Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Feb. 22, 2016 | Jun. 30, 2015 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2015 | ||
Document Fiscal Year Focus | 2,015 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MNKD | ||
Entity Registrant Name | MANNKIND CORP | ||
Entity Central Index Key | 899,460 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 428,850,858 | ||
Entity Public Float | $ 1,461,620,053 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 59,074 | $ 120,841 |
Receivables from collaboration | 23 | 50,436 |
Inventory-current | 9,670 | |
Deferred product costs from collaboration | 13,539 | |
Prepaid expenses and other current assets | 4,018 | 20,206 |
Total current assets | 76,654 | 201,153 |
Property and equipment - net | 48,749 | 192,127 |
State research and development credit exchange receivable - net of current portion | 311 | |
Other assets | 1,009 | 848 |
Total | 126,412 | 394,439 |
Current liabilities: | ||
Accounts payable | 15,599 | 7,394 |
Accrued expenses and other current liabilities | 7,929 | 26,206 |
Facility financing obligation | 74,582 | 72,995 |
Senior convertible notes - current | 99,355 | |
Deferred product sales from collaboration | 17,503 | 436 |
Purchase commitment liabilities - current | 12,475 | |
Deferred payments from collaboration | 140,231 | 196,967 |
Total current liabilities | 268,319 | 403,353 |
Note payable to principal stockholder | 49,521 | 49,521 |
Sanofi loan facility and loss share obligation | 62,371 | 3,034 |
Senior convertible notes - long term | 27,613 | |
Purchase commitments - long term | 53,692 | |
Other liabilities | 15,225 | 12,301 |
Total liabilities | $ 476,741 | $ 468,209 |
Commitments and contingencies | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2015 and 2014 | ||
Common stock, $0.01 par value - 550,000,000 shares authorized at December 31, 2015 and 2014, respectively; 428,670,943 and 406,059,089 shares issued and outstanding at December 31, 2015 and 2014, respectively | $ 4,287 | $ 4,061 |
Additional paid-in capital | 2,508,633 | 2,416,967 |
Accumulated other comprehensive loss | (20) | (14) |
Accumulated deficit | (2,863,229) | (2,494,784) |
Total stockholders' deficit | (350,329) | (73,770) |
Total | $ 126,412 | $ 394,439 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2015 | Dec. 31, 2014 |
Undesignated preferred stock, par value | $ 0.01 | $ 0.01 |
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Undesignated preferred stock, shares issued | 0 | 0 |
Undesignated preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 550,000,000 | 550,000,000 |
Common stock, shares issued | 428,670,943 | 406,059,089 |
Common stock, shares outstanding | 428,670,943 | 406,059,089 |
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 | |
Revenue | $ 0 | $ 0 | $ 0 |
Operating expenses: | |||
Research and development | 29,674 | 100,244 | 109,719 |
General and administrative | 40,960 | 79,383 | 59,682 |
Product manufacturing | 67,442 | ||
Property and equipment impairment | 140,412 | 0 | 0 |
Loss on purchase commitments | 66,167 | ||
Total operating expenses | 344,655 | 179,627 | 169,401 |
Loss from operations | (344,655) | (179,627) | (169,401) |
Other income (expense) | 1,366 | 1,679 | (635) |
Loss on extinguishment of debt | (1,049) | ||
Interest expense on note payable to principal stockholder | (2,894) | (2,894) | (6,309) |
Interest expense on notes | (21,231) | (17,549) | (15,153) |
Interest income | 18 | 9 | 8 |
Loss before benefit for income taxes | (368,445) | (198,382) | (191,490) |
Income tax benefit | 0 | 0 | 0 |
Net loss | $ (368,445) | $ (198,382) | $ (191,490) |
Net loss per share - basic and diluted | $ (0.91) | $ (0.51) | $ (0.64) |
Shares used to compute basic and diluted net loss per share | 406,165 | 385,229 | 299,591 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Net loss | $ (368,445) | $ (198,382) | $ (191,490) |
Other comprehensive loss: | |||
Other comprehensive (loss) income - cumulative translation (loss) gain | (6) | (10) | 2 |
Other comprehensive (loss) gain | (6) | (10) | 2 |
Comprehensive loss | $ (368,451) | $ (198,392) | $ (191,488) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) - USD ($) $ in Thousands | Total | TEL AVIV STOCK EXCHANGE | Common Stock | Common StockTEL AVIV STOCK EXCHANGE | Additional Paid-in Capital | Additional Paid-in CapitalTEL AVIV STOCK EXCHANGE | Accumulated Other Comprehensive Income (Loss) | Deficit Accumulated During the Development Stage |
Beginning Balance (in shares) at Dec. 31, 2012 | 286,035,000 | |||||||
Beginning Balance at Dec. 31, 2012 | $ (110,679) | $ 2,860 | $ 1,991,379 | $ (6) | $ (2,104,912) | |||
Exercise of stock options (in shares) | 880,000 | |||||||
Exercise of stock options | 2,270 | $ 9 | 2,261 | |||||
Issuance of common shares from the release of restricted stock units (in shares) | 1,870,000 | |||||||
Issuance of common shares from the release of restricted stock units | (4,801) | $ 20 | (4,821) | |||||
Issuance of common shares pursuant to warrant exercises (in shares) | 66,353,000 | |||||||
Issuance of common shares pursuant to warrant exercises | 172,149 | $ 664 | 171,485 | |||||
Issuance of common shares pursuant to debt conversions by Deerfield (in Shares) | 1,095,000 | |||||||
Issuance of common shares pursuant to debt conversions by Deerfield | 5,501 | $ 12 | 5,489 | |||||
Issuance of common stock | $ 48,888 | $ 99 | 48,789 | |||||
Issuance of common stock (Shares) | 9,824,000 | |||||||
Issuance of common shares pursuant to litigation settlement (in shares) | 2,778,000 | |||||||
Issuance of common shares pursuant to litigation settlement | $ 28 | (28) | ||||||
Issuance of common shares under Employee Stock Purchase Plan (in shares) | 463,290 | 557,000 | ||||||
Issuance of common shares under Employee Stock Purchase Plan | $ 1,263 | $ 5 | 1,258 | |||||
Stock-based compensation | 45,186 | 45,186 | ||||||
Unrealized gain/(loss) on foreign currency translation | 2 | 2 | ||||||
Commitment to deliver common shares pursuant to Deerfield conversion to additional paid-in capital | 998 | 998 | ||||||
Net loss | (191,490) | (191,490) | ||||||
Ending Balance (in shares) at Dec. 31, 2013 | 369,392,000 | |||||||
Ending Balance at Dec. 31, 2013 | (30,713) | $ 3,697 | 2,261,996 | (4) | (2,296,402) | |||
Exercise of stock options (in shares) | 3,251,000 | |||||||
Exercise of stock options | 10,978 | $ 35 | 10,943 | |||||
Issuance of common shares from the release of restricted stock units (in shares) | 3,996,000 | |||||||
Issuance of common shares from the release of restricted stock units | (26,908) | $ 38 | (26,946) | |||||
Issuance of common shares pursuant to warrant exercises (in shares) | 11,575,000 | |||||||
Issuance of common shares pursuant to warrant exercises | 27,779 | $ 115 | 27,664 | |||||
Issuance of common shares pursuant to debt conversions by Deerfield (in Shares) | 17,521,000 | |||||||
Issuance of common shares pursuant to debt conversions by Deerfield | $ 93,501 | $ 174 | 93,327 | |||||
Issuance of common shares under Employee Stock Purchase Plan (in shares) | 305,076 | 324,000 | ||||||
Issuance of common shares under Employee Stock Purchase Plan | $ 1,363 | $ 2 | 1,361 | |||||
Remeasurement of performance based grants pursuant to the modification of terms | 22,962 | 22,962 | ||||||
Stock-based compensation | 25,660 | 25,660 | ||||||
Unrealized gain/(loss) on foreign currency translation | (10) | (10) | ||||||
Net loss | (198,382) | (198,382) | ||||||
Ending Balance (in shares) at Dec. 31, 2014 | 406,059,000 | |||||||
Ending Balance at Dec. 31, 2014 | $ (73,770) | $ 4,061 | 2,416,967 | (14) | (2,494,784) | |||
Return of loaned common stock (in shares) | (9,000,000) | |||||||
Exercise of stock options (in shares) | 1,700,964 | 1,701,000 | ||||||
Exercise of stock options | $ 3,258 | $ 17 | 3,241 | |||||
Issuance of common shares from the release of restricted stock units (in shares) | 720,000 | |||||||
Issuance of common shares from the release of restricted stock units | $ 7 | (7) | ||||||
Restricted stock units taxes paid in cash | (1,856) | (1,856) | ||||||
Issuance of common shares pursuant to warrant exercises (in shares) | 4,216,000 | |||||||
Issuance of common shares pursuant to warrant exercises | 10,123 | $ 42 | 10,081 | |||||
Capital contribution | 40 | 40 | ||||||
Issuance of common shares pursuant to conversions of certain 2015 note holders (in shares) | 1,874,000 | |||||||
Issuance of common shares pursuant to conversions of certain 2015 notes | 7,926 | $ 19 | 7,907 | |||||
Issuance of common stock for lender financing fees (in shares) | 39,000 | |||||||
Issuance of common stock for lender financing fees | 160 | 160 | ||||||
Discount on notes-for-stock exchange | 169 | 169 | ||||||
Return of loaned common stock | $ (90) | 90 | ||||||
Issuance of common stock | $ 27,844 | $ 34,710 | $ 89 | $ 139 | 27,754 | $ 34,571 | ||
Issuance of common stock (Shares) | 8,940,000 | 13,853,000 | ||||||
Issuance of common shares under Employee Stock Purchase Plan (in shares) | 321,228 | 269,000 | ||||||
Issuance of common shares under Employee Stock Purchase Plan | $ 887 | $ 3 | 884 | |||||
Issuance of warrant liability | (202) | (202) | ||||||
Reclassification of warrant liability to equity | 108 | 108 | ||||||
Stock-based compensation | 8,725 | 8,725 | ||||||
Unrealized gain/(loss) on foreign currency translation | (6) | (6) | ||||||
Net loss | (368,445) | (368,445) | ||||||
Ending Balance (in shares) at Dec. 31, 2015 | 428,671,000 | |||||||
Ending Balance at Dec. 31, 2015 | $ (350,329) | $ 4,287 | 2,508,633 | (20) | (2,863,229) | |||
Return of loaned common stock (in shares) | (9,000,000) | |||||||
Net loss | $ (277,020) | |||||||
Ending Balance (in shares) at Dec. 31, 2015 | 428,671,000 | |||||||
Ending Balance at Dec. 31, 2015 | $ (350,329) | $ 4,287 | $ 2,508,633 | $ (20) | $ (2,863,229) | |||
Return of loaned common stock (in shares) | (9,000,000) |
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 loss | $ (368,445) | $ (198,382) | $ (191,490) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and accretion | 13,276 | 18,575 | 14,057 |
Stock-based compensation expense | 8,725 | 48,622 | 45,186 |
Loss on extinguishment of debt | 1,049 | ||
Loss on purchase commitments | 66,167 | ||
Write-off of Inventory | 36,104 | ||
Loss on sale, abandonment/disposal or impairment of property and equipment | 140,582 | 97 | 817 |
Interest incurred through borrowings under Sanofi Loan Facility | 1,652 | ||
Write-off of derivative liability | (363) | ||
Foreign exchange loss | 2,697 | (10) | 2 |
Changes in assets and liabilities: | |||
Inventory | (26,434) | (9,670) | |
Receivables from collaboration | 50,413 | (50,436) | |
Prepaid expenses and other current assets | 13,485 | (14,734) | (499) |
Deferred product costs from collaboration | (13,539) | ||
Other assets | 150 | (615) | |
Accounts payable | 8,413 | 3,622 | (1,071) |
Accrued expenses and other current liabilities | (12,467) | 2,276 | 3,675 |
Deferred product sales from collaboration | 17,067 | ||
Deferred payments from collaboration | 950 | 200,436 | |
Other liabilities | 2,927 | 2,915 | 591 |
Net cash (used in) provided by operating activities | (57,232) | 4,086 | (128,732) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchase of property and equipment | (10,285) | (24,097) | (7,987) |
Proceeds from sale of property and equipment | 82 | ||
Net cash used in investing activities | (10,203) | (24,097) | (7,987) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock | 4,146 | 12,341 | 3,534 |
Exercise of warrants for common stock | 10,123 | 27,779 | 94,147 |
Proceeds from issuance of facility financing obligation & milestone rights | 40,000 | 119,500 | |
Facility financing obligation & milestone rights issuance costs | (598) | ||
Milestone payment | (4,219) | (3,150) | |
Proceeds from issuance of common stock pursuant to at-the-market issuance | 28,392 | 49,990 | |
Issuance costs associated with the Tel Aviv Stock Exchange | (548) | (1,103) | |
Other | 40 | ||
Payment of employment taxes related to vested restricted stock units | (1,858) | (26,908) | (4,801) |
Net cash provided by financing activities | 5,668 | 70,062 | 145,669 |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS | (61,767) | 50,051 | 8,950 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 120,841 | 70,790 | 61,840 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 59,074 | 120,841 | 70,790 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | |||
Interest paid in cash, net of amounts capitalized to Construction in progress | 13,355 | 11,218 | 13,452 |
Payment of 2015 notes and interest through issuance of common stock | 8,253 | ||
Issuance of common stock pursuant to debt conversion by Deerfield | 93,500 | 6,500 | |
Non-cash construction in progress and property and equipment | 1,768 | 856 | |
Capitalization of interest on note payable to principal stockholder | 7,886 | ||
Reduction of principal on note payable to principal stockholder upon issuance of common stock and exercise of warrants | 78,000 | ||
Reclassification of deferred payments from collaboration to Sanofi loan facility and loss share obligation | 59,337 | 3,034 | |
TEL AVIV STOCK EXCHANGE | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of common stock | 36,142 | ||
Issuance costs associated with the Tel Aviv Stock Exchange | (1,432) | ||
2015 Notes | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Payment of 2015 notes | (64,287) | ||
2018 Notes | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Facility financing obligation & milestone rights issuance costs | $ (831) | ||
2013 Notes | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Payment of 2015 notes | $ (115,000) | ||
Less portion of commitment asset | |||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Write-off Tranche B Commitment Asset | 1,753 | ||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from issuance of facility financing obligation & milestone rights | $ 20,000 |
Description of business and bas
Description of business and basis of presentation | 12 Months Ended |
Dec. 31, 2015 | |
Description of business and basis of presentation | 1. Description of business and basis of presentation Business Basis of Presentation At December 31, 2015, the Company’s capital resources consisted of cash and cash equivalents of $59.1 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing and sales and marketing of AFREZZA and the development of other product candidates. The facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) and the First Amendment to Facility Agreement and Registration Rights Agreement (the “First Amendment”) that resulted in additional sales of an additional tranche of notes (the “Tranche B notes”) (see Note 17 — Facility Agreement) requires the Company to maintain at least $25.0 million in cash and cash equivalents or available borrowings under the loan arrangement, dated as of October 2, 2007, between The Company and The Mann Group LLC (as amended, restated, or otherwise modified as of the date hereof, “the Mann Group Loan Arrangement”), as of the last day of each fiscal quarter. The Company will need to continue to incur expenses for the commercialization of AFREZZA and will need to raise additional capital to finance such activities. The Company cannot be certain that it will be able to raise additional capital on favorable terms, or at all, which raises substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. On August 11, 2014, we executed a license and collaboration agreement (the “Sanofi License Agreement”) with Sanofi-Aventis Deutschland GmbH (which subsequently assigned its rights and obligations under the agreement to Sanofi-Aventis U.S. LLC (“Sanofi”)), pursuant to which Sanofi is responsible for global commercial, regulatory and development activities for AFREZZA. The Sanofi License Agreement became effective on September 23, 2014. The Company manufactured AFREZZA at its manufacturing facility in Danbury, Connecticut to supply Sanofi’s demand for the product pursuant to a supply agreement dated August 11, 2014 (the “Sanofi Supply Agreement”). On January 4, 2016 the Company received notification from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. Sanofi’s notice indicated that the termination was pursuant to Sanofi’s right to terminate the Sanofi License Agreement upon Sanofi’s good faith determination that the commercialization of AFREZZA is no longer economically viable in the United States, in which case the effective date of termination (the “Termination Date”) will be April 4, 2016. In the alternative, Sanofi indicated that the termination was also pursuant to its right to terminate the Sanofi License Agreement for any reason, in which case the Termination Date will be July 4, 2016. In the interest of an expedient transition, the Company is working with Sanofi to transfer and wind down the agreement activities by April 4, 2016, or as soon as practicable thereafter. Under the Sanofi License Agreement, worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by the Company and Sanofi that are specifically attributable or related to the development, regulatory filings, manufacturing, or commercialization of AFREZZA, are shared 65% by Sanofi and 35% by the us. As a result of the loss share provision, and because the Company does not have the ability to estimate the amount of costs that would potentially be incurred related to the Sanofi License Agreement, the amount of up-front cash payment or milestone payments that could be recognized as revenue is not fixed or determinable. In connection with the Sanofi License Agreement, an affiliate of Sanofi provided the Company with a secured loan facility (the “Sanofi Loan Facility”) of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. Additional funding sources that are, or in certain circumstances may be available to the Company, include approximately $30.1 million principal amount of available borrowings under The Mann Group Loan Arrangement. A portion of these available borrowings may be used to capitalize accrued interest into principal, upon mutual agreement of the parties, as it becomes due and payable under The Mann Group Loan Arrangement. (see note 7 — Related-party arrangements). The Company cannot provide assurances that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company will need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, asset sales or other means, in order to continue the development and commercialization of AFREZZA and other product candidates and to support its other ongoing activities. However, the Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. Principles of Consolidation Segment Information Segment Reporting |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2015 | |
