Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Jun. 30, 2018 | Aug. 06, 2018 | |
Document And Entity Information [Abstract] | ||
Entity Registrant Name | Teligent, Inc. | |
Entity Central Index Key | 352,998 | |
Document Period End Date | Jun. 30, 2018 | |
Entity Filer Category | Accelerated Filer | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2,018 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Trading Symbol | TLGT | |
Entity Common Stock, Shares Outstanding | 53,537,888 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Current assets: | |||
Cash and cash equivalents | $ 13,675 | $ 26,692 | [1] |
Accounts receivable, net | 16,232 | 18,143 | [1] |
Inventories, net | 17,575 | 16,075 | [1] |
Prepaid expenses and other receivables | 2,206 | 3,622 | [1] |
Total current assets | 49,688 | 64,532 | [1] |
Property, plant and equipment, net | 83,027 | 68,355 | [1] |
Intangible assets, net | 52,930 | 56,017 | [1] |
Goodwill | 445 | 471 | [1] |
Other assets | 577 | 611 | [1] |
Total assets | 186,667 | 189,986 | [1] |
Current liabilities: | |||
Accounts payable | 8,654 | 10,595 | [1] |
Accrued expenses | 9,269 | 13,502 | [1] |
Total current liabilities | 17,923 | 24,097 | [1] |
2021 Term Loan, net of debt discount and debt issuance costs (face of $15,000 as of June 30, 2018) | 14,198 | 0 | |
Convertible 3.75% Senior Notes, net of debt discount and debt issuance costs (face of $68,660 and $143,750 as of June 30, 2018 and December 31, 2017, respectively) | 60,312 | 120,977 | [1] |
Convertible 4.75% Senior Notes, net of debt discount and debt issuance costs (face of $75,090 as of June 30, 2018) | 54,963 | 0 | |
Deferred tax liability | 148 | 159 | [1] |
Total liabilities | 147,544 | 145,233 | [1] |
Commitments and Contingencies | [1] | ||
Stockholders’ equity: | |||
Common stock, $0.01 par value, 100,000,000 shares authorized; 53,512,888 and 53,400,281 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively | 554 | 554 | [1] |
Additional paid-in capital | 126,532 | 106,312 | [1] |
Accumulated deficit | (85,612) | (60,094) | [1] |
Accumulated other comprehensive loss | (2,351) | (2,019) | [1] |
Total stockholders’ equity | 39,123 | 44,753 | [1] |
Total liabilities and stockholders' equity | $ 186,667 | $ 189,986 | [1] |
[1] | Derived from the audited December 31, 2017 financial statement |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) | Jun. 30, 2018 | Dec. 31, 2017 | [1] |
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) | 53,512,888 | 53,400,281 | |
Common stock, shares outstanding (in shares) | 53,512,888 | 53,400,281 | |
Term Loan 2021 | |||
Face amount of the Notes | $ 15,000,000 | ||
Convertible Note 2019 | |||
Stated interest rate | 3.75% | 3.75% | |
Face amount of the Notes | $ 68,660,000 | $ 143,750,000 | |
Convertible Note 2023 | |||
Stated interest rate | 4.75% | 4.75% | |
Face amount of the Notes | $ 75,090,000 | ||
[1] | Derived from the audited December 31, 2017 financial statement |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenues: | ||||
Revenue, net | $ 16,751 | $ 18,408 | $ 31,296 | $ 38,299 |
Costs and expenses: | ||||
Cost of revenues | 11,728 | 10,371 | 21,053 | 19,328 |
Selling, general and administrative expenses | 5,961 | 4,706 | 11,321 | 9,005 |
Product development and research expenses | 3,967 | 5,113 | 7,358 | 8,781 |
Total costs and expenses | 21,656 | 20,190 | 39,732 | 37,114 |
Operating income (loss) | (4,905) | (1,782) | (8,436) | 1,185 |
Other Income (Expense): | ||||
Foreign currency exchange (loss) gain | (3,220) | 3,822 | (1,895) | 4,901 |
Debt partial extinguishment of Convertible 3.75% Senior Notes | (10,069) | 0 | (10,069) | 0 |
Interest and other expense, net | (2,499) | (2,936) | (5,071) | (6,068) |
(Loss) income before income tax expense | (20,693) | (896) | (25,471) | 18 |
Income tax expense | 23 | 23 | 47 | 106 |
Net loss | $ (20,716) | $ (919) | $ (25,518) | $ (88) |
Basic and diluted loss per share (in dollars per share) | $ (0.39) | $ (0.02) | $ (0.48) | $ 0 |
Weighted average shares of common stock outstanding: | ||||
Basic and diluted shares (in shares) | 53,510,712 | 53,304,407 | 53,484,756 | 53,250,109 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (Parenthetical) | Jun. 30, 2018 | Dec. 31, 2017 | |
Convertible Note 2019 | |||
Stated interest rate | 3.75% | 3.75% | [1] |
[1] | Derived from the audited December 31, 2017 financial statement |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (20,716) | $ (919) | $ (25,518) | $ (88) |
Other comprehensive loss, net of tax; | ||||
Foreign currency translation adjustment | (28) | (163) | (332) | (245) |
Other comprehensive loss | (28) | (163) | (332) | (245) |
Comprehensive loss | $ (20,744) | $ (1,082) | $ (25,850) | $ (333) |
CONDENSED CONSOLIDATED STATEME7
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - 6 months ended Jun. 30, 2018 - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Convertible Note 2023 | Convertible Note 2023Additional Paid-in Capital | |
Balance (in shares) at Dec. 31, 2017 | 53,400,281 | |||||||
Balance at Dec. 31, 2017 | $ 44,753 | [1] | $ 554 | $ 106,312 | $ (2,019) | $ (60,094) | ||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock based compensation expense | 1,165 | 1,165 | ||||||
Stock options exercised | 12 | 12 | ||||||
Issuance of stock for vested restricted stock units (in shares) | 112,607 | |||||||
Fair value of conversion feature on Convertible 4.75% Senior Notes | $ 19,043 | $ 19,043 | ||||||
Cumulative translation adjustment | (332) | (332) | ||||||
Net loss | (25,518) | |||||||
Balance (in shares) at Jun. 30, 2018 | 53,512,888 | |||||||
Balance at Jun. 30, 2018 | $ 39,123 | $ 554 | $ 126,532 | $ (2,351) | $ (85,612) | |||
[1] | Derived from the audited December 31, 2017 financial statement |
CONDENSED CONSOLIDATED STATEME8
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) | Jun. 30, 2018 | Dec. 31, 2017 | |
Convertible Note 2023 | |||
Stated interest rate | 4.75% | 4.75% | [1] |
[1] | Derived from the audited December 31, 2017 financial statement |
CONDENSED CONSOLIDATED STATEME9
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Cash flows from operating activities: | ||
Net loss | $ (25,518) | $ (88) |
Reconciliation of net loss to net cash used in operating activities | ||
Depreciation and amortization of fixed assets | 1,133 | 822 |
Provision for bad debt expense | 811 | 26 |
Provision for write down of inventory | 1,154 | 918 |
Stock based compensation | 1,113 | 1,739 |
Amortization of debt issuance costs | 502 | 456 |
Amortization of intangibles | 1,550 | 1,396 |
Foreign currency exchange loss (gain) | 1,895 | (4,901) |
Partial extinguishment of Convertible 3.75% Senior Notes | 10,069 | 0 |
Amortization of debt discount | 4,425 | 4,183 |
Loss on impairment of intangible assets | 22 | 0 |
Changes in operating assets and liabilities | ||
Accounts receivable | 1,023 | (5,530) |
Inventories | (3,210) | (2,554) |
Prepaid expenses and other current receivables | 1,443 | (208) |
Other assets | 35 | 20 |
Accounts payable and accrued expenses | (9,604) | 2,414 |
Net cash used in operating activities | (12,763) | (1,307) |
Cash flows from investing activities: | ||
Capital expenditures | (12,270) | (15,286) |
Net cash used in investing activities | (12,270) | (15,286) |
Cash flows from financing activities: | ||
Proceeds from exercise of common stock options | 12 | 267 |
Proceeds from 2021 Term Loan | 15,000 | 0 |
Debt issuance costs on Convertible 4.75% Senior Notes and 2021 Term Loan | (2,457) | 0 |
Net cash provided by financing activities | 12,555 | 267 |
Effect of exchange rate on cash and cash equivalents | (540) | 536 |
Net decrease in cash, cash equivalents and restricted cash | (12,478) | (16,326) |
Cash, cash equivalents and restricted cash at beginning of period | 27,165 | 66,481 |
Cash, cash equivalents and restricted cash at end of period | 14,147 | 50,691 |
Supplemental Cash flow information: | ||
Cash payments for interest | 2,475 | 2,695 |
Cash payments for income taxes | 48 | 93 |
Non cash investing and financing transactions: | ||
Acquisition of capital expenditures in accounts payable and accrued expenses | 3,042 | 4,260 |
Capitalized interest in capital expenditures | 477 | 0 |
Capitalized stock compensation in capital expenditures | $ 53 | $ 66 |
CONDENSED CONSOLIDATED STATEM10
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - Senior Notes | Jun. 30, 2018 | Jun. 30, 2017 |
3.75% Senior Note | ||
Stated interest rate | 3.75% | 3.75% |
4.75% Senior Note | ||
Stated interest rate | 4.75% | 4.75% |
Nature of the Business and Liqu
Nature of the Business and Liquidity | 6 Months Ended |
Jun. 30, 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. and its subsidiaries (collectively the “Company”), is a specialty generic pharmaceutical company. Our mission is to become a leader in the specialty generic pharmaceutical market in alternate dosage forms. Under our own label, we currently market and sell generic topical and generic and branded generic injectable pharmaceutical products in the United States and Canada. In the United States, we currently market 28 generic topical pharmaceutical products and four branded generic injectable pharmaceutical products. In Canada, we sell over 30 generic and branded generic injectable products and medical devices. Generic pharmaceutical products are bioequivalent to their brand name counterparts. We also provide contract manufacturing services to the pharmaceutical, over-the-counter ("OTC"), and cosmetic markets. We operate our business under one segment. Our common stock is traded on the NASDAQ Global Select Market under the trading symbol “TLGT.” Our principal executive office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. We have additional offices located in Iselin, New Jersey, Toronto, Canada, and Tallinn, Estonia. Liquidity For the six months ended June 30, 2018, we incurred a net loss of $25.5 million and cash outflows of $12.5 million . Additionally, we have an accumulated deficit of $85.6 million . The reduction in cash was largely due to the additional year-to-date investment of $12.3 million in the Company's new manufacturing facility, along with the timing of accounts receivable collections and expense payments related primarily to the launch of five new products in the U.S. market. Our liquidity needs have typically arisen from the funding of our manufacturing facility, research and development programs and the launch of new products. In the past, we have met these cash requirements through cash inflows from operations, working capital management, and proceeds from our Convertible 3.75% Senior Notes ("2019 Notes"). The 2019 Notes were issued in December 2014 and are due in December 2019. On April 27, 2018, the Company entered into separate exchange agreements with certain holders of the 2019 Notes. The agreements gave the holder 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 (“2023 Notes”). Additional information is provided in Note 6. In order to continue normal business operations and execution of the Company’s growth strategy, the Company has and will continue to exercise its ability to significantly defer or reduce planned discretionary investments in research and development and capital projects or seek other financing alternatives. Other financing alternatives may include raising additional capital through the sale of its equity, a strategic alliance with a third party or securing debt. If additional acquisition and growth opportunities arise, external financing will be required. On May 4, 2018, the Company filed Form S-3 under the Securities Act of 1933. The S-3 registration allows the Company to issue, from time to time and at prices to be determined at or prior to the offering, up to $50.0 million of any combination of the securities described in the prospectus, either individually or in units should the need to raise cash arise. On June 1, 2018, the Company secured a term loan ("2021 Term Loan") for $25.0 million to support the operations of the business. The first $15.0 million of loan proceeds was received on June 1, 2018. The remaining loan proceeds of $10.0 million was received on July 16, 2018. The Company is currently evaluating alternative financing methods. As the Company continues to review its capital and debt structure, there can be no assurance that a strategic alliance or debt financing will be available on terms acceptable to the Company, or at all. The board of directors and management of the Company intend to exercise all options available in order to enable the Company to support its current growth strategy and operations beyond August 2019. Out of Period Adjustments For the three and six months ended June 30, 2018, the Company recorded net adjustments of $0.4 million and $0.3 million , respectively, related to prior periods. The net impact of the adjustments, described below, on any prior annual or interim periods financial statements was not significant. Three months ended Six months ended June 30, 2018 June 30, 2018 Wholesale fees (Revenue) $ 0.9 $ 0.9 Medicaid (Revenue) 0.3 — Sales return reserve (Revenue) — (0.6 ) Inventory adjustments (Cost of revenues) — 0.8 Bad debt expense (Selling, general and administrative expenses) (0.8 ) (0.8 ) $ 0.4 $ 0.3 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the 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 on the Condensed Consolidated Balance Sheet. The Company also presents restricted cash with cash and cash equivalents in the Condensed 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): June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016 Cash and cash equivalents $ 13,675 $ 26,692 $ 50,216 $ 66,006 Restricted cash in other assets 472 473 475 475 Cash, cash equivalents and restricted cash in the statement of cash flows $ 14,147 $ 27,165 $ 50,691 $ 66,481 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. Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, trade receivables, notes payable, accounts payable and other accrued liabilities at June 30, 2018 approximate their fair value for all periods presented. As of June 30, 2018 , the net carrying value of the 2019 Notes and 2023 Notes (discussed in Note 6) was approximately $115.3 million compared to their face value of $143.75 million . This variance is due to the conversion feature in the Notes rather than to changes in market interest rates. The Notes carry a fixed interest rate and therefore do not subject the Company to interest rate risk. As of June 30, 2018, the net carrying value of the 2021 Term Loan (discussed in Note 6) was approximately $14.2 million compared to the face value of $15.0 million . The variance is due to debt discount and debt financing costs. The 2021 Term Loan bears interest at a rate of LIBOR plus 9% , and is therefore subject to market risk. Loss Per 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 2019 and 2023 Notes, the exercise of options, and the vesting of restricted stock units ("RSU's"). For the three and six months ended June 30, 2018 , the potential dilutive common stock equivalents have been excluded from the computation of diluted loss per share, as their effect would have been anti-dilutive. (in thousands except shares and per share data) Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Basic loss per share computation: Net loss - basic and diluted $ (20,716 ) $ (919 ) $ (25,518 ) $ (88 ) Weighted average common shares - basic and diluted 53,510,712 53,304,407 53,484,756 53,250,109 Basic and diluted loss per share $ (0.39 ) $ (0.02 ) $ (0.48 ) $ 0.00 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 policies 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. See more detailed information in Note 3. 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 Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Operations, and Condensed 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. The new revenue standard also provides additional clarity on the balance sheet classification of the Company's provisions for estimated sales returns and allowances. This resulted in reclassification of certain amounts previously reflected as accrued expenses to reductions in accounts receivable. See more detailed information in Note 3. 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: Useful Lives Buildings and Improvements 10 - 40 years Machinery and Equipment 5 - 15 years Computer Hardware and Software 3 - 5 years Furniture 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. Concentration of Credit Risk Major customers of the Company are defined as those constituting greater than 10% of our total revenue. For the three months ended June 30, 2018 , two of the Company’s customers accounted for 47% of the Company’s revenue, consisting of 34% and 13% , respectively. For the three months ended June 30, 2017 , three of the Company’s customers accounted for 55% of the Company’s revenue, consisting of 26% , 12% and 17% , respectively. For the six months ended June 30, 2018 , two of the Company's customers accounted for 48% of the Company's revenue, consisting of 36% and 12% , respectively. For the six months ended June 30, 2017 , three of the company's customers accounted for 57% of the Company's revenue, consisting of 26% , 15% and 16% , respectively. Accounts receivable related to the Company’s major customers comprised 49% of all accounts receivable as of June 30, 2018 , and 82% of all accounts receivable as of June 30, 2017 . This decrease is a result of the adoption of ASC 606, “Revenue from Contracts with Customers.” The loss of one or more of these major customers could have a significant impact on our revenues and harm our business and results of operations . For the three months ended June 30, 2018 , domestic net revenues were $11.9 million and foreign net revenues were $4.9 million . For the six months ended June 30, 2018 , domestic net revenues were $22.1 million and foreign net revenues were $9.2 million . As of June 30, 2018 , domestic assets were $125.8 million and foreign assets were $60.9 million . For the three months ended June 30, 2017 , domestic net revenues were $14.8 million and foreign net revenues were $3.6 million . For the six months ended June 30, 2017 , domestic net revenues were $31.8 million and foreign net revenues were $6.5 million . As of June 30, 2017 , domestic assets were $127.4 million and foreign assets were $69.0 million . 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 Foreign currency exchange gain line item under the Other income (expense), net section of the Income Statement. 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 is to be recorded as interest expense on the income statement. Reclassification Certain prior year amounts were reclassified to conform to current year presentation. 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. It affects those reporting entities that are required to evaluate whether they should consolidate a variable interest entity "VIE". 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 were effective January 1, 2018. 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 2017-01, 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 were 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 were effective at the same time as the amendments in ASU 2014-09. Therefore, for the Company, the amendments were 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 any 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 were 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 Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842): “Recognition and Measurement of Financial Assets and Financial Liabilities”. The update supersedes Topic 840, Leases and requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. Topic 842 retains a distinction between finance leases and operating leases, with cash payments from operating leases classified within operating activities in the statement of cash flows. The amendments in this update are effective for fiscal years beginning after December 15, 2018 for public business entities, which for the Company means January 1, 2019. The Company is reviewing all lease agreements inclusive of supplier agreements. The Company is currently evaluating the impact of this ASU on its consolidated financial statements. 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. It affects public entities that have goodwill reported in their financial statements and have not elected the private company alternative for the subsequent measurement of goodwill. A public entity that is a U.S. Securities and Exchange Commission ("SEC") filer should adopt the amendments in this update for its annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. 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. |
Revenues, Recognition and Allow
Revenues, Recognition and Allowances | 6 Months Ended |
Jun. 30, 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. The table below summarizes the effect of the adoption of ASC 606 on the Company's Condensed Consolidated Balance Sheet as of June 30, 2018 : As Reported Balance Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) ASSETS Current assets: Accounts receivable, net $ 16,232 $ 18,144 $ (1,912 ) LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accrued expenses $ 9,269 $ 11,181 $ (1,912 ) The table below summarizes the effect of the adoption of ASC 606 on the Company's Condensed Consolidated Statement of Operations as of June 30, 2018 : Three months ended June 30, Six months ended June 30, As Reported Balance Without Adoption of New Revenue Standard Effect of Change Increase/(Decrease) As Reported Balance Without Adoption of New Revenue Standard Effect of Change Increase/(Decrease) Revenue, net $ 16,751 $ 17,228 $ (477 ) $ 31,296 $ 32,408 $ (1,112 ) Cost of revenue 11,728 12,205 (477 ) 21,053 22,165 (1,112 ) Gross margin 30 % 29 % (1 )% 33 % 32 % (1 )% 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 (collectively, sales returns and allowances or “SRA”). Contract Manufacturing Sales The Company recognizes revenue for contract manufacturing sales upon transfer of control of a product to a customer, which is generally upon shipment of products. However, with the new adoption of revenue recognition for contracts, the Company recognizes the revenue over time, rather than upon shipment. These 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 Product sales, net in the Company's Condensed 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 for purposes of segment reporting, consistent with internal management reporting for the chief decision makers. Net Sales (in thousands) for the three and six months ended June 30, 2018 and 2017 were as follows (prior-period amounts are not adjusted under the modified-retrospective method of adoption): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Company product sales $ 15,179 $ 15,888 $ 28,415 $ 32,324 Contract manufacturing sales 1,450 2,407 2,748 5,824 Research and development services and other income 122 113 $ 133 $ 151 Revenue, net $ 16,751 $ 18,408 $ 31,296 $ 38,299 Disaggregated information for the Company product sales revenue has been recognized in the accompanying unaudited interim Condensed Consolidated Statements of Operations is presented below according to contract type (in thousands): Three months ended June 30, Six months ended June 30, Company Product Sales 2018 2017 2018 2017 Topical $ 8,369 $ 9,885 $ 16,277 $ 18,833 Injectables 6,810 6,003 12,138 13,491 Total $ 15,179 $ 15,888 $ 28,415 $ 32,324 In the six months ended June 30, 2018 , Company did not incur, and therefore did not defer, any material incremental costs to obtain contracts. 