income from continuing operations
|
$
|
(28,783
|
)
|
|
$
|
14,894
|
|
|
$
|
(68,603
|
)
|
|
$
|
(4,279
|
)
|
Income (loss) from discontinued operations, net of income taxes (
Note 11
)
|
388
|
|
|
(1,150
|
)
|
|
21,053
|
|
|
2,205
|
|
||||
Net (loss) income
|
$
|
(28,395
|
)
|
|
$
|
13,744
|
|
|
$
|
(47,550
|
)
|
|
$
|
(2,074
|
)
|
|
|
|
|
|
|
|
|
||||||||
Basic (loss) income per share:
|
|
|
|
|
|
|
|
||||||||
(Loss) income per common share from continuing operations
|
$
|
(0.26
|
)
|
|
$
|
0.15
|
|
|
$
|
(0.63
|
)
|
|
$
|
(0.04
|
)
|
Income (loss) per common share from discontinued operations
|
—
|
|
|
(0.01
|
)
|
|
0.19
|
|
|
0.02
|
|
||||
Net (loss) income per common share
|
$
|
(0.26
|
)
|
|
$
|
0.13
|
|
|
$
|
(0.43
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
||||||||
Diluted (loss) income per share:
|
|
|
|
|
|
|
|
||||||||
(Loss) income per common share from continuing operations
|
$
|
(0.26
|
)
|
|
$
|
0.14
|
|
|
$
|
(0.63
|
)
|
|
$
|
(0.04
|
)
|
Income (loss) per common share from discontinued operations
|
—
|
|
|
(0.01
|
)
|
|
0.19
|
|
|
0.02
|
|
||||
Net (loss) income per common share
|
$
|
(0.26
|
)
|
|
$
|
0.13
|
|
|
$
|
(0.43
|
)
|
|
$
|
(0.02
|
)
|
|
|
|
|
|
|
|
|
||||||||
Weighted average shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
110,345,135
|
|
|
102,597,059
|
|
|
109,744,405
|
|
|
101,747,416
|
|
||||
Diluted
|
110,345,135
|
|
|
112,617,150
|
|
|
109,744,405
|
|
|
101,747,416
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Net (loss) income
|
$
|
(28,395
|
)
|
|
$
|
13,744
|
|
|
$
|
(47,550
|
)
|
|
$
|
(2,074
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
||||||||
Unrealized gain on available-for-sale securities, net of income tax expense of $33 thousand, $0, and $33 thousand, $0 for the three and six months ended June 30, 2019 and 2018, respectively.
|
100
|
|
|
—
|
|
|
100
|
|
|
—
|
|
||||
Foreign currency translation adjustments
|
228
|
|
|
(2,269
|
)
|
|
(162
|
)
|
|
(1,876
|
)
|
||||
Other comprehensive income (loss)
|
328
|
|
|
(2,269
|
)
|
|
(62
|
)
|
|
(1,876
|
)
|
||||
Total comprehensive (loss) income
|
$
|
(28,067
|
)
|
|
$
|
11,475
|
|
|
$
|
(47,612
|
)
|
|
$
|
(3,950
|
)
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated
Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total
Stockholders' Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2018
|
110,525,141
|
|
|
$
|
110
|
|
|
$
|
886,740
|
|
|
$
|
(3,702
|
)
|
|
$
|
(599,886
|
)
|
|
$
|
283,262
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(19,155
|
)
|
|
(19,155
|
)
|
|||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
(390
|
)
|
|
—
|
|
|
(390
|
)
|
|||||
Employee stock-based compensation expense
|
—
|
|
|
—
|
|
|
7,481
|
|
|
—
|
|
|
—
|
|
|
7,481
|
|
|||||
Issuance of common stock to 401(k) plan for employee match
|
47,347
|
|
|
—
|
|
|
519
|
|
|
—
|
|
|
—
|
|
|
519
|
|
|||||
Issuance of common stock upon exercise of stock options
|
146,785
|
|
|
—
|
|
|
831
|
|
|
—
|
|
|
—
|
|
|
831
|
|
|||||
RSA grants, net of forfeitures
|
259,539
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Issuance of common stock upon vesting of RSUs
|
233,760
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Balance as of March 31, 2019
|
111,212,572
|
|
|
$
|
111
|
|
|
$
|
895,571
|
|
|
$
|
(4,092
|
)
|
|
$
|
(619,041
|
)
|
|
$
|
272,549
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(28,395
|
)
|
|
(28,395
|
)
|
|||||
Other comprehensive income, net
|
—
|
|
|
—
|
|
|
—
|
|
|
328
|
|
|
—
|
|
|
328
|
|
|||||
Employee stock-based compensation expense
|
—
|
|
|
—
|
|
|
4,814
|
|
|
—
|
|
|
—
|
|
|
4,814
|
|
|||||
Issuance of common stock to 401(k) plan for employee match
|
24,382
|
|
|
—
|
|
|
205
|
|
|
—
|
|
|
—
|
|
|
205
|
|
|||||
Issuance of common stock for ESPP
|
60,606
|
|
|
—
|
|
|
444
|
|
|
—
|
|
|
—
|
|
|
444
|
|
|||||
Issuance of common stock upon exercise of stock options
|
504,226
|
|
|
—
|
|
|
3,023
|
|
|
—
|
|
|
—
|
|
|
3,023
|
|
|||||
RSA grants, net of forfeitures
|
651,072
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Issuance of common stock upon vesting of RSUs
|