Summary of significant accounting policies | 2. Summary of significant accounting policies Financial Statement Estimates License and Collaboration and Supply Agreements The Company analyzes consideration received under the provisions of ASC 605, Revenue Recognition, to determine whether the consideration, or a portion thereof, could be recognized as revenue. ASC 605 provides that revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collection is reasonably assured. In arrangements involving the delivery of more than one element, each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is generally based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration that is fixed and determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price and (iii) best estimate of selling price (BESP). The BESP reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. In general, the consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. The assessment of multiple element arrangements requires judgment in order to determine the appropriate units of accounting and the points in time that, or periods over which, revenue should be recognized. Given that, as of December 31, 2015, the Company did not have the ability to estimate the amount of costs that would potentially be incurred under the loss share provision related to the Sanofi License Agreement and the Sanofi Supply Agreement, the Company believe the fixed and determinable fee requirement for revenue recognition was not met. Cash and Cash Equivalents Concentration of Credit Risk State Research and Development Credit Exchange Receivable Prepaid expenses and other current assets — Sale of intellectual property Milestone Rights The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s Statement of Operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event (see Note 17 — Facility Agreement). As of December 31, 2015, the remaining liability balance of $8.9 million was classified as long-term liability in other liabilities. Deferred product costs from collaboration Fair Value of Financial Instruments Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. The carrying amounts reflected in the consolidated balance sheets for cash equivalents, other current assets, accounts payable, and accrued expenses and other current liabilities, approximate fair value due to their relatively short maturities. Inventories We analyzed our inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. We performed an assessment of projected sales and to evaluate the lower of cost or market and the potential excess inventory on hand at December 31, 2015. As a result of this assessment, we recorded a charge of $39.3 million to record the inventory raw materials on hand at the lower of cost or market, inventory expiry, and write-off other inventory related assets. In connection with the projected sales assessment, we also evaluated our inventory purchase commitments totalling $116.2 million for potential impairment. As a result of this assessment, we recorded a $66.2 million charge related to a loss on future purchase commitments both from a lower of cost or market excess inventory perspective. The purchase commitment obligation has been reduced to reflect our expectation that a portion will be recoverable from a third party. Property and Equipment Impairment of Long-Lived Assets Property Plant and Equipment. • significant changes in the Company’s strategic business objectives and utilization of the assets; • a determination that the carrying value of such assets cannot be recovered through undiscounted cash flows; • loss of legal ownership or title to the assets; • a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator; or • the impact of significant negative industry or economic trends. If the Company believes an asset to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Any write-downs would be treated as permanent reductions in the carrying amount of the asset and an operating loss would be recognized. The Company recorded an asset impairment of $140.4 million for the year ended December 31, 2015 (see Note 5 — Property and Equipment). No asset impairment was recognized during the years ended December 31, 2014, and 2013, respectively. Income Taxes Income tax positions are considered for uncertainty in accordance with ASC 740-10-25 Income Taxes, Significant management judgment is involved in determining the provision for income taxes, deferred tax assets, deferred tax liabilities, and any valuation allowance recorded against deferred tax assets. Due to uncertainties related to the realization of the Company’s deferred tax assets as a result of its history of operating losses, a valuation allowance has been established against the total deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income by jurisdiction in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company’s financial position and results of operations. Contingencies Contingencies. Stock-Based Compensation . Compensation — Stock Compensation Warrants Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock Comprehensive Loss Comprehensive Income, Research and Development Expenses Research and Development. Clinical Trial Expenses Interest Expense Net Loss Per Share of Common Stock Recently Issued Accounting Standards In May 2014, the FASB issued ASU 2014-09 related to revenue recognition, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The guidance requires a company to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration it expects to be entitled to receive in exchange for those goods or services. In July 2015, the FASB issued ASU 2015-14, which delayed the effective date of the new revenue standard by one year. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The standard is effective beginning the first quarter of the Company’s 2018 fiscal year and is required to be adopted using either a full retrospective or a modified retrospective approach. The Company is assessing the potential impact of the new standard on its consolidated financial statements and has not yet selected a transition method. In August 2014, the FASB issued ASU 2014-15, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern”. The ASU is effective for annual periods ending after December 15, 2016, and interim periods thereafter; early adoption is permitted. The Company is evaluating the impact the adoption of ASU 2014-15 will have on its consolidated financial statements. In April 2015, the FASB issued ASU 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” The guidance requires debt issuance costs to be presented in the balance sheet as a direct deduction from the carrying value of the associated debt, consistent with the presentation of a debt discount. The guidance is effective for annual reporting periods beginning after December 15, 2015 and interim periods thereafter. As permitted by the standard, the Company adopted the new presentation prospectively and the adoption did not have an impact on its consolidated financial statements and disclosures. In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendments are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company is evaluating the impact the adoption of ASU 2015-11 will have on its consolidated financial statements. In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. The new standard requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. For public business entities, the amendments in this Update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. As permitted by the standard, the Company adopted the new presentation and the adoption did not have an impact on its consolidated financial statements and disclosures. In January 2016, the FASB issued ASU 2016-01, Financial Instruments — Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The update is intended to improve the recognition and measurement of financial instruments. The update are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is evaluating the impact the adoption of ASU 2016-01 will have on its consolidated financial statements. |
State research and development
State research and development credit exchange receivable | 12 Months Ended |
Dec. 31, 2015 | |
State research and development credit exchange receivable | 3. State research and development credit exchange receivable The State of Connecticut provides certain companies with the opportunity to exchange certain research and development income tax credit carryforwards for cash in exchange for forgoing the carryforward of the research and development income tax credits. The program provides for an exchange of research and development income tax credits for cash equal to 65% of the value of corporation tax credit available for exchange. Estimated amounts receivable under the program are recorded as a reduction of research and development expenses. During the years ended December 31, 2015, 2014 and 2013, research and development expenses were offset by $743,000, $816,000, and $282,000, respectively. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2015 | |
Inventories | 4. Inventories Inventories consist of the following (in thousands): December 31, 2015 2014 Raw materials $ — $ 4,856 Work-in-process — 4,719 Finished goods — 95 Inventory — current — 9,670 Total Inventory $ — $ 9,670 |
Property and equipment
Property and equipment | 12 Months Ended |
Dec. 31, 2015 | |
Property and equipment | 5. Property and equipment Property and equipment consist of the following (dollar amounts in thousands): Estimated December 31, 2015 2014 Land — $ 5,273 $ 5,273 Buildings 39-40 54,948 54,948 Building improvements 5-40 131,383 114,131 Machinery and equipment 3-15 95,182 80,919 Furniture, fixtures and office equipment 5-10 4,137 5,015 Computer equipment and software 3 9,707 10,465 Leasehold improvements 4 — 17 Construction in progress 8,044 39,580 308,674 310,348 Less impairment (140,412 ) — Less accumulated depreciation and amortization (119,513 ) (118,221 ) Total property and equipment, net $ 48,749 $ 192,127 Leasehold improvements are amortized over four years which is the shorter of the term or the service lives of the improvements. Depreciation and amortization expense related to property and equipment for the years ended December 31, 2015, 2014, and 2013, was $11.0 million, $9.8 million, and $11.5 million, respectively. In connection with the Company’s quarterly assessment of impairment indicators, the Company evaluated the continued lower than expected sales of AFREZZA as reported by Sanofi throughout the fourth quarter of 2015, revised forecasts for sales of AFREZZA provided by Sanofi in the fourth quarter of 2015 and level of commercial production in the fourth quarter of 2015, as well as the uncertainty associated with Sanofi’s announcement during the fourth quarter of their intent to reorganize their diabetes business. These factors indicated potentially significant changes in the timing and extent of cash flows, and the Company therefore determined that an impairment indicator existed in the fourth quarter of 2015. On January 4, 2016, the Company received written notice from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. Sanofi’s notice indicated that the termination was pursuant to Sanofi’s right to terminate the agreement upon Sanofi’s good faith determination that the commercialization of AFREZZA is no longer economically viable in the United States, in which case the effective date of termination would be April 4, 2016. In the alternative, Sanofi indicated that the termination was also pursuant to its right to terminate the License Agreement for any reason, in which case the Termination Date would be July 4, 2016. In the interest of an expedient transition, the Company is currently working with Sanofi to transfer and wind down the agreement activities by April 4, 2016, or as soon as practicable thereafter. The Company identified two primary asset groups to be evaluated for impairment: the Danbury manufacturing facility, which currently performs all the manufacturing of AFREZZA, and the Valencia facility, which was previously the Company’s corporate headquarters. The Danbury manufacturing facility is the primary asset group that has been impacted by the impairment indicators noted above but the Company also evaluated the Valencia facility for potential impairment given the circumstances and identified an impairment charge of $1.8 million based on a valuation utilizing a combination of market, income and cost approaches. Within the Danbury manufacturing facility, the Company identified the machinery and equipment as the primary assets within the asset group as they are associated with the production of AFREZZA. As such, the Company performed the fixed asset impairment test and performed the first step to test for recoverability of the Danbury manufacturing facility by utilizing two undiscounted cash flow projections and applying a probability weighted average to those cash flow projections. The first undiscounted cash flow projection was developed under a scenario assuming Sanofi would continue to sell and market AFREZZA as the termination of the arrangement by Sanofi was not known as of the balance sheet date. The second undiscounted cash flow projection assumed Sanofi would terminate the Sanofi License Agreement and that the Company would manufacture, sell and market AFREZZA independently. Based on the evaluation performed, the probabilities assigned to the two undiscounted cash flows were not significant to the evaluation due to the projected negative cash flows over the estimation period, and it was determined that the probability weighted undiscounted cash flows were not sufficient to recover the carrying value of the Danbury manufacturing facility. As such, the Company was required to determine the fair value of the Danbury manufacturing facility to recognize an impairment loss if the carrying amount exceeds its fair value. The Company determined the fair value of the Danbury manufacturing facility by applying the highest and best use valuation concept and utilizing the market approach valuation technique to value the machinery and equipment and a combination of the market approach and cost approach in valuing the land, buildings, and building improvements. As a result of this assessment, the Company recorded an impairment charge of $138.6 million for the Danbury manufacturing facility. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2015 | |
Accrued expenses and other current liabilities | 6. Accrued expenses and other current liabilities Accrued expenses and other current liabilities are comprised of the following (in thousands): December 31, 2015 2014 Salary and related expenses $ 5,662 $ 14,928 Accrued interest 615 2,396 Construction in progress 238 1,343 Other 1,414 7,539 Accrued expenses and other current liabilities $ 7,929 $ 26,206 |
Related-party arrangements
Related-party arrangements | 12 Months Ended |
Dec. 31, 2015 | |
Related-party arrangements | 7. Related-party arrangements In October 2007, the Company entered into a $350.0 million loan arrangement with its principal stockholder. The Loan Arrangement has been amended from time to time. On October 31, 2013, the promissory note underlying The Mann Group Loan Arrangement was amended to, among other things, extend the maturity date of the loan to January 5, 2020, extend the date through which the Company can borrow under The Mann Group Loan Arrangement to December 31, 2019, increase the aggregate borrowing amount under The Mann Group Loan Arrangement from $350.0 million to $370.0 million and provide that repayments or cancellations of principal under The Mann Group Loan Arrangement will not be available for reborrowing. As of December 31, 2015, the total principal amount outstanding under The Mann Group Loan Arrangement was $49.5 million, and the amount available for future borrowings was $30.1 million. Interest, at a fixed rate of 5.84%, is due and payable quarterly in arrears on the first day of each calendar quarter for the preceding quarter, or at such other time as the Company and The Mann Group mutually agree. All or any portion of accrued and unpaid interest that becomes due and payable may be paid-in-kind and capitalized as additional borrowings at any time upon mutual agreement of the parties, and has been classified as non-current. The Mann Group can require the Company to prepay up to $200.0 million in advances that have been outstanding for at least 12 months (less approximately $105.0 million aggregate principal amount that has been cancelled in connection with two common stock purchase agreements). If The Mann Group exercises this right, the Company will have 90 days after The Mann Group provides written notice (or the number of days to maturity of the note if less than 90 days) to prepay such advances. However, pursuant to a letter agreement entered into in August 2010, The Mann Group has agreed to not require the Company to prepay amounts outstanding under the amended and restated promissory note if the prepayment would require the Company to use its working capital resources. In addition, The Mann Group entered into a subordination agreement with Deerfield pursuant to which The Mann Group agreed with Deerfield not to demand or accept any payment under The Mann Group Loan Arrangement until the Company’s payment obligations to Deerfield under the Facility Agreement have been satisfied in full. Subject to the foregoing, in the event of a default under The Mann Group Loan Arrangement, all unpaid principal and interest either becomes immediately due and payable or may be accelerated at The Mann Group’s option, and the interest rate will increase to the one-year LIBOR rate calculated on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum. All borrowings under The Mann Group Loan Arrangement are unsecured. The Mann Group Loan Arrangement contains no financial covenants. As of December 31, 2015 and 2014, the Company had accrued and unpaid interest of $6.4 million and $3.5 million, in long term other liabilities respectively, which related to the amount outstanding and had $30.1 million of available borrowings. Interest expense on the Company’s note payable to the Company’s principal stockholder for the years ended December 31, 2015, 2014, and 2013 was $2.9 million, $2.9 million, and $6.3 million, respectively. In May 2015, the Company entered into sublease agreement with the Alfred Mann Foundation for Scientific Research (the “Mann Foundation”), a California Not-For-Profit Corporation. The lease is for approximately 12,500 square feet of office space in Valencia, California and expires in April 2017. The office space contains the Company’s principal executive offices. Lease payments to the Mann Foundation for the year ended December 31, 2015 were $175,000. There were no lease payments to the Mann Foundation for the years ended December 31, 2014 and 2013. In connection with certain meetings of the Company’s board of directors and on other occasions when the Company’s business necessitated air travel for the Company’s principal stockholder and other Company employees, the Company utilized the principal stockholder’s private aircraft, and the Company paid the charter company that manages the aircraft on behalf of the Company’s principal stockholder approximately $18,000, $79,000, and $82,000, respectively, for the years ended December 31, 2015, 2014, and 2013 on the basis of the corresponding cost of commercial airfare. The Company has entered into indemnification agreements with each of its directors and executive officers, in addition to the indemnification provided for in its amended and restated certificate of incorporation and amended and restated bylaws (see Note 14 — Commitments and contingencies). |
Senior convertible notes
Senior convertible notes | 12 Months Ended |
Dec. 31, 2015 | |
Senior convertible notes | 8. Senior convertible notes Senior convertible notes consist of the following (in thousands): December 31, 2015 2014 2015 notes Principal amount $ — $ 100,000 Unaccreted debt issuance cost — (645 ) Net carrying amount $ — $ 99,355 2018 notes Principal amount $ 27,690 $ — Unamortized premium 660 — Unaccreted debt issuance costs (737 ) — Net carrying amount $ 27,613 $ — Issuance of new 5.75% Convertible Senior Subordinated Exchange Notes due 2018 in exchange for 2015 notes On July 28, 2015, the Company entered into privately-negotiated exchange agreements (the “Note Exchange Agreements”) with a select holder of the Company’s 5.75% Senior Convertible Notes due 2015 (the “2015 notes”), pursuant to which the Company agreed to issue $27.7 million aggregate principal amount of new 5.75% Convertible Senior Subordinated Exchange Notes due 2018 (the “2018 notes”) to such holders in exchange for the delivery to the Company of the same principal amount of 2015 notes. The 2018 notes were issued at the closing of the exchange on August 10, 2015. The Company analyzed this exchange under the provisions of ASC 470-50 and concluded that the exchange represents an extinguishment of the 2015 notes and a new issuance of 2018 notes and recorded such notes at fair value which resulted in a premium of $0.7 million. The 2018 notes are the Company’s general, unsecured, senior obligations, except that the 2018 notes are subordinated in right of payment to the outstanding notes issued pursuant to the Facility Agreement and the Company’s borrowings under the Sanofi Loan Facility with an affiliate of Sanofi-Aventis U.S. LLC. The 2018 notes rank equally in right of payment with the Company’s other unsecured senior debt. The 2018 notes bear interest at the rate of 5.75% per year on the principal amount, payable semiannually in arrears in cash on February 15 and August 15 of each year, beginning February 15, 2016, with interest accruing from August 15, 2015. The 2018 notes mature on August 15, 2018. The 2018 notes are convertible, at the option of the holder, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at an initial conversion rate of 147.0859 shares per $1,000 principal amount of 2018 notes, which is equal to a conversion price of approximately $6.80 per share, the same conversion price as that of the 2015 notes on the date of exchange. The conversion rate is subject to adjustment under certain circumstances described in an indenture governing the 2018 notes dated August 10, 2015 with Wells Fargo, National Association, including in connection with a make-whole fundamental change. If certain fundamental changes occur, the Company will be obligated to pay a fundamental change make-whole premium on any 2018 notes converted in connection with such fundamental change by increasing the conversion rate on such 2018 notes. In such instances, the amount of the fundamental change make-whole premium will be based on the Company’s common stock price and the effective date of the applicable fundamental change. If the Company undergoes certain fundamental changes, except in certain circumstances, each holder of 2018 notes will have the option to require the Company to repurchase all or any portion of that holder’s 2018 notes. The fundamental change repurchase price will be 100% of the principal amount of the 2018 notes to be repurchased plus accrued and unpaid interest, if any. On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. Under the terms of the 2018 Note Indenture, the conversion option can be net-share settled and the maximum number of shares that could be required to be delivered under the indenture, including the make-whole shares, is fixed and less than