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 SRA, which are established at the time of sale. The Company analyzes the adequacy of its accruals for SRA 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 SRA 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 SRA reserves. Net Company product sales of $15.2 million and $15.9 million for the three months ended June 30, 2018 and 2017 , respectively, are included in product sales, net in the Condensed Consolidated Statements of Operations. Net Company product revenue of $ 28.4 million and $ 32.3 million for the six months ended June 30, 2018 and 2017 , respectively, are included in product sales, net in the Condensed Consolidated Statements of Operations. Accounts receivable are presented net of SRA balances of $19.3 million and $30.9 million at June 30, 2018 and 2017 , respectively. Accounts payable and accrued expenses include $0.0 million and $5.5 million at June 30, 2018 and 2017 , respectively, for certain fees related to services provided by the wholesalers. For the six months ended June 30, 2018 , the Company recorded income of $0.8 million due to a decrease in the Medicaid reserve primarily related to finalizing the payment per the terms of the product acquisition agreement. The accrual for chargebacks is 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. The rebate accrual is 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. The Company's adjustments for the deductions to gross product sales are as follows (in thousands): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Gross product sales $ 48,142 $ 66,744 $ 84,690 $ 121,044 Deduction to gross product sales: Chargebacks and billbacks 21,449 44,090 38,364 74,105 Wholesaler fees for service 477 — 1,112 — Sales discounts and other allowances 11,037 6,766 16,799 14,615 Total reduction to gross product sales $ 32,963 $ 50,856 $ 56,275 $ 88,720 Company product sales, net $ 15,179 $ 15,888 $ 28,415 $ 32,324 Financing and Payment The Company's payment terms vary by the type and location of the customer and the products or services offered. The term between invoicing and when payment is due is not significant. The Company generally does not have incremental costs to obtain contracts that would otherwise not have been incurred. The Company does not adjust revenue for the promised amount of consideration for the effects of a significant financing component because the Company's customers generally pay the Company within 100 days. Costs to Obtain or Fulfill a Customer Contract Sales commissions are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in selling, general and administrative expense in the Condensed Consolidated Statements of Operations. Costs related to shipping and handling is comprised of outbound freight and associated labor. The Company accounts for shipping and handling activities related to contracts with customers as fulfillment costs which are included in cost of sales in the Condensed Consolidated Statements of Operations. In connection with four of the 30 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 the pharmaceutical partner. In accordance with the agreement, net sales exclude fees related to services provided by the wholesalers. Accounts payable and accrued expenses include $0.6 million and $0.4 million at June 30, 2018 and 2017 , respectively, related to these royalties. Royalty expense of $0.7 million and $0.4 million was included in cost of sales in the Condensed Consolidated Statements of Operations for the three months ended June 30, 2018 and 2017 , respectively. Royalty expense of $1.5 million and $0.9 million was included in cost of sales in the Condensed Consolidated Statements of Operations for the six months ended June 30, 2018 and 2017 , respectively. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value, using the first-in-first-out method and consist of the following (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Raw materials $ 10,655 $ 8,231 Work in progress 944 616 Finished goods 8,434 8,532 Inventories reserve (2,458 ) (1,304 ) Inventories, net $ 17,575 $ 16,075 |
Property, Plant and Equipment
Property, Plant and Equipment | 6 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment consists of the following (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Land $ 257 $ 257 Building and improvements 17,474 8,613 Machinery and equipment 9,674 9,142 Computer hardware and software 4,059 3,244 Furniture and fixtures 553 449 Construction in progress 60,268 55,017 92,285 76,722 Less accumulated depreciation and amortization (9,258 ) (8,367 ) Property, plant and equipment, net $ 83,027 $ 68,355 The Company recorded depreciation expense of $1.1 million and $0.8 million for the six months ended June 30, 2018 and June 30, 2017 , respectively. During the three months ended June 30, 2018 and June 30, 2017 , there was $1.5 million of interest and $0.7 million of interest, respectively, capitalized into construction in progress. For the six months ended June 30, 2018 and June 30, 2017 , there was $2.8 million of interest and $1.2 million of interest, respectively, capitalized into construction in progress. This increase in capitalized interest is related to outstanding costs for the Company's facility expansion project in Buena. During the three months ended June 30, 2018 and June 30, 2017 , there was $0.4 million of payroll costs and $0.2 million of payroll costs, respectively, capitalized into construction in progress. For the six months ended June 30, 2018 and June 30, 2017 , there was $0.8 million of payroll costs and $0.4 million of payroll costs, respectively, capitalized into construction in progress. |
Debt
Debt | 6 Months Ended |
Jun. 30, 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 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 holder 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. The 2023 Notes incurred loan issue costs of $1.6 million and a discount of $19.0 million . Consistent with the 2019 Notes, the 2023 Notes are convertible into shares of the Company’s common stock, cash or a combination thereof. The discount is directly related to the convertible feature on the 2023 Notes. 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 issue costs and discount are recognized as interest expense over the term of the Notes. The effective interest, inclusive of the debt discounts and issue costs, is 12.10% . The $75.1 million exchange of the 2019 Notes for 2023 Notes is considered an extinguishment under ASC 470, as the present value of the future cash flows has changed greater than 10% . The extinguishment of this portion of the 2019 Notes has been referenced here as "partial extinguishment". The partial extinguishment resulted in the recognition of an additional $10.1 million of non-cash interest expense in the quarter ended June 30, 2018. The $10.1 million is related to an unamortized debt discount of $9.1 million and unamortized debt financing costs of $1.0 million associated with the partial extinguishment of the $75.1 million of the 2019 Notes. 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 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 loan issue costs of $0.5 million and a discount of $0.4 million . The discount is due to lender fees paid on the initial drawdown of $15.0 million . The issue costs and discount are recognized as interest expense over the term of the 2021 Term Loan. The 2021 Term Loan bears interest at a rate of LIBOR plus 9% , with a stated floor of 2% . The effective interest, inclusive of the debt discounts and issue costs is 13.56% per year. At June 30, 2018 and December 31, 2017, the net carrying value of the debt and the remaining unamortized debt discounts and debt issuance costs were as follows (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Face amount of the 2019 Notes (due December 2019) $ 68,660 $ 143,750 Face amount of the 2021 Loan (due June 2021) 15,000 — Face amount of the 2023 Notes (due May 2023) 75,090 — 158,750 143,750 Less unamortized discounts and debt issuance costs 29,277 22,773 Total Carrying Value, Net $ 129,473 $ 120,977 For the six months ended June 30, 2018 and 2017 , the Company recorded the following expenses in relation to the debt (in thousands): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Interest expense of the 2019 Notes (1) $ 878 $ 1,347 $ 2,226 $ 2,695 Interest expense of the 2021 Loan 141 — 141 — Interest expense of the 2023 Notes (1) 634 — 634 — Debt partial extinguishment of 2019 Notes 10,069 — 10,069 — Debt discount amortization of the 2019 Notes (1) 1,571 2,126 3,910 4,183 Debt discount amortization of the 2021 Loan 17 — 17 — Debt discount amortization of the 2023 Notes (1) 498 — 498 — Debt financing amortization of the 2019 Notes (1) 191 232 446 456 Debt financing amortization of the 2021 Loan 14 — 14 Debt financing amortization of the 2023 Notes (1) 42 — 42 Interest expense $ 14,055 $ 3,705 $ 17,997 $ 7,334 (1) Included within "Interest and other expense, net" on the Condensed Consolidated Statements of Operations, offset by interest income and capitalized interest, as disclosed Note 5. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 6 Months Ended |
Jun. 30, 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 assess the recoverability of the carrying value of goodwill in the fourth quarter of each year, and whenever events occur or circumstances change that would, more likely than not, reduce the fair value of our 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 from December 31, 2017 , through June 30, 2018 . No impairment losses were recognized during the six months ended June 30, 2018 . Changes in goodwill during the six months ended June 30, 2018 were as follows (in thousands): Goodwill balance at December 31, 2017 $ 471 Foreign currency translation (26 ) Goodwill balance at June 30, 2018 $ 445 Intangible Assets The following sets forth the major categories of the Company’s intangible assets and the weighted-average remaining amortization period as of June 30, 2018 and December 31, 2017 (in thousands). June 30, 2018 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 39,294 $ (6,875 ) $ 32,419 12.4 In process research and development ("IPR&D") 17,831 — 17,831 N/A Customer relationships 3,637 (957 ) 2,680 7.6 Total $ 60,762 $ (7,832 ) $ 52,930 December 31, 2017 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,380 $ (5,684 ) $ 34,696 12.8 In-process research and development ("IPR&D") 18,311 — 18,311 N/A Customer relationships 3,783 (773 ) 3,010 7.9 Total $ 62,474 $ (6,457 ) $ 56,017 Changes in intangibles during the six months ended June 30, 2018 were as follows (in thousands): Trademarks and Technology IPR&D Customer Relationships Balance at January 1, 2018 $ 34,696 $ 18,311 $ 3,010 Amortization (1,363 ) — (187 ) Loss on impairment (7 ) (15 ) — Foreign currency translation (907 ) (465 ) (143 ) Balance at June 30, 2018 $ 32,419 $ 17,831 $ 2,680 Assuming no additions, disposals or adjustments are made to the carrying values and/or useful lives of the intangible assets, annual amortization expense on product rights and other related intangibles as of June 30, 2018 over the remainder of 2018 and each of the next five years is estimated to be as follows (in thousands): Amortization Expense * 2018 (remainder of the year) $ 1,550 2019 3,099 2020 3,099 2021 3,099 2022 3,099 2023 3,099 Thereafter 18,054 Total $ 35,099 *IPR&D amounts are assessed for impairment at least annually and will be amortized once products are approved, including the product's respective manufacturing process approvals, and are not included in the table. The useful lives of the Company’s intangibles are as follows: Intangibles Category Amortizable Life Trademarks and Technology 15 Customer Relationships 10 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 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 June 30, 2018 . A total of 2,634,798 options had been granted to non-employee directors through December 31, 2017 , with no change as of June 30, 2018 . A total of 807,782 of those had been forfeited through December 31, 2017 and returned to the option pool for future issuance, with no change as of June 30, 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 December 31, 2017 and June 30, 2018 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 June 30, 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 June 30, 2018, there are 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 June 30, 2018 , there were 24,376 RSUs outstanding, 1,493,960 shares of stock outstanding, and options to purchase 2,932,846 shares of common stock outstanding. As of December 31, 2017 , there were 99,626 RSUs outstanding, 1,422,020 shares of stock outstanding and options to purchase 3,038,634 shares of common stock 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 June 30, 2018 , an additional 98,098 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 June 30, 2018 , there were 174,472 RSUs outstanding, 49,667 shares of common stock outstanding and options to purchase 1,335,529 shares of common stock outstanding under the 2016 Plan. As compared to 2017 , as of December 31, 2017 , there were 89,003 RSUs 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 June 30, 2018 and December 31, 2017 , there were a total of 2,935,736 shares of common stock and 1,526,857 shares of common stock available under the 2016 Plan, respectively. As of June 30, 2018 and December 31, 2017 , there were options to purchase 4,768,105 and 4,299,810 shares of common stock outstanding, respectively, collectively 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 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 June 30, 2018 , and therefore no additional stock compensation expense was recognized related to the amendments. 