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v3.19.3
Stockholders' Equity (Details) - USD ($)
3 Months Ended
6 Months Ended
9 Months Ended
Apr. 05, 2019
Sep. 30, 2019
Sep. 30, 2019
Sep. 30, 2019
Sep. 30, 2018
Equity [Abstract]
Maximum proceeds
$ 150,000,000
Proceeds Received (Net of Broker Commissions and Fees )
$ 0
$ 1,814,000
$ 1,817,000
$ 0
Common stock issued (shares)
221,529
X
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- Definition The cash inflow from the additional capital contribution to the entity.
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v3.19.3
Convertible Senior Notes and Interest Expense - Additional Information (Details) - 2.75% Convertible Senior Notes Due 2018 [Member] - USD ($)
24 Months Ended
Dec. 15, 2018
Dec. 17, 2013
Dec. 31, 2017
Debt Disclosure [Line Items]
Sale of convertible notes, principal amount
$ 120,000,000
Interest rate
2.75%
Debt instrument, convertible, repurchased amount
$ 79,500,000
Conversion rate, shares (shares)
95
Conversion rate, price per share ($ per share)
$ 1,000
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v3.19.3
Net Loss Per Share - Computation of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands
3 Months Ended
9 Months Ended
Sep. 30, 2019
Jun. 30, 2019
Mar. 31, 2019
Sep. 30, 2018
Jun. 30, 2018
Mar. 31, 2018
Sep. 30, 2019
Sep. 30, 2018
Earnings Per Share [Abstract]
Weighted average shares outstanding - basic and diluted (shares)
111,178,880
104,106,295
110,291,090
102,571,850
Net loss
$ (25,985)
$ (28,395)
$ (19,155)
$ (68,718)
$ 13,744
$ (15,816)
$ (73,535)
$ (70,792)
Net loss per share - basic and diluted ($ per share)
$ (0.23)
$ (0.66)
$ (0.67)
$ (0.69)
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v3.19.3
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands
9 Months Ended
12 Months Ended
Sep. 30, 2019
Dec. 31, 2018
Commercial/Medicaid Rebates and Government Chargebacks [Member]
Accounts Payable and Other Liabilities [Roll Forward]
Beginning balance
$ 11,101
$ 10,358
Add: GTN accruals recorded for product sales
7,252
65,751
(Less): Payments made and credits against GTN accruals
(15,295)
(65,008)
Ending balance
3,058
11,101
Distribution, Data, Inventory and GPO Administrative Fees [Member]
Accounts Payable and Other Liabilities [Roll Forward]
Beginning balance
3,932
5,727
Add: GTN accruals recorded for product sales
1,197
13,962
(Less): Payments made and credits against GTN accruals
(3,918)
(15,757)
Ending balance
1,211
3,932
Product Return Allowances [Member]
Accounts Payable and Other Liabilities [Roll Forward]
Beginning balance
5,171
4,045
Add: GTN accruals recorded for product sales
167
1,700
(Less): Payments made and credits against GTN accruals
(353)
(574)
Ending balance
$ 4,985
$ 5,171
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v3.19.3
Restructuring Costs Related To Sale Of Commercial Product Portfolio
9 Months Ended
Sep. 30, 2019
Restructuring and Related Activities [Abstract]
Restructuring Costs Related To Sale Of Commercial Product Portfolio
RESTRUCTURING COSTS RELATED TO SALE OF COMMERCIAL PRODUCT PORTFOLIOEmployee Severance
On March 1, 2019, we completed the Commercial Product Portfolio Transaction (see Note 1(b) ) and 87 of our employees were (1) terminated March 1, 2019 or (2) given notice of May 31, 2019 termination and asked to provide transition services for the benefit of Acrotech through that date (as provided by a transition services agreement with Acrotech entered contemporaneously with our sale). For the three and nine months ended September 30, 2019 , we recognized $0 and $0.7 million of income for services rendered to Acrotech under this agreement within “other income (expense), net” on our accompanying Condensed Consolidated Statements of Operations.
The employees in (1) above were entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options. For the nine months ended September 30, 2019 , we fully recognized the aggregate value of $5.1 million for this severance benefit, of which $3.9 million , $1.0 million , and $0.2 million is included on the accompanying Condensed Consolidated Statements of Operations within “income from discontinued operations, net of income taxes” (see Note 11 ), “selling, general, and administrative” expenses and “research and development” expenses, respectively.
The employees in (2) above were also entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options, though on May 31, 2019. The aggregate value of these one-time cash payments and stock-based award accelerations was $0.5 million . Due to then ongoing service requirements of these employees, we amortized this value through expense on a ratable basis beginning March 1, 2019 through May 31, 2019. For the three and nine months ended
September 30, 2019 , we recognized $0 and $0.5 million for this severance benefit, which is included within “selling, general, and administrative” expenses on the accompanying Condensed Consolidated Statements of Operations, and within “accrued payroll and benefits” and “additional paid-in capital” (for stock-based awards) on the accompanying Condensed Consolidated Balance Sheets as of September 30, 2019 .
Unpaid cash severance for our former employees was $0.4 million at September 30, 2019 and is recorded within “accrued payroll and benefits” on the accompanying Condensed Consolidated Balance Sheets.
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v3.19.3
Stock-Based Compensation (Tables)
9 Months Ended
Sep. 30, 2019
Share-based Payment Arrangement [Abstract]
Summary of Stock-Based Compensation Expense
Stock-based compensation expense, included within “total operating costs and expenses” for the three and nine months ended September 30, 2019 and 2018 , was as follows:
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Selling, general and administrative
$
3,156
$
1,902
$
10,550
$
6,686
Research and development
1,030
603
3,251
1,884
Total stock-based compensation
$
4,186
$
2,505
$
13,801
$
8,570
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v3.19.3
Financial Commitments & Contingencies and Key License Agreements (Tables)
9 Months Ended
Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
Assets And Liabilities, Leases
“Facility and equipment under lease” consists of the following :
September 30, 2019
December 31, 2018
Office and research facilities
$
3,092
$
—
Office equipment
439
—
Facility and equipment under lease ( Note 9(a) )
$
3,531
$
—
The below table summarizes these lease asset and liability accounts presented on our accompanying Condensed Consolidated Balance Sheets:
Operating Leases*
Condensed Consolidated Balance Sheet Caption
Balance as of September 30, 2019
Operating lease right-of-use assets - non-current
Facility and equipment under lease
$
3,531
Operating lease liabilities - current
Accounts payable and other accrued liabilities
$
326
Operating lease liabilities - non-current
Other long-term liabilities
3,429
Total operating lease liabilities
$
3,755
* As of September 30, 2019 , we have no “finance leases” as defined in Topic 842 .
Lease, Cost
The components of our aggregate lease expense is summarized below:
Three Months Ended September 30, 2019
Nine Months Ended September 30, 2019
Operating lease cost
$
351
$
1,202
Variable lease cost
108
323
Short-term lease cost
20
59
Total lease cost
$
479
$
1,584
Weighted Average Remaining Lease Term and Applied Discount Rate
Weighted Average Remaining Lease Term
Weighted Average Discount Rate
Operating leases as of September 30, 2019
3 years
7.8%
Lessee, Operating Lease, Liability, Maturity
The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments:
Operating Leases - future payments
September 30, 2019
2019 (remaining)
$
383
2020
1,441
2021
1,465
2022
828
2023
87
Total future lease payments, undiscounted
$
4,204
(Less): Implied interest
(449
)
Present value of operating lease payments
$
3,755
Schedule of Future Minimum Rental Payments for Operating Leases
The below is required tabular disclosure for comparative purposes with our current period-end balance sheet date above:
Operating Leases - future payments
December 31, 2018
2019
$
1,486
2020
1,441
2021
1,465
2022
828
2023 and thereafter
87
$
5,308
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Balance Sheet Account Detail - Facility and Equipment Under Lease (Details) - USD ($) $ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Lessee, Lease, Description [Line Items]
Facility and equipment under lease (Note 9(a))
$ 3,531
$ 0
Building [Member]
Lessee, Lease, Description [Line Items]
Facility and equipment under lease (Note 9(a))
3,092
0
Office Equipment [Member]
Lessee, Lease, Description [Line Items]
Facility and equipment under lease (Note 9(a))
$ 439
$ 0
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- Definition The amount of expense recognized in the current period that reflects the allocation of the cost of tangible assets over the assets' useful lives. Includes production and non-production related depreciation.
