Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 09, 2015 | |
Document and Entity Information [Abstract] | ||
Entity Registrant Name | Amphastar Pharmaceuticals, Inc. | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 45,019,525 | |
Amendment Flag | false | |
Entity Central Index Key | 1,297,184 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and Cash Equivalents, at Carrying Value | $ 70,681 | $ 67,828 |
Restricted cash and restricted short-term investments | 1,285 | 1,495 |
Accounts receivable, net | 24,998 | 22,852 |
Inventories, net | 72,422 | 82,332 |
Income tax refund and deposits | 6,297 | 273 |
Prepaid expenses and other assets | 4,200 | 3,683 |
Deferred tax assets | 19,176 | 19,533 |
Total current assets | 199,059 | 197,996 |
Property, plant, and equipment, net | 141,181 | 138,289 |
Goodwill and intangible assets, net | 40,485 | 42,565 |
Other assets | 4,364 | 3,588 |
Deferred tax assets | 9,938 | 6,932 |
Total assets | 395,027 | 389,370 |
Current Liabilities: | ||
Accounts payable | 12,265 | 10,161 |
Accrued liabilities | 22,622 | 13,144 |
Income taxes payable | 2,094 | 3,123 |
Accrued payroll and related benefits | 15,711 | 11,449 |
Current portion of product return accrual | 2,395 | 1,918 |
Current portion of deferred revenue | 643 | 14,013 |
Current portion of long-term debt and capital leases | 14,762 | 7,594 |
Current portion of deferred tax liabilities | 161 | 1,193 |
Total current liabilities | 70,653 | 62,595 |
Long-term product return accrual | 751 | 490 |
Long-term reserve for income tax liabilities | 514 | 499 |
Long-term deferred revenue | 1,500 | 1,982 |
Long-term debt and capital leases, net of current portion | 31,354 | 36,106 |
Long-term deferred tax liabilities | 5,838 | 5,838 |
Other long-term liabilities | 631 | |
Total liabilities | $ 111,241 | $ 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—45,206,511 and 44,646,767 at September 30, 2015 and December 31, 2014, respectively | $ 5 | $ 4 |
Additional paid-in capital | 240,745 | 220,745 |
Retained earnings | 52,790 | 63,110 |
Accumulated other comprehensive loss | (3,760) | (1,654) |
Treasury stock | (5,994) | (345) |
Total stockholders’ equity | 283,786 | 281,860 |
Total liabilities and stockholders’ equity | $ 395,027 | $ 389,370 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock; authorized shares | 300,000,000 | 300,000,000 |
Common stock; shares issued | 45,206,511 | 44,646,767 |
Common stock; outstanding shares | 45,206,511 | 44,646,767 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net revenues | $ 63,868 | $ 59,711 | $ 174,607 | $ 154,584 |
Cost of revenue | 46,290 | 47,920 | 130,431 | 115,288 |
Gross profit | 17,578 | 11,791 | 44,176 | 39,296 |
Operating expenses: | ||||
Selling, distribution, and marketing | 1,171 | 1,454 | 4,163 | 4,066 |
General and administrative | 9,034 | 9,556 | 32,793 | 25,040 |
Research and development | 11,117 | 8,585 | 28,411 | 20,788 |
Impairment of long-lived assets | 4 | 13 | 78 | 361 |
Total operating expenses | 21,326 | 19,608 | 65,445 | 50,255 |
Income (loss) from operations | (3,748) | (7,817) | (21,269) | (10,959) |
Non-operating income (expense): | ||||
Interest income | 83 | 94 | 240 | 154 |
Interest expense | (232) | (504) | (783) | (1,159) |
Other income (expense), net | (379) | 243 | 1,110 | (367) |
Total non-operating income (expense), net | (528) | (167) | 567 | (1,372) |
Income (loss) before income taxes | (4,276) | (7,984) | (20,702) | (12,331) |
Income tax benefit | (1,268) | (2,605) | (10,382) | (4,153) |
Net loss | $ (3,008) | $ (5,379) | $ (10,320) | $ (8,178) |
Net loss per share: | ||||
Basic (in Dollars per share) | $ (0.07) | $ (0.12) | $ (0.23) | $ (0.20) |
Diluted (in Dollars per share) | $ (0.07) | $ (0.12) | $ (0.23) | $ (0.20) |
Weighted-average shares used to compute net loss per share: | ||||
Basic (in Shares) | 45,310 | 44,644 | 44,920 | 41,060 |
Diluted (in Shares) | 45,310 | 44,644 | 44,920 | 41,060 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||||
Net loss | $ (3,008) | $ (5,379) | $ (10,320) | $ (8,178) |
Accumulated other comprehensive income (loss) | ||||
Foreign currency translation adjustment | 374 | (1,535) | (2,106) | (1,803) |
Total accumulated other comprehensive income (loss) | 374 | (1,535) | (2,106) | (1,803) |
Total comprehensive loss | $ (2,634) | $ (6,914) | $ (12,426) | $ (9,981) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (10,320) | $ (8,178) |
Reconciliation to net cash provided by (used in) operating activities: | ||
Impairment of long-lived assets | 78 | 361 |
Loss on disposal of property, plant, and equipment | 19 | 44 |
Depreciation of property, plant, and equipment | 8,516 | 9,235 |
Amortization of product rights, trademarks, and patents | 1,458 | 1,437 |
Imputed interest accretion | 83 | 66 |
Employee share-based compensation expense | 8,687 | 5,952 |
Non-employee share-based compensation expense | 670 | 728 |
Reserve for income tax liabilities | 16 | |
Changes in deferred taxes | (3,541) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,706) | (2,019) |
Inventories, net | 8,549 | 1,609 |
Income tax refund and deposits | 21 | 2,690 |
Prepaid expenses and other assets | (6,516) | (1,318) |
Income taxes payable | (1,083) | (5,456) |
Accounts payable and accrued liabilities | 3,463 | 3,578 |
Net cash provided by (used in) operating activities | 7,394 | 8,729 |
Cash Flows From Investing Activities: | ||
Acquisition of business | (18,352) | |
Purchases of property, plant, and equipment | (10,685) | (11,118) |
Capitalized labor, overhead, and interest on self-constructed assets | (1,242) | (555) |
Proceeds from the sale of property, plant and equipment | 51 | |
Decrease (increase) in restricted cash | 210 | (170) |
Deposits and other assets, net | (800) | 350 |
Net cash used in investing activities | (12,466) | (29,845) |
Cash Flows From Financing Activities: | ||
Net proceeds from issuance of common stock | 38,018 | |
Net proceeds from equity plans | 11,539 | 216 |
Cost related to public offering | (1,920) | |
Repurchase of common stock | (857) | |
Payments on treasury stock | (5,687) | |
Proceeds from borrowing under lines of credit | 25,000 | |
Repayments under lines of credit | (40,000) | |
Proceeds from issuance of long-term debt | 6,786 | 26,505 |
Principal payments on long-term debt | (3,973) | (7,149) |
Net Cash Provided by Financing Activities | 7,808 | 40,670 |
Effect of exchange rate changes on cash | 117 | (260) |
Net increase in cash and cash equivalents | 2,853 | 19,294 |
Cash and cash equivalents at beginning of period | 67,828 | 53,587 |
Cash and cash equivalents at end of period | 70,681 | 72,881 |
Noncash Investing and Financing Activities: | ||
Equipment acquired under capital leases | 150 | 78 |
Supplemental Disclosures of Cash Flow Information: | ||
Interest paid | 1,345 | 978 |
Income taxes paid | $ 45 | $ 86 |
General
General | 9 Months Ended |
Sep. 30, 2015 | |
General | |
General | 1. Genera l 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 (hereinafter referred to as “the Company”). The Company is a specialty pharmaceutical company that primarily develops, manufactures, markets, and sells generic and proprietary injectable and inhalation products, including products with high technical barriers to market entry. Additionally, in 2014, the Company commenced sales of insulin active pharmaceutical ingredient, or API products. Most of the Company’s products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company’s insulin API products are primarily sold to other pharmaceutical companies for use in their own products. The Company’s inhalation products will be primarily distributed through drug retailers once they are brought to market. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements of the Company for the year ended December 31, 201 4 and the notes thereto as filed with the Securities and Exchange Commission in the Company’s A nnual Report on Form 10-K for the year ended December 31, 2014. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with generally accepted accounting principles, or GAAP, have been condensed or omitted from the accompanying condensed consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from the audited financial statements. The accompanying interim financial statements are unaudited, but reflect all adjustments which are, in the opinion of management, necessary for a fair statement of the Company’s consolidated financial position, results of operations, comprehensive loss and cash flows for the periods presented. Unless otherwise noted, all such adjustments are of a normal, recurring nature. The Company’s results of operations , comprehensive loss and cash flows for the interim periods are not necessarily indicative of the results of operations and cash flows that it may achieve in future periods. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 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 condensed consolidated financial statements. The unaudited condensed consolidated financial statements have been prepared in accordance with the requirements of Form 10-Q and Rule 10-01 of Regulation S-X. 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. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The accompanying condensed 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 subsidiaries 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 Company’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 exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive loss. Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. Comprehensive Loss For the Company’s French subsidiary, AFP, the Euro, which is the local currency, has been determined to be the functional currency. The results of AFP’s operations are translated into USD using the average exchange rates during the period. For the three and nine months ended September 30 , 201 5 and 2014 , the Company included its foreign currency translation as part of its comprehensive loss. 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 1 2 ). 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. 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 April 2014, the FASB issued an accounting standards update that raised the threshold for disposals to qualify as discontinued operations and allows companies to have significant continuing involvement with and continuing cash flows from or to the discontinued operation. It also requires additional disclosures for discontinued operations and new disclosures for individually material disposal transactions that do not meet the definition of a discontinued operation. This guidance is effective for fiscal years beginning after December 15, 2014, which is the Company's fiscal year 2015, with early adoption permitted. T he adoption of the guidance did not have a material impact on the Company's consolidated financial statements. In May 2014, the 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 year 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 year 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 year 2016. Early application is permitted. The new guidance must be applied prospectively. 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. |
Business Acquisition
Business Acquisition | 9 Months Ended |
Sep. 30, 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 1 2 ): 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. 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 condensed 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 condensed consolidated results of operations. The following unaudited pro forma financial information for the nine months ended September 30 , 201 5 and 201 4 gives effect to the transaction as if it had 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. Nine Months Ended September 30, 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 | 9 Months Ended |
Sep. 30, 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 1 6 ). 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: Nine Months Ended September 30, 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: Nine Months Ended September 30, 2015 2014 (in thousands) Beginning balance $ $ Provision for product returns Credits issued to third parties Ending balance $ $ For the nine months ended September 30, 2015 and 2014 , the Company’s aggregate product return rate was 1.1% and 1. 2 % of qualified sales, respectively. |
Loss per Share
Loss per Share | 9 Months Ended |
Sep. 30, 2015 | |
Loss per Share | |
Loss per Share | 5. Loss per Share Basic 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 three and nine months ended September 30, 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 three and nine months ended September 30, 2015 , net loss per share were 12,471,789; 877,665 , and 165,167 , respectively. Additionally, as the Company reported a net loss for the three and nine months ended September 30, 2014 , total stock options and nonvested RSUs excluded from the three and nine months ended September 30, 2014, net loss per share were 11,511,431 and 529,774 , respectively. The following table provides the calculation of basic and diluted net loss per share for each of the periods presented: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands, except per share data) Basic and dilutive numerator: Net 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 loss per share — basic $ $ $ $ Net loss per share — diluted $ $ $ $ |
Segment Reporting
Segment Reporting | 9 Months Ended |
Sep. 30, 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 ® , naloxone, lidocaine jelly, as well as various other critical and non-critical care drugs. The API segment manufactures and distributes recombinant human insulin and porcine insulin. Selected financial information by reporting segment is presented below: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands) Net revenues: Finished pharmaceutical products $ $ $ $ API Total net revenues Gross Profit: Finished pharmaceutical products API Total gross profit Operating expenses Loss from operations Non-operating income (expenses) 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 Three Months Ended Nine Months Ended September 30, September 30, September 30, December 31, 2015 2014 2015 2014 2015 2014 (in thousands) U.S. $ $ $ $ $ $ China — — — — France Total $ $ $ $ $ $ |
Customer and Supplier Concentra
Customer and Supplier Concentration | 9 Months Ended |
Sep. 30, 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 three and nine months ended September 30 , 201 5 and 201 4 and accounts receivable as of September 30, 2015 and December 31, 201 4 . The following table provides accounts receivable and net revenues information for these major customers: % of Total Accounts % of Net Receivable Revenue Three Months Ended Nine Months Ended September 30, December 31, September 30, September 30, 2015 2014 2015 2014 2015 2014 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 | 9 Months Ended |
Sep. 30, 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 September 30, 2015 and December 31, 201 4 , 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 September 30, 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 September 30, 2015 and December 31, 201 4 , there were no significant adjustments to fair value for nonfinancial assets or liabilities . |
Goodwill and Intangible Assets
Goodwill and Intangible Assets | 9 Months Ended |
Sep. 30, 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 * — API * — Subtotal * — As of September 30, 2015 * $ $ $ 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 * — API * — Subtotal * — As of December 31, 2014 * $ $ $ * Intangible assets with indefinite lives have an indeterminable average life. Goodwill The Changes in the carrying amounts of goodwill were as follows: September 30, December 31, 2015 2014 (in thousands) Beginning balance $ $ Goodwill related to acquisition of business — Currency translation and other adjustments Ending balance $ $ Primatene ® Mist 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 September 30, 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 ® Mist that utilizes hydrofluoroalkane, or HFA, as a propellant. In 2013, the Company filed a new drug application, or NDA, for Primatene ® Mist 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 and actual use) to assess consumers’ ability to use the device correctly to support approval of the product in the over-the-counter setting. Additionally the CRL noted current Good Manufacturing Practices, or cGMP, deficiencies in a recent inspection of the Company’s API supplier’s manufacturing facility, which produces epinephrine, and indicated that the Company’s NDA could not be approved until these issues were resolved. Subsequent to the receipt of the CRL, the supplier notified the Company that the cGMP deficiencies were satisfactorily resolved. Accordingly, the Company believes this condition for approval has been satisfied. 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 is in the process of generating the remaining data required by the CRL and will submit an NDA Amendment 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 ® Mist HFA, the Company’s plan to submit an NDA amendment to address the FDA’s concerns, the long history of the Primatene ® Mist 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. |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 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: September 30, 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 | 9 Months Ended |
Sep. 30, 2015 | |
Property, Plant, and Equipment | |
