Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Nov. 02, 2017 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Amphastar Pharmaceuticals, Inc. | |
Trading Symbol | amph | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Entity Central Index Key | 1,297,184 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Document Period End Date | Sep. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 | |
Entity Common Stock, Shares Outstanding | 45,975,746 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 66,920 | $ 72,354 |
Short-term investments | 2,522 | 527 |
Restricted short-term investments | 4,155 | 1,390 |
Accounts receivable, net | 24,152 | 26,777 |
Inventories | 69,640 | 79,754 |
Income tax refund and deposits | 443 | 22 |
Prepaid expenses and other assets | 8,660 | 3,272 |
Total current assets | 176,492 | 184,096 |
Property, plant, and equipment, net | 173,046 | 152,944 |
Goodwill and intangible assets, net | 45,731 | 50,307 |
Other assets | 10,623 | 9,390 |
Deferred tax assets | 31,874 | 31,001 |
Total assets | 437,766 | 427,738 |
Current Liabilities: | ||
Accounts payable | 9,590 | 16,196 |
Accrued liabilities | 16,421 | 15,703 |
Income taxes payable | 4,181 | 7,705 |
Accrued payroll and related benefits | 17,344 | 13,847 |
Current portion of product return accrual | 3,649 | 1,800 |
Current portion of long-term debt and capital leases | 6,212 | 5,366 |
Total current liabilities | 57,397 | 60,617 |
Long-term product return accrual | 1,865 | 1,343 |
Long-term reserve for income tax liabilities | 845 | 845 |
Long-term deferred revenue | 1,215 | 97 |
Long-term debt and capital leases, net of current portion | 42,232 | 32,356 |
Deferred Tax Liabilities, Net, Noncurrent | 1,586 | 1,455 |
Other long-term liabilities | 1,971 | 1,770 |
Total liabilities | 107,111 | 98,483 |
Stockholders’ equity: | ||
Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding | ||
Common stock: par value $0.0001; 300,000,000 shares authorized; 48,991,134 and 45,896,393 shares issued and outstanding as of September 30, 2017 and 47,765,149 and 46,248,622 shares issued and outstanding as of December 31, 2016, respectively | 5 | 5 |
Additional paid-in capital | 303,208 | 283,123 |
Retained earnings | 74,767 | 70,855 |
Accumulated other comprehensive loss | (2,595) | (4,696) |
Treasury stock | (44,730) | (20,032) |
Total stockholders’ equity | 330,655 | 329,255 |
Total liabilities and stockholders’ equity | $ 437,766 | $ 427,738 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock; shares authorized | 300,000,000 | 300,000,000 |
Common stock; shares issued | 48,991,134 | 47,765,149 |
Common stock; shares outstanding | 45,896,393 | 46,248,622 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net revenues | $ 57,916 | $ 64,223 | $ 179,773 | $ 191,622 |
Cost of revenues | 37,275 | 36,611 | 109,557 | 107,394 |
Gross profit | 20,641 | 27,612 | 70,216 | 84,228 |
Operating (income) expenses: | ||||
Selling, distribution, and marketing | 1,756 | 1,291 | 4,831 | 3,975 |
General and administrative | 11,665 | 10,801 | 35,237 | 31,129 |
Research and development | 10,040 | 9,723 | 32,022 | 28,922 |
Gain on sale of intangible assets | (2,643) | |||
Total operating expenses | 23,461 | 21,815 | 69,447 | 64,026 |
Income (loss) from operations | (2,820) | 5,797 | 769 | 20,202 |
Non-operating income (expense): | ||||
Interest income | 124 | 63 | 302 | 187 |
Interest expense | (264) | (281) | (692) | (970) |
Other income (expense), net | 969 | 422 | 2,307 | 150 |
Total non-operating income (expense), net | 829 | 204 | 1,917 | (633) |
Income (loss) before income taxes | (1,991) | 6,001 | 2,686 | 19,569 |
Income tax expense (benefit) | (2,166) | 2,111 | (354) | 6,295 |
Net income | $ 175 | $ 3,890 | $ 3,040 | $ 13,274 |
Net income (loss) per share: | ||||
Basic (in Dollars per share) | $ 0 | $ 0.09 | $ 0.07 | $ 0.29 |
Diluted (in Dollars per share) | $ 0 | $ 0.08 | $ 0.06 | $ 0.29 |
Weighted-average shares used to compute net income (loss) per share: | ||||
Basic (in Shares) | 46,101 | 45,398 | 46,065 | 45,132 |
Diluted (in Shares) | 48,215 | 47,953 | 48,046 | 46,365 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||||
Net income | $ 175 | $ 3,890 | $ 3,040 | $ 13,274 |
Other comprehensive income (loss), net of income taxes | ||||
Foreign currency translation adjustment | 625 | 109 | 2,101 | (106) |
Total other comprehensive income (loss) | 625 | 109 | 2,101 | (106) |
Total comprehensive income | $ 800 | $ 3,999 | $ 5,141 | $ 13,168 |
CONDENSED CONSOLIDATED STATEME6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Cash Flows From Operating Activities: | ||
Net income | $ 3,040 | $ 13,274 |
Reconciliation to net cash provided by operating activities: | ||
Loss (gain) on disposal and impairment of long-lived assets | (2,283) | 994 |
Depreciation of property, plant, and equipment | 9,376 | 9,009 |
Amortization of product rights, trademarks, and patents | 2,139 | 1,751 |
Share-based compensation | 12,905 | 11,604 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 2,909 | 6,756 |
Inventories | 12,382 | (19,477) |
Prepaid expenses and other assets | (3,791) | 173 |
Income tax refund, deposits, and payable | (5,213) | 3,215 |
Accounts payable and accrued liabilities | (2,020) | (2,745) |
Net cash provided by operating activities | 29,444 | 24,554 |
Cash Flows From Investing Activities: | ||
Business Acquisitions | (12,461) | |
Purchases and construction of property, plant, and equipment | (24,981) | (16,045) |
Sale of intangible assets | 2,000 | |
Purchase of short-term investments | (5,645) | (2,270) |
Maturity of short-term investments | 3,650 | 1,414 |
Changes in restricted short-term investments | (2,765) | (105) |
Payment of deposits and other assets | (885) | (2,921) |
Net cash used in investing activities | (28,626) | (32,388) |
Cash Flows From Financing Activities: | ||
Net proceeds from equity plans | 7,255 | 17,157 |
Purchase of treasury stock | (24,773) | (8,986) |
Proceeds from issuance of long-term debt | 18,983 | 10,198 |
Principal payments on long-term debt | (8,381) | (9,968) |
Net cash provided by (used in) financing activities | (6,916) | 8,401 |
Effect of exchange rate changes on cash | 664 | (43) |
Net increase (decrease) in cash and cash equivalents | (5,434) | 524 |
Cash and cash equivalents at beginning of period | 72,354 | 66,074 |
Cash and cash equivalents at end of period | 66,920 | 66,598 |
Noncash Investing and Financing Activities: | ||
Equipment acquired under capital leases | 1,263 | |
Supplemental Disclosures of Cash Flow Information: | ||
Interest paid, net of capitalized interest | 1,334 | 1,381 |
Income taxes paid | $ 4,876 | $ 3,263 |
General
General | 9 Months Ended |
Sep. 30, 2017 | |
General | |
General | Note 1. Genera Amphastar Pharmaceuticals, Inc., a California corporation, was incorporated on February 29, 1996 and merged with and into Amphastar Pharmaceuticals, Inc., a Delaware corporation, in July 2004 (together with its subsidiaries, hereinafter referred to as “the Company”). The Company is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable, inhalation, and intranasal products, including products with high technical barriers to market entry. Additionally, the Company sells insulin active pharmaceutical ingredient, or API, products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are sold to other pharmaceutical companies for use in their own products and are being used by the Company in the development of injectable finished pharmaceutical products. The Company’s inhalation products will be primarily distributed through drug retailers if they are approved and brought to market. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 2016, and the notes thereto as filed with the Securities and Exchange Commission, or SEC, in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair statement of the Company’s consolidated financial position, results of operations, comprehensive income (loss) and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations, comprehensive income (loss) and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | Note 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, and are prepared in accordance with the requirements of the SEC for interim reporting. Certain amounts in the prior period condensed consolidated statements of operations and statement of cash flows have been reclassified to conform to the current quarter presentation. All significant intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. Effective January 1, 2017, the Company prospectively adopted certain requirements of Auditing Standards Update, or ASU, No. 2016-09 to classify cash flows related to excess tax benefits in operating activities without adjusting prior periods. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Nanjing Letop Fine Chemistry Co., Ltd., or Letop, (5) Nanjing Hanxin Medical Technology Co., Ltd, or Hanxin, (6) Amphastar France Pharmaceuticals, S.A.S., or AFP, (7) Amphastar UK Ltd., or AUK, and (8) International Medication Systems (UK) Limited, or IMS UK. Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for doubtful accounts and discounts, provision for chargebacks, provision for product returns, adjustment of inventory to their net realizable values, impairment of long-lived and intangible assets and goodwill, self-insured claims, workers’ compensation liabilities, litigation reserves, stock price volatilities for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. Foreign Currency The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary, ANP, and its U.K. subsidiary, AUK, is the U.S. dollar, or USD. ANP maintains its books of record in Chinese Yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s statements of operations. The Company’s French subsidiary, AFP, maintains its books of record in Euros. Its Chinese subsidiary, Letop, maintain its books of record in Chinese Yuan. Its U.K. subsidiary, IMS UK, maintains its books of record in Great Britain Pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. These books of record are translated into USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other accumulated comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss). The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the three and nine months ended September 30, 2017 were a $1.1 million gain and a $3.8 million gain, respectively, and for the three and nine months ended September 30, 2016 were a $0.3 million gain and a $0.6 million gain, respectively. Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. Comprehensive Income (loss) For the three and nine months ended September 30, 2017 and 2016, the Company included its foreign currency translation as part of its comprehensive income (loss). Financial Instruments The carrying amounts of cash and cash equivalents, short-term investments, restricted short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. A majority of the Company’s long-term obligations consist of variable rate debt, and their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. However, the Company has one fixed-rate, long-term mortgage for which the carrying value differs from the fair value and is not remeasured on a recurring basis (see Note 12). The Company at times enters into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates without the exchange of the underlying notional debt amounts. Such interest rate swap contracts are recorded at their fair values. Deferred Income Taxes The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. Business Combinations If an acquired set of activities and assets is capable of being operated as a business consisting of inputs and processes from the viewpoint of a market participant, the asset acquired and liabilities assumed are a business. Business combinations are accounted for using the acquisition method of accounting, which requires an acquirer to recognize the assets acquired and the liabilities assumed at the acquisition date measured at their fair values as of that date. Fair value determinations are based on discounted cash flow analyses or other valuation techniques. In determining the fair value of the assets acquired and liabilities assumed in a material acquisition, the Company may utilize appraisals from third party valuation firms to determine fair values of some or all of the assets acquired and liabilities assumed, or may complete some or all of the valuations internally. In either case, the Company takes full responsibility for the determination of the fair value of the assets acquired and liabilities assumed. The value of goodwill reflects the excess of the fair value of the consideration conveyed to the seller over the fair value of the net assets received. Acquisition-related costs that the Company incurs to effect a business combination are expensed in the periods in which the costs are incurred. When the operations of the acquired businesses were not material to the Company’s condensed consolidated financial statements, no pro forma presentations were disclosed. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2014-09 Revenue from Contracts with Customers , which creates a single source of revenue guidance for companies in all industries. Subsequently, the FASB issued multiple updates. The new standard provides guidance for all revenue arising from contracts with customers and affects all entities that enter into contracts to provide goods or services to their customers, unless the contracts are within the scope of other accounting standards. It also provides a model for the measurement and recognition of gains and losses on the sale of certain nonfinancial assets. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required regarding customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. This guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). Based on ASU No. 2015-14 Deferral of the Effective Date , issued in August 2015, this guidance will be effective for the Company beginning in the first quarter of 2018, including interim periods within the year. The Company expects to adopt the standard in 2018 using the modified retrospective transition method. The majority of the Company’s revenue relates to sale of pharmaceutical products to various customers, and the adoption of the new standard is not expected to have a material impact on these transactions. The Company is continuing to evaluate the impact of all transactions. In February 2016, the FASB issued ASU No. 2016-02 Leases , that is aimed at making leasing activities more transparent and comparable, and which requires substantially all leases be recognized by lessees on their balance sheets as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. This guidance will become effective for the Company’s interim and annual reporting periods during the year ending December 31, 2019, and all annual and interim reporting periods thereafter. Early adoption is permitted. The Company is required to use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements for the reporting periods in which the guidance is adopted. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13 Financial Instruments – Credit Losses , which is aimed at providing financial statement users with more useful information about the expected credit losses on financial instruments and other commitments to extend credit. The standard update changes the impairment model for financial assets measured at amortized cost, requiring presentation at the net amount expected to be collected. The measurement of expected credit losses requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Available-for-sale debt securities with unrealized losses will be recorded through an allowance for credit losses. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2020. Early adoption is permitted for interim or annual periods during the year ended December 31, 2019. The Company will be required to apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15 Classification of Certain Cash Receipts and Cash Payments , which is aimed at addressing certain issues regarding classifications of certain cash receipts and cash payments on the statement of cash flows where diversity in practice was identified. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted. The Company will be required to apply the guidance retrospectively in the first interim and each annual period in which the guidance is adopted. The Company does not believe that the adoption of this accounting guidance will have a material impact on the Company’s consolidated financial statements and related disclosures. In October 2016, the FASB issued ASU No. 2016-16 Intra-Entity Transfers of Assets Other Than Inventory , which requires an entity to recognize the income tax consequences of intra-entity transfer of an asset other than inventory when the transfer occurs. The guidance is effective for the Company's interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted as of the beginning of an annual reporting period for which financial statements, interim or annual, have not been issued. The amendments will be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU No. 2016-18 Statement of Cash Flows: Restricted Cash , which requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, the Company will no longer present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. The guidance is effective for the Company's interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted, including adoption in an interim period. The amendments will be applied using a retrospective transition method to each period presented. The Company will be required to apply the guidance retrospectively when adopted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU No. 2017-01 Clarifying the Definition of a Business , which provides guidance to assist entities with evaluating when a set of transferred assets and activities is a business. Under the updated guidance, a set is not a business if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar assets. If the threshold is not met, the update requires that, to be a business, the set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. The definition of outputs was also aligned with Accounting Standard Codification, or ASC, 606 by focusing on revenue-generating activities. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018, and prospectively applicable to any transactions occurring within the period of adoption. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU No. 2017-04 Simplifying the Test for Goodwill Impairment , which eliminates the requirement to calculate the implied fair value of goodwill. An entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The update also eliminated the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity is required to disclose the amount of goodwill allocated to each reporting unit with a zero or negative carrying amount of net assets. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2020, and applied on a prospective basis. Early adoption is permitted for interim and annual goodwill impairment testing dates after January 1, 2017. The Company currently does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In May 2017, the FASB issued ASU No. 2017-09 Scope of Modification Accounting , that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018, and applied prospectively to awards modified on or after the adoption date. Early adoption is permitted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In August 2017, the FASB issued ASU No. 2017-12 Targeted Improvements to Accounting for Hedging Activities , which amends the hedge accounting model in ASC 815 to enable entities to better portray the economics of their risk management activities in the financial statements and enhance the transparency and understandability of hedge results. The amendments also simplify the application of hedge accounting in certain situations. The new guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2019. Early adoption is permitted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. |
Business Acquisitions
Business Acquisitions | 9 Months Ended |
Sep. 30, 2017 | |
Business Acquisitions | |
