Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2019 | Jul. 31, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2019 | |
Document Transition Report | false | |
Entity File Number | 001-35006 | |
Entity Registrant Name | SPECTRUM PHARMACEUTICALS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 93-0979187 | |
Entity Address, Address Line One | 11500 South Eastern Avenue | |
Entity Address, Address Line Two | Suite 240 | |
Entity Address, City or Town | Henderson | |
Entity Address, State or Province | NV | |
Entity Address, Postal Zip Code | 89052 | |
City Area Code | 702 | |
Local Phone Number | 835-6300 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SPPI | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 112,855,657 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0000831547 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 118,251 | $ 157,480 |
Restricted cash | 4,020 | 0 |
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) | 0 | 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 | 0 |
Discontinued operations, non-current assets (Note 11) | 0 | 132,625 |
Total assets | 322,668 | 390,886 |
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) | 0 | 2,311 |
Total current liabilities | 56,962 | 86,474 |
Deferred tax liabilities | 0 | 1,469 |
Other long-term liabilities | 10,923 | 5,650 |
Discontinued operations, non-current liabilities (Note 11) | 0 | 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 | 0 | 0 |
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 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Jun. 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement [Abstract] | ||||
Revenues (Note 1(b)) | $ 0 | $ 0 | $ 0 | $ 0 |
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 ($ per share) | $ (0.26) | $ 0.15 | $ (0.63) | $ (0.04) |
Income (loss) per common share from discontinued operations ($ per share) | 0 | (0.01) | 0.19 | 0.02 |
Net (loss) income per common share ($ per share) | (0.26) | 0.13 | (0.43) | (0.02) |
Diluted (loss) income per share: | ||||
(Loss) income per common share from continuing operations ($ per share) | (0.26) | 0.14 | (0.63) | (0.04) |
Income (loss) per common share from discontinued operations ($ per share) | 0 | (0.01) | 0.19 | 0.02 |
Net (loss) income per common share ($ per share) | $ (0.26) | $ 0.13 | $ (0.43) | $ (0.02) |
Weighted average shares outstanding: | ||||
Basic (shares) | 110,345,135 | 102,597,059 | 109,744,405 | 101,747,416 |
Diluted (shares) | 110,345,135 | 112,617,150 | 109,744,405 | 101,747,416 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive (Loss) Income - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
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 | 0 | 100 | 0 |
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) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Comprehensive (Loss) Income (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Statement of Comprehensive Income [Abstract] | ||||
Unrealized loss on available-for-sale securities, tax | $ 33 | $ 0 | $ 33 | $ 0 |
Consolidated Statements of Stoc
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, net | 393 | 393 | |||
Employee stock-based compensation expense | 4,144 | 4,144 | |||
Issuance of common stock to 401(k) plan for employee match (shares) | 16,834 | ||||
Issuance of common stock to 401(k) plan for employee match | 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 | ||
RSA grants, net of forfeitures (shares) | 614,035 | ||||
RSA 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 | (2,074) | ||||
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) |
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 | ||||
Other comprehensive income, 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 (shares) | 14,736 | ||||
Issuance of common stock to 401(k) plan for employee match | 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 | $ 0 | 2,884 | ||
RSA grants, net of forfeitures (shares) | 176,954 | ||||
RSA 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) |
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, net | (390) | (390) | |||
Employee stock-based compensation expense | 7,481 | 7,481 | |||
Issuance of common stock to 401(k) plan for employee match (shares) | 47,347 | ||||
Issuance of common stock to 401(k) plan for employee match | 519 | 519 | |||
Issuance of common stock upon exercise of stock options (shares) | 146,785 | ||||
Issuance of common stock upon exercise of stock options | 831 | $ 0 | 831 | ||
RSA grants, net of forfeitures (shares) | 259,539 | ||||
RSA 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 | (47,550) | ||||
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) |
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, net | 328 | 328 | |||
Employee stock-based compensation expense | 4,814 | 4,814 | |||
Issuance of common stock to 401(k) plan for employee match (shares) | 24,382 | ||||
Issuance of common stock to 401(k) plan for employee match | 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 | ||
RSA grants, net of forfeitures (shares) | 651,072 | ||||
RSA 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 | 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) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 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) income | (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 | 0 |
Non-cash lease expense (Note 9(a)) | 874 | 0 |
Unrealized gain on available-for-sale securities (Note 3(a)) | 133 | 0 |
Amortization of discount on available-for-sale securities (Note 3(a)) | (331) | 0 |
Income tax recognition on unrealized gain on available-for-sale securities | (33) | 0 |
Realized gain on sale of CASI stock (Note 7) | (2,674) | 0 |
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 | 0 | 1,079 |
Amortization of deferred financing costs on 2018 Convertible Notes, recorded to interest expense | 0 | 124 |
Change in cash surrender value of corporate-owned life insurance policy | 0 | (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 | 0 |
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 | 0 |
Proceeds from sale of CASI stock (Note 7) | 5,074 | 0 |
Purchase of available-for-sale securities (Note 3(a)) | (127,564) | 0 |
Purchases of property and equipment (Note 3(b)) | (1,241) | (46) |
Proceeds from redemption of corporate-owned life insurance policy | 0 | 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 Issuance of Common Stock | 1,814 | 0 |
Proceeds, Issuance of Shares, Share-based Payment Arrangement, Excluding Option Exercised | 444 | 734 |
Proceeds from employees, for our remittance to tax authorities, upon vesting of restricted stock and exercises of stock options | 0 | 4,645 |
Payments to tax authorities upon employees' surrender of restricted stock at vesting and exercises of stock options | 0 | (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 | 0 |
Cash paid for income taxes | 33 | 27 |
Cash paid for interest | 0 | 558 |
Noncash investing activities: | ||
Additions of property and equipment that remain in accounts payable (Note 3(b)) | $ 3,209 | $ 0 |
Description of Business, Basis
Description of Business, Basis of Presentation, and Operating Segment | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business, Basis of Presentation, and Operating Segment | DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT (a) Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of clinical and commercial products. We have a full in-house development organization including clinical development, regulatory, quality and data management capabilities, as well as commercial and marketing capabilities upon product launch. We have two drugs in late-stage development: • 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. We have a technology platform that enables the fusion of an interferon-alpha with a monoclonal anti-body: • 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). Our business strategy is to develop our late stage assets through commercialization, while sourcing additional assets that are synergistic with our existing portfolio through acquisitions, in-licensing, or co-development and marketing arrangements. (b) Basis of Presentation Interim Financial Statements The interim financial data for the three and six months ended June 30, 2019 and 2018 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three and six months ended June 30, 2019 and 2018 . Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (filed with the SEC on February 28, 2019 ). Discontinued Operations - Sale of our Commercial Product Portfolio On March 1, 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing we received $158.8 million in an upfront cash payment (of which $4 million is held in escrow). We are also entitled to receive up to an aggregate of $140 million upon Acrotech's achievement of certain regulatory (totaling $40 million ) and sales-based milestones (totaling $100 million ) relating to the Commercial Product Portfolio. These Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with our Commercial Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations” - see Note 11 . We have presented our face financial statements in general conformity with our historical format, even where presented values are $-0- within continuing operations due to required discontinued operations classification for all periods presented. We believe this format provides increased clarity and comparability with our previously filed financial statements, as well as our expectation that these financial statement captions and associated footnote disclosures will remain relevant to our future business activities. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. In May 2019, we dissolved Spectrum Pharma Canada, previously consolidated as a “variable interest entity” (as defined under applicable GAAP). (c) Operating Segment We operate one reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the three and six months ended June 30, 2019 and 2018 , all of our revenue and operating costs and expenses were solely attributable to these activities (and as applicable, currently and retrospectively classified as “discontinued” within the accompanying Condensed Consolidated Balance Sheet and Condensed Consolidated Statement of Operations - see Note 11 ). All of our assets are held in the U.S, except for cash held in certain foreign bank accounts. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates its most critical estimates and assumptions, including those related to: (i) gross-to-net revenue adjustments; (ii) the timing of revenue recognition; (iii) the collectability of customer accounts; (iv) whether the cost of our inventories can be recovered; (v) the realization of our tax assets and estimates of our tax liabilities; (vi) the fair value of our investments; (vii) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (viii) the potential outcome of our ongoing or threatened litigation. Our accounting policies and estimates that most significantly impact the presented amounts within these Condensed Consolidated Financial Statements are further described below: (i) Revenue Recognition Impact of the Adoption of the New Revenue Recognition Standard : ASU No. 2014-09 , Revenue from Contracts with Customers ( “Topic 606” ), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of Topic 606; this resulted in the recognition of an aggregate $4.7 million , net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under Topic 605, Revenue Recognition (“Topic 605”) . Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Topic 606 in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (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. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities within Note 3(g) ) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after its expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to its expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization (“GPO”), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • 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. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. (ii) Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. Our restricted cash is currently held in an escrow account as part of our completed Commercial Product Portfolio Transaction (see Note 1(b) ). (iii) Marketable Securities Our marketable securities consist of our holdings in equity securities, mutual funds, bank certificates of deposit (“Bank CDs”), government-related debt securities, and corporate debt securities. Since we classify these investments as “available-for-sale” any (1) realized gains (losses) or (2) unrealized gains (losses) on these securities are respectively recognized in (1) “other income (expense), net” on the accompanying Condensed Consolidated Statements of Operations, or recognized in (2) “accumulated other comprehensive loss as a separate component of stockholder’s equity on the accompanying Condensed Consolidated Statements of Stockholders’ Equity. (iv) Accounts Receivable Our accounts receivable are derived from our product sales and license fees, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. (v) Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are exclusively recognized through “research and development” expense on the accompanying Condensed Consolidated Statements of Operations. (vi) Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. (vii) Basic and Diluted Net (Loss) Income per Share We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. (viii) Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit (provision) for income taxes from continuing operations” within the accompanying Condensed Consolidated Statements of Operations for the period in which we received the notice. (ix) Research and Development Costs Our research and development costs are expensed as incurred (see Note 9(c) ), or as certain milestone payments become contractually due to our licensors, as triggered by the achievement of clinical or regulatory events. (x) Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: |
Balance Sheet Account Detail
Balance Sheet Account Detail | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The 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 June 30, 2019 and December 31, 2018 , our “cash and cash equivalents” were held with major financial institutions. As of June 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 in excess of federally insured limits with select financial institutions. To a limited degree, the Federal Deposit Insurance Corporation and other third parties insure these deposits. However, these cash deposits are not insured against the possibility of a 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 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 June 30, 2019 , no ne of the securities that we hold were in an unrealized loss position with respect to our cost basis. The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Foreign Currency Translation Cash and Cash 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 * 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 income (loss)” on the Condensed Consolidated Statements of Comprehensive (Loss) Income). 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 gain (loss) on these equity securities for the three and six months ended June 30, 2019 was $0.4 million and $(11.8) 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 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 record 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” of these securities (i.e., June 30, 2019 fair value versus amortized book value) as a separate component of “accumulated other comprehensive income (loss)” on the accompanying Condensed Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended June 30, 2019 . (b) Property and Equipment, net of Accumulated Depreciation “Property and equipment, net of accumulated depreciation” consists of the following: 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 *This new account was created for our current period and future equipment purchases for ROLONTIS production through our contract manufacturer. Depreciation expense (included within “total operating costs and expenses” in the accompanying Condensed Consolidated Statements of Operations) for the three and six months ended June 30, 2019 and 2018 , was $0.1 million , $0.1 million , $0.1 million and $0.1 million respectively. (c) Prepaid Expenses and Other Assets “Prepaid expenses and other assets” consists of the following: June 30, 2019 December 31, 2018 Deposits $ 10,549 $ 6,792 Prepaid insurance 290 782 Prepaid expenses and other assets $ 10,839 $ 7,574 (d) Other Receivables “Other receivables” consists of the following: 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 *This insurance receivable balance represents legal fees and pending settlement offers that are expected to be reimbursed by our insurance carriers. (e) Other Assets “Other assets” consists of the following: 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 * This value represents the non-current portion of the refundable alternative minimum tax credit that is 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 : 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 $ — (g) Accounts Payable and Other Accrued Liabilities “Accounts payable and other accrued liabilities” consists of the following : 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 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 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 (h) Contract Liabilities “Contract liabilities” consists of the following: 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 (i) Other Long-Term Liabilities “Other long-term liabilities” consists of the following: 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 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION We 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 six months ended June 30, 2019 and 2018 , was as follows: Three Months Ended Six Months Ended 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 |