the number of authorized and unissued shares less the maximum number of shares that could be required to be delivered during the term of the 2018 notes under existing commitments. Applying the Company’s sequencing policy, the Company performed an analysis at the time of the offering of the 2018 notes and each reporting date since and has concluded that the number of available authorized shares at the time of the offering and each subsequent reporting date was sufficient to deliver the number of shares that could be required to be delivered during the term of the 2018 notes under existing commitments. The 2018 notes provide that upon an acceleration of certain indebtedness, including the 9.75% Senior Convertible Notes due 2019 (the “2019 notes”) and the 8.75% Senior Convertible Notes due 2019 (the “Tranche B notes”) issued to Deerfield pursuant to the Facility Agreement (see Note 17 — Facility Agreement), the holders may elect to accelerate the Company’s repayment obligations under the notes if such acceleration is not cured, waived, rescinded or annulled. There can be no assurance that the holders would not choose to exercise these rights in the event such events were to occur. The Company incurred approximately $0.8 million in issuance costs which are recorded as an offset to the 2018 notes in the accompanying condensed consolidated balance sheet. These costs are being accreted to interest expense using the effective interest method over the term of the 2018 notes. Accretion of debt issuance expense in connection with the 2018 notes during the year ended December 31, 2015 was $93,000. Amortization of 2018 notes premium during the year ended December 31, 2015 was $86,000. Issuance of common stock in exchange for 2015 notes On July 28, 2015, the Company entered into separate, privately-negotiated exchange agreements (the “Stock-for-Note Exchange Agreements”) with certain holders of the 2015 notes pursuant to which the Company agreed to issue shares of its common stock to such holders in exchange for the delivery to the Company of up to $56.9 million aggregate principal amount of 2015 notes. Pursuant to the Stock-for-Note Exchange Agreements, the parties agreed to price the exchange transactions over a 10 trading day period spanning from July 29, 2015 to and including August 11, 2015. Between July 28, 2015 and August 10, 2015, the Company issued an aggregate of 1.9 million shares of common stock to such holders in exchange for such holders’ delivery to the Company of $8.0 million aggregate principal amount of 2015 notes, resulting in a weighted-average exchange price of $4.40 per share. Issuance of new 5.75% Convertible Senior Subordinated Exchange Notes due 2015 in exchange for 2015 notes On August 14, 2015, the Company exchanged $32.1 million aggregate principal amount of newly issued, 5.75% Convertible Senior Subordinated Exchange Notes due 2015 (the “Exchange Notes”) for the same principal amount of the Company’s previously outstanding 2015 notes. The Exchange Notes, payable at maturity on September 30, 2015, were convertible, at the option of each holder thereof, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date. The holders of the Exchange Notes did not elect to convert any of the outstanding principal amount of the Exchange Notes into shares of the Company’s common stock. As a result, on September 30, 2015, the Company paid $32.1 million to settle the Exchange Notes. Settlement of 2015 notes and Exchange Notes On August 17, 2015, the Company paid $32.2 million to settle the remaining 2015 notes. As of September 30, 2015, all 2015 notes, including the Exchange Notes, have been settled resulting in a total loss on extinguishment equal to $1.0 million. The loss on extinguishment resulted from write-off of debt discount and debt issuance costs associated with the 2015 notes and Exchange Notes and the difference between the principal amounts being exchanged for shares of the Company’s common stock, pursuant to the various Stock-for-Note Exchange Agreements, and the fair market value of the Company’s common stock issued in exchange for such reduction in principal. Accretion of debt issuance expense in connection with the 2015 notes during the years ended December 31, 2015, 2014, and 2013 was $0.6 million, $0.9 million, and $0.9 million, respectively. |
Collaboration arrangement
Collaboration arrangement | 12 Months Ended |
Dec. 31, 2015 | |
Collaboration arrangement | 9. Collaboration arrangement Sanofi License Agreement and Sanofi Supply Agreement On August 11, 2014, the Company and Sanofi entered into the Sanofi License Agreement, which became effective on September 23, 2014. Under the terms of the Sanofi License Agreement, the Company granted to Sanofi exclusive, worldwide licenses to certain of the Company’s patents, trademarks and know-how for the development and commercialization of AFREZZA. Under the terms of the Sanofi License Agreement, Sanofi has the exclusive right and responsibility to develop AFREZZA worldwide, subject to certain development activities that will be performed by the Company. Sanofi will also be obligated to use commercially reasonable efforts to file for, obtain and maintain marketing approvals for AFREZZA in certain major markets and countries. In addition, Sanofi will have exclusive, worldwide rights to commercialize AFREZZA and will be obligated to use commercially reasonable efforts to market, promote and commercialize AFREZZA in all countries in the world where regulatory approval for AFREZZA has been received. Pursuant to the terms of the Sanofi Supply Agreement, the Company is responsible for the manufacture and supply to Sanofi of its requirements of AFREZZA. Under the Sanofi License Agreement, Sanofi paid the Company an up-front cash payment of $150.0 million in the third quarter of 2014. If certain manufacturing, regulatory and sales milestones are achieved, the Company will also be eligible to receive up to $775.0 million in milestone payments, of which $75.0 million relates to certain development and manufacturing milestone events, $50.0 million relates to the filing and completion of regulatory approvals and $650.0 million relates to the achievement of certain product sales milestones. As of December 31, 2014, the Company earned and recorded a total of $50.0 million in milestone payments in connection with the satisfaction of manufacturing milestones specified in the Sanofi agreement, which were received subsequent to December 31, 2014. In addition, worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by the Company and Sanofi that are specifically attributable or related to the development, improvement, regulatory filings, manufacturing, and commercialization of AFREZZA will be shared 65% by Sanofi and 35% by the Company. In accordance with the terms of the Sanofi License Agreement, profit and loss sharing commenced in the fourth quarter of 2014. Pursuant to the terms of the Sanofi Supply Agreement, the Company will be the exclusive manufacturer and supplier of AFREZZA until the specified conditions are met, upon which a portion of the manufacturing activities may be assumed by Sanofi. The Company analyzed the agreements entered into with Sanofi under the provisions of ASC 605, Revenue Recognition, to determine whether the consideration, or a portion thereof, could be recognized as revenue. ASC 605 provides that revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collection is reasonably assured. In addition, revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer. When deliverables are separable, consideration received is allocated to the separate units of accounting based on the relative selling price of each deliverable and the appropriate revenue recognition principles are applied to each unit. The assessment of multiple element arrangements requires judgment in order to determine the appropriate units of accounting and the points in time that, or periods over which, revenue should be recognized. Under the terms of the Sanofi License Agreement, Sanofi Supply Agreement and the Sanofi Loan Facility the Company determined that the arrangement contained significant deliverables including (i) licenses to develop and commercialize AFREZZA and to use the Company’s trademarks, (ii) development activities, and (iii) manufacture and supply services for AFREZZA. Due to the proprietary nature of the manufacturing services being provided by the Company, the Company determined that all of the significant deliverables should be combined into a single unit of accounting. The Company believes that the manufacturing services are proprietary due to the fact that since the late 1990’s, the Company has developed proprietary knowledge and patented equipment and tools that are used in the manufacturing process of AFREZZA. Due to the complexities of particle formulation and the specialized knowledge and equipment needed to handle the AFREZZA powder, neither Sanofi nor any third-party contract manufacturing organization currently possesses the capability of manufacturing AFREZZA. In order for revenue to be recognized, the seller’s price to the buyer must be fixed and determinable. Given that as of December 31, 2015, the Company did not have the ability to estimate the amount of costs that would potentially be incurred under the loss share provision related to the Sanofi License Agreement and the Sanofi Supply Agreement, the Company believes this requirement for revenue recognition has not been met. As such, the Company did not recognize any revenue pursuant to the Sanofi License Agreement or the Sanofi Supply Agreement for the years ended December 31, 2015 and 2014. The Company has recorded the $150.0 million up-front payment and $50.0 million from milestone payments as deferred payments from collaboration. In addition, as of December 31, 2015 the Company has recorded $17.5 million in AFREZZA product shipments to Sanofi as deferred product sales from collaboration and recorded $13.5 million as deferred product costs from collaboration. Deferred product costs represent the costs of product manufactured and shipped to Sanofi, not to exceed the amount of deferred product sales, for which recognition of revenue has been deferred. During the year ended December 31, 2015, the Company’s portion of the loss sharing was $57.7 million, which resulted in the reclassification from current deferred payments from collaboration to Sanofi loan facility and loss share obligation to reflect amounts owed to Sanofi. Sanofi Loan Facility On September 23, 2014, the Company entered into the Sanofi Loan Facility, consisting of a senior secured revolving promissory note and a guaranty and security agreement (the “Security Agreement”) with an affiliate of Sanofi which provides the Company with a secured loan facility of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. In the event of certain future defaults under the Sanofi Loan facility agreement for which the Company is not able to obtain waivers, the lender under the Sanofi Loan Facility may accelerate all of the Company’s repayment obligations, and take control of the Company’s pledged assets, potentially requiring the Company to renegotiate the terms of its indebtedness on terms less favorable to the Company, or to immediately cease operations. The obligations of the Company under the Sanofi Loan Facility are guaranteed by the Company’s wholly-owned subsidiary, MannKind LLC, and are secured by a first priority security interest in certain insulin inventory located in the United States and any contractual rights and obligations pursuant to which the Company purchases or has purchased such insulin, and a second priority security interest in the Company’s assets that secure the Company’s obligations under the Facility Agreement, as amended. In addition, the Company granted to Sanofi, as additional security for the obligations under the Sanofi Loan Facility, a first priority mortgage on the Company’s facility in Valencia, California, which has a carrying value of $17.9 million as of December 31, 2015. Advances under the Sanofi Loan Facility bear interest at a rate of 8.5% per annum and are payable in-kind and compounded quarterly and added to the outstanding principal balance under the Sanofi Loan Facility. The Company is required to make mandatory prepayments on the outstanding loans under the Sanofi Loan Facility from its share of any Profits (as defined in the Sanofi License Agreement) under the Sanofi License Agreement within 30 days of receipt of its share of any such Profits. No advances may be made under the Sanofi Loan Agreement if Deerfield has commenced enforcement proceedings in connection with an event of default under the Facility Agreement. The outstanding principal of all loans under the Sanofi Loan Facility, if not prepaid, will become due and payable on September 23, 2024 unless accelerated pursuant to the terms of the Sanofi Loan Facility. Additionally, if the Company sells its Valencia facility, the Company is required to prepay the loans under the Sanofi Loan Facility from the net cash proceeds of the sale within five business days of receipt. The Company’s total portion of the loss sharing was $57.7 million for the year ended December 31, 2015, of which $44.5 million was borrowed under the Sanofi Loan Facility as of December 31, 2015. Subsequent to December 31, 2015, the Company borrowed $17.9 million under the Sanofi Loan Facility to finance the portion of the Company’s loss for the quarter ended December 31, 2015. The total amount owed to Sanofi is $62.4 million, which includes $1.7 million in paid-in-kind interest. The Sanofi Loan Facility includes customary representations, warranties and covenants by the Company, including restrictions on its ability to incur additional indebtedness, grant certain liens and make certain changes to its organizational documents. Events of default under the Sanofi Loan Facility include: the Company’s failure to timely make payments due under the Sanofi Loan Facility; inaccuracies in the Company’s representations and warranties to the noteholder; the Company’s failure to comply with any of its covenants under any of the Sanofi Loan Facility or certain other related security agreements and documents entered into in connection with the Sanofi Loan Facility, subject to a cure period with respect to most covenants; the Company’s insolvency or the occurrence of certain bankruptcy-related events; termination by Sanofi of the Sanofi License Agreement as a result of the Company’s breach of the Sanofi License Agreement; and the failure of any material provision under any of the Sanofi Loan Facility or certain other related security agreements and documents entered into in connection with the Sanofi Loan Facility to remain in full force and effect. If one or more events of default occurs and is continuing, Sanofi may terminate its obligation to make advances under the Sanofi Loan Facility, and, if certain specified events of default (including the Company’s failure to timely make payments due under the Sanofi Loan Facility; the Company’s failure to comply with the negative covenants under the Sanofi Loan Facility limiting the Company’s ability to incur additional indebtedness or grant certain liens; the Company’s insolvency or the occurrence of certain bankruptcy-related events; termination by Sanofi of the Sanofi License Agreement as a result of the Company’s breach of the non-compete provisions of the Sanofi License Agreement; or the failure of any material provision under any of the Sanofi Loan Facility or certain other related security agreements and documents entered into in connection with the Sanofi Loan Facility to remain in full force and effect) occur and are continuing, the noteholder may accelerate all of the Company’s repayment obligations under the Sanofi Loan Facility and otherwise exercise any of its remedies as a secured creditor. There can be no assurance that the noteholder would not choose to exercise these rights in the event such events were to occur. Subsequent to December 31, 2015, the Company received written notice on January 4, 2016 from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. Pursuant to its terms, the Sanofi Supply Agreement will terminate concurrently with the Sanofi License Agreement. Sanofi’s notice indicated that the termination was pursuant to Sanofi’s right to terminate the Sanofi License Agreement upon Sanofi’s good faith determination that the commercialization of AFREZZA is no longer economically viable in the United States, in which case the effective date of termination will be April 4, 2016. In the alternative, Sanofi indicated that the termination was also pursuant to its right to terminate the Sanofi License Agreement for any reason, in which case the effective date of termination will be July 4, 2016. In the interest of an expedient transition, the Company is currently working with Sanofi to transfer and wind down the agreement activities by April 4, 2016, or as soon as practicable thereafter. Pursuant to the terms of the Sanofi License Agreement, the Company and Sanofi are required to use diligent efforts to facilitate the smooth and orderly transition of relevant obligations and rights to the Company with respect to development and commercialization activities related to AFREZZA, and are also required to negotiate in good faith a written transition agreement for this purpose. As a result of the foregoing termination, effective on the Termination Date and thereafter during any period which Sanofi is required to perform any wind-down activities pursuant to the terms of the Sanofi License Agreement, the rights granted to Sanofi under the Sanofi License Agreement to develop and commercialize AFREZZA will become non-exclusive and the Company will have the right to engage one or more other distributors and/or licensees of AFREZZA. Sanofi will continue to distribute AFREZZA during the wind-down period as required by the agreement until such time that the Company or its designee takes over responsibility for distribution. All profits and losses from AFREZZA product sales by Sanofi or its affiliates after the Termination Date, if any, will continue to be shared 65% by Sanofi and 35% by the Company pursuant to the terms of the License Agreement. In addition to the Sanofi License Agreement and Sanofi Supply Agreement, as discussed above, the Company and Aventisub LLC, an affiliate of Sanofi, are parties to a Senior Secured Revolving Promissory Note, dated September 23, 2014 and a Guaranty and Security Agreement. Both the Sanofi Loan Facility and the Security Agreement remain in effect. The original maturity date of September 23, 2024 for repayment of the outstanding principal amount of the loans under the Sanofi Loan Facility will not be affected by the termination of the Sanofi License Agreement. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2015 | |
