Document And Entity Information
Document And Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Mar. 08, 2016 | Jun. 30, 2015 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Amphastar Pharmaceuticals, Inc. | ||
Document Type | 10-K | ||
Current Fiscal Year End Date | --12-31 | ||
Amendment Flag | false | ||
Entity Central Index Key | 1,297,184 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Entity Common Stock, Shares Outstanding | 44,913,928 | ||
Entity Public Float | $ 625,638,657 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and Cash Equivalents, at Carrying Value | $ 66,074 | $ 67,828 |
Restricted cash and restricted short-term investments | 1,285 | 1,495 |
Accounts receivable, net | 33,233 | 22,852 |
Inventories, net | 70,665 | 82,332 |
Income tax refund and deposits | 238 | 273 |
Prepaid expenses and other assets | 4,439 | 3,683 |
Deferred tax assets | 19,533 | |
Total current assets | 175,934 | 197,996 |
Property, plant, and equipment, net | 142,161 | 138,289 |
Goodwill and intangible assets, net | 39,901 | 42,565 |
Other assets | 4,696 | 3,588 |
Deferred tax assets | 27,444 | 6,932 |
Total assets | 390,136 | 389,370 |
Current Liabilities: | ||
Accounts payable | 13,872 | 10,161 |
Accrued liabilities | 16,732 | 13,144 |
Income taxes payable | 3,076 | 3,123 |
Accrued payroll and related benefits | 12,840 | 11,449 |
Current portion of product return accrual | 1,858 | 1,918 |
Current portion of deferred revenue | 643 | 14,013 |
Current portion of long-term debt and capital leases | 10,934 | 7,594 |
Current portion of deferred tax liabilities | 1,193 | |
Total current liabilities | 59,955 | 62,595 |
Long-term product return accrual | 763 | 490 |
Long-term reserve for income tax liabilities | 497 | 499 |
Long-term deferred revenue | 1,339 | 1,982 |
Long-term debt and capital leases, net of current portion | 30,165 | 36,106 |
Long-term deferred tax liabilities | 5,838 | |
Other long-term liabilities | 1,907 | |
Total liabilities | $ 94,626 | $ 107,510 |
Stockholders’ equity: | ||
Preferred stock: par value $.0001; authorized shares—20,000,000; no shares issued and outstanding | ||
Common stock: par value $.0001; authorized shares—300,000,000; issued and outstanding shares—45,960,206 and 45,198,491 at December 31, 2015 and 44,676,167 and 44,646,767 at December 31, 2014, respectively | $ 5 | $ 4 |
Additional paid-in capital | 247,829 | 220,745 |
Retained earnings | 60,323 | 63,110 |
Accumulated other comprehensive loss | (2,475) | (1,654) |
Treasury stock | (10,172) | (345) |
Total stockholders’ equity | 295,510 | 281,860 |
Total liabilities and stockholders’ equity | $ 390,136 | $ 389,370 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parentheticals) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
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; authorized shares | 300,000,000 | 300,000,000 |
Common stock; shares issued | 45,960,206 | 44,676,167 |
Common stock; outstanding shares | 45,198,491 | 44,646,767 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
CONSOLIDATED STATEMENTS OF OPERATIONS | |||
Net revenues | $ 251,519 | $ 210,461 | $ 229,681 |
Cost of revenues | 174,172 | 159,205 | 142,725 |
Gross profit | 77,347 | 51,256 | 86,956 |
Operating expenses: | |||
Selling, distribution, and marketing | 5,470 | 5,564 | 5,349 |
General and administrative | 41,504 | 34,809 | 30,972 |
Research and development | 37,065 | 28,427 | 33,019 |
Impairment of long-lived assets | 206 | 439 | 126 |
Total operating expenses | 84,245 | 69,239 | 69,466 |
Income (loss) from operations | (6,898) | (17,983) | 17,490 |
Non-operating income (expense): | |||
Interest income | 315 | 243 | 187 |
Interest expense | (987) | (609) | (958) |
Other income (expense), net | (2,794) | 201 | 508 |
Total non-operating income (expense), net | (3,466) | (165) | (263) |
Income (loss) before income taxes | (10,364) | (18,148) | 17,227 |
Income tax expense (benefit) | (7,577) | (7,449) | 5,365 |
Net income (loss) | $ (2,787) | $ (10,699) | $ 11,862 |
Net income (loss) per share: | |||
Basic (in Dollars per share) | $ (0.06) | $ (0.25) | $ 0.31 |
Diluted (in Dollars per share) | $ (0.06) | $ (0.25) | $ 0.31 |
Weighted-average shares used to compute net income (loss) per share: | |||
Basic (in Shares) | 44,961,000 | 41,957,000 | 38,712,000 |
Diluted (in Shares) | 44,961,000 | 41,957,000 | 38,883,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | |||
Net income (loss) | $ (2,787) | $ (10,699) | $ 11,862 |
Accumulated other comprehensive income (loss) | |||
Foreign currency translation adjustment | (805) | (1,810) | |
Other Comprehensive (Income) Loss, Pension and Other Postretirement Benefit Plans, Adjustment, Net of Tax | (16) | 156 | |
Total accumulated other comprehensive income (loss) | (821) | (1,654) | |
Total comprehensive income (loss) | $ (3,608) | $ (12,353) | $ 11,862 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common StockNonemployee | Common StockEmployee | Common Stock | Additional Paid-in Capital [Member]Nonemployee | Additional Paid-in Capital [Member]Employee | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Treasury Stock [Member] | Nonemployee | Employee | Total |
Stockholders’ equity at the beginning of period at Dec. 31, 2012 | $ 4 | $ 171,488 | $ 61,947 | $ 233,439 | ||||||||
Balance as of at Dec. 31, 2012 | 38,681,660 | |||||||||||
Changes in Stockholders' Equity | ||||||||||||
Net income (loss) | 11,862 | $ 11,862 | ||||||||||
Accumulated other comprehensive loss | ||||||||||||
Reduction of excess tax benefit of share-based awards | (647) | $ (647) | ||||||||||
Exercise of stock options | 55 | 55 | ||||||||||
Exercise of stock options, shares | 4,200 | |||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards | $ (199) | $ (199) | ||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards, shares | 66,057 | 14,023 | ||||||||||
Share-based compensation expense | $ 946 | 6,089 | $ 946 | 6,089 | ||||||||
Stockholders’ equity at the end of period at Dec. 31, 2013 | $ 4 | 177,732 | 73,809 | 251,545 | ||||||||
Balance as of at Dec. 31, 2013 | 38,765,940 | |||||||||||
Changes in Stockholders' Equity | ||||||||||||
Net income (loss) | (10,699) | (10,699) | ||||||||||
Accumulated other comprehensive loss | $ (1,654) | (1,654) | ||||||||||
Reduction of excess tax benefit of share-based awards | (1,109) | (1,109) | ||||||||||
Common stock issued through initial public offering | 38,018 | 38,018 | ||||||||||
Common stock issued through initial public offering (in Shares) | 5,840,000 | |||||||||||
Cost related to public offering | (3,358) | (3,358) | ||||||||||
Treasury stock acquired | $ (345) | (345) | ||||||||||
Treasury stock acquired (in Shares) | (29,400) | |||||||||||
Exercise of stock options | 571 | $ 571 | ||||||||||
Exercise of stock options, shares | 30,000 | 65,000 | ||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards | (389) | (389) | ||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards, shares | 25,921 | 14,306 | ||||||||||
Share-based compensation expense | 946 | 8,334 | 946 | 8,334 | ||||||||
Stockholders’ equity at the end of period at Dec. 31, 2014 | $ 4 | 220,745 | 63,110 | (1,654) | $ (345) | $ 281,860 | ||||||
Balance as of at Dec. 31, 2014 | 44,676,167 | (29,400) | 44,646,767 | |||||||||
Changes in Stockholders' Equity | ||||||||||||
Net income (loss) | (2,787) | $ (2,787) | ||||||||||
Accumulated other comprehensive loss | (821) | (821) | ||||||||||
Reduction of excess tax benefit of share-based awards | 107 | 107 | ||||||||||
Treasury stock acquired | $ (9,865) | (9,865) | ||||||||||
Treasury stock acquired (in Shares) | (735,679) | |||||||||||
Issuance of common stock from treasury | (38) | $ 38 | ||||||||||
Issuance of common stock from treasury, shares | 3,364 | |||||||||||
Exercise of stock options | $ 1 | 13,501 | $ 13,502 | |||||||||
Exercise of stock options, shares | 1,067,466 | 1,262,663 | ||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards | (621) | (621) | ||||||||||
Issuance of common stock in connection with the release of vested restricted stock units, net of common stock withheld to settle equity awards, shares | 676 | 91,517 | ||||||||||
Share-based compensation expense | $ 1,131 | 11,684 | $ 1,131 | 11,684 | ||||||||
Issuance of common stock to employees under ESPP | $ 1,320 | $ 1,320 | ||||||||||
Issuance of common stock to employees under ESPP, Shares | 124,380 | |||||||||||
Stockholders’ equity at the end of period at Dec. 31, 2015 | $ 5 | $ 247,829 | $ 60,323 | $ (2,475) | $ (10,172) | $ 295,510 | ||||||
Balance as of at Dec. 31, 2015 | 45,960,206 | (761,715) | 45,198,491 |
Consolidated Statements of Sto7
Consolidated Statements of Stockholders' Equity (Parentheticals) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Nonemployee | |||
Share-based compensation expense, stock option awards | $ 579 | $ 576 | $ 499 |
Share-based compensation expense, RSU awards | 552 | 370 | 447 |
Employee | |||
Share-based compensation expense, stock option awards | 7,908 | 6,728 | 5,926 |
Share-based compensation expense, RSU awards | 3,364 | $ 1,606 | $ 163 |
Adjustments to Additional Paid in Capital, Share-based Compensation, Employee Stock Purchase Program, Requisite Service Period Recognition | $ 412 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash Flows From Operating Activities: | |||
Net income (loss) | $ (2,787) | $ (10,699) | $ 11,862 |
Reconciliation to net cash provided by operating activities: | |||
Impairment of long-lived assets | 206 | 439 | 126 |
Loss on disposal of property, plant, and equipment | 104 | 46 | 91 |
Depreciation of property, plant, and equipment | 11,314 | 12,528 | 11,171 |
Amortization of product rights, trademarks, and patents | 1,938 | 1,920 | 1,907 |
Imputed interest accretion | 110 | 163 | |
Employee share-based compensation expense | 11,684 | 8,334 | 6,089 |
Non-employee share-based compensation expense | 1,131 | 946 | 946 |
Reserve for income tax liabilities | (1) | 499 | (167) |
Changes in deferred taxes | (7,880) | (8,743) | 2,248 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (11,012) | 1,210 | 11,824 |
Inventories, net | 9,775 | 6,565 | (18,538) |
Income tax refund and deposits | 21 | 1,873 | (576) |
Prepaid expenses and other assets | (699) | (88) | 29 |
Income taxes payable | (92) | 559 | (173) |
Accounts payable and accrued liabilities | (3,131) | 5,500 | 4,203 |
Net cash provided by operating activities | 10,681 | 21,052 | 31,042 |
Cash Flows From Investing Activities: | |||
Acquisition of business | (18,352) | ||
Purchases of property, plant, and equipment | (14,418) | (18,671) | (17,642) |
Capitalized labor, overhead, and interest on self-constructed assets | (1,629) | (1,828) | (660) |
Proceeds from the sale of property, plant and equipment | 51 | ||
Sales of short-term investments, net | 513 | ||
Decrease (increase) in restricted cash | 210 | (170) | 50 |
Deposits and other assets, net | (1,139) | (752) | (559) |
Net cash used in investing activities | (16,925) | (39,773) | (18,298) |
Cash Flows From Financing Activities: | |||
Net proceeds from issuance of common stock | 1,320 | 38,018 | |
Repurchase of common stock | (621) | (389) | (199) |
Excess tax benefit (reduction) related to share-based compensation | 107 | (1,109) | (647) |
Net proceeds from equity plans | 13,502 | 571 | 55 |
Cost related to public offering | (1,920) | ||
Deferred offering cost | (1,427) | ||
Payments on treasury stock | (9,865) | (345) | |
Proceeds from borrowing under lines of credit | 25,000 | 66,000 | |
Repayments under lines of credit | (40,000) | (71,000) | |
Proceeds from issuance of long-term debt | 6,785 | 26,505 | |
Principal payments on long-term debt | (8,991) | (8,216) | (2,152) |
Principal payments on short-term debt | (5,998) | ||
Net cash provided by (used in) financing activities | 2,237 | 32,117 | (9,370) |
Effect of exchange rate changes on cash | 2,253 | 845 | |
Net increase (decrease) in cash and cash equivalents | (1,754) | 14,241 | 3,374 |
Cash and cash equivalents at beginning of period | 67,828 | 53,587 | 50,213 |
Cash and cash equivalents at end of period | 66,074 | 67,828 | 53,587 |
Noncash Investing and Financing Activities: | |||
Equipment acquired under capital leases | 150 | 78 | 1,323 |
Supplemental Disclosures of Cash Flow Information: | |||
Interest paid | 1,941 | 2,607 | 1,100 |
Income taxes paid | $ 146 | $ 436 | $ 4,158 |
General
General | 12 Months Ended |
Dec. 31, 2015 | |
General | |
General | 1. General 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, in 2014, the Company commenced sales of insulin active pharmaceutica l 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 once they are brought to market. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation All significant intercompany activity has been eliminated in the preparation of the consolidated financial statements. Some information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted pursuant to those rules and regulations. The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: International Medication Systems, Limited, or IMS; Amphastar Laboratories, Inc.; Armstrong Pharmaceuticals, Inc., or Armstrong; Amphastar Nanjing Pharmaceuticals Co., Ltd., or ANP; and Amphastar France Pharmaceuticals, S.A.S., or AFP. Use of Estimates The preparation of consolidated financial statements in accordance with U.S. 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, liabilities for product returns, reserves for excess or unsellable inventory, 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, fair market values of the Company’s common stock, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. Foreign Currency The functional currency of the Company and its domestic and Chinese subsidiari es is the U.S. dollar, or USD. The Company’s Chinese subsidiary, 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 exchange gains and losses are reflected in the Comp any’s statement of operations. The Company’s French subsidiary, AFP, maintains its books of record in Euros, which is the local currency in France and has been determined to be its functional currency. These books are translated into USD using average exc hange rates during the period. Assets and liabilities are translated at the rate of exchange prevail ing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the da te of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive income (loss). Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. Comprehensive Income (Loss) For the years ended December 31, 2015 and 2014, the Company included its foreign currency translation as part of its comprehensive income ( loss ) . For the year ended December 31, 2013, net income equaled total comprehensive income. Shipping and Handling Costs For the years ended December 31, 2015, 2014, and 2013, the Company included shipping and handling costs of approximately $2.6 million, $2.5 million, and $2.4 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities including salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research ‑related overhead expenses and fees paid to external service providers. The Company may produce inventories prior to or with the expectation of receiving marketing authorization in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre ‑launch inventory. The Company’s policy is to expense pre ‑launch inventory as research and development costs, as incurred, until the drug candidate receives marketing authorization. As a result of the policy, while marketing authorization may have been received by the end of a reporting period, any inventories produced prior to such authorization are expensed. If marketing authorization is received and previously expensed pre ‑launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre ‑launch inventory costs include cost of work in process materials and finished drug products. Financial Instruments The carrying amounts of cash and cash equivalents, 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 13). Cash and Cash Equivalents Cash and cash equivalents consist of cash, money market funds, certificates of deposit and highly liquid investments purchased with original maturities of three months or less. Restricted Cash and Restricted Short ‑Term Investments Restricted cash and restricted short ‑term investments as of December 31, 2015 and 2014 included $1.3 million and $1.5 million, respectively, in certificates of deposit, which is the collateral required for the Company to qualify for workers’ compensation self ‑insurance and is available to meet the Company’s workers’ compensation obligations on a current basis, as needed. These funds are classified as current assets. The Company’s short ‑term investments are classified as held ‑ to ‑maturity and consist of certificates of deposit purchased with maturities greater than three months but mature within one year of the date of purchase. The estimated fair value of each investment approximates its amortized cost. Allowance for Doubtful Accounts Receivable The Company evaluates the collectability of accounts receivable based on a combination of factors. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company will record a specific allowance to reduce the amounts due to the amount the Company reasonably believes will be collected. For all other customers, the Company recognizes an allowance for doubtful accounts based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current business environment and historical collection experience. Inventories Inventories are stated at the lower of cost or market, using the first ‑in, first ‑out method. Provisions are made for slow ‑moving, unsellable, or obsolete items. Inventories consist of currently marketed products and products manufactured under contract. Property, Plant and Equipment Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight ‑line method over the estimated useful lives of the related assets as follows: Buildings 20 - 31 years Machinery and equipment 2 - 12 years Furniture and fixtures 3 - 7 years Automobiles 4 - 5 years Leasehold improvements Lesser of remaining lease term or useful life Goodwill and Intangible Assets Intangible assets with finite lives are amortized over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company. Product rights are amortized over their estimated useful lives ranging from five to 15 years on a straight ‑line basis since their projected revenues are expected to be consistent each year. Patents and trademarks are amortized on a straight ‑line basis over their estimated useful lives, generally ranging from 10 to 20 years. Land ‑use rights are amortized on a straight ‑line basis over their useful lives, generally ranging from 37 to 50 years. In accordance with the Company’s accounting policy, the Company tests all intangible assets on an annual basis and between annual tests whenever there is an indication of impairment. Impairment of Long ‑Lived Assets The Company reviews long ‑lived assets and definite ‑lived intangibles for impairment in the fourth quarter of each year or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount of the asset exceeds the fair value of the assets (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also reviews the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized. 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. The Company has adopted the with-and-without methodology for determining when excess tax benefits from the exercise of share ‑based awards are realized. Under the with-and-without methodology, current year operating loss deductions and prior-year operating loss carryforwards are deemed to be utilized prior to the utilization of current-year excess tax benefits from share ‑based awards. Self-Insured Claims The Company is primarily self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 annually or aggregate claims exceeding $1.9 million annually. Operations are charged with the cost of claims reported and an estimate of claims incurred but not reported . A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $1.2 million, $1.0 million, and $0.8 million, for the years ended December 31, 2015, 2014 and 2013, respectively. The self-insured claims liability was $2.7 million and $2.2 million at December 31, 2015 and 2014, respectively. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified. Business Combinations Business combinations are accounted for in accordance with Accounting Standards Codification, or ASC 805, Business Combinations, 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 are costs the Company incurs to effect a business combination. The Company accounts for acquisition-related costs as expenses in the periods in which the costs are incurred. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued an accounting standards update that creates a single source of revenue guidance for companies in all industries. 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. This guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach and will be effective for fiscal years beginning after December 15, 2017, which will be the Company's fiscal 2018. The Company has not yet evaluated the potential impact of adopting the guidance on the Company's consolidated financial statements. In June 2014, the FASB issued an accounting standards update that requires a performance target that affects vesting of a share-based payment award and that could be achieved after the requisite service period to be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation cost should be recognized over the required service period, if it is probable that the performance target will be achieved. This guidance will be effective for fiscal years beginning after December 15, 2015, which will be the Company's fiscal 2016, with early adoption permitted. The Company does not expect the adoption of the guidance will have a material impact on the Company's consolidated financial statements. In August 2014, the FASB issued an accounting standards update that will require management to evaluate if there is substantial doubt about the Company’s ability to continue as a going concern and, if so, to disclose this in both interim and annual reporting periods. This guidance will become effective for the Company’s annual filing for the period ending December 31, 2016 and interim periods thereafter, and allows for early adoption. The Company does not expect the adoption of the guidance will have a material impact on the Company’s consolidated financial statements. In July 2015, the FASB issued an accounting standards update which requires entities to measure most inventories at the lower of cost and net realizable value, or NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured at the lower of cost and net realizable value, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. The standard will be effective for the Company for the first quarter of the Company’s fiscal 201 7. Early application is permitted. The new guidance must be applied prospec tively. The Company does not believe the adoption of this accounting guidance will have a material impact on the Company’s consolidated financial statements and related disclosures. In November 2015, the FASB issued an accounting standards update the balance sheet classification of deferred taxes. Under existing standards, deferred taxes for each tax-paying jurisdiction are presented as a net current asset or liability and net long-term asset or liability. To simplify presentation, the new guidance will require that all deferred tax assets and liabilities, along with related valuation allowances, be classified as long-term on the balance sheet. As a result, each tax-paying jurisdiction will now only have one net long-term deferred tax asset or liability. The new guidance does not change the existing requirement that prohibits offsetting deferred tax liabilities from one jurisdiction against deferred tax assets of another jurisdiction. The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein . Early adoption is permitted. The new guidance may be applied prospectively or retrospectively. The Company has elected to adopt the guidance early and apply the guidance prospectively, therefore, prior periods were not retrospectively adjusted. The reclassification of the Company’s deferred tax assets and liabilities does not have any impact to the Company’s net income or cash flow, thus the adoption of the guidance does not have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued accounting standards update that is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet 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 currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. |