10,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common shares under an at-the-market sales agreement (
Note 13
)
|
221,529
|
|
|
—
|
|
|
1,814
|
|
|
—
|
|
|
—
|
|
|
1,814
|
|
|||||
Balance as of June 30, 2019
|
112,684,387
|
|
|
$
|
112
|
|
|
$
|
905,871
|
|
|
$
|
(3,764
|
)
|
|
$
|
(647,436
|
)
|
|
$
|
254,783
|
|
|
Common Stock
|
|
Additional Paid-In Capital
|
|
Accumulated
Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total
Stockholders' Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance as of December 31, 2017
|
100,742,735
|
|
|
$
|
100
|
|
|
$
|
837,347
|
|
|
$
|
15,999
|
|
|
$
|
(502,107
|
)
|
|
$
|
351,339
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,816
|
)
|
|
(15,816
|
)
|
|||||
Cumulative-effect adjustment of ASU 2016-01 adoption (Note 3(a))
|
—
|
|
|
—
|
|
|
—
|
|
|
(17,211
|
)
|
|
17,211
|
|
|
—
|
|
|||||
Cumulative-effect adjustment of Topic 606 adoption (Note 2(i))
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,678
|
|
|
4,678
|
|
|||||
Foreign currency adjustment related to adoptions of ASU 2016-01 and Topic 606
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
342
|
|
|
342
|
|
|||||
Other comprehensive income, net
|
—
|
|
|
—
|
|
|
—
|
|
|
393
|
|
|
—
|
|
|
393
|
|
|||||
Employee stock-based compensation expense
|
—
|
|
|
—
|
|
|
4,144
|
|
|
—
|
|
|
—
|
|
|
4,144
|
|
|||||
Issuance of common stock to 401(k) plan for employee match
|
16,834
|
|
|
—
|
|
|
334
|
|
|
—
|
|
|
—
|
|
|
334
|
|
|||||
Issuance of common stock upon exercise of stock options
|
5,793,413
|
|
|
6
|
|
|
41,417
|
|
|
—
|
|
|
—
|
|
|
41,423
|
|
|||||
RSA grants, net of forfeitures
|
614,035
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Retirement of RSAs and shares as part of stock option cashless exercises to satisfy employee tax withholdings
|
(3,463,873
|
)
|
|
(3
|
)
|
|
(62,541
|
)
|
|
—
|
|
|
—
|
|
|
(62,544
|
)
|
|||||
Issuance of common stock upon vesting of RSUs
|
200,652
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
31,602
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Balance as of March 31, 2018
|
103,935,398
|
|
|
$
|
103
|
|
|
$
|
820,701
|
|
|
$
|
(819
|
)
|
|
$
|
(495,692
|
)
|
|
$
|
324,293
|
|
Net income (loss)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
13,744
|
|
|
13,744
|
|
|||||
Other comprehensive loss, net
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,269
|
)
|
|
—
|
|
|
(2,269
|
)
|
|||||
Employee stock-based compensation expense
|
—
|
|
|
—
|
|
|
4,461
|
|
|
—
|
|
|
—
|
|
|
4,461
|
|
|||||
Issuance of common stock to 401(k) plan for employee match
|
14,736
|
|
|
—
|
|
|
272
|
|
|
—
|
|
|
—
|
|
|
272
|
|
|||||
Issuance of common stock for ESPP
|
45,543
|
|
|
—
|
|
|
734
|
|
|
—
|
|
|
—
|
|
|
734
|
|
|||||
Issuance of common stock upon exercise of stock options
|
732,694
|
|
|
—
|
|
|
2,884
|
|
|
—
|
|
|
—
|
|
|
2,884
|
|
|||||
RSA grants, net of forfeitures
|
176,954
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Issuance of common stock upon exercise of warrants
|
225,278
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Balance as of June 30, 2018
|
105,130,603
|
|
|
$
|
103
|
|
|
$
|
829,052
|
|
|
$
|
(3,088
|
)
|
|
$
|
(481,948
|
)
|
|
$
|
344,119
|
|
|
Six Months Ended
June 30, |
||||||
|
2019
|
|
2018
|
||||
Cash Flows From Operating Activities:
|
|
|
|
||||
Loss from continuing operations
|
$
|
(68,603
|
)
|
|
$
|
(4,279
|
)
|
Income from discontinued operations, net of income taxes (
Note 11
)
|
21,053
|
|
|
2,205
|
|
||
Net loss
|
(47,550
|
)
|
|
(2,074
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization
|
1,400
|
|
|
13,993
|
|
||
Stock-based compensation (
Note 4
)
|
13,019
|
|
|
9,211
|
|
||
Gain on Commercial Product Portfolio Transaction (
Note 11
)
|
(33,644
|
)
|
|
—
|
|
||
Non-cash lease expense (
Note 9(a)
)
|
874
|
|
|
—
|
|
||
Unrealized gain on available-for-sale securities (
Note 3(a)
)
|
133
|
|
|
—
|
|
||
Amortization of discount on available-for-sale securities (
Note 3(a)
)
|
(331
|
)
|
|
—
|
|
||
Income tax recognition on unrealized gain on available-for-sale securities
|
(33
|
)
|
|
—
|
|
||
Realized gain on sale of CASI stock (
Note 7
)
|
(2,674
|
)
|
|