Net (Loss) Income Per Share
Net (Loss) Income Per Share | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Net (Loss) Income Per Share | NET (LOSS) INCOME PER SHARE Net (loss) income per share was computed by dividing net (loss) income by the weighted average number of common shares outstanding for the three and six months ended June 30, 2019 and 2018 : Three Months Ended Six Months Ended 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 ) The below outstanding securities for the three and six months ended June 30, 2019 , and the six months ended June 30, 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 Six Months Ended 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 |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories (see Note 2(x)) : June 30, 2019 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 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 * The reported amount of “deferred compensation investments” is based on the cash surrender value of life insurance policies of named current and former employees at each period-end. The reported amount of “deferred executive compensation liability” is based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. We did not have any transfers between “Level 1” and “Level 2” (see Note 2(x) ) measurement categories for any periods presented except for “money market funds” included within Level 1 as of June 30, 2019 that remain presented within Level 2 as of December 31, 2018. We believe this change is appropriate since these money market funds have quoted daily prices in active markets that are publicly accessible. |
Casi Holdings and Evomela Suppl
Casi Holdings and Evomela Supply Contract | 6 Months Ended |
Jun. 30, 2019 | |
Other Commitments [Abstract] | |
Casi Holdings and Evomela Supply Contract | CASI HOLDINGS AND EVOMELA SUPPLY CONTRACT Overview 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, we will tentatively supply CASI with EVOMELA under an active contract not yet assumed by Acrotech (see Note 3(h) ). After we fulfill this open order, Acrotech will assume all future supply of this product to CASI and we will not have any further involvement with this arrangement. Our Ownership in CASI at June 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 June 30, 2019 represented an approximate 10.5% ownership with a fair market value of $32.2 million (see Note 3(a) ) . In April 2019, we completed the sale of 1.5 million of these shares under a forward-sales contract and recognized a $2.7 million gain within “other income (expense), net” within the accompanying Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2019 . |
Convertible Senior Notes and In
Convertible Senior Notes and Interest Expense | 6 Months Ended |
Jun. 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 of principal. 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 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 % |
Financial Commitments & Conting
Financial Commitments & Contingencies and Key License Agreements | 6 Months Ended |
Jun. 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 . None include any residual value guarantees, restrictive covenants, term extension, 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 six months ended June 30, 2019 and 2018 , we had no sublease arrangements. 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 Statement of Operations. For the three and six months ended June 30, 2019 and 2018 , this expense aggregated $0.6 million , $0.4 million , $1.1 million and $0.9 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 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 * As of June 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 Statement of Operations. The components of our aggregate lease expense is summarized below: 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 and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of June 30, 2019 3 years 7.8 % Future Contractual Lease Payments as of June 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 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 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 from 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 Product Portfolio that were previously disclosed in Note 17(b) to our 2018 Annual Report on Form 10-K were transferred to Acrotech at closing. 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 for $10 million and sales milestones of up to $120 million per calendar year. 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 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 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 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, 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 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 three and six months ended June 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 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 entered into various agreements and/or have issued purchase orders to vendors which obligate us to agreed-upon raw material purchases from certain vendors and purchase drug production services through designated contract manufacturers. These commitments do not exceed our planned commercial requirements and the contracted prices for these goods and services do not exceed 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 June 30, 2019 and December 31, 2018 , the aggregate value of this DC Plan liability was $7.4 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 June 30, 2019 Condensed Consolidated Balance Sheet. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods, as required under GAAP. We recorded a benefit for income taxes from continuing operations of $8.5 million and $0.7 million for the six months ended June 30, 2019 and 2018, respectively. Our ETR differs from the U.S. federal statutory tax rate of 21% primarily as a result of nondeductible expenses and the impact of the valuation allowance on our deferred tax assets. Our provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for the expected future tax benefit to be derived from tax loss and credit carryforwards. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction by jurisdiction basis, and includes a review of all available positive and negative evidence. We recognize the impact of a tax position in our financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense. The intraperiod tax allocation guidance requires that we allocate income taxes between continuing operations and other categories of earnings. When we have a year-to-date pre-tax loss from continuing operations and year-to-date pre-tax income in discontinued operations, applicable GAAP ( ASC 740-20-45-7 ) requires that we allocate the income tax provision to other categories of earnings (including discontinued operations), and then record a related tax benefit in continuing operations. For the six months ended June 30, 2019 and 2018 , we recognized net income from discontinued operations while sustaining losses from continuing operations. Because of the required allocation, we recorded an income tax benefit for the six months ended June 30, 2019 and 2018 of $8.5 and $0.7 million , respectively, within “benefit (provision) for income taxes from continuing operations” and income tax expense of $7.0 million and $0.7 million , respectively, within “income (loss) from discontinued operations, net of income taxes” on the accompanying Condensed Consolidated Statements of Operations. For the three months ended June 30, 2019 and 2018 , we recorded an income tax benefit of $0.2 million and income tax expense of $0.4 million , respectively, within “benefit (provision) for income taxes from continuing operations,” and income tax expense of $0.2 million and income tax benefit of $0.4 million , respectively, within “income (loss) from discontinued operations, net of income taxes” on the accompanying Condensed Consolidated Statements of Operations. Our net tax benefit for the three and six months ended June 30, 2019 , prior to the application of intraperiod tax allocation guidance was $0 and $1.5 million , respectively. The $1.5 million tax benefit arose from the reversal of deferred tax liabilities recorded on our Consolidated Balance Sheets as of December 31, 2018 that were associated with indefinite-lived intangible assets that were sold as part of our Commercial Product Portfolio Transaction. The tax expense for the three and six months ended June 30, 2018 , prior to the application of intraperiod tax allocation guidance was $3 thousand and $6 thousand , respectively. |