Business Acquisition
Business Acquisition | 12 Months Ended |
Dec. 31, 2015 | |
Business Acquisition | |
Business Acquisition | 3. Business Acquisition 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. 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 fluctuations. The terms of the purchase include multiple payments over four years as follows (see Note 13): U.S. Euros Dollars (in thousands) At Closing, April 2014 € $ December 2014 December 2015 December 2016 December 2017 € $ In order to facilitate the acquisition, the Company established a subsidiary in France, AFP. The Company will continue the current site manufacturing activities, which consist of the manufacturing of porcine insulin API and recombinant human insulin API, or 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 from Merck to AFP. This process will require capital expenditures at AFP and is expected to take two or more years to complete. The transaction is accounted for as a business combination in accordance with ASC 805. The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date: Fair Value U.S. Euros Dollars (in thousands) Inventory € $ Real property Machinery and equipment Intangibles Goodwill Total assets acquired € $ Accrued liabilities € $ Deferred tax liabilities Total liabilities assumed Total fair value of consideration transferred € $ The operations of the acquired business have been included in the Company’s consolidated financial statements commencing on the acquisition date. The results of operations for this acquisition have not been separately presented because this acquisition is not material to the Company’s consolidated results of operations. The following unaudited pro forma financial information for the years ended December 31, 2015 and 2014 gives effect to the transaction as if it ha d occurred on January 1, 2013. Such unaudited pro forma information is based on historical financial information prior to the transaction as well as actual results subsequent to the acquisition with respect to the transaction and does not reflect estimated operational and administrative cost savings, or synergies, for periods prior to the transaction, that management of the combined company estimates may be achieved as a result of the transaction. The unaudited pro forma information primarily reflects the additional depreciation related to the fair value adjustment to property, plant and equipment acquired, valuation step up related to the fair value of inventory and additional interest expense associated with the financing obtained by the Company in connection with the acquisition. Year Ended December 31, 2015 2014 (in thousands, except per share data) Net revenues $ $ Net loss Diluted net loss per share $ $ Acquisition Loan with Cathay Bank 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. 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. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 2015 | |
Revenue Recognition | |
Revenue Recognition | 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. The Company also records profit-sharing revenue stemming from a distribution agreement with Allergan plc, or Allergan (see Note 17). Profit-sharing revenue is recognized at the time Allergan sells the products to its customers. 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. 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 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 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 provision for chargebacks is reflected in net revenues and a reduction to accounts receivable. The following table is an analysis of the chargeback provision: Year Ended December 31, 2015 2014 (in thousands) Beginning balance $ $ Provision related to sales made in the current period Credits issued to third parties Ending balance $ $ 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 Company continually monitors the provision for chargebacks and makes adjustments when it believes that the actual chargebacks may differ from the estimates. The settlement of chargebacks generally occurs within 30 days after the sale to wholesalers. 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 Allergan 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. The provision for product returns is reflected in net revenues. The following table is an analysis of product return liability: Year Ended December 31, 2015 2014 (in thousands) Beginning balance $ $ Provision for product returns Credits issued to third parties Ending balance $ $ For the years ended December 31, 2015 and 2014 , the Company’s aggregate product return rate was 1 .1% and 1.1 % of qualified sales, respectively. |
Income (Loss) per Share
Income (Loss) per Share | 12 Months Ended |
Dec. 31, 2015 | |
Income (Loss) per Share | |
Income (Loss) per Share | 5. Income (Loss) per Share Basic income (loss) per share is calculated based upon the weighted-average number of shares outstanding during the period and contingently issuable shares such as fully vested deferred stock units, or DSUs, and in 2015, such equity was issued as restricted stock units, or RSUs (such RSUs and DSUs are collectively referred to herein as RSUs), in addition to shares expected to be issued under the Company’s employee stock purchase plan, or ESPP, as of the date all necessary conditions for issuance have been met. Diluted income per share gives effect to all potential dilutive shares outstanding during the period, such as stock options, nonvested RSUs and shares issuable under the Company’s ESPP. As the Company reported a net loss for the years ended December 31, 2015 and 2014, the diluted net loss per share, as reported, is equal to the basic net loss per share since the effect of the assumed exercise of stock options, vesting of nonvested RSUs, and issuance of common shares under the Company’s ESPP are anti-dilutive. Total stock options, nonvested RSUs, and shares issuable under the Company’s ESPP excluded from the year ended December 31, 2015 net loss per share were 12,240,467; 866,540 , and 61,766 , respectively. Total stock options and nonvested RSUs excluded from the year ended December 31, 2014 net loss per share were 11,371,891 and 503,010 , respectively. For the year ended December 31, 2013, options to purchase 7,124,091 shares of stock with a weighted-average exercise price of $17.62 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. The following table provides the calculation of basic and diluted net income (loss) per share for each of the periods presented: Year Ended December 31, 2015 2014 2013 (in thousands, except per share data) Basic and dilutive numerator: Net income (loss) $ $ $ Denominator: Shares outstanding Contingently issuable shares – vested RSUs — — Weighted-average shares outstanding — basic Net effect of dilutive securities: Stock options — — Contingently issuable shares – nonvested RSUs — — Weighted-average shares outstanding — diluted Net income (loss) per share — basic $ $ $ Net income (loss) per share — diluted $ $ $ |
Segment Reporting
Segment Reporting | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting | |
Segment Reporting | 6. Segment Reporting The Company’s business is the development, manufacture, and marketing of pharmaceutical products. 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, Cortrosyn ® , Amphadase ® , naloxone, lidocaine jelly, as well as various other critica l and non-critical care drugs. The API segment manufactures and distributes recombinant hum an insulin and porcine insulin for external customers and internal product development. Selected financial information by reporting segment is presented below: Year Ended December 31, 2015 2014 2013 (in thousands) Net revenues: Finished pharmaceutical products $ $ $ API — Total net revenues Gross Profit: Finished pharmaceutical products API — Total gross profit Operating expenses Income (loss) from operations Non-operating income (expenses) Income (loss) before income taxes $ $ $ 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. Net revenues and carrying values of long-lived assets of enterprises by geographic regions are as follows: Net Revenue Long-Lived Assets Year Ended December 31, December 31, 2015 2014 2013 2015 2014 (in thousands) U.S. $ $ $ $ $ China — — — France — Total $ $ $ $ $ |
Customer and Supplier Concentra
Customer and Supplier Concentration | 12 Months Ended |
Dec. 31, 2015 | |
Customer and Supplier Concentration | |
Customer and Supplier Concentration | 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. Allergan plc. has exclusive marketing rights of the Company’s enoxaparin product to the U.S. retail pharmacy market. MannKind Corporation began buying RHI API from the Company in December 2014. The Company considers these five 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 years ended December 31, 2015 , 2014, and 2013, and accounts receivable as of December 31, 2015 and 2014. The following table provides accounts receivable and net revenues information for these major customers: % of Total Accounts % of Net Receivable Revenue December 31, December 31, Year Ended December 31, 2015 2014 2015 2014 2013 Allergan plc (1) % % % % % AmerisourceBergen % % % % % Cardinal Health % % % % % MannKind Corporation % % % % — McKesson % % % % % (1) In June 2015, Actavis plc adopted Allergan plc as its new global name. Supplier Concentrations The Company depends on suppliers for raw materials, active pharmaceutical ingredients, and other components that are subject to stringent U.S. Food and Drug Administration, or 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 | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | 8. Fair Value Measurements The accounting standards of the Financial Accounting Standards Board, or 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 Company measures fair value based on the prices that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The Company classifies its cash equivalents and short-term investments as Level 1 assets, as they are valued on a recurring basis using quoted market prices with no valuation adjustments applied. The Company does not hold any Level 2 or Level 3 instruments that are measured for fair value on a recurring basis. The fair values of the Company’s financial assets and liabilities measured on a recurring basis, as of December 31, 2015 and 2014, are as follows: Quoted Prices in Active Markets Significant Other Significant Other for Identical Observable Unobservable Assets Inputs Inputs Total (Level 1) (Level 2) (Level 3) (in thousands) Cash equivalents: Money market accounts $ $ $ — $ — Restricted short-term investments: Certificates of deposit — — Fair value measurement as of December 31, 2015 $ $ $ — $ — Cash equivalents: Money market accounts $ $ $ — $ — Restricted short-term investments: Certificates of deposit — — Fair value measurement as of December 31, 2014 $ $ $ — $ — The fair value of the Company’s cash equivalents includes money market funds and certificates of deposit with original maturities of three months or less. Short-term investments consist of certificate of deposit accounts that expire within 12 months for which market prices are readily available. 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. The Company adopted the required fair value measurements and disclosures provisions related to nonfinancial assets and liabilities. These 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 December 31, 2015 and 2014, there were no significant adjustments to fair value for nonfinancial assets or liabilities. |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 12 Months Ended |
Dec. 31, 2015 | |
Goodwill and Intangible Assets | |
Goodwill and Intangible Assets | 9. Goodwill and Intangible Assets Intangible assets include product rights, trademarks, patents, land-use rights, and goodwill. 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 Product rights 12 $ $ $ Patents 10 Trademarks 11 — Land-use rights 39 Other intangible assets 1 Subtotal 12 Indefinite-lived intangible assets Trademark * — Goodwill Finished pharmaceutical products (1) * — Subtotal * — As of December 31, 2015 * $ $ $ Weighted-Average Accu mulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Product rights 12 $ $ $ Patents 10 Trademarks 11 Land-use rights 39 Other intangible assets 1 Subtotal 12 Indefinite-lived intangible assets Trademark * — Goodwill Finished pharmaceutical products * — API * — Subtotal * — As of December 31, 2014 * $ $ $ * Intangible assets with indefinite lives have an indeterminable average life. (1) During the year ended December 31, 2015 , we recorded a reclassification to correct an immaterial error in the allocation between segments. The correction of this error would not have resulted in an impairment of either segment’s goodwill in any prior period. Additionally, the correction did not have an effect on the Company’s consolidated financial statements or segment results of operations for any period. Goodwill The c hanges in the carrying amounts of goodwill were as follows: December 31, 2015 2014 (in thousands) Beginning balance $ $ Goodwill related to acquisition of business — Currency translation and other adjustments Ending balance $ $ 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, for a total consideration of $29.2 million, which is its carrying value as of December 31, 2015. In determining the useful life of the trademark, 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 ® HFA 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 requires 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 is currently in the process of generating the remaining data required by the CRL and plans to submit an NDA a mendment that it believes will address the FDA’s concerns. However, there can be no guarantee that any amendment to the Company’s NDA will result in timely approval of the product or approval at all. Based on the Company’s filed version of Primatene ® HFA, the Company’s plan to submit an NDA amendment to address the FDA’s concerns, the long history of the Primatene ® trademark (marketed since 1963) and the Company’s perpetual rights to the trademark, the Company has determined that the trademark has an indefinite useful life. If the HFA version is approved by the FDA, it will be marketed under the same trade name; therefore, an impairment charge would not be required. Amortization Included in cost of revenues for the years ended December 31, 2015, 2014 and 2013 is product rights amortization expense of $1.8 million each year, primarily related to Cortrosyn ® . As of December 31, 2015, the expected amortization expense for all amortizable intangible assets during the next five fiscal years ended December 31 and thereafter is as follows: (in thousands) 2016 $ 2017 2018 2019 2020 Thereafter Total amortizable intangible assets Indefinite-lived intangibles Total intangibles (net of accumulated amortization) $ |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2015 | |
Inventories | |
Inventories | 10 . Inventories Inventories are stated at the lower of cost or market, using the first-in, first-out method. Provisions are made for slow-moving, unsellable or obsolete items. Inventories consist of the following: December 31, 2015 2014 (in thousands) Raw materials and supplies $ $ Work in process Finished goods Total inventory Less reserve for excess and obsolete inventories Total inventory, net $ $ |
Property, Plant, and Equipment
Property, Plant, and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant, and Equipment | |
Property, Plant, and Equipment | 11. Property, Plant, and Equipment Property, plant, and equipment consist of the following: December 31, 2015 2014 (in thousands) Building $ $ Leasehold improvements Land Machinery and equipment Furniture, fixtures, and automobiles Construction in progress Total property, plant, and equipment Less accumulated depreciation Total property, plant, and equipment, net $ $ The Company incurred depreciation expense of $11.3 million, $12.5 million, and $11.2 million for the years ended December 31, 2015, 2014, and 2013, respectively. Interest expense capitalized was approximately $1.1 million, $1.2 million, and $0.1 million, for the years ended December 31, 2015, 2014, and 2013, respectively. The interest expense capitalized is primarily related to certain foreign construction projects during the year. As of December 31, 2015 and 2014, the Company had $2.9 million and $3.4 million, respectively, in capitalized manufacturing equipment that is intended to be used specifically for the manufacture of Primatene ® HFA. The Company will continue to monitor developments with the FDA as it relates to its Primatene ® HFA indefinite lived intangible assets in determining if there is an impairment of these related fixed assets (see Note 9). |
Impairment of Long-Lived Assets
Impairment of Long-Lived Assets | 12 Months Ended |
Dec. 31, 2015 | |
Impairment of Long-Lived Assets | |
Impairment of Long-Lived Assets | 12. Impairment of Long-Lived Assets All of the Company’s impairments relate primarily to the write-off of certain manufacturing equipment related to abandoned projects. For the years ended December 31, 2015, 2014 and 2013, the Company recorded an impairment loss of $0.2 million, $0.4 million, and $0.1 million, respectively, in the Finished Pharmaceutical Product segment. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt | |
Debt | 13. Debt Debt consists of the following: December 31, 2015 2014 (in thousands) Loans with East West Bank Mortgage payable due January 2016 $ $ Mortgage payable due September 2016 Line of credit facility due March 2016 — — Equipment loan due April 2017 Equipment loan due January 2019 — Loans with Cathay Bank Mortgage payable due April 2021 Revolving line of credit due May 2016 — — Acquisition loan due April 2019 Loans with Seine-Normandie Water Agency French government loan 1 due March 2018 — French government loan 2 due June 2020 — French government loan 3 due July 2021 — Payment obligation to Merck Equipment under Capital Leases Total debt and capital leases Less current portion of long-term debt and capital leases Long-term debt and capital leases, net of current portion $ $ Loans with East West Bank Mortgage Payable—Due January 2016 In December 2010, the Company refinanced an existing mortgage term loan, which had a principal balance outstanding of $4.5 million at December 31, 2010. The loan was payable in monthly installments with a final balloon payment of $3.8 million. The loan was secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex, as well as one of its buildings at its Chino, California, complex. The loan had a variable interest rate at the prime rate as published by The Wall Street Journal, with a minimum interest rate of 5.00% , and matured in January 2016. Subsequent to the Company’s year-end, the Company refinanced the existing mortgage term loan in January 2016, which had a principal balance outstanding of $3.7 million at December 31, 2015. The loan is payable in monthly installments with a final balloon payment of $3.3 million. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The loan has a variable interest rate at the prime rate as published by The Wall Street Journal . Subsequently, the Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest payment over the life of the loan without the exchange of the underlying notional debt amount. The loan bears interest at a fixed rate of 4.39% , and matures in February 2021. Mortgage Payable—Due September 2016 In September 2006, the Company entered into a mortgage term loan in the principal amount of $2.8 million, which matures in September 2016. The loan is payable in monthly installments with a final balloon payment of $2.2 million plus interest. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The variable interest rate is equal to the three-month LIBOR plus 2.50% . Line of Credit Facility—Due March 2016 In March 2012, the Company entered into a $10.0 million line of credit facility. Borrowings under the facility are secured by inventory and accounts receivable. Borrowings under the facility bear interest at the prime rate as published by The Wall Street Journal . This facility was to mature in July 2014. In April 2014, the Company extended the maturity date to March 2016. As of December 31, 2015, the Company did not have any amounts outstanding under this facility . Equipment Loan—Due 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 are secured by equipment purchased with debt proceeds. Borrowings under the facility bear interest at the prime rate as published by The Wall Street Journal plus 0.25% , with a minimum interest rate of 3.50% . This facility matures in April 2017. Equipment Loan—Due January 2019 In July 2013, the Company entered into an $8.0 million line of credit facility. Borrowings under the facility were secured by equipment. The facility bore interest at the prime rate as published in The Wall Street Journal plus 0.25% and was to mature in January 2019. In January 2015, the Company drew down $6.2 million from the line of credit facility. Subsequently, the facility was then converted into an equipment loan with an outstanding principal balance of $6.2 million. Borrowings under the facility are secured by equipment purchased with the debt proceeds. The Company entered into a fixed interest rate swap contract on this facility to exchange the floating rate for a fixed interest payment over the life of the facility without the exchange of the underlying notional debt amount. The fair value of the derivative and unrealized loss was immaterial to the Company’s consolidated financial statements at December 31, 2015. The facility bears interest at a fixed rate of 4.48% and matures in January 2019. As of December 31, 2015, the loan had a book value of $4.7 million, which approximates fair value. The variable interest rate is deemed to be a Level 2 input for measuring fair value. Loans with Cathay Bank Mortgage Payable—Due April 2021 In March 2007, the Company entered into a mortgage term loan in the principal amount of $5.3 million, which matured in March 2014. In April 2014, the Company refinanced the mortgage term loan, which had a principal balance outstanding of $4.6 million. The loan is payable in monthly installments with a final balloon payment of $3.9 million. The loan is secured by the building at the Company’s Canton, Massachusetts location and bears interest at a fixed rate of 5.42% and matures in April 2021. As of December 31, 2015, the loan had a fair value of $ 4.7 million , compared to a book value of $4.5 million. The fair value of the loan was determined by using the interest rate associated with the Company’s mortgage loans with similar terms and collateral that has variable interest rates. The fair value of debt obligations is not measured on a recurring basis and the variable interest rate is deemed to be a Level 2 input for measuring fair value. Revolving Line of Credit—Due May 2016 In April 2012, the Company entered into a $20.0 million revo lving line of credit facility. Borrowings under the facility are secured by inventory, accounts receivable, and intangibles held by the Company. The facility bears interest at the prime rate as published by The Wall Street Journal with a minimum interest rate of 4.00% . This revolving line of credit was to mature in May 2014. In April 2014, the Company modified the facility to extend the maturity date to May 2016. As of December 31, 2015, 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. 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. 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 December 31, 2015, the payment obligation had an aggregate book value of €0.5 million, or $0.5 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% . The fair value of the debt obligation is not measured on a recurring basis and the variable interest rate is deemed to be a Level 2 input for measuring fair value. Payment Obligation 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 c urrency exchange fluctuations. The terms of the purchase price include annual payments over four years and bear a fixed interest rate of 3.00% . The final payment to Merck relating to this obligation is due December 2017. In December 2015 and 2014, the Company made a principal payment of €3.2 million, or $3.5 million and €4.9 million, or $6.0 million, respectively. As of December 31, 2015, the payment obligation had a book value of €3.6 million, or $3.9 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% . The fair value of the debt obligation is not re-measured on a recurring basis and the variable interest rate is deemed to be a Level 2 input for measuring fair value. Covenants At December 31, 2015, the Company was in compliance with its debt covenants, which include a minimum current ratio, minimum debt service coverage, minimum tangible net worth, and maximum debt-to-effective-tangible-net-worth ratio, computed on a consolidated basis in some instances and on a separate-company basis in others. At December 31, 2014, the Company was not in compliance with two of its financial covenants with Cathay Bank. The first one requiring a fixed charge coverage ratio of 1.2 to 1.0, or greater, and the second one required a minimum debt service coverage ratio of 1.5 to 1.0, or greater. On March 13, 2015, the Company obtained waivers of these covenants for the period ending December 31, 2014. Equipment under Capital Leases The Company entered into leases for certain equipment under capital leasing arrangements, which will expire at various times through 2020. The cost of equipment under capital leases was $1.5 million at December 31, 2015 and 2014, respectively. The accumulated depreciation of equipment under capital leases was $0.7 million and $0.4 million at December 31, 2015 and 2014, respectively. Depreciation of assets recorded under capital leases is included in depreciation expense in the accompanying consolidated financial statements. Long-Term Debt Maturities As of December 31, 2015, the principal amounts of long-term debt maturities during each of the next five fiscal years ending December 31 are as follows: Capital Debt Leases Total (in thousands) 2016 $ $ 2017 2018 2019 2020 Thereafter — Less amount representing interest — $ $ $ |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Income Taxes | 14. Income Taxes The Company’s income (loss) before income taxes generated from its United States and foreign operations were: Year Ended December 31, 2015 2014 2013 (in thousands) Income (loss) before income taxes: United States $ $ $ Foreign Total income (loss) before taxes $ $ $ The Company’s provision (benefit) for income taxes consisted of the following: Year Ended December 31, 2015 2014 2013 (in thousands) Current provision (benefit): Federal $ $ $ State Foreign Total current provision (benefit) Deferred provision (benefit): Federal State Foreign Total deferred provision (benefit) Total provision (benefit) for income taxes $ $ $ A reconciliation of the statutory federal income tax rate to the Company’s effective tax rate is as follows: Year Ended December 31, 2015 2014 2013 Statutory federal income tax (benefit) % % % State tax expense, net of federal tax benefit Foreign income tax Qualified production activities deduction — — Research and development credits ISO portion of stock options deductions Other — Effective tax rate (benefit) % % % Deferred Tax Assets and Liabilities Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2015 2014 (in thousands) Deferred tax assets: Net operating loss carryforward $ $ State income taxes Inventory capitalization and reserve Deferred revenue Accrued payroll and benefits Share-based compensation Research and development credits Alternative minimum tax Accrued professional fees Product return allowance Accrued chargebacks Bad debt reserve Intangibles Accrued for workers’ compensation insurance Total deferred tax assets Deferred tax liabilities: Depreciation/amortization Intangibles Federal impact of state deferred taxes Other Total deferred tax liabilities Valuation allowance Net deferred tax assets $ $ Net Operating Loss Carryforwards and Tax Credits At December 31, 2015, the Company had U.S. federal, California, and other State net operating loss, or NOL carryforwards of approximately $11.4 million, $13.2 million, and $1.5 million, respectively. The federal, California and other states loss carryforwards begin to expire in 2034 , 2030 , and 2030 , respectively. The Company also had foreign NOL carryforwards of approximately $9. 9 million which can be used annually with certain limitations and have an indefinite carryforward period. The California and other state NOL carryforwards exclude $15.8 million and $0.1 million, respectively, related to excess tax benefits from share-based awards. When the related tax benefits from these share-based awards are utilized, the tax benefit of these adjustments , which will reduce the amount of income taxes payable , will be offset against additional paid in capital. At December 31, 2015, the Company had federal and California research and development tax credit carryforwards of approximately $6.0 million and $10.7 million, respectively. The federal research and development tax credit begins to expire in 2031 . The California research and development tax credit has an indefinite carryforward period. The Company also had a U.S. federal alternative minimum tax credit carryforward of $0.5 million which can be used to offset future regular tax to the extent of the current AMT; the credit has an indefinite carryforward period. The utilization of the NOL and credit carryforwards and other tax attributes could be subject to an annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986 (the “Code”), whereby they could be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period, as defined in the Code. 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 connection with the AFP purchase accounting in 2014 , the Company recorded a valuation allowance against an intangible deferred tax asset of €3.2 million, or $4.4 million with an offsetting entry to goodwill, since management did not believe that it was more likely than not that the deferre d tax asset would be realized. In March 2015, the Company reversed the €3.2 million, or $3.3 million , deferred tax valuation allowance in conjunction with the transfer of AFPs intangible assets from France to the U.S. The difference in U.S. dollars relates to the currency exchange fluctuation, which is recorded in the Company’s accumulated other comprehensive loss as a foreign currency translation adjustment. In 2015, the Company continued to assess the realizability of the deferred tax assets for AFP. Due to the potential impact of reduced revenues from the MannKind contract and other factors, the Company determined that it was not more likely than not that the net deferred tax assets of AFP would be realized and established a full valuation allowance of $0.9 million as of December 31, 2015; therefore, contributing to the recognition of $0.9 million in income tax expense for the year ended December 31, 2015. Undistributed Earnings (Losses) from Foreign Operations As of December 31, 2015 and 2014, deferred income taxes have not been provided on the accumulated undistributed losses of the Company’s foreign subsidiaries of approximately $7.1 million and $10.5 million, respectively. In addition, it is the Company’s plan not to repatriate future foreign earnings to the U.S. It is not practicable to compute the tax on undistributed earnings of the Company's foreign subsidiaries as of December 31, 2015 since they have accumulated undistributed losses. Uncertain Income Tax Positions A reconciliation of the beginning and ending balances of unrecognized tax benefits is as follows: December 31, 2015 2014 2013 (in thousands) Balance at the beginning of the year $ $ $ Additions based on tax positions related to the current year Deductions based on tax audit settlement — — Deductions based on statute of limitations — Balance at the end of the year $ $ $ Included in the balance of unrecognized tax benefits as of December 31, 2015 was $5.0 million that represents the portion that would impact the effective income tax rate if recognized. The Company believes that it is reasonably possible that the total amount of unrecognized tax benefit as of December 31, 2015 will decline by $1.9 million in the next 12 months as a result of the expected resolution of a current U.S. state audit. The Company recognizes accrued interest and penalties related to unrecognized tax benefits in its income tax provision. For the years ended December 31, 2015 and 2014, the Company recognized accrued interest of approximately $0.1 million and $0.1 million, respectively, related to its uncertain tax position. The Company and/or one or more of its subsidiaries filed income tax returns in the U.S. federal jurisdiction and various U.S. sta tes and foreign jurisdictions. As of December 31, 201 5 , the Company is not subject to U.S. federal, state, and foreign income tax examinations for years before 2006. In August 2011, the California FTB commenced an audit of the Company’s 2007 , 2008 , and 2009 tax returns; th is audit is currently ongoing. The Company is subject to income tax audit by tax authorities for tax years 2012 , 2013 and 2014 for federal and 2007 to 2014 for states. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | 15. Stockholders' Equity Common and Preferred Stock In June 2014, the Company completed an initial public offering in which the Company sold 5,840,000 shares of its common stock, which included 1,200,000 shares of the Company’s common stock pursuant to the underwriters’ exercise of their over-allotment option, at a price to the public of $7.00 per share, resulting in gross proceeds of $40.9 million. In connection with the offering, the Company paid $6.2 million in underwriting discounts, commissions, and offering costs, resulting in net proceeds of $34.7 million. The Company’s Certificate of Incorporation, as amended and restated in June 2014 in connection with the closing of its initial public offering, authorizes the Company to issue 300,000,000 shares of common stock, $0.0001 par value per share, and 20,000,000 shares of preferred stock, $0.0001 par value per share. As of December 31, 2015 and 2014, there were no shares of preferred stock issued or outstanding . Equity Plans As of December 31, 2015, the Company had two equity plans, the 2015 Equity Incentive Award Plan, or 2015 Plan, and the 2014 Employee Stock Purchase Plan or ESPP. Prior to the adoption of these plans, the Company granted options pursuant to the Amended and Restated 2005 Equity Incentive Award Plan, 2002 Amended and Restated Stock Option/Stock Issuance Plan and, from 1998 through 2001, the Company’s board of directors granted options to purchase shares of its common stock under the Key Employee Stock Incentive Plan, the 2001 Employee Incentive Plan, the 2000 Employee Incentive Plan and the 1999 Employee Incentive Plan. Upon termination of the predecessor plans, the shares available for grant at the time of termination, and shares subsequently returned to the plans upon forfeiture or option termination, were transferred to the successor plan in effect at the time of share return. The Company issues new shares of common stock upon exercise of stock options. The 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 percen t ( 2.5% ) o f the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares as determi ned by the Board of Directors. As of the effective date, there were 5,300,296 shares available for grant under the 2015 Plan. As of December 31, 2015, the Company reserved an aggregate of 5.4 million shares of common stock for future issuance under the 2015 Plan. In March 2016, an additional 1,129,962 shares were reserved under the 2015 Plan. Amended and Restated 2005 Equity Incentive Award Plan The Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan provided for the grant of incentive stock options, or ISOs, nonqualified stock options, or NQSOs, restricted stock awards, restricted stock unit awards, stock appreciation rights, or SARs, dividend equivalents and stock payments to the Company’s employees, members of the Board of Directors and consultants. Stock options under the 2005 Plan were granted with a term of up to ten years and at prices no less than the fair market value of the Company’s common stock on the date of grant. To date, stock options granted to existing employees generally vest over three to five years and stock options granted to new employees vest over four years. The 2005 Plan also contained an "evergreen provision" that allowed for an annual increase in the number of shares available for issuance on January 1 of each year during the ten -year term of the 2005 Plan, beginning January 1, 2007. The annual increase in the number of shares shall be either 2% of the Company’s outstanding shares on the applicable January 1 or a lesser amount determined by its Board of Directors. As of March 2015, consequent to the 2015 Plan becoming effective, awards were no longer being made under the 2005 Plan. 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 to the lower of 85% of the fair market value of the common stock at the beginning of an offering period or on the date of purchase. The first offering period commenced on February 1, 2015 and ended on November 30, 2015. As of December 31, 2015, the Company has issued 124,380 shares of common stock under the ESPP and 1,875,620 shares of its common stock remained available for issuance under the ESPP. For the year ended December 31, 2015, the Company recorded ESPP expense of $0.4 million. Share Buyback Program On November 6, 2014 the Company’s Board of Directors authorized a $10.0 million 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. On November 10, 2015, the Company’s Board of Directors authorized an increase of $10.0 million to the Company’s share buyback program. Purchases are being made through the 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 Secur ities and Exchange Commission. The timing and actual number of shares repurchased will depend on a variety of factors including price, corporate and regulatory requirements , and other conditions. These repurchased shares 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 repurchase program, the Company purchased 735,679 and 29,400 shares of its common stock during the years ended December 31, 2015 and 2014, totaling $ 9.9 million and $0.3 million, respectively. 