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. Six months ended June 30, Assumptions 2018 2017 Expected dividends — — Risk-free rate 2.36 % 1.55 % Expected volatility 60.5% - 62.3% 58.0% - 69.7% Expected term (in years) 3.2 - 3.3 years 3.2 - 3.3 years Expected 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 options valuation model are highly subjective, and can materially affect the resulting valuation. A summary of option activity under the Director Plan, the 2009 Plan and the 2016 Plan as of June 30, 2018 and changes during the period are presented below: Number of Options Weighted Average Exercise Price Outstanding as of January 1, 2018 4,299,810 $ 5.09 Issued 679,785 3.29 Exercised (11,000 ) 1.08 Forfeited (200,490 ) 7.02 Expired — — Outstanding as of June 30, 2018 4,768,105 $ 4.76 Exercisable as of June 30, 2018 3,546,700 $ 4.63 The following tables summarize information regarding options outstanding and exercisable at June 30, 2018 : Outstanding: Range of Exercise Prices Stock Options Outstanding Weighted Average Exercise Price Weighted Average Remaining Contractual Life $0.55 - $1.50 1,735,000 $ 1.06 3.61 $1.51 - $5.50 873,469 3.18 8.52 $5.51 - $10.67 2,159,636 8.38 7.45 Total 4,768,105 $ 4.76 6.25 Exercisable: Range of Exercise Prices Stock Options Exercisable Weighted Average Exercise Price $0.55 - $1.50 1,735,000 $ 1.06 $1.51 - $5.50 202,166 2.75 $5.51 - $10.67 1,609,534 8.72 Total 3,546,700 $ 4.63 As of June 30, 2018 , the intrinsic value of the options outstanding was $4.5 million and the intrinsic value of the options exercisable was $4.3 million . As of June 30, 2018 , there was $2.0 million of total unrecognized compensation expense related to non-vested share-based compensation arrangements granted under the Plan. The costs will be recognized through February 2021. Restricted Stock and RSUs The Company periodically grants restricted stock and RSU awards to certain officers and other employees that typically vest one to three years from their grant date. The Company recognized $120,000 and $ 245,000 of compensation expense during the three months ended June 30, 2018 and 2017 , respectively, and $303,000 and $468,000 during the six months ended June 30, 2018 and 2017, respectively, related to restricted stock and RSU awards. Stock compensation expense is recognized over the vesting period of the restricted stock and RSUs. At June 30, 2018 , the Company had approximately $0.8 million of total unrecognized compensation cost related to non-vested restricted stock and RSUs, all of which will be recognized through April 2021. The following table summarizes the number of unvested RSUs and their weighted average exercise price for the six months ended June 30, 2018 . Number of RSUs Weighted Average Exercise Price Non-vested balance at January 1, 2018 188,629 $ 8.27 Changes during the period: Shares granted 122,949 3.36 Shares vested (101,607 ) 9.07 Shares forfeited (11,123 ) 7.21 Non-vested balance at June 30, 2018 198,848 $ 4.88 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company conducts operations in the United States and certain foreign countries. It is the intent of the Company to permanently reinvest any earnings and profits generated by its foreign affiliates. One of its foreign affiliates is subject to tax in Estonia. Estonia has a dual tax regime: 0% tax rate for earnings and profits as they are generated and 14% to 20% tax rates for earnings and profits that are distributed to shareholders. The Company has taken the position that the 14% to 20% tax rates apply only when dividends have been declared and recognized as a liability. Accordingly, the Company has provided no taxes on the current earnings generated by its Estonian affiliate. Income tax expense for the three and six months ended June 30, 2018 and June 30, 2017 , is recognized based on the Company’s estimated annual effective tax rate, which is based on the tax rate expected for the full calendar year applied to the pre-tax income of the interim period adjusted for discrete items. The Company excludes from the calculation of the annual effective tax rate those jurisdictions that are projected to operate at a loss and in which a tax benefit will not be recognized or which operate in a zero tax rate jurisdiction. The Company has assessed the impacts of the changes resulting from the United States Tax Cuts and Jobs Act (U.S. TCJA) and has recognized an income tax benefit and a corresponding receivable of $0.1 million related to the recoverability of Alternative Minimum Tax Credits. Deferred tax assets, liabilities and valuation allowances have been remeasured at the new rate of 21% . Except for the recognition of the Alternative Minimum Tax Credit, there was no income impact from the remeasurement since all U.S. net deferred tax assets are fully reserved by the Company. At present, we do not estimate any material impacts from the repatriation tax. While we have completed our provisional analysis of the income tax effects of the U.S.TCJA, the related tax effects may need to be adjusted, possibly materially, due to further refinement of our calculations, changes in interpretations and assumptions that we have made, additional guidance that may be issued by regulatory bodies, and actions and related accounting policy decision we may take as a result of the new legislation. We will complete our analysis over the one-year measurement period from the enactment of the law as provided for by SAB 118, and any adjustments during this measurement period will be included in net earnings from continuing operations as an adjustment to income tax expense in the reporting period(s) when such adjustments are determined. The Company evaluates the recoverability of its net deferred tax assets based on its history of operating results, its expectations for the future and expiration dates. Based on the preponderance of the evidence, the Company has concluded that it is more likely than not it will be unable to realize the net deferred tax assets in the immediate future and has established a valuation allowance for all U.S. and foreign net deferred tax assets. At December 31, 2017 , the Company’s U.S. federal net operating loss carryforwards totaled $41.7 million . The Company’s ability to use net operating loss carry forwards is subject to 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 $23.1 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 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. For federal purposes, 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 2013 to 2017. The Company has not recorded any liability for uncertain tax positions. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2018 | |
Other Income and Expenses [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses represent various obligations of the Company including certain operating expenses and taxes payable. As of June 30, 2018 and December 31, 2017 , the largest components of accrued expenses were (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Capital expenditures $ 2,476 $ 1,947 Payroll 1,483 1,580 Professional fees 1,284 546 Interest expense 763 240 Clinical studies 603 596 Royalties 578 856 Medicaid and Medicare * 542 — Inventory and Supplies 460 58 Rebates * 332 — Income Tax 60 58 Wholesaler fees * — 7,044 Other 688 577 $ 9,269 $ 13,502 * Wholesale fees ( $2.8 million ) have been reclassified to Accounts Receivable and Medicaid $0.5 million , Medicare Fees $0.1 million and Rebates $0.3 million have been reclassified to Accrued Expenses upon adoption of ASC Topic 606, "Revenue from Contracts and Customers" in 2018. |
Legal and U.S. Regulatory Proce
Legal and U.S. Regulatory Proceedings | 6 Months Ended |
Jun. 30, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal and U.S. Regulatory Proceedings | Legal and U.S. Regulatory Proceedings The Company is involved from time to time in claims which arise in the ordinary course of business. In management's opinion, the Company has made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against the Company relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on its business, financial condition and operating results. 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. One “opt-out” action has additionally been filed against the Company along with thirty-four generic manufacturer co-defendants regarding the pricing of econazole nitrate cream along with twenty-nine additional drug products not manufactured or sold by the Company. 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, and the class actions have been consolidated into three actions: the direct purchaser, end payer and indirect reseller actions. 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 opt-out plaintiffs allege a conspiracy by thirty-five generic manufacturers to fix prices for thirty drug products, including econazole nitrate cream, in violation of federal antitrust laws. The opt-out plaintiffs seek treble damages for alleged price overcharges for the thirty drug products identified in the complaint during the alleged period of conspiracy, and also seek injunctive relief against the defendants. All of these cases are in their initial stages and motions to dismiss have been filed with respect to each of the three consolidated class actions. 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 a counter-claim 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. |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2018 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the 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. |
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. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of cash and cash equivalents, trade receivables, notes payable, accounts payable and other accrued liabilities at June 30, 2018 approximate their fair value for all periods presented. |
Earnings (Loss) Per Share | Loss Per 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 2019 and 2023 Notes, the exercise of options, and the vesting of restricted stock units ("RSU's"). |
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 policies 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. See more detailed information in Note 3. 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 Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Operations, and Condensed 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. The new revenue standard also provides additional clarity on the balance sheet classification of the Company's provisions for estimated sales returns and allowances. This resulted in reclassification of certain amounts previously reflected as accrued expenses to reductions in accounts receivable. |
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: Useful Lives Buildings and Improvements 10 - 40 years Machinery and Equipment 5 - 15 years Computer Hardware and Software 3 - 5 years Furniture 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. |
Concentration of Credit Risk | Concentration of Credit Risk Major customers of the Company are defined as those constituting greater than 10% of our total revenue. |
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 Foreign currency exchange gain line item under the Other income (expense), net section of the Income Statement. |
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 is to be recorded as interest expense on the income statement. |