Discontinued Operations
Discontinued Operations | 6 Months Ended |
Jun. 30, 2019 | |
Discontinued Operations and Disposal Groups [Abstract] | |
Discontinued Operations | DISCONTINUED OPERATIONS Overview 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 Six Months Ended 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 *This pre-tax gain on sale represents the $158.8 million 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 for the six months ended June 30, 2019 aggregating $3.9 million . **This income tax provision (benefit) 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. ***The “Product sales, net” is inclusive of our commercial product sales for January and February 2019, as well as recognized EVOMELA product sales during the second quarter of 2019 to a single customer under an active contract not yet assumed by Acrotech (see Note 7 ). The negative revenue value for the second quarter of 2019 reflects actual government chargeback claims we received during the three months ended June 30, 2019 that were in excess of our estimated allowance for government chargebacks (see Note 3(g) ). ****The “Restructuring - employee severance” negative value in the second quarter of 2019 reflects a current period reclassification to continuing operations “selling, general and administrative” and “research and development” expenses within the accompanying Statements of Operations. This $2.4 million amount was previously included within “income (loss) from discontinued operations, net of income taxes” in the first quarter of 2019. 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: Six Months Ended 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 |
Restructuring Costs Related To
Restructuring Costs Related To Sale Of Commercial Product Portfolio | 6 Months Ended |
Jun. 30, 2019 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs Related To Sale Of Commercial Product Portfolio | RESTRUCTURING COSTS RELATED TO SALE OF COMMERCIAL PRODUCT PORTFOLIO Employee 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 six months ended June 30, 2019 , we recognized $0.5 million 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 six months ended June 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 six months ended June 30, 2019 , we recognized $0.3 million 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. Unpaid cash severance for our former employees was $0.4 million at June 30, 2019 , and is recorded within “accrued payroll and benefits” on the accompanying Condensed Consolidated Balance Sheets. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY Sale 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. During the three months ended June 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 three months ended June 30, 2019 221,529 $ 1,814 |
Description of Business, Basi_2
Description of Business, Basis of Presentation, and Operating Segment (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Accounting Policies [Abstract] | |
Description of Business | Description of Business Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of clinical and commercial products. We have a full in-house development organization including clinical development, regulatory, quality and data management capabilities, as well as commercial and marketing capabilities upon product launch. We have two drugs in late-stage development: • 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. |
Basis of Presentation | Basis of Presentation Interim Financial Statements The interim financial data for the three and six months ended June 30, 2019 and 2018 is unaudited and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the three and six months ended June 30, 2019 and 2018 . Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (filed with the SEC on February 28, 2019 ). Discontinued Operations - Sale of our Commercial Product Portfolio On March 1, 2019, we completed the sale of our seven then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN , MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing we received $158.8 million in an upfront cash payment (of which $4 million is held in escrow). We are also entitled to receive up to an aggregate of $140 million upon Acrotech's achievement of certain regulatory (totaling $40 million ) and sales-based milestones (totaling $100 million ) relating to the Commercial Product Portfolio. These Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with our Commercial Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations” - see Note 11 . We have presented our face financial statements in general conformity with our historical format, even where presented values are $-0- within continuing operations due to required discontinued operations classification for all periods presented. We believe this format provides increased clarity and comparability with our previously filed financial statements, as well as our expectation that these financial statement captions and associated footnote disclosures will remain relevant to our future business activities. Principles of Consolidation The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation. In May 2019, we dissolved Spectrum Pharma Canada, previously consolidated as a “variable interest entity” (as defined under applicable GAAP). |
Operating Segment | Operating Segment We operate one reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the three and six months ended June 30, 2019 and 2018 , all of our revenue and operating costs and expenses were solely attributable to these activities (and as applicable, currently and retrospectively classified as “discontinued” within the accompanying Condensed Consolidated Balance Sheet and Condensed Consolidated Statement of Operations - see Note 11 ). All of our assets are held in the U.S, except for cash held in certain foreign bank accounts. |
Revenue Recognition | Revenue Recognition Impact of the Adoption of the New Revenue Recognition Standard : ASU No. 2014-09 , Revenue from Contracts with Customers ( “Topic 606” ), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of Topic 606; this resulted in the recognition of an aggregate $4.7 million , net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under Topic 605, Revenue Recognition (“Topic 605”) . Required Elements of Our Revenue Recognition : Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under Topic 606 in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements: (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. These five elements, as applied to each of our revenue categories, are summarized below: (a) Product Sales : We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers). Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration. Our gross product sales (i.e., delivered units multiplied by the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales. These GTN estimate categories (that comprise our GTN liabilities within Note 3(g) ) are each discussed below: Product Returns Allowances : Our customers are contractually permitted to return certain purchased products within the contractual allowable time before/after its expiration date. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns using our historical return rates. Returned product is typically destroyed since substantially all are due to its expiry and cannot be resold. Government Chargebacks : Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers. Prompt Pay Discounts : Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage. Commercial Rebates : Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization (“GPO”), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us. Medicaid Rebates : Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment. Distribution, Data, and GPO Administrative Fees : Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products for various commercial services including: contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales. (b) License Fees : Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows: (1) Upfront License Fees: We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer). (2) Royalties : Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt. (3) Sales Milestones : Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt. (4) Regulatory Milestones : Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee. • 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. (c) Service Revenue : We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services. Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events. We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of three months or less from the purchase date. Our restricted cash is currently held in an escrow account as part of our completed Commercial Product Portfolio Transaction (see Note 1(b) ). |