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, directors, and nonemployees. Under these standards, the fair value of share ‑based payment awards is estimated at the grant date using an option-pricing model and the portion that is ultimately expected to vest is recognized as compensation cost over the requisite service period. The Company uses the Black-Scholes option-pricing model to estimate the fair value of share ‑based awards and recognizes share ‑based compensation cost over the vesting period using the strai ght-line single option method. Non ‑vested stock options held by non-employees are revalued using the Company’s estimate of fair value at each balance sheet date. Options issued under the Company’s 2015 Plan and 2005 Plan, are granted at prices equal to or greater than the fair value of the underlying shares on the date of grant and vest based on continuous service. The options have a contractual term of five to ten years and generally vest over a three - to five ‑year period. The fair value of each option is amortized into compensation expense on a straight ‑line basis between the grant date for the option and the vesting date. The awards of restricted common stock such as Restricted Stock Units, or RSUs are valued at fair value on the date of grant. The Company uses the Black ‑Scholes option pricing model to determine the fair value of share ‑based awards. The Black ‑Scholes option pricing model has various inputs such as the estimated common share price, the risk ‑free interest rate, volatility, expected life and dividend yield, all of which are estimates. The Company also records share ‑based compensation expense net of expected forfeitures. The change of any of these inputs could significantly impact the determination of the fair value of the Company’s options and thus could significantly impact its results of operations. There are no awards with performance conditions and no awards with market conditions. Valuation models and significant assumptions for share ‑based compensation are as follows: · Determining Fair Value. For all equity awards granted after the completion of the Company’s initial public offering, the fair value for its underlying common stock is determined using the closing price on the date of grant as reported on the NASDAQ Global Select Market. The Company uses the Black ‑Scholes formula to estimate the fair value of its share ‑based payments using a single option award approach. The application of this valuation model involves assumptions that are judgmental and sensitive in the determination of compensation expense. Key assumptions and estimation methodologies for inputs to the Black ‑Scholes calculation are developed in accordance with ASC 718. The Company amortizes its share ‑based compensation expense over the requisite service period, which in most cases is the vesting period of the award. For all equity grants granted, the primary factor in the valuation of equity awards was the fair value of the underlying common stock at the time of grant. Since the Company’s common stock was not traded in a public stock market exchange prior to June 25, 2014, prior to such date the Board of Directors considered numerous factors including recent cash sales of the Company’s common stock to third-party investors, new business and economic developments affecting the Company and independent appraisals, when appropriate, to determine the fair value of the Company’s common stock. Independent appraisal reports were prepared using conventional valuation techniques, such as discounted cash flow analyses and the guideline company method using revenue and earnings multiples for comparable publicly traded companies, and a calculation of total option proceeds, from which a discount factor for lack of marketability was applied. This determination of the fair value of the common stock was performed on a contemporaneous basis. Prior to the Company’s initial public offering, t he Board of Directors determined the Company’s common stock fair market value on a quarterly basis and in some cases more frequently when appropriate. · Expected Volatility. The Company has limited data regarding company ‑specific historical or implied volatility of its share price. Consequently, the Company estimates its volatility based on the average of the historical volatilities of peer group companies from publicly available data for sequential periods approximately equal to the expected terms of its option grants. Management considers factors such as stage of life cycle, competitors, size, market capitalization and financial leverage in the selection of similar entities. · Expected Term. The expected term represents the period of time in which the options granted are expected to be outstanding. The Company estimates the expected term of options granted based on the midpoint between the vesting date and the end of the contractual term under the “short ‑cut” or simplified method permitted by the SEC implementation guidance for “plain vanilla” options. Applying this method, the weighted ‑average expected term of the Company’s options is approximately five years. The use of the short ‑cut method is permitted by the SEC, under certain circumstances, as described in the SEC implementation guidance. The Company will continue to use the short ‑cut method, as permitted, until it has developed sufficient historical data for employee exercise and post ‑vesting employment termination behavior after its common stock has been publicly traded for a reasonable period of time. · Forfeitures. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual experience differs from those estimates. For the years ended December 31, 2015, 2014 and 2013, the Company estimated an average overall forfeiture rate of 8% for each year , based on historical forfeitures since 1998. Forfeiture rates are separately calculated for its (1) directors and officers, (2) management personnel and (3) other employees. Share ‑based compensation is recorded net of expected forfeitures. The Company will periodically assess the forfeiture rate and the amount of expense recognized based on estimated historical forfeitures as compared to actual forfeitures. Changes in estimates are recorded in the period they are identified. · Risk ‑Free Rate. The risk ‑free interest rate is selected based upon the implied yields in effect at the time of the option grant on U.S. Treasury zero ‑coupon issues with a term approximately equal to the expected life of the option being valued. · Dividends. The Company does not anticipate paying cash dividends in the foreseeable future. Consequently, the Company uses an expected dividend yield rate of zero . Tax benefits resulting from tax deductions in excess of the share ‑based compensation cost recognized (excess tax benefits) are recorded in the statements of cash flows as financing activities. The weighted-averages for key assumptions used in determining the fair value of options granted during the years ended December 31, 2015, 2014, and 2013 are as follows: Year Ended December 31, 2015 2014 2013 Average volatility % % % Risk-free interest rate % % % Weighted-average expected life in years Dividend yield rate — % — % — % Stock Options A summary of option activity under all plans for the year ended December 31, 2015 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, 2014 $ Options granted Options exercised Options cancelled Options expired Outstanding as of December 31, 2015 $ $ Exercisable as of December 31, 2015 $ $ (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 December 31, 2015. A summary of option activity under all plans for the year ended December 31, 2014 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, 2013 $ Options granted Options exercised Options cancelled Options expired Outstanding as of December 31, 2014 $ $ Exercisable as of December 31, 2014 $ $ (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 December 31, 2014. For the years ended December 31, 2015, 2014, and 2013 , the Company recorded stock option expense related to employees under all plans of $7.9 million, $6.7 million, and $5.9 million , respectively. Information relating to option grants and exercises is as follows: Year Ended December 31, 2015 2014 2013 (in thousands, except per share data) Weighted-average grant date fair value $ $ $ Intrinsic value of options exercised — Cash received Total fair value of the options vested during the year A summary of the status of the Company’s nonvested options as of December 31, 2015, and changes during the year ended December 31, 2015, are presented below: Weighted-Average Grant Date Options Fair Value Nonvested as of December 31, 2014 $ Options granted Options vested Options forfeited Nonvested as of December 31, 2015 A summary of the status of the Company’s nonvested options as of December 31, 2014, and changes during the year ended December 31, 2014, are presented below: Weighted-Average Grant Date Options Fair Value Nonvested as of December 31, 2013 $ Options granted Options vested Options forfeited Nonvested as of December 31, 2014 As of December 31, 2015, there was $11.4 million of total unrecognized compensation cost, net of forfeitures, related to nonvested stock option based compensation arrangements granted under all plans. The cost is expected to be recognized over a weighted-average period of 2.0 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. The Company recorded a total expense of $3.9 million, $2.0 million, and $0.6 million for the years ended December 31, 2015, 2014, and 2013, respectively, for these RSU awards . As of December 31, 2015, there was $8.2 million of total unrecognized compensation cost, net of forfeitures, related to nonvested RSU-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. Additionally, prior to the Company’s initial public offering, the Company issued RSUs that were treated as an accounting exchange for expiring stock options, whereby the fair value of the expiring stock options equaled the fair value of the RSUs at the date of the exchange. As such, the Company did not record any expense related to these award modifications. 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, 2013 RSUs granted $ RSUs forfeited RSUs surrendered for taxes Common stock delivered for RSUs RSUs outstanding at December 31, 2014 RSUs granted $ RSUs forfeited RSUs surrendered for taxes Common stock delivered RSUs outstanding at December 31, 2015 (1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant. Equity Awards to Consultants The Company has entered into various consulting agreements with Company stockholders and outside consultants. Consulting expenses are accrued as services are rendered. Consulting services are paid in cash and/or in common stock or stock options. 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 all services under the agreement. During the year ended December 31, 2015, the Company recorded $0.2 million in share-based compensation related to the issuance of equity awards for services rendered by consultants. During the year ended December 31, 2014 , the Company recorded an immaterial amount of share-based compensation related to the issuance of equity awards for services rendered by consultants. For the year ended December 31, 2013, the Company did not record any share-based compensation expense for services rendered by consultants. The Company recorded share-based compensation expense under all plans and is included in the Company’s consolidated statement of operations as follows: Year Ended December 31, 2015 2014 2013 (in thousands) Cost of revenues $ $ $ Operating expenses: Selling, distribution and marketing General and administrative Research and development Total share-based compensation $ $ $ |
Employee Benefits
Employee Benefits | 12 Months Ended |
Dec. 31, 2015 | |
Employee Benefits | |
Employee Benefits | 16. 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 4% of employee contributions, or up to 2% of their annual compensation, and pays the administrative costs of the Plan. Employer contributions vest over four years. Total employer contributions for the years ended December 31, 2015, 2014, and 2013 were approximately $0.7 million, $0.7 million, and $0.6 million, 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 with 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 AFPs turnover rate. The liability under the plan is based on a discount rate of 1.75% as of December 31, 2015 and 2014. 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 $1.6 million and $1.1 million at December 31, 2015 and 2014, respectively. Expense under the plan was $0.1 million and $0.2 million for the years ended December 31, 2015 and 2014, respectively. For the year ended December 31, 2015, the Company recorded an immaterial amount of unrecognized loss in its accumulated other comprehensive loss related to the change in actuarial valuation of the Company’s defined benefit pension plan. The Company recorded an unrecognized gain of $0.2 million in its accumulated other comprehensive loss during the year ended December 31, 2014 related to the change in actuarial valuation of the Company’s defined benefit pension plan. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies | |
Commitments and Contingencies | 17. Commitments and Contingencies Distribution Agreement with Allergan plc. In May 2005, the Company entered into an agreement to grant certain exclusive marketing rights for its enoxaparin product to Andrx Pharmaceuticals, Inc., or Andrx, which generally extends to the U.S. retail pharmacy market. To obtain such rights, Andrx made a non-refundable, upfront payment of $4.5 million to the Company upon execution of the agreement which was classified as deferred revenues. Under the agreement, the Company is paid a fixed cost per unit sold to Andrx and also shares in the gross profits (as defined) from Andrx’s sales of the product in the U.S. retail pharmacy market. In November 2006, Watson Pharmaceuticals, Inc., or Watson, acquired Andrx and all of the rights and obligations associated with the agreement. In January 2013, Watson adopted Actavis, Inc. as its new global name. In March 2015, Actavis acquired Allergan plc and adopted Allergan plc as its new global name in June 2015. The agreement has a term that expires in January 2019 and can be extended by Allergan for an additional three years. The agreement may only be terminated prior to the end of the term by either party in the case of a breach of contract or insolvency of the other party, by the Company if Allergan fails to purchase a minimum number of units and by Allergan if an infringement claim is made against Allergan. In January 2012, the Company launched enoxaparin, beginning the seven -year period in which Allergan has the exclusive marketing rights for the Company’s enoxaparin product in the U.S. retail pharmacy market and the start of the Company’s recognition of the $4.5 million deferred revenue over this period on a straight-line basis. Allergan has an option to renew the agreement for an additional three years. As of December 31, 2015 and 2014, the balance of the deferred revenue was $2.0 million and $2.6 million, respectively. The Company manufactures its enoxaparin product for the retail market according to demand specifications of Allergan. Upon shipment of enoxaparin to Allergan, the Company recognizes product sales at an agreed transfer price and records the related cost of products sold. Based on the terms of the Company’s distribution agreement with Allergan, the Company is entitled to a share of the ultimate profits based on the eventual net revenue from enoxaparin sales by Allergan to the end user less the agreed transfer price originally paid by Allergan to the Company. Allergan provides the Company with a quarterly sales report that calculates the Company’s share of Allergan enoxaparin gross profit. The Company records its share of Allergan gross profit as a component of net revenue. Supply Agreement with MannKind Corporation On July 31, 2014, the Company entered in a supply agreement with MannKind Corporation, or MannKind, pursuant to which the Company will manufacture for and supply to MannKind certain quantities of recombinant human insulin, or RHI, for use in MannKind’s product Afrezza ® . Under the terms of the supply agreement, the Company will be responsible for manufacturing the RHI in accordance with MannKind’s specifications and agreed-upon quality standards. MannKind has agreed to purchase annual minimum quantities of RHI under the supply agreement of an aggregate amount of approximately €120.1 million, or approximately $146.0 million, in calendar years 2015 through 2019. MannKind paid a non-refundable reservation fee to the Company in the amount of €11.0 million, or approximately $14.0 million upon entry into the agreement. Under the agreement, the non-refundable reservation fee was considered as partial payment for the purchase commitment quantity for 2015. The Company classified the amount as deferred revenue. As of December 31, 2014, the full amount of the deferred revenue has been recognized. Unless earlier terminated, the term of the supply agreement expires on December 31, 2019, and can be renewed for additional, successive two -year terms upon 12 month’s written notice given prior to the end of the initial term or any additional two -year term. MannKind and the Company each have customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy, or insolvency of the other party. In addition, MannKind may terminate the supply agreement upon two years’ prior written notice to the Company without cause or upon 30 days prior written notice to the Company if a controlling regulatory authority withdraws approval for Afrezza ® ; provided, however, in the event of a termination pursuant to either of these scenarios, the provisions of the supply agreement require MannKind to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. In January 2015, the Company entered into a supply option agreement with MannKind, pursuant to which MannKind will have the option to purchase RHI, for use in MannKind’s product Afrezza ® , in addition to the amounts specified in the July 2014 supply agreement. Under the agreement, MannKind has the option to purchase additional RHI in calendar years 2016 through 2019. In the event MannKind elects not to exercise its minimum annual purchase option for any year, MannKind shall pay the Company a capacity cancellation fee. By mutual agreement, MannKind did not purchase the full contractually obligated amount in 2015. The 2015 sales of RHI to MannKind were $ 20 . 8 million. The Company is currently in discussions with MannKind regarding the timing of future purchases. In October 2015, MannKind informed the Company they were not going to exercise the option to purchase additional quantities of RHI for 2016 under the option agreement. Accordingly, MannKind paid the Company a capacity cancellation fee in 2015 for 2016. The Company recognized this payment as revenue in 2015. Collaboration agreement with a medical device manufacturer The Company has 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 December 31, 2015, the Company has paid an upfront payment of $0.5 million and $0.4 million in milestone payments under this agreement, which was classified as research and development expense. The Company is obligated to pay up to an additional $1.7 million if certain milestones are met. 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 years ended December 31, 2015, 2014 and 2013 was approximately $3.3 million, $3.1 million, and $3.1 million, respectively. Future minimum rental payments under operating leases that have initial or remaining non-cancelable lease terms in excess of 12 months for fiscal years ending December 31 are as follows: Operating Leases (in thousands) 2016 $ 2017 2018 2019 2020 $ Purchase Commitments As of December 31, 2015, the Company has entered into commitments to purchase equipment and raw materials for an aggregate amount of approximately $11.0 million. The Company anticipates that most of these commitments will be fulfilled by 2017. 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, 2015, the Company had invested approximately $49.0 million in ANP of its registered capital commitment of $61.0 million. The Company has committed to invest an additional $12.0 million in ANP by December 2017. This investment in ANP will result 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. |
Litigation
Litigation | 12 Months Ended |
Dec. 31, 2015 | |
Litigation | |
Litigation | 18. 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 District Court. In October 2011, the 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 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 infringement contentions. On January 24, 2014, the District Court judge entered final judgment in the Company’s favor on both patents. Momenta and Sandoz also filed a motion to collect attorney’s fees and costs relating to a discovery motion which the District Court granted. 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. The Company intends to attempt to collect the $100.1 million bond posted by Momenta and Sandoz following a decision on the merits in the event the Company prevails. 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 District Court granting summary judgment of non-infringement as to the Company, and it remanded the case to the District Court for further proceedings consistent with its opinion. The Federal Circuit panel affirmed the 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 ha rbor. The Federal Circuit panel also left to the District Court’s discretion whether to reconsider on remand its denial of leave for Momenta and Sandoz to amend t heir 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 will return to the District Court for further proceedings. The Company intends to vigorously defend this case on further appeal and/or in the 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 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 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 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 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 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 have completed and filed their respective appeal briefs with the Ninth Circuit. A date for oral argument has not been set by the Ninth Circuit. The 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 District Court issued a ruling concluding that the Company is not an original source under the False Claims Act, and the District Court entered final judgment dismissing the case for lack of subject matter jurisdiction. On July 27, 2015, Aventis filed a request for attorneys’ fees with the District Court, and on August 3, 2015, the Company filed ob jections to Aventis’s request. On July 20, 2015, the Company filed with the Ninth Circuit a notice of appeal of the District Court’s dismissal of the case, and Aventis filed a notice of cross-appeal on August 5, 2015. The Company’s opening appeal brief is due to be filed with the Ninth Circuit by March 28, 2016. On November 12, 2015, Aventis filed a pleading asking that the 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 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 District Court opposing the imposition of sanctions, and on January 20, 2016, Aventis filed a response pleading further pressing for the imposition of sanctions. While the outcome of litigation is inherently uncertain, the Company believes Aventis’s request is without merit, and it intends to vigorously defend against it. California Employment Litigation On January 6, 2015, the Company received a formal demand from Plaintiff’s counsel in an employment related lawsuit captioned Eva Hernandez v. International Medication Systems Limited, in connection with a complaint originally filed on February 4, 2013 in the Superior Court of California County of Los Angeles, or the Court, by plaintiff Eva Hernandez on behalf of herself and others similarly situated. Plaintiff’s complaint included alleged violations of the California Labor Code stemming from the Company’s alleged timekeeping practices, as well as other similar and related claims brought under California law. In the complaint, Plaintiff sought damages and related remedies under California law, as well as various penalty payments under the California Labor Code, on behalf of herself and others similarly situated. On April 7, 2015, solely to resolve the dispute, minimize disruption to the Company due to ongoing litigation, and other similar and related factors (but unrelated to the alleged merits of Plaintiff’s claims), the Company reached an agreement in principle to settle this matter on a class wide basis for a total amount of $3.2 million, plus applicable payroll taxes. The Joint Stipulation of Settlement as executed by the parties was filed with the Court on June 2, 2015. On July 1, 2015, the Court preliminarily approved the settlement, and on November 5, 2015, the Court entered an order granting final approval of the settlement. Momenta/Sandoz Antitrust Litigation On September 17, 2015, the Company initiated a lawsuit by filing a Complaint in the Central District of California against Momenta and Sandoz. The Company’s c omplaint generally asserts that Momenta and Sandoz 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 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 and is currently awaiting further action by the District Court. On February 9, 2016, the Company filed a writ of mandamus with the Ninth Circuit Court of Appeals to attempt to appeal the Court’s granting of Defendants’ motion to transfer to the District of Massachusetts. 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 e stimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a materially 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. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events | |