—
|
|
||
Unrealized loss (gain) on marketable securities (
Note 3(a)
)
|
11,758
|
|
|
(58,634
|
)
|
||
Unrealized gains from transactions denominated in foreign currency
|
(5
|
)
|
|
10
|
|
||
Deferred tax liabilities
|
(1,469
|
)
|
|
9
|
|
||
Change in fair value of contingent consideration (
Note 9(b)
)
|
1,478
|
|
|
483
|
|
||
Accretion of debt discount on 2018 Convertible Notes, recorded to interest expense
|
—
|
|
|
1,079
|
|
||
Amortization of deferred financing costs on 2018 Convertible Notes, recorded to interest expense
|
—
|
|
|
124
|
|
||
Change in cash surrender value of corporate-owned life insurance policy
|
—
|
|
|
(5
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
27,314
|
|
|
5,087
|
|
||
Other receivables
|
(6,535
|
)
|
|
(781
|
)
|
||
Inventories
|
(2,037
|
)
|
|
816
|
|
||
Prepaid expenses and other assets
|
(3,164
|
)
|
|
1,167
|
|
||
Other assets
|
(1,087
|
)
|
|
3,451
|
|
||
Accounts payable and other accrued obligations
|
(33,438
|
)
|
|
(8,210
|
)
|
||
Accrued payroll and benefits
|
(4,592
|
)
|
|
(4,314
|
)
|
||
FOLOTYN development liability
|
(4
|
)
|
|
(195
|
)
|
||
Contract liabilities (
Note 3(h)
)
|
2,395
|
|
|
—
|
|
||
Other long-term liabilities
|
1,843
|
|
|
(464
|
)
|
||
Net cash used in operating activities
|
(76,349
|
)
|
|
(39,247
|
)
|
||
Cash Flows From Investing Activities:
|
|
|
|
||||
Proceeds from Commercial Product Portfolio Transaction (
Note 1(b)
)
|
158,765
|
|
|
—
|
|
||
Proceeds from sale of CASI stock (
Note 7
)
|
5,074
|
|
|
—
|
|
||
Purchase of available-for-sale securities (
Note 3(a)
)
|
(127,564
|
)
|
|
—
|
|
||
Purchases of property and equipment (
Note 3(b)
)
|
(1,241
|
)
|
|
(46
|
)
|
||
Proceeds from redemption of corporate-owned life insurance policy
|
—
|
|
|
4,130
|
|
||
Net cash provided by investing activities
|
35,034
|
|
|
4,084
|
|
||
Cash Flows From Financing Activities:
|
|
|
|
||||
Proceeds from employees for exercises of stock options
|
3,854
|
|
|
4,804
|
|
||
Proceeds from sale of common stock under an at-the-market sales agreement (
Note 13
)
|
1,814
|
|
|
—
|
|
||
Proceeds from sale of stock under our employee stock purchase plan
|
444
|
|
|
734
|
|
||
Proceeds from employees, for our remittance to tax authorities, upon vesting of restricted stock and exercises of stock options
|
—
|
|
|
4,645
|
|
||
Payments to tax authorities upon employees' surrender of restricted stock at vesting and exercises of stock options
|
—
|
|
|
(27,686
|
)
|
||
Net cash provided by (used in) financing activities
|
6,112
|
|
|
(17,503
|
)
|
||
Effect of exchange rates on cash, cash equivalents and restricted cash
|
(6
|
)
|
|
(286
|
)
|
||
Net decrease in cash, cash equivalents and restricted cash
|
(35,209
|
)
|
|
(52,952
|
)
|
||
Cash, cash equivalents and restricted cash—beginning of period
|
157,480
|
|
|
227,323
|
|
||
Cash, cash equivalents and restricted cash—end of period
|
$
|
122,271
|
|
|
$
|
174,371
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Cash paid for facility and equipment under lease
|
$
|
921
|
|
|
$
|
—
|
|
Cash paid for income taxes
|
$
|
33
|
|
|
$
|
27
|
|
Cash paid for interest
|
$
|
—
|
|
|
$
|
558
|
|
Noncash investing activities:
|
|
|
|
||||
Additions of property and equipment that remain in accounts payable (
Note 3(b)
)
|
$
|
3,209
|
|
|
$
|
—
|
|
•
|
Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations; and
|
•
|
ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) for chemotherapy-induced neutropenia.
|
•
|
Anti-CD20-IFNa, the first antibody-interferon fusion molecule directed against CD20 from this platform that is in Phase 1 development for treating relapsed or refractory Non-Hodgkin Lymphoma patients (including diffuse large b-cell lymphoma).
|
(1)
|
we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable;
|
(2)
|
we identify the “performance obligations” in the respective contract;
|
(3)
|
we determine the “transaction price” for each performance obligation in the respective contract;
|
(4)
|
we allocate the transaction price to each performance obligation; and
|
(5)
|
we recognize revenue only when we satisfy each performance obligation.