Business Acquisition | Note 3. Business Acquisitions Acquisition of International Medication Systems (UK) Limited from UCB PHARMA GmbH In August 2016, the Company’s UK subsidiary, AUK, acquired IMS UK, a UK-based subsidiary of UCB PHARMA GmbH, including its trademarks, assets related to the products, as well as marketing authorizations for 33 products in the UK, Ireland, Australia, and New Zealand, representing 11 different injectable chemical entities. The Company paid $7.7 million in cash as consideration for the transaction. The Company is in the process of transferring the manufacturing of the purchased products to its facilities in California. The transfer will require approval of the UK Medicines and Healthcare products Regulatory Agency and other related regulatory agencies before the products can be sold by the Company. The transaction is accounted for as a business combination in accordance with ASC 805. The fair values of the assets acquired and liabilities assumed include marketing authorizations of $9.2 million, manufacturing equipment of $0.1 million, and deferred tax liability of $1.6 million. The acquired marketing authorizations intangible assets are subject to a straight-line amortization over a useful life of approximately 10 years. Acquisition of fourteen injectable products from Hikma Pharmaceuticals PLC In March 2016, the Company acquired 14 abbreviated new drug application, or ANDAs, representing 11 different injectable chemical entities from Hikma Pharmaceuticals PLC, or Hikma, for $4.0 million. This transaction was accounted for as a business combination in accordance with ASC 805. The ANDAs had an estimated fair value of $4.0 million, and were subject to a straight-line amortization over a useful life of approximately 15 years. In February 2017, the Company sold these products to an unrelated party (see Note 9). Acquisition of Nanjing Letop Medical Technology Co. Ltd. In January 2016, the Company’s Chinese subsidiary, ANP, acquired Nanjing Letop Medical Technology Co. Ltd. for $1.7 million consisting of $0.8 million in cash and a deposit of $0.9 million that ANP had previously paid to Letop and which was effectively eliminated upon the consummation of the transaction. The Company accounted for this transaction as a business combination in accordance with ASC 805. The Company recognized $1.4 million of acquired assets, $0.1 million of assumed liabilities, and $0.4 million of goodwill. Letop had previously supplied ANP with intermediates used in making various active pharmaceutical ingredients. In March 2016, the acquired subsidiary was renamed Nanjing Letop Fine Chemistry Co., Ltd. Acquisition of Merck’s API Manufacturing Business On April 30, 2014, the Company completed the acquisition of the Merck Sharpe & Dohme’s API manufacturing business in Éragny-sur-Epte, France, or the Merck API Transaction, which manufactures porcine insulin API and recombinant human insulin API, or RHI API. The purchase price of the transaction totaled €24.8 million, or $34.4 million on April 30, 2014, subject to certain customary post‑closing adjustments and currency exchange rate fluctuations. The terms of the purchase include multiple payments over four years as follows (see Note 12): U.S. Euros Dollars (in thousands) At Closing, April 2014 € 13,252 $ 18,352 December 2014 4,899 5,989 December 2015 3,186 3,483 December 2016 3,186 3,427 December 2017 500 591 € 25,023 $ 31,842 In order to facilitate the acquisition, the Company established AFP in France. The Company is continuing the current site manufacturing activities, which consist of the manufacturing of porcine insulin API and RHI API. As part of the transaction, the Company has entered into various additional agreements, including various supply agreements, as well as the assignment and/or licensing of patents under which Merck was operating at this facility. In addition, certain existing customer agreements have been assigned to AFP. Currently, the Company is in the process of transferring the manufacturing of starting material for RHI API from Merck to AFP. This process will require capital expenditures at AFP and is expected to take up to two years to complete. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2017 | |
Revenue Recognition | |
Revenue Recognition | Note 4. Revenue Recognition Generally, revenue is recognized at the time of product delivery to the Company’s customers. In some cases, revenue is recognized at the time of shipment when stipulated by the terms of the sale agreements. Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers, after the customer has accepted test samples of the products to be shipped. On June 30, 2016, the Company and Actavis, Inc., or Actavis, amended the distribution agreement, which terminated the agreement in December 2016. Profit-sharing revenue under this agreement was recognized at the time Actavis sold the products to its customers. The Company does not recognize product revenue unless the following fundamental criteria are met: (i) persuasive evidence of an arrangement exists, (ii) transfer of title has occurred, (iii) the price to the customer is fixed or determinable, and (iv) collection is reasonably assured. Furthermore, the Company does not recognize revenue until all customer acceptance requirements have been met. The Company estimates and records reductions to revenue for discounts, product returns, and pricing adjustments, such as wholesaler chargebacks, in the same period that the related revenue is recorded. The Company’s accounting policy is to review each agreement involving contract development and manufacturing services to determine if there are multiple revenue-generating activities that constitute more than one unit of accounting. Revenues are recognized for each unit of accounting based on revenue recognition criteria relevant to that unit. The Company does not have any revenue arrangements with multiple deliverables. Provision for Wholesaler Chargebacks The provision for chargebacks is a significant estimate used in the recognition of revenue. As part of its sales terms with wholesale customers, the Company agrees to reimburse wholesalers for differences between the gross sales prices at which the Company sells its products to wholesalers, or list prices, and the actual prices of such products at the time wholesalers resell them under the Company’s various contractual arrangements with third parties such as retailers, hospitals and group purchasing organizations. The Company estimates chargebacks at the time of sale to wholesalers based on wholesaler inventory stocking levels, historic chargeback rates, and current contract pricing. The settlement of chargebacks generally occurs within 30 days after the sale to wholesalers. The provision for chargebacks is reflected in net revenues. Accounts receivable and/or accrued liabilities are also reduced and/or increased by the chargebacks amount depending on whether the Company has the right of offset with the customer. The following table is an analysis of the chargeback provision: Nine Months Ended September 30, 2017 2016 (in thousands) Beginning balance $ 37,820 $ 15,217 Provision for chargebacks 115,824 105,772 Credits issued to third parties (144,142) (110,073) Ending balance $ 9,502 $ 10,916 Changes in chargeback provision from period to period are primarily dependent on the Company’s sales to its wholesalers, the level of inventory held by the wholesalers, and on the wholesaler’s customer mix. The approach that the Company uses to estimate chargebacks has been consistently applied for all periods presented. Variations in estimates have been historically small. The chargeback provision has decreased in the nine months ended September 30, 2017, primarily due to a decrease in the list price of enoxaparin in the first half of 2017. The Company continually monitors the provision for chargebacks and makes adjustments when it believes that the actual chargebacks may differ from the estimates. Chargeback provisions as of September 30, 2017 and 2016 are included as a reduction to account receivables. Accrual for Product Returns The Company offers most customers the right to return qualified excess or expired inventory for partial credit; however, products sold to Actavis and API product sales are non-returnable. The Company’s product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, the Company records an accrual for estimated returns. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. The Company also assesses other factors that could affect product returns including market conditions, product obsolescence, and the introduction of new competition. Although these factors do not normally give the Company’s customers the right to return products outside of the regular return policy, the Company realizes that such factors could ultimately lead to increased returns. The Company analyzes these situations on a case-by-case basis and makes adjustments to the product return reserve as appropriate. If the available information is not sufficient to estimate a reasonable product return accrual, revenues from the sales of the new product would not be recognized until the product is consumed by the end customer or rights of return granted under the return policy have expired. As of September 30, 2017 and December 31, 2016, cumulative sales of approximately $1.1 million and $0.5 million, respectively, for one of the Company’s products were not recognized in revenues, due to insufficient information available to estimate a reasonable product return accrual. The provision for product returns is reflected in net revenues. The following table is an analysis of product return liability: Nine Months Ended September 30, 2017 2016 (in thousands) Beginning balance $ 3,143 $ 2,621 Provision for product returns 4,196 958 Credits issued to third parties (1,825) (873) Ending balance $ 5,514 $ 2,706 For the nine months ended September 30, 2017 and 2016 , the Company’s aggregate product return rate was 1.2% and 1.1% of qualified sales, respectively. |
Income per Share
Income per Share | 9 Months Ended |
Sep. 30, 2017 | |
Income per Share | |
Income per Share | Note 5. Income per Share Basic income per share is calculated based upon the weighted-average number of shares outstanding during the period. Diluted income per share gives effect to all potential dilutive shares outstanding during the period, such as stock options, nonvested deferred stock units and restricted stock units (collectively referred to herein as “RSUs”), and shares issuable under the Company’s Employee Stock Purchase Plan, or ESPP. For the three and nine months ended September 30, 2017, options to purchase 1,162,850 and 2,424,430 shares of stock with a weighted-average exercise price of $27.87 per share and $21.93 per share, respectively, were excluded in the computation of diluted net income per share because the effect from the assumed exercise of these options would be anti-dilutive. For the three and nine months ended September 30, 2016, options to purchase 1,357,154 and 4,510,729 shares of stock with a weighted-average exercise price of $29.31 per share and $19.84 per shares, respectively, were excluded in the computation of diluted net income per share because the effect from the assumed exercise of these options would be anti-dilutive. The following table provides the calculation of basic and diluted net income per share for each of the periods presented: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands, except per share data) Basic and dilutive numerator: Net income $ 175 $ 3,890 $ 3,040 $ 13,274 Denominator: Weighted-average shares outstanding — basic 46,101 45,398 46,065 45,132 Net effect of dilutive securities: Incremental shares from equity awards 2,114 2,555 1,981 1,233 Weighted-average shares outstanding — diluted 48,215 47,953 48,046 46,365 Net income per share — basic $ 0.00 $ 0.09 $ 0.07 $ 0.29 Net income per share — diluted $ 0.00 $ 0.08 $ 0.06 $ 0.29 |
Segment Reporting
Segment Reporting | 9 Months Ended |
Sep. 30, 2017 | |
Segment Reporting | |
Segment Reporting | Note 6. Segment Reporting The Company has established two reporting segments that each report to the Chief Operating Decision Maker, or CODM, as defined in ASC 280, Segment Reporting. The Company’s performance is assessed and resources are allocated by the CODM based on the following two reportable segments: · Finished pharmaceutical products · Active pharmaceutical ingredients, or API The finished pharmaceutical products segment manufactures, markets and distributes enoxaparin, naloxone, lidocaine, as well as various other critical and non-critical care drugs. The API segment manufactures and distributes recombinant human insulin API and porcine insulin API for external customers and internal product development. Selected financial information by reporting segment is presented below: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Net revenues: Finished pharmaceutical products $ 54,455 $ 59,058 $ 174,154 $ 181,368 API 3,461 5,165 5,619 10,254 Total net revenues 57,916 64,223 179,773 191,622 Gross profit: Finished pharmaceutical products 21,310 28,621 74,486 85,042 API (669) (1,009) (4,270) (814) Total gross profit 20,641 27,612 70,216 84,228 Operating expenses 23,461 21,815 69,447 64,026 Income (loss) from operations (2,820) 5,797 769 20,202 Non-operating income (expenses) 829 204 1,917 (633) Income (loss) before income taxes $ (1,991) $ 6,001 $ 2,686 $ 19,569 The Company manages its business segments to the gross profit level and manages its operating and other costs on a company-wide basis. The Company does not identify total assets by segment for internal purposes, as the Company’s CODM does not assess performance, make strategic decisions, or allocate resources based on assets. The amount of net revenues in the finished pharmaceutical product segment is presented below: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Finished pharmaceutical products net revenues: Enoxaparin $ 6,549 $ 15,363 $ 25,247 $ 51,049 Naloxone 12,709 12,407 33,909 38,222 Lidocaine 9,596 8,279 27,218 26,378 Phytonadione 9,352 8,667 27,242 23,555 Epinephrine 2,027 5,303 22,249 14,921 Other finished pharmaceutical products 14,222 9,039 38,289 27,243 Total finished pharmaceutical products net revenues $ 54,455 $ 59,058 $ 174,154 $ 181,368 Discontinuation of epinephrine injection, USP vial product In February 2017, the U.S. Food and Drug Administration, or FDA, requested the Company to discontinue the manufacturing and distribution of its epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. The Company discontinued selling this product in the second quarter of 2017. For the year ended December 31, 2016, the Company recognized $18.6 million in net revenues for the sale of this product. A charge of $3.3 million was included in the cost of revenues in its consolidated statements of operations for the year ended December 31, 2016 to adjust the related inventory and firm purchase commitments to their net realizable value due to the anticipated discontinuation of the product. Net revenues and carrying values of long-lived assets of enterprises by geographic regions are as follows: Net Revenue Long-Lived Assets Three Months Ended Nine Months Ended September 30, September 30, September 30, December 31, 2017 2016 2017 2016 2017 2016 (in thousands) United States $ 55,346 $ 62,691 $ 175,075 $ 188,865 $ 105,311 $ 104,110 China — — — — 39,639 35,085 France 2,570 1,532 4,698 2,757 28,004 13,659 United Kingdom — — — — 92 90 Total $ 57,916 $ 64,223 $ 179,773 $ 191,622 $ 173,046 $ 152,944 |
Customer and Supplier Concentra
Customer and Supplier Concentration | 9 Months Ended |
Sep. 30, 2017 | |
Customer and Supplier Concentration | |
Customer and Supplier Concentration | Note 7. Customer and Supplier Concentration Customer Concentrations Three large wholesale drug distributors, AmerisourceBergen Corporation, or AmerisourceBergen, Cardinal Health, Inc., or Cardinal, and McKesson Corporation, or McKesson, are all distributors of the Company’s products, as well as suppliers of a broad range of health care products. Actavis had exclusive marketing rights of the Company’s enoxaparin product to the U.S. retail pharmacy market until December 2016. The Company considers these four customers to be its major customers, as each individually, and these customers collectively, represented a significant percentage of the Company’s net revenue for the three and nine months ended September 30, 2017 and 2016, and accounts receivable as of September 30, 2017 and December 31, 2016, respectively. The following table provides accounts receivable and net revenue information for these major customers: % of Total Accounts % of Net Receivable Revenue Three Months Ended Nine Months Ended September 30, December 31, September 30, September 30, 2017 2016 2017 2016 2017 2016 Actavis (1) — 1 % — 16 % — 19 % AmerisourceBergen 12 % 30 % 24 % 19 % 27 % 19 % Cardinal Health 23 % 28 % 25 % 19 % 25 % 20 % McKesson 27 % 19 % 27 % 21 % 27 % 20 % (1) The agreement with Actavis was terminated in December 2016. Supplier Concentrations The Company depends on suppliers for raw materials, active pharmaceutical ingredients, and other components that are subject to stringent FDA, requirements. Some of these materials may only be available from one or a limited number of sources. Establishing additional or replacement suppliers for these materials may take a substantial period of time, as suppliers must be approved by the FDA. Furthermore, a significant portion of raw materials may only be available from foreign sources. If the Company is unable to secure, on a timely basis, sufficient quantities of the materials it depends on to manufacture and market its products, it could have a materially adverse effect on the Company’s business, financial condition, and results of operations. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2017 | |
Fair Value Measurements | |
Fair Value Measurements | Note 8. Fair Value Measurements The accounting standards of the FASB, define fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal or most advantageous market for the asset or liability at the measurement date (an exit price). These standards also establish a hierarchy that prioritizes observable and unobservable inputs used in measuring fair value of an asset or liability, as described below: · Level 1 – Inputs to measure fair value are based on quoted prices (unadjusted) in active markets on identical assets or liabilities; · Level 2 – Inputs to measure fair value are based on the following: a) quoted prices in active markets on similar assets or liabilities, b) quoted prices for identical or similar instruments in inactive markets, or c) observable (other than quoted prices) or collaborated observable market data used in a pricing model from which the fair value is derived; and · Level 3 – Inputs to measure fair value are unobservable and the assets or liabilities have little, if any, market activity; these inputs reflect the Company’s own assumptions about the assumptions that market participants would use in pricing the assets or liabilities based on best information available in the circumstances. The fair values of the Company’s cash equivalents, short-term investments, and restricted short-term investments approximate their respective carrying amounts. As of September 30, 2017 and December 31, 2016, cash equivalents include money market accounts and money market funds. Short-term investments consist of certificate of deposits and held-to-maturity municipal bonds with original maturities greater than three months. The municipal bonds are carried at amortized cost in the Company’s consolidated balance sheet, which approximates their fair value determined based on Level 2 inputs. The Company does not intend to and will not be required to sell the investments before recovery of their amortized cost basis. Restricted short-term investments consist of certificates of deposits with original maturities great than three months. The restrictions placed on the certificate of deposit accounts have a negligible effect on the fair value of these financial assets; these funds are restricted to meet the Company’s obligation for workers’ compensation claims and performance bonds. The Company does not hold any Level 3 instruments that are measured for fair value on a recurring basis. Nonfinancial assets and liabilities are not measured at fair value on a recurring basis but are subject to fair value adjustments in certain circumstances. These items primarily include long-lived assets, goodwill, and intangible assets for which the fair value of assets is determined as part of the related impairment test. As of September 30, 2017 and December 31, 2016, there were no significant adjustments to fair value for nonfinancial assets or liabilities. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets | |
Goodwill and Intangible Assets | Note 9. Goodwill and Intangible Assets The table below shows the weighted-average life, original cost, accumulated amortization, and net book value by major intangible asset classification: Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Cortrosyn® product rights 12 $ 27,134 $ 25,797 $ 1,337 IMS (UK) international product rights (1) 10 9,371 1,093 8,278 Patents 12 486 160 326 Land-use rights 39 2,540 403 2,137 Other intangible assets 4 69 42 27 Subtotal 12 39,600 27,495 12,105 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 4,401 — 4,401 Subtotal * 33,626 — 33,626 As of September 30, 2017 * $ 73,226 $ 27,495 $ 45,731 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Cortrosyn® product rights 12 $ 27,134 $ 24,461 $ 2,673 IMS (UK) international product rights (1) 10 8,632 359 8,273 Acquired ANDAs (2) 15 4,000 222 3,778 Patents 10 293 137 156 Land-use rights 39 2,540 354 2,186 Other intangible assets 1 574 534 40 Subtotal 12 43,173 26,067 17,106 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,976 — 3,976 Subtotal * 33,201 — 33,201 As of December 31, 2016 * $ 76,374 $ 26,067 $ 50,307 * Intangible assets with indefinite lives have an indeterminable average life. (1) In August 2016, the Company acquired International Medication Systems (UK) Limited from UCB PHARMA GmbH for $7.7 million. The fair value of the marketing authorization was $9.2 million as of the acquisition date (see Note 3). (2) In February 2017, the Company sold the 14 ANDAs it had acquired from Hikma to an unrelated party for $6.4 million. Sale of Fourteen Injectable ANDAs In February 2017, the Company sold the 14 ANDAs it acquired in March 2016 from Hikma to an unrelated party. The consideration included a purchase price of $6.4 million of which the amount of $1.0 million was received upon closing, $1.0 million was received in the second quarter of 2017 and the remaining $4.4 million will be paid upon certain milestones. If the purchaser is not able to achieve these milestones by December 31, 2017, the purchaser will pay the remaining payments within 30 days of December 31, 2017. In addition to the purchase price, the purchaser agreed to pay the Company a royalty fee equal to 2% of net sales derived from purchaser’s sales of the products for the period from February 2017 through February 2027. The Company has not recognized any royalty fees. The Company is also subject to certain indemnification liability payable to the purchaser, which is limited up to $0.6 million. The Company recognized a gain of $2.6 million within operating (income) expenses on its condensed consolidated statement of operations for the nine months ended September 30, 2017, and a receivable of $4.4 million in current other assets on its condensed consolidated balance sheet as of September 30, 2017. Goodwill The changes in the carrying amounts of goodwill were as follows: September 30, December 31, 2017 2016 (in thousands) Beginning balance $ 3,976 $ 3,726 Goodwill related to acquisition of business — 391 Currency translation and other adjustments 425 (141) Ending balance $ 4,401 $ 3,976 Primatene ® Trademark In January 2009, the Company acquired the exclusive rights to the trademark, domain name, website and domestic marketing, distribution and selling rights related to Primatene ® Mist, an over-the-counter bronchodilator product, which are recorded at the allocated fair value of $29.2 million, which is its carrying value as of September 30, 2017. The trademark was determined to have an indefinite life. In determining its indefinite life, the Company considered the following: the expected use of the intangible; the longevity of the brand; the legal, regulatory and contractual provisions that affect their maximum useful life; the Company’s ability to renew or extend the asset’s legal or contractual life without substantial costs; effects of the regulatory environment; expected changes in distribution channels; maintenance expenditures required to obtain the expected future cash flows from the asset; and considerations for obsolescence, demand, competition and other economic factors. As a result of environmental concerns about Chlorofluorocarbons, or CFCs, the FDA issued a final ruling on January 16, 2009 that required the CFC formulation of its Primatene ® Mist product to be phased out by December 31, 2011. The former formulation of Primatene ® Mist contained CFCs as a propellant; however, the Company intends to use the trademark for a future version of Primatene ® that utilizes hydrofluoroalkane, or HFA, as a propellant. In 2013, the Company filed a new drug application, or NDA, for Primatene ® Mist and received a Prescription Drug User Fee Act date set for May 2014. In May 2014, the Company received a complete response letter, or CRL, from the FDA, which required additional non-clinical information, label revisions and follow-up studies (label comprehension, behavioral/human factors and actual use) to assess consumers’ ability to use the device correctly to support approval of the product in the over-the-counter setting. The Company met with the FDA in October 2014 to discuss preliminary data results and to clarify the FDA requirements for further studies. The Company received further advice regarding its ongoing studies from the FDA in January 2016 and subsequently completed the process of generating the remaining data required by the CRL and plans to submit human factor studies accordingly. The Company submitted a responsive NDA amendment in June 2016 and received another CRL from the FDA in December 2016, which requires additional packaging and label revisions and follow-up studies to assess consumers’ ability to use the device correctly to support approval of the product in the over-the-counter setting. The Company intends to continue to work with the FDA during the post-action phase to address their concerns in the CRL and bring Primatene ® Mist back to the over-the-counter market. However, there can be no guarantee that any future amendment to the Company’s NDA will result in timely approval of Primatene ® Mist or approval at all. Based on the Company’s filed version of Primatene ® Mist, the long history of the Primatene ® trademark (marketed since 1963), and the Company’s perpetual rights to the trademark, the nature of the CRL received in December 2016, the plan that the HFA version will be marketed under the same trademark if approved by the FDA, and other factors previously considered, the trademark continues to have an indefinite useful life, and an impairment charge is not required based on the Company’s qualitative assessment as of September 30, 2017. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2017 | |
Inventories | |
Inventories | Note 10. Inventories Inventories consist of the following: September 30, December 31, 2017 2016 (in thousands) Raw materials and supplies $ 22,008 $ 36,209 Work in process 24,780 22,266 Finished goods 22,852 21,279 Total inventories $ 69,640 $ 79,754 A charge of $2.2 million and $7.3 million were included in the cost of revenues in the Company’s condensed consolidated statements of operations for the three and nine months ended September 30, 2017, respectively, to adjust inventory to their net realizable value, including a $2.0 million and $4.9 million charge in the three and nine months ended September 30, 2017, respectively, related to enoxaparin inventory as a result of a decrease in the forecasted average selling price. |
Property, Plant, and Equipment
Property, Plant, and Equipment | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant, and Equipment | |
Property, Plant, and Equipment | Note 11. Property, Plant, and Equipment Property, plant, and equipment consist of the following: September 30, December 31, 2017 2016 (in thousands) Buildings $ 87,313 $ 85,283 Leasehold improvements 29,807 24,619 Land 7,092 6,857 Machinery and equipment 116,777 111,041 Furniture, fixtures, and automobiles 15,679 15,113 Construction in progress 46,759 32,044 Total property, plant, and equipment 303,427 274,957 Less accumulated depreciation (130,381) (122,013) Total property, plant, and equipment, net $ 173,046 $ 152,944 As of September 30, 2017 and December 31, 2016, the Company had $2.3 million and $2.6 million, respectively, in capitalized manufacturing equipment that is intended to be used specifically for the manufacture of Primatene ® Mist. The Company will continue to monitor developments with the FDA as it relates to its Primatene ® Mist indefinite lived intangible assets in determining if there is an impairment of these related fixed assets (see Note 9). |
Debt
Debt | 9 Months Ended |
Sep. 30, 2017 | |
Debt | |
Debt | Note 12. Debt Debt consists of the following: September 30, December 31, 2017 2016 (in thousands) Loans with East West Bank Equipment loan paid off April 2017 $ — $ 433 Line of credit facility due December 2018 — — Equipment loan due January 2019 2,053 3,208 Mortgage payable due February 2021 3,598 3,660 Equipment loan due June 2021 4,592 2,882 Equipment line of credit due December 2022 — — Mortgage payable due October 2026 3,539 3,582 Mortgage payable due June 2027 8,968 — Loans with Cathay Bank Line of credit facility due May 2018 — — Acquisition loan due April 2019 15,580 17,079 Mortgage payable due August 2027 7,836 4,367 Loans with Seine-Normandie Water Agency French government loan 1 due March 2018 17 French government loan 2 due June 2020 83 French government loan 3 due July 2021 233 Payment Obligation to Merck 585 506 Equipment under Capital Leases 1,360 1,614 Total debt and capital leases 48,444 37,722 Less current portion of long-term debt and capital leases 6,212 5,366 Long-term debt and capital leases, net of current portion $ 42,232 $ 32,356 Loans with East West Bank Equipment Loan—Paid off April 2017 In March 2012, the Company entered into an $8.0 million revolving credit facility. In March 2013, the Company converted the outstanding principal balance of $4.9 million into an equipment loan. Borrowings under the facility were secured by equipment. Borrowings under the facility bore a variable interest rate at the prime rate as published by The Wall Street Journal , plus 0.25%, with a minimum interest rate of 3.50%. In April 2017, the Company repaid all outstanding amounts due under this loan. Line of Credit Facility—Due December 2018 In March 2012, the Company entered into a $10.0 million line of credit facility, which bears a variable interest rate at the prime rate as published by The Wall Street Journal . Borrowings under the facility are secured by inventory and accounts receivable. This facility matured in March 2016. In March 2016, the facility was amended to increase the line of credit to $15.0 million and to extend the maturity date to September 2017. In May 2017, the Company amended the facility to extend the maturity date to December 2018. As of September 30, 2017, the Company did not have any amounts outstanding under this facility. Equipment Loan—Due January 2019 In July 2013, the Company entered into an $8.0 million line of credit facility. In January 2015, the Company drew down $6.2 million from the line of credit facility. Subsequently, the facility was converted into a term equipment loan with an outstanding principal balance of $6.2 million and a maturity date of January 2019. Borrowings under the facility are secured by equipment. As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company has entered into a fixed interest rate swap contract on this facility to exchange the variable interest rate for a fixed interest rate of 4.48% over the life of the facility without the exchange of the underlying notional debt amount. The interest rate swap contract does not qualify for hedge accounting and is recorded at fair value for an immaterial amount based on Level 2 inputs. Mortgage Payable—Due February 2021 The Company refinanced the mortgage term loan in January 2016, which had an outstanding principal balance of $3.7 million at December 31, 2015, and a maturity date of February 2021. The refinanced loan is payable in monthly installments with a final balloon payment of $3.3 million. The refinanced loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The refinanced loan has a variable interest rate at the prime rate as published by The Wall Street Journal . As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company has entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.39% over the life of the loan without the exchange of the underlying notional debt amount. The interest rate swap contract does not qualify for hedge accounting, and is recorded at fair value for an immaterial amount based on Level 2 inputs. Equipment Loan—Due June 2021 In March 2016, the Company entered into a $5.0 million equipment credit facility. In May 2017, the Company converted the outstanding balance of $5.0 million into a term equipment loan which matures in June 2021. Borrowings under the loan are secured by equipment. The loan bears a variable interest rate at the prime rate as published by The Wall Street Journal . As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company has entered into a fixed interest rate swap contract on this facility to exchange the variable interest rate for a fixed interest rate of 4.86% over the life of the facility without the exchange of the underlying notional debt amount. The interest rate swap contract does not qualify for hedge accounting and is recorded at fair value for an immaterial amount based on Level 2 inputs. Equipment Credit Line—Due December 2022 In June 2017, the Company entered into an $8.0 million equipment credit line with an 18-month draw down period. Interest payments are due monthly through December 2018 at the prime rate as published by The Wall Street Journal . After the draw down period, the outstanding principal balance converts into a 48-month term loan which bears a variable interest rate at the prime rate as published by The Wall Street Journal . The loan matures in December 2022, and the principal and interest payments are due monthly. Borrowings under the facility are secured by equipment. As of September 30, 2017, the Company did not have any amounts outstanding under this facility. Mortgage Payable—Due October 2026 In September 2006, the Company entered into a mortgage term loan in the principal amount of $2.8 million, which matured in September 2016. The Company refinanced the mortgage term loan in September 2016, which increased the principal amount to $3.6 million and extended the maturity date to October 2026. The refinanced loan is payable in monthly installments with a final balloon payment of $2.9 million. The refinanced loan was secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The refinanced loan bears a variable interest rate at the one-month LIBOR rate plus 2.75%. As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. Subsequently, the Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.15% until October 2021 without the exchange of the underlying notional debt amount. The interest rate swap contract does not qualify for hedge accounting, and is recorded at fair value for an immaterial amount based on Level 2 inputs. Mortgage Payable—Due June 2027 In May 2017, the Company entered into a mortgage term loan in the principal amount of $9.0 million, which matures in June 2027. The loan is payable in monthly installments with a final balloon payment of $7.4 million plus interest. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex and two buildings at the Company’s Chino, California, facility. The loan bears a variable interest rate at the one-month LIBOR rate plus 2.5%. As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest rate of 4.79% until June 2024 without the exchange of the underlying notional debt amount. The interest rate swap contract does not qualify for hedge accounting, and is recorded at fair value of approximately $0.2 million based on Level 2 inputs. Loans with Cathay Bank Line of Credit Facility—Due May 2018 In April 2012, the Company entered into a $20.0 million revolving line of credit facility. Borrowings under the facility are secured by inventory, accounts receivable, and intangibles held by the Company. The facility bears a variable interest rate at the prime rate as published by The Wall Street Journal with a minimum interest rate of 4.00%. In June 2016, the Company amended the facility to extend the maturity date from May 2016 to May 2018. As of September 30, 2017, the Company did not have any amounts outstanding under this facility. Acquisition Loan with Cathay Bank—Due April 2019 On April 22, 2014, in conjunction with the Merck API Transaction, the Company entered into a secured term loan with Cathay Bank as lender. The principal amount of the loan is $21.9 million and bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00%. Beginning on June 1, 2014, and through the maturity date April 22, 2019, the Company must make monthly payments of principal and interest based on the then outstanding amount of the loan amortized over a 120‑month period. On April 22, 2019, all amounts outstanding under the loan become due and payable, which would be approximately $12.0 million based upon an interest rate of 4.00%. The loan is secured by 65% of the issued and outstanding shares of stock in AFP and certain assets of the Company, including accounts receivable, inventory, certain investment property, goods, deposit accounts, and general intangibles but not including the Company’s equipment and real property. As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. The loan includes customary restrictions on, among other things, the Company’s ability to incur additional indebtedness, pay dividends in cash or make other distributions in cash, make certain investments, create liens, sell assets, and make loans. The loan also includes customary events of defaults, the occurrence and continuation of any of which provide Cathay Bank the right to exercise remedies against the Company and the collateral securing the loan. These events of default include, among other things, the Company’s failure to pay any amounts due under the loan, the Company’s insolvency, the occurrence of any default under certain other indebtedness or material agreements, and a final judgment against the Company that is not discharged in 30 days. Mortgage Payable—Due August 2027 In April 2014, the Company refinanced the mortgage term loan, which had a principal balance outstanding of $4.6 million. The loan was payable in monthly installments with a final balloon payment of $3.9 million. The loan was secured by the building at the Company’s Canton, Massachusetts location, and bore interest at a fixed rate of 5.42% and was to have matured in April 2021. In August 2017, the Company refinanced the mortgage term loan, with a principal balance outstanding of $7.9 million. The loan is payable in monthly installments and is secured by the building at the Company’s Canton, Massachusetts location. The loan bears interest at a fixed rate of 4.70% for the first five years of the loan, thereafter; the loan bears a variable interest rate at the prime rate as published by The Wall Street Journal and matures in June 2027. As of September 30, 2017, the fair value of the loan approximates its book value. The interest rate used in the fair value estimation was determined to be a Level 2 input. Loans with Seine-Normandie Water Agency In January 2015, the Company entered into three French government loans with the Seine-Normandie water agency in the aggregate amount of €0.6 million, or $0.7 million, subject to currency exchange fluctuations. The life of the loans range between three to six years, and includes annual equal payments and bears no interest over the life of the loans. As of September 30, 2017, the payment obligation had an aggregate book value of €0.3 million, or $0.3 million, subject to currency exchange rate fluctuations, which approximates fair value. The fair value of the payment obligation was determined by using the interest rate associated with the Company’s acquisition loan with Cathay Bank that bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00%. Such interest rate is deemed to be a Level 2 input for measuring fair value. Payment Obligation to Merck Merck—Due December 2017 On April 30, 2014, in conjunction with the Merck API Transaction, the Company entered into a commitment obligation with Merck, in the principal amount of €11.6 million, or $16.0 million, subject to currency exchange rate fluctuations. The terms of the purchase price include annual payments over four years and bear a fixed interest rate of 3.00%. As of September 30, 2017, the payment obligation had a balance of €0.5 million, or $0.6 million, which approximates fair value. The fair value of the payment obligation was determined by using the interest rate associated with the Company’s acquisition loan with Cathay Bank that bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00%. Such interest rate is deemed to be a Level 2 input for measuring fair value. Covenants At September 30, 2017 and December 31, 2016, the Company was in compliance with its debt covenants, which include a minimum current ratio, minimum debt service coverage, minimum tangible net worth, maximum debt-to-effective-tangible-net-worth ratio, and minimum deposit requirement, computed on a consolidated basis. Equipment under Capital Leases The Company entered into leases for certain equipment under capital leasing arrangements, which will expire at various times through 2021. The cost of equipment under capital leases was $1.6 million and $2.0 million at September 30, 2017 and December 31, 2016, respectively. The accumulated depreciation of equipment under capital leases was $0.1 million and $0.2 million at September 30, 2017 and December 31, 2016, respectively. Depreciation of assets recorded under capital leases is included in depreciation expense in the accompanying consolidated financial statements. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Taxes | |