Subsequent Events | 19. Subsequent Event s Mortgage Payable with East West Bank—Due February 2021 In January 2016, the Company refinanced the existing mortgage term loan with East West Bank, which had a principal balance outstanding of $3.7 million at December 31, 2015. The loan is payable in monthly installments with a final balloon payment of $3.3 million. The loan is secured by one of the buildings at the Company’s Rancho Cucamonga, California, headquarters complex. The loan has a variable interest rate at the prime rate as published by The Wall Street Journal . Subsequently, the Company entered into a fixed interest rate swap contract on this loan to exchange the variable interest rate for a fixed interest payment over the life of the loan without the exchange of the underlying notional debt amount. The loan bears interest at a fixed rate of 4.39% , and matures in February 2021. Acquisition of Nanjing Letop Medical Technology Co. Ltd. In January 2016, the Company’s subsidiary ANP acquired Nanjing Letop Medical Technology Co. Ltd. or Letop, for $0.7 million. Letop had previously supplied ANP with intermediates used in making various active pharmaceutical ingredients . The Company has concluded that this transaction will be accounted for as a business combination in accordance with ASC 805. Acquisition of fourteen injectable products from Hikma Pharmaceuticals PLC In March 2016, the Company acquired fourteen ANDAs, representing eleven different injectable chemical entities from Hikma Pharmaceuticals PLC for $4.0 million. The Company plans to transfer the products to its facilities in California, which will require FDA approval before the products can be launched. |
Quarterly Financial Data
Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Data | |
Quarterly Financial Data | 20. Quarterly Financial Data (Unaudited) 2015 Quarters First Second Third Fourth Net revenues Finished pharmaceutical products $ $ $ $ API Total net revenues $ $ $ $ Gross profit Finished pharmaceutical products $ $ $ $ API Total gross profit $ $ $ $ Net income (loss) $ $ $ $ Weighted-average shares used to compute net income (loss) per share Basic Diluted Net income (loss) per share Basic $ $ $ $ Diluted $ $ $ $ 2014 Quarters First Second Third Fourth Net revenue Finished pharmaceutical products $ $ $ $ API — Total net revenues $ $ $ $ Gross profit Finished pharmaceutical products $ $ $ $ API — Total gross profit $ $ $ $ Net loss $ $ $ $ Weighted-average shares used to compute net loss per share Basic Diluted Net loss per share Basic $ $ $ $ Diluted $ $ $ $ Net income ( loss ) per share amounts for the fiscal quarters have been calculated independently and may not in the aggregate equal the amount for the full year. During the fourth quarter of 2015, the Company identified an immaterial error in each of its previously reported quarters of 2015, primarily pertaining to the result of not recognizing non-operating expense for certain foreign currency trans actions . The Company corrected the immaterial error in the fourth quarter of 2015 , resulting in a decrease to net income of $1.1 million . Based on management's evaluation of the materiality of the error from a qualitative and quantitative perspective as required by authoritative guidance, the Company concluded that correcting the error had no material impact on any of the Company's previously issued interim financial statements and had no effect on the trend of financial results. |
Summary of Significant Accoun29
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation All significant intercompany activity has been eliminated in the preparation of the consolidated financial statements. Some information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted pursuant to those rules and regulations. The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries: International Medication Systems, Limited, or IMS; Amphastar Laboratories, Inc.; Armstrong Pharmaceuticals, Inc., or Armstrong; Amphastar Nanjing Pharmaceuticals Co., Ltd., or ANP; and Amphastar France Pharmaceuticals, S.A.S., or AFP. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in accordance with U.S. 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, liabilities for product returns, reserves for excess or unsellable inventory, 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, fair market values of the Company’s common stock, valuation allowances for deferred tax assets, and liabilities for uncertain income tax positions. |
Foreign Currency | Foreign Currency The functional currency of the Company and its domestic and Chinese subsidiari es is the U.S. dollar, or USD. The Company’s Chinese subsidiary, 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 exchange gains and losses are reflected in the Comp any’s statement of operations. The Company’s French subsidiary, AFP, maintains its books of record in Euros, which is the local currency in France and has been determined to be its functional currency. These books are translated into USD using average exc hange rates during the period. Assets and liabilities are translated at the rate of exchange prevail ing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the da te of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive income (loss). Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. |
Comprehensive Loss | Comprehensive Income (Loss) For the years ended December 31, 2015 and 2014, the Company included its foreign currency translation as part of its comprehensive income ( loss ) . For the year ended December 31, 2013, net income equaled total comprehensive income. |
Shipping and Handling Costs | Shipping and Handling Costs For the years ended December 31, 2015, 2014, and 2013, the Company included shipping and handling costs of approximately $2.6 million, $2.5 million, and $2.4 million, respectively, in selling, distribution and marketing expenses in the accompanying consolidated statements of operations. |
Research and Development Costs | Research and Development Costs Research and development costs are charged to expense as incurred and consist of costs incurred to further the Company’s research and development activities including salaries and related employee benefits, costs associated with clinical trials, nonclinical research and development activities, regulatory activities, research ‑related overhead expenses and fees paid to external service providers. The Company may produce inventories prior to or with the expectation of receiving marketing authorization in the near term, based on operational decisions about the most effective use of existing resources. This inventory is referred to as pre ‑launch inventory. The Company’s policy is to expense pre ‑launch inventory as research and development costs, as incurred, until the drug candidate receives marketing authorization. As a result of the policy, while marketing authorization may have been received by the end of a reporting period, any inventories produced prior to such authorization are expensed. If marketing authorization is received and previously expensed pre ‑launch inventory is sold, such sales may contribute up to a 100% margin to the Company’s operating results. Pre ‑launch inventory costs include cost of work in process materials and finished drug products. |
Fair Value of Financial Instruments, Policy [Policy Text Block] | Financial Instruments The carrying amounts of cash and cash equivalents, 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 13). |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash, money market funds, certificates of deposit and highly liquid investments purchased with original maturities of three months or less. |
Restricted Cash and Restricted Short Term Investments | Restricted Cash and Restricted Short ‑Term Investments Restricted cash and restricted short ‑term investments as of December 31, 2015 and 2014 included $1.3 million and $1.5 million, respectively, in certificates of deposit, which is the collateral required for the Company to qualify for workers’ compensation self ‑insurance and is available to meet the Company’s workers’ compensation obligations on a current basis, as needed. These funds are classified as current assets. The Company’s short ‑term investments are classified as held ‑ to ‑maturity and consist of certificates of deposit purchased with maturities greater than three months but mature within one year of the date of purchase. The estimated fair value of each investment approximates its amortized cost. |
Allowance for Doubtful Accounts Receivable | Allowance for Doubtful Accounts Receivable The Company evaluates the collectability of accounts receivable based on a combination of factors. When the Company is aware of circumstances that may impair a customer’s ability to pay subsequent to the original sale, the Company will record a specific allowance to reduce the amounts due to the amount the Company reasonably believes will be collected. For all other customers, the Company recognizes an allowance for doubtful accounts based on factors that include the length of time the receivables are past due, industry and geographic concentrations, the current business environment and historical collection experience. |
Inventories | Inventories Inventories are stated at the lower of cost or market, using the first ‑in, first ‑out method. Provisions are made for slow ‑moving, unsellable, or obsolete items. Inventories consist of currently marketed products and products manufactured under contract. |
Property, Plant and Equipment | Property, Plant and Equipment Property, plant and equipment are stated at cost or, in the case of assets acquired in a business combination, at fair value on the purchase date. Depreciation and amortization expense is computed using the straight ‑line method over the estimated useful lives of the related assets as follows: Buildings 20 - 31 years Machinery and equipment 2 - 12 years Furniture and fixtures 3 - 7 years Automobiles 4 - 5 years Leasehold improvements Lesser of remaining lease term or useful life |
Goodwill and Intangible Assets | Goodwill and Intangible Assets Intangible assets with finite lives are amortized over the period the asset is expected to contribute directly or indirectly to the future cash flows of the Company. Product rights are amortized over their estimated useful lives ranging from five to 15 years on a straight ‑line basis since their projected revenues are expected to be consistent each year. Patents and trademarks are amortized on a straight ‑line basis over their estimated useful lives, generally ranging from 10 to 20 years. Land ‑use rights are amortized on a straight ‑line basis over their useful lives, generally ranging from 37 to 50 years. In accordance with the Company’s accounting policy, the Company tests all intangible assets on an annual basis and between annual tests whenever there is an indication of impairment. |
Impairment of Long Lived Assets | Impairment of Long ‑Lived Assets The Company reviews long ‑lived assets and definite ‑lived intangibles for impairment in the fourth quarter of each year or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the expected future undiscounted cash flows is less than the carrying amount of the asset, further impairment analysis is performed. An impairment loss is measured as the amount by which the carrying amount of the asset exceeds the fair value of the assets (assets to be held and used) or fair value less cost to sell (assets to be disposed of). The Company also reviews the useful lives of its assets periodically to determine whether events and circumstances warrant a revision to the remaining useful life. Changes in the useful life are adjusted prospectively by revising the remaining period over which the asset is amortized. |
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. The Company has adopted the with-and-without methodology for determining when excess tax benefits from the exercise of share ‑based awards are realized. Under the with-and-without methodology, current year operating loss deductions and prior-year operating loss carryforwards are deemed to be utilized prior to the utilization of current-year excess tax benefits from share ‑based awards. |
Self-Insured Claims | Self-Insured Claims The Company is primarily self-insured, up to certain limits, for workers’ compensation claims. The Company has purchased stop-loss insurance, which will reimburse the Company for individual claims in excess of $350,000 annually or aggregate claims exceeding $1.9 million annually. Operations are charged with the cost of claims reported and an estimate of claims incurred but not reported . A liability for unpaid claims and the associated claim expenses, including incurred but not reported losses, is actuarially determined and reflected in accrued liabilities in the accompanying consolidated balance sheets. Total expense under the program was approximately $1.2 million, $1.0 million, and $0.8 million, for the years ended December 31, 2015, 2014 and 2013, respectively. The self-insured claims liability was $2.7 million and $2.2 million at December 31, 2015 and 2014, respectively. The determination of such claims and expenses and the appropriateness of the related liability is reviewed periodically and updated, as necessary. Changes in estimates are recorded in the period identified. |
Business Combinations | Business Combinations Business combinations are accounted for in accordance with Accounting Standards Codification, or ASC 805, Business Combinations, 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 are costs the Company incurs to effect a business combination. The Company accounts for acquisition-related costs as expenses in the periods in which the costs are incurred. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, or FASB, issued an accounting standards update that creates a single source of revenue guidance for companies in all industries. 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. This guidance must be adopted using either a full retrospective approach for all periods presented or a modified retrospective approach and will be effective for fiscal years beginning after December 15, 2017, which will be the Company's fiscal 2018. The Company has not yet evaluated the potential impact of adopting the guidance on the Company's consolidated financial statements. In June 2014, the FASB issued an accounting standards update that requires a performance target that affects vesting of a share-based payment award and that could be achieved after the requisite service period to be treated as a performance condition. As such, the performance target should not be reflected in estimating the grant-date fair value of the award. Compensation cost should be recognized over the required service period, if it is probable that the performance target will be achieved. This guidance will be effective for fiscal years beginning after December 15, 2015, which will be the Company's fiscal 2016, with early adoption permitted. The Company does not expect the adoption of the guidance will have a material impact on the Company's consolidated financial statements. In August 2014, the FASB issued an accounting standards update that will require management to evaluate if there is substantial doubt about the Company’s ability to continue as a going concern and, if so, to disclose this in both interim and annual reporting periods. This guidance will become effective for the Company’s annual filing for the period ending December 31, 2016 and interim periods thereafter, and allows for early adoption. The Company does not expect the adoption of the guidance will have a material impact on the Company’s consolidated financial statements. In July 2015, the FASB issued an accounting standards update which requires entities to measure most inventories at the lower of cost and net realizable value, or NRV, thereby simplifying the current guidance under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is measured at the lower of cost and net realizable value, which eliminates the need to determine replacement cost and evaluate whether it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. The standard will be effective for the Company for the first quarter of the Company’s fiscal 201 7. Early application is permitted. The new guidance must be applied prospec tively. The Company does not believe the adoption of this accounting guidance will have a material impact on the Company’s consolidated financial statements and related disclosures. In November 2015, the FASB issued an accounting standards update the balance sheet classification of deferred taxes. Under existing standards, deferred taxes for each tax-paying jurisdiction are presented as a net current asset or liability and net long-term asset or liability. To simplify presentation, the new guidance will require that all deferred tax assets and liabilities, along with related valuation allowances, be classified as long-term on the balance sheet. As a result, each tax-paying jurisdiction will now only have one net long-term deferred tax asset or liability. The new guidance does not change the existing requirement that prohibits offsetting deferred tax liabilities from one jurisdiction against deferred tax assets of another jurisdiction. The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein . Early adoption is permitted. The new guidance may be applied prospectively or retrospectively. The Company has elected to adopt the guidance early and apply the guidance prospectively, therefore, prior periods were not retrospectively adjusted. The reclassification of the Company’s deferred tax assets and liabilities does not have any impact to the Company’s net income or cash flow, thus the adoption of the guidance does not have a material impact on the Company’s consolidated financial statements. In February 2016, the FASB issued accounting standards update that is aimed at making leasing activities more transparent and comparable, and requires substantially all leases be recognized by lessees on their balance sheet 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 currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statements and related disclosures. |
Summary of Significant Accoun30
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Policies | |
Schedule of estimated use life of property, plant and equipment | Buildings 20 - 31 years Machinery and equipment 2 - 12 years Furniture and fixtures 3 - 7 years Automobiles 4 - 5 years Leasehold improvements Lesser of remaining lease term or useful life |
Business Acquisition (Tables)
Business Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Business Acquisition | |
Schedule of payments for business acquisition | U.S. Euros Dollars (in thousands) At Closing, April 2014 € $ December 2014 December 2015 December 2016 December 2017 € $ |
Schedule of estimated fair values of the assets acquired and liabilities assumed | Fair Value U.S. Euros Dollars (in thousands) Inventory € $ Real property Machinery and equipment Intangibles Goodwill Total assets acquired € $ Accrued liabilities € $ Deferred tax liabilities Total liabilities assumed Total fair value of consideration transferred € $ |
Schedule of pro forma information related to the acquisition | Year Ended December 31, 2015 2014 (in thousands, except per share data) Net revenues $ $ Net loss Diluted net loss per share $ $ |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Revenue Recognition | |
Schedule of chargeback provision analysis | Year Ended December 31, 2015 2014 (in thousands) Beginning balance $ $ Provision related to sales made in the current period Credits issued to third parties Ending balance $ $ |
Schedule of product return liability analysis | Year Ended December 31, 2015 2014 (in thousands) Beginning balance $ $ Provision for product returns Credits issued to third parties Ending balance $ $ |
Income (Loss) per Share (Tables
Income (Loss) per Share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income (Loss) per Share | |
Schedule of basic and diluted net loss per share calculation | Year Ended December 31, 2015 2014 2013 (in thousands, except per share data) Basic and dilutive numerator: Net income (loss) $ $ $ Denominator: Shares outstanding Contingently issuable shares – vested RSUs — — Weighted-average shares outstanding — basic Net effect of dilutive securities: Stock options — — Contingently issuable shares – nonvested RSUs — — Weighted-average shares outstanding — diluted Net income (loss) per share — basic $ $ $ Net income (loss) per share — diluted $ $ $ |
Segment Reporting (Tables)
Segment Reporting (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Segment Reporting | |
Schedule of financial information by reporting segment | Year Ended December 31, 2015 2014 2013 (in thousands) Net revenues: Finished pharmaceutical products $ $ $ API — Total net revenues Gross Profit: Finished pharmaceutical products API — Total gross profit Operating expenses Income (loss) from operations Non-operating income (expenses) Income (loss) before income taxes $ $ $ |
Schedule of net revenues and long-lived assets by geographic region | Net Revenue Long-Lived Assets Year Ended December 31, December 31, 2015 2014 2013 2015 2014 (in thousands) U.S. $ $ $ $ $ China — — — France — Total $ $ $ $ $ |
Customer and Supplier Concent35
Customer and Supplier Concentration (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Customer and Supplier Concentration | |
Schedule of accounts receivable and net revenues by major customer | % of Total Accounts % of Net Receivable Revenue December 31, December 31, Year Ended December 31, 2015 2014 2015 2014 2013 Allergan plc (1) % % % % % AmerisourceBergen % % % % % Cardinal Health % % % % % MannKind Corporation % % % % — McKesson % % % % % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Schedule of financial assets and liabilities measured on a recurring basis | Quoted Prices in Active Markets Significant Other Significant Other for Identical Observable Unobservable Assets Inputs Inputs Total (Level 1) (Level 2) (Level 3) (in thousands) Cash equivalents: Money market accounts $ $ $ — $ — Restricted short-term investments: Certificates of deposit — — Fair value measurement as of December 31, 2015 $ $ $ — $ — Cash equivalents: Money market accounts $ $ $ — $ — Restricted short-term investments: Certificates of deposit — — Fair value measurement as of December 31, 2014 $ $ $ — $ — |
Goodwill and Intangible Assets
Goodwill and Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
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 Product rights 12 $ $ $ Patents 10 Trademarks 11 — Land-use rights 39 Other intangible assets 1 Subtotal 12 Indefinite-lived intangible assets Trademark * — Goodwill Finished pharmaceutical products (1) * — Subtotal * — As of December 31, 2015 * $ $ $ Weighted-Average Accu mulated Life (Years) Original Cost Amortization Net Book Value (in thousands) Definite-lived intangible assets Product rights 12 $ $ $ Patents 10 Trademarks 11 Land-use rights 39 Other intangible assets 1 Subtotal 12 Indefinite-lived intangible assets Trademark * — Goodwill Finished pharmaceutical products * — API * — Subtotal * — As of December 31, 2014 * $ $ $ * Intangible assets with indefinite lives have an indeterminable average life. |
Schedule of changes in carrying amounts of goodwill | December 31, 2015 2014 (in thousands) Beginning balance $ $ Goodwill related to acquisition of business — Currency translation and other adjustments Ending balance $ $ |
Schedule of finite-lived intangible assets, future amortization expense | (in thousands) 2016 $ 2017 2018 2019 2020 Thereafter Total amortizable intangible assets Indefinite-lived intangibles Total intangibles (net of accumulated amortization) $ |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Inventories | |
Schedule of inventories | December 31, 2015 2014 (in thousands) Raw materials and supplies $ $ Work in process Finished goods Total inventory Less reserve for excess and obsolete inventories Total inventory, net $ $ |
Property, Plant, and Equipment
Property, Plant, and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, Plant, and Equipment | |
Schedule of property, plant, and equipment | December 31, 2015 2014 (in thousands) Building $ $ Leasehold improvements Land Machinery and equipment Furniture, fixtures, and automobiles Construction in progress Total property, plant, and equipment Less accumulated depreciation Total property, plant, and equipment, net $ $ |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt | |
Schedule of debt | December 31, 2015 2014 (in thousands) Loans with East West Bank Mortgage payable due January 2016 $ $ Mortgage payable due September 2016 Line of credit facility due March 2016 — — Equipment loan due April 2017 Equipment loan due January 2019 — Loans with Cathay Bank Mortgage payable due April 2021 Revolving line of credit due May 2016 — — Acquisition loan due April 2019 Loans with Seine-Normandie Water Agency French government loan 1 due March 2018 — French government loan 2 due June 2020 — French government loan 3 due July 2021 — Payment obligation to Merck Equipment under Capital Leases Total debt and capital leases Less current portion of long-term debt and capital leases Long-term debt and capital leases, net of current portion $ $ |
Schedule of Maturities of Long-term Debt [Table Text Block] | Capital Debt Leases Total (in thousands) 2016 $ $ 2017 2018 2019 2020 Thereafter — Less amount representing interest — $ $ $ |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Schedule of income (loss) before income taxes | Year Ended December 31, 2015 2014 2013 (in thousands) Income (loss) before income taxes: United States $ $ $ Foreign Total income (loss) before taxes $ $ $ |
Summary of provision (benefit) for income taxes | Year Ended December 31, 2015 2014 2013 (in thousands) Current provision (benefit): Federal $ $ $ State Foreign Total current provision (benefit) Deferred provision (benefit): Federal State Foreign Total deferred provision (benefit) Total provision (benefit) for income taxes $ $ $ |
Schedule of reconciliation of the statutory federal income tax rate | Year Ended December 31, 2015 2014 2013 Statutory federal income tax (benefit) % % % State tax expense, net of federal tax benefit Foreign income tax Qualified production activities deduction — — Research and development credits ISO portion of stock options deductions Other — Effective tax rate (benefit) % % % |
Summary of deferred tax assets and liabilities | December 31, 2015 2014 (in thousands) Deferred tax assets: Net operating loss carryforward $ $ State income taxes Inventory capitalization and reserve Deferred revenue Accrued payroll and benefits Share-based compensation Research and development credits Alternative minimum tax Accrued professional fees Product return allowance Accrued chargebacks Bad debt reserve Intangibles Accrued for workers’ compensation insurance Total deferred tax assets Deferred tax liabilities: Depreciation/amortization Intangibles Federal impact of state deferred taxes Other Total deferred tax liabilities Valuation allowance Net deferred tax assets $ $ |
Schedule of unrecognized tax benefits | December 31, 2015 2014 2013 (in thousands) Balance at the beginning of the year $ $ $ Additions based on tax positions related to the current year Deductions based on tax audit settlement — — Deductions based on statute of limitations — Balance at the end of the year $ $ $ |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' Equity | |
Schedule of key assumptions to determine fair value of options | Year Ended December 31, 2015 2014 2013 Average volatility % % % Risk-free interest rate % % % Weighted-average expected life in years Dividend yield rate — % — % — % |
Schedule of the summary of option activity under all plans | A summary of option activity under all plans for the year ended December 31, 2015 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, 2014 $ Options granted Options exercised Options cancelled Options expired Outstanding as of December 31, 2015 $ $ Exercisable as of December 31, 2015 $ $ (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 December 31, 2015. A summary of option activity under all plans for the year ended December 31, 2014 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, 2013 $ Options granted Options exercised Options cancelled Options expired Outstanding as of December 31, 2014 $ $ Exercisable as of December 31, 2014 $ $ (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 December 31, 2014. |
Schedule of information relating to options grants | Year Ended December 31, 2015 2014 2013 (in thousands, except per share data) Weighted-average grant date fair value $ $ $ Intrinsic value of options exercised — Cash received Total fair value of the options vested during the year |
Schedule of the summary of nonvested options status | A summary of the status of the Company’s nonvested options as of December 31, 2015, and changes during the year ended December 31, 2015, are presented below: Weighted-Average Grant Date Options Fair Value Nonvested as of December 31, 2014 $ Options granted Options vested Options forfeited Nonvested as of December 31, 2015 A summary of the status of the Company’s nonvested options as of December 31, 2014, and changes during the year ended December 31, 2014, are presented below: Weighted-Average Grant Date Options Fair Value Nonvested as of December 31, 2013 $ Options granted Options vested Options forfeited Nonvested as of December 31, 2014 |
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, 2013 RSUs granted $ RSUs forfeited RSUs surrendered for taxes Common stock delivered for RSUs RSUs outstanding at December 31, 2014 RSUs granted $ RSUs forfeited RSUs surrendered for taxes Common stock delivered RSUs outstanding at December 31, 2015 (1) The total FMV is derived from the number of RSUs granted times the current stock price on the date of grant. |
Schedule of recorded share-based compensation expense under all plans | Year Ended December 31, 2015 2014 2013 (in thousands) Cost of revenues $ $ $ Operating expenses: Selling, distribution and marketing General and administrative Research and development Total share-based compensation $ $ $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies | |
Schedule of future minimum rental payments for operating leases | Operating Leases (in thousands) 2016 $ 2017 2018 2019 2020 $ |
Quarterly Financial Data (Unaud
Quarterly Financial Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Financial Data | |
Schedule of Quarterly Financial Information | 2015 Quarters First Second Third Fourth Net revenues Finished pharmaceutical products $ $ $ $ API Total net revenues $ $ $ $ Gross profit Finished pharmaceutical products $ $ $ $ API Total gross profit $ $ $ $ Net income (loss) $ $ $ $ Weighted-average shares used to compute net income (loss) per share Basic Diluted Net income (loss) per share Basic $ $ $ $ Diluted $ $ $ $ 2014 Quarters First Second Third Fourth Net revenue Finished pharmaceutical products $ $ $ $ API — Total net revenues $ $ $ $ Gross profit Finished pharmaceutical products $ $ $ $ API — Total gross profit $ $ $ $ Net loss $ $ $ $ Weighted-average shares used to compute net loss per share Basic Diluted Net loss per share Basic $ $ $ $ Diluted $ $ $ $ |
Summary of Significant Accoun45
Summary of Significant Accounting Policies (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Summary of Significant Accounting Policies | |||
Shipping, Handling and Transportation Costs | $ 2,600 | $ 2,500 | $ 2,400 |
Research and Development Costs disclosures | |||
Margin potential on sale of pre-launch inventory (as a percentage) | 100.00% | ||
Restricted Cash and Restricted Short-Term Investments disclosures | |||
Restricted cash and restricted short-term investments | $ 1,285 | $ 1,495 |
Summary of Significant Accoun46
Summary of Significant Accounting Policies (Schedule of PP&E Useful Lives) (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Buildings | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 20 years |
Buildings | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 31 years |
Machinery and equipment | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 2 years |
Machinery and equipment | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 12 years |
Furniture and Fixtures | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 3 years |
Furniture and Fixtures | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 7 years |
Automobiles | Minimum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 4 years |
Automobiles | Maximum | |
Property, Plant and Equipment | |
Property, Plant and Equipment Useful Life | 5 years |
Summary of Significant Accoun47
Summary of Significant Accounting Policies (Summary of Intangible Assets Useful Lives) (Details) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 12 years | 12 years |
Product rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 12 years | 12 years |
Land-use rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 39 years | 39 years |
Minimum | Product rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 5 years | |
Minimum | Patents and Trademarks | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 10 years | |
Minimum | Land-use rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 37 years | |
Maximum | Product rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 15 years | |
Maximum | Patents and Trademarks | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 20 years | |
Maximum | Land-use rights | ||
Goodwill and Intangible Assets | ||
Finite-Lived Intangible Asset, Useful Life | 50 years |
Summary of Significant Accoun48
Summary of Significant Accounting Policies (Summary of Self-Insured Claims) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Summary of Significant Accounting Policies | |||
Amount retained, individual claims | $ 350,000 | ||
Amount retained, aggregate claims | 1,900,000 | ||
Actuarially Determined Self-insurance Expense | 1,200,000 | $ 1,000,000 | $ 800,000 |
Self-insurance Claims Liability | $ 2,700,000 | $ 2,200,000 |
Business Acquisition (Details)
Business Acquisition (Details) - Apr. 30, 2014 € in Millions, $ in Millions | EUR (€) | USD ($) |
Merck Sharpe & Dohme's API | ||
Business Acquisition | ||
Business Combination, Consideration Transferred | € 24.8 | $ 34.4 |
Business Acquisition (Details 2
Business Acquisition (Details 2) - Apr. 30, 2014 - Merck Sharpe & Dohme's API € in Thousands, $ in Thousands | EUR (€) | USD ($) |
Business Acquisition | ||
At Closing, April 2014 | € 13,252 | $ 18,352 |
December 2,014 | 4,899 | 5,989 |
December 2,015 | 3,186 | 3,483 |
December 2,016 | 3,186 | 3,475 |
December 2,017 | 500 | 545 |
Total - estimated | € 25,023 | $ 31,844 |
Business Acquisition (Details 3
Business Acquisition (Details 3) € in Thousands, $ in Thousands | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014EUR (€) | Apr. 30, 2014USD ($) | Dec. 31, 2013USD ($) |
Business Acquisition | |||||
Goodwill | $ 3,726 | $ 4,467 | $ 280 | ||
Merck Sharpe & Dohme's API | |||||
Business Acquisition | |||||
Inventory | € 15,565 | $ 21,554 | |||
Real property | 4,800 | 6,647 | |||
Machinery & equipment | 6,800 | 9,417 | |||
Intangibles | 80 | 111 | |||
Goodwill | 3,155 | 4,369 | |||
Total assets acquired | 30,400 | 42,098 | |||
Accrued liabilities | 2,425 | 3,358 | |||
Deferred tax liabilities | 3,155 | 4,369 | |||
Total liabilities assumed | 5,580 | 7,727 | |||
Total fair value of consideration transferred | € 24,820 | $ 34,371 |
Business Acquisition (Details 4
Business Acquisition (Details 4) - Merck Sharpe & Dohme's API - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Business Acquisition | ||
Net revenues | $ 251,519 | $ 212,745 |
Net loss | $ (2,787) | $ (11,928) |
Diluted net loss per share (in Dollars per share) | $ (0.06) | $ (0.28) |
Business Acquisition (Details 5
Business Acquisition (Details 5) € in Millions, $ in Millions | Jun. 01, 2014 | Apr. 22, 2014USD ($) | Apr. 30, 2014EUR (€) | Dec. 31, 2015USD ($) | Apr. 30, 2014USD ($) |
Note Payable To Merck | |||||
Debt Instrument | |||||
Debt Instrument, Face Amount | € 11.6 | $ 16 | |||
Debt Instrument, Term | 4 years | ||||
Note Payable To Merck | Minimum | |||||
Debt Instrument | |||||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% | 4.00% | 3.00% | ||
Cathay Bank | Acquisition Loan - Due April 2019 | |||||
Debt Instrument | |||||
Debt Instrument, Face Amount | $ 21.9 | ||||
Debt Instrument, Term | 120 months | ||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 12 | ||||
Debt Instrument Loan Collateral Percentage | 65.00% | ||||
Debt Instrument Covenant Period To Discharge Final Judgment | 30 days | ||||
Cathay Bank | Acquisition Loan - Due April 2019 | Minimum | |||||
Debt Instrument | |||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||
Merck Sharpe & Dohme's API | Cathay Bank | Acquisition Loan - Due April 2019 | |||||
Debt Instrument | |||||
Debt Instrument, Face Amount | $ 21.9 | ||||
Debt Instrument, Maturity Date | Apr. 22, 2019 | ||||
Debt Instrument, Term | 120 months | ||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 12 | ||||
Debt Instrument Loan Collateral Percentage | 65.00% | ||||
Merck Sharpe & Dohme's API | Cathay Bank | Acquisition Loan - Due April 2019 | Minimum | |||||
Debt Instrument | |||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% |
Revenue Recognition (Details)
Revenue Recognition (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue Recognition | ||
Beginning balance | $ 11,872 | $ 18,104 |
Provision related to sales made in the current period | 162,238 | 156,235 |
Credits issued to third parties | (158,893) | (162,467) |
Ending balance | $ 15,217 | $ 11,872 |
Revenue Recognition (Details 2)
Revenue Recognition (Details 2) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue Recognition | ||
Beginning balance | $ 2,408 | $ 4,592 |
Provision for product returns | 1,675 | (714) |
Credits issued to third parties | (1,462) | (1,470) |
Ending balance | $ 2,621 | $ 2,408 |
Revenue Recognition (Details 3)
Revenue Recognition (Details 3) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue Recognition | ||
Product Return Rate, Percentage | 1.10% | 1.10% |
Income (Loss) per Share (Detail
Income (Loss) per Share (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Weighted-average exercise price | $ 15.41 | $ 15.12 | $ 15.39 |
Employee and Non-Employee Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 12,240,467 | 11,371,891 | 7,124,091 |
Weighted-average exercise price | $ 17.62 | ||
Restricted Stock Units (RSUs) | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 866,540 | 503,010 | |
Common Shares Expected to be Issued under ESPP | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 61,766 |
Income (Loss) per Share (Deta58
Income (Loss) per Share (Details 2) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Basic and dilutive numerator: | |||||||||||
Net income (loss) | $ 7,533 | $ (3,008) | $ (6,647) | $ (665) | $ (2,521) | $ (5,379) | $ (1,180) | $ (1,619) | $ (2,787) | $ (10,699) | $ 11,862 |
Denominator: | |||||||||||
Shares outstanding | 44,961,000 | 41,957,000 | 38,705,000 | ||||||||
Contingently issuable shares - vested RSUs | 7,000 | ||||||||||
Weighted-average shares outstanding—basic | 45,085 | 45,310 | 44,849 | 44,601 | 44,648 | 44,644 | 39,767 | 38,769 | 44,961,000 | 41,957,000 | 38,712,000 |
Net effect of dilutive securities: | |||||||||||
Stock options | 104,000 | ||||||||||
Contingently issuable shares – nonvested RSUs | 67,000 | ||||||||||
Weighted-average shares outstanding—diluted | 46,709 | 45,310 | 44,849 | 44,601 | 44,648 | 44,644 | 39,767 | 38,769 | 44,961,000 | 41,957,000 | 38,883,000 |
Net loss per share—basic (in Dollars per share) | $ 0.17 | $ (0.07) | $ (0.15) | $ (0.01) | $ (0.06) | $ (0.12) | $ (0.03) | $ (0.04) | $ (0.06) | $ (0.25) | $ 0.31 |
Net loss per share—diluted (in Dollars per share) | $ 0.16 | $ (0.07) | $ (0.15) | $ (0.01) | $ (0.06) | $ (0.12) | $ (0.03) | $ (0.04) | $ (0.06) | $ (0.25) | $ 0.31 |
Segment Reporting (Details)
Segment Reporting (Details) | 12 Months Ended |
Dec. 31, 2015segment | |
Segment Reporting | |
Number of Reportable Segments | 2 |
Segment Reporting (Details 2)
Segment Reporting (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net revenues: | |||||||||||
Net Revenue | $ 76,912 | $ 63,868 | $ 53,853 | $ 56,886 | $ 55,877 | $ 59,711 | $ 49,003 | $ 45,870 | $ 251,519 | $ 210,461 | $ 229,681 |
Gross Profit: | |||||||||||
Gross Profit | 33,171 | 17,578 | 13,318 | 13,280 | 11,960 | 11,791 | 14,996 | 12,509 | 77,347 | 51,256 | 86,956 |
Operating expenses | 84,245 | 69,239 | 69,466 | ||||||||
Income (loss) from operations | (6,898) | (17,983) | 17,490 | ||||||||
Non-operating income (expenses) | (3,466) | (165) | (263) | ||||||||
Income (loss) before income taxes | (10,364) | (18,148) | 17,227 | ||||||||
Finished Pharmaceutical Products | |||||||||||