|
•
|
When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
•
|
When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
|
Historical or Amortized Cost
|
|
Foreign Currency Translation
|
|
Unrealized Gains |
|
Fair Value |
|
Cash and Cash
Equivalents |
|
Marketable Securities
|
|
||||||||||||
June 30, 2019
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Equity securities* (see
Note 7
)
|
$
|
8,710
|
|
|
$
|
(4,678
|
)
|
|
$
|
28,121
|
|
|
$
|
32,153
|
|
|
$
|
—
|
|
|
$
|
32,153
|
|
|
Money market funds
|
72,384
|
|
|
—
|
|
|
—
|
|
|
72,384
|
|
|
72,384
|
|
|
—
|
|
|
||||||
Government-related debt securities**
|
104,440
|
|
|
|
|
|
95
|
|
|
104,535
|
|
|
7,497
|
|
|
97,038
|
|
|
||||||
Corporate debt securities**
|
39,818
|
|
|
—
|
|
|
25
|
|
|
39,843
|
|
|
15,484
|
|
|
24,359
|
|
|
||||||
Bank deposits
|
22,886
|
|
|
—
|
|
|
—
|
|
|
22,886
|
|
|
22,886
|
|
|
—
|
|
|
||||||
Bank CDs
|
6,571
|
|
|
—
|
|
|
13
|
|
|
6,584
|
|
|
—
|
|
|
6,584
|
|
|
||||||
Total cash and cash equivalents and marketable securities
|
$
|
254,809
|
|
|
$
|
(4,678
|
)
|
|
$
|
28,254
|
|
|
$
|
278,385
|
|
|
$
|
118,251
|
|
|
$
|
160,134
|
|
|
December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Equity securities* (see
Note 7
)
|
$
|
8,710
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
46,422
|
|
|
$
|
—
|
|
|
$
|
46,422
|
|
|
Money market funds
|
142,745
|
|
|
—
|
|
|
—
|
|
|
142,745
|
|
|
142,745
|
|
|
—
|
|
|
||||||
Bank deposits
|
14,735
|
|
|
—
|
|
|
—
|
|
|
14,735
|
|
|
14,735
|
|
|
—
|
|
|
||||||
Bank CDs
|
86
|
|
|
—
|
|
|
—
|
|
|
86
|
|
|
—
|
|
|
86
|
|
|
||||||
Total cash and cash equivalents and marketable securities
|
$
|
166,276
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
203,988
|
|
|
$
|
157,480
|
|
|
$
|
46,508
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Manufacturing equipment*
|
$
|
3,654
|
|
|
$
|
—
|
|
Computer hardware and software
|
3,449
|
|
|
3,079
|
|
||
Laboratory equipment
|
670
|
|
|
635
|
|
||
Office furniture
|
335
|
|
|
212
|
|
||
Leasehold improvements
|
2,957
|
|
|
2,957
|
|
||
Property and equipment, at cost
|
11,065
|
|
|
6,883
|
|
||
(Less): Accumulated depreciation
|
(6,531
|
)
|
|
(6,498
|
)
|
||
Property and equipment, net of accumulated depreciation
|
$
|
4,534
|
|
|
$
|
385
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Deposits
|
$
|
10,549
|
|
|
$
|
6,792
|
|
Prepaid insurance
|
290
|
|
|
782
|
|
||
Prepaid expenses and other assets
|
$
|
10,839
|
|
|
$
|
7,574
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Insurance receivable*
|
$
|
5,674
|
|
|
$
|
206
|
|
Other miscellaneous receivables (including Medicaid rebate credits and royalty receivables from licensees)
|
1,926
|
|
|
1,189
|
|
||
Secured promissory note (see
Note 7
)
|
1,528
|
|
|
1,525
|
|
||
Income tax receivable - current portion
|
632
|
|
|
643
|
|
||
Interest receivable from marketable securities (see
Note 3(a)
)
|
414
|
|
|
—
|
|
||
Reimbursements due from development partners for incurred research and development expenses
|
55
|
|
|
135
|
|
||
Other receivables
|
$
|
10,229
|
|
|
$
|
3,698
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Key employee life insurance – cash surrender value associated with deferred compensation plan (
Note 9(f)
)
|
$
|
7,410
|
|
|
$
|
6,274
|
|
Income tax receivable - non-current portion*
|
668
|
|
|
668
|
|
||
Research & development supplies and other
|
199
|
|
|
246
|
|
||
Other assets
|
$
|
8,277
|
|
|
$
|
7,188
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Office and research facilities
|
$
|
3,379
|
|
|
$
|
—
|
|
Office equipment
|
463
|
|
|
—
|
|
||
Facility and equipment under lease (
Note 9(a)
)
|
$
|
3,842
|
|
|
$
|
—
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Trade accounts payable and other
|
$
|
33,593
|
|
|
$
|
44,919
|
|
Lease liability - current portion (
Note 9(a)
)
|
642
|
|
|
—
|
|
||
Accrued commercial/Medicaid rebates
|
3,526
|
|
|
8,371
|
|
||
Accrued product royalty due to licensors
|
235
|
|
|
4,337
|
|
||
Allowance for product returns
|
5,309
|
|
|
5,171
|
|
||
Accrued data and distribution fees
|
753
|
|
|
3,248
|
|
||
Accrued GPO administrative fees
|
29
|
|
|
296
|
|
||
Accrued inventory management fees
|
368
|
|
|
388
|
|
||
Allowance for government chargebacks
|
—
|
|
|
2,730
|
|
||
Accounts payable and other accrued liabilities
|
$
|
44,455
|
|
|
$
|
69,460
|
|
|
Commercial/Medicaid Rebates and Government Chargebacks
|
|
Distribution, Data, Inventory and