Property, Plant, and Equipment | 11. Property, Plant, and Equipment Property, plant, and equipment consist of the following: September 30, 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 $ $ As of September 30, 2015 , the Company had $2.9 million in capitalized manufacturing equipment that is intended to be used specifically for the manufacture of Primatene ® Mist HFA. The Company will continue to monitor developments with the FDA as it relates to its Primatene ® Mist HFA indefinite lived intangible asset in determining if there is an impairment of these related fixed assets (see Note 9). |
Debt
Debt | 9 Months Ended |
Sep. 30, 2015 | |
Debt | |
Debt | 1 2 . Debt Debt consists of the following: September 30, 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 is payable in monthly installments with a final balloon payment of $3.8 million. The loan is 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 bears a variable interest rate at the prime rate as published by The Wall Street Journal, with a minimum interest rate of 5.00% , and matures in January 2016. 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 September 30, 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 , 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 b ore 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 statement at September 30, 2015. The facility bears interest at a fixed rate of 4.48% and matures in January 2019. As of September 30, 2015, the loan had a book value of $5.1 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 September 30, 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 revolving 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 September 30, 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 September 30, 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 currency 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 2014, the Company made a principal payment of €4.9 million, or $6.0 million. As of September 30, 2015 , the payment obligation had a book value of €6.8 million, or $ 7.6 million, which approximates fair value. The fair value of the payment obligation was determined by using the interest rate associated with the Company’s acquisition loan with Cathay Bank that bears a variable interest rate at the prime rate as published by The Wall Street Journal , with a minimum interest rate of 4.00% . 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. Covenants At September 30, 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 the debt 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 20 20 . The cost of equipment under capital leases was $1.5 million at September 30, 2015 and December 31, 201 4 . The accumulated depreciation of equipment under capital leases was $0.6 million and $0. 4 million at September 30, 2015 and December 31, 201 4 , respectively. Depreciation of assets recorded under capital leases is included in depreciation expense in the accompanying consolidated financial statements. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2015 | |
Income Taxes | |
Income Taxes | 1 3 . Income Taxes The following table sets forth the Company’s income tax provision for the periods indicated: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands) Loss before taxes $ $ $ $ Income tax benefit Net loss $ $ $ $ Income tax benefit as a percentage of income before income taxes % % % % The Company’s income tax benefit for the three and nine months ended September 30, 2015 was 29.7% and 50.1% of income before income taxes, respectively. The blended effective income tax rate expected for the year ended December 31, 201 5 is 51.5% . This tax provision rate factors in various domestic deductions and the impact of foreign o perations on the Company’s overall tax rate. The Company’s income tax benefit of 32.6% and 33.7% during the three and nine months ended September 30, 2014 , respectively, factored in similar deductions as well as the impact of foreign operations. 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, projected future taxable income, and tax-planning strategies. Based on all available evidence, management believes that the Company’s deferred tax assets will more likely than not be realized in future years. In connection with the AFP purchase accounting, 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 deferred 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. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2015 | |
Stockholders' Equity | |
Stockholders' Equity | 1 4 . Stockholders' Equity A summary of the changes in stockholders’ equity for the nine months ended September 30, 2015 consisted of the following: Nine Months Ended September 30, 2015 (in thousands) Stockholders’ equity as of December 31, 2014 $ Net loss Accumulated other comprehensive loss Exercise of stock options Nonemployee share-based compensation expense Employee share-based compensation expense Repurchase of common stock (1) Purchase of treasury stock Stockholders’ equity as of September 30, 2015 $ (1) Repurchase of common stock relating to the tax withholding of equity award settlements. 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 ends on November 30, 2015. As of September 30, 2015, the Company has not issued any shares of common stock under the ESPP and 2,000,000 shares of its common stock remained available for issuance. For the three and nine months ended September 30, 2015 , the Company recorded ESPP expense of $0.1 million and $0.4 million, respectively . Share Buyback Program On November 6, 2014 the Company’s Board of Directors authorized a $10.0 million share buyback program, which is expected to continue for an indefinite period of time. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. Purchases are 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 Securities 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 208,000 and 403,700 shares of its common stock during the three and nine months ended September 30, 2015 totaling $3.0 million and $ 5.7 million, respectively. 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 percent ( 2.5% ) of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares as determined by the Board of Directors. As of the effective date, there were 5,300,296 shares available for grant under the 2015 Plan. 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 straight-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. The weighted-averages for key assumptions used in determining the fair value of options granted during the three and nine months ended September 30, 2015 and 2014 are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 (1) 2015 2014 Average volatility % — % % % Risk-free interest rate % — % % % Weighted-average expected life in years — Dividend yield rate — % — % — % — % (1) The Company did not grant any stock options during the three months ended September 30, 2014. A summary of option activity under all plans for the nine months ended September 30, 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 September 30, 2015 $ $ Exercisable as of September 30, 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 September 30, 2015 . For the three and nine months ended September 30, 2015 , the Company recorded stock option expense related to employees under all plans of $ 1.9 million and $ 5.8 million, respectively. For the three and nine months ended September 30, 2014 , the Company recorded stock option expense related to employees under all plans of $ 2.0 million and $ 5.1 million, respectively. Information relating to option grants and exercises is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (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 September 30, 2015 , and changes during the nine months ended September 30, 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 September 30, 2015 As of September 30, 2015 , there was $ 13.5 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 2.1 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 $1.1 million and $2.8 million for the three and nine months ended September 30, 2015, respectively, for these RSU awards, compared to the prior year expense of $0.5 million and $1.2 million for the three and nine months ended September 30, 2014, respectively . As of September 30, 2015, there was $9.3 million of total unrecognized compensation cost, net of forfeitures, related to nonvested RSU-based compensation arrangements granted under the 2005 Plan. The cost is expected to be recognized over a weighted-average period of 2.5 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, 2014 RSUs granted $ RSUs forfeited Common stock delivered RSUs surrendered for taxes RSUs outstanding at September 30, 2015 (1) The total fair market value is derived from the number of RSUs granted times the current stock price on the date of grant. The Company recorded share-based compensation expense under all plans and is included in the Company’s consolidated statement of operations as follows: Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (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 | 9 Months Ended |
Sep. 30, 2015 | |
Employee Benefits | |