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- Definition Aggregate Amount Receivable Based On Achievement Of Milestones
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Stock-Based Compensation
9 Months Ended
Sep. 30, 2019
Share-based Payment Arrangement [Abstract]
Stock-Based Compensation
STOCK-BASED COMPENSATIONWe report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Condensed Consolidated Statements of Operations, based on the assigned department of the recipient. Stock-based compensation expense, included within “total operating costs and expenses” for the three and nine months ended September 30, 2019 and 2018 , was as follows:
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Selling, general and administrative
$
3,156
$
1,902
$
10,550
$
6,686
Research and development
1,030
603
3,251
1,884
Total stock-based compensation
$
4,186
$
2,505
$
13,801
$
8,570
X
- Definition The entire disclosure for share-based payment arrangement.
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v3.19.3
Convertible Senior Notes and Interest Expense
9 Months Ended
Sep. 30, 2019
Debt Disclosure [Abstract]
Convertible Senior Notes and Interest Expense
CONVERTIBLE SENIOR NOTES AND INTEREST EXPENSE
Overview of 2013 Convertible Notes
On December 17, 2013, we entered into an agreement for the sale of $120 million aggregate principal amount of 2.75% Convertible Senior Notes (the “2013 Convertible Notes”). During 2016 and 2017, we completed certain open market purchases
to retire $79.5 million in principal amount of the 2013 Convertible Notes. Maturity of the 2013 Convertible Notes occurred on December 15, 2018 and substantially all remaining notes were converted into our common stock at a rate of 95 shares per $1,000 principal units.
Components of Interest Expense on 2013 Convertible Notes
The following table sets forth the components of interest expense recognized in the accompanying Condensed Consolidated Statements of Operations for the 2013 Convertible Notes.
Three Months Ended September 30, 2018
Nine Months Ended September 30, 2018
Stated coupon interest expense
$
246
$
798
Amortization of debt issuance costs
56
178
Accretion of debt discount
491
1,558
Total interest expense
$
793
$
2,534
Effective interest rate
8.4
%
8.4
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Condensed Consolidated Balance Sheets - USD ($) $ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Current assets:
Cash and cash equivalents
$ 124,598
$ 157,480
Restricted cash
4,040
0
Marketable securities
123,164
46,508
Accounts receivable, net of allowance for doubtful accounts of $67 and $67, respectively
483
29,873
Other receivables
7,752
3,698
Prepaid expenses and other assets
12,680
7,574
Discontinued operations, current assets (Note 11)
0
5,555
Total current assets
272,717
250,688
Property and equipment, net of accumulated depreciation
8,965
385
Other assets
8,613
7,188
Facility and equipment under lease
3,531
0
Discontinued operations, non-current assets
0
132,625
Total assets
293,826
390,886
Current liabilities:
Accounts payable and other accrued liabilities
39,959
69,460
Accrued payroll and benefits
6,475
9,853
Contract liabilities
1,360
4,850
Discontinued operations, current liabilities (Note 11)
0
2,311
Total current liabilities
47,794
86,474
Deferred tax liabilities
0
1,469
Other long-term liabilities
11,313
5,650
Discontinued operations, non-current liabilities
0
14,031
Total liabilities
59,107
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
0
0
Common stock, $0.001 par value; 300,000,000 shares authorized; 112,988,706 and 110,525,141 issued and outstanding at September 30, 2019 and December 31, 2018, respectively
113
110
Additional paid-in capital
912,558
886,740
Accumulated other comprehensive loss
(4,531)
(3,702)
Accumulated deficit
(673,421)
(599,886)
Total stockholders’ equity
234,719
283,262
Total liabilities and stockholders’ equity
$ 293,826
$ 390,886
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IDEA: XBRL DOCUMENT
v3.19.3
Discontinued Operations - Financial Results of Discontinued Operations (Details) - USD ($) $ in Thousands
3 Months Ended
9 Months Ended
Mar. 01, 2019
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Other (expense) income:
Provision for income taxes from discontinued operations
$ (200)
$ (100)
$ (7,200)
$ (800)
Income from discontinued operations, net of income taxes
572
454
21,625
2,659
Discontinued Operations, Disposed of by Sale [Member] | Commercial Product Portfolio [Member]
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]
Total revenues
5,968
25,268
19,196
79,930
Operating costs and expenses:
Cost of sales (excluding amortization of intangible assets)
5,115
6,472
8,716
19,892
Selling, general and administrative
69
6,730
5,959
21,279
Research and development
(194)
5,745
2,597
15,167
Amortization of intangible assets
0
6,923
1,248
20,803
Restructuring charges - employee severance (Note 12)
0
0
3,858
0
Total operating costs and expenses
4,990
25,870
22,378
77,141
Income (loss) from discontinued operations
978
(602)
(3,182)
2,789
Other (expense) income:
Change in fair value of contingent consideration
0
1,200
(1,478)
717
Gain on sale of Commercial Product Portfolio
(193)
0
33,451
0
Total other (expense) income
(193)
1,200
31,973
717
Income from discontinued operations before income taxes
785
598
28,791
3,506
Provision for income taxes from discontinued operations
(213)
(144)
(7,166)
(847)
Income from discontinued operations, net of income taxes
572
454
21,625
2,659
Proceeds from sale of discontinued operations
$ 158,800
Carrying value of net assets transferred
121,200
Transaction expenses
3,900
Contract termination fee
200
Escrow deposits
$ 4,000
4,000
4,000
Discontinued Operations, Disposed of by Sale [Member] | Commercial Product Portfolio [Member] | Product [Member]
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]
Total revenues
5,968
24,556
18,906
76,419
Discontinued Operations, Disposed of by Sale [Member] | Commercial Product Portfolio [Member] | License and Service [Member]
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]
Total revenues
$ 0
$ 712
$ 290
$ 3,511
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R34.htm
IDEA: XBRL DOCUMENT
v3.19.3
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
$ 15,583
$ 6,883
(Less): Accumulated depreciation
(6,618)
(6,498)
Property and equipment, net of accumulated depreciation
8,965
385
Manufacturing Equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
7,601
0
Computer hardware and software [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
3,589
3,079
Laboratory equipment [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
669
635
Leasehold improvements [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
3,389
2,957
Office furniture [Member]
Property, Plant and Equipment [Line Items]
Property and equipment, at cost
$ 335
$ 212
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Stockholders' Equity (Tables)
9 Months Ended
Sep. 30, 2019
Equity [Abstract]
Schedule of Stock by Class
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 nine months ended September 30, 2019
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Net Loss Per Share
9 Months Ended
Sep. 30, 2019
Earnings Per Share [Abstract]
Net Loss Per Share
NET LOSS PER SHARENet loss per share was computed by dividing net loss by the weighted average number of common shares outstanding for the three and nine months ended September 30, 2019 and 2018 :
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Weighted average shares outstanding - basic and diluted
111,178,880
104,106,295
110,291,090
102,571,850
Net loss
$
(25,985
)
$
(68,718
)
$
(73,535
)
$
(70,792
)
Net loss per share – basic and diluted
$
(0.23
)
$
(0.66
)
$
(0.67
)
$
(0.69
)
The below outstanding securities for the three and nine months ended September 30, 2019 and 2018 , were excluded from the above calculation of net loss because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share in each respective period, as summarized below.