Fair Value of Financial Instruments | 10. Fair Value of Financial Instruments The carrying amounts of financial instruments, which include cash equivalents and accounts payable, approximate their fair values due to their relatively short maturities. The fair value of the note payable to the Company’s principal stockholder cannot be reasonably estimated as the Company would not be able to obtain a similar credit arrangement in the current economic environment. As of December 31, 2015 and 2014, the Company held $59.1 million and $120.8 million, respectively of cash and cash equivalents, consisting of money market funds of $55.8 million and $118.5 million, respectively, and the remaining funds in non-interest bearing checking accounts. The fair value of these money market funds was determined by using quoted prices for identical investments in an active market (Level 1 in the fair value hierarchy). 2018 notes, facility financing obligation and Sanofi Loan Facility The following is a summary of the carrying values and estimated fair values of the 2018 notes, the facility financing obligation (i.e., the 2019 notes and Tranche B notes), and the Sanofi Loan Facility (in millions): December 31, 2015 December 31, 2014 Carrying Estimated Carrying Estimated 2015 notes $ — $ — $ 99.4 $ 102.9 2018 notes $ 27.6 $ 21.3 $ — $ — Facility financing obligation $ 74.6 $ 78.4 $ 73.0 $ 75.1 Sanofi Loan Facility $ 44.5 $ 36.5 $ 3.0 $ 3.0 2015 notes The estimated fair value of the 2015 notes was calculated based on model-derived valuations whose inputs were observable, such as the Company’s stock price, and non-observable, such as the Company’s longer-term historical volatility (55%) (Level 3 in the fair value hierarchy). As there was no current active and observable market for the 2015 notes, the Company determined the estimated fair value using a convertible bond valuation model within a lattice framework. The convertible bond valuation model combined expected cash outflows with market-based assumptions regarding risk-adjusted yields, stock price volatility and recent price quotes and trading information regarding Company issued debt instruments and shares of common stock into which the notes are convertible. As of December 31, 2015, all 2015 notes, including the Exchange Notes, have been extinguished through exchange for stock, exchange for 2018 notes or settlement in cash. (See Note 8 —Senior convertible notes). 2018 notes The estimated fair value of the 2018 notes was calculated based on model-derived valuations whose inputs were observable, such as the Company’s stock price and yields on U.S. Treasury notes and actively traded bonds, and non-observable, such as the Company’s longer-term historical volatility, and estimated yields implied from any available market trades of the Company’s issued debt instruments. As there is no current active and observable market for the 2018 notes, the Company determined the estimated fair value using a convertible bond valuation model within a lattice framework. The convertible bond valuation model combined expected cash flows based on terms of the notes with market-based assumptions regarding risk-free rate, risk-adjusted yields (20%), stock price volatility (90%) and recent price quotes and trading information regarding Company issued debt instruments and shares of common stock into which the notes are convertible (Level 3 in the fair value hierarchy). Facility financing agreement As discussed in Note 17 — Facility Agreement, in connection with the Facility Agreement, the Company issued 2019 notes and subsequently issued Tranche B notes (the “Facility Financing Obligation”). As there is no current observable market for the 2019 notes or Tranche B notes, the Company determined the estimated fair value using a bond valuation model based on a discounted cash flow methodology. The bond valuation model combined expected cash flows associated with principal repayment and interest based on the contractual terms of the debt agreement discounted to present value using a selected market discount rate. On December 31, 2015 the market discount rate was recalculated at 12.0% for the 2019 notes and the Tranche B notes (Level 3 in the fair value hierarchy). In addition to the 2019 notes and Tranche B notes, the Company also issued certain rights to receive payments of up to $90.0 million upon occurrence of specified strategic and sales milestones (the “Milestone Rights”). These rights are not reflected in the facility financing obligation. The estimated fair value of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy). The expected timing and probability of achieving the milestones, starting in 2014, was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate (15.0%) was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. As of December 31, 2015, the carrying value of the Milestone Rights is $8.9 million, classified as a long-term liability in other liabilities and the fair value is estimated at $14.4 million. Sanofi Loan Facility As discussed in Note 9 — the Sanofi Loan Facility, consists of a senior secured revolving promissory note and a guaranty and security agreement with an affiliate of Sanofi which provides the Company with a secured loan facility of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. The estimated fair value was determined using a discounted cash flow model in which time outstanding and discount rate were primary variables. This method considered the key elements of the contractual terms of the Sanofi Loan Facility, market-based estimated cost of capital, and time value of money, namely the amount of time to settlement and the estimated discount rate (11%) appropriate for the liability (Level 3 in the fair value hierarchy). As of December 31, 2015 the carrying value of the Sanofi Loan Facility is $44.5 million and the fair value is estimated at $36.5 million. There were no material re-measurements to fair value during the year ended December 31, 2015 of financial assets and liabilities that are not measured at fair value on a recurring basis. There were no transfers of assets or liabilities between the fair value measurement levels during the twelve months ended December 31, 2015, 2014, and 2013. Assets and Liabilities Measured at Fair Value on a Non-recurring Basis In accordance with ASC 360, Property, Plant, and Equipment Our assessment of the real property includes Level 3 inputs, and was based on a combination of the income, market and cost approaches and the market approach was used for machinery and equipment which required Level 3 inputs. Embedded Derivatives The Company identified and evaluated a number of embedded features in the notes issued under the Facility Agreement to determine if they represented embedded derivatives that are required to be separated from the notes and accounted for as freestanding instruments pursuant to ASC 815. In 2014, the Company analyzed the Tranche B notes and identified embedded derivatives which required separate accounting under ASC 815; however all of the embedded derivatives were determined to have a de minimis At December 31, 2015, all of the embedded derivatives identified in the Tranche B notes were deemed to have a de minimis |
Common and preferred stock
Common and preferred stock | 12 Months Ended |
Dec. 31, 2015 | |
Common and preferred stock | 11. Common and preferred stock The Company is authorized to issue 550,000,000 shares of common stock, par value $0.01 per share, and 10,000,000 shares of undesignated preferred stock, par value $0.01 per share, issuable in one or more series designated by the Company’s board of directors. No other class of capital stock is authorized. As of December 31, 2015 and 2014, 428,670,943 and 406,059,089 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding. On November 9, 2015, the Company entered into a series of stock purchase agreements to sell up to an aggregate of 50,000,000 shares its common stock in a registered direct offering to selected investment funds in Israel that hold securities included within certain stock indexes of the Tel Aviv Stock Exchange (the “TASE”). Pursuant to the agreements, the shares of common stock were sold at a price per share equal to 97% of the closing price of the Company’s common stock on the TASE on November 12, 2015. During November 2015, the Company sold 13,852,435 shares of common stock for an aggregate price of approximately $34,710,000, or $2.61 per share, which is net of $1,433,000 of issuance costs. The Company engaged Sunrise Securities Corporation as its exclusive placement agent in connection with the offering of 50,000,000 shares. In connection with the services provided the Company issued to Sunrise Securities Corporation, or its designee, restricted warrants to purchase a number of shares of the Company’s common stock in an aggregate equal to 1.15% of the aggregate shares sold in the offering, which totaled 159,303 shares on November 16, 2015. The warrants are exercisable for a five year period at an exercise price of $2.61, the price paid per share in connection with the offering. The Company had an obligation to register the common stock that may be issued pursuant to the exercise of the warrants, which resulted in their initial classification as liability and were deemed immaterial. On December 15, 2015 the warrants were reclassified to equity as the Company registered the common stock pursuant to registration statement. As of December 31, 2015 the warrants were classified within equity. Included in the common stock outstanding as of December 31, 2014 is 9,000,000 shares of common stock loaned to Bank of America under a share lending agreement in connection with the offering of the $100.0 million aggregate principal amount of 2015 notes. Bank of America was obligated to return the borrowed shares (or, in certain circumstances, the cash value thereof) to the Company on or about the 45th business day following the date as of which the entire principal amount of the 2015 notes ceases to be outstanding, subject to extension or acceleration in certain circumstances or early termination at Bank of America’s option. On October 23, 2015, the 9,000,000 shares of common stock loaned to Bank of America were returned, as the Company settled all payments and deliveries in respect of such convertible notes on August 17, 2015. The Company did not receive any proceeds from the sale of the borrowed shares by Bank of America, but the Company did receive a nominal lending fee of $0.01 per share from Bank of America for the use of borrowed shares. On February 8, 2012, the Company sold 35,937,500 units in an underwritten public offering, including 4,687,500 units sold pursuant to the full exercise of an over-allotment option granted to the underwriters, with each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock. All of the securities were offered by the Company at a combined price to the public of $2.40 per unit and the underwriters purchased the units at a price of $2.256 per unit. Net proceeds from this offering were approximately $80.6 million, excluding any warrant exercises. The 21,562,500 shares of common stock underlying the warrants are exercisable at $2.40 per share and expire four years from the date of the issuance. For the years ended December 31, 2015, 2014, and 2013, the Company received $10.1 million, $27.8 million, and $94.2 million in proceeds, respectively, from the exercise of the February 2012 public offering warrants. Any unexercised February 2012 public offering warrants expired on February 8, 2016. |
Net loss per common share
Net loss per common share | 12 Months Ended |
Dec. 31, 2015 | |
Net loss per common share | 12. Net loss per common share Basic net loss per share excludes dilution for potentially dilutive securities and is computed by dividing net loss by the weighted average number of common shares outstanding during the period excluding the 9,000,000 shares loaned to Bank of America under a share lending arrangement (see Note 11 — Common and preferred stock). In the third quarter of 2015, the 9,000,000 million shares loaned to Bank of America were returned. Prior to the return of those shares, the borrowed shares were not considered outstanding for the purpose of computing and reporting basic or diluted earnings (loss) per share because the share borrower had to return all borrowed shares to the Company (or, in certain circumstances, the cash value thereof). Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. Potentially dilutive securities are excluded from the computation of diluted net loss per share for all of the periods presented in the accompanying condensed consolidated statements of operations because the reported net loss in each of these periods results in their inclusion being antidilutive. Antidilutive securities, which consist of stock options, restricted stock units, warrants, and shares that could be issued upon conversion of the senior convertible notes, that are not included in the diluted net loss per share calculation and excluded the 9,000,000 shares of the Company’s common stock loaned under the share lending arrangement as of December 31, 2014, and 2013. Potentially dilutive securities outstanding are summarized as follows (in shares): December 31, 2015 2014 2013 Exercise of common stock options 19,779,229 21,541,664 24,237,940 Conversion of senior convertible notes into common stock 4,072,809 17,323,080 25,415,366 Exercise of common stock warrants 4,074,596 9,987,876 19,706,240 Vesting of restricted stock units 1,804,620 2,610,720 9,115,821 29,731,254 51,463,340 78,475,367 |
Stock award plans
Stock award plans | 12 Months Ended |
Dec. 31, 2015 | |
Stock award plans | 13. Stock award plans On May 23, 2013, the Company adopted the 2013 Equity Incentive Plan (the “2013 Plan”) as the successor to and continuation of the 2004 Equity Incentive Plan (the “2004 Plan”). The 2013 Plan consists of 21.5 million newly requested shares and the number of unallocated shares remaining available for grant for new awards under the 2004 Plan. The 2013 Plan provides for the granting of stock awards including stock options and restricted stock units, to employees, directors and consultants. The Plan also provides for the automatic, non-discretionary grant of options to the Company’s non-employee directors. No additional awards will be granted under the 2004 Plan or under the 2004 Non-Employee Directors’ Stock Option Plan (the “NED Plan”) as all future awards will be made out of the 2013 Plan. As of December 31, 2015, the Company has two active stock-based compensation plans — the 2013 Plan and the 2004 Employee Stock Purchase Plan (the “ESPP”). The following table summarizes information about the Company’s stock-based award plans as of December 31, 2015: Outstanding Outstanding Shares Available 2004 Equity Incentive Plan 11,309,136 276,784 — 2013 Equity Incentive Plan 8,026,762 1,527,836 15,540,652 2004 Non-Employee Directors’ Stock Option Plan 443,331 — — Total 19,779,229 1,804,620 15,540,652 In March 2004, the Company’s board of directors approved the ESPP, which became effective upon the closing of the Company’s initial public offering. Initially, the aggregate number of shares that could be sold under the 2004 Plan was 2,000,000 shares of common stock. On January 1 of each year, for a period of ten years beginning January 1, 2005, the share reserve automatically increases by the lesser of: 700,000 shares, 1% of the total number of shares of common stock outstanding on that date, or an amount as may be determined by the board of directors. However, under no event can the annual increase cause the total number of shares reserved under the ESPP to exceed 10% of the total number of shares of capital stock outstanding on December 31 of the prior year. On January 1, 2013 and 2014 the ESPP share reserve was increased by 700,000 and 700,000 shares, respectively. There was no ESPP share reserve increase during 2015. As of December 31, 2015, 2,752,703 shares were available for issuance under the ESPP. For the years ended December 31, 2015, 2014 and 2013 the Company sold 321,228, 305,076, and 463,290 shares, respectively, of its common stock to employees participating in the ESPP. The ESPP purchase for the period ending December 31, 2015 was initiated prior to year-end but did not settle until January 5, 2016. As a result, the shares sold are reflected in the ESPP share reserves but is excluded from common stock outstanding as of December 31, 2015. The Company’s board of directors determines eligibility, vesting schedules and exercise prices for stock awards granted under the 2013 Plan. Options and other stock awards under the 2013 Plan expire not more than ten years from the date of the grant and are exercisable upon vesting. Stock options generally vest over four years. Current stock option grants vest and become exercisable at the rate of 25% after one year and ratably on a monthly basis over a period of 36 months thereafter. Restricted stock units generally vest at a rate of 25% per year over four years with consideration satisfied by service to the Company. There are no outstanding performance-based awards as all milestones have been achieved as of December 31, 2015. The 2013 Plan provides for full acceleration of vesting if an employee is terminated within three months of a change in control, as defined in the 2013 Plan. In accordance with ASC 718, share-based payment transactions are recognized as compensation cost based on the fair value of the instrument on the date of grant. The Company accounts for non-employee stock-based compensation expense based on the estimated fair value of the options, which is determined using the Black-Scholes option valuation model and amortizes such expense on a straight-line basis over the service period for time-based awards and over the expected dates of achievement for performance-based awards. These awards are subject to re-measurement until service is complete. As of December 31, 2015, there were options to purchase 523,487 shares of common stock outstanding to consultants. During the years ended December 31, 2015, 2014 and 2013 the Company recorded stock-based compensation expense related to its stock award plans and the ESPP of $8.7 million, $48.6 million, and $45.2 million, respectively. Total stock-based compensation expense recognized in the accompanying statements of operations is as follows (in thousands): Year Ended December 31, 2015 2014 2013 Employee-related $ 8,407 $ 48,622 $ 45,181 Consultant-related 318 — 5 Total $ 8,725 $ 48,622 $ 45,186 Total stock-based compensation expense recognized in the accompanying statements of operations is included in the following categories (in thousands): Year Ended December 31, 2015 2014 2013 Research and development $ 3,029 $ 22,357 $ 20,409 General and administrative 5,696 26,265 24,777 Total $ 8,725 $ 48,622 $ 45,186 The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options. The expected term of an option granted is based on combining historical exercise data with expected weighted time outstanding. Expected weighted time outstanding is calculated by assuming the settlement of outstanding awards is at the midpoint between the remaining weighted average vesting date and the expiration date. Beginning in the third quarter of 2014, the Company began to assess both historical and implied volatility in order to determine its estimated volatility rate. Implied volatility was considered due to the change in the Company’s business, which occurred with the approval for the sale of AFREEZA. The Company has selected risk-free interest rates based on U.S. Treasury securities with an equivalent expected term in effect on the date the options were granted. Additionally, the Company uses historical data and management judgment to estimate stock option exercise behavior and employee turnover rates to estimate the number of stock option awards that will eventually vest. The Company calculated the fair value of employee stock options granted during the years ended December 31, 2015, 2014 and 2013 using the following assumptions: Year Ended December 31, 2015 2014 2013 Risk-free interest rate 1.61% — 1.86% 1.64% — 2.11% 0.94% — 1.82% Expected lives 5.79 — 5.86 years 5.77 — 6.09 years 2.64 — 5.77 years Volatility 69.76% — 71.84% 73.98% — 84.85% 75.83% — 86.26% Dividends — — — The following table summarizes information about stock options outstanding: Number Weighted Aggregate Outstanding at January 1, 2015 21,541,664 4.53 $ 33,495 Granted 1,541,100 4.11 Exercised (1,700,964 ) 1.91 Forfeited (706,387 ) 5.78 Expired (896,184 ) 7.70 Outstanding at December 31, 2015 19,779,229 4.54 $ — Vested and expected to vest at December 31, 2015 19,597,097 4.53 $ — Exercisable at December 31, 2015 17,217,332 4.47 $ — The weighted average grant date fair value of the stock options granted during the years ended December 31, 2015, 2014 and 2013 was $2.56, $4.76 and $3.26 per option, respectively. The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 was $6.2 million, $14.9 million and $3.1 million, respectively. Intrinsic value is measured using the fair market value at the date of exercise (for options exercised) or at December 31 (for outstanding options), less the applicable exercise price. Cash received from the exercise of options during the years ended December 31, 2015, 2014 and 2013 was approximately $3.3 million, $11.0 million and $2.3 million, respectively. The weighted-average remaining contractual terms for options outstanding, vested and expected to vest, and exercisable at December 31, 2015 was 6.34 years, 6.31 years and 5.97 years, respectively. A summary of restricted stock unit activity for the year ended December 31, 2015 is presented below: Number Weighted Outstanding at January 1, 2015 2,610,720 $ 5.20 Granted 1,133,404 $ 4.14 Vested (1,111,134 ) $ 4.93 Forfeited (828,370 ) $ 4.88 Outstanding at December 31, 2015 1,804,620 $ 4.85 The total restricted stock units expected to vest as of December 31, 2015 was 1,651,859 with a weighted average grant date fair value of $4.86. The total intrinsic value of restricted stock units expected to vest as of December 31, 2015 was $2.4 million. Intrinsic value of restricted stock units expected to vest is measured using the closing share price at December 31, 2015. Total intrinsic value of restricted stock units vested during the years ended December 31, 2015, 2014 and 2013 was $5.2 million, $62.7 million and $13.9 million, respectively. Intrinsic value of restricted stock units vested is measured using the closing share price on the day prior to the vest date. The total grant date fair value of restricted stock units vested during the years ended December 31, 2015, 2014 and 2013 was $5.5million, $36.4 million and $14.9 million, respectively. As of December 31, 2015, there was $4.9 million and $6.7 million of unrecognized compensation expense related to options and restricted stock units, respectively, which is expected to be recognized over the weighted average vesting period of 2.7 years. The Company evaluates stock awards with performance conditions as to the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. As of December 31, 2015, all milestones have been achieved. During the year ended December 31, 2015, there was $1.6 million of stock compensation expense related to certain Executives who entered into severance agreements which resulted in a modification to the terms of their awards. The severance agreements generally allowed for the separated Executives to continue to vest under their original award terms for a stated period of time without providing substantive services. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2015 | |