Employee Benefits | 15. Employee Benefits 401(k) Plan The Company has a defined contribution 401(k) plan, or the Plan, whereby eligible employees voluntarily contribute up to a defined percentage of their annual compensation. The Company matches contributions at a rate of 50% on the first 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 three and nine months ended September 30, 2015 were approximately $0.2 million and $0.5 million, respectively, compared to the prior year expense of $0.2 million and $0.5 million for the three and nine months ended September 30, 2014, 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 September 30, 2015 and December 31, 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 $1.7 million and $1.1 million at September 30, 2015 and December 31, 2014, respectively. The Company recorded an immaterial amount of expense under the plan for the three months ended September 30, 2015, and $0.1 million for the nine months ended September 30, 2015. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2015 | |
Commitments and Contingencies | |
Commitments and Contingencies | 1 6 . 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 September 30, 2015 and December 31, 2014, the balance of the deferred revenue was $2.1 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. Under the agreement, the non-refundable reservation fee is considered as partial payment for the purchase commitment quantity for 2015. The Company classified the amount as deferred revenue. As of September 30, 2015, 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. 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 September 30, 2015 the Company has paid an upfront payment of $0.5 million and a $0.1 million milestone payment under this agreement, which was classified as research and development expense. The Company is obligated to pay up to an additional $1.9 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 receives appropriate regulatory approval, the Company intends to enter into a commercial supply agreement with such medical device manufacturer for a minimum purchase of 1.0 million units during the first 12 months. Operating Lease Agreements The Company leases real and personal property, in the normal course of business, under various non-cancelable operating leases. The Company, at its option, can renew a substantial portion of its leases, at the market rate, for various renewal periods ranging from one to six years. Rental expense under these leases for the three and nine months ended September 30, 2015 was approximately $0.8 million and $2.5 million, respectively, compared to $0.8 million and $2.3 million for the three and nine months ended September 30, 2014, respectively . Purchase Commitments As of September 30, 2015 , the Company has entered into commitments to purchase equipment and raw materials for an aggregate of $7.3 million. The Company anticipates that most of these commitments will be fulfilled by 201 6 . 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 September 30, 2015 , the Company had invested approximately $4 9 .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 201 7 . 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 | 9 Months Ended |
Sep. 30, 2015 | |
Litigation | |
Litigation | 1 7 . 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 harbor. 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 their infringement contentions. The Company intends to consider all appeal options, and 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 objections 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 December 28, 2015, and Aventis’s answering appeal brief is due to be filed by January 27, 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. 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 Complaint 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. Other Litigation The Company is also subject to various other claims and lawsuits from time-to-time arising in the ordinary course of business. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. In the opinion of management, the ultimate resolution of any such matters is not expected to have a 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 | 9 Months Ended |
Sep. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 18. Subsequent Events On November 10, 2015, the Company’s Board of Directors authorized an increase of $10.0 million to the Company’s share buyback program, which is expected to continue for an indefinite period of time. The primary goal of the program is to offset dilution created by the Company’s equity compensation programs. Purchases may be 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 Securities 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. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation All significant intercompany activity has been eliminated in the preparation of the condensed consolidated financial statements. The unaudited condensed consolidated financial statements have been prepared in accordance with the requirements of Form 10-Q and Rule 10-01 of Regulation S-X. 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. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the consolidated financial position, results of operations, and cash flows of the Company. The accompanying condensed 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 subsidiaries 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 Company’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 exchange rates during the period. Assets and liabilities are translated at the rate of exchange prevailing on the balance sheet date. Equity is translated at the prevailing rate of exchange at the date of the equity transactions. Translation adjustments are reflected in stockholders’ equity and are included as a component of other comprehensive loss. Additionally, the Company does not undertake hedging transactions to cover its foreign currency exposure. |
Comprehensive Loss | Comprehensive Loss For the Company’s French subsidiary, AFP, the Euro, which is the local currency, has been determined to be the functional currency. The results of AFP’s operations are translated into USD using the average exchange rates during the period. For the three and nine months ended September 30 , 201 5 and 2014 , the Company included its foreign currency translation as part of its comprehensive loss. |
Financial Instruments | 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 1 2 ). |
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. |
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 April 2014, the FASB issued an accounting standards update that raised the threshold for disposals to qualify as discontinued operations and allows companies to have significant continuing involvement with and continuing cash flows from or to the discontinued operation. It also requires additional disclosures for discontinued operations and new disclosures for individually material disposal transactions that do not meet the definition of a discontinued operation. This guidance is effective for fiscal years beginning after December 15, 2014, which is the Company's fiscal year 2015, with early adoption permitted. T he adoption of the guidance did not have a material impact on the Company's consolidated financial statements. In May 2014, the 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 year 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 year 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 year 2016. Early application is permitted. The new guidance must be applied prospectively. 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. |
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 1 6 ). 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. |
Business Acquisition (Tables)
Business Acquisition (Tables) | 9 Months Ended |
Sep. 30, 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 | Nine Months Ended September 30, 2015 2014 (in thousands, except per share data) Net revenues $ $ Net loss Diluted net loss per share $ $ |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Revenue Recognition | |
Schedule of chargeback provision analysis | Nine Months Ended September 30, 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 | Nine Months Ended September 30, 2015 2014 (in thousands) Beginning balance $ $ Provision for product returns Credits issued to third parties Ending balance $ $ |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Loss per Share | |
Schedule of basic and diluted net loss per share calculation | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands, except per share data) Basic and dilutive numerator: Net 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 loss per share — basic $ $ $ $ Net loss per share — diluted $ $ $ $ |
Segment Reporting (Tables)
Segment Reporting (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Segment Reporting | |
Schedule of financial information by reporting segment | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands) Net revenues: Finished pharmaceutical products $ $ $ $ API Total net revenues Gross Profit: Finished pharmaceutical products API Total gross profit Operating expenses Loss from operations Non-operating income (expenses) Loss before income taxes $ $ $ $ |
Schedule of net revenues and long-lived assets by geographic region | Net Revenue Long-Lived Assets Three Months Ended Nine Months Ended September 30, September 30, September 30, December 31, 2015 2014 2015 2014 2015 2014 (in thousands) U.S. $ $ $ $ $ $ China — — — — France Total $ $ $ $ $ $ |
Customer and Supplier Concent30
Customer and Supplier Concentration (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Customer and Supplier Concentration | |
Schedule of accounts receivable and net revenues by major customer | % of Total Accounts % of Net Receivable Revenue Three Months Ended Nine Months Ended September 30, December 31, September 30, September 30, 2015 2014 2015 2014 2015 2014 Allergan plc (1) % % % % % % AmerisourceBergen % % % % % % Cardinal Health % % % % % % MannKind Corporation % % % — % — McKesson % % % % % % (1) In June 2015, Actavis plc adopted Allergan plc as its new global name. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 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 September 30, 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) | 9 Months Ended |
Sep. 30, 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 * — API * — Subtotal * — As of September 30, 2015 * $ $ $ 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 * — 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 | September 30, December 31, 2015 2014 (in thousands) Beginning balance $ $ Goodwill related to acquisition of business — Currency translation and other adjustments Ending balance $ $ |
Inventories (Tables)
Inventories (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Inventories | |
Schedule of inventories | September 30, 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 $ $ |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Debt | |
Schedule of debt | September 30, 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 $ $ |
Income Taxes (Tables)
Income Taxes (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Income Taxes | |
Schedule of income tax provision | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (in thousands) Loss before taxes $ $ $ $ Income tax benefit Net loss $ $ $ $ Income tax benefit as a percentage of income before income taxes % % % % |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Stockholders' Equity | |
Schedule of changes in stockholders' equity | Nine Months Ended September 30, 2015 (in thousands) Stockholders’ equity as of December 31, 2014 $ Net loss Accumulated other comprehensive loss Exercise of stock options Nonemployee share-based compensation expense Employee share-based compensation expense Repurchase of common stock (1) Purchase of treasury stock Stockholders’ equity as of September 30, 2015 $ (1) Repurchase of common stock relating to the tax withholding of equity award settlements. |
Schedule of key assumptions to determine fair value of options | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 (1) 2015 2014 Average volatility % — % % % Risk-free interest rate % — % % % Weighted-average expected life in years — Dividend yield rate — % — % — % — % The Company did not grant any stock options during the three months ended September 30, 2014. |
Schedule of the summary of option activity under all plans | Weighted-Average Weighted-Average Remaining Aggregate Exercise Contractual Intrinsic Options Price Term (Years) Value (1) (in thousands) Outstanding as of December 31, 2014 $ Options granted Options exercised Options cancelled Options expired Outstanding as of September 30, 2015 $ $ Exercisable as of September 30, 2015 $ $ The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying awards and the estimated fair value of the Company’s common stock for those awards that have an exercise price below the estimated fair value at September 30, 2015 . |
Schedule of information relating to options grants | Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 (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 | Weighted-Average Grant Date Options Fair Value Nonvested as of December 31, 2014 $ Options granted Options vested Options forfeited Nonvested as of September 30, 2015 |
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, 2014 RSUs granted $ RSUs forfeited Common stock delivered RSUs surrendered for taxes RSUs outstanding at September 30, 2015 The total fair market value 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 | Three Months Ended September 30, Nine Months Ended September 30, 2015 2014 2015 2014 (in thousands) Cost of revenues $ $ $ $ Operating expenses: Selling, distribution and marketing General and administrative Research and development Total share-based compensation $ $ $ $ |
Business Acquisition (Details)
Business Acquisition (Details) - Apr. 30, 2014 € in Millions, $ in Millions | USD ($) | EUR (€) |
Merck Sharpe & Dohme's API | ||
Business Acquisition [Line Items] | ||
Business Combination, Consideration Transferred | $ 34.4 | € 24.8 |
Business Acquisition (Details 2
Business Acquisition (Details 2) - Merck Sharpe & Dohme's API € in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | ||||
Dec. 31, 2014USD ($) | Dec. 31, 2014EUR (€) | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) | Sep. 30, 2015USD ($) | Sep. 30, 2015EUR (€) | |
Business Acquisition [Line Items] | ||||||
At Closing, April 2014 | $ 18,352 | € 13,252 | ||||
December 2,014 | $ 5,989 | € 4,899 | ||||
December 2,015 | $ 3,582 | € 3,186 | ||||
December 2,016 | 3,582 | 3,186 | ||||
December 2,017 | 562 | 500 | ||||
Total | $ 32,067 | € 25,023 |
Business Acquisition (Details 3
Business Acquisition (Details 3) € in Thousands, $ in Thousands | Sep. 30, 2015USD ($) | Dec. 31, 2014USD ($) | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) | Dec. 31, 2013USD ($) |
Business Acquisition [Line Items] | |||||
Goodwill | $ 3,832 | $ 4,467 | $ 280 | ||
Merck Sharpe & Dohme's API | |||||
Business Acquisition [Line Items] | |||||
Inventory | $ 21,554 | € 15,565 | |||
Real property | 6,647 | 4,800 | |||
Machinery & equipment | 9,417 | 6,800 | |||
Intangibles | 111 | 80 | |||
Goodwill | 4,369 | 3,155 | |||
Total assets acquired | 42,098 | 30,400 | |||
Accrued liabilities | 3,358 | 2,425 | |||
Deferred tax liabilities | 4,369 | 3,155 | |||
Total liabilities assumed | 7,727 | 5,580 | |||
Total fair value of consideration transferred | $ 34,371 | € 24,820 |
Business Acquisition (Details 4
Business Acquisition (Details 4) - Merck Sharpe & Dohme's API - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Business Acquisition [Line Items] | ||
Net revenues | $ 174,607 | $ 156,868 |
Net loss | $ (10,320) | $ (9,407) |
Diluted net loss per share (in Dollars per share) | $ (0.23) | $ (0.23) |
Business Acquisition (Details 5
Business Acquisition (Details 5) € in Millions, $ in Millions | Jun. 01, 2014 | Apr. 22, 2014USD ($) | Apr. 30, 2014USD ($) | Sep. 30, 2015USD ($) | Apr. 30, 2014EUR (€) |
Note Payable To Merck | |||||
Debt Instrument | |||||
Debt Instrument, Face Amount | $ 16 | € 11.6 | |||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||
Debt Instrument, Term | 4 years | ||||
Note Payable To Merck | Minimum | |||||
Debt Instrument | |||||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% | 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 | ||||
Merck Sharpe & Dohme's API | Cathay Bank | Acquisition Loan - Due April 2019 | |||||
Debt Instrument | |||||
Debt Instrument, Face Amount | $ 21.9 | ||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | ||||
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 | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue Recognition | ||
Beginning balance | $ 11,872 | $ 18,104 |
Provision related to sales made in the current period | 121,714 | 118,643 |
Credits issued to third parties | (121,914) | (124,449) |
Ending balance | $ 11,672 | $ 12,298 |
Revenue Recognition (Details 2)
Revenue Recognition (Details 2) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue Recognition | ||
Beginning balance | $ 2,408 | $ 4,592 |
Provision for product returns | 1,971 | (261) |
Credits issued to third parties | (1,233) | (1,042) |
Ending balance | $ 3,146 | $ 3,289 |
Revenue Recognition (Details 3)
Revenue Recognition (Details 3) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue Recognition | ||
Product Return Rate, Percentage | 1.10% | 1.20% |
Loss Per Share (Details)
Loss Per Share (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
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 | 12,471,789 | 11,511,431 | 12,471,789 | 11,511,431 |
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 | 877,665 | 529,774 | 877,665 | 529,774 |
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 | 165,167 | 165,167 |