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Common stock options issued
635,175
3,702,092
1,198,358
4,175,866
Restricted stock awards issued
1,695,123
1,751,876
1,695,123
1,751,876
Restricted stock units issued
385,919
245,214
385,919
245,214
Employee stock purchase plan shares pending issuance
30,823
21,033
30,823
21,033
2013 Convertible Notes outstanding- if converted into common shares
—
3,403,659
—
3,403,659
Total
2,747,040
9,123,874
3,310,223
9,597,648
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v3.19.3
Financial Commitments & Contingencies and Key License Agreements
9 Months Ended
Sep. 30, 2019
Commitments and Contingencies Disclosure [Abstract]
Financial Commitments & Contingencies and Key License Agreements
FINANCIAL COMMITMENTS & CONTINGENCIES AND KEY LICENSE AGREEMENTS
(a) Facility and Equipment Leases
Overview
In the ordinary course of our business, we enter into leases with unaffiliated parties for the use of (i) office and research facilities and (ii) office equipment. Our current leases have remaining terms ranging from less than one year to five years and none include any residual value guarantees, restrictive covenants, term extensions, or early-termination options.
Our facility leases have minimum annual rents, payable monthly, and some carry fixed annual rent increases. Under some of these arrangements, real estate taxes, insurance, certain operating expenses, and common area maintenance are reimbursable to the lessor. These amounts are expensed as incurred, as they are variable in nature and therefore excluded from the measurement of our reported lease asset and liability discussed below. During the three and nine months ended September 30, 2019 and 2018 , we had no sublease arrangements with us as lessor.
Adoption of the New Lease Accounting Standard
Beginning January 1, 2019, we adopted ASU 2016-02, Leases (“ Topic 842 ”). Under this new lease accounting standard, we recognized a "right-of-use asset" and "lease liability" on our accompanying Condensed Consolidated Balance Sheets for all leases (except for any lease with an original term of less than 12 months). We elected the “optional transition method” upon adoption of Topic 842 and the available practical expedients. Accordingly, we did not reassess (i) lease classification (as either operating or financing) or (ii) initial direct costs for existing leases.
This reported asset and liability, respectively, represents (i) the economic benefit of our use of leased facilities and equipment and (ii) the present-value of our contractual minimum lease payments, applying our estimated incremental borrowing rate as of the lease commencement date (since an implicit interest rate is not readily determinable in any of our leases). We recorded $4.2 million to our January 1, 2019 balance sheet for both (i) our right-of-use asset within “facility and equipment under lease” and (ii) our lease liability within “accounts payable and accrued liabilities” and “other long-term liabilities.” The recorded asset and liability associated with each lease is amortized over the respective lease term using the “effective interest rate” method.
We elected to (1) not separate “lease components” from “non-lease components” in our measurement of minimum payments for (i) facility leases and (ii) office equipment leases and (2) not recognize a lease asset and liability for a term of 12 months or less.
We recognize lease expense on a straight-line basis over the expected term of these operating leases, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statements of Operations. For the three and nine months ended September 30, 2019 and 2018 , this expense aggregated $0.5 million , $0.5 million , $1.6 million and $1.3 million , respectively.
Financial Reporting Captions
The below table summarizes these lease asset and liability accounts presented on our accompanying Condensed Consolidated Balance Sheets:
Operating Leases*
Condensed Consolidated Balance Sheet Caption
Balance as of September 30, 2019
Operating lease right-of-use assets - non-current
Facility and equipment under lease
$
3,531
Operating lease liabilities - current
Accounts payable and other accrued liabilities
$
326
Operating lease liabilities - non-current
Other long-term liabilities
3,429
Total operating lease liabilities
$
3,755
* As of September 30, 2019 , we have no “finance leases” as defined in Topic 842 .
Components of Lease Expense
We recognize lease expense on a straight-line basis over the term of our operating leases, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statements of Operations. The components of our aggregate lease expense is summarized below:
Three Months Ended September 30, 2019
Nine Months Ended September 30, 2019
Operating lease cost
$
351
$
1,202
Variable lease cost
108
323
Short-term lease cost
20
59
Total lease cost
$
479
$
1,584
Weighted Average Remaining Lease Term and Applied Discount Rate
Weighted Average Remaining Lease Term
Weighted Average Discount Rate
Operating leases as of September 30, 2019
3 years
7.8%
Future Contractual Lease Payments as of September 30, 2019
The below table summarizes our (i) minimum lease payments over the next five years, (ii) lease arrangement implied interest, and (iii) present value of future lease payments:
Operating Leases - future payments
September 30, 2019
2019 (remaining)
$
383
2020
1,441
2021
1,465
2022
828
2023
87
Total future lease payments, undiscounted
$
4,204
(Less): Implied interest
(449
)
Present value of operating lease payments
$
3,755
On October 9, 2019, we entered into an operating lease agreement for office space in the Greater Boston area. Our undiscounted payment obligations are $0.8 million for the November 2019 through May 2021 term of this lease.
Contractual Lease Payments as of December 31, 2018
The below is required tabular disclosure for comparative purposes with our current period-end balance sheet date above:
Operating Leases - future payments
December 31, 2018
2019
$
1,486
2020
1,441
2021
1,465
2022
828
2023 and thereafter
87
$
5,308
(b) In/Out Licensing Agreements and Co-Development Arrangements
Overview
The in-license agreements for our development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. We also may enter into out-license agreements for territory-specific rights to these drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments based on our licensees’ sales or regulatory achievements. For certain drug products, we may enter into cost-sharing arrangements with licensees and licensors.
Impact of Commercial Product Portfolio Transaction on Rights and Obligations Associated with the Product Portfolio
On March 1, 2019, we completed the Commercial Product Portfolio Transaction and substantially all of the contractual rights and obligations associated with the Commercial Product Portfolio that were previously disclosed in Note 17(b) to our 2018 Annual Report on Form 10-K were transferred to Acrotech at the closing of the Commercial Product Portfolio Transaction. However, under the terms of this transaction we retained our trade “accounts receivable” and GTN liabilities included within “accounts payable and other accrued liabilities” (see Note 3(g) ) associated with our product sales made on and prior to February 28, 2019.
Accordingly, these Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with our Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations” - see Notes 1 and 11 . The most significant
remaining agreements associated with our continuing operations are listed below, along with the key financial terms and our corresponding accounting and reporting conventions for each:
(i) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Co. Ltd
In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd., or Hanmi, for ROLONTIS (formerly referred to as “LAPS-G-CSF” or “SPI-2012”), a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi tiered royalties that range from the low double-digits to mid-teen on our net sales of ROLONTIS.
In January 2016, the first patient was dosed with ROLONTIS as part of our clinical trial. This triggered our contractual milestone payment to Hanmi, and in April 2016, we issued 318,750 shares of our common stock to Hanmi. We are responsible for further contractual payments upon the achievement, at our expense, of a regulatory milestone (which will generate a payment of $10 million to Hanmi), and sales milestone payments of up to $120 million per calendar year based on our net sales of ROLONTIS.
Depending on the nature of the milestone achievement we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the value within “research and development” or “cost of product sales” within the Consolidated Statements of Operations. The corresponding payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
(ii) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson
In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials, (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers) and made an upfront payment for these rights.
Under the terms of this agreement, we received the exclusive rights to commercialize poziotinib, excluding Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are contractually obligated to make payments to Hanmi upon the achievement, at our expense, of various regulatory milestones aggregating $33 million and annual net sales milestones of up to $325 million . We are also contractually obligated to pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib, potentially reduced by royalties due to other third parties.
