Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 19, 2016 | Jun. 30, 2015 | |
Document and Entity Information [Abstract] | |||
Entity Registrant Name | Emergent BioSolutions Inc. | ||
Entity Central Index Key | 1,367,644 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Public Float | $ 1,000,000,000 | ||
Entity Common Stock, Shares Outstanding | 0 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 312,795 | $ 280,499 |
Accounts receivable | 120,767 | 58,834 |
Inventories | 76,936 | 65,674 |
Deferred tax assets, net | 0 | 1,710 |
Income tax receivable, net | 6,573 | 1,357 |
Prepaid expenses and other current assets | 21,541 | 24,101 |
Total current assets | 538,612 | 432,175 |
Property, plant and equipment, net | 331,856 | 313,979 |
In-process research and development | 42,501 | 60,628 |
Intangible assets, net | 57,375 | 58,344 |
Goodwill, net book value | 54,902 | 52,585 |
Deferred tax assets, net | 11,286 | 12,764 |
Other assets | 7,060 | 8,216 |
Total assets | 1,043,592 | 938,691 |
Current liabilities: | ||
Accounts payable | 45,966 | 40,930 |
Accrued expenses and other current liabilities | 6,229 | 6,274 |
Accrued compensation | 34,683 | 31,654 |
Contingent purchase consideration, current portion | 2,553 | 6,487 |
Provision for chargebacks | 2,238 | 2,246 |
Short-term deferred revenue | 7,942 | 5,345 |
Total current liabilities | 99,611 | 92,936 |
Contingent purchase consideration, net of current portion | 23,046 | 34,599 |
Long-term indebtedness, net of current portion | 253,000 | 251,000 |
Deferred revenue, net of current portion | 6,590 | 5,713 |
Other liabilities | 1,328 | 1,242 |
Total liabilities | $ 383,575 | $ 385,490 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 15,000,000 shares authorized, 0 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively | $ 0 | $ 0 |
Common stock, $0.001 par value; 100,000,000 shares authorized, 39,829,408 shares issued and 39,406,578, shares outstanding at December 31, 2015; 38,129,872 shares issued and 37,709,683 shares outstanding at December 31, 2014 | 40 | 38 |
Treasury stock, at cost, 422,830 and 420,189 common shares at December 31, 2015 and 2014, respectively | (6,420) | (6,320) |
Additional paid-in capital | 317,971 | 274,222 |
Accumulated other comprehensive loss | (2,713) | (3,008) |
Retained earnings | 351,139 | 288,269 |
Total stockholders' equity | 660,017 | 553,201 |
Total liabilities and stockholders' equity | $ 1,043,592 | $ 938,691 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Stockholders' equity: | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 39,829,408 | 38,129,872 |
Common stock, shares outstanding (in shares) | 39,406,578 | 37,709,683 |
Treasury stock (in shares) | 422,830 | 420,189 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
Product sales | $ 356,916 | $ 311,881 | $ 257,922 |
Contract manufacturing | 42,968 | 30,944 | 0 |
Contracts, grants and collaborations | 122,905 | 107,313 | 54,823 |
Total revenues | 522,789 | 450,138 | 312,745 |
Operating expenses: | |||
Cost of product sales and contract manufacturing | 124,295 | 118,412 | 62,127 |
Research and development | 153,997 | 150,829 | 119,933 |
Selling, general and administrative | 148,458 | 122,841 | 87,883 |
Income from operations | 96,039 | 58,056 | 42,802 |
Other income (expense): | |||
Interest income | 572 | 320 | 139 |
Interest expense | (6,523) | (8,240) | 0 |
Other income (expense), net | (319) | 2,926 | 426 |
Total other income (expense) | (6,270) | (4,994) | 565 |
Income before provision for income taxes | 89,769 | 53,062 | 43,367 |
Provision for income taxes | 26,899 | 16,321 | 13,108 |
Net income | 62,870 | 36,741 | 30,259 |
Net loss attributable to noncontrolling interest | 0 | 0 | 876 |
Net income attributable to Emergent BioSolutions Inc. | $ 62,870 | $ 36,741 | $ 31,135 |
Earnings per share - basic (in dollars per share) | $ 1.63 | $ 0.98 | $ 0.86 |
Earnings per share - diluted (in dollars per share) | $ 1.41 | $ 0.88 | $ 0.85 |
Weighted-average number of shares - basic (in shares) | 38,595,435 | 37,344,891 | 36,201,283 |
Weighted-average number of shares - diluted (in shares) | 47,255,842 | 45,802,807 | 36,747,556 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Consolidated Statements of Comprehensive Income [Abstract] | |||
Net income attributable to Emergent BioSolutions Inc. | $ 62,870 | $ 36,741 | $ 31,135 |
Reclassification of cumulative currency translation adjustment to income, net of tax | 0 | 0 | 58 |
Foreign currency translations, net of tax | 295 | 457 | 606 |
Comprehensive income | $ 63,165 | $ 37,198 | $ 31,799 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cash flows from operating activities: | |||
Net income | $ 62,870 | $ 36,741 | $ 30,259 |
Adjustments to reconcile to net cash provided by operating activities: | |||
Stock-based compensation expense | 15,848 | 12,829 | 11,238 |
Other Depreciation and Amortization | 35,335 | 32,453 | 18,958 |
Deferred income taxes | 3,464 | 16,493 | 13,858 |
Non-cash development expenses from joint venture | 0 | 0 | (347) |
Change in fair value of contingent obligations | (10,599) | 3,133 | 735 |
Write off of debt issuance costs | 0 | 1,831 | 0 |
Impairment of in-process research and development | 9,827 | 0 | 0 |
Impairment of long-lived assets | 1,147 | 0 | 1,172 |
Bad debt expense | 3,481 | 0 | 0 |
Excess tax benefits from stock-based compensation | (11,281) | (5,987) | (3,099) |
Other | 271 | 1,284 | 51 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (64,351) | 21,405 | 35,456 |
Inventories | (11,262) | 4,229 | 518 |
Income taxes | (3,550) | (4,711) | (7,179) |
Prepaid expenses and other assets | 2,319 | (8,472) | (6,226) |
Accounts payable | 4,749 | (9,279) | (551) |
Accrued expenses and other liabilities | 45 | 2,685 | 7 |
Accrued compensation | 2,680 | 4,539 | 2,092 |
Provision for chargebacks | (8) | 299 | 0 |
Deferred revenue | 3,474 | 2,846 | 26 |
Net cash provided by operating activities | 44,459 | 112,318 | 96,968 |
Cash flows from investing activities: | |||
Purchases of property, plant and equipment | (44,812) | (30,673) | (42,021) |
Acquisitions, net of acquired cash | (650) | (179,379) | (25,873) |
Net cash used in investing activities | (45,462) | (210,052) | (67,894) |
Cash flows from financing activities: | |||
Proceeds from convertible debenture, net of debt issuance costs | 0 | 241,588 | 0 |
Proceeds from borrowings on long-term indebtedness | 2,000 | 1,000 | 62,000 |
Issuance of common stock subject to employee equity plans | 25,961 | 14,078 | 6,848 |
Excess tax benefits from stock-based compensation | 11,281 | 5,987 | 3,099 |
Principal payments on long-term indebtedness and line of credit | 0 | (62,000) | (62,774) |
Contingent obligation payments | (5,693) | (1,579) | (348) |
Purchase of treasury stock | (100) | (200) | (213) |
Net cash provided by (used in) financing activities | 33,449 | 198,874 | 8,612 |
Effect of exchange rate changes on cash and cash equivalents | (150) | 21 | (14) |
Net increase (decrease) in cash and cash equivalents | 32,296 | 101,161 | 37,672 |
Cash and cash equivalents at beginning of year | 280,499 | 179,338 | 141,666 |
Cash and cash equivalents at end of year | 312,795 | 280,499 | 179,338 |
Supplemental disclosure of cash flow information: | |||
Cash paid during the year for interest | 7,751 | 3,761 | 2,055 |
Cash paid during the year for income taxes | 28,271 | 4,711 | 6,331 |
Supplemental information on non-cash investing and financing activities: | |||
Purchases of property, plant and equipment unpaid at year end | $ 4,379 | $ 5,394 | $ 2,755 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) $ in Thousands | $0.001 Par Value Common Stock [Member] | Additional Paid-in Capital [Member] | Treasury Stock [Member] | Accumulated Other Comprehensive Loss [Member] | Noncontrolling Interest in Subsidiary [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2012 | $ 36 | $ 230,964 | $ (5,906) | $ (4,129) | $ 770 | $ 220,393 | $ 442,128 |
Balance (in shares) at Dec. 31, 2012 | 36,272,550 | (403,158) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Employee equity award plans activity | $ 1 | 16,673 | 0 | 0 | 0 | 16,674 | |
Employee equity award plans activity (in shares) | 764,446 | ||||||
Non-cash development expenses from joint venture | (347) | 0 | (347) | ||||
Net loss attributable to noncontrolling interest | (876) | 0 | (876) | ||||
Treasury stock | $ (213) | 0 | 0 | (213) | |||
Treasury stock (in shares) | (9,795) | ||||||
Net income | 0 | 31,135 | 31,135 | ||||
Foreign currency translations, net of tax | 664 | 0 | 0 | 664 | |||
Balance at Dec. 31, 2013 | $ 37 | 247,637 | $ (6,119) | (3,465) | (453) | 251,528 | 489,165 |
Balance (in shares) at Dec. 31, 2013 | 37,036,996 | (412,953) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Employee equity award plans activity | $ 1 | 26,585 | 0 | 0 | 0 | 26,586 | |
Employee equity award plans activity (in shares) | 1,092,876 | ||||||
Non-cash development expenses from joint venture | 0 | 453 | 0 | 453 | |||
Net loss attributable to noncontrolling interest | 0 | ||||||
Treasury stock | $ (201) | 0 | 0 | (201) | |||
Treasury stock (in shares) | (7,236) | ||||||
Net income | 0 | 0 | 36,741 | 36,741 | |||
Foreign currency translations, net of tax | 457 | 0 | 0 | 457 | |||
Balance at Dec. 31, 2014 | $ 38 | 274,222 | $ (6,320) | (3,008) | 0 | 288,269 | $ 553,201 |
Balance (in shares) at Dec. 31, 2014 | 38,129,872 | (420,189) | 37,709,683 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||
Employee equity award plans activity | $ 2 | 43,749 | 0 | 0 | 0 | $ 43,751 | |
Employee equity award plans activity (in shares) | 1,699,536 | ||||||
Net loss attributable to noncontrolling interest | 0 | ||||||
Treasury stock | $ (100) | 0 | 0 | (100) | |||
Treasury stock (in shares) | (2,641) | ||||||
Net income | 0 | 0 | 62,870 | 62,870 | |||
Foreign currency translations, net of tax | 295 | 0 | 0 | 295 | |||
Balance at Dec. 31, 2015 | $ 40 | $ 317,971 | $ (6,420) | $ (2,713) | $ 0 | $ 351,139 | $ 660,017 |
Balance (in shares) at Dec. 31, 2015 | 39,829,408 | (422,830) | 39,406,578 |
Nature of the business and orga
Nature of the business and organization | 12 Months Ended |
Dec. 31, 2015 | |
Nature of the business and organization [Abstract] | |
Nature of the business and organization | 1. Nature of the business and organization Emergent BioSolutions Inc. (the "Company" or "Emergent") is a global specialty biopharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging public health threats. The Company As a result of the Reorganization, BioPort became a wholly owned subsidiary of the Company. The Company subsequently renamed and converted this subsidiary to Emergent Biodefense Operations Lansing LLC. The Company acquired a portion of its portfolio of vaccine and therapeutic product candidates through an acquisition of Microscience Limited ("Microscience") in a share exchange in June 2005, and acquisitions of substantially all of the assets, for cash, of Antex Biologics Inc. in May 2003 and ViVacs GmbH, Germany in July 2006. The Company renamed Microscience as Emergent Product Development UK Limited. The assets acquired from Antex are held in an entity incorporated as Emergent Product Development Gaithersburg Inc., and the assets acquired from ViVacs are held in an entity incorporated as Emergent Product Development Germany GmbH. On October 28, 2010, the Company acquired Trubion Pharmaceuticals, Inc. ("Trubion") for cash, equity and contingent value rights. Concurrent with the acquisition, the Company converted Trubion to Emergent Product Development Seattle, LLC. In August 2013, the Company acquired substantially all of the assets of the Health Protective Products Division of Bracco Diagnostics Inc. ("Bracco") for cash along with contingent purchase consideration obligations. In February 2014, the Company acquired all the shares of Cangene Corporation ("Cangene") for cash. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2015 | |
Summary of significant accounting policies [Abstract] | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Basis of presentation and consolidation The accompanying consolidated financial statements include the accounts of Emergent and its wholly owned and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. For investments in variable interest entities, the Company consolidates when it is determined to be the primary beneficiary. Use of estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and cash equivalents Cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions. Also, the Company maintains cash balances with financial institutions in excess of insured limits. The Company does not anticipate any losses with such cash balances. Fair value of measurements The Company measures and records cash equivalents and investment securities considered available-for-sale at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value include: Level 1 — Observable inputs for identical assets or liabilities such as quoted prices in active markets; Level 2 — Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3 — Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use. The carrying amounts of the Company's short-term financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable, approximate their fair values due to their short maturities. Significant customers and accounts receivable For the years ended December 31, 2015, 2014 and 2013, the Company's primary customer was the U.S. Department of Health and Human Services ("HHS"). For the years ended December 31, 2015, 2014 and 2013, revenues from HHS and HHS agencies comprised 81%, 74% and 95%, respectively, of total revenues and are included in the Company's Biodefense segment. As of December 31, 2015 and 2014, the Company's accounts receivable balances were comprised of 78% and 40%, respectively, from this customer. The overall increase in the percentage of accounts receivable attributed to HHS was due primarily to the timing of payments received for BioThrax product sales from the Centers for Disease Control ("CDC"), an operating division of HHS, under the Company's contract with CDC. As of December 31, 2015 and 2014, unbilled accounts receivable, which is included in accounts receivable, were $18.6 million and $18.9 million, respectively. Unbilled accounts receivable relates to various service contracts for which work has been performed, though invoicing has not yet occurred. Accounts receivable are stated at invoice amounts and consist primarily of amounts due from the U.S. government and collaborative partners, as well as amounts due under reimbursement contracts with other government entities and non-government and philanthropic organizations. If necessary, the Company records a provision for doubtful receivables to allow for any amounts which may be unrecoverable. This provision is based upon an analysis of the Company's prior collection experience, customer creditworthiness and current economic trends. Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company places its cash and cash equivalents with high quality financial institutions. Management believes that the financial risks associated with its cash and cash equivalents are minimal. Because accounts receivable consist primarily of amounts due from the U.S. government for product sales and from government agencies under government grants and development contracts, management deems there to be minimal credit risk. Inventories Inventories are stated at the lower of cost or market with cost being determined using a standard cost method, which approximates average cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs) and includes the services and products of third party suppliers. The Company analyzes its inventory levels quarterly and writes down, in the applicable period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected customer demand. The Company also writes off, in the applicable period, the costs related to expired inventory. Costs of purchased inventories are recorded using weighted-average costing. The Company determines normal capacity for each production facility and allocates fixed production-overhead costs on that basis. Property, plant and equipment Property, plant and equipment are stated at cost. Depreciation is computed using the straight-line method over the following estimated useful lives: Buildings 31-39 years Building improvements 10-39 years Furniture and equipment 3-15 years Software 3-7 years or product life Leasehold improvements Lesser of the asset life or lease term Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred. The Company capitalizes internal-use software when both (a) the software is internally developed, acquired, or modified solely to meet the entity's internal needs and (b) during the software's development or modification, no substantive plan either exists or is being developed to market the software externally. Capitalization of qualifying internal-use software costs begins when the preliminary project stage is completed, management with the relevant authority, implicitly or explicitly, authorizes and commits to the funding of the software project, and it is probable that the project will be completed and the software will be used to perform the function intended. Income taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss and research and development tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The Company's ability to realize deferred tax assets depends upon future taxable income as well as the limitations discussed below. For financial reporting purposes, a deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized prior to expiration. The Company considers future taxable income and ongoing tax planning strategies in assessing the need for valuation allowances. In general, if the Company determines that it is more likely than not to realize more than the recorded amounts of net deferred tax assets in the future, the Company will reverse all or a portion of the valuation allowance established against its deferred tax assets, resulting in a decrease to the provision for income taxes in the period in which the determination is made. Likewise, if the Company determines that it is not more likely than not to realize all or part of the net deferred tax asset in the future, the Company will establish a valuation allowance against deferred tax assets, with an offsetting increase to the provision for income taxes, in the period in which the determination is made. Under sections 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a "loss corporation", as defined, there are annual limitations on the amount of net operating losses and deductions that are available. The Company believes the use of net operating losses and research and development tax credits acquired in the Trubion acquisition will not be significantly limited. Due to the acquisition of Microscience in 2005 and the Company's initial public offering, the Company believes the use of the operating losses incurred prior to 2005 will be significantly limited. Because tax laws are complex and subject to different interpretations, significant judgment is required. As a result, the Company make certain estimates and assumptions, in (1) calculating the Company's income tax expense, deferred tax assets and deferred tax liabilities, (2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as the interest and penalties related to such uncertain tax positions. The Company's estimates and assumptions may differ significantly from tax benefits ultimately realized. In November 2015, the Financial Accounting Standards Board ("FASB") issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes ("ASU No. 2015-17"). The amendments in ASU No. 2015-17 change the presentation requirements for deferred tax assets and liabilities, along with any related valuation allowance, to classify the balances solely as noncurrent on the balance sheet. As a result, each jurisdiction will now only have one net noncurrent deferred tax asset or liability. The amendments in ASU No. 2015-17 are effective for years beginning after December 15, 2017, and early adoption is permitted. The Company has elected to prospectively adopt the accounting standard for the year ended December 31, 2015. Prior periods in the Company's consolidated financial statements were not retrospectively adjusted. Revenue recognition The Company recognizes revenues from product sales and contract manufacturing  there is persuasive evidence of an arrangement;  delivery has occurred or title has passed to the Company's customer;  the fee is fixed or determinable; and  collectability is reasonably assured. All revenues from product sales are recorded net of applicable allowances for sales rebates, special promotional programs, and discounts. The Company estimates allowances for revenue reducing obligations using a combination of information received from third parties including market data, inventory reports from major wholesalers, historical information and analysis. These estimates are subject to the inherent limitations of estimates that rely on third-party data, as certain third-party information may itself rely on estimates and reflect other limitations. Provisions for estimated rebates and right of returns along with other allowances, such as discounts and promotional and other credits, are estimated based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and contract terms, and actual discounts offered. The Company markets and sells its Biosciences products through commercial wholesalers (direct customers) who purchase the products at a price referred to as the wholesale acquisition cost ("WAC"). Additionally, the Company enters into agreements with indirect customers for a contracted price that is less than the WAC. The indirect customers, such as group-purchasing organizations, physician practice-management groups and hospitals, purchase the Company's products from the wholesalers. Under these agreements with wholesalers, the Company guarantees to credit the wholeseller for the difference between the WAC and the indirect customers' contracted price. This credit is referred to as a chargeback. Adjustments to the Company's chargeback provisions are made periodically to reflect new facts and circumstances that may indicate that historical experience may not be indicative of current and/or future results. The Company makes subjective judgments primarily based on its evaluation of current market conditions and trade inventory levels related to the Company's products. This evaluation may result in an increase or decrease in the experience rate that is applied to current and future sales, or as an adjustment to past sales, or both . Under previous contracts with HHS, the Company invoiced HHS and recognized the related revenues upon delivery of the product to the government carrier, at which time title to the product passed to HHS. Effective September 30, 2011, the Company has a contract with the CDC, to supply up to 44.75 million doses of BioThrax over a five year period. Under the Company's contract with the CDC, the Company invoices the CDC and recognizes the related revenue upon acceptance by the government at delivery site, at which time title to the product passes to the CDC. Collaborative research and development agreements can provide for one or more of upfront license fees, research payments, and milestone payments. The Company analyzes its multiple element revenue-generating arrangements to determine whether the elements can be separated and accounted for individually as separate units of accounting. An item can generally be considered a separate unit of accounting if both of the following criteria are met: the delivered item(s) has value to the customer on a stand-alone basis and if the arrangement includes a general right of return and delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Items that cannot be divided into separate units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units based on the unit's relative selling price and is recognized when the appropriate revenue recognition criteria are met. The Company deems services to be rendered if no continuing obligation exists on the part of the Company. The Company's contract with the Biomedical Advanced Research and Development Authority ("BARDA") to establish a Center for Innovation in Advanced Development and Manufacturing ("CIADM") is a service arrangement that includes multiple elements. The CIADM contract requires the Company to provide a flexible infrastructure to supply medical countermeasures to the U.S. government over the contract period and includes such items as construction and facility design, workforce development and licensure of a pandemic flu vaccine. Since none of the individual elements by themselves satisfy the purpose of the contract, the Company has concluded that the CIADM contract elements cannot be separated as they do not have stand-alone value to the U.S. government. Therefore, the Company has concluded that there is a single unit of accounting associated with the CIADM contract. The Company recognizes revenue under the CIADM contract on a straight-line basis, based upon its estimate of the total payments to be received under the contract. The Company analyzes the estimated payments to be received on a quarterly basis to determine if an adjustment to revenue is required. Changes in estimates attributed to modifications in the estimate of total payments to be received are recorded prospectively. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting is deferred and recognized as revenue either on a straight-line basis over the Company's continued involvement in the research and development process or based on the proportional performance of the Company's expected future obligation under the contract. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, the Company recognizes such milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable, (2) achievement of the milestone was not reasonably assured at the inception of the arrangement, (3) substantive effort is involved to achieve the milestone, and (4) the amount of the milestone appears reasonable in relation to the effort expended. Payments received in advance of work performed are recorded as deferred revenue. The Company generates contract and grant revenue from cost-plus-fee contracts. Revenues on reimbursable contracts are recognized as costs are incurred, generally based on allowable costs incurred during the period, plus any recognizable earned fee. The Company considers fixed fees under cost-plus-fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. The Company analyzes costs for contracts and reimbursable grants to ensure reporting of revenues gross versus net is appropriate. For each of the three years in the period ended December 31, 2015, the costs incurred under the contracts and grants approximated the revenue earned. Revenue associated with non-refundable upfront license fees that can be treated as a single unit of accounting are recognized when all ongoing obligations have been delivered. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting are deferred and recognized as revenue either on a straight-line basis over the Company's continued involvement in the research and development process or based on the proportional performance of the Company's expected future obligations under the contract. In May 2014, the FASB issued ASU No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers (Topic 606) and Other Assets and Deferred Costs—Contracts with Customers (Subtopic 340-40). ASU No. 2014-09 supercedes the revenue recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The FASB has deferred ASU No. 2014-09 for one year, and with that deferral, the standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, which for the Company will be its 2018 first quarter. The Company is permitted to use either the retrospective or the modified retrospective method when adopting ASU No. 2014-09. The Company is still assessing the potential impact that ASU No. 2014-09 will have on its financial statements and disclosures, but believe that there could be changes to the revenue recognition for government contracts and its collaboration agreement . Mergers and Acquisitions In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the merger or acquisition at their respective fair values with limited exceptions. Assets acquired and liabilities assumed in a business combination that arise from contingencies are recognized at fair value if fair value can reasonably be estimated. If the acquisition date fair value of an asset acquired or liability assumed that arises from a contingency cannot be determined, the asset or liability is recognized if probable and reasonably estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair value measures that do not reflect the Company's intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company's consolidated financial statements after the date of the merger or acquisition. If the Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an acquisition of assets rather than a business combination and, therefore, no goodwill will be recorded. The fair values of intangible assets, including acquired in-process research and development ("IPR&D"), are determined utilizing information available near the merger or acquisition date based on expectations and assumptions that are deemed reasonable by management. Given the considerable judgment involved in determining fair values, the Company typically obtains assistance from third-party valuation specialists for significant items. Amounts allocated to acquired IPR&D are capitalized and accounted for as indefinite-lived intangible assets. Upon successful completion of each project, the Company will make a separate determination as to the then useful life of the asset and begin amortization. The judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a business combination, as well as asset lives, can materially affect the Company's results of operations. The fair values of identifiable intangible assets related to currently marketed products and product rights are primarily determined by using an "income approach" through which fair value is estimated based on each asset's discounted projected net cash flows. The Company's estimates of market participant net cash flows consider historical and projected pricing, margins and expense levels, the performance of competing products where applicable, relevant industry and therapeutic area growth drivers and factors, current and expected trends in technology and product life cycles, the time and investment that will be required to develop products and technologies, the ability to obtain marketing and regulatory approvals, the ability to manufacture and commercialize the products, the extent and timing of potential new product introductions by the Company's competitors, and the life of each asset's underlying patent, if any. The net cash flows are then probability-adjusted where appropriate to consider the uncertainties associated with the underlying assumptions, as well as the risk profile of the net cash flows utilized in the valuation. The probability-adjusted future net cash flows of each product are then discounted to present value utilizing an appropriate discount rate. The fair values of identifiable intangible assets related to IPR&D are determined using an income approach, through which fair value is estimated based on each asset's probability-adjusted future net cash flows, which reflect the different stages of development of each product and the associated probability of successful completion. The net cash flows are then discounted to present value using an appropriate discount rate. Indefinite-lived intangible assets are tested for impairment annually or whenever events or changes in circumstances indicate that its carrying amount may not be recoverable. In process research and development and long-lived assets The Company assesses IPR&D assets for impairment on an annual basis or more frequently if indicators of impairment are present. The Company's annual assessment includes a comparison of the fair value of IPR&D assets to existing carrying value, and recognizes an impairment when the carrying value is greater than the determined fair value. The Company believes that the assumptions used in valuing the intangible and IPR&D assets are reasonable and are based upon its best estimate of likely outcomes of sales and clinical development. The underlying assumptions and estimates used to value these assets are subject to change in the future, and actual results may differ significantly from the assumptions and estimates. The Company has selected October 1 as its annual impairment test date for indefinite-lived intangible assets. The Company assesses the recoverability of its long-lived assets or asset groups for which an indicator of impairment exists by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If the Company concludes that the carrying value will not be recovered, the Company measures the amount of such impairment by comparing the fair value to the carrying value of the assets or asset groups. Goodwill The Company assesses the carrying value of goodwill on an annual basis, or whenever events or changes in circumstances indicate the carrying value of goodwill may not be recoverable, The determination of the fair value of a reporting unit is judgmental in nature and involves the use of significant estimates and assumptions. The estimates and assumptions used in calculating fair value include identifying future cash flows, which requires that the Company makes a number of critical legal, economic, market and business assumptions that reflect best estimates as of the testing date. The Company's assumptions and estimates may differ significantly from actual results, or circumstances could change that would cause the Company to conclude that an impairment now exists or that it previously understated the extent of impairment. The Company selected October 1 as its annual impairment test date. Contingent Consideration The Company records contingent consideration associated with (a) sales based royalties and (b) development and regulatory milestones at fair value. The fair value model used to calculate this obligation is based on the income approach (a discounted cash flow model) that has been risk adjusted based on the probability of achievement of net sales and achievement of the milestones. The inputs the Company use for determining the fair value of the contingent consideration associated with sales based royalties and development and regulatory milestones are Level 3 fair value measurements. The Company re-evaluates the fair value on a quarterly basis. Changes in the fair value can result from adjustments to the discount rates and updates in the assumed timing of or achievement of net sales. Any future increase in the fair value of the contingent consideration associated with sales based royalties along with development and regulatory milestones are based on an increased likelihood that the underlying net sales or milestones will be achieved. The associated payment or payments which will therefore become due and payable for sales based royalties associated with marketed products will result in a charge to cost of product sales and contract manufacturing in the period in which the increase is determined. Similarly, any future decrease in the fair value of contingent consideration associated with sales based royalties will result in a reduction in cost of product sales and contract manufacturing. The changes in fair value for potential future sales based royalties associated with product candidates in development will result in a charge to selling, general and administrative expense in the period in which the increase is determined. Similarly, any future decrease in the fair value of contingent consideration associated with potential future sales based royalties for products candidates will result in a reduction in selling, general and administrative expense. The associated payment or payments which will therefore become due and payable for development and regulatory milestones will result in a charge to research and development expense in the period in which the increase is determined. Similarly, any future decrease in the fair value for development and regulatory milestones will result in a reduction in research and development expense. Research and development Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and fees paid to outside service providers and the costs of materials used in clinical trials and research and development. Other research and development expenses include fees paid to consultants, materials and related expenses for personnel and facility expenses. Comprehensive income Comprehensive income is comprised of net income and other changes in equity that are excluded from net income. The Company includes translation gains and losses incurred when converting its subsidiaries' financial statements from their functional currency to the U.S. dollar in accumulated other comprehensive income. Foreign currencies Except for the Company's Canadian subsidiaries, the local currency is the functional currency for the Company's foreign subsidiaries and, as such, assets and liabilities are translated into U.S. dollars at year-end exchange rates. Income and expense items are translated at average exchange rates during the year. Translation adjustments resulting from this process are charged or credited to other comprehensive income. The Company's Canadian subsidiaries functional currency is U.S. dollars due primarily to a significant amount of the transactions of the subsidiaries being denominated in U.S. dollars. Capitalized interest The Company capitalizes interest based on the cost of major ongoing capital projects which have not yet been placed in service. For the years ended December 31, 2015, 2014 and 2013, the Company incurred interest of $7.8 million, $7.5 million and $2.0 million, respectively. Of these amounts, the Company capitalized $2.9 million, $2.5 million and $2.0 million, respectively. Certain risks and uncertainties The Company has derived a majority of its revenue from sales of BioThrax under contracts with the U.S. government. The Company's current CDC contract does not necessarily increase the likelihood that it will secure future comparable contracts with the U.S. government. The Company expects that a significant portion of the business that it will seek in the near future, in particular for BioThrax, will be under government contracts that present a number of risks that are not typically present in the commercial contracting process. U.S. government contracts for BioThrax are subject to unilateral termination or modification by the government. The Company may fail to achieve significant sales of BioThrax to customers in addition to the U.S. government, which would harm its growth opportunities. The Company may not be able to sustain or increase profitability. The Company m |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2015 | |
Acquisitions [Abstract] | |
Acquisitions | 3. Acquisitions EV-035 series of molecules On December 17, 2014, the Company acquired the EV-035 series of molecules from Evolva Holding SA ("Evolva") for $1.5 million in cash along with contingent consideration payable to Evolva, triggered upon the future achievement of various milestones. The EV-035 series is a group of novel small molecule broad spectrum antibiotics of the 4-oxoquinolizine class and targets bacterial type IIa topoisomerase. The lead molecule in the series, GC-072, had demonstrated protection in vivo B. pseudomallei B. pseudomallei B. pseudomallei The contingent value rights are based on the novation of the DTRA contract ($4.0 million) along with the achievement of certain development ($15.0 million) and regulatory filing ($50.0 million) milestones. In addition, the Company is required to make sales-based royalty payments of between 5%-10% based on levels of annual net sales. During the first half of 2015, based on facts that existed at the date of acquisition, the Company obtained additional information and analysis and recast the fair value of the total purchase consideration transferred to Evolva via a measurement period adjustment, as follows. The table below summarizes the total purchase price: (in thousands) Purchase Price Measurement Period Adjustment Recast Purchase Price Amount of cash paid to Evolva Holdings SA $ 1,500 $ - $ 1,500 Fair value of contingent consideration 28,200 (6,571 ) 21,629 Total purchase price $ 29,700 $ (6,571 ) $ 23,129 In conjunction with the revision to the total purchase price and based on this same information and analysis, the Company has recast of the fair value of the in-process research and development ("IPR&D") asset attributed to the EV-035 series of molecules, via a measurement period adjustment through June 30, 2015. The table below summarizes the recast allocation of the purchase price based upon fair values of assets acquired. (in thousands) Purchase Price Allocation Measurement Period Adjustment Recast Purchase Price Allocation Acquired intangible assets $ 27,700 $ (17,172 ) $ 10,528 Goodwill 2,000 10,601 12,601 Total purchase price $ 29,700 $ (6,571 ) $ 23,129 The recast fair value was determined using the income approach, which discounts expected future cash flows to present value. The Company estimated the fair value using a discount rate of 12%. The Company believes this rate is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value this IPR&D asset. The projected cash flows for EV-035 series of molecules were based on key assumptions including: estimates of revenues and operating profits considering its stage of development on the acquisition date, the time and resources needed to complete the development and approval of the product candidate, the life of the potential commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and other regulatory agencies, and risks related to the viability of and potential for alternative treatments in any future target markets. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. The Company recorded approximately $12.6 million in goodwill related to the EV-035 series of molecules, representing the purchase price paid in excess of the fair value of the IPR&D assets acquired. None of the goodwill generated is expected to be deductible for tax purposes. The Company has recast, in this filing, the historical December 31, 2014 balance sheet line items for in-process research and development, goodwill and contingent consideration. (in thousands) Balance as of December 31, 2014 EV-035 Purchase Price Adjustments Adjusted Balance as of December 31, 2014 Assets: In-process research and development $ 77,800 $ (17,172 ) $ 60,628 Goodwill 41,984 10,601 52,585 Total assets $ 119,784 $ (6,571 ) $ 113,213 Liabilities: Contingent consideration, net of current portion $ 41,170 $ (6,571 ) $ 34,599 Total liabilities $ 41,170 $ (6,571 ) $ 34,599 In addition, the Company has reflected the impact of the above adjustments to the disclosures in Notes 4 and 9. In September 2015, the Company received data for the leading molecule in the series, GC-072, that indicated a potential toxicity issue. The Company considered this information an indicator of impairment of the related EV-035 series of molecules IPR&D asset, and completed an impairment assessment of this asset. As a result of the impairment of the EV-035 series of molecules IPR&D asset, the Company also performed an interim goodwill qualitative impairment assessment of the Biodefense Therapeutics and Vaccines reporting unit, a component of the Biodefense segment, which contains $22.0 million of the goodwill reported on the Company's consolidated balance sheets as of September 30, 2015. Based on the assessment, the Company concluded that the goodwill was not impaired. The fair value of contingent consideration obligations are based on management's assessment of certain development and regulatory milestones, along with updates in the assumed achievement of potential future net sales for the EV-035 series of molecules, which are inputs that have no observable market (Level 3). For year ended December 31, 2015, the contingent consideration obligation decreased by $9.4 million. The change was primarily due to the estimated timing and probability of success for certain development and regulatory milestones and the estimated timing and volume of potential future sales of EV-035. For the year ended December 31, 2015, $3.2 million and $6.2 million, respectively, of the adjustment was recorded in the Company's statement of operations as a reduction in selling, general and administrative expense and research and development expense within the Biodefense segment. During the year ended December 31, 2015, the Company received novation of the DTRA contract and paid the $4.0 million milestone to Evolva in the second quarter of 2015. Cangene Corporation On February 21, 2014, the Company acquired 100% of the voting interest of Cangene for $3.24 per share in cash (on a fully-diluted basis), which represents a total purchase price of $221.5 million. This transaction was accounted for by the Company under the acquisition method of accounting, with the Company as the acquirer. Under the acquisition method of accounting, the assets and liabilities of Cangene were recorded as of the acquisition date, at their respective fair values, and combined with those of the Company. This acquisition diversified the product portfolio of the Company's Biodefense and Biosciences divisions and expanded the Company's manufacturing capabilities. The table below summarizes the allocation of the purchase price based upon estimated fair values of assets acquired and liabilities assumed at February 21, 2014. (in thousands) Fair value of tangible assets acquired and liabilities assumed: Cash $ 43,631 Accounts receivable 19,652 Inventory (i) 55,259 Prepaid expenses and other assets 2,375 Property, plant and equipment 40,264 Deferred taxes, net 21,337 Income tax receivable 2,452 Accounts payable and accrued liabilities (22,918 ) Provision for chargebacks (1,946 ) Contingent purchase consideration (1,284 ) Deferred revenue (6,378 ) Total fair value of tangible assets acquired and liabilities assumed 152,444 Acquired in-process research and development 8,300 Acquired intangible assets 36,200 Goodwill 24,566 Total purchase price $ 221,510 (i) Acquired inventory reflects a $8.8 million adjustment to record inventory at fair value, referred to as a step-up adjustment. The $8.8 million step-up is estimated to be amortized through cost of product sales and contract manufacturing over the next five years based on expected inventory turnover, which will increase cost of product sales and contract manufacturing during such period. The table below summarizes the fair value of intangible assets acquired and the estimated amortization periods: Amortization Period ( in thousands) Amount in years Corporate Trade Name $ 2,800 5.0 Marketed Products 8,100 10.0 Licensed Products 3,100 7.0 Biodefense Products 16,700 12.0 Contract Manufacturing 5,500 8.0 Total identified intangible assets $ 36,200 The Company determined the fair value of the intangible assets using the income approach, which is based on the present value of future cash flows. The fair value measurements are based on significant unobservable inputs that are developed by the Company using estimates and assumptions of the respective market and market penetration of the Company's products. A portion of the assets acquired from Cangene consisted of intangible assets. The Marketed Products intangible asset consists of WinRho ® o ® ® TM Anthrasil The Company determined the fair value of the Marketed, Licensed and Biodefense Products intangible assets using the income approach with a present value discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of Cangene. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value these intangible assets. The projected cash flows from these Marketed, Licensed and Biodefense Products intangible assets were based on key assumptions, including: estimates of revenues and operating profits, the life of the potential commercialized product and associated risks, and risks related to the viability of and potential alternative treatments in any future target markets. The Company determined the fair value of the Contract Manufacturing intangible asset using the income approach with a present value discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of Cangene. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value this intangible asset. The projected cash flows from the Contract Manufacturing intangible asset were based on key assumptions, including: estimates of revenues and operating profits, and viability of attaining/maintaining future third-party manufacturing relationships with the Company's customers. The Company determined the fair value of the Corporate Trade Name intangible asset using the relief of royalty method with a present value discount rate of 15%, based on the estimated weighted-average cost of capital for companies with profiles substantially similar to that of Cangene. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value this intangible asset. The intangible asset associated with IPR&D acquired from Cangene is the IXINITY product candidate. Management determined that the estimated acquisition-date fair value of intangible assets related to IPR&D was $8.3 million. The estimated fair value was determined using the income approach, which discounts expected future cash flows to present value. The Company estimated the fair value using a present value discount rate of 16%, which is based on the estimated weighted-average cost of capital for companies with that profiles substantially similar to that of Cangene and IPR&D assets at a similar stage of development as IXINITY. This is comparable to the estimated internal rate of return for the acquisition and represents the rate that market participants would use to value the IPR&D. The projected cash flows for IXINITY were based on key assumptions including: estimates of revenues and operating profits, considering its stage of development on the acquisition date, the time and resources needed to complete the development and approval of the product candidate, the life of the potential commercialized product and associated risks, including the inherent difficulties and uncertainties in developing a product candidate, such as obtaining marketing approval from the FDA and other regulatory agencies, and risks related to the viability of and potential for alternative treatments in any future target markets. IPR&D assets are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts (see Note 9). The Company recorded approximately $24.6 million in goodwill related to the Cangene acquisition, representing the purchase price paid in the acquisition that was in excess of the fair value of the tangible and intangible assets acquired. None of the goodwill generated from the Cangene acquisition is expected to be deductible for tax purposes. The Company has incurred transaction costs related to the Cangene acquisition of approximately $3.7 million and $3.3 million for the years ended December 31, 2014 and 2013, respectively, which has been recorded in selling, general and administrative expenses within the Company's Biosciences segment. The following pro forma information is presented as if the acquisition had occurred on January 1, 2013, and combines the historical results of operations of the Company and Cangene for the year ended December 31, 2014 and 2013. December 31, (in thousands) 2014 2013 Pro forma revenue $ 462,446 $ 428,194 Pro forma net income $ 34,624 $ 10,994 |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair value measurements [Abstract] | |
