Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 17, 2016 | Jun. 30, 2015 | |
Document and Entity Information | |||
Entity Registrant Name | ACORDA THERAPEUTICS INC | ||
Entity Central Index Key | 1,008,848 | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2015 | ||
Amendment Flag | false | ||
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 | $ 706,885,171 | ||
Entity Common Stock, Shares Outstanding | 45,749,265 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 153,204 | $ 182,170 |
Restricted cash | 6,032 | 1,205 |
Short-term investments | 200,101 | 125,448 |
Trade accounts receivable, net of allowances of $884 and $771, as of December 31, 2015 and 2014, respectively | 31,466 | 32,211 |
Prepaid expenses | 16,079 | 15,523 |
Finished goods inventory held by the Company | 36,476 | 26,256 |
Finished goods inventory held by others | 581 | |
Other current assets | 7,959 | 7,324 |
Total current assets | 451,317 | 390,718 |
Property and equipment, net of accumulated depreciation | 40,204 | 46,090 |
Goodwill | 183,636 | 182,952 |
Deferred tax asset | 2,128 | 2,806 |
Intangible assets, net of accumulated amortization | 430,856 | 432,822 |
Non-current portion of deferred cost of license revenue | 2,906 | 3,540 |
Other assets | 5,296 | 6,137 |
Total assets | 1,116,343 | 1,065,065 |
Current liabilities: | ||
Accounts payable | 14,233 | 17,751 |
Accrued expenses and other current liabilities | 66,133 | 56,118 |
Deferred product revenue-Zanaflex | 29,420 | |
Current portion of deferred license revenue | 9,057 | 9,057 |
Current portion of revenue interest liability | 25 | 893 |
Current portion of convertible notes payable | 1,144 | 1,144 |
Total current liabilities | 90,592 | 114,383 |
Convertible senior notes (due 2021) | 295,469 | 287,699 |
Acquired Contingent consideration | 63,500 | 52,600 |
Non-current portion of deferred license revenue | 41,513 | 50,570 |
Non-current portion of convertible notes payable | 1,107 | 2,184 |
Deferred tax liability | 12,146 | 8,271 |
Other non-current liabilities | $ 8,991 | $ 9,103 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Common stock, $0.001 par value. Authorized 80,000,000 shares at December 31, 2015 and 2014; issued and outstanding 42,999,377 and 41,883,843 shares, including those held in treasury, as of December 31, 2015 and 2014, respectively | $ 43 | $ 42 |
Treasury stock at cost (12,420 shares at December 31, 2015 and December 31, 2014) | (329) | (329) |
Additional paid-in capital | 812,782 | 761,026 |
Accumulated deficit | (209,352) | (220,410) |
Accumulated other comprehensive loss | (119) | (74) |
Total stockholders' equity | 603,025 | 540,255 |
Total liabilities and stockholders' equity | $ 1,116,343 | $ 1,065,065 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Consolidated Balance Sheets | ||
Trade accounts receivable, allowances (in dollars) | $ 884 | $ 771 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, Authorized shares | 80,000,000 | 80,000,000 |
Common stock, issued shares | 42,999,377 | 41,883,843 |
Common stock, outstanding shares | 42,999,377 | 41,883,843 |
Treasury stock, shares | 12,420 | 12,420 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Revenues: | |||
Net product revenues | $ 466,111 | $ 373,292 | $ 310,317 |
Royalty revenues | 17,492 | 19,131 | 17,056 |
License revenue | 9,057 | 9,057 | 9,057 |
Total net revenues | 492,660 | 401,480 | 336,430 |
Costs and expenses: | |||
Cost of sales | 92,297 | 79,981 | 66,009 |
Cost of milestone and license revenue | 634 | 634 | 634 |
Research and development | 149,209 | 73,470 | 53,877 |
Selling, general and administrative | 205,630 | 201,813 | 185,545 |
Asset impairment | 6,991 | ||
Changes in fair value of acquired contingent consideration | 10,900 | 2,200 | |
Total operating expenses | 458,670 | 365,089 | 306,065 |
Operating income | 33,990 | 36,391 | 30,365 |
Other expense (net): | |||
Interest and amortization of debt discount expense | (15,472) | (9,288) | (2,170) |
Interest income | 440 | 674 | 668 |
Other income | 411 | 232 | |
Total other expense (net) | (14,621) | (8,382) | (1,502) |
Income before taxes | 19,369 | 28,009 | 28,863 |
Provision for income taxes | (8,311) | (10,337) | (12,422) |
Net income | $ 11,058 | $ 17,672 | $ 16,441 |
Net income per share-basic (in dollars per share) | $ 0.26 | $ 0.43 | $ 0.41 |
Net income per share-diluted (in dollars per share) | $ 0.25 | $ 0.42 | $ 0.39 |
Weighted average common shares outstanding used in computing net income per share-basic (in shares) | 42,230 | 41,150 | 40,208 |
Weighted average common shares outstanding used in computing net income per share-diluted (in shares) | 43,621 | 42,544 | 41,682 |
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 | |||
Net income | $ 11,058 | $ 17,672 | $ 16,441 |
Other comprehensive loss : | |||
Unrealized losses on available-for-sale securities, net of tax | (45) | (111) | (25) |
Other comprehensive loss, net of tax | (45) | (111) | (25) |
Comprehensive income | $ 11,013 | $ 17,561 | $ 16,416 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common stock | Treasury stock | Additional paid-in capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Total |
Balance at Dec. 31, 2012 | $ 40 | $ (329) | $ 640,671 | $ (254,523) | $ 62 | $ 385,921 |
Balance (in shares) at Dec. 31, 2012 | 39,804,000 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense for issuance of stock options to employees | 18,036 | 18,036 | ||||
Compensation expense for issuance of restricted stock to employees | 7,103 | 7,103 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 264,000 | |||||
Exercise of stock options | $ 1 | 12,785 | 12,786 | |||
Exercise of stock options (in shares) | 828,000 | |||||
Excess tax benefit from share-based compensation arrangements | 91 | 91 | ||||
Other comprehensive loss, net of tax | (25) | (25) | ||||
Net income | 16,441 | 16,441 | ||||
Balance at Dec. 31, 2013 | $ 41 | (329) | 678,686 | (238,082) | 37 | 440,353 |
Balance (in shares) at Dec. 31, 2013 | 40,896,000 | |||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense for issuance of stock options to employees | 21,910 | 21,910 | ||||
Compensation expense for issuance of restricted stock to employees | 7,527 | 7,527 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 242,000 | |||||
Exercise of stock options | $ 1 | 16,014 | 16,015 | |||
Exercise of stock options (in shares) | 746,000 | |||||
Equity component of the convertible notes, issuance, net | 37,795 | 37,795 | ||||
Debt issuance costs | (1,277) | (1,277) | ||||
Excess tax benefit from share-based compensation arrangements | 371 | 371 | ||||
Other comprehensive loss, net of tax | (111) | (111) | ||||
Net income | 17,672 | 17,672 | ||||
Balance at Dec. 31, 2014 | $ 42 | (329) | 761,026 | (220,410) | (74) | $ 540,255 |
Balance (in shares) at Dec. 31, 2014 | 41,884,000 | 41,883,843 | ||||
Increase (Decrease) in Stockholders' Equity | ||||||
Compensation expense for issuance of stock options to employees | 25,026 | $ 25,026 | ||||
Compensation expense for issuance of restricted stock to employees | 8,441 | 8,441 | ||||
Compensation expense for issuance of restricted stock to employees (in shares) | 244,000 | |||||
Exercise of stock options | $ 1 | 18,095 | 18,096 | |||
Exercise of stock options (in shares) | 871,000 | |||||
Excess tax benefit from share-based compensation arrangements | 194 | 194 | ||||
Other comprehensive loss, net of tax | (45) | (45) | ||||
Net income | 11,058 | 11,058 | ||||
Balance at Dec. 31, 2015 | $ 43 | $ (329) | $ 812,782 | $ (209,352) | $ (119) | $ 603,025 |
Balance (in shares) at Dec. 31, 2015 | 42,999,000 | 42,999,377 |
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 | $ 11,058 | $ 17,672 | $ 16,441 |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Recognition of deferred product revenue- Zanaflex | (22,186) | ||
Share-based compensation expense | 33,467 | 29,437 | 25,139 |
Amortization of net premiums and discounts on investments | 3,366 | 3,571 | 2,526 |
Amortization of debt discount and debt issuance costs | 8,562 | 4,291 | |
Amortization of revenue interest issuance cost | 15 | 27 | 50 |
Depreciation and amortization expense | 15,012 | 8,473 | 6,999 |
Intangible asset impairment | 6,991 | ||
Change in contingent consideration obligation | 10,900 | 2,200 | |
Gain on put/call liability | (147) | (182) | |
Deferred tax provision | 3,975 | 6,681 | 9,520 |
Excess tax benefit from share-based compensation arrangements | (194) | (371) | (91) |
Changes in assets and liabilities: | |||
Decrease (increase) in accounts receivable | 744 | (1,427) | (4,457) |
Increase in prepaid expenses and other current assets | (998) | (4,083) | (377) |
Increase in inventory held by the Company | (10,220) | (721) | (5,269) |
Decrease in inventory held by others | 581 | 56 | 145 |
Decrease in non-current portion of deferred cost of license revenue | 634 | 634 | 634 |
Decrease in other assets | 34 | 34 | 34 |
(Decrease) increase in accounts payable, accrued expenses, other current liabilities | (825) | 13,180 | (5,785) |
(Decrease) increase in revenue interest liability interest payable | (374) | 108 | 18 |
Decrease in non-current portion of deferred license revenue | (9,057) | (9,057) | (9,057) |
(Decrease) increase in other non-current liabilities | (198) | (301) | 78 |
(Decrease) increase in deferred product revenue-Zanaflex | (989) | (2,670) | 2,816 |
(Increase) decrease in restricted cash | (4,826) | 71 | 103 |
Net cash provided by operating activities | 38,481 | 74,649 | 39,285 |
Cash flows from investing activities: | |||
Purchases of property and equipment | (5,921) | (5,084) | (4,043) |
Purchases of intangible assets | (1,145) | (2,699) | (3,121) |
Acquisitions, net of cash received | (476,151) | (7,499) | |
Purchases of investments | (434,670) | (580,381) | (221,429) |
Proceeds from maturities of investments | 356,500 | 770,490 | 191,000 |
Net cash used in investing activities | (85,236) | (293,825) | (45,092) |
Cash flows from financing activities: | |||
Proceeds from issuance of convertible senior notes | 345,000 | ||
Debt issuance costs | (7,516) | ||
Proceeds from issuance of common stock and option exercises | 18,096 | 16,015 | 12,786 |
Excess tax benefit from share-based compensation arrangements | 194 | 371 | 91 |
Repayments of revenue interest liability | (501) | (562) | (909) |
Net cash provided by financing activities | 17,789 | 353,308 | 11,968 |
Net (decrease) increase in cash and cash equivalents | (28,966) | 134,133 | 6,161 |
Cash and cash equivalents at beginning of period | 182,170 | 48,037 | 41,876 |
Cash and cash equivalents at end of period | 153,204 | 182,170 | 48,037 |
Supplemental disclosure: | |||
Cash paid for interest | 7,218 | 4,522 | 2,022 |
Cash paid for taxes | $ 4,697 | $ 4,392 | $ 2,630 |
Organization and Business Activ
Organization and Business Activities | 12 Months Ended |
Dec. 31, 2015 | |
Organization and Business Activities | |
Organization and Business Activities | (1) Organization and Business Activities Acorda Therapeutics, Inc. (“Acorda” or the “Company”) is a biopharmaceutical company dedicated to the identification, development and commercialization of novel therapies to restore function and improve the lives of people with neurological disorders. The management of the Company is responsible for the accompanying audited consolidated financial statements and the related information included in the notes to the consolidated financial statements. In the opinion of management, the audited consolidated financial statements reflect all adjustments, including normal recurring adjustments necessary for the fair presentation of the Company’s financial position and results of operations and cash flows for the periods presented. Certain reclassifications were made to prior period amounts in the consolidated financial statements and accompanying notes to conform with the current presentation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | (2) Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (U.S.) and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of the consolidated financial statements requires management to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share-based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities. Actual results could differ from those estimates. Cash and Cash Equivalents The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund and U.S. Treasury bonds, which are unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. We maintain cash balances in excess of insured limits. We do not anticipate any losses with respect to such cash balances. Restricted Cash Restricted cash represents a bank account with funds to cover the Company’s self-funded employee health insurance and cash deposits held in connection with obligations under facility leases. At December 31, 2015, restricted cash of $5.8 million is related to cash collateralized standby letters of credit (see Note 14). Investments Short-term investments consist of U.S. Treasury bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period is longer than one year. The Company classifies its short-term investments as available-for-sale. Available-for-sale securities are recorded at the fair value of the investments based on quoted market prices. Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive loss. Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective-interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income are included in interest income. Realized gains and losses are included in other income. Other Comprehensive (Loss) Income The Company’s other comprehensive (loss) income is comprised of unrealized gains and losses on available-for-sale securities and is recorded and presented net of income tax. Inventory Inventory is stated at the lower of cost or market value and includes amounts for Ampyra, Zanaflex tablet, Zanaflex Capsule and Qutenza inventories and is recorded at its net realizable value. The Company capitalizes inventory costs associated with the Company’s products prior to regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company establishes reserves as necessary for obsolescence and excess inventory. Ampyra The cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) is based on agreed upon pricing with Alkermes. In the event Alkermes does not manufacture the products, Alkermes is entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances. Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which ranges from one to seven years. Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on a straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred. Goodwill Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. See Note 13 for discussion on goodwill. Intangible Assets The Company has finite lived intangible assets related to milestones for Ampyra, and for certain website development costs. These intangible assets are amortized on a straight line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If the carrying value is not recoverable, impairment is measured as the amount by which the carrying value exceeds its estimated fair value. Fair value is generally estimated based on either appraised value or other valuation techniques. The Company also has indefinite lived intangible assets for the value of acquired in-process research and development related to CVT-301. The Company reviews the carrying value of indefinite lived intangible assets annually and whenever indicators of impairment are present. See also “In-Process Research and Development” and Note 13 for discussion on intangible assets. Contingent Consideration The Company may record contingent consideration as part of the cost of business acquisitions. Contingent consideration is recognized at fair value as of the date of acquisition and recorded as a liability on the consolidated balance sheet. The contingent consideration is re-valued on a quarterly basis using a probability weighted discounted cash-flow approach until fulfillment or expiration of the contingency. Changes in the fair value of the contingent consideration are recognized in the statement of operations. See Note 10 for discussion on the Alkermes ARCUS agreement. Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Any write-downs are treated as permanent reductions in the carrying amount of the assets. Patent Costs Patent application and maintenance costs are expensed as incurred. Research and Development Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses. In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. All research and development costs are expensed as incurred except when accounting for nonrefundable advance payments for goods or services to be used in future research and development activities. These payments are capitalized at the time of payment and expensed ratably over the period the research and development activity is performed. In-Process Research and Development The cost of in-process research and development (IPR&D) acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise they are expensed. The fair values of IPR&D projects acquired in business combinations are capitalized. Several methods may be used to determine the estimated fair value of the IPR&D acquired in a business combination. The Company utilizes the “income method”, and uses estimated future net cash flows that are derived from projected sales revenues and estimated costs. These projections are based on factors such as relevant market size, patent protection, historical pricing and expected industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. IPR&D intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense is recognized in the statement of operations. These assets are tested at least annually or sooner when a triggering event occurs that could indicate a potential impairment. Accounting for Income Taxes The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized. On December 31, 2015, the Company early adopted the provisions of Accounting Standards updated 2015-17, “Income Taxes” (Topic 740): Balance Sheet Classification of Deferred Taxes (ASU 2015-17), which simplifies the presentation of deferred income taxes by requiring that deferred tax liabilities and assets be classified as noncurrent in the balance sheet. The Company adopted the new guidance retrospectively and updated the classification of the deferred tax liabilities and assets to noncurrent in the balance sheet for the current year and all prior periods presented. In determining whether a tax position is effectively settled for the purpose of recognizing previously unrecognized tax benefits, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. Revenue Recognition Ampyra Ampyra is available only through a network of specialty pharmacy providers that provide the medication to patients by mail; Kaiser Permanente, which distributes Ampyra to patients through a closed network of on-site pharmacies; and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate), which distributes Ampyra to the U.S. Bureau of Prisons, the U.S. Department of Defense, the U.S. Department of Veterans Affairs, or VA, and other federal agencies. Ampyra is not available in retail pharmacies. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes product sales of Ampyra following shipment of product to a network of specialty pharmacy providers, Kaiser Permanente, and ASD Specialty Healthcare, Inc. The specialty pharmacy providers, Kaiser Permanente, and ASD Specialty Healthcare, Inc. are contractually obligated to hold no more than an agreed number of days of inventory, ranging from 10 to 30 days. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, and chargebacks. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, are characterized as a reduction of revenue. At the time product is shipped to specialty pharmacies, Kaiser Permanente and ASD Specialty Healthcare, Inc., an adjustment is recorded for estimated discounts, rebates, and chargebacks. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for discounts, rebates, and chargebacks are established based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Product shipping and handling costs are included in cost of sales. The Company does not accept returns of Ampyra with the exception of product damages that occur during shipping. Zanaflex The Company applies the revenue recognition guidance in Accounting Standards Codification (ASC) 605-15-25, which among other criteria requires that future returns can be reasonably estimated in order to recognize revenue. Prior to the three-month period ended September 30, 2015, the Company accounted for Zanaflex tablet and capsule (Zanaflex products) shipments using a deferred revenue recognition model (sell-through). Under the deferred revenue recognition model, the Company did not recognize revenue upon product shipment. For product shipments, the Company invoiced the wholesaler, recorded deferred revenue at gross invoice sales price, and classified the cost basis of the product held by the wholesaler as a separate component of inventory. The Company recognized revenue when prescribed to the end-user, on a first-in first-out (FIFO) basis. The Company’s revenue to be recognized was based on the estimated prescription demand, based on pharmacy sales for its products using third-party information, including third-party market research data. The Company’s sales and revenue recognition reflected the Company’s estimate of actual product prescribed to the end-user. Beginning in the third quarter of 2015, the Company is recognizing sales for Zanaflex products when the product is shipped to its wholesale distributors (sell-in), as the Company believes there is now sufficient history to reasonably estimate expected returns. For the three-month period ended September 30, 2015, the Company recognized a one-time increase in net revenue of $22.2 million, representing previously deferred product sales as of June 30, 2015, net of an allowance for estimated returns. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, chargebacks and returns. Qutenza Qutenza is distributed in the U.S. by Besse Medical, Inc., a specialty distributor that furnishes the medication to physician offices; and by ASD Specialty Healthcare, Inc., a specialty distributor that furnishes the medication to hospitals and clinics. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. This means that, for Qutenza, the Company recognizes product sales following shipment of product to its specialty distributors. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated rebates, chargebacks, and returns. Milestones and royalties In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones using the criteria as provided by the Financial Accounting Standards Boards (FASB) guidance on the milestone method of revenue recognition. At the inception of a collaboration agreement the Company evaluates if payments are substantive. The criteria requires that (i) the Company determines if the milestone is commensurate with either its performance to achieve the milestone or the enhancement of value resulting from the Company’s activities to achieve the milestone, (ii) the milestone be related to past performance, and (iii) the milestone be reasonably relative to all deliverable and payment terms of the collaboration arrangement. If these criteria are met then the contingent milestones can be considered as substantive milestones and will be recognized as revenue in the period that the milestone is achieved. Royalties are recognized as earned in accordance with the terms of various research and collaboration agreements. Collaborations The Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it shall be accounted for as a separate element or single unit of accounting. If an element shall be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue shall be recognized. If an element shall not be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue shall be recognized. Payments received in excess of revenues recognized are recorded as deferred revenue until such time as the revenue recognition criteria have been met. Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash, cash equivalents, restricted cash and accounts receivable. The Company maintains cash, cash equivalents, restricted cash and short-term investments with approved financial institutions. The Company is exposed to credit risks and liquidity in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution. The Company does not own or operate, and currently does not plan to own or operate, facilities for production and packaging of Ampyra or its other commercial products, Zanaflex Capsules, Zanaflex tablets or Qutenza. It relies and expects to continue to rely on third parties for the production and packaging of its commercial products and clinical trial materials for all of its products except CVT-301. As part of the Civitas acquisition in 2014, the Company leases a manufacturing facility in Chelsea, Massachusetts which produces CVT-301 for clinical trials and eventually will produce commercial supply, if approved. The Company relies primarily on Alkermes for its supply of Ampyra. Under its supply agreement with Alkermes, the Company is obligated to purchase at least 75% of its yearly supply of Ampyra from Alkermes, and it is required to make compensatory payments if it does not purchase 100% of its requirements from Alkermes, subject to certain specified exceptions. The Company and Alkermes have agreed that the Company may purchase up to 25% of its annual requirements from Patheon, a mutually agreed-upon second manufacturing source, with compensatory payment. The Company and Alkermes also rely on a single third-party manufacturer, Regis, to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra. If Regis experiences any disruption in their operations, a delay or interruption in the supply of Ampyra product could result until Regis cures the problem or it locates an alternate source of supply. The Company’s principal direct customers as of December 31, 2015 were a network of specialty pharmacies, Kaiser Permanente, and ASD Specialty Healthcare, Inc. for Ampyra, wholesale pharmaceutical distributors for Zanaflex Capsules and Zanaflex tablets, and two specialty distributors for Qutenza. The Company periodically assesses the financial strength of these customers and establishes allowances for anticipated losses, if necessary. Three customers individually accounted for more than 10% of the Company’s revenue in 2015 and four customers individually accounted for more than 10% of the Company’s revenue in 2014 and 2013. Three customers individually accounted for more than 10% of the Company’s accounts receivable as of December 31, 2015 and four customers individually accounted for more than 10% of the Company’s accounts receivable as of December 31, 2014. The Company’s net product revenues are generated in the U. S. Allowance for Cash Discounts An allowance for cash discounts is accrued based on historical usage rates at the time of product shipment. The Company adjusts accruals based on actual activity as necessary. Cash discounts are typically settled with customers within 30 days after the end of each calendar month. The Company had cash discount allowances of $5.1 million and $4.1 million for the years ended December 31, 2015 and 2014, respectively. The Company’s accruals for cash discount allowances were $0.5 million and $0.4 million as of December 31, 2015 and 2014, respectively. Allowance for Doubtful Accounts A portion of the Company’s accounts receivable may not be collected due principally to customer disputes. The Company provides reserves for these situations based on the evaluation of the aging of its trade receivable portfolio and an analysis of high-risk customers. The Company has not historically experienced material losses related to credit risk. The Company has recognized an allowance related to one customer of approximately $0.4 million as of December 31, 2015 and December 31, 2014. For the year ended December 31, 2015 and 2014, the Company recorded no provision and did not record any write-offs. Contingencies The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. Litigation expenses are expensed as incurred. Fair Value of Financial Instruments The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts. The Company considers that fair value should be based on the assumptions market participants would use when pricing the asset or liability. The following methods are used to estimate the fair value of the Company’s financial instruments: (a) Cash equivalents, grants receivable, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these instruments; (b) Available-for-sale securities are recorded based primarily on quoted market prices; (c) Put/call liability’s fair value is based on revenue projections and business, general economic and market conditions that could be reasonably evaluated as of the valuation date; (d) Contingent purchase price related to the NeurogesX acquisition was measured at fair value using a Monte Carlo simulation; (e) Acquired contingent consideration related to the Civitas acquisition is measured at fair value using a probability weighted, discounted cash flow approach; and (f) Convertible Senior Notes were measured at fair value based on market quoted prices of debt securities with similar terms and maturities using other observable inputs. Earnings per Share Basic net income per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method), the vesting of restricted stock and the potential dilutive effects of the conversion option on the Company’s convertible debt. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. See Note 8 for discussion on earnings per share. Share-based Compensation The Company has various share-based employee and non-employee compensation plans, which are described more fully in Note 7. The Company accounts for stock options and restricted stock granted to employees and non-employees by recognizing the costs resulting from all share-based payment transactions in the consolidated financial statements at their fair values. The Company estimates the fair value of each option on the date of grant using the Black-Scholes closed-form option-pricing model based on assumptions of expected volatility of its common stock, prevailing interest rates, an estimated forfeiture rate, and the expected term of the stock options, and the Company recognizes that cost as an expense ratably over the associated employee service period. Segment and Geographic Information The Company is managed and operated as one business which is focused on the identification, development and commercialization of novel therapies to improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location . Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported to date are derived from the sales of Ampyra, Zanaflex and Qutenza in the U.S . Accumulated Other Comprehensive (Loss) Income Unrealized gains (losses) from the Company’s investment securities are included in accumulated other comprehensive loss within the consolidated balance sheet. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (Topic 606) (ASU 2014-09). This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. In July 2015, the FASB decided to defer the effective date of the new revenue standard for interim and annual periods beginning after December 15, 2017 (previously December 15, 2016). The change will allow public entities to adopt the new standard as early as the original public entity effective date (i.e. annual reporting periods beginning after December 15, 2016 and interim periods therein). Early adoption prior to that date will not be permitted. ASU 2014-09 allows for either full retrospective or modified retrospective adoption. The Company is evaluating the transition method that will be elected and the potential effects of adopting the provisions of ASU No. 2014-09. In August 2014, the FASB issued Accounting Standards Update 2014-15, “Presentation of Financial Statements-Going Concern” (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (ASU 2014-15), which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements. In April 2015, the FASB issued Accounting Standards Update 2015-03, “Interest – Imputation of Interest” (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs (ASU 2015-03), which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. ASU-2014-15 is effective for fiscal years and interim periods therein beginning after December 15, 2015, with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements or related disclosures. On June 12, 2015, the FASB issued Accounting Standards Update 2015-10, “Technical Corrections and Improvements”. With regard to fair value measurement disclosures, ASU 2015-10 clarified that, for nonrecurring measurements estimated at a date during the reporting period other than the end of the reporting period, an entity should clearly indicate that the fair value information presented is not as of the period’s end as well as the date or period that the measurement was taken. This change was effective immediately upon issuance of ASU 2015-10. The adoption of this guidance did not have a significant impact on the Company’s consolidated financial statements or related |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2015 | |
Acquisitions | |
Acquisitions | (3) Acquisitions Civitas Therapeutics, Inc. Acquisition On October 22, 2014, the Company completed the acquisition of Civitas Therapeutics, Inc., a Delaware corporation (Civitas). As a result of the acquisition, the Company acquired global rights to CVT-301, a Phase 3 treatment candidate for OFF periods of Parkinson’s disease and CVT-427 which at the time of acquisition was a pre-clinical developmental stage candidate. The acquisition of Civitas also included rights to Civitas’s proprietary ARCUS pulmonary delivery technology, which management believes has applications in multiple disease areas, and a subleased manufacturing facility in Chelsea, Massachusetts with commercial-scale capabilities. The approximately 90,000 square foot facility also includes office and laboratory space. Approximately 45 Civitas employees based at the Chelsea facility joined the Acorda workforce in connection with the acquisition. The Civitas acquisition was completed under an Agreement and Plan of Merger, dated as of September 24, 2014 (the Merger Agreement), by and among Acorda, Five A Acquisition Corporation, a Delaware corporation and its wholly-owned subsidiary (Merger Sub), Civitas and Shareholder Representative Services LLC, a Colorado limited liability company, solely in its capacity as the securityholders’ representative (SRS). Pursuant to the terms of the Merger Agreement, Merger Sub has merged with and into Civitas, which is the surviving corporation in the Merger and which is continuing as a wholly-owned subsidiary of Acorda under the Civitas name. Pursuant to the terms of the Merger Agreement, aggregate merger consideration was $525 million plus $4.5 million in Civitas transaction costs paid by the Company. Additionally and pursuant to the Merger Agreement, upon consummation of the merger, $39.375 million of the aggregate merger consideration was deposited into escrow to secure representation and warranty indemnification obligations of Civitas and Civitas’ securityholders. The escrow amount was released in the fourth quarter of 2015 in accordance with the Merger Agreement. The transaction was financed with cash on hand. The Company incurred approximately $7.2 million of its own transactions costs related to legal, valuation and other professional and consulting fees associated with the acquisition. These transaction costs were expensed as selling, general and administrative expenses in the year ended December 31, 2014. The fair value of consideration transferred as of the acquisition date of October 22, 2014 totaled approximately $529.5 million summarized as follows: (In thousands) Cash paid $ Extinguishment of long-term debt Fair value of consideration transferred $ In accordance with the acquisition method of accounting, the Company allocated the purchase price to the estimated fair values of the identifiable assets acquired and liabilities assumed, with any excess allocated to goodwill. The fair value of the IPR&D will be classified as an indefinite lived intangible asset until the successful completion or abandonment of the associated research and development efforts. The Company accounted for the transaction as a business combination. The results of Civitas’ operations have been included in the consolidated statements of operations from the date of acquisition. Acquired contingent consideration represents the estimated fair value of certain royalty payments due under a prior acquisition agreement between Alkermes and Civitas pertaining to sales of licensed products using the ARCUS technology. The estimated fair value of the acquired contingent consideration was determined by applying a probability adjusted, discounted cash flow approach based on estimated future sales expected from CVT-301 and CVT-427. CVT-427 is an inhaled triptan intended to provide acute treatment of migraine episodes by using the ARCUS delivery system. Refer to Note 10 for further discussion about the Alkermes ARCUS agreement. Goodwill represents the amount of the purchase price paid in excess of the estimated fair value of the assets acquired and liabilities assumed. The goodwill recorded as part of the acquisition is primarily related to establishing a deferred tax liability for the IPR&D intangible assets which have no tax basis and, therefore, will not result in a future tax deduction. None of the goodwill is deductible for tax purposes. The following table presents the final allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date of October 22, 2014: (In thousands) Current assets $ Property and equipment Identifiable intangible assets: In-process research and development Other non-current assets Current liabilities Contingent consideration Deferred taxes Other non-current liabilities Fair value of acquired assets and liabilities Goodwill Aggregate purchase price Amount paid to extinguish long-term debt Cash Paid $ The Company completed its purchase price allocation for the Civitas acquisition in the third quarter of 2015 which resulted in an increase of approximately $0.7 million to the provisional amount recorded for deferred tax liabilities, resulting in an increase to goodwill. The following table presents the changes to the goodwill balance associated with the completion of the accounting for the Civitas acquisition: (In thousands) Goodwill – balance at October 22, 2014 $ Increase to goodwill for final purchase price allocation Goodwill – balance at December 31, 2015 $ NeurogesX Acquisition On July 8, 2013, Acorda acquired certain assets from NeurogesX, Inc. (NeurogesX), including two neuropathic pain management assets: Qutenza and NP-1998. Qutenza is approved by the FDA for the management of neuropathic pain associated with post-herpetic neuralgia. NP-1998 is a Phase 3 ready prescription strength capsaicin topical solution being assessed for the treatment of neuropathic pain. NP-1998 was previously referred to as NGX-1998. Prior to the acquisition, NeurogesX was a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid pain management therapies headquartered in San Mateo, CA. Acquisition-related costs during the year ended December 31, 2013 of approximately $1.0 million for advisory, legal, regulatory and valuation costs incurred in connection with the NeurogesX acquisition were expensed as selling, general and administrative expenses. Astellas Pharma Europe Ltd. (Astellas) has exclusive commercialization rights for Qutenza in the European Economic Area including the 28 countries of the European Union, Iceland, Norway, and Liechtenstein as well as Switzerland, certain countries in Eastern Europe, the Middle East and Africa. Astellas also has an option to develop NP-1998 in those same territories. In consideration for the acquisition of assets pursuant to the Asset Purchase Agreement, Acorda paid NeurogesX $7.5 million in cash and may pay up to an additional $5.0 million of post-closing milestone payments (Milestone Payments), as follows: · $2.0 million upon the approval for sale of an NP-1998 liquid formulation product in the U.S. for the cutaneous treatment of PDN in humans, if FDA approval is obtained prior to December 31, 2016; and · $3.0 million if net sales of an NP-1998 approved product in Acorda’s territory reaches $100 million during the first 12 months that such product is sold in Acorda’s territory, commencing with the first date that such product is commercially available for purchase anywhere in Acorda’s territory. Acorda’s territory consists of all territories worldwide other than those jurisdictions covered by the Astellas Agreement, which generally comprise countries in Europe, Africa and the Middle East. There is no assurance that any of the conditions for the Milestone Payments will be met. Refer to Note 15 for information regarding the contingent consideration liability. Total purchase price as of the acquisition date of July 8, 2013 is summarized as follows: (In thousands) Cash paid to NeurogesX shareholders and its creditors $ Fair value of contingent liabilities Total purchase price $ The allocation of the purchase price to the fair value of the assets acquired reflected the estimated fair values of NeurogesX’s assets as of the acquisition date. In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the NeurogesX transaction to the underlying assets acquired by the Company, based upon the estimated fair values of those assets at the date of acquisition and classified the fair value of the acquired IPR&D as an indefinite-lived intangible asset until the successful completion or abandonment of the associated research and development efforts. The Company accounted for the transaction as a business combination. The following table presents the allocation of the purchase price to the assets acquired as of the acquisition date of July 8, 2013: (In thousands) Inventory $ Equipment Identifiable intangible assets: Developed technology – Qutenza In-process research and development – NP-1998 Fair value of acquired assets Aggregate purchase price Goodwill $ — Refer to Note 13 for information regarding the full impairment of IPR&D in 2014. Pro-Forma Financial Information Associated with Acquisitions (Unaudited) The following table summarizes certain supplemental pro forma financial information for the years ended December 31, 2014 and 2013 as if the acquisitions of Civitas and NeurogesX had occurred as of January 1, 2013 and January 1, 2012, respectively. The unaudited pro forma financial information for the year ended December 31, 2014 reflects (i) the impact to operations resulting from the elimination of transaction costs related to the Civitas acquisition; (ii) the impact to depreciation expense based on fair value adjustments to the property, plant and equipment acquired from Civitas; (iii) the elimination of interest costs associated with Civitas’ debt retired during the acquisition that were included in the results of operations for the year ended December 31, 2014; and the related tax effects of those adjustments. The unaudited pro forma financial information for December 31, 2013 reflects (i) the impact to depreciation expense based on fair value adjustments to the property, plant and equipment acquired from Civitas, (ii) the impact to operations resulting from the elimination of transaction costs related to the NeurogesX transaction; and the related tax effects of those adjustments. The unaudited pro forma financial information was prepared for comparative purposes only and is not necessarily indicative of what would have occurred had the acquisitions been made at those times or of results which may occur in the future. Year ended Year ended December 31, 2014 December 31, 2013 (In thousands) Reported Pro Forma Reported Pro Forma Net revenues $ $ $ $ Net income/(loss) |
Investments
Investments | 12 Months Ended |
Dec. 31, 2015 | |
Investments | |
Investments | (4) Investments The Company has determined that all of its investments are classified as available-for-sale. Available-for-sale securities are carried at fair value with interest on these securities included in interest income and are recorded based primarily on quoted market prices. Available-for-sale securities consisted of the following: (In thousands) Amortized Cost Gross unrealized gains Gross unrealized losses Estimated fair value December 31, 2015 US Treasury bonds $ $— $ $ December 31, 2014 US Treasury bonds $ $ $ $ The Company’s short-term investments consist of US Treasury bonds. A decline in the market value of any available-for-sale security below cost that is deemed to be other-than-temporary results in a reduction in carrying amount to fair value. The impairment would be charged to earnings for the difference between the investment’s cost and fair value at such date and a new cost basis for the security established. Factors evaluated to determine if an investment is other-than-temporarily impaired include significant deterioration in the earnings performance, credit rating, asset quality, or business prospects of the issuer; adverse changes in the general market condition in which the issuer operates; the intent and ability to retain the investment for a sufficient period of time to allow for recovery in the market value of the investment; and, issues that raise concerns about the issuer’s ability to continue as a going concern. The Company has determined that there were no other-than-temporary declines in the fair values of its short term investments as of December 31, 2015. Short-term investments with maturity of three months or less from date of purchase have been classified as cash and cash equivalents, and amounted to $83.5 million and $149.8 million as of December 31, 2015 and 2014, respectively. Short-term investments have original maturities of greater than 3 months but less than 1 year and long-term investments are greater than 1 year. There were no investments classified as long-term at December 31, 2015 and 2014. The Company holds available-for-sale investment securities which are reported at fair value on the Company’s balance sheet. Unrealized holding gains and losses are reported within accumulated other comprehensive (loss) income (AOCI) in the statements of comprehensive income. The changes in AOCI associated with the net unrealized holding losses on available-for-sale investments during the years ended December 31, 2015 and 2014 were as follows (in thousands): (In thousands) Net Unrealized Gains (Losses) on Marketable Securities Balance at December 31, 2013 $ 37 Other comprehensive loss before reclassifications: Amounts reclassified from accumulated other comprehensive loss Net current period other comprehensive loss Balance at December 31, 2014 Other comprehensive loss before reclassifications: Amounts reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss Balance at December 31, 2015 $ |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment | |
Property and Equipment | (5) Property and Equipment Property and equipment consisted of the following: (In thousands) December 31, 2015 December 31, 2014 Estimated useful lives used Machinery and equipment $ $ 2-7 years Leasehold improvements Lesser of useful life or remaining lease term Computer equipment 1-3 years Laboratory equipment 2-5 years Furniture and fixtures 4-7 years Capital in progress Less accumulated depreciation $ $ Depreciation and amortization expense on property and equipment was $11.9 million and $5.1 million for the years ended December 31, 2015 and 2014, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | (6) Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: (In thousands) December 31, 2015 December 31, 2014 Product allowance accruals $ $ Bonus payable Research and development expense accruals Accrued inventory Commercial and marketing expense accruals Royalties payable Vacation accrual Sales force commissions and incentive payments payable Medical affairs expenses Administrative expenses Other accrued expenses Total $ $ |
Common Stock Options and Restri
Common Stock Options and Restricted Stock | 12 Months Ended |
Dec. 31, 2015 | |
Common Stock Options and Restricted Stock | |
Common Stock Options and Restricted Stock | (7) Common Stock Options and Restricted Stock On June 18, 1999, the Company’s board of directors approved the adoption of the Acorda Therapeutics, Inc. 1999 Employee Stock Option Plan (the 1999 Plan). All employees of the Company were eligible to participate in the 1999 Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The number of shares authorized for issuance under the 1999 Plan was 2,481,334. As of December 31, 2015, the Company had granted an aggregate of 2,384,345 shares as restricted stock of stock options under the 1999 Plan, of which there were no remaining shares subject to outstanding options. On January 12, 2006, the Company’s board of directors approved the adoption of the Acorda Therapeutics, Inc. 2006 Employee Incentive Plan (the 2006 Plan). The 2006 Plan served as the successor to the Company’s 1999 Plan, as amended, and no further option grants or stock issuances were to be made under the 1999 Plan after the effective date, as determined under Section 14 of the 2006 Plan. All employees of the Company were eligible to participate in the 2006 Plan, including executive officers, as well as directors, independent contractors, and agents of the Company. The 2006 Plan also covered the issuance of restricted stock. The 2006 Plan was administered by the Compensation Committee of the Board of Directors, which selected the individuals to be granted options and restricted stock, determined the time or times at which options and restricted stock were to be granted, determined the number of shares to be granted subject to any option or restricted stock and the duration of each option and restricted stock, and made any other determinations necessary, advisable, and/or appropriate to administer the 2006 Plan. Under the 2006 Plan, each option granted expires no later than the tenth anniversary of the date of its grant. The number of shares of common stock authorized for issuance under the 2006 Plan as of December 31, 2015 was 14,912,048 shares. The total number of shares of common stock available for issuance under the 2006 Plan, including shares of common stock subject to the then outstanding awards, automatically increased on January 1 of each year during the term of the 2006 Plan, beginning 2007, by a number of shares of common stock equal to 4% of the outstanding shares of common stock on that date, unless otherwise determined by the Board of Directors. The Board approved the automatic increases of 4% for 2015, 2014, and 2013. As of December 31, 2015, the Company had granted an aggregate of 13,221,911 shares as restricted stock or subject to issuance upon exercise of stock options under the 2006 Plan, of which 7,899,235 shares remained subject to outstanding options. On June 9, 2015, the Company’s stockholders approved the adoption of the Acorda Therapeutics, Inc. 2015 Omnibus Incentive Compensation Plan (the 2015 Plan). The 2015 Plan serves as the successor to the Company’s 2006 Plan, as amended, and no further option grants or stock issuances will be made under the 2006 Plan after the effective date, as determined under Section 1 of the 2015 Plan. All employees of the Company are eligible to participate in the 2015 Plan, including executive officers, as well as directors, consultants, advisors and other service providers of the Company or any of its subsidiaries. The 2015 Plan also covers the issuance of restricted stock. The 2015 Plan is administered by the Compensation Committee of the Board of Directors, which selects the individuals to be granted options and restricted stock, determines the time or times at which options and restricted stock are to be granted, determines the number of shares to be granted subject to any option or restricted stock and the duration of each option and restricted stock, and makes any other determinations necessary, advisable, and/or appropriate to administer the 2015 Plan. Under the 2015 Plan, each option granted expires no later than the tenth anniversary of the date of its grant. Since inception, the number of shares of common stock authorized for issuance under the 2015 Plan as of December 31, 2015 is 3,000,000 shares. Upon the exercise of options in the future, the Company intends to issue new shares. As of December 31, 2015, the Company had granted an aggregate of 332,904 shares either as restricted stock or shares subject to issuance upon the exercise of stock options under the 2015 Plan, of which 324,250 shares remained subject to outstanding options. The fair value of each option granted is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions: Year ended December 31, 2015 2014 2013 Employees and directors: Estimated volatility Expected life in years Risk free interest rate Dividend yield — — — The Company estimated volatility for purposes of computing compensation expense on its employee and non-employee options using the historic volatility of the Company’s stock price. The expected life used to estimate the fair value of employee options is 5.88 years which is based on the historical life of the Company’s options based on exercise data. The weighted average fair value per share of options granted to employees and directors for the years ended December 31, 2015, 2014 and 2013 amounted to approximately $15.85, $17.61, and $15.95, respectively. No options were granted to non-employees for the years ended December 31, 2015, 2014 and 2013. During the year ended December 31, 2015, the Company granted 1,872,592 stock options and restricted stock awards to employees and directors under the 2015 Omnibus Plan. The stock options were issued with a weighted average exercise price of $35.45 per share. As a result of these grants the total compensation charge to be recognized over the service period is $30.2 million, of which $7.5 million was recognized during the year ended December 31, 2015. Compensation costs for options and restricted stock granted to employees and directors amounted to $33.5 million, $29.4 million, and $25.1 million, for the years ended December 31, 2015, 2014 and 2013, respectively. There were no compensation costs capitalized in inventory balances. Compensation expense for options and restricted stock granted to employees and directors are classified between research and development, and selling, general and administrative expense based on employee job function. The following table summarizes share-based compensation expense included within the Company’s consolidated statements of operations: Year ended December 31, (In thousands) 2015 2014 2013 Research and development $ $ $ Selling, general and administrative Total $ $ $ A summary of share-based compensation activity for the year ended December 31, 2015 is presented below: Stock Option Activity Number of Shares (In thousands) Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In thousands) Balance at December 31, 2012 Granted Forfeited and expired Exercised Balance at December 31, 2013 Granted Forfeited and expired Exercised Balance at December 31, 2014 $ Granted Forfeited and expired Exercised Balance at December 31, 2015 $ $ Vested and expected to vest at December 31, 2015 $ $ Vested and exercisable at December 31, 2015 $ $ Options Outstanding Options Exercisable Range of exercise price Outstanding as of December 31, 2015 (In thousands) Weighted- average remaining contractual life Weighted- average exercise price Exercisable as of December 31, 2015 (In thousands) Weighted- average exercise price $2.45 - $25.33 $ $ $25.39 - $30.46 $30.49 - $35.01 $35.09 - $39.38 $39.67 - $44.50 $ $ Restricted Stock Activity Restricted Stock Number of Shares (In thousands) Nonvested at December 31, 2012 Granted Vested Forfeited Nonvested at December 31, 2013 Granted Vested Forfeited Nonvested at December 31, 2014 Granted Vested Forfeited Nonvested at December 31, 2015 Unrecognized compensation cost for unvested stock options and restricted stock awards as of December 31, 2015 totaled $57.5 million and is expected to be recognized over a weighted average period of approximately 2.4 years. |
Earnings Per Share
Earnings Per Share | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share | |