Depending on the nature of the milestone achievement we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the value within “research and development” or “cost of product sales” within the Consolidated Statements of Operations. The corresponding payment due to this licensor will be recognized in the Consolidated Balance Sheets within “other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
In April 2018, we executed an exclusive patent and technology agreement for the use of poziotinib in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”) that had discovered its use in treating these patient-types (“Exon 19/20 Patients”) and made an upfront payment for these rights.
We are contractually obligated to pay nominal fixed annual license maintenance fees to MD Anderson and pay additional fees upon the achievement, at our expense, of various regulatory milestones aggregating $9 million and sales milestones of up to $30 million . We are also contractually obligated to pay MD Anderson royalties in the low single-digits on our net sales of poziotinib.
Depending on the nature of the milestone achievement we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the value within “research and development” or “cost of product sales” within the Consolidated Statements of Operations. The corresponding payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
(iii) In-License Agreement with ImmunGene for FIT Drug Delivery Platform and Two Early-Stage Drugs
In April 2019, we executed an asset transfer, license, and sublicense agreement with ImmunGene, Inc. (“ImmunGene”) for an exclusive license for the intellectual property related to the Focused Interferon Therapeutics (“FIT”) drug delivery platform and two early-stage drugs: (i) Anti-CD20-IFNa, an antibody-interferon fusion molecule directed against CD20 that is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients, representing a considerable unmet medical need and (ii) an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies that has the potential for treating both solid and hematologic malignancies.
We made upfront payments aggregating $2.8 million to ImmunGene and to several other third parties, all of which were recorded within “research and development” expense within our accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2019 . We will make further payments to ImmunGene upon our achievement, at our expense, of various regulatory milestones that aggregate $26.1 million , plus an additional $5 million milestone payment for each new indication (beyond those described above) approved for either drug in the U.S., Europe, or Japan.
Our contractual royalties to ImmunGene are in the high-single digits on our net sales of each drug, potentially reduced by our royalties due to other third parties. We are also contractually obligated to pay nominal fixed annual license maintenance fees to two FIT platform licensors.
Depending on the nature of the milestone achievement we will either (a) capitalize the value to “intangible assets” in the Consolidated Balance Sheets or (b) recognize the value within “research and development” or “cost of product sales” within the Consolidated Statements of Operations. The corresponding payment due to this licensor will be recognized in the Consolidated Balance Sheets within “accounts payable and other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
(c) Service Agreements for Research and Development Activities
We have entered into various contracts with numerous third party service providers for the execution of our research and development initiatives (to which we assign discreet project codes in order to compile and monitor such expenses). These vendors include raw material suppliers and contract manufacturers for drug products not yet FDA approved, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies.
We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice.
(d) Supply and Service Agreements Associated with Product Production
We have various product supply agreements and/or have issued vendor purchase orders that obligate us to agreed-upon raw material purchases from certain vendors. We also have certain drug production service agreements with select contract manufacturers that obligate us to service fees during the contractual period. These collective commitments do not exceed our planned commercial requirements; the corresponding contracted prices do not exceed their current fair market values.
(e) Employment Agreements
We entered into revised employment agreements with each of our named executive officers (chief executive officer, chief operating officer, chief financial officer, chief legal officer, and chief medical officer) in April/June 2018 and June 2019, which supersede any prior Change in Control Severance Agreements with such individuals. These agreements provide for the payment of certain benefits to each executive upon his separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction.
(f) Deferred Compensation Plan
The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended.
The DC Plan is maintained to provide special benefits for a select group of our employees (the “DC Participants”). DC Participants make annual elections to defer a portion of their eligible cash compensation which is then placed into their DC Plan accounts. We match a fixed percentage of these deferrals, and may make additional discretionary contributions. At September 30, 2019 and December 31, 2018 , the aggregate value of this DC Plan liability was $7.8 million and $6.2 million , respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Condensed Consolidated Balance Sheets.
(g) Litigation
We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time.
We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition.
Stockholder Litigation
Olutayo Ayeni v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 21, 2016 in the United States District Court, Central District of California; Case No. 2:16-cv-07074) (the “Ayeni Action”) and Glen Hartsock v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 28, 2016 in the United States District Court, District Court of Nevada Case; No. 2:16-cv-02279-RFB-GWF) (the “Hartsock Action”). On November 15, 2016, the Ayeni Action was transferred to the United States District Court for the District of Nevada. The parties have stipulated to a consolidation of the Ayeni Action with the Hartsock Action. These class action lawsuits allege that we and certain of our executive officers made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our New Drug Application to the FDA for QAPZOLA in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended.
On July 23, 2019, we entered into a memorandum of understanding with these plaintiffs for a collective settlement that is pending court approval. The value of this proposed settlement is included within “other receivables” (see Note 3(d) ) and “accounts payable and other accrued liabilities” on the accompanying Condensed Consolidated Balance Sheet as of September 30, 2019 .
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Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Statement of Financial Position [Abstract]
Allowance for doubtful accounts receivable
$ 67
$ 67
Preferred stock, par value ($ per share)
$ 0.001
$ 0.001
Preferred stock, shares authorized (shares)
5,000,000
5,000,000
Preferred stock, shares issued (shares)
0
0
Preferred stock, shares outstanding (shares)
0
0
Common stock, par value ($ per share)
$ 0.001
$ 0.001
Common stock, shares authorized (shares)
300,000,000
300,000,000
Common stock, shares issued (shares)
112,684,387
110,525,141
Common stock, shares outstanding (shares)
112,684,387
110,525,141
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36
R7.htm
IDEA: XBRL DOCUMENT
v3.19.3
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands
Total
Common Stock [Member]
Additional Paid-In Capital [Member]
AOCI Attributable to Parent [Member]
Accumulated Deficit [Member]
Beginning Balance, (shares) at Dec. 31, 2017
100,742,735
Beginning Balance at Dec. 31, 2017
$ 351,339
$ 100
$ 837,347
$ 15,999
$ (502,107)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(15,816)
(15,816)
Other comprehensive income (loss), net
393
393
Employee stock-based compensation expense
4,144
4,144
Issuance of common stock to 401(k) plan for employees (shares)
16,834
Issuance of common stock to 401(k) plan for employees
334
334
Issuance of common stock upon exercise of stock options (shares)
5,793,413