Marketable Securities | Marketable Securities Our marketable securities consist of our holdings in equity securities, mutual funds, bank certificates of deposit (“Bank CDs”), government-related debt securities, and corporate debt securities. Since we classify these investments as “available-for-sale” any (1) realized gains (losses) or (2) unrealized gains (losses) on these securities are respectively recognized in (1) “other income (expense), net” on the accompanying Condensed Consolidated Statements of Operations, or recognized in (2) “accumulated other comprehensive loss as a separate component of stockholder’s equity on the accompanying Condensed Consolidated Statements of Stockholders’ Equity. |
Accounts Receivable | Accounts Receivable Our accounts receivable are derived from our product sales and license fees, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted. |
Inventories | Inventories We value our inventory at the lower of (i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates of each product lot. Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are exclusively recognized through “research and development” expense on the accompanying Condensed Consolidated Statements of Operations. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting. The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term. With regard to (a)-(d) above: we estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option. |
Basic and Diluted Net (Loss) Income per Share | Basic and Diluted Net (Loss) Income per Share We calculate basic and diluted net (loss) income per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain. We have recorded a valuation allowance to reduce our deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made. In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit (provision) for income taxes from continuing operations” within the accompanying Condensed Consolidated Statements of Operations for the period in which we received the notice. |
Research and Development Costs | Research and Development Costs Our research and development costs are expensed as incurred (see Note 9(c) ), or as certain milestone payments become contractually due to our licensors, as triggered by the achievement of clinical or regulatory events. |
Fair Value Measurements | Fair Value Measurements We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following: Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. Level 3: Unobservable inputs are used when little or no market data is available. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, Cash Equivalents and Investments | The following is a summary of our presented composition of “cash and cash equivalents” and “marketable securities”: Historical or Amortized Cost Foreign Currency Translation Cash and Cash 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 * 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 income (loss)” on the Condensed Consolidated Statements of Comprehensive (Loss) Income). 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 gain (loss) on these equity securities for the three and six months ended June 30, 2019 was $0.4 million and $(11.8) 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 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 record 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” of these securities (i.e., June 30, 2019 fair value versus amortized book value) as a separate component of “accumulated other comprehensive income (loss)” on the accompanying Condensed Consolidated Statements of Comprehensive (Loss) Income for the three and six months ended June 30, 2019 |
Schedule of Property and Equipment Net of Accumulated Depreciation | “Property and equipment, net of accumulated depreciation” consists of the following: 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 |
Prepaid Expenses and Other Assets | “Prepaid expenses and other assets” consists of the following: June 30, 2019 December 31, 2018 Deposits $ 10,549 $ 6,792 Prepaid insurance 290 782 Prepaid expenses and other assets $ 10,839 $ 7,574 |
Schedule of Other Receivables | “Other receivables” consists of the following: 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 *This insurance receivable balance represents legal fees and pending settlement offers that are expected to be reimbursed by our insurance carriers. |
Summary of Other Assets | “Other assets” consists of the following: 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 * This value represents the non-current portion of the refundable alternative minimum tax credit that is expected to be received over the next few years (see Note 10 ). |
Assets And Liabilities, Leases | “Facility and equipment under lease” consists of the following : 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 $ — 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 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 * As of June 30, 2019 , we have no “finance leases” as defined in Topic 842 . |
Schedule of Accounts Payable and Other Accrued Liabilities | “Accounts payable and other accrued liabilities” consists of the following : 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 |
Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities | 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 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 |
Deferred Revenue, by Arrangement, Disclosure | “Contract liabilities” consists of the following: 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 |
Summary of Other Long-Term Liabilities | “Other long-term liabilities” consists of the following: 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 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 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 six months ended June 30, 2019 and 2018 , was as follows: Three Months Ended Six Months Ended 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 |
Net (Loss) Income Per Share (Ta
Net (Loss) Income Per Share (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Earnings Per Share [Abstract] | |
Computation of Net Loss Per Share | Net (loss) income per share was computed by dividing net (loss) income by the weighted average number of common shares outstanding for the three and six months ended June 30, 2019 and 2018 : Three Months Ended Six Months Ended 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 ) |
Schedule of Securities Excluded from Calculation of Net Loss Per Share | The below outstanding securities for the three and six months ended June 30, 2019 , and the six months ended June 30, 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 Six Months Ended 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Fair Value Disclosures [Abstract] | |
Summary of Asset and Liability Fair Values | The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories (see Note 2(x)) : June 30, 2019 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 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 * The reported amount of “deferred compensation investments” is based on the cash surrender value of life insurance policies of named current and former employees at each period-end. The reported amount of “deferred executive compensation liability” is based on the period-end market value of mutual fund investments selected by employee participants of the deferred compensation plan. |
Convertible Senior Notes and _2
Convertible Senior Notes and Interest Expense (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Debt Disclosure [Abstract] | |
Components of the Interest Expense Recognized | 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 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 % |
Financial Commitments & Conti_2
Financial Commitments & Contingencies and Key License Agreements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Assets And Liabilities, Leases | “Facility and equipment under lease” consists of the following : 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 $ — 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 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 * As of June 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 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 and Applied Discount Rate Weighted Average Remaining Lease Term Weighted Average Discount Rate Operating leases as of June 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 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 |