Commitments and contingencies | 14. Commitments and contingencies Operating Leases Rent expense under all operating leases, including office space and equipment, for the years ended December 31, 2015, 2014, and 2013 was approximately $426,000, $737,000, and $645,000 respectively. Leases Guarantees and Indemnifications Litigation Contingencies In addition, several complaints were filed in the U.S. District Court for the Central District of California against the Company and certain of its officers and directors on behalf of certain purchasers of its common stock. The complaints include claims asserted under Sections 10(b) and 20(a) of the Exchange Act and have been pled as putative shareholder class actions. In general, the complaints allege that the Company and certain of its officers and directors violated federal securities laws by making materially false and misleading statements regarding the prospects for AFREZZA, thereby artificially inflating the price of its common stock. The plaintiffs are seeking monetary damages and other relief. The Company expects the complaints to be transferred to a single court and consolidated for all purposes, following which the court would be expected to appoint a lead plaintiff and lead counsel and to order the lead plaintiff to file a consolidated complaint. The Company will vigorously defend against the claims advanced. Following the receipt by the Company of the notice of termination from Sanofi regarding the Sanofi License Agreement and the subsequent decline of the price of its common stock, two motions were submitted to the District Court at Tel Aviv (Economic Department) for the certification of a class action against the Company and certain of its officers and directors. In general, the complaints allege that the Company and certain of its officers and directors violated Israeli and US securities laws by making materially false and misleading statements regarding the prospects for AFREZZA, thereby artificially inflating the price of its common stock. The plaintiffs are seeking monetary damages. The Company will vigorously defend against these claims. Contingencies — Commitment — Unless earlier terminated, the term of the Insulin Supply Agreement expires on December 31, 2019 and can be renewed for additional, successive two year terms upon 12 months’ written notice given prior to the end of the initial term or any additional two year term. The Company and Amphastar each have normal and customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, the Company may terminate the Insulin Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days’ prior written notice to Amphastar if a controlling regulatory authority withdraws approval for AFREZZA, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Insulin Supply Agreement require the Company to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. |
Employee benefit plans
Employee benefit plans | 12 Months Ended |
Dec. 31, 2015 | |
Employee benefit plans | 15. Employee benefit plans The Company administers a 401(k) Savings Retirement Plan (the “MannKind Retirement Plan”) for its employees. For the years ended December 31, 2015, 2014, and 2013, the Company contributed $593,000, $623,000, and $533,000 respectively, to the MannKind Retirement Plan. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2015 | |
Income taxes | 16. Income taxes There is no provision for income taxes because the Company has incurred operating losses since inception. At December 31, 2015, the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. Accordingly, the net deferred tax assets have been fully reserved. The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2015 2014 2013 Current U.S. federal $ — $ — $ — U.S. state — — — Non-U.S. — — — Total current — — — Deferred U.S. federal 109,512 57,873 59,379 U.S. state (29,394 ) 7,631 7,470 Non-U.S. — — — Valuation Allowance (80,118 ) (65,504 ) (66,849 ) Total deferred — — — Total $ — $ — $ — Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. A valuation allowance is established when uncertainty exists as to whether all or a portion of the net deferred tax assets will be realized. Components of the net deferred tax asset as of December 31, 2015 and 2014 are approximately as follows (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 721,588 $ 699,997 Research and development credits 73,646 73,227 Capitalized research 5,872 28,516 Payments from collaboration 52,484 19,217 Milestone Rights 3,242 5,321 Accrued expenses 251 768 Loss on purchase commitment 24,084 — Non-qualified stock option expense 16,941 43,691 Capitalized patent costs 8,574 8,624 Other 7,186 131 Depreciation 48,755 3,010 Total net deferred tax assets 962,623 882,502 Valuation allowance (962,623 ) (882,502 ) Net deferred tax assets $ — $ — As a result of certain realization requirements of ASC 718, the table of deferred tax assets and liabilities does not include certain deferred tax assets as of December 31, 2015 that arose directly from tax deductions related to equity compensation which are greater than the compensation recognized for financial reporting. Equity would be increased by $10.0 million if and when such deferred tax assets are ultimately realized. The Company considered the requirements under ASC 740 Income Taxes The Company’s effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2015, 2014 and 2013: December 31, 2015 2014 2013 Federal tax benefit rate 35.0 % 35.0 % 35.0 % State tax benefit, net of federal benefit — — — Permanent items — 0.9 — Intercompany transfer of intellectual property (1.0 ) (4.1 ) (4.3 ) Valuation allowance (34 ) (31.8 ) (30.7 ) Effective income tax rate 0.0 % 0.0 % 0.0 % As required by ASC 740, management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Management has concluded, in accordance with the applicable accounting standards, that it is more likely than not that the Company may not realize the benefit of its deferred tax assets. Accordingly, the net deferred tax assets have been fully reserved. Management reevaluates the positive and negative evidence on an annual basis. During the years ended December 31, 2015, 2014 and 2013, the change in the valuation allowance was $ 62.6 80.1 80.1 66.8 At December 31, 2015, the Company had federal and state net operating loss carryforwards of approximately $1.9 billion and $1.3 billion available, respectively, to reduce future taxable income. The federal net operating loss carryforwards will expire at various dates beginning in 2018 and the state net operating loss carryforwards have started expiring, starting current year through various future dates. As a result of the Company’s initial public offering, an ownership change within the meaning of Internal Revenue Code Section 382 occurred in August 2004. As a result, federal net operating loss and credit carry forwards of approximately $216.0 million are subject to an annual use limitation of approximately $13.0 million. The annual limitation is cumulative and therefore, if not fully utilized in a year can be utilized in future years in addition to the Section 382 limitation for those years. The federal net operating losses generated subsequent to the Company’s initial public offering in August 2004 are currently not subject to any such limitation as there have been no ownership changes since August 2004 within the meaning of Internal Revenue Code Section 382. At December 31, 2015, the Company had research and development credits of $49.1 million and $37.7 million for federal and state purposes, respectively. The federal credits begin to expire in 2024, and the state credits may be carried forward indefinitely. The Company has evaluated the impact of ASC 740, previously FIN 48 Accounting for Uncertainty in Income Taxes |
Facility Agreement
Facility Agreement | 12 Months Ended |
Dec. 31, 2015 | |
Facility Agreement | 17. Facility Agreement As of December 31, 2015 and 2014, there were $60.0 million principal amount of 2019 notes and $20.0 million principal amount of Tranche B notes outstanding. The 2019 notes accrue interest at annual rate of 9.75% and the Tranche B notes accrue interest at an annual rate of 8.75% and is paid quarterly in arrears on the last day of each March, June, September, and December. The Facility Agreement principal repayment schedule is comprised of annual payments beginning on July 1, 2016 and ending December 9, 2019. Future principal payments for the years ended December 31, 2016, 2017, 2018, and 2019 are $5.0 million, $20.0 million, $20.0 million, and $35.0 million, respectively. In conjunction with the Facility Agreement, the Company entered into a Milestone Rights Agreement with Deerfield which requires the Company to make contingent payments to Deerfield, totaling up to $90.0 million, upon the Company achieving specified commercialization milestones. The Milestone Rights were initially recorded as a short-term liability equal to $3.2 million included in accrued expenses and other current liabilities in the accompanying condensed consolidated balance sheet and a long-term liability equal to $13.1 million included in other liabilities. During the first quarter of 2015, a milestone triggering event was achieved following the Company’s product launch on February 3, 2015, which resulted in a $5.8 million incremental charge to interest expense due to the increase in carrying value of the liability to the required $10.0 million payment made in February of 2015. During the year ended December 31, 2014, the first milestone triggering event was achieved following the Company’s entry into the Sanofi License Agreement, which resulted in a $1.9 million incremental charge to interest expense due to the increase in carrying value of the liability to the required $5.0 million payment, which was paid to Deerfield pursuant to the terms of the Milestone Agreement. As of December 31, 2015, the remaining liability balance of $8.9 million is classified as long-term liability in other liabilities. As of December 31, 2015, the uncreated debt discount and debt issuance costs were $5.3 million and $0.1 million, respectively. Accretion of debt issuance cost and debt discount in connection with the Deerfield financing during the year ended December 31, 2015 and 2014 are as follows (in thousands): December 31, 2015 2014 Accretion expense- debt issuance cost $ 35 $ 326 Accretion expense- debt discount $ 1,553 $ 7,550 The Facility Agreement includes customary representations, warranties and covenants, including, a restriction on the incurrence of additional indebtedness, and a financial covenant which requires the Company’s cash and cash equivalents, which includes available borrowings on the principal stockholder note, on the last day of each fiscal quarter to not be less than $25.0 million. As discussed in Note 1 — Basis of Presentation, the Company will need to raise additional capital to support its current operating plans. Due to the uncertainties related to maintaining sufficient resources to comply with the aforementioned covenant, the 2019 notes have been classified as current liabilities in the accompanying balance sheet as of December 31, 2015. In the event of non-compliance, Deerfield may declare all or any portion of the 2019 notes and/or Tranche B notes to be immediately due and payable. Milestone Rights The Milestone Agreement includes customary representations and warranties and covenants by the Company, including restrictions on transfers of intellectual property related to AFREZZA. The Milestone Rights are subject to acceleration in the event the Company transfers its intellectual property related to AFREZZA in violation of the terms of the Milestone Agreement. The Company analyzed the Milestone Rights under the provisions of ASC 815 Derivatives and Hedging, The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate. In determining the fair value of the Milestone Rights, the 13 individual milestone payments were adjusted for both (i) the expected timing and (ii) the probability of achieving the milestones, and then discounted to present value using a discount rate of 17.5%. Once the initial valuation of each specified milestone payment was determined, the individual milestone payments were then aggregated to arrive at a total fair value of $16.3 million. The discount rate was based on the estimated cost of equity which was derived using the capital asset pricing model. In addition, a 5% risk premium was added to the computation of the cost of equity to adjust for non-systemic risk factors, such as the Company’s lack of product diversification and history of financial losses, which were not captured in other model inputs. Security Agreement In connection with the Facility Agreement, the Company and its subsidiary, MannKind LLC, entered into a Guaranty and Security Agreement (the “Security Agreement”) with Deerfield and HS (collectively, the “Purchasers”), pursuant to which the Company and MannKind LLC each granted the Purchasers a security interest in substantially all of their respective assets, including respective intellectual property, accounts, receivables, equipment, general intangibles, inventory and investment property, and all of the proceeds and products of the foregoing. The Security Agreement includes customary covenants by the Company and MannKind LLC, remedies of the Purchasers and representations and warranties by the Company and MannKind LLC. The security interests granted by the Company and MannKind LLC will terminate upon repayment of the 2019 notes and tranche B notes, if applicable, in full. The Company’s obligations under the Facility Agreement and the Milestone Agreement are also secured by the mortgage on the Company’s facilities in Danbury, Connecticut, which has a carrying value of $23.0 million. Embedded Derivatives The Company identified and evaluated a number of embedded features in the notes issued under the Facility Agreement to determine if they represented embedded derivatives that are required to be separated from the notes and accounted for as freestanding instruments pursuant to ASC 815. In 2014, the Company analyzed the Tranche B notes and identified embedded derivatives which required separate accounting under ASC 815; however all of the embedded derivatives were determined to have a de minimis At December 31, 2015, all of the embedded derivatives identified in the Tranche B notes were deemed to have a de minimis |
Restructuring Charges
Restructuring Charges | 12 Months Ended |
Dec. 31, 2015 | |
Restructuring Charges | 18. Restructuring Charges On September 2015, the Company initiated a restructuring of the organization as a result of its shift to commercial production of AFREZZA. In connection with the restructuring, the Company reduced its total workforce by approximately 26% to 198 employees. The Company recorded restructuring charges of $5.9 million, $1.9 million, and $0.4 million for the years ended December 31, 2015, 2014, and 2013, respectively. As of December 31, 2015, the Company paid $2.8 million and the remaining balance is expected to be paid in the first quarter of 2016. The $5.9 million of costs associated with the restructuring are included in “Research and development” and “General and administrative” operating expenses in the condensed consolidated statements of operations as $3.0 million and $2.9 million, respectively, for the year ended December 31, 2015. As of December 31, 2015 and 2014, the Company had a restructuring accrual of $3.0 million and $0.3 million, respectively. The Company did not have a restructuring accrual as of December 31, 2013. |
Selected quarterly financial da
Selected quarterly financial data (unaudited) | 12 Months Ended |
Dec. 31, 2015 | |
Selected quarterly financial data (unaudited) | 19. Selected quarterly financial data (unaudited) Summarized quarterly financial data for the years ended December 31, 2015 and 2014 are set forth in the following tables: March 31 June 30 September 30 December 31 (In thousands, except per share data) 2015 Net loss $ (30,658 ) $ (28,910 ) $ (31,857 ) $ (277,020 ) Net loss per share — basic and diluted $ (0.08 ) $ (0.07 ) $ (0.08 ) $ (0.66 ) Weighted average common shares used to compute basic and diluted net loss per share 398,916 401,018 405,199 419,314 March 31 June 30 September 30 December 31 (In thousands, except per share data) 2014 Net loss $ (52,056 ) $ (73,365 ) $ (36,520 ) $ (36,439 ) Net loss per share — basic and diluted $ (0.14 ) $ (0.19 ) $ (0.09 ) $ (0.09 ) Weighted average common shares used to compute basic and diluted net loss per share 368,784 380,770 394,163 396,793 Impairment charges recorded in 2015 for $242.7 million related to long-lived assets, inventory and loss on purchase commitments. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2015 | |
Subsequent Events | 20. Subsequent Events Sanofi Termination On January 4, 2016, the Company received written notice from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. Sanofi’s notice indicated that the termination was pursuant to Sanofi’s right to terminate the agreement upon Sanofi’s good faith determination that the commercialization of AFREZZA is no longer economically viable in the United States, in which case the effective date of termination would be April 4, 2016. In the alternative, Sanofi indicated that the termination was also pursuant to its right to terminate the Sanofi License Agreement for any reason, in which case the Termination Date would be July 4, 2016. In the interest of an expedient transition, the Company is currently working with Sanofi to transfer and wind down the agreement activities by April 4, 2016, or as soon as practicable thereafter. Pursuant to the terms of the Sanofi License Agreement, the Company and Sanofi are required to use diligent efforts to facilitate the smooth and orderly transition of relevant obligations and rights to the Company with respect to development and commercialization activities related to AFREZZA, and are also required to negotiate in good faith a written transition agreement for this purpose. As a result of the foregoing termination, effective on the Termination Date and thereafter during any period which Sanofi is required to perform any wind-down activities pursuant to the terms of the Sanofi License Agreement, the rights granted to Sanofi under the Sanofi License Agreement to develop and commercialize AFREZZA will become non-exclusive and the Company will have the right to engage one or more other distributors and/or licensees of AFREZZA. Sanofi will continue to distribute AFREZZA during the wind-down period as required by the agreement until such time that the Company or its designee takes over responsibility for distribution. All profits and losses from AFREZZA product sales by Sanofi or its affiliates after the Termination Date, if any, will continue to be shared 65% by Sanofi and 35% by the Company pursuant to the terms of the Sanofi License Agreement. The Company and Sanofi are also parties to the Sanofi Supply Agreement, pursuant to which the Company is required to supply Sanofi or its affiliates or its sublicensees such quantities of AFREZZA as requested by Sanofi to cover its commercial requirements. As a result of the termination of the Sanofi License Agreement, the Sanofi Supply Agreement will terminate by its terms on the Termination Date. Borrowings under Sanofi Loan Facility On February 10, 2016, the Company borrowed $17.9 million under the Sanofi Loan Facility to finance the portion of its losses for the quarter ended December 31, 2015 (see Note 9 — Collaboration arrangement). |
Description of business and b28
Description of business and basis of presentation (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
Business | Business |