Net revenues: | |||||||||||
Net Revenue | 66,092 | 57,902 | 50,075 | 50,872 | 49,980 | 53,729 | 48,901 | 45,870 | 224,941 | 198,480 | 229,681 |
Gross Profit: | |||||||||||
Gross Profit | 29,357 | 19,302 | 12,634 | 12,853 | 13,132 | 12,122 | 14,961 | $ 12,509 | 74,146 | 52,724 | $ 86,956 |
API | |||||||||||
Net revenues: | |||||||||||
Net Revenue | 10,820 | 5,966 | 3,778 | 6,014 | 5,897 | 5,982 | 102 | 26,578 | 11,981 | ||
Gross Profit: | |||||||||||
Gross Profit | $ 3,814 | $ (1,724) | $ 684 | $ 427 | $ (1,172) | $ (331) | $ 35 | $ 3,201 | $ (1,468) |
Segment Reporting (Details 3)
Segment Reporting (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Net Revenue | $ 76,912 | $ 63,868 | $ 53,853 | $ 56,886 | $ 55,877 | $ 59,711 | $ 49,003 | $ 45,870 | $ 251,519 | $ 210,461 | $ 229,681 |
Long-Lived Assets | 142,161 | 138,289 | 142,161 | 138,289 | |||||||
UNITED STATES | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Net Revenue | 243,295 | 198,480 | $ 229,681 | ||||||||
Long-Lived Assets | 100,404 | 102,313 | 100,404 | 102,313 | |||||||
CHINA | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Long-Lived Assets | 28,547 | 22,170 | 28,547 | 22,170 | |||||||
FRANCE | |||||||||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||||||||
Net Revenue | 8,224 | 11,981 | |||||||||
Long-Lived Assets | $ 13,210 | $ 13,806 | $ 13,210 | $ 13,806 |
Customer and Supplier Concent62
Customer and Supplier Concentration (Details) - Customer Concentration Risk [Member] - item | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Number of major customers | 5 | ||
Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Number of major customers | 5 | ||
Allergan plc | Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 12.00% | 18.00% | |
Allergan plc | Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 21.00% | 30.00% | 35.00% |
AmerisourceBergen | Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 12.00% | 5.00% | |
AmerisourceBergen | Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 17.00% | 15.00% | 15.00% |
Cardinal Health | Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 20.00% | 15.00% | |
Cardinal Health | Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 17.00% | 14.00% | 13.00% |
MannKind Corporation | Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 13.00% | 21.00% | |
MannKind Corporation | Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 8.00% | 2.00% | |
McKesson | Accounts receivable | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 21.00% | 13.00% | |
McKesson | Net Revenues | |||
Revenue, Major Customer [Line Items] | |||
Major Customers | 22.00% | 22.00% | 26.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Restricted short-term investments: | ||
Fair value measurement | $ 43,771 | $ 44,489 |
Money market accounts | ||
Cash equivalents: | ||
Cash equivalents | 42,486 | 42,994 |
Certificates of deposit | ||
Restricted short-term investments: | ||
Restricted short-term investments | 1,285 | 1,495 |
Level 1 | ||
Restricted short-term investments: | ||
Fair value measurement | 43,771 | 44,489 |
Level 1 | Money market accounts | ||
Cash equivalents: | ||
Cash equivalents | 42,486 | 42,994 |
Level 1 | Certificates of deposit | ||
Restricted short-term investments: | ||
Restricted short-term investments | $ 1,285 | $ 1,495 |
Fair Value Measurements (Deta64
Fair Value Measurements (Details 2) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Fair Value Measurements | ||
Assets, Fair Value Adjustment | $ 0 | $ 0 |
Liabilities, Fair Value Adjustment | $ 0 | $ 0 |
Goodwill and Intangible Asset65
Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 12 years | 12 years | |
Original Cost | $ 30,572 | $ 30,588 | |
Accumulated Amortization | 23,622 | 21,715 | |
Total amortizable intangible assets | 6,950 | 8,873 | |
Indefinite-lived intangible assets | |||
Goodwill | 3,726 | 4,467 | $ 280 |
Subtotal, Original Cost | 32,951 | 33,692 | |
Subtotal, Net Book Value | 32,951 | 33,692 | |
Balance, Original Cost | 63,523 | 64,280 | |
Balance, Net Book Value | 39,901 | 42,565 | |
Finished Pharmaceutical Products | |||
Indefinite-lived intangible assets | |||
Goodwill | 3,726 | 280 | |
API | |||
Indefinite-lived intangible assets | |||
Goodwill | 4,187 | ||
Trademarks | |||
Indefinite-lived intangible assets | |||
Indefinite-lived intangible assets | $ 29,225 | $ 29,225 | |
Product rights | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 12 years | 12 years | |
Original Cost | $ 27,134 | $ 27,134 | |
Accumulated Amortization | 22,679 | 20,896 | |
Total amortizable intangible assets | $ 4,455 | $ 6,238 | |
Patents | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 10 years | 10 years | |
Original Cost | $ 293 | $ 293 | |
Accumulated Amortization | 107 | 78 | |
Total amortizable intangible assets | $ 186 | $ 215 | |
Trademarks | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 11 years | 11 years | |
Original Cost | $ 15 | $ 19 | |
Accumulated Amortization | $ 15 | 15 | |
Total amortizable intangible assets | $ 4 | ||
Land-use rights | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 39 years | 39 years | |
Original Cost | $ 2,540 | $ 2,540 | |
Accumulated Amortization | 288 | 221 | |
Total amortizable intangible assets | $ 2,252 | $ 2,319 | |
Other intangible assets | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 1 year | 1 year | |
Original Cost | $ 590 | $ 602 | |
Accumulated Amortization | 533 | 505 | |
Total amortizable intangible assets | $ 57 | $ 97 |
Goodwill and Intangible Asset66
Goodwill and Intangible Assets (Details 2) - Trademarks - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Indefinite-lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, carrying value | $ 29,225 | $ 29,225 |
Primatene Mist HFA | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, carrying value | $ 29,200 |
Goodwill and Intangible Asset67
Goodwill and Intangible Assets (Details 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Goodwill and Intangible Assets | ||
Beginning balance | $ 4,467 | $ 280 |
Goodwill related to acquisition of business | 4,369 | |
Currency translation and other adjustments | (741) | (182) |
Ending balance | $ 3,726 | $ 4,467 |
Goodwill and Intangible Asset68
Goodwill and Intangible Assets (Details 4) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ 1,938 | $ 1,920 | $ 1,907 |
Product rights | Cortrosyn | |||
Finite-Lived Intangible Assets [Line Items] | |||
Amortization of intangible assets | $ 1,800 | $ 1,800 | $ 1,800 |
Goodwill and Intangible Asset69
Goodwill and Intangible Assets (Details 5) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Goodwill and Intangible Assets | ||
2,016 | $ 1,894 | |
2,017 | 1,894 | |
2,018 | 1,003 | |
2,019 | 101 | |
2,020 | 95 | |
Thereafter | 1,963 | |
Total amortizable intangible assets | 6,950 | $ 8,873 |
Indefinite-lived intangibles | 32,951 | |
Balance, Net Book Value | $ 39,901 | $ 42,565 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Inventories | ||
Raw materials and supplies | $ 31,878 | $ 41,996 |
Work in process | 21,455 | 16,221 |
Finished goods | 19,867 | 24,755 |
Total inventory | 73,200 | 82,972 |
Less reserve for excess and obsolete inventories | (2,535) | (640) |
Total inventory, net | $ 70,665 | $ 82,332 |
Property, Plant, and Equipmen71
Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 254,419 | $ 240,840 |
Less accumulated depreciation and amortization | (112,258) | (102,551) |
Total property, plant, and equipment, net | 142,161 | 138,289 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 82,309 | 67,760 |
Leasehold improvement | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 23,392 | 23,960 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 6,895 | 7,020 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 108,442 | 104,819 |
Furniture, fixtures, and automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 13,439 | 12,213 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 19,942 | $ 25,068 |
Property, Plant, and Equipmen72
Property, Plant, and Equipment (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Depreciation expense | $ 11,314 | $ 12,528 | $ 11,171 |
Interest Costs Capitalized | 1,100 | 1,200 | $ 100 |
Property, Plant and Equipment, Gross | 254,419 | 240,840 | |
Equipment | Primatene Mist HFA | |||
Property, Plant and Equipment [Line Items] | |||
Property, Plant and Equipment, Gross | $ 2,900 | $ 3,400 |
Impairment of Long-Lived Asse73
Impairment of Long-Lived Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Impairment of Long-Lived Assets | |||
Impairment of long-lived assets | $ 206 | $ 439 | $ 126 |
Debt (Details)
Debt (Details) $ in Thousands, € in Millions | Dec. 31, 2015EUR (€) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) |
Debt Instrument | |||
Long Term Debt | $ 40,295 | ||
Total debt and capital leases | 41,099 | $ 43,700 | |
Less current portion of long-term debt and capital leases | 10,934 | 7,594 | |
Long-term debt and capital leases, net of current portion | 30,165 | 36,106 | |
Mortgage Payable - Due January 2016 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 3,725 | 3,887 | |
Mortgage Payable - Due September 2016 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 2,211 | 2,289 | |
Equipment Loan - Due April 2017 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 1,700 | 2,923 | |
Line of Credit Facility - Due January 2019 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 4,748 | ||
Mortgage Payable - Due April 2021 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 4,460 | 4,549 | |
Acquisition Loan - Due April 2019 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 19,012 | 20,870 | |
French Government Loan - Due March 2018 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 46 | ||
French Government Loan - Due June 2020 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 128 | ||
French Government Loan - Due July 2021 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 325 | ||
Note Payable To Merck | |||
Debt Instrument | |||
Long Term Debt | € 3.6 | 3,942 | 8,160 |
Capital Lease Obligations | |||
Debt Instrument | |||
Total debt and capital leases | $ 802 | $ 1,022 |
Debt (Details 2)
Debt (Details 2) $ in Thousands, € in Millions | Jan. 05, 2015USD ($) | Apr. 22, 2014USD ($) | Mar. 05, 2007USD ($) | Dec. 31, 2015EUR (€)building | Dec. 31, 2015USD ($) | Jan. 31, 2015EUR (€) | Dec. 31, 2014EUR (€) | Dec. 31, 2014USD ($) | Apr. 30, 2014EUR (€) | Jul. 31, 2013 | Dec. 31, 2015EUR (€)building | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Jan. 08, 2016USD ($)building | Dec. 31, 2015USD ($)building | Jan. 31, 2015USD ($) | Jan. 13, 2015USD ($) | Apr. 30, 2014USD ($) | Jul. 05, 2013USD ($) | Mar. 15, 2013USD ($) | Apr. 10, 2012USD ($) | Mar. 31, 2012USD ($) | Mar. 05, 2012USD ($) | Dec. 31, 2010USD ($) | Sep. 15, 2006USD ($) |
Debt | |||||||||||||||||||||||||
Proceeds from borrowing under lines of credit | $ 25,000 | $ 66,000 | |||||||||||||||||||||||
Long-term Debt and Capital Lease Obligations | $ 36,106 | 36,106 | $ 30,165 | ||||||||||||||||||||||
Payment to Acquire Business, Gross | $ 18,352 | ||||||||||||||||||||||||
Long Term Debt | 40,295 | ||||||||||||||||||||||||
Cathay Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt instrument fixed charge coverage ratio waived | 1.2 | 1.2 | |||||||||||||||||||||||
Debt instrument minimum debt service coverage ratio waived | 1.5 | 1.5 | |||||||||||||||||||||||
Mortgage Payable - Due January 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 4,500 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | 3,800 | ||||||||||||||||||||||||
Long Term Debt | $ 3,887 | $ 3,887 | 3,725 | ||||||||||||||||||||||
Mortgage Payable - Due January 2016 | East West Bank | Subsequent Event | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 3,700 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 3,300 | ||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.39% | ||||||||||||||||||||||||
Mortgage Payable - Due September 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Long Term Debt | 2,289 | 2,289 | 2,211 | ||||||||||||||||||||||
Line of Credit Facility - Due March 2016 | East West Bank | Line of Credit | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 10,000 | ||||||||||||||||||||||||
Equipment Loan - Due April 2017 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 4,900 | ||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 8,000 | ||||||||||||||||||||||||
Long Term Debt | 2,923 | 2,923 | 1,700 | ||||||||||||||||||||||
Equipment Loan - Due April 2017 | East West Bank | Prime Rate | Line of Credit | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.25% | ||||||||||||||||||||||||
Line of Credit Facility - Due January 2019 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Long Term Debt | 4,748 | ||||||||||||||||||||||||
Line of Credit Facility - Due January 2019 | East West Bank | Line of Credit | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 8,000 | ||||||||||||||||||||||||
Proceeds from borrowing under lines of credit | $ 6,200 | ||||||||||||||||||||||||
Line of Credit Facility - Due January 2019 | East West Bank | Prime Rate | Line of Credit | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 0.25% | ||||||||||||||||||||||||
Equipment Loan Due January 2019 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.48% | ||||||||||||||||||||||||
Secured Debt. | 4,700 | ||||||||||||||||||||||||
Line Of Credit Replaced By Equipment Loan | $ 6,200 | ||||||||||||||||||||||||
Mortgage Payable - Due April 2021 | Cathay Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | 3,900 | ||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.42% | ||||||||||||||||||||||||
Debt Instrument, Fair Value Disclosure | 4,700 | ||||||||||||||||||||||||
Long-term Debt, Gross | 4,500 | ||||||||||||||||||||||||
Debt Instrument Replaced By Mortgage Loan | $ 5,300 | ||||||||||||||||||||||||
Long Term Debt | 4,549 | 4,549 | 4,460 | ||||||||||||||||||||||
Mortgage Payable - Due April 2021 | Cathay Bank | Scenario, Refinanced | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 4,600 | ||||||||||||||||||||||||
Revolving Line of Credit - Due May 2016 | Cathay Bank | Revolving Credit Facility | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 20,000 | ||||||||||||||||||||||||
Long-term Line of Credit | 0 | ||||||||||||||||||||||||
Acquisition Loan - Due April 2019 | Cathay Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 21,900 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | 12,000 | ||||||||||||||||||||||||
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 | 20,870 | 20,870 | 19,012 | ||||||||||||||||||||||
French Government Loans | Seine-Normandie Water Agency | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | € 0.6 | $ 700 | |||||||||||||||||||||||
Notes Payable | € 0.5 | € 0.5 | 500 | ||||||||||||||||||||||
Note Payable To Merck | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | € 11.6 | $ 16,000 | |||||||||||||||||||||||
Debt Instrument, Term | 4 years | ||||||||||||||||||||||||
Payment to Acquire Business, Gross | 3.2 | $ 3,500 | € 4.9 | 6,000 | |||||||||||||||||||||
Long Term Debt | € 3.6 | 8,160 | € 3.6 | 8,160 | 3,942 | ||||||||||||||||||||
Capital Lease Obligations | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Capital Leased Assets, Gross | 1,500 | 1,500 | 1,500 | ||||||||||||||||||||||
Capital Leases, Lessee Balance Sheet, Assets by Major Class, Accumulated Depreciation | $ 400 | $ 400 | $ 700 | ||||||||||||||||||||||
Minimum | Mortgage Payable - Due January 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | 5.00% | 5.00% | ||||||||||||||||||||||
Minimum | Equipment Loan - Due April 2017 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.50% | 3.50% | 3.50% | ||||||||||||||||||||||
Minimum | Revolving Line of Credit - Due May 2016 | Cathay Bank | Revolving Credit Facility | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||||||||||||||||||||||
Minimum | Acquisition Loan - Due April 2019 | Cathay Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 4.00% | ||||||||||||||||||||||||
Minimum | French Government Loans | Seine-Normandie Water Agency | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | 4.00% | 4.00% | ||||||||||||||||||||||
Debt Instrument, Term | 3 years | ||||||||||||||||||||||||
Minimum | Note Payable To Merck | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | 3.00% | 4.00% | 4.00% | 3.00% | ||||||||||||||||||||
Maximum | French Government Loans | Seine-Normandie Water Agency | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Term | 6 years | ||||||||||||||||||||||||
Rancho Cucamonga | Mortgage Payable - Due January 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | 1 | 1 | ||||||||||||||||||||||
Rancho Cucamonga | Mortgage Payable - Due January 2016 | East West Bank | Subsequent Event | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | ||||||||||||||||||||||||
Rancho Cucamonga | Mortgage Payable - Due September 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Principal amount | $ 2,800 | ||||||||||||||||||||||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 2,200 | ||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | 1 | 1 | ||||||||||||||||||||||
Rancho Cucamonga | Mortgage Payable - Due September 2016 | East West Bank | LIBOR | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Debt Instrument, Basis Spread on Variable Rate | 2.50% | ||||||||||||||||||||||||
Chino | Mortgage Payable - Due January 2016 | East West Bank | |||||||||||||||||||||||||
Debt | |||||||||||||||||||||||||
Number of Buildings Securing Loan | building | 1 | 1 | 1 |
Debt (Details 3)
Debt (Details 3) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Debt | ||
2,016 | $ 10,639 | |
2,017 | 4,768 | |
2,018 | 3,924 | |
2,019 | 13,374 | |
2,020 | 291 | |
Thereafter | 7,299 | |
Long Term Debt | 40,295 | |
Long-term Debt, Excluding Current Maturities | 40,295 | |
Capital Leases | ||
2,016 | 333 | |
2,017 | 331 | |
2,018 | 159 | |
2,019 | 33 | |
2,020 | 13 | |
Capital Leases, Future Minimum Payments Due | 869 | |
Less amount representing interest | 65 | |
Capital Leases, Future Minimum Payments, Present Value of Net Minimum Payments | 804 | |
Total debt and capital leases | $ 41,099 | $ 43,700 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income (loss) before income taxes: | |||
United States | $ (4,344) | $ (12,946) | $ 20,116 |
Foreign | (6,020) | (5,202) | (2,889) |
Income (loss) before income taxes | $ (10,364) | $ (18,148) | $ 17,227 |
Income Taxes (Details 2)
Income Taxes (Details 2) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current provision (benefit): | |||
Federal | $ 82 | $ (131) | $ 3,306 |
State | 73 | 193 | 541 |
Foreign | (112) | 1,388 | 104 |
Total current provision (benefit) | 43 | 1,450 | 3,951 |
Deferred provision (benefit): | |||
Federal | (5,222) | (4,309) | 2,254 |
State | (1,250) | (1,699) | 227 |
Foreign | (1,148) | (2,891) | (1,067) |
Total deferred provision (benefit) | (7,620) | (8,899) | 1,414 |
Total provision (benefit) for income taxes | $ (7,577) | $ (7,449) | $ 5,365 |
Income Taxes (Details 3)
Income Taxes (Details 3) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of the statutory federal income tax rate to the Companys effective rate: | |||
Statutory federal income tax (benefit) | (35.00%) | (35.00%) | 35.00% |
State tax expense, net of federal tax benefit | (7.40%) | (5.40%) | 2.90% |
Foreign income tax | (24.40%) | 1.80% | 0.30% |
Qualified production activities deduction | (3.30%) | ||
Research and development credits | (15.40%) | (6.40%) | (9.90%) |
ISO portion of stock options deductions | 7.70% | 4.00% | 6.30% |
Other | 1.40% | (0.20%) | |
Effective tax rate (benefit) | (73.10%) | (41.00%) | 31.10% |
Income Taxes (Details 4)
Income Taxes (Details 4) $ in Thousands, € in Millions | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014EUR (€) | Apr. 30, 2014USD ($) |
Deferred tax assets: | ||||
Net operating loss carryforward | $ 8,616 | $ 7,877 | ||
State income taxes | 300 | 270 | ||
Inventory capitalization and reserve | 5,365 | 6,843 | ||
Deferred revenue | 584 | 864 | ||
Accrued payroll and benefits | 1,793 | 1,571 | ||
Share-based compensation | 10,125 | 8,437 | ||
Research and development credits | 13,071 | 9,863 | ||
Alternative minimum tax | 529 | 447 | ||
Accrued professional fees | 987 | 568 | ||
Product return allowance | 1,545 | 1,221 | ||
Accrued chargebacks | 5,910 | 4,792 | ||
Bad debt reserve | 253 | 67 | ||
Intangibles | 3,370 | 3,861 | ||
Accrued for workers’ compensation insurance | 1,035 | 864 | ||
Total deferred tax assets | 53,483 | 47,545 | ||
Deferred tax liabilities: | ||||
Depreciation/amortization | 15,065 | 15,649 | ||
Intangibles | 5,430 | 4,753 | ||
Federal impact of state deferred taxes | 3,380 | 2,910 | ||
Other | 1,241 | 937 | ||
Total deferred tax liabilities | 25,116 | 24,249 | ||
Valuation allowance | (923) | (3,862) | € (3.2) | $ (4,400) |
Net deferred tax assets | $ 27,444 | $ 19,434 |
Income Taxes (Details 5)
Income Taxes (Details 5) $ in Millions | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Domestic Tax Authority | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 11.4 |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2034 |
Foreign Tax Authority [Member] | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 9.9 |
California Franchise Tax Board | State and Local Jurisdiction | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 13.2 |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2030 |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 15.8 |
Other States Taxing Agencies | State and Local Jurisdiction | |
Operating Loss Carryforwards [Line Items] | |
Operating Loss Carryforwards | $ 1.5 |
Operating Loss Carryforwards, Expiration Date | Dec. 31, 2030 |