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 |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 6 Months Ended |
Jun. 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 Six Months Ended 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 *This pre-tax gain on sale represents the $158.8 million 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 for the six months ended June 30, 2019 aggregating $3.9 million . **This income tax provision (benefit) 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. ***The “Product sales, net” is inclusive of our commercial product sales for January and February 2019, as well as recognized EVOMELA product sales during the second quarter of 2019 to a single customer under an active contract not yet assumed by Acrotech (see Note 7 ). The negative revenue value for the second quarter of 2019 reflects actual government chargeback claims we received during the three months ended June 30, 2019 that were in excess of our estimated allowance for government chargebacks (see Note 3(g) ). ****The “Restructuring - employee severance” negative value in the second quarter of 2019 reflects a current period reclassification to continuing operations “selling, general and administrative” and “research and development” expenses within the accompanying Statements of Operations. This $2.4 million amount was previously included within “income (loss) from discontinued operations, net of income taxes” in the first quarter of 2019. 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: Six Months Ended 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 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 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 three months ended June 30, 2019 221,529 $ 1,814 |
Description of Business, Basi_3
Description of Business, Basis of Presentation, and Operating Segment (Details) $ in Millions | Mar. 01, 2019USD ($)product | Jun. 30, 2019USD ($)productSegment |
Segment Reporting Information [Line Items] | ||
Number of late stage development products | product | 2 | |
Number of products | product | 7 | |
Potential payments based on achievement of sales milestones | $ 325 | |
Number of reportable operating segment | Segment | 1 | |
FUSILEV, FOLOTYN, ZEVALIN, MARQIBO, BELEODAQ, EVOMELA, and KHAPZORY [Member] | Acrotech Biopharma LLC [Member] | ||
Segment Reporting Information [Line Items] | ||
Disposal group, including discontinued operation, consideration | $ 158.8 | |
Escrow deposits related to property sales | 4 | |
Aggregate amount receivable based on achievement of milestones | 140 | |
Payments receivable based on achievement of regulatory milestones | 40 | |
Potential payments based on achievement of sales milestones | $ 100 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies and Use of Estimates (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 | Jan. 01, 2018 |
Accounting Policies [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ (647,436) | $ (599,886) | |
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | |||
Accounting Policies [Line Items] | |||
Increase (decrease) in retained earnings due to revenue recognition | $ 4,700 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Summary of Cash and Cash Equivalents and Marketable Securities (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Jan. 01, 2018 | |
Schedule of Investments [Line Items] | ||||
Cost of equity securities | $ 8,710 | $ 8,710 | ||
Foreign currency translation on equity securities | (4,678) | (2,168) | ||
Gross unrealized gain on equity securities | 28,121 | 39,880 | ||
Equity securities (Note 7) | 32,153 | 46,422 | ||
Cash, cash equivalents and short-term investments, amortized cost | 254,809 | 166,276 | ||
Cash and cash equivalents and short-term investments, accumulated unrealized gain | 28,254 | |||
Cash, cash equivalents, and short-term investments | 278,385 | 203,988 | ||
Equity securities, unrealized gain (loss) | 400 | $ (11,800) | ||
Accounting Standards Update 2016-01 [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cumulative effect of new accounting principle in period of adoption | $ 0 | |||
Retained Earnings [Member] | Accounting Standards Update 2016-01 [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cumulative effect of new accounting principle in period of adoption | 17,211 | |||
AOCI Attributable to Parent [Member] | Accounting Standards Update 2016-01 [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cumulative effect of new accounting principle in period of adoption | $ (17,211) | |||
Money market funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 72,384 | 142,745 | ||
Available-for-sale, debt securities, estimated fair value | 72,384 | 142,745 | ||
US Government Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 104,440 | |||
Debt securities, available for sale, unrealized gain | 95 | |||
Available-for-sale, debt securities, estimated fair value | 104,535 | |||
Corporate Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 39,818 | |||
Debt securities, available for sale, unrealized gain | 25 | |||
Available-for-sale, debt securities, estimated fair value | 39,843 | |||
Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 22,886 | 14,735 | ||
Debt securities, available for sale, unrealized gain | 0 | |||
Available-for-sale, debt securities, estimated fair value | 22,886 | 14,735 | ||
Bank CDs [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, amortized cost | 6,571 | 86 | ||
Debt securities, available for sale, unrealized gain | 13 | |||
Available-for-sale, debt securities, estimated fair value | 6,584 | 86 | ||
Cash and Cash Equivalents [Member] | ||||
Schedule of Investments [Line Items] | ||||
Cash, cash equivalents, and short-term investments | 118,251 | 157,480 | ||
Cash and Cash Equivalents [Member] | Money market funds [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 72,384 | 142,745 | ||
Cash and Cash Equivalents [Member] | US Government Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 7,497 | |||
Cash and Cash Equivalents [Member] | Corporate Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 15,484 | |||
Cash and Cash Equivalents [Member] | Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 22,886 | 14,735 | ||
Short-term Investments [Member] | ||||
Schedule of Investments [Line Items] | ||||
Equity securities (Note 7) | 32,153 | 46,422 | ||
Cash, cash equivalents, and short-term investments | 160,134 | 46,508 | ||
Short-term Investments [Member] | US Government Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 97,038 | |||
Short-term Investments [Member] | Corporate Debt Securities [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 24,359 | |||
Short-term Investments [Member] | Bank Deposits [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | 0 | |||
Short-term Investments [Member] | Bank CDs [Member] | ||||
Schedule of Investments [Line Items] | ||||
Available-for-sale, debt securities, estimated fair value | $ 6,584 | $ 86 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Schedule of Property and Equipment Net of Accumulated Depreciation (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
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 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 3,654 | 0 |
Computer hardware and software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 3,449 | 3,079 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 670 | 635 |
Office furniture [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 335 | 212 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 2,957 | $ 2,957 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Depreciation | $ 0.1 | $ 0.1 | $ 0.1 | $ 0.1 |
Balance Sheet Account Detail _4
Balance Sheet Account Detail - Prepaid Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deposits | $ 10,549 | $ 6,792 |
Prepaid insurance | 290 | 782 |
Prepaid expenses and other assets | $ 10,839 | $ 7,574 |
Balance Sheet Account Detail _5
Balance Sheet Account Detail - Schedule of Other Receivables (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
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 | 0 |
Reimbursements due from development partners for incurred research and development expenses | 55 | 135 |
Other receivables | $ 10,229 | $ 3,698 |
Balance Sheet Account Detail _6
Balance Sheet Account Detail - Summary of Other Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
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 |
Balance Sheet Account Detail _7