Basis of Presentation | Basis of Presentation At December 31, 2015, the Company’s capital resources consisted of cash and cash equivalents of $59.1 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing and sales and marketing of AFREZZA and the development of other product candidates. The facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) and the First Amendment to Facility Agreement and Registration Rights Agreement (the “First Amendment”) that resulted in additional sales of an additional tranche of notes (the “Tranche B notes”) (see Note 17 — Facility Agreement) requires the Company to maintain at least $25.0 million in cash and cash equivalents or available borrowings under the loan arrangement, dated as of October 2, 2007, between The Company and The Mann Group LLC (as amended, restated, or otherwise modified as of the date hereof, “the Mann Group Loan Arrangement”), as of the last day of each fiscal quarter. The Company will need to continue to incur expenses for the commercialization of AFREZZA and will need to raise additional capital to finance such activities. The Company cannot be certain that it will be able to raise additional capital on favorable terms, or at all, which raises substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. On August 11, 2014, we executed a license and collaboration agreement (the “Sanofi License Agreement”) with Sanofi-Aventis Deutschland GmbH (which subsequently assigned its rights and obligations under the agreement to Sanofi-Aventis U.S. LLC (“Sanofi”)), pursuant to which Sanofi is responsible for global commercial, regulatory and development activities for AFREZZA. The Sanofi License Agreement became effective on September 23, 2014. The Company manufactured AFREZZA at its manufacturing facility in Danbury, Connecticut to supply Sanofi’s demand for the product pursuant to a supply agreement dated August 11, 2014 (the “Sanofi Supply Agreement”). On January 4, 2016 the Company received notification from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. Sanofi’s notice indicated that the termination was pursuant to Sanofi’s right to terminate the Sanofi License Agreement upon Sanofi’s good faith determination that the commercialization of AFREZZA is no longer economically viable in the United States, in which case the effective date of termination (the “Termination Date”) will be April 4, 2016. In the alternative, Sanofi indicated that the termination was also pursuant to its right to terminate the Sanofi License Agreement for any reason, in which case the Termination Date will be July 4, 2016. In the interest of an expedient transition, the Company is working with Sanofi to transfer and wind down the agreement activities by April 4, 2016, or as soon as practicable thereafter. Under the Sanofi License Agreement, worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by the Company and Sanofi that are specifically attributable or related to the development, regulatory filings, manufacturing, or commercialization of AFREZZA, are shared 65% by Sanofi and 35% by the us. As a result of the loss share provision, and because the Company does not have the ability to estimate the amount of costs that would potentially be incurred related to the Sanofi License Agreement, the amount of up-front cash payment or milestone payments that could be recognized as revenue is not fixed or determinable. In connection with the Sanofi License Agreement, an affiliate of Sanofi provided the Company with a secured loan facility (the “Sanofi Loan Facility”) of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. Additional funding sources that are, or in certain circumstances may be available to the Company, include approximately $30.1 million principal amount of available borrowings under The Mann Group Loan Arrangement. A portion of these available borrowings may be used to capitalize accrued interest into principal, upon mutual agreement of the parties, as it becomes due and payable under The Mann Group Loan Arrangement. (see note 7 — Related-party arrangements). The Company cannot provide assurances that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company will need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, asset sales or other means, in order to continue the development and commercialization of AFREZZA and other product candidates and to support its other ongoing activities. However, the Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. |
Principles of Consolidation | Principles of Consolidation |
Segment Information | Segment Information Segment Reporting |
Financial Statement Estimates | Financial Statement Estimates |
License and Collaboration and Supply Agreements | License and Collaboration and Supply Agreements The Company analyzes consideration received under the provisions of ASC 605, Revenue Recognition, to determine whether the consideration, or a portion thereof, could be recognized as revenue. ASC 605 provides that revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collection is reasonably assured. In arrangements involving the delivery of more than one element, each required deliverable is evaluated to determine whether it qualifies as a separate unit of accounting. This determination is generally based on whether the deliverable has “stand-alone value” to the customer. The arrangement’s consideration that is fixed and determinable is then allocated to each separate unit of accounting based on the relative selling price of each deliverable. The estimated selling price of each deliverable is determined using the following hierarchy of values: (i) vendor-specific objective evidence of fair value, (ii) third-party evidence of selling price and (iii) best estimate of selling price (BESP). The BESP reflects the Company’s best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis. In general, the consideration allocated to each unit of accounting is recognized as the related goods or services are delivered, limited to the consideration that is not contingent upon future deliverables. The assessment of multiple element arrangements requires judgment in order to determine the appropriate units of accounting and the points in time that, or periods over which, revenue should be recognized. Given that, as of December 31, 2015, the Company did not have the ability to estimate the amount of costs that would potentially be incurred under the loss share provision related to the Sanofi License Agreement and the Sanofi Supply Agreement, the Company believe the fixed and determinable fee requirement for revenue recognition was not met. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Concentration of Credit Risk | Concentration of Credit Risk |
State Research and Development Credit Exchange Receivable | State Research and Development Credit Exchange Receivable |
Prepaid expenses and other current assets | Prepaid expenses and other current assets — |
Sale of intellectual property | Sale of intellectual property |
Milestone Rights | Milestone Rights The initial fair value estimate of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones and discounted to present value using a selected market discount rate. The expected timing and probability of achieving the milestones was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The Milestone Rights liability will be remeasured as the specified milestone events are achieved. Specifically, as each milestone event is achieved, the portion of the initially recorded Milestone Rights liability that pertains to the milestone event being achieved, will be remeasured to the amount of the specified related milestone payment. The resulting change in the balance of the Milestone Rights liability due to remeasurement will be recorded in the Company’s Statement of Operations as interest expense. Furthermore, the Milestone Rights liability will be reduced upon the settlement of each milestone payment. As a result, each milestone payment would be effectively allocated between a reduction of the recorded Milestone Rights liability and an expense representing a return on a portion of the Milestone Rights liability paid to the investor for the achievement of the related milestone event (see Note 17 — Facility Agreement). As of December 31, 2015, the remaining liability balance of $8.9 million was classified as long-term liability in other liabilities. |
Deferred product costs from collaboration | Deferred product costs from collaboration |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. The carrying amounts reflected in the consolidated balance sheets for cash equivalents, other current assets, accounts payable, and accrued expenses and other current liabilities, approximate fair value due to their relatively short maturities. |
Inventories | Inventories We analyzed our inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. We performed an assessment of projected sales and to evaluate the lower of cost or market and the potential excess inventory on hand at December 31, 2015. As a result of this assessment, we recorded a charge of $39.3 million to record the inventory raw materials on hand at the lower of cost or market, inventory expiry, and write-off other inventory related assets. In connection with the projected sales assessment, we also evaluated our inventory purchase commitments totalling $116.2 million for potential impairment. As a result of this assessment, we recorded a $66.2 million charge related to a loss on future purchase commitments both from a lower of cost or market excess inventory perspective. The purchase commitment obligation has been reduced to reflect our expectation that a portion will be recoverable from a third party. |
Property and Equipment | Property and Equipment Impairment of Long-Lived Assets Property Plant and Equipment. • significant changes in the Company’s strategic business objectives and utilization of the assets; • a determination that the carrying value of such assets cannot be recovered through undiscounted cash flows; • loss of legal ownership or title to the assets; • a significant adverse change in legal factors or in the business climate that could affect the value of a long-lived asset (asset group), including an adverse action or assessment by a regulator; or • the impact of significant negative industry or economic trends. If the Company believes an asset to be impaired, the impairment recognized is the amount by which the carrying value of the assets exceeds the fair value of the assets. Any write-downs would be treated as permanent reductions in the carrying amount of the asset and an operating loss would be recognized. The Company recorded an asset impairment of $140.4 million for the year ended December 31, 2015 (see Note 5 — Property and Equipment). No asset impairment was recognized during the years ended December 31, 2014, and 2013, respectively. |
Income Taxes | Income Taxes Income tax positions are considered for uncertainty in accordance with ASC 740-10-25 Income Taxes, Significant management judgment is involved in determining the provision for income taxes, deferred tax assets, deferred tax liabilities, and any valuation allowance recorded against deferred tax assets. Due to uncertainties related to the realization of the Company’s deferred tax assets as a result of its history of operating losses, a valuation allowance has been established against the total deferred tax asset balance. The valuation allowance is based on management’s estimates of taxable income by jurisdiction in which the Company operates and the period over which deferred tax assets will be recoverable. In the event that actual results differ from these estimates or the Company adjusts these estimates in future periods, a change in the valuation allowance may be needed, which could materially impact the Company’s financial position and results of operations. |
Contingencies | Contingencies Contingencies. |
Stock-Based Compensation | Stock-Based Compensation . Compensation — Stock Compensation |
Warrants | Warrants Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock |
Comprehensive Loss | Comprehensive Loss Comprehensive Income, |
Research and Development Expenses | Research and Development Expenses Research and Development. |
Clinical Trial Expenses | Clinical Trial Expenses |
Interest Expense | Interest Expense |
Net Loss Per Share of Common Stock | Net Loss Per Share of Common Stock |
Recently Issued Accounting Standards | Recently Issued Accounting Standards to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption. In May 2014, the FASB issued ASU 2014-09 related to revenue recognition, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The guidance requires a company to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration it expects to be entitled to receive in exchange for those goods or services. In July 2015, the FASB issued ASU 2015-14, which delayed the effective date of the new revenue standard by one year. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The standard is effective beginning the first quarter of the Company’s 2018 fiscal year and is required to be adopted using either a full retrospective or a modified retrospective approach. The Company is assessing the potential impact of the new standard on its consolidated financial statements and has not yet selected a transition method. In August 2014, the FASB issued ASU 2014-15, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern”. The ASU is effective for annual periods ending after December 15, 2016, and interim periods thereafter; early adoption is permitted. The Company is evaluating the impact the adoption of ASU 2014-15 will have on its consolidated financial statements. In April 2015, the FASB issued ASU 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” The guidance requires debt issuance costs to be presented in the balance sheet as a direct deduction from the carrying value of the associated debt, consistent with the presentation of a debt discount. The guidance is effective for annual reporting periods beginning after December 15, 2015 and interim periods thereafter. As permitted by the standard, the Company adopted the new presentation prospectively and the adoption did not have an impact on its consolidated financial statements and disclosures. In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendments are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company is evaluating the impact the adoption of ASU 2015-11 will have on its consolidated financial statements. In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. The new standard requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. For public business entities, the amendments in this Update are effective for financial statements issued for annual periods beginning after December 15, 2016, and interim periods within those annual periods. As permitted by the standard, the Company adopted the new presentation and the adoption did not have an impact on its consolidated financial statements and disclosures. In January 2016, the FASB issued ASU 2016-01, Financial Instruments — Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The update is intended to improve the recognition and measurement of financial instruments. The update are effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company is evaluating the impact the adoption of ASU 2016-01 will have on its consolidated financial statements. |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Components of Inventories | Inventories consist of the following (in thousands): December 31, 2015 2014 Raw materials $ — $ 4,856 Work-in-process — 4,719 Finished goods — 95 Inventory — current — 9,670 Total Inventory $ — $ 9,670 |
Property and equipment (Tables)
Property and equipment (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Property and Equipment | Property and equipment consist of the following (dollar amounts in thousands): Estimated December 31, 2015 2014 Land — $ 5,273 $ 5,273 Buildings 39-40 54,948 54,948 Building improvements 5-40 131,383 114,131 Machinery and equipment 3-15 95,182 80,919 Furniture, fixtures and office equipment 5-10 4,137 5,015 Computer equipment and software 3 9,707 10,465 Leasehold improvements 4 — 17 Construction in progress 8,044 39,580 308,674 310,348 Less impairment (140,412 ) — Less accumulated depreciation and amortization (119,513 ) (118,221 ) Total property and equipment, net $ 48,749 $ 192,127 |
Accrued expenses and other cu31
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities are comprised of the following (in thousands): December 31, 2015 2014 Salary and related expenses $ 5,662 $ 14,928 Accrued interest 615 2,396 Construction in progress 238 1,343 Other 1,414 7,539 Accrued expenses and other current liabilities $ 7,929 $ 26,206 |
Senior convertible notes (Table
Senior convertible notes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Senior Convertible Notes | Senior convertible notes consist of the following (in thousands): December 31, 2015 2014 2015 notes Principal amount $ — $ 100,000 Unaccreted debt issuance cost — (645 ) Net carrying amount $ — $ 99,355 2018 notes Principal amount $ 27,690 $ — Unamortized premium 660 — Unaccreted debt issuance costs (737 ) — Net carrying amount $ 27,613 $ — |
Fair Value of Financial Instr33
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Summary of Carrying Values Estimated Fair Values of Notes and Facility Financing Obligation | The following is a summary of the carrying values and estimated fair values of the 2018 notes, the facility financing obligation (i.e., the 2019 notes and Tranche B notes), and the Sanofi Loan Facility (in millions): December 31, 2015 December 31, 2014 Carrying Estimated Carrying Estimated 2015 notes $ — $ — $ 99.4 $ 102.9 2018 notes $ 27.6 $ 21.3 $ — $ — Facility financing obligation $ 74.6 $ 78.4 $ 73.0 $ 75.1 Sanofi Loan Facility $ 44.5 $ 36.5 $ 3.0 $ 3.0 |
Net loss per common share (Tabl
Net loss per common share (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Potential Dilutive Securities Outstanding | Potentially dilutive securities outstanding are summarized as follows (in shares): December 31, 2015 2014 2013 Exercise of common stock options 19,779,229 21,541,664 24,237,940 Conversion of senior convertible notes into common stock 4,072,809 17,323,080 25,415,366 Exercise of common stock warrants 4,074,596 9,987,876 19,706,240 Vesting of restricted stock units 1,804,620 2,610,720 9,115,821 29,731,254 51,463,340 78,475,367 |
Stock award plans (Tables)
Stock award plans (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Stock Based Award Plans | The following table summarizes information about the Company’s stock-based award plans as of December 31, 2015: Outstanding Outstanding Shares Available 2004 Equity Incentive Plan 11,309,136 276,784 — 2013 Equity Incentive Plan 8,026,762 1,527,836 15,540,652 2004 Non-Employee Directors’ Stock Option Plan 443,331 — — Total 19,779,229 1,804,620 15,540,652 |
Stock Based Compensation Expense Recognized in Accompanying Statements of Operations | Total stock-based compensation expense recognized in the accompanying statements of operations is as follows (in thousands): Year Ended December 31, 2015 2014 2013 Employee-related $ 8,407 $ 48,622 $ 45,181 Consultant-related 318 — 5 Total $ 8,725 $ 48,622 $ 45,186 |
Stock Based Compensation Expense Recognized in Accompanying Statements of Operations by Category | Total stock-based compensation expense recognized in the accompanying statements of operations is included in the following categories (in thousands): Year Ended December 31, 2015 2014 2013 Research and development $ 3,029 $ 22,357 $ 20,409 General and administrative 5,696 26,265 24,777 Total $ 8,725 $ 48,622 $ 45,186 |
Assumptions Used to Calculate Fair Value of Employee Stock Options | The Company calculated the fair value of employee stock options granted during the years ended December 31, 2015, 2014 and 2013 using the following assumptions: Year Ended December 31, 2015 2014 2013 Risk-free interest rate 1.61% — 1.86% 1.64% — 2.11% 0.94% — 1.82% Expected lives 5.79 — 5.86 years 5.77 — 6.09 years 2.64 — 5.77 years Volatility 69.76% — 71.84% 73.98% — 84.85% 75.83% — 86.26% Dividends — — — |
Summary of Stock Options Outstanding | The following table summarizes information about stock options outstanding: Number Weighted Aggregate Outstanding at January 1, 2015 21,541,664 4.53 $ 33,495 Granted 1,541,100 4.11 Exercised (1,700,964 ) 1.91 Forfeited (706,387 ) 5.78 Expired (896,184 ) 7.70 Outstanding at December 31, 2015 19,779,229 4.54 $ — Vested and expected to vest at December 31, 2015 19,597,097 4.53 $ — Exercisable at December 31, 2015 17,217,332 4.47 $ — |
Summary of Restricted Stock Unit Activity | A summary of restricted stock unit activity for the year ended December 31, 2015 is presented below: Number Weighted Outstanding at January 1, 2015 2,610,720 $ 5.20 Granted 1,133,404 $ 4.14 Vested (1,111,134 ) $ 4.93 Forfeited (828,370 ) $ 4.88 Outstanding at December 31, 2015 1,804,620 $ 4.85 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Provision for Income Taxes | The provision for income taxes consists of the following (in thousands): Year Ended December 31, 2015 2014 2013 Current U.S. federal $ — $ — $ — U.S. state — — — Non-U.S. — — — Total current — — — Deferred U.S. federal 109,512 57,873 59,379 U.S. state (29,394 ) 7,631 7,470 Non-U.S. — — — Valuation Allowance (80,118 ) (65,504 ) (66,849 ) Total deferred — — — Total $ — $ — $ — |
Components of Net Deferred Tax Asset | Components of the net deferred tax asset as of December 31, 2015 and 2014 are approximately as follows (in thousands): December 31, 2015 2014 Deferred tax assets: Net operating loss carryforwards $ 721,588 $ 699,997 Research and development credits 73,646 73,227 Capitalized research 5,872 28,516 Payments from collaboration 52,484 19,217 Milestone Rights 3,242 5,321 Accrued expenses 251 768 Loss on purchase commitment 24,084 — Non-qualified stock option expense 16,941 43,691 Capitalized patent costs 8,574 8,624 Other 7,186 131 Depreciation 48,755 3,010 Total net deferred tax assets 962,623 882,502 Valuation allowance (962,623 ) (882,502 ) Net deferred tax assets $ — $ — |