Employee Service Share-based Compensation, Tax Benefit from Compensation Expense | $ 0.1 |
Income Taxes (Details 6)
Income Taxes (Details 6) | 12 Months Ended |
Dec. 31, 2015 | |
Tax Year 2007 | California Franchise Tax Board | |
Income Tax Contingency [Line Items] | |
Income Tax Examination, Year under Examination | 2,007 |
Tax Year 2008 | California Franchise Tax Board | |
Income Tax Contingency [Line Items] | |
Income Tax Examination, Year under Examination | 2,008 |
Tax Year 2009 | California Franchise Tax Board | |
Income Tax Contingency [Line Items] | |
Income Tax Examination, Year under Examination | 2,009 |
Domestic Tax Authority | Tax Year 2012 | |
Income Tax Contingency [Line Items] | |
Open Tax Year | 2,012 |
Domestic Tax Authority | Tax Year 2013 | |
Income Tax Contingency [Line Items] | |
Open Tax Year | 2,013 |
Domestic Tax Authority | Tax Year 2014 | |
Income Tax Contingency [Line Items] | |
Open Tax Year | 2,014 |
State and Local Jurisdiction | Earliest Tax Year | |
Income Tax Contingency [Line Items] | |
Open Tax Year | 2,007 |
State and Local Jurisdiction | Latest Tax Year | |
Income Tax Contingency [Line Items] | |
Open Tax Year | 2,014 |
Income Taxes (Details 7)
Income Taxes (Details 7) $ in Thousands, € in Millions | 1 Months Ended | 12 Months Ended | ||||
Mar. 31, 2015EUR (€) | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014EUR (€) | Apr. 30, 2014USD ($) | |
Tax Credit Carryforward [Line Items] | ||||||
Deferred Tax Assets, Valuation Allowance | $ 923 | $ 3,862 | € 3.2 | $ 4,400 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | € (3.2) | $ (3,300) | ||||
Domestic Tax Authority | ||||||
Tax Credit Carryforward [Line Items] | ||||||
Tax Credit Carryforward, Expiration Date | Dec. 31, 2031 | |||||
Domestic Tax Authority | Research and Development Tax Credit | ||||||
Tax Credit Carryforward [Line Items] | ||||||
Tax Credit Carryforward, Amount | $ 6,000 | |||||
Domestic Tax Authority | AMT | ||||||
Tax Credit Carryforward [Line Items] | ||||||
Tax Credit Carryforward, Amount | 500 | |||||
State and Local Jurisdiction | California Franchise Tax Board | Research and Development Tax Credit | ||||||
Tax Credit Carryforward [Line Items] | ||||||
Tax Credit Carryforward, Amount | $ 10,700 |
Income Taxes (Details 8)
Income Taxes (Details 8) $ in Thousands, € in Millions | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014EUR (€) | Apr. 30, 2014USD ($) |
Income Taxes | ||||
Deferred Tax Assets, Valuation Allowance | $ 923 | $ 3,862 | € 3.2 | $ 4,400 |
Accumulated Undistributed Foreign Earnings | $ 7,100 | $ 10,500 |
Income Taxes (Details 9)
Income Taxes (Details 9) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Balance at the beginning of the year | $ 4,783 | $ 4,186 | $ 3,532 |
Additions based on tax positions related to the current year | 812 | 655 | 766 |
Deductions based on tax audit settlement | (93) | ||
Deductions based on statute of limitations | (58) | (19) | |
Balance at the end of the year | 5,595 | 4,783 | $ 4,186 |
Unrecognized Tax Benefits, Income Tax Penalties and Interest Accrued | 5,000 | ||
Unrecognized Tax Benefits, Decrease Resulting from Prior Period Tax Positions | 1,900 | ||
Unrecognized Tax Benefits, Income Tax Penalties and Interest Expense | $ 100 | $ 100 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Jun. 25, 2014 | Jun. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Jun. 05, 2014 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Proceeds from issuance of common stock | $ 1,320 | $ 38,018 | ||||
Payments of Stock Issuance Costs | 1,920 | |||||
Allocated Share-based Compensation Expense | $ 12,815 | $ 9,280 | $ 7,035 | |||
Common stock; authorized shares | 300,000,000 | 300,000,000 | 300,000,000 | |||
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares authorized | 20,000,000 | 20,000,000 | 20,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Preferred stock, shares issued | 0 | 0 | ||||
Preferred stock, shares outstanding | 0 | 0 | ||||
Employee Consultant And Directors Stock Options | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Allocated Share-based Compensation Expense | $ 7,900 | $ 6,700 | $ 5,900 | |||
IPO [Member] | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 5,840,000 | |||||
Share Price (in Dollars per share) | $ 7 | |||||
Proceeds from issuance of common stock | $ 40,900 | |||||
Payments of Stock Issuance Costs | $ 6,200 | |||||
Proceeds from Issuance Initial Public Offering, Net of Issuance Costs (in Dollars) | $ 34,700 | |||||
IPO [Member] | Underwriter | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Stock Issued During Period, Shares, New Issues | 1,200,000 |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Mar. 31, 2016 | Jun. 30, 2014 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Mar. 18, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Allocated share base compensation | $ 12,815 | $ 9,280 | $ 7,035 | ||||
2014 Employee Stock Purchase Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Employe Stock Purchase Plan ESPP, 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) | 124,380 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 1,875,620 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 2,000,000 | ||||||
Allocated share base compensation | $ 400 | ||||||
The 2015 Equity Incentive Plan | |||||||
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) | 5,400,000 | 5,300,296 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 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% | ||||||
The 2015 Equity Incentive Plan | Subsequent Event | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Additional Shares Authorized | 1,129,962 | ||||||
The 2005 Plan | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Equity Incentive Plan, Term | 10 years | ||||||
Equity Incentive Plan Potential Increase In Shares | 2.00% | ||||||
Employee Consultant And Directors Stock Options | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Allocated share base compensation | $ 7,900 | 6,700 | 5,900 | ||||
Restricted Stock Units (RSUs) | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Allocated share base compensation | $ 3,900 | $ 2,000 | $ 600 |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Nov. 10, 2015 | Nov. 06, 2014 | |
Equity, Class of Treasury Stock [Line Items] | ||||
Stock buyback program, authorized amount | $ 10,000 | $ 10,000 | ||
Treasury Stock, Value, Acquired, Cost Method | $ 9,865 | $ 345 | ||
November 2014 Share Repurchase Plan | ||||
Equity, Class of Treasury Stock [Line Items] | ||||
Treasury Stock, Shares, Acquired (in Shares) | 735,679 | 29,400 | ||
Treasury Stock, Value, Acquired, Cost Method | $ 9,900 | $ 300 |
Stockholders' Equity (Details 4
Stockholders' Equity (Details 4) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average expected life in years | 5 years | ||
Dividend yield rate | 0.00% | 0.00% | 0.00% |
Employee Consultant And Directors Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Average volatility | 27.10% | 29.90% | 28.60% |
Risk-free interest rate | 1.30% | 1.70% | 1.30% |
Weighted-average expected life in years | 4 years 6 months | 5 years | 4 years 6 months |
Stockholders' Equity (Details 5
Stockholders' Equity (Details 5) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Options | ||
Outstanding Options, Beginning of period | 11,371,891 | 10,771,755 |
Options granted | 2,281,786 | 1,661,862 |
Options exercised | (1,262,663) | (65,000) |
Options cancelled | (73,229) | (135,398) |
Options expired | (77,318) | (861,328) |
Outstanding Options, End of period | 12,240,467 | 11,371,891 |
Exercisable at the end of period | 7,038,372 | 6,281,300 |
Weighted-Average Exercise Price | ||
Outstanding Exercise Price (in dollars per share) | $ 15.12 | $ 15.39 |
Options granted (in dollars per share) | 15.70 | 15.04 |
Options exercised (in dollars per share) | 13.06 | 10.79 |
Options cancelled (in dollars per share) | 13.27 | 15.74 |
Options expired (in dollars per share) | 22.26 | 18.48 |
Outstanding Exercise Price (in dollars per share) | 15.41 | 15.12 |
Exercisable at the end of period | $ 16.31 | $ 16.95 |
Additional Disclosures | ||
Outstanding Contractual Term (in Years) | 4 years 4 months 6 days | 4 years 7 months 13 days |
Outstanding Intrinsic Value | $ 14,438 | $ 1,815 |
Exercisable at the end of period (in Years) | 3 years 4 months 28 days | 3 years 6 months 15 days |
Exercisable aggregate intrinsic value | $ 9,940 | $ 871 |
Stockholders' Equity (Details 6
Stockholders' Equity (Details 6) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | $ 12,815 | $ 9,280 | $ 7,035 |
Employee Consultant And Directors Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | 7,900 | $ 6,700 | $ 5,900 |
Company Stockholders And Outside Consultants | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | $ 200 |
Stockholders' Equity (Details 7
Stockholders' Equity (Details 7) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stockholders' Equity | |||
Weighted-average grant date fair value (in Dollars per share) | $ 3.45 | $ 4.02 | $ 2.79 |
Intrinsic value of options exercised | $ 3,247 | $ 144 | |
Cash received | 13,502 | 571 | $ 55 |
Total fair value of the options vested during the year | $ 6,634 | $ 6,407 | $ 6,067 |
Stockholders' Equity (Details 8
Stockholders' Equity (Details 8) - $ / shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Options | |||
Nonvested at beginning of period | 5,090,591 | 5,617,554 | |
Options granted | 2,281,786 | 1,661,862 | |
Options vested | (2,097,053) | (2,053,427) | |
Options forfeited | (73,229) | (135,398) | |
Nonvested at end of period | 5,202,095 | 5,090,591 | 5,617,554 |
Weighted-Average Grant Date Fair Value | |||
Nonvested at beginning of period (in dollars per share) | $ 3.34 | $ 3.12 | |
Options granted (in dollars per share) | 3.45 | 4.02 | $ 2.79 |
Options vested (in dollars per share) | 3.16 | 3.12 | |
Options forfeited (in dollars per share) | 4.61 | 5.60 | |
Nonvested at end of period (in dollars per share) | $ 3.44 | $ 3.34 | $ 3.12 |
Stockholders' Equity (Details 9
Stockholders' Equity (Details 9) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2015 | Dec. 31, 2015USD ($)itemshares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Sharebased Compensation Arrangement Number Of Current Plans | item | 2 | |||
Outstanding Contractual Term (in Years) | 4 years 4 months 6 days | 4 years 7 months 13 days | ||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 5 years | |||
Assumed Forfeiture Rates Used in Estimates | 8.00% | 8.00% | 8.00% | |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | 0.00% | 0.00% | |
Allocated share base compensation | $ 12,815 | $ 9,280 | $ 7,035 | |
Share-based Compensation Arrangement by Share-based Payment Award, Restricted Stock Units, Number of Shares of Common Stock Per Award (in Shares) | shares | 1 | |||
Employee Consultant And Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 4 years 6 months | 5 years | 4 years 6 months | |
Allocated share base compensation | $ 7,900 | $ 6,700 | $ 5,900 | |
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 11,400 | |||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | $ 3,900 | $ 2,000 | $ 600 | |
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 3 months 18 days | |||
Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 8,200 | |||
2015 Plan and 2005 Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding Contractual Term (in Years) | 10 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Weighted Average Remaining Contractual Term | 5 years | |||
2015 Plan and 2005 Plan | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding Contractual Term (in Years) | 5 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Weighted Average Remaining Contractual Term | 3 years | |||
The 2005 Plan | Maximum | Employee Consultant And Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Expiration Period | 10 years | |||
The 2005 Plan | Existing Employees | Maximum | Employee Consultant And Directors Stock Options | ||||
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 | |||
The 2005 Plan | Existing Employees | Minimum | Employee Consultant And Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 3 years | |||
The 2005 Plan | New Employees | Employee Consultant And Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 4 years | |||
2014 Employee Stock Purchase Plan | ||||
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) | shares | 1,875,620 | |||
Allocated share base compensation | $ 400 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 10) - Restricted Stock Units (RSUs) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
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 | 503,010 | 98,495 |
RSUs granted | 526,707 | 456,406 |
RSUs forfeited | (8,711) | (994) |
RSUs surrendered for taxes | (58,909) | (10,670) |
Common stock delivered for RSUs | (95,557) | (40,227) |
Total RSUs outstanding at the end of the period | 866,540 | 503,010 |
Total Fair Market Value of RSUs Issued | ||
RSUs granted (in Dollars) | $ 7,888 | $ 6,474 |
Stockholders' Equity (Details96
Stockholders' Equity (Details 11) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | $ 12,815 | $ 9,280 | $ 7,035 |
Cost of revenues | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | 2,526 | 1,678 | 1,503 |
Selling, distribution and marketing | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | 192 | 137 | 132 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | 9,185 | 6,800 | 4,701 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Allocated share base compensation | $ 912 | $ 665 | $ 699 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Benefits | |||
Defined Contribution Plan, Employer Matching Contribution, Percent of Match | 50.00% | ||
Defined Contribution Plan, Employer Matching Contribution, Percent of Employees' Gross Pay | 4.00% | ||
Defined Contribution Plan, Maximum Employer Matching Per Employee, Percent | 2.00% | ||
Defined Contribution Plan, Employer Contribution Vesting Period | 4 years | ||
Defined Contribution Plan, Employer Discretionary Contribution Amount | $ 0.7 | $ 0.7 | $ 0.6 |
Defined Benefit Plan, Assumptions Used Calculating Benefit Obligation, Discount Rate | 1.75% | 1.75% | |
Defined Benefit Plan, Benefit Obligation | $ 1.6 | $ 1.1 | |
Pension and Other Postretirement Benefit Plans, Accumulated Other Comprehensive Income (Loss), Net Gains (Losses), before Tax | 0.2 | ||
Pension Expense | $ 0.1 | $ 0.2 |
Commitments and Contingencies98
Commitments and Contingencies (Details) - Distribution Agreement - Allergan plc - Enoxaparin - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2012 | May. 31, 2005 | Dec. 31, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Proceeds from Customers | $ 4.5 | |||
Deferred Revenue | $ 4.5 | $ 2 | $ 2.6 | |
Distribution Agreement With Corporate Partner, Renewal Option Period | 3 years | |||
Deferred Revenue, Period for Recognition | 7 years |
Commitments and Contingencies99
Commitments and Contingencies (Details 2) - MannKind Corporation - Recombinant Human Insulin € in Millions, $ in Millions | 1 Months Ended | 12 Months Ended | |
Jul. 31, 2014EUR (€) | Dec. 31, 2015USD ($) | Jul. 31, 2014USD ($) | |
Supply Commitment [Line Items] | |||
Sales | $ 20.8 | ||
Supply Commitment | |||
Supply Commitment [Line Items] | |||
Supply commitment annual amount commited | € 120.1 | $ 146 | |
Deferred Revenue | € 11 | $ 14 | |
Long-term Supply Commitment, Optional Renewal Period | 2 years |
Commitments and Contingencie100
Commitments and Contingencies (Details 3) - Drug delivery system item in Millions, $ in Millions | 12 Months Ended |
Dec. 31, 2015USD ($)item | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Collaborative Agreement, Upfront Payment | $ 0.5 |
Collaborative Agreement, Milestone Payments | 0.4 |
Collaborative Agreement, Contingent Obligation | $ 1.7 |
Collaborative Agreement, Contingent Purchase Obligation First 12 Months, Units | item | 1 |
Purchase period | 12 months |
Commitments and Contingencie101
Commitments and Contingencies (Details 4) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating Leased Assets [Line Items] | |||
Operating Leases, Rent Expense | $ 3.3 | $ 3.1 | $ 3.1 |
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 Contingencie102
Commitments and Contingencies (Details 5) $ in Thousands | Dec. 31, 2015USD ($) |
Future Minimum Rental Payments [Abstract] | |
2,016 | $ 3,028 |
2,017 | 2,838 |
2,018 | 2,094 |
2,019 | 1,538 |
2,020 | 699 |
Operating Leases, Future Minimum Payments Due, Total | $ 10,197 |
Commitments and Contingencie103
Commitments and Contingencies (Details 6) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2014 | Nov. 30, 2012 | Jan. 31, 2010 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Finite-Lived Intangible Assets, Gross | $ 30,572 | $ 30,588 | ||
Commitments to Purchase Equipment and Raw Materials | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Long-term Purchase Commitment, Amount | 11,000 | |||
Commitment to invest | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Contractual Obligation | $ 15,000 | |||
Commitment to invest | ANP | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Investments in and Advance to Affiliates, Subsidiaries, Associates, and Joint Ventures | 49,000 | |||
Contractual Obligation | 61,000 | |||
Contractual Obligation, Due in Second Year | 12,000 | |||
Land-use rights | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Finite-Lived Intangible Assets, Gross | $ 2,540 | $ 2,540 | ||
Land-use rights | Commitment to invest | ||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||
Finite-Lived Intangible Assets, Gross | $ 1,300 | $ 1,200 |
Litigation (Details)
Litigation (Details) $ in Millions | Apr. 07, 2015USD ($) | Oct. 31, 2011USD ($) | Sep. 21, 2011item |
Pending Litigation [Member] | Enoxaparin Patent Litigation | |||
Loss Contingencies [Line Items] | |||
Number of Alleged Patent Infringements | item | 2 | ||
Litigation, Plaintiff Preliminary Injunction Bond, Amount | $ 100.1 | ||
Settled Litigation [Member] | Eva Hernandez vs International Medication Systems Limited | |||
Loss Contingencies [Line Items] | |||
Litigation Settlement, Amount | $ 3.2 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | 1 Months Ended | ||||
Mar. 31, 2016USD ($)item | Jan. 31, 2016USD ($) | Jan. 08, 2016USD ($)building | Dec. 31, 2015USD ($)building | Dec. 31, 2010USD ($) | |
East West Bank | Mortgage Payable - Due January 2016 | |||||
Subsequent Events | |||||
Principal amount | $ 4.5 | ||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 3.8 | ||||
Rancho Cucamonga | East West Bank | Mortgage Payable - Due January 2016 | |||||
Subsequent Events | |||||
Number of Buildings Securing Loan | building | 1 | ||||
Subsequent Event | East West Bank | Mortgage Payable - Due January 2016 | |||||
Subsequent Events | |||||
Principal amount | $ 3.7 | ||||
Debt Instrument, Periodic Payment Terms, Balloon Payment to be Paid | $ 3.3 | ||||
Debt Instrument, Interest Rate, Stated Percentage | 4.39% | ||||
Subsequent Event | Rancho Cucamonga | East West Bank | Mortgage Payable - Due January 2016 | |||||
Subsequent Events | |||||
Number of Buildings Securing Loan | building | 1 | ||||
Letop | Subsequent Event | ANP | |||||
Subsequent Events | |||||
Business Combination, Consideration Transferred | $ 0.7 | ||||
Hikma Pharmaceuticals PLC | Subsequent Event | |||||
Subsequent Events | |||||
Business Combination, Consideration Transferred | $ 4 | ||||
Number of Injectable Products Acquired | item | 14 | ||||
Number of Different Injectable Chemical Entities | item | 11 |
Quarterly Financial Data (Un106
Quarterly Financial Data (Unaudited) - Quarterly Financial Data (Details) (Imported) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Condensed Income Statements, Captions [Line Items] | |||||||||||
Total net revenues | $ 76,912 | $ 63,868 | $ 53,853 | $ 56,886 | $ 55,877 | $ 59,711 | $ 49,003 | $ 45,870 | $ 251,519 | $ 210,461 | $ 229,681 |
Gross profit | 33,171 | 17,578 | 13,318 | 13,280 | 11,960 | 11,791 | 14,996 | 12,509 | 77,347 | 51,256 | 86,956 |
Net income (loss) | 7,533 | $ (3,008) | $ (6,647) | $ (665) | $ (2,521) | $ (5,379) | $ (1,180) | $ (1,619) | $ (2,787) | $ (10,699) | $ 11,862 |
Decrease to net income due to not recognizing non-operating expense for certain foreign currency transactions | $ 1,100 | ||||||||||
Weighted-average shares used to compute net income (loss) per share: | |||||||||||
Basic (in Shares) | 45,085 | 45,310 | 44,849 | 44,601 | 44,648 | 44,644 | 39,767 | 38,769 | 44,961,000 | 41,957,000 | 38,712,000 |
Diluted (in Shares) | 46,709 | 45,310 | 44,849 | 44,601 | 44,648 | 44,644 | 39,767 | 38,769 | 44,961,000 | 41,957,000 | 38,883,000 |
Net income (loss) per share: | |||||||||||
Basic (in Dollars per share) | $ 0.17 | $ (0.07) | $ (0.15) | $ (0.01) | $ (0.06) | $ (0.12) | $ (0.03) | $ (0.04) | $ (0.06) | $ (0.25) | $ 0.31 |
Diluted (in Dollars per share) | $ 0.16 | $ (0.07) | $ (0.15) | $ (0.01) | $ (0.06) | $ (0.12) | $ (0.03) | $ (0.04) | $ (0.06) | $ (0.25) | $ 0.31 |
Finished Pharmaceutical Products | |||||||||||
Condensed Income Statements, Captions [Line Items] | |||||||||||
Total net revenues | $ 66,092 | $ 57,902 | $ 50,075 | $ 50,872 | $ 49,980 | $ 53,729 | $ 48,901 | $ 45,870 | $ 224,941 | $ 198,480 | $ 229,681 |
Gross profit | 29,357 | 19,302 | 12,634 | 12,853 | 13,132 | 12,122 | 14,961 | $ 12,509 | 74,146 | 52,724 | $ 86,956 |
API | |||||||||||
Condensed Income Statements, Captions [Line Items] | |||||||||||
Total net revenues | 10,820 | 5,966 | 3,778 | 6,014 | 5,897 | 5,982 | 102 | 26,578 | 11,981 | ||
Gross profit | $ 3,814 | $ (1,724) | $ 684 | $ 427 | $ (1,172) | $ (331) | $ 35 | $ 3,201 | $ (1,468) |