Earnings Per Share | (8) Earnings Per Share The following table sets forth the computation of basic and diluted earnings per share for the years ended December 31, 2015, 2014 and 2013: (In thousands, except per share data) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Basic and diluted Net income $ $ $ Weighted average common shares outstanding used in computing net income per share—basic Plus: net effect of dilutive stock options and unvested restricted common shares Weighted average common shares outstanding used in computing net income per share—diluted Net income per share—basic $ $ $ Net income per share—diluted $ $ $ The difference between basic and diluted shares is that diluted shares include the dilutive effect of the assumed exercise of outstanding securities. The Company’s stock options and unvested shares of restricted common stock could have the most significant impact on diluted shares. Securities that could potentially be dilutive are excluded from the computation of diluted earnings per share when a loss from continuing operations exists or when the exercise price exceeds the average closing price of the Company’s common stock during the period, because their inclusion would result in an anti-dilutive effect on per share amounts. The following amounts were not included in the calculation of net income per diluted share because their effects were anti-dilutive: (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Denominator Stock options and restricted common shares Convertible note Additionally, the impact of the convertible debt was determined to be anti-dilutive and excluded from the calculation of net income per diluted share. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Income Taxes | (9) Income Taxes The (provision for) income taxes is based on income before income taxes as follows: (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Income before taxes $ $ $ The (provision for) income taxes in 2015, 2014 and 2013 consists of current and deferred federal, state and foreign taxes as follows: (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Current: Federal $ $ $ State Foreign Deferred: Federal State Foreign — — — Total (provision for) income taxes $ $ $ Due to the amount of net operating loss (NOL) and tax credit carryforwards, the Company does not currently pay substantial U.S. federal income taxes. The Company expects to pay cash taxes in various US states and Puerto Rico where it has operations and NOL carryforwards are not available or limited. The Company was subject to the alternative minimum tax during 2015 and 2014 and expects it will continue to be subject to such tax in the near term. The payment of alternative minimum tax generates a credit that may be carried forward indefinitely and can be used to offset its future regular income tax liability. The Company had available federal NOL carryforwards of approximately $195.0 million and $215.2 million and state NOL carryforwards of approximately $11.8 million and $14.7 million as of December 31, 2015 and 2014, respectively, which are available to offset future taxable income. The net operating loss carryforwards include approximately $34.6 million of deductions related to the exercise of stock options. This amount represents an excess tax benefit and has not been included in the gross deferred tax asset reflected above. The tax benefit of $12 million associated with the exercise of these stock options will be recorded in additional paid-in capital when the associated net operating loss is recognized. The federal losses are expected to begin to expire in 2025, while the state losses are expected to expire during similar periods, although not all states conform to the federal carryforward period and occasionally limit the use of net operating losses for a period of time. The Company is no longer subject to federal income tax audits for tax years prior to 2012 however, such net operating losses utilized by the Company in years subsequent to 2002 is subject to review. In 2013 the Company completed an IRS exam for tax years 2009 through 2011. In 2015, the IRS began an audit of the Company for the tax year 2013. The Company also has research and development credit carry-forwards of $20.3 million and $11.9 million as of December 31, 2015 and 2014, respectively and begin to expire in 2017. The Company also has Alternative Minimum Tax credit carry-forwards of $3.8 million and $3.3 million as of December 31, 2015 and 2014, respectively. Such credits can be carried forward indefinitely and have no expiration date. The Tax Reform Act of 1986 contains certain provisions that can limit a taxpayer’s ability to utilize net operating loss and tax credit carryforwards in any given year resulting from cumulative changes in ownership interests in excess of 50 percent over a three-year period. The Company has determined that these limiting provisions were triggered during a prior year for both Acorda Therapeutics and Neuronex, its wholly owned subsidiary and a limitation was triggered in the year of acquisition of Civitas, another wholly owned subsidiary of Acorda Therapeutics. However, it believes that such limitation is not expected to result in the expiration or loss of any of its federal NOL’s and income tax credit carryforwards. Future ownership changes may limit the use of these carryforwards. The provision (benefit) for income taxes differs from the U.S. federal statutory tax rate. The reconciliation of the statutory U.S. federal income tax rate to the Company’s effective income tax rate is as follows: Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 U.S. federal statutory tax rate State and local income taxes Non-deductible payment to prior shareholders — — Foreign income tax Stock option compensation Stock option shortfall — — Research and development and orphan drug credits Increase to Uncertain Tax Positions Other nondeductible and permanent differences Provision (benefit) attributable to valuation allowance — Effective income tax rate The effective tax rate related to state taxes is primarily driven by Acorda’s state tax return filings as a stand-alone entity, without the benefit of Civitas losses. The state taxes reflect amended tax return filings and the deferred impact of customary state tax law and apportionment changes that occurred during the year; the state effective tax rate is not necessarily indicative of the company’s expected state tax rate for the foreseeable future. Provisions have been made for deferred taxes based on the differences between the basis of the assets and liabilities for financial statement purposes and the basis of the assets and liabilities for tax purposes using currently enacted tax rates and regulations that will be in effect when the differences are expected to be recovered or settled. The components of the deferred tax assets and liabilities are as follows: (In thousands) December 31, 2015 December 31, 2014 Deferred tax assets: Net operating loss and other carryforwards $ $ Tax credits Deferred revenue Stock based compensation Contingent consideration Other Total deferred tax assets $ $ Valuation allowance $ $ Total deferred tax assets net of valuation allowance $ $ Deferred tax liabilities: Intangible assets Convertible debt Total deferred tax liabilities $ $ Net deferred tax asset (liability) $ $ In November 2015, the FASB issued ASU No. 2015-17, Balance Sheet Classification of Deferred Income Taxes, which provides presentation requirements to classify all deferred tax assets and liabilities as noncurrent in a classified statement of financial position. The standard is effective for fiscal years ending after December 15, 2016. Early adoption is permitted for any interim and annual financial statements that had not been issued as of the date of the pronouncement. The Company has elected to early adopt ASU 2015-17 effectively December 31, 2015, retrospectively. The effects of the accounting change on December 31, 2014 were as follows: December 31, 2014 (In thousands) Revised As Reported Current deferred tax asset $— $ Non-current deferred tax asset — Current deferred tax liability — — Non-current deferred tax liability Net deferred tax (liabilities)/assets $ $ The Company follows authoritative guidance regarding accounting for uncertainty in income taxes, which prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The beginning and ending amounts of unrecognized tax benefits reconciles as follows: (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Beginning of period balance $ $ $ Increases for tax positions taken during a prior period Decreases for tax positions taken during a prior period — Increases for tax positions taken during the current period Reduction as a result of a lapse of statute of limitations — — — $ $ $ Due to the amount of the Company’s NOLs and tax credit carryforwards, it has not accrued interest relating to these unrecognized tax benefits. Accrued interest and penalties, however, would be disclosed within the related liabilities lines in the consolidated balance sheet and recorded as a component of income tax expense. Unless related to excess tax benefits from stock options, all of its unrecognized tax benefits, if recognized, would impact the effective tax rate. The Company files federal and state income tax returns in the U.S. and Puerto Rico. The U.S. and Puerto Rico have statute of limitations ranging from 3 to 5 years. However, the statute of limitations could be extended due to the Company’s NOL carryforward position in a number of its jurisdictions. The tax authorities, generally, have the ability to review income tax returns for periods where the statute of limitation has previously expired and can subsequently adjust the NOL carryforward or tax credit amounts. Accordingly, the Company does not expect to reverse any portion of the unrecognized tax benefits within the next year. |
License, Research and Collabora
License, Research and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2015 | |
License, Research and Collaboration Agreements | |
License, Research and Collaboration Agreements | (10) License, Research and Collaboration Agreements Alkermes plc, formerly Elan plc The Company has entered into agreements with Elan Corporation plc, including those described immediately below and elsewhere in these financial statements. In September 2011, Alkermes plc acquired Elan’s Drug Technologies business and Elan transferred the agreements to Alkermes as part of that transaction. Throughout this report, references to “Alkermes” include Alkermes plc and also, as the context may require, Elan Corporation plc as the predecessor to Alkermes plc under the agreements. The Company is a party to a 2003 amended and restated license agreement and a 2003 supply agreement with Alkermes for Ampyra, which replaced two prior license and supply agreements for Ampyra. Under the license agreement, the Company has exclusive worldwide rights to Ampyra, as well as Alkermes’s formulation for any other mono or di-aminopyridines, for all indications, including multiple sclerosis and spinal cord injury. The Company is obligated to pay Alkermes milestone payments and royalties based on a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. Subject to early termination provisions, the Alkermes license terminates on a country by country basis on the latter to occur of fifteen years from the date of the agreement, the expiration of the last to expire Alkermes patent or the existence of competition in that country. Under the supply agreement, Alkermes has the right to manufacture for the Company, subject to certain exceptions, Ampyra and other products covered by these agreements at specified prices calculated as a percentage of net product sales of the product shipped by Alkermes to Acorda. In the event Alkermes does not manufacture 100% of the products, it is entitled to a compensating payment for the quantities of product provided by the alternative manufacturer. Convertible Note Under the Agreement, Alkermes also loaned to the Company an aggregate of $7.5 million pursuant to two convertible promissory notes. On December 23, 2005, Alkermes transferred these promissory notes to funds affiliated with Saints Capital. One promissory note in the amount of $5.0 million bears interest at a rate of 3% beginning on the first anniversary of the issuance of the note. The original unpaid principal was convertible into 67,476 shares of common stock. As of December 31, 2015 the unpaid principal is convertible into 19,279 shares of common stock. Principal and interest are repayable, if not converted, ratably over a seven-year period beginning one year after the Company receives certain regulatory approval for the products to be developed, subject to limitations related to gross margin on product sales. The $5.0 million promissory note restricts the Company’s ability to incur indebtedness that is senior to the notes, subject to certain exceptions, including for the Company’s revenue interests assignment arrangement (See Note 14). The second promissory note was in the amount of $2.5 million and was non-interest bearing. In December 2006, Saints Capital exercised the conversion of this note into 210,863 shares of common stock. On January 22, 2010, the Company received regulatory approval for the product under development that was subject to this convertible note payable. Saints Capital held the option to convert the outstanding principal into common stock until the first anniversary of regulatory approval or January 22, 2011. Saints Capital did not convert by the first anniversary date, therefore the Company is obligated to pay the outstanding principal sum on the promissory note, together with all accrued and unpaid interest, subject to limitations related to gross margin on product sales, in seven equal installments, the first of which was paid on the maturity date, and the balance shall be paid on the six successive anniversaries of the maturity date. The Company, at its option, may at any time prepay in whole or in part, without penalty, the principal balance together with accrued interest to the date of payment, by giving Saints Capital written notice at least thirty days prior to the date of prepayment. Interest on this convertible promissory note has been recorded using 3% on the $5 million note . Supply Agreement The Company is a party to a 2003 supply agreement with Alkermes relating to the manufacture and supply of Ampyra by Alkermes. The Company is obligated to purchase at least 75% of its annual requirements of Ampyra from Alkermes, unless Alkermes is unable or unwilling to meet its requirements, for a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. In those circumstances, where the Company elects to purchase less than 100% of its requirements from Alkermes, the Company is obligated to make certain compensatory payments to Alkermes. Alkermes is required to assist the Company in qualifying a second manufacturer to manufacture and supply the Company with Ampyra subject to its obligations to Alkermes. As permitted by the agreement with Alkermes, the Company has designated Patheon, Inc. (Patheon) as a qualified second manufacturing source of Ampyra. In connection with that designation, the Company entered into a manufacturing agreement with Patheon, and Alkermes assisted the Company in transferring manufacturing technology to Patheon. The Company and Alkermes have agreed that a purchase of up to 25% of annual requirements from Patheon is allowed if compensatory payments are made to Alkermes. In addition, Patheon may supply the Company with Ampyra if Alkermes is unable or unwilling to meet the Company’s requirements. Rush-Presbyterian St. Luke’s Medical Center In 1990, Alkermes licensed from Rush know-how relating to dalfampridine (4-aminopyridine, 4-AP, the formulation used in Ampyra), for the treatment of MS. The Company subsequently licensed this know-how from Alkermes. In September 2003, the Company entered into an agreement with Rush and Alkermes terminating the Rush license to Alkermes and providing for mutual releases. The Company also entered into a license agreement with Rush in 2003 in which Rush granted the Company an exclusive worldwide license to its know-how relating to dalfampridine for the treatment of MS. Rush has also assigned to the Company its Orphan Drug Designation for dalfampridine for the relief of symptoms of MS. Under the Company’s license agreement with Rush-Presbyterian-St. Luke’s Medical Center, it is obligated to make royalty payments as a percentage of net sales in the United States and in countries other than the United States. As of December 31, 2015, the Company made or accrued royalty payments totaling $37.4 million. Biogen Inc. On June 30, 2009, the Company entered into an exclusive collaboration and license agreement with Biogen Inc. (formerly, Biogen Idec International GmbH, (Biogen) to develop and commercialize Ampyra (known as Fampyra outside the U.S.) in markets outside the United States (the Collaboration Agreement). Under the Collaboration Agreement, Biogen was granted the exclusive right to commercialize Ampyra and other products containing aminopyridines developed under that agreement in all countries outside of the U. S., which grant includes a sublicense of the Company’s rights under an existing license agreement between the Company and Alkermes plc (Alkermes), formerly Elan Corporation, plc (Elan). Biogen has responsibility for regulatory activities and future clinical development of Fampyra in ex-U.S. markets worldwide. The Company also entered into a related supply agreement with Biogen (the Supply Agreement), pursuant to which the Company will supply Biogen with its requirements for the licensed products through the Company’s existing supply agreement with Alkermes. Under the Collaboration Agreement, the Company was entitled to an upfront payment of $110.0 million as of June 30, 2009, which was received in July 2009, and a $25 million milestone payment upon approval of the product in the European Union, which was received in August 2011. The Company is also entitled to receive additional payments of up to $10 million based on the successful achievement of future regulatory milestones and up to $365 million based on the successful achievement of future sales milestones. Due to the uncertainty surrounding the achievement of the future regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned. The Company is not able to reasonably predict if and when the milestones will be achieved. Under the Collaboration Agreement, Biogen will be required to make double-digit tiered royalty payments to the Company on ex-U.S. sales. In addition, the consideration that Biogen will pay for licensed products under the Supply Agreement will reflect the price owed to the Company’s suppliers under its supply arrangements with Alkermes or other suppliers for ex-U.S. sales. The Company and Biogen may also carry out future joint development activities regarding licensed product under a cost-sharing arrangement. Under the terms of the Collaboration Agreement, the Company, in part through its participation in joint committees with Biogen, will participate in overseeing the development and commercialization of Ampyra and other licensed products in markets outside the U.S. pursuant to that agreement. Acorda will continue to develop and commercialize Ampyra independently in the U.S. As of June 30, 2009, the Company recorded deferred revenue of $110.0 million for the upfront payment from Biogen under the Collaboration Agreement. Also, as a result of such payment to Acorda, a payment of $7.7 million was made to Alkermes and recorded as a deferred expense. The payment of $110.0 million was received from Biogen on July 1, 2009 and the payment of $7.7 million was made to Alkermes on July 7, 2009. The Company considered the following deliverables with respect to the revenue recognition of the $110.0 million upfront payment: (1) the license to use the Company’s technology, (2) the Collaboration Agreement to develop and commercialize licensed product in all countries outside the U.S., and (3) the Supply Agreement. Due to the inherent uncertainty in obtaining regulatory approval, the applicability of the Supply Agreement is outside the control of the Company and Biogen. Accordingly, the Company has determined the Supply Agreement is a contingent deliverable at the onset of the agreement. As a result, the Company has determined the Supply Agreement does not meet the definition of a deliverable that needs to be accounted for at the inception of the arrangement. The Company has also determined that there is no significant and incremental discount related to the supply agreement since Biogen will pay the same amount for inventory that the Company would pay and the Company effectively acts as a middle man in the arrangement for which it adds no significant value due to various factors such as the Company does not have any manufacturing capabilities or other know-how with respect to the manufacturing process. The Company has determined that the identified non-contingent deliverables (deliverables 1 and 2 immediately preceding) would have no value on a standalone basis if they were sold separately by a vendor and the customer could not resell the delivered items on a standalone basis, nor does the Company have objective and reliable evidence of fair value for the deliverables. Accordingly, the non-contingent deliverables are treated as one unit of accounting. As a result, the Company will recognize the non-refundable upfront payment from Biogen as revenue and the associated payment to Alkermes as expense ratably over the estimated term of regulatory exclusivity for the licensed products under the Collaboration Agreement as the Company had determined this was the most probable expected benefit period. The Company recognized $9.1 million in amortized license revenue, a portion of the $110.0 million received from Biogen, and $0.6 million in cost of license revenue, a portion of the $7.7 million paid to Alkermes, during each of the years ended December 31, 2015, 2014 and 2013. As part of its ex-U.S. license agreement, Biogen owes Acorda royalties based on ex-U.S. net sales, and milestones based on ex-U.S. regulatory approval and new indications. These milestones included a $25.0 million payment for approval of the product in the European Union which was recorded and paid in the three-month period ended September 30, 2011. Based on Acorda’s worldwide license and supply agreement with Alkermes, Alkermes received 7% of this milestone payment from Acorda during the same period. For revenue recognition purposes, the Company has determined this milestone to be substantive in accordance with applicable accounting guidance related to milestone revenue. Substantive uncertainty existed at the inception of the arrangement as to whether the milestone would be achieved because of the numerous variables, such as the high rate of failure inherent in the research and development of new products and the uncertainty involved with obtaining regulatory approval. Biogen leveraged Acorda’s U.S. Ampyra study results that contributed to the regulatory approval process. Therefore, the milestone was achieved based in part on Acorda’s past performance. The milestone was also reasonable relative to all deliverable and payment terms of the collaboration arrangement. Therefore, the payment was recognized in its entirety as revenue and the cost of the milestone revenue was recognized in its entirety as an expense during the three-month period ended September 30, 2011. Allergan/Watson The Company has an agreement with an Allergan plc subsidiary (originally Watson Pharma, Inc.), or Allergan, to market tizanidine hydrochloride capsules, an authorized generic version of Zanaflex Capsules, which was launched in February 2012. In accordance with the agreement, the Company receives a royalty based on Allergan’s gross margin, as defined by the agreement, of the authorized generic product. During the years ended December 31, 2015 and 2014, the Company recognized royalty revenue of $7.0 million and $9.1 million, respectively, related to the gross margin of the Zanaflex Capsule authorized generic. During the years ended December 31, 2015 and 2014, the Company also recognized revenue and a corresponding cost of sales of $3.8 million and $4.6 million, respectively, related to the purchase and sale of the related Zanaflex Capsule authorized generic product to Allergan, which is recorded in net product revenues and cost of sales. Alkermes (ARCUS products) In December 2010, Civitas, the Company’s wholly-owned subsidiary, entered into the Alkermes Agreement, in which Civitas licensed or acquired from Alkermes certain pulmonary development programs and INDs, underlying intellectual property and laboratory equipment associated with the pulmonary business of Alkermes. The assets acquired includes (i) patents, patent applications and related know-how and documentation; (ii) a formulation of inhaled L-dopa; (iii) several other pulmonary development programs and INDs, which are part of the platform device and formulation IP; (iv) instruments, laboratory equipment and apparatus; and (v) inhalers, inhaler molds, tools, and the associated assembled equipment. In addition, Civitas signed the sublease for the facility where the Alkermes operations were housed in Chelsea, Massachusetts. Under the terms of the Alkermes Agreement, Civitas will also pay to Alkermes royalties for each licensed product as follows: (i) for all licensed products sold by Civitas, Civitas will pay Alkermes a mid-single digit percentage of net sales of such licensed products and (ii) for all licensed products sold by a collaboration partner, Civitas will pay Alkermes the lower of a mid-single digit percentage of net sales of such licensed products in a given calendar year or a percentage in the low-to-mid-double digits of all collaboration partner revenue received in such calendar year. Notwithstanding the foregoing, in no event shall the royalty paid be less than a low-single digit percentage of net sales of a licensed product in any calendar year. As consideration for the agreement with Alkermes, Civitas issued stock and also agreed to pay Alkermes royalties on future net product sales from products developed from licensed technology under the Alkermes Agreement. The fair value of the future royalties is classified as contingent consideration. The Company estimates the fair value of this contingent consideration based on future revenue projections and estimated probabilities of receiving regulatory approval and commercializing such products. Refer to Note 15 – Fair Value Measurements for more information on the contingent consideration liability. Neuronex In December 2012, the Company acquired Neuronex, Inc., a privately-held development stage pharmaceutical company (Neuronex) developing Plumiaz (our trade name for Diazepam Nasal Spray). Plumiaz is a proprietary nasal spray formulation of diazepam that we are developing under Section 505(b)(2) of the Food, Drug and Cosmetic Act as an acute treatment for selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs, or AEDs, who experience bouts of increased seizure activity also known as seizure clusters or acute repetitive seizures, or ARS. The Company completed the acquisition pursuant to a merger agreement with Neuronex and Moise A. Khayrallah, acting as the Stockholders’ Representative on behalf of the former Neuronex equity holders. In July 2015, the Company entered into an amendment to the merger agreement (Amendment) with Mr. Khayrallah, as Stockholders’ Representative. Pursuant to the Amendment, the Stockholders’ Representative, acting on behalf of the former Neuronex equity holders, agreed to certain modifications to the Company’s future contingent payment obligations regarding the development and potential commercialization of Plumiaz, described below. In consideration of those modifications, pursuant to the Amendment the Company paid the former Neuronex equity holders $8.75 million in July 2015. Under the terms of the agreement, the Company made an upfront payment of $2.0 million in February 2012. The Company also paid $1.5 million during the year ended December 31, 2012 pursuant to a commitment under the agreement to fund research to prepare for the Plumiaz pre-NDA meeting with the FDA. In December 2012, the Company completed the acquisition by paying $6.8 million to former Neuronex shareholders less a $0.3 million holdback provision. After adjustment for Neuronex’s working capital upon closing of the acquisition, approximately $0.1 million of the holdback amount was remaining as of December 31, 2013. This balance was paid to the former equity holders of Neuronex pursuant to the merger agreement in February 2014. Under the merger agreement, the former equity holders of Neuronex will be entitled to receive payments from the Company, in addition to payments the Company has already made under the merger agreement, upon the achievement of specified regulatory, manufacturing-related, and sales milestones with respect to Diazepam Nasal Spray products (Plumiaz). Pursuant to the merger agreement as amended by the Amendment, the Company is obligated to pay (i) up to $3 million in specified regulatory and manufacturing-related milestone payments, a reduction from up to $18 million in such payments that were originally specified in the merger agreement, and (ii) up to $100 million upon the achievement of specified sales milestones, a reduction from up to $105 million in such payments that were originally specified in the merger agreement. Under the merger agreement, the former equity holders of Neuronex will also be entitled to receive tiered royalty-like earnout payments on worldwide net sales of Diazepam Nasal Spray products (Plumiaz), if any. The rates for these payments pursuant to the merger agreement originally ranged from the upper single digits to lower double digits, but were modified pursuant to the Amendment and now range from the mid-single digits to mid double digits. These payments are payable on a country-by-country basis until the earlier to occur of ten years after the first commercial sale of a product in such country and the entry of generic competition in such country as defined in the Agreement. The patent and other intellectual property and other rights relating to Diazepam Nasal Spray products are licensed from SK Biopharmaceuticals Co., Ltd. (SK). Pursuant to the SK license, which granted worldwide rights to Neuronex, except certain specified Asian countries, the Company’s subsidiary Neuronex is obligated to pay SK up to $8 million upon the achievement of specified development milestones with respect to the Diazepam Nasal Spray product (including a $1 million payment that was triggered during the three-month period ending September 30, 2013 upon the FDA’s acceptance for review of the first NDA for Plumiaz and paid during the three-month period ending December 31, 2013), and up to $3 million upon the achievement of specified sales milestones with respect to the Diazepam Nasal Spray product. Also, Neuronex is obligated to pay SK a tiered, mid-single digit royalty on net sales of Diazepam Nasal Spray products. The Company evaluated the transaction based upon the guidance of ASC 805, Business Combinations , and concluded that it only acquired inputs and did not acquire any processes. The Company needed to develop its own processes in order to produce an output. Therefore the Company accounted for the transaction as an asset acquisition and accordingly the $2.0 million upfront payment, $1.5 million in research funding and $6.8 million of closing consideration net of tangible net assets acquired of $3.7 million which were primarily the taxable amount of net operating loss carryforwards, were expensed as research and development expense during the year ended December 31, 2012. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2015 | |