Income Taxes | Note 13. Income Taxes The following table sets forth the Company’s income tax provision for the periods indicated: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Income (loss) before taxes $ (1,991) $ 6,001 $ 2,686 $ 19,569 Income tax expense (benefit) (2,166) 2,111 (354) 6,295 Net income $ 175 $ 3,890 $ 3,040 $ 13,274 Income tax provision as a percentage of income before income taxes 108.8 % 35.2 % (13.2) % 32.2 % The Company has a full valuation allowance against its French deferred tax assets; however, a tax benefit is included in the annual effective tax rate computation due to the French entity reporting a year-to-date foreign exchange gain in other comprehensive income. The Company calculates an estimated annual effective income tax rate based upon its forecasted income. This estimated effective tax rate factors in various permanent differences, including domestic deductions, the impact of foreign operations, and various credits, as well as discrete tax items recognized during each period. During the three and nine months ended September 30, 2017, the Company recognized discrete tax benefits of $1.3 million and $1.4 million, respectively. During the three and nine months ended September 30, 2016, the Company recognized discrete tax benefits of $0.3 million and $0.3 million, respectively. Effective January 1, 2017, the Company adopted ASU 2016-09, under which, differences between the tax deduction for share-based awards and the related compensation expenses recognized under ASC 718 are prospectively accounted for as a component of the provision for income taxes. In addition, ASU 2016-09 eliminated the requirement that excess tax benefits from share-based compensation reduce taxes payable prior to being recognized in the financial statements. As a result of the adoption of ASU 2016-09, the cumulative excess benefits of stock compensation of $0.9 million that was not previously recognized was established on the balance sheet resulting in an increase in deferred tax assets and retained earnings. The Company’s income tax return for the 2015 tax year is currently under examination by the Internal Revenue Service. There are differing interpretations of tax laws and regulations and, as a result, significant disputes may arise with tax authorities involving issues of timing and amount of deductions and allocations of income. Resolution of uncertain tax positions may have an impact on the results of operations for that period. Valuation Allowance In assessing the need for a valuation allowance, management considers whether it is more likely than not that some portion or all of the deferred tax assets will be realized. Ultimately, the realization of deferred tax assets depends on the existence of future taxable income. M anagement considers sources of taxable income such as income in prior carryback periods, future reversal of existing deferred taxable temporary differences, tax-planning strategies, and projected future taxable income. In 2015, the Company assessed the realizability of the deferred tax assets of AFP and determined that it was not more likely than not that the net deferred tax assets of AFP would be realized. Therefore, the Company established a full valuation allowance of $0.9 million as of December 31, 2015, and continues to maintain a full valuation allowance on all AFP deferred tax assets. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity | |
Stockholders' Equity | Note 14. Stockholders’ Equity A summary of the changes in stockholders’ equity for the nine months ended September 30, 2017, consisted of the following: Nine Months Ended September 30, 2017 (in thousands) Stockholders’ equity as of December 31, 2016 $ 329,255 Beginning balance adjustment to retained earnings as a result of the adoption of ASU 2016-09 872 Adjusted stockholders’ equity as of January 1, 2017 330,127 Net income 3,040 Other comprehensive income 2,101 Net proceeds from equity plans 7,255 Share-based compensation expense 12,905 Purchase of treasury stock (24,773) Stockholders’ equity as of September 30, 2017 $ 330,655 2014 Employee Stock Purchase Plan In June 2014, the Company adopted the Employee Stock Purchase Plan, or ESPP, in connection with its initial public offering. A total of 2,000,000 shares of common stock are reserved for issuance under this plan. The Company’s ESPP permits eligible employees to purchase common stock at a discount through payroll deductions during defined offering periods. Under the ESPP, the Company may specify offerings with durations of not more than 27 months, and may specify shorter purchase periods within each offering. Each offering will have one or more purchase dates on which shares of its common stock will be purchased for employees participating in the offering. An offering may be terminated under certain circumstances. The price at which the stock is purchased is equal 85% of the lower of the fair market value of the common stock at the beginning of an offering period or on the date of purchase. As of September 30, 2017, the Company has issued 320,623 shares of common stock under the ESPP and 1,679,377 shares of its common stock remained available for issuance. For the three and nine months ended September 30, 2017 , the Company recorded ESPP expense of $0.1 million and $0.4 million, respectively . For the three and nine months ended September 30, 2016 , the Company recorded ESPP expense of $0.1 million and $0.4 million, respectively . Share Buyback Program On November 6, 2014, the Company’s Board of Directors authorized a $10.0 million share buyback program, which was completed in December 2015. On November 10, 2015, the Company’s Board of Directors authorized an additional $10.0 million to the Company’s share buyback program, which was completed in December 2016. On November 7, 2016, the Company’s Board of Directors authorized an increase of $20.0 million to the Company’s share buyback program, which was completed in August 2017. On August 7, 2017, the Company’s Board of Directors authorized an additional $20.0 million to the Company’s share buyback program, which is expected to continue for an indefinite period of time. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. Purchases are made through open market and private block transactions pursuant to Rule 10b5-1 plans, privately negotiated transactions or other means as determined by the Company’s management and in accordance with the requirements of the SEC. The timing and actual number of treasury stock share purchases depend on a variety of factors including price, corporate and regulatory requirements, and other conditions. These treasury stock share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s consolidated balance sheets. Pursuant to the Company’s share buyback program, the Company purchased 472,379 and 1,584,661 shares of its common stock during the three and nine months ended September 30, 2017, for total consideration of $7.6 million and $24.8 million, respectively. The Company purchased 46,333 and 710,833 shares of its common stock during the three and nine months ended September 30, 2016, for total consideration of $0.8 million and $9.0 million, respectively. 2015 Equity Incentive Plan In March 2015, the Board of Directors adopted the Company’s 2015 Equity Incentive Plan, or the 2015 Plan, which was approved by the Company’s stockholders in May 2015 and is set to expire in March 2025. The 2015 Plan is designed to meet the needs of a publicly traded company, including the requirements for granting “performance based compensation” under Section 162(m) of the Internal Revenue Code. The 2015 Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, performance shares, and other stock or cash awards to employees of the Company and its subsidiaries, members of the Board of Directors and consultants. The Company initially reserved 5,000,000 shares of common stock for issuance under the 2015 Plan. This number will be increased by the number of shares available for issuance under the Company’s prior equity incentive plans or arrangements that are not subject to options or other awards, plus the number of shares of common stock related to options or other awards granted under the Company’s prior equity incentive plans or arrangements that are repurchased, forfeited, expired, or cancelled on or after the effective date of the 2015 Plan. The 2015 Plan also contains an “evergreen provision” that allows for an annual increase in the number of shares available for issuance on January 1 of each year during the 10 year term of the 2015 Plan, beginning January 1, 2016. The annual increase in the number of shares shall be the lessor of (i) 3,000,000 shares, (ii) two and one-half percent (2.5%) of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares as determined by the Board of Directors. As of the effective date, there were 5,300,296 shares available for grant under the 2015 Plan. In January 2017, an additional 1,156,216 shares were reserved under the 2015 Plan pursuant to the evergreen provision. As of September 30, 2017, the Company reserved an aggregate of 3,469,873 shares of common stock for future issuance under the 2015 Plan. Share-Based Award Activity and Balances The Company accounts for share-based compensation payments in accordance with ASC 718, which requires measurement and recognition of compensation expense at fair value for all share-based payment awards made to employees and directors. Under these standards, the fair value of option awards and the option components of the ESPP awards are estimated at the grant date using the Black-Scholes option-pricing model. The fair value of RSUs is estimated at the grant date using the Company’s common share price. Non-vested stock options held by non-employees are revalued at each balance sheet date. The portion that is ultimately expected to vest is amortized and recognized in the compensation expenses on a straight-line basis over the requisite service period, generally from the grant date to the vesting date. The weighted-averages for key assumptions used in determining the fair value of options granted during the three and nine months ended September 30, 2017 and 2016, are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Average volatility 36.9 % 31.9 % 37.0 % 30.4 % Risk-free interest rate 2.0 % 1.3 % 2.1 % 1.5 % Weighted-average expected life in years 6.3 6.3 5.5 5.5 Dividend yield rate — % — % — % — % A summary of option activity under all plans for the nine months ended September 30, 2017, is presented below: Weighted-Average Weighted-Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term (Years) Value (1) (in thousands) Outstanding as of December 31, 2016 12,530,297 $ 14.57 Options granted 1,815,813 14.23 Options exercised (1,134,259) 11.60 Options cancelled (44,473) 13.57 Options expired (118,378) 25.48 Outstanding as of September 30, 2017 13,049,000 $ 14.69 4.49 $ 53,235 Exercisable as of September 30, 2017 8,683,400 $ 15.22 3.05 $ 34,772 (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s common stock for those awards that have an exercise price below the estimated fair value at September 30, 2017. For the three and nine months ended September 30, 2017 , the Company recorded expenses of $1 .9 million and $5 .9 million, respectively, related to stock options granted to employees under all plans and expenses of $0.2 million and $0.5 million, respectively, related to stock options granted to the Board of Directors under all plans. For the three and nine months ended September 30, 2016 , the Company recorded expenses of $1.8 million and $6.2 million, respectively, related to stock options granted to employees under all plans and expenses of $0.1 million and $0.5 million, respectively, related to stock options granted to the Board of Directors under all plans. Information relating to option grants and exercises is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 6.23 $ 6.34 $ 4.95 $ 3.42 Intrinsic value of options exercised 1,668 4,998 4,730 5,980 Cash received from options exercises 782 14,331 9,521 17,584 Total fair value of the options vested during the year 779 2,688 6,984 7,948 A summary of the status of the Company’s non-vested options as of September 30, 2017, and changes during the nine months ended September 30, 2017, is presented below: Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2016 4,592,187 $ 3.61 Options granted 1,815,813 4.95 Options vested (1,997,927) 3.50 Options forfeited (44,473) 4.71 Non-vested as of September 30, 2017 4,365,600 4.21 As of September 30, 2017, there was $12.9 million of total unrecognized compensation cost, net of forfeitures, related to non-vested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.3 years and will be adjusted for future changes in estimated forfeitures. Deferred Stock Units/Restricted Stock Units Beginning in 2007, the Company granted deferred stock units, or DSUs, to certain employees and members of the Board of Directors with a vesting period of up to five years, and commencing in 2015, such equity was issued as restricted stock units, or RSUs (such RSUs and DSUs are collectively referred to herein as RSUs). The grantee receives one share of common stock at a specified future date for each RSU awarded. The RSUs may not be sold or otherwise transferred until certificates of common stock have been issued, recorded, and delivered to the participant. The RSUs do not have any voting or dividend rights prior to the issuance of certificates of the underlying common stock. The share-based expense associated with these grants was based on the Company’s common stock fair value at the time of grant and is amortized over the requisite service period, which generally is the vesting period using the straight-line method. During the three and nine months ended September 30, 2017, the Company recorded expenses of $1.7 million and $5.4 million, respectively, related to RSU awards granted to employees under all plans and expenses of $0.2 million and $0.5 million, respectively, related to RSU awards granted to the Board of Directors . During the three and nine months ended September 30, 2016, the Company recorded expenses of $1.4 million and $3.9 million, respectively, related to RSU awards granted to employees under all plans and expenses of $0.2 million and $0.5 million, respectively, related to RSU awards granted to the Board of Directors. As of September 30, 2017, there was $14.2 million of total unrecognized compensation cost, net of forfeitures, related to non-vested RSU-based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.4 years and will be adjusted for future changes in estimated forfeitures. Information relating to RSU grants and deliveries is as follows: Total Fair Market Value of RSUs Issued Total RSUs as Issued Compensation (1) (in thousands) RSUs outstanding at December 31, 2016 1,215,786 RSUs granted 676,482 $ 9,298 RSUs forfeited (13,302) RSUs vested (2) (484,739) RSUs outstanding at September 30, 2017 1,394,227 (1) The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 184,341 shares of common stock were surrendered to fulfil tax withholding obligations. Equity Awards to Consultants and Advisory Board Members The Company pays certain consultants and advisory board members in the form of share-based awards. Such share-based compensation expense is recorded over the service period based on the estimated fair market value of the equity award at the date services are performed or upon completion of services. During the three and nine months ended September 30, 2017, the Company recorded expenses of $0.1 million and $0.3 million, respectively, in relation to such share-based compensation. During the three months ended September 30, 2016, the Company recorded an immaterial amount of expense in relation to such share-based compensation. During the nine months ended September 30, 2016, the Company recorded an expense of approximately $0.1 million in relation to such share-based compensation. The Company recorded share-based compensation expense under all plans and it is included in the Company’s consolidated statement of operations as follows: Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Cost of revenues $ 815 $ 675 $ 2,843 $ 2,245 Operating expenses: Selling, distribution, and marketing 88 45 237 176 General and administrative 2,947 2,593 8,715 8,339 Research and development 306 242 1,110 844 Total share-based compensation $ 4,156 $ 3,555 $ 12,905 $ 11,604 |
Employee Benefits
Employee Benefits | 9 Months Ended |
Sep. 30, 2017 | |
Employee Benefits | |
Employee Benefits | Note 15. Employee Benefits 401(k) Plan The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50% on the first 6% of employee contributions, and pays the administrative costs of the Plan. Employer contributions vest over four years. Total employer contributions for the three and nine months ended September 30, 2017, were approximately $0.3 million and $0.8 million, respectively, compared to the prior year expense of $0.3 million and $0.7 million for the three and nine months ended September 30, 2016, respectively. Defined Benefit Pension Plan In connection with the Merck API Transaction, the Company assumed an obligation associated with a defined-benefit plan for eligible employees of AFP. This plan provides benefits to the employees from the date of retirement and is based on the employee’s length of time employed by the Company. The calculation is based on a statistical calculation combining a number of factors that include the employee’s age, length of service, and AFP employee turnover rate. The liability under the plan is based on a discount rate of 1.60% and 1.75% as of September 30, 2017 and December 31, 2016, respectively. The liability is included in accrued liabilities in the accompanying consolidated balance sheets. The plan is currently unfunded, and the benefit obligation under the plan was $1.9 million and $1.7 million at September 30, 2017 and December 31, 2016, respectively. The Company recorded an immaterial amount of expense under the plan for the three months ended September 30, 2017, and $0.1 million for the nine months ended September 30, 2017. The Company recorded an immaterial amount of expense under the plan for the three months ended September 30, 2016, and $0.1 million for the nine months ended September 30, 2016. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies | |
Commitments and Contingencies | Note 16. Commitments and Contingencies Supply Agreement with MannKind Corporation On July 31, 2014, the Company entered into a supply agreement with MannKind Corporation, or MannKind, or the Supply Agreement, pursuant to which the Company agreed to manufacture for and supply to MannKind certain quantities of RHI API for use in MannKind’s product Afrezza ® . Under the Supply Agreement, MannKind agreed to purchase annual minimum quantities of RHI API in an aggregate amount of approximately €120.1 million, or approximately $146.0 million, over five years from calendar years 2015 through 2019. Specifically, the minimum annual purchase commitment was approximately €27.1 million in 2015 and approximately €23.3 million each year from 2016 through 2019. In January 2015, the Company entered into a supply option agreement with MannKind, or the Option Agreement, pursuant to which MannKind will have the option to purchase RHI API, in excess of the minimum amounts specified in the Supply Agreement in calendar years 2016 through 2019. In the event MannKind elects not to exercise its minimum annual purchase option for any year under the Option Agreement, MannKind is obligated to pay the Company a specified capacity cancellation fee. In October 2015, MannKind informed the Company that it was not exercising the option to purchase additional quantities of RHI API for 2016 under the Option Agreement and paid the Company the specified capacity cancellation fee of $0.8 million. Such capacity cancellation fee was recorded as net revenue in the Company’s consolidated statement of operations for the year ended December 31, 2015. For the year ended December 31, 2016, sales of RHI API to MannKind totaled $6.8 million, which fulfilled the remaining unfulfilled 2015 commitment of RHI under the Supply Agreement. In November 2016, the Company amended the Supply Agreement with MannKind, whereby MannKind’s aggregate total commitment of RHI API under the Supply Agreement has not been reduced; however, the annual minimum purchase commitments of RHI API under the Supply Agreement have been modified and extended through 2023, which timeframe had previously lapsed after calendar year 2019. Specifically, the minimum annual purchase commitment in calendar year 2016 has been cancelled, and the minimum annual purchase commitments in calendar years 2017 through 2023 have been modified to be €2.7 million of insulin in the fourth quarter of 2017, €8.9 million in 2018, €11.6 million in 2019, €15.5 million in 2020 and in 2021, and €19.4 million in 2022 and in 2023. MannKind may request to purchase additional quantities of RHI API in excess of its annual minimum purchase commitments. The Supply Agreement Amendment also (i) shortened the required expiry dates for RHI API delivered to MannKind pursuant to the Supply Agreement, (ii) modified the timing of MannKind’s payment for the minimum annual purchase commitment in calendar year 2017, and (iii) added a pre-payment requirement for purchases of RHI API by MannKind in calendar years 2017 and 2018. The amendment can be renewed for additional, successive two-year terms upon 12 months’ written notice, given prior to the end of the initial term or any additional two-year term. Concurrent with the amendment of the Supply Agreement, the Company amended the Option Agreement with MannKind, whereby the amendment to the Option Agreement extends the timing for payment of the capacity cancellation fee for 2017 and decreases the amounts payable as capacity cancellation fees for 2018 and 2019 in the event MannKind fails to exercise its minimum annual purchase option for any given year. The Company recognized the cancellation fee for 2017 of $1.5 million in net revenues in its consolidated statement of operations for the year ended December 31, 2016, and subsequently collected on this receivable. In August 2017, MannKind notified the Company that it would not exercise its minimum annual purchase option of RHI API for 2018. The Company recognized the cancellation fee for 2018 of $0.9 million in net revenues in its condensed consolidated statements of operations for the three and nine months ended September 30, 2017, and subsequently collected on this receivable. In addition to, and in consideration of the amended timeframe and other amendments contained in the amendment to the Supply Agreement in the amendment to the Option Agreement, the Supply Agreement Amendment provided the Company right of first refusal to participate in the development and commercialization of Afrezza ® in China through a collaborative arrangement. Collaboration Agreement with a Medical Device Manufacturer In 2014, the Company entered into a collaboration agreement with a medical device manufacturer to develop a drug delivery system to be used by the Company for one of its pipeline products. As of September 30, 2017, the