Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2013 | Nov. 04, 2013 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-13 | ' |
Document Fiscal Year Focus | '2013 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'MNKD | ' |
Entity Registrant Name | 'MANNKIND CORP | ' |
Entity Central Index Key | '0000899460 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 357,312,740 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $93,803 | $61,840 |
State research and development credit exchange receivable - current | 298 | 450 |
Prepaid expenses and other current assets | 5,228 | 4,520 |
Total current assets | 99,329 | 66,810 |
Property and equipment - net | 177,829 | 183,961 |
State research and development credit exchange receivable - net of current portion | 223 | 313 |
Other assets | 10,227 | 230 |
Total | 287,608 | 251,314 |
Current liabilities: | ' | ' |
Accounts payable | 7,786 | 4,555 |
Accrued expenses and other current liabilities | 21,553 | 25,777 |
Senior convertible notes | 114,897 | 114,443 |
Facility financing obligation | 72,933 | ' |
Total current liabilities | 217,169 | 144,775 |
Senior convertible notes | 98,220 | 97,583 |
Note payable to related party | 119,635 | 119,635 |
Other liabilities | 20,306 | ' |
Total liabilities | 455,330 | 361,993 |
Commitments and contingencies | ' | ' |
Stockholders' deficit: | ' | ' |
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at September 30, 2013 and December 31, 2012 | ' | ' |
Common stock, $0.01 par value - 550,000,000 shares authorized at September 30, 2013 and December 31, 2012; 309,993,285 and 286,035,082 shares issued and outstanding at September 30, 2013 and December 31, 2012, respectively | 3,100 | 2,860 |
Additional paid-in capital | 2,072,006 | 1,991,379 |
Accumulated other comprehensive loss | -9 | -6 |
Deficit accumulated during the development stage | -2,242,819 | -2,104,912 |
Total stockholders' deficit | -167,722 | -110,679 |
Total | $287,608 | $251,314 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
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 | ' | ' |
Undesignated preferred stock, shares outstanding | ' | ' |
Common stock, par value | $0.01 | $0.01 |
Common stock, shares authorized | 550,000,000 | 550,000,000 |
Common stock, shares issued | 309,993,285 | 286,035,082 |
Common stock, shares outstanding | 309,993,285 | 286,035,082 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements Of Operations (USD $) | 3 Months Ended | 9 Months Ended | 272 Months Ended | ||
In Thousands, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Revenue | ' | $35 | ' | $35 | $3,166 |
Operating expenses: | ' | ' | ' | ' | ' |
Research and development | 27,281 | 25,453 | 80,731 | 76,247 | 1,548,304 |
General and administrative | 17,481 | 10,069 | 42,053 | 37,262 | 467,757 |
In-process research and development costs | ' | ' | ' | ' | 19,726 |
Goodwill impairment | ' | ' | ' | ' | 151,428 |
Total operating expenses | 44,762 | 35,522 | 122,784 | 113,509 | 2,187,215 |
Loss from operations | -44,762 | -35,487 | -122,784 | -113,474 | -2,184,049 |
Other income (expense) | 10 | -2,651 | 48 | 12,078 | -2,219 |
Interest expense on note payable to related party | -1,745 | -2,245 | -5,123 | -8,321 | -43,948 |
Interest expense on senior convertible notes and facility financing obligation | -4,323 | -2,859 | -10,052 | -8,278 | -49,985 |
Interest income | 2 | ' | 4 | 2 | 37,000 |
Loss before benefit for income taxes | -50,818 | -43,242 | -137,907 | -117,993 | -2,243,201 |
Income tax benefit | ' | 408 | ' | 408 | 382 |
Net loss | -50,818 | -42,834 | -137,907 | -117,585 | -2,242,819 |
Deemed dividend related to beneficial conversion feature of convertible preferred stock | ' | ' | ' | ' | -22,260 |