Reclassification | Reclassification Certain prior year amounts were reclassified to conform to current year presentation. |
Adoption of Recent Accounting Pronouncements and Recently Issued 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. It affects those reporting entities that are required to evaluate whether they should consolidate a variable interest entity "VIE". 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 were effective January 1, 2018. 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 2017-01, 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 were 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 were effective at the same time as the amendments in ASU 2014-09. Therefore, for the Company, the amendments were 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 any 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 were 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 Accounting Pronouncements In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842): “Recognition and Measurement of Financial Assets and Financial Liabilities”. The update supersedes Topic 840, Leases and requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous GAAP. Topic 842 retains a distinction between finance leases and operating leases, with cash payments from operating leases classified within operating activities in the statement of cash flows. The amendments in this update are effective for fiscal years beginning after December 15, 2018 for public business entities, which for the Company means January 1, 2019. The Company is reviewing all lease agreements inclusive of supplier agreements. The Company is currently evaluating the impact of this ASU on its consolidated financial statements. 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. It affects public entities that have goodwill reported in their financial statements and have not elected the private company alternative for the subsequent measurement of goodwill. A public entity that is a U.S. Securities and Exchange Commission ("SEC") filer should adopt the amendments in this update for its annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. 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. |
Nature of the Business and Li23
Nature of the Business and Liquidity (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Error Corrections and Prior Period Adjustments | The net impact of the adjustments, described below, on any prior annual or interim periods financial statements was not significant. Three months ended Six months ended June 30, 2018 June 30, 2018 Wholesale fees (Revenue) $ 0.9 $ 0.9 Medicaid (Revenue) 0.3 — Sales return reserve (Revenue) — (0.6 ) Inventory adjustments (Cost of revenues) — 0.8 Bad debt expense (Selling, general and administrative expenses) (0.8 ) (0.8 ) $ 0.4 $ 0.3 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 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): June 30, 2018 December 31, 2017 June 30, 2017 December 31, 2016 Cash and cash equivalents $ 13,675 $ 26,692 $ 50,216 $ 66,006 Restricted cash in other assets 472 473 475 475 Cash, cash equivalents and restricted cash in the statement of cash flows $ 14,147 $ 27,165 $ 50,691 $ 66,481 |
Schedule of Earnings Per Share, Basic and Diluted | For the three and six months ended June 30, 2018 , the potential dilutive common stock equivalents have been excluded from the computation of diluted loss per share, as their effect would have been anti-dilutive. (in thousands except shares and per share data) Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Basic loss per share computation: Net loss - basic and diluted $ (20,716 ) $ (919 ) $ (25,518 ) $ (88 ) Weighted average common shares - basic and diluted 53,510,712 53,304,407 53,484,756 53,250,109 Basic and diluted loss per share $ (0.39 ) $ (0.02 ) $ (0.48 ) $ 0.00 |
Schedule Of Property, Plant and Equipment 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: Useful Lives Buildings and Improvements 10 - 40 years Machinery and Equipment 5 - 15 years Computer Hardware and Software 3 - 5 years Furniture Fixtures 5 years The useful lives of the Company’s intangibles are as follows: Intangibles Category Amortizable Life Trademarks and Technology 15 Customer Relationships 10 |
Revenues, Recognition and All25
Revenues, Recognition and Allowances (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | The table below summarizes the effect of the adoption of ASC 606 on the Company's Condensed Consolidated Balance Sheet as of June 30, 2018 : As Reported Balance Without Adoption of New Revenue Standard Effect of Change Higher/(Lower) ASSETS Current assets: Accounts receivable, net $ 16,232 $ 18,144 $ (1,912 ) LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accrued expenses $ 9,269 $ 11,181 $ (1,912 ) The table below summarizes the effect of the adoption of ASC 606 on the Company's Condensed Consolidated Statement of Operations as of June 30, 2018 : Three months ended June 30, Six months ended June 30, As Reported Balance Without Adoption of New Revenue Standard Effect of Change Increase/(Decrease) As Reported Balance Without Adoption of New Revenue Standard Effect of Change Increase/(Decrease) Revenue, net $ 16,751 $ 17,228 $ (477 ) $ 31,296 $ 32,408 $ (1,112 ) Cost of revenue 11,728 12,205 (477 ) 21,053 22,165 (1,112 ) Gross margin 30 % 29 % (1 )% 33 % 32 % (1 )% |
Disaggregation of Revenues | Net Sales (in thousands) for the three and six months ended June 30, 2018 and 2017 were as follows (prior-period amounts are not adjusted under the modified-retrospective method of adoption): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Company product sales $ 15,179 $ 15,888 $ 28,415 $ 32,324 Contract manufacturing sales 1,450 2,407 2,748 5,824 Research and development services and other income 122 113 $ 133 $ 151 Revenue, net $ 16,751 $ 18,408 $ 31,296 $ 38,299 Disaggregated information for the Company product sales revenue has been recognized in the accompanying unaudited interim Condensed Consolidated Statements of Operations is presented below according to contract type (in thousands): Three months ended June 30, Six months ended June 30, Company Product Sales 2018 2017 2018 2017 Topical $ 8,369 $ 9,885 $ 16,277 $ 18,833 Injectables 6,810 6,003 12,138 13,491 Total $ 15,179 $ 15,888 $ 28,415 $ 32,324 |
Schedule of Accounts, Notes, Loans and Financing Receivable | The Company's adjustments for the deductions to gross product sales are as follows (in thousands): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Gross product sales $ 48,142 $ 66,744 $ 84,690 $ 121,044 Deduction to gross product sales: Chargebacks and billbacks 21,449 44,090 38,364 74,105 Wholesaler fees for service 477 — 1,112 — Sales discounts and other allowances 11,037 6,766 16,799 14,615 Total reduction to gross product sales $ 32,963 $ 50,856 $ 56,275 $ 88,720 Company product sales, net $ 15,179 $ 15,888 $ 28,415 $ 32,324 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories are valued at the lower of cost or net realizable value, using the first-in-first-out method and consist of the following (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Raw materials $ 10,655 $ 8,231 Work in progress 944 616 Finished goods 8,434 8,532 Inventories reserve (2,458 ) (1,304 ) Inventories, net $ 17,575 $ 16,075 |
Property, Plant and Equipment (
Property, Plant and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | Property, plant and equipment consists of the following (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Land $ 257 $ 257 Building and improvements 17,474 8,613 Machinery and equipment 9,674 9,142 Computer hardware and software 4,059 3,244 Furniture and fixtures 553 449 Construction in progress 60,268 55,017 92,285 76,722 Less accumulated depreciation and amortization (9,258 ) (8,367 ) Property, plant and equipment, net $ 83,027 $ 68,355 |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Debt | At June 30, 2018 and December 31, 2017, the net carrying value of the debt and the remaining unamortized debt discounts and debt issuance costs were as follows (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Face amount of the 2019 Notes (due December 2019) $ 68,660 $ 143,750 Face amount of the 2021 Loan (due June 2021) 15,000 — Face amount of the 2023 Notes (due May 2023) 75,090 — 158,750 143,750 Less unamortized discounts and debt issuance costs 29,277 22,773 Total Carrying Value, Net $ 129,473 $ 120,977 |
Schedule of Debt Expense | For the six months ended June 30, 2018 and 2017 , the Company recorded the following expenses in relation to the debt (in thousands): Three months ended June 30, Six months ended June 30, 2018 2017 2018 2017 Interest expense of the 2019 Notes (1) $ 878 $ 1,347 $ 2,226 $ 2,695 Interest expense of the 2021 Loan 141 — 141 — Interest expense of the 2023 Notes (1) 634 — 634 — Debt partial extinguishment of 2019 Notes 10,069 — 10,069 — Debt discount amortization of the 2019 Notes (1) 1,571 2,126 3,910 4,183 Debt discount amortization of the 2021 Loan 17 — 17 — Debt discount amortization of the 2023 Notes (1) 498 — 498 — Debt financing amortization of the 2019 Notes (1) 191 232 446 456 Debt financing amortization of the 2021 Loan 14 — 14 Debt financing amortization of the 2023 Notes (1) 42 — 42 Interest expense $ 14,055 $ 3,705 $ 17,997 $ 7,334 (1) Included within "Interest and other expense, net" on the Condensed Consolidated Statements of Operations, offset by interest income and capitalized interest, as disclosed Note 5. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Goodwill | Changes in goodwill during the six months ended June 30, 2018 were as follows (in thousands): Goodwill balance at December 31, 2017 $ 471 Foreign currency translation (26 ) Goodwill balance at June 30, 2018 $ 445 |
Schedule of 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 June 30, 2018 and December 31, 2017 (in thousands). June 30, 2018 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 39,294 $ (6,875 ) $ 32,419 12.4 In process research and development ("IPR&D") 17,831 — 17,831 N/A Customer relationships 3,637 (957 ) 2,680 7.6 Total $ 60,762 $ (7,832 ) $ 52,930 December 31, 2017 Gross Carrying Accumulated Net Carrying Weighted Average Trademarks and Technology $ 40,380 $ (5,684 ) $ 34,696 12.8 In-process research and development ("IPR&D") 18,311 — 18,311 N/A Customer relationships 3,783 (773 ) 3,010 7.9 Total $ 62,474 $ (6,457 ) $ 56,017 |
Schedule of Changes in Intangible Assets Other Than Goodwill | Changes in intangibles during the six months ended June 30, 2018 were as follows (in thousands): Trademarks and Technology IPR&D Customer Relationships Balance at January 1, 2018 $ 34,696 $ 18,311 $ 3,010 Amortization (1,363 ) — (187 ) Loss on impairment (7 ) (15 ) — Foreign currency translation (907 ) (465 ) (143 ) Balance at June 30, 2018 $ 32,419 $ 17,831 $ 2,680 |
Schedule of 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 product rights and other related intangibles as of June 30, 2018 over the remainder of 2018 and each of the next five years is estimated to be as follows (in thousands): Amortization Expense * 2018 (remainder of the year) $ 1,550 2019 3,099 2020 3,099 2021 3,099 2022 3,099 2023 3,099 Thereafter 18,054 Total $ 35,099 *IPR&D amounts are assessed for impairment at least annually and will be amortized once products are approved, including the product's respective manufacturing process approvals, and are not included in the table. |
Schedule Of Property, Plant and Equipment 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: Useful Lives Buildings and Improvements 10 - 40 years Machinery and Equipment 5 - 15 years Computer Hardware and Software 3 - 5 years Furniture Fixtures 5 years The useful lives of the Company’s intangibles are as follows: Intangibles Category Amortizable Life Trademarks and Technology 15 Customer Relationships 10 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of 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. Six months ended June 30, Assumptions 2018 2017 Expected dividends — — Risk-free rate 2.36 % 1.55 % Expected volatility 60.5% - 62.3% 58.0% - 69.7% Expected term (in years) 3.2 - 3.3 years 3.2 - 3.3 years |