Employee Benefit Plan | |
Employee Benefit Plan | (11) Employee Benefit Plan Effective September 1, 1999, the Company adopted a defined contribution 401(k) savings plan (the 401(k) plan) covering all employees of the Company. Participants may elect to defer a percentage of their annual pretax compensation to the 401(k) plan, subject to defined limitations. The plan includes an employer match contribution to employee deferrals. For each dollar an employee invests up to 6% of his or her earnings, the Company will contribute an additional 50 cents into the funds. The Company’s expense related to the plan was $2.4 million, $1.9 million and $1.5 million for the years ended December 31, 2015, 2014, and 2013, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies | |
Commitments and Contingencies | (12) Commitments and Contingencies Operating Leases Ardsley, New York In June 2011, the Company entered into a 15 year lease for an aggregate of approximately 138,000 square feet of office and laboratory space in Ardsley, New York. In July 2012, the Company relocated its corporate headquarters, and all employees based at the prior Hawthorne, NY location, to the Ardsley facility. The Company has grown substantially over the last several years, and the new facility provides state-of-the art office and laboratory space that accommodates the Company’s current needs and allows for future growth. The Company has options to extend the term of the lease for three additional five-year periods, and the Company has an option to terminate the lease after 10 years subject to payment of an early termination fee. Also, the Company has rights to lease up to approximately 120,000 additional square feet of space in additional buildings at the same location. The Company’s extension, early termination, and expansion rights are subject to specified terms and conditions, including specified time periods when they must be exercised, and are also subject to limitations including that the Company not be in default under the lease. In 2014, the Company exercised its option to expand into an additional 25,405 square feet of office space, which the Company occupied in January 2015. The Ardsley lease provides for monthly payments of rent during the term. These payments consist of base rent, which takes into account the costs of the facility improvements funded by the facility owner prior to the Company’s occupancy, and additional rent covering customary items such as charges for utilities, taxes, operating expenses, and other facility fees and charges. The base rent is currently $4.4 million per year, which reflects an annual 2.5% escalation factor as well as the recent expansion, described above. Chelsea, Massachusetts Our 2014 acquisition of Civitas included a subleased manufacturing facility in Chelsea, Massachusetts with commercial-scale capabilities. The approximately 90,000 square foot facility also includes office and laboratory space. Civitas, now our wholly-owned subsidiary, previously subleased the Chelsea, Massachusetts facility from Alkermes, Inc., which leased the facility from the owner, H&N Associates, LLC. The Civitas sublease and Alkermes head lease were scheduled to expire on December 31, 2015, but in the first quarter of 2015 Civitas and Alkermes exercised options that extended the terms of the sublease and head lease for five additional years, until December 31, 2020. In the fourth quarter of 2015, Civitas entered into an assignment and amendment of the head lease with Alkermes and H&N Associates pursuant to which, among other things, Civitas became the direct lessee of the Chelsea facility from H&N Associates under the terms and conditions of the Alkermes head lease, as modified by the assignment and amendment. Pursuant to the assignment and amendment, the term of the head lease has been extended an additional five years, to December 31, 2025, and Civitas has two additional extension options of five years each. The assignment and amendment also specifies the rent during the current extended term, as well as during the additional extension periods should Civitas exercise its options for those extension periods. The base annual rent under the head lease is currently $1.0 million per year. Future minimum commitments under all non-cancelable operating leases subsequent to December 31, 2015 are as follows: (In thousands) 2016 $ 2017 2018 2019 2020 Later years $ Rent expense under these operating leases during the years ended December 31, 2015, 2014 and 2013 was approximately $4.8 million, $3.5 million, and $3.4 million, respectively. License Agreements Under the Company’s Ampyra license agreement with Alkermes, the Company is obligated to make milestone payments to Alkermes of up to $15.0 million over the life of the contract and royalty payments as a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. In addition, under the Company’s various other research, license and collaboration agreements with other parties, it is obligated to make milestone payments of up to an aggregate of approximately $157 million over the life of the contracts. The FDA approval of Ampyra triggered a milestone of $2.5 million to Alkermes that was paid during the quarter ended June 30, 2010. An additional milestone payment to Alkermes was paid during the quarter ended March 31, 2012 with an additional $2.5 million recorded as an intangible asset. Further milestone amounts are payable in connection with additional indications. Under the Company’s Ampyra supply agreement with Alkermes, payments for product manufactured by Alkermes are calculated as a percentage of net product sales and the quantity of product shipped by Alkermes to Acorda. Under this agreement, Acorda also has the option to purchase up to an agreed to quantity of product from a second source. However, if Acorda obtains supply from the second source, Acorda must make a compensating payment to Alkermes for the quantities of product provided by the second source. Under the Company’s license agreement with Rush-Presbyterian-St. Luke’s Medical Center, it is obligated to make royalty payments as a percentage of net sales in the United States and in countries other than the United States. Under the Company’s supply agreement with Alkermes, it provides Alkermes with monthly written 18-month forecasts, and with annual written five-year forecasts for its supply requirements of Ampyra and two-year forecasts for its supply requirements of Zanaflex Capsules. In each of the five months for Zanaflex and three months for Ampyra following the submission of its written 18-month forecast, the Company is obligated to purchase the quantity specified in the forecast, even if its actual requirements are greater or less. Inventory purchase commitments were $34.6 million as of December 31, 2015. Employment Agreements The Company has employment agreements with all of its executive officers which provide for, among other benefits, certain severance, bonus and other payments and COBRA premium coverage, as well as certain rights relating to their equity compensation awards, if their employment is terminated for reasons other than cause or if they terminate their employment for good reason (as those terms are defined in the agreements). The agreements also provide for certain increased rights if their employment terminates following a change in control (as defined in the agreements). Our contractual commitments table does not include these severance payment obligations. Other The Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. While losses, if any, are possible the Company is not able to estimate any ranges of losses as of December 31, 2015. Litigation expenses are expensed as incurred. The Company is currently a party to various legal proceedings which are principally patent litigation matters. The Company has assessed such legal proceedings and does not believe that it is probable that a liability has been incurred or that the amount of any potential liability or range of losses can be reasonably estimated. As a result, the Company did not record any loss contingencies for any of these matters. While it is not possible to determine the outcome of these matters the Company believes that the resolution of all such matters will not have a material adverse effect on its consolidated financial position or liquidity, but could possibly be material to the Company’s consolidated results of operations in any one accounting period. Litigation expenses are expensed as incurred. |
Intangible Assets and Goodwill
Intangible Assets and Goodwill | 12 Months Ended |
Dec. 31, 2015 | |
Intangible Assets and Goodwill | |
Intangible Assets And Goodwill | (13) Intangible Assets and Goodwill Intangible Assets CVT-301 and ARCUS Technology IPR&D In October 2014, the Company acquired through the acquisition of Civitas (Note 3), global rights to CVT-301, a Phase 3 treatment candidate for OFF periods of Parkinson’s disease. The acquisition of Civitas also included rights to Civitas’s proprietary ARCUS pulmonary delivery technology, which the Company believes has potential applications in multiple disease areas. CVT-301 is an inhaled formulation of levodopa, or L-dopa, for the treatment of OFF periods in Parkinson’s disease. In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the transaction to the underlying assets acquired and liabilities assumed by the Company, based upon the estimated fair values of those assets and liabilities at the date of acquisition and classified the fair value of the acquired IPR&D as an indefinite-lived intangible asset until the successful completion or abandonment of the associated research and development efforts. The value allocated to the indefinite lived intangible asset was $423 million. Ampyra On January 22, 2010, the Company received marketing approval from the FDA for Ampyra triggering two milestone payments of $2.5 million to Alkermes and $0.8 million to Rush-Presbyterian St. Luke’s Medical Center (Rush) and an additional $2.5 million payable to Alkermes two years from date of approval. The Company made milestone payments totaling $3.25 million which were recorded as intangible assets in the consolidated financial statements during the three-month period ended March 31, 2010. An additional milestone payment to Alkermes was paid during the three-month period ended March 31, 2012 with an additional $2.5 million recorded as an intangible asset. In April 2011 the Company announced the United States Patent and Trademark Office (USPTO) allowed U.S. Patent Application No. 11/010,828 entitled “Sustained Release Aminopyridine Composition.” The claims of the patent application relate to methods to improve walking in patients with multiple sclerosis by administering 10 mg of sustained release 4-aminopyridine (dalfampridine) twice daily. The patent that issued from this application was accorded an initial patent term adjustment by the USPTO of 298 days, initially extending its term to early October 2025. In August 2011 the USPTO issued the Company’s Patent Application No. 11/010,828 as U.S. Patent No.8,007,826 entitled “Sustained Release Aminopyridine Composition.” The patent, which is listed in the FDA Orange Book, expires in May 2027. The estimated remaining useful life of this asset is presented in the table below. In August 2003, the Company entered into an Amended and Restated License Agreement with the Canadian Spinal Research Organization (CSRO). Under this agreement, the Company was granted an exclusive and worldwide license under certain patent assets and know-how of CSRO relating to the use of dalfampridine in the reduction of chronic pain and spasticity in a spinal cord injured subject. The agreement required the Company to pay to CSRO royalties based on a percentage of net sales of any product incorporating the licensed rights, including royalties on the sale of Ampyra and on the sale of dalfampridine for any other indication. During the three-month period ended March 31, 2010, the Company purchased CSRO’s rights to all royalty payments under the agreement with CSRO for $3.0 million. This payment was recorded as an intangible asset in the consolidated financial statements. The estimated remaining useful life of this asset is presented in the table below. NP-1998 IPR&D and Qutenza Developed Technology In July 2013, the Company acquired rights in the U.S., Canada, Latin America and certain other countries to two neuropathic pain management assets from NeurogesX, Inc., including: Qutenza®, which is approved by the FDA for the management of neuropathic pain associated with post-herpetic neuralgia, also known as post-shingles pain; and NP-1998, a Phase 3 ready, prescription strength capsaicin topical solution, that was being assessed for the treatment of neuropathic pain. In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the NeurogesX transaction to the underlying assets acquired by the Company, based upon the estimated fair values of those assets at the date of acquisition and classified the fair value of the acquired IPR&D as an indefinite-lived asset classified under intangible assets until the successful completion or abandonment of the associated research and development efforts. The value allocated to this indefinite lived asset was approximately $7.0 million. The value allocated to the Qutenza developed technology was determined to be approximately $450,000 and was recorded as an intangible asset. The Company evaluated and reprioritized its research and development pipeline based on the 2014 acquisition of Civitas, and as a result has no current plans to invest in further development of NP-1998 for neuropathic pain. Therefore, the Company believes that the intangible assets associated with NP-1998 and Qutenza were fully impaired based on the currently estimated fair value of the assets, and the Company recorded asset impairment charges of approximately $7.0 million and $0.3 million to fully write off the carrying value of the NP-1998 and Qutenza assets, respectively, during the three-month period ended December 31, 2014. Websites Intangible assets also include certain website development costs which have been capitalized. The Company has developed several websites, each with its own purpose, including the general corporate website, product information websites and various other websites. The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful life of its intangible assets may warrant revision or that the carrying value of these assets may be impaired. As of December 31, 2015, the Company does not believe that there are any facts or circumstances that would indicate a need for changing the estimated remaining useful life of the Company’s other intangible assets. Intangible assets consisted of the following: (In thousands) December 31, 2015 December 31, 2014 Estimated remaining useful lives as of December 31, 2015 In-process research & development – CVT-301/ARCUS $ $ Indefinite-lived Ampyra milestones 11 years Ampyra CSRO royalty buyout 4 years Website development costs 3 years Website development costs – in process Less accumulated amortization $ $ The Company recorded $3.1 million and $3.3 million in amortization expense related to these intangible assets in the years ended December 31, 2015 and 2014, respectively. The Company recorded impairment charges of approximately $7.0 million and $0.3 million to write-off the carrying value of NP-1998 and Qutenza, respectively during the year ended December 31, 2014. Estimated future amortization expense for intangible assets subsequent to December 31, 2015 is as follows: (In thousands) 2016 $ 2017 2018 2019 2020 Thereafter $ Goodwill At December 31, 2014, the Company recorded goodwill associated with the acquisition of Civitas Therapeutics. The carrying value of the goodwill was $183.6 million and $183.0 million at December 31, 2015 and 2014, respectively. |
Debt
Debt | 12 Months Ended |
Dec. 31, 2015 | |
Debt | |
Debt | (14) Debt Convertible Senior Notes On June 17, 2014, the Company issued $345 million aggregate principal amount of 1.75% Convertible Senior Notes due 2021 (the Notes) in an underwritten public offering. The net proceeds from the offering, after deducting the Underwriter’s discount and the offering expenses paid by the Company, were approximately $337.5 million. The Notes will be convertible into cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election, based on an initial conversion rate, subject to adjustment, of 23.4968 shares per $1,000 principal amount of Notes (which represents an initial conversion price of approximately $42.56 per share), only in the following circumstances and to the following extent: (1) during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; (2) during any calendar quarter commencing after the calendar quarter ending on September 30, 2014 (and only during such calendar quarter), if the last reported sale price of the common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day; (3) if the Company calls any or all of the Notes for redemption, at any time prior to the close of business on the scheduled trading day immediately preceding the redemption date; (4) upon the occurrence of specified events, as described; and (5) at any time on or after December 15, 2020 through the second scheduled trading day immediately preceding the maturity date. The Company may not redeem the Notes prior to June 20, 2017. The Company may redeem for cash all or part of the Notes, at the Company’s option, on or after June 20, 2017 if the last reported sale price of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending within five trading days prior to the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. The Company will pay 1.75% interest per annum on the principal amount of the Notes, payable semiannually in arrears in cash on June 15 and December 15 of each year, beginning on December 15, 2014. The Notes will mature on June 15, 2021. If the Company undergoes a “fundamental change” (as defined in the Indenture), subject to certain conditions, holders may require the Company to repurchase for cash all or part of their Notes in principal amounts of $1,000 or an integral multiple thereof. The fundamental change repurchase price will be equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. If a make-whole fundamental change, as described in the Indenture, occurs and a holder elects to convert its Notes in connection with such make-whole fundamental change, such holder may be entitled to an increase in the conversion rate as described in the Indenture. The Indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency or reorganization involving the Company) occurs and is continuing, the Trustee by notice to the Company, or the holders of at least 25% in principal amount of the outstanding Notes by notice to the Company and the Trustee, may declare 100% of the principal of and accrued and unpaid interest, if any, on all the Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any, will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving the Company, 100% of the principal and accrued and unpaid interest, if any, on all of the Notes will become due and payable automatically. Notwithstanding the foregoing, the Indenture provides that, to the extent the Company elects and for up to 270 days, the sole remedy for an event of default relating to certain failures by the Company to comply with certain reporting covenants in the Indenture consists exclusively of the right to receive additional interest on the Notes. The Notes will be senior unsecured obligations and will rank equally with all of the Company’s existing and future senior debt and senior to any of the Company’s subordinated debt. The Notes will be structurally subordinated to all existing or future indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries and will be effectively subordinated to the Company’s existing or future secured indebtedness to the extent of the value of the collateral. The Indenture does not limit the amount of debt that the Company or its subsidiaries may incur. In accounting for the issuance of the Notes, the Company separated the Notes into liability and equity components. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The carrying amount of the equity component representing the conversion option was determined by deducting the fair value of the liability component from the par value of the Notes as a whole. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. The outstanding note balance as of December 31, 2015 and 2014 consisted of the following: (In thousands) December 31, 2015 December 31, 2014 Liability component: Principal $ $ Less: debt discount, net ) ) Net carrying amount $ $ Equity component $ $ In connection with the issuance of the Notes, the Company incurred approximately $7.5 million of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $7.5 million of debt issuance costs, $1.3 million were allocated to the equity component and recorded as a reduction to additional paid-in capital and $6.2 million were allocated to the liability component and recorded as deferred financing costs included in other assets on the balance sheet. The portion allocated to the liability component is amortized to interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven year term on the Notes. The fair value of the Company’s convertible senior notes was approximately $398.0 million as of December 31, 2015. As of December 31, 2015, the remaining contractual life of the Notes is approximately 5.5 years. The effective interest rate on the liability component was approximately 4.8% for the period from the date of issuance through December 31, 2015. The following table sets forth total interest expense recognized related to the Notes for the years ended December 31, 2015 and 2014: (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Contractual interest expense $ $ Amortization of debt issuance costs Amortization of debt discount Total interest expense $ $ Convertible Note The Company is a party to an amended and restated license agreement and a supply agreement with Alkermes, which replaced two prior license and supply agreements for Ampyra. Under the license agreement, Alkermes also loaned to the Company an aggregate of $7.5 million pursuant to two convertible promissory notes. On December 23, 2005, Alkermes transferred these promissory notes to funds affiliated with Saints Capital. One promissory note remains outstanding in the amount of $5.0 million and bears interest at a rate of 3% beginning on the first anniversary of the issuance of the note (See Note 10). Revenue Interests Assignment On December 23, 2005, the Company entered into an agreement with an affiliate of Paul Royalty Fund (PRF), under which the Company received $15 million in cash. In exchange the Company has assigned PRF revenue interest in Zanaflex Capsules, Zanaflex tablets and any future Zanaflex products. The agreement covers all Zanaflex net revenues (as defined in the agreement) generated from October 1, 2005 through and including December 31, 2015, unless the agreement terminates earlier. In November 2006, the Company entered into an amendment to the revenue interests assignment agreement with PRF. Under the terms of the amendment, PRF paid the Company $5.0 million in November 2006. An additional $5.0 million was due to the Company if net revenues during the fiscal year 2006 equaled or exceeded $25.0 million. This milestone was met and the receivable was reflected in the Company’s December 31, 2006 financial statements. Under the terms of the amendment, the Company repaid PRF $5.0 million on December 1, 2009 and an additional $5.0 million on December 1, 2010 since the net revenues milestone was met. In November 2014 PRF sold its Zanaflex revenue interest to Valeant Pharmaceuticals International, Inc. Under the revenue interests assignment agreement and the amendment to the agreement, PRF was entitled to, and now as PRF’s successor Valeant is entitled to, the following portion of Zanaflex net revenues: · with respect to Zanaflex net revenues up to and including $30.0 million for each fiscal year during the term of the agreement, 15% of such net revenues; · with respect to Zanaflex net revenues in excess of $30.0 million but less than and including $60.0 million for each fiscal year during the term of the agreement, 6% of such net revenues; and · with respect to Zanaflex net revenues in excess of $60.0 million for each fiscal year during the term of the agreement, 1% of such net revenues. Notwithstanding the foregoing, once PRF and Valeant, as PRF’s successor, have received and retained payments under the amended agreement that are at least 2.1 times the aggregate amount PRF paid the Company under the agreement, Valeant will only be entitled to 1% of Zanaflex net revenues. In connection with the transaction, the Company recorded a liability, referred to as the revenue interest liability . The Company imputes interest expense associated with this liability using the effective interest rate method and records a corresponding accrued interest liability. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of Zanaflex sales. The Company currently estimates that the imputed interest rate associated with this liability will be approximately 5.8%. Payments made to Valeant as a result of Zanaflex sales levels will reduce the accrued interest liability and the principal amount of the revenue interest liability. The Company recorded approximately $0.9 million, $1.7 million and $2.0 million in interest expense related to this agreement in 2015, 2014 and 2013, respectively. Through December 31, 2015, $52.5 million in payments have been made as a result of Zanaflex sales levels and milestones reached. The agreement also contains put and call options whereby the Company may repurchase the revenue interest at its option or can be required by Valeant to repurchase the revenue interest, contingent upon certain events. If the Company experiences a change of control, undergoes certain bankruptcy events, transfers any of their interests in Zanaflex (other than pursuant to a license agreement, development, commercialization, co-promotion, collaboration, partnering or similar agreement), transfers all or substantially all of its assets, or breaches certain of the covenants, representations or warranties made under the agreement, Valeant has the right, which the Company refers to as Valeant’s put option, to require the Company to repurchase the rights sold to under the revenue interests assignment agreement at the “put/call price” in effect on the date such right is exercised. If the Company experiences a change of control it has the right, which the Company refers to as the Company’s call option, to repurchase the rights sold to PRF/Valeant at the “put/call price” in effect on the date such right is exercised. If the Company’s call option becomes exercisable as a result of this trigger, the Company will have a period of 180 days during which to exercise the option. The put/call price on a given date is the greater of (i) 150% of all payments made by PRF as of such date, less all payments received by PRF/Valeant as of such date, and (ii) an amount that would generate an internal rate of return to PRF/Valeant of 25% on all payments made by PRF/Valeant as of such date, taking into account the amount and timing of all payments received by PRF/Valeant as of such date. The Company has determined that Valeant’s put option and the Company’s call option meet the criteria to be considered an embedded derivative and should be accounted for as such. As of December 31, 2015 and 2014 the Company had no liability related to the put/call option to reflect its current estimated fair value . This liability is revalued as needed to reflect any changes in the fair value and any gain or loss resulting from the revaluation is recorded in earnings. For the year ended December 31, 2014, a gain of $147,000 was recorded as a result of the change in the fair value of the net put/call liability balance from December 31, 2013. Letters of Credit As of December 31, 2015, the Company has $5.8 million of cash collateralized standby letters of credit outstanding (see Note 2). |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value Measurements | |
Fair Value Measurements | (15) Fair Value Measurements The Company defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the market in which the reporting entity transacts. The Company bases fair value on the assumptions market participants would use when pricing the asset or liability. The Company utilizes a fair value hierarchy which requires it to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company primarily applies the market approach for recurring fair value measurements. The standard describes three levels of inputs that may be used to measure fair value: · Level 1 Quoted prices in active markets for identical assets or liabilities. · Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Recurring The following table presents information about the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2015 and December 31, 2014, and indicates the fair value hierarchy of the valuation techniques utilized to determine such fair value. (In thousands) Level 1 Level 2 Level 3 2015 Assets Carried at Fair Value: Cash equivalents $ $ $— Short-term investments — — Liabilities Carried at Fair Value: Acquired contingent consideration — — 2014 Assets Carried at Fair Value: Cash equivalents $ $— $— Short-term investments — — Liabilities Carried at Fair Value: Acquired contingent consideration — — Put/call liability — — — The following tables present additional information about assets and/or liabilities measured at fair value on a recurring basis and for which the Company utilizes Level 3 inputs to determine fair value. Acquired contingent consideration (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Acquired contingent consideration: Balance, beginning of period $ $— Fair value of acquired contingent consideration as of October 22, 2014 — Total losses included in the statement of operations Balance, end of period $ $ The Company estimates the fair value of its acquired contingent consideration using a probability weighted discounted cash flow valuation approach based on estimated future sales expected from CVT-301, a phase 3 candidate for the treatment of OFF periods of Parkinson’s disease and CVT-427, a Phase 1 candidate. CVT-427 is an inhaled triptan intended to provide acute treatment of migraine episodes using the ARCUS delivery system. Using this approach, expected future cash flows are calculated over the expected life of the agreement, are discounted, and then exercise scenario probabilities are applied. Some of the more significant assumptions made in the valuation include (i) the estimated CVT-301 and CVT 427 revenue forecasts, (ii) probabilities of success, and (iii) discount periods and rate. The probability of achievement of revenue milestones ranged from 28.5% to 70% with milestone payment outcomes ranging from $0 to $60 million in the aggregate for CVT-301 and CVT-427. The valuation is performed quarterly. Gains and losses are included in the statement of operations. For the year ended December 31, 2015, changes in the fair value of the acquired contingent consideration were due to the recalculation of cash flows for the passage of time and updates to certain other estimated assumptions. Refer to Note 10 for more information on the Alkermes ARCUS agreement. The acquired contingent consideration has been classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach including, but not limited to, assumptions involving probability adjusted sales estimates for CVT-301 and CVT-427 and estimated discount rates, the estimated fair value could be significantly higher or lower than the fair value determined. Put/call liability (In thousands) Year ended December 31, 2014 Put/call liability: Balance, beginning of period $ 147 Total (gains) losses included in selling, general and administrative expenses Balance, end of period $ — The Company estimates the fair value of its put/call liability using a discounted cash flow valuation technique. Using this approach, historical and expected future cash flows are calculated over the expected life of the PRF agreement, are discounted, and then exercise scenario probabilities are applied. Some of the more significant assumptions made in the valuation include (i) the estimated Zanaflex revenue forecast and (ii) the likelihood of put/call exercise trigger events such as bankruptcy and change of control. The valuation is performed periodically when the significant assumptions change. Realized gains and losses are included in selling, general and administrative expenses. The put/call liability has been classified as a Level 3 liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the various inputs to the valuation approach including, but not limited to, assumptions involving the estimated Zanaflex revenue forecast and the likelihood of trigger events, the estimated fair value could be significantly higher or lower than the fair value determined Contingent purchase price (In thousands) Year ended December 31, 2014 Contingent purchase price: Balance, beginning of period $ Total (gains) losses included in selling, general and administrative expenses: Balance, end of period $— The Company measured the fair value of the contingent purchase price and determined that the fair value was $0 at December 31, 2015 and 2014. Refer to the “Assets Measured and Recorded at Fair Value on a Nonrecurring Basis” section below for further information regarding the Company’s plans to no longer invest in further development of NP-1998. Assets Measured and Recorded at Fair Value on a Nonrecurring Basis The Company’s non-financial assets, such as intangible assets and property, plant and equipment are only recorded at fair value if an impairment charge is recognized. The table below presents non-financial assets that were measured and recorded at fair value on a nonrecurring basis and the total impairment losses recorded during 2014. There were no impairment losses recorded during 2015. Net Carrying Value as of Fair Value Measured and Recorded Using Impairment Losses (Level 3) December 31, December 31, (in thousands) 2014 Level 1 Level 2 Level 3 2014 In-process research & development – NP-1998 $— $— $— $— $ Qutenza developed technology — — — — Total impairment losses $ The Company evaluated and reprioritized its research and development pipeline based on the 2014 acquisition of Civitas, and as a result has no current plans to invest in further development of NP-1998 for neuropathic pain. Therefore, the Company believes that the intangible assets associated with NP-1998 and Qutenza were fully impaired based on the currently estimated fair value of the assets and the Company recorded asset impairment charges of approximately $7.0 million and $0.3 million to fully write off the carrying value of the NP-1998 and Qutenza assets, respectively, during the three-month period ended December 31, 2014. The impairment charges of $7.0 million for the IPR&D and $0.3 million for Qutenza were recorded in asset impairment and cost of sales, respectively. |
Quarterly Consolidated Financia
Quarterly Consolidated Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Consolidated Financial Data (unaudited) | |
Quarterly Consolidated Financial Data (unaudited) | (16) Quarterly Consolidated Financial Data (unaudited) (In thousands, except per share amounts) 2015 March 31 June 30 September 30 December 31 Total net revenues (1) $ $ $ $ Gross profit Net (loss) income—basic and diluted (2) Net (loss) income per share—basic $ $ $ $ Net (loss) income per share—diluted 2014 March 31 June 30 September 30 December 31 Total net revenues $ $ $ $ Gross profit Net income—basic and diluted (3) Net income per share—basic $ $ $ $ Net income per share—diluted (1) In the third quarter of 2015, the Company recognized a one-time increase in net revenue of $22.2 million, representing previously deferred product sales for Zanaflex products due to the Company’s conversion from the deferred revenue recognition model (sell-through) to the traditional revenue recognition model (sell-in). (2) In the third quarter of 2015, the Company made a payment of $8.75 million to the former shareholders of Neuronex in exchange for certain modifications to the Company’s future contingent payment obligations pertaining to Plumiaz. This payment was reflected as R&D expense. (3) In the fourth quarter of 2014 the Company realized a non-recurring impairment charge of $7.0 million to write-off the IPR&D related to the NP-1998 program. |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Significant Accounting Policies | |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (U.S.) and include the results of operations of the Company and its majority owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements requires management to make a number of estimates and assumptions relating to the reported amount of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Significant items subject to such estimates and assumptions include share-based compensation accounting, which are largely dependent on the fair value of the Company’s equity securities. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid debt instruments with original maturities of three months or less from date of purchase to be cash equivalents. All cash and cash equivalents are held in highly rated securities including a Treasury money market fund and U.S. Treasury bonds, which are unrestricted as to withdrawal or use. To date, the Company has not experienced any losses on its cash and cash equivalents. The carrying amount of cash and cash equivalents approximates its fair value due to its short-term and liquid nature. We maintain cash balances in excess of insured limits. We do not anticipate any losses with respect to such cash balances. |
Restricted Cash | Restricted Cash Restricted cash represents a bank account with funds to cover the Company’s self-funded employee health insurance and cash deposits held in connection with obligations under facility leases. At December 31, 2015, restricted cash of $5.8 million is related to cash collateralized standby letters of credit (see Note 14). |
Investments | Investments Short-term investments consist of U.S. Treasury bonds. The Company classifies marketable securities available to fund current operations as short-term investments in current assets on its consolidated balance sheets. Marketable securities are classified as long-term investments in long-term assets on the consolidated balance sheets if the Company has the ability and intent to hold them and such holding period is longer than one year. The Company classifies its short-term investments as available-for-sale. Available-for-sale securities are recorded at the fair value of the investments based on quoted market prices. Unrealized holding gains and losses on available-for-sale securities, which are determined to be temporary, are excluded from earnings and are reported as a separate component of accumulated other comprehensive loss. Premiums and discounts on investments are amortized over the life of the related available-for-sale security as an adjustment to yield using the effective-interest method. Dividend and interest income are recognized when earned. Amortized premiums and discounts, dividend and interest income are included in interest income. Realized gains and losses are included in other income. |
Other Comprehensive (Loss) Income | Other Comprehensive Income The Company’s other comprehensive (loss) income is comprised of unrealized gains and losses on available-for-sale securities and is recorded and presented net of income tax. |
Inventory | Inventory Inventory is stated at the lower of cost or market value and includes amounts for Ampyra, Zanaflex tablet, Zanaflex Capsule and Qutenza inventories and is recorded at its net realizable value. The Company capitalizes inventory costs associated with the Company’s products prior to regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Cost is determined using the first-in, first-out method (FIFO) for all inventories. The Company establishes reserves as necessary for obsolescence and excess inventory. Ampyra The cost of Ampyra inventory manufactured by Alkermes plc (Alkermes) is based on agreed upon pricing with Alkermes. In the event Alkermes does not manufacture the products, Alkermes is entitled to a compensating payment for the quantities of product provided by Patheon, the Company’s alternative manufacturer. This compensating payment is included in the Company’s inventory balances. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed on a straight-line basis over the estimated useful lives of the assets, which ranges from one to seven years. Leasehold improvements are recorded at cost, less accumulated amortization, which is computed on a straight-line basis over the shorter of the useful lives of the assets or the remaining lease term. Expenditures for maintenance and repairs are charged to expense as incurred. |
Goodwill | Goodwill Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. See Note 13 for discussion on goodwill. |
Intangible Assets | Intangible Assets The Company has finite lived intangible assets related to milestones for Ampyra, and for certain website development costs. These intangible assets are amortized on a straight line basis over the period in which the Company expects to receive economic benefit and are reviewed for impairment when facts and circumstances indicate that the carrying value of the asset may not be recoverable. The determination of the expected life will be dependent upon the use and underlying characteristics of the intangible asset. In the Company’s evaluation of the intangible assets, it considers the term of the underlying asset life and the expected life of the related product line. If the carrying value is not recoverable, impairment is measured as the amount by which the carrying value exceeds its estimated fair value. Fair value is generally estimated based on either appraised value or other valuation techniques. The Company also has indefinite lived intangible assets for the value of acquired in-process research and development related to CVT-301. The Company reviews the carrying value of indefinite lived intangible assets annually and whenever indicators of impairment are present. See also “In-Process Research and Development” and Note 13 for discussion on intangible assets. |
Contingent Consideration | Contingent Consideration The Company may record contingent consideration as part of the cost of business acquisitions. Contingent consideration is recognized at fair value as of the date of acquisition and recorded as a liability on the consolidated balance sheet. The contingent consideration is re-valued on a quarterly basis using a probability weighted discounted cash-flow approach until fulfillment or expiration of the contingency. Changes in the fair value of the contingent consideration are recognized in the statement of operations. See Note 10 for discussion on the Alkermes ARCUS agreement. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company continually evaluates whether events or circumstances have occurred that indicate that the estimated remaining useful lives of its long-lived assets may warrant revision or that the carrying value of the assets may be impaired. The Company evaluates the realizability of its long-lived assets based on profitability and cash flow expectations for the related assets. Any write-downs are treated as permanent reductions in the carrying amount of the assets. |
Patent Costs | Patent Costs Patent application and maintenance costs are expensed as incurred. |
Research and Development | Research and Development Research and development expenses include the costs associated with the Company’s internal research and development activities, including salaries and benefits, occupancy costs, and research and development conducted for it by third parties, such as contract research organizations (CROs), sponsored university-based research, clinical trials, contract manufacturing for its research and development programs, and regulatory expenses. In addition, research and development expenses include the cost of clinical trial drug supply shipped to the Company’s clinical study vendors. For those studies that the Company administers itself, the Company accounts for its clinical study costs by estimating the patient cost per visit in each clinical trial and recognizes this cost as visits occur, beginning when the patient enrolls in the trial. This estimated cost includes payments to the trial site and patient-related costs, including laboratory costs related to the conduct of the trial. Cost per patient varies based on the type of clinical trial, the site of the clinical trial, and the length of the treatment period for each patient. For those studies for which the Company uses a CRO, the Company accounts for its clinical study costs according to the terms of the CRO contract. These costs include upfront, milestone and monthly expenses as well as reimbursement for pass through costs. As actual costs become known to the Company, it adjusts the accrual; such changes in estimate may be a material change in its clinical study accrual, which could also materially affect its results of operations. All research and development costs are expensed as incurred except when accounting for nonrefundable advance payments for goods or services to be used in future research and development activities. These payments are capitalized at the time of payment and expensed ratably over the period the research and development activity is performed. |
In-Process Research and Development | In-Process Research and Development The cost of in-process research and development (IPR&D) acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise they are expensed. The fair values of IPR&D projects acquired in business combinations are capitalized. Several methods may be used to determine the estimated fair value of the IPR&D acquired in a business combination. The Company utilizes the “income method”, and uses estimated future net cash flows that are derived from projected sales revenues and estimated costs. These projections are based on factors such as relevant market size, patent protection, historical pricing and expected industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. IPR&D intangible assets which are determined to have had a drop in their fair value are adjusted downward and an expense is recognized in the statement of operations. These assets are tested at least annually or sooner when a triggering event occurs that could indicate a potential impairment. |
Accounting for Income Taxes | Accounting for Income Taxes The Company provides for income taxes in accordance with ASC Topic 740 (ASC 740). Income taxes are accounted for under the asset and liability method with deferred tax assets and liabilities recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be reversed or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. Deferred tax assets are reduced by a valuation allowance for the amounts of any tax benefits which, more likely than not, will not be realized. On December 31, 2015, the Company early adopted the provisions of Accounting Standards updated 2015-17, “Income Taxes” (Topic 740): Balance Sheet Classification of Deferred Taxes (ASU 2015-17), which simplifies the presentation of deferred income taxes by requiring that deferred tax liabilities and assets be classified as noncurrent in the balance sheet. The Company adopted the new guidance retrospectively and updated the classification of the deferred tax liabilities and assets to noncurrent in the balance sheet for the current year and all prior periods presented. In determining whether a tax position is effectively settled for the purpose of recognizing previously unrecognized tax benefits, a two-step process is utilized whereby the threshold for recognition is a more likely-than-not test that the tax position will be sustained upon examination and the tax position is measured at the largest amount of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. |
Revenue Recognition | Revenue Recognition Ampyra Ampyra is available only through a network of specialty pharmacy providers that provide the medication to patients by mail; Kaiser Permanente, which distributes Ampyra to patients through a closed network of on-site pharmacies; and ASD Specialty Healthcare, Inc. (an AmerisourceBergen affiliate), which distributes Ampyra to the U.S. Bureau of Prisons, the U.S. Department of Defense, the U.S. Department of Veterans Affairs, or VA, and other federal agencies. Ampyra is not available in retail pharmacies. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. The Company recognizes product sales of Ampyra following shipment of product to a network of specialty pharmacy providers, Kaiser Permanente, and ASD Specialty Healthcare, Inc. The specialty pharmacy providers, Kaiser Permanente, and ASD Specialty Healthcare, Inc. are contractually obligated to hold no more than an agreed number of days of inventory, ranging from 10 to 30 days. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, and chargebacks. These allowances are recorded for cash consideration given by a vendor to a customer that is presumed to be a reduction of the selling prices of the vendor’s products or services and, therefore, are characterized as a reduction of revenue. At the time product is shipped to specialty pharmacies, Kaiser Permanente and ASD Specialty Healthcare, Inc., an adjustment is recorded for estimated discounts, rebates, and chargebacks. These allowances are established by management as its best estimate based on available information and will be adjusted to reflect known changes in the factors that impact such allowances. Allowances for discounts, rebates, and chargebacks are established based on the contractual terms with customers, historical trends, communications with customers and the levels of inventory remaining in the distribution channel, as well as expectations about the market for the product and anticipated introduction of competitive products. Product shipping and handling costs are included in cost of sales. The Company does not accept returns of Ampyra with the exception of product damages that occur during shipping. Zanaflex The Company applies the revenue recognition guidance in Accounting Standards Codification (ASC) 605-15-25, which among other criteria requires that future returns can be reasonably estimated in order to recognize revenue. Prior to the three-month period ended September 30, 2015, the Company accounted for Zanaflex tablet and capsule (Zanaflex products) shipments using a deferred revenue recognition model (sell-through). Under the deferred revenue recognition model, the Company did not recognize revenue upon product shipment. For product shipments, the Company invoiced the wholesaler, recorded deferred revenue at gross invoice sales price, and classified the cost basis of the product held by the wholesaler as a separate component of inventory. The Company recognized revenue when prescribed to the end-user, on a first-in first-out (FIFO) basis. The Company’s revenue to be recognized was based on the estimated prescription demand, based on pharmacy sales for its products using third-party information, including third-party market research data. The Company’s sales and revenue recognition reflected the Company’s estimate of actual product prescribed to the end-user. Beginning in the third quarter of 2015, the Company is recognizing sales for Zanaflex products when the product is shipped to its wholesale distributors (sell-in), as the Company believes there is now sufficient history to reasonably estimate expected returns. For the three-month period ended September 30, 2015, the Company recognized a one-time increase in net revenue of $22.2 million, representing previously deferred product sales as of June 30, 2015, net of an allowance for estimated returns. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated discounts, rebates, chargebacks and returns. Qutenza Qutenza is distributed in the U.S. by Besse Medical, Inc., a specialty distributor that furnishes the medication to physician offices; and by ASD Specialty Healthcare, Inc., a specialty distributor that furnishes the medication to hospitals and clinics. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product, and the amount of returns can be reasonably estimated and collectability is reasonably assured. This means that, for Qutenza, the Company recognizes product sales following shipment of product to its specialty distributors. The Company’s net revenues represent total revenues less allowances for customer credits, including estimated rebates, chargebacks, and returns. Milestones and royalties In order to determine the revenue recognition for contingent milestones, the Company evaluates the contingent milestones using the criteria as provided by the Financial Accounting Standards Boards (FASB) guidance on the milestone method of revenue recognition. At the inception of a collaboration agreement the Company evaluates if payments are substantive. The criteria requires that (i) the Company determines if the milestone is commensurate with either its performance to achieve the milestone or the enhancement of value resulting from the Company’s activities to achieve the milestone, (ii) the milestone be related to past performance, and (iii) the milestone be reasonably relative to all deliverable and payment terms of the collaboration arrangement. If these criteria are met then the contingent milestones can be considered as substantive milestones and will be recognized as revenue in the period that the milestone is achieved. Royalties are recognized as earned in accordance with the terms of various research and collaboration agreements. |
Collaborations | Collaborations The Company recognizes collaboration revenues and expenses by analyzing each element of the agreement to determine if it shall be accounted for as a separate element or single unit of accounting. If an element shall be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for that element are applied to determine when revenue shall be recognized. If an element shall not be treated separately for revenue recognition purposes, the revenue recognition principles most appropriate for the bundled group of elements are applied to determine when revenue shall be recognized. Payments received in excess of revenues recognized are recorded as deferred revenue until such time as the revenue recognition criteria have been met. |
Concentration of Credit Risk | Concentration of Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of investments in cash, cash equivalents, restricted cash and accounts receivable. The Company maintains cash, cash equivalents, restricted cash and short-term investments with approved financial institutions. The Company is exposed to credit risks and liquidity in the event of default by the financial institutions or issuers of investments in excess of FDIC insured limits. The Company performs periodic evaluations of the relative credit standing of these financial institutions and limits the amount of credit exposure with any institution. The Company does not own or operate, and currently does not plan to own or operate, facilities for production and packaging of Ampyra or its other commercial products, Zanaflex Capsules, Zanaflex tablets or Qutenza. It relies and expects to continue to rely on third parties for the production and packaging of its commercial products and clinical trial materials for all of its products except CVT-301. As part of the Civitas acquisition in 2014, the Company leases a manufacturing facility in Chelsea, Massachusetts which produces CVT-301 for clinical trials and eventually will produce commercial supply, if approved. The Company relies primarily on Alkermes for its supply of Ampyra. Under its supply agreement with Alkermes, the Company is obligated to purchase at least 75% of its yearly supply of Ampyra from Alkermes, and it is required to make compensatory payments if it does not purchase 100% of its requirements from Alkermes, subject to certain specified exceptions. The Company and Alkermes have agreed that the Company may purchase up to 25% of its annual requirements from Patheon, a mutually agreed-upon second manufacturing source, with compensatory payment. The Company and Alkermes also rely on a single third-party manufacturer, Regis, to supply dalfampridine, the active pharmaceutical ingredient, or API, in Ampyra. If Regis experiences any disruption in their operations, a delay or interruption in the supply of Ampyra product could result until Regis cures the problem or it locates an alternate source of supply. The Company’s principal direct customers as of December 31, 2015 were a network of specialty pharmacies, Kaiser Permanente, and ASD Specialty Healthcare, Inc. for Ampyra, wholesale pharmaceutical distributors for Zanaflex Capsules and Zanaflex tablets, and two specialty distributors for Qutenza. The Company periodically assesses the financial strength of these customers and establishes allowances for anticipated losses, if necessary. Three customers individually accounted for more than 10% of the Company’s revenue in 2015 and four customers individually accounted for more than 10% of the Company’s revenue in 2014 and 2013. Three customers individually accounted for more than 10% of the Company’s accounts receivable as of December 31, 2015 and four customers individually accounted for more than 10% of the Company’s accounts receivable as of December 31, 2014. The Company’s net product revenues are generated in the U. S. |
Allowance for Cash Discounts | Allowance for Cash Discounts An allowance for cash discounts is accrued based on historical usage rates at the time of product shipment. The Company adjusts accruals based on actual activity as necessary. Cash discounts are typically settled with customers within 30 days after the end of each calendar month. The Company had cash discount allowances of $5.1 million and $4.1 million for the years ended December 31, 2015 and 2014, respectively. The Company’s accruals for cash discount allowances were $0.5 million and $0.4 million as of December 31, 2015 and 2014, respectively. |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts A portion of the Company’s accounts receivable may not be collected due principally to customer disputes. The Company provides reserves for these situations based on the evaluation of the aging of its trade receivable portfolio and an analysis of high-risk customers. The Company has not historically experienced material losses related to credit risk. The Company has recognized an allowance related to one customer of approximately $0.4 million as of December 31, 2015 and December 31, 2014. For the year ended December 31, 2015 and 2014, the Company recorded no provision and did not record any write-offs. |
Contingencies | Contingencies The Company accrues for amounts related to legal matters if it is probable that a liability has been incurred and the amount is reasonably estimable. Litigation expenses are expensed as incurred. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The fair value of a financial instrument represents the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced sale or liquidation. Significant differences can arise between the fair value and carrying amounts of financial instruments that are recognized at historical cost amounts. The Company considers that fair value should be based on the assumptions market participants would use when pricing the asset or liability. The following methods are used to estimate the fair value of the Company’s financial instruments: (a) Cash equivalents, grants receivable, accounts receivable, accounts payable and accrued liabilities approximate their fair values due to the short-term nature of these instruments; (b) Available-for-sale securities are recorded based primarily on quoted market prices; (c) Put/call liability’s fair value is based on revenue projections and business, general economic and market conditions that could be reasonably evaluated as of the valuation date; (d) Contingent purchase price related to the NeurogesX acquisition was measured at fair value using a Monte Carlo simulation; (e) Acquired contingent consideration related to the Civitas acquisition is measured at fair value using a probability weighted, discounted cash flow approach; and (f) Convertible Senior Notes were measured at fair value based on market quoted prices of debt securities with similar terms and maturities using other observable inputs. |
Earnings per Share | Earnings per Share Basic net income per share is based upon the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares outstanding during the period plus the effect of additional weighted average common equivalent shares outstanding during the period when the effect of adding such shares is dilutive. Common equivalent shares result from the assumed exercise of outstanding stock options (the proceeds of which are then assumed to have been used to repurchase outstanding stock using the treasury stock method), the vesting of restricted stock and the potential dilutive effects of the conversion option on the Company’s convertible debt. In addition, the assumed proceeds under the treasury stock method include the average unrecognized compensation expense of stock options that are in-the-money. This results in the “assumed” buyback of additional shares, thereby reducing the dilutive impact of stock options. See Note 8 for discussion on earnings per share. |
Share-based Compensation | Share-based Compensation The Company has various share-based employee and non-employee compensation plans, which are described more fully in Note 7. The Company accounts for stock options and restricted stock granted to employees and non-employees by recognizing the costs resulting from all share-based payment transactions in the consolidated financial statements at their fair values. The Company estimates the fair value of each option on the date of grant using the Black-Scholes closed-form option-pricing model based on assumptions of expected volatility of its common stock, prevailing interest rates, an estimated forfeiture rate, and the expected term of the stock options, and the Company recognizes that cost as an expense ratably over the associated employee service period. |
Segment and Geographic Information | Segment and Geographic Information The Company is managed and operated as one business which is focused on the identification, development and commercialization of novel therapies to improve the lives of people with neurological disorders. The entire business is managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business with respect to any of its products or product candidates and the Company does not prepare discrete financial information with respect to separate products or product candidates or by location . Accordingly, the Company views its business as one reportable operating segment. Net product revenues reported to date are derived from the sales of Ampyra, Zanaflex and Qutenza in the U.S . |
Accumulated Other Comprehensive (Loss) Income | Accumulated Other Comprehensive (Loss) Income Unrealized gains (losses) from the Company’s investment securities are included in accumulated other comprehensive loss within the consolidated balance sheet. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers” (Topic 606) (ASU 2014-09). This new standard will replace all current U.S. GAAP guidance on this topic and eliminate all industry-specific guidance. In July 2015, the FASB decided to defer the effective date of the new revenue standard for interim and annual periods beginning after December 15, 2017 (previously December 15, 2016). The change will allow public entities to adopt the new standard as early as the original public entity effective date (i.e. annual reporting periods beginning after December 15, 2016 and interim periods therein). Early adoption prior to that date will not be permitted. ASU 2014-09 allows for either full retrospective or modified retrospective adoption. The Company is evaluating the transition method that will be elected and the potential effects of adopting the provisions of ASU No. 2014-09. In August 2014, the FASB issued Accounting Standards Update 2014-15, “Presentation of Financial Statements-Going Concern” (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (ASU 2014-15), which defines management’s responsibility to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The pronouncement is effective for annual reporting periods ending after December 15, 2016 with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements. In April 2015, the FASB issued Accounting Standards Update 2015-03, “Interest – Imputation of Interest” (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs (ASU 2015-03), which requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct deduction from the debt liability rather than as an asset. ASU-2014-15 is effective for fiscal years and interim periods therein beginning after December 15, 2015, with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements or related disclosures. On June 12, 2015, the FASB issued Accounting Standards Update 2015-10, “Technical Corrections and Improvements”. With regard to fair value measurement disclosures, ASU 2015-10 clarified that, for nonrecurring measurements estimated at a date during the reporting period other than the end of the reporting period, an entity should clearly indicate that the fair value information presented is not as of the period’s end as well as the date or period that the measurement was taken. This change was effective immediately upon issuance of ASU 2015-10. The adoption of this guidance did not have a significant impact on the Company’s consolidated financial statements or related disclosures. In July 2015, the FASB issued Accounting Standards Update 2015-11, “Inventory” (Topic 330): Simplifying the Measurement of Inventory (ASU 2015-11), which requires the measurement of inventory at the lower of cost and net realizable value. ASU 2015-11 is effective for fiscal years beginning after December 15, 2016, and interim periods therein with early adoption permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements, results of operations or related disclosures. In September 2015, the FASB issued Accounting Standards update 2015-16, “Business Combinations” (Topic 805): Simplifying the Accounting for Measurement-Period Adjustments (ASU 2015-16), which requires that an acquirer recognize adjustments to provisional amounts that are identified during the measurement period in the period in which the adjustment amount is determined. The acquirer is required to also record, in the same period’s financial statements, the effect on earnings of changes in depreciation, amortization, or other income effects, if any, as a result of the change to the provisional amounts, calculated as if the accounting had been completed at the acquisition date. In addition the acquirer is required to present separately on the face of the income statement or disclose in the notes to the financial statements the portion of the amount recorded in current-period earnings by line item that would have been recorded in previous reporting periods if the adjustment to the provisional amounts had been recognized as of the acquisition date. This guidance is effective for fiscal years and interim periods therein beginning after December 15, 2015, and requires prospective application. Early adoption is permitted. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements, results of operations or related disclosures. In November 2015, the FASB issued Accounting Standards updated 2015-17, “Income Taxes” (Topic 740): Balance Sheet Classification of Deferred Taxes (ASU 2015-17), which simplifies the presentation of deferred income taxes by requiring that deferred tax liabilities and assets and associated valuation allowances be classified as noncurrent on the balance sheet instead of distinguishing between current and noncurrent. This guidance is effective for fiscal years and interim periods therein beginning after December 15, 2016, and may be applied prospectively or retrospectively with early adoption permitted. The Company early adopted this guidance effective with its fiscal year ending December 31, 2015 and elected to apply this guidance retrospectively. The adoption of this guidance did not have a significant impact on the Company’s consolidated financial statements or related disclosures. The impact of the adoption of this guidance on the Company’s Consolidated Balance Sheet as of December 31, 2014 was a reclassification of $18.4 million of current deferred tax assets and $23.8 million of noncurrent deferred tax liabilities to $2.8 million of noncurrent deferred tax assets and $8.2 million of non current deferred tax liabilities. In January 2016, the FASB issued Accounting Standards Update 2016-01, “Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities.” The main objective of this update is to enhance the reporting model for financial instruments to provide users of financial statements with more decision-useful information. The new guidance addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements. In February 2016, the FASB issued Accounting Standards Update 2016-02, “Leases” (Topic 842). The main objective of this update is to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing key information about leasing arrangements. This ASU is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements. |
Subsequent Events | Subsequent Events Subsequent events are defined as those events or transactions that occur after the balance sheet date, but before the financial statements are filed with the Securities and Exchange Commission. The Company completed an evaluation of the impact of any subsequent events through the date these financial statements were issued, and determined the following subsequent event required disclosure in our financial statements. On January 19, 2016, we entered into a Combination Agreement to acquire Biotie Therapies Corp. for a cash purchase price of approximately $363 million. Biotie Therapies is a biopharmaceutical company primarily focused on developing therapeutics for central nervous system disorders. Biotie’s currently active pipeline includes: · Tozadenant, an oral product candidate, and selective inhibitor of the adenosine A 2a receptor that Biotie Therapies is developing as an adjunct to levodopa for the treatment of Parkinson’s disease in patients experiencing end-of-dose wearing-off; · SYN120, an oral product candidate to treat both cognitive deficits and psychosis, which frequently coincide in neurodegenerative diseases such as Parkinson’s disease and Alzheimer’s disease; and · BTT1023, a product candidate for the orphan disease Primary Sclerosing Cholangitis (PSC), a chronic and progressive fibrotic liver disease for which there is no FDA-approved treatment. Also, Biotie Therapies receives double digit royalties from sales of Selincro , a European Medicines Agency (EMA)-approved orally administered therapy for alcohol dependence therapy. Selincro is not approved for use in the U.S. and is not under development for use in the U.S. Concurrently with the announcement of the Biotie Therapies transaction, we announced two separate financing transactions. The first was a private placement of 2,250,900 shares of our common stock for an aggregate purchase price of approximately $75 million. We paid discounts and commissions of $2.3 million in connection with the private placement, which settled on January 26, 2016. We intend to use the net proceeds from the private placement to fund, in part, the acquisition of Biotie Therapies described above. If the acquisition is not consummated for any reason, we will use all of the net proceeds from the private placement for general corporate purposes. We also announced a commitment from JPMorgan Chase, N.A. for an asset-based credit facility for up to $60 million. The closing of this credit facility transaction is expected to occur in the first quarter of 2016. |
Acquisitions (Tables)
Acquisitions (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Civitas Therapeutics | |
Summary of consideration transferred | (In thousands) Cash paid $ Extinguishment of long-term debt Fair value of consideration transferred $ |
Schedule of preliminary allocation of purchase price to assets acquired | The following table presents the final allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date of October 22, 2014: (In thousands) Current assets $ Property and equipment Identifiable intangible assets: In-process research and development Other non-current assets Current liabilities Contingent consideration Deferred taxes Other non-current liabilities Fair value of acquired assets and liabilities Goodwill Aggregate purchase price Amount paid to extinguish long-term debt Cash Paid $ |
Business Combinations Schedule of Changes In Goodwill | (In thousands) Goodwill – balance at October 22, 2014 $ Increase to goodwill for final purchase price allocation Goodwill – balance at December 31, 2015 $ |
NeurogesX | |
Summary of consideration transferred | Total purchase price as of the acquisition date of July 8, 2013 is summarized as follows: (In thousands) Cash paid to NeurogesX shareholders and its creditors $ Fair value of contingent liabilities Total purchase price $ |
Schedule of preliminary allocation of purchase price to assets acquired | The following table presents the allocation of the purchase price to the assets acquired as of the acquisition date of July 8, 2013: (In thousands) Inventory $ Equipment Identifiable intangible assets: Developed technology – Qutenza In-process research and development – NP-1998 Fair value of acquired assets Aggregate purchase price Goodwill $ — |
Summary of supplemental pro forma financial information | Year ended Year ended December 31, 2014 December 31, 2013 (In thousands) Reported Pro Forma Reported Pro Forma Net revenues $ $ $ $ Net income/(loss) |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Investments | |
Schedule of available-for-sale securities | (In thousands) Amortized Cost Gross unrealized gains Gross unrealized losses Estimated fair value December 31, 2015 US Treasury bonds $ $— $ $ December 31, 2014 US Treasury bonds $ $ $ $ |
Schedule of changes in accumulated other comprehensive income | The changes in AOCI associated with the net unrealized holding losses on available-for-sale investments during the years ended December 31, 2015 and 2014 were as follows (in thousands): (In thousands) Net Unrealized Gains (Losses) on Marketable Securities Balance at December 31, 2013 $ 37 Other comprehensive loss before reclassifications: Amounts reclassified from accumulated other comprehensive loss Net current period other comprehensive loss Balance at December 31, 2014 Other comprehensive loss before reclassifications: Amounts reclassified from accumulated other comprehensive loss — Net current period other comprehensive loss Balance at December 31, 2015 $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment | |
Schedule of property and equipment | (In thousands) December 31, 2015 December 31, 2014 Estimated useful lives used Machinery and equipment $ $ 2-7 years Leasehold improvements Lesser of useful life or remaining lease term Computer equipment 1-3 years Laboratory equipment 2-5 years Furniture and fixtures 4-7 years Capital in progress Less accumulated depreciation $ $ |
Accrued Expenses and Other Cu28
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | (In thousands) December 31, 2015 December 31, 2014 Product allowance accruals $ $ Bonus payable Research and development expense accruals Accrued inventory Commercial and marketing expense accruals Royalties payable Vacation accrual Sales force commissions and incentive payments payable Medical affairs expenses Administrative expenses Other accrued expenses Total $ $ |
Common Stock Options and Rest29
Common Stock Options and Restricted Stock (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Common Stock Options and Restricted Stock | |
Schedule of weighted average assumptions using the Black-Scholes option pricing model | Year ended December 31, 2015 2014 2013 Employees and directors: Estimated volatility Expected life in years Risk free interest rate Dividend yield — — — |
Schedule of share-based compensation expense | Year ended December 31, (In thousands) 2015 2014 2013 Research and development $ $ $ Selling, general and administrative Total $ $ $ |
Schedule of stock option activity | Number of Shares (In thousands) Weighted Average Exercise Price Weighted Average Remaining Contractual Term Intrinsic Value (In thousands) Balance at December 31, 2012 Granted Forfeited and expired Exercised Balance at December 31, 2013 Granted Forfeited and expired Exercised Balance at December 31, 2014 $ Granted Forfeited and expired Exercised Balance at December 31, 2015 $ $ Vested and expected to vest at December 31, 2015 $ $ Vested and exercisable at December 31, 2015 $ $ |
Schedule of stock options activity, by exercise price range | Options Outstanding Options Exercisable Range of exercise price Outstanding as of December 31, 2015 (In thousands) Weighted- average remaining contractual life Weighted- average exercise price Exercisable as of December 31, 2015 (In thousands) Weighted- average exercise price $2.45 - $25.33 $ $ $25.39 - $30.46 $30.49 - $35.01 $35.09 - $39.38 $39.67 - $44.50 $ $ |
Schedule of restricted stock activity | Restricted Stock Number of Shares (In thousands) Nonvested at December 31, 2012 Granted Vested Forfeited Nonvested at December 31, 2013 Granted Vested Forfeited Nonvested at December 31, 2014 Granted Vested Forfeited Nonvested at December 31, 2015 |
Earnings Per Share (Tables)
Earnings Per Share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Earnings Per Share | |
Schedule of computation of basic and diluted earnings per share | (In thousands, except per share data) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Basic and diluted Net income $ $ $ Weighted average common shares outstanding used in computing net income per share—basic Plus: net effect of dilutive stock options and unvested restricted common shares Weighted average common shares outstanding used in computing net income per share—diluted Net income per share—basic $ $ $ Net income per share—diluted $ $ $ |
Schedule of antidilutive securities excluded from calculation of net [(loss) income] per diluted share | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Denominator Stock options and restricted common shares Convertible note |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Income Taxes | |
Schedule of income before income taxes as basis for (provision for) income taxes | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Income before taxes $ $ $ |
Schedule of (provision for) income taxes | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Current: Federal $ $ $ State Foreign Deferred: Federal State Foreign — — — Total (provision for) income taxes $ $ $ |
Schedule of reconciliation of the statutory U.S. federal income tax rate to the entity's effective income tax rate | Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 U.S. federal statutory tax rate State and local income taxes Non-deductible payment to prior shareholders — — Foreign income tax Stock option compensation Stock option shortfall — — Research and development and orphan drug credits Increase to Uncertain Tax Positions Other nondeductible and permanent differences Provision (benefit) attributable to valuation allowance — Effective income tax rate |
Schedule of deferred tax assets and liabilities | (In thousands) December 31, 2015 December 31, 2014 Deferred tax assets: Net operating loss and other carryforwards $ $ Tax credits Deferred revenue Stock based compensation Contingent consideration Other Total deferred tax assets $ $ Valuation allowance $ $ Total deferred tax assets net of valuation allowance $ $ Deferred tax liabilities: Intangible assets Convertible debt Total deferred tax liabilities $ $ Net deferred tax asset (liability) $ $ |
Schedule of early adopt ASU 2015-17 | December 31, 2014 (In thousands) Revised As Reported Current deferred tax asset $— $ Non-current deferred tax asset — Current deferred tax liability — — Non-current deferred tax liability Net deferred tax (liabilities)/assets $ $ |
Schedule of reconciliation of beginning and ending amounts of unrecognized tax benefits | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Year ended December 31, 2013 Beginning of period balance $ $ $ Increases for tax positions taken during a prior period Decreases for tax positions taken during a prior period — Increases for tax positions taken during the current period Reduction as a result of a lapse of statute of limitations — — — $ $ $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and Contingencies | |
Future minimum commitments under all non-cancelable leases | Future minimum commitments under all non-cancelable operating leases subsequent to December 31, 2015 are as follows: (In thousands) 2016 $ 2017 2018 2019 2020 Later years $ |
Intangible Assets and Goodwill
Intangible Assets and Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Intangible Assets and Goodwill | |
Schedule of intangible assets | (In thousands) December 31, 2015 December 31, 2014 Estimated remaining useful lives as of December 31, 2015 In-process research & development – CVT-301/ARCUS $ $ Indefinite-lived Ampyra milestones 11 years Ampyra CSRO royalty buyout 4 years Website development costs 3 years Website development costs – in process Less accumulated amortization $ $ |
Schedule of future amortization expense for intangible assets | Estimated future amortization expense for intangible assets subsequent to December 31, 2015 is as follows: (In thousands) 2016 $ 2017 2018 2019 2020 Thereafter $ |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Debt | |
Summary of outstanding note balances | (In thousands) December 31, 2015 December 31, 2014 Liability component: Principal $ $ Less: debt discount, net ) ) Net carrying amount $ $ Equity component $ $ |
Schedule of interest expense recognized related to the Notes | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Contractual interest expense $ $ Amortization of debt issuance costs Amortization of debt discount Total interest expense $ $ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Schedule of assets and liabilities measured at fair value on a recurring basis | (In thousands) Level 1 Level 2 Level 3 2015 Assets Carried at Fair Value: Cash equivalents $ $ $— Short-term investments — — Liabilities Carried at Fair Value: Acquired contingent consideration — — 2014 Assets Carried at Fair Value: Cash equivalents $ $— $— Short-term investments — — Liabilities Carried at Fair Value: Acquired contingent consideration — — Put/call liability — — — |
Schedule of put/call liability | (In thousands) Year ended December 31, 2014 Put/call liability: Balance, beginning of period $ 147 Total (gains) losses included in selling, general and administrative expenses Balance, end of period $ — |
Schedule of non-financial assets measured and recorded at fair value on a nonrecurring basis and total impairment losses | Net Carrying Value as of Fair Value Measured and Recorded Using Impairment Losses (Level 3) December 31, December 31, (in thousands) 2014 Level 1 Level 2 Level 3 2014 In-process research & development – NP-1998 $— $— $— $— $ Qutenza developed technology — — — — Total impairment losses $ |
Contingent liability | |
Schedule of contingent liabilities | (In thousands) Year ended December 31, 2015 Year ended December 31, 2014 Acquired contingent consideration: Balance, beginning of period $ $— Fair value of acquired contingent consideration as of October 22, 2014 — Total losses included in the statement of operations Balance, end of period $ $ |
Contingent purchase price | |
Schedule of contingent liabilities | (In thousands) Year ended December 31, 2014 Contingent purchase price: Balance, beginning of period $ Total (gains) losses included in selling, general and administrative expenses: Balance, end of period $— |
Quarterly Consolidated Financ36
Quarterly Consolidated Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Quarterly Consolidated Financial Data (unaudited) | |
Quarterly Consolidated Financial Data (unaudited) | (16) Quarterly Consolidated Financial Data (unaudited) (In thousands, except per share amounts) 2015 March 31 June 30 September 30 December 31 Total net revenues (1) $ $ $ $ Gross profit Net (loss) income—basic and diluted (2) Net (loss) income per share—basic $ $ $ $ Net (loss) income per share—diluted 2014 March 31 June 30 September 30 December 31 Total net revenues $ $ $ $ Gross profit Net income—basic and diluted (3) Net income per share—basic $ $ $ $ Net income per share—diluted (1) In the third quarter of 2015, the Company recognized a one-time increase in net revenue of $22.2 million, representing previously deferred product sales for Zanaflex products due to the Company’s conversion from the deferred revenue recognition model (sell-through) to the traditional revenue recognition model (sell-in). (2) In the third quarter of 2015, the Company made a payment of $8.75 million to the former shareholders of Neuronex in exchange for certain modifications to the Company’s future contingent payment obligations pertaining to Plumiaz. This payment was reflected as R&D expense. (3) In the fourth quarter of 2014 the Company realized a non-recurring impairment charge of $7.0 million to write-off the IPR&D related to the NP-1998 program. |
Summary of Significant Accoun37
Summary of Significant Accounting Policies - Policies 1 (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended |
Sep. 30, 2015 | Dec. 31, 2015 | |
Revenue Recognition | ||
Net adjustment from previously deferred product sales | $ 22.2 | |
Letters of Credit | ||
Restricted Cash | ||
Restricted Cash and Cash Equivalents | $ 5.8 | |
Minimum | ||
Property and Equipment | ||
Estimated useful lives | 1 year | |
Minimum | Ampyra | ||
Revenue Recognition | ||
Contractually obligated inventory holdings period | 10 days | |
Maximum | ||
Property and Equipment | ||
Estimated useful lives | 7 years | |
Maximum | Ampyra | ||
Revenue Recognition | ||
Contractually obligated inventory holdings period | 30 days |
Summary of Significant Accoun38
Summary of Significant Accounting Policies - Policies 2 (Details) $ in Thousands | 12 Months Ended | 24 Months Ended | ||
Dec. 31, 2015USD ($)customeritem | Dec. 31, 2014USD ($)customer | Dec. 31, 2013customer | Dec. 31, 2015USD ($)item | |
Concentration of Risk | ||||
Number of specialty distributors for Qutenza | item | 2 | 2 | ||
Allowance for Cash Discounts | ||||
Time period needed typically to settle cash discounts | 30 days | |||
Allowance for cash discounts | $ 5,100 | $ 4,100 | $ 5,100 | |
Accrual for allowance for cash discounts | $ 500 | 400 | 500 | |
Allowance for Doubtful Accounts | ||||
Number of customer to whom an allowance for doubtful accounts recognized | item | 1 | |||
Allowance for doubtful accounts related to one customer | $ 400 | $ 400 | 400 | |
Provision for doubtful accounts | $ 0 | |||
Segment and Geographic Information | ||||
Number of reportable operating segments | item | 1 | |||
Product revenue | ||||
Concentration of Risk | ||||
Number of customers | customer | 3 | 4 | 4 | |
Accounts receivable | ||||
Concentration of Risk | ||||
Number of customers | customer | 3 | 4 | ||
Supply agreement | Alkermes License Agreement | Maximum | ||||
Concentration of Risk | ||||
Compensatory Payments Purchase Requirements Threshold Percentage | 100.00% | |||
Supply agreement | Patheon Inc Second Manufacturing agreement | Maximum | ||||
Concentration of Risk | ||||
Compensatory Payments Purchase Requirements Threshold Percentage | 25.00% | |||
Supply agreement | Alkermes License Agreement | Minimum | ||||
Concentration of Risk | ||||
Purchase Obligation Percentage | 75.00% | |||
Scenario, Previously Reported [Member] | Accounting Standards Update 2015-17 | Recent accounting pronouncements adjustment | ||||
Recent Accounting Pronouncements | ||||
Current deferred tax asset | $ 18,420 | |||
Non-current deferred tax liability | (23,885) | |||
Restatement Adjustment [Member] | Accounting Standards Update 2015-17 | Recent accounting pronouncements adjustment | ||||
Recent Accounting Pronouncements | ||||
Non-current deferred tax asset | 2,806 | |||
Non-current deferred tax liability | $ (8,271) |
Summary of Significant Accoun39
Summary of Significant Accounting Policies - Subsequent Events (Details) - Subsequent Events $ in Millions | Jan. 19, 2016USD ($)itemshares |
Asset based credit facility | JPMorgan Chase, N.A. | |
Subsequent Events | |
Maximum borrowing capacity | $ 60 |
Biotie Therapies Corp. | |
Subsequent Events | |
Cash paid | $ 363 |
Number of financing transactions announced | item | 2 |
Biotie Therapies Corp. | Private placement | |
Subsequent Events | |
Number of common shares issued under private placement | shares | 2,250,900 |
Proceeds from private placement | $ 75 |
Discounts and commissions paid | $ 2.3 |
Acquisitions - Civitas (Details
Acquisitions - Civitas (Details) $ in Thousands | Oct. 22, 2014USD ($)ft²item | Dec. 31, 2014USD ($) | Dec. 31, 2015USD ($) |
Purchase price : | |||
Current assets | $ 390,718 | $ 451,317 | |
Property and equipment | 59,818 | 65,833 | |
Other non-current assets | 6,137 | 5,296 | |
Current liabilities | (114,383) | (90,592) | |
Other non-current liabilities | (9,103) | (8,991) | |
Goodwill, Ending Balance | 182,952 | 183,636 | |
Civitas Therapeutics | |||
Business Acquisitions [Line Items] | |||
Size of the office and laboratory space (in square feet) | ft² | 90,000 | ||
Number of Civitas Employees | item | 45 | ||
Purchase price, gross of liabilities assumed | $ 525,000 | ||
Acquisition-related cost | 4,500 | 7,200 | |
Escrow Deposit | 39,375 | ||
Purchase price : | |||
Cash paid | 524,201 | ||
Extinguishment of long-term debt | 5,325 | ||
Fair value of consideration transferred | 529,526 | ||
Goodwill deductible for tax | 0 | ||
Current assets | 54,911 | ||
Property and equipment | 27,913 | ||
Other non-current assets | 1,002 | ||
Current liabilities | (6,154) | ||
Contingent consideration | (50,400) | ||
Deferred taxes | (103,317) | ||
Other non-current liabilities | (1,065) | ||
Fair value of acquired assets and liabilities | 345,890 | ||
Goodwill, Beginning Balance | 182,952 | 182,952 | |
Increase to goodwill for final adjustment to deferred taxes | 684 | ||
Goodwill, Ending Balance | 183,636 | $ 183,000 | $ 183,636 |
Civitas Therapeutics | In-process research and development | |||
Purchase price : | |||
Identifiable intangible assets | $ 423,000 |
Acquisitions - NeurogesX (Detai
Acquisitions - NeurogesX (Details) | Oct. 22, 2014USD ($) | Jul. 08, 2013USD ($)item | Jul. 08, 2013USD ($) | Jul. 31, 2013USD ($)item | Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Oct. 21, 2014USD ($) |
Allocation of purchase price to assets acquired | ||||||||
Goodwill | $ 183,636,000 | $ 182,952,000 | ||||||
Pro Forma Financial Information (Unaudited) | ||||||||
Net revenues | 492,660,000 | 401,480,000 | $ 336,430,000 | |||||
Net income (loss) | 11,058,000 | 17,672,000 | 16,441,000 | |||||
Civitas Therapeutics | ||||||||
Purchase price : | ||||||||
Cash paid to NeurogesX shareholders and its creditors | $ 524,201,000 | |||||||
Fair value of contingent liabilities | 5,325,000 | |||||||
Total purchase price | 529,526,000 | |||||||
Allocation of purchase price to assets acquired | ||||||||
Fair value of acquired assets and liabilities | 345,890,000 | |||||||
Aggregate purchase price | 529,526,000 | |||||||
Goodwill | 183,636,000 | $ 183,636,000 | 183,000,000 | $ 182,952,000 | ||||
Pro Forma Financial Information (Unaudited) | ||||||||
Net revenues | 401,480,000 | 336,430,000 | ||||||
Net income (loss) | 17,672,000 | 16,441,000 | ||||||
Pro Forma net revenues | 401,480,000 | 337,130,000 | ||||||
Pro Forma net income (loss) | $ (14,084,000) | (5,976,000) | ||||||
Civitas Therapeutics | In-process research and development | ||||||||
Allocation of purchase price to assets acquired | ||||||||
Identifiable intangible assets | $ 423,000,000 | |||||||
NeurogesX | ||||||||
Acquisitions | ||||||||
Number of neuropathic pain management assets acquired | item | 2 | 2 | ||||||
Acquisition-related charges, net | $ 1,000,000 | |||||||
Purchase price : | ||||||||
Cash paid to NeurogesX shareholders and its creditors | $ 7,499,000 | |||||||
Fair value of contingent liabilities | 205,000 | |||||||
Total purchase price | 7,704,000 | $ 7,704,000 | ||||||
Allocation of purchase price to assets acquired | ||||||||
Inventory | 90,000 | 90,000 | ||||||
Equipment | 173,000 | 173,000 | ||||||
Fair value of acquired assets and liabilities | 7,704,000 | 7,704,000 | ||||||
Aggregate purchase price | 7,704,000 | 7,704,000 | ||||||
NeurogesX | Maximum | ||||||||
Acquisitions | ||||||||
Contingent milestone payments | 5,000,000 | 5,000,000 | ||||||
Qutenza and NP-1998 | Astellas Pharma Europe | ||||||||
Acquisitions | ||||||||
Number of countries | item | 28 | |||||||
NP-1998 | In-process research and development | ||||||||
Allocation of purchase price to assets acquired | ||||||||
Identifiable intangible assets | 6,991,000 | 6,991,000 | ||||||
NP-1998 | Approval for sale of liquid formulation product | ||||||||
Acquisitions | ||||||||
Contingent milestone payments | 2,000,000 | 2,000,000 | ||||||
NP-1998 | Achievement of sales target | ||||||||
Acquisitions | ||||||||
Contingent milestone payments | 3,000,000 | 3,000,000 | ||||||
Target amount of sales to be achieved for contingent consideration | $ 100,000,000 | |||||||
Period for achievement of sales target for contingent consideration | 12 months | |||||||
Qutenza | Developed technology | ||||||||
Allocation of purchase price to assets acquired | ||||||||
Identifiable intangible assets | $ 450,000 | $ 450,000 | $ 450,000 |
Investments - Available-for-sal
Investments - Available-for-sale (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Investments | ||
Other-than-temporary declines in the fair values of investments | $ 0 | |
Long-term Investments | 0 | $ 0 |
Short-term investments classified as cash and cash equivalents | $ 83,500 | 149,800 |
Minimum | ||
Investments | ||
Short-term investments maturity term | 3 months | |
Long-term investments maturity term | 1 year | |
Maximum | ||
Investments | ||
Short-term investments maturity term | 1 year | |
US Treasury bonds | ||
Investments | ||
Amortized Cost | $ 200,244 | 125,443 |
Gross unrealized gains | 14 | |
Gross unrealized losses | (143) | (9) |
Estimated fair value | $ 200,101 | $ 125,448 |
Investments - AOCI (Details)
Investments - AOCI (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Changes in accumulated other comprehensive loss | |||
Balance at the beginning of the period | $ (74) | ||
Net current period other comprehensive loss | (45) | $ (111) | $ (25) |
Balance at the end of the period | (119) | (74) | |
Net Unrealized Gains (Losses) on Marketable Securities | |||
Changes in accumulated other comprehensive loss | |||
Balance at the beginning of the period | (74) | 37 | |
Other comprehensive income before reclassifications | (45) | (356) | |
Amounts reclassified from accumulated other comprehensive loss | 245 | ||
Net current period other comprehensive loss | (45) | (111) | |
Balance at the end of the period | $ (119) | $ (74) | $ 37 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Property and Equipment | ||
Property and equipment | $ 65,833 | $ 59,818 |
Less accumulated depreciation | (25,629) | (13,728) |
Property and equipment, net | 40,204 | 46,090 |
Depreciation and amortization expense | $ 11,900 | 5,100 |
Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 1 year | |
Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years | |
Machinery and equipment | ||
Property and Equipment | ||
Property and equipment | $ 21,026 | 21,026 |
Machinery and equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 2 years | |
Machinery and equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years | |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment | $ 19,135 | 15,763 |
Computer equipment | ||
Property and Equipment | ||
Property and equipment | $ 15,776 | 12,118 |
Computer equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 1 year | |
Computer equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 3 years | |
Laboratory equipment | ||
Property and Equipment | ||
Property and equipment | $ 6,514 | 5,247 |
Laboratory equipment | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 2 years | |
Laboratory equipment | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 5 years | |
Furniture and fixtures | ||
Property and Equipment | ||
Property and equipment | $ 2,064 | 1,163 |
Furniture and fixtures | Minimum | ||
Property and Equipment | ||
Estimated useful lives used | 4 years | |
Furniture and fixtures | Maximum | ||
Property and Equipment | ||
Estimated useful lives used | 7 years | |
Capital in progress | ||
Property and Equipment | ||
Property and equipment | $ 1,318 | $ 4,501 |
Accrued Expenses and Other Cu45
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Expenses and Other Current Liabilities | ||
Product allowance accruals | $ 18,325 | $ 10,165 |
Bonus payable | 12,324 | 10,696 |
Research and development expense accruals | 10,447 | 6,918 |
Accrued inventory | 6,497 | 12,453 |
Commercial and marketing expense accruals | 3,054 | 2,091 |
Royalties payable | 2,838 | 2,540 |
Vacation accrual | 2,270 | 2,038 |
Sales force commissions and incentive payments payable | 1,978 | 3,039 |
Medical affairs expenses | 1,498 | 223 |
Administrative expenses | 1,133 | 1,025 |
Other accrued expenses | 5,769 | 4,930 |
Total | $ 66,133 | $ 56,118 |
Common Stock Options and Rest46
Common Stock Options and Restricted Stock - Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | 7 Months Ended | 12 Months Ended | 120 Months Ended | 198 Months Ended | |||
Dec. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | Dec. 31, 2015 | Jun. 18, 1999 | |
Share based compensation disclosure | |||||||
Share-based compensation expense recognized | $ 33,466 | $ 29,437 | $ 25,139 | ||||
The 1999 Plan | |||||||
Share-based compensation expense | |||||||
Number of shares authorized for issuance | 2,481,334 | ||||||
Aggregate restricted stock granted (in shares) | 2,384,345 | ||||||
Remaining restricted stock subject to outstanding options (in shares) | 0 | ||||||
The 2006 Plan | |||||||
Share-based compensation expense | |||||||
Expiration period | 10 years | ||||||
Number of shares authorized for issuance | 14,912,048 | 14,912,048 | 14,912,048 | 14,912,048 | |||
Annual automatic increase in common stock available for issuance (as a percent) | 4.00% | ||||||
Board Approval Automatic Increases in Common Stock Available for Issuance | 4.00% | 4.00% | 4.00% | ||||
Aggregate restricted stock granted (in shares) | 13,221,911 | ||||||
Remaining restricted stock subject to outstanding options (in shares) | 7,899,235 | ||||||
The 2015 Plan | |||||||
Share-based compensation expense | |||||||
Expiration period | 10 years | ||||||
Number of shares authorized for issuance | 3,000,000 | 3,000,000 | 3,000,000 | 3,000,000 | |||
Aggregate restricted stock granted (in shares) | 332,904 | ||||||
Remaining restricted stock subject to outstanding options (in shares) | 324,250 | ||||||
Stock Options | |||||||
Share based compensation disclosure | |||||||
Estimated volatility (as a percent) | 46.68% | 51.26% | 55.91% | ||||
Expected life | 5 years 10 months 17 days | 5 years 10 months 2 days | 5 years 9 months 26 days | ||||
Risk free interest rate (as a percent) | 1.74% | 1.79% | 1.16% | ||||
Options granted (in shares) | 1,651,000 | 2,352,000 | 1,835,000 | ||||
Stock Option Activity | |||||||
Beginning balance (in shares) | 7,786,000 | 6,486,000 | 5,667,000 | ||||
Granted (in shares) | 1,651,000 | 2,352,000 | 1,835,000 | ||||
Forfeited and expired (in shares) | (343,000) | (306,000) | (188,000) | ||||
Exercised (in shares) | (871,000) | (746,000) | (828,000) | ||||
Ending balance (in shares) | 8,223,000 | 8,223,000 | 7,786,000 | 6,486,000 | 8,223,000 | 8,223,000 | |
Vested and expected to vest at end of period (in shares) | 8,141,000 | 8,141,000 | 8,141,000 | 8,141,000 | |||
Vested and exercisable at end of period (in shares) | 5,110,000 | 5,110,000 | 5,110,000 | 5,110,000 | |||
Weighted Average Exercise Price | |||||||
Balance at the beginning of the period (in dollars per share) | $ 29.05 | $ 25.61 | $ 22.30 | ||||
Granted (in dollars per share) | 35.45 | 36.56 | 31.50 | ||||
Forfeited and expired (in dollars per share) | 34.85 | 32.40 | 27.90 | ||||
Exercised (in dollars per share) | 20.77 | 21.46 | 15.45 | ||||
Balance at the end of the period (in dollars per share) | $ 30.97 | 30.97 | 29.05 | 25.61 | $ 30.97 | $ 30.97 | |
Vested and expected to vest at the end of the period (in dollars per share) | 30.92 | 30.92 | 30.92 | 30.92 | |||
Vested and exercisable at the end of the period (in dollars per share) | $ 28.50 | $ 28.50 | $ 28.50 | $ 28.50 | |||
Vested and expected to vest at the end of the period | 6 years 8 months 12 days | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term | 6 years 8 months 12 days | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Exercisable, Weighted Average Remaining Contractual Term | 5 years 7 months 6 days | ||||||
Intrinsic Value | |||||||
Balance at the end of the period | $ 97,163 | $ 97,163 | $ 97,163 | $ 97,163 | |||
Vested and expected to vest at the end of the period | 96,569 | 96,569 | 96,569 | 96,569 | |||
Vested and exercisable at the end of the period | $ 72,974 | $ 72,974 | $ 72,974 | $ 72,974 | |||
Stock Options | Employees and Directors | |||||||
Share based compensation disclosure | |||||||
Weighted average fair value of options granted (in dollars per share) | $ 15.85 | $ 17.61 | $ 15.95 | ||||
Stock Options | Non Employee | |||||||
Share based compensation disclosure | |||||||
Options granted (in shares) | 0 | 0 | 0 | ||||
Stock Option Activity | |||||||
Granted (in shares) | 0 | 0 | 0 | ||||
Stock Options | The 2015 Plan | Employees and Directors | |||||||
Weighted Average Exercise Price | |||||||
Balance at the end of the period (in dollars per share) | $ 35.45 | $ 35.45 | $ 35.45 | $ 35.45 | |||
Restricted Stock | |||||||
Share-based compensation expense | |||||||
Aggregate restricted stock granted (in shares) | 205,000 | 387,000 | 258,000 | ||||
Stock Options and Restricted Stock Awards | |||||||
Share based compensation disclosure | |||||||
Compensation costs capitalized in inventory balances | $ 0 | ||||||
Stock Options and Restricted Stock Awards | Employees and Directors | |||||||
Share based compensation disclosure | |||||||
Share-based compensation expense recognized | 33,500 | $ 29,400 | $ 25,100 | ||||
Stock Options and Restricted Stock Awards | The 2015 Plan | Employees and Directors | |||||||
Share based compensation disclosure | |||||||
Share-based compensation expense recognized | 7,500 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | $ 30,200 | ||||||
Stock options and restricted stock awards granted during period (in shares) | 1,872,592 | ||||||
Research and development. | |||||||
Share based compensation disclosure | |||||||
Share-based compensation expense recognized | $ 8,474 | 5,939 | 5,805 | ||||
Selling, general, and administrative | |||||||
Share based compensation disclosure | |||||||
Share-based compensation expense recognized | $ 24,992 | $ 23,498 | $ 19,334 |
Common Stock Options and Rest47
Common Stock Options and Restricted Stock - Options (Details 2) shares in Thousands | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 8,223 |
Weighted-average remaining contractual life | 6 years 8 months 12 days |
Weighted-average exercise price (in dollars per share) | $ 30.97 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 5,110 |
Weighted-average exercise price (In dollars per share) | $ 28.50 |
Range $2.45-$25.33 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 2.45 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 25.33 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 1,682 |
Weighted-average remaining contractual life | 3 years 6 months |
Weighted-average exercise price (in dollars per share) | $ 20.94 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 1,658 |
Weighted-average exercise price (In dollars per share) | $ 20.90 |
Range $25.39-$30.46 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 25.39 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 30.46 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 2,067 |
Weighted-average remaining contractual life | 6 years 7 months 6 days |
Weighted-average exercise price (in dollars per share) | $ 28.70 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 1,500 |
Weighted-average exercise price (In dollars per share) | $ 28.29 |
Range $30.49-$35.01 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 30.49 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 35.01 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 1,646 |
Weighted-average remaining contractual life | 7 years |
Weighted-average exercise price (in dollars per share) | $ 32.87 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 1,080 |
Weighted-average exercise price (In dollars per share) | $ 32.95 |
Range $35.09-$39.38 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 35.09 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 39.38 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 2,648 |
Weighted-average remaining contractual life | 8 years 6 months |
Weighted-average exercise price (in dollars per share) | $ 37.19 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 852 |
Weighted-average exercise price (In dollars per share) | $ 37.72 |
Range $36.67-$44.50 | |
Range of Exercise Price | |
Stock option, exercise price range, lower limit (in dollars per share) | 39.67 |
Stock option, exercise price range, upper limit (in dollars per share) | $ 44.50 |
Options Outstanding | |
Outstanding ending balance (in shares) | shares | 181 |
Weighted-average remaining contractual life | 9 years 1 month 6 days |
Weighted-average exercise price (in dollars per share) | $ 41.72 |
Options Exercisable | |
Exercisable ending balance (in shares) | shares | 20 |
Weighted-average exercise price (In dollars per share) | $ 41.05 |
Common Stock Options and Rest48
Common Stock Options and Restricted Stock - Restricted Stock (Details) - USD ($) $ in Millions | 7 Months Ended | 12 Months Ended | 120 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2015 | |
The 2006 Plan | |||||
Restricted Stock Activity | |||||
Granted (in shares) | 13,221,911 | ||||
The 2015 Plan | |||||
Restricted Stock Activity | |||||
Granted (in shares) | 332,904 | ||||
Restricted Stock | |||||
Restricted Stock Activity | |||||
Nonvested at the beginning of the period (in shares) | 519,000 | 421,000 | 458,000 | ||
Granted (in shares) | 205,000 | 387,000 | 258,000 | ||
Vested (in shares) | (244,000) | (241,000) | (264,000) | ||
Forfeited (in shares) | (39,000) | (48,000) | (31,000) | ||
Nonvested at the end of the period (in shares) | 441,000 | 441,000 | 519,000 | 421,000 | 441,000 |
Stock Options and Restricted Stock Awards | |||||
Share based compensation, other disclosures | |||||
Total unrecognized compensation costs related to unvested stock options and restricted stock awards that the company expects to recognize | $ 57.5 | $ 57.5 | $ 57.5 | ||
Weighted average period | 2 years 4 months 24 days |
Earnings Per Share - EPS (Detai
Earnings Per Share - EPS (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Basic and diluted | |||||||||||
Net income | $ 9,205 | $ 3,941 | $ 997 | $ (3,085) | $ 331 | $ 11,953 | $ 4,685 | $ 703 | $ 11,058 | $ 17,672 | $ 16,441 |
Weighted average common shares outstanding used in computing net income per share-basic (in shares) | 42,230 | 41,150 | 40,208 | ||||||||
Plus: net effect of dilutive stock options and unvested restricted common shares | 1,391 | 1,394 | 1,474 | ||||||||
Weighted average common shares outstanding used in computing net income per share-diluted | 43,621 | 42,544 | 41,682 | ||||||||
Net income per share-basic (in dollars per share) | $ 0.22 | $ 0.09 | $ 0.02 | $ (0.07) | $ 0.01 | $ 0.29 | $ 0.11 | $ 0.02 | $ 0.26 | $ 0.43 | $ 0.41 |
Net income per share-diluted (in dollars per share) | $ 0.21 | $ 0.09 | $ 0.02 | $ (0.07) | $ 0.01 | $ 0.28 | $ 0.11 | $ 0.02 | $ 0.25 | $ 0.42 | $ 0.39 |
Earnings Per Share - Amounts no
Earnings Per Share - Amounts not included (Details) - shares shares in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Stock options and restricted common shares | |||
Antidilutive Securities | |||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | 4,179 | 4,078 | 2,419 |
Convertible note | |||
Antidilutive Securities | |||
Anti-dilutive securities excluded from computation of earnings per share (in shares) | 19 | 29 | 39 |
Income Taxes - Overview (Detail
Income Taxes - Overview (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Tax credit carry-forwards | |||
Tax benefit associated with the exercise of stock options | $ 34,600 | ||
Limitation on use of carryforwards, cumulative change of control ownership interests, threshold percentage | 50.00% | ||
Limitation on use of carryforwards, cumulative change of control ownership interests, measurement period | 3 years | ||
(Provision for)/benefit from income taxes | |||
Income before taxes | $ 19,369 | $ 28,009 | $ 28,863 |
Current: | |||
Federal | (603) | (1,105) | (665) |
State | (2,773) | (1,819) | (2,050) |
Foreign | (960) | (732) | (154) |
Total | (4,336) | (3,656) | (2,869) |
Deferred: | |||
Federal | (2,960) | (6,085) | (6,815) |
State | (1,015) | (596) | (2,738) |
Total | (3,975) | (6,681) | (9,553) |
Total (provision for)/benefit from income taxes | $ (8,311) | $ (10,337) | $ (12,422) |