Fair value measurements | 4. Fair value measurements The following table represents the Company's fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis: At December 31, 2015 (in thousands) Level 1 Level 2 Level 3 Total Assets: Investment in money market funds (1) $ 3,323 $ - $ - $ 3,323 Total assets $ 3,323 $ - $ - $ 3,323 Liabilities: Contingent consideration $ - $ - $ 25,599 $ 25,599 Total liabilities $ - $ - $ 25,599 $ 25,599 At December 31, 2014 (in thousands) Level 1 Level 2 Level 3 Total Assets: Investment in money market funds (1) $ 8,069 $ - $ - $ 8,069 Total assets $ 8,069 $ - $ - $ 8,069 Liabilities: Contingent price consideration $ - $ - $ 41,086 $ 41,086 Total liabilities $ - $ - $ 41,086 $ 41,086 (1) Included in cash and cash equivalents in accompanying consolidated balance sheets. As of December 31, 2015 and 2014, the Company did not have any transfers between Level 1 and Level 2 assets or liabilities. In addition to the contingent consideration obligations to Evolva, the fair value of contingent consideration obligations changes as a result of management's assessment of adjustments to the discount rates and updates in the assumed and actual achievement of future net sales for RSDL and HepaGam B, which are inputs that have no observable market (Level 3). For the years ended December 31, 2015 and 2014, the contingent purchase consideration obligation decreased by $1.2 million and increased by $3.1 million, respectively. The decrease and increase are primarily due to an adjustment to the actual and expected timing and volume of RSDL and HepaGam B sales. The changes for RSDL and HepaGam b are classified in the Company's statement of operations as cost of product sales and contract manufacturing, within the Biodefense and Biosciences segments, respectively. The following table is a reconciliation of the beginning and ending balance of the liabilities measured at fair value using significant unobservable inputs (Level 3) during the years ended December 31, 2015 and 2014. (in thousands) Balance at December 31, 2013 $ 16,619 Expense (income) included in earnings 3,133 Settlements (1,579 ) Purchases, sales and issuances 22,913 Transfers in/(out) of Level 3 - Balance at December 31, 2014 $ 41,086 Expense (income) included in earnings (10,599 ) Settlements (5,693 ) Purchases, sales and issuances 805 Transfers in/(out) of Level 3 - Balance at December 31, 2015 $ 25,599 Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. As of December 31, 2015, the EV-035 series of molecules IPR&D asset was measured at fair value on a non-recurring basis due to the toxicity issue. As of December 31, 2015, the assets acquired and liabilities assumed as part of the December 2014 acquisition of the EV-035 series of molecules were measured at fair value on a non-recurring basis. During the year ended December 31, 2014, the assets acquired and liabilities assumed as part of the February 2014 acquisition of Cangene Corporation and EV-035 series of molecules acquisitions (Note 3) and the evaluation of the IXINITY IPR&D asset for impairment (Note 9) were measured at fair value on a non-recurring basis. |
MorphSys collaboration agreemen
MorphSys collaboration agreement | 12 Months Ended |
Dec. 31, 2015 | |
MorphoSys collaboration agreement [Abstract] | |
MorphoSys collaboration agreement | 5. MorphoSys collaboration agreement In August 2014, the Company entered into a collaboration agreement ("MorphoSys Agreement") with MorphoSys AG ("MorphoSys") for the joint worldwide development and commercialization of MOR209/ES414, a targeted immunotherapeutic protein, which activates host T-cell immunity specifically against cancer cells expressing prostate specific membrane antigen, an antigen commonly overexpressed on prostate cancer cells. MOR209/ES414 was constructed using the Company's proprietary ADAPTIR platform technology. In accordance with the initial terms of the MorphoSys Agreement, the Company received a nonrefundable $20.0 million upfront payment and could have received up to $163.0 million in additional contingent payments, of which $80.0 million and $83.0 million, respectively, were due upon the achievement of specified development and regulatory milestones. The Company determined that payments for the achievement of the development and regulatory milestones are substantive milestones and will be accounted for as revenue in the period in which the milestone is achieved. MorphoSys and the Company jointly fund further development of Mor209/ES414, with the Company responsible for 36% of the total development costs and MorphoSys responsible for the remainder, with the funding requirement capped at $186.0 million. The Company retains commercialization rights in the U.S. and Canada, with a tiered royalty obligation to MorphoSys, ranging from mid-single digit up to 20%. MorphoSys has worldwide commercialization rights excluding the U.S. and Canada, with a low single digit royalty obligation to the Company. The Company's current obligations under the collaboration includes the performance of non-clinical, clinical, manufacturing and regulatory activities. In December 2015, after a joint review of data from the ongoing Phase 1 dose escalation study of MOR209/ES414 in prostate cancer patients, the Company and MorphoSys decided to adjust the dosing regimen and administration of MOR209/ES414. The Company plans to continue the current clinical trial under an amended protocol with recruitment to start around mid-2016. As a result of the required dosing regimen and administration change and the impact to overall development timeline and technical risk, the co-development agreement with MorphoSys was re-structured. In December 2015, the Company and MorphoSys amended the collaboration agreement to decrease the additional contingent payments due upon the achievement of specified development and regulatory milestones to $32.5 million and $41.5 million, respectively. In addition, the amended collaboration agreement changed the total expected funding requirement for the Company to $460.0 million and changed the jointly funded development cost allocation to the following: · 2016: Company is responsible for 75%; MorphoSys responsible for 25% · 2017-2018: Company is responsible for 49%; MorphoSys responsible for 51% · 2019 and beyond: Company is responsible for 36%; MorphoSys responsible for 64% The Company evaluated the MorphoSys Agreement and determined that it was a revenue arrangement with multiple deliverables, or performance obligations. The Company determined there were two units of accounting under the collaboration agreement with MorphoSys: (1) the delivered license to further develop and commercialize MOR209/ES414 and (2) undelivered items related to development services. The Company determined that the license had stand-alone value as the drug candidate has been (1) developed and is currently Phase 1 clinical trial ready, (2) MorphoSys possesses the knowledge, technology, skills, experience and infrastructure necessary to complete all further development of the drug through commercialization, and (3) MorphoSys has the right to further sublicense the product. The Company allocated the $20.0 million upfront payment to the two units of accounting using the relative selling price method. The Company determined the estimated selling price for the license using the income approach and a discount rate of 12%. The estimated selling price includes unobservable inputs (Level 3), such as estimates of revenues and operating margins; the time and resources needed to complete the development and approval of the product candidate; and the risk related to the viability of and potential for alternative treatments. The Company determined the estimated selling price of the development services unit of accounting based on the estimated number of full-time equivalent personnel at the contractual rate as defined in the MorphoSys Agreement, which represents the approximate terms of other service related contracts both entered by the Company and observed generally through other collaboration negotiations. The allocation resulted in $15.3 million of the upfront payment being allocated to the license and $4.7 million being allocated to the development services. The Company determined the license fee unit of accounting was delivered on the date the MorphoSys agreement was executed and therefore has recognized revenue of $15.3 million, which is included in contracts, grants and collaborations revenues within the Company's Biosciences segment. Revenue related to the undelivered item will be recognized as the services are performed. The current estimated service period for the undelivered item under the MorphoSys Agreement is through 2022. The amount allocable to the units of accounting is limited to the amount that is not contingent upon the delivery of additional items or meeting other specified performance conditions (the noncontingent amount). As such, the Company excluded from the allocable arrangement consideration the milestone payments and royalties regardless of the probability of receipt. For the years ended December 31, 2015 and 2014, respectively, the collaboration provides for sharing of development and clinical costs, with the Company responsible for 36% of such costs and MorphoSys responsible for the remainder. In the event the Company's share of the total cost for a given quarter exceeds 36% of the total costs for the project, the Company records a net receivable in its financial statements equal to the difference between the Company's costs and 36% of the total costs for the period, and reduces research and development expense in this amount. For the years ended December 31, 2015 and 2014, the Company has recorded a net reduction to research and development expense of $4.3 million and $1.5 million, respectively. During the year ended December 31, 2015, the Company received a $5.0 million milestone payment from MorphoSys reflecting the initiation of a Phase I clinical study to evaluate the safety, tolerability, and clinical activity of MOR209/ES414 in patients with metastatic castration-resistant prostate cancer. The Company recorded this payment in contracts, grants and collaborations revenue within the Company's statement of operations. As of December 31, 2015 and 2014, accounts receivable from MorphoSys was $0.5 million and $1.0 million, respectively. As of December 31, 2015 and 2014, deferred revenue related to the MorphoSys Agreement consisted of $0.7 million and $0.9 million and $3.2 million and $3.5 million of current and long-term deferred revenue, respectively. |
Accounts receivable
Accounts receivable | 12 Months Ended |
Dec. 31, 2015 | |
Accounts receivable [Abstract] | |
Accounts receivable | 6. Accounts receivable Accounts receivable consist of the following: December 31, (in thousands) 2015 2014 Billed $ 102,155 $ 39,948 Unbilled 18,612 18,886 Total $ 120,767 $ 58,834 For the year ended December 31, 2015, the Company |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2015 | |
Inventories [Abstract] | |
Inventories | 7. Inventories Inventories consist of the following: December 31, (in thousands) 2015 2014 Raw materials and supplies $ 23,099 $ 17,375 Work-in-process 37,209 33,477 Finished goods 16,628 14,822 Total inventories $ 76,936 $ 65,674 |
Property, plant and equipment
Property, plant and equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property, plant and equipment [Abstract] | |
Property, plant and equipment | 8. Property, plant and equipment Property, plant and equipment consist of the following: December 31, (in thousands) 2015 2014 Land and improvements $ 16,520 $ 12,838 Buildings, building improvements and leasehold improvements 111,060 107,202 Furniture and equipment 136,528 130,131 Software 39,784 25,354 Construction-in-progress 127,489 117,884 431,381 393,409 Less: Accumulated depreciation and amortization (99,525 ) (79,430 ) Total property, plant and equipment, net $ 331,856 $ 313,979 For the years ended December 31, 2015 and 2014, construction-in-progress primarily included costs related to Building 55, the Company's large-scale manufacturing facility, for which the Company is in the process of receiving regulatory approval. Depreciation and amortization expense was $24.5 million, $23.0 million and $17.0 million for the years ended December 31, 2015, 2014 and 2013, respectively. The increase in depreciation expense for December 31, 2014 as compared to December 31, 2013 was primarily due to the Company's Baltimore facility being placed-in-service in December 2013. For the years ended December 31, 2015 and 2014, the Company had $10.7 million and $2.4 million, respectively, of capitalized software development costs. For the year ended December 31, 2015, the Company recorded amortization of capitalized software of $0.4 million. There was no amortization of capitalized software costs for the year ended December 31, 2014 and 2013. |
Intangible assets, in-process r
Intangible assets, in-process research and development and goodwill | 12 Months Ended |
Dec. 31, 2015 | |
Intangible assets, in-process research and development and goodwill [Abstract] | |
Intangible assets, in-process research and development and goodwill | 9. Intangible assets, in-process research and development and goodwill For the year ended December 31, 2015, the Company had $41.8 million of IPR&D assets included in the Biosciences business segment related to the Company's otlertuzumab product candidate. For the year ended December 31, 2014, the Company had $50.1 million of IPR&D assets included in the Biosciences business segment. This included $41.8 million related to the Company's otlertuzumab product candidate and $8.3 million related to the Company's IXINITY product candidate. On April 29, 2015, the FDA approved IXINITY for the treatment of Hemophilia B. As a result of the approval, the $8.3 million IXINITY IPR&D asset The Company completed its annual impairment assessments for its IPR&D assets and goodwill as of October 1, 2015 and 2014, respectively, and determined that the fair value of the Company's IPR&D assets and reporting units was significantly in excess of carrying value. As of October 1, 2015, the Company performed a As of October 1, 2014, t Intangible assets consisted of the following: Biodefense Biosciences (in thousands) Segment Segment Total Cost basis Balance at December 31, 2014 $ 48,799 $ 19,500 $ 68,299 Additions - 8,300 8,300 Balance at December 31, 2015 $ 48,799 $ 27,800 $ 76,599 Accumulated amortization Balance at December 31, 2014 $ (7,820 ) $ (2,135 ) $ (9,955 ) Amortization (6,209 ) (3,060 ) (9,269 ) Balance at December 31, 2015 $ (14,029 ) $ (5,195 ) $ (19,224 ) Net book value at December 31, 2015 $ 34,770 $ 22,605 $ 57,375 Amortization expense consisted of the following: December 31, (in thousands) 2015 2014 2013 Biodefense segment $ 6,209 $ 5,869 $ 1,951 Biosciences segment 3,060 2,135 - Total amortization expense $ 9,269 $ 8,004 $ 1,951 As of December 31, 2015, the weighted average amortization period remaining for intangible assets in the Biodefense and Biosciences segments was 88 and 90 months, respectively. Future amortization expense as of December 31, 2015 is as follows: (in thousands) 2016 $ 8,976 2017 8,300 2018 8,300 2019 7,821 2020 and beyond 23,978 Total remaining amortization $ 57,375 The following table is a summary of changes in goodwill by reporting unit: (in thousands) Biosciences therapeutics Biosciences contracts manufacturing Biodefense therapeutics and vaccines Biodefense medical device(s) Total Cost Basis Balance at December 31, 2014 $ 13,902 $ 6,736 $ 22,031 $ 9,916 $ 52,585 Additions - - 2,317 - 2,317 Balance at December 31, 2015 $ 13,902 $ 6,736 $ 24,348 $ 9,916 $ 54,902 |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 2015 | |
Long-term debt [Abstract] | |
Long-term debt | 10. Long-term debt On January 29, 2014, the Company issued $250.0 million aggregate principal amount of 2.875% Convertible Senior Notes due 2021 (the "Notes"). The Notes bear interest at a rate of 2.875% per year, payable semi-annually in arrears on January 15 and July 15 of each year. The Notes mature on January 15, 2021, unless earlier purchased by the Company or converted. The conversion rate is equal to 30.8821 shares of common stock per $1,000 principal amount of notes (which is equivalent to a conversion price of approximately $32.38 per share of common stock). The conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. The Company incurred approximately $8.3 million in debt issuance costs associated with the Notes, which has been capitalized on the consolidated balance sheets and is being amortized over seven years. On December 11, 2013, the Company entered into a senior secured credit agreement (the "Credit Agreement") with three lending financial institutions. The Credit Agreement originally provided for a revolving credit facility of up to $100.0 million through December 11, 2018 (or such earlier date required by the terms of the Credit Agreement) and a term loan facility of up to $125.0 million to be drawn in full, if at all, on or prior to March 31, 2014. In connection with the Credit Agreement, the Company borrowed $62.0 million under the revolving credit facility primarily to repay obligations under existing loan agreements. On January 29, 2014, in connection with the Company's issuance of the Notes, the unused $125.0 million term loan portion of the Credit Agreement terminated automatically in accordance with the terms of the Credit Agreement. In addition, following the closing of the Notes offering, the Company repaid the $62.0 million outstanding indebtedness under the revolving credit facility, which restored the full $100.0 million revolving credit capacity under this facility. Under the revolving credit facility, the Company is required to pay an unused fee of approximately 0.5% annually, on a quarterly basis. In addition, during the year ended December 31, 2014, the Company expensed $1.8 million of debt issuance cost associated with the term loan facility. As of December 31, 2015, no amounts were drawn under the revolving credit facility. The Company's payment obligations under the Credit Agreement are secured by a lien on substantially all of the Company's assets, including the stock of all of the Company's subsidiaries, and the assets of the subsidiary guarantors, including mortgages over certain of their real properties, including the Company's large-scale vaccine manufacturing facility in Lansing, Michigan and the Company's product development and manufacturing facility in Baltimore, Maryland. The Credit Agreement, as amended, contains affirmative and negative covenants customary for financings of this type. Negative covenants in the Credit Agreement limit the Company's ability to, among other things: incur indebtedness (other than the issuance of the Notes) and liens; dispose of assets; make investments including loans, advances or guarantees; and enter into certain mergers or similar transactions. The Credit Agreement also contains financial covenants, tested quarterly and in connection with any triggering events under the Credit Agreement that include the maintenance of: (1) a minimum consolidated debt service coverage ratio of 2.50 to 1.00, (2) a maximum consolidated leverage ratio for the period ending on or prior to September 30, 2014 of 4.00 to 1.00, for the measurement period ending December 31, 2014 of 3.75 to 1.00, and thereafter of 3.50 to 1.00, and (3) a minimum liquidity requirement of $50.0 million. Upon the occurrence and continuance of an event of default under the Credit Agreement, the commitments of the lenders to make loans under the Credit Agreement may be terminated and the Company's payment obligations under the Credit Agreement may be accelerated. The events of default under the Credit Agreement include, among others, subject in some cases to specified cure periods: payment defaults; inaccuracy of representations and warranties in any material respect; defaults in the observance or performance of covenants; bankruptcy and insolvency related defaults; the entry of a final judgment in excess of a threshold amount; change of control; and the invalidity of loan documents relating to the Credit Agreement. The Company was in compliance with these covenants as of December 31, 2015 and 2014. In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30), which simplifies the presentation of debt issuance costs. ASU 2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. Prior to the issuance of ASU 2015-03, debt issuance costs were required to be presented as an asset in the balance sheet. ASU 2015-03 is effective for interim and annual periods beginning after December 15, 2015 and early adoption is permitted. As of December 31, 2015, the Company had debt issuance costs of $1.5 million and $5.6 million, respectively, classified in the consolidated balance sheet as prepaid expenses and other current assets and other assets, of which $1.2 million and $4.9 million, respectively, would have been reclassified in the consolidated balance sheet as a reduction |