Issuance of common stock upon exercise of stock options
41,423
$ 6
41,417
Restricted stock award grants, net of forfeitures (shares)
614,035
Restricted stock award grants, net of forfeitures
0
Retirement of RSAs and shares as part of stock option cashless exercises to satisfy employee tax withholdings (shares)
(3,463,873)
Retirement of RSAs and shares as part of stock option cashless exercises to satisfy employee tax withholdings
(62,544)
$ (3)
(62,541)
Issuance of common stock upon vesting of RSUs (shares)
200,652
Issuance of common stock upon vesting of RSUs
0
Issuance of common stock upon exercise of warrants (shares)
31,602
Issuance of common stock upon exercise of warrants
0
Ending Balance, (shares) at Mar. 31, 2018
103,935,398
Ending Balance at Mar. 31, 2018
324,293
$ 103
820,701
(819)
(495,692)
Beginning Balance, (shares) at Dec. 31, 2017
100,742,735
Beginning Balance at Dec. 31, 2017
351,339
$ 100
837,347
15,999
(502,107)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(70,792)
Ending Balance, (shares) at Sep. 30, 2018
106,060,681
Ending Balance at Sep. 30, 2018
286,779
$ 106
840,681
(3,342)
(550,666)
Beginning Balance, (shares) at Mar. 31, 2018
103,935,398
Beginning Balance at Mar. 31, 2018
324,293
$ 103
820,701
(819)
(495,692)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
13,744
13,744
Other comprehensive income (loss), net
(2,269)
(2,269)
Employee stock-based compensation expense
4,461
4,461
Issuance of common stock to 401(k) plan for employees (shares)
14,736
Issuance of common stock to 401(k) plan for employees
272
272
Issuance of common stock for ESPP (shares)
45,543
Issuance of common stock for ESPP
734
734
Issuance of common stock upon exercise of stock options (shares)
732,694
Issuance of common stock upon exercise of stock options
2,884
2,884
Restricted stock award grants, net of forfeitures (shares)
176,954
Restricted stock award grants, net of forfeitures
0
Issuance of common stock upon exercise of warrants (shares)
225,278
Issuance of common stock upon exercise of warrants
0
Ending Balance, (shares) at Jun. 30, 2018
105,130,603
Ending Balance at Jun. 30, 2018
344,119
$ 103
829,052
(3,088)
(481,948)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(68,718)
(68,718)
Other comprehensive income (loss), net
(254)
(254)
Employee stock-based compensation expense
3,690
3,690
Issuance of common stock to 401(k) plan for employees (shares)
15,010
Issuance of common stock to 401(k) plan for employees
296
296
Issuance of common stock upon exercise of stock options (shares)
428,770
Issuance of common stock upon exercise of stock options
3,042
$ 2
3,040
Restricted stock award grants, net of forfeitures (shares)
(697)
Restricted stock award grants, net of forfeitures
0
Issuance of common stock upon exercise of warrants (shares)
35,695
Issuance of common stock upon exercise of warrants
0
Common stock redeemed on 2018 Convertible Notes (Note 8) (shares)
451,300
Common stock redeemed on 2018 Convertible Notes (Note 8)
4,604
$ 1
4,603
Ending Balance, (shares) at Sep. 30, 2018
106,060,681
Ending Balance at Sep. 30, 2018
286,779
$ 106
840,681
(3,342)
(550,666)
Beginning Balance, (shares) at Dec. 31, 2018
110,525,141
Beginning Balance at Dec. 31, 2018
283,262
$ 110
886,740
(3,702)
(599,886)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(19,155)
(19,155)
Other comprehensive income (loss), net
(390)
(390)
Employee stock-based compensation expense
7,481
7,481
Issuance of common stock to 401(k) plan for employees (shares)
47,347
Issuance of common stock to 401(k) plan for employees
519
519
Issuance of common stock upon exercise of stock options (shares)
146,785
Issuance of common stock upon exercise of stock options
831
831
Restricted stock award grants, net of forfeitures (shares)
259,539
Restricted stock award grants, net of forfeitures
1
$ 1
Issuance of common stock upon vesting of RSUs (shares)
233,760
Issuance of common stock upon vesting of RSUs
0
Ending Balance, (shares) at Mar. 31, 2019
111,212,572
Ending Balance at Mar. 31, 2019
272,549
$ 111
895,571
(4,092)
(619,041)
Beginning Balance, (shares) at Dec. 31, 2018
110,525,141
Beginning Balance at Dec. 31, 2018
283,262
$ 110
886,740
(3,702)
(599,886)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(73,535)
Ending Balance, (shares) at Sep. 30, 2019
112,988,706
Ending Balance at Sep. 30, 2019
234,719
$ 113
912,558
(4,531)
(673,421)
Beginning Balance, (shares) at Mar. 31, 2019
111,212,572
Beginning Balance at Mar. 31, 2019
272,549
$ 111
895,571
(4,092)
(619,041)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(28,395)
(28,395)
Other comprehensive income (loss), net
328
328
Employee stock-based compensation expense
4,814
4,814
Issuance of common stock to 401(k) plan for employees (shares)
24,382
Issuance of common stock to 401(k) plan for employees
205
205
Issuance of common stock for ESPP (shares)
60,606
Issuance of common stock for ESPP
444
444
Issuance of common stock upon exercise of stock options (shares)
504,226
Issuance of common stock upon exercise of stock options
3,023
$ 0
3,023
Restricted stock award grants, net of forfeitures (shares)
651,072
Restricted stock award grants, net of forfeitures
1
$ 1
Issuance of common stock upon vesting of RSUs (shares)
10,000
Issuance of common stock upon vesting of RSUs
0
Issuance of common shares under an at-the-market sales agreement (Note 13) (shares)
221,529
Issuance of common shares under an at-the-market sales agreement (Note 13)
1,814
1,814
Ending Balance, (shares) at Jun. 30, 2019
112,684,387
Ending Balance at Jun. 30, 2019
254,783
$ 112
905,871
(3,764)
(647,436)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net loss
(25,985)
(25,985)
Other comprehensive income (loss), net
(767)
(767)
Employee stock-based compensation expense
4,021
4,021
Issuance of common stock to 401(k) plan for employees (shares)
21,454
Issuance of common stock to 401(k) plan for employees
165
165
Issuance of common stock upon exercise of stock options (shares)
364,358
Issuance of common stock upon exercise of stock options
2,499
2,498
Restricted stock award grants, net of forfeitures (shares)
(81,493)
Restricted stock award grants, net of forfeitures
0
Refund of SEC fees in connection with an at-the-market sales agreement for our common shares
3
3
Ending Balance, (shares) at Sep. 30, 2019
112,988,706
Ending Balance at Sep. 30, 2019
$ 234,719
$ 113
$ 912,558
$ (4,531)
$ (673,421)
X
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Discontinued Operations - Summary of Assets and Liabilities of Discontinued Operations (Details) - USD ($) $ in Thousands
Sep. 30, 2019
Dec. 31, 2018
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]
Discontinued operations, current assets
$ 0
$ 5,555
Discontinued operations, non-current assets
0
132,625
Discontinued operations, current liabilities
0
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Discontinued operations, non-current liabilities
$ 0
14,031
Discontinued Operations, Disposed of by Sale [Member] | Commercial Product Portfolio [Member]
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items]
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
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Financial Commitments & Contingencies and Key License Agreements - Additional Information (Details) $ in Thousands
1 Months Ended
3 Months Ended
9 Months Ended
Apr. 30, 2019
USD ($)
product
Apr. 30, 2016
shares
Sep. 30, 2019
USD ($)
Sep. 30, 2018
USD ($)
Sep. 30, 2019
USD ($)
Sep. 30, 2018
USD ($)
Oct. 09, 2019
USD ($)
Jan. 01, 2019
USD ($)
Dec. 31, 2018
USD ($)
Long-term Purchase Commitment [Line Items]
Operating lease right-of-use assets
$ 3,531
$ 3,531
$ 0
Operating lease liability
3,755
3,755
Lease cost
479
$ 500
1,584
$ 1,300
Lessee, operating lease, liability, payments due
4,204
4,204
Deferrals and contributions
$ 7,800
7,800
$ 6,200
SPI-2012 [Member]
Long-term Purchase Commitment [Line Items]
Issuance (shares) | shares
318,750
Potential payments based on achievement of regulatory milestones
10,000
Potential payments based on achievement of sales milestones
120,000
Poziotinib [Member] | Licensing Agreements [Member]
Long-term Purchase Commitment [Line Items]
Potential payments based on achievement of regulatory milestones
33,000
Potential payments based on achievement of sales milestones
325,000
MD Anderson [Member]
Long-term Purchase Commitment [Line Items]
Potential payments based on achievement of regulatory milestones
9,000
Potential payments based on achievement of sales milestones
$ 30,000
Accounting Standards Update 2016-02 [Member]