Effective Income Tax Rate | The Company’s effective income tax rate differs from the statutory federal income tax rate as follows for the years ended December 31, 2015, 2014 and 2013: December 31, 2015 2014 2013 Federal tax benefit rate 35.0 % 35.0 % 35.0 % State tax benefit, net of federal benefit — — — Permanent items — 0.9 — Intercompany transfer of intellectual property (1.0 ) (4.1 ) (4.3 ) Valuation allowance (34 ) (31.8 ) (30.7 ) Effective income tax rate 0.0 % 0.0 % 0.0 % |
Facility Agreement (Tables)
Facility Agreement (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Accretion of Debt Issuance Cost and Debt Discount | Accretion of debt issuance cost and debt discount in connection with the Deerfield financing during the year ended December 31, 2015 and 2014 are as follows (in thousands): December 31, 2015 2014 Accretion expense- debt issuance cost $ 35 $ 326 Accretion expense- debt discount $ 1,553 $ 7,550 |
Selected quarterly financial 38
Selected quarterly financial data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
Selected Quarterly Financial Data | Summarized quarterly financial data for the years ended December 31, 2015 and 2014 are set forth in the following tables: March 31 June 30 September 30 December 31 (In thousands, except per share data) 2015 Net loss $ (30,658 ) $ (28,910 ) $ (31,857 ) $ (277,020 ) Net loss per share — basic and diluted $ (0.08 ) $ (0.07 ) $ (0.08 ) $ (0.66 ) Weighted average common shares used to compute basic and diluted net loss per share 398,916 401,018 405,199 419,314 March 31 June 30 September 30 December 31 (In thousands, except per share data) 2014 Net loss $ (52,056 ) $ (73,365 ) $ (36,520 ) $ (36,439 ) Net loss per share — basic and diluted $ (0.14 ) $ (0.19 ) $ (0.09 ) $ (0.09 ) Weighted average common shares used to compute basic and diluted net loss per share 368,784 380,770 394,163 396,793 |
Description of Business and B39
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) | Jan. 04, 2016 | Aug. 11, 2014 | Sep. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 23, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||
Accumulated deficit | $ (2,863,229,000) | $ (2,494,784,000) | ||||||
Cash and cash equivalents | 59,074,000 | $ 120,841,000 | $ 70,790,000 | $ 61,840,000 | ||||
Amount available for future borrowings | $ 30,100,000 | |||||||
License and Collaboration Agreement with Sanofi | ||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||
Up-front fee | $ 150,000,000 | |||||||
Profits and losses sharing percentage | 35.00% | 35.00% | ||||||
Maximum secured loan facility | $ 175,000,000 | |||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | ||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||
Up-front fee | $ 150,000,000 | |||||||
Profits and losses sharing percentage | 65.00% | 65.00% | ||||||
Maximum secured loan facility | $ 175,000,000 | |||||||
Senior convertible notes due December 31, 2019 | Deerfield | Minimum | Facility Agreement | Less portion of commitment asset | ||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||
Available amount of credit facility under covenant restrictions | $ 25,000,000 | |||||||
Subsequent Event | License and Collaboration Agreement with Sanofi | ||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||
Termination date | Jul. 4, 2016 |
Summary Of Significant Accoun40
Summary Of Significant Accounting Policies - Additional Information (Detail) $ in Thousands, € in Millions | Jul. 18, 2014USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2015EUR (€) | Jul. 01, 2013USD ($) |
Summary Of Significant Accounting Policies [Line Items] | ||||||
Maturity period of cash equivalents | 90 days or less at the time of purchase | |||||
Percentage of credit exchange receivable | 65.00% | |||||
Prepaid expenses and other current assets | $ 4,018 | $ 20,206 | ||||
Prepayment for 2015 quantities of insulin and prepaid insurance | 15,000 | |||||
Other income (expense) | 1,366 | 1,679 | $ (635) | |||
Inventory charge | 36,300 | |||||
Purchase commitment obligation | 116,200 | € 98.5 | ||||
Loss on purchase commitments | 66,167 | |||||
Property and equipment impairment | 140,412 | 0 | 0 | |||
Interest expense, net of interest capitalized | 24,100 | 20,400 | 21,500 | |||
Interest cost capitalized | 100 | $ 800 | $ 400 | |||
Deerfield | Milestone Rights Liability | Senior convertible notes due December 31, 2019 | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Long term liability | 8,900 | $ 13,100 | ||||
Intellectual property | ||||||
Summary Of Significant Accounting Policies [Line Items] | ||||||
Total consideration received | $ 9,300 | |||||
Intellectual property sold, net | 7,900 | |||||
Accrued expense associated with intellectual property | $ 1,400 | |||||
Other income (expense) | $ 1,400 |
State Research and Developmen41
State Research and Development Credit Exchange Receivable - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Accounts and Other Receivables [Line Items] | |||
Percentage of credit exchange receivable | 65.00% | ||
Estimated amounts receivable under program | $ 743,000 | $ 816,000 | $ 282,000 |
Components of Inventories (Deta
Components of Inventories (Detail) $ in Thousands | Dec. 31, 2014USD ($) |
Inventory [Line Items] | |
Raw materials | $ 4,856 |
Work-in-process | 4,719 |
Finished goods | 95 |
Inventory - current | 9,670 |
Total Inventory | $ 9,670 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 308,674 | $ 310,348 | |
Less impairment | (140,412) | 0 | $ 0 |
Less accumulated depreciation and amortization | (119,513) | (118,221) | |
Total property and equipment, net | 48,749 | 192,127 | |
Land | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | 5,273 | 5,273 | |
Buildings | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 54,948 | 54,948 | |
Buildings | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 39 years | ||
Buildings | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 40 years | ||
Building Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 131,383 | 114,131 | |
Building Improvements | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 5 years | ||
Building Improvements | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 40 years | ||
Machinery and Equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 95,182 | 80,919 | |
Machinery and Equipment | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 3 years | ||
Machinery and Equipment | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 15 years | ||
Furniture, fixtures and office equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 4,137 | 5,015 | |
Furniture, fixtures and office equipment | Minimum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 5 years | ||
Furniture, fixtures and office equipment | Maximum | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 10 years | ||
Computer Equipment and Software | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 3 years | ||
Property and equipment - gross | $ 9,707 | 10,465 | |
Leasehold Improvements | |||
Property, Plant and Equipment [Line Items] | |||
Estimated Useful Life (Years) | 4 years | ||
Property and equipment - gross | 17 | ||
Construction in Progress | |||
Property, Plant and Equipment [Line Items] | |||
Property and equipment - gross | $ 8,044 | $ 39,580 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) $ in Thousands | Jan. 04, 2016 | Dec. 31, 2015USD ($)asset_group | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Depreciation and Other Amortization Expenses [Line Items] | ||||
Amortization period of lease hold improvements | 4 years | |||
Depreciation and amortization expense | $ 11,000 | $ 9,800 | $ 11,500 | |
Number of primary asset groups | asset_group | 2 | |||
Impairment charge | $ 242,700 | |||
Danbury Facility | ||||
Depreciation and Other Amortization Expenses [Line Items] | ||||
Impairment charge | 138,600 | |||
Valencia | ||||
Depreciation and Other Amortization Expenses [Line Items] | ||||
Impairment charge | $ 1,800 | |||
Subsequent Event | License and Collaboration Agreement with Sanofi | ||||
Depreciation and Other Amortization Expenses [Line Items] | ||||
Termination date | Jul. 4, 2016 |
Accrued Expenses and Other Cu45
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Accrued Expenses and Other Current Liabilities [Line Items] | ||
Salary and related expenses | $ 5,662 | $ 14,928 |
Accrued interest | 615 | 2,396 |
Construction in progress | 238 | 1,343 |
Other | 1,414 | 7,539 |
Accrued expenses and other current liabilities | $ 7,929 | $ 26,206 |
Related-Party Arrangements - Ad
Related-Party Arrangements - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Oct. 31, 2013USD ($) | Oct. 31, 2007USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | May. 31, 2015ft² | |
Related Party Transaction [Line Items] | ||||||
Amount available for future borrowings | $ 30,100,000 | |||||
Accrued interest of related party debt | 6,400,000 | $ 3,500,000 | ||||
Available borrowings under loan agreement | 30,100,000 | 30,100,000 | ||||
Interest expense on note payable principal stockholder | 2,894,000 | 2,894,000 | $ 6,309,000 | |||
Expenses related to charter service on behalf of principal shareholder | $ 18,000 | 79,000 | 82,000 | |||
Mann Foundation | Sublease Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Area of office space leased | ft² | 12,500 | |||||
Lease expiration period | 2017-04 | |||||
Lease payment | $ 175,000 | $ 0 | $ 0 | |||
Principal stockholder | ||||||
Related Party Transaction [Line Items] | ||||||
Loan agreement with related party | $ 370,000,000 | $ 350,000,000 | ||||
Principal stockholder | Amended Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Maturity date | Jan. 5, 2020 | |||||
Principal stockholder | Loan Arrangement | ||||||
Related Party Transaction [Line Items] | ||||||
Principal amount outstanding under credit facility | $ 49,500,000 | |||||
Amount available for future borrowings | $ 30,100,000 | |||||
Fixed borrowing rate | 5.84% | |||||
Related party transaction prepayment period | 90 days | |||||
Aggregate principal amount cancelled | $ 105,000,000 | |||||
Principal stockholder | Loan Arrangement | Maximum | ||||||
Related Party Transaction [Line Items] | ||||||
Amount prepaid for cancellation of indebtedness | $ 200,000,000 | |||||
Principal stockholder | Loan Arrangement | Minimum | ||||||
Related Party Transaction [Line Items] | ||||||
Number of months advances outstanding | 12 months | |||||
Related Party Debt | Letter Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Description of variable rate interest | The interest rate will increase to the one-year LIBOR rate calculated on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum. | |||||
Related Party Debt | Letter Agreement | LIBOR | ||||||
Related Party Transaction [Line Items] | ||||||
Interest rate (LIBOR) | 5.00% |
Summary of Senior Convertible N
Summary of Senior Convertible Notes (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Aug. 14, 2015 | Aug. 10, 2015 | Dec. 31, 2014 |
Senior convertible notes due August 15, 2015 | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 32,100 | $ 100,000 | ||
Unaccreted debt issuance cost | (645) | |||
Net carrying amount | $ 99,355 | |||
Senior convertible notes due August 15, 2018 | ||||
Debt Instrument [Line Items] | ||||
Principal amount | $ 27,690 | $ 27,700 | ||
Unamortized premium | 660 | $ 700 | ||
Unaccreted debt issuance cost | (737) | |||
Net carrying amount | $ 27,613 |
Senior Convertible Notes - Addi
Senior Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands, shares in Millions | Sep. 30, 2015USD ($) | Aug. 17, 2015USD ($) | Aug. 10, 2015USD ($)$ / sharesshares | Aug. 10, 2015USD ($)d$ / shares | Jul. 28, 2015USD ($) | Aug. 18, 2010USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Aug. 14, 2015USD ($) |
Debt Instrument [Line Items] | ||||||||||
Aggregate principal amount for conversion | $ 93,500 | $ 6,500 | ||||||||
Loss on extinguishment of debt | $ (1,049) | |||||||||
Deerfield | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Premium of issuance of 2018 debt | 1,553 | 7,550 | ||||||||
2018 Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Accretion of debt issuance costs | 93,000 | |||||||||
2015 Notes | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Accretion of debt issuance costs | 600 | 900 | $ 900 | |||||||
Payments on senior notes | 64,287 | |||||||||
Senior convertible notes due August 15, 2018 | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 27,700 | $ 27,700 | 27,690 | |||||||
Senior notes, effective interest rate | 5.75% | 5.75% | ||||||||
Unamortized premium | $ 700 | $ 700 | $ 660 | |||||||
Maturity date | Aug. 15, 2018 | |||||||||
No of convertible shares | 147.0859 | |||||||||
Principal amount per share | $ / shares | $ 1,000 | |||||||||
Conversion price of shares | $ / shares | $ 6.80 | $ 6.80 | ||||||||
Percentage of repurchase price | 100.00% | |||||||||
Debt Instrument, redemption description | On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. | |||||||||
Percentage of conversion price equaling stock price | 130.00% | |||||||||
Number of trading days | d | 20 | |||||||||
Consecutive trading days | 30 days | |||||||||
Debt Issuance Cost | $ 800 | |||||||||
Premium of issuance of 2018 debt | $ 86,000 | |||||||||
Senior convertible notes due August 15, 2015 | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | 100,000 | $ 32,100 | ||||||||
Senior notes, effective interest rate | 5.75% | |||||||||
Conversion price of shares | $ / shares | $ 4.40 | $ 4.40 | ||||||||
Aggregate principal amount for conversion | $ 56,900 | |||||||||
Number of shares issued up on conversion of debt | shares | 1.9 | |||||||||
Principal amount of debt converted | $ 8,000 | |||||||||
Payments on senior notes | $ 32,100 | $ 32,200 | ||||||||
Loss on extinguishment of debt | $ 1,000 | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 60,000 | 60,000 | ||||||||
Senior notes, effective interest rate | 9.75% | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Principal amount | $ 20,000 | $ 20,000 | ||||||||
Senior notes, effective interest rate | 8.75% |
Collaborative Arrangement - Add
Collaborative Arrangement - Additional Information (Detail) - USD ($) | Feb. 10, 2016 | Jan. 04, 2016 | Aug. 11, 2014 | Sep. 30, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 23, 2014 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Paid-in-kind interest | $ 1,652,000 | ||||||
Sanofi-Aventis Deutschland GmbH | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Carrying value | 44,500,000 | $ 3,000,000 | |||||
Sanofi-Aventis Deutschland GmbH | CALIFORNIA | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Carrying value | $ 17,900,000 | ||||||
License and Collaboration Agreement with Sanofi | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Up-front fee | $ 150,000,000 | ||||||
Potential milestone payment | $ 775,000,000 | ||||||
Profits and losses sharing percentage | 35.00% | 35.00% | |||||
Maximum secured loan facility | $ 175,000,000 | ||||||
Senior notes, effective interest rate | 8.50% | ||||||
License and Collaboration Agreement with Sanofi | Subsequent Event | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Termination date | Jul. 4, 2016 | ||||||
License and Collaboration Agreement with Sanofi | Manufacturing Milestone Events | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Milestone payments earned | $ 50,000,000 | ||||||
License and Collaboration Agreement with Sanofi | Development Milestone Event | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | $ 75,000,000 | ||||||
License and Collaboration Agreement with Sanofi | Regulatory Approvals | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | 50,000,000 | ||||||
License and Collaboration Agreement with Sanofi | Product Sales Milestones | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | $ 650,000,000 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Up-front fee | $ 150,000,000 | ||||||
Profits and losses sharing percentage | 65.00% | 65.00% | |||||
Deferred revenue from collaboration product shipments | $ 150,000,000 | ||||||
Milestone receivable | 50,000,000 | ||||||
Deferred cost | 13,500,000 | ||||||
Company's total portion of loss sharing | 57,700,000 | ||||||
Maximum secured loan facility | 175,000,000 | ||||||
Carrying value | 44,500,000 | ||||||
Secured loan facility, amount borrowed | 44,500,000 | ||||||
Secured loan facility, amount owed | 62,400,000 | ||||||
Paid-in-kind interest | 1,700,000 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Subsequent Event | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Secured loan facility, amount borrowed | $ 17,900,000 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Operating loss Sharing | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Company's total portion of loss sharing | 60,700,000 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | AFREZZA product sales | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred revenue from collaboration product shipments | $ 17,500,000 |
Fair Value of Financial Instr50
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) | Jul. 01, 2013 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | Sep. 23, 2014 | Dec. 31, 2012 |
Fair Value of Financial Instruments [Line Items] | ||||||
Cash and cash equivalents | $ 59,074,000 | $ 120,841,000 | $ 70,790,000 | $ 61,840,000 | ||
Cash equivalents, money market funds | 55,800,000 | 118,500,000 | ||||
Transfers of assets between fair value measurement | 0 | 0 | 0 | |||
Transfers of liabilities between fair value measurement | 0 | 0 | 0 | |||
Property and equipment, net | 48,749,000 | 192,127,000 | ||||
Property and equipment impairment | 140,412,000 | 0 | $ 0 | |||
Sanofi-Aventis Deutschland GmbH | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Carrying value | 44,500,000 | 3,000,000 | ||||
Estimated fair value | 36,500,000 | 3,000,000 | ||||
Senior convertible notes due August 15, 2015 | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Carrying value | 99,355,000 | |||||
Senior convertible notes due August 15, 2015 | Convertible Debt Securities | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Carrying value | 99,400,000 | |||||
Estimated fair value | $ 102,900,000 | |||||
Senior convertible notes due August 15, 2018 | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Carrying value | 27,613,000 | |||||
Senior convertible notes due August 15, 2018 | Convertible Debt Securities | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Carrying value | 27,600,000 | |||||
Estimated fair value | 21,300,000 | |||||
License and Collaboration Agreement with Sanofi | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Maximum secured loan facility | $ 175,000,000 | |||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Maximum secured loan facility | 175,000,000 | |||||
Carrying value | 44,500,000 | |||||
Estimated fair value | 36,500,000 | |||||
Reported Value Measurement | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Property and equipment, net | 189,200,000 | |||||
Milestone Rights Liability | Deerfield | Maximum | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Contingent liability for milestone payments | $ 90,000,000 | |||||
Milestone Rights Liability | Senior convertible notes due December 31, 2019 | Deerfield | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 17.50% | |||||
Long term liability | $ 13,100,000 | 8,900,000 | ||||
Fair Value, Inputs, Level 3 | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Property, plant, and equipment, fair value | $ 48,800,000 | |||||
Fair Value, Inputs, Level 3 | License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 11.00% | |||||
Fair Value, Inputs, Level 3 | Milestone Rights Liability | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Fair value of Milestone Rights | $ 14,400,000 | |||||
Fair Value, Inputs, Level 3 | Income Approach Valuation Technique | Senior convertible notes due December 31, 2019 | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 12.00% | |||||
Fair Value, Inputs, Level 3 | Income Approach Valuation Technique | Milestone Rights Liability | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 15.00% | |||||
Fair Value, Inputs, Level 3 | Market Approach Valuation Technique | Senior convertible notes due August 15, 2015 | Convertible Debt Securities | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Fair value assumption, stock price volatility | 55.00% | |||||
Fair Value, Inputs, Level 3 | Market Approach Valuation Technique | Senior convertible notes due August 15, 2018 | Convertible Debt Securities | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Fair value assumption, stock price volatility | 90.00% | |||||
Fair value assumption, risk-free rate | 20.00% |
Summary of Carrying Values Esti
Summary of Carrying Values Estimated Fair Values of Notes and Facility Financing Obligation and Sanofi Loan Facility (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Sanofi-Aventis Deutschland GmbH | ||
Convertible Debt [Line Items] | ||
Carrying value | $ 44,500 | $ 3,000 |
Estimated fair value | 36,500 | 3,000 |
Senior convertible notes due August 15, 2018 | ||
Convertible Debt [Line Items] | ||
Carrying value | 27,613 | |