GPO Administrative Fees |
|
Product Return Allowances
|
||||||
Balance as of December 31, 2017
|
$
|
10,358
|
|
|
$
|
5,727
|
|
|
$
|
4,045
|
|
Add: GTN accruals recorded for product sales
|
65,751
|
|
|
13,962
|
|
|
1,700
|
|
|||
(Less): Payments made and credits against GTN accruals
|
(65,008
|
)
|
|
(15,757
|
)
|
|
(574
|
)
|
|||
Balance as of December 31, 2018
|
$
|
11,101
|
|
|
$
|
3,932
|
|
|
$
|
5,171
|
|
Add: GTN accruals recorded for product sales
|
7,252
|
|
|
1,197
|
|
|
250
|
|
|||
(Less): Payments made and credits against GTN accruals
|
(14,827
|
)
|
|
(3,979
|
)
|
|
(112
|
)
|
|||
Balance as of June 30, 2019
|
$
|
3,526
|
|
|
$
|
1,150
|
|
|
$
|
5,309
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Customer deposit for EVOMELA supply in China territory (
see Note 7
)
|
$
|
7,245
|
|
|
$
|
4,850
|
|
Contract liabilities
|
$
|
7,245
|
|
|
$
|
4,850
|
|
|
June 30, 2019
|
|
December 31, 2018
|
||||
Deferred compensation liability (
Note 9(f)
)
|
$
|
7,318
|
|
|
$
|
5,474
|
|
Lease liability - non-current portion (
Note 9(a)
)
|
3,429
|
|
|
—
|
|
||
Other tax liabilities
|
176
|
|
|
176
|
|
||
Other long-term liabilities
|
$
|
10,923
|
|
|
$
|
5,650
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Selling, general and administrative
|
$
|
3,675
|
|
|
$
|
2,531
|
|
|
$
|
7,326
|
|
|
$
|
4,784
|
|
Research and development
|
1,344
|
|
|
650
|
|
|
2,289
|
|
|
1,281
|
|
||||
Total stock-based compensation
|
$
|
5,019
|
|
|
$
|
3,181
|
|
|
$
|
9,615
|
|
|
$
|
6,065
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Basic weighted average shares outstanding
|
110,345,135
|
|
|
102,597,059
|
|
|
109,744,405
|
|
|
101,747,416
|
|
||||
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
2013 Convertible Notes (see
Note 8
)
|
—
|
|
|
3,854,959
|
|
|
—
|
|
|
—
|
|
||||
Common stock options
|
—
|
|
|
3,870,462
|
|
|
—
|
|
|
—
|
|
||||
Restricted stock awards
|
—
|
|
|
1,797,089
|
|
|
—
|
|
|
—
|
|
||||
Restricted stock units
|
—
|
|
|
245,214
|
|
|
—
|
|
|
—
|
|
||||
Common stock warrants
|
—
|
|
|
252,368
|
|
|
—
|
|
|
—
|
|
||||
Diluted average shares outstanding
|
110,345,135
|
|
|
112,617,151
|
|
|
109,744,405
|
|
|
101,747,416
|
|
||||
Net (loss) income as reported
|
$
|
(28,395
|
)
|
|
$
|
13,744
|
|
|
$
|
(47,550
|
)
|
|
$
|
(2,074
|
)
|
Interest attributable to 2013 Convertible Notes
|
—
|
|
|
886
|
|
|
—
|
|
|
—
|
|
||||
Net (loss) income for diluted earnings per share
|
$
|
(28,395
|
)
|
|
$
|
14,630
|
|
|
$
|
(47,550
|
)
|
|
$
|
(2,074
|
)
|
Net (loss) income per share – basic
|
$
|
(0.26
|
)
|
|
$
|
0.13
|
|
|
$
|
(0.43
|
)
|
|
$
|
(0.02
|
)
|
Net (loss) income per share – diluted
|
$
|
(0.26
|
)
|
|
$
|
0.13
|
|
|
$
|
(0.43
|
)
|
|
$
|
(0.02
|
)
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||
Common stock options
|
1,099,016
|
|
|
—
|
|
|
1,467,293
|
|
|
4,396,587
|
|
Restricted stock awards
|
1,790,556
|
|
|
—
|
|
|
1,790,556
|
|
|
1,797,089
|
|
Restricted stock units
|
385,919
|
|
|
—
|
|
|
385,919
|
|
|
245,214
|
|
2013 Convertible Notes
|
—
|
|
|
—
|
|
|
—
|
|
|
3,854,959
|
|
Common stock warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
257,039
|
|
Total
|
3,275,491
|
|
|
—
|
|
|
3,643,768
|
|
|
10,550,888
|
|
|
June 30, 2019
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Equity securities (
Note 7
)
|
$
|
32,153
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
32,153
|
|
|
Bank CDs
|
—
|
|
|
6,584
|
|
|
—
|
|
|
6,584
|
|
|
||||
Mutual funds
|
—
|
|
|
30
|
|
|
—
|
|
|
30
|
|
|
||||
Restricted cash
|
4,020
|
|
|
—
|
|
|
—
|
|
|
4,020
|
|
|
||||
Deferred compensation investments (life insurance cash surrender value (
Note 3(e)
)
|
—
|
|
|
7,410
|
|
|
—
|
|
|
7,410
|
|
*
|
||||
Money market funds
|
72,384
|
|
|
—
|
|
|
—
|
|
|
72,384
|
|
|
||||
Government-related debt securities
|
59,776
|
|
|
44,759
|
|
|
—
|
|
|
104,535
|
|
|
||||
Corporate debt securities
|
—
|
|
|
39,843
|
|
|
—
|
|
|
39,843
|
|
|
||||
|
$
|
168,333
|
|
|
$
|
98,626
|
|
|
$
|
—
|
|
|
$
|
266,959
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred compensation liability (
Note 9(f)
)
|
$
|
—
|
|
|
$
|
7,433
|
|
|
$
|
—
|
|
|
$
|
7,433
|
|
*
|
|
$
|
—
|
|
|
$
|
7,433
|
|
|
$
|
—
|
|
|
$
|
7,433
|
|
|
|
December 31, 2018
Fair Value Measurements |
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Bank CDs
|
$
|
—
|
|
|
$
|
86
|
|
|
$
|
—
|
|
|
$
|
86
|
|
|
Money market funds
|
—
|
|
|
142,745
|
|
|
—
|
|
|
142,745
|
|