Long-term Purchase Commitment [Line Items]
Operating lease right-of-use assets
$ 4,200
Operating lease liability
$ 4,200
Minimum [Member]
Long-term Purchase Commitment [Line Items]
Lessee, operating lease, remaining lease term
1 year
Maximum [Member]
Long-term Purchase Commitment [Line Items]
Lessee, operating lease, remaining lease term
5 years
ImmunGene, Inc. [Member]
Long-term Purchase Commitment [Line Items]
Potential payments based on achievement of regulatory milestones
$ 26,100
Number of products | product
2
Asset purchase agreement, upfront payment
$ 2,800
Potential payments based on additional achievements of regulatory milestones
$ 5,000
Subsequent Event [Member]
Long-term Purchase Commitment [Line Items]
Lessee, operating lease, liability, payments due
$ 800
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Stock-Based Compensation (Details) - USD ($) $ in Thousands
3 Months Ended
9 Months Ended
Sep. 30, 2019
Sep. 30, 2018
Sep. 30, 2019
Sep. 30, 2018
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation
$ 4,186
$ 2,505
$ 13,801
$ 8,570
Selling, general and administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation
3,156
1,902
10,550
6,686
Research and development [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total share-based compensation
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$ 603
$ 3,251
$ 1,884
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Sep. 30, 2019
Dec. 31, 2018
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Trade accounts payable and other
$ 30,321
$ 44,919
Lease liability - current portion (Note 9(a))
326
0
Accrued commercial/Medicaid rebates
3,058
8,371
Accrued product royalty due to licensors
58
4,337
Allowance for product returns
4,985
5,171
Accrued data and distribution fees
832
3,248
Accrued GPO administrative fees
11
296
Accrued inventory management fees
368
388
Allowance for government chargebacks
0
2,730
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$ 39,959
$ 69,460
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v3.19.3
Casi Holdings and Evomela Supply Contract - Additional Information (Details) $ in Thousands, shares in Millions
1 Months Ended
9 Months Ended
12 Months Ended
Apr. 30, 2019
USD ($)
shares
Sep. 30, 2019
USD ($)
shares
Sep. 30, 2018
USD ($)
Dec. 31, 2014
agreement
Dec. 31, 2018
USD ($)
Other Commitments [Line Items]
Equity securities
$ 33,559
$ 46,422
Gain (loss) on shares of common stock
$ 2,674
$ 0
CASI Out-License [Member]
Other Commitments [Line Items]
Number of agreements | agreement
3
Number of shares held in investment (shares) | shares
10.0
Percentage of ownership
10.40%
Equity securities
$ 33,600
Number of shares sold (shares) | shares
1.5
Gain (loss) on shares of common stock
$ 2,700
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v3.19.3
Discontinued Operations (Tables)
9 Months Ended
Sep. 30, 2019
Discontinued Operations and Disposal Groups [Abstract]
Disposal Groups, Including Discontinued Operations
The following table presents the various elements of “income from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statement of Operations:
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Product sales, net*
$
5,968
$
24,556
$
18,906
$
76,419
License fees and service revenue
—
712
290
3,511
Total revenues
$
5,968
$
25,268
$
19,196
$
79,930
Operating costs and expenses:
Cost of sales (excluding amortization of intangible assets)
5,115
6,472
8,716
19,892
Selling, general and administrative
69
6,730
5,959
21,279
Research and development
(194
)
5,745
2,597
15,167
Amortization of intangible assets
—
6,923
1,248
20,803
Restructuring charges - employee severance ( Note 12 )
—
—
3,858
—
Total operating costs and expenses
$
4,990
$
25,870
$
22,378
$
77,141
Income (loss) from discontinued operations
$
978
$
(602
)
$
(3,182
)
$
2,789
Other (expense) income:
Change in fair value of contingent consideration
—
1,200
(1,478
)
717
Gain on sale of Commercial Product Portfolio**
(193
)
—
33,451
—
Total other (expense) income
$
(193
)
$
1,200
$
31,973
$
717
Income from discontinued operations before income taxes
785
598
28,791
3,506
Provision for income taxes from discontinued operations***
(213
)
(144
)
(7,166
)
(847
)
Income from discontinued operations, net of income taxes
$
572
$
454
$
21,625
$
2,659
* This revenue for the three and nine months ended September 30, 2019 includes: (i) sales from our Commercial Product Portfolio in January and February 2019 (prior to the completion of the Commercial Product Portfolio Transaction) and (ii) EVOMELA sales to a licensee during the second and third quarters of 2019 since a related supply contract was not assumed by Acrotech at the time of sale (see Note 7 ).
** This pre-tax gain on sale represents the $158.8 million gross proceeds from the Commercial Product Portfolio Transaction less our $121.2 book value of transferred net assets (inclusive of assumed liabilities) to Acrotech on the March 1, 2019 closing date less legal and banker fees aggregating $3.9 million . In the third quarter of 2019, we reduced this gain for a $0.2 million contract cancellation fee associated with our sold commercial operations; this value was deducted from the $4.0 million escrow account (reported as “restricted cash” on the accompanying Condensed Consolidated Balance Sheets until its release on November 5, 2019).
*** This income tax provision represents an allocation of taxes as required under intraperiod allocation guidance (see Note 10 ). Due to our aggregate net operating loss-carryforwards, no federal or state income tax payments are expected to be made relating to our current year activity, inclusive of our recognized gain on sale of the Commercial Product Portfolio.
Condensed Consolidated Balance Sheets
Accounts receivable derived from our product sales on and prior to February 28, 2019 were not transferred to Acrotech as part of Commercial Product Portfolio Transaction, nor were our GTN liabilities and trade accounts payable assumed by Acrotech that were associated with our commercial activities on and prior to February 28, 2019 (see Note 3(g) ). Accordingly, these specific assets and liabilities remain presented within “accounts receivable, net of allowance for doubtful accounts” and “accounts payable and other accrued liabilities” on the accompanying Condensed Consolidated Balance Sheets.
The following table presents a summary of our “discontinued operations, assets” and “discontinued operations, liabilities” as of December 31, 2018 within the accompanying Condensed Consolidated Balance Sheets (representing those assets and
liabilities transferred to Acrotech as part of the Commercial Product Portfolio Transaction):
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
Condensed Consolidated Statement of Cash Flows
The following table presents significant non-cash items for our discontinued operations that are included as adjustments in the accompanying Condensed Consolidated Statements of Cash Flows:
Nine Months Ended September 30,
2019
2018
Depreciation and amortization
$
1,263
$
20,871
Stock-based compensation
$
3,404
$
4,626
Change in fair value of contingent consideration
$
1,478
$
(655
)
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v3.19.3
Stockholders' Equity
9 Months Ended
Sep. 30, 2019
Equity [Abstract]
Stockholders' Equity
STOCKHOLDERS’ EQUITYSale of Common Stock Under ATM Agreement
We entered into a new collective at-market-issuance (ATM) sales agreement with Cantor Fitzgerald & Co., H.C. Wainwright & Co., LLC and B. Riley FBR, Inc. (the “April 2019 ATM Agreement”) connected to our automatic shelf registration statement on Form S-3ASR, filed with the SEC on April 5, 2019.
The April 2019 ATM Agreement allows us to raise aggregate gross proceeds of $150 million from the periodic sales of our common stock on the public market. Through September 30, 2019 , we raised aggregate net proceeds of $1.8 million under this ATM. These proceeds and any future proceeds raised will support the advancement of our in-development drug candidates, activities in connection with the launch of our in-development drug candidates, including hiring and building inventory supply, making acquisitions of assets, businesses, companies or securities, capital expenditures, and for working capital. 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 nine months ended September 30, 2019
221,529
$
1,814
There were no sales of our common shares under the April 2019 ATM Agreement during the three months ended September 30, 2019 .