Loss Per Share (Details 2)
Loss Per Share (Details 2) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Basic and dilutive numerator: | ||||
Net loss | $ (3,008) | $ (5,379) | $ (10,320) | $ (8,178) |
Denominator: | ||||
Shares outstanding | 45,310 | 44,642 | 44,920 | 41,058 |
Contingently issuable shares - vested RSUs | 2 | 2 | ||
Weighted-average shares outstanding—basic | 45,310 | 44,644 | 44,920 | 41,060 |
Net effect of dilutive securities: | ||||
Weighted-average shares outstanding—diluted | 45,310 | 44,644 | 44,920 | 41,060 |
Net loss per share—basic (in Dollars per share) | $ (0.07) | $ (0.12) | $ (0.23) | $ (0.20) |
Net loss per share—diluted (in Dollars per share) | $ (0.07) | $ (0.12) | $ (0.23) | $ (0.20) |
Segment Reporting (Details)
Segment Reporting (Details) | 9 Months Ended |
Sep. 30, 2015segment | |
Segment Reporting | |
Number of Reportable Segments | 2 |
Segment Reporting (Details 2)
Segment Reporting (Details 2) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Net revenues: | ||||
Net Revenue | $ 63,868 | $ 59,711 | $ 174,607 | $ 154,584 |
Gross Profit: | ||||
Gross Profit | 17,578 | 11,791 | 44,176 | 39,296 |
Operating expenses | 21,326 | 19,608 | 65,445 | 50,255 |
Income (loss) from operations | (3,748) | (7,817) | (21,269) | (10,959) |
Non-operating income (expenses) | (528) | (167) | 567 | (1,372) |
Income (loss) before income taxes | (4,276) | (7,984) | (20,702) | (12,331) |
Finished pharmaceutical products | ||||
Net revenues: | ||||
Net Revenue | 57,902 | 53,729 | 158,849 | 148,500 |
Gross Profit: | ||||
Gross Profit | 19,302 | 12,122 | 44,789 | 39,592 |
API | ||||
Net revenues: | ||||
Net Revenue | 5,966 | 5,982 | 15,758 | 6,084 |
Gross Profit: | ||||
Gross Profit | $ (1,724) | $ (331) | $ (613) | $ (296) |
Segment Reporting (Details 3)
Segment Reporting (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | $ 63,868 | $ 59,711 | $ 174,607 | $ 154,584 | |
Long-Lived Assets | 141,181 | 141,181 | $ 138,289 | ||
UNITED STATES | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | 62,955 | 53,729 | 168,705 | 148,500 | |
Long-Lived Assets | 100,415 | 100,415 | 102,313 | ||
CHINA | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Long-Lived Assets | 27,535 | 27,535 | 22,170 | ||
FRANCE | |||||
Revenues from External Customers and Long-Lived Assets [Line Items] | |||||
Net Revenue | 913 | $ 5,982 | 5,902 | $ 6,084 | |
Long-Lived Assets | $ 13,231 | $ 13,231 | $ 13,806 |
Customer and Supplier Concent50
Customer and Supplier Concentration (Details) - Customer Concentration Risk [Member] - item | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Revenue, Major Customer [Line Items] | |||||
Number of major customers that are wholesale distributors | 3 | ||||
Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Number of major customers | 5 | 5 | |||
Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Number of major customers | 5 | 5 | 5 | 5 | |
Allergan plc | Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 17.00% | 18.00% | |||
Allergan plc | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 22.00% | 35.00% | 22.00% | 33.00% | |
AmerisourceBergen | Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 13.00% | 5.00% | |||
AmerisourceBergen | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 17.00% | 14.00% | 17.00% | 15.00% | |
Cardinal Health | Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 17.00% | 15.00% | |||
Cardinal Health | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 14.00% | 13.00% | 16.00% | 14.00% | |
MannKind Corporation | Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 5.00% | 21.00% | |||
MannKind Corporation | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 7.00% | 7.00% | |||
McKesson | Accounts receivable | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 25.00% | 13.00% | |||
McKesson | Net Revenues | |||||
Revenue, Major Customer [Line Items] | |||||
Major Customers | 25.00% | 19.00% | 22.00% | 23.00% |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Restricted short-term investments: | ||
Fair value measurement | $ 49,205 | $ 44,489 |
Money market accounts | ||
Cash equivalents: | ||
Cash equivalents | 47,920 | 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 | 49,205 | 44,489 |
Level 1 | Money market accounts | ||
Cash equivalents: | ||
Cash equivalents | 47,920 | 42,994 |
Level 1 | Certificates of deposit | ||
Restricted short-term investments: | ||
Restricted short-term investments | $ 1,285 | $ 1,495 |
Fair Value Measurements (Deta52
Fair Value Measurements (Details 2) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2014 | |
Fair Value Measurements | ||
Assets, Fair Value Adjustment | $ 0 | $ 0 |
Liabilities, Fair Value Adjustment | $ 0 | $ 0 |
Goodwill and Intangible Asset53
Goodwill and Intangible Assets (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended | |
Sep. 30, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 12 years | 12 years | |
Finite-Lived Intangible Assets, Gross | $ 30,577 | $ 30,588 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 23,149 | 21,715 | |
Finite-Lived Intangible Assets, Net, Total | 7,428 | 8,873 | |
Balance, Accumulated Amortization | 23,149 | 21,715 | |
Indefinite-lived intangible assets | |||
Goodwill | 3,832 | 4,467 | $ 280 |
Indefinite Lived Intangible Assets Including Goodwill Gross | 33,057 | 33,692 | |
Indefinite Lived Intangible Assets Including Goodwill Net | 33,057 | 33,692 | |
Original cost | 63,634 | 64,280 | |
Net Book Value | 40,485 | 42,565 | |
Finished pharmaceutical products | |||
Indefinite-lived intangible assets | |||
Goodwill | 280 | 280 | |
API | |||
Indefinite-lived intangible assets | |||
Goodwill | 3,552 | 4,187 | |
Trademarks | |||
Indefinite-lived intangible assets | |||
Indefinite-lived intangible assets, carrying value | $ 29,225 | $ 29,225 | |
Product rights | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 12 years | 12 years | |
Finite-Lived Intangible Assets, Gross | $ 27,134 | $ 27,134 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 22,233 | 20,896 | |
Finite-Lived Intangible Assets, Net, Total | 4,901 | 6,238 | |
Balance, Accumulated Amortization | $ 22,233 | $ 20,896 | |
Patents | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 10 years | 10 years | |
Finite-Lived Intangible Assets, Gross | $ 293 | $ 293 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 100 | 78 | |
Finite-Lived Intangible Assets, Net, Total | 193 | 215 | |
Balance, Accumulated Amortization | $ 100 | $ 78 | |
Trademarks | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 11 years | 11 years | |
Finite-Lived Intangible Assets, Gross | $ 15 | $ 19 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 15 | 15 | |
Finite-Lived Intangible Assets, Net, Total | 4 | ||
Balance, Accumulated Amortization | $ 15 | $ 15 | |
Land-use rights | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 39 years | 39 years | |
Finite-Lived Intangible Assets, Gross | $ 2,540 | $ 2,540 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 271 | 221 | |
Finite-Lived Intangible Assets, Net, Total | 2,269 | 2,319 | |
Balance, Accumulated Amortization | $ 271 | $ 221 | |
Other intangible assets | |||
Definite-lived intangible assets | |||
Weighted-Average Life (Years) | 1 year | 1 year | |
Finite-Lived Intangible Assets, Gross | $ 595 | $ 602 | |
Finite-Lived Intangible Assets, Accumulated Amortization | 530 | 505 | |
Finite-Lived Intangible Assets, Net, Total | 65 | 97 | |
Balance, Accumulated Amortization | $ 530 | $ 505 |
Goodwill and Intangible Asset54
Goodwill and Intangible Assets (Details 2) - Trademarks - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Indefinite-lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, carrying value | $ 29,225 | $ 29,225 |
Primatene Mist | ||
Indefinite-lived Intangible Assets [Line Items] | ||
Indefinite-lived intangible assets, carrying value | $ 29,200 |
Goodwill and Intangible Asset55
Goodwill and Intangible Assets (Details 3) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 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 | (635) | (182) |
Ending balance | $ 3,832 | $ 4,467 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Inventories | ||
Raw materials and supplies | $ 32,555 | $ 41,996 |
Work in process | 21,537 | 16,221 |
Finished goods | 19,351 | 24,755 |
Total inventory | 73,443 | 82,972 |
Less reserve for excess and obsolete inventories | (1,021) | (640) |
Total inventory, net | $ 72,422 | $ 82,332 |
Property, Plant, and Equipment
Property, Plant, and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 250,918 | $ 240,840 |
Less accumulated depreciation and amortization | (109,737) | (102,551) |
Total property, plant, and equipment, net | 141,181 | 138,289 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 69,050 | 67,760 |
Leasehold improvement | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 23,320 | 23,960 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 6,929 | 7,020 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 107,030 | 104,819 |
Furniture, fixtures, and automobiles | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | 12,910 | 12,213 |
Construction in progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property, plant, and equipment | $ 31,679 | $ 25,068 |
Property, Plant, and Equipmen58
Property, Plant, and Equipment (Details 2) - USD ($) $ in Thousands | Sep. 30, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 250,918 | $ 240,840 |
Equipment | Primatene Mist | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 2,900 |
Debt (Details)
Debt (Details) $ in Thousands, € in Millions | Sep. 30, 2015USD ($) | Sep. 30, 2015EUR (€) | Dec. 31, 2014USD ($) |
Debt Instrument | |||
Total debt and capital leases | $ 46,116 | $ 43,700 | |
Less current portion of long-term debt and capital leases | 14,762 | 7,594 | |
Long-term debt and capital leases, net of current portion | 31,354 | 36,106 | |
Mortgage Payable - Due January 2016 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 3,766 | 3,887 | |
Mortgage Payable - Due September 2016 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 2,231 | 2,289 | |
Equipment Loan - Due April 2017 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 2,010 | 2,923 | |
Equipment Loan Due January 2019 | East West Bank | |||
Debt Instrument | |||
Long Term Debt | 5,133 | ||
Mortgage Payable - Due April 2021 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 4,483 | 4,549 | |
Acquisition Loan - Due April 2019 | Cathay Bank | |||
Debt Instrument | |||
Long Term Debt | 19,484 | 20,870 | |
French Government Loan - Due March 2018 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 47 | ||
French Government Loan - Due June 2020 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 131 | ||
French Government Loan - Due July 2021 | Seine-Normandie Water Agency | |||
Debt Instrument | |||
Long Term Debt | 333 | ||
Note Payable To Merck | |||
Debt Instrument | |||
Long Term Debt | 7,621 | € 6.8 | 8,160 |
Capital Lease Obligations | |||
Debt Instrument | |||
Total debt and capital leases | $ 877 | $ 1,022 |
Debt (Details 2)
Debt (Details 2) $ in Thousands, € in Millions | Jan. 05, 2015USD ($) | Jun. 01, 2014 | Apr. 22, 2014USD ($) | Jul. 31, 2013 | Mar. 05, 2007USD ($) | Jan. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2014EUR (€) | Apr. 30, 2014USD ($) | Sep. 30, 2015USD ($)item | Sep. 30, 2014USD ($) | Sep. 30, 2015EUR (€)item | Jan. 31, 2015EUR (€)item | Apr. 30, 2014EUR (€) | Jul. 05, 2013USD ($) | Mar. 15, 2013USD ($) | Apr. 10, 2012USD ($) | Mar. 05, 2012USD ($) | Dec. 31, 2010USD ($) | Sep. 15, 2006USD ($) |
Debt | ||||||||||||||||||||
Proceeds from borrowing under lines of credit | $ 25,000 | |||||||||||||||||||
Long-term Debt and Capital Lease Obligations | $ 36,106 | $ 31,354 | ||||||||||||||||||
Payment to Acquire Business, Gross | $ 18,352 | |||||||||||||||||||
Cathay Bank | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Debt instrument fixed charge coverage ratio waived | 1.2 | |||||||||||||||||||
Debt instrument minimum debt service coverage ratio waived | 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 | $ 3,766 | ||||||||||||||||||
Mortgage Payable - Due September 2016 | East West Bank | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Number of Buildings Securing Loan | item | 1 | 1 | ||||||||||||||||||
Long Term Debt | 2,289 | $ 2,231 | ||||||||||||||||||
Line of Credit Facility - Due March 2016 | East West Bank | Line of Credit | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Line of Credit Facility, Maximum Borrowing Capacity | $ 10,000 | |||||||||||||||||||
Long-term Line of Credit | 0 | |||||||||||||||||||
Equipment Loan - Due April 2017 | East West Bank | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Principal amount | $ 4,900 | |||||||||||||||||||
Line Of Credit Replaced By Equipment Loan | $ 8,000 | |||||||||||||||||||
Long Term Debt | 2,923 | 2,010 | ||||||||||||||||||
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 | 5,100 | |||||||||||||||||||
Line Of Credit Replaced By Equipment Loan | $ 6,200 | |||||||||||||||||||
Long Term Debt | 5,133 | |||||||||||||||||||
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, Frequency of Periodic Payment | monthly | |||||||||||||||||||
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 | 4,483 | ||||||||||||||||||
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 | $ 19,484 | ||||||||||||||||||
French Government Loans | Seine-Normandie Water Agency | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Principal amount | $ 700 | € 0.6 | ||||||||||||||||||
Number of Loans with Government Agency | item | 3 | 3 | ||||||||||||||||||
Debt Instrument, Periodic Payment, Interest | $ 0 | |||||||||||||||||||
Notes Payable | $ 500 | € 0.5 | ||||||||||||||||||
Note Payable To Merck | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Principal amount | $ 16,000 | € 11.6 | ||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 4.00% | 4.00% | ||||||||||||||||||
Debt Instrument, Term | 4 years | |||||||||||||||||||
Payment to Acquire Business, Gross | 6,000 | € 4.9 | ||||||||||||||||||
Long Term Debt | 8,160 | $ 7,621 | € 6.8 | |||||||||||||||||
Capital Lease Obligations | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Capital Leased Assets, Gross | 1,500 | 1,500 | ||||||||||||||||||
Capital Leases, Lessee Balance Sheet, Assets by Major Class, Accumulated Depreciation | $ 400 | $ 600 | ||||||||||||||||||
Minimum | Mortgage Payable - Due January 2016 | East West Bank | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | 5.00% | ||||||||||||||||||
Minimum | Equipment Loan - Due April 2017 | East West Bank | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 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, 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% | ||||||||||||||||||
Debt Instrument, Term | 3 years | |||||||||||||||||||
Minimum | Note Payable To Merck | ||||||||||||||||||||
Debt | ||||||||||||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 3.00% | 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 | item | 1 | 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 | |||||||||||||||||||
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 | item | 1 | 1 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2015 | |
Loss before taxes | $ (4,276) | $ (7,984) | $ (20,702) | $ (12,331) | |
Income tax benefit | (1,268) | (2,605) | (10,382) | (4,153) | |
Net loss | $ (3,008) | $ (5,379) | $ (10,320) | $ (8,178) | |
Income tax benefit as a percentage of income before income taxes | 29.70% | 32.60% | 50.10% | 33.70% | |
Forecast | |||||
Income tax benefit as a percentage of income before income taxes | 51.50% |
Income Taxes (Details 2)
Income Taxes (Details 2) - Intangible Deferred Tax Asset € in Millions, $ in Millions | 1 Months Ended | |||
Mar. 31, 2015USD ($) | Mar. 31, 2015EUR (€) | Apr. 30, 2014USD ($) | Apr. 30, 2014EUR (€) | |
Valuation Allowance [Line Items] | ||||
Deferred Tax Assets, Valuation Allowance | $ 4.4 | € 3.2 | ||
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 3.3 | € 3.2 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders’ equity at the beginning of period | $ 281,860 | |||
Net Income (Loss) Attributable to Parent | $ (3,008) | $ (5,379) | (10,320) | $ (8,178) |
Accumulated other comprehensive loss | (2,106) | |||
Exercise of stock options | 11,539 | |||
Repurchase of common stock | (857) | |||
Purchase of treasury stock | (5,687) | |||
Stockholders’ equity at the end of period | $ 283,786 | 283,786 | ||
Nonemployee | ||||
Share-based compensation expense | 670 | |||
Employee | ||||
Share-based compensation expense | $ 8,687 |
Stockholders' Equity (Details 2
Stockholders' Equity (Details 2) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Jun. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Mar. 18, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Allocated share base compensation | $ 3,427 | $ 2,660 | $ 9,357 | $ 6,680 | ||
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) | 0 | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant (in Shares) | 2,000,000 | 2,000,000 | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized (in Shares) | 2,000,000 | |||||
Allocated share base compensation | $ 100 | $ 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) | 5,300,296 | 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% | |||||
Employee Stock Option | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Allocated share base compensation | $ 1,900 | 2,000 | $ 5,800 | 5,100 | ||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Allocated share base compensation | $ 1,100 | $ 500 | $ 2,800 | $ 1,200 |
Stockholders' Equity (Details 3
Stockholders' Equity (Details 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2015 | Nov. 06, 2014 | |
Equity, Class of Treasury Stock [Line Items] | |||
Treasury Stock, Value, Acquired, Cost Method | $ 5,687 | ||
November 2014 Share Repurchase Plan | |||
Equity, Class of Treasury Stock [Line Items] | |||
Stock buyback program, authorized amount | $ 10,000 | ||
Treasury Stock, Shares, Acquired (in Shares) | 208,000 | 403,700 | |
Treasury Stock, Value, Acquired, Cost Method | $ 3,000 |
Stockholders' Equity (Details 4
Stockholders' Equity (Details 4) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders' Equity | ||||
Average volatility | 27.50% | 27.10% | 29.90% | |
Risk-free interest rate | 2.00% | 1.30% | 1.70% | |
Weighted-average expected life in years | 6 years 3 months 18 days | 4 years 6 months | 5 years | |
Dividend yield rate | 0.00% | 0.00% | 0.00% | 0.00% |
Stockholders' Equity (Details 5
Stockholders' Equity (Details 5) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)$ / sharesshares | |
Options | |
Outstanding Options, Beginning of period | shares | 11,371,891 |
Options granted | shares | 2,270,661 |
Options exercised | shares | (1,070,843) |
Options cancelled | shares | (30,590) |
Options expired | shares | (69,330) |
Outstanding Options, End of period | shares | 12,471,789 |
Exercisable at the end of period | shares | 6,964,360 |
Weighted-Average Exercise Price | |
Outstanding Exercise Price (in dollars per share) | $ 15.12 |
Options granted (in dollars per share) | 15.71 |
Options exercised (in dollars per share) | 13.32 |
Options cancelled (in dollars per share) | 13.76 |
Options expired (in dollars per share) | 21.63 |
Outstanding Exercise Price (in dollars per share) | 15.35 |
Exercisable at the end of period | $ 16.33 |
Additional Disclosures | |
Outstanding Contractual Term (in Years) | 4 years 6 months 26 days |
Outstanding Intrinsic Value | $ | $ 1,953 |
Exercisable at the end of period (in Years) | 3 years 5 months 27 days |
Exercisable aggregate intrinsic value | $ | $ 1,185 |
Stockholders' Equity (Details 6
Stockholders' Equity (Details 6) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders' Equity | ||||
Allocated share base compensation | $ 3,427 | $ 2,660 | $ 9,357 | $ 6,680 |
Stockholders' Equity (Details 7
Stockholders' Equity (Details 7) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders' Equity | ||||
Weighted-average grant date fair value (in Dollars per share) | $ 4.54 | $ 3.44 | $ 4.02 | |
Intrinsic value of options exercised | $ 268 | $ 283 | $ 2,721 | $ 144 |
Cash received | 816 | 130 | 11,257 | 701 |
Total fair value of the options vested during the year | $ 2,888 | $ 3,510 | $ 5,423 | $ 4,324 |
Stockholders' Equity (Details 8
Stockholders' Equity (Details 8) - $ / shares | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | |
Options | |||
Nonvested at beginning of period | 5,090,591 | ||
Options granted | 2,270,661 | ||
Options vested | (1,823,233) | ||
Options forfeited | (30,590) | ||
Nonvested at end of period | 5,507,429 | 5,507,429 | |
Weighted-Average Grant Date Fair Value | |||
Nonvested at beginning of period (in dollars per share) | $ 3.34 | ||
Options granted (in dollars per share) | $ 4.54 | 3.44 | $ 4.02 |
Options vested (in dollars per share) | 2.97 | ||
Options forfeited (in dollars per share) | 4.95 | ||
Nonvested at end of period (in dollars per share) | $ 3.49 | $ 3.49 |
Stockholders' Equity (Details 9
Stockholders' Equity (Details 9) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated Share-based Compensation Expense | $ 3,427 | $ 2,660 | $ 9,357 | $ 6,680 |
Employee Stock Option | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated Share-based Compensation Expense | 1,900 | 2,000 | 5,800 | 5,100 |
Employee Consultant And Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ 13,500 | $ 13,500 | ||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 1 month 6 days | |||
Restricted Stock Units (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Restricted Stock Units, Number of Shares of Common Stock Per Award (in Shares) | 1 | 1 | ||
Allocated Share-based Compensation Expense | $ 1,100 | $ 500 | $ 2,800 | $ 1,200 |
Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Share-based Awards Other than Options | $ 9,300 | $ 9,300 | ||
Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 6 months | |||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 0 |
Stockholders' Equity (Details 1
Stockholders' Equity (Details 10) $ in Thousands | 9 Months Ended |
Sep. 30, 2015USD ($)shares | |
Restricted Stock Units (RSUs) | |
Total RSUs Issued | |
Total RSUs outstanding at the beginning of the period | 503,010 |
RSUs granted | 523,203 |
RSUs forfeited | (3,938) |
Common stock delivered | (55,426) |
RSUs surrendered for taxes | (89,184) |
Total RSUs outstanding at the end of the period | 877,665 |
Restricted Stock Units Issued as Compensation | |
Total Fair Market Value of RSUs Issued | |
RSUs granted (in Dollars) | $ | $ 7,838 |
Stockholders' Equity (Details73
Stockholders' Equity (Details 11) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | $ 3,427 | $ 2,660 | $ 9,357 | $ 6,680 |
Cost of revenues | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | 638 | 477 | 1,856 | 1,164 |
Selling, distribution and marketing | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | 49 | 46 | 148 | 96 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | 2,536 | 1,923 | 6,676 | 4,935 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated share base compensation | $ 204 | $ 214 | $ 677 | $ 485 |
Employee Benefits (Details)
Employee Benefits (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
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 | $ 0.2 | $ 0.2 | $ 0.5 | $ 0.5 | |
Defined Benefit Plan, Assumptions Used Calculating Benefit Obligation, Discount Rate | 1.75% | 1.75% | 1.75% | ||
Defined Benefit Plan, Benefit Obligation | $ 1.7 | $ 1.7 | $ 1.1 | ||
Pension Expense | $ 0.1 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - Distribution Agreement - Allergan plc - Enoxaparin - USD ($) $ in Millions | 1 Months Ended | |||
Jan. 31, 2012 | May. 31, 2005 | Sep. 30, 2015 | Dec. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Proceeds from Customers | $ 4.5 | |||
Deferred Revenue, Period for Recognition | 7 years | |||
Deferred Revenue | $ 4.5 | $ 2.1 | $ 2.6 | |
Distribution Agreement With Corporate Partner, Renewal Option Period | 3 years |
Commitments and Contingencies76
Commitments and Contingencies (Details 2) - Jul. 31, 2014 - MannKind Corporation - Supply Commitment - Recombinant Human Insulin € in Millions, $ in Millions | USD ($) | EUR (€) |
Supply Commitment [Line Items] | ||
Supply commitment annual amount commited | $ 146 | € 120.1 |
Deferred Revenue | $ 14 | € 11 |
Long-term Supply Commitment, Optional Renewal Period | 2 years | |
Supply Agreement Renewal Notice Period | 12 months | |
Termination notice period without cause | 2 years | |
Termination notice period, change of regulatory approval | 30 days | |
Payment period upon termination | 60 days |
Commitments and Contingencies77
Commitments and Contingencies (Details 3) - Development agreement - Drug delivery system item in Millions, $ in Millions | 9 Months Ended |
Sep. 30, 2015USD ($)item | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |
Collaborative Agreement, Upfront Payment | $ 0.5 |
Collaborative Agreement, Milestone Payments | 0.1 |
Collaborative Agreement, Contingent Obligation | $ 1.9 |
Collaborative Agreement, Contingent Purchase Obligation First 12 Months, Units | item | 1 |
Purchase period | 12 months |
Commitments and Contingencies78
Commitments and Contingencies (Details 4) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Operating Leased Assets [Line Items] | ||||
Operating Leases, Rent Expense | $ 0.8 | $ 0.8 | $ 2.5 | $ 2.3 |
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 Contingencies79
Commitments and Contingencies (Details 5) - USD ($) $ in Millions | 1 Months Ended | 9 Months Ended | |
Nov. 30, 2012 | Jan. 31, 2010 | Sep. 30, 2015 | |
Commitments to Purchase Equipment and Raw Materials | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Long-term Purchase Commitment, Amount | $ 7.3 | ||
Commitment to invest | ANP | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Investments in and Advance to Affiliates, Subsidiaries, Associates, and Joint Ventures | 49 | ||
Contractual Obligation, Total | 61 | ||
Contractual Obligation, Due in Second Year | $ 12 | ||
Land-use rights | Commitment to invest | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Finite-lived Intangible Assets Acquired | $ 1.3 | $ 1.2 | |
Land-use rights | Commitment to develop land | |||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | |||
Contractual Obligation, Total | $ 15 |
Litigation (Details)
Litigation (Details) $ in Millions | Apr. 07, 2015USD ($) | Sep. 21, 2011item | Oct. 31, 2011USD ($) |
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 | Nov. 10, 2015USD ($) |
Subsequent Events | |
Subsequent Events | |
Stock buyback program, increase authorized amount | $ 10 |