|
||||
Equity securities (
Note 7
)
|
46,422
|
|
|
—
|
|
|
—
|
|
|
46,422
|
|
|
||||
Mutual funds
|
—
|
|
|
78
|
|
|
—
|
|
|
78
|
|
|
||||
Deferred compensation investments (life insurance cash surrender value (
Note 3(e)
)
|
—
|
|
|
6,274
|
|
|
—
|
|
|
6,274
|
|
*
|
||||
|
$
|
46,422
|
|
|
$
|
149,183
|
|
|
$
|
—
|
|
|
$
|
195,605
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Deferred compensation liability (
Note 9(f)
)
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
*
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
|
Three Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2018
|
||||
Stated coupon interest expense
|
$
|
279
|
|
|
$
|
558
|
|
Amortization of debt issuance costs
|
62
|
|
|
124
|
|
||
Accretion of debt discount
|
545
|
|
|
1,079
|
|
||
Total
|
$
|
886
|
|
|
$
|
1,761
|
|
Effective interest rate
|
8.4
|
%
|
|
8.4
|
%
|
Operating Leases*
|
|
Condensed Consolidated Balance Sheet Caption
|
|
Balance as of June 30, 2019
|
||
Operating lease right-of-use assets - non-current
|
|
Facility and equipment under lease
|
|
$
|
3,842
|
|
|
|
|
|
|
||
Operating lease liabilities - current
|
|
Accounts payable and other accrued liabilities
|
|
$
|
642
|
|
Operating lease liabilities - non-current
|
|
Other long-term liabilities
|
|
3,429
|
|
|
Total operating lease liabilities
|
|
|
|
$
|
4,071
|
|
|
|
Three Months Ended June 30, 2019
|
|
Six Months Ended June 30, 2019
|
||||
Operating lease cost
|
|
$
|
459
|
|
|
$
|
851
|
|
Variable lease cost
|
|
108
|
|
|
215
|
|
||
Short-term lease cost
|
|
15
|
|
|
39
|
|
||
Total lease cost
|
|
$
|
582
|
|
|
$
|
1,105
|
|
|
|
Weighted Average Remaining Lease Term
|
|
Weighted Average Discount Rate
|
|
Operating leases as of June 30, 2019
|
|
3 years
|
|
7.8
|
%
|
Operating Leases - future payments
|
|
June 30, 2019
|
||
2019 (remaining)
|
|
$
|
775
|
|
2020
|
|
1,442
|
|
|
2021
|
|
1,465
|
|
|
2022
|
|
828
|
|
|
2023
|
|
87
|
|
|
Total future lease payments, undiscounted
|
|
$
|
4,597
|
|
Less: Implied interest
|
|
(526
|
)
|
|
Present value of operating lease payments
|
|
$
|
4,071
|
|
Operating Leases - future payments
|
|
December 31, 2018
|
||
2019
|
|
1,486
|
|
|
2020
|
|
1,441
|
|
|
2021
|
|
1,465
|
|
|
2022
|
|
828
|
|
|
2023 and thereafter
|
|
87
|
|
|
|
|
$
|
5,308
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Product sales, net***
|
|
$
|
(1,245
|
)
|
|
$
|
23,753
|
|
|
$
|
12,938
|
|
|
$
|
51,863
|
|
License fees and service revenue
|
|
—
|
|
|
415
|
|
|
290
|
|
|
2,799
|
|
||||
Total revenues
|
|
$
|
(1,245
|
)
|
|
$
|
24,168
|
|
|
$
|
13,228
|
|
|
$
|
54,662
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
||||||||
Cost of sales (excluding amortization of intangible assets)
|
|
433
|
|
|
6,606
|
|
|
3,601
|
|
|
13,420
|
|
||||
Selling, general and administrative
|
|
(61
|
)
|
|
7,060
|
|
|
5,890
|
|
|
14,549
|
|
||||
Research and development
|
|
255
|
|
|
4,893
|
|
|
2,791
|
|
|
9,422
|
|
||||
Amortization of intangible assets
|
|
—
|
|
|
6,934
|
|
|
1,248
|
|
|
13,880
|
|
||||
Restructuring - employee severance (
Note 12
)****
|
|
(2,439
|
)
|
|
—
|
|
|
3,858
|
|
|
—
|
|
||||
Total operating costs and expenses
|
|
$
|
(1,812
|
)
|
|
$
|
25,493
|
|
|
$
|
17,388
|
|
|
$
|
51,271
|
|
Income (loss) from discontinued operations
|
|
$
|
567
|
|
|
$
|
(1,325
|
)
|
|
$
|
(4,160
|
)
|
|
$
|
3,391
|
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
||||||||
Change in fair value of contingent consideration
|
|
—
|
|
|
(192
|
)
|
|
(1,478
|
)
|
|
(483
|
)
|
||||
Gain on sale of Commercial Product Portfolio*
|
|
—
|
|
|
—
|
|
|
33,644
|
|
|
—
|
|
||||
Total other (expense) income
|
|
$
|
—
|
|
|
$
|
(192
|
)
|
|
$
|
32,166
|
|
|
$
|
(483
|
)
|
Income (loss) from discontinued operations before income taxes
|
|
567
|
|
|
(1,517
|
)
|
|
28,006
|
|
|
2,908
|
|
||||
(Provision) benefit for income taxes from discontinued operations**
|
|
(179
|
)
|
|
367
|
|
|
(6,953
|
)
|
|
(703
|
)
|
||||
Income (loss) from discontinued operations, net of income taxes
|
|
$
|
388
|
|
|
$
|
(1,150
|
)
|
|
$
|
21,053
|
|
|
$
|
2,205
|
|
|
|
December 31, 2018
|
||
Inventories
|
|
$
|
3,550
|
|
Prepaid expenses and other assets
|
|
2,005
|
|
|
Discontinued operations, current assets
|
|
$
|
5,555
|
|
|
|
|
||
Intangible assets, net of accumulated amortization
|
|
111,594
|
|
|
Goodwill
|
|
18,061
|
|
|
Other assets
|
|
2,970
|
|
|
Discontinued operations, non-current assets
|
|
$
|
132,625
|
|
|
|
|