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v3.19.3
Net Loss Per Share (Tables)
9 Months Ended
Sep. 30, 2019
Earnings Per Share [Abstract]
Computation of Net Loss Per Share
Net loss per share was computed by dividing net loss by the weighted average number of common shares outstanding for the three and nine months ended September 30, 2019 and 2018 :
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Weighted average shares outstanding - basic and diluted
111,178,880
104,106,295
110,291,090
102,571,850
Net loss
$
(25,985
)
$
(68,718
)
$
(73,535
)
$
(70,792
)
Net loss per share – basic and diluted
$
(0.23
)
$
(0.66
)
$
(0.67
)
$
(0.69
)
Schedule of Securities Excluded from Calculation of Net Loss Per Share
The below outstanding securities for the three and nine months ended September 30, 2019 and 2018 , were excluded from the above calculation of net loss because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share in each respective period, as summarized below.
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Common stock options issued
635,175
3,702,092
1,198,358
4,175,866
Restricted stock awards issued
1,695,123
1,751,876
1,695,123
1,751,876
Restricted stock units issued
385,919
245,214
385,919
245,214
Employee stock purchase plan shares pending issuance
30,823
21,033
30,823
21,033
2013 Convertible Notes outstanding- if converted into common shares
—
3,403,659
—
3,403,659
Total
2,747,040
9,123,874
3,310,223
9,597,648
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v3.19.3
Balance Sheet Account Detail
9 Months Ended
Sep. 30, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Balance Sheet Account Detail
BALANCE SHEET ACCOUNT DETAILThe composition of selected financial statement captions that comprise the accompanying Condensed Consolidated Balance Sheets are summarized below:
(a) Cash and Cash Equivalents and Marketable Securities
As of September 30, 2019 and December 31, 2018 , our “cash and cash equivalents” were held with major financial institutions. As of September 30, 2019 , our “marketable securities” include our equity holdings in CASI Pharmaceuticals, Inc. (“CASI”), mutual funds, government-related debt securities, corporate debt securities, and bank certificates of deposits (“bank CDs”).
We maintain cash balances with select financial institutions. The Federal Deposit Insurance Corporation (FDIC) and other third parties insure a fraction of these deposits. Accordingly, these cash deposits are not insured against the possibility of a substantial or complete loss of principal and are inherently subject to the credit risk of the corresponding financial institution.
Our investment policy requires that purchased investments may only be in highly-rated and liquid financial instruments and limits our holdings of any single issuer (excluding any debt or equity securities that may be received from our strategic partners in connection with licensing arrangements, as discussed in Note 7 ).
The carrying amount of our equity securities, money market funds, and Bank CDs approximates their fair value (utilizing “ Level 1” or “ Level 2” inputs – see Note 2(x) ) because of our ability to immediately convert these instruments into cash with minimal expected change in value. As of September 30, 2019 , our held securities that remain in an unrealized loss position for less than one year were insignificant and are presented in the table below.
The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”:
Historical or Amortized Cost
Foreign Currency Translation
Unrealized Gains
Unrealized Losses
Fair Value
Cash and Cash Equivalents
Marketable Securities
September 30, 2019
Equity securities* (see Note 7 )
$
8,710
$
(5,285
)
$
30,134
$
—
$
33,559
$
—
$
33,559
Money market funds
89,041
—
—
—
89,041
89,041
—
Government-related debt securities**
60,087
—
55
—
60,142
—
60,142
Corporate debt securities**
44,182
—
47
(5
)
44,224
20,913
23,311
Bank deposits
14,644
—
—
—
14,644
14,644
—
Bank CDs
6,126
—
26
—
6,152
—
6,152
Total cash and cash equivalents and marketable securities
$
222,790
$
(5,285
)
$
30,262
$
(5
)
$
247,762
$
124,598
$
123,164
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
* Beginning January 1, 2018, under the requirements of ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities , the unrealized gain (loss) on our CASI equity securities are recognized as an increase (decrease) to “other income (expense), net” on the Condensed Consolidated Statements of Operations (rather than through “other comprehensive loss”) on the Condensed Consolidated Statements of Comprehensive Loss). Our adoption of ASU 2016-01 on January 1, 2018 resulted in a $17.2 million cumulative-effect adjustment, net of income tax, reported as a decrease to “accumulated other comprehensive loss” and a decrease to “accumulated deficit” on the accompanying Condensed Consolidated Balance Sheets. Our unrealized gains (losses) on these equity securities for the three and nine months ended September 30, 2019 was $2.0 million and ($9.7) million , respectively, as reported in “other income (expense), net” on the accompanying Condensed Consolidated Statements of Operations.
** Beginning in the second quarter of 2019, we purchased certain government and corporate debt securities. We have classified these as “available-for-sale” since we may redeem or sell these investments before their stated maturity to fund our operations. Under the requirements of ASC 320, Investments - Debt and Equity Securities: (i) we recorded these securities at initial “book value” and then amortize, through maturity, the determined “discount” or “premium” within “interest income” on the accompanying Condensed Consolidated Statements of Operations, and (ii) we recognize the “unrealized gains (loss)” of these securities (i.e., fair value versus amortized book value) as a separate component of “other comprehensive loss” on the accompanying Condensed Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2019 .
(b) Property and Equipment, net of Accumulated Depreciation
“Property and equipment, net of accumulated depreciation” consists of the following:
September 30, 2019
December 31, 2018
Manufacturing equipment*
$
7,601
$
—
Computer hardware and software
3,589
3,079
Laboratory equipment
669
635
Leasehold improvements
3,389
2,957
Office furniture
335
212
Property and equipment, at cost
15,583
6,883
(Less): Accumulated depreciation
(6,618
)
(6,498
)
Property and equipment, net of accumulated depreciation
$
8,965
$
385
* This represents owned ROLONTIS production equipment on location at our contract manufacturer.
Depreciation expense (included within “total operating costs and expenses” in the accompanying Condensed Consolidated Statements of Operations) for the three and nine months ended September 30, 2019 and 2018 was $0.1 million , $0.1 million , $0.2 million , and $0.2 million , respectively.
(c) Prepaid Expenses and Other Assets
“Prepaid expenses and other assets” consists of the following:
September 30, 2019
December 31, 2018
Vendor deposits
$
12,628
$
6,792
Prepaid insurance
52
782
Prepaid expenses and other assets
$
12,680
$
7,574
(d) Other Receivables
“Other receivables” consists of the following:
September 30, 2019
December 31, 2018
Insurance receivable*
$
4,781
$
206
Other miscellaneous receivables (including Medicaid rebate credits and royalty receivables from licensees)
1,549
1,189
Secured promissory note (see Note 7 )
—
1,525
Income tax receivable - current portion
632
643
Interest receivable from marketable securities (see Note 3(a) )
627
—
Reimbursements due from development partners for incurred research and development expenses
163
135
Other receivables
$
7,752
$
3,698
* This insurance receivable balance represents our incurred legal fees and pending and completed settlements that are expected to be reimbursed by our insurance carriers.
(e) Other Assets
“Other assets” consists of the following:
September 30, 2019
December 31, 2018
Key employee life insurance – cash surrender value associated with deferred compensation plan ( Note 9(f) )
$
7,882
$
6,274
Income tax receivable - non-current portion*
668
668
Research & development supplies and other
63
246
Other assets
$
8,613
$
7,188
* This value represents the non-current portion of refundable alternative minimum tax payments made that are expected to be received over the next few years (see Note 10 ).