Reconciliation of statutory federal income tax rate to effective income tax rate | |||
U.S. federal statutory tax rate (as a percent) | 35.00% | 35.00% | 35.00% |
State and local income taxes (as a percent) | 13.30% | 3.70% | 10.70% |
Non-deductible payment to prior shareholders (as a percent) | 15.80% | ||
Foreign income tax (as a percent) | 3.20% | 1.80% | 0.10% |
Stock option compensation (as a percent) | 10.40% | 4.80% | 3.50% |
Stock option shortfall (as a percent) | 0.30% | ||
Research and development and orphan drug credits (as a percent) | (42.90%) | (15.50%) | (9.10%) |
Increase to Uncertain Tax Positions | 7.10% | 2.30% | 1.50% |
Other nondeductible and permanent differences (as a percent) | 1.90% | 2.60% | 1.00% |
Provision (benefit) attributable to valuation allowance (as a percent) | (0.90%) | 2.20% | |
Effective income tax rate (as a percent) | 42.90% | 36.90% | 43.00% |
Deferred tax assets: | |||
Net operating loss and other carryforwards | $ 60,889 | $ 69,149 | |
Tax credit | 20,778 | 13,199 | |
Deferred revenue | 13,949 | 29,144 | |
Stock based compensation | 27,142 | 22,776 | |
Contingent consideration | 23,298 | 19,142 | |
Other | 13,723 | 11,359 | |
Total deferred tax assets | 159,779 | 164,769 | |
Valuation allowance | (5,277) | (5,497) | |
Total deferred tax assets net of valuation allowance | 154,502 | 159,272 | |
Deferred tax liabilities: | |||
Intangible assets | (145,433) | (142,735) | |
Convertible debt | (19,087) | (22,002) | |
Total deferred tax liabilities | 164,520 | 164,737 | |
Deferred tax liabilities, net, total | 10,018 | 5,465 | |
Reconciliation of unrecognized tax benefits | |||
Beginning of period balance | 3,295 | 2,244 | $ 1,936 |
Increases for tax positions taken during a prior period | 308 | 451 | 589 |
Decreases for tax positions taken during a prior period | (200) | (511) | |
Increases for tax positions taken during the current period | 1,232 | 800 | 230 |
Ending period balance | 4,835 | 3,295 | $ 2,244 |
Deferred Tax Expense from Stock Options Exercised | 12,000 | ||
Accounting Standards Update 2015-17 | Scenario, Previously Reported [Member] | Recent accounting pronouncements adjustment | |||
Deferred tax liabilities: | |||
Deferred tax liabilities, net, total | 5,465 | ||
Accounting Standards Update 2015-17 | Restatement Adjustment [Member] | Recent accounting pronouncements adjustment | |||
Deferred tax liabilities: | |||
Deferred tax liabilities, net, total | 5,465 | ||
Research and development | |||
Tax credit carry-forwards | |||
Tax credit carry-forwards | 20,300 | 11,900 | |
Alternative Minimum Tax credit carry-forwards | |||
Tax credit carry-forwards | |||
Tax credit carry-forwards | $ 3,800 | $ 3,300 |
Income Taxes - Operating Loss C
Income Taxes - Operating Loss Carryforwards (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Recent Accounting Pronouncements | ||
Net deferred tax assets (liability) | $ (10,018) | $ (5,465) |
Minimum | ||
Recent Accounting Pronouncements | ||
Expiration term for statute of limitations | 3 years | |
Maximum | ||
Recent Accounting Pronouncements | ||
Expiration term for statute of limitations | 5 years | |
Federal | ||
Recent Accounting Pronouncements | ||
Operating Loss Carryforwards | $ 195,000 | 215,200 |
State | ||
Recent Accounting Pronouncements | ||
Operating Loss Carryforwards | $ 11,800 | $ 14,700 |
License, Research and Collabo53
License, Research and Collaboration Agreements - Alkermes License (Details) - Alkermes License Agreement - item | Dec. 31, 2003 | Dec. 31, 2015 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Number of prior license and supply agreements | 2 | |
License termination period | 15 years | |
Percentage of products under supply agreement | 100.00% |
License, Research and Collabo54
License, Research and Collaboration Agreements - Convertible Note (Details) $ in Thousands | Dec. 31, 2015USD ($)instrument | Dec. 23, 2005instrument | Dec. 31, 2003USD ($)item | Dec. 31, 2006shares | Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | Jun. 17, 2014USD ($) |
Notes | |||||||
Convertible Note | |||||||
Aggregate loan | $ | $ 345,000 | $ 345,000 | $ 345,000 | $ 345,000 | |||
Interest rate (as a percent) | 1.75% | 1.75% | |||||
Debt instrument payment period | 7 years | ||||||
Notes | Alkermes License Agreement | |||||||
Convertible Note | |||||||
Aggregate loan | $ | $ 7,500 | ||||||
Number of convertible promissory notes | item | 2 | ||||||
Convertible promissory note 1 | Alkermes License Agreement | |||||||
Convertible Note | |||||||
Aggregate loan | $ | $ 7,500 | ||||||
Number of convertible promissory notes | item | 2 | ||||||
Number of promissory notes outstanding | item | 1 | ||||||
Convertible Notes Payable | $ | $ 5,000 | $ 5,000 | |||||
Interest rate (as a percent) | 3.00% | 3.00% | |||||
Number of shares of common stock note can be converted into | instrument | 19,279 | 67,476 | |||||
Debt instrument payment period | 7 years | ||||||
Debt instrument payment period before regulatory approval for the products developed | 1 year | ||||||
Convertible promissory note 2 | Alkermes License Agreement | |||||||
Convertible Note | |||||||
Convertible Notes Payable | $ | $ 2,500 | ||||||
Converted principal into shares of common stock | shares | 210,863 | ||||||
Debt instrument payment, number of installments | item | 7 | ||||||
Debt instrument, frequency of periodic payment number of successive anniversaries | item | 6 | ||||||
Minimum prepayment written notice term | 30 days |
License, Research and Collabo55
License, Research and Collaboration Agreements - Supply Agreement (Details) - Supply agreement | 12 Months Ended |
Dec. 31, 2015 | |
Alkermes License Agreement | Minimum | |
Supply Agreement | |
Purchase obligation percentage | 75.00% |
Alkermes License Agreement | Maximum | |
Supply Agreement | |
Purchase requirements threshold percentage | 100.00% |
Patheon Inc Second Manufacturing agreement | Maximum | |
Supply Agreement | |
Purchase requirements threshold percentage | 25.00% |
License, Research and Collabo56
License, Research and Collaboration Agreements - Rush Agreement (Details) $ in Millions | Dec. 31, 2015USD ($) |
Rush Agreement | |
Collaboration agreement | |
Amount or royalty payments made or accrued | $ 37.4 |
License, Research and Collabo57
License, Research and Collaboration Agreements - Biogen Agreement (Details) - USD ($) $ in Thousands | Jul. 07, 2009 | Jul. 01, 2009 | Jun. 30, 2009 | Jul. 31, 2015 | Dec. 31, 2012 | Feb. 29, 2012 | Aug. 31, 2011 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Sep. 30, 2013 | Sep. 30, 2011 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Collaboration agreement | |||||||||||||||||||||
Royalty revenues | $ 17,492 | $ 19,131 | $ 17,056 | ||||||||||||||||||
Revenue recognized | $ 130,903 | $ 148,199 | $ 113,707 | $ 99,851 | $ 117,872 | $ 105,961 | $ 97,129 | $ 80,518 | 466,111 | 373,292 | 310,317 | ||||||||||
Cost of sales | 92,297 | 79,981 | 66,009 | ||||||||||||||||||
Neuronex Acquisition | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Additional payment pursuant to the amendment of the merger agreement | $ 8,750 | $ 8,750 | |||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Fair value of consideration transferred | $ 6,800 | ||||||||||||||||||||
Tangible net assets acquired, primarily the taxable amount of net operating loss carryforwards | 3,700 | $ 3,700 | |||||||||||||||||||
Holdback provision | 300 | 100 | 300 | ||||||||||||||||||
Upfront payments recorded as research and development expense | 2,000 | ||||||||||||||||||||
Advance funding payments recorded as research and development expense | $ 1,500 | ||||||||||||||||||||
DZNS | Neuronex Acquisition | |||||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Payments recorded as research and development expense | $ 2,000 | 1,500 | |||||||||||||||||||
Royalty payment period | 10 years | ||||||||||||||||||||
DZNS | Maximum | Neuronex Acquisition | Achievement of Manufacturing and Regulatory Milestones | |||||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Maximum contingent acquisition payment | $ 18,000 | 3,000 | 3,000 | 18,000 | |||||||||||||||||
DZNS | Maximum | Neuronex Acquisition | Achievement of Sales Milestones | |||||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Maximum contingent acquisition payment | $ 105,000 | 100,000 | 100,000 | $ 105,000 | |||||||||||||||||
Biogen | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Additional payments based on the successful achievement of future regulatory or sales milestones | $ 25,000 | ||||||||||||||||||||
Amortized license revenue | $ 110,000 | 9,100 | 9,100 | 9,100 | |||||||||||||||||
Deferred Revenue | 110,000 | ||||||||||||||||||||
Cash received | $ 110,000 | ||||||||||||||||||||
Amount of significant and incremental discount related to the supply agreement | 0 | ||||||||||||||||||||
Identified non-contingent deliverables value on standalone basis, if sold separately | 0 | ||||||||||||||||||||
Biogen | Maximum | Achievement of Manufacturing and Regulatory Milestones | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Additional payments based on the successful achievement of future regulatory or sales milestones | 10,000 | ||||||||||||||||||||
Biogen | Maximum | Achievement of Sales Milestones | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Additional payments based on the successful achievement of future regulatory or sales milestones | 365,000 | ||||||||||||||||||||
Alkermes License Agreement | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Cost of license payable | $ 7,700 | 600 | $ 600 | 600 | 600 | $ 600 | |||||||||||||||
Payment for product license | $ 7,700 | ||||||||||||||||||||
Portion of milestone payment from Acorda to Alkermes (as a percent) | 7.00% | ||||||||||||||||||||
Allergan/Watson | Zanaflex Capsules | |||||||||||||||||||||
Collaboration agreement | |||||||||||||||||||||
Royalty revenues | 7,000 | 9,100 | |||||||||||||||||||
Revenue recognized | 3,800 | 4,600 | |||||||||||||||||||
Cost of sales | 3,800 | $ 4,600 | |||||||||||||||||||
SK | DZNS | Neuronex Acquisition | Achievement of Manufacturing and Regulatory Milestones | |||||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Maximum contingent acquisition payment | 8,000 | 8,000 | |||||||||||||||||||
Cost of license | $ 1,000 | ||||||||||||||||||||
SK | DZNS | Neuronex Acquisition | Achievement of Sales Milestones | |||||||||||||||||||||
Business Acquisition | |||||||||||||||||||||
Maximum contingent acquisition payment | $ 3,000 | $ 3,000 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - 401(k) plan - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Employee Benefit Plan | |||
Maximum percentage of employee earnings eligible for additional company contribution | 6.00% | ||
Additional company contribution for each dollar of employee contribution (as a percent) | 50.00% | ||
Company expense related to the defined contribution plan | $ 2.4 | $ 1.9 | $ 1.5 |
Commitments and Contingencies59
Commitments and Contingencies (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2011 | Mar. 31, 2012USD ($) | Jun. 30, 2010USD ($) | Dec. 31, 2015USD ($)ft²item | Dec. 31, 2014USD ($)ft² | Dec. 31, 2013USD ($) | |
Commitments and contingencies | ||||||
Lease Term | 15 years | |||||
Area of facility including office and laboratory space | ft² | 138,000 | |||||
Number of additional periods | item | 3 | |||||
Lease options duration | 5 years | |||||
Termination option period | 10 years | |||||
Additional lease option rights (in square feet) | ft² | 120,000 | |||||
Additional Lease Option Rights Exercised (In Square Feet) | ft² | 25,405 | |||||
Base rent | $ 4,400 | |||||
Annual rent increase percentage | 2.50% | |||||
Future Rent Payments | ||||||
2,016 | $ 5,396 | |||||
2,017 | 5,531 | |||||
2,018 | 5,669 | |||||
2,019 | 5,811 | |||||
2,020 | 5,956 | |||||
Later years | 18,177 | |||||
Total rent payments | 46,540 | |||||
Rent expense under operating leases | $ 4,800 | $ 3,500 | $ 3,400 | |||
Civitas Therapeutics | ||||||
Commitments and contingencies | ||||||
Area of facility including office and laboratory space | ft² | 90,000 | |||||
Number of additional periods | item | 2 | |||||
Lease options duration | 5 years | |||||
Base rent | $ 1,000 | |||||
Ampyra license agreement | ||||||
Commitments and contingencies | ||||||
Purchase commitments | 34,600 | |||||
Maximum | ||||||
Commitments and contingencies | ||||||
Maximum milestone payments | $ 157,000 | |||||
Ampyra and Zanaflex supply requirements | ||||||
Commitments and contingencies | ||||||
Written forecasts for supply requirements and agreements | 18 months | |||||
Ampyra supply requirements | ||||||
Commitments and contingencies | ||||||
Written forecasts for supply requirements and agreements | 5 years | |||||
Time period after submission of forecast the company is obligated to purchase product | 3 months | |||||
Zanaflex supply requirements | ||||||
Commitments and contingencies | ||||||
Written forecasts for supply requirements and agreements | 2 years | |||||
Time period after submission of forecast the company is obligated to purchase product | 5 months | |||||
Alkermes License Agreement | ||||||
Commitments and contingencies | ||||||
Milestone payment triggered upon acceptance of FDA new drug application | $ 2,500 | |||||
Alkermes License Agreement | Ampyra license agreement | ||||||
Commitments and contingencies | ||||||
Milestone payment recorded as intangible asset | $ 2,500 | |||||
Alkermes License Agreement | Maximum | ||||||
Commitments and contingencies | ||||||
Maximum milestone payments | $ 15,000 |
Intangible Assets and Goodwil60
Intangible Assets and Goodwill - CVT & Ampyra (Details) $ in Thousands | Jan. 22, 2010USD ($)item | Apr. 30, 2011 | Mar. 31, 2012USD ($) | Mar. 31, 2010USD ($) |
Alkermes License Agreement | Ampyra | ||||
Disclosures related to various arrangements entered into by the entity | ||||
Number of milestone payments | item | 2 | |||
Milestone payments made under agreement | $ 2,500 | $ 2,500 | ||
Additional payments based on the successful achievement of future regulatory or sales milestones | $ 2,500 | |||
Period for milestone payment | 2 years | |||
Aggregate milestone payments made under agreement | $ 3,250 | |||
Rush Agreement | Ampyra | ||||
Disclosures related to various arrangements entered into by the entity | ||||
Milestone payments made under agreement | $ 800 | |||
CRSO Agreement | Ampyra | ||||
Disclosures related to various arrangements entered into by the entity | ||||
U.S. sales, marketing and distribution rights | $ 3,000 | |||
Ampyra Agreement | ||||
Disclosures related to various arrangements entered into by the entity | ||||
Initial patent term adjustment | 298 days |
Intangible Assets and Goodwil61
Intangible Assets and Goodwill - NP, Wbesites, and Goodwill (Details) | Jul. 08, 2013USD ($)item | Jul. 31, 2013USD ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Oct. 22, 2014USD ($) | Oct. 21, 2014USD ($) |
Finite-Lived Intangible Assets | |||||||
Impairment charge | $ 6,991,000 | ||||||
Intangible asset amount | $ 443,375,000 | $ 444,520,000 | 443,375,000 | ||||
Less accumulated amortization | 10,553,000 | 13,664,000 | 10,553,000 | ||||
Total | 432,822,000 | 430,856,000 | 432,822,000 | ||||
Amortization expense | 3,100,000 | 3,300,000 | |||||
Estimated future amortization expense | |||||||
2,016 | 2,558,000 | ||||||
2,017 | 1,587,000 | ||||||
2,018 | 918,000 | ||||||
2,019 | 588,000 | ||||||
2,020 | 316,000 | ||||||
Thereafter | 1,889,000 | ||||||
Total | 7,856,000 | ||||||
Goodwill carrying value | |||||||
Goodwill | 182,952,000 | 183,636,000 | 182,952,000 | ||||
NeurogesX | |||||||
Finite-Lived Intangible Assets | |||||||
Number of neuropathic pain management assets acquired | item | 2 | 2 | |||||
Qutenza | |||||||
Finite-Lived Intangible Assets | |||||||
Impairment charge | 300,000 | 257,000 | |||||
Civitas Therapeutics | |||||||
Goodwill carrying value | |||||||
Goodwill | 183,000,000 | 183,636,000 | 183,000,000 | $ 183,636,000 | $ 182,952,000 | ||
In-process research and development | NP-1998 | |||||||
Allocation of purchase price to assets acquired | |||||||
Value allocated to acquired intangible asset | $ 6,991,000 | ||||||
In-process research and development | CVT-301 and ARCUS | |||||||
Finite-Lived Intangible Assets | |||||||
Indefinite lived intangible asset | 423,000,000 | 423,000,000 | 423,000,000 | ||||
In-process research and development | Civitas Therapeutics | |||||||
Allocation of purchase price to assets acquired | |||||||
Value allocated to acquired intangible asset | $ 423,000,000 | ||||||
Ampyra milestones | |||||||
Finite-Lived Intangible Assets | |||||||
Intangible asset amount | 5,750,000 | $ 5,750,000 | 5,750,000 | ||||
Estimated remaining useful lives | 11 years | ||||||
Ampyra CSRO royalty buyout | |||||||
Finite-Lived Intangible Assets | |||||||
Intangible asset amount | 3,000,000 | $ 3,000,000 | 3,000,000 | ||||
Estimated remaining useful lives | 4 years | ||||||
Developed technology | Qutenza | |||||||
Allocation of purchase price to assets acquired | |||||||
Value allocated to acquired intangible asset | $ 450,000 | $ 450,000 | |||||
Website development costs | |||||||
Finite-Lived Intangible Assets | |||||||
Intangible asset amount | 11,319,000 | $ 12,504,000 | 11,319,000 | ||||
Estimated remaining useful lives | 3 years | ||||||
Website development costs - in process | |||||||
Finite-Lived Intangible Assets | |||||||
Intangible asset amount | 306,000 | $ 266,000 | 306,000 | ||||
IPR&D | |||||||
Finite-Lived Intangible Assets | |||||||
Impairment charge | $ 6,991,000 | ||||||
IPR&D | NP-1998 | |||||||
Finite-Lived Intangible Assets | |||||||
Impairment charge | $ 7,000,000 |
Debt - Convertible Senior Notes
Debt - Convertible Senior Notes (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2015USD ($)item$ / shares | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Jun. 17, 2014USD ($) | |
Convertible senior notes | ||||
Amortization of debt issuance costs | $ 15 | $ 27 | $ 50 | |
Amortization of debt discount | 3,366 | 3,571 | 2,526 | |
Total interest expense | $ 15,472 | 9,288 | $ 2,170 | |
Notes | ||||
Convertible senior notes | ||||
Interest rate (as a percent) | 1.75% | |||
Net proceeds from offering, after deducting Underwriter's discount and estimated offering expenses payable | $ 337,500 | |||
Redemption price of debt (as a percent) | 100.00% | |||
Period to comply with covenants | 270 days | |||
Principal | $ 345,000 | 345,000 | $ 345,000 | |
Less: debt discount, net | (49,531) | (57,301) | ||
Net carrying amount | 295,469 | 287,699 | ||
Equity component | 61,195 | 61,195 | ||
Debt issuance costs | 7,500 | |||
Debt issuance costs allocated to equity component | 1,300 | |||
Debt issuance costs allocated to liability component | $ 6,200 | |||
Term of debt | 7 years | |||
Debt fair value amount | $ 398,000 | |||
Remaining contractual life | 5 years 6 months | |||
Effective interest rate on liability component (as a percent) | 4.80% | |||
Contractual interest expense | $ 6,038 | 3,153 | ||
Amortization of debt issuance costs | 792 | 397 | ||
Amortization of debt discount | 7,770 | 3,894 | ||
Total interest expense | 14,600 | $ 7,444 | ||
Notes | Debt Conversion Terms upon Occurrence of Certain Fundamental Company Changes | ||||
Convertible senior notes | ||||
Principal amount of Notes or an integral multiple thereof in which holder may repurchase the Notes | $ 1 | |||
Redemption price as percentage of principal amount of notes plus accrued and unpaid interest | 100.00% | |||
Notes | Debt Conversion Event Term | ||||
Convertible senior notes | ||||
Minimum percentage of aggregate principal amount held by bondholders to declare notes due and payable | 25.00% | |||
In event of default arising out of certain bankruptcy events, percentage of principal amount due and payable | 100.00% | |||
Notes | Convertible Debt Holder | ||||
Convertible senior notes | ||||
Initial conversion rate of common stock | 23.4968 | |||
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares | $ 42.56 | |||
Number of trading days in the measurement period that the entity's common stock closing price to conversion price must exceed a specified percentage of conversion price to trigger conversion feature of notes | item | 5 | |||
Ratio of closing share price to conversion price as a condition for conversion of Convertible Notes (as a percent) | 98.00% | |||
Number of trading days within which redemption condition is to be met prior to provision of notice | 5 days | |||
Notes | Convertible Debt Holder | Minimum | ||||
Convertible senior notes | ||||
Number of trading days in the measurement period that the entity's common stock closing price to conversion price must exceed a specified percentage of conversion price to trigger conversion feature of notes | item | 20 | |||
Number of trading days triggering conversion of redemption feature | 30 days | |||
Target ratio of closing share price to conversion price as a condition for conversion or redemption of Convertible Notes (as a percent) | 130.00% |
Debt - Convertible Note and Int
Debt - Convertible Note and Interests (Details) | Dec. 31, 2003USD ($)item | Dec. 31, 2003USD ($)item | 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 ($)item | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2006USD ($) | Dec. 01, 2010USD ($) | Dec. 01, 2009USD ($) | Nov. 30, 2006USD ($) | Dec. 23, 2005USD ($) |
Sale of Revenue Interest | ||||||||||||||||||
Net product revenues | $ 130,903,000 | $ 148,199,000 | $ 113,707,000 | $ 99,851,000 | $ 117,872,000 | $ 105,961,000 | $ 97,129,000 | $ 80,518,000 | $ 466,111,000 | $ 373,292,000 | $ 310,317,000 | |||||||
Letters of Credit | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Restricted Cash and Cash Equivalents | 5,800,000 | $ 5,800,000 | ||||||||||||||||
Alkermes License Agreement | ||||||||||||||||||
Convertible Note | ||||||||||||||||||
Number of prior license and supply agreements | item | 2 | |||||||||||||||||
Alkermes License Agreement | Convertible promissory note 1 | ||||||||||||||||||
Convertible Note | ||||||||||||||||||
Number of promissory notes outstanding | item | 1 | |||||||||||||||||
Remaining outstanding amount | $ 5,000,000 | $ 5,000,000 | ||||||||||||||||
Interest rate (as a percent) | 3.00% | 3.00% | ||||||||||||||||
Convertible Note | ||||||||||||||||||
Aggregate loan | $ 7,500,000 | $ 7,500,000 | ||||||||||||||||
Number of convertible promissory notes | item | 2 | |||||||||||||||||
PRF | Zanaflex | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Cash received on assignment of revenue interest | $ 5,000,000 | $ 15,000,000 | ||||||||||||||||
Additional milestone payments due | $ 5,000,000 | |||||||||||||||||
Threshold of net revenue for additional milestone payments | $ 25,000,000 | |||||||||||||||||
Cash repaid on achievement of milestone | $ 5,000,000 | $ 5,000,000 | ||||||||||||||||
Valeant | Zanaflex | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Multiplier of the aggregate amount that has been paid to the Company under the agreement | item | 2.1 | |||||||||||||||||
Percentage of net revenue the amended agreement | 1.00% | |||||||||||||||||
Imputed interest rate (as a percent) | 5.80% | |||||||||||||||||
Interest expense | $ 900,000 | 1,700,000 | $ 2,000,000 | |||||||||||||||
Cumulative payments made for reaching sales levels and milestones | $ 52,500,000 | |||||||||||||||||
Period for exercising call option | 180 days | |||||||||||||||||
Put/call price as percentage of net payments | 150.00% | |||||||||||||||||
Percentage of internal rate of return to third party based on net payments | 25.00% | |||||||||||||||||
Estimated fair value of net liability related to the put/call option | $ 0 | $ 0 | $ 0 | 0 | ||||||||||||||
Gain (loss) recorded due to change in fair value of the net put/call liability | $ 147,000 | |||||||||||||||||
Valeant | Zanaflex | Up to and including $30.0 million | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Net product revenues | $ 30,000,000 | |||||||||||||||||
Percentage of net revenues assigned | 15.00% | |||||||||||||||||
Valeant | Zanaflex | In excess of $30.0 million but less than and including $60.0 million | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Percentage of net revenues assigned | 6.00% | |||||||||||||||||
Valeant | Zanaflex | In excess of $30.0 million but less than and including $60.0 million | Minimum | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Net product revenues | $ 30,000,000 | |||||||||||||||||
Valeant | Zanaflex | In excess of $30.0 million but less than and including $60.0 million | Maximum | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Net product revenues | 60,000,000 | |||||||||||||||||
Valeant | Zanaflex | In excess of $60.0 million | ||||||||||||||||||
Sale of Revenue Interest | ||||||||||||||||||
Net product revenues | $ 60,000,000 | |||||||||||||||||
Percentage of net revenues assigned | 1.00% |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Assets Carried at Fair Value: | ||
Short-term investments | $ 200,101 | $ 125,448 |
Recurring basis | Level 1 | ||
Assets Carried at Fair Value: | ||
Cash equivalents | 70,504 | 149,754 |
Recurring basis | Level 2 | ||
Assets Carried at Fair Value: | ||
Cash equivalents | 13,009 | |
Short-term investments | 200,101 | 125,448 |
Recurring basis | Level 3 | Contingent liability | ||
Liabilities Carried at Fair Value: | ||
Acquired contingent consideration | $ 63,500 | $ 52,600 |
Fair Value Measurements - Level
Fair Value Measurements - Level 3 (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Contingent liability | ||
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||
Balance, beginning of period | $ 52,600 | |
Fair value of acquired contingent consideration | $ 50,400 | |
Total losses included in the statement of operations | 10,900 | 2,200 |
Balance, end of period | $ 63,500 | 52,600 |
Milestone payment, minimum (as a percent) | 28.50% | |
Milestone payment, maximum (as a percent) | 70.00% | |
Milestone payment, minimum | $ 0 | |
Milestone payment, maximum | $ 60,000 | |
Put/call liability | ||
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||
Balance, beginning of period | 147 | |
Total losses included in the statement of operations | (147) | |
Contingent purchase price | ||
Assets and liabilities measured at fair value on a recurring basis utilizing Level 3 inputs | ||
Balance, beginning of period | 236 | |
Total losses included in the statement of operations | $ (236) |
Fair Value Measurements - Nonre
Fair Value Measurements - Nonrecurring (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Non-financial assets | |||
Intangible asset impairment | $ 6,991 | ||
Total impairment losses | $ 0 | 7,248 | |
IPR&D | |||
Non-financial assets | |||
Intangible asset impairment | 6,991 | ||
NP-1998 | IPR&D | |||
Non-financial assets | |||
Intangible asset impairment | $ 7,000 | ||
NP-1998 | IPR&D | Asset Impairment | |||
Non-financial assets | |||
Intangible asset impairment | 7,000 | ||
Qutenza | |||
Non-financial assets | |||
Intangible asset impairment | 300 | $ 257 | |
Qutenza | Cost of Sales [Member] | |||
Non-financial assets | |||
Intangible asset impairment | $ 300 |
Quarterly Consolidated Financ67
Quarterly Consolidated Financial Data (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Jul. 31, 2015 | 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 | |
Total net revenues | $ 130,903 | $ 148,199 | $ 113,707 | $ 99,851 | $ 117,872 | $ 105,961 | $ 97,129 | $ 80,518 | $ 466,111 | $ 373,292 | $ 310,317 | |
Gross profit | 104,343 | 123,299 | 90,840 | 81,247 | 92,737 | 85,227 | 78,071 | 64,831 | ||||
Net income (loss)-basic and diluted | $ 9,205 | $ 3,941 | $ 997 | $ (3,085) | $ 331 | $ 11,953 | $ 4,685 | $ 703 | $ 11,058 | $ 17,672 | $ 16,441 | |
Net income per share-basic (in dollars per share) | $ 0.22 | $ 0.09 | $ 0.02 | $ (0.07) | $ 0.01 | $ 0.29 | $ 0.11 | $ 0.02 | $ 0.26 | $ 0.43 | $ 0.41 | |
Net income per share-diluted (in dollars per share) | $ 0.21 | $ 0.09 | $ 0.02 | $ (0.07) | $ 0.01 | $ 0.28 | $ 0.11 | $ 0.02 | $ 0.25 | $ 0.42 | $ 0.39 | |
Net adjustment from previously deferred product sales | $ 22,200 | |||||||||||
Impairment charge | $ 6,991 | |||||||||||
IPR&D | ||||||||||||
Impairment charge | $ 6,991 | |||||||||||
NP-1998 | IPR&D | ||||||||||||
Impairment charge | $ 7,000 | |||||||||||
Neuronex Acquisition | ||||||||||||
Additional payment pursuant to the amendment of the merger agreement | $ 8,750 | $ 8,750 |