||
FOLOTYN development liability
|
|
2,311
|
|
|
Discontinued operations, current liabilities
|
|
$
|
2,311
|
|
|
|
|
||
FOLOTYN development liability, less current portion
|
|
9,686
|
|
|
Acquisition-related contingent obligations
|
|
4,345
|
|
|
Discontinued operations, non-current liabilities
|
|
$
|
14,031
|
|
|
|
Six Months Ended
June 30, |
||||||
|
|
2019
|
|
2018
|
||||
Depreciation and amortization
|
|
$
|
1,263
|
|
|
$
|
13,925
|
|
Stock-based compensation
|
|
$
|
3,404
|
|
|
$
|
3,146
|
|
Change in fair value of contingent consideration
|
|
$
|
1,311
|
|
|
$
|
291
|
|
Description of Financing Transaction
|
|
No. of Common Shares Issued
|
|
Proceeds Received
(Net of Broker Commissions and Fees )
|
|||
Common shares issued pursuant to the April 2019 ATM Agreement during the three months ended June 30, 2019
|
|
221,529
|
|
|
$
|
1,814
|
|
•
|
our ability to successfully develop, obtain regulatory approval, and market our products;
|
•
|
the approval, or timing of approval, of our products or new indications for our products by the U.S. Food and Drug Administration (the “FDA”) and other international regulatory agencies;
|
•
|
the timing and/or results of pending or future clinical trials, and our reliance on contract research organizations;
|
•
|
our ability to maintain sufficient cash resources to fund our business operations;
|
•
|
our competitors’ progress with their drug development programs, which could adversely impact the perceived or actual value of our in-development drugs;
|
•
|
the ability of our manufacturing partners to meet our product demands and timelines;
|
•
|
our ability to identify and acquire new product candidates and to successfully integrate those product candidates into our operations;
|
•
|
our ability to protect our intellectual property rights;
|
•
|
the impact of legislative or regulatory reform on the pricing for pharmaceutical products;
|
•
|
the impact of any litigation to which we are, or may become a party;
|
•
|
our ability, and that of our suppliers, development partners, and manufacturing partners, to comply with laws, regulations and standards that govern or affect the pharmaceutical and biotechnology industries; and
|
•
|
our ability to maintain the services of our key executives and other personnel.
|
•
|
Poziotinib, a novel irreversible tyrosine kinase inhibitor under investigation for non-small cell lung cancer (“NSCLC”) tumors with various mutations; and
|
•
|
ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) for chemotherapy-induced neutropenia.
|
•
|
Anti-CD20-IFNa, the first antibody-interferon fusion molecule directed against CD20 from this platform that is in Phase 1 development for treating relapsed or refractory Non-Hodgkin Lymphoma patients (including diffuse large b-cell lymphoma).
|
•
|
In 44 evaluable patients with EGFR exon-20 mutations, the confirmed overall response rate was 43% and disease control rate was 90%. Median progression free survival was 5.5 months.
|
•
|
In evaluable patients with HER2 exon-20 mutations, the confirmed overall response rate was 42% and disease control rate was 83%. Median progression free survival was 5.1 months.
|
•
|
EGFR-related toxicities (including rash, diarrhea, and paronychia) were manageable and required dose reductions in 60% of patients. Discontinuation due to poor tolerance was rare (approximately 3% of patients).
|
•
|
Revenue recognition;
|
•
|
Income taxes;
|
•
|
Stock-based compensation; and
|
•
|
Litigation accruals (as required)
|
|
|
Three Months Ended
June 30, |
Six Months Ended
June 30, |
|||||||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
|
|
($ in thousands)
|
($ in thousands)
|
|||||||||||||
Revenues (
Note 1(b)
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative
|
|
17,230
|
|
|
16,391
|
|
|
33,182
|
|
|
33,007
|
|
||||
Research and development
|
|
16,982
|
|
|
16,595
|
|
|
38,868
|
|
|
29,960
|
|
||||
Total operating costs and expenses
|
|
34,212
|
|
|
32,986
|
|
|
72,050
|
|
|
62,967
|
|
||||
Loss from continuing operations
|
|
(34,212
|
)
|
|
(32,986
|
)
|
|
(72,050
|
)
|
|
(62,967
|
)
|
||||
Interest income (expense), net
|
|
1,495
|
|
|
(242
|
)
|
|
2,556
|
|
|
(473
|
)
|
||||
Other income (expense), net
|
|
3,722
|
|
|
48,492
|
|
|
(7,563
|
)
|
|
58,463
|
|
||||
(Loss) income from continuing operations before income taxes
|
|
(28,995
|
)
|
|
15,264
|
|
|
(77,057
|
)
|
|
(4,977
|
)
|
||||