Company has paid an upfront payment of $0.5 million and has paid $1.5 million in milestone payments under this agreement, which were classified as research and development expense as the milestones were met. The Company is obligated to pay up to an additional $0.5 million if certain milestones are met. As of September 30, 2017, no such obligation existed. Pursuant to the collaboration agreement, if the medical device manufacturer is successful in the development of this drug delivery system and the Company’s pipeline products receive appropriate regulatory approval, the Company intends to enter into a commercial supply agreement with such medical device manufacturer for a minimum purchase of 1.0 million units during the first 12 months. Operating Lease Agreements The Company leases real and personal property, in the normal course of business, under various non-cancelable operating leases. The Company, at its option, can renew a substantial portion of its leases, at the market rate, for various renewal periods ranging from one to six years. Rental expense under these leases for the three and nine months ended September 30, 2017, was approximately $0.9 million and $2.6 million, respectively, compared to $0.8 million and $2.5 million for the three and nine months ended September 30, 2016, respectively. Purchase Commitments As of September 30, 2017, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $48.4 million. The Company anticipates that most of these commitments with a remaining term in excess of one year will be fulfilled by 2018. In addition, the Company is obligated to pay a supplier certain payments up to $1.5 million based on its launch and sale of one of the Company’s pipeline products. The Company entered into agreements with a Chinese governmental entity to acquire land-use rights to real property in Nanjing, China. Under the terms of these agreements, the Company committed to invest capital in its wholly-owned subsidiary, ANP, and to develop these properties as an API manufacturing facility for the Company’s pipeline products. In conjunction with these agreements, ANP modified its business license on July 3, 2012, to increase its authorized capital. As of December 31, 2016, the Company had completed its investment of total registered capital commitment of $61.0 million to ANP. This investment in ANP resulted in cash being transferred from the U.S. parent company to ANP. Per these agreements, in January 2010, the Company acquired certain land-use rights with a carrying value of $1.2 million. In addition, the Company purchased additional land-use rights in November 2012 for $1.3 million. The Company committed to spend approximately $15.0 million in land development. The agreements require the construction of fixed assets on the property and specified a timetable for the construction of these fixed assets. The current pace of development of the property is behind the schedules described in the purchase agreements and, per the purchase agreement, potential monetary penalties could result if the development is delayed or not completed in accordance with the guidelines stated in the purchase agreements. The Company is in discussions with the Chinese government regarding the development and believes that the likelihood of incurring any penalty is remote. |
Litigation
Litigation | 9 Months Ended |
Sep. 30, 2017 | |
Litigation | |
Litigation | Note 17. Litigation Enoxaparin Patent Litigation In September 2011, Momenta Pharmaceuticals, Inc., or Momenta, a Boston‑based pharmaceutical company, and Sandoz Inc., or Sandoz, the generic division of Novartis, initiated litigation against the Company for alleged patent infringement of two patents related to testing methods for batch release of enoxaparin, which the Company refers to as the “‘886 patent” and the “‘466 patent.” The lawsuit was filed in the United States District Court for the District of Massachusetts, or the Massachusetts District Court. In October 2011, the Massachusetts District Court issued a preliminary injunction barring the Company from selling its generic enoxaparin product and also requiring Momenta and Sandoz to post a $100.1 million bond. The preliminary injunction was stayed by the United States Court of Appeals for the Federal Circuit, or the Federal Circuit, in January 2012, and reversed by the Federal Circuit in August 2012. In January 2013, the Company moved for summary judgment of non‑infringement of both patents. Momenta and Sandoz withdrew their allegations as to the ‘466 patent, and in July 2013, the Massachusetts District Court granted the Company’s motion for summary judgment of non‑infringement of the ‘886 patent and denied Momenta and Sandoz’s motion for leave to amend their infringement contentions. On January 24, 2014, the Massachusetts District Court judge entered final judgment in the Company’s favor on both patents. Momenta and Sandoz also filed a motion to collect attorneys’ fees and costs relating to a discovery motion, which the Massachusetts District Court granted. On May 9, 2016, the Massachusetts District Court issued an order imposing fees and costs of approximately $0.4 million in relation to this discovery motion. This amount has been accrued in the general and administrative expense for the quarter ended March 31, 2016 . On January 30, 2014, Momenta and Sandoz filed a notice of appeal to the Federal Circuit appealing the court’s final judgment including summary judgment denying Momenta and Sandoz’s motion for leave to amend their infringement contentions. Following appeal briefing filed by the parties, t he Federal Circuit held oral argument on May 4, 2015. On November 10, 2015, the Federal Circuit panel affirmed-in-part and vacated-in-part the decision of the Massachusetts District Court granting summary judgment of non-infringement as to the Company, and it remanded the case to the Massachusetts District Court for further proceedings consistent with its opinion. The Federal Circuit panel affirmed the Massachusetts District Court’s holding in the Company’s favor that the Company does not infringe under 35 U.S.C. 271(g), and the panel vacated the grant of summary judgment to the extent it was based on the determination that the Company’s activities fall within the 35 U.S.C. 271(e)(1) safe harbor. The Federal Circuit panel also left to the Massachusetts District Court’s discretion whether to reconsider on remand its denial of leave for Momenta and Sandoz to amend their infringement contentions. On January 11, 2016, the Company filed a Petition for Rehearing En Banc with the Federal Circuit. On February 17, 2016, the Federal Circuit denied the Company’s Petition, and the Federal Circuit issued its mandate on February 24, 2016, whereby the case returned to the Massachusetts District Court for further proceedings. On March 18, 2016, the parties filed a joint status report with the Massachusetts District Court. On June 21, 2016, the Massachusetts District Court granted Momenta and Sandoz’s Motion for Leave to Amend its Infringement Contentions. In light of Momenta and Sandoz’s Amended Infringement Contentions and recent changes in Supreme Court precedent since the case was stayed in 2012, the Company sought to amend its Non-Infringement and Invalidity Contentions. On July 18, 2016, the Company submitted its Motion for Leave to Amend Its Non-Infringement and Invalidity Contentions and Momenta and Sandoz responded on July 25, 2016. In light of the new arguments made in their response, the Company further filed a Motion For Leave to Reply in Further Support of Defendants’ Motion for Leave to Amend Non-Infringement and Invalidity Contentions, which was granted. A hearing was held on August 23, 2016, where the Magistrate Judge ordered the Company to file its proposed amended contentions, which it filed on August 31, 2016. On February 4, 2017, the Magistrate Judge issued an order denying the Company leave to amend its contentions. The Company filed objections to this order with the District Court on February 21, 2017. On April 13, 2017, the District Court rejected the determination of the Magistrate Judge with respect to the Company’s amended non-infringement contentions, and allowed the Company to amend its non-infringement contentions. With respect to the Company’s amended invalidity contentions, the District Court accepted the Magistrate Judge’s determination; however, the District Court specifically stated that the Company can argue changes in law at the summary judgment stage or at trial. In parallel with the Massachusetts District Court proceedings, the Company appealed the Federal Circuit’s decision to vacate the grant of the Company’s summary judgment to the extent it was based on the determination that the Company’s activities are protected under the Safe Harbor. The Company filed a Petition for a Writ of Certiorari with the Supreme Court on May 17, 2016. Momenta and Sandoz initially waived their right to respond to the petition; however, on May 31, 2016, the Supreme Court requested a response from Momenta and Sandoz. The response from Momenta and Sandoz was initially due on June 30, 2016, but they requested an extension. Momenta and Sandoz filed their response on August 1, 2016. On October 3, 2016, the Supreme Court declined the Petition for a Writ of Certiorari. Fact discovery in the Massachusetts District Court proceedings closed on November 22, 2016, and the parties proceeded with expert discovery and exchanged opening and rebuttal expert reports. Expert discovery closed on March 24, 2017. On April 14, 2017, Plaintiffs filed a Motion for Summary Judgment seeking to dismiss the Company’s equitable defenses. On April 14, 2017, the Company filed Defendants’ Motion for Summary Judgment of Invalidity and Noninfringement. In the Motion, the Company moved for the District Court to grant summary judgment in favor of the Company on the following issues: (1) the ’886 patent is invalid under 35 U.S.C. § 101 as claiming non-patentable subject matter; (2) the ’886 patent is invalid under 35 U.S.C. § 112 because the claims are indefinite; and (3) the Company’s tests do not infringe the claims of the ’886 patent. Oppositions to the motions for summary judgment were filed on May 5, 2017. Replies in support of the motions for summary judgment were filed on May 19, 2017. On June 16, 2017, the District Court issued an order denying the summary judgment motions. The District Court also denied Plaintiffs’ motion for summary judgment dismissing the Company’s defenses of implied waiver and equitable estoppel, and denied Plaintiffs’ alternative request for a separate hearing on the implied waiver and equitable estoppel defenses holding that the defenses would be submitted to the jury for an advisory verdict. Trial in the Massachusetts District Court on all claims and defenses began on July 10, 2017. On July 21, 2017, the jury returned a unanimous verdict finding that although the Company’s tests infringed the asserted patent, the patent was invalid for lack of enablement and lack of written description and the jury further found that Plaintiffs are entitled to zero ($0) damages. As for the Company’s defenses of implied waiver and equitable estoppel, the jury found that Plaintiffs waived their right to recover for infringement of the asserted patent and that Plaintiffs are estopped from enforcing the asserted patent against the Company. The verdict on these equitable defenses will be briefed by the parties and submitted to the court, which will render a final judgment on the matter. In the post-trial briefing, the Company has requested the Massachusetts District Court to adopt the findings of the jury on the equitable defenses, and has requested the Massachusetts District Court to set aside the jury’s finding of infringement. In Plaintiffs’ post-trial briefing, Plaintiffs have requested a new trial, and have requested the Massachusetts District Court to set aside the jury’s finding that the asserted patent was invalid for lack of enablement and lack of written description. Post-trial briefing on the issues of infringement, invalidity, the equitable defenses, and Plaintiffs’ request for a new trial concluded on October 25, 2017. The Company will continue to vigorously defend the jury’s verdict, including against any potential appeal by the Plaintiffs . The Company intends to attempt to collect the $100.1 million bond posted by Momenta and Sandoz following a final judgement by the Massachusetts District Court. False Claims Act Litigation In January 2009, the Company filed a qui tam complaint in the U.S. District Court for the Central District of California, or the California District Court, alleging that Aventis Pharma S.A., or Aventis, through its acquisition of a patent through false and misleading statements to the U.S. Patent and Trademark Office, as well as through false and misleading statements to the FDA, overcharged the federal and state governments for its Lovenox ® product. If the Company is successful in this litigation, it could be entitled to a portion of any damage award that the government ultimately may recover from Aventis. In October 2011, the California District Court unsealed the Company’s complaint. On February 28, 2014, Aventis filed a motion for summary judgment on the issue of the adequacy of the Company’s notice letter to the government, and the California District Court denied Aventis’ motion for summary judgment in a final order it issued on May 12, 2014. On June 9, 2014, at Aventis’ request, the California District Court issued an order certifying for appeal its order denying Aventis’ motion for summary judgment. On June 9, 2014, Aventis filed with the United States Court of Appeals for the Ninth Circuit, or the Ninth Circuit, a petition for permission to appeal the California District Court’s denial of Aventis’ motion for summary judgment, and the Company filed an opposition to Aventis’ petition on June 19, 2014. On August 22, 2014, the Ninth Circuit granted Aventis’ petition. The parties filed their respective appeal briefs with the Ninth Circuit. On November 10, 2016, the Ninth Circuit heard oral argument on the appeal. The California District Court set an evidentiary hearing for July 7, 2014 on the “original source” issue, a key element under the False Claims Act. The evidentiary hearing was conducted as scheduled, from July 7, 2014 through July 10, 2014. On July 13, 2015, the California District Court issued a ruling concluding that the Company is not an original source under the False Claims Act, and entered final judgment dismissing the case for lack of subject matter jurisdiction. On July 20, 2015, the Company filed with the Ninth Circuit a notice of appeal of the California District Court’s dismissal of the case, and Aventis filed a notice of cross-appeal on August 5, 2015. On November 12, 2015, Aventis filed a pleading asking that the California District Court impose various monetary penalties and fines against the Company, including disgorgement of enoxaparin revenues and attorneys’ fees expended by Aventis in this action, based on Aventis’s allegations that the Company engaged in sanctionable conduct. On November 23, 2015, the California District Court issued an order setting forth a procedure for sanctions proceedings as to the Company as well as its outside counsel. On December 24, 2015, the Company filed a pleading with the California District Court opposing the imposition of sanctions, and on January 20, 2016, Aventis filed a response pleading further pressing for the imposition of sanctions. On May 4, 2016, the California District Court issued three orders requesting that the Company and its outside counsel file a document showing cause as to why sanctions should not be imposed and to set up a conference call with the partiers and the court to discuss whether any discovery and/or a hearing is necessary. On June 13, 2016, the Company and its outside counsel each filed responses to the court’s order to show cause as to why sanctions should not be imposed. On July 21, 2016, Aventis filed a response contending that the court should impose sanctions. On February 10, 2017, the Court held a show cause hearing regarding the potential imposition of sanctions and took the matter under submission. On September 18, 2017, the District Court issued its decision that no sanctions will be imposed on either the Company or its counsel. On March 28, 2016, the Company filed its opening brief with the Ninth Circuit Court of Appeals setting forth detailed arguments as to why the False Claims Act litigation should not have been dismissed by the California District Court. On June 20, 2016, Aventis filed its principal brief in the appeal, responding to the Company’s arguments regarding dismissal of the False Claims Act litigation, and setting forth Aventis’s argument that it should be awarded attorneys’ fees and expenses. On September 19, 2016, the Company filed its reply brief to Aventis’s principal brief. On October 3, 2016, Aventis filed its reply brief in support of its cross-appeal of the District Court’s denial of attorneys’ fees. On November 10, 2016, the Ninth Circuit heard oral argument on the appeals. On May 11, 2017, the Ninth Circuit issued an opinion affirming the California District Court’s dismissal of the action for lack of subject matter jurisdiction; dismissing as moot Aventis’s appeal from the District Court’s denial of its motion for summary judgment on the issue of the adequacy of the Company’s notice letter to the government; reversing the District Court’s denial of Aventis’s motion for attorneys’ fees; and remanding the case to the District Court for resolution of the attorneys’ fees issue. On July 14, 2017, Aventis filed an application with the District Court for entitlement to attorneys’ fees and expenses. The Company intends to continue to vigorously defend against any such imposition of attorneys’ fees or sanctions. Momenta/Sandoz Antitrust Litigation On September 17, 2015, the Company initiated a lawsuit by filing a complaint in the California District Court against Momenta and Sandoz, or the Defendants. The Company’s complaint generally asserts that Defendants have engaged in certain types of illegal, monopolistic, and anticompetitive conduct giving rise to various causes of action against them. On December 9, 2015, Defendants filed a motion to dismiss and a motion to transfer the case to the District of Massachusetts. On January 4, 2016, the Company filed oppositions to both motions. On January 26, 2016, the California District Court granted Defendants’ motion to transfer and did not rule on Defendants’ motion to dismiss. Accordingly, the case was transferred to the District of Massachusetts. On February 9, 2016, the Company filed a writ of mandamus with the Ninth Circuit to attempt to appeal the California District Court’s granting of Defendants’ motion to transfer to the District of Massachusetts. The Ninth Circuit denied this petition on May 20, 2016, and as such the case will remain before the District of Massachusetts. On July 27, 2016, the Massachusetts District Court granted Defendants’ motion to dismiss based on antitrust immunity doctrine, without addressing the substantive merits of the claims. On August 25, 2016, the Company filed with the First Circuit Court of Appeals a notice of appeal of the Massachusetts District Court’s dismissal of the antitrust case. On April 6, 2017, the District Court held a status conference to address scheduling matters for the rest of the case. The Court set a briefing schedule for Defendants’ supplemental motion to dismiss and a full case schedule in the event that it denies Defendants’ supplemental motion to dismiss. On April 20, 2017, Defendants filed their supplemental motion to dismiss and the Company filed its opposition on May 4, 2017. No reply briefs are allowed. The Court promised to rule on the motion to dismiss by the end of May but did not do so. If the Court denies Defendants’ supplemental motion to dismiss, discovery will commence. Summary judgment arguments would be due on November 15, 2018; oppositions would be due on December 15, 2018; and replies would be due on January 15, 2019. Trial is currently scheduled for April 1, 2019. Other Litigation The Company is also subject to various other claims and lawsuits from time-to-time arising in the ordinary course of business. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a material adverse effect on its financial position, results of operations, or cash flows; however, the results of litigation and claims are inherently unpredictable and the Company’s view of these matters may change in the future. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, and are prepared in accordance with the requirements of the SEC for interim reporting. Certain amounts in the prior period condensed consolidated statements of operations and statement of cash flows have been reclassified to conform to the current quarter presentation. All significant intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. Effective January 1, 2017, the Company prospectively adopted certain requirements of Auditing Standards Update, or ASU, No. 2016-09 to classify cash flows related to excess tax benefits in operating activities without adjusting prior periods. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The Company’s subsidiaries include: (1) International Medication Systems, Limited, or IMS, (2) Armstrong Pharmaceuticals, Inc., or Armstrong, (3) Amphastar Nanjing Pharmaceuticals Inc., or ANP, (4) Nanjing Letop Fine Chemistry Co., Ltd., or Letop, (5) Nanjing Hanxin Medical Technology Co., Ltd, or Hanxin, (6) Amphastar France Pharmaceuticals, S.A.S., or AFP, (7) Amphastar UK Ltd., or AUK, and (8) International Medication Systems (UK) Limited, or IMS UK. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. The principal accounting estimates include: determination of allowances for doubtful accounts and discounts, provision for chargebacks, provision for product returns, adjustment of inventory to their net realizable values, impairment of long-lived and intangible assets and goodwill, self-insured claims, workers’ compensation liabilities, litigation reserves, stock price volatilities for share-based compensation expense, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. |