Schedule of Stock Option Activity | A summary of option activity under the Director Plan, the 2009 Plan and the 2016 Plan as of June 30, 2018 and changes during the period are presented below: Number of Options Weighted Average Exercise Price Outstanding as of January 1, 2018 4,299,810 $ 5.09 Issued 679,785 3.29 Exercised (11,000 ) 1.08 Forfeited (200,490 ) 7.02 Expired — — Outstanding as of June 30, 2018 4,768,105 $ 4.76 Exercisable as of June 30, 2018 3,546,700 $ 4.63 |
Schedule of Stock Options Outstanding and Exercisable | The following tables summarize information regarding options outstanding and exercisable at June 30, 2018 : Outstanding: Range of Exercise Prices Stock Options Outstanding Weighted Average Exercise Price Weighted Average Remaining Contractual Life $0.55 - $1.50 1,735,000 $ 1.06 3.61 $1.51 - $5.50 873,469 3.18 8.52 $5.51 - $10.67 2,159,636 8.38 7.45 Total 4,768,105 $ 4.76 6.25 Exercisable: Range of Exercise Prices Stock Options Exercisable Weighted Average Exercise Price $0.55 - $1.50 1,735,000 $ 1.06 $1.51 - $5.50 202,166 2.75 $5.51 - $10.67 1,609,534 8.72 Total 3,546,700 $ 4.63 |
Schedule of Nonvested Restricted Stock Units Activity | The following table summarizes the number of unvested RSUs and their weighted average exercise price for the six months ended June 30, 2018 . Number of RSUs Weighted Average Exercise Price Non-vested balance at January 1, 2018 188,629 $ 8.27 Changes during the period: Shares granted 122,949 3.36 Shares vested (101,607 ) 9.07 Shares forfeited (11,123 ) 7.21 Non-vested balance at June 30, 2018 198,848 $ 4.88 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2018 | |
Other Income and Expenses [Abstract] | |
Schedule of Accrued Expenses | As of June 30, 2018 and December 31, 2017 , the largest components of accrued expenses were (in thousands): June 30, 2018 December 31, 2017 (Unaudited) (Audited) Capital expenditures $ 2,476 $ 1,947 Payroll 1,483 1,580 Professional fees 1,284 546 Interest expense 763 240 Clinical studies 603 596 Royalties 578 856 Medicaid and Medicare * 542 — Inventory and Supplies 460 58 Rebates * 332 — Income Tax 60 58 Wholesaler fees * — 7,044 Other 688 577 $ 9,269 $ 13,502 * Wholesale fees ( $2.8 million ) have been reclassified to Accounts Receivable and Medicaid $0.5 million , Medicare Fees $0.1 million and Rebates $0.3 million have been reclassified to Accrued Expenses upon adoption of ASC Topic 606, "Revenue from Contracts and Customers" in 2018. |
Nature of the Business and Li32
Nature of the Business and Liquidity (Details) | Jul. 16, 2018USD ($) | Jun. 01, 2018USD ($) | May 04, 2018USD ($) | Apr. 27, 2018USD ($) | Jun. 30, 2018USD ($)productsegment | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)productsegment | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($) | [1] | Dec. 16, 2014 |
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Segments | segment | 1 | 1 | |||||||||
Net loss | $ (20,716,000) | $ (919,000) | $ (25,518,000) | $ (88,000) | |||||||
Net decrease in cash, cash equivalents and restricted cash | 12,478,000 | $ 16,326,000 | |||||||||
Accumulated deficit | (85,612,000) | (85,612,000) | $ (60,094,000) | ||||||||
Investments | 12,300,000 | ||||||||||
Shelf offering | $ 50,000,000 | ||||||||||
Prior period reclassification adjustment | $ 400,000 | $ 300,000 | |||||||||
United States | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Generic products marketed | product | 28 | ||||||||||
Branded generic products marketed | product | 4 | ||||||||||
Number of products, launched | product | 5 | ||||||||||
Minimum | Canada | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Generic and branded products marketed | product | 30 | ||||||||||
Convertible Note 2019 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Stated interest rate | 3.75% | 3.75% | 3.75% | ||||||||
Debt, transfer | $ 75,100,000 | ||||||||||
Face amount of the Notes | $ 68,660,000 | $ 68,660,000 | $ 143,750,000 | ||||||||
Convertible Note 2023 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Stated interest rate | 4.75% | 4.75% | 4.75% | ||||||||
Face amount of the Notes | $ 75,090,000 | $ 75,090,000 | |||||||||
Term Loan 2021 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Face amount of the Notes | $ 25,000,000 | $ 15,000,000 | $ 15,000,000 | ||||||||
Proceeds from lines of credit | $ 15,000,000 | ||||||||||
Subsequent Event | Term Loan 2021 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Proceeds from lines of credit | $ 10,000,000 | ||||||||||
Convertible Notes Payable | Convertible Note 2019 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Stated interest rate | 3.75% | 3.75% | 3.75% | ||||||||
Debt, transfer | $ 75,100,000 | ||||||||||
Convertible Notes Payable | Convertible Note 2023 | |||||||||||
Summary of Significant Accounting Policies Details [Line Items] | |||||||||||
Stated interest rate | 4.75% | 4.75% | 4.75% | ||||||||
Debt, transfer | $ 75,100,000 | $ 75,100,000 | |||||||||
[1] | Derived from the audited December 31, 2017 financial statement |
Nature of the Business and Li33
Nature of the Business and Liquidity Nature of the Business and Liquidity (Details 1) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | $ 0.4 | $ 0.3 |
Wholesale fees (Revenue) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | 0.9 | 0.9 |
Medicaid (Revenue) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | 0.3 | 0 |
Sales return reserve (Revenue) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | 0 | (0.6) |
Inventory adjustments (Cost of revenues) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | 0 | 0.8 |
Bad debt expense (SG&A) | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Prior period reclassification adjustment | $ (0.8) | $ (0.8) |
Summary of Significant Accoun34
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | Dec. 31, 2016 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 13,675 | $ 26,692 | $ 50,216 | $ 66,006 |
Restricted cash in other assets | 472 | 473 | 475 | 475 |
Cash, cash equivalents and restricted cash in the statement of cash flows | $ 14,147 | $ 27,165 | $ 50,691 | $ 66,481 |
Summary of Significant Accoun35
Summary of Significant Accounting Policies (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | [1] | |
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Product sales, net | $ 15,179 | $ 15,888 | $ 28,415 | $ 32,324 | ||
Assets | 186,667 | 186,667 | $ 189,986 | |||
Domestic | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Product sales, net | 11,900 | 14,800 | 22,100 | 31,800 | ||
Assets | 125,800 | 127,400 | 125,800 | 127,400 | ||
Foreign | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Product sales, net | 4,900 | 3,600 | 9,200 | 6,500 | ||
Assets | $ 60,900 | $ 69,000 | $ 60,900 | $ 69,000 | ||
Sales Revenue | Customer concentration risk | Two Customers | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 47.00% | 48.00% | ||||
Sales Revenue | Customer concentration risk | Three Customers | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 55.00% | 57.00% | ||||
Sales Revenue | Customer concentration risk | Customer One | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 34.00% | 26.00% | 36.00% | 26.00% | ||
Sales Revenue | Customer concentration risk | Customer Two | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 13.00% | 12.00% | 12.00% | 15.00% | ||
Sales Revenue | Customer concentration risk | Customer Three | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 17.00% | 16.00% | ||||
Accounts Receivable | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Concentration risk | 49.00% | 82.00% | ||||
Convertible Notes Payable | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Net carrying value of notes | $ 115,300 | $ 115,300 | ||||
Face value of notes | 143,750 | 143,750 | ||||
Term Loan 2021 | Convertible Notes Payable | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Net carrying value of notes | 14,200 | 14,200 | ||||
Face value of notes | $ 15,000 | $ 15,000 | ||||
London Interbank Offered Rate (LIBOR) | Term Loan 2021 | Convertible Notes Payable | ||||||
Summary of Significant Accounting Policies Details [Line Items] | ||||||
Basis spread on variable rate | 9.00% | 9.00% | ||||
[1] | Derived from the audited December 31, 2017 financial statement |
Summary of Significant Accoun36
Summary of Significant Accounting Policies (Details 1) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Basic loss per share computation: | ||||
Net loss | $ (20,716) | $ (919) | $ (25,518) | $ (88) |
Weighted average common shares - basic and diluted | 53,510,712 | 53,304,407 | 53,484,756 | 53,250,109 |
Basic and diluted loss per share (in dollars per share) | $ (0.39) | $ (0.02) | $ (0.48) | $ 0 |
Summary of Significant Accoun37
Summary of Significant Accounting Policies (Details 2) | 6 Months Ended |
Jun. 30, 2018 | |
Buildings and Improvements | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 10 years |
Buildings and Improvements | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 40 years |
Machinery and Equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Machinery and Equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 15 years |
Computer hardware and software | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 3 years |
Computer hardware and software | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property, plant and equipment useful life | 5 years |
Revenues, Recognition and All38
Revenues, Recognition and Allowances (Details Textual) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||||||
Jun. 30, 2018USD ($)transaction_typesegment | Jun. 30, 2017USD ($) | Jun. 30, 2018USD ($)transaction_type | Jun. 30, 2018USD ($)transaction_type | Jun. 30, 2018USD ($)drugtransaction_type | Jun. 30, 2018USD ($)transaction_typeproduct | Jun. 30, 2018USD ($)transaction_typesegment | Jun. 30, 2018USD ($)transaction_type | Jun. 30, 2017USD ($) | Dec. 31, 2017USD ($) | |
Disaggregation of Revenue [Line Items] | ||||||||||
Types of transactions | transaction_type | 3 | 3 | 3 | 3 | 3 | 3 | 3 | |||
Segments | segment | 1 | 1 | ||||||||
Company product sales, net | $ 15,179 | $ 15,888 | $ 28,415 | $ 32,324 | ||||||
Accounts payable and accrued liabilities | 0 | 5,500 | $ 0 | $ 0 | $ 0 | $ 0 | $ 0 | 0 | 5,500 | |
Increase (decrease) to medicaid reserve | (800) | |||||||||
Accounts receivable, terms of customer credit | 100 days | |||||||||
Percentage of net sales for royalty | 40.00% | |||||||||
Royalties | 578 | 400 | $ 578 | $ 578 | $ 578 | $ 578 | 578 | 578 | 400 | $ 856 |
Royalty expense | 700 | 400 | 1,500 | 900 | ||||||
United States | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Products which the company pays royalties | 4 | 4 | ||||||||
Products manufactured, marketed and distributed | drug | 30 | |||||||||
IGI Product | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Company product sales, net | 15,200 | 15,900 | 28,400 | 32,300 | ||||||
Net Of SRA Balance | ||||||||||
Disaggregation of Revenue [Line Items] | ||||||||||
Accounts receivable | $ 19,300 | $ 30,900 | $ 19,300 | $ 19,300 | $ 19,300 | $ 19,300 | $ 19,300 | $ 19,300 | $ 30,900 |
Revenues, Recognition and All39
Revenues, Recognition and Allowances (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | [1] | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Accounts receivable, net | $ 16,232 | $ 16,232 | $ 18,143 | |||
Accrued expenses | 9,269 | 9,269 | $ 13,502 | |||
Revenue, net | 16,751 | $ 18,408 | 31,296 | $ 38,299 | ||
Cost of revenues | $ 11,728 | $ 10,371 | $ 21,053 | $ 19,328 | ||
Gross margin | 30.00% | 33.00% | ||||
Balance Without Adoption of New Revenue Standard | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Accounts receivable, net | $ 18,144 | $ 18,144 | ||||
Accrued expenses | 11,181 | 11,181 | ||||
Revenue, net | 17,228 | 32,408 | ||||
Cost of revenues | $ 12,205 | $ 22,165 | ||||
Gross margin | 29.00% | 32.00% | ||||
Effect of Change Increase/(Decrease) | Accounting Standards Update 2014-09 | ||||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||||
Accounts receivable, net | $ (1,912) | $ (1,912) | ||||
Accrued expenses | (1,912) | (1,912) | ||||
Revenue, net | (477) | (1,112) | ||||
Cost of revenues | $ (477) | $ (1,112) | ||||
Gross margin | (1.00%) | (1.00%) | ||||
[1] | Derived from the audited December 31, 2017 financial statement |
Revenues, Recognition and All40