(f) Facility and Equipment Under Lease
“Facility and equipment under lease” consists of the following :
September 30, 2019
December 31, 2018
Office and research facilities
$
3,092
$
—
Office equipment
439
—
Facility and equipment under lease ( Note 9(a) )
$
3,531
$
—
(g) Accounts Payable and Other Accrued Liabilities
“Accounts payable and other accrued liabilities” consists of the following :
September 30, 2019
December 31, 2018
Trade accounts payable and other
$
30,321
$
44,919
Lease liability - current portion ( Note 9(a) )
326
—
Accrued commercial/Medicaid rebates
3,058
8,371
Accrued product royalty due to licensors
58
4,337
Allowance for product returns
4,985
5,171
Accrued data and distribution fees
832
3,248
Accrued GPO administrative fees
11
296
Accrued inventory management fees
368
388
Allowance for government chargebacks
—
2,730
Accounts payable and other accrued liabilities
$
39,959
$
69,460
Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates (see Note 2(i) ) were as follows:
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
167
(Less): Payments made and credits against GTN accruals
(15,295
)
(3,918
)
(353
)
Balance as of September 30, 2019
$
3,058
$
1,211
$
4,985
(h) Contract Liabilities
“Contract liabilities” consists of the following:
September 30, 2019
December 31, 2018
Customer deposit for EVOMELA supply in China territory ( see Note 7 )
$
1,360
$
4,850
Contract liabilities
$
1,360
$
4,850
(i) Other Long-Term Liabilities
“Other long-term liabilities” consists of the following:
September 30, 2019
December 31, 2018
Deferred compensation liability ( Note 9(f) )
$
7,708
$
5,474
Lease liability - non-current portion ( Note 9(a) )
3,429
—
Other tax liabilities
176
176
Other long-term liabilities
$
11,313
$
5,650
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Casi Holdings and Evomela Supply Contract
9 Months Ended
Sep. 30, 2019
Other Commitments [Abstract]
Casi Holdings and Evomela Supply Contract
CASI HOLDINGS AND EVOMELA SUPPLY CONTRACTOverview of CASI Transaction
In 2014, we executed three perpetual out-license agreements for our former products ZEVALIN, MARQIBO, and EVOMELA (“CASI Out-Licensed Products”) with CASI, a publicly-traded biopharmaceutical company (NASDAQ: CASI) with a primary focus on the China market (collectively, the “CASI Out-License”). Under the CASI Out-License, we received CASI common stock and a secured promissory note and CASI gained the exclusive rights to distribute the CASI Out-Licensed Products in greater China (which includes Taiwan, Hong Kong, and Macau).
On March 1, 2019, we completed the Commercial Product Portfolio Transaction (see Note 1(b) ) and substantially all of the contractual rights and obligations associated with these products, including the CASI Out-License, were transferred to Acrotech at closing. However, on an interim basis we retained our original supply agreement with CASI for EVOMELA. Corresponding revenue for shipped product has been recognized within discontinued operations “product sales, net” (see Note 11 ). With our fulfillment of this order in October 2019, we will not have any further involvement with this arrangement.
Our Ownership in CASI at September 30, 2019
Under certain conditions that expired in December 2017, we exercised our rights during 2016 and 2017 to purchase additional shares of CASI common stock at par value in order to maintain our post-investment ownership percentage. Our aggregate holding of 10.0 million CASI common shares as of September 30, 2019 represented an approximate 10.4% ownership with a fair market value of $33.6 million (see Note 3(a) ) . In April 2019, we completed the sale of 1.5 million shares and recognized a $2.7 million gain within “other income (expense), net” within the accompanying Condensed Consolidated Statements of Operations for the nine months ended September 30, 2019 .
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Discontinued Operations
9 Months Ended
Sep. 30, 2019
Discontinued Operations and Disposal Groups [Abstract]
Discontinued Operations
DISCONTINUED OPERATIONSOverview
On March 1, 2019, we completed the Commercial Product Portfolio Transaction -- see Note 1(b) (as we first announced on January 17, 2019 on Form 8-K, upon the signing of a definitive asset purchase agreement).
In accordance with applicable GAAP ( ASC 205-20, Presentation of Financial Statements ), the revenue-deriving activities and allocable expenses of our sold commercial operation, as well as the assets and liabilities connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet.
Condensed Consolidated Statement of Operations
The following table presents the various elements of “income from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statement of Operations:
Three Months Ended September 30,
Nine Months Ended September 30,
2019
2018
2019
2018
Product sales, net*
$
5,968
$
24,556
$
18,906
$
76,419
License fees and service revenue
—
712
290
3,511
Total revenues
$
5,968
$
25,268
$
19,196
$
79,930
Operating costs and expenses:
Cost of sales (excluding amortization of intangible assets)
5,115
6,472
8,716
19,892
Selling, general and administrative
69
6,730
5,959
21,279
Research and development
(194
)
5,745
2,597
15,167
Amortization of intangible assets
—
6,923
1,248
20,803
Restructuring charges - employee severance ( Note 12 )
—
—
3,858
—
Total operating costs and expenses
$
4,990
$
25,870
$
22,378
$
77,141
Income (loss) from discontinued operations
$
978
$
(602
)
$
(3,182
)
$
2,789
Other (expense) income:
Change in fair value of contingent consideration
—
1,200
(1,478
)
717
Gain on sale of Commercial Product Portfolio**
(193
)
—
33,451
—
Total other (expense) income
$
(193
)
$
1,200
$
31,973
$
717
Income from discontinued operations before income taxes
785
598
28,791
3,506
Provision for income taxes from discontinued operations***
(213
)
(144
)
(7,166
)
(847
)
Income from discontinued operations, net of income taxes
$
572
$
454
$
21,625
$
2,659
* This revenue for the three and nine months ended September 30, 2019 includes: (i) sales from our Commercial Product Portfolio in January and February 2019 (prior to the completion of the Commercial Product Portfolio Transaction) and (ii) EVOMELA sales to a licensee during the second and third quarters of 2019 since a related supply contract was not assumed by Acrotech at the time of sale (see Note 7 ).
** This pre-tax gain on sale represents the $158.8 million gross proceeds from the Commercial Product Portfolio Transaction less our $121.2 book value of transferred net assets (inclusive of assumed liabilities) to Acrotech on the March 1, 2019 closing date less legal and banker fees aggregating $3.9 million . In the third quarter of 2019, we reduced this gain for a $0.2 million contract cancellation fee associated with our sold commercial operations; this value was deducted from the $4.0 million escrow account (reported as “restricted cash” on the accompanying Condensed Consolidated Balance Sheets until its release on November 5, 2019).
*** This income tax provision represents an allocation of taxes as required under intraperiod allocation guidance (see Note 10 ). Due to our aggregate net operating loss-carryforwards, no federal or state income tax payments are expected to be made relating to our current year activity, inclusive of our recognized gain on sale of the Commercial Product Portfolio.
Condensed Consolidated Balance Sheets
Accounts receivable derived from our product sales on and prior to February 28, 2019 were not transferred to Acrotech as part of Commercial Product Portfolio Transaction, nor were our GTN liabilities and trade accounts payable assumed by Acrotech that were associated with our commercial activities on and prior to February 28, 2019 (see Note 3(g) ). Accordingly, these specific assets and liabilities remain presented within “accounts receivable, net of allowance for doubtful accounts” and “accounts payable and other accrued liabilities” on the accompanying Condensed Consolidated Balance Sheets.
The following table presents a summary of our “discontinued operations, assets” and “discontinued operations, liabilities” as of December 31, 2018 within the accompanying Condensed Consolidated Balance Sheets (representing those assets and
liabilities transferred to Acrotech as part of the Commercial Product Portfolio Transaction):
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
Condensed Consolidated Statement of Cash Flows
The following table presents significant non-cash items for our discontinued operations that are included as adjustments in the accompanying Condensed Consolidated Statements of Cash Flows:
Nine Months Ended September 30,
2019
2018
Depreciation and amortization
$
1,263
$
20,871
Stock-based compensation
$
3,404
$
4,626
Change in fair value of contingent consideration
$
1,478
$
(655
)
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