Foreign Currency | Foreign Currency The functional currency of the Company, its domestic subsidiaries, its Chinese subsidiary, ANP, and its U.K. subsidiary, AUK, is the U.S. dollar, or USD. ANP maintains its books of record in Chinese Yuan. These books are remeasured into the functional currency of USD using the current or historical exchange rates. The resulting currency remeasurement adjustments and other transactional foreign currency exchange gains and losses are reflected in the Company’s statements of operations. The Company’s French subsidiary, AFP, maintains its books of record in Euros. Its Chinese subsidiary, Letop, maintain its books of record in Chinese Yuan. Its U.K. subsidiary, IMS UK, maintains its books of record in Great Britain Pounds. These local currencies have been determined to be the subsidiaries’ respective functional currencies. These books of record are translated into USD using average exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other accumulated comprehensive income (loss). The unrealized gains or losses of intercompany foreign currency transactions that are of a long-term investment nature are reported in other accumulated comprehensive income (loss). The unrealized gains and losses of intercompany foreign currency transactions that are of a long-term investment nature for the three and nine months ended September 30, 2017 were a $1.1 million gain and a $3.8 million gain, respectively, and for the three and nine months ended September 30, 2016 were a $0.3 million gain and a $0.6 million gain, respectively. Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. |
Comprehensive Income (Loss) | Comprehensive Income (loss) For the three and nine months ended September 30, 2017 and 2016, the Company included its foreign currency translation as part of its comprehensive income (loss). |
Financial Instruments | Financial Instruments The carrying amounts of cash and cash equivalents, short-term investments, restricted short-term investments, accounts receivable, accounts payable, accrued expenses, and short-term borrowings approximate fair value due to the short maturity of these items. A majority of the Company’s long-term obligations consist of variable rate debt, and their carrying value approximates fair value as the stated borrowing rates are comparable to rates currently offered to the Company for instruments with similar maturities. However, the Company has one fixed-rate, long-term mortgage for which the carrying value differs from the fair value and is not remeasured on a recurring basis (see Note 12). The Company at times enters into fixed interest rate swap contracts to exchange the variable interest rates for fixed interest rates without the exchange of the underlying notional debt amounts. Such interest rate swap contracts are recorded at their fair values. |
Deferred Income Taxes | Deferred Income Taxes The Company utilizes the liability method of accounting for income taxes, under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. |
Business Combinations | Business Combinations If an acquired set of activities and assets is capable of being operated as a business consisting of inputs and processes from the viewpoint of a market participant, the asset acquired and liabilities assumed are a business. Business combinations are accounted for using the acquisition method of accounting, which requires an acquirer to recognize the assets acquired and the liabilities assumed at the acquisition date measured at their fair values as of that date. Fair value determinations are based on discounted cash flow analyses or other valuation techniques. In determining the fair value of the assets acquired and liabilities assumed in a material acquisition, the Company may utilize appraisals from third party valuation firms to determine fair values of some or all of the assets acquired and liabilities assumed, or may complete some or all of the valuations internally. In either case, the Company takes full responsibility for the determination of the fair value of the assets acquired and liabilities assumed. The value of goodwill reflects the excess of the fair value of the consideration conveyed to the seller over the fair value of the net assets received. Acquisition-related costs that the Company incurs to effect a business combination are expensed in the periods in which the costs are incurred. When the operations of the acquired businesses were not material to the Company’s condensed consolidated financial statements, no pro forma presentations were disclosed. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2014-09 Revenue from Contracts with Customers , which creates a single source of revenue guidance for companies in all industries. Subsequently, the FASB issued multiple updates. The new standard provides guidance for all revenue arising from contracts with customers and affects all entities that enter into contracts to provide goods or services to their customers, unless the contracts are within the scope of other accounting standards. It also provides a model for the measurement and recognition of gains and losses on the sale of certain nonfinancial assets. The guidance also requires expanded disclosures relating to the nature, amount, timing, and uncertainty of revenue and cash flows arising from contracts with customers. Additionally, qualitative and quantitative disclosures are required regarding customer contracts, significant judgments and changes in judgments, and assets recognized from the costs to obtain or fulfill a contract. This guidance permits two methods of adoption: retrospectively to each prior reporting period presented (full retrospective method), or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). Based on ASU No. 2015-14 Deferral of the Effective Date , issued in August 2015, this guidance will be effective for the Company beginning in the first quarter of 2018, including interim periods within the year. The Company expects to adopt the standard in 2018 using the modified retrospective transition method. The majority of the Company’s revenue relates to sale of pharmaceutical products to various customers, and the adoption of the new standard is not expected to have a material impact on these transactions. The Company is continuing to evaluate the impact of all transactions. In February 2016, the FASB issued ASU No. 2016-02 Leases , that is aimed at making leasing activities more transparent and comparable, and which requires substantially all leases be recognized by lessees on their balance sheets as a right-of-use asset and corresponding lease liability, including leases currently accounted for as operating leases. This guidance will become effective for the Company’s interim and annual reporting periods during the year ending December 31, 2019, and all annual and interim reporting periods thereafter. Early adoption is permitted. The Company is required to use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements for the reporting periods in which the guidance is adopted. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In June 2016, the FASB issued ASU No. 2016-13 Financial Instruments – Credit Losses , which is aimed at providing financial statement users with more useful information about the expected credit losses on financial instruments and other commitments to extend credit. The standard update changes the impairment model for financial assets measured at amortized cost, requiring presentation at the net amount expected to be collected. The measurement of expected credit losses requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. Available-for-sale debt securities with unrealized losses will be recorded through an allowance for credit losses. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2020. Early adoption is permitted for interim or annual periods during the year ended December 31, 2019. The Company will be required to apply the standard’s provisions as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is effective. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In August 2016, the FASB issued ASU No. 2016-15 Classification of Certain Cash Receipts and Cash Payments , which is aimed at addressing certain issues regarding classifications of certain cash receipts and cash payments on the statement of cash flows where diversity in practice was identified. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted. The Company will be required to apply the guidance retrospectively in the first interim and each annual period in which the guidance is adopted. The Company does not believe that the adoption of this accounting guidance will have a material impact on the Company’s consolidated financial statements and related disclosures. In October 2016, the FASB issued ASU No. 2016-16 Intra-Entity Transfers of Assets Other Than Inventory , which requires an entity to recognize the income tax consequences of intra-entity transfer of an asset other than inventory when the transfer occurs. The guidance is effective for the Company's interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted as of the beginning of an annual reporting period for which financial statements, interim or annual, have not been issued. The amendments will be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In November 2016, the FASB issued ASU No. 2016-18 Statement of Cash Flows: Restricted Cash , which requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, the Company will no longer present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. The guidance is effective for the Company's interim and annual reporting periods during the year ending December 31, 2018. Early adoption is permitted, including adoption in an interim period. The amendments will be applied using a retrospective transition method to each period presented. The Company will be required to apply the guidance retrospectively when adopted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU No. 2017-01 Clarifying the Definition of a Business , which provides guidance to assist entities with evaluating when a set of transferred assets and activities is a business. Under the updated guidance, a set is not a business if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar assets. If the threshold is not met, the update requires that, to be a business, the set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. The definition of outputs was also aligned with Accounting Standard Codification, or ASC, 606 by focusing on revenue-generating activities. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018, and prospectively applicable to any transactions occurring within the period of adoption. Early adoption is permitted. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. In January 2017, the FASB issued ASU No. 2017-04 Simplifying the Test for Goodwill Impairment , which eliminates the requirement to calculate the implied fair value of goodwill. An entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The update also eliminated the requirements for any reporting unit with a zero or negative carrying amount to perform a qualitative assessment and, if it fails that qualitative test, to perform Step 2 of the goodwill impairment test. An entity is required to disclose the amount of goodwill allocated to each reporting unit with a zero or negative carrying amount of net assets. The guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2020, and applied on a prospective basis. Early adoption is permitted for interim and annual goodwill impairment testing dates after January 1, 2017. The Company currently does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In May 2017, the FASB issued ASU No. 2017-09 Scope of Modification Accounting , that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. The new guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2018, and applied prospectively to awards modified on or after the adoption date. Early adoption is permitted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures. In August 2017, the FASB issued ASU No. 2017-12 Targeted Improvements to Accounting for Hedging Activities , which amends the hedge accounting model in ASC 815 to enable entities to better portray the economics of their risk management activities in the financial statements and enhance the transparency and understandability of hedge results. The amendments also simplify the application of hedge accounting in certain situations. The new guidance is effective for the Company’s interim and annual reporting periods during the year ending December 31, 2019. Early adoption is permitted. The Company does not believe that the adoption of this accounting guidance will have a material impact on its consolidated financial statements and related disclosures |
Business Acquisitions (Tables)
Business Acquisitions (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Business Acquisitions | |
Schedule of payments for business acquisition | U.S. Euros Dollars (in thousands) At Closing, April 2014 € 13,252 $ 18,352 December 2014 4,899 5,989 December 2015 3,186 3,483 December 2016 3,186 3,427 December 2017 500 591 € 25,023 $ 31,842 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Revenue Recognition | |
Schedule of chargeback provision analysis | Nine Months Ended September 30, 2017 2016 (in thousands) Beginning balance $ 37,820 $ 15,217 Provision for chargebacks 115,824 105,772 Credits issued to third parties (144,142) (110,073) Ending balance $ 9,502 $ 10,916 |
Schedule of product return liability analysis | Nine Months Ended September 30, 2017 2016 (in thousands) Beginning balance $ 3,143 $ 2,621 Provision for product returns 4,196 958 Credits issued to third parties (1,825) (873) Ending balance $ 5,514 $ 2,706 |
Income per Share (Tables)
Income per Share (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Income per Share | |
Schedule of basic and diluted net income (loss) per share calculation | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands, except per share data) Basic and dilutive numerator: Net income $ 175 $ 3,890 $ 3,040 $ 13,274 Denominator: Weighted-average shares outstanding — basic 46,101 45,398 46,065 45,132 Net effect of dilutive securities: Incremental shares from equity awards 2,114 2,555 1,981 1,233 Weighted-average shares outstanding — diluted 48,215 47,953 48,046 46,365 Net income per share — basic $ 0.00 $ 0.09 $ 0.07 $ 0.29 Net income per share — diluted $ 0.00 $ 0.08 $ 0.06 $ 0.29 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Segment Reporting | |
Schedule of financial information by reporting segment | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Net revenues: Finished pharmaceutical products $ 54,455 $ 59,058 $ 174,154 $ 181,368 API 3,461 5,165 5,619 10,254 Total net revenues 57,916 64,223 179,773 191,622 Gross profit: Finished pharmaceutical products 21,310 28,621 74,486 85,042 API (669) (1,009) (4,270) (814) Total gross profit 20,641 27,612 70,216 84,228 Operating expenses 23,461 21,815 69,447 64,026 Income (loss) from operations (2,820) 5,797 769 20,202 Non-operating income (expenses) 829 204 1,917 (633) Income (loss) before income taxes $ (1,991) $ 6,001 $ 2,686 $ 19,569 |
Schedule of net revenues in the finished pharmaceutical products segment | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Finished pharmaceutical products net revenues: Enoxaparin $ 6,549 $ 15,363 $ 25,247 $ 51,049 Naloxone 12,709 12,407 33,909 38,222 Lidocaine 9,596 8,279 27,218 26,378 Phytonadione 9,352 8,667 27,242 23,555 Epinephrine 2,027 5,303 22,249 14,921 Other finished pharmaceutical products 14,222 9,039 38,289 27,243 Total finished pharmaceutical products net revenues $ 54,455 $ 59,058 $ 174,154 $ 181,368 |
Schedule of net revenues and carrying values of long-lived assets by geographic region | Net Revenue Long-Lived Assets Three Months Ended Nine Months Ended September 30, September 30, September 30, December 31, 2017 2016 2017 2016 2017 2016 (in thousands) United States $ 55,346 $ 62,691 $ 175,075 $ 188,865 $ 105,311 $ 104,110 China — — — — 39,639 35,085 France 2,570 1,532 4,698 2,757 28,004 13,659 United Kingdom — — — — 92 90 Total $ 57,916 $ 64,223 $ 179,773 $ 191,622 $ 173,046 $ 152,944 |
Customer and Supplier Concent29
Customer and Supplier Concentration (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Customer and Supplier Concentration | |
Schedule of accounts receivable and net revenues by major customer | % of Total Accounts % of Net Receivable Revenue Three Months Ended Nine Months Ended September 30, December 31, September 30, September 30, 2017 2016 2017 2016 2017 2016 Actavis (1) — 1 % — 16 % — 19 % AmerisourceBergen 12 % 30 % 24 % 19 % 27 % 19 % Cardinal Health 23 % 28 % 25 % 19 % 25 % 20 % McKesson 27 % 19 % 27 % 21 % 27 % 20 % (1) The agreement with Actavis was terminated in December 2016. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets | |
Schedule of weighted-average life, original cost, accumulated amortization and net book value by major class | Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Cortrosyn® product rights 12 $ 27,134 $ 25,797 $ 1,337 IMS (UK) international product rights (1) 10 9,371 1,093 8,278 Patents 12 486 160 326 Land-use rights 39 2,540 403 2,137 Other intangible assets 4 69 42 27 Subtotal 12 39,600 27,495 12,105 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 4,401 — 4,401 Subtotal * 33,626 — 33,626 As of September 30, 2017 * $ 73,226 $ 27,495 $ 45,731 Weighted-Average Accumulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Cortrosyn® product rights 12 $ 27,134 $ 24,461 $ 2,673 IMS (UK) international product rights (1) 10 8,632 359 8,273 Acquired ANDAs (2) 15 4,000 222 3,778 Patents 10 293 137 156 Land-use rights 39 2,540 354 2,186 Other intangible assets 1 574 534 40 Subtotal 12 43,173 26,067 17,106 Indefinite-lived intangible assets Trademark * 29,225 — 29,225 Goodwill - Finished pharmaceutical products * 3,976 — 3,976 Subtotal * 33,201 — 33,201 As of December 31, 2016 * $ 76,374 $ 26,067 $ 50,307 * Intangible assets with indefinite lives have an indeterminable average life. (1) In August 2016, the Company acquired International Medication Systems (UK) Limited from UCB PHARMA GmbH for $7.7 million. The fair value of the marketing authorization was $9.2 million as of the acquisition date (see Note 3). (2) In February 2017, the Company sold the 14 ANDAs it had acquired from Hikma to an unrelated party for $6.4 million. |
Schedule of changes in carrying amounts of goodwill | September 30, December 31, 2017 2016 (in thousands) Beginning balance $ 3,976 $ 3,726 Goodwill related to acquisition of business — 391 Currency translation and other adjustments 425 (141) Ending balance $ 4,401 $ 3,976 |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Inventories | |
Schedule of inventories | September 30, December 31, 2017 2016 (in thousands) Raw materials and supplies $ 22,008 $ 36,209 Work in process 24,780 22,266 Finished goods 22,852 21,279 Total inventories $ 69,640 $ 79,754 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Property, Plant, and Equipment | |
Schedule of property, plant, and equipment | September 30, December 31, 2017 2016 (in thousands) Buildings $ 87,313 $ 85,283 Leasehold improvements 29,807 24,619 Land 7,092 6,857 Machinery and equipment 116,777 111,041 Furniture, fixtures, and automobiles 15,679 15,113 Construction in progress 46,759 32,044 Total property, plant, and equipment 303,427 274,957 Less accumulated depreciation (130,381) (122,013) Total property, plant, and equipment, net $ 173,046 $ 152,944 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt | |
Schedule of debt | September 30, December 31, 2017 2016 (in thousands) Loans with East West Bank Equipment loan paid off April 2017 $ — $ 433 Line of credit facility due December 2018 — — Equipment loan due January 2019 2,053 3,208 Mortgage payable due February 2021 3,598 3,660 Equipment loan due June 2021 4,592 2,882 Equipment line of credit due December 2022 — — Mortgage payable due October 2026 3,539 3,582 Mortgage payable due June 2027 8,968 — Loans with Cathay Bank Line of credit facility due May 2018 — — Acquisition loan due April 2019 15,580 17,079 Mortgage payable due August 2027 7,836 4,367 Loans with Seine-Normandie Water Agency French government loan 1 due March 2018 17 French government loan 2 due June 2020 83 French government loan 3 due July 2021 233 Payment Obligation to Merck 585 506 Equipment under Capital Leases 1,360 1,614 Total debt and capital leases 48,444 37,722 Less current portion of long-term debt and capital leases 6,212 5,366 Long-term debt and capital leases, net of current portion $ 42,232 $ 32,356 |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Income Taxes | |
Summary of provision (benefit) for income taxes | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Income (loss) before taxes $ (1,991) $ 6,001 $ 2,686 $ 19,569 Income tax expense (benefit) (2,166) 2,111 (354) 6,295 Net income $ 175 $ 3,890 $ 3,040 $ 13,274 Income tax provision as a percentage of income before income taxes 108.8 % 35.2 % (13.2) % 32.2 % |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity | |
Summary of changes in stockholders' equity | Nine Months Ended September 30, 2017 (in thousands) Stockholders’ equity as of December 31, 2016 $ 329,255 Beginning balance adjustment to retained earnings as a result of the adoption of ASU 2016-09 872 Adjusted stockholders’ equity as of January 1, 2017 330,127 Net income 3,040 Other comprehensive income 2,101 Net proceeds from equity plans 7,255 Share-based compensation expense 12,905 Purchase of treasury stock (24,773) Stockholders’ equity as of September 30, 2017 $ 330,655 |
Schedule of key assumptions to determine fair value of options | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 Average volatility 36.9 % 31.9 % 37.0 % 30.4 % Risk-free interest rate 2.0 % 1.3 % 2.1 % 1.5 % Weighted-average expected life in years 6.3 6.3 5.5 5.5 Dividend yield rate — % — % — % — % |
Schedule of the summary of option activity under all plans | Weighted-Average Weighted-Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term (Years) Value (1) (in thousands) Outstanding as of December 31, 2016 12,530,297 $ 14.57 Options granted 1,815,813 14.23 Options exercised (1,134,259) 11.60 Options cancelled (44,473) 13.57 Options expired (118,378) 25.48 Outstanding as of September 30, 2017 13,049,000 $ 14.69 4.49 $ 53,235 Exercisable as of September 30, 2017 8,683,400 $ 15.22 3.05 $ 34,772 The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s common stock for those awards that have an exercise price below the estimated fair value at September 30, 2017. |
Schedule of information relating to options grants | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands, except per share data) Weighted-average grant date fair value per option share $ 6.23 $ 6.34 $ 4.95 $ 3.42 Intrinsic value of options exercised 1,668 4,998 4,730 5,980 Cash received from options exercises 782 14,331 9,521 17,584 Total fair value of the options vested during the year 779 2,688 6,984 7,948 |
Schedule of the summary of nonvested options status | Weighted-Average Grant Date Options Fair Value Non-vested as of December 31, 2016 4,592,187 $ 3.61 Options granted 1,815,813 4.95 Options vested (1,997,927) 3.50 Options forfeited (44,473) 4.71 Non-vested as of September 30, 2017 4,365,600 4.21 |
Schedule of information relating to RSU grants and deliveries | Total Fair Market Value of RSUs Issued Total RSUs as Issued Compensation (1) (in thousands) RSUs outstanding at December 31, 2016 1,215,786 RSUs granted 676,482 $ 9,298 RSUs forfeited (13,302) RSUs vested (2) (484,739) RSUs outstanding at September 30, 2017 1,394,227 (1) The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. (2) Of the vested RSUs, 184,341 shares of common stock were surrendered to fulfil tax withholding obligations. |
Schedule of recorded share-based compensation expense under all plans | Three Months Ended Nine Months Ended September 30, September 30, 2017 2016 2017 2016 (in thousands) Cost of revenues $ 815 $ 675 $ 2,843 $ 2,245 Operating expenses: Selling, distribution, and marketing 88 45 237 176 General and administrative 2,947 2,593 8,715 8,339 Research and development 306 242 1,110 844 Total share-based compensation $ 4,156 $ 3,555 $ 12,905 $ 11,604 |
Summary of Significant Accoun36
Summary of Significant Accounting Policies (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Summary of Significant Accounting Policies | ||||
Gains and losses of intercompany foreign currency transactions | $ 1.1 | $ 0.3 | $ 3.8 | $ 0.6 |
Business Acquisition (Narrative
Business Acquisition (Narrative) (Details) $ in Thousands, € in Millions | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) | Aug. 31, 2016USD ($)item | Mar. 31, 2016USD ($)item | Jan. 31, 2016USD ($) | Sep. 30, 2017 | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) |
Business Acquisition | ||||||||
Payment to Acquire Business, Gross | $ 12,461 | |||||||
Useful life of intangibles | 12 years | 12 years | ||||||
Goodwill related to acquisition of business | $ 391 | |||||||
International Medication Systems (UK) Limited | ||||||||
Business Acquisition | ||||||||
Marketing authorizations acquired | $ 9,200 | |||||||
Manufacturing equipment acquired | 100 | |||||||
Deferred tax liability assumed | $ 1,600 | |||||||
Number of Marketing Authorizations Acquired | item | 33 | |||||||
Number of Different Injectable Chemical Entities | item | 11 | |||||||
Payment to Acquire Business, Gross | $ 7,700 | |||||||
Useful life of intangibles | 10 years | |||||||
Hikma Pharmaceuticals PLC | ||||||||
Business Acquisition | ||||||||
Number of Injectable Products Acquired | item | 14 | |||||||
Number of Different Injectable Chemical Entities | item | 11 | |||||||
Payment to Acquire Business, Gross | $ 4,000 | |||||||
Useful life of intangibles | 15 years | |||||||
Assets acquired | $ 4,000 | |||||||
Merck Sharpe & Dohme's API | ||||||||
Business Acquisition | ||||||||
Purchase price | $ 34,400 | € 24.8 | ||||||
Number Of Years Required To Transfer Starting Material | 2 years | |||||||
Letop | ||||||||
Business Acquisition | ||||||||
Purchase price | $ 1,700 | |||||||
Payment to Acquire Business, Gross | 800 | |||||||
Deposit that ANP previously paid which was effectively eliminated upon the consummation of the transaction | 900 | |||||||
Assets acquired | 1,400 | |||||||
Liabilities assumed | $ 100 |
Business Acquisition (Acquisiti
Business Acquisition (Acquisition of Merck's API Manufacturing Business) (Details) - Merck Sharpe & Dohme's API € in Thousands, $ in Thousands | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) |
Business Acquisition | ||||
Purchase price | $ 34,400 | € 24,800 | ||
At Closing, April 2014 | $ 18,352 | € 13,252 | ||
December 2,014 | 5,989 | 4,899 | ||
December 2,015 | 3,483 | 3,186 | ||
December 2,016 | 3,427 | 3,186 | ||
December 2,017 | 591 | 500 | ||
Total - estimated | $ 31,842 | € 25,023 |
Revenue Recognition (Analysis o
Revenue Recognition (Analysis of the Chargeback Provision) (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Revenue Recognition | ||
Beginning balance | $ 37,820 | $ 15,217 |
Provision for chargebacks | 115,824 | 105,772 |
Credits issued to third parties | (144,142) | (110,073) |
Ending balance | $ 9,502 | $ 10,916 |
Revenue Recognition (Analysis40
Revenue Recognition (Analysis of Product Return Liability) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Revenue Recognition | |||
Beginning balance | $ 3,143 | $ 2,621 | $ 2,621 |
Provision for product returns | 4,196 | 958 | |
Credits issued to third parties | (1,825) | (873) | |
Ending balance | 5,514 | $ 2,706 | 3,143 |
Sales not recognized in revenues due to insufficient information available to estimate a reasonable product return accrual | $ 1,100 | $ 500 | |
Aggregate product return rate | 1.20% | 1.10% |
Income per Share (Narrative) (D
Income per Share (Narrative) (Details) - Stock Options - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Shares | 1,162,850 | 1,357,154 | 2,424,430 | 4,510,729 |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Exercise Price of Excluded Securities | $ 27.87 | $ 29.31 | $ 21.93 | $ 19.84 |
Income per Share (Calculation o
Income per Share (Calculation of Basic and Diluted Net Income (Loss) Per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Basic and dilutive numerator: | ||||
Net income | $ 175 | $ 3,890 | $ 3,040 | $ 13,274 |
Denominator: | ||||
Shares outstanding | 46,101 | 45,398 | 46,065 | 45,132 |
Weighted-average shares outstanding—basic | 46,101 | 45,398 | 46,065 | 45,132 |
Net effect of dilutive securities: | ||||
Incremental shares from equity awards | 2,114 | 2,555 | 1,981 | 1,233 |
Weighted-average shares outstanding — diluted | 48,215 | 47,953 | 48,046 | 46,365 |
Net income (loss) per share — basic | $ 0 | $ 0.09 | $ 0.07 | $ 0.29 |
Net income (loss) per share — diluted | $ 0 | $ 0.08 | $ 0.06 | $ 0.29 |
Segment Reporting (Selected Fin
Segment Reporting (Selected Financial Information by Reporting Segment) (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)segment | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) | |
Segment Reporting Information [Line Items] | |||||
Number of Reportable Segments | segment | 2 | ||||
Net revenues: | |||||
Net Revenue | $ 57,916 | $ 64,223 | $ 179,773 | $ 191,622 | |
Gross Profit: | |||||
Gross Profit | 20,641 | 27,612 | 70,216 | 84,228 | |
Operating expenses | 23,461 | 21,815 | 69,447 | 64,026 | |
Income (loss) from operations | (2,820) | 5,797 | 769 | 20,202 | |
Non-operating income (expenses) | 829 | 204 | 1,917 | (633) | |
Income (loss) before income taxes | (1,991) | 6,001 | 2,686 | 19,569 | |
Finished Pharmaceutical Products | |||||
Net revenues: | |||||
Net Revenue | 54,455 | 59,058 | 174,154 | 181,368 | |
Gross Profit: | |||||
Gross Profit | 21,310 | 28,621 | 74,486 | 85,042 | |
Epinephrine | |||||
Segment Reporting Information [Line Items] | |||||
Net revenues recognized | $ 18,600 | ||||
Cost of revenues | $ 3,300 | ||||
API | |||||
Net revenues: | |||||
Net Revenue | 3,461 | 5,165 | 5,619 | 10,254 | |
Gross Profit: | |||||
Gross Profit | $ (669) | $ (1,009) | $ (4,270) | $ (814) |
Segment Reporting (Summary of N
Segment Reporting (Summary of Net Revenues by Product Segment) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | $ 57,916 | $ 64,223 | $ 179,773 | $ 191,622 |
Finished Pharmaceutical Products | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 54,455 | 59,058 | 174,154 | 181,368 |
Finished Pharmaceutical Products | Enoxaparin | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 6,549 | 15,363 | 25,247 | 51,049 |
Finished Pharmaceutical Products | Naloxone | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 12,709 | 12,407 | 33,909 | 38,222 |
Finished Pharmaceutical Products | Lidocaine | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 9,596 | 8,279 | 27,218 | 26,378 |
Finished Pharmaceutical Products | Phytonadione | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 9,352 | 8,667 | 27,242 | 23,555 |
Finished Pharmaceutical Products | Epinephrine | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | 2,027 | 5,303 | 22,249 | 14,921 |
Finished Pharmaceutical Products | Other Finished Pharmaceutical Products | ||||
Segment Reporting Information, Revenue for Reportable Segment [Abstract] | ||||
Net Revenue | $ 14,222 | $ 9,039 | $ 38,289 | $ 27,243 |
Segment Reporting (Summary of R
Segment Reporting (Summary of Revenues and Long-Lived Assets by Geographic Region) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | $ 57,916 | $ 64,223 | $ 179,773 | $ 191,622 | |
Long-Lived Assets | 173,046 | 173,046 | $ 152,944 | ||
UNITED STATES | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | 55,346 | 62,691 | 175,075 | 188,865 | |
Long-Lived Assets | 105,311 | 105,311 | 104,110 | ||
CHINA | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Long-Lived Assets | 39,639 | 39,639 | 35,085 | ||
FRANCE | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | 2,570 | $ 1,532 | 4,698 | $ 2,757 | |
Long-Lived Assets | 28,004 | 28,004 | 13,659 | ||
UNITED KINGDOM | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Long-Lived Assets | $ 92 | $ 92 | $ 90 |
Customer and Supplier Concent46
Customer and Supplier Concentration (Details) - Customer Concentration Risk [Member] - item | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Revenue, Major Customer [Line Items] | |||||
Number of major customers that are wholesale distributors | 3 | ||||
Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Number of major customers | 4 | 4 | |||
Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Number of major customers | 4 | 4 | 4 | 4 | |
Actavis, Inc. | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 1.00% | ||||
Actavis, Inc. | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 16.00% | 19.00% | |||
AmerisourceBergen | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 12.00% | 30.00% | |||
AmerisourceBergen | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 24.00% | 19.00% | 27.00% | 19.00% | |
Cardinal Health | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 23.00% | 28.00% | |||
Cardinal Health | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 25.00% | 19.00% | 25.00% | 20.00% | |
McKesson | Accounts Receivable, Net | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 27.00% | 19.00% | |||
McKesson | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 27.00% | 21.00% | 27.00% | 20.00% |
Goodwill and Intangible Asset47
Goodwill and Intangible Assets (Summary of Intangible Assets) (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Feb. 28, 2017USD ($)item | Aug. 31, 2016USD ($)item | Mar. 31, 2016USD ($)item | Jan. 31, 2016USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 12 years | 12 years | |||||||
Finite-Lived Intangible Assets, Gross | $ 39,600 | $ 39,600 | $ 43,173 | ||||||
Accumulated Amortization | 27,495 | 27,495 | 26,067 | ||||||
Finite-Lived Intangible Assets, Net | 12,105 | 12,105 | 17,106 | ||||||
Indefinite-lived intangible assets | |||||||||
Goodwill recognized | 4,401 | 4,401 | 3,976 | $ 3,726 | |||||
Subtotal, Original Cost | 33,626 | 33,626 | 33,201 | ||||||
Subtotal, Net Book Value | 33,626 | 33,626 | 33,201 | ||||||
Balance, Original Cost | 73,226 | 73,226 | 76,374 | ||||||
Balance, Net Book Value | 45,731 | 45,731 | 50,307 | ||||||
Payment to Acquire Business, Gross | $ 12,461 | ||||||||
Proceeds received from sale of ANDAs | 2,000 | ||||||||
Hikma Pharmaceuticals PLC | |||||||||
Indefinite-lived intangible assets | |||||||||
Number of Injectable Products Sold | item | 14 | ||||||||
Sale price of intangible assets | $ 6,400 | ||||||||
Proceeds received from sale of ANDAs | 1,000 | 1,000 | |||||||
Remaining Amount to be Paid Upon Completion of Certain Milestones | $ 4,400 | ||||||||
Number of Days Upon Which Remainder of Payment is Due after Milestone Date | 30 days | ||||||||
Royalty Fee Percentage | 2.00% | ||||||||
Indemnification Liability Payable | $ 600 | ||||||||
Gain recognized within operating (income) expenses | 2,600 | ||||||||
Finished Pharmaceutical Products | |||||||||
Indefinite-lived intangible assets | |||||||||
Goodwill recognized | 4,401 | 4,401 | 3,976 | ||||||
Trademarks | |||||||||
Indefinite-lived intangible assets | |||||||||
Indefinite-lived intangible assets | 29,225 | $ 29,225 | $ 29,225 | ||||||
Product rights | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 12 years | 12 years | |||||||
Finite-Lived Intangible Assets, Gross | 27,134 | $ 27,134 | $ 27,134 | ||||||
Accumulated Amortization | 25,797 | 25,797 | 24,461 | ||||||
Finite-Lived Intangible Assets, Net | 1,337 | $ 1,337 | $ 2,673 | ||||||
Acquired international product rights | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 10 years | ||||||||
Finite-Lived Intangible Assets, Gross | 9,371 | $ 9,371 | |||||||
Accumulated Amortization | 1,093 | 1,093 | |||||||
Finite-Lived Intangible Assets, Net | 8,278 | $ 8,278 | |||||||
Patents | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 12 years | 10 years | |||||||
Finite-Lived Intangible Assets, Gross | 486 | $ 486 | $ 293 | ||||||
Accumulated Amortization | 160 | 160 | 137 | ||||||
Finite-Lived Intangible Assets, Net | 326 | $ 326 | $ 156 | ||||||
Land-use rights | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 39 years | 39 years | |||||||
Finite-Lived Intangible Assets, Gross | 2,540 | $ 2,540 | $ 2,540 | ||||||
Accumulated Amortization | 403 | 403 | 354 | ||||||
Finite-Lived Intangible Assets, Net | 2,137 | $ 2,137 | $ 2,186 | ||||||
Other intangible assets | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 4 years | 1 year | |||||||
Finite-Lived Intangible Assets, Gross | 69 | $ 69 | $ 574 | ||||||
Accumulated Amortization | 42 | 42 | 534 | ||||||
Finite-Lived Intangible Assets, Net | $ 27 | $ 27 | $ 40 | ||||||
International Medication Systems (UK) Limited | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 10 years | ||||||||
Indefinite-lived intangible assets | |||||||||
Payment to Acquire Business, Gross | $ 7,700 | ||||||||
Marketing authorizations acquired | $ 9,200 | ||||||||
Number of Different Injectable Chemical Entities | item | 11 | ||||||||
International Medication Systems (UK) Limited | Acquired international product rights | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 10 years | ||||||||
Finite-Lived Intangible Assets, Gross | $ 8,632 | ||||||||
Accumulated Amortization | 359 | ||||||||
Finite-Lived Intangible Assets, Net | $ 8,273 | ||||||||
Hikma Pharmaceuticals PLC | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 15 years | ||||||||
Indefinite-lived intangible assets | |||||||||
Payment to Acquire Business, Gross | $ 4,000 | ||||||||
Number of Injectable Products Acquired | item | 14 | ||||||||
Number of Different Injectable Chemical Entities | item | 11 | ||||||||
Hikma Pharmaceuticals PLC | Acquired ANDAs | |||||||||
Definite-lived intangible assets | |||||||||
Weighted-Average Life (Years) | 15 years | ||||||||
Finite-Lived Intangible Assets, Gross | $ 4,000 | ||||||||
Accumulated Amortization | 222 | ||||||||
Finite-Lived Intangible Assets, Net | $ 3,778 | ||||||||
Letop | |||||||||
Indefinite-lived intangible assets | |||||||||
Payment to Acquire Business, Gross | $ 800 |
Goodwill and Intangible Asset48
Goodwill and Intangible Assets (Summary of Changes in the Carrying Amount of Goodwill) (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2017 | Dec. 31, 2016 | |
Goodwill and Intangible Assets | ||
Beginning balance | $ 3,976 | $ 3,726 |
Goodwill related to acquisition of business | 391 | |
Currency translation and other adjustments | 425 | (141) |
Ending balance | $ 4,401 | $ 3,976 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2017 | Dec. 31, 2016 | |
Raw materials and supplies | $ 22,008 | $ 22,008 | $ 36,209 |
Work in process | 24,780 | 24,780 | 22,266 |
Finished goods | 22,852 | 22,852 | 21,279 |
Total inventory, net | 69,640 | 69,640 | $ 79,754 |
Inventory adjustment to reflect net realizable value | 2,200 | 7,300 | |
Enoxaparin | |||
Inventory adjustment to reflect net realizable value | $ 2,000 | $ 4,900 |
Property, Plant, and Equipmen50
Property, Plant, and Equipment (Summary of Property, Plant, and Equipment) (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 303,427 | $ 274,957 |
Less accumulated depreciation and amortization | (130,381) | (122,013) |
Total property, plant, and equipment, net | 173,046 | 152,944 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 87,313 | 85,283 |
Leasehold improvement | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 29,807 | 24,619 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 7,092 | 6,857 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 116,777 | 111,041 |
Furniture, fixtures, and automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 15,679 | 15,113 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 46,759 | 32,044 |
Equipment | Primatene Mist | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 2,300 | $ 2,600 |
Debt (Schedule of Debt) (Detail
Debt (Schedule of Debt) (Details) $ in Thousands, € in Millions | Sep. 30, 2017USD ($) | Sep. 30, 2017EUR (€) | Dec. 31, 2016USD ($) |
Debt Instrument | |||
Equipment under Capital Leases | $ 1,360 | $ 1,614 | |
Total debt and capital leases | 48,444 | 37,722 | |
Less current portion of long-term debt and capital leases | 6,212 | 5,366 | |
Long-term debt and capital leases, net of current portion | 42,232 | 32,356 | |
Equipment Loan - Due April 2017 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 433 | ||
Equipment Loan - Due January 2019 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 2,053 | 3,208 | |
Mortgage Payable - Due February 2021 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 3,598 | 3,660 | |
Equipment Loan - Due June 2021 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 4,592 | 2,882 | |
Mortgage Payable - Due October 2026 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 3,539 | 3,582 | |
Mortgage Payable - Due June 2027 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 8,968 | ||
Acquisition Loan - Due April 2019 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 15,580 | 17,079 | |
Mortgage Payable - Due August 2027 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 7,836 | 4,367 | |
French Government Loan - Due March 2018 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 17 | 30 | |
French Government Loan - Due June 2020 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 83 | 99 | |
French Government Loan - Due July 2021 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 233 | 262 | |
Note Payable To Merck | |||
Debt Instrument | |||
Long Term Debt | $ 585 | € 0.5 | $ 506 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) € in Millions | Aug. 14, 2017USD ($) | Jun. 28, 2017USD ($) | May 18, 2017USD ($)building | May 11, 2017USD ($) | Sep. 08, 2016USD ($)building | Jan. 05, 2015USD ($) | Jun. 01, 2014 | Apr. 22, 2014USD ($) | Jan. 31, 2015USD ($)item | Apr. 30, 2014USD ($) | Mar. 31, 2013 | Sep. 30, 2017USD ($) | Sep. 30, 2016USD ($) | Sep. 30, 2017EUR (€) | Dec. 31, 2016USD ($) | Mar. 31, 2016USD ($) | Jan. 31, 2016USD ($)building | Jan. 31, 2015EUR (€)item | Apr. 30, 2014EUR (€) | Apr. 09, 2014USD ($) | Jul. 05, 2013USD ($) | Mar. 15, 2013USD ($) | Apr. 10, 2012USD ($) | Mar. 31, 2012USD ($) | Mar. 05, 2012USD ($) | Sep. 15, 2006USD ($) |
Debt | ||||||||||||||||||||||||||
Long-term Debt and Capital Lease Obligations | $ 42,232,000 | $ 32,356,000 | ||||||||||||||||||||||||