Revenues, Recognition and Allowances (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Disaggregation of Revenue [Line Items] | ||||
Company product sales, net | $ 15,179 | $ 15,888 | $ 28,415 | $ 32,324 |
Research and development services and other income | 122 | 113 | 133 | 151 |
Revenue, net | 16,751 | 18,408 | 31,296 | 38,299 |
Company product sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Company product sales, net | 15,179 | 15,888 | 28,415 | 32,324 |
Topical | ||||
Disaggregation of Revenue [Line Items] | ||||
Company product sales, net | 8,369 | 9,885 | 16,277 | 18,833 |
Injectables | ||||
Disaggregation of Revenue [Line Items] | ||||
Company product sales, net | 6,810 | 6,003 | 12,138 | 13,491 |
Contract manufacturing sales | ||||
Disaggregation of Revenue [Line Items] | ||||
Company product sales, net | $ 1,450 | $ 2,407 | $ 2,748 | $ 5,824 |
Revenues, Recognition and All41
Revenues, Recognition and Allowances (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Revenue from Contract with Customer [Abstract] | ||||
Gross Company product sales | $ 48,142 | $ 66,744 | $ 84,690 | $ 121,044 |
Deduction to gross product sales: | ||||
Chargebacks and billbacks | 21,449 | 44,090 | 38,364 | 74,105 |
Wholesaler fees for service | 477 | 0 | 1,112 | 0 |
Sales discounts and other allowances | 11,037 | 6,766 | 16,799 | 14,615 |
Total reduction to gross product sales | 32,963 | 50,856 | 56,275 | 88,720 |
Company product sales, net | $ 15,179 | $ 15,888 | $ 28,415 | $ 32,324 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |||
Raw materials | $ 10,655 | $ 8,231 | |
Work in progress | 944 | 616 | |
Finished goods | 8,434 | 8,532 | |
Inventories reserve | (2,458) | (1,304) | |
Inventories, net | $ 17,575 | $ 16,075 | [1] |
[1] | Derived from the audited December 31, 2017 financial statement |
Property, Plant and Equipment43
Property, Plant and Equipment (Details) - USD ($) $ in Thousands | Jun. 30, 2018 | Dec. 31, 2017 | |
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | $ 92,285 | $ 76,722 | |
Less accumulated depreciation and amortization | (9,258) | (8,367) | |
Property, plant and equipment, net | 83,027 | 68,355 | [1] |
Land | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | 257 | 257 | |
Building and improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | 17,474 | 8,613 | |
Machinery and equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | 9,674 | 9,142 | |
Computer hardware and software | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | 4,059 | 3,244 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | 553 | 449 | |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property plant and equipment | $ 60,268 | $ 55,017 | |
[1] | Derived from the audited December 31, 2017 financial statement |
Property, Plant and Equipment44
Property, Plant and Equipment (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation expense | $ 1,133 | $ 822 | ||
Interest costs capitalized | 477 | 0 | ||
Construction in progress | ||||
Property, Plant and Equipment [Line Items] | ||||
Interest costs capitalized | $ 1,500 | $ 700 | 2,800 | 1,200 |
Payroll costs | $ 400 | $ 200 | $ 800 | $ 400 |
Debt (Details Textual)
Debt (Details Textual) - USD ($) | Jul. 16, 2018 | Jun. 01, 2018 | Apr. 27, 2018 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | [1] | Dec. 22, 2014 | Dec. 16, 2014 |
Debt Instrument [Line Items] | |||||||||||
Partial extinguishment of Convertible 3.75% Senior Notes | $ 10,069,000 | $ 0 | $ 10,069,000 | $ 0 | |||||||
Convertible Notes Payable | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Unamortized discount | $ 9,100,000 | ||||||||||
Partial extinguishment of Convertible 3.75% Senior Notes | $ 75,100,000 | ||||||||||
Future cash flow, percent change | 10.00% | ||||||||||
Non-cash interest expense | 10,100,000 | ||||||||||
Qualified Institutional Buyers | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face amount of the Notes | $ 18,750,000 | $ 125,000,000 | |||||||||
Convertible Note 2019 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face amount of the Notes | $ 68,660,000 | $ 68,660,000 | $ 143,750,000 | ||||||||
Stated interest rate | 3.75% | 3.75% | 3.75% | ||||||||
Debt, transfer | $ 75,100,000 | ||||||||||
Convertible Note 2019 | Convertible Notes Payable | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Stated interest rate | 3.75% | 3.75% | 3.75% | ||||||||
Debt, transfer | $ 75,100,000 | ||||||||||
Partial extinguishment of Convertible 3.75% Senior Notes | 75,100,000 | ||||||||||
Non-cash interest expense | $ 10,100,000 | ||||||||||
Unamortized debt issuance expense | $ 1,000,000 | ||||||||||
Convertible Note 2023 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face amount of the Notes | $ 75,090,000 | $ 75,090,000 | |||||||||
Stated interest rate | 4.75% | 4.75% | 4.75% | ||||||||
Convertible Note 2023 | Convertible Notes Payable | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Stated interest rate | 4.75% | 4.75% | 4.75% | ||||||||
Debt, transfer | $ 75,100,000 | $ 75,100,000 | |||||||||
Debt issuance costs | 1,600,000 | ||||||||||
Unamortized discount | $ 19,000,000 | ||||||||||
Initial conversion price (dollars per share) | $ 224.71 | ||||||||||
Settlement conversion price (dollars per share) | $ 280.90 | ||||||||||
Interest rate, effective percentage | 12.10% | ||||||||||
Term Loan 2021 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Face amount of the Notes | $ 25,000,000 | $ 15,000,000 | $ 15,000,000 | ||||||||
Debt issuance costs | 500,000 | ||||||||||
Unamortized discount | $ 400,000 | ||||||||||
Interest rate, effective percentage | 13.56% | ||||||||||
Covenant, minimum cash balance | $ 5,000,000 | ||||||||||
Proceeds from lines of credit | $ 15,000,000 | ||||||||||
Floor interest rate | 2.00% | ||||||||||
London Interbank Offered Rate (LIBOR) | Term Loan 2021 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Basis spread on variable rate | 9.00% | ||||||||||
Subsequent Event | Term Loan 2021 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Proceeds from lines of credit | $ 10,000,000 | ||||||||||
[1] | Derived from the audited December 31, 2017 financial statement |
Debt (Details)
Debt (Details) - USD ($) | Jun. 30, 2018 | Jun. 01, 2018 | Dec. 31, 2017 | |
Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | $ 158,750,000 | $ 143,750,000 | ||
Less unamortized discounts and debt issuance costs | 29,277,000 | 22,773,000 | ||
Carrying amount of the Notes | 129,473,000 | 120,977,000 | ||
Convertible Note 2019 | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | 68,660,000 | 143,750,000 | [1] | |
Convertible Note 2019 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | 68,660,000 | 143,750,000 | ||
Term Loan 2021 | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | 15,000,000 | $ 25,000,000 | ||
Term Loan 2021 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | 15,000,000 | 0 | ||
Convertible Note 2023 | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | 75,090,000 | |||
Convertible Note 2023 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Face amount of the Notes | $ 75,090,000 | $ 0 | ||
[1] | Derived from the audited December 31, 2017 financial statement |
Debt (Details 1)
Debt (Details 1) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | |
Debt Instrument [Line Items] | ||||
Debt partial extinguishment | $ 10,069 | $ 0 | $ 10,069 | $ 0 |
Debt discount amortization | 4,425 | 4,183 | ||
Debt financing amortization | 502 | 456 | ||
Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Interest expense | 14,055 | 3,705 | 17,997 | 7,334 |
Convertible Note 2019 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Interest expense | 878 | 1,347 | 2,226 | 2,695 |
Debt partial extinguishment | 10,069 | 0 | 10,069 | 0 |
Debt discount amortization | 1,571 | 2,126 | 3,910 | 4,183 |
Debt financing amortization | 191 | 232 | 446 | 456 |
Term Loan 2021 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Interest expense | 141 | 0 | 141 | 0 |
Debt discount amortization | 17 | 0 | 17 | 0 |
Debt financing amortization | 14 | 0 | 14 | |
Convertible Note 2023 | Convertible Notes Payable | ||||
Debt Instrument [Line Items] | ||||
Interest expense | 634 | 0 | 634 | 0 |
Debt discount amortization | 498 | 0 | 498 | $ 0 |
Debt financing amortization | $ 42 | $ 0 | $ 42 |
Goodwill and Intangible Asset48
Goodwill and Intangible Assets (Details Textual) - USD ($) | 6 Months Ended | ||
Jun. 30, 2018 | Dec. 31, 2017 | [1] | |
Goodwill [Line Items] | |||
Goodwill | $ 445,000 | $ 471,000 | |
Impairment losses, goodwill | 0 | ||
Alveda Pharmaceuticals | |||
Goodwill [Line Items] | |||
Goodwill | $ 400,000 | ||
[1] | Derived from the audited December 31, 2017 financial statement |
Goodwill and Intangible Asset49
Goodwill and Intangible Assets (Details) $ in Thousands | 6 Months Ended | |
Jun. 30, 2018USD ($) | ||
Goodwill [Roll Forward] | ||
Goodwill beginning balance | $ 471 | [1] |
Foreign currency translation | (26) | |
Goodwill ending balance | $ 445 | |
[1] | Derived from the audited December 31, 2017 financial statement |
Goodwill and Intangible Asset50
Goodwill and Intangible Assets (Details 1) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 | ||
Finite-Lived Intangible Assets [Line Items] | ||||
Finite-lived intangible assets, accumulated amortization | $ (7,832) | $ (6,457) | ||
Total | 52,930 | 56,017 | [1] | |
Indefinite-lived Intangible Assets [Line Items] | ||||
Intangible assets gross carrying amount | 60,762 | 62,474 | ||
Intangible assets net carrying amount | 52,930 | 56,017 | ||
In process research and development (IPR&D) | ||||
Indefinite-lived Intangible Assets [Line Items] | ||||
Indefinite-lived intangible assets | 17,831 | 18,311 | ||
Trademarks and Technology | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Finite-lived intangible assets, gross carrying amount | 39,294 | 40,380 | ||
Finite-lived intangible assets, accumulated amortization | (6,875) | (5,684) | ||
Total | $ 32,419 | 34,696 | ||
Weighted average remaining amortization period | 12 years 4 months 24 days | 12 years 9 months 18 days | ||
Customer relationships | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Finite-lived intangible assets, gross carrying amount | $ 3,637 | 3,783 | ||
Finite-lived intangible assets, accumulated amortization | (957) | (773) | ||
Total | $ 2,680 | $ 3,010 | ||
Weighted average remaining amortization period | 7 years 7 months 3 days | 7 years 10 months 24 days | ||
[1] | Derived from the audited December 31, 2017 financial statement |
Goodwill and Intangible Asset51
Goodwill and Intangible Assets (Details 2) - USD ($) $ in Thousands | 6 Months Ended | ||
Jun. 30, 2018 | Jun. 30, 2017 | ||
Finite-lived Intangible Assets [Roll Forward] | |||
Finite-lived intangible assets beginning balance | [1] | $ 56,017 | |
Amortization | (1,550) | $ (1,396) | |
Finite-lived intangible assets ending balance | 52,930 | ||
Indefinite-lived Intangible Assets [Roll Forward] | |||
Loss on impairment | (22) | $ 0 | |
In process research and development (IPR&D) | |||
Indefinite-lived Intangible Assets [Roll Forward] | |||
Indefinite-lived intangible assets, beginning balance | 18,311 | ||
Loss on impairment | (15) | ||
Foreign currency translation | (465) | ||
Indefinite-lived intangible assets, ending balance | 17,831 | ||
Trademarks and Technology | |||
Finite-lived Intangible Assets [Roll Forward] | |||
Finite-lived intangible assets beginning balance | 34,696 | ||
Amortization | (1,363) | ||
Impairment of Intangible Assets, Finite-lived | (7) | ||
Foreign currency translation | (907) | ||
Finite-lived intangible assets ending balance | 32,419 | ||
Customer relationships | |||
Finite-lived Intangible Assets [Roll Forward] | |||
Finite-lived intangible assets beginning balance | 3,010 | ||
Amortization | (187) | ||
Foreign currency translation | (143) | ||
Finite-lived intangible assets ending balance | $ 2,680 | ||
[1] | Derived from the audited December 31, 2017 financial statement |
Goodwill and Intangible Asset52
Goodwill and Intangible Assets (Details 3) $ in Thousands | Jun. 30, 2018USD ($) |
Goodwill and Intangible Assets Disclosure [Abstract] | |
2018 (remainder of the year) | $ 1,550 |
2,019 | 3,099 |
2,020 | 3,099 |
2,021 | 3,099 |
2,022 | 3,099 |
2,023 | 3,099 |
Thereafter | 18,054 |
Total | $ 35,099 |
Goodwill and Intangible Asset53
Goodwill and Intangible Assets (Details 4) | 6 Months Ended |
Jun. 30, 2018 | |
Trademarks and Technology | |
Finite-Lived Intangible Assets [Line Items] | |
Finite-lived intangible asset, useful life | 15 years |
Customer relationships | |
Finite-Lived Intangible Assets [Line Items] | |
Finite-lived intangible asset, useful life | 10 years |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details Textual) - USD ($) $ in Thousands | May 25, 2016 | May 29, 2010 | Apr. 12, 2010 | Jun. 30, 2018 | Jun. 30, 2017 | Jun. 30, 2018 | Jun. 30, 2017 | Dec. 31, 2017 |
Stock Based Compensation Details [Line Items] | ||||||||
Shares available for grant (in shares) | 20,000,000 | |||||||
Unrecognized compensation costs | $ 2,000 | $ 2,000 | ||||||
Employee Stock Option | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Number of options issued (in shares) | 679,785 | |||||||
Number of options forfeited (in shares) | 200,490 | |||||||
Shares of common stock options outstanding (in shares) | 4,768,105 | 4,768,105 | 4,299,810 | |||||
Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 89,003,000 | |||||||
Unrecognized compensation costs | $ 800 | $ 800 | ||||||
Compensation expense | $ 120 | $ 245 | $ 303 | $ 468 | ||||
Restricted Stock | Minimum | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Vesting period | 1 year | |||||||
Restricted Stock | Maximum | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Vesting period | 3 years | |||||||
Director Stock Option Plan - 1999 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 1,975,000 | |||||||
Number of options issued (in shares) | 2,634,798 | |||||||
Number of options forfeited (in shares) | 807,782 | |||||||
Vesting period | 1 year | |||||||
Maximum term | 10 years | |||||||
Shares of common stock options outstanding (in shares) | 500,000 | 500,000 | 500,000 | |||||
Director Stock Option Plan - 1999 | Employee Stock Option | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares available for grant (in shares) | 147,984 | |||||||
1999 Stock Incentive Plan | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 3,200,000 | 3,200,000 | ||||||
Number of options issued (in shares) | 2,892,500 | |||||||
Vesting period | 4 years | |||||||
Maximum term | 10 years | |||||||
Shares of common stock options outstanding (in shares) | 0 | 0 | ||||||
FMV common stock options granted (as a percent) | 100.00% | |||||||
Service period | 1 year | |||||||
Plan 2,009 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 5,000,000 | |||||||
Number of options forfeited (in shares) | 2,500,000 | |||||||
Shares of common stock options outstanding (in shares) | 2,932,846 | 2,932,846 | 3,038,634 | |||||
Shares available for grant (in shares) | 1,493,960 | 1,493,960 | 1,422,020 | |||||
Additional shares authorized (in shares) | 2,000,000 | 2,000,000 | ||||||
Maximum number of shares to any individual (in shares) | 1,000,000 | |||||||
Plan 2009 | Employee Stock Option | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares available for grant (in shares) | 98,098 | 98,098 | 249,052,000 | |||||
Plan 2009 | Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 24,376 | 24,376 | 99,626,000 | |||||
Plan 2,016 | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares approved and authorized (in shares) | 4,000,000 | |||||||
Shares of common stock options outstanding (in shares) | 49,667 | 49,667 | 761,176,000 | |||||
Shares available for grant (in shares) | 2,935,736 | 2,935,736 | 1,526,857 | |||||
Maximum number of shares to any individual (in shares) | 1,000,000 | |||||||
Plan 2016 | Common Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares of common stock options outstanding (in shares) | 1,335,529 | 1,335,529 | ||||||
Plan 2016 | Restricted Stock | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
RSUs outstanding (in shares) | 174,472 | 174,472 | ||||||
Plan 2016, Plan 2009 And Director Plan | Employee Stock Option | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Shares of common stock options outstanding (in shares) | 4,768,105 | 4,768,105 | 4,299,810,000 | |||||
Director Plan And The 2009 Plan | ||||||||
Stock Based Compensation Details [Line Items] | ||||||||
Intrinsic value of options outstanding | $ 4,500 | $ 4,500 | ||||||
Intrinsic value of options exercisable | $ 4,300 | $ 4,300 |
Stock-Based Compensation (Det55
Stock-Based Compensation (Details) | 6 Months Ended | |
Jun. 30, 2018 | Jun. 30, 2017 | |
Stock Based Compensation [Line Items] | ||
Expected dividends | 0.00% | 0.00% |
Risk-free rate | 2.36% | 1.55% |
Minimum | ||
Stock Based Compensation [Line Items] | ||
Expected volatility | 60.50% | 58.00% |
Expected term (in years) | 3 years 2 months 12 days | 3 years 2 months 12 days |
Maximum | ||
Stock Based Compensation [Line Items] | ||
Expected volatility | 62.30% | 69.70% |
Expected term (in years) | 3 years 3 months 18 days | 3 years 3 months 18 days |
Stock-Based Compensation (Det56
Stock-Based Compensation (Details 1) - Employee Stock Option | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Number of Options | |
Number of options outstanding, balance beginning (in shares) | shares | 4,299,810 |
Number of options issued (in shares) | shares | 679,785 |
Number of options exercised (in shares) | shares | (11,000) |
Number of options forfeited (in shares) | shares | (200,490) |
Number of options expired (in shares) | shares | 0 |
Number of options outstanding, balance ending (in shares) | shares | 4,768,105 |
Number of options exercisable (in shares) | shares | 3,546,700 |
Weighted Average Exercise Price | |
Shares outstanding exercise price, balance beginning (in dollars per share) | $ / shares | $ 5.09 |
Issued, exercise price (in dollars per share) | $ / shares | 3.29 |
Exercised, exercise price (in dollars per share) | $ / shares | 1.08 |
Forfeited, exercise price (in dollars per share) | $ / shares | 7.02 |
Expired, exercise price (in dollars per share) | $ / shares | 0 |
Shares outstanding exercise price, balance ending (in dollars per share) | $ / shares | 4.76 |
Exercisable, exercise price (in dollars per share) | $ / shares | $ 4.63 |
Stock-Based Compensation (Det57
Stock-Based Compensation (Details 2) | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Stock options outstanding (in shares) | shares | 4,768,105 |
Weighted average exercise price (in dollars per share) | $ 4.76 |
Weighted average remaining contractual life | 6 years 3 months 1 day |
Stock options exercisable (in shares) | shares | 3,546,700 |
Weighted average exercise price (in dollars per share) | $ 4.63 |
$0.55 - $1.50 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices (in dollars per share) | 0.55 |
Range of exercise prices (in dollars per share) | $ 1.50 |
Stock options outstanding (in shares) | shares | 1,735,000 |
Weighted average exercise price (in dollars per share) | $ 1.06 |
Weighted average remaining contractual life | 3 years 7 months 10 days |
Stock options exercisable (in shares) | shares | 1,735,000 |
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] | |
Range of exercise prices (in dollars per share) | 1.51 |
Range of exercise prices (in dollars per share) | $ 5.50 |
Stock options outstanding (in shares) | shares | 873,469 |
Weighted average exercise price (in dollars per share) | $ 3.18 |
Weighted average remaining contractual life | 8 years 6 months 8 days |
Stock options exercisable (in shares) | shares | 202,166 |
Weighted average exercise price (in dollars per share) | $ 2.75 |
$5.51 - $10.67 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices (in dollars per share) | 5.51 |
Range of exercise prices (in dollars per share) | $ 10.67 |
Stock options outstanding (in shares) | shares | 2,159,636 |
Weighted average exercise price (in dollars per share) | $ 8.38 |
Weighted average remaining contractual life | 7 years 5 months 13 days |
Stock options exercisable (in shares) | shares | 1,609,534 |
Weighted average exercise price (in dollars per share) | $ 8.72 |
Stock-Based Compensation (Det58
Stock-Based Compensation (Details 3) - Restricted Stock Units (RSUs) | 6 Months Ended |
Jun. 30, 2018$ / sharesshares | |
Number of RSUs | |
Non-vested balance at beginning of period (in shares) | shares | 188,629 |
Shares granted (in shares) | shares | 122,949 |
Shares vested (in shares) | shares | (101,607) |
Shares forfeited (in shares) | shares | (11,123) |
Non-vested balance at end of period (in shares) | shares | 198,848 |
Weighted Average Exercise Price | |
Weighted average exercise price, non-vested balance beginning (in dollars per share) | $ / shares | $ 8.27 |
Shares granted - weighted average exercise price (in dollars per share) | $ / shares | 3.36 |
Shares vested - weighted average exercise price (in dollars per share) | $ / shares | 9.07 |
Shares forfeited - weighted average exercise price (in dollars per share) | $ / shares | 7.21 |
Weighted average exercise price, non-vested balance ending (in dollars per share) | $ / shares | $ 4.88 |
Income Taxes (Details Textual)
Income Taxes (Details Textual) $ in Millions | 6 Months Ended | |
Jun. 30, 2018USD ($)affiliate | Dec. 31, 2017USD ($) | |
Income Tax Examination [Line Items] | ||
Number of foreign affiliates subject to tax in Estonia | affiliate | 1 | |
Tax rate for earnings and profits as they are generated | 0.00% | |
Remeasurement at new rate, percent | 21.00% | |
Operating loss carryforwards | $ 41.7 | |
Change in ownership percent | 50.00% | |
Ownership change (greater than) | 5.00% | |
Minimum | ||
Income Tax Examination [Line Items] | ||
Tax rate for earnings and profits that are distributed to shareholders | 14.00% | |
Tax rate applied to dividends | 14.00% | |
Maximum | ||
Income Tax Examination [Line Items] | ||
Tax rate for earnings and profits that are distributed to shareholders | 20.00% | |
Tax rate applied to dividends | 20.00% | |
Not Subject to Limitations | Subsequent To Change Date In 2010 | ||
Income Tax Examination [Line Items] | ||
Operating loss carryforwards | $ 23.1 | |
Subject to Limitations | Minimum | ||
Income Tax Examination [Line Items] | ||
Operating loss carryforwards | 1 | |
Subject to Limitations | Maximum | ||
Income Tax Examination [Line Items] | ||
Operating loss carryforwards | $ 2.3 | |
Alternative Minimum Tax Carryover | ||
Income Tax Examination [Line Items] | ||
Credit receivable | $ 0.1 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | ||
Schedule of Accrued Liabilities [Line Items] | ||||
Capital expenditures | $ 2,476 | $ 1,947 | ||
Payroll | 1,483 | 1,580 | ||
Professional fees | 1,284 | 546 | ||
Interest expense | 763 | 240 | ||
Clinical studies | 603 | 596 | ||
Royalties | 578 | 856 | $ 400 | |
Medicaid and Medicare | 542 | 0 | ||
Inventory and Supplies | 460 | 58 | ||
Rebates | 332 | 0 | ||
Income Tax | 60 | 58 | ||
Wholesaler fees | 0 | 7,044 | ||
Other | 688 | 577 | ||
Accrued expenses | 9,269 | $ 13,502 | [1] | |
Accounting Standards Update 2014-09 | ||||
Schedule of Accrued Liabilities [Line Items] | ||||
Wholesale fees | 2,800 | |||
Accounts receivable and medicaid fees | 500 | |||
Medicare fees | 100 | |||
Rebates | $ 300 | |||
[1] | Derived from the audited December 31, 2017 financial statement |
Legal and U.S. Regulatory Pro61
Legal and U.S. Regulatory Proceedings (Details) $ in Millions | Oct. 20, 2017USD ($)drug | Jun. 30, 2018druglegal_actionlawsuitgeneric_manufacturer_defendant |
Loss Contingencies [Line Items] | ||
Number of legal actions | legal_action | 3 | |
Anti-Trust Lawsuit | ||
Loss Contingencies [Line Items] | ||
Number of putative class action antitrust lawsuits | 12 | |
Loss contingency, number of defendants | generic_manufacturer_defendant | 34 | |
Number of drugs involved | drug | 29 | |
Stayma | ||
Loss Contingencies [Line Items] | ||
Number of drugs involved | drug | 2 | |
Damages sought | $ | $ 1.7 | |
Opt Out | Anti-Trust Lawsuit | ||
Loss Contingencies [Line Items] | ||
Number of putative class action antitrust lawsuits | 1 | |
Loss contingency, number of defendants | 35 | |
Number of drugs involved | 30 | |
Motion To Dismiss | Anti-Trust Lawsuit | ||
Loss Contingencies [Line Items] | ||
Number of putative class action antitrust lawsuits | 3 |