Senior convertible notes due August 15, 2018 | Convertible Debt Securities | ||
Convertible Debt [Line Items] | ||
Carrying value | 27,600 | |
Estimated fair value | 21,300 | |
Facility financing obligation | ||
Convertible Debt [Line Items] | ||
Carrying value | 74,600 | 73,000 |
Estimated fair value | $ 78,400 | 75,100 |
Senior convertible notes due August 15, 2015 | ||
Convertible Debt [Line Items] | ||
Carrying value | 99,355 | |
Senior convertible notes due August 15, 2015 | Convertible Debt Securities | ||
Convertible Debt [Line Items] | ||
Carrying value | 99,400 | |
Estimated fair value | $ 102,900 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) $ / shares in Units, $ in Thousands | Nov. 16, 2015shares | Nov. 09, 2015shares | Feb. 08, 2012USD ($)$ / shares$ / Rightshares | Nov. 01, 2015USD ($)$ / sharesshares | Dec. 31, 2015USD ($)$ / sharesshares | Dec. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2013USD ($) | Oct. 23, 2015shares | Sep. 30, 2015shares | Aug. 14, 2015USD ($) |
Class of Stock [Line Items] | ||||||||||
Common stock, shares authorized | 550,000,000 | 550,000,000 | ||||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 | ||||||||
Undesignated preferred stock, par value | $ / shares | $ 0.01 | $ 0.01 | ||||||||
Common stock, shares issued | 428,670,943 | 406,059,089 | ||||||||
Common stock, shares outstanding | 428,670,943 | 406,059,089 | ||||||||
Common stock shares sold aggregate price | $ | $ 27,844 | $ 48,888 | ||||||||
Issuance costs associated with the Tel Aviv Stock Exchange | $ | $ 548 | 1,103 | ||||||||
Percentage of shares of common stock issued for offering | 1.15% | |||||||||
Restricted warrants issued to purchase number of common stock for offering | 159,303 | |||||||||
Exercise price of restricted warrants per share in connection with the offering | $ / shares | $ 2.61 | |||||||||
Warrants exercisable period | 5 years | |||||||||
Common stock loaned under share lending agreement, shares | 9,000,000 | 9,000,000 | ||||||||
Nominal lending fee | $ / shares | $ 0.01 | |||||||||
Returned shares of common stock under share lending agreement | 9,000,000 | |||||||||
Number of Unit Sold in an Underwritten public offering | 35,937,500 | |||||||||
Warrant to purchase of a share of common stock | $ / Right | 0.6 | |||||||||
Net proceeds from offering | $ | $ 80,600 | |||||||||
Proceeds from exercise warrants | $ | $ 10,123 | $ 27,779 | $ 94,147 | |||||||
Warrants expiration, date | Feb. 8, 2016 | |||||||||
Warrant Liability | ||||||||||
Class of Stock [Line Items] | ||||||||||
Exercise price of restricted warrants per share in connection with the offering | $ / shares | $ 2.40 | |||||||||
Number of warrants are exercisable | 21,562,500 | |||||||||
Duration for Expiration of warrants | 4 years | |||||||||
Underwriters | ||||||||||
Class of Stock [Line Items] | ||||||||||
Number of Unit Sold in an Underwritten public offering | 4,687,500 | |||||||||
Purchased Price of the units by underwriters | $ / Right | 2.256 | |||||||||
Public | ||||||||||
Class of Stock [Line Items] | ||||||||||
Purchased Price of the units by underwriters | $ / Right | 2.40 | |||||||||
Related Party | ||||||||||
Class of Stock [Line Items] | ||||||||||
Units sold composition description | Each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock | |||||||||
TEL AVIV STOCK EXCHANGE | ||||||||||
Class of Stock [Line Items] | ||||||||||
Common stock, shares authorized | 50,000,000 | |||||||||
Percentage of shares price per share | 97.00% | |||||||||
Common stock shares sold | 13,852,435 | |||||||||
Common stock shares sold aggregate price | $ | $ 34,710 | $ 34,710 | ||||||||
Share price | $ / shares | $ 2.61 | |||||||||
Issuance costs associated with the Tel Aviv Stock Exchange | $ | $ 1,433 | $ 1,432 | ||||||||
Senior convertible notes due August 15, 2015 | ||||||||||
Class of Stock [Line Items] | ||||||||||
Principal amount | $ | $ 100,000 | $ 32,100 |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Detail) - shares | Sep. 30, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Net Income Loss Per Common Share [Line Items] | |||
Return of loaned common stock (in shares) | 9,000,000 | 9,000,000 | |
Shares loaned under the share lending arrangement | 9,000,000 | 9,000,000 |
Potentially Dilutive Securities
Potentially Dilutive Securities Outstanding (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities outstanding | 29,731,254 | 51,463,340 | 78,475,367 |
Stock Options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities outstanding | 19,779,229 | 21,541,664 | 24,237,940 |
Convertible Debt Securities | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities outstanding | 4,072,809 | 17,323,080 | 25,415,366 |
Warrant | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities outstanding | 4,074,596 | 9,987,876 | 19,706,240 |
Restricted Stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities outstanding | 1,804,620 | 2,610,720 | 9,115,821 |
Stock Award Plans - Additional
Stock Award Plans - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2004 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | May. 23, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share reserve | 700,000 | 700,000 | |||
Share of common stock outstanding | 1.00% | ||||
Shares sold to employees | 321,228 | 305,076 | 463,290 | ||
Stock option grants vest exercisable rate | 25.00% | ||||
Vesting period | 4 years | ||||
Number of shares outstanding | 19,779,229 | 21,541,664 | |||
Stock based compensation expense related to stock award plans and the ESPP | $ 8,725 | $ 48,622 | $ 45,186 | ||
Weighted average grant date fair value of the stock options granted | $ 2.56 | $ 4.76 | $ 3.26 | ||
Total intrinsic value of options exercised | $ 6,200 | $ 14,900 | $ 3,100 | ||
Cash received from the exercise of options | $ 3,300 | $ 11,000 | $ 2,300 | ||
Weighted-average remaining contractual term | 5 years 11 months 19 days | 6 years 3 months 22 days | 6 years 4 months 2 days | ||
Restricted stock units expected to vest | 1,651,859 | ||||
Weighted average grant date fair value | $ 4.86 | ||||
Total intrinsic value of restricted stock units expected to vest | $ 2,400 | ||||
Total intrinsic value of restricted stock units vested | 5,200 | $ 62,700 | $ 13,900 | ||
Fair value of restricted stock units vested | $ 5,500 | 36,400 | 14,900 | ||
Weighted average vesting period for unrecognized compensation cost | 2 years 8 months 12 days | ||||
Stock compensation expense | $ 8,725 | $ 48,622 | $ 45,186 | ||
Employee Severance | Executive Officer | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Stock compensation expense | $ 1,600 | ||||
Tranche One | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock vesting rate | 25.00% | ||||
Maximum | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares reserved under ESPP | 10.00% | ||||
Options granted expiry term | 10 years | ||||
Consultant | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares outstanding | 523,487 | ||||
Stock Options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 36 months | ||||
Unrecognized compensation cost related to non vested stock options | $ 4,900 | ||||
Restricted Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 4 years | ||||
Restricted Stock Units (RSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized compensation cost related to non vested stock options | $ 6,700 | ||||
Performance-based stock options | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Number of shares outstanding | 0 | ||||
2013 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Equity incentive plan, shares | 21,500,000 | ||||
Number of shares outstanding | 8,026,762 | ||||
Employee Stock Purchase Plans | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares reserved for issuance | 2,000,000 | 2,752,703 | |||
Share reserve automatic increase each year | 700,000 |
Stock Based Award Plans (Detail
Stock Based Award Plans (Detail) - shares | Dec. 31, 2015 | Dec. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 19,779,229 | 21,541,664 |
Outstanding Restricted Stock Units | 1,804,620 | 2,610,720 |
Shares Available for Future Issuance | 15,540,652 | |
2004 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 11,309,136 | |
Outstanding Restricted Stock Units | 276,784 | |
2013 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 8,026,762 | |
Outstanding Restricted Stock Units | 1,527,836 | |
Shares Available for Future Issuance | 15,540,652 | |
2004 Non Employee Directors Stock Option Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding Options | 443,331 |
Stock Based Compensation Expens
Stock Based Compensation Expense Recognized in Accompanying Statements of Operation (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 8,725 | $ 48,622 | $ 45,186 |
Employee | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 8,407 | $ 48,622 | 45,181 |
Consultant | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 318 | $ 5 |
Stock Based Compensation Expe58
Stock Based Compensation Expense Recognized in Accompanying Statements of Operations by Category (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 8,725 | $ 48,622 | $ 45,186 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | 3,029 | 22,357 | 20,409 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation | $ 5,696 | $ 26,265 | $ 24,777 |
Fair Value of Employee Stock Op
Fair Value of Employee Stock Options Assumptions (Detail) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Risk free interest rate, minimum | 1.61% | 1.64% | 0.94% |
Risk free interest rate, maximum | 1.86% | 2.11% | 1.82% |
Volatility, minimum | 69.76% | 73.98% | 75.83% |
Volatility, maximum | 71.84% | 84.85% | 86.26% |
Dividends | 0.00% | 0.00% | 0.00% |
Minimum | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Expected lives | 5 years 9 months 15 days | 5 years 9 months 7 days | 2 years 7 months 21 days |
Maximum | |||
Fair Value Inputs, Liabilities, Quantitative Information [Line Items] | |||
Expected lives | 5 years 10 months 10 days | 6 years 1 month 2 days | 5 years 9 months 7 days |
Summary of Stock Options Outsta
Summary of Stock Options Outstanding (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2015USD ($)$ / sharesshares | |
Number of Shares | |
Outstanding at January 1, 2015 | shares | 21,541,664 |
Granted | shares | 1,541,100 |
Exercised | shares | (1,700,964) |
Forfeited | shares | (706,387) |
Expired | shares | (896,184) |
Outstanding at December 31, 2015 | shares | 19,779,229 |
Vested and expected to vest at December 31, 2015 | shares | 19,597,097 |
Exercisable at December 31, 2015 | shares | 17,217,332 |
Weighted Average Exercise Price per Share | |
Outstanding at January 1, 2015 | $ / shares | $ 4.53 |
Granted | $ / shares | 4.11 |
Exercised | $ / shares | 1.91 |
Forfeited | $ / shares | 5.78 |
Expired | $ / shares | 7.70 |
Outstanding at December 31, 2015 | $ / shares | 4.54 |
Vested and expected to vest at December 31, 2015 | $ / shares | 4.53 |
Exercisable at December 31, 2015 | $ / shares | $ 4.47 |
Aggregate Intrinsic Value | |
Outstanding at January 1, 2015 | $ | $ 33,495 |
Outstanding at December 31, 2015 | $ | |
Vested and expected to vest at December 31, 2015 | $ | 0 |
Exercisable at December 31, 2015 | $ | $ 0 |
Summary of Restricted Stock Uni
Summary of Restricted Stock Unit Activity (Detail) | 12 Months Ended |
Dec. 31, 2015$ / sharesshares | |
Number of shares | |
Outstanding at January 1, 2015 | shares | 2,610,720 |
Granted | shares | 1,133,404 |
Vested | shares | (1,111,134) |
Forfeited | shares | (828,370) |
Outstanding at December 31, 2015 | shares | 1,804,620 |
Weighted average grant date fair value Per share | |
Outstanding at January 1, 2015 | $ / shares | $ 5.20 |
Granted | $ / shares | 4.14 |
Vested | $ / shares | 4.93 |
Forfeited | $ / shares | 4.88 |
Outstanding at December 31, 2015 | $ / shares | $ 4.85 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | Jul. 31, 2014EUR (€) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) | Dec. 31, 2015EUR (€) | Jul. 01, 2013USD ($) |
Commitments and Contingencies [Line Items] | ||||||
Operating lease rent expenses | $ | $ 426,000 | $ 737,000 | $ 645,000 | |||
Purchase commitment amount under Insulin Supply Agreement | € 120.1 | |||||
Purchase obligation remaining amount in 2015 | 116,200,000 | € 98.5 | ||||
Purchase obligation, due in 2016 | 28.8 | |||||
Purchase obligation, due in 2017 | 23.3 | |||||
Purchase obligation, due in 2018 | 23.3 | |||||
Purchase obligation, due in 2019 | € 23.3 | |||||
Purchase commitment cancellation fees | $ | $ 5,200,000 | |||||
Supply Agreement expiration period | Dec. 31, 2019 | |||||
Supply Agreement renewal period | 2 years | |||||
Deerfield | Milestone Rights Liability | Maximum | ||||||
Commitments and Contingencies [Line Items] | ||||||
Contingent liability for milestone payments | $ | $ 90,000,000 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Defined Benefit Plans and Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employer contribution savings retirement plan | $ 593,000 | $ 623,000 | $ 533,000 |
Provision for Income Taxes (Det
Provision for Income Taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Current | |||
U.S. federal | $ 0 | $ 0 | $ 0 |
U.S. state | 0 | 0 | 0 |
Non-U.S. | 0 | 0 | 0 |
Total current | 0 | 0 | 0 |
Deferred | |||
U.S. federal | 109,512 | 57,873 | 59,379 |
U.S. state | (29,394) | 7,631 | 7,470 |
Non-U.S. | 0 | 0 | 0 |
Valuation Allowance | (80,118) | (65,504) | (66,849) |
Total deferred | 0 | 0 | 0 |
Total | $ 0 | $ 0 | $ 0 |
Components of Net Deferred Tax
Components of Net Deferred Tax Asset (Detail) - USD ($) $ in Thousands | Dec. 31, 2015 | Dec. 31, 2014 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 721,588 | $ 699,997 |
Research and development credits | 73,646 | 73,227 |
Capitalized research | 5,872 | 28,516 |
Payments from collaboration | 52,484 | 19,217 |
Milestone Rights | 3,242 | 5,321 |
Accrued expenses | 251 | 768 |
Loss on purchase commitment | 24,084 | |
Non-qualified stock option expense | 16,941 | 43,691 |
Capitalized patent costs | 8,574 | 8,624 |
Other | 7,186 | 131 |
Depreciation | 48,755 | 3,010 |
Total net deferred tax assets | 962,623 | 882,502 |
Valuation allowance | (962,623) | (882,502) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes -Additional Inform
Income Taxes -Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2004 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Income Taxes [Line Items] | ||||
Amount Equity would be increased | $ 10 | |||
Change in the valuation allowance | 80.1 | $ 65.5 | $ 66.8 | |
Federal operating loss carryforwards | 1,900 | |||
State operating loss carryforwards | $ 1,300 | |||
Net operating loss carryforwards | $ 216 | |||
Net operating loss and credit carryforwards, annual use limitation | $ 13 | |||
Federal | ||||
Income Taxes [Line Items] | ||||
Net operating loss carryforwards, expiration year | 2,018 | |||
Research and development credits subject to expiration | $ 49.1 | |||
Federal research and development credits begin to expire | 2,024 | |||
State | ||||
Income Taxes [Line Items] | ||||
Research and development credits not subject to expiration | $ 37.7 |
Effective Income Tax Rate (Deta
Effective Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Schedule Of Income Taxes [Line Items] | |||
Federal tax benefit rate | 35.00% | 35.00% | 35.00% |
State tax benefit, net of federal benefit | 0.00% | 0.00% | 0.00% |
Permanent items | 0.90% | ||
Intercompany transfer of intellectual property | (1.20%) | (4.10%) | (4.30%) |
Valuation allowance | (33.80%) | (31.80%) | (30.70%) |
Effective income tax rate | 0.00% | 0.00% | 0.00% |
Facility Agreement - Additional
Facility Agreement - Additional Information (Detail) - USD ($) | Jul. 01, 2013 | Mar. 31, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Debt Instrument [Line Items] | |||||
Facility Agreement, total principle payment in 2016 | $ 5,000,000 | ||||
Facility Agreement, total principle payment in 2017 | 20,000,000 | ||||
Facility Agreement, total principle payment in 2018 | 20,000,000 | ||||
Facility Agreement, total principle payment in 2019 | 35,000,000 | ||||
Short term liability | 74,582,000 | $ 72,995,000 | |||
Interest expense on notes | 21,231,000 | 17,549,000 | $ 15,153,000 | ||
Sanofi-Aventis Deutschland GmbH | |||||
Debt Instrument [Line Items] | |||||
Carrying value | $ 44,500,000 | 3,000,000 | |||
Deerfield | |||||
Debt Instrument [Line Items] | |||||
Principal repayment schedule, start date | Jul. 1, 2016 | ||||
Principal repayment schedule, end date | Dec. 9, 2019 | ||||
Deerfield | Senior convertible notes due December 31, 2019 | |||||
Debt Instrument [Line Items] | |||||
Debt facility principal amount | $ 60,000,000 | 60,000,000 | |||
Senior notes, effective interest rate | 9.75% | ||||
Deerfield | Senior convertible notes due December 31, 2019 | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Uncreated debt discount | $ 5,300,000 | ||||
Uncreated debt issuance cost | 100,000 | ||||
Deerfield | Less portion of commitment asset | Senior convertible notes due December 31, 2019 | |||||
Debt Instrument [Line Items] | |||||
Debt facility principal amount | $ 20,000,000 | 20,000,000 | |||
Senior notes, effective interest rate | 8.75% | ||||
Deerfield | Less portion of commitment asset | Minimum | Senior convertible notes due December 31, 2019 | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Available amount of credit facility under covenant restrictions | $ 25,000,000 | ||||
Deerfield | Milestone Rights Liability | Senior convertible notes due December 31, 2019 | |||||
Debt Instrument [Line Items] | |||||
Short term liability | $ 3,200,000 | ||||
Long term liability | $ 13,100,000 | 8,900,000 | |||
Interest expense on notes | $ 5,800,000 | ||||
Required payment pursuant to the terms of the Milestone Agreement | $ 10,000,000 | ||||
Discount rate | 17.50% | ||||
Risk premium | 5.00% | ||||
Fair value of milestone rights | $ 16,300,000 | ||||
Deerfield | Milestone Rights Liability | Senior convertible notes due December 31, 2019 | Sanofi-Aventis Deutschland GmbH | |||||
Debt Instrument [Line Items] | |||||
Interest expense on notes | 1,900,000 | ||||
Required payment pursuant to the terms of the Milestone Agreement | $ 5,000,000 | ||||
Deerfield | Milestone Rights Liability | Senior convertible notes due December 31, 2019 | Danbury Facility | |||||
Debt Instrument [Line Items] | |||||
Carrying value | $ 23,000,000 | ||||
Deerfield | Milestone Rights Liability | Maximum | |||||
Debt Instrument [Line Items] | |||||
Contingent liability for milestone payments | $ 90,000,000 |
Accretion of Debt Issuance Cost
Accretion of Debt Issuance Cost and Debt Discount in Connection with Deerfield Financing (Detail) - Deerfield - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Debt Instrument [Line Items] | ||
Accretion expense- debt issuance cost | $ 35 | $ 326 |
Accretion expense- debt discount | $ 1,553 | $ 7,550 |
Restructuring Charges - Additio
Restructuring Charges - Additional Information (Detail) $ in Millions | Dec. 31, 2015USD ($) | Sep. 30, 2015Employee | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Restructuring Cost and Reserve [Line Items] | |||||
Percentage of workforce reduction | 26.00% | ||||
Number of employees eliminated | Employee | 198 | ||||
Restructuring charges | $ 5.9 | $ 1.9 | $ 0.4 | ||
Payment to restructuring | $ 2.8 | ||||
Restucturing accrual | $ 3 | 3 | $ 0.3 | $ 0 | |
Research and development | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Restructuring charges | 3 | ||||
General and administrative | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Restructuring charges | $ 2.9 |
Selected Quarterly Financial 71
Selected Quarterly Financial Data (Detail) - 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 | |
Interim Reporting [Line Items] | |||||||||||
Net loss | $ (277,020) | $ (31,857) | $ (28,910) | $ (30,658) | $ (36,439) | $ (36,520) | $ (73,365) | $ (52,056) | $ (368,445) | $ (198,382) | $ (191,490) |
Net loss per share - basic and diluted | $ (0.66) | $ (0.08) | $ (0.07) | $ (0.08) | $ (0.09) | $ (0.09) | $ (0.19) | $ (0.14) | $ (0.91) | $ (0.51) | $ (0.64) |
Weighted average common shares used to compute basic and diluted net loss per share | 419,314 | 405,199 | 401,018 | 398,916 | 396,793 | 394,163 | 380,770 | 368,784 |
Selected Quarterly Financial 72
Selected Quarterly Financial Data - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Interim Reporting [Line Items] | |
Asset impairment charges | $ 242.7 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - License and Collaboration Agreement with Sanofi - USD ($) $ in Millions | Feb. 10, 2016 | Jan. 04, 2016 | Aug. 11, 2014 | Dec. 31, 2015 |
Subsequent Event [Line Items] | ||||
Profits and losses sharing percentage | 35.00% | 35.00% | ||
Sanofi-Aventis Deutschland GmbH | ||||
Subsequent Event [Line Items] | ||||
Profits and losses sharing percentage | 65.00% | 65.00% | ||
Secured loan facility, amount borrowed | $ 44.5 | |||
Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Termination date | Jul. 4, 2016 | |||
Subsequent Event | Sanofi-Aventis Deutschland GmbH | ||||
Subsequent Event [Line Items] | ||||
Secured loan facility, amount borrowed | $ 17.9 |