Payment to Acquire Business, Gross | $ 12,461,000 | |||||||||||||||||||||||||
Equipment Loan - Due April 2017 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 4,900,000 | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 8,000,000 | |||||||||||||||||||||||||
Long Term Debt | 433,000 | |||||||||||||||||||||||||
Equipment Loan - Due April 2017 | East West Bank | Prime Rate | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.25% | |||||||||||||||||||||||||
Line of Credit Facility - Due December 2018 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 15,000,000 | $ 10,000,000 | ||||||||||||||||||||||||
Line of Credit outstanding | 0 | |||||||||||||||||||||||||
Equipment Loan - Due January 2019 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 6,200,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.48% | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 8,000,000 | |||||||||||||||||||||||||
Proceeds from borrowing under lines of credit | $ 6,200,000 | |||||||||||||||||||||||||
Long Term Debt | 2,053,000 | 3,208,000 | ||||||||||||||||||||||||
Mortgage Payable - Due February 2021 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 3,700,000 | |||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 3,300,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.39% | |||||||||||||||||||||||||
Long Term Debt | 3,598,000 | 3,660,000 | ||||||||||||||||||||||||
Mortgage Payable - Due February 2021 | East West Bank | Rancho Cucamonga, California | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | |||||||||||||||||||||||||
Equipment Loan - Due June 2021 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Line of Credit Converted into Equipment Loan, Amount | $ 5,000,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.86% | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 5,000,000 | |||||||||||||||||||||||||
Long Term Debt | 4,592,000 | 2,882,000 | ||||||||||||||||||||||||
Equipment Line of Credit - Due December 2022 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 8,000,000 | |||||||||||||||||||||||||
Line of Credit outstanding | 0 | |||||||||||||||||||||||||
Draw down period | 18 months | |||||||||||||||||||||||||
Term of loan after draw down period expires | 48 months | |||||||||||||||||||||||||
Mortgage Payable - Due October 2026 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Long Term Debt | 3,539,000 | 3,582,000 | ||||||||||||||||||||||||
Mortgage Payable - Due October 2026 | East West Bank | Rancho Cucamonga, California | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 3,600,000 | $ 2,800,000 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 2,900,000 | |||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.15% | |||||||||||||||||||||||||
Mortgage Payable - Due October 2026 | East West Bank | LIBOR | Rancho Cucamonga, California | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.75% | |||||||||||||||||||||||||
Mortgage Payable - Due June 2027 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 9,000,000 | |||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 7,400,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.79% | |||||||||||||||||||||||||
Interest rate swap, fair value | 200,000 | |||||||||||||||||||||||||
Long Term Debt | 8,968,000 | |||||||||||||||||||||||||
Mortgage Payable - Due June 2027 | East West Bank | Rancho Cucamonga, California | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | |||||||||||||||||||||||||
Mortgage Payable - Due June 2027 | East West Bank | Chino, California | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 2 | |||||||||||||||||||||||||
Mortgage Payable - Due June 2027 | East West Bank | LIBOR | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% | |||||||||||||||||||||||||
Line of Credit Facility - Due May 2018 | Cathay Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 20,000,000 | |||||||||||||||||||||||||
Line of Credit outstanding | $ 0 | |||||||||||||||||||||||||
Acquisition Loan - Due April 2019 | Cathay Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 21,900,000 | |||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 12,000,000 | |||||||||||||||||||||||||
Debt Instrument, Term | 120 months | |||||||||||||||||||||||||
Debt Instrument Loan Collateral Percentage | 65.00% | |||||||||||||||||||||||||
Debt Instrument Covenant Period To Discharge Final Judgment | 30 days | |||||||||||||||||||||||||
Long Term Debt | $ 15,580,000 | 17,079,000 | ||||||||||||||||||||||||
Mortgage Payable - Due August 2027 | Cathay Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 4,600,000 | |||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 3,900,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.42% | |||||||||||||||||||||||||
Long Term Debt | 7,836,000 | 4,367,000 | ||||||||||||||||||||||||
Mortgage Payable - Due August 2027 | Cathay Bank | Canton, Massachusetts | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 7,900,000 | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.70% | |||||||||||||||||||||||||
Duration by which the loan bears interest at fixed rate | 5 years | |||||||||||||||||||||||||
French Government Loans | Seine-Normandie Water Agency | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 700,000 | € 0.6 | ||||||||||||||||||||||||
Number of Loans with Government Agency | item | 3 | 3 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment, Interest | $ 0 | |||||||||||||||||||||||||
Notes Payable | 300,000 | € 0.3 | ||||||||||||||||||||||||
Note Payable To Merck | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Principal amount | $ 16,000,000 | € 11.6 | ||||||||||||||||||||||||
Debt Instrument, Term | 4 years | |||||||||||||||||||||||||
Long Term Debt | 585,000 | € 0.5 | 506,000 | |||||||||||||||||||||||
Equipment under Capital Leases | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Capital Leased Assets, Gross | 1,600,000 | 2,000,000 | ||||||||||||||||||||||||
Capital Leases, Lessee Balance Sheet, Assets by Major Class, Accumulated Depreciation | $ 100,000 | $ 200,000 | ||||||||||||||||||||||||
Minimum | Equipment Loan - Due April 2017 | East West Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.50% | |||||||||||||||||||||||||
Minimum | Line of Credit Facility - Due May 2018 | Cathay Bank | Prime Rate | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | |||||||||||||||||||||||||
Minimum | Acquisition Loan - Due April 2019 | Cathay Bank | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 4.00% | |||||||||||||||||||||||||
Minimum | Acquisition Loan - Due April 2019 | Cathay Bank | Prime Rate | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 4.00% | |||||||||||||||||||||||||
Minimum | French Government Loans | Seine-Normandie Water Agency | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Term | 3 years | |||||||||||||||||||||||||
Minimum | French Government Loans | Seine-Normandie Water Agency | Prime Rate | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | 4.00% | ||||||||||||||||||||||||
Minimum | Note Payable To Merck | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% | 3.00% | ||||||||||||||||||||||||
Minimum | Note Payable To Merck | Prime Rate | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | 4.00% | ||||||||||||||||||||||||
Maximum | French Government Loans | Seine-Normandie Water Agency | ||||||||||||||||||||||||||
Debt | ||||||||||||||||||||||||||
Debt Instrument, Term | 6 years |
Income Taxes (Summary of Income
Income Taxes (Summary of Income Tax Provision) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Income (loss) before income taxes: | ||||
Income before taxes | $ (1,991) | $ 6,001 | $ 2,686 | $ 19,569 |
Income tax expense (benefit) | (2,166) | 2,111 | (354) | 6,295 |
Net income | $ 175 | $ 3,890 | $ 3,040 | $ 13,274 |
Income tax provision as a percentage of income before income taxes | 108.80% | 35.20% | (13.20%) | 32.20% |
Discrete tax benefits | $ 1,300 | $ 300 | $ 1,400 | $ 300 |
Income Taxes (Valuation Allowan
Income Taxes (Valuation Allowance - Narrative) (Details) $ in Millions | Dec. 31, 2015USD ($) |
Income Taxes | |
Deferred Tax Assets, Valuation Allowance | $ 0.9 |
Stockholders' Equity (Summary o
Stockholders' Equity (Summary of the Changes in Stockholders' Equity) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Jan. 01, 2017 | |
Stockholders' Equity | |||||
Balance | $ 329,255 | ||||
Beginning balance adjustment to retained earnings as a result of the adoption of ASU 2016-09 | $ 872 | ||||
Adjusted stockholders' equity as of January 1, 2017 | $ 330,127 | ||||
Net income | $ 175 | $ 3,890 | 3,040 | $ 13,274 | |
Accumulated other comprehensive income | 2,101 | ||||
Settlement of share-based compensation | 7,255 | ||||
Share-based compensation expense | 12,905 | ||||
Treasury stock repurchase | (24,773) | ||||
Balance | $ 330,655 | $ 330,655 |
Stockholders' Equity (2014 Empl
Stockholders' Equity (2014 Employee Stock Purchase Plan) (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jun. 30, 2014 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Allocated share based compensation | $ 4,156 | $ 3,555 | $ 12,905 | $ 11,604 | |
2014 Employee Stock Purchase Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Employee Stock Purchase Plan, Offering Duration, Maximum | 27 months | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Discount from Market Price, Offering Date | 85.00% | ||||
Stock Issued During Period, Shares, Employee Stock Purchase Plans (in Shares) | 320,623 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 1,679,377 | 1,679,377 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 2,000,000 | ||||
Allocated share based compensation | $ 100 | $ 100 | $ 400 | $ 400 |
Stockholders' Equity (Share Buy
Stockholders' Equity (Share Buyback Program) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Aug. 07, 2017 | Nov. 07, 2016 | Nov. 10, 2015 | Nov. 06, 2014 | |
Equity, Class of Treasury Stock [Line Items] | ||||||||
Treasury Stock, Value, Acquired, Cost Method | $ 24,773 | |||||||
November 2014 Share Repurchase Plan | ||||||||
Equity, Class of Treasury Stock [Line Items] | ||||||||
Stock buyback program, authorized amount | $ 20,000 | $ 10,000 | $ 10,000 | |||||
Increase authorized for share buyback program | $ 20,000 | |||||||
Treasury Stock, Shares, Acquired (in Shares) | 472,379 | 46,333 | 1,584,661 | 710,833 | ||||
Treasury Stock, Value, Acquired, Cost Method | $ 7,600 | $ 800 | $ 24,800 | $ 9,000 |
Stockholders' Equity (The 2015
Stockholders' Equity (The 2015 Equity Incentive Plan) (Details) - The 2015 Equity Incentive Plan - shares | 1 Months Ended | 9 Months Ended | |
Jan. 31, 2017 | Sep. 30, 2017 | Mar. 18, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 5,300,296 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 3,469,873 | 5,000,000 | |
Equity Incentive Plan, Term | 10 years | ||
Share Based Compensation Arrangement By Share Based Payment Award Potential Number of Additional Shares Authorized (in Shares) | 3,000,000 | ||
Share Based Compensation Arrangement by Share Based Payment Award Potential Annual Increase in Shares, Percentage | 2.50% | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,156,216 |
Stockholders' Equity (Key Assum
Stockholders' Equity (Key Assumptions Used in Determining Fair Value of Options Granted) (Details) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stockholders' Equity | ||||
Average volatility | 36.90% | 31.90% | 37.00% | 30.40% |
Risk-free interest rate | 2.00% | 1.30% | 2.10% | 1.50% |
Weighted-average expected life in years | 6 years 3 months 18 days | 6 years 3 months 18 days | 5 years 6 months | 5 years 6 months |
Dividend yield rate | 0.00% | 0.00% | 0.00% | 0.00% |
Stockholders' Equity (Summary60
Stockholders' Equity (Summary of Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Options | ||||
Outstanding Options, Beginning of period | 12,530,297 | |||
Options granted | 1,815,813 | |||
Options exercised | (1,134,259) | |||
Options cancelled | (44,473) | |||
Options expired | (118,378) | |||
Outstanding Options, End of period | 13,049,000 | 13,049,000 | ||
Exercisable at the end of period | 8,683,400 | 8,683,400 | ||
Weighted-Average Exercise Price | ||||
Outstanding Exercise Price (in dollars per share) | $ 14.57 | |||
Options granted (in dollars per share) | 14.23 | |||
Options exercised (in dollars per share) | 11.60 | |||
Options cancelled (in dollars per share) | 13.57 | |||
Options expired (in dollars per share) | 25.48 | |||
Outstanding Exercise Price (in dollars per share) | $ 14.69 | 14.69 | ||
Exercisable at the end of period (in dollars per share) | $ 15.22 | $ 15.22 | ||
Additional Disclosures | ||||
Outstanding Contractual Term (in Years) | 4 years 5 months 27 days | |||
Outstanding Intrinsic Value | $ 53,235 | $ 53,235 | ||
Exercisable at the end of period (in Years) | 3 years 18 days | |||
Exercisable aggregate intrinsic value | 34,772 | $ 34,772 | ||
Allocated share based compensation | 4,156 | $ 3,555 | 12,905 | $ 11,604 |
Employee Stock Option | ||||
Additional Disclosures | ||||
Allocated share based compensation | 1,900 | 1,800 | 5,900 | 6,200 |
Employee Stock Option | Board of Directors | ||||
Additional Disclosures | ||||
Allocated share based compensation | $ 200 | $ 100 | $ 500 | $ 500 |
Stockholders' Equity (Informati
Stockholders' Equity (Information Relating to Option Grants and Exercises) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stockholders' Equity | ||||
Weighted-average grant date fair value (in Dollars per share) | $ 6.23 | $ 6.34 | $ 4.95 | $ 3.42 |
Intrinsic value of options exercised | $ 1,668 | $ 4,998 | $ 4,730 | $ 5,980 |
Cash received | 782 | 14,331 | 9,521 | 17,584 |
Total fair value of the options vested during the year | $ 779 | $ 2,688 | $ 6,984 | $ 7,948 |
Stockholders' Equity (Summary62
Stockholders' Equity (Summary of Nonvested Options) (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Options | ||||
Nonvested at beginning of period | 4,592,187 | |||
Options granted | 1,815,813 | |||
Options vested | (1,997,927) | |||
Options forfeited | (44,473) | |||
Nonvested at end of period | 4,365,600 | 4,365,600 | ||
Weighted-Average Grant Date Fair Value | ||||
Nonvested at beginning of period (in dollars per share) | $ 3.61 | |||
Options granted (in dollars per share) | $ 6.23 | $ 6.34 | 4.95 | $ 3.42 |
Options vested (in dollars per share) | 3.50 | |||
Options forfeited (in dollars per share) | 4.71 | |||
Nonvested at end of period (in dollars per share) | $ 4.21 | $ 4.21 | ||
Employee Consultant And Directors Stock Options | ||||
Weighted-Average Grant Date Fair Value | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 12.9 | $ 12.9 | ||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 3 months 18 days |
Stockholders' Equity (Restricte
Stockholders' Equity (Restricted Stock Units) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding Contractual Term (in Years) | 4 years 5 months 27 days | |||
Allocated share based compensation | $ 4,156 | $ 3,555 | $ 12,905 | $ 11,604 |
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | |||
Allocated share based compensation | $ 1,700 | 1,400 | $ 5,400 | 3,900 |
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 4 months 24 days | |||
Share-based Compensation Arrangement by Share-based Payment Award, Restricted Stock Units, Number of Shares of Common Stock Per Award (in Shares) | 1 | 1 | ||
Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 14,200 | $ 14,200 | ||
Board of Directors | Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 200 | $ 200 | $ 500 | $ 500 |
Stockholders' Equity (Informa64
Stockholders' Equity (Information Relating to RSU Grants and Deliveries) (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2017USD ($)shares | |
Restricted Stock Units (RSUs) | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Total RSUs outstanding at the beginning of the period | 1,215,786 |
RSUs granted | 676,482 |
RSUs forfeited | (13,302) |
RSUs vested(2) | (484,739) |
Total RSUs outstanding at the end of the period | 1,394,227 |
Stock surrendered to fulfill tax withholding obligations | 184,341 |
Restricted Stock Units Issued as Compensation | |
Total Fair Market Value of RSUs Issued | |
RSUs granted (in Dollars) | $ | $ 9,298 |
Stockholders' Equity (Equity Aw
Stockholders' Equity (Equity Awards to Consultants and Advisory Board Members) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 4,156 | $ 3,555 | $ 12,905 | $ 11,604 |
Consultants and Advisory Board [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 100 | $ 0 | $ 300 | $ 100 |
Stockholders' Equity (Share-Bas
Stockholders' Equity (Share-Based Compensation Expense Included in the Statement of Operations) (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 4,156 | $ 3,555 | $ 12,905 | $ 11,604 |
Cost of revenues | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 815 | 675 | 2,843 | 2,245 |
Selling, distribution and marketing | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 88 | 45 | 237 | 176 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | 2,947 | 2,593 | 8,715 | 8,339 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share based compensation | $ 306 | $ 242 | $ 1,110 | $ 844 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Employee Benefits | |||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50.00% | ||||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 6.00% | ||||
Defined Contribution Plan, Employer Contribution Vesting Period | 4 years | ||||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0.3 | $ 0.3 | $ 0.8 | $ 0.7 | |
Defined Benefit Plan, Assumptions Used Calculating Benefit Obligation, Discount Rate | 1.60% | 1.60% | 1.75% | ||
Defined Benefit Plan, Benefit Obligation | $ 1.9 | $ 1.9 | $ 1.7 | ||
Pension Expense | $ 0 | $ 0 | $ 0.1 | $ 0.1 |
Commitments and Contingencies (
Commitments and Contingencies (Supply Agreement with MannKind Corporation) (Details) - MannKind Corporation - Supply Commitment - Recombinant Human Insulin (RHI) € in Millions, $ in Millions | Jul. 31, 2014USD ($) | Nov. 30, 2016EUR (€) | Oct. 31, 2015USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2017EUR (€) | Dec. 31, 2015EUR (€) | Jul. 31, 2014EUR (€) |
Supply Commitment [Line Items] | ||||||||
Supply commitment annual amount committed | $ 146 | € 23.3 | € 27.1 | € 120.1 | ||||
Supply Commitment, Number of Years Committed | 5 years | |||||||
Supply Commitment, Cancellation Fee | $ | $ 0.8 | $ 0.9 | $ 1.5 | |||||
Sales | $ | $ 6.8 | |||||||
Supply commitment in fourth quarter of 2017 | € 2.7 | |||||||
Supply commitment in 2018 | 8.9 | |||||||
Supply commitment in 2019 | 11.6 | |||||||
Supply commitment in 2020 and 2021 | 15.5 | |||||||
Supply commitment in 2022 and 2023 | € 19.4 | |||||||
Long-term Supply Commitment, Optional Renewal Period | 2 years | |||||||
Supply Agreement Renewal Notice Period | 12 months |
Commitments and Contingencies69
Commitments and Contingencies (Collaboration Agreement) (Details) - Development agreement - Drug delivery system item in Millions, $ in Millions | 9 Months Ended |
Sep. 30, 2017USD ($)item | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Collaborative Agreement, Upfront Payment | $ 0.5 |
Collaborative Agreement, Milestone Payments | 1.5 |
Collaborative Agreement, Contingent Obligation | $ 0.5 |
Collaborative Agreement, Contingent Purchase Obligation First 12 Months, Units | item | 1 |
Purchase period | 12 months |
Commitments and Contingencies70
Commitments and Contingencies (Operating Lease Agreements) (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Operating Leased Assets [Line Items] | ||||
Operating Leases, Rent Expense | $ 0.9 | $ 0.8 | $ 2.6 | $ 2.5 |
Minimum | ||||
Operating Leased Assets [Line Items] | ||||
Lessee Leasing Arrangements, Operating Leases, Renewal Term | 1 year | |||
Maximum | ||||
Operating Leased Assets [Line Items] | ||||
Lessee Leasing Arrangements, Operating Leases, Renewal Term | 6 years |
Commitments and Contingencies71
Commitments and Contingencies (Purchase Commitments) (Details) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | |
Nov. 30, 2012 | Jan. 31, 2010 | Sep. 30, 2017 | Dec. 31, 2016 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Maximum Royalty Amount Owed, Contingent On Sales of Products | $ 1.5 | |||
Commitments to Purchase Equipment and Raw Materials | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Long-term Purchase Commitment, Amount | $ 48.4 | |||
Commitment to invest | ANP | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Purchase Commitments Amount Fulfilled | $ 61 | |||
Land-use rights | Commitment to invest | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Finite-lived Intangible Assets Acquired | $ 1.3 | $ 1.2 | ||
Land-use rights | Commitment to develop land | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Contractual Obligation | $ 15 |
Litigation (Details)
Litigation (Details) | May 09, 2016USD ($) | May 04, 2016item | Oct. 31, 2011USD ($) | Sep. 30, 2011item | Sep. 30, 2017USD ($) |
Enoxaparin Patent Litigation | |||||
Loss Contingencies [Line Items] | |||||
Fees and costs relating to a discovery motion | $ 400,000 | ||||
False Claims Act Litigation | |||||
Loss Contingencies [Line Items] | |||||
Number of orders issued by district court | item | 3 | ||||
Pending Litigation [Member] | Enoxaparin Patent Litigation | |||||
Loss Contingencies [Line Items] | |||||
Number of Alleged Patent Infringements | item | 2 | ||||
Litigation, Plaintiff Preliminary Injunction Bond, Amount | $ 100,100,000 | ||||
Settled Litigation [Member] | Enoxaparin Patent Litigation | |||||
Loss Contingencies [Line Items] | |||||
Litigation Settlement, Amount | $ 0 |