Stockholders' equity
Stockholders' equity | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' equity [Abstract] | |
Stockholders' equity | 11. Stockholders' equity Preferred stock The Company is authorized to issue up to 15.0 million shares of preferred stock, $0.001 par value per share ("Preferred Stock"). Any Preferred Stock issued may have dividend rights, voting rights, conversion privileges, redemption characteristics, and sinking fund requirements as approved by the Company's board of directors. Common stock The Company currently has one class of common stock, $0.001 par value per share common stock ("Common Stock"), authorized and outstanding. The Company is authorized to issue up to 100.0 million shares of Common Stock. Holders of Common Stock are entitled to one vote for each share of Common Stock held on all matters, except as may be provided by law. Stock options and restricted stock units The following is a summary of option award activity under the Emergent Plans: 2006 Plan 2004 Plan Number of Shares Weighted-Average Exercise Price Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Outstanding at December 31, 2014 3,837,993 $ 20.04 43,156 $ 10.28 $ 29,181,534 Granted 690,221 29.03 - - Exercised (1,360,955 ) 18.09 (13,457 ) 10.28 Forfeited (189,439 ) 24.29 - - Outstanding at December 31, 2015 2,977,820 $ 22.74 29,699 $ 10.28 $ 52,324,284 Exercisable at December 31, 2015 1,442,178 $ 19.12 29,699 $ 10.28 $ 31,006,178 Options expected to vest at December 31, 2015 1,195,677 $ 25.76 - $ - $ 17,043,405 The following is a summary of restricted stock unit award activity under the 2006 Plan: Number of Shares Weighted-Average Grant Price Aggregate Intrinsic Value Outstanding at December 31, 2014 927,356 $ 22.44 $ 25,251,904 Granted 473,111 29.61 Vested (422,515 ) 20.60 Forfeited (82,156 ) 25.10 Outstanding at December 31, 2015 895,796 $ 26.85 $ 35,840,796 The weighted average remaining contractual term of options outstanding as of December 31, 2015 and 2014 was 4.4 years and 4.0 years, respectively. The weighted average remaining contractual term of options exercisable as of December 31, 2015 and 2014 was 3.4 years and 3.2 years, respectively. The weighted average grant date fair value of options granted during the years ended December 31, 2015, 2014 and 2013 was $8.66, $8.84 and $5.38, respectively. The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 was $20.2 million, $7.5 million and $6.9 million, respectively. The total fair value of awards vested during 2015, 2014 and 2013 was $14.4 million, $12.3 million and $9.1 million, respectively. Stock-based compensation expense was recorded in the following financial statement line items: Years ended December 31, (in thousands) 2015 2014 2013 Cost of product sales $ 1,183 $ 1,145 $ 575 Research and development 3,112 3,606 3,283 General and administrative 11,553 8,078 7,380 Total stock-based compensation expense $ 15,848 $ 12,829 $ 11,238 |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income taxes [Abstract] | |
Income taxes | 12. Income taxes Significant components of the provisions for income taxes attributable to operations consist of the following: Year ended December 31, (in thousands) 2015 2014 2013 Current Federal $ 20,664 $ 10,412 $ (878 ) State 1,401 479 (173 ) International 1,370 112 300 Total current 23,435 11,003 (751 ) Deferred Federal 7,802 7,693 12,679 State 185 128 1,028 International (4,523 ) (2,503 ) 152 Total deferred 3,464 5,318 13,859 Total provision for income taxes $ 26,899 $ 16,321 $ 13,108 The Company's net deferred tax asset (liability) consists of the following: December 31, (in thousands) 2015 2014 Federal losses carryforward $ 5,394 $ 8,487 State losses carryforward 12,751 12,043 Research and development carryforward 3,545 8,049 Scientific research and experimental development credit carryforward 25,771 29,556 Intangible assets 5,792 5,689 Stock compensation 9,391 8,196 Foreign deferrals 80,920 75,511 Inventory reserves 3,754 4,122 Other 8,484 7,463 Deferred tax asset 155,802 159,116 Fixed assets (31,925 ) (34,839 ) Intangible assets (4,760 ) (6,538 ) Other (17,192 ) (10,891 ) Deferred tax liability (53,877 ) (52,268 ) Valuation allowance (90,639 ) (92,374 ) Net deferred tax (liabilities)/ asset $ 11,286 $ 14,474 As of December 31, 2015, the Company currently has approximately $15.4 million ($5.4 million tax effected) in net operating loss carryforwards along with $3.5 million in research and development tax credit carryforwards for U.S. federal tax purposes that will begin to expire in 2026 and 2023, respectively. The U.S. federal tax carryforwards are recorded with no valuation allowance. The Company has $237.8 million ($12.8 million tax effected) in state net operating loss carryforwards, primarily in Maryland, that will begin to expire in 2018. The U.S. state tax loss carryforwards are recorded with a valuation allowance of $190.0 million ($10.2 million tax effected). The Company has approximately $231.1 million ($59.8 million tax effected) in net operating losses from foreign jurisdictions (excluding Canada) that will have an indefinite life unless the foreign entities have a change in the nature or conduct of the business in the three years following a change in ownership. A valuation allowance in respect to these foreign losses has been recorded in the amount of $59.8 million. The Company has approximately $66.9 million ($17.4 million tax effected) in Canadian loss carryforwards which are recorded with no valuation allowance. The Company currently has approximately $5.1 million of Canadian federal scientific research and experimental development credit carryforwards that will begin to expire in 2029. In addition, the Company has approximately $20.6 million in Manitoba scientific research and experimental development credit carryforwards that will begin to expire in 2026. Due to the timing of the expiry of the Manitoba credits, the Company has recorded a valuation allowance with respect to the Manitoba credits in the amount of $20.6 million, as it is uncertain whether sufficient future taxable income will be generated in Manitoba during the carryforward period. The use of any of these net operating losses and research and development tax credit carryforwards may be restricted due to changes in the Company's ownership. The provision for income taxes differs from the amount of taxes determined by applying the U.S. federal statutory rate to loss before provision for income taxes as a result of the following: Year ended December 31, (in thousands) 2015 2014 2013 US $ 88,525 $ 59,764 $ 52,749 International 1,244 (6,702 ) (8,506 ) Earnings before taxes on income 89,769 53,062 44,243 Federal tax at statutory rates $ 31,394 $ 18,572 $ 15,485 State taxes, net of federal benefit 613 257 538 Impact of foreign operations (144 ) 186 (1,116 ) Change in valuation allowance (1,735 ) 1,808 1,434 Tax credits (4,849 ) (7,137 ) (5,918 ) Other differences 748 124 (227 ) Permanent differences 872 2,511 2,912 Provision for income taxes $ 26,899 $ 16,321 $ 13,108 The effective annual tax rate for the years ended December 31, 2015, 2014 and 2013 was 30%, 31% and 30%, respectively. The Company recognizes interest in interest expense and recognizes potential penalties related to unrecognized tax benefits in selling, general and administrative expense. Of the total unrecognized tax benefits recorded at December 31, 2015 and 2014, $0.3 million and $0.2 million, respectively, is classified as a current liability and $1.1 million for both periods, respectively, is classified as a non-current liability on the balance sheet. The table below presents the gross unrecognized tax benefits activity for 2015, 2014 and 2013: (in thousands) Gross unrecognized tax benefits at December 31, 2012 $ 1,016 Increases for tax positions for prior years 165 Decreases for tax positions for prior years - Increases for tax positions for current year 15 Settlements - Lapse of statute of limitations (75 ) Gross unrecognized tax benefits at December 31, 2013 1,121 Increases for tax positions for prior years 150 Decreases for tax positions for prior years - Increases for tax positions for current year 102 Settlements - Lapse of statute of limitations (125 ) Gross unrecognized tax benefits at December 31, 2014 1,248 Increases for tax positions for prior years 150 Decreases for tax positions for prior years - Increases for tax positions for current year 59 Settlements - Lapse of statute of limitations - Gross unrecognized tax benefits at December 31, 2015 $ 1,457 When resolved, substantially all of these reserves would impact the effective tax rate. The Company's federal and state income tax returns for the tax years 2011 to 2014 remain open to examination. The Company's tax returns in the United Kingdom remain open to examination for the tax years 2007 to 2014, and tax returns in Germany remain open indefinitely. The Company's tax returns for Canada remains open to examination for the tax years 2009 to 2013. As of December 31, 2015, the Company's 2009 and 2010 federal income tax returns are in appeals with the Internal Revenue service. The Company believes appropriate provisions have been made for any outstanding issues. As of December 31, 2015, the Company's 2011 and 2012 federal income tax returns are under audit. |
Assets held for sale
Assets held for sale | 12 Months Ended |
Dec. 31, 2015 | |
Assets held for sale [Abstract] | |
Assets held for sale | 13. Assets held for sale The Company currently owns a manufacturing and development facility in Winnipeg, Manitoba, Canada, within the Company's Biosciences segment, that it is actively seeking to sell. In October 2014, the Company determined that this facility, along with associated equipment, would not be placed into service and committed to a plan to sell the facility. As a result, this facility and related equipment are classified on the Company's balance sheet as an asset held for sale within the prepaid and other current assets line item. The Company recorded the assets held for sale at fair market value of $2.4 million, based on factors that include recent purchase offers less estimated selling costs. |
Purchase commitment
Purchase commitment | 12 Months Ended |
Dec. 31, 2015 | |
Purchase commitment [Abstract] | |
Purchase commitment | 14. Purchase commitment During 2014 the Company entered into a contract with Norwood Laboratories Inc. ("Norwood") to purchase $15.2 million of raw materials related to the Company's RSDL product. For the years ended December 31, 2015 and 2014, the Company purchased $6.2 million and $1.5 million, respectively, of materials under this commitment. |
401(k) savings plan
401(k) savings plan | 12 Months Ended |
Dec. 31, 2015 | |
401(k) savings plan [Abstract] | |
401(k) savings plan | 15. 401(k) savings plan The Company has established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code. The 401(k) Plan covers substantially all U.S. employees. Under the 401(k) Plan, employees may make elective salary deferrals. The Company currently provides for matching of qualified deferrals up to 50% of the first 6% of the employee's salary. During the years ended December 31, 2015, 2014, and 2013, the Company made matching contributions of approximately $2.5 million, $2.4 million and $2.0 million, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2015 | |
Leases [Abstract] | |
Leases | 16. Leases The Company leases laboratory and office facilities, office equipment and vehicles under various operating lease agreements. The Company leases office space in Washington, D.C. under an operating lease that contains a 2.5% escalation clause, which expires in May 2027. Future minimum lease payments under operating lease obligations as of December 31, 2015 were as follows: (in thousands) 2016 $ 2,577 2017 2,324 2018 2,044 2019 1,988 2020 924 2021 and beyond 2,137 Total minimum lease payments 11,994 Minimum lease receipts (1,105 ) Total minimum lease payments $ 10,889 |
Related party transactions
Related party transactions | 12 Months Ended |
Dec. 31, 2015 | |
Related party transactions [Abstract] | |
Related party transactions | 17. Related party transactions In November 2015, the Company entered into a consulting arrangement with a member of the Company's Board of Directors to provide assistance in connection with the planned spin-off of the biosciences business into a separate company, to be named Aptevo Therapeutics Inc. ("Aptevo"). The maximum compensation under the agreement is $0.1 million per year. The consulting agreement will terminate with the completion of the spin-off, at which time the member of the Board of Directors is expected to become the CEO of Aptevo. The Company entered into an agreement in February 2009 with an entity controlled by family members of the Company's Executive Chairman to market and sell BioThrax. The agreement was effective as of November 2008 and requires payment based on a percentage of net sales of biodefense products of 17.5% in Saudi Arabia and 15% in Qatar and United Arab Emirates, and reimbursement of certain expenses. No expenses were incurred under this agreement during 2015, 2014 and 2013. |
Earnings per share
Earnings per share | 12 Months Ended |
Dec. 31, 2015 | |
Earnings per share [Abstract] | |
Earnings per share | 18. Earnings per share The following table presents the calculation of basic and diluted net income per share: Years ended December 31, (in thousands, except share and per share data) 2015 2014 2013 Numerator: Net income $ 62,870 $ 36,741 $ 31,135 Interest expense applicable to convertible debt, net of tax 3,019 2,879 - Amortization of debt issuance costs, net of tax 868 735 - Adjusted net income $ 66,757 $ 40,355 $ 31,135 Denominator: Weighted-average number of shares—basic 38,595,435 37,344,891 36,201,283 Dilutive securities—equity awards 939,882 737,391 546,273 Dilutive securities—convertible debt 7,720,525 7,720,525 - Weighted-average number of shares—diluted 47,255,842 45,802,807 36,747,556 Earnings per share-basic $ 1.63 $ 0.98 $ 0.86 Earnings per share-diluted $ 1.41 $ 0.88 $ 0.85 For the year ending December 31, 2015, substantially all of the outstanding stock options to purchase shares of common stock were included in the calculation of diluted earnings per share. For the years ending December 31, 2014 and 2013, outstanding stock options to purchase approximately 1.4 million and 1.5 million shares of common stock, respectively, are not considered in the diluted earnings per share calculation because the exercise price of these options is greater than the average per share closing price during the year. |
Segment information
Segment information | 12 Months Ended |
Dec. 31, 2015 | |
Segment information [Abstract] | |
Segment information | 19. Segment information For financial reporting purposes, the Company reports financial information for two business segments: Biodefense and Biosciences. The Company's two business segments, or divisions, engage in business activities for which discrete financial information is provided to and resources are allocated by the chief operating decision maker. The accounting policies of the reportable segments are the same as those described in the summary of significant accounting policies. The Company's reportable segments offer different products, product candidates, manufacturing processes and services, development processes, sales and marketing processes, and are managed separately. The Biodefense division is a specialty biopharmaceutical business focused on countermeasures that address public health threats, specifically Chemical, Biological, Radiological, Nuclear and Explosive threats, as well as emerging infectious diseases and consists of two business units: vaccines and therapeutics, and medical devices. Revenues in this segment are primarily from sales of the Company's FDA-licensed product, BioThrax® (Anthrax Vaccine Adsorbed), to the U.S. government. The Biosciences division is a specialty biopharmaceutical business focused on therapeutics primarily in hematology/oncology with secondary areas of focus in transplantation, infectious disease and autoimmunity. The Biosciences division consists of three business units: therapeutics, vaccines and contract manufacturing. The "All Other" segment relates to the general operating costs of the Company and includes costs of the centralized services departments, which are not allocated to the other segments, as well as spending on activities that are not classified as Biodefense or Biosciences. The assets in this segment consist primarily of cash. For the years ended December 31, 2015, 2014 and 2013, the Company had total assets of $270.0 million, $242.5 million and $56.7 million, respectively, located in foreign jurisdictions. Reportable Segments (in thousands) Biodefense Biosciences All Other Total Year Ended December 31, 2015 External revenue $ 450,088 $ 72,701 $ - $ 522,789 Intersegment revenue (expense) (1,877 ) 1,877 - - Research and development 111,663 37,816 4,518 153,997 Interest income 149 - 423 572 Interest expense - (41 ) (6,482 ) (6,523 ) Depreciation and amortization 18,677 5,597 227 24,501 Net income (loss) 125,609 (55,644 ) (7,095 ) 62,870 Intangible assets 34,770 22,605 - 57,375 In-process research and development assets 701 41,800 - 42,501 Goodwill 34,264 20,638 - 54,902 Total assets 511,875 345,995 185,722 1,043,592 Expenditures for long-lived assets 37,735 6,689 388 44,812 Year Ended December 31, 2014 External revenue $ 370,547 $ 79,591 $ - $ 450,138 Intersegment revenue (expense) - - - - Research and development 81,975 60,821 8,033 150,829 Interest income 62 - 258 320 Interest expense - - (8,240 ) (8,240 ) Depreciation and amortization 17,669 5,070 267 23,006 Net income (loss) 96,966 (51,300 ) (8,925 ) 36,741 Intangible assets 40,979 17,365 - 58,344 In-process research and development assets 10,528 50,100 - 60,628 Goodwill 31,239 21,346 - 52,585 Total assets 433,226 344,420 161,045 938,691 Expenditures for long-lived assets 26,736 2,444 1,493 30,673 Year Ended December 31, 2013 External revenue $ 311,564 $ 1,181 $ - $ 312,745 Intersegment revenue (expense) - - - - Research and development 62,663 50,652 6,618 119,933 Interest income - - 139 139 Interest expense - - - - Depreciation and amortization 15,584 1,238 186 17,008 Net income (loss) 87,289 (50,925 ) (5,229 ) 31,135 Intangible assets 30,148 0 0 30,148 In-process research and development assets - 41,800 - 41,800 Goodwill 8,452 5,502 - 13,954 Total assets 331,827 98,510 196,293 626,630 Expenditures for long-lived assets 30,700 1,343 9,978 42,021 |
Quarterly financial data (unaud
Quarterly financial data (unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly financial data (unaudited) [Abstract] | |
Quarterly financial data (unaudited) | 20. Quarterly financial data (unaudited) Quarterly financial information for the years ended December 31, 2015 and 2014 is presented in the following tables: Quarter Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2015: Revenue $ 63,633 $ 126,112 $ 164,940 $ 168,104 Income (loss) from operations (28,310 ) 21,452 53,005 49,892 Net income (loss) (21,519 ) 14,100 36,942 33,347 Net income (loss) per share, basic (0.57 ) 0.37 0.95 0.85 Net income (loss) per share, diluted (0.57 ) 0.32 0.79 0.71 2014: Revenue $ 53,884 $ 110,325 $ 137,954 $ 147,975 Income (loss) from operations (25,458 ) 7,862 31,032 44,620 Net income (loss) (20,236 ) 5,029 21,832 30,116 Net income (loss) per share, basic (0.55 ) 0.13 0.58 0.80 Net income (loss) per share, diluted (0.55 ) 0.13 0.49 0.66 |
Summary of significant accoun28
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of significant accounting policies [Abstract] | |
Basis of presentation and consolidation | Basis of presentation and consolidation The accompanying consolidated financial statements include the accounts of Emergent and its wholly owned and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. For investments in variable interest entities, the Company consolidates when it is determined to be the primary beneficiary. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and cash equivalents | Cash and cash equivalents Cash equivalents are highly liquid investments with a maturity of 90 days or less at the date of purchase and consist of time deposits and investments in money market funds with commercial banks and financial institutions. Also, the Company maintains cash balances with financial institutions in excess of insured limits. The Company does not anticipate any losses with such cash balances. |
Fair value of measurements | Fair value of measurements The Company measures and records cash equivalents and investment securities considered available-for-sale at fair value in the accompanying financial statements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability, an exit price, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value include: Level 1 — Observable inputs for identical assets or liabilities such as quoted prices in active markets; Level 2 — Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3 — Unobservable inputs in which little or no market data exists, which are therefore developed by the Company using estimates and assumptions that reflect those that a market participant would use. The carrying amounts of the Company's short-term financial instruments, which include cash and cash equivalents, accounts receivable and accounts payable, approximate their fair values due to their short maturities. |
Significant customers and accounts receivable | Significant customers and accounts receivable For the years ended December 31, 2015, 2014 and 2013, the Company's primary customer was the U.S. Department of Health and Human Services ("HHS"). For the years ended December 31, 2015, 2014 and 2013, revenues from HHS and HHS agencies comprised 81%, 74% and 95%, respectively, of total revenues and are included in the Company's Biodefense segment. As of December 31, 2015 and 2014, the Company's accounts receivable balances were comprised of 78% and 40%, respectively, from this customer. The overall increase in the percentage of accounts receivable attributed to HHS was due primarily to the timing of payments received for BioThrax product sales from the Centers for Disease Control ("CDC"), an operating division of HHS, under the Company's contract with CDC. As of December 31, 2015 and 2014, unbilled accounts receivable, which is included in accounts receivable, were $18.6 million and $18.9 million, respectively. Unbilled accounts receivable relates to various service contracts for which work has been performed, though invoicing has not yet occurred. Accounts receivable are stated at invoice amounts and consist primarily of amounts due from the U.S. government and collaborative partners, as well as amounts due under reimbursement contracts with other government entities and non-government and philanthropic organizations. If necessary, the Company records a provision for doubtful receivables to allow for any amounts which may be unrecoverable. This provision is based upon an analysis of the Company's prior collection experience, customer creditworthiness and current economic trends. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company places its cash and cash equivalents with high quality financial institutions. Management believes that the financial risks associated with its cash and cash equivalents are minimal. Because accounts receivable consist primarily of amounts due from the U.S. government for product sales and from government agencies under government grants and development contracts, management deems there to be minimal credit risk. |
Inventories | Inventories Inventories are stated at the lower of cost or market with cost being determined using a standard cost method, which approximates average cost. Average cost consists primarily of material, labor and manufacturing overhead expenses (including fixed production-overhead costs) and includes the services and products of third party suppliers. The Company analyzes its inventory levels quarterly and writes down, in the applicable period, inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected customer demand. The Company also writes off, in the applicable period, the costs related to expired inventory. Costs of purchased inventories are recorded using weighted-average costing. The Company determines normal capacity for each production facility and allocates fixed production-overhead costs on that basis. |
Property, plant and equipment | Property, plant and equipment Property, plant and equipment are stated at cost. Depreciation is computed using the straight-line method over the following estimated useful lives: Buildings 31-39 years Building improvements 10-39 years Furniture and equipment 3-15 years Software 3-7 years or product life Leasehold improvements Lesser of the asset life or lease term Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to operations. Repairs and maintenance costs are expensed as incurred. The Company capitalizes internal-use software when both (a) the software is internally developed, acquired, or modified solely to meet the entity's internal needs and (b) during the software's development or modification, no substantive plan either exists or is being developed to market the software externally. Capitalization of qualifying internal-use software costs begins when the preliminary project stage is completed, management with the relevant authority, implicitly or explicitly, authorizes and commits to the funding of the software project, and it is probable that the project will be completed and the software will be used to perform the function intended. |
Income taxes | Income taxes Income taxes are accounted for using the liability method. Deferred tax assets and liabilities are recognized for future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss and research and development tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the year in which those temporary differences are expected to be recovered or settled. The Company's ability to realize deferred tax assets depends upon future taxable income as well as the limitations discussed below. For financial reporting purposes, a deferred tax asset must be reduced by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized prior to expiration. The Company considers future taxable income and ongoing tax planning strategies in assessing the need for valuation allowances. In general, if the Company determines that it is more likely than not to realize more than the recorded amounts of net deferred tax assets in the future, the Company will reverse all or a portion of the valuation allowance established against its deferred tax assets, resulting in a decrease to the provision for income taxes in the period in which the determination is made. Likewise, if the Company determines that it is not more likely than not to realize all or part of the net deferred tax asset in the future, the Company will establish a valuation allowance against deferred tax assets, with an offsetting increase to the provision for income taxes, in the period in which the determination is made. Under sections 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a "loss corporation", as defined, there are annual limitations on the amount of net operating losses and deductions that are available. The Company believes the use of net operating losses and research and development tax credits acquired in the Trubion acquisition will not be significantly limited. Due to the acquisition of Microscience in 2005 and the Company's initial public offering, the Company believes the use of the operating losses incurred prior to 2005 will be significantly limited. Because tax laws are complex and subject to different interpretations, significant judgment is required. As a result, the Company make certain estimates and assumptions, in (1) calculating the Company's income tax expense, deferred tax assets and deferred tax liabilities, (2) determining any valuation allowance recorded against deferred tax assets and (3) evaluating the amount of unrecognized tax benefits, as well as the interest and penalties related to such uncertain tax positions. The Company's estimates and assumptions may differ significantly from tax benefits ultimately realized. In November 2015, the Financial Accounting Standards Board ("FASB") issued ASU No. 2015-17, Balance Sheet Classification of Deferred Taxes ("ASU No. 2015-17"). The amendments in ASU No. 2015-17 change the presentation requirements for deferred tax assets and liabilities, along with any related valuation allowance, to classify the balances solely as noncurrent on the balance sheet. As a result, each jurisdiction will now only have one net noncurrent deferred tax asset or liability. The amendments in ASU No. 2015-17 are effective for years beginning after December 15, 2017, and early adoption is permitted. The Company has elected to prospectively adopt the accounting standard for the year ended December 31, 2015. Prior periods in the Company's consolidated financial statements were not retrospectively adjusted. |
Revenue recognition | Revenue recognition The Company recognizes revenues from product sales and contract manufacturing  there is persuasive evidence of an arrangement;  delivery has occurred or title has passed to the Company's customer;  the fee is fixed or determinable; and  collectability is reasonably assured. All revenues from product sales are recorded net of applicable allowances for sales rebates, special promotional programs, and discounts. The Company estimates allowances for revenue reducing obligations using a combination of information received from third parties including market data, inventory reports from major wholesalers, historical information and analysis. These estimates are subject to the inherent limitations of estimates that rely on third-party data, as certain third-party information may itself rely on estimates and reflect other limitations. Provisions for estimated rebates and right of returns along with other allowances, such as discounts and promotional and other credits, are estimated based on historical payment experience, historical relationship to revenues, estimated customer inventory levels and contract terms, and actual discounts offered. The Company markets and sells its Biosciences products through commercial wholesalers (direct customers) who purchase the products at a price referred to as the wholesale acquisition cost ("WAC"). Additionally, the Company enters into agreements with indirect customers for a contracted price that is less than the WAC. The indirect customers, such as group-purchasing organizations, physician practice-management groups and hospitals, purchase the Company's products from the wholesalers. Under these agreements with wholesalers, the Company guarantees to credit the wholeseller for the difference between the WAC and the indirect customers' contracted price. This credit is referred to as a chargeback. Adjustments to the Company's chargeback provisions are made periodically to reflect new facts and circumstances that may indicate that historical experience may not be indicative of current and/or future results. The Company makes subjective judgments primarily based on its evaluation of current market conditions and trade inventory levels related to the Company's products. This evaluation may result in an increase or decrease in the experience rate that is applied to current and future sales, or as an adjustment to past sales, or both . Under previous contracts with HHS, the Company invoiced HHS and recognized the related revenues upon delivery of the product to the government carrier, at which time title to the product passed to HHS. Effective September 30, 2011, the Company has a contract with the CDC, to supply up to 44.75 million doses of BioThrax over a five year period. Under the Company's contract with the CDC, the Company invoices the CDC and recognizes the related revenue upon acceptance by the government at delivery site, at which time title to the product passes to the CDC. Collaborative research and development agreements can provide for one or more of upfront license fees, research payments, and milestone payments. The Company analyzes its multiple element revenue-generating arrangements to determine whether the elements can be separated and accounted for individually as separate units of accounting. An item can generally be considered a separate unit of accounting if both of the following criteria are met: the delivered item(s) has value to the customer on a stand-alone basis and if the arrangement includes a general right of return and delivery or performance of the undelivered item(s) is considered probable and substantially in the control of the Company. Items that cannot be divided into separate units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units based on the unit's relative selling price and is recognized when the appropriate revenue recognition criteria are met. The Company deems services to be rendered if no continuing obligation exists on the part of the Company. The Company's contract with the Biomedical Advanced Research and Development Authority ("BARDA") to establish a Center for Innovation in Advanced Development and Manufacturing ("CIADM") is a service arrangement that includes multiple elements. The CIADM contract requires the Company to provide a flexible infrastructure to supply medical countermeasures to the U.S. government over the contract period and includes such items as construction and facility design, workforce development and licensure of a pandemic flu vaccine. Since none of the individual elements by themselves satisfy the purpose of the contract, the Company has concluded that the CIADM contract elements cannot be separated as they do not have stand-alone value to the U.S. government. Therefore, the Company has concluded that there is a single unit of accounting associated with the CIADM contract. The Company recognizes revenue under the CIADM contract on a straight-line basis, based upon its estimate of the total payments to be received under the contract. The Company analyzes the estimated payments to be received on a quarterly basis to determine if an adjustment to revenue is required. Changes in estimates attributed to modifications in the estimate of total payments to be received are recorded prospectively. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting is deferred and recognized as revenue either on a straight-line basis over the Company's continued involvement in the research and development process or based on the proportional performance of the Company's expected future obligation under the contract. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, the Company recognizes such milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable, (2) achievement of the milestone was not reasonably assured at the inception of the arrangement, (3) substantive effort is involved to achieve the milestone, and (4) the amount of the milestone appears reasonable in relation to the effort expended. Payments received in advance of work performed are recorded as deferred revenue. The Company generates contract and grant revenue from cost-plus-fee contracts. Revenues on reimbursable contracts are recognized as costs are incurred, generally based on allowable costs incurred during the period, plus any recognizable earned fee. The Company considers fixed fees under cost-plus-fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. The Company analyzes costs for contracts and reimbursable grants to ensure reporting of revenues gross versus net is appropriate. For each of the three years in the period ended December 31, 2015, the costs incurred under the contracts and grants approximated the revenue earned. Revenue associated with non-refundable upfront license fees that can be treated as a single unit of accounting are recognized when all ongoing obligations have been delivered. Revenue associated with non-refundable upfront license fees under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting are deferred and recognized as revenue either on a straight-line basis over the Company's continued involvement in the research and development process or based on the proportional performance of the Company's expected future obligations under the contract. In May 2014, the FASB issued ASU No. 2014-09, Summary and Amendments That Create Revenue from Contracts with Customers (Topic 606) and Other Assets and Deferred Costs—Contracts with Customers (Subtopic 340-40). ASU No. 2014-09 supercedes the revenue recognition requirements in Topic 605, Revenue Recognition, as well as most industry-specific guidance, and significantly enhances comparability of revenue recognition practices across entities and industries by providing a principles-based, comprehensive framework for addressing revenue recognition issues. In order for a provider of promised goods or services to recognize as revenue the consideration that it expects to receive in exchange for the promised goods or services, the provider should apply the following five steps: (1) identify the contract with a customer(s); (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. ASU No. 2014-09 also specifies the accounting for some costs to obtain or fulfill a contract with a customer and provides enhanced disclosure requirements. The FASB has deferred ASU No. 2014-09 for one year, and with that deferral, the standard will be effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, which for the Company will be its 2018 first quarter. The Company is permitted to use either the retrospective or the modified retrospective method when adopting ASU No. 2014-09. The Company is still assessing the potential impact that ASU No. 2014-09 will have on its financial statements and disclosures, but believe that there could be changes to the revenue recognition for government contracts and its collaboration agreement . |
Mergers and Acquisitions | Mergers and Acquisitions In a business combination, the acquisition method of accounting requires that the assets acquired and liabilities assumed be recorded as of the date of the merger or acquisition at their respective fair values with limited exceptions. Assets acquired and liabilities assumed in a business combination that arise from contingencies are recognized at fair value if fair value can reasonably be estimated. If the acquisition date fair value of an asset acquired or liability assumed that arises from a contingency cannot be determined, the asset or liability is recognized if probable and reasonably estimable; if these criteria are not met, no asset or liability is recognized. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Accordingly, the Company may be required to value assets at fair value measures that do not reflect the Company's intended use of those assets. Any excess of the purchase price (consideration transferred) over the estimated fair values of net assets acquired is recorded as goodwill. Transaction costs and costs to restructure the acquired company are expensed as incurred. The operating results of the acquired business are reflected in the Company's consolidated financial statements after the date of the merger or acquisition. If the Company determines the assets acquired do not meet the definition of a business under the acquisition method of accounting, the transaction will be accounted for as an acquisition of assets rather than a business combination and, therefore, no goodwill will be recorded. The fair values of intangible assets, including acquired in-process research and development ("IPR&D"), are determined utilizing information available near the merger or acquisition date based on expectations and assumptions that are deemed reasonable by management. Given the considerable judgment involved in determining fair values, the Company typically obtains assistance from third-party valuation specialists for significant items. Amounts allocated to acquired IPR&D are capitalized and accounted for as indefinite-lived intangible assets. Upon successful completion of each project, the Company will make a separate determination as to the then useful life of the asset and begin amortization. The judgments made in determining estimated fair values assigned to assets acquired and liabilities assumed in a business combination, as well as asset lives, can materially affect the Company's results of operations. The fair values of identifiable intangible assets related to currently marketed products and product rights are primarily determined by using an "income approach" through which fair value is estimated based on each asset's discounted projected net cash flows. The Company's estimates of market participant net cash flows consider historical and projected pricing, margins and expense levels, the performance of competing products where applicable, relevant industry and therapeutic area growth drivers and factors, current and expected trends in technology and product life cycles, the time and investment that will be required to develop products and technologies, the ability to obtain marketing and regulatory approvals, the ability to manufacture and commercialize the products, the extent and timing of potential new product introductions by the Company's competitors, and the life of each asset's underlying patent, if any. The net cash flows are then probability-adjusted where appropriate to consider the uncertainties associated with the underlying assumptions, as well as the risk profile of the net cash flows utilized in the valuation. The probability-adjusted future net cash flows of each product are then discounted to present value utilizing an appropriate discount rate. The fair values of identifiable intangible assets related to IPR&D are determined using an income approach, through which fair value is estimated based on each asset's probability-adjusted future net cash flows, which reflect the different stages of development of each product and the associated probability of successful completion. The net cash flows are then discounted to present value using an appropriate discount rate. Indefinite-lived intangible assets are tested for impairment annually or whenever events or changes in circumstances indicate that its carrying amount may not be recoverable. |
Goodwill | Goodwill The Company assesses the carrying value of goodwill on an annual basis, or whenever events or changes in circumstances indicate the carrying value of goodwill may not be recoverable, The determination of the fair value of a reporting unit is judgmental in nature and involves the use of significant estimates and assumptions. The estimates and assumptions used in calculating fair value include identifying future cash flows, which requires that the Company makes a number of critical legal, economic, market and business assumptions that reflect best estimates as of the testing date. The Company's assumptions and estimates may differ significantly from actual results, or circumstances could change that would cause the Company to conclude that an impairment now exists or that it previously understated the extent of impairment. The Company selected October 1 as its annual impairment test date. |
Contingent purchase consideration obligations | Contingent Consideration The Company records contingent consideration associated with (a) sales based royalties and (b) development and regulatory milestones at fair value. The fair value model used to calculate this obligation is based on the income approach (a discounted cash flow model) that has been risk adjusted based on the probability of achievement of net sales and achievement of the milestones. The inputs the Company use for determining the fair value of the contingent consideration associated with sales based royalties and development and regulatory milestones are Level 3 fair value measurements. The Company re-evaluates the fair value on a quarterly basis. Changes in the fair value can result from adjustments to the discount rates and updates in the assumed timing of or achievement of net sales. Any future increase in the fair value of the contingent consideration associated with sales based royalties along with development and regulatory milestones are based on an increased likelihood that the underlying net sales or milestones will be achieved. The associated payment or payments which will therefore become due and payable for sales based royalties associated with marketed products will result in a charge to cost of product sales and contract manufacturing in the period in which the increase is determined. Similarly, any future decrease in the fair value of contingent consideration associated with sales based royalties will result in a reduction in cost of product sales and contract manufacturing. The changes in fair value for potential future sales based royalties associated with product candidates in development will result in a charge to selling, general and administrative expense in the period in which the increase is determined. Similarly, any future decrease in the fair value of contingent consideration associated with potential future sales based royalties for products candidates will result in a reduction in selling, general and administrative expense. The associated payment or payments which will therefore become due and payable for development and regulatory milestones will result in a charge to research and development expense in the period in which the increase is determined. Similarly, any future decrease in the fair value for development and regulatory milestones will result in a reduction in research and development expense. |
Impairment of long-lived assets | In process research and development and long-lived assets The Company assesses IPR&D assets for impairment on an annual basis or more frequently if indicators of impairment are present. The Company's annual assessment includes a comparison of the fair value of IPR&D assets to existing carrying value, and recognizes an impairment when the carrying value is greater than the determined fair value. The Company believes that the assumptions used in valuing the intangible and IPR&D assets are reasonable and are based upon its best estimate of likely outcomes of sales and clinical development. The underlying assumptions and estimates used to value these assets are subject to change in the future, and actual results may differ significantly from the assumptions and estimates. The Company has selected October 1 as its annual impairment test date for indefinite-lived intangible assets. The Company assesses the recoverability of its long-lived assets or asset groups for which an indicator of impairment exists by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If the Company concludes that the carrying value will not be recovered, the Company measures the amount of such impairment by comparing the fair value to the carrying value of the assets or asset groups. |
Research and development | Research and development Research and development costs are expensed as incurred. Research and development costs primarily consist of salaries and fees paid to outside service providers and the costs of materials used in clinical trials and research and development. Other research and development expenses include fees paid to consultants, materials and related expenses for personnel and facility expenses. |
Comprehensive income | Comprehensive income Comprehensive income is comprised of net income and other changes in equity that are excluded from net income. The Company includes translation gains and losses incurred when converting its subsidiaries' financial statements from their functional currency to the U.S. dollar in accumulated other comprehensive income. |
Foreign currencies | Foreign currencies Except for the Company's Canadian subsidiaries, the local currency is the functional currency for the Company's foreign subsidiaries and, as such, assets and liabilities are translated into U.S. dollars at year-end exchange rates. Income and expense items are translated at average exchange rates during the year. Translation adjustments resulting from this process are charged or credited to other comprehensive income. The Company's Canadian subsidiaries functional currency is U.S. dollars due primarily to a significant amount of the transactions of the subsidiaries being denominated in U.S. dollars. |
Capitalized interest | Capitalized interest The Company capitalizes interest based on the cost of major ongoing capital projects which have not yet been placed in service. For the years ended December 31, 2015, 2014 and 2013, the Company incurred interest of $7.8 million, $7.5 million and $2.0 million, respectively. Of these amounts, the Company capitalized $2.9 million, $2.5 million and $2.0 million, respectively. |
Certain risks and uncertainties | Certain risks and uncertainties The Company has derived a majority of its revenue from sales of BioThrax under contracts with the U.S. government. The Company's current CDC contract does not necessarily increase the likelihood that it will secure future comparable contracts with the U.S. government. The Company expects that a significant portion of the business that it will seek in the near future, in particular for BioThrax, will be under government contracts that present a number of risks that are not typically present in the commercial contracting process. U.S. government contracts for BioThrax are subject to unilateral termination or modification by the government. The Company may fail to achieve significant sales of BioThrax to customers in addition to the U.S. government, which would harm its growth opportunities. The Company may not be able to sustain or increase profitability. The Company may not be able to manufacture BioThrax consistently in accordance with FDA specifications. |
Earnings Per Share | Earnings per share The Company calculates basic earnings per share by dividing net income by the weighted average number of shares of common stock outstanding during the period. For the years ended December 31, 2015 and 2014, the Company calculated diluted earnings per share using the if-converted method by dividing the adjusted net income by the adjusted weighted average number of shares of common stock outstanding during the period. The adjusted net income is adjusted for interest expense and amortization of debt issuance cost, both net of tax, associated with the Company's 2.875% Convertible Senior Notes due 2021 (the "Notes"). The weighted average number of diluted shares is adjusted for the potential dilutive effect of the exercise of stock options and the vesting of restricted stock units along with the assumption of the conversion of the Notes, each at the beginning of the period. For the year ended December 31, 2013, diluted earnings per share is computed using the treasury method by dividing net income by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of other securities if such securities were converted or exercised. |
Accounting for stock-based compensation | Accounting for stock-based compensation The Company has two stock-based employee compensation plans, the Third Amended and Restated Emergent BioSolutions Inc. 2006 Stock Incentive Plan (the "2006 Plan") and the Emergent BioSolutions Employee Stock Option Plan (the "2004 Plan" and together with the 2006 Plan, the "Emergent Plans"). The Company has granted options to purchase shares of common stock under the Emergent Plans and has granted restricted stock units under the 2006 Plan. The Emergent Plans have both incentive and non-qualified stock option features. The Company no longer grants equity awards under the 2004 Plan. On May 22, 2014, the Company's shareholders approved an amendment to the 2006 Plan, which increased the number of shares of common stock available for issuance under plan awards by 4.0 million. As part of this amendment, awards of restricted stock units granted after May 22, 2014 are counted against the maximum aggregate number of shares of common stock available for issuance under the 2006 Plan as 2.3 shares of common stock for every one restricted stock unit granted. The maximum number of shares subject to awards that may be granted per year under the 2006 Plan to a single participant is 1.0 million. As of December 31, 2015, an aggregate of 15.2 million shares of common stock were authorized for issuance under the 2006 Plan, of which a total of 3.4 million shares of common stock remain available for future awards to be made to plan participants. The exercise price of each option must be not less than 100% of the fair market value of the shares underlying such option on the date of grant. Awards granted under the 2006 Plan have a contractual life of no more than 10 years. The terms and conditions of equity awards (such as price, vesting schedule, term and number of shares) under the Emergent Plans are determined by the compensation committee of the Company's board of directors, which administers the Emergent Plans. Each equity award granted under the Emergent Plans vests as specified in the relevant agreement with the award recipient and no option can be exercised after ten years from the date of grant. On May 17, 2012, the Company's shareholders approved the 2012 Employee Stock Purchase Plan ("ESPP"). All employees of the Company are eligible to participate in the ESPP, except those owning 5% or more of the Company's stock. One million shares of common stock have been authorized for issuance under the ESPP. The ESPP has two plan periods each year: December 1 to May 31 and June 1 to November 30. Employees are permitted to contribute between 1% and 10% of compensation during a plan period. The ESPP allows for employees to purchase shares of the Company's stock at a 15% discount at the end of each plan period based on the share price at that time. The maximum number of shares an employee may purchase during any plan period is 800 shares. The Company utilizes the Black-Scholes valuation model for estimating the fair value of all shares under its ESPP. The Company determines the fair value of restricted stock units using the closing market price of the Company's common stock on the day prior to the date of grant. The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company's methodology for developing each of the assumptions used: Year Ended December 31, 2015 2014 2013 Expected dividend yield 0% 0% 0% Expected volatility 34-35% 35-38% 39-49% Risk-free interest rate 1.27-1.61% 1.14-1.65% 0.32-0.70% Expected average life of options 4.3 years 4.5 years 4.4 years  Expected dividend yield — the Company does not pay regular dividends on its common stock and does not anticipate paying any dividends in the foreseeable future.  Expected volatility — a measure of the amount by which a financial variable, such as share price, has fluctuated (historical volatility) or is expected to fluctuate (implied volatility) during a period. The Company analyzed its own historical volatility to estimate expected volatility over the same period as the expected average life of the options.  Risk-free interest rate — the range of U.S. Treasury rates with a term that most closely resembles the expected life of the option as of the date on which the option is granted.  Expected average life of options — the period of time that options granted are expected to remain outstanding, based primarily on the Company's expectation of optionee exercise behavior subsequent to vesting of options. |
Summary of significant accoun29
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of significant accounting policies [Abstract] | |
Estimated useful lives of property, plant and equipment | Property, plant and equipment are stated at cost. Depreciation is computed using the straight-line method over the following estimated useful lives: Buildings 31-39 years Building improvements 10-39 years Furniture and equipment 3-15 years Software 3-7 years or product life Leasehold improvements Lesser of the asset life or lease term |
Assumptions used in valuing stock options granted | The Company determines the fair value of restricted stock units using the closing market price of the Company's common stock on the day prior to the date of grant. The Company utilizes the Black-Scholes valuation model for estimating the fair value of all stock options granted. Set forth below are the assumptions used in valuing the stock options granted and a discussion of the Company's methodology for developing each of the assumptions used: Year Ended December 31, 2015 2014 2013 Expected dividend yield 0% 0% 0% Expected volatility 34-35% 35-38% 39-49% Risk-free interest rate 1.27-1.61% 1.14-1.65% 0.32-0.70% Expected average life of options 4.3 years 4.5 years 4.4 years |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Cangene Corporation [Member] | |
Business Acquisition [Line Items] | |
Purchase Price Allocation | The table below summarizes the allocation of the purchase price based upon estimated fair values of assets acquired and liabilities assumed at February 21, 2014. (in thousands) Fair value of tangible assets acquired and liabilities assumed: Cash $ 43,631 Accounts receivable 19,652 Inventory (i) 55,259 Prepaid expenses and other assets 2,375 Property, plant and equipment 40,264 Deferred taxes, net 21,337 Income tax receivable 2,452 Accounts payable and accrued liabilities (22,918 ) Provision for chargebacks (1,946 ) Contingent purchase consideration (1,284 ) Deferred revenue (6,378 ) Total fair value of tangible assets acquired and liabilities assumed 152,444 Acquired in-process research and development 8,300 Acquired intangible assets 36,200 Goodwill 24,566 Total purchase price $ 221,510 (i) Acquired inventory reflects a $8.8 million adjustment to record inventory at fair value, referred to as a step-up adjustment. The $8.8 million step-up is estimated to be amortized through cost of product sales and contract manufacturing over the next five years based on expected inventory turnover, which will increase cost of product sales and contract manufacturing during such period. |
Fair Value of Intangible Assets | The table below summarizes the fair value of intangible assets acquired and the estimated amortization periods: Amortization Period ( in thousands) Amount in years Corporate Trade Name $ 2,800 5.0 Marketed Products 8,100 10.0 Licensed Products 3,100 7.0 Biodefense Products 16,700 12.0 Contract Manufacturing 5,500 8.0 Total identified intangible assets $ 36,200 |
Cangene pro forma | The following pro forma information is presented as if the acquisition had occurred on January 1, 2013, and combines the historical results of operations of the Company and Cangene for the year ended December 31, 2014 and 2013. December 31, (in thousands) 2014 2013 Pro forma revenue $ 462,446 $ 428,194 Pro forma net income $ 34,624 $ 10,994 |
EV 035 [Member] | |
Business Acquisition [Line Items] | |
Purchase Price Allocation | In conjunction with the revision to the total purchase price and based on this same information and analysis, the Company has recast of the fair value of the in-process research and development ("IPR&D") asset attributed to the EV-035 series of molecules, via a measurement period adjustment through June 30, 2015. The table below summarizes the recast allocation of the purchase price based upon fair values of assets acquired. (in thousands) Purchase Price Allocation Measurement Period Adjustment Recast Purchase Price Allocation Acquired intangible assets $ 27,700 $ (17,172 ) $ 10,528 Goodwill 2,000 10,601 12,601 Total purchase price $ 29,700 $ (6,571 ) $ 23,129 |
Preliminary Purchase Price | The table below summarizes the total purchase price: (in thousands) Purchase Price Measurement Period Adjustment Recast Purchase Price Amount of cash paid to Evolva Holdings SA $ 1,500 $ - $ 1,500 Fair value of contingent consideration 28,200 (6,571 ) 21,629 Total purchase price $ 29,700 $ (6,571 ) $ 23,129 |
Adjusted Balance Sheet | The Company has recast, in this filing, the historical December 31, 2014 balance sheet line items for in-process research and development, goodwill and contingent consideration. (in thousands) Balance as of December 31, 2014 EV-035 Purchase Price Adjustments Adjusted Balance as of December 31, 2014 Assets: In-process research and development $ 77,800 $ (17,172 ) $ 60,628 Goodwill 41,984 10,601 52,585 Total assets $ 119,784 $ (6,571 ) $ 113,213 Liabilities: Contingent consideration, net of current portion $ 41,170 $ (6,571 ) $ 34,599 Total liabilities $ 41,170 $ (6,571 ) $ 34,599 In addition, the Company has reflected the impact of the above adjustments to the disclosures in Notes 4 and 9. |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Fair value measurements [Abstract] | |
Fair Value Hierarchy for Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table represents the Company's fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis: At December 31, 2015 (in thousands) Level 1 Level 2 Level 3 Total Assets: Investment in money market funds (1) $ 3,323 $ - $ - $ 3,323 Total assets $ 3,323 $ - $ - $ 3,323 Liabilities: Contingent consideration $ - $ - $ 25,599 $ 25,599 Total liabilities $ - $ - $ 25,599 $ 25,599 At December 31, 2014 (in thousands) Level 1 Level 2 Level 3 Total Assets: Investment in money market funds (1) $ 8,069 $ - $ - $ 8,069 Total assets $ 8,069 $ - $ - $ 8,069 Liabilities: Contingent price consideration $ - $ - $ 41,086 $ 41,086 Total liabilities $ - $ - $ 41,086 $ 41,086 (1) Included in cash and cash equivalents in accompanying consolidated balance sheets. |
Reconciliation of Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Level 3) | The following table is a reconciliation of the beginning and ending balance of the liabilities measured at fair value using significant unobservable inputs (Level 3) during the years ended December 31, 2015 and 2014. (in thousands) Balance at December 31, 2013 $ 16,619 Expense (income) included in earnings 3,133 Settlements (1,579 ) Purchases, sales and issuances 22,913 Transfers in/(out) of Level 3 - Balance at December 31, 2014 $ 41,086 Expense (income) included in earnings (10,599 ) Settlements (5,693 ) Purchases, sales and issuances 805 Transfers in/(out) of Level 3 - Balance at December 31, 2015 $ 25,599 |
Accounts receivable (Tables)
Accounts receivable (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accounts receivable [Abstract] | |
Accounts receivable | Accounts receivable consist of the following: December 31, (in thousands) 2015 2014 Billed $ 102,155 $ 39,948 Unbilled 18,612 18,886 Total $ 120,767 $ 58,834 For the year ended December 31, 2015, the Company |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Inventories [Abstract] | |
Inventories | Inventories consist of the following: December 31, (in thousands) 2015 2014 Raw materials and supplies $ 23,099 $ 17,375 Work-in-process 37,209 33,477 Finished goods 16,628 14,822 Total inventories $ 76,936 $ 65,674 |
Property, plant and equipment (
Property, plant and equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property, plant and equipment [Abstract] | |
Property, plant and equipment | Property, plant and equipment consist of the following: December 31, (in thousands) 2015 2014 Land and improvements $ 16,520 $ 12,838 Buildings, building improvements and leasehold improvements 111,060 107,202 Furniture and equipment 136,528 130,131 Software 39,784 25,354 Construction-in-progress 127,489 117,884 431,381 393,409 Less: Accumulated depreciation and amortization (99,525 ) (79,430 ) Total property, plant and equipment, net $ 331,856 $ 313,979 |
Intangible assets, in-process35
Intangible assets, in-process research and development and goodwill (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Intangible assets, in-process research and development and goodwill [Abstract] | |
Intangible Assets | Intangible assets consisted of the following: Biodefense Biosciences (in thousands) Segment Segment Total Cost basis Balance at December 31, 2014 $ 48,799 $ 19,500 $ 68,299 Additions - 8,300 8,300 Balance at December 31, 2015 $ 48,799 $ 27,800 $ 76,599 Accumulated amortization Balance at December 31, 2014 $ (7,820 ) $ (2,135 ) $ (9,955 ) Amortization (6,209 ) (3,060 ) (9,269 ) Balance at December 31, 2015 $ (14,029 ) $ (5,195 ) $ (19,224 ) Net book value at December 31, 2015 $ 34,770 $ 22,605 $ 57,375 |
Finite-lived Intangible Assets Amortization Expense | Amortization expense consisted of the following: December 31, (in thousands) 2015 2014 2013 Biodefense segment $ 6,209 $ 5,869 $ 1,951 Biosciences segment 3,060 2,135 - Total amortization expense $ 9,269 $ 8,004 $ 1,951 As of December 31, 2015, the weighted average amortization period remaining for intangible assets in the Biodefense and Biosciences segments was 88 and 90 months, respectively. |
Future Amortization Expense | Future amortization expense as of December 31, 2015 is as follows: (in thousands) 2016 $ 8,976 2017 8,300 2018 8,300 2019 7,821 2020 and beyond 23,978 Total remaining amortization $ 57,375 |
Goodwill | The following table is a summary of changes in goodwill by reporting unit: (in thousands) Biosciences therapeutics Biosciences contracts manufacturing Biodefense therapeutics and vaccines Biodefense medical device(s) Total Cost Basis Balance at December 31, 2014 $ 13,902 $ 6,736 $ 22,031 $ 9,916 $ 52,585 Additions - - 2,317 - 2,317 Balance at December 31, 2015 $ 13,902 $ 6,736 $ 24,348 $ 9,916 $ 54,902 |
Stockholders' equity (Tables)
Stockholders' equity (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stockholders' equity [Abstract] | |
Option award activity | The following is a summary of option award activity under the Emergent Plans: 2006 Plan 2004 Plan Number of Shares Weighted-Average Exercise Price Number of Shares Weighted-Average Exercise Price Aggregate Intrinsic Value Outstanding at December 31, 2014 3,837,993 $ 20.04 43,156 $ 10.28 $ 29,181,534 Granted 690,221 29.03 - - Exercised (1,360,955 ) 18.09 (13,457 ) 10.28 Forfeited (189,439 ) 24.29 - - Outstanding at December 31, 2015 2,977,820 $ 22.74 29,699 $ 10.28 $ 52,324,284 Exercisable at December 31, 2015 1,442,178 $ 19.12 29,699 $ 10.28 $ 31,006,178 Options expected to vest at December 31, 2015 1,195,677 $ 25.76 - $ - $ 17,043,405 |
Restricted stock units activity | The following is a summary of restricted stock unit award activity under the 2006 Plan: Number of Shares Weighted-Average Grant Price Aggregate Intrinsic Value Outstanding at December 31, 2014 927,356 $ 22.44 $ 25,251,904 Granted 473,111 29.61 Vested (422,515 ) 20.60 Forfeited (82,156 ) 25.10 Outstanding at December 31, 2015 895,796 $ 26.85 $ 35,840,796 |
Allocated stock-based compensation expense | Stock-based compensation expense was recorded in the following financial statement line items: Years ended December 31, (in thousands) 2015 2014 2013 Cost of product sales $ 1,183 $ 1,145 $ 575 Research and development 3,112 3,606 3,283 General and administrative 11,553 8,078 7,380 Total stock-based compensation expense $ 15,848 $ 12,829 $ 11,238 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income taxes [Abstract] | |
Components of the provision for income taxes attributable to operations | Significant components of the provisions for income taxes attributable to operations consist of the following: Year ended December 31, (in thousands) 2015 2014 2013 Current Federal $ 20,664 $ 10,412 $ (878 ) State 1,401 479 (173 ) International 1,370 112 300 Total current 23,435 11,003 (751 ) Deferred Federal 7,802 7,693 12,679 State 185 128 1,028 International (4,523 ) (2,503 ) 152 Total deferred 3,464 5,318 13,859 Total provision for income taxes $ 26,899 $ 16,321 $ 13,108 |
Net deferred tax asset | The Company's net deferred tax asset (liability) consists of the following: December 31, (in thousands) 2015 2014 Federal losses carryforward $ 5,394 $ 8,487 State losses carryforward 12,751 12,043 Research and development carryforward 3,545 8,049 Scientific research and experimental development credit carryforward 25,771 29,556 Intangible assets 5,792 5,689 Stock compensation 9,391 8,196 Foreign deferrals 80,920 75,511 Inventory reserves 3,754 4,122 Other 8,484 7,463 Deferred tax asset 155,802 159,116 Fixed assets (31,925 ) (34,839 ) Intangible assets (4,760 ) (6,538 ) Other (17,192 ) (10,891 ) Deferred tax liability (53,877 ) (52,268 ) Valuation allowance (90,639 ) (92,374 ) Net deferred tax (liabilities)/ asset $ 11,286 $ 14,474 |
Reconciliation of taxes determined by applying U.S. federal statutory rate to loss before provision for income taxes | The provision for income taxes differs from the amount of taxes determined by applying the U.S. federal statutory rate to loss before provision for income taxes as a result of the following: Year ended December 31, (in thousands) 2015 2014 2013 US $ 88,525 $ 59,764 $ 52,749 International 1,244 (6,702 ) (8,506 ) Earnings before taxes on income 89,769 53,062 44,243 Federal tax at statutory rates $ 31,394 $ 18,572 $ 15,485 State taxes, net of federal benefit 613 257 538 Impact of foreign operations (144 ) 186 (1,116 ) Change in valuation allowance (1,735 ) 1,808 1,434 Tax credits (4,849 ) (7,137 ) (5,918 ) Other differences 748 124 (227 ) Permanent differences 872 2,511 2,912 Provision for income taxes $ 26,899 $ 16,321 $ 13,108 |
Gross unrecognized tax benefits activity | The table below presents the gross unrecognized tax benefits activity for 2015, 2014 and 2013: (in thousands) Gross unrecognized tax benefits at December 31, 2012 $ 1,016 Increases for tax positions for prior years 165 Decreases for tax positions for prior years - Increases for tax positions for current year 15 Settlements - Lapse of statute of limitations (75 ) Gross unrecognized tax benefits at December 31, 2013 1,121 Increases for tax positions for prior years 150 Decreases for tax positions for prior years - Increases for tax positions for current year 102 Settlements - Lapse of statute of limitations (125 ) Gross unrecognized tax benefits at December 31, 2014 1,248 Increases for tax positions for prior years 150 Decreases for tax positions for prior years - Increases for tax positions for current year 59 Settlements - Lapse of statute of limitations - Gross unrecognized tax benefits at December 31, 2015 $ 1,457 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Leases [Abstract] | |
Future Minimum Lease Payments under Operating Lease Obligations | Future minimum lease payments under operating lease obligations as of December 31, 2015 were as follows: (in thousands) 2016 $ 2,577 2017 2,324 2018 2,044 2019 1,988 2020 924 2021 and beyond 2,137 Total minimum lease payments 11,994 Minimum lease receipts (1,105 ) Total minimum lease payments $ 10,889 |
Earnings per share (Tables)
Earnings per share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Earnings per share [Abstract] | |
Summary of basic and diluted net income per share | The following table presents the calculation of basic and diluted net income per share: Years ended December 31, (in thousands, except share and per share data) 2015 2014 2013 Numerator: Net income $ 62,870 $ 36,741 $ 31,135 Interest expense applicable to convertible debt, net of tax 3,019 2,879 - Amortization of debt issuance costs, net of tax 868 735 - Adjusted net income $ 66,757 $ 40,355 $ 31,135 Denominator: Weighted-average number of shares—basic 38,595,435 37,344,891 36,201,283 Dilutive securities—equity awards 939,882 737,391 546,273 Dilutive securities—convertible debt 7,720,525 7,720,525 - Weighted-average number of shares—diluted 47,255,842 45,802,807 36,747,556 Earnings per share-basic $ 1.63 $ 0.98 $ 0.86 Earnings per share-diluted $ 1.41 $ 0.88 $ 0.85 |
Segment information (Tables)
Segment information (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Segment information [Abstract] | |
Segment information | Reportable Segments (in thousands) Biodefense Biosciences All Other Total Year Ended December 31, 2015 External revenue $ 450,088 $ 72,701 $ - $ 522,789 Intersegment revenue (expense) (1,877 ) 1,877 - - Research and development 111,663 37,816 4,518 153,997 Interest income 149 - 423 572 Interest expense - (41 ) (6,482 ) (6,523 ) Depreciation and amortization 18,677 5,597 227 24,501 Net income (loss) 125,609 (55,644 ) (7,095 ) 62,870 Intangible assets 34,770 22,605 - 57,375 In-process research and development assets 701 41,800 - 42,501 Goodwill 34,264 20,638 - 54,902 Total assets 511,875 345,995 185,722 1,043,592 Expenditures for long-lived assets 37,735 6,689 388 44,812 Year Ended December 31, 2014 External revenue $ 370,547 $ 79,591 $ - $ 450,138 Intersegment revenue (expense) - - - - Research and development 81,975 60,821 8,033 150,829 Interest income 62 - 258 320 Interest expense - - (8,240 ) (8,240 ) Depreciation and amortization 17,669 5,070 267 23,006 Net income (loss) 96,966 (51,300 ) (8,925 ) 36,741 Intangible assets 40,979 17,365 - 58,344 In-process research and development assets 10,528 50,100 - 60,628 Goodwill 31,239 21,346 - 52,585 Total assets 433,226 344,420 161,045 938,691 Expenditures for long-lived assets 26,736 2,444 1,493 30,673 Year Ended December 31, 2013 External revenue $ 311,564 $ 1,181 $ - $ 312,745 Intersegment revenue (expense) - - - - Research and development 62,663 50,652 6,618 119,933 Interest income - - 139 139 Interest expense - - - - Depreciation and amortization 15,584 1,238 186 17,008 Net income (loss) 87,289 (50,925 ) (5,229 ) 31,135 Intangible assets 30,148 0 0 30,148 In-process research and development assets - 41,800 - 41,800 Goodwill 8,452 5,502 - 13,954 Total assets 331,827 98,510 196,293 626,630 Expenditures for long-lived assets 30,700 1,343 9,978 42,021 |
Quarterly financial data (una41
Quarterly financial data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly financial data (unaudited) [Abstract] | |
Quarterly financial information | Quarterly financial information for the years ended December 31, 2015 and 2014 is presented in the following tables: Quarter Ended (in thousands, except per share data) March 31, June 30, September 30, December 31, 2015: Revenue $ 63,633 $ 126,112 $ 164,940 $ 168,104 Income (loss) from operations (28,310 ) 21,452 53,005 49,892 Net income (loss) (21,519 ) 14,100 36,942 33,347 Net income (loss) per share, basic (0.57 ) 0.37 0.95 0.85 Net income (loss) per share, diluted (0.57 ) 0.32 0.79 0.71 2014: Revenue $ 53,884 $ 110,325 $ 137,954 $ 147,975 Income (loss) from operations (25,458 ) 7,862 31,032 44,620 Net income (loss) (20,236 ) 5,029 21,832 30,116 Net income (loss) per share, basic (0.55 ) 0.13 0.58 0.80 Net income (loss) per share, diluted (0.55 ) 0.13 0.49 0.66 |
Nature of the business and or42
Nature of the business and organization (Details) | Dec. 31, 2015a |
Nature of the business and organization [Abstract] | |
Area of land in Lansing, Michigan | 12.5 |
Summary of significant accoun43
Summary of significant accounting policies (Details) Dose in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015USD ($)DosePlanshares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Unbilled accounts receivable | $ | $ 120,767 | $ 58,834 | |
Revenue recognition [Abstract] | |||
Number of doses of BioThrax to be supplied under contract | Dose | 44,750 | ||
Period of contractual agreement | 5 years | ||
Capitalized interest [Abstract] | |||
Interest costs incurred | $ | $ 7,800 | 7,500 | $ 2,000 |
Interest costs capitalized | $ | $ 2,900 | $ 2,500 | $ 2,000 |
Buildings [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 31 years | ||
Buildings [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 39 years | ||
Building Improvements [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 10 years | ||
Building Improvements [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 39 years | ||
Furniture and Equipment [Member] | Minimum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 3 years | ||
Furniture and Equipment [Member] | Maximum [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 15 years | ||
Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | 3-7 years or product life | ||
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Estimated useful lives | Lesser of the asset life or lease term | ||
2006 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Increase in number of shares of common stock available for issuance (in shares) | shares | 4,000,000 | ||
2006 Plan [Member] | Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock authorized for issuance under the plan (in shares) | shares | 15,200,000 | ||
Common stock available for future awards (in shares) | shares | 3,400,000 | ||
Contractual life of awards | 10 years | ||
Exercise period of options, maximum | 10 years | ||
Assumptions used in valuing the stock options granted [Abstract] | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Expected average life of options | 4 years 3 months 18 days | 4 years 6 months | 4 years 4 months 24 days |
2006 Plan [Member] | Stock Options [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of option as percentage of fair market value at grant date, minimum | 100.00% | ||
Assumptions used in valuing the stock options granted [Abstract] | |||
Expected volatility | 34.00% | 35.00% | 39.00% |
Risk-free interest rate, minimum | 1.27% | 1.14% | 0.32% |
2006 Plan [Member] | Stock Options [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum number of shares that may be granted per year to a single participant (in shares) | shares | 1 | ||
Assumptions used in valuing the stock options granted [Abstract] | |||
Expected volatility | 35.00% | 38.00% | 49.00% |
Risk-free interest rate, maximum | 1.61% | 1.65% | 0.70% |
2006 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Restricted stock unit conversion ratio | 2.3 | ||
Emergent Plans [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock based employee compensation plans | Plan | 2 | ||
Revenues [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 81.00% | 74.00% | 95.00% |
Accounts Receivable [Member] | Customer Concentration Risk [Member] | |||
Concentration Risk [Line Items] | |||
Concentration risk percentage | 78.00% | 40.00% | |
Unbilled [Member] | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Unbilled accounts receivable | $ | $ 18,612 | $ 18,886 |
Acquisitions (Details)
Acquisitions (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 17, 2014 | Feb. 21, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Goodwill, net book value | $ 54,902 | $ 52,585 | $ 13,954 | |||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill) | 9,827 | 0 | 0 | |||
Net book value of intangible assets | 57,375 | 57,375 | ||||
Purchase Price Allocation [Abstract] | ||||||
Goodwill | 54,902 | 52,585 | 13,954 | |||
Business Acquisition, Pro Forma Information [Abstract] | ||||||
Pro forma revenue | 462,446 | 428,194 | ||||
Pro forma net income | 34,624 | 10,994 | ||||
Assets: | ||||||
In process research and development | 42,501 | 60,628 | 41,800 | |||
Goodwill | 54,902 | 52,585 | 13,954 | |||
Total assets | 1,043,592 | 938,691 | 626,630 | |||
Liabilities: | ||||||
Contingent consideration, net of current portion | 23,046 | 34,599 | ||||
Total liabilities | 383,575 | 385,490 | ||||
Cangene Corporation [Member] | ||||||
Business Acquisition [Line Items] | ||||||
Percentage of voting interest acquired | 100.00% | |||||
Step up adjustment to inventory | $ 8,800 | |||||
Price paid per share of acquisition (in dollars per share) | $ 3.24 | |||||
Amortization period of step up adjustment | 5 years | |||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Cash | $ 43,631 | |||||
Accounts receivable | 19,652 | |||||
Inventory | [1] | 55,259 | ||||
Prepaid expenses and other assets | 2,375 | |||||
Property, plant and equipment | 40,264 | |||||
Deferred taxes, net | 21,337 | |||||
Income tax receivable | 2,452 | |||||
Accounts payable and accrued liabilities | (22,918) | |||||
Provision for chargebacks | (1,946) | |||||
Contingent consideration | (1,284) | |||||
Deferred revenue | (6,378) | |||||
Total fair value of tangible assets acquired and liabilities assumed | 152,444 | |||||
Acquired in-process research and development | 8,300 | |||||
Acquired intangible assets | 36,200 | |||||
Goodwill, net book value | 24,566 | $ 24,600 | ||||
Total purchase price | 221,510 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 36,200 | |||||
Amortization period | 110 months | |||||
Present value discount rate | 16.00% | |||||
Transaction costs | 3,700 | $ 3,300 | ||||
Purchase Price [Abstract] | ||||||
Total purchase price | $ 221,510 | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | 36,200 | |||||
Goodwill | 24,566 | $ 24,600 | ||||
Assets: | ||||||
Goodwill | 24,566 | 24,600 | ||||
Cangene Corporation [Member] | Corporate Trade Name [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 2,800 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 2,800 | |||||
Amortization period | 5 years | |||||
Present value discount rate | 15.00% | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | $ 2,800 | |||||
Cangene Corporation [Member] | Marketed Products [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 8,100 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 8,100 | |||||
Amortization period | 10 years | |||||
Present value discount rate | 15.00% | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | $ 8,100 | |||||
Cangene Corporation [Member] | Licensed Products [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 3,100 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 3,100 | |||||
Amortization period | 7 years | |||||
Present value discount rate | 15.00% | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | $ 3,100 | |||||
Cangene Corporation [Member] | Biodefense Products [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 16,700 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 16,700 | |||||
Amortization period | 12 years | |||||
Present value discount rate | 15.00% | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | $ 16,700 | |||||
Cangene Corporation [Member] | Contract Manufacturing [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 5,500 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 5,500 | |||||
Amortization period | 8 years | |||||
Present value discount rate | 15.00% | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | $ 5,500 | |||||
EV 035 [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | $ 10,528 | |||||
Goodwill, net book value | 12,601 | 52,585 | ||||
Total purchase price | 23,129 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | $ 10,528 | |||||
Present value discount rate | 12.00% | |||||
Transaction costs | $ 0 | |||||
Research and development contract costs | 15,000 | |||||
Contingent value rights based on the novation of the contract | 4,000 | |||||
Contingent value rights based on the achievement of certain development | 15,000 | |||||
Contingent value rights based on the regulatory filing milestones | 50,000 | |||||
Impairment of Intangible Assets, Indefinite-lived (Excluding Goodwill) | 9,800 | |||||
Net book value of intangible assets | 700 | |||||
Change In Fair Value Of Contingent Obligations | (9,400) | |||||
Purchase Price [Abstract] | ||||||
Amount of cash paid | 1,500 | |||||
Fair value of contingent purchase consideration | 21,629 | |||||
Total purchase price | 23,129 | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | 10,528 | |||||
Goodwill | 12,601 | 52,585 | ||||
Total purchase price | 23,129 | |||||
Assets: | ||||||
In process research and development | 60,628 | |||||
Goodwill | 12,601 | 52,585 | ||||
Total assets | 113,213 | |||||
Liabilities: | ||||||
Contingent consideration, net of current portion | 34,599 | |||||
Total liabilities | 34,599 | |||||
EV 035 [Member] | Previously Reported [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Goodwill, net book value | 41,984 | |||||
Purchase Price Allocation [Abstract] | ||||||
Goodwill | 41,984 | |||||
Assets: | ||||||
In process research and development | 77,800 | |||||
Goodwill | 41,984 | |||||
Total assets | 119,784 | |||||
Liabilities: | ||||||
Contingent consideration, net of current portion | 41,170 | |||||
Total liabilities | 41,170 | |||||
EV 035 [Member] | EV-035 Purchase Price Adjustments [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Goodwill, net book value | 10,601 | |||||
Purchase Price Allocation [Abstract] | ||||||
Goodwill | 10,601 | |||||
Assets: | ||||||
In process research and development | (17,172) | |||||
Goodwill | 10,601 | |||||
Total assets | (6,571) | |||||
Liabilities: | ||||||
Contingent consideration, net of current portion | (6,571) | |||||
Total liabilities | $ (6,571) | |||||
EV 035 [Member] | Preliminary Purchase Price [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Total purchase price | 29,700 | |||||
Purchase Price [Abstract] | ||||||
Amount of cash paid | 1,500 | |||||
Fair value of contingent purchase consideration | 28,200 | |||||
Total purchase price | 29,700 | |||||
EV 035 [Member] | Preliminary Allocation [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | 27,700 | |||||
Goodwill, net book value | 2,000 | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | 27,700 | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | 27,700 | |||||
Goodwill | 2,000 | |||||
Total purchase price | 29,700 | |||||
Assets: | ||||||
Goodwill | 2,000 | |||||
EV 035 [Member] | Measurement Period Adjustment [Member] | ||||||
Fair value of tangible assets acquired and liabilities assumed [Abstract] | ||||||
Acquired intangible assets | (17,172) | |||||
Goodwill, net book value | 10,601 | |||||
Total purchase price | (6,571) | |||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Acquired intangible assets | (17,172) | |||||
Purchase Price [Abstract] | ||||||
Amount of cash paid | 0 | |||||
Fair value of contingent purchase consideration | (6,571) | |||||
Total purchase price | (6,571) | |||||
Purchase Price Allocation [Abstract] | ||||||
Acquired intangible assets | (17,172) | |||||
Goodwill | 10,601 | |||||
Total purchase price | (6,571) | |||||
Assets: | ||||||
Goodwill | $ 10,601 | |||||
EV 035 [Member] | Minimum [Member] | ||||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Sales-based royalty payments | 5.00% | |||||
EV 035 [Member] | Maximum [Member] | ||||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Sales-based royalty payments | 10.00% | |||||
EV-035 Research and Development [Member] | ||||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Change In Fair Value Of Contingent Obligations | (6,200) | |||||
EV-035 Selling, General and Administrative Member [Member] | ||||||
Summary of the preliminary estimated fair value of intangible assets acquired and the estimated amortization periods [Abstract] | ||||||
Change In Fair Value Of Contingent Obligations | $ (3,200) | |||||
[1] | Acquired inventory reflects a $6.2 million adjustment to record inventory at fair value, referred to as a step-up adjustment. The $6.2 million step-up is estimated to be amortized through cost of product sales and contract manufacturing over the next five years based on expected inventory turnover, which will increase cost of product sales and contract manufacturing during such period. |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | ||
Liabilities [Abstract] | |||
Payment of contingent obligations | |||
Unobservable Input Reconciliation [Roll Forward] | |||
Balance, beginning of period | $ 41,086 | $ 16,619 | |
Expense (income) included in earnings | (10,599) | 3,133 | |
Settlements | (5,693) | (1,579) | |
Purchases, sales and issuances | 805 | 22,913 | |
Transfers in/(out) of Level 3 | 0 | 0 | |
Balance, end of period | 25,599 | 41,086 | |
RSDL and HepaGam [Member] | |||
Liabilities [Abstract] | |||
Fair value adjustment for contingent obligations | (1,200) | 3,100 | |
Fair Value, Measurements, Recurring [Member] | |||
Assets [Abstract] | |||
Investment in money market funds | [1] | 3,323 | 8,069 |
Total assets | 3,323 | 8,069 | |
Liabilities [Abstract] | |||
Contingent price consideration | 25,599 | 41,086 | |
Total liabilities | 25,599 | 41,086 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | |||
Assets [Abstract] | |||
Investment in money market funds | [1] | 3,323 | 8,069 |
Total assets | 3,323 | 8,069 | |
Liabilities [Abstract] | |||
Contingent price consideration | 0 | 0 | |
Total liabilities | 0 | 0 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | |||
Assets [Abstract] | |||
Investment in money market funds | [1] | 0 | 0 |
Total assets | 0 | 0 | |
Liabilities [Abstract] | |||
Contingent price consideration | 0 | 0 | |
Total liabilities | 0 | 0 | |
Fair Value, Measurements, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | |||
Assets [Abstract] | |||
Investment in money market funds | [1] | 0 | 0 |
Total assets | 0 | 0 | |
Liabilities [Abstract] | |||
Contingent price consideration | 25,599 | 41,086 | |
Total liabilities | $ 25,599 | $ 41,086 | |
[1] | Included in cash and cash equivalents in accompanying consolidated balance sheets. |
MorphoSys collaboration agreeme
MorphoSys collaboration agreement (Details) | 12 Months Ended | |
Dec. 31, 2015USD ($)Unit | Dec. 31, 2014USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Short-term deferred revenue | $ 7,942,000 | $ 5,345,000 |
Long-term deferred revenue | 6,590,000 | 5,713,000 |
Morphosys [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Non refundable receipt | 20,000,000 | |
First contingent payment received based upon development and regulatory milestones | $ 5,000,000 | |
Tiered royalty obligation | 20.00% | |
Number of units of accounting | Unit | 2 | |
Proceeds allocated to two units of accounting | $ 20,000,000 | |
Proceeds allocated to license | 15,300,000 | |
Proceeds allocated to development services | $ 4,700,000 | |
Present value factor for estimating selling price of license | 12.00% | |
Revenue from license fee | $ 15,300,000 | |
Reduction to research and development expense | 4,262,000 | 1,509,000 |
Accounts receivable | 0.5 | 1 |
Short-term deferred revenue | 700,000 | 900,000 |
Long-term deferred revenue | 3,200,000 | $ 3,500,000 |
Morphosys Amended Agreement [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
First contingent payment received based upon development and regulatory milestones | 32,500,000 | |
Second contingent payment received based upon development and regulatory milestones | 41,500,000 | |
Funding requirement cap | 460,000,000 | |
Morphosys Original Agreement [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Additional contingent payment that may be received | 163,000,000 | |
First contingent payment received based upon development and regulatory milestones | 80,000,000 | |
Second contingent payment received based upon development and regulatory milestones | $ 83,000,000 | |
Collaborative agreement, rights and obligations | 0.36 | |
Funding requirement cap | $ 186,000,000 | |
Morphosys Amended-2016 [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaborative agreement, rights and obligations | 0.75 | |
Morphosys Amended 2017-2018 [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaborative agreement, rights and obligations | 0.49 | |
Morphosys Amended 2019 and Beyond [Member] | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Collaborative agreement, rights and obligations | 0.36 |
Accounts receivable (Details)
Accounts receivable (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts receivable | $ 120,767 | $ 58,834 | |
Provision for Doubtful Accounts | 3,481 | 0 | $ 0 |
Billed [Member] | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts receivable | 102,155 | 39,948 | |
Unbilled [Member] | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts receivable | 18,612 | 18,886 | |
Accounts Receivable [Member] | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts receivable | $ 120,767 | $ 58,834 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Inventories [Abstract] | ||
Raw materials and supplies | $ 23,099 | $ 17,375 |
Work-in-process | 37,209 | 33,477 |
Finished goods | 16,628 | 14,822 |
Total inventories | $ 76,936 | $ 65,674 |
Property, plant and equipment49
Property, plant and equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | $ 431,381 | $ 393,409 | |
Less: Accumulated depreciation and amortization | (99,525) | (79,430) | |
Total Property, plant and equipment, net | 331,856 | 313,979 | |
Depreciation and amortization | 24,501 | 23,006 | $ 17,008 |
Capitalized Software Development Costs | 10,700 | 2,400 | |
Amortization of capitalized software | 400 | ||
Land and Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 16,520 | 12,838 | |
Buildings, Building Improvements and Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 111,060 | 107,202 | |
Furniture and Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 136,528 | 130,131 | |
Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | 39,784 | 25,354 | |
Construction-in-progress [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant and equipment | $ 127,489 | $ 117,884 |
Intangible assets, in-process50
Intangible assets, in-process research and development and goodwill (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Cost Basis [Abstract] | |||
Intangible Assets, Beginning Balance | $ 68,299,000 | ||
Additions | 8,300,000 | ||
Intangible Assets, Ending Balance | 76,599,000 | $ 68,299,000 | |
Accumulated Amortization [Abstract] | |||
Accumulated Amortization, Beginning Balance | (9,955,000) | ||
Amortization | 9,269,000 | 8,004,000 | $ 1,951,000 |
Accumulated Amortization, Ending balance | (19,224,000) | (9,955,000) | |
Net book value of intangible assets | 57,375,000 | 57,375,000 | |
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
2,015 | 8,976,000 | ||
2,016 | 8,300,000 | ||
2,017 | 8,300,000 | ||
2,018 | 7,821,000 | ||
2019 and beyond | 23,978,000 | ||
Finite-Lived Intangible Assets, Net | 57,375,000 | 57,375,000 | |
Goodwill, Cost Basis [Abstract] | |||
Goodwill, Beginning Balance | 52,585,000 | ||
Goodwill, Additions | 2,317,000 | ||
Goodwill, Ending Balance | 54,902,000 | 52,585,000 | |
In-process research and development assets | 42,501,000 | 60,628,000 | 41,800,000 |
Finite-Lived Intangible Assets, Net | 57,375,000 | 57,375,000 | |
Biosciences [Member] | |||
Cost Basis [Abstract] | |||
Intangible Assets, Beginning Balance | 19,500,000 | ||
Additions | 8,300,000 | ||
Intangible Assets, Ending Balance | 27,800,000 | 19,500,000 | |
Accumulated Amortization [Abstract] | |||
Accumulated Amortization, Beginning Balance | (2,135,000) | ||
Amortization | 3,060,000 | 2,135,000 | 0 |
Accumulated Amortization, Ending balance | $ (5,195,000) | (2,135,000) | |
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 90 months | ||
Net book value of intangible assets | $ 34,770,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
Finite-Lived Intangible Assets, Net | 34,770,000 | ||
Goodwill, Cost Basis [Abstract] | |||
In-process research and development assets | 41,800,000 | ||
Finite-Lived Intangible Assets, Net | 34,770,000 | ||
Biosciences [Member] | Biosciences Therapeutics [Member] | |||
Accumulated Amortization [Abstract] | |||
Net book value of intangible assets | 8,300,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
Finite-Lived Intangible Assets, Net | 8,300,000 | ||
Goodwill, Cost Basis [Abstract] | |||
Goodwill, Beginning Balance | 13,902,000 | ||
Goodwill, Additions | 0 | ||
Goodwill, Ending Balance | 13,902,000 | 13,902,000 | |
Finite-Lived Intangible Assets, Net | 8,300,000 | ||
Biosciences [Member] | Biosciences Contracts Manufacturing [Member] | |||
Goodwill, Cost Basis [Abstract] | |||
Goodwill, Beginning Balance | 6,736,000 | ||
Goodwill, Additions | 0 | ||
Goodwill, Ending Balance | 6,736,000 | 6,736,000 | |
Biodefense [Member] | |||
Cost Basis [Abstract] | |||
Intangible Assets, Beginning Balance | 48,799,000 | ||
Additions | 0 | ||
Intangible Assets, Ending Balance | 48,799,000 | 48,799,000 | |
Accumulated Amortization [Abstract] | |||
Accumulated Amortization, Beginning Balance | (7,820,000) | ||
Amortization | 6,209,000 | 5,869,000 | 1,951,000 |
Accumulated Amortization, Ending balance | $ (14,029,000) | (7,820,000) | |
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 88 months | ||
Net book value of intangible assets | $ 22,605,000 | ||
Finite-Lived Intangible Assets, Amortization Expense, Maturity Schedule [Abstract] | |||
Finite-Lived Intangible Assets, Net | 22,605,000 | ||
Goodwill, Cost Basis [Abstract] | |||
In-process research and development assets | 50,100,000 | ||
Finite-Lived Intangible Assets, Net | 22,605,000 | ||
Biodefense [Member] | Biodefense Therapeutics [Member] | |||
Goodwill, Cost Basis [Abstract] | |||
Goodwill, Beginning Balance | 22,031,000 | ||
Goodwill, Additions | 2,317,000 | ||
Goodwill, Ending Balance | 24,348,000 | $ 22,031,000 | |
Biodefense [Member] | Biodefense Medical Devices [Member] | |||
Goodwill, Cost Basis [Abstract] | |||
Goodwill, Beginning Balance | 9,916,000 | ||
Goodwill, Additions | 0 | ||
Goodwill, Ending Balance | $ 9,916,000 | $ 9,916,000 |
Long-term debt (Details)
Long-term debt (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||
Jan. 29, 2014USD ($)shares$ / shares | Sep. 30, 2014 | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($)Unit | Dec. 31, 2013USD ($) | Mar. 31, 2014USD ($) | |
Long-Term Debt [Line Items] | ||||||
Payments on borrowings on long-term indebtedness | $ 0 | $ 62,000 | $ 62,774 | |||
BAML Revolving Credit Facility [Memeber] | ||||||
Long-Term Debt [Line Items] | ||||||
Maturity date | Dec. 11, 2018 | |||||
Maximum borrowing capacity | $ 100,000 | |||||
Proceeds from borrowings on long-term indebtedness | $ 62,000 | |||||
Payments on borrowings on long-term indebtedness | $ 62,000 | |||||
Credit Agreement [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Number of lending institutions | Unit | 3 | |||||
Debt covenant, consolidated debt service coverage ratio, minimum | 2.50 | |||||
Debt covenant, leverage ratio, maximum | 4 | 3.50 | 3.75 | |||
Debt covenant, minimum cash and liquid investments balance | $ 50,000 | |||||
2.875% Convertible Senior Notes Due 2021 [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Face amount of debt instrument | $ 250,000 | |||||
Interest rate, stated percentage | 2.875% | |||||
Maturity date | Jan. 15, 2021 | |||||
Conversion rate of notes per $1,000 principal amount (in shares) | shares | 30.8821 | |||||
Conversion price per share (in dollars per share) | $ / shares | $ 32.38 | |||||
Debt issuance costs | $ 8,300 | |||||
BAML Term Loan [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Maturity date | Dec. 11, 2018 | |||||
Maximum borrowing capacity | $ 125,000 | |||||
Other assets -debt issuance costs [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Debt issuance costs | 5,600 | $ 7,100 | ||||
Prepaid expense and other current assets [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Debt issuance costs | 1,500 | 1,500 | ||||
Long term debt, net of debt issuance costs [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Debt issuance costs | 246,900 | 243,700 | ||||
Amount of debt issuance costs in other assets, netted against long term debt [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Debt issuance costs | 4,900 | 6,100 | ||||
Amount of debt issuance costs in prepaid and other current assets, netted against long term debt [Member] | ||||||
Long-Term Debt [Line Items] | ||||||
Debt issuance costs | $ 1,200 | $ 1,200 |
Stockholders' equity (Details)
Stockholders' equity (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Preferred stock | ||
Preferred stock, shares authorized (in shares) | 15,000,000 | 15,000,000 |
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, voting rights | 1 | |
Senior Managment [Member] | ||
Treasury Stock [Abstract] | ||
Stock repurchased as part of stock swap (in shares) |
Stockholders' equity, share-bas
Stockholders' equity, share-based compensation arrangements by share-based payment award (Details) | 12 Months Ended | ||
Dec. 31, 2015USD ($)Plan$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2013USD ($)$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock-based compensation expense | $ | $ 15,848,000 | $ 12,829,000 | $ 11,238,000 |
Aggregate intrinsic value [Abstract] | |||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 1 year 10 months 24 days | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Not yet Recognized, Stock Options | $ | $ 20,000,000 | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ | 15,848,000 | 12,829,000 | $ 11,238,000 |
Stock Options [Member] | |||
Aggregate Intrinsic Value [Abstract] | |||
Outstanding, beginning of period | $ | 29,181,534 | ||
Outstanding, end of period | $ | 52,324,284 | $ 29,181,534 | |
Exercisable, end of period | $ | 31,006,178 | ||
Options expected to vest, end of period | $ | $ 17,043,405 | ||
Aggregate intrinsic value [Abstract] | |||
Weighted average remaining contractual term of options outstanding | 4 years 4 months 24 days | 4 years | |
Weighted average remaining contractual term of options exercisable | 3 years 4 months 24 days | 3 years 2 months 12 days | |
Weighted average grant date fair value of options granted (in dollars per share) | $ / shares | $ 8.66 | $ 8.84 | $ 5.38 |
Total intrinsic value of options exercised | $ | $ 20,200,000 | $ 7,500,000 | $ 6,900,000 |
Total fair value of awards vested | $ | $ 14,400,000 | $ 12,300,000 | 9,100,000 |
2006 Plan [Member] | Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock authorized for issuance under the plan (in shares) | 15,200,000 | ||
Options outstanding [Roll Forward] | |||
Outstanding, beginning of period (in shares) | 3,837,993 | ||
Granted (in shares) | 690,221 | ||
Exercised (in shares) | (1,360,955) | ||
Forfeited (in shares) | (189,439) | ||
Outstanding, end of period (in shares) | 2,977,820 | 3,837,993 | |
Exercisable, end of period (in shares) | 1,442,178 | ||
Options expected to vest, end of period (in shares) | 1,195,677 | ||
Weighted-Average Exercise Price [Roll Forward] | |||
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 20.04 | ||
Granted (in dollars per share) | $ / shares | 29.03 | ||
Exercised (in dollars per share) | $ / shares | 18.09 | ||
Forfeited (in dollars per share) | $ / shares | 24.29 | ||
Outstanding, end of period (in dollars per share) | $ / shares | 22.74 | $ 20.04 | |
Exercisable, end of period (in dollars per share) | $ / shares | 19.12 | ||
Options expected to vest, end of period (in dollars per share) | $ / shares | $ 25.76 | ||
2006 Plan [Member] | Stock Options [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Maximum number of shares that may be granted per year to a single participant (in shares) | 1 | ||
2006 Plan [Member] | Restricted Stock Units (RSUs) [Member] | |||
Restricted stock unit award activity [Roll Forward] | |||
Outstanding, beginning of period (in shares) | 927,356 | ||
Granted (in shares) | 473,111 | ||
Vested (in shares) | (422,515) | ||
Forfeited (in shares) | (82,156) | ||
Outstanding, end of period (in shares) | 895,796 | 927,356 | |
Weighted-Average Grant Price [Roll Forward] | |||
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 22.44 | ||
Granted (in dollars per share) | $ / shares | 29.61 | ||
Vested (in dollars per share) | $ / shares | 20.60 | ||
Forfeited (in dollars per share) | $ / shares | 25.10 | ||
Outstanding, end of period (in dollars per share) | $ / shares | $ 26.85 | $ 22.44 | |
Aggregate intrinsic value [Abstract] | |||
Outstanding, beginning of period | $ | $ 25,251,904 | ||
Outstanding, end of period | $ | $ 35,840,796 | $ 25,251,904 | |
2004 Plan [Member] | Stock Options [Member] | |||
Options outstanding [Roll Forward] | |||
Outstanding, beginning of period (in shares) | 43,156 | ||
Granted (in shares) | 0 | ||
Exercised (in shares) | (13,457) | ||
Forfeited (in shares) | 0 | ||
Outstanding, end of period (in shares) | 29,699 | 43,156 | |
Exercisable, end of period (in shares) | 29,699 | ||
Options expected to vest, end of period (in shares) | 0 | ||
Weighted-Average Exercise Price [Roll Forward] | |||
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 10.28 | ||
Granted (in dollars per share) | $ / shares | 0 | ||
Exercised (in dollars per share) | $ / shares | 10.28 | ||
Forfeited (in dollars per share) | $ / shares | 0 | ||
Outstanding, end of period (in dollars per share) | $ / shares | 10.28 | $ 10.28 | |
Exercisable, end of period (in dollars per share) | $ / shares | 10.28 | ||
Options expected to vest, end of period (in dollars per share) | $ / shares | $ 0 | ||
Employee Stock Purchase Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Threshold limit for common stock ownership to be ineligible to participate in ESPP | 5.00% | ||
Common stock authorized for issuance under the plan (in shares) | 1,000,000 | ||
Number of plan periods | Plan | 2 | ||
Discount from market price | 15.00% | ||
Maximum number of shares that may be granted per year to a single participant (in shares) | 800 | ||
Employee Stock Purchase Plan [Member] | Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Employee subscription rate | 1.00% | ||
Employee Stock Purchase Plan [Member] | Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Employee subscription rate | 10.00% | ||
Cost of Product Sales [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ | $ 1,183,000 | $ 1,145,000 | 575,000 |
Research and Development [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ | 3,112,000 | 3,606,000 | 3,283,000 |
Selling, General and Administrative [Member] | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Total stock-based compensation expense | $ | $ 11,553,000 | $ 8,078,000 | $ 7,380,000 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current | |||
Federal | $ 20,664 | $ 10,412 | $ (878) |
State | 1,401 | 479 | (173) |
International | 1,370 | 112 | 300 |
Total current | 23,435 | 11,003 | (751) |
Deferred | |||
Federal | 7,802 | 7,693 | 12,679 |
State | 185 | 128 | 1,028 |
International | (4,523) | (2,503) | 152 |
Total deferred | 3,464 | 5,318 | 13,859 |
Total provision for income taxes | 26,899 | 16,321 | 13,108 |
Net deferred tax asset [Abstract] | |||
Net operating loss carryforward (federal) | 5,394 | 8,487 | |
Net Operating Loss Carryforward (state) | 12,751 | 12,043 | |
Research and development carryforward | 3,545 | 8,049 | |
Scientific research and experimental development credit carryforward | 25,771 | 29,556 | |
Intangible assets | 5,792 | 5,689 | |
Stock compensation | 9,391 | 8,196 | |
Foreign deferrals | 80,920 | 75,511 | |
Inventory reserves | 3,754 | 4,122 | |
Other | 8,484 | 7,463 | |
Deferred tax asset | 155,802 | 159,116 | |
Fixed assets | (31,925) | (34,839) | |
Intangible assets | (4,760) | (6,538) | |
Other | (17,192) | (10,891) | |
Deferred tax liability | (53,877) | (52,268) | |
Valuation allowance | (90,639) | (92,374) | |
Net deferred tax asset | 11,286 | 14,474 | |
Operating Loss Carryforwards [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 90,639 | 92,374 | |
Income tax reconciliation [Abstract] | |||
US | 88,525 | 59,764 | 52,749 |
International | 1,244 | (6,702) | (8,506) |
Earnings before taxes on income | 89,769 | 53,062 | 44,243 |
Federal tax at statutory rates | 31,394 | 18,572 | 15,485 |
State taxes, net of federal benefit | 613 | 257 | 538 |
Impact of foreign operations | (144) | 186 | (1,116) |
Change in valuation allowance | (1,735) | 1,808 | 1,434 |
Tax credits | (4,849) | (7,137) | (5,918) |
Other differences | 748 | 124 | (227) |
Permanent differences | 872 | 2,511 | 2,912 |
Total provision for income taxes | $ 26,899 | $ 16,321 | $ 13,108 |
Effective annual tax rate | 30.00% | 31.00% | 30.00% |
Research and Development Tax Credit [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward, amount | $ 3,500 | ||
Tax credit carryforwards, expiration date | Dec. 31, 2023 | ||
Canadian Federal Scientific Research And Experimental Development [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward, amount | $ 5,100 | ||
Tax credit carryforwards, expiration date | Dec. 31, 2029 | ||
Manitoba Scientific Research And Experimental Development [Member] | |||
Tax Credit Carryforward [Line Items] | |||
Tax credit carryforward, amount | $ 20,600 | ||
Tax credit carryforwards, expiration date | Dec. 31, 2026 | ||
U.S. Federal Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 15,400 | ||
Operating loss carryforwards, expiration year | Dec. 31, 2026 | ||
State and Local Jurisdiction [Member] | |||
Net deferred tax asset [Abstract] | |||
Valuation allowance | $ (190,000) | ||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 237,800 | ||
Operating loss carryforwards, expiration year | Dec. 31, 2018 | ||
Deferred Tax Assets, Valuation Allowance | $ 190,000 | ||
Foreign Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 231,100 | ||
Period of change in the nature or conduct of business following change in ownership | 3 years | ||
U.S. Federal Tax Authority-Tax Effected [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | $ 5,400 | ||
State and Local Jurisdiction -tax effected [Member] | |||
Net deferred tax asset [Abstract] | |||
Valuation allowance | (10,200) | ||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 12,800 | ||
Deferred Tax Assets, Valuation Allowance | 10,200 | ||
Canadian Federal Gross [Member] | |||
Net deferred tax asset [Abstract] | |||
Valuation allowance | (66,900) | ||
Operating Loss Carryforwards [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 66,900 | ||
Canadian Federal Tax effected [Member] | |||
Net deferred tax asset [Abstract] | |||
Valuation allowance | (17,400) | ||
Operating Loss Carryforwards [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | 17,400 | ||
Foreign Tax Authority Tax Effected [Member] | |||
Net deferred tax asset [Abstract] | |||
Valuation allowance | (59,800) | ||
Operating Loss Carryforwards [Line Items] | |||
Deferred Tax Assets, Valuation Allowance | $ 59,800 |
Income taxes, income tax contin
Income taxes, income tax contingency (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Tax Contingency [Line Items] | |||
Unrecognized tax benefits, current | $ 318,000 | $ 183,000 | |
Unrecognized tax benefits, noncurrent | 1,064,000 | 1,064,000 | |
Gross unrecognized tax benefits activity [Roll Forward] | |||
Gross unrecognized tax benefits, beginning balance | 1,248,000 | 1,121,000 | $ 1,016,000 |
Increases for tax positions for prior years | 150,000 | 150,000 | 165,000 |
Decreases for tax positions for prior years | 0 | 0 | 0 |
Increases for tax positions for current year | 59,000 | 102,000 | 15,000 |
Settlements | 0 | 0 | 0 |
Lapse of statute of limitations | 0 | (125,000) | (75,000) |
Gross unrecognized tax benefits, ending balance | $ 1,457,000 | $ 1,248,000 | $ 1,121,000 |
U.S. Federal Tax Authority [Member] | Minimum [Member] | |||
Gross unrecognized tax benefits activity [Roll Forward] | |||
Open tax year | 2,011 | ||
Federal income tax year selected for audit | 2,009 | ||
U.S. Federal Tax Authority [Member] | Maximum [Member] | |||
Gross unrecognized tax benefits activity [Roll Forward] | |||
Open tax year | 2,014 | ||
Federal income tax year selected for audit | 2,012 | ||
United Kingdom Tax Authority [Member] | Minimum [Member] | |||
Gross unrecognized tax benefits activity [Roll Forward] | |||
Open tax year | 2,007 | ||
United Kingdom Tax Authority [Member] | Maximum [Member] | |||
Gross unrecognized tax benefits activity [Roll Forward] | |||
Open tax year | 2,014 |
Assets held for sale (Details)
Assets held for sale (Details) $ in Millions | Dec. 31, 2014USD ($) |
Assets held for sale [Abstract] | |
Facility and equipment held for sale in Winnipeg, Manitoba, Canada | $ 2.4 |
Purchase commitment (Details)
Purchase commitment (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Purchase commitment [Abstract] | ||
Total purchase commitment to Norwood Laboratories Inc. | $ 0 | $ 15,200,000 |
Materials purchased from Norwood Laboratories Inc as of December 31, 2014 | $ 6,200,000 | $ 1,500,000 |
401(k) savings plan (Details)
401(k) savings plan (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
401(k) savings plan [Abstract] | |||
Matching of qualified deferrals by employer, maximum | 50.00% | ||
Percentage of employee's gross salary subject to employer's matching contribution | 6.00% | ||
Matching contributions made by employer | $ 2.5 | $ 2.4 | $ 2 |
Leases (Details)
Leases (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Operating Leased Assets [Line Items] | |||
Total lease expense | $ 3,000,000 | $ 4,600,000 | $ 3,900,000 |
Rental income | 400,000 | $ 3,100,000 | $ 400,000 |
Future minimum lease payments under operating lease | |||
2,015 | 2,577,000 | ||
2,016 | 2,324,000 | ||
2,017 | 2,044,000 | ||
2,018 | 1,988,000 | ||
2,019 | 924,000 | ||
2020 and beyond | 2,137,000 | ||
Total minimum lease payments | 11,994,000 | ||
Minimum lease receipts | (1,105,000) | ||
Total net minimum lease payments | $ 10,889,000 | ||
Office and Laboratory Space - Washington [Member] | |||
Operating Leased Assets [Line Items] | |||
Operating lease expiration date | Apr. 30, 2020 | ||
Annual escalation percentage | 2.00% | ||
Office and laboratory space - Washington, DC [Member] | |||
Operating Leased Assets [Line Items] | |||
Operating lease expiration date | May 31, 2027 | ||
Annual escalation percentage | 2.50% |
Related party transactions (Det
Related party transactions (Details) | 12 Months Ended |
Dec. 31, 2015 | |
Saudi Arabia [Member] | |
Related Party Transaction [Line Items] | |
Percentage of net sales of biodefense products subject to payment to related party | 17.50% |
Qatar [Member] | |
Related Party Transaction [Line Items] | |
Percentage of net sales of biodefense products subject to payment to related party | 15.00% |
United Arab Emirates [Member] | |
Related Party Transaction [Line Items] | |
Percentage of net sales of biodefense products subject to payment to related party | 15.00% |
Earnings per share (Details)
Earnings per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Numerator [Abstract] | |||||||||||
Net income | $ 33,347 | $ 36,942 | $ 14,100 | $ (21,519) | $ 30,116 | $ 21,832 | $ 5,029 | $ (20,236) | $ 62,870 | $ 36,741 | $ 31,135 |
Interest on Convertible Debt, Net of Tax | 3,019 | 2,879 | 0 | ||||||||
Amortization of Financing Costs | 868 | 735 | 0 | ||||||||
Adjusted net loss | $ 66,757 | $ 40,355 | $ 31,135 | ||||||||
Denominator [Abstract] | |||||||||||
Weighted-average number of shares-basic (in shares) | 38,595,435 | 37,344,891 | 36,201,283 | ||||||||
Dilutive securities-equity awards (in shares) | 939,882 | 737,391 | 546,273 | ||||||||
Dilutive securities-convertible debt (in shares) | 7,720,525 | 7,720,525 | 0 | ||||||||
Weighted-average number of shares-diluted (in shares) | 47,255,842 | 45,802,807 | 36,747,556 | ||||||||
Earnings per share-basic (in dollars per share) | $ 0.85 | $ 0.95 | $ 0.37 | $ (0.57) | $ 0.80 | $ 0.58 | $ 0.13 | $ (0.55) | $ 1.63 | $ 0.98 | $ 0.86 |
Earnings per share-diluted (in dollars per share) | $ 0.71 | $ 0.79 | $ 0.32 | $ (0.57) | $ 0.66 | $ 0.49 | $ 0.13 | $ (0.55) | $ 1.41 | $ 0.88 | $ 0.85 |
Stock Options [Member] | |||||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||||||
Antidilutive shares excluded from calculation (in shares) | 1,400,000 | 1,500,000 |
Segment information (Details)
Segment information (Details) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015USD ($) | Sep. 30, 2015USD ($) | Jun. 30, 2015USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2014USD ($) | Mar. 31, 2014USD ($) | Dec. 31, 2015USD ($)SegmentBusinessUnit | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | |
Segment Reporting Information [Line Items] | |||||||||||
Number of business segments | Segment | 2 | ||||||||||
Assets | $ 1,043,592,000 | $ 938,691,000 | $ 1,043,592,000 | $ 938,691,000 | $ 626,630,000 | ||||||
Revenue | 522,789,000 | 450,138,000 | 312,745,000 | ||||||||
Research and development | 153,997,000 | 150,829,000 | 119,933,000 | ||||||||
Interest revenue | 572,000 | 320,000 | 139,000 | ||||||||
Interest expense | (6,523,000) | (8,240,000) | 0 | ||||||||
Depreciation and amortization | 24,501,000 | 23,006,000 | 17,008,000 | ||||||||
Net income (loss) | 33,347,000 | $ 36,942,000 | $ 14,100,000 | $ (21,519,000) | 30,116,000 | $ 21,832,000 | $ 5,029,000 | $ (20,236,000) | 62,870,000 | 36,741,000 | 31,135,000 |
Intangible assets | 57,375,000 | 58,344,000 | 57,375,000 | 58,344,000 | 30,148,000 | ||||||
In-process research and development assets | 42,501,000 | 60,628,000 | 42,501,000 | 60,628,000 | 41,800,000 | ||||||
Goodwill, net book value | 54,902,000 | 52,585,000 | 54,902,000 | 52,585,000 | 13,954,000 | ||||||
Total assets | 1,043,592,000 | 938,691,000 | 1,043,592,000 | 938,691,000 | 626,630,000 | ||||||
Expenditures for long-lived assets | 44,812,000 | 30,673,000 | 42,021,000 | ||||||||
Foreign Jurisdictions [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Assets | 270,000,000 | 242,500,000 | 270,000,000 | 242,500,000 | 56,700,000 | ||||||
Total assets | 270,000,000 | 242,500,000 | 270,000,000 | 242,500,000 | 56,700,000 | ||||||
Intersegment Eliminations [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenue | $ 0 | 0 | 0 | ||||||||
Biodefense [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Number of business units | BusinessUnit | 2 | ||||||||||
In-process research and development assets | 50,100,000 | $ 50,100,000 | |||||||||
Biodefense [Member] | Intersegment Eliminations [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenue | (1,877,000) | 0 | 0 | ||||||||
Biodefense [Member] | Operating Segments [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Assets | 511,875,000 | 433,226,000 | 511,875,000 | 433,226,000 | 331,827,000 | ||||||
Revenue | 450,088,000 | 370,547,000 | 311,564,000 | ||||||||
Research and development | 111,663,000 | 81,975,000 | 62,663,000 | ||||||||
Interest revenue | 149,000 | 62,000 | 0 | ||||||||
Interest expense | 0 | 0 | 0 | ||||||||
Depreciation and amortization | 18,677,000 | 17,669,000 | 15,584,000 | ||||||||
Net income (loss) | 125,609,000 | 96,966,000 | 87,289,000 | ||||||||
Intangible assets | 34,770,000 | 40,979,000 | 34,770,000 | 40,979,000 | 30,148,000 | ||||||
In-process research and development assets | 701,000 | 10,528,000 | 701,000 | 10,528,000 | 0 | ||||||
Goodwill, net book value | 34,264,000 | 31,239,000 | 34,264,000 | 31,239,000 | 8,452,000 | ||||||
Total assets | 511,875,000 | 433,226,000 | 511,875,000 | 433,226,000 | 331,827,000 | ||||||
Expenditures for long-lived assets | $ 37,735,000 | 26,736,000 | 30,700,000 | ||||||||
Biosciences [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Number of business units | BusinessUnit | 3 | ||||||||||
In-process research and development assets | 41,800,000 | $ 41,800,000 | |||||||||
Biosciences [Member] | Intersegment Eliminations [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenue | 1,877,000 | 0 | 0 | ||||||||
Biosciences [Member] | Operating Segments [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Assets | 345,995,000 | 344,420,000 | 345,995,000 | 344,420,000 | 98,510,000 | ||||||
Revenue | 72,701,000 | 79,591,000 | 1,181,000 | ||||||||
Research and development | 37,816,000 | 60,821,000 | 50,652,000 | ||||||||
Interest revenue | 0 | 0 | 0 | ||||||||
Interest expense | (41,000) | 0 | 0 | ||||||||
Depreciation and amortization | 5,597,000 | 5,070,000 | 1,238,000 | ||||||||
Net income (loss) | (55,644,000) | (51,300,000) | (50,925,000) | ||||||||
Intangible assets | 22,605,000 | 17,365,000 | 22,605,000 | 17,365,000 | 0 | ||||||
In-process research and development assets | 41,800,000 | 50,100,000 | 41,800,000 | 50,100,000 | 41,800,000 | ||||||
Goodwill, net book value | 20,638,000 | 21,346,000 | 20,638,000 | 21,346,000 | 5,502,000 | ||||||
Total assets | 345,995,000 | 344,420,000 | 345,995,000 | 344,420,000 | 98,510,000 | ||||||
Expenditures for long-lived assets | 6,689,000 | 2,444,000 | 1,343,000 | ||||||||
All Other [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Assets | 185,722,000 | 161,045,000 | 185,722,000 | 161,045,000 | 196,293,000 | ||||||
Revenue | 0 | 0 | 0 | ||||||||
Research and development | 4,518,000 | 8,033,000 | 6,618,000 | ||||||||
Interest revenue | 423,000 | 258,000 | 139,000 | ||||||||
Interest expense | (6,482,000) | (8,240,000) | 0 | ||||||||
Depreciation and amortization | 227,000 | 267,000 | 186,000 | ||||||||
Net income (loss) | (7,095,000) | (8,925,000) | (5,229,000) | ||||||||
Intangible assets | 0 | 0 | 0 | ||||||||
In-process research and development assets | 0 | 0 | 0 | 0 | 0 | ||||||
Goodwill, net book value | 0 | 0 | 0 | ||||||||
Total assets | $ 185,722,000 | $ 161,045,000 | 185,722,000 | 161,045,000 | 196,293,000 | ||||||
Expenditures for long-lived assets | 388,000 | 1,493,000 | 9,978,000 | ||||||||
All Other [Member] | Intersegment Eliminations [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Revenue | $ 0 | $ 0 | $ 0 |
Quarterly financial data (una63
Quarterly financial data (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Quarterly financial data (unaudited) [Abstract] | |||||||||||
Revenue | $ 168,104 | $ 164,940 | $ 126,112 | $ 63,633 | $ 147,975 | $ 137,954 | $ 110,325 | $ 53,884 | $ 522,789 | $ 450,138 | $ 312,745 |
Income (loss) from operations | 49,892 | 53,005 | 21,452 | (28,310) | 44,620 | 31,032 | 7,862 | (25,458) | 96,039 | 58,056 | 42,802 |
Net income (loss) | $ 33,347 | $ 36,942 | $ 14,100 | $ (21,519) | $ 30,116 | $ 21,832 | $ 5,029 | $ (20,236) | $ 62,870 | $ 36,741 | $ 31,135 |
Net income (loss) per share, basic (in dollars per share) | $ 0.85 | $ 0.95 | $ 0.37 | $ (0.57) | $ 0.80 | $ 0.58 | $ 0.13 | $ (0.55) | $ 1.63 | $ 0.98 | $ 0.86 |
Net income (loss) per share, diluted (in dollars per share) | $ 0.71 | $ 0.79 | $ 0.32 | $ (0.57) | $ 0.66 | $ 0.49 | $ 0.13 | $ (0.55) | $ 1.41 | $ 0.88 | $ 0.85 |