Benefit (provision) for income taxes from continuing operations
|
|
212
|
|
|
(370
|
)
|
|
8,454
|
|
|
698
|
|
||||
(Loss) income from continuing operations
|
|
(28,783
|
)
|
|
14,894
|
|
|
(68,603
|
)
|
|
(4,279
|
)
|
||||
Income (loss) from discontinued operations, net of income taxes (
Note 11
)
|
|
388
|
|
|
(1,150
|
)
|
|
21,053
|
|
|
2,205
|
|
||||
Net (loss) income
|
|
$
|
(28,395
|
)
|
|
$
|
13,744
|
|
|
$
|
(47,550
|
)
|
|
$
|
(2,074
|
)
|
|
|
Three months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
|
$
|
17.2
|
|
|
$
|
16.4
|
|
|
$
|
0.8
|
|
|
4.9
|
%
|
Research and development
|
|
17.0
|
|
|
16.6
|
|
|
0.4
|
|
|
2.4
|
%
|
|||
Total operating costs and expenses
|
|
$
|
34.2
|
|
|
$
|
33.0
|
|
|
$
|
1.2
|
|
|
3.6
|
%
|
|
|
Three months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Total other income
|
|
$
|
5.2
|
|
|
$
|
48.3
|
|
|
$
|
(43.1
|
)
|
|
(89.2
|
)%
|
|
|
Three months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Benefit (provision) for income taxes from continuing operations
|
|
$
|
0.2
|
|
|
$
|
(0.4
|
)
|
|
$
|
0.6
|
|
|
150.0
|
%
|
|
|
Six months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Operating costs and expenses:
|
|
|
|
|
|
|
|
|
|||||||
Selling, general and administrative
|
|
33.2
|
|
|
33.0
|
|
|
0.2
|
|
|
0.6
|
%
|
|||
Research and development
|
|
38.9
|
|
|
30.0
|
|
|
8.9
|
|
|
29.7
|
%
|
|||
Total operating costs and expenses
|
|
$
|
72.1
|
|
|
$
|
63.0
|
|
|
$
|
9.1
|
|
|
14.4
|
%
|
|
|
Six months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Total other (expense) income
|
|
$
|
(5.0
|
)
|
|
$
|
58.0
|
|
|
$
|
(63.0
|
)
|
|
(108.6
|
)%
|
|
|
Six months ended June 30,
|
|
|
|
|
|||||||||
|
|
2019
|
|
2018
|
|
$ Change
|
|
% Change
|
|||||||
|
|
($ in millions)
|
|
|
|
|
|||||||||
Benefit for income taxes from continuing operations
|
|
$
|
8.5
|
|
|
$
|
0.7
|
|
|
$
|
7.8
|
|
|
—
|
%
|
|
June 30, 2019
|
|
December 31, 2018
|
|
June 30, 2018
|
||||||
|
(in thousands, except financial metrics data)
|
||||||||||
Cash, cash equivalents, marketable securities, and restricted cash
|
$
|
282,405
|
|
|
$
|
203,988
|
|
|
$
|
269,658
|
|
Accounts receivable, net
|
$
|
2,542
|
|
|
$
|
29,873
|
|
|
$
|
27,658
|
|
Total current assets
|
$
|
306,015
|
|
|
$
|
250,688
|
|
|
$
|
309,520
|
|
Total current liabilities
|
$
|
56,962
|
|
|
$
|
86,474
|
|
|
$
|
94,470
|
|
Working capital surplus (a)
|
$
|
249,053
|
|
|
$
|
164,214
|
|
|
$
|
215,050
|
|
Current ratio (b)
|
5.4
|
|
|
2.9
|
|
|
3.3
|
|
(a)
|
Total current assets at period end
minus
total current liabilities at period end.
|
(b)
|
Total current assets at period end
divided by
total current liabilities at period end.
|
•
|
the need for additional capital to fund future development programs;
|
•
|
the need for additional capital to fund strategic acquisitions;
|
•
|
the need for additional capital to fund licensing arrangements;
|
•
|
our requirement for additional information technology infrastructure and systems; and
|
•
|
adverse outcomes from potential litigation and the cost to defend such litigation.
|
|
|
|
Incorporated by Reference
|
||||
Exhibit
Number
|
Description
|
Form
|
Form No.
|
Exhibit
|
Filing Date
|
Filed Herewith
|
|
1.2
|
S-3ASR
|
333-230821
|
1.2
|
4/5/2019
|
|
||
2.1
1
|
8-K
|
001-35006
|
10.1
|
1/17/2019
|
|
||
3.1
|
8-K
|
001-35006
|
3.1
|
6/18/18
|
|
||
3.2
|
8-K
|
001-35006
|
3.1
|
3/29/2018
|
|
||
4.1
|
8-K
|
001-35006
|
4.1
|
12/13/2010
|
|
||
4.2
|
8-K
|
001-35006
|
4.1
|
10/13/2017
|
|
||
4.3
|
8-K
|
001-35006
|
4.1
|
3/29/2018
|
|
||
10.1
|
|
|
|
|
X
|
||
31.1
|
|
|
|
|
X
|
||
31.2
|
|
|
|
|
X
|
||
32.1
|
|
|
|
|
X
|
||
32.2
|
|
|
|
|
X
|
||
101.INS
|
XBRL Instance Document.
|
|
|
|
|
X
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document.
|
|
|
|
|
X
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document.
|
|
|
|
|
X
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document.
|
|
|
|
|
X
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document.
|
|
|
|
|
X
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document.
|
|
|
|
|
X
|
|
|
SPECTRUM PHARMACEUTICALS, INC.
|
|
|
|
|
|
Date:
|
August 9, 2019
|
By:
|
/s/ Kurt A. Gustafson
|
|
|
|
Kurt A. Gustafson
|
|
|
|
Executive Vice President and Chief Financial Officer
|
|
|
|
(Authorized Signatory and Principal Financial and Accounting Officer)
|
1 Year Spectrum Pharmaceuticals Chart |
1 Month Spectrum Pharmaceuticals Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions