Document And Entity Information
Document And Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 25, 2019 | Jun. 29, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Entity Emerging Growth Company | false | ||
Entity Small Business | true | ||
Entity Shell Company | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Teligent, Inc. | ||
Entity Central Index Key | 0000352998 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Public Float | $ 117.7 | ||
Trading Symbol | TLGT | ||
Entity Common Stock, Shares Outstanding | 53,845,427 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Components of Revenue: | |||
Revenue, net | $ 65,865 | $ 60,202 | $ 63,012 |
Costs and Expenses: | |||
Cost of revenues | 43,480 | 32,830 | 28,325 |
Selling, general and administrative expenses | 23,408 | 19,904 | 15,005 |
Product development and research expenses | 14,076 | 19,265 | 17,140 |
Total costs and expenses | 80,964 | 71,999 | 60,470 |
Operating (loss) income | (15,099) | (11,797) | 2,542 |
Other (Expense) Income: | |||
Foreign currency exchange (loss) gain | (3,371) | 7,719 | (936) |
Debt partial extinguishment of 2019 Notes | (4,235) | 0 | 0 |
Debt extinguishment of 2021 Term Loan | (1,315) | 0 | 0 |
Interest and other expense, net | (12,298) | (11,198) | (13,304) |
Loss before income tax expense | (36,318) | (15,276) | (11,698) |
Income tax (benefit) expense | (62) | (85) | 287 |
Net loss attributable to common stockholders | $ (36,256) | $ (15,191) | $ (11,985) |
Basic and diluted loss per share (in dollars per share) | $ (0.68) | $ (0.28) | $ (0.23) |
Weighted average shares of common stock outstanding: | |||
Basic and diluted (in shares) | 53,592,930 | 53,323,954 | 53,078,158 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 9,705 | $ 26,692 |
Restricted cash | 2,892 | 0 |
Accounts receivable, net of allowance for doubtful accounts of $2,636 and $2,185, as of December 31, 2018 and December 31, 2017, respectively | 16,120 | 12,742 |
Inventories | 16,296 | 16,075 |
Prepaid expenses and other receivables | 3,373 | 3,622 |
Total current assets | 48,386 | 59,131 |
Property, plant and equipment, net | 91,775 | 68,355 |
Intangible assets, net | 48,375 | 56,017 |
Goodwill | 470 | 471 |
Other | 1,886 | 611 |
Total assets | 190,892 | 184,585 |
Current liabilities: | ||
Accounts payable | 5,933 | 10,595 |
Accrued expenses | 9,842 | 8,101 |
Deferred income, current | 2,426 | 0 |
Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $15,702 as of December 31, 2018 ) | 14,411 | 0 |
Total current liabilities | 32,612 | 18,696 |
Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $143,750 as of December 31, 2017) | 0 | 120,977 |
Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090 as of December 31, 2018) | 56,909 | 0 |
Revolver, net of debt issuance costs (face of $15,000 as of December 31, 2018) | 15,000 | 0 |
2023 Term Loan, net of debt issuance costs (face of $70,000 as of December 31, 2018) | 67,662 | 0 |
Deferred tax liability | 215 | 159 |
Other long term liabilities | 73 | 0 |
Total liabilities | 172,471 | 139,832 |
Commitments and Contingencies | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value, 100,000,000 shares authorized; 53,774,221 and 53,400,281 shares issued and outstanding as of December 31, 2018 and December 31, 2017, respectively | 557 | 554 |
Additional paid-in capital | 116,864 | 106,312 |
Accumulated deficit | (96,350) | (60,094) |
Accumulated other comprehensive loss, net of taxes | (2,650) | (2,019) |
Total stockholders’ equity | 18,421 | 44,753 |
Total liabilities and stockholders’ equity | $ 190,892 | $ 184,585 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Allowance for doubtful accounts | $ 2,636,000 | $ 2,185,000 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 53,774,221 | 53,400,281 |
Common stock, shares outstanding (in shares) | 53,774,221 | 53,400,281 |
Convertible Notes Payable | ||
Face amount of the Notes | $ 160,090,000 | $ 0 |
Convertible Notes Payable | ||
Stated interest rate | 3.75% | |
Revolving Credit Facility | ||
Stated interest rate | 4.75% | |
Revolving Credit Facility | Convertible Notes Payable | ||
Face amount of the Notes | $ 15,000,000 | 0 |
2023 Term Loan | ||
Stated interest rate | 4.75% | |
Senior Notes, due December 2019 | ||
Stated interest rate | 3.75% | |
Senior Notes, due December 2019 | Convertible Notes Payable | ||
Face amount of the Notes | $ 15,702,000 | $ 143,750,000 |
Stated interest rate | 3.75% | 3.75% |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (36,256) | $ (15,191) | $ (11,985) |
Other comprehensive loss, net of tax | |||
Foreign currency translation adjustment | (631) | (414) | (1,475) |
Other comprehensive loss | (631) | (414) | (1,475) |
Comprehensive loss | $ (36,887) | $ (15,605) | $ (13,460) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net loss | $ (36,256) | $ (15,191) | $ (11,985) |
Reconciliation of net loss to net cash provided by (used in) operating activities: | |||
Depreciation of fixed assets | 2,579 | 1,711 | 946 |
Gain on sale of assets | (20) | 0 | 0 |
Provision for write down of inventory | 1,363 | 2,132 | 1,400 |
Provision for bad debt | 452 | 1,767 | 327 |
Issuance of stock to consultant | 102 | 0 | 189 |
Stock based compensation | 1,970 | 3,295 | 2,999 |
Amortization of debt costs and debt discount | 9,226 | 9,586 | 8,427 |
Amortization of intangibles | 3,096 | 2,930 | 2,833 |
Deferred income taxes | 73 | 0 | 0 |
Foreign currency exchange loss (gain) | 3,371 | (7,719) | 936 |
Partial extinguishment of 3.75% senior notes | 4,235 | 0 | 0 |
Extinguishment of 2021 term loan | 1,315 | 0 | 0 |
Loss on impairment of intangible assets | 1,924 | 113 | 16 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (4,047) | 5,964 | (7,936) |
Inventories | (1,877) | (5,275) | (5,042) |
Prepaid expenses and other current receivables | 224 | (748) | 3,427 |
Other assets | (26) | 192 | 667 |
Accounts payable and accrued expenses | (3,405) | 1,641 | 2,825 |
Deferred income | 2,426 | 0 | (476) |
Net cash (used in) provided by operating activities | (13,275) | 398 | (447) |
Cash flows from investing activities: | |||
Capital expenditures | (25,332) | (40,429) | (16,655) |
Disposal of fixed assets | 38 | 0 | 0 |
Product acquisition costs, net | 0 | 0 | (3,421) |
Net cash used in investing activities | (25,294) | (40,429) | (20,076) |
Cash flows from financing activities: | |||
Proceeds from 2021 revolver | 15,000 | 0 | 0 |
Repayment of 2021 term loan, net | (25,550) | 0 | 0 |
Debt issuance costs | (6,239) | 0 | 0 |
Repurchase of 3.75% senior notes | (53,123) | 0 | 0 |
Proceeds from exercise of common stock options and warrants | 251 | 269 | 96 |
Principal payments on capital lease obligations | (6) | 0 | (70) |
Payment (recovery) from stockholder, net | 0 | 0 | (36) |
Net cash provided by (used in) financing activities | 25,333 | 269 | (10) |
Effect of exchange rate on cash, cash equivalents and restricted cash | (860) | 446 | (301) |
Net decrease in cash, cash equivalents and restricted cash | (13,236) | (39,762) | (20,533) |
Cash, cash equivalents and restricted cash at beginning of year | 27,165 | 66,481 | 87,315 |
Cash, cash equivalents and restricted cash at end of year | 13,069 | 27,165 | 66,481 |
Supplemental Cash flow information: | |||
Cash payments for interest | 7,340 | 5,391 | 5,393 |
Cash payments for income taxes | 89 | 126 | 113 |
Non cash investing and financing transactions: | |||
Acquisition of capital expenditures in accounts payable and accrued expenses | 568 | 3,186 | 1,805 |
Capitalized stock compensation in capital expenditures | 96 | 127 | 91 |
Issuance of stock to consultant | 102 | 0 | 189 |
2021 Term Loan | |||
Cash flows from financing activities: | |||
Proceeds from term loan | 25,000 | 0 | 0 |
2023 Term Loan | |||
Cash flows from financing activities: | |||
Proceeds from term loan | $ 70,000 | $ 0 | $ 0 |
CONSOLIDATED STATEMENTS OF CA_2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) | Dec. 31, 2018 |
Revolving Credit Facility | |
Stated interest rate | 4.75% |
Convertible Notes Payable | |
Stated interest rate | 3.75% |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Loss |
Balance at Dec. 31, 2015 | $ 66,759 | $ 549 | $ 99,258 | $ (32,918) | $ (130) |
Balance (in shares) at Dec. 31, 2015 | 53,000,689 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of stock to consultant | 189 | 189 | |||
Issuance of stock to consultant (in shares) | 25,000 | ||||
Stock based compensation expense | 3,090 | 3,090 | |||
Stock options exercised | 96 | $ 1 | 95 | ||
Stock options exercised (in shares) | 61,834 | ||||
Issuance of stock for vested restricted stock units | 1 | $ 1 | |||
Issuance of stock for vested restricted stock units (in shares) | 60,918 | ||||
Recovery from stockholder, net | (36) | (36) | |||
Tax benefit related to stock options | 28 | 28 | |||
Cumulative translation adjustment | (1,475) | (1,475) | |||
Net loss | (11,985) | (11,985) | |||
Balance at Dec. 31, 2016 | 56,667 | $ 551 | 102,624 | (44,903) | (1,605) |
Balance (in shares) at Dec. 31, 2016 | 53,148,441 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock based compensation expense | 3,422 | 3,422 | |||
Stock options exercised | 269 | $ 2 | 267 | ||
Stock options exercised (in shares) | 171,566 | ||||
Issuance of stock for vested restricted stock units | 0 | $ 1 | (1) | ||
Issuance of stock for vested restricted stock units (in shares) | 80,274 | ||||
Cumulative translation adjustment | (414) | (414) | |||
Net loss | (15,191) | (15,191) | |||
Balance at Dec. 31, 2017 | 44,753 | $ 554 | 106,312 | (60,094) | (2,019) |
Balance (in shares) at Dec. 31, 2017 | 53,400,281 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of stock to consultant | 102 | 102 | |||
Issuance of stock to consultant (in shares) | 25,000 | ||||
Stock based compensation expense | 2,066 | 2,066 | |||
Stock options exercised | 251 | $ 2 | 249 | ||
Stock options exercised (in shares) | 239,000 | ||||
Issuance of stock for vested restricted stock units | 0 | $ 1 | (1) | ||
Issuance of stock for vested restricted stock units (in shares) | 109,940 | ||||
Fair value of conversion feature on Convertible 4.75% Senior Notes | 18,658 | 18,658 | |||
Partial extinguishment of equity component of Convertible 3.75% Senior Notes | (10,522) | (10,522) | |||
Cumulative translation adjustment | (631) | ||||
Net loss | (36,256) | (36,256) | |||
Balance at Dec. 31, 2018 | $ 18,421 | $ 557 | $ 116,864 | $ (96,350) | $ (2,650) |
Balance (in shares) at Dec. 31, 2018 | 53,774,221 |
CONSOLIDATED STATEMENTS OF ST_2
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) | Dec. 31, 2018 |
Senior Notes, due December 2019 | |
Stated interest rate | 3.75% |
2023 Term Loan | |
Stated interest rate | 4.75% |
Correction to Previously Issued
Correction to Previously Issued Consolidated Financial Statements | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Correction to Previously Issued Consolidated Financial Statements | Correction of Previously Issued Consolidated Financial Statements Subsequent to the issuance of the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, management determined adjustments were needed to correct the presentation of certain immaterial accounting errors in the Company’s previously reported consolidated financial statements for the years ended December 31, 2017 and 2016. Accordingly, the accompanying consolidated financial statements as of and for the years ended December 31, 2017 and 2016, and the related notes hereto (including the Company’s quarterly results disclosed in Note 15, Quarterly Results ), have been revised to correct these immaterial accounting errors (the “Revision”). A summary of these immaterial accounting errors, and their impact on the accompanying consolidated financial statements are, as follows: (1) The Company pays wholesalers certain fees associated with the sale of the Company's product. The payment of these fees had been historically classified by the Company as cost of revenues and accrued expenses prior to the adoption of ASC 606, Revenue from Contracts with Customers ("ASC 606"). As disclosed in Note 7, Revenues, Recognition and Allowances, the Company adopted ASC 606 on January 1, 2018 using the modified retrospective method, at which time the Company began classifying the payment of wholesaler fees as a reduction of revenue and accounts receivable. Upon further analysis, however, management determined that these fees should have always been classified as a reduction of revenue and accounts receivable, rather than as costs of revenues and accrued expenses, because the services provided by the Company’s wholesalers cannot generally be provided by third parties and the underlying fees are not specifically identifiable from other services. As a result, the accompanying Consolidated Statement of Operations, Consolidated Balance Sheet and Consolidated Statements of Cash Flows for the years ended December 31, 2017 and 2016 have been revised to correct the presentation of wholesaler fees as a reduction of revenue rather than as cost of revenues. The correction of this immaterial error resulted in a reduction in previously reported revenue and cost of revenue of approximately $7.0 million and $3.9 million, respectively, for the years ended December 31, 2017 and 2016. In addition, the correction of this error resulted in a reduction in previously reported accounts receivable and decrease in previously reported accrued expenses of approximately $7.0 million, respectively, as of December 31, 2017. (2) Prior to the adoption of ASC 606, the Company classified Medicaid, Medicare and other rebates (the "Rebates") as a reduction of accounts receivable, whereas subsequent to adoption of ASC 606 the Company began classifying the Rebates as accrued expenses. Upon further analysis, management determined that the Rebates should have always been classified as accrued expenses because their terms require cash settlement and are payable to third parties that are other than the Company's customer. The correction of this immaterial error resulted in an increase in previously reported accounts receivable and increase in previously reported accrued expenses of $1.6 million, respectively, as of December 31, 2017. The following tables summarize the effects of the Revision on the accompanying consolidated financial statements of the Company (in thousands): Consolidated Statements of Operations Year Ended December 31, 2017 Year Ended December 31, 2016 As Previously As Previously Reported Adjustment As Revised Reported Adjustment As Revised Revenue, net $ 67,251 $ (7,049) (1) $ 60,202 $ 66,881 $ (3,869) (1) $ 63,012 Cost of revenues 39,879 (7,049) (1) 32,830 32,194 (3,869) (1) 28,325 Total costs and expenses 79,048 (7,049) (1) 71,999 64,339 (3,869) (1) 60,470 Consolidated Balance Sheet December 31, 2017 As Previously Reported Adjustment As Revised Accounts receivable, net $ 18,143 $ (5,401) (1),(2) $ 12,742 Total current assets 64,532 (5,401) (1),(2) 59,131 Total assets 189,986 (5,401) (1),(2) 184,585 Accrued expenses 13,502 (5,401) (1),(2) 8,101 Total current liabilities 24,097 (5,401) (1),(2) 18,696 Total liabilities 145,233 (5,401) (1),(2) 139,832 Total liabilities and stockholders' equity 189,986 (5,401) (1),(2) 184,585 Consolidated Statement of Cash Flows Consolidated Statement of Cash Flows Twelve Months Ended December 31, 2017 Twelve Months Ended December 31, 2016 As Previously As Previously Reported Adjustment As Revised Reported Adjustment As Revised Cash flows from operating activities Accounts receivable $ 1,894 $ 4,070 (1),(2) $ 5,964 $ (8,008) $ 72 (1),(2) $ (7,936) Accounts payable and accrued expenses 5,711 (4,070) (1),(2) 1,641 2,897 (72) (1),(2) 2,825 |
Nature of the Business and Liqu
Nature of the Business and Liquidity | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Liquidity | Nature of the Business and Liquidity Nature of the Business Teligent, Inc. is a Delaware corporation incorporated in 1977 and is a specialty generic pharmaceutical company. Under its own label, the Company markets and sells generic topical and branded generic and generic injectable pharmaceutical products in the United States and Canada. In the United States, the Company currently markets 35 generic topical pharmaceutical products and four branded generic pharmaceutical products. In Canada, the Company sells over 27 generic and branded generic injectable products and medical devices. Generic pharmaceutical products are bioequivalent to their brand name counterparts. The Company also provides contract manufacturing services to the pharmaceutical, over-the-counter, ("OTC"), and cosmetic markets. The Company operates its business under one segment. Our common stock is trading on the Nasdaq Global Select Market, under the trading symbol “TLGT.” Teligent also develops, manufactures, fills, and packages topical semi-solid and liquid products for branded and generic pharmaceutical customers, as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. Teligent has completed the facility expansion in Buena, New Jersey, to support the increased capacity demand expected from future product approvals from the FDA and is planning for a plant approval inspection in 2019. As the Company continues to execute the expansion of our development and commercial base beyond topical generics to include injectable generics, complex generics and ophthalmic generics (what we call our “TICO strategy”), it will compete in other markets, including the ophthalmic generic pharmaceutical market, and expects to face other competitors. Liquidity The Company’s principal sources of liquidity are cash and cash equivalents of approximately $9.7 million at December 31, 2018 and ongoing cash from operations. The Company has access to an additional $10.0 million on its Revolver and an additional $25.0 million still available on its 2023 Term Loans, in each case at December 31, 2018, as part of the credit facilities executed with Ares Capital Management in December 2018. In January 2019, the Company drew $5.0 million from its remaining $10.0 million Revolver. The Company also has the ability to defer certain product development and other programs, as well as exercise its option to defer the payment of interest on its 2023 Term Loans, if necessary. However, the Company may require additional funding and this funding will depend, in part, on the timing and structure of potential business arrangements. If necessary, the Company may continue to seek to raise additional capital through the sale of its equity or through a strategic alliance with a third party, subject to certain restrictions in the Ares Credit Facility agreements. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to the Company, or at all. The Company believes that its existing capital resources will be sufficient to support its current business plan and operations beyond March 2020. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company consolidates the following entities: Igen, Inc., Teligent Pharma. Inc., Teligent Luxembourg S.à.r.l., Teligent OÜ, Teligent Canada Inc., and Teligent Jersey Limited., in addition to the following inactive entities: Microburst Energy, Inc., Blood Cells, Inc. and Flavorsome, Ltd. All inter-company accounts and transactions have been eliminated. Certain amounts in the prior periods presented have been reclassified to conform to the current period financial statement presentation. These reclassifications have no effect on previously reported net income. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the historical valuation of the derivative liability, sales returns and allowances, allowances for excess and obsolete inventories, allowances for doubtful accounts, provisions for income taxes and related valuation allowances, stock based compensation, the assessment for the impairment of long-lived assets (including intangibles, goodwill and property, plant and equipment), property, plant and equipment and legal accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates. Cash Equivalents The Company considers all highly liquid instruments purchased with the original maturity of three months or less to be cash equivalents to the extent the funds are not being held for investment purposes. Cash and cash equivalents include cash on hand and bank demand deposits used in the Company’s cash management program. The Company has restricted cash, consisting of escrow accounts and letter of credits, which is included within other assets, non-current on the Consolidated Balance Sheet. In addition, pursuant to the New Credit Facilities agreement, proceeds from the 2023 Term Loan are deposited in a blocked bank account and restricted for use with the exception of repurchasing remaining 2019 Notes, which is included within restricted cash at December 31, 2018 in the table below. The Company presents restricted cash with cash and cash equivalents in the Consolidated Statement of Cash Flows. The following table provides a reconciliation of cash and cash equivalents and restricted cash reported in the Consolidated Balance Sheet to the total amounts in the Consolidated Statement of Cash Flows as follows (in thousands): December 31, 2018 December 31, 2017 December 31, 2016 Cash and cash equivalents $ 9,705 $ 26,692 $ 66,006 Restricted cash 2,892 — — Restricted cash in other assets 472 473 475 Cash, cash equivalents and restricted cash in the statement of cash flows $ 13,069 $ 27,165 $ 66,481 Inventories Inventories are valued at the lower of cost, using the first-in, first-out (“FIFO”) method, or market. The Company records an inventory reserve for losses associated with dated, expired, excess and obsolete raw materials. This reserve is based on management’s current knowledge with respect to inventory levels, planned production, and extension capabilities of materials on hand. Management does not believe the Company’s inventory is subject to significant risk of obsolescence in the near term. Property, Plant and Equipment Depreciation and amortization of property, plant and equipment is provided for under the straight-line method over the assets’ estimated useful lives as follows: Descriptions Useful Lives Buildings and improvements 10 - 40 years Machinery and equipment 5 - 15 years Computer hardware and software 3 - 5 years Furniture and fixtures 5 years Leasehold improvements are amortized over the shorter of estimated useful life or the lease term. Repair and maintenance costs are charged to operations as incurred while major improvements are capitalized. Construction in progress ("CIP") costs are amortized based on the asset class when they are put into service. When assets are retired or disposed, the related cost and accumulated depreciation thereon are removed and any gains or losses are included in operating results. Intangible Assets Definite-lived intangible assets are stated at cost less accumulated amortization. Amortization of definite-lived intangible assets is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 10 to 15 years. The Company continually evaluates the reasonableness of the useful lives of these assets. Indefinite-lived intangible assets are not amortized, but instead are tested at least annually for impairment. Costs to renew or extend the term of a recognized intangible asset are expensed as incurred. An impairment is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values and would be recorded in the selling, general and administrative expense on the Consolidated Statements of Operations. In-Process Research and Development Amounts allocated to in-process research and development (“IPR&D”) in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets subject to the impairment testing in accordance with the Company’s impairment testing policy for indefinite-lived intangible assets. As products in development are approved for sale, amounts will be allocated to product rights and will be amortized over their estimated useful lives. These valuations reflect, among other things, the impact of changes to the development programs, the projected development and regulatory time frames and the current competitive environment. The Company had a third party perform a valuation of the intangible assets included in IPR&D as of December 31, 2018. IPR&D are solely those assets acquired in the 2015 business combination of Alveda. Due to changing market conditions, the Company recorded an impairment loss of $1.2 million in the fourth quarter. Going forward, changes in any of the Company’s assumptions may result in a further reduction to the estimated fair value of IPR&D assets and could result in future impairment charges. Long-Lived Assets In accordance with the provisions of ASC 360-10-55, the Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. In performing such review for recoverability, the Company compares expected future cash flows of assets to the carrying value of the long-lived assets and related identifiable intangibles. If the expected future cash flows (undiscounted) are less than the carrying amount of such assets, the Company recognizes an impairment loss for the difference between the carrying value of the assets and their estimated fair value, with fair values being determined using projected discounted cash flows at the lowest level of cash flows identifiable in relation to the assets being reviewed. Product Acquisition Costs Product acquisition costs represent ANDAs and NDAs acquired in asset acquisitions, which are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. The Company expects to amortize these costs over a ten year useful life commencing when the product is sold. At December 31, 2018, product acquisition costs included assets acquired from AstraZeneca, Valeant and Sebala. The Company recorded an impairment loss of $0.7 million in the fourth quarter of 2018 related to product acquisition costs. Goodwill Goodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is tested for impairment on an annual basis on October 1, 2018 of each fiscal year or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company first performs a qualitative assessment to determine if the quantitative impairment test is required. If changes in circumstances indicate an asset may be impaired, the Company performs the quantitative impairment test. In accordance with accounting standards, a two-step quantitative method is used for determining goodwill impairment. In the first step, the Company determines the fair value. If the net book value exceeds its fair value, the second step of the impairment test which requires allocation of the fair value to all of its assets and liabilities using the acquisition method prescribed under authoritative guidance for business combinations would then be performed. Any residual fair value is allocated to goodwill. An impairment charge is recognized only if the implied fair value of our reporting unit’s goodwill is less than its carrying amount. The carrying value of goodwill at December 31, 2018 was $0.5 million. We believe it is unlikely that there will be a material change in the future estimates or assumptions used to test for impairment losses on goodwill. However, if actual results were not consistent with our estimates or assumptions, we could be exposed to an impairment charge. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, trade receivables, restricted cash, accounts payable and other accrued liabilities at December 31, 2018 approximate their fair value for all periods presented. The Company measures fair value in accordance with ASC 820-10, “Fair Value Measurements and Disclosures”. ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value: Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. As of December 31, 2018, based on level 2 inputs, the fair value of our Notes (2019 Notes and 2023 Notes) was approximately $67.6 million compared to their carrying value of $71.3 million. In addition, the value of our Senior Credit Facilities was stated at carrying value at December 31, 2018. The Company believes it could obtain borrowings at December 31, 2018 with comparable terms as the December 13, 2018 Senior Credit Facilities, therefore, the carrying value approximates fair value. Debt Issuance Costs Expenses related to debt financing activities are capitalized and amortized on an effective interest method, over the term of the loan and are to be netted against the carrying value of the financial liability, as required by ASU 2015-3. This standard aligns the treatment of debt issuance costs and debt discounts in that both reduce the carrying value of the liability. Amortization of debt issuance costs are recorded as interest expense on the Consolidated Statement of Operations. Revenue Recognition The Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenue is recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. The Company derives its revenues from three types of transactions: sales of its own pharmaceutical products (Company product sales), sales of manufactured product for its customers (contract manufacturing sales), and research and product development services performed for third parties. Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition polices for each. Taxes collected from customers and remitted to government authorities and that are related to the sales of the Company’s products are excluded from revenues. Adoption of ASC Topic 606, "Revenue from Contracts with Customers” In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers (Topic 606).” The standard, including subsequently issued amendments, replaces most existing revenue recognition guidance in U.S. GAAP. The key focus of the new standard is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company performed a comprehensive review of its existing revenue arrangements as of January 1, 2018 following the aforementioned five-step model. Based on the Company's analysis, there were no changes identified that impacted the amount or timing of revenues recognized under the new guidance as compared to the previous guidance. Additionally, the Company's analysis indicated that there were no changes to how costs to obtain and fulfill our customer contracts would be recognized under the new guidance as compared to the previous guidance. The impact of the adoption of this standard on the Company's Consolidated Balance Sheet, Consolidated Statement of Operations, and Consolidated Statement of Cash Flows was not material. The adoption of the new guidance impacted the way the Company analyzes, documents, and discloses revenue recognition under customer contracts beginning on January 1, 2018 and resulted in additional disclosures in the Company's financial statements. Company Product Sales Revenue from Company product sales is recognized upon transfer of control of a product to a customer at a point in time, generally as the Company's products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Company product sales are recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. Contract Manufacturing Sales: The Company recognizes revenue for contract manufacturing sales over-time, as milestones are achieved. Shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. Contract manufacturing sales are recognized net of accruals for cash discounts and returns which are established at the time of sale, and are included in Revenue, net in the Company's Consolidated Statement of Operations. Research and Development Income: The Company establishes agreed upon product development agreements with its customers to perform product development services. Revenues are recognized in accordance with the agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Other types of revenue include royalty or licensing revenue, and would be recognized over time, or at a point in time, based upon the contractual term upon completion of the earnings process. Judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Revenue and Provision for Sales Returns and Allowances As is customary in the pharmaceutical industry, the Company’s product sales are subject to a variety of deductions including chargebacks, rebates, cash discounts, other allowances, and returns. Product sales are recorded net of accruals for returns and allowances ("SRA"), which are established at the time of sale. The Company analyzes the adequacy of its accruals for returns and allowances quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that an adjustment is appropriate. Accruals are also adjusted to reflect actual results. These provisions are estimates based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The Company uses a variety of methods to assess the adequacy of its returns and allowances reserves to ensure that its financial statements are fairly stated. These include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience, and product pricing trends to analyze and validate the return and allowances reserves. Chargebacks are one of the Company's most significant estimates for recognition of product sales. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by its wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company validates the chargeback accrual quarterly through a review of the inventory reports obtained from its largest wholesale customers. This customer inventory information is used to establish the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent a majority of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated. Rebates are used for various discounts and rebates provided to customers. This account has been used for various one-time discounts given to customers. The Company reviews the percentage of products sold through these programs by reviewing chargeback data and uses the appropriate percentages to calculate the rebate accrual. Rebates are invoiced monthly, quarterly or annually and reviewed against the accruals. Other items that could be included in accrued rebates would be price protection fees, shelf stock adjustments (SSAs), or other various amounts that would serve as one time discounts on specific products. Net revenues and accounts receivable balances in the Company’s consolidated financial statements are presented net of SRA estimates. Certain SRA balances are included in accounts payable and accrued expenses. Accounts receivable are presented net of SRA balances of $18.1 million and $31.8 million at December 31, 2018 and 2017, respectively. The allowance for doubtful accounts was $2.6 million and $2.2 million at December 31, 2018 and 2017, respectively. These balances are primarily related to one specific customer in the amount of $1.7 million. In addition, in connection with four of the 39 products the Company currently manufactures, markets and distributes in its own label in the U.S., in accordance with an agreement entered into in December of 2011, the Company is required to pay a royalty calculated based on net sales to one of its pharmaceutical partners. The royalty is calculated based on contracted terms of 40% of net sales for the four products, which is to be paid quarterly to its partner. Accounts payable and accrued expenses include $0.2 million and $0.9 million at December 31, 2018 and 2017, respectively, related to these royalties. Royalty expense of $2.2 million, $2.2 million and $3.0 million was included in cost of goods sold for the years ended December 31, 2018, 2017, and 2016 respectively. The Company includes significant estimates to arrive at net product sales arising from wholesaler chargebacks, Medicaid and Medicare rebates, allowances and other pricing and promotional programs. Concentration of Risk Financial instruments, which subject the Company to concentration of credit risk, consist primarily of cash equivalents and trade receivables. The Company maintains its cash in accounts with quality financial institutions. Although the Company currently believes that the financial institutions with which the Company does business will be able to fulfill their commitments to us, there is no assurance that those institutions will be able to continue to do so. Major customers of the Company are defined as those constituting greater than 10% of our total revenue. In 2018, we had sales to three customers which individually accounted for more than 10% of our total revenue. These customers had sales of $21.2 million, $7.3 million and $6.9 million, respectively, and represented 54% of total revenues in the aggregate. Accounts receivable related to these major customers comprised of 30%, 19% and 19%, respectively, and represented 68% of all accounts receivable as of December 31, 2018. In 2017, we had sales to three customers which individually accounted for more than 10% of our total revenue. These customers had sales of $17.0 million, $7.4 million and $6.9 million, respectively, and represented 52% of total revenues in the aggregate. Accounts receivable related to these major customers comprised of 15%, 4% and 44%, respectively, and represented 63% of all accounts receivable as of December 31, 2017. In 2016, we had sales to three customers which individually accounted for more than 10% of our total revenue. These customers had sales of $12.3 million, $7.2 million and $6.8 million, respectively, and represented 41% of total revenues in the aggregate. The Company had net revenue from one product, Econazole Nitrate Cream 1%, which accounted for 2%, 4%, and 8% of total revenues in 2018, 2017 and 2016, respectively. Lidocaine Ointment 5%, which the Company launched at the end of the first quarter of 2016 accounted for 7%, 17% and 23% of total revenues in 2018, 2017 and 2016. Zantac for injection, which the Company acquired in the fourth quarter of 2015, accounted for 5%, 10% and 3% of total revenues in 2018, 2017 and 2016. For the year ended December 31, 2018, domestic net revenues were $45.6 million and foreign net revenues were $20.2 million. As of December 31, 2018, domestic assets were $132.7 million and foreign assets were $58.2 million. For the year ended December 31, 2017, domestic net revenues were $47.0 million and foreign net revenues were $13.2 million. As of December 31, 2017, domestic assets were $112.6 million and foreign assets were $72.0 million. For the year ended December 31, 2016, domestic net revenues were $52.8 million and foreign net revenues were $10.2 million. While the company purchases raw materials to manufacture certain products, it also utilizes CMO's to purchase finished products. The Company currently purchases from numerous sources which therefore reduces the risk of delays or difficulties in getting materials and/or products. Acquisitions The Company accounts for acquired businesses using the acquisition method of accounting, which requires with limited exceptions, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When net assets that do not constitute a business are acquired, no goodwill is recognized. Contingent consideration, if any, is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings. Accounts Receivable and Allowance for Doubtful Accounts The Company extends credit to its contract services customers based upon credit evaluations in the normal course of business, primarily with 30-day terms. The Company does not require collateral from its customers. Bad debt provisions are provided for on the allowance method based on historical experience and management’s evaluation of outstanding accounts receivable. The Company reviews the allowance for doubtful accounts regularly, and past due balances are reviewed individually for collectability. The Company charges off uncollectible receivables against the allowance when the likelihood of collection is remote. The Company extends credit to wholesaler and distributor customers and national retail chain customers, based upon credit evaluations, in the normal course of business, primarily with 60 to 90 day terms. The Company maintains customer-related accruals and allowances that consist primarily of chargebacks, rebates, sales returns, shelf stock allowances, administrative fees and other incentive programs. Some of these adjustments relate specifically to the generic prescription pharmaceutical business. Typically, the aggregate gross-to-net adjustments related to these customers can exceed 70% of the gross sales through this distribution channel. Certain of these accruals and allowances are recorded in the balance sheet as current liabilities and others are recorded as a reduction to accounts receivable. Foreign Currency Translation The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recorded in the foreign currency translation account, which is included in accumulated other comprehensive income (loss) (AOCI) and reflected as a separate component of equity. For those subsidiaries where the U.S. dollar has been determined to be the functional currency, non-monetary foreign currency assets and liabilities are translated using historical rates, while monetary assets and liabilities are translated at current rates, with the U.S. dollar effects of rate changes included in Other (income) expense, net. Foreign exchange loss of $3.4 million was recorded for the year ended December 31, 2018, primarily related to the foreign currency translation of our intercompany loans denominated in U.S. dollars to our foreign subsidiaries. These loans are to be repaid in November 2022. Depending on the changes in foreign currency exchange rates, we will continue to record a non-cash gain or loss on translation for the remainder of the term of these loans. Due to the nature of this transaction, there is no economic benefit to the Company to hedge this transaction. Accounting for Environmental Costs Accruals for environmental remediation are recorded when it is probable a liability has been incurred and costs are reasonably estimable. The estimated liabilities are recorded at undiscounted amounts. Environmental insurance recoveries are included in the statement of operations in the year in which the issue is resolved through settlement or other appropriate legal process. Income Taxes The Company records income taxes in accordance with ASC 740-10, “Accounting for Income Taxes,” under the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred income taxes are recognized for the tax consequences of temporary differences by applying enacted statutory tax rates applicable to future years to operating loss and tax credit carry forwards and differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded based on a determination of the ultimate realizability of future deferred tax assets. The Company complies with the provisions of ASC 740-10-25 that clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with ASC 740-10, “Accounting for Income Taxes,” and prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Additionally, ASC 740-10 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. There were no unrecognized tax benefits as of the date of adoption. As such, there are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate. The Company records interest and penalties relating to uncertain tax positions as a component of income tax expense. Stock-Based Compensation ASC 718-10 defines the fair-value-based method of accounting for stock-based employee compensation plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in which the Company issues stock-based compensation to employees, directors and advisors and for goods or services received from non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in determining the fair values of options, RSU's and warrants issued as stock-based compensation. These pricing models utilize the market price of the Company’s common stock and the exercise price of the option or warrant, as well as time value and volatility factors underlying the positions. Stock-based compensation expense is recognized over the requisite service period of the award, which usually coincides with the vesting period of the grant. Product Development and Research The Company’s research and development costs are expensed as incurred. Shipping and Handling Costs Costs related to shipping and handling is comprised of outbound freight and the associated labor. These costs are recorded in costs of sales. For the years ended December 31, 2018, 2017 and 2016, the costs relating to shipping and handling totaled $2.1 million, $1.2 million and $0.7 million, respectively. Loss per Common Share Basic loss per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted loss per share of common stock is computed using the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period. Potential dilutive common stock equivalents include shares issuable upon the conversion of the notes and the exercise of options and warrants. Due to the net loss for the years ended December 31, 2018, 2017 and 2016, the effect of the Company’s potential dilutive common stock equivalents was anti-dilutive; as a result, the basic and diluted weighted average number of common shares outstanding and net loss per common share are the same. As of December 31, 2018, the shares of common stock issuable in connection with stock options and warrants have been excluded from the diluted loss per share, as their effect would have been anti-dilutive. For the years ended December 31, 2018, 2017 and 2016 (in thousands except shares and per share data) 2018 2017 2016 Basic loss per share computa |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories as of December 31, 2018 and 2017 consisted of (in thousands): 2018 2017 Raw materials $ 10,456 $ 8,231 Work in progress 116 616 Finished goods 8,391 8,532 Inventories reserve (2,667) (1,304) $ 16,296 $ 16,075 |
Property, Plant and Equipment
Property, Plant and Equipment | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment, at cost, as of December 31, 2018 and 2017, consisted of (in thousands): 2018 2017 Land $ 401 $ 257 Building and improvements 53,813 8,613 Machinery and equipment 12,229 9,142 Computer hardware and software 4,182 3,244 Furniture and fixtures 694 449 Construction in progress 30,949 55,017 102,268 76,722 Less accumulated depreciation and amortization (10,493) (8,367) Property, plant and equipment, net $ 91,775 $ 68,355 The Company recorded depreciation expense of $2.6 million, $1.7 million and $0.9 million in 2018, 2017 and 2016, respectively. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Debt Convertible Notes On December 16, 2014, the Company issued $125.0 million aggregate principal amount of Convertible 3.75% Senior Notes, due 2019, (the "2019 Notes"). On December 22, 2014, the Company announced the closing of the initial purchasers’ exercise in full of their option to purchase an additional $18.75 million aggregate principal amount of the 2019 Notes. The 2019 Notes bear interest at a fixed rate of 3.75% per year, payable semiannually in arrears on June 15 and December 15 of each year, beginning on June 15, 2015 and mature on December 15, 2019, unless earlier repurchased, redeemed or converted. The 2019 Notes are convertible into shares of the Company’s common stock, cash or a combination thereof. On May 20, 2015, the Company received shareholder approval for the increase in the number of shares of common stock authorized and available for issuance upon conversion of the 2019 Notes. On April 27, 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. The agreements gave the holders the right to exchange, in aggregate, $75.1 million of the 2019 Notes for $75.1 million of new Convertible 4.75% Senior Notes due 2023 (the “2023 Notes”). The new 2023 Notes bear a fixed interest rate of 4.75% per year, payable semi-annually with the principal payable in May 2023. At the option of the holders, the 2023 Notes are convertible into shares of the Company’s common stock, cash or a combination thereof. The initial conversion rate is $224.71 per share, subject to certain adjustments, related to either the Company's stock price volatility, or the Company's declaration of a stock dividend, stock distribution, share combination or share split expected dividends or other anti-dilutive activities. In addition, holders will be entitled to receive additional shares of common stock for a potential increase of the conversion rate up to $280.90 per share under a make-whole provision in some circumstances. The Company incurred debt issuance costs of $1.6 million upon issuance of the 2023 Notes. In accordance with accounting for convertible debt within the cash conversion guidance of ASC 470-20, the Company allocated the principal amount of the 2023 Notes between its liability and equity components. The carrying amount of the liability component was determined by measuring the fair value of a similar debt instrument of similar credit quality and maturity that did not have the conversion feature. The carrying amount of the equity component, representing the embedded conversion option, was determined by deducting the fair value of the liability component from the principal amount of the 2023 Notes as a whole. The equity component was recorded to additional paid-in capital and is not remeasured as long as it continues to meet the conditions for equity classification. The excess of the principal amount of the 2023 Notes over the carrying amount of the liability component was recorded as a debt discount of $19.0 million, and is being amortized to interest expense using the effective interest method through the maturity date. The Company allocated the total amount of debt issuance costs incurred to the liability and equity components using the same proportions as the proceeds from the 2023 Notes. The debt issuance costs attributable to the liability component were recorded as a direct deduction from the liability component of the 2023 Notes, and are being amortized to interest expense using the effective interest method through the maturity date. Transaction costs attributable to the equity component were netted with the equity component of the 2023 Notes in additional paid-in capital. The effective interest rate of the 2023 Notes, inclusive of the debt discount and issuance costs, is 11.9%. The exchange of $75.1 million of the 2019 Notes for the 2023 Notes is considered a debt extinguishment under ASC 470-50. The 2019 Notes are accounted for under cash conversion guidance ASC 470-20, which requires the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition. In accordance with the aforementioned guidance, the Company allocated a portion of the $75.1 million to the extinguishment of the liability component equal to the fair value of that component immediately before extinguishment and recognized a $2.5 million extinguishment loss in the Consolidated Statement of Operations to measure the difference between (i) the fair value of the liability component and (ii) the net carrying amount of the liability component (which is already net of any unamortized debt issuance costs). In addition, the Company recorded a $7.6 million reduction of Additional Paid in Capital in connection with the extinguishment of $75.1 million of the 2019 Notes. In December 2018 the Company used $52.8 million of proceeds from the Senior Credit Facilities (see below) to repurchase the 2019 Notes as well as $0.3 million of proceeds to pay for transaction costs. The repurchase of the 2019 Notes is considered a debt extinguishment under ASC 470-50. The 2019 Notes are accounted for under cash conversion guidance ASC 470-20, which requires the Company to allocate the fair value of the consideration transferred upon settlement to the extinguishment of the liability component and the reacquisition of the equity component upon derecognition. In accordance with the guidance above, the Company allocated a portion of the $52.8 million to the extinguishment of the liability component equal to the fair value of that component immediately before extinguishment and recognized a $1.7 million extinguishment loss in the Consolidated Statement of Operations to measure the difference between (i) the fair value of the liability component and (ii) the net carrying value amount of the liability component (which is already net of any unamortized debt issuance costs). In addition, the Company recorded a $2.9 million reduction of Additional Paid in Capital in connection with the extinguishment of the 2019 Notes. In January and February of 2019, the Company used $0.5 million and $2.2 million, respectively, of proceeds from the Senior Credit Facilities to repurchase the 2019 Notes. 2021 Term Loan On June 1, 2018, the Company entered into a credit agreement for $25.0 million secured by all Company assets, due June 1, 2021 (“2021 Term Loan”). The 2021 Term Loan has limited financial and non-financial covenants inclusive of a minimum cash carry balance of $5.0 million. The 2019 Notes and 2023 Notes are subordinate to the 2021 Term Loan. The first $15.0 million million of loan proceeds was received on June 1, 2018. The remaining loan proceeds of $10.0 million were subject to closing conditions as defined in the agreement and were received on July 16, 2018. The 2021 Term Loan incurred debt issuance costs of $0.5 million and a debt discount of $0.4 million. The debt discount is due to lender fees paid on the initial drawdown of $15.0 million. The debt issuance costs and debt discount are amortized to interest expense using the effective interest method through the maturity date. The 2021 Term Loan bears interest at a rate of LIBOR plus 9.0%, with a stated floor of 2.0%. The effective interest, inclusive of the debt discounts and issue costs, was 12.78% as of September 30, 2018. In December 2018, the Company used $25.6 million of proceeds from the Senior Credit Facilities (see below) to repay the 2021 Term Loan which was comprised of $25.0 million of principal, $0.5 million of transaction costs and $0.1 million of interest. The repayment of the 2021 Term Loan is considered a debt extinguishment under ASC 470-50. The Company recorded $1.3 million of an extinguishment loss related to the repayment of the 2021 Term Loan in the Consolidated Statement of Operations. Senior Credit Facilities On December 13, 2018, the Company entered into a $25.0 million Revolving Credit Agreement (the “Revolver”) and Term Loan Agreement (the “2023 Term Loan”, and together with the Revolver, the “Senior Credit Facilities”). The Term Loan consists of (i) a $50.0 million initial term loan (the “Initial Term Loan”); (ii) a $30.0 million delayed draw term loan A (the “Delayed Draw Term Loan A”) and (iii) a $15.0 million delayed draw term loan B (the “Delayed Draw Term Loan B” and, together with the Delayed Draw Term Loan A, the “Delayed Draw Term Loans”). The Initial Term Loan matures on the earlier to occur of (a) three months prior to maturity of the 2023 Notes and (b) June 13, 2024. Commitments related to undrawn amounts of the Delayed Draw Term Loan A terminate on June 30, 2019, and drawn amounts under the Delayed Draw Term Loans mature at the same time as the Initial Term Loan. The Revolver matures on the earlier to occur of (a) six months prior to the maturity of the 2023 Notes and (b) December 13, 2023. The Company’s ability to borrow under the Revolver is subject to a borrowing base determined based upon eligible inventory, eligible equipment, eligible real estate and eligible receivables. The Senior Credit Facilities are secured by substantially all of the Company’s assets. All of the Company’s debt is subordinated to the Senior Credit Facilities. The 2023 Term Loan is subordinate to the Revolver. The Senior Credit Facilities have customary financial and non-financial covenants, including affirmative, negative and reporting covenants, representations and warranties, and events of default, including cross-defaults on other material indebtedness, as well as events of default triggered by a change of control and certain actions initiated by the FDA. The financial covenants consist of a minimum revenue test, a minimum adjusted EBITDA test and a maximum total net leverage ratio. The interest rate under the Revolver and the 2023 Term Loan is calculated, at the option of the Company, at either the one, two, three or six-month London Inter-Bank Offered Rate (or LIBOR) plus 3.75% or the base rate plus 2.75%. The interest rate on the 2023 Term Loan is calculated, at the option of the Company, at either LIBOR plus 8.75% or the base rate plus 7.75%. Interest on the Senior Credit Facilities is payable in cash except that interest on the 2023 Term Loan is payable, at the option of the Company, in cash or in kind by being added to the principal balance thereof, until the earlier of December 13, 2020 and the date the Company has provided the lenders of the Senior Credit Facilities financial statements demonstrating that the Company has attained twelve months of revenue of at least $125.0 million. A commitment fee of 1.0% per annum is payable by the Company quarterly in arrears on the unused portion of the Delayed Draw Term Loans. Amounts drawn under the Revolver may be prepaid at the option of the Company without premium or penalty, subject, in the case of acceleration of the Revolver or termination of the revolving credit commitments thereunder, to certain call protections which vary depending on the time at which such prepayments are made. Amounts drawn under the Revolver are subject to mandatory prepayment to the extent that aggregate extensions under the Revolver exceed the lesser of the revolving credit commitment then in effect and the borrowing base then in effect, and upon the occurrence of certain events and conditions, including non-ordinary course asset dispositions, receipt of certain insurance proceeds and condemnation awards and issuances of certain debt obligations. Amounts outstanding under the 2023 Term Loan may be prepaid at the option of the Company subject to applicable premiums, including a make-whole premium, and certain call protections which vary depending on the time at which such prepayments are made. Subject to payment of outstanding obligations under the Revolver as a result of any corresponding mandatory prepayment requirements thereunder, amounts outstanding under the 2023 Term Loan are subject to mandatory prepayment upon the occurrence of certain events and conditions, including non-ordinary course asset dispositions, receipt of certain insurance proceeds and condemnation awards, issuances of certain debt obligations and a change of control transaction. The Initial Term Loan of $50.0 million and $15.0 million of the Revolver were drawn by the Company on December 13, 2018. On December 21, 2018, the Company drew $20.0 million of the Delayed Draw Term Loan A. As of December 31, 2018, the $10.0 million of the Delayed Draw Term Loan A, $15.0 million of the Delayed Draw Term Loan B and $10.0 million of the Revolver remain available to the Company. In addition, in January 2019, the Company drew $5.0 million from the remaining $10.0 million Revolver. In connection with the Revolver the Company incurred a debt discount of $0.5 million and debt issuance issue costs of $0.3 million. The debt discount is due to annual fees and lender fees paid on the initial drawdown of $15.0 million. The debt issuance costs and debt discount are recorded as an asset on the Consolidated Balance Sheet and are amortized to interest expense using the straight-line method through the estimated Revolver maturity date. The annual fees related to the Revolver and the Initial Term Loan are amortized to interest expense using the straight-line method over the annual period they relate to. In connection with the Initial Term Loan and Delayed Draw Term Loan A, the Company incurred a debt discount of $1.8 million and debt issuance issue costs of $0.8 million. The debt discount is due to lender fees paid on the Initial Term Loan of $50.0 million and drawdown of Delayed Draw Term Loan A of $20.0 million. The debt issuance costs and debt discount costs are amortized to interest expense using the effective interest rate method through the estimated maturity date. In addition, the Company incurred $0.5 million of debt issuance costs related to the commitment fees paid to the lenders for the undrawn amounts of the Delayed Draw Term Loans. These debt issuance costs are recorded as an asset on the balance sheet and amortized on a straight-line basis over the access period of the Delayed Draw Term Loans through June 30, 2019. As of December 31, 2018, the effective interest, inclusive of the debt discounts and issue costs, of the Revolver and Initial Term Loan and Delayed Draw Term Loan A is 9.3% and 12.4%, respectively. At December 31, 2018 and December 31, 2017, the net carrying amount of the debt and the remaining unamortized debt discounts and debt issuance costs were as follows (in thousands): December 31, 2018 December 31, 2017 (Current) (Non-current) Face amount of the 2019 Notes (due December 2019) $ 15,702 $ 143,750 Less unamortized discounts and debt issuance costs 1,291 22,773 Total net carrying value $ 14,411 $ 120,977 December 31, 2018 December 31, 2017 Face amount of the 2023 Notes (due May 2023) $ 75,090 $ — Face amount of the Revolver Credit Facility (due December 2022) 15,000 — Face amount of the 2023 Loan (due February 2023) 70,000 — Total carrying value, non-current $ 160,090 $ — Less unamortized discounts and debt issuance costs 20,519 — Total net carrying value, non-current $ 139,571 $ — Debt Maturities Schedule Aggregate maturities of the Company’s debt are presented below (in thousands): Year Ending December 31, 2019 $ 15,702 2020 — 2021 — 2022 15,000 2023 145,090 Total $ 175,792 |
Revenues, Recognition and Allow
Revenues, Recognition and Allowances | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Revenues, Recognition and Allowances | Revenues, Recognition and Allowances Revenue Recognition As of January 1, 2018, the Company adopted the ASC 606 guidance for revenue recognition for contracts, using the modified retrospective method. The implementation of this guidance had no material impact on the measurement or recognition of revenue from customer contracts of prior periods. Upon adoption of this new guidance, the Company recognizes revenue using the following five steps: • Identification of the contract, or contracts, with a customer; • Identification of the performance obligations in the contract; • Determination of the transaction price, including the identification and estimation of variable consideration; • Allocation of the transaction price to the performance obligations in the contract; and • Recognition of revenue when we satisfy a performance obligation. The Company derives its revenues from three types of transactions: sales of its own pharmaceutical products (Company product sales), sales of manufactured product for its customers (contract manufacturing sales), and research and product development services performed for third parties. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using the expected value method based on historical experience as well as applicable information currently available. Company Product Sales Revenue from Company product sales is recognized upon transfer of control of a product to a customer at a point in time, generally as the Company's products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Company product sales are recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. Contract Manufacturing Sales The Company recognizes revenue for contract manufacturing sales over-time, as milestones are achieved. Shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. Contract manufacturing sales are recognized net of accruals for cash discounts and returns which are established at the time of sale, and are included in Revenue, net in the Company's Consolidated Statement of Operations. Research and Development Services and Other Income The Company establishes agreed upon product development agreements with its customers to perform product development services. Revenues are recognized in accordance with the agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Other types of revenue include royalty or licensing revenue, and would be recognized over time, or at a point in time, based upon the contractual term upon completion of the earnings process. Judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Revenues by Transaction Type The Company operates in one reportable segment and, therefore, the results of the Company's operations are reported on a consolidated basis, consistent with internal management reporting for the chief decision maker. Net Sales (in thousands) for the three years ended December 31, 2018, 2017 and 2016 were as follows (prior-period amounts are not adjusted under the modified-retrospective method of adoption): Years ended December 31, 2018 2017 2016 Company product sales $ 59,591 $ 50,955 $ 45,002 Contract manufacturing sales 6,047 8,995 17,033 Research and development services and other income 227 252 977 Revenue, net $ 65,865 $ 60,202 $ 63,012 Disaggregated information for the Company product sales revenue has been recognized in the accompanying audited Consolidated Statements of Operations, and is presented below according to contract type (in thousands): Years ended December 31, Company Product Sales 2018 2017 2016 Topical $ 35,118 $ 29,446 $ 29,011 Injectables 24,473 21,509 15,991 Total $ 59,591 $ 50,955 $ 45,002 In the twelve months ended December 31, 2018, Company did not incur, and therefore did not defer, any material incremental costs to obtain contracts. Returns and Allowances As is customary in the pharmaceutical industry, the Company’s product sales are subject to a variety of deductions including chargebacks, rebates, cash discounts, other allowances, and returns. Product sales are recorded net of accruals for returns and allowances, which are established at the time of sale. The Company analyzes the adequacy of its accruals for returns and allowances quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that an adjustment is appropriate. Accruals are also adjusted to reflect actual results. These provisions are estimates based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The Company uses a variety of methods to assess the adequacy of its returns and allowances reserves to ensure that its financial statements are fairly stated. These include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience, and product pricing trends to analyze and validate the return and allowances reserves. Accounts receivable are presented net of returns and allowances of $18.1 million and $31.8 million at December 31, 2018 and 2017, respectively. The allowance for doubtful accounts was $2.6 million and $2.2 million at December 31, 2018 and 2017, respectively. These balances are primarily related to one specific customer in the amount of $1.7 million. Chargebacks are one of the Company's most significant estimates for recognition of product sales. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by its wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company validates the chargeback accrual quarterly through a review of the inventory reports obtained from its largest wholesale customers. This customer inventory information is used to establish the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent a majority of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated. Rebates are used for various discounts and rebates provided to customers. This account has been used for various one-time discounts given to customers. The Company reviews the percentage of products sold through these programs by reviewing chargeback data and uses the appropriate percentages to calculate the rebate accrual. Rebates are invoiced monthly or quarterly and reviewed against the accruals. Other items that could be included in accrued rebates would be price protection fees, shelf stock adjustments (SSAs), or other various amounts that would serve as one time discounts on specific products. In 2018, the Company reduced wholesaler acquisition costs on several products sold to major wholesalers as part of the Company's cash management strategy. As a result, its gross product sales and related chargebacks and billbacks are reduced accordingly. The Company's adjustments for the deductions to gross product sales for the three years ended December 31, 2018, 2017 and 2016 are as follows (in thousands): Years ended December 31, 2018 2017 2016 Gross product sales $ 158,278 $ 215,883 $ 217,633 Reduction to gross product sales: Chargebacks and billbacks 60,770 125,159 141,343 Wholesaler fees for service 5,503 7,049 3,869 Sales discounts and other allowances 32,414 32,720 27,419 Total reduction to gross product sales $ 98,687 $ 164,928 $ 172,631 Product sales, net $ 59,591 $ 50,955 $ 45,002 Contract manufacturing product sales $ 6,047 $ 8,995 $ 17,033 Total product sales, net $ 65,865 $ 60,202 $ 63,012 |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Goodwill The Company acquired the assets of Canadian pharmaceutical company Alveda Pharmaceuticals, Inc., in November 2015. As a result of the acquisition, we recorded goodwill of $0.4 million. We assessed the recoverability of the carrying value of goodwill at October 1, 2018. Whenever events occur or circumstances change, more likely than not, the company is likely to reduce the fair value of its reporting unit below its carrying value. There have been no events or changes in circumstances that would have reduced the fair value of our reporting unit below its carrying value. No impairment losses were recognized during the year ended December 31, 2018. Changes in goodwill during the two years ended December 31, 2018 and December 31, 2017 were as follows (in thousands): Goodwill December 31, 2016 $ 446 Foreign currency translation 25 December 31, 2017 471 Foreign currency translation (1) December 31, 2018 $ 470 Intangible Assets The following sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period as of December 31, 2018 and December 31, 2017 for those assets that are not already fully amortized (in thousands): December 31, 2018 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,169 $ (8,239) $ 31,930 11.8 Product acquisition costs 13,308 — 13,308 N/A - See description below In-process research and development 719 — 719 N/A - See description below Customer relationships 3,557 (1,139) 2,418 6.9 Total $ 57,753 $ (9,378) $ 48,375 December 31, 2017 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,380 $ (5,684) $ 34,696 12.8 Product acquisition costs 14,682 — 14,682 N/A - See description below In-process research and development 3,629 — 3,629 N/A - See description below Customer relationships 3,783 (773) 3,010 7.9 Total $ 62,474 $ (6,457) $ 56,017 Changes in intangibles during the year ended December 31, 2018 were as follows (in thousands): Product Acquisition Costs Trademarks and IPR&D Customer Balance at December 31, 2017 $ 14,682 $ 34,696 $ 3,629 $ 3,010 Amortization — (2,727) — (369) Intangible assets placed in service — 1,346 (1,346) — Loss on impairment (716) (7) (1,201) — Foreign currency translation (658) (1,378) (363) (223) Balance at December 31, 2018 $ 13,308 $ 31,930 $ 719 $ 2,418 The Company recorded amortization expense of $3.1 million, $2.9 million and $2.8 million in 2018, 2017 and 2016, respectively. In addition, the Company recorded impairment loss of $0.7 million and $1.2 million related with product acquisition costs and IPR&D respectively in 2018, and nil and $0.1 million impairment loss related with IPR&D and product acquisition costs in 2017. During the preparation of the 2018 consolidated financial statements, management identified a misclassification within the product acquisition costs and in-process research and development (“IPR&D”) categories for the year ended December 31, 2017. Accordingly, a reclassification has been made to the December 31, 2017 balances to decrease IPR&D and increase product acquisition costs in the amount of $14.7 million. The correction has no impact on the Company’s consolidated financial statements. Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on trademarks and technology and customer relationships for each of the following years is estimated to be as follows (in thousands): Year ending December 31, Amortization Expense * 2019 $ 3,096 2020 3,096 2021 3,096 2022 3,096 2023 3,096 Thereafter 18,868 Total $ 34,348 *IPR&D and Product Acquisition Costs are assessed for impairment at least annually and will be amortized once products are commercialized, and are not included in the table. The useful lives of the Company’s intangible assets are as follows: Intangibles Category Amortizable Life Product Acquisition Costs 10 years Trademarks & Technology 15 years Customer Relationships 10 years |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock Options The 1999 Director Stock Option Plan, as amended (the “Director Plan”), provides for the grant of stock options to non-employee directors of the Company at an exercise price equal to the fair market value per share on the date of the grant. As of December 31, 2017, an aggregate of 1,975,000 shares had been approved and authorized for issuance pursuant to the Director Plan, with no change as of December 31, 2018. A total of 2,634,798 options had been granted to non-employee directors as of December 31, 2017, with no change as of December 31, 2018. A total of 807,782 of those options had been forfeited as of December 31, 2017 and returned to the option pool for future issuance, with no change as of December 31, 2018. The options granted under the Director Plan vest in full one year after their respective grant dates and have a maximum term of ten years. As of each of December 31, 2018 and December 31, 2017, there were 500,000 shares of common stock options outstanding. As of December 31, 2017, the 147,984 options available were transferred to a plan that has superseded the Director Plan, as discussed further in this section, with no additional options transferred as of December 31, 2018. The 1999 Stock Incentive Plan, as amended (“1999 Plan”), replaced all previously authorized employee stock option plans, and no additional options may be granted under those previous plans. Under the 1999 Plan, options or stock awards may be granted to all of the Company’s employees, officers, directors, consultants and advisors to purchase a maximum of 3,200,000 shares of common stock. However, pursuant to the terms of the 1999 Plan, no awards may be granted after March 16, 2009. A total of 2,892,500 options, having a maximum term of ten years, have been granted at 100% of the fair market value of the Company’s common stock at the date of grant. Options outstanding under the 1999 Plan were generally exercisable in cumulative increments over four years commencing one year from date of grant. As of December 31, 2018, there were no options outstanding under the 1999 Plan. On June 26, 2009, the Board of Directors adopted, and the Company’s stockholders subsequently approved by written consent, the IGI Laboratories, Inc. 2009 Equity Incentive Plan (the “2009 Plan”). The 2009 Plan became effective on July 29, 2009. The 2009 Plan allows the Company to continue to grant options and restricted stock, as under the 1999 Plan, but also authorizes the Board of Directors to grant a broad range of other equity-based awards, including stock appreciation rights, restricted stock units ("RSUs") and performance awards. The 2009 Plan has been created, pursuant to and consistent with the Company’s current compensation philosophy, to assist the Company in attracting, retaining and rewarding designated employees, directors, consultants and other service providers of the Company and its subsidiaries and affiliates, in a manner that will be cost efficient to the Company from both an economic and financial accounting perspective. On April 12, 2010, the Board of Directors adopted, and the Company’s stockholders subsequently approved, an amendment and restatement of the 2009 Plan to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of Common Stock. The 2009 Plan, as amended on May 29, 2010, authorizes up to 5,000,000 shares of the Company’s common stock for issuance pursuant to the terms of the 2009 Plan. The maximum number of shares that may be subject to awards made to any individual in any single calendar year under the 2009 Plan is 1,000,000 shares. As of December 31, 2018, there were 14,377 RSUs outstanding, 1,853,925 shares of stock outstanding and 2,458,106 shares of common stock options outstanding. As of December 31, 2017, there were 99,626 RSUs outstanding, 1,422,020 shares of stock outstanding and 3,038,634 shares of common stock options outstanding. As of December 31, 2017, the 249,052 options available were transferred to a plan that has superseded the 2009 Plan, as discussed further in this section. As of December 31, 2018, an additional 346,504 options available were transferred to the superseded plan. On May 25, 2016, the Board of Directors approved the Company's 2016 Equity Incentive Plan (the "2016 Plan"). On May 21, 2018, the Board of Directors adopted, and the Company's stockholders subsequently approved, an amendment and restatement of the 2016 Plan to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of Common Stock. The 2016 Plan, as amended, provides for the issuance of awards of up to 4,000,000 shares of the Company's common stock, plus any shares of common stock that are represented by awards granted under our Director Plan and 2009 Plan that are forfeited, expire or are canceled without delivery of shares of common stock or which result in the forfeiture of shares of common stock back to the Company on or after May 25, 2016 up to 2,500,000 shares. Generally, shares of common stock reserved for awards under the 2016 Plan that lapse or are canceled, will be added back to the share reserve available for future awards. However, shares of common stock tendered in payment for an award or shares of common stock withheld for taxes will not be available again for grant. The 2016 Plan provides that no participant may receive awards for more than 1,000,000 shares of common stock in any fiscal year. As the 2016 Plan supersedes both the Director Plan and the 2009 Plan, any available shares from both are now incorporated into the 2016 Plan. As of December 31, 2018, there were 161,214 RSU's outstanding, 74,667 shares of common stock outstanding and options to purchase 1,394,285 shares of common stock outstanding under the 2016 Plan. As of December 31, 2017, there were 89,003 RSU's outstanding, 20,000 shares of common stock outstanding and options to purchase 761,176 shares of common stock outstanding under the 2016 Plan. As of December 31, 2018 and December 31, 2017, there were a total of 3,113,374 shares of common stock and 1,526,857 shares of common stock available under the 2016 Plan, respectively. As of December 31, 2018 and December 31, 2017, there were options to purchase 4,352,391 and 4,299,810 shares of common stock outstanding, respectively, in the Director Plan, 2009 Plan, and the 2016 Plan. In the interest of maintaining consistency with the Company's 2016 Equity Incentive Plan, on March 13, 2017, the Company entered into (i) an amendment to the option agreements governing each option grant currently outstanding under the Company's 2009 Equity Incentive Plan, and (ii) an amendment to the restricted stock unit, or RSU, agreements governing each RSU grant currently outstanding under the 2009 Plan. The amendments provide for the automatic vesting upon a change of control of the Company of each option grant and RSU grant, as applicable, outstanding under the 2009 Plan. The amendments had a de minimis value to the holders as of December 31, 2018, and therefore no additional stock compensation expense was recognized related to the amendments. The forms of amendment are Exhibits 10.31 and 10.32, respectively, and are incorporated by reference herein. The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities and risk-free interest rates are based upon the expected life of the grant. Assumptions 2018 2017 2016 Expected dividends 0 % 0 % 0 % Risk free rate 2.44 % 1.56 % 1.14 % Expected volatility 52.7%-72.5% 58.0% - 69.7% 68.0% - 71.3% Expected term (in years) 2.3 – 3.3 years 3.2 – 3.3 years 3.1 – 3.3 years Estimated volatility was calculated using the historical volatility of the Company’s stock over the expected life of the options. The expected life of the options was estimated based on the Company’s historical data. The risk-free interest rate is based on U.S. Treasury yields for securities with terms approximating the terms of the grants. Forfeitures are recognized in the period they occur. The assumptions used in the Black-Scholes option valuation model are highly subjective, and can materially affect the resulting valuation. Stock option transactions in each of the past three years under the aforementioned plans in total were: Shares Exercise Weighted January 1, 2016 shares issuable under options 3,592,734 $0.79 - $10.67 $ 4.36 Granted 739,135 4.72 - 8.81 7.26 Exercised (61,834) 1.10 - 6.51 1.54 Expired — — — Forfeited (164,666) 4.55 – 10.67 8.37 December 31, 2016 shares issuable under options 4,105,369 $0.79 - $10.67 $ 4.76 Granted 577,845 3.38 - 9.28 7.15 Exercised (171,566) 0.79 - 5.85 1.92 Expired — — — Forfeited (211,838) 4.80 - 10.67 7.70 December 31, 2017 shares issuable under options 4,299,810 $0.79 - $10.67 $ 5.09 Granted 839,785 1.73-4.25 3.34 Exercised (239,000) 1.02-1.83 1.05 Expired — — — Forfeited (548,204) 2.02-10.67 8.04 December 31, 2018 shares issuable under options 4,352,391 $0.79-$10.67 $ 4.61 The following table summarizes information concerning outstanding and exercisable options as of December 31, 2018: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.50 1,510,000 3.12 $ 1.06 1,510,000 $ 1.06 $1.51 - $5.50 992,457 8.27 3.23 199,826 2.76 $5.51 - $10.67 1,849,934 6.99 8.24 1,528,686 8.45 Total 4,352,391 5.94 $ 4.61 3,238,512 $ 4.65 The following table summarizes information concerning outstanding and exercisable options as of December 31, 2017: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.00 25,000 2.01 $ 0.79 25,000 $ 0.79 $1.01 - $1.50 1,721,000 4.14 1.06 1,721,000 1.06 $1.51 - $10.67 2,553,810 7.76 7.85 1,369,466 7.92 Total 4,299,810 6.28 $ 5.09 3,115,466 $ 4.07 The following table summarizes information concerning outstanding and exercisable options as of December 31, 2016: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.00 50,000 3.01 $ 0.79 50,000 $ 0.79 $1.01 - $1.50 1,808,400 5.11 1.07 1,808,400 1.07 $1.51 - $10.67 2,246,969 8.35 7.82 805,803 7.15 Total 4,105,369 6.86 $ 4.76 2,664,203 $ 2.90 The Company has recorded $1.5 million, $2.3 million and $2.3 million related to its stock option based expenses in cost of sales, product development and research expenses, and selling, general and administrative expenses on the accompanying Consolidated Statements of Operations for the years ended December 31, 2018, 2017 and 2016, respectively. The aggregate intrinsic value of options outstanding was $0.5 million at December 31, 2018, $4.7 million at December 31, 2017 and $11.5 million at December 31, 2016. The aggregate intrinsic value of the options exercisable was $0.5 million at December 31, 2018, $4.7 million at December 31, 2017 and $11.3 million at December 31, 2016. The total intrinsic value of the options exercised during 2018, 2017 and 2016 was $0.1 million, $0.4 million and $0.3 million, respectively. A summary of non-vested options at December 31, 2018 and changes during the year ended December 31, 2018 is presented below: Options Weighted Non-vested options at January 1, 2018 1,184,344 $ 3.48 Granted 839,785 1.44 Vested (699,572) 3.54 Forfeited (210,678) 3.37 Non-vested options at December 31, 2018 1,113,879 $ 2.00 As of December 31, 2018, there was $1.2 million of total unrecognized compensation cost related to non-vested share-based compensation arrangements under the Plan. The costs will be recognized through December 2020. Restricted Stock and RSUs The Company periodically grants restricted stock and RSU awards to certain officers and other employees that typically vest one three There have been no restricted stock issuances in the years ended 2018, 2017 or 2016. A summary of non-vested RSUs and changes during each of the past three years is as follows: Number of Weighted Average Non-vested balance at January 1, 2016 182,750 $10.23 Changes during the period: Shares granted 58,068 7.50 Shares vested (60,918) 10.13 Shares forfeited — — Non-vested balance at December 31, 2016 179,900 $9.35 Changes during the period: Shares granted 93,468 7.26 Shares vested (80,274) 9.57 Shares forfeited (4,465) 7.09 Non-vested balance at December 31, 2017 188,629 $8.27 Changes during the period: Shares granted 122,949 3.36 Shares vested (109,940) 8.95 Shares forfeited (26,047) 5.76 Non-vested balance at December 31, 2018 175,591 $4.78 |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses represent various obligations of the Company including certain operating expenses and taxes payable. For the fiscal years ended December 31, 2018, and 2017 the largest components of accrued expenses were (in thousands): 2018 2017 Professional fees $ 2,153 $ 546 Payroll 1,908 1,580 Inventory and supplies 1,809 58 Interest expense 1,042 240 Rebates 714 83 Medicaid and Medicare 383 1,487 Clinical Studies 334 596 Royalties 222 856 Capital expenditures 275 1,947 Wholesaler Fees 203 — Income Tax 45 58 Other 754 650 $ 9,842 $ 8,101 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company is subject to U.S. federal income tax and files a consolidated federal income tax return which includes all eligible U.S. subsidiary companies. The Company is also subject to tax in the states of Alabama, Illinois, Montana, New Jersey and Tennessee. The Company conducts significant operations in certain foreign countries and is, accordingly, subject to tax in those foreign jurisdictions consisting of Canada (including the province of Ontario), Estonia, Luxembourg and Jersey. Loss before income tax for the years ended December 31, 2018, 2017 and 2016 consisted of the following (in thousands): 2018 2017 2016 U.S. operations $ (32,183) $ (21,938) $ (9,514) Foreign operations (4,135) 6,662 (2,184) Global Total $ (36,318) $ (15,276) $ (11,698) The Company’s current tax (benefit) expense was $(0.1) million, $(0.1) million and $0.3 million for the years ended December 31, 2018, 2017 and 2016, respectively. The (credit) provision for income taxes attributable to continuing operations before income taxes for the years ended December 31, 2018, 2017 and 2016 is as follows (in thousands): 2018 2017 2016 Current tax expense (benefit): Federal $ — $ (86) $ 26 State and local 30 20 35 Foreign (157) 42 272 Total current tax (benefit) expense (127) (24) 333 Deferred tax expense: Federal — — — State and local — — — Foreign 65 (61) (46) Total deferred tax expense (benefit) 65 (61) (46) Total income tax (benefit) expense $ (62) $ (85) $ 287 A comparison of income tax (benefit) expense at the U.S. statutory rate of 21% in 2018 and 35% in 2017 and 2016 to the Company's effective rate is as follows (in thousands): 2018 2017 2016 Expected Statutory expense (benefit) $ (7,627) $ (5,195) $ (3,977) U.S. TCJA recovery of alternative minimum tax credits — (73) — Change in the fair values of derivative and amortization of debt discount — 2,939 2,584 Other non-deductible expenses 256 24 63 Change in valuation allowance including U.S. TCJA rate reduction 6,572 (2,012) 590 Reduction in deferred tax assets related to U.S. TCJA rate reduction — 7,504 — Change to Accounting for Equity Compensation Windfalls — (1,112) — Tax rate differential - foreign vs. U.S. 791 (2,276) 822 State income taxes, net of federal benefit 23 13 23 Shortfalls related to stock compensation expense — 129 154 Prior year true-up (93) (13) — Exchange gain 16 (13) 28 $ (62) $ (85) $ 287 On December 22, 2017, the President signed into law the United States Tax Cuts and Jobs Act (U.S. TCJA) significantly revising the Internal Revenue Code of 1986, as amended. The U.S. TCJA includes, among other items, (1) a permanent reduction of the corporate tax rate from a top marginal rate of 35% to a flat rate of 21%; (2) limitations on the tax deduction for net interest expense, (3) a one-time transition tax on certain unrepatriated earnings of foreign subsidiaries; (4) a shift of the U.S. taxation of multinational corporations from a tax on worldwide income to a territorial system; (5) elimination of the Alternative Minimum Tax regulations; (6) recovery of Alternative Minimum Tax Credits over a five year period; and (7) modifying or repealing many other business deductions and credits. The Company has assessed the impacts of the changes resulting from the U.S. TCJA and during the fourth quarter of 2017 recognized an income tax benefit and a corresponding receivable of $73 thousand related to the recoverability of Alternative Minimum Tax Credits. Also, during the fourth quarter of 2017, deferred tax assets, liabilities and valuation allowances were remeasured at the new rate of 21%. There was no income impact from the remeasurement since all U.S. net deferred tax assets are fully reserved by the Company. In December 2017, the SEC provided regulatory guidance for accounting of the impacts of the TCJA, referred to as SAB 118. Under the guidance of SAB 118, the income tax effects, for which the accounting under ASC 740 is incomplete, are reported as a provisional amount based on a reasonable estimate. The reasonable estimate is subject to adjustment during a “measurement period”, not to exceed one year, until the accounting is complete. The estimate is also subject to the finalization of management’s analysis related to certain matters, such as developing interpretations of the provisions of the TCJA, changes to certain estimates and profits of certain subsidiaries and the filing of tax returns. During the fourth quarter of 2018, the Company completed its full assessment and finalized the accounting for the impact of TCJA and concluded that there was no additional impact. Deferred tax balances included in the Consolidated Balance Sheets as of December 31, 2018 and 2017 consisted of the following (in thousands): 2018 2017 Deferred Tax Assets: Sales allowances and doubtful accounts $ 1,964 $ 506 Inventory reserve 962 619 Deferred revenue 590 — Accrued expenses 23 664 Property, plant and equipment 258 214 Tax operating loss carryforwards 9,951 9,327 Tax credit and other carryforwards 1,299 168 Stock compensation 538 1,817 Total deferred tax assets 15,585 13,315 Less valuation allowance (12,120) (13,309) Net deferred tax assets 3,465 6 Deferred Tax Liabilities: Convertible debt conversion features (3,514) — Foreign exchange (28) — Intangible assets (138) (165) Total deferred tax liabilities (3,680) (165) Net deferred tax liability $ (215) $ (159) The Company evaluates the recoverability of its deferred tax assets based on its history of operating results, its expectations for the future, and the expiration dates of the net operating loss carry forwards. Based on the preponderance of the evidence, the Company has concluded that it is more likely than not that it will be unable to realize the net deferred tax assets in the immediate future and has established a full valuation allowance for substantially all deferred tax assets. Accordingly, the Company has provided a valuation allowance of $12.1 million and $13.3 million for the years ended December 31, 2018 and 2017, respectively, on its deferred tax assets. The valuation allowance decreased $1.2 million during 2018. This decrease was due to a decrease of $2.0 million related to changes in deferred taxes offset by an increase of $0.8 million related to the 2018 net operating loss. Operating loss, tax credit and other carry forwards as of December 31, 2018 and 2017 were as follows (in thousands): 2018 2017 Federal: Net operating losses (see below) $ 45,081 $ 41,688 Disallowed interest expense (no expiration) 5,018 — Contributions (expiring through 2023) 524 210 Research tax credits (expiring through 2025) 135 168 State: New Jersey (expiring in 2038) 2,976 4,320 Other states (expiring through 2038) 2,307 1072 Foreign Net operating losses (no expiration) $ 257 $ 255 At December 31, 2018, the Company’s U.S. federal net operating loss carryforwards will expire as follows (in thousands): Year Net Operating Loss 2020 - 2023 $ 8,227 2024 - 2029 9,063 2030 - 2032 9,926 2033 - 2036 6,296 2037 8,116 No expiration but subject to limitation 3,453 Total $ 45,081 Federal net operating losses arising during and after 2018 are not subject to expiration; however, their usage is limited to 80% of taxable income during the year of use. The Company’s ability to use net operating loss carry forwards is subject to substantial limitation in future periods under certain provisions of Section 382 of the Internal Revenue Code of 1986, as amended, which limit the utilization of net operating losses upon a more than 50% change in ownership of the Company’s stock that is held by 5% or greater stockholders. The Company examined the application of Section 382 with respect to an ownership change that took place during 2010, as well as the limitation on the application of net operating loss carry forwards. The Company believes that operating losses subsequent to the change date in 2010 (aggregating $26.5 million) are not subject to Section 382 limitations. The Company has estimated that the annual limitation starting in 2010 aggregates from $1.0 million to $2.3 million per year including the effect of amortization of built in gains. The Company's loss carryforwards may be further limited in the future if additional ownership changes occur. The Company is subject to the provisions of ASC 740-10-25, Income Taxes (ASC 740). ASC 740 prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. On a quarterly basis, the Company undergoes a process to evaluate whether income tax accruals are in accordance with ASC 740 guidance on uncertain tax positions. Federal income tax returns for the years 2014 and 2015 have been examined by the U.S. Internal Revenue Service without any income tax expense consequences. For federal purposes (except for the years 2014 and 2015), post 1998 tax years remain open to examination as a result of net operating loss carryforwards. The Company is currently open to audit by the appropriate state income taxing authorities for tax years 2014 through 2017. The Company has not recorded any liability for uncertain tax positions at December 31, 2018 or December 31, 2017. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Commitments | Commitments The Company’s commitments and contingencies consisted of operating leases for warehouse and office space and equipment. Future minimum lease payments under non-cancelable operating leases are as follows (in thousands): Commitments 2019 $ 573 2020 611 2021 633 2022 610 2023 607 2024 200 $ 3,234 Rent expense was $0.5 million, $0.5 million and $0.9 million for the years ended December 31, 2018, 2017 and 2016, respectively. The Company has certain licensing and development agreement in place under which the Company will pay certain licensing fees and milestones over the lives of certain projects. These commitments totaled approximately $2.4 million as of December 31, 2018, and will be paid over the next several years in accordance with agreed upon milestones. |
Legal and U.S. Regulatory Proce
Legal and U.S. Regulatory Proceedings | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal and U.S. Regulatory Proceedings | Legal and U.S. Regulatory Proceedings To date, twelve putative class action antitrust lawsuits have been filed against the Company along with co-defendants, including Taro Pharmaceuticals U.S.A., Inc. and Perrigo New York Inc., regarding the pricing of generic econazole nitrate cream (“econazole”). The class plaintiffs seek to represent nationwide or state classes consisting of persons who directly purchased, indirectly purchased, paid and/or reimbursed patients for the purchase of generic econazole from July 1, 2014 until the time the defendants’ allegedly unlawful conduct ceased or will cease. The class plaintiffs seek treble damages for alleged overcharges for econazole during the alleged period of conspiracy, and certain of the class plaintiffs also seek injunctive relief against the defendants. All actions have been consolidated by the Judicial Panel on Multidistrict Litigation to the Eastern District of Pennsylvania for pre-trial proceedings as part of the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter. On October 16, 2018 the court dismissed the class plaintiffs’ claims against the Company with leave to replead. On December 21, 2018 the class plaintiffs filed amended complaints, which the Company moved to dismiss on February 21, 2019. This motion remains pending. Three “opt-out” antitrust lawsuits have additionally been filed against the Company by Humana Inc.; The Kroger Co. et al.; and United HealthCare Services, Inc., and consolidated into the In re Generic Pharmaceuticals Pricing Antitrust Litigation matter by the Judicial Panel on Multidistrict Litigation. Each of the opt-out complaints names between thirty-six and forty-three defendants (including the Company) and involves allegations regarding the pricing of econazole along with between twenty-four and twenty-nine other drug products that were not manufactured or sold by the Company during the period at issue. The opt-out plaintiffs seek treble damages for alleged overcharges for the drug products identified in the complaint during the alleged period of conspiracy, and two of the complaints also seek injunctive relief. A motion to dismiss the Humana Inc. and The Kroger Co., et al. opt-out complaints was filed on February 21, 2019. A motion to dismiss the United HealthCare Services, Inc. opt-out complaint has not yet been filed. Due to the early stage of these cases, we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe these cases are without merit, and we intend to vigorously defend against these claims. On October 20, 2017, a Demand for Arbitration was filed with the American Arbitration Association by Stayma Consulting Services, Inc. (“Stayma”) against the Company regarding the Company’s development and manufacture for Stayma of two generic drug products, one a lotion and one a cream, containing 0.05% of the active pharmaceutical ingredient flurandrenolide. The Company developed the two products and Stayma purchased commercial quantities of each; however, Stayma alleges that the Company breached agreements between the parties by developing an additional and different generic drug product, an ointment, containing flurandrenolide, and failing to meet certain contractual requirements. Stayma seeks monetary damages. Because discovery in this matter is ongoing, the Company is unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. The Company believes this case is without merit, and the Company intends to vigorously defend against these claims. The Company filed three counter-claims against Stayma for its failure to pay several past due invoices of approximately $1.7 million relating to the development and commercial supply of the two subject products and for breaching the confidentiality provisions and exclusivity provisions of the parties’ agreements. On December 13, 2018, Valdepharm SA filed a lawsuit alleging that the Company breached contracts regarding two drug products that the Company had sought to have Valdepharm manufacture. On February 12, 2019 the Company answered the complaint and counterclaimed, alleging that Valdepharm breached the contracts by failing to perform its work in compliance with FDA regulations and current Good Manufacturing Practices. Each party seeks damages associated with the alleged breach and related claims. Due to the early stage of the case we are unable to form a judgment at this time as to whether an unfavorable outcome is either probable or remote or to provide an estimate of the amount or range of potential loss. We believe the claims against Teligent are without merit, and we intend to vigorously defend against them. |
Employee Benefits
Employee Benefits | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefits | Employee Benefits The Company has a 401(k) contribution plan, pursuant to which employees may elect to contribute to the plan, in whole percentages, up to 100% of compensation. Employees’ contributions are subject to a minimum contribution by participants of 1% of compensation and a maximum contribution of $18,500 for 2018, $18,000 for 2017 and $18,000 for 2016, plus a catch-up contribution of up to $6,000 for 2018, $6,000 for 2017 and $6,000 for 2016, if a participant qualifies. The Company matches 100% of the first 3% of compensation contributed by participants and 50% of the next 2% of compensation contributed by participants. The Company contribution is in the form of cash, which is vested immediately. The Company has recorded charges to expense related to this plan of approximately $358,167, $311,467 and $228,619 in 2018, 2017 and 2016, respectively. |
Quarterly Results (Unaudited)
Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Results (Unaudited) | Quarterly Results (Unaudited) As disclosed in Note 1, Correction of Prior Year Consolidated Financial Statements, the Company’s consolidated financial statements for the years ended December 31, 2017 and 2016 have been revised to correct certain immaterial accounting errors described therein. Accordingly, the effect of the correction of these immaterial accounting errors resulted in a reduction in the Company’s previously reported revenue and cost of revenue of $2.2 million, $2.0 million, $1.5 million, and $1.3 million for the quarters ended March 31, 2017, June 30, 2017, September 30, 2017 and December 31, 2017, respectively. The following is a summary of certain quarterly financial information for the fiscal years 2018 and 2017: First Second Third Fourth Total (in thousands, except per share data) Year Ended December 31, 2018 Total revenues, net $ 14,545 $ 16,249 $ 18,294 $ 16,777 $ 65,865 Gross profit 5,220 4,784 6,719 5,662 22,385 Operating loss (3,531) (4,910) (1,213) (5,445) (15,099) Net loss (4,802) (13,119) (3,945) (14,390) (36,256) Net loss attributable to common stockholders (4,802) (13,119) (3,945) (14,390) (36,256) Basic loss per share $ (0.09) $ (0.25) $ (0.07) $ (0.27) $ (0.68) Diluted loss per share $ (0.09) $ (0.25) $ (0.07) $ (0.27) $ (0.68) Year Ended December 31, 2017 Total revenues, net $ 17,663 $ 16,432 $ 11,340 $ 14,767 $ 60,202 Gross profit 10,934 8,037 2,538 5,863 27,372 Operating income (loss) 2,967 (1,782) (8,039) (4,943) (11,797) Net income (loss) 831 (919) (8,982) (6,121) (15,191) Net income (loss) attributable to common stockholders 831 (919) (8,982) (6,121) (15,191) Basic income (loss) per share $ 0.02 $ (0.02) $ (0.17) $ (0.11) $ (0.28) Diluted income (loss) per share $ 0.02 $ (0.02) $ (0.17) $ (0.11) $ (0.28) |
SCHEDULE II-VALUATION AND QUALI
SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS | 12 Months Ended |
Dec. 31, 2018 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Schedule II - Valuation and Qualifying Accounts | Additions Balance at Charged to Charged Deductions Balance at Year Ended December 31, 2016 Change in Tax Valuation Allowance $ 14,309 — 941 — $ 15,250 Allowance for Doubtful Accounts $ 90 347 — 20 $ 417 Reserve for Inventory Obsolescence $ 121 872 — 583 $ 410 Year Ended December 31, 2017 Change in Tax Valuation Allowance $ 15,250 (61) (1,880) — $ 13,309 Allowance for Doubtful Accounts $ 417 1,768 — — $ 2,185 Reserve for Inventory Obsolescence $ 410 2,000 9 1,115 $ 1,304 Year Ended December 31, 2018 Change in Tax Valuation Allowance $ 13,309 67 (1,256) — $ 12,120 Allowance for Doubtful Accounts $ 2,185 451 — — $ 2,636 Reserve for Inventory Obsolescence $ 1,304 3,343 — 1,980 $ 2,667 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company consolidates the following entities: Igen, Inc., Teligent Pharma. Inc., Teligent Luxembourg S.à.r.l., Teligent OÜ, Teligent Canada Inc., and Teligent Jersey Limited., in addition to the following inactive entities: Microburst Energy, Inc., Blood Cells, Inc. and Flavorsome, Ltd. All inter-company accounts and transactions have been eliminated. Certain amounts in the prior periods presented have been reclassified to conform to the current period financial statement presentation. These reclassifications have no effect on previously reported net income. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include the historical valuation of the derivative liability, sales returns and allowances, allowances for excess and obsolete inventories, allowances for doubtful accounts, provisions for income taxes and related valuation allowances, stock based compensation, the assessment for the impairment of long-lived assets (including intangibles, goodwill and property, plant and equipment), property, plant and equipment and legal accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates. |
Cash Equivalents | Cash Equivalents The Company considers all highly liquid instruments purchased with the original maturity of three months or less to be cash equivalents to the extent the funds are not being held for investment purposes. Cash and cash equivalents include cash on hand and bank demand deposits used in the Company’s cash management program. |
Inventories | InventoriesInventories are valued at the lower of cost, using the first-in, first-out (“FIFO”) method, or market. The Company records an inventory reserve for losses associated with dated, expired, excess and obsolete raw materials. This reserve is based on management’s current knowledge with respect to inventory levels, planned production, and extension capabilities of materials on hand. Management does not believe the Company’s inventory is subject to significant risk of obsolescence in the near term. |
Property, Plant and Equipment | Property, Plant and Equipment Depreciation and amortization of property, plant and equipment is provided for under the straight-line method over the assets’ estimated useful lives as follows: Descriptions Useful Lives Buildings and improvements 10 - 40 years Machinery and equipment 5 - 15 years Computer hardware and software 3 - 5 years Furniture and fixtures 5 years Leasehold improvements are amortized over the shorter of estimated useful life or the lease term. Repair and maintenance costs are charged to operations as incurred while major improvements are capitalized. Construction in progress ("CIP") costs are amortized based on the asset class when they are put into service. When assets are retired or disposed, the related cost and accumulated depreciation thereon are removed and any gains or losses are included in operating results. |
Intangible Assets | Intangible Assets Definite-lived intangible assets are stated at cost less accumulated amortization. Amortization of definite-lived intangible assets is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 10 to 15 years. The Company continually evaluates the reasonableness of the useful lives of these assets. Indefinite-lived intangible assets are not amortized, but instead are tested at least annually for impairment. Costs to renew or extend the term of a recognized intangible asset are expensed as incurred. An impairment is recognized in the amount, if any, by which the carrying amount of such assets exceeds their respective fair values and would be recorded in the selling, general and administrative expense on the Consolidated Statements of Operations. |
In-Process Research and Development | In-Process Research and DevelopmentAmounts allocated to in-process research and development (“IPR&D”) in connection with a business combination are recorded at fair value and are considered indefinite-lived intangible assets subject to the impairment testing in accordance with the Company’s impairment testing policy for indefinite-lived intangible assets. As products in development are approved for sale, amounts will be allocated to product rights and will be amortized over their estimated useful lives. These valuations reflect, among other things, the impact of changes to the development programs, the projected development and regulatory time frames and the current competitive environment. The Company had a third party perform a valuation of the intangible assets included in IPR&D as of December 31, 2018. IPR&D are solely those assets acquired in the 2015 business combination of Alveda. Due to changing market conditions, the Company recorded an impairment loss of $1.2 million in the fourth quarter. Going forward, changes in any of the Company’s assumptions may result in a further reduction to the estimated fair value of IPR&D assets and could result in future impairment charges. |
Long-Lived Assets | Long-Lived AssetsIn accordance with the provisions of ASC 360-10-55, the Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets may not be recoverable. In performing such review for recoverability, the Company compares expected future cash flows of assets to the carrying value of the long-lived assets and related identifiable intangibles. If the expected future cash flows (undiscounted) are less than the carrying amount of such assets, the Company recognizes an impairment loss for the difference between the carrying value of the assets and their estimated fair value, with fair values being determined using projected discounted cash flows at the lowest level of cash flows identifiable in relation to the assets being reviewed. |
Product Acquisition Costs | Product Acquisition CostsProduct acquisition costs represent ANDAs and NDAs acquired in asset acquisitions, which are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of these assets may not be recoverable. The Company expects to amortize these costs over a ten year useful life commencing when the product is sold. At December 31, 2018, product acquisition costs included assets acquired from AstraZeneca, Valeant and Sebala. |
Goodwill | GoodwillGoodwill, which represents the excess of purchase price over the fair value of net assets acquired, is carried at cost. Goodwill is tested for impairment on an annual basis on October 1, 2018 of each fiscal year or more frequently if events or changes in circumstances indicate that the asset might be impaired. The Company first performs a qualitative assessment to determine if the quantitative impairment test is required. If changes in circumstances indicate an asset may be impaired, the Company performs the quantitative impairment test. In accordance with accounting standards, a two-step quantitative method is used for determining goodwill impairment. In the first step, the Company determines the fair value. If the net book value exceeds its fair value, the second step of the impairment test which requires allocation of the fair value to all of its assets and liabilities using the acquisition method prescribed under authoritative guidance for business combinations would then be performed. Any residual fair value is allocated to goodwill. An impairment charge is recognized only if the implied fair value of our reporting unit’s goodwill is less than its carrying amount. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, trade receivables, restricted cash, accounts payable and other accrued liabilities at December 31, 2018 approximate their fair value for all periods presented. The Company measures fair value in accordance with ASC 820-10, “Fair Value Measurements and Disclosures”. ASC 820-10 clarifies that fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. As a basis for considering such assumptions, ASC 820-10 establishes a three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value: Level 1 Inputs: Unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. Level 2 Inputs: Other than quoted prices included in Level 1 inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the asset or liability. Level 3 Inputs: Unobservable inputs for the asset or liability used to measure fair value to the extent that observable inputs are not available, thereby allowing for situations in which there is little, if any, market activity for the asset or liability at measurement date. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. |
Debt Issuance Costs | Debt Issuance Costs Expenses related to debt financing activities are capitalized and amortized on an effective interest method, over the term of the loan and are to be netted against the carrying value of the financial liability, as required by ASU 2015-3. This standard aligns the treatment of debt issuance costs and debt discounts in that both reduce the carrying value of the liability. Amortization of debt issuance costs are recorded as interest expense on the Consolidated Statement of Operations. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. The Company’s revenue is recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. The Company derives its revenues from three types of transactions: sales of its own pharmaceutical products (Company product sales), sales of manufactured product for its customers (contract manufacturing sales), and research and product development services performed for third parties. Due to differences in the substance of these transaction types, the transactions require, and the Company utilizes, different revenue recognition polices for each. Taxes collected from customers and remitted to government authorities and that are related to the sales of the Company’s products are excluded from revenues. Adoption of ASC Topic 606, "Revenue from Contracts with Customers” In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers (Topic 606).” The standard, including subsequently issued amendments, replaces most existing revenue recognition guidance in U.S. GAAP. The key focus of the new standard is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company performed a comprehensive review of its existing revenue arrangements as of January 1, 2018 following the aforementioned five-step model. Based on the Company's analysis, there were no changes identified that impacted the amount or timing of revenues recognized under the new guidance as compared to the previous guidance. Additionally, the Company's analysis indicated that there were no changes to how costs to obtain and fulfill our customer contracts would be recognized under the new guidance as compared to the previous guidance. The impact of the adoption of this standard on the Company's Consolidated Balance Sheet, Consolidated Statement of Operations, and Consolidated Statement of Cash Flows was not material. The adoption of the new guidance impacted the way the Company analyzes, documents, and discloses revenue recognition under customer contracts beginning on January 1, 2018 and resulted in additional disclosures in the Company's financial statements. Company Product Sales Revenue from Company product sales is recognized upon transfer of control of a product to a customer at a point in time, generally as the Company's products are sold on an FOB destination basis and because inventory risk and risk of ownership passes to the customer upon delivery. Company product sales are recorded net of accruals for estimated chargebacks, rebates, cash discounts, other allowances, and returns. Contract Manufacturing Sales: The Company recognizes revenue for contract manufacturing sales over-time, as milestones are achieved. Shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. Contract manufacturing sales are recognized net of accruals for cash discounts and returns which are established at the time of sale, and are included in Revenue, net in the Company's Consolidated Statement of Operations. Research and Development Income: The Company establishes agreed upon product development agreements with its customers to perform product development services. Revenues are recognized in accordance with the agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Other types of revenue include royalty or licensing revenue, and would be recognized over time, or at a point in time, based upon the contractual term upon completion of the earnings process. Judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Revenue and Provision for Sales Returns and Allowances As is customary in the pharmaceutical industry, the Company’s product sales are subject to a variety of deductions including chargebacks, rebates, cash discounts, other allowances, and returns. Product sales are recorded net of accruals for returns and allowances ("SRA"), which are established at the time of sale. The Company analyzes the adequacy of its accruals for returns and allowances quarterly. Amounts accrued for sales deductions are adjusted when trends or significant events indicate that an adjustment is appropriate. Accruals are also adjusted to reflect actual results. These provisions are estimates based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and current contract sales terms with direct and indirect customers. The Company uses a variety of methods to assess the adequacy of its returns and allowances reserves to ensure that its financial statements are fairly stated. These include periodic reviews of customer inventory data, customer contract programs, subsequent actual payment experience, and product pricing trends to analyze and validate the return and allowances reserves. Chargebacks are one of the Company's most significant estimates for recognition of product sales. A chargeback represents an amount payable in the future to a wholesaler for the difference between the invoice price paid to the Company by its wholesale customer for a particular product and the negotiated contract price that the wholesaler’s customer pays for that product. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in customer pricing and changes to estimated wholesaler inventories. The provision for chargebacks also takes into account an estimate of the expected wholesaler sell-through levels to indirect customers at contract prices. The Company validates the chargeback accrual quarterly through a review of the inventory reports obtained from its largest wholesale customers. This customer inventory information is used to establish the estimated liability for future chargeback claims based on historical chargeback and contract rates. These large wholesalers represent a majority of the Company’s chargeback payments. The Company continually monitors current pricing trends and wholesaler inventory levels to ensure the liability for future chargebacks is fairly stated. Rebates are used for various discounts and rebates provided to customers. This account has been used for various one-time discounts given to customers. The Company reviews the percentage of products sold through these programs by reviewing chargeback data and uses the appropriate percentages to calculate the rebate accrual. Rebates are invoiced monthly, quarterly or annually and reviewed against the accruals. Other items that could be included in accrued rebates would be price protection fees, shelf stock adjustments (SSAs), or other various amounts that would serve as one time discounts on specific products. |
Concentration of Risk | Concentration of Risk Financial instruments, which subject the Company to concentration of credit risk, consist primarily of cash equivalents and trade receivables. The Company maintains its cash in accounts with quality financial institutions. Although the Company |
Acquisitions | Acquisitions The Company accounts for acquired businesses using the acquisition method of accounting, which requires with limited exceptions, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. When net assets that do not constitute a business are acquired, no goodwill is recognized. Contingent consideration, if any, is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts The Company extends credit to its contract services customers based upon credit evaluations in the normal course of business, primarily with 30-day terms. The Company does not require collateral from its customers. Bad debt provisions are provided for on the allowance method based on historical experience and management’s evaluation of outstanding accounts receivable. The Company reviews the allowance for doubtful accounts regularly, and past due balances are reviewed individually for collectability. The Company charges off uncollectible receivables against the allowance when the likelihood of collection is remote. The Company extends credit to wholesaler and distributor customers and national retail chain customers, based upon credit evaluations, in the normal course of business, primarily with 60 to 90 day terms. The Company maintains customer-related accruals and allowances that consist primarily of chargebacks, rebates, sales returns, shelf stock allowances, administrative fees and other incentive programs. Some of these adjustments relate specifically to the generic prescription pharmaceutical business. Typically, the aggregate gross-to-net adjustments related to these customers can exceed 70% of the gross sales through this distribution channel. Certain of these accruals and allowances are recorded in the balance sheet as current liabilities and others are recorded as a reduction to accounts receivable. |
Foreign Currency Translation | Foreign Currency Translation The net assets of international subsidiaries where the local currencies have been determined to be the functional currencies are translated into U.S. dollars using current exchange rates. The U.S. dollar effects that arise from translating the net assets of these subsidiaries at changing rates are recorded in the foreign currency translation account, which is included in accumulated other comprehensive income (loss) (AOCI) and reflected as a separate component of equity. For those subsidiaries where the U.S. dollar has been determined to be the functional currency, non-monetary foreign currency assets and liabilities are translated using historical rates, while monetary assets and liabilities are translated at current rates, with the U.S. dollar effects of rate changes included in Other (income) expense, net. |
Accounting for Environmental Costs | Accounting for Environmental Costs Accruals for environmental remediation are recorded when it is probable a liability has been incurred and costs are reasonably estimable. The estimated liabilities are recorded at undiscounted amounts. Environmental insurance recoveries are included in the statement of operations in the year in which the issue is resolved through settlement or other appropriate legal process. |
Income Taxes | Income Taxes The Company records income taxes in accordance with ASC 740-10, “Accounting for Income Taxes,” under the asset and liability method of accounting for income taxes. Under the asset and liability method, deferred income taxes are recognized for the tax consequences of temporary differences by applying enacted statutory tax rates applicable to future years to operating loss and tax credit carry forwards and differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recorded based on a determination of the ultimate realizability of future deferred tax assets. The Company complies with the provisions of ASC 740-10-25 that clarifies the accounting for uncertainty in income taxes recognized in an entity’s financial statements in accordance with ASC 740-10, “Accounting for Income Taxes,” and prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. Additionally, ASC 740-10 provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. There were no unrecognized tax benefits as of the date of adoption. As such, there are no unrecognized tax benefits included in the balance sheet that would, if recognized, affect the effective tax rate. The Company records interest and penalties relating to uncertain tax positions as a component of income tax expense. |
Stock-Based Compensation | Stock-Based Compensation ASC 718-10 defines the fair-value-based method of accounting for stock-based employee compensation plans and transactions used by the Company to account for its issuances of equity instruments to record compensation cost for stock-based employee compensation plans at fair value as well as to acquire goods or services from non-employees. Transactions in which the Company issues stock-based compensation to employees, directors and advisors and for goods or services received from non-employees are accounted for based on the fair value of the equity instruments issued. The Company utilizes pricing models in determining the fair values of options, RSU's and warrants issued as stock-based compensation. These pricing models utilize the market price of the Company’s common stock and the exercise price of the option or warrant, as well as time value and volatility factors underlying the positions. Stock-based compensation expense is recognized over the requisite service period of the award, which usually coincides with the vesting period of the grant. |
Shipping and Handling Costs | Shipping and Handling Costs |
Product Development and Research | Product Development and Research The Company’s research and development costs are expensed as incurred. |
Loss per Common Share | Loss per Common Share |
Adoption of Other Recent Accounting Pronouncements | Adoption of Other Recent Accounting Pronouncements In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows (Topic 230): "Restricted Cash (a consensus of the FASB Emerging Issues Task Force)". The update addresses the diversity in the industry with respect to classification and presentation of changes in restricted cash on the statement of cash flows. These amendments require that a statement of cash flows explain the restricted cash change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The amendments in this update were effective for fiscal years beginning after December 15, 2017 for public business entities, including interim periods within those fiscal years. For the Company, the amendments are effective January 1, 2018. The Company's adoption of this ASU was a full retrospective adoption, effective January 1, 2018, which did not have a significant impact on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-01, Business Combinations (Topic 805): “Clarifying the Definition of a Business”. The update clarifies the definition of a business, specifically for companies to better evaluate whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The amendments in this update are effective for public companies for annual periods beginning after December 15, 2017, including interim periods within those annual periods. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements. In January 2017, the FASB issued ASU 2017-03, Accounting Changes and Error Corrections (Topic 250) and Investments—Equity Method and Joint Ventures (Topic 323): “Amendments to SEC Paragraphs Pursuant to Staff Announcements at the September 22, 2016 and November 17, 2016 EITF Meetings”. The update shows amendments to two SEC Announcements made late in 2016 regarding four specific standards as follows: ASU 2014-09, Revenue from Contracts with Customers (Topic 606), ASU 2016-02, Leases (Topic 842), ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), and ASU 2014-01, Investments - Equity Method and Joint Ventures (Topic 323). The amendments in this update require changes to the U.S. GAAP Financial Reporting Taxonomy and the changes will be incorporated into the proposed 2018 Taxonomy which are available for public comment and finalized as part of the annual release process. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements. In February 2017, the FASB issued ASU 2017-05, Other Income—Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-20): “Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets”. This update addresses guidance for partial sales of nonfinancial assets. It affects (i) an entity that enters into a contract to transfer to a customer a nonfinancial asset, group of nonfinancial assets, or ownership interest in a consolidated subsidiary that is not a business or nonprofit entity, (ii) an entity that historically had transactions within the scope of the real estate-specific derecognition guidance, and (iii) an entity that contributes nonfinancial assets that are not a business or a nonprofit activity to a joint venture or other noncontrolled investee. The amendments are effective at the same time as the amendments in ASU 2014-09. Therefore, for the Company, the amendments are effective for annual reporting periods beginning after December 15, 2017, including interim reporting periods within that reporting period. Public entities may apply the guidance earlier but only as of annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period. The Company does not currently expect to enter into any such nonfinancial asset or ownership interest in its consolidated subsidiaries agreements but will refer to the guidance in ASU 2017-05 should that occur. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements. In May 2017, the FASB issued ASU 2017-09, Compensation—Stock Compensation (Topic 718): “Scope of Modification Accounting”. This update provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718, Compensation—Stock Compensation, to a change to the terms or conditions of a share-based payment award. The amendments affect any entity that changes the terms or conditions of a share-based payment award. The amendments are effective for fiscal years beginning after December 15, 2017. For the Company, the amendments are effective January 1, 2018. The Company has not made any changes to the terms or conditions of share-based payment awards but will refer to the guidance in ASU 2017-09 should that occur. The Company's adoption of this ASU, effective January 1, 2018, did not have a significant impact on its consolidated financial statements. Recently Issued and Not Yet Adopted Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842), which supersedes the existing lease guidance under Topic 840. The new standard requires lessees to recognize Right-of-Use ("ROU") assets and lease liabilities for all leases with terms greater than 12 months, including those leases that were previously classified as operating leases. Topic 842 retains a distinction between finance leases and operating leases, with measurement and presentation of expenses and cash flows being dependent upon the classification. The Company adopted the new standard on January 1, 2019 utilizing the optional transition method allowed under ASU 2018-11, Leases (Topic 842): Targeted Improvements. As a result, the effects of applying the new standard will be recognized as a cumulative effect adjustment to the opening balance of retained earnings on the date of initial adoption without recasting comparative periods under ASC 842. The Company elected to adopt the package of practical expedients allowed under the new accounting guidance, which allows the Company to not reassess previous conclusions regarding 1) whether existing or expired leases are or contain leases 2) the lease classification of existing or expired leases and 3) initial direct costs for existing leases. In addition, the Company adopted the practical expedient to combine lease and non-lease components. Lastly, the Company elected the short-term lease recognition exemption. The Company reviewed its portfolio of lease agreements, and other service contracts to identify embedded leases, and reached conclusions on key accounting assessments related to the standard and is finalizing the related accounting policies. As a result of the implementation of the new standard all leases with a term greater than 12 months previously classified as operating leases and only expensed through the Consolidated Statements of Operations will now be recorded on the Consolidated Balance Sheets. Per the requirements of the standard the company will record a ROU asset and a lease liability representing the present value of future lease payments to be paid in exchange of the use of an asset. However, there will be no impact on the net assets as the assets and the liabilities will off-set each other. Based on the assessment performed the adoption of the new standard is not expected to have a material impact on the financial statements. The value of the ROU asset and lease liability to be recorded upon adoption is less than 5% of total assets and total liabilities. In January 2017, the FASB issued ASU 2017-04, Intangibles - Goodwill and Other (Topic 350): “Simplifying the Test for Goodwill Impairment”. The update simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. For the Company, the amendments are effective January 1, 2020. The Company is currently evaluating the impact of this ASU on its consolidated financial statements. In February 2018, the FASB issued ASU 2018-02, “Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income,” which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Cuts and Jobs Act. This guidance is effective for all entities for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. The amendments in ASU 2018-02 should be applied either in the period of adoption or retrospectively to each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act is recognized. The adoption of this guidance is not expected to have a material impact on the Company's consolidated financial statements and related disclosures. |
Correction to Previously Issu_2
Correction to Previously Issued Consolidated Financial Statements (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Changes and Error Corrections [Abstract] | |
Schedule of Adjustments | The following tables summarize the effects of the Revision on the accompanying consolidated financial statements of the Company (in thousands): Consolidated Statements of Operations Year Ended December 31, 2017 Year Ended December 31, 2016 As Previously As Previously Reported Adjustment As Revised Reported Adjustment As Revised Revenue, net $ 67,251 $ (7,049) (1) $ 60,202 $ 66,881 $ (3,869) (1) $ 63,012 Cost of revenues 39,879 (7,049) (1) 32,830 32,194 (3,869) (1) 28,325 Total costs and expenses 79,048 (7,049) (1) 71,999 64,339 (3,869) (1) 60,470 Consolidated Balance Sheet December 31, 2017 As Previously Reported Adjustment As Revised Accounts receivable, net $ 18,143 $ (5,401) (1),(2) $ 12,742 Total current assets 64,532 (5,401) (1),(2) 59,131 Total assets 189,986 (5,401) (1),(2) 184,585 Accrued expenses 13,502 (5,401) (1),(2) 8,101 Total current liabilities 24,097 (5,401) (1),(2) 18,696 Total liabilities 145,233 (5,401) (1),(2) 139,832 Total liabilities and stockholders' equity 189,986 (5,401) (1),(2) 184,585 Consolidated Statement of Cash Flows Consolidated Statement of Cash Flows Twelve Months Ended December 31, 2017 Twelve Months Ended December 31, 2016 As Previously As Previously Reported Adjustment As Revised Reported Adjustment As Revised Cash flows from operating activities Accounts receivable $ 1,894 $ 4,070 (1),(2) $ 5,964 $ (8,008) $ 72 (1),(2) $ (7,936) Accounts payable and accrued expenses 5,711 (4,070) (1),(2) 1,641 2,897 (72) (1),(2) 2,825 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Restrictions on Cash and Cash Equivalents | The following table provides a reconciliation of cash and cash equivalents and restricted cash reported in the Consolidated Balance Sheet to the total amounts in the Consolidated Statement of Cash Flows as follows (in thousands): December 31, 2018 December 31, 2017 December 31, 2016 Cash and cash equivalents $ 9,705 $ 26,692 $ 66,006 Restricted cash 2,892 — — Restricted cash in other assets 472 473 475 Cash, cash equivalents and restricted cash in the statement of cash flows $ 13,069 $ 27,165 $ 66,481 |
Schedule Useful Lives | Depreciation and amortization of property, plant and equipment is provided for under the straight-line method over the assets’ estimated useful lives as follows: Descriptions Useful Lives Buildings and improvements 10 - 40 years Machinery and equipment 5 - 15 years Computer hardware and software 3 - 5 years Furniture and fixtures 5 years |
Schedule of Earnings Per Share, Basic and Diluted | For the years ended December 31, 2018, 2017 and 2016 (in thousands except shares and per share data) 2018 2017 2016 Basic loss per share computation: Net loss attributable to common stockholders —basic and diluted $ (36,256) $ (15,191) $ (11,985) Weighted average common shares —basic and diluted 53,592,930 53,323,954 53,078,158 Basic and diluted loss per share $ (0.68) $ (0.28) $ (0.23) |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories as of December 31, 2018 and 2017 consisted of (in thousands): 2018 2017 Raw materials $ 10,456 $ 8,231 Work in progress 116 616 Finished goods 8,391 8,532 Inventories reserve (2,667) (1,304) $ 16,296 $ 16,075 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment, at cost, as of December 31, 2018 and 2017, consisted of (in thousands): 2018 2017 Land $ 401 $ 257 Building and improvements 53,813 8,613 Machinery and equipment 12,229 9,142 Computer hardware and software 4,182 3,244 Furniture and fixtures 694 449 Construction in progress 30,949 55,017 102,268 76,722 Less accumulated depreciation and amortization (10,493) (8,367) Property, plant and equipment, net $ 91,775 $ 68,355 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Convertible debt | At December 31, 2018 and December 31, 2017, the net carrying amount of the debt and the remaining unamortized debt discounts and debt issuance costs were as follows (in thousands): December 31, 2018 December 31, 2017 (Current) (Non-current) Face amount of the 2019 Notes (due December 2019) $ 15,702 $ 143,750 Less unamortized discounts and debt issuance costs 1,291 22,773 Total net carrying value $ 14,411 $ 120,977 December 31, 2018 December 31, 2017 Face amount of the 2023 Notes (due May 2023) $ 75,090 $ — Face amount of the Revolver Credit Facility (due December 2022) 15,000 — Face amount of the 2023 Loan (due February 2023) 70,000 — Total carrying value, non-current $ 160,090 $ — Less unamortized discounts and debt issuance costs 20,519 — Total net carrying value, non-current $ 139,571 $ — |
Debt maturities schedule | Aggregate maturities of the Company’s debt are presented below (in thousands): Year Ending December 31, 2019 $ 15,702 2020 — 2021 — 2022 15,000 2023 145,090 Total $ 175,792 |
Revenues, Recognition and All_2
Revenues, Recognition and Allowances (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Disaggregation of Revenues | Net Sales (in thousands) for the three years ended December 31, 2018, 2017 and 2016 were as follows (prior-period amounts are not adjusted under the modified-retrospective method of adoption): Years ended December 31, 2018 2017 2016 Company product sales $ 59,591 $ 50,955 $ 45,002 Contract manufacturing sales 6,047 8,995 17,033 Research and development services and other income 227 252 977 Revenue, net $ 65,865 $ 60,202 $ 63,012 Disaggregated information for the Company product sales revenue has been recognized in the accompanying audited Consolidated Statements of Operations, and is presented below according to contract type (in thousands): Years ended December 31, Company Product Sales 2018 2017 2016 Topical $ 35,118 $ 29,446 $ 29,011 Injectables 24,473 21,509 15,991 Total $ 59,591 $ 50,955 $ 45,002 |
Schedule of Financing Receivable | The Company's adjustments for the deductions to gross product sales for the three years ended December 31, 2018, 2017 and 2016 are as follows (in thousands): Years ended December 31, 2018 2017 2016 Gross product sales $ 158,278 $ 215,883 $ 217,633 Reduction to gross product sales: Chargebacks and billbacks 60,770 125,159 141,343 Wholesaler fees for service 5,503 7,049 3,869 Sales discounts and other allowances 32,414 32,720 27,419 Total reduction to gross product sales $ 98,687 $ 164,928 $ 172,631 Product sales, net $ 59,591 $ 50,955 $ 45,002 Contract manufacturing product sales $ 6,047 $ 8,995 $ 17,033 Total product sales, net $ 65,865 $ 60,202 $ 63,012 |
Schedule Of Annual Activity Allowance For Customer Deductions Disclosure |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Goodwill | Changes in goodwill during the two years ended December 31, 2018 and December 31, 2017 were as follows (in thousands): Goodwill December 31, 2016 $ 446 Foreign currency translation 25 December 31, 2017 471 Foreign currency translation (1) December 31, 2018 $ 470 |
Finite and Indefinite Lived Intangible Assets | The following sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period as of December 31, 2018 and December 31, 2017 for those assets that are not already fully amortized (in thousands): December 31, 2018 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,169 $ (8,239) $ 31,930 11.8 Product acquisition costs 13,308 — 13,308 N/A - See description below In-process research and development 719 — 719 N/A - See description below Customer relationships 3,557 (1,139) 2,418 6.9 Total $ 57,753 $ (9,378) $ 48,375 December 31, 2017 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,380 $ (5,684) $ 34,696 12.8 Product acquisition costs 14,682 — 14,682 N/A - See description below In-process research and development 3,629 — 3,629 N/A - See description below Customer relationships 3,783 (773) 3,010 7.9 Total $ 62,474 $ (6,457) $ 56,017 |
Changes in Intangible Assets Other Than Goodwill | Changes in intangibles during the year ended December 31, 2018 were as follows (in thousands): Product Acquisition Costs Trademarks and IPR&D Customer Balance at December 31, 2017 $ 14,682 $ 34,696 $ 3,629 $ 3,010 Amortization — (2,727) — (369) Intangible assets placed in service — 1,346 (1,346) — Loss on impairment (716) (7) (1,201) — Foreign currency translation (658) (1,378) (363) (223) Balance at December 31, 2018 $ 13,308 $ 31,930 $ 719 $ 2,418 |
Finite-Lived Intangible Assets Future Amortization Expense | Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on trademarks and technology and customer relationships for each of the following years is estimated to be as follows (in thousands): Year ending December 31, Amortization Expense * 2019 $ 3,096 2020 3,096 2021 3,096 2022 3,096 2023 3,096 Thereafter 18,868 Total $ 34,348 *IPR&D and Product Acquisition Costs are assessed for impairment at least annually and will be amortized once products are commercialized, and are not included in the table. |
Finite-Lived Intangible Assets Useful Lives | The useful lives of the Company’s intangible assets are as follows: Intangibles Category Amortizable Life Product Acquisition Costs 10 years Trademarks & Technology 15 years Customer Relationships 10 years |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock Option Valuation Assumptions | The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities and risk-free interest rates are based upon the expected life of the grant. Assumptions 2018 2017 2016 Expected dividends 0 % 0 % 0 % Risk free rate 2.44 % 1.56 % 1.14 % Expected volatility 52.7%-72.5% 58.0% - 69.7% 68.0% - 71.3% Expected term (in years) 2.3 – 3.3 years 3.2 – 3.3 years 3.1 – 3.3 years |
Schedule of Stock Option Transactions | Stock option transactions in each of the past three years under the aforementioned plans in total were: Shares Exercise Weighted January 1, 2016 shares issuable under options 3,592,734 $0.79 - $10.67 $ 4.36 Granted 739,135 4.72 - 8.81 7.26 Exercised (61,834) 1.10 - 6.51 1.54 Expired — — — Forfeited (164,666) 4.55 – 10.67 8.37 December 31, 2016 shares issuable under options 4,105,369 $0.79 - $10.67 $ 4.76 Granted 577,845 3.38 - 9.28 7.15 Exercised (171,566) 0.79 - 5.85 1.92 Expired — — — Forfeited (211,838) 4.80 - 10.67 7.70 December 31, 2017 shares issuable under options 4,299,810 $0.79 - $10.67 $ 5.09 Granted 839,785 1.73-4.25 3.34 Exercised (239,000) 1.02-1.83 1.05 Expired — — — Forfeited (548,204) 2.02-10.67 8.04 December 31, 2018 shares issuable under options 4,352,391 $0.79-$10.67 $ 4.61 |
Schedule of Outstanding and Exercisable Stock Options | The following table summarizes information concerning outstanding and exercisable options as of December 31, 2018: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.50 1,510,000 3.12 $ 1.06 1,510,000 $ 1.06 $1.51 - $5.50 992,457 8.27 3.23 199,826 2.76 $5.51 - $10.67 1,849,934 6.99 8.24 1,528,686 8.45 Total 4,352,391 5.94 $ 4.61 3,238,512 $ 4.65 The following table summarizes information concerning outstanding and exercisable options as of December 31, 2017: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.00 25,000 2.01 $ 0.79 25,000 $ 0.79 $1.01 - $1.50 1,721,000 4.14 1.06 1,721,000 1.06 $1.51 - $10.67 2,553,810 7.76 7.85 1,369,466 7.92 Total 4,299,810 6.28 $ 5.09 3,115,466 $ 4.07 The following table summarizes information concerning outstanding and exercisable options as of December 31, 2016: Options Outstanding Options Exercisable Range of Number of Weighted Weighted Number of Weighted $0.79 - $1.00 50,000 3.01 $ 0.79 50,000 $ 0.79 $1.01 - $1.50 1,808,400 5.11 1.07 1,808,400 1.07 $1.51 - $10.67 2,246,969 8.35 7.82 805,803 7.15 Total 4,105,369 6.86 $ 4.76 2,664,203 $ 2.90 |
Nonvested Stock Option Activity | A summary of non-vested options at December 31, 2018 and changes during the year ended December 31, 2018 is presented below: Options Weighted Non-vested options at January 1, 2018 1,184,344 $ 3.48 Granted 839,785 1.44 Vested (699,572) 3.54 Forfeited (210,678) 3.37 Non-vested options at December 31, 2018 1,113,879 $ 2.00 |
Schedule of Nonvested Shares of Restricted Stock | A summary of non-vested RSUs and changes during each of the past three years is as follows: Number of Weighted Average Non-vested balance at January 1, 2016 182,750 $10.23 Changes during the period: Shares granted 58,068 7.50 Shares vested (60,918) 10.13 Shares forfeited — — Non-vested balance at December 31, 2016 179,900 $9.35 Changes during the period: Shares granted 93,468 7.26 Shares vested (80,274) 9.57 Shares forfeited (4,465) 7.09 Non-vested balance at December 31, 2017 188,629 $8.27 Changes during the period: Shares granted 122,949 3.36 Shares vested (109,940) 8.95 Shares forfeited (26,047) 5.76 Non-vested balance at December 31, 2018 175,591 $4.78 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Liabilities | For the fiscal years ended December 31, 2018, and 2017 the largest components of accrued expenses were (in thousands): 2018 2017 Professional fees $ 2,153 $ 546 Payroll 1,908 1,580 Inventory and supplies 1,809 58 Interest expense 1,042 240 Rebates 714 83 Medicaid and Medicare 383 1,487 Clinical Studies 334 596 Royalties 222 856 Capital expenditures 275 1,947 Wholesaler Fees 203 — Income Tax 45 58 Other 754 650 $ 9,842 $ 8,101 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Loss From Continuing Operations | Loss before income tax for the years ended December 31, 2018, 2017 and 2016 consisted of the following (in thousands): 2018 2017 2016 U.S. operations $ (32,183) $ (21,938) $ (9,514) Foreign operations (4,135) 6,662 (2,184) Global Total $ (36,318) $ (15,276) $ (11,698) |
Components of Income Tax Expense (Benefit) | The (credit) provision for income taxes attributable to continuing operations before income taxes for the years ended December 31, 2018, 2017 and 2016 is as follows (in thousands): 2018 2017 2016 Current tax expense (benefit): Federal $ — $ (86) $ 26 State and local 30 20 35 Foreign (157) 42 272 Total current tax (benefit) expense (127) (24) 333 Deferred tax expense: Federal — — — State and local — — — Foreign 65 (61) (46) Total deferred tax expense (benefit) 65 (61) (46) Total income tax (benefit) expense $ (62) $ (85) $ 287 |
Effective Income Tax Rate Reconciliation | A comparison of income tax (benefit) expense at the U.S. statutory rate of 21% in 2018 and 35% in 2017 and 2016 to the Company's effective rate is as follows (in thousands): 2018 2017 2016 Expected Statutory expense (benefit) $ (7,627) $ (5,195) $ (3,977) U.S. TCJA recovery of alternative minimum tax credits — (73) — Change in the fair values of derivative and amortization of debt discount — 2,939 2,584 Other non-deductible expenses 256 24 63 Change in valuation allowance including U.S. TCJA rate reduction 6,572 (2,012) 590 Reduction in deferred tax assets related to U.S. TCJA rate reduction — 7,504 — Change to Accounting for Equity Compensation Windfalls — (1,112) — Tax rate differential - foreign vs. U.S. 791 (2,276) 822 State income taxes, net of federal benefit 23 13 23 Shortfalls related to stock compensation expense — 129 154 Prior year true-up (93) (13) — Exchange gain 16 (13) 28 $ (62) $ (85) $ 287 |
Deferred Tax Balances | Deferred tax balances included in the Consolidated Balance Sheets as of December 31, 2018 and 2017 consisted of the following (in thousands): 2018 2017 Deferred Tax Assets: Sales allowances and doubtful accounts $ 1,964 $ 506 Inventory reserve 962 619 Deferred revenue 590 — Accrued expenses 23 664 Property, plant and equipment 258 214 Tax operating loss carryforwards 9,951 9,327 Tax credit and other carryforwards 1,299 168 Stock compensation 538 1,817 Total deferred tax assets 15,585 13,315 Less valuation allowance (12,120) (13,309) Net deferred tax assets 3,465 6 Deferred Tax Liabilities: Convertible debt conversion features (3,514) — Foreign exchange (28) — Intangible assets (138) (165) Total deferred tax liabilities (3,680) (165) Net deferred tax liability $ (215) $ (159) |
Operating Loss and Tax Credit Carryforward | Operating loss, tax credit and other carry forwards as of December 31, 2018 and 2017 were as follows (in thousands): 2018 2017 Federal: Net operating losses (see below) $ 45,081 $ 41,688 Disallowed interest expense (no expiration) 5,018 — Contributions (expiring through 2023) 524 210 Research tax credits (expiring through 2025) 135 168 State: New Jersey (expiring in 2038) 2,976 4,320 Other states (expiring through 2038) 2,307 1072 Foreign Net operating losses (no expiration) $ 257 $ 255 |
Operating Loss Carryforwards Expiration | At December 31, 2018, the Company’s U.S. federal net operating loss carryforwards will expire as follows (in thousands): Year Net Operating Loss 2020 - 2023 $ 8,227 2024 - 2029 9,063 2030 - 2032 9,926 2033 - 2036 6,296 2037 8,116 No expiration but subject to limitation 3,453 Total $ 45,081 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Future Minimum Lease Payments | Future minimum lease payments under non-cancelable operating leases are as follows (in thousands): Commitments 2019 $ 573 2020 611 2021 633 2022 610 2023 607 2024 200 $ 3,234 |
Quarterly Results (Unaudited) (
Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Information | The following is a summary of certain quarterly financial information for the fiscal years 2018 and 2017: First Second Third Fourth Total (in thousands, except per share data) Year Ended December 31, 2018 Total revenues, net $ 14,545 $ 16,249 $ 18,294 $ 16,777 $ 65,865 Gross profit 5,220 4,784 6,719 5,662 22,385 Operating loss (3,531) (4,910) (1,213) (5,445) (15,099) Net loss (4,802) (13,119) (3,945) (14,390) (36,256) Net loss attributable to common stockholders (4,802) (13,119) (3,945) (14,390) (36,256) Basic loss per share $ (0.09) $ (0.25) $ (0.07) $ (0.27) $ (0.68) Diluted loss per share $ (0.09) $ (0.25) $ (0.07) $ (0.27) $ (0.68) Year Ended December 31, 2017 Total revenues, net $ 17,663 $ 16,432 $ 11,340 $ 14,767 $ 60,202 Gross profit 10,934 8,037 2,538 5,863 27,372 Operating income (loss) 2,967 (1,782) (8,039) (4,943) (11,797) Net income (loss) 831 (919) (8,982) (6,121) (15,191) Net income (loss) attributable to common stockholders 831 (919) (8,982) (6,121) (15,191) Basic income (loss) per share $ 0.02 $ (0.02) $ (0.17) $ (0.11) $ (0.28) Diluted income (loss) per share $ 0.02 $ (0.02) $ (0.17) $ (0.11) $ (0.28) |
Correction to Previously Issu_3
Correction to Previously Issued Consolidated Financial Statements - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Reduction of revenue on wholesale fees | $ 7,000 | $ 3,900 | |||||||||
Increase (decrease) to accrued expenses | $ 1,600 | 1,600 | |||||||||
Revenue, net | $ 16,777 | $ 18,294 | $ 16,249 | $ 14,545 | $ 14,767 | $ 11,340 | $ 16,432 | $ 17,663 | $ 65,865 | 60,202 | 63,012 |
Adjustment | |||||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Revenue, net | $ (7,049) | $ (3,869) |
Correction to Previously Issu_4
Correction to Previously Issued Consolidated Financial Statements - Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Revenue, net | $ 16,777 | $ 18,294 | $ 16,249 | $ 14,545 | $ 14,767 | $ 11,340 | $ 16,432 | $ 17,663 | $ 65,865 | $ 60,202 | $ 63,012 |
Cost of revenues | 32,830 | 28,325 | |||||||||
Total costs and expenses | $ 80,964 | 71,999 | 60,470 | ||||||||
As Previously Reported | |||||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Revenue, net | 67,251 | 66,881 | |||||||||
Cost of revenues | 39,879 | 32,194 | |||||||||
Total costs and expenses | 79,048 | 64,339 | |||||||||
Adjustment | |||||||||||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||||||||||
Revenue, net | (7,049) | (3,869) | |||||||||
Cost of revenues | (7,049) | (3,869) | |||||||||
Total costs and expenses | $ (7,049) | $ (3,869) |
Correction to Previously Issu_5
Correction to Previously Issued Consolidated Financial Statements - Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Accounts receivable net | $ 12,742 | |
Total current assets | $ 48,386 | 59,131 |
Total assets | 190,892 | 184,585 |
Accrued expenses | 9,842 | 8,101 |
Total current liabilities | 32,612 | 18,696 |
Total liabilities | 172,471 | 139,832 |
Total liabilities and stockholders' equity | $ 190,892 | 184,585 |
As Previously Reported | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Accounts receivable net | 18,143 | |
Total current assets | 64,532 | |
Total assets | 189,986 | |
Accrued expenses | 13,502 | |
Total current liabilities | 24,097 | |
Total liabilities | 145,233 | |
Total liabilities and stockholders' equity | 189,986 | |
Adjustment | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Accounts receivable net | (5,401) | |
Total current assets | (5,401) | |
Total assets | (5,401) | |
Accrued expenses | (5,401) | |
Total current liabilities | (5,401) | |
Total liabilities | (5,401) | |
Total liabilities and stockholders' equity | $ (5,401) |
Correction to Previously Issu_6
Correction to Previously Issued Consolidated Financial Statements - Consolidated Statement of Cash Flows (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accounts receivable | $ (4,047) | $ 5,964 | $ (7,936) |
Accounts payable and accrued expenses | $ (3,405) | 1,641 | 2,825 |
As Previously Reported | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accounts receivable | 1,894 | (8,008) | |
Accounts payable and accrued expenses | 5,711 | 2,897 | |
Adjustment | |||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | |||
Accounts receivable | 4,070 | 72 | |
Accounts payable and accrued expenses | $ (4,070) | $ (72) |
Nature of the Business and Li_2
Nature of the Business and Liquidity (Details) | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2019USD ($) | Dec. 31, 2018USD ($)productsegment | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Business Combination Segment Allocation [Line Items] | ||||
Operating segments | segment | 1 | |||
Cash and cash equivalents | $ 9,705,000 | $ 26,692,000 | $ 66,006,000 | |
Proceeds from 2021 revolver | 15,000,000 | $ 0 | $ 0 | |
2023 Notes | Convertible debt | ||||
Business Combination Segment Allocation [Line Items] | ||||
Amount still available on loan agreements | 25,000,000 | |||
Revolving Credit Facility | ||||
Business Combination Segment Allocation [Line Items] | ||||
Remaining borrowing capacity | $ 10,000,000 | |||
Revolving Credit Facility | Subsequent Event | ||||
Business Combination Segment Allocation [Line Items] | ||||
Proceeds from 2021 revolver | $ 5,000,000 | |||
US | ||||
Business Combination Segment Allocation [Line Items] | ||||
Generic products marketed | product | 35 | |||
Branded generic products marketed | product | 4 | |||
CANADA | ||||
Business Combination Segment Allocation [Line Items] | ||||
Generic and branded generic products marketed | product | 27 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Reconciliation of Cash and Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Summary of Significant Accounting Policies Details [Line Items] | ||||
Cash and cash equivalents | $ 9,705 | $ 26,692 | $ 66,006 | |
Restricted Cash | 2,892 | 0 | 0 | |
Cash, cash equivalents and restricted cash in the statement of cash flows | 13,069 | 27,165 | 66,481 | $ 87,315 |
Other Assets | ||||
Summary of Significant Accounting Policies Details [Line Items] | ||||
Restricted Cash | $ 472 | $ 473 | $ 475 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - PP&E Useful Life (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Buildings and improvements | Minimum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 10 years |
Buildings and improvements | Maximum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 40 years |
Machinery and equipment | Minimum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Machinery and equipment | Maximum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 15 years |
Computer hardware and software | Minimum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 3 years |
Computer hardware and software | Maximum | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Furniture and fixtures | |
Summary of Significant Accounting Policies Details Depreciation of Property Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)product | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | |
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Impairment loss on IPR&D | $ 1,200,000 | ||||||||||
Loss on impairment of intangible assets | 700,000 | $ 1,924,000 | $ 113,000 | $ 16,000 | |||||||
Goodwill | 470,000 | $ 471,000 | 470,000 | 471,000 | 446,000 | ||||||
Accounts receivable net | 12,742,000 | 12,742,000 | |||||||||
Allowance for doubtful accounts | 2,636,000 | 2,185,000 | 2,636,000 | 2,185,000 | |||||||
Allowance for doubtful accounts related to one customer | 1,700,000 | $ 1,700,000 | |||||||||
Percentage of net sales for royalty | 40.00% | ||||||||||
Royalties | 222,000 | 856,000 | $ 222,000 | 856,000 | |||||||
Royalty expense | 2,200,000 | 2,200,000 | 3,000,000 | ||||||||
Company product sales, net | 16,777,000 | $ 18,294,000 | $ 16,249,000 | $ 14,545,000 | 14,767,000 | $ 11,340,000 | $ 16,432,000 | $ 17,663,000 | 65,865,000 | 60,202,000 | 63,012,000 |
Revenue, net | 158,278,000 | 215,883,000 | 217,633,000 | ||||||||
Total assets | 190,892,000 | 184,585,000 | 190,892,000 | 184,585,000 | |||||||
Foreign currency loss | 3,400,000 | ||||||||||
Unrecognized tax benefits | 0 | 0 | |||||||||
Unrecognized tax benefits that would impact effective tax rate | 0 | 0 | |||||||||
Cost of revenues | $ 43,480,000 | $ 32,830,000 | $ 28,325,000 | ||||||||
Net sales revenue | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 54.00% | 52.00% | 41.00% | ||||||||
Accounts receivable | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 68.00% | 63.00% | |||||||||
Customer one | Sales | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Company product sales, net | $ 21,200,000 | $ 17,000,000 | $ 12,300,000 | ||||||||
Customer one | Accounts receivable | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 30.00% | 15.00% | |||||||||
Customer two | Sales | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Company product sales, net | $ 6,900,000 | $ 7,400,000 | 7,200,000 | ||||||||
Customer two | Accounts receivable | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 19.00% | 44.00% | |||||||||
Customer three | Sales | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Company product sales, net | $ 7,300,000 | $ 6,900,000 | $ 6,800,000 | ||||||||
Customer three | Accounts receivable | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 19.00% | 4.00% | |||||||||
Maximum | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Intangible assets useful life | 15 years | ||||||||||
Minimum | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Intangible assets useful life | 10 years | ||||||||||
Net Of SRA Balance | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Accounts receivable net | 18,100,000 | 31,800,000 | $ 18,100,000 | $ 31,800,000 | |||||||
US | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Products which the company pays royalties | product | 4 | ||||||||||
Products manufactured, marketed, and distributed | product | 39 | ||||||||||
Wholesalers, Distributors, National Retail Chains | Maximum | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Terms of customer credit | 90 days | ||||||||||
Wholesalers, Distributors, National Retail Chains | Minimum | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Terms of customer credit | 60 days | ||||||||||
Econazole Nitrate Cream | Product Concentration Risk | Net sales revenue | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 2.00% | 4.00% | 8.00% | ||||||||
Lidocaine Ointment | Product Concentration Risk | Net sales revenue | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 7.00% | 17.00% | 23.00% | ||||||||
Zantac Injection | Product Concentration Risk | Net sales revenue | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Concentration risk | 5.00% | 10.00% | 3.00% | ||||||||
Shipping and Handling | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Cost of revenues | $ 2,100,000 | $ 1,200,000 | $ 700,000 | ||||||||
Domestic | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Revenue, net | 45,600,000 | 47,000,000 | 52,800,000 | ||||||||
Total assets | 132,700,000 | 112,600,000 | 132,700,000 | 112,600,000 | |||||||
Foreign | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Revenue, net | 20,200,000 | 13,200,000 | $ 10,200,000 | ||||||||
Total assets | 58,200,000 | $ 72,000,000 | 58,200,000 | $ 72,000,000 | |||||||
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 2 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Debt instrument, fair value disclosure | 67,600,000 | 67,600,000 | |||||||||
Reported Value Measurement | Fair Value, Inputs, Level 2 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Debt instrument, fair value disclosure | $ 71,300,000 | $ 71,300,000 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Computation of Earnings (Loss) per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Basic earnings (loss) per share computation: | |||||||||||
Net income (loss) attributable to common stockholders —basic | $ (14,390) | $ (3,945) | $ (13,119) | $ (4,802) | $ (6,121) | $ (8,982) | $ (919) | $ 831 | $ (36,256) | $ (15,191) | $ (11,985) |
Weighted average common shares - basic and diluted (in shares) | 53,592,930 | 53,323,954 | 53,078,158 | ||||||||
Basic and diluted loss per share (in dollars per share) | $ (0.68) | $ (0.28) | $ (0.23) |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 10,456 | $ 8,231 |
Work in progress | 116 | 616 |
Finished goods | 8,391 | 8,532 |
Inventories reserve | (2,667) | (1,304) |
Total | $ 16,296 | $ 16,075 |
Property, Plant and Equipment -
Property, Plant and Equipment - Schedule of Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 102,268 | $ 76,722 |
Less accumulated depreciation and amortization | (10,493) | (8,367) |
Property, plant and equipment, net | 91,775 | 68,355 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 401 | 257 |
Building and improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 53,813 | 8,613 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 12,229 | 9,142 |
Computer hardware and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 4,182 | 3,244 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 694 | 449 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 30,949 | $ 55,017 |
Property, Plant and Equipment_2
Property, Plant and Equipment - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation | $ 2,579 | $ 1,711 | $ 946 | |
Interest costs capitalized | 4,400 | 3,600 | ||
Construction in progress | ||||
Property, Plant and Equipment [Line Items] | ||||
Payroll | $ 1,800 | $ 800 | ||
Building and improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Amount reclassified from Construction in process to Building and improvements | $ 37,000 |
Debt - Narrative (Details)
Debt - Narrative (Details) - USD ($) | Dec. 21, 2018 | Dec. 13, 2018 | Jul. 16, 2018 | Jun. 01, 2018 | Apr. 27, 2018 | Feb. 28, 2019 | Jan. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 22, 2014 | Dec. 16, 2014 |
Debt Instrument [Line Items] | |||||||||||||
Partial extinguishment of equity component of Convertible 3.75% Senior Notes | $ (10,522,000) | ||||||||||||
Proceeds from 2021 revolver | $ 15,000,000 | $ 0 | $ 0 | ||||||||||
Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from 2021 revolver | $ 52,800,000 | ||||||||||||
Covenant, revenue required to attain | $ 125,000,000 | ||||||||||||
Convertible debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stated interest rate | 3.75% | 3.75% | |||||||||||
Initial Issuance | Convertible debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 125,000,000 | ||||||||||||
Additional Principal | Convertible debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 18,750,000 | ||||||||||||
Senior Notes, due December 2019 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stated interest rate | 3.75% | 3.75% | |||||||||||
Loss on debt extinguishment | $ 1,700,000 | $ 2,500,000 | |||||||||||
Partial extinguishment of equity component of Convertible 3.75% Senior Notes | (2,900,000) | ||||||||||||
Senior Notes, due December 2019 | Convertible debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 75,090,000 | $ 75,090,000 | |||||||||||
Stated interest rate | 4.75% | 4.75% | |||||||||||
Debt transfer amount | $ 75,100,000 | ||||||||||||
Partial extinguishment of equity component of Convertible 3.75% Senior Notes | $ (7,600,000) | ||||||||||||
Transaction costs | $ 300,000 | ||||||||||||
Senior Notes, due December 2019 | Convertible debt | Subsequent Event | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Repayment of term loan | $ 2,200,000 | $ 500,000 | |||||||||||
Senior Notes, Due 2023 | Convertible debt | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stated interest rate | 4.75% | ||||||||||||
Conversion price (in dollars per share) | $ 224.71 | ||||||||||||
Settlement conversion price (dollars per share) | $ 280.90 | ||||||||||||
Debt issuance costs | $ 1,600,000 | ||||||||||||
Unamortized discount | $ 19,000,000 | ||||||||||||
Interest rate, effective percentage | 11.90% | ||||||||||||
Deferred financing costs | $ 1,600,000 | ||||||||||||
Term Loan, due 2021 | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 25,000,000 | ||||||||||||
Debt issuance costs | 500,000 | ||||||||||||
Unamortized discount | $ 400,000 | ||||||||||||
Interest rate, effective percentage | 12.78% | ||||||||||||
Loss on debt extinguishment | 1,300,000 | ||||||||||||
Covenant, minimum cash balance | $ 5,000,000 | ||||||||||||
Proceeds from 2021 revolver | $ 10,000,000 | 15,000,000 | |||||||||||
Deferred financing costs | $ 500,000 | ||||||||||||
Transaction costs | 500,000 | ||||||||||||
Interest rate floor | 2.00% | ||||||||||||
Repayment of term loan | 25,600,000 | ||||||||||||
Repayments of long-term debt, interest | 100,000 | ||||||||||||
Term Loan, due 2021 | LIBOR | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Applicable margin | 9.00% | ||||||||||||
Revolving Credit Facility | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 15,000,000 | $ 15,000,000 | |||||||||||
Debt issuance costs | 300,000 | ||||||||||||
Unamortized discount | 500,000 | ||||||||||||
Line of credit maximum borrowing capacity | 25,000,000 | ||||||||||||
Proceeds from 2021 revolver | 15,000,000 | ||||||||||||
Deferred financing costs | $ 300,000 | ||||||||||||
Effective interest rate | 9.30% | 9.30% | |||||||||||
Revolving Credit Facility | Line of Credit | Subsequent Event | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Proceeds from 2021 revolver | 5,000,000 | ||||||||||||
Remaining borrowing capacity | $ 10,000,000 | ||||||||||||
Revolving Credit Facility | LIBOR | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Applicable margin | 3.75% | ||||||||||||
Revolving Credit Facility | Base Rate | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Applicable margin | 2.75% | ||||||||||||
Term Loan | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt issuance costs | $ 800,000 | ||||||||||||
Unamortized discount | 1,800,000 | ||||||||||||
Interest rate, effective percentage | 12.40% | 12.40% | |||||||||||
Deferred financing costs | $ 800,000 | ||||||||||||
Unused borrowing capacity, fee percentage | 1.00% | ||||||||||||
Term Loan | LIBOR | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Applicable margin | 8.75% | ||||||||||||
Term Loan | Base Rate | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Applicable margin | 7.75% | ||||||||||||
Term Loan | Initial Term Loan | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 50,000,000 | $ 70,000,000 | $ 70,000,000 | ||||||||||
Term Loan | Delayed Draw Term Loan A | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Debt issuance costs | 500,000 | ||||||||||||
Deferred financing costs | 500,000 | ||||||||||||
Amount drawn on term loan | $ 20,000,000 | ||||||||||||
Term Loan | Delayed Draw Term Loan A | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | 30,000,000 | ||||||||||||
Amount still available on loan agreements | 10,000,000 | 10,000,000 | |||||||||||
Term Loan | Delayed Draw Term Loan B | Line of Credit | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Face amount of the Notes | $ 15,000,000 | ||||||||||||
Amount still available on loan agreements | $ 15,000,000 | $ 15,000,000 |
Debt - Net Carrying Amount of L
Debt - Net Carrying Amount of Liability Component of Debt Discount (Details) - Convertible Notes Payable - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Face amount of the Notes | $ 160,090,000 | $ 0 |
Less unamortized discounts and debt issuance costs | 20,519,000 | 0 |
Carrying amount of the Notes | 139,571,000 | 0 |
Revolving Credit Facility | ||
Debt Instrument [Line Items] | ||
Face amount of the Notes | 15,000,000 | 0 |
Senior Notes, due December 2019 | ||
Debt Instrument [Line Items] | ||
Face amount of the Notes | 15,702,000 | 143,750,000 |
Less unamortized discounts and debt issuance costs | 1,291,000 | 22,773,000 |
Total net carrying value | 14,411,000 | 120,977,000 |
Senior Notes, due May 2023 | ||
Debt Instrument [Line Items] | ||
Face amount of the Notes | 75,090,000 | 0 |
Senior Notes, due February 2023 | ||
Debt Instrument [Line Items] | ||
Face amount of the Notes | $ 70,000,000 | $ 0 |
Debt - Debt Maturities Schedule
Debt - Debt Maturities Schedule (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Debt Disclosure [Abstract] | |
2019 | $ 15,702 |
2020 | 0 |
2021 | 0 |
2022 | 15,000 |
2023 | 145,090 |
Long-term debt | $ 175,792 |
Revenues, Recognition and All_3
Revenues, Recognition and Allowances - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)segmenttransaction_type | Dec. 31, 2017USD ($) | |
Revenue from Contract with Customer [Abstract] | ||
Types of transactions | transaction_type | 3 | |
Operating segments | segment | 1 | |
Allowance for doubtful accounts | $ 18,100 | $ 31,800 |
Allowance for doubtful accounts, current | 2,636 | $ 2,185 |
Allowance for doubtful accounts related to one customer | $ 1,700 |
Revenues, Recognition and All_4
Revenues, Recognition and Allowances - Disaggregation of Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | $ 16,777 | $ 18,294 | $ 16,249 | $ 14,545 | $ 14,767 | $ 11,340 | $ 16,432 | $ 17,663 | $ 65,865 | $ 60,202 | $ 63,012 |
Company product sales | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | 59,591 | 50,955 | 45,002 | ||||||||
Contract manufacturing sales | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | 6,047 | 8,995 | 17,033 | ||||||||
Research and development services and other income | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | 227 | 252 | 977 | ||||||||
Topical | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | 35,118 | 29,446 | 29,011 | ||||||||
Injectables | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue, net | $ 24,473 | $ 21,509 | $ 15,991 |
Revenues, Recognition and All_5
Revenues, Recognition and Allowances - Adjustments to Gross Product Sales (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Gross product sales | $ 158,278 | $ 215,883 | $ 217,633 | ||||||||
Reduction to gross product sales: | |||||||||||
Chargebacks and billbacks | 60,770 | 125,159 | 141,343 | ||||||||
Wholesaler fees for service | 5,503 | 7,049 | 3,869 | ||||||||
Sales discounts and other allowances | 32,414 | 32,720 | 27,419 | ||||||||
Total reduction to gross product sales | 98,687 | 164,928 | 172,631 | ||||||||
Revenue, net | $ 16,777 | $ 18,294 | $ 16,249 | $ 14,545 | $ 14,767 | $ 11,340 | $ 16,432 | $ 17,663 | 65,865 | 60,202 | 63,012 |
Company Product | |||||||||||
Reduction to gross product sales: | |||||||||||
Revenue, net | 59,591 | 50,955 | 45,002 | ||||||||
Contract Manufacturing Product | |||||||||||
Reduction to gross product sales: | |||||||||||
Revenue, net | 6,047 | 8,995 | 17,033 | ||||||||
Product sales, net | |||||||||||
Reduction to gross product sales: | |||||||||||
Revenue, net | $ 65,865 | $ 60,202 | $ 63,012 |
Goodwill and Intangible Asset_2
Goodwill and Intangible Assets - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 30, 2015 | |
Business Acquisition [Line Items] | ||||
Goodwill | $ 470 | $ 471 | $ 446 | |
Amortization of intangibles | 3,096 | 2,930 | $ 2,833 | |
Alveda Acquisition | ||||
Business Acquisition [Line Items] | ||||
Goodwill | $ 400 | |||
In-process research and development (IPR&D) | ||||
Business Acquisition [Line Items] | ||||
Intangible asset impairment | 1,200 | |||
Change in intangible assets | (14,700) | |||
Product Acquisition Costs | ||||
Business Acquisition [Line Items] | ||||
Amortization of intangibles | 0 | |||
Intangible asset impairment | $ 700 | 100 | ||
Change in product acquisition costs | $ 14,700 |
Goodwill and Intangible Asset_3
Goodwill and Intangible Assets - Schedule of Changes in Goodwill (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill [Roll Forward] | ||
Goodwill beginning balance | $ 471 | $ 446 |
Foreign currency translation | (1) | 25 |
Goodwill ending balance | $ 470 | $ 471 |
Goodwill and Intangible Asset_4
Goodwill and Intangible Assets - Major Categories of Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | ||
Intangible assets accumulated amortization | $ (9,378) | $ (6,457) |
Finite-lived intangible assets, net carrying amount | 48,375 | 56,017 |
Intangible assets gross carrying amount | 57,753 | 62,474 |
Intangible assets net carrying amount | 48,375 | 56,017 |
In-process research and development (IPR&D) | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets | 719 | 3,629 |
Product Acquisition Costs | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-lived intangible assets, gross carrying amount | 13,308 | 14,682 |
Intangible assets accumulated amortization | 0 | 0 |
Finite-lived intangible assets, net carrying amount | 13,308 | 14,682 |
Trademarks and Technology | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-lived intangible assets, gross carrying amount | 40,169 | 40,380 |
Intangible assets accumulated amortization | (8,239) | (5,684) |
Finite-lived intangible assets, net carrying amount | $ 31,930 | $ 34,696 |
Intangible assets remaining amortization period | 11 years 9 months 18 days | 12 years 9 months 18 days |
Customer Relationships | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-lived intangible assets, gross carrying amount | $ 3,557 | $ 3,783 |
Intangible assets accumulated amortization | (1,139) | (773) |
Finite-lived intangible assets, net carrying amount | $ 2,418 | $ 3,010 |
Intangible assets remaining amortization period | 6 years 10 months 24 days | 7 years 10 months 24 days |
Goodwill and Intangible Asset_5
Goodwill and Intangible Assets - Changes in Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Indefinite-lived Intangible Assets [Roll Forward] | ||||
Loss on impairment | $ (1,200) | |||
Finite-lived Intangible Assets [Roll Forward] | ||||
Intangible assets net beginning balance | $ 56,017 | |||
Amortization | (3,096) | $ (2,930) | $ (2,833) | |
Loss on impairment | (700) | (1,924) | (113) | $ (16) |
Intangible assets net ending balance | 48,375 | 48,375 | 56,017 | |
In-process research and development (IPR&D) | ||||
Indefinite-lived Intangible Assets [Roll Forward] | ||||
Indefinite intangible assets net beginning balance | 3,629 | |||
Intangible assets placed in service | (1,346) | |||
Loss on impairment | (1,201) | |||
Foreign currency translation | (363) | |||
Indefinite intangible assets net ending balance | 719 | 719 | 3,629 | |
Product Acquisition Costs | ||||
Finite-lived Intangible Assets [Roll Forward] | ||||
Intangible assets net beginning balance | 14,682 | |||
Amortization | 0 | |||
Intangible assets placed in service | 0 | |||
Loss on impairment | (716) | |||
Foreign currency translation | (658) | |||
Intangible assets net ending balance | 13,308 | 13,308 | 14,682 | |
Trademarks and Technology | ||||
Finite-lived Intangible Assets [Roll Forward] | ||||
Intangible assets net beginning balance | 34,696 | |||
Amortization | (2,727) | |||
Intangible assets placed in service | 1,346 | |||
Loss on impairment | (7) | |||
Foreign currency translation | (1,378) | |||
Intangible assets net ending balance | 31,930 | 31,930 | 34,696 | |
Customer Relationships | ||||
Finite-lived Intangible Assets [Roll Forward] | ||||
Intangible assets net beginning balance | 3,010 | |||
Amortization | (369) | |||
Intangible assets placed in service | 0 | |||
Loss on impairment | 0 | |||
Foreign currency translation | (223) | |||
Intangible assets net ending balance | $ 2,418 | $ 2,418 | $ 3,010 |
Goodwill and Intangible Asset_6
Goodwill and Intangible Assets - Schedule of Amortization Expense (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2019 | $ 3,096 |
2020 | 3,096 |
2021 | 3,096 |
2022 | 3,096 |
2023 | 3,096 |
Thereafter | 18,868 |
Total | $ 34,348 |
Goodwill and Intangible Asset_7
Goodwill and Intangible Assets - Useful Lives of Intangibles (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Product Acquisition Costs | |
Finite-Lived Intangible Assets [Line Items] | |
Intangible assets useful life | 10 years |
Trademarks and Technology | |
Finite-Lived Intangible Assets [Line Items] | |
Intangible assets useful life | 15 years |
Customer Relationships | |
Finite-Lived Intangible Assets [Line Items] | |
Intangible assets useful life | 10 years |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - USD ($) $ in Millions | May 25, 2016 | Apr. 12, 2010 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | May 21, 2018 | Dec. 31, 2015 | May 29, 2010 |
Stock Based Compensation Details [Line Items] | ||||||||
Shares of common stock outstanding | 53,774,221 | 53,400,281 | ||||||
Intrinsic value of options outstanding | $ 0.5 | $ 4.7 | $ 11.5 | |||||
Intrinsic value of options exercisable | 0.5 | 4.7 | 11.3 | |||||
Intrinsic value of options exercised | 0.1 | 0.4 | 0.3 | |||||
Unrecognized compensation costs | 1.2 | |||||||
General and Administrative Expense | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Stock option based expenses | $ 1.5 | $ 2.3 | $ 2.3 | |||||
Director Stock Option Plan - 1999 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 1,975,000 | |||||||
Number of options granted (in shares) | 2,634,798 | |||||||
Number of options forfeited (in shares) | 807,782 | |||||||
Vesting period | 1 year | |||||||
Maximum term | 10 years | |||||||
Number of options outstanding (in shares) | 500,000 | 500,000 | ||||||
Shares available for grant | 147,984 | |||||||
Nineteen Ninety Nine Stock Incentive Plan | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 3,200,000 | |||||||
Number of options granted (in shares) | 2,892,500 | |||||||
Vesting period | 4 years | |||||||
Maximum term | 10 years | |||||||
Percent of FMV options granted | 100.00% | |||||||
Service period | 1 year | |||||||
Plan 2009 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 2,500,000 | 5,000,000 | ||||||
Number of options outstanding (in shares) | 2,458,106 | |||||||
Additional shares authorized (in shares) | 2,000,000 | |||||||
Maximum number of shares to any individual (in shares) | 1,000,000 | |||||||
Shares of common stock outstanding | 1,853,925 | 1,422,020 | ||||||
Options transferred (in shares) | 346,504 | 249,052 | ||||||
Plan 2016 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 2,000,000 | 4,000,000 | ||||||
Shares available for grant | 3,113,374 | 1,526,857 | ||||||
Maximum number of shares to any individual (in shares) | 1,000,000 | |||||||
Shares of common stock outstanding | 74,667 | 20,000 | ||||||
Plan 2016, Plan 2009 And Director Plan | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Number of options outstanding (in shares) | 4,352,391 | 4,299,810 | ||||||
Restricted Stock Units (RSUs) | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 175,591 | 188,629 | 179,900 | 182,750 | ||||
Restricted Stock Units (RSUs) | Plan 2009 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 14,377 | 99,626 | ||||||
Restricted Stock Units (RSUs) | Plan 2016 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 161,214 | |||||||
Shares of common stock outstanding | 89,003 | |||||||
Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Stock option based expenses | $ 0.5 | $ 1 | $ 0.8 | |||||
Unrecognized compensation costs | $ 0.5 | |||||||
Common Stock | Plan 2009 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Number of options outstanding (in shares) | 3,038,634 | |||||||
Common Stock | Plan 2016 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Number of options outstanding (in shares) | 1,394,285 | 761,176 | ||||||
Minimum | Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Vesting period | 1 year | |||||||
Maximum | Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Vesting period | 3 years |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Valuation Assumptions (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock Based Compensation [Line Items] | |||
Expected dividends | 0.00% | 0.00% | 0.00% |
Risk free rate | 2.44% | 1.56% | 1.14% |
Minimum | |||
Stock Based Compensation [Line Items] | |||
Expected volatility | 52.70% | 58.00% | 68.00% |
Expected term (in years) | 2 years 3 months 18 days | 3 years 2 months 12 days | 3 years 1 month 6 days |
Maximum | |||
Stock Based Compensation [Line Items] | |||
Expected volatility | 72.50% | 69.70% | 71.30% |
Expected term (in years) | 3 years 3 months 18 days | 3 years 3 months 18 days | 3 years 3 months 18 days |
Stock-Based Compensation - Sc_2
Stock-Based Compensation - Schedule of Stock Option Activity (Details) - Employee Stock Option - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |||
Number of options outstanding (in shares), beginning | 4,299,810 | 4,105,369 | 3,592,734 |
Number of options granted (in shares) | 839,785 | 577,845 | 739,135 |
Number of options exercised (in shares) | (239,000) | (171,566) | (61,834) |
Number of options expired (in shares) | 0 | 0 | 0 |
Number of options forfeited (in shares) | (548,204) | (211,838) | (164,666) |
Number of options outstanding (in shares), ending | 4,352,391 | 4,299,810 | 4,105,369 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Shares issuable under options exercise price per share (in dollars per share) | $ 5.09 | $ 4.76 | $ 4.36 |
Granted, exercise price per share (in dollars per share) | 3.34 | 7.15 | 7.26 |
Exercised, exercise price per share (in dollars per share) | 1.05 | 1.92 | 1.54 |
Expired, exercise price per share (in dollars per share) | 0 | 0 | 0 |
Forfeited, exercise price per share (in dollars per share) | 8.04 | 7.70 | 8.37 |
Shares issuable under options exercise price per share (in dollars per share) | 4.61 | 5.09 | 4.76 |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Shares issuable under options exercise price per share (in dollars per share) | 0.79 | 0.79 | 0.79 |
Granted, exercise price per share (in dollars per share) | 1.73 | 3.38 | 4.72 |
Exercised, exercise price per share (in dollars per share) | 1.02 | 0.79 | 1.10 |
Forfeited, exercise price per share (in dollars per share) | 2.02 | 4.80 | 4.55 |
Shares issuable under options exercise price per share (in dollars per share) | 0.79 | 0.79 | 0.79 |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||
Shares issuable under options exercise price per share (in dollars per share) | 10.67 | 10.67 | 10.67 |
Granted, exercise price per share (in dollars per share) | 4.25 | 9.28 | 8.81 |
Exercised, exercise price per share (in dollars per share) | 1.83 | 5.85 | 6.51 |
Forfeited, exercise price per share (in dollars per share) | 10.67 | 10.67 | 10.67 |
Shares issuable under options exercise price per share (in dollars per share) | $ 10.67 | $ 10.67 | $ 10.67 |
Stock-Based Compensation - Sc_3
Stock-Based Compensation - Schedule of Outstanding and Exercisable Options (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, number of options (in shares) | 4,352,391 | 4,299,810 | 4,105,369 |
Options outstanding, weighted average remaining contractual term | 5 years 11 months 8 days | 6 years 3 months 10 days | 6 years 10 months 9 days |
Options outstanding, weighted average exercise price (in dollars per share) | $ 4.61 | $ 5.09 | $ 4.76 |
Options exercisable, number of options (in shares) | 3,238,512 | 3,115,466 | 2,664,203 |
Options exercisable, weighted average exercise price (in dollars per share) | $ 4.65 | $ 4.07 | $ 2.90 |
$0.79 - $1.50 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 0.79 | ||
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 1.50 | ||
Options outstanding, number of options (in shares) | 1,510,000 | ||
Options outstanding, weighted average remaining contractual term | 3 years 1 month 13 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 1.06 | ||
Options exercisable, number of options (in shares) | 1,510,000 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 1.06 | ||
$1.51 - $5.50 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 1.51 | ||
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 5.50 | ||
Options outstanding, number of options (in shares) | 992,457 | 50,000 | |
Options outstanding, weighted average remaining contractual term | 8 years 3 months 7 days | 3 years 3 days | |
Options outstanding, weighted average exercise price (in dollars per share) | $ 3.23 | $ 0.79 | |
Options exercisable, number of options (in shares) | 199,826 | 50,000 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 2.76 | $ 0.79 | |
$5.51 - $10.67 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 5.51 | ||
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 10.67 | ||
Options outstanding, number of options (in shares) | 1,849,934 | 2,246,969 | |
Options outstanding, weighted average remaining contractual term | 6 years 11 months 26 days | 8 years 4 months 6 days | |
Options outstanding, weighted average exercise price (in dollars per share) | $ 8.24 | $ 7.82 | |
Options exercisable, number of options (in shares) | 1,528,686 | 805,803 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 8.45 | $ 7.15 | |
$0.79 - $1.00 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 0.79 | 0.79 | |
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 1 | 1 | |
Options outstanding, number of options (in shares) | 25,000 | ||
Options outstanding, weighted average remaining contractual term | 2 years 3 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 0.79 | ||
Options exercisable, number of options (in shares) | 25,000 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 0.79 | ||
1.01 - 1.50 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 1.01 | 1.01 | |
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 1.50 | $ 1.50 | |
Options outstanding, number of options (in shares) | 1,721,000 | 1,808,400 | |
Options outstanding, weighted average remaining contractual term | 4 years 1 month 20 days | 5 years 1 month 9 days | |
Options outstanding, weighted average exercise price (in dollars per share) | $ 1.06 | $ 1.07 | |
Options exercisable, number of options (in shares) | 1,721,000 | 1,808,400 | |
Options exercisable, weighted average exercise price (in dollars per share) | $ 1.06 | $ 1.07 | |
1.51 - 10.67 | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |||
Options outstanding, exercise price range, lower range limit (in dollars per share) | 1.51 | 1.51 | |
Options outstanding, exercise price range, upper range limit (in dollars per share) | $ 10.67 | $ 10.67 | |
Options outstanding, number of options (in shares) | 2,553,810 | ||
Options outstanding, weighted average remaining contractual term | 7 years 9 months 3 days | ||
Options outstanding, weighted average exercise price (in dollars per share) | $ 7.85 | ||
Options exercisable, number of options (in shares) | 1,369,466 | ||
Options exercisable, weighted average exercise price (in dollars per share) | $ 7.92 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Non-Vested Options (Details) - Non Vested | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Non-vested options at beginning of period (in shares) | shares | 1,184,344 |
Options, granted (in shares) | shares | 839,785 |
Option, Vested (in shares) | shares | (699,572) |
Options, Forfeited (in shares) | shares | (210,678) |
Non-vested options at end of period (in shares) | shares | 1,113,879 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Non-vested options at beginning of period (in dollars per share) | $ / shares | $ 3.48 |
Granted (in dollars per share) | $ / shares | 1.44 |
Vested (in dollars per share) | $ / shares | 3.54 |
Forfeited (in dollars per share) | $ / shares | 3.37 |
Non-vested options at end of period (in dollars per share) | $ / shares | $ 2 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary and Changes of Non-Vested Restricted Stock (Details) - Restricted Stock Units (RSUs) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Number of restricted stock, non-vested balance beginning (in shares) | 188,629 | 179,900 | 182,750 |
Shares granted (in shares) | 122,949 | 93,468 | 58,068 |
Shares vested (in shares) | (109,940) | (80,274) | (60,918) |
Shares forfeited (in shares) | (26,047) | (4,465) | 0 |
Number of restricted stock, non-vested balance ending (in shares) | 175,591 | 188,629 | 179,900 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Exercise price, non-vested balance beginning (in dollars per share) | $ 8.27 | $ 9.35 | $ 10.23 |
Shares granted - exercise price (in dollars per share) | 3.36 | 7.26 | 7.50 |
Shares vested - exercise price (in dollars per share) | 8.95 | 9.57 | 10.13 |
Shares forfeited - exercise price (in dollars per share) | 5.76 | 7.09 | 0 |
Exercise price, non-vested balance beginning (in dollars per share) | $ 4.78 | $ 8.27 | $ 9.35 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables and Accruals [Abstract] | ||
Professional fees | $ 2,153 | $ 546 |
Payroll | 1,908 | 1,580 |
Inventory and supplies | 1,809 | 58 |
Interest expense | 1,042 | 240 |
Rebates | 714 | 83 |
Medicaid and Medicare | 383 | 1,487 |
Clinical Studies | 334 | 596 |
Royalties | 222 | 856 |
Capital expenditures | 275 | 1,947 |
Wholesaler Fees | 203 | 0 |
Income Tax | 45 | 58 |
Other | 754 | 650 |
Accrued Liabilities | $ 9,842 | $ 8,101 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Examination [Line Items] | |||
Income tax (benefit) expense | $ (62) | $ (85) | $ 287 |
U.S. TCJA recovery of alternative minimum tax credits | 0 | 73 | $ 0 |
Deferred tax assets valuation allowance | 12,120 | 13,309 | |
Valuation allowance increase (decrease) | (1,200) | ||
Decrease related to changes in deferred taxes | 2,000 | ||
Valuation allowance, net operating loss | $ 800 | ||
Change in ownership percentage (more than) | 50.00% | ||
Stockholder ownership (or greater) | 5.00% | ||
Not Subject to Limitations | |||
Income Tax Examination [Line Items] | |||
Proceeds from sale of operating loss carryforward | $ 26,500 | ||
Subject to Limitations | Minimum | |||
Income Tax Examination [Line Items] | |||
Net operating losses | 1,000 | ||
Subject to Limitations | Maximum | |||
Income Tax Examination [Line Items] | |||
Net operating losses | $ 2,300 | ||
Alternative Minimum Tax Carryover | |||
Income Tax Examination [Line Items] | |||
U.S. TCJA recovery of alternative minimum tax credits | $ 73 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income (Loss) Before Income Tax (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
U.S. operations | $ (32,183) | $ (21,938) | $ (9,514) |
Foreign operations | (4,135) | 6,662 | (2,184) |
Loss before income tax expense | $ (36,318) | $ (15,276) | $ (11,698) |
Income Taxes - Schedule of In_2
Income Taxes - Schedule of Income Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Current tax expense (benefit): | |||
Federal | $ 0 | $ (86) | $ 26 |
State and local | 30 | 20 | 35 |
Foreign | (157) | 42 | 272 |
Total current tax (benefit) expense | (127) | (24) | 333 |
Deferred tax expense: | |||
Federal | 0 | 0 | 0 |
State and local | 0 | 0 | 0 |
Foreign | 65 | (61) | (46) |
Total deferred tax expense (benefit) | 65 | (61) | (46) |
Total income tax (benefit) expense | $ (62) | $ (85) | $ 287 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax (Benefit) Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||
Expected Statutory expense (benefit) | $ (7,627) | $ (5,195) | $ (3,977) |
U.S. TCJA recovery of alternative minimum tax credits | 0 | (73) | 0 |
Change in the fair values of derivative and amortization of debt discount | 0 | 2,939 | 2,584 |
Other non-deductible expenses | 256 | 24 | 63 |
Change in valuation allowance including U.S. TCJA rate reduction | 6,572 | (2,012) | 590 |
Reduction in deferred tax assets related to U.S. TCJA rate reduction | 0 | 7,504 | 0 |
Change to Accounting for Equity Compensation Windfalls | 0 | (1,112) | 0 |
Tax rate differential - foreign vs. U.S. | 791 | (2,276) | 822 |
State income taxes, net of federal benefit | 23 | 13 | 23 |
Shortfalls related to stock compensation expense | 0 | 129 | 154 |
Prior year true-up | (93) | (13) | 0 |
Exchange gain | 16 | (13) | 28 |
Total income tax (benefit) expense | $ (62) | $ (85) | $ 287 |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred Tax Assets: | ||
Sales allowances and doubtful accounts | $ 1,964 | $ 506 |
Inventory reserve | 962 | 619 |
Deferred revenue | 590 | 0 |
Accrued expenses | 23 | 664 |
Property, plant and equipment | 258 | 214 |
Tax operating loss carryforwards | 9,951 | 9,327 |
Tax credit and other carryforwards | 1,299 | 168 |
Stock compensation | 538 | 1,817 |
Total deferred tax assets | 15,585 | 13,315 |
Less valuation allowance | (12,120) | (13,309) |
Net deferred tax assets | 3,465 | 6 |
Deferred Tax Liabilities: | ||
Convertible debt conversion features | (3,514) | 0 |
Foreign exchange | (28) | 0 |
Intangible assets | (138) | (165) |
Total deferred tax liabilities | (3,680) | (165) |
Net deferred tax liability | $ (215) | $ (159) |
Income Taxes - Schedule of Oper
Income Taxes - Schedule of Operating Loss and Tax Credit Carryforwards (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Operating Loss Carryforwards [Line Items] | ||
Contributions (expiring through 2023) | $ 45,081 | |
Federal | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 45,081 | $ 41,688 |
Disallowed interest expense (no expiration) | 5,018 | 0 |
Contributions (expiring through 2023) | 524 | 210 |
Research tax credits (expiring through 2025) | 135 | 168 |
State | New Jersey (expiring in 2038) | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 2,976 | 4,320 |
State | Other states (expiring through 2038) | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | 2,307 | 1,072 |
Foreign | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating losses | $ 257 | $ 255 |
Income Taxes - Schedule of Fede
Income Taxes - Schedule of Federal Net Operating Loss Carryforward Expirations (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Income Tax Disclosure [Line Items] | |
Net operating loss | $ 45,081 |
2020 - 2023 | |
Income Tax Disclosure [Line Items] | |
Net operating loss | 8,227 |
2024 - 2029 | |
Income Tax Disclosure [Line Items] | |
Net operating loss | 9,063 |
2030 - 2032 | |
Income Tax Disclosure [Line Items] | |
Net operating loss | 9,926 |
2033 - 2036 | |
Income Tax Disclosure [Line Items] | |
Net operating loss | 6,296 |
2037 | |
Income Tax Disclosure [Line Items] | |
Net operating loss | 8,116 |
No expiration but subject to limitation | |
Income Tax Disclosure [Line Items] | |
Net operating loss | $ 3,453 |
Commitments - Schedule of Futur
Commitments - Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Maturity | |
2019 | $ 573 |
2020 | 611 |
2021 | 633 |
2022 | 610 |
2023 | 607 |
2024 | 200 |
Total | $ 3,234 |
Commitments - Narrative (Detail
Commitments - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Leases [Abstract] | |||
Rent expense | $ 0.5 | $ 0.5 | $ 0.9 |
Other commitment | $ 2.4 |
Legal and U.S. Regulatory Pro_2
Legal and U.S. Regulatory Proceedings (Details) $ in Millions | Oct. 20, 2017USD ($) | Dec. 31, 2018numberOfDrugslawsuitdefendant |
Minimum | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Number of defendants | defendant | 36 | |
Maximum | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Number of defendants | defendant | 43 | |
Anti-Trust Lawsuit | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Number of actions | lawsuit | 12 | |
Anti-Trust Lawsuit | Minimum | Opt Out | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Number of drugs involved | numberOfDrugs | 24 | |
Anti-Trust Lawsuit | Maximum | Opt Out | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Number of drugs involved | numberOfDrugs | 29 | |
Stayma Consulting Services | ||
Legal and U.S. Regulatory Proceedings Details [Line Items] | ||
Damages sought | $ | $ 1.7 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Maximum annual contribution per employee, percent | 100.00% | ||
Minimum annual contribution per employee, percent | 1.00% | ||
Maximum annual contribution per employee | $ 18,500 | $ 18,000 | $ 18,000 |
Cost recognized | 358,167 | 311,467 | 228,619 |
Catchup Contribution Max | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Maximum annual contribution per employee | $ 6,000 | $ 6,000 | $ 6,000 |
Tranche one | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Employer matching contribution, percent of match | 100.00% | ||
Percentage of participant contribution | 3.00% | ||
Tranche two | |||
Defined Contribution Plan Disclosure [Line Items] | |||
Employer matching contribution, percent of match | 50.00% | ||
Percentage of participant contribution | 2.00% |
Quarterly Results (Unaudited)_2
Quarterly Results (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Product Information [Line Items] | |||||||||||
Revenue, net | $ 16,777 | $ 18,294 | $ 16,249 | $ 14,545 | $ 14,767 | $ 11,340 | $ 16,432 | $ 17,663 | $ 65,865 | $ 60,202 | $ 63,012 |
Cost of revenues | 32,830 | 28,325 | |||||||||
Gross profit | 5,662 | 6,719 | 4,784 | 5,220 | 5,863 | 2,538 | 8,037 | 10,934 | 22,385 | 27,372 | |
Operating (loss) income | (5,445) | (1,213) | (4,910) | (3,531) | (4,943) | (8,039) | (1,782) | 2,967 | (15,099) | (11,797) | 2,542 |
Net loss | (14,390) | (3,945) | (13,119) | (4,802) | (6,121) | (8,982) | (919) | 831 | (36,256) | (15,191) | (11,985) |
Net income (loss) attributable to common stockholders | $ (14,390) | $ (3,945) | $ (13,119) | $ (4,802) | $ (6,121) | $ (8,982) | $ (919) | $ 831 | $ (36,256) | $ (15,191) | (11,985) |
Basic income (loss) per share (in dollars per share) | $ (0.27) | $ (0.07) | $ (0.25) | $ (0.09) | $ (0.11) | $ (0.17) | $ (0.02) | $ 0.02 | $ (0.68) | $ (0.28) | |
Diluted income (loss) per share (in dollars per share) | $ (0.27) | $ (0.07) | $ (0.25) | $ (0.09) | $ (0.11) | $ (0.17) | $ (0.02) | $ 0.02 | $ (0.68) | $ (0.28) | |
Adjustment | |||||||||||
Product Information [Line Items] | |||||||||||
Revenue, net | $ (7,049) | (3,869) | |||||||||
Cost of revenues | $ (7,049) | $ (3,869) | |||||||||
Adjustment | Immaterial Accounting Errors | |||||||||||
Product Information [Line Items] | |||||||||||
Revenue, net | $ 1,300 | $ 1,500 | $ 2,000 | $ 2,200 | |||||||
Cost of revenues | $ 1,300 | $ 1,500 | $ 2,000 | $ 2,200 |
SCHEDULE II-VALUATION AND QUA_2
SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Change in Tax Valuation Allowance | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Valuation allowances and reserves balance, beginning of year | $ 13,309 | $ 15,250 | $ 14,309 |
Charged to Costs and Expenses | 67 | (61) | 0 |
Charged other Accounts | (1,256) | (1,880) | 941 |
Deductions | 0 | 0 | 0 |
Valuation allowances and reserves balance, end of year | 12,120 | 13,309 | 15,250 |
Allowance for Doubtful Accounts | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Valuation allowances and reserves balance, beginning of year | 2,185 | 417 | 90 |
Charged to Costs and Expenses | 451 | 1,768 | 347 |
Charged other Accounts | 0 | 0 | |
Deductions | 0 | 0 | 20 |
Valuation allowances and reserves balance, end of year | 2,636 | 2,185 | 417 |
Reserve for Inventory Obsolescence | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Valuation allowances and reserves balance, beginning of year | 1,304 | 410 | 121 |
Charged to Costs and Expenses | 3,343 | 2,000 | 872 |
Charged other Accounts | 0 | 9 | 0 |
Deductions | 1,980 | 1,115 | 583 |
Valuation allowances and reserves balance, end of year | $ 2,667 | $ 1,304 | $ 410 |