Balance Sheet Account Detail - Facility and Equipment Under Lease (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Lessee, Lease, Description [Line Items] | ||
Facility and equipment under lease (Note 9(a)) | $ 3,842 | $ 0 |
Building [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Facility and equipment under lease (Note 9(a)) | 3,379 | 0 |
Office Equipment [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Facility and equipment under lease (Note 9(a)) | $ 463 | $ 0 |
Balance Sheet Account Detail _8
Balance Sheet Account Detail - Schedule of Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 33,593 | $ 44,919 |
Lease liability - current portion (Note 9(a)) | 642 | 0 |
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 | 0 | 2,730 |
Accounts payable and other accrued liabilities | $ 44,455 | $ 69,460 |
Balance Sheet Account Detail _9
Balance Sheet Account Detail - Schedule of Amounts Presented in Accounts Payable and Other Accrued Liabilities (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 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 | (14,827) | (65,008) |
Ending balance | 3,526 | 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 | (3,979) | (15,757) |
Ending balance | 1,150 | 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 | 250 | 1,700 |
(Less): Payments made and credits against GTN accruals | (112) | (574) |
Ending balance | $ 5,309 | $ 5,171 |
Balance Sheet Account Detail_10
Balance Sheet Account Detail - Deferred Revenue (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Contract liabilities | $ 7,245 | $ 4,850 |
Balance Sheet Account Detail_11
Balance Sheet Account Detail - Summary of Other Long-Term Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Deferred compensation liability (Note 9(f)) | $ 7,318 | $ 5,474 |
Lease liability - non-current portion (Note 9(a)) | 3,429 | 0 |
Other tax liabilities | 176 | 176 |
Other long-term liabilities | $ 10,923 | $ 5,650 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation | $ 5,019 | $ 3,181 | $ 9,615 | $ 6,065 |
Selling, general and administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation | 3,675 | 2,531 | 7,326 | 4,784 |
Research and development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total share-based compensation | $ 1,344 | $ 650 | $ 2,289 | $ 1,281 |
Net (Loss) Income Per Share - C
Net (Loss) Income Per Share - Computation of Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Mar. 31, 2019 | Jun. 30, 2018 | Mar. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Basic weighted average shares outstanding (shares) | 110,345,135 | 102,597,059 | 109,744,405 | 101,747,416 | ||
Diluted average shares outstanding (in shares) | 110,345,135 | 112,617,151 | 109,744,405 | 101,747,416 | ||
Net (loss) income as reported | $ (28,395) | $ (19,155) | $ 13,744 | $ (15,816) | $ (47,550) | $ (2,074) |
Interest attributable to 2013 Convertible Notes | 0 | 886 | 0 | 0 | ||
Net (loss) income for diluted earnings per share | $ (28,395) | $ 14,630 | $ (47,550) | $ (2,074) | ||
Net (loss) income per share - basic ($ per share) | $ (0.26) | $ 0.13 | $ (0.43) | $ (0.02) | ||
Net (loss) income per share - diluted ($ per share) | $ (0.26) | $ 0.13 | $ (0.43) | $ (0.02) | ||
2013 Convertible Notes [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Diluted average shares outstanding (in shares) | 0 | 3,854,959 | 0 | 0 | ||
Common stock options [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Diluted average shares outstanding (in shares) | 0 | 3,870,462 | 0 | 0 | ||
Restricted stock awards [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Diluted average shares outstanding (in shares) | 0 | 1,797,089 | 0 | 0 | ||
Restricted stock units [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Diluted average shares outstanding (in shares) | 0 | 245,214 | 0 | 0 | ||
Common stock warrants [Member] | ||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||||
Diluted average shares outstanding (in shares) | 0 | 252,368 | 0 | 0 |
Net (Loss) Income Per Share - S
Net (Loss) Income Per Share - Schedule of Securities Excluded from Calculation of Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 3,275,491 | 0 | 3,643,768 | 10,550,888 |
Common stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 1,099,016 | 0 | 1,467,293 | 4,396,587 |
Restricted stock awards [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 1,790,556 | 0 | 1,790,556 | 1,797,089 |
Restricted stock units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 385,919 | 0 | 385,919 | 245,214 |
2018 Convertible Notes [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 0 | 0 | 0 | 3,854,959 |
Common stock warrant [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive excluded from computation of earnings per share amount (shares) | 0 | 0 | 0 | 257,039 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Asset and Liability Fair Values (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Assets: | ||
Equity securities (Note 7) | $ 32,153 | $ 46,422 |
Restricted cash | 4,020 | 0 |
Deferred compensation investments (life insurance cash surrender value (Note 3(e)) | 7,410 | 6,274 |
Total Assets | 266,959 | 195,605 |
Liabilities: | ||
Deferred compensation liability (Note 9(f)) | 7,433 | 6,167 |
Total Liabilities | 7,433 | 6,167 |
Bank CDs [Member] | ||
Assets: | ||
Available-for-sale | 6,584 | 86 |
Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 30 | 78 |
Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 72,384 | 142,745 |
US Government Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 104,535 | |
Corporate Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 39,843 | |
Level 1 [Member] | ||
Assets: | ||
Equity securities (Note 7) | 32,153 | 46,422 |
Restricted cash | 4,020 | |
Deferred compensation investments (life insurance cash surrender value (Note 3(e)) | 0 | 0 |
Total Assets | 168,333 | 46,422 |
Liabilities: | ||
Deferred compensation liability (Note 9(f)) | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 1 [Member] | Bank CDs [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 1 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 1 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 72,384 | 0 |
Level 1 [Member] | US Government Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 59,776 | |
Level 1 [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 0 | |
Level 2 [Member] | ||
Assets: | ||
Equity securities (Note 7) | 0 | 0 |
Restricted cash | 0 | |
Deferred compensation investments (life insurance cash surrender value (Note 3(e)) | 7,410 | 6,274 |
Total Assets | 98,626 | 149,183 |
Liabilities: | ||
Deferred compensation liability (Note 9(f)) | 7,433 | 6,167 |
Total Liabilities | 7,433 | 6,167 |
Level 2 [Member] | Bank CDs [Member] | ||
Assets: | ||
Available-for-sale | 6,584 | 86 |
Level 2 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 30 | 78 |
Level 2 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 142,745 |
Level 2 [Member] | US Government Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 44,759 | |
Level 2 [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 39,843 | |
Level 3 [Member] | ||
Assets: | ||
Equity securities (Note 7) | 0 | 0 |
Restricted cash | 0 | |
Deferred compensation investments (life insurance cash surrender value (Note 3(e)) | 0 | 0 |
Total Assets | 0 | 0 |
Liabilities: | ||
Deferred compensation liability (Note 9(f)) | 0 | 0 |
Total Liabilities | 0 | 0 |
Level 3 [Member] | Bank CDs [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 [Member] | Mutual Funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | 0 |
Level 3 [Member] | Money market funds [Member] | ||
Assets: | ||
Available-for-sale | 0 | $ 0 |
Level 3 [Member] | US Government Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | 0 | |
Level 3 [Member] | Corporate Debt Securities [Member] | ||
Assets: | ||
Available-for-sale | $ 0 |
Casi Holdings and Evomela Sup_2
Casi Holdings and Evomela Supply Contract - Additional Information (Details) $ in Thousands, shares in Millions | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||
Apr. 30, 2019USD ($)shares | Jun. 30, 2019USD ($)shares | Jun. 30, 2018USD ($) | Dec. 31, 2014agreement | Dec. 31, 2018USD ($) | |
Other Commitments [Line Items] | |||||
Equity securities | $ 32,153 | $ 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 | ||||
Percentage of ownership | 10.50% | ||||
Equity securities | $ 32,200 | ||||
Number of shares sold (shares) | shares | 1.5 | ||||
Gain (loss) on shares of common stock | $ 2,700 |
Convertible Senior Notes and _3
Convertible Senior Notes and Interest Expense - Additional Information (Details) - 2.75% Convertible Senior Notes Due 2018 [Member] - USD ($) | 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 |
Convertible Senior Notes and _4
Convertible Senior Notes and Interest Expense - Components of the Interest Expense Recognized (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |||
Stated coupon interest expense | $ 279 | $ 558 | |
Amortization of debt issuance costs | 62 | $ 0 | 124 |
Accretion of debt discount | 545 | $ 0 | 1,079 |
Total | $ 886 | $ 1,761 | |
Effective interest rate | 8.40% | 8.40% |
Financial Commitments & Conti_3
Financial Commitments & Contingencies and Key License Agreements - Additional Information (Details) $ in Thousands | Mar. 01, 2019product | Apr. 30, 2019USD ($)product | Apr. 30, 2018USD ($) | Apr. 30, 2016shares | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jan. 01, 2019USD ($) | Dec. 31, 2018USD ($) |
Long-term Purchase Commitment [Line Items] | ||||||||||
Operating lease right-of-use assets | $ 3,842 | $ 3,842 | $ 0 | |||||||
Present value of operating lease payments | 4,071 | 4,071 | ||||||||
Lease cost | 582 | $ 400 | 1,105 | $ 900 | ||||||
Potential payments based on achievement of sales milestones | 325,000 | |||||||||
Number of products | product | 7 | |||||||||
Deferrals and contributions | $ 7,400 | 7,400 | $ 6,200 | |||||||
SPI-2012 [Member] | ||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||
Issuance (shares) | shares | 318,750 | |||||||||
Spi Two Thousand Twelve [Member] | ||||||||||
Long-term Purchase Commitment [Line Items] | ||||||||||
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 | |||||||||
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 | |||||||||
Present value of operating lease payments | $ 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 | |||||||||
Potential payments based on additional achievements of regulatory milestones | $ 5,000 | |||||||||
Number of products | product | 2 | |||||||||
Asset purchase agreement, upfront payment | $ 2,800 |
Financial Commitments & Conti_4
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Balance Sheet Information (Details) - USD ($) $ in Thousands | Jun. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease right-of-use assets | $ 3,842 | $ 0 |
Operating lease current liabilities | 642 | 0 |
Operating lease liabilities | 3,429 | $ 0 |
Total operating lease liabilities | $ 4,071 |
Financial Commitments & Conti_5
Financial Commitments & Contingencies and Key License Agreements - Components of Lease Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 459 | $ 851 | ||
Short-term lease cost | 108 | 215 | ||
Variable lease cost | 15 | 39 | ||
Total lease cost | $ 582 | $ 400 | $ 1,105 | $ 900 |
Financial Commitments & Conti_6
Financial Commitments & Contingencies and Key License Agreements - Summary of Operating Lease Term and Discount Rate (Details) | Jun. 30, 2019 |
Commitments and Contingencies Disclosure [Abstract] | |
Weighted Average Remaining Lease Term | 3 years |
Weighted Average Discount Rate | 7.80% |
Financial Commitments & Conti_7
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Minimum Payments Due After Adoption of 842 (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
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 |
Financial Commitments & Conti_8
Financial Commitments & Contingencies and Key License Agreements - Operating Lease Minimum Payments Due Before Adoption of 842 (Details) $ in Thousands | Jun. 30, 2019USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 1,486 |
2020 | 1,441 |
2021 | 1,465 |
2022 | 828 |
2023 and thereafter | 87 |
Total | $ 5,308 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | ||||
Provision (benefit) for income taxes | $ (212,000) | $ 370,000 | $ (8,454,000) | $ (698,000) |
Income tax expense (benefit) from discontinued operations | 200,000 | (400,000) | 7,000,000 | 700,000 |
Income tax expense (benefit) from continuing and discontinued operations | $ 0 | $ 3,000 | $ (1,500,000) | $ 6,000 |
Discontinued Operations - Finan
Discontinued Operations - Financial Results of Discontinued Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Other (expense) income: | ||||
(Provision) benefit for income taxes from discontinued operations | $ (200) | $ 400 | $ (7,000) | $ (700) |
Income (loss) from discontinued operations, net of income taxes | 388 | (1,150) | 21,053 | 2,205 |
Discontinued Operations, Disposed of by Sale [Member] | Product Portfolio [Member] | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
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 | 0 | 6,934 | 1,248 | 13,880 |
Restructuring - employee severance (Note 12) | (2,439) | 0 | 3,858 | 0 |
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 | 0 | (192) | (1,478) | (483) |
Gain on sale of Commercial Product Portfolio | 0 | 0 | 33,644 | 0 |
Total other (expense) income | 0 | (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 |
Proceeds from sale of discontinued operations | 158,800 | |||
Carrying value of net assets transferred | 121,200 | |||
Transaction expenses | 3,900 | |||
Discontinued Operations, Disposed of by Sale [Member] | Product Portfolio [Member] | Product [Member] | ||||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||||
Total revenues | (1,245) | 23,753 | 12,938 | 51,863 |
Discontinued Operations, Disposed of by Sale [Member] | 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 | $ 415 | $ 290 | $ 2,799 |
Discontinued Operations - Summa
Discontinued Operations - Summary of Assets and Liabilities of Discontinued Operations (Details) - USD ($) $ in Thousands | Jun. 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 | 2,311 |
Discontinued operations, non-current liabilities | $ 0 | 14,031 |
Discontinued Operations, Disposed of by Sale [Member] | 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 |
Discontinued Operations - Signi
Discontinued Operations - Significant Non-cash Supplemental Cash Flow Items of Discontinued Operations (Details) - Product Portfolio [Member] - Discontinued Operations, Disposed of by Sale [Member] - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Depreciation and amortization | $ 1,263 | $ 13,925 |
Stock-based compensation | 3,404 | 3,146 |
Change in fair value of contingent consideration | $ 1,311 | $ 291 |
Restructuring Costs Related T_2
Restructuring Costs Related To Sale Of Commercial Product Portfolio (Details) $ in Thousands | Mar. 01, 2019employee | Jun. 30, 2019USD ($) | May 31, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) |
Restructuring Cost and Reserve [Line Items] | ||||||
Number of employees terminated or given notice of termination | employee | 87 | |||||
Revenue from contract with customer | $ 0 | $ 0 | $ 0 | $ 0 | ||
Employee Severance [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs expected cost remaining | 400 | 400 | ||||
Employee Severance, Terminated March 1, 2019 [Member] | Employee Severance [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs | 5,100 | |||||
Employee Severance, Terminated March 1, 2019 [Member] | Employee Severance [Member] | Income (Loss) From Discontinued Operations [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs | 3,900 | |||||
Employee Severance, Terminated March 1, 2019 [Member] | Employee Severance [Member] | Selling, general and administrative [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs | 1,000 | |||||
Employee Severance, Terminated March 1, 2019 [Member] | Employee Severance [Member] | Research and development [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs | 200 | |||||
Employee Severance, Terminated May 31, 2019 [Member] | Employee Severance [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Restructuring costs | 300 | $ 500 | 500 | |||
Acrotech Biopharma LLC [Member] | Service [Member] | ||||||
Restructuring Cost and Reserve [Line Items] | ||||||
Revenue from contract with customer | $ 500 | $ 700 |
Stockholders' Equity (Detail)
Stockholders' Equity (Detail) - USD ($) | Apr. 12, 2019 | Jun. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 |
Equity [Abstract] | ||||
Maximum proceeds | $ 150,000,000 | |||
Proceeds Received (Net of Broker Commissions and Fees ) | $ 1,814,000 | $ 1,814,000 | $ 0 | |
Common stock issued (shares) | 221,529 |
Uncategorized Items - sppi20190
Label | Element | Value |
Cumulative Effect Of Foreign Currency Adjustment Due To New Accounting Adoption | sppi_CumulativeEffectOfForeignCurrencyAdjustmentDueToNewAccountingAdoption | $ 342,000 |
Retained Earnings [Member] | ||
Cumulative Effect Of Foreign Currency Adjustment Due To New Accounting Adoption | sppi_CumulativeEffectOfForeignCurrencyAdjustmentDueToNewAccountingAdoption | 342,000 |
Accounting Standards Update 2014-09 [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | 4,678,000 |
Accounting Standards Update 2014-09 [Member] | Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 4,678,000 |