Accretion on redeemable preferred stock | ' | ' | ' | ' | -952 |
Net loss applicable to common stockholders | ($50,818) | ($42,834) | ($137,907) | ($117,585) | ($2,266,031) |
Net loss per share applicable to common stockholders - basic and diluted | ($0.17) | ($0.22) | ($0.48) | ($0.71) | ' |
Shares used to compute basic and diluted net loss per share applicable to common stockholders | 296,386 | 190,534 | 286,889 | 164,611 | ' |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statements Of Comprehensive Loss (USD $) | 3 Months Ended | 9 Months Ended | 272 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
Net loss | ($50,818) | ($42,834) | ($137,907) | ($117,585) | ($2,242,819) |
Other comprehensive loss: | ' | ' | ' | ' | ' |
Cumulative translation (loss) gain | -1 | -1 | -3 | 4 | -9 |
Unrealized gain (loss) on investments: | ' | ' | ' | ' | ' |
Unrealized holding gain during the period | ' | ' | ' | ' | 48 |
Less: reclassification adjustment for gains (losses) included in net loss | ' | ' | ' | 48 | -48 |
Net unrealized gain on investments | ' | ' | ' | 48 | ' |
Other comprehensive loss | -1 | -1 | -3 | 52 | -9 |
Comprehensive loss | ($50,819) | ($42,835) | ($137,910) | ($117,533) | ($2,242,828) |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements Of Cash Flows (USD $) | 9 Months Ended | 272 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 |
CASH FLOWS FROM OPERATING ACTIVITIES: | ' | ' | ' |
Net loss | ($137,907) | ($117,585) | ($2,242,819) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and accretion | 10,109 | 10,929 | 136,886 |
Stock-based compensation expense | 31,304 | 9,770 | 169,222 |
Stock expense for shares issued pursuant to research agreement | ' | ' | 3,018 |
(Gain) loss on sale, abandonment/disposal or impairment of property and equipment | 686 | -73 | 24,939 |
Accrued interest on investments, net of amortization of discounts | ' | ' | -191 |
In-process research and development | ' | ' | 19,726 |
Goodwill impairment | ' | ' | 151,428 |
Loss on available-for-sale securities | ' | 117 | 990 |
Litigation settlement in stock | ' | ' | 6,494 |
Fair value of forward purchase contract | ' | -12,011 | 1,237 |
Other, net | -3 | -4 | 1,096 |
Changes in assets and liabilities: | ' | ' | ' |
State research and development credit exchange receivable | 242 | -270 | -521 |
Prepaid expenses and other current assets | -708 | -18,007 | -3,278 |
Other assets | ' | ' | -230 |
Accounts payable | -1,929 | -1,526 | 2,489 |
Accrued expenses and other current liabilities | 3,525 | 36,898 | 38,574 |
Other liabilities | ' | ' | -2 |
Net cash used in operating activities | -94,681 | -91,762 | -1,690,942 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ' | ' | ' |
Purchase of marketable securities | ' | ' | -796,779 |
Sales and maturities of marketable securities | ' | ' | 796,393 |
Purchase of property and equipment | -1,821 | -572 | -329,567 |
Proceeds from sale of property and equipment | ' | 73 | 454 |
Net cash used in investing activities | -1,821 | -499 | -329,499 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ' | ' | ' |
Issuance of common stock and warrants, net of issuance costs | 2,488 | 80,982 | 1,400,244 |
Collection of Series C convertible preferred stock subscriptions receivable | ' | ' | 50,000 |
Issuance of Series B convertible preferred stock for cash | ' | ' | 15,000 |
Cash received for common stock to be issued | ' | ' | 3,900 |
Repurchase of common stock | ' | ' | -1,028 |
Put shares sold to majority stockholder | ' | ' | 623 |
Exercise of warrants for common stock | 49,170 | ' | 49,170 |
Borrowings under lines of credit | ' | ' | 4,220 |
Proceeds from notes receivables | ' | ' | 1,742 |
Proceeds from issuance of facility financing obligation & milestone rights | 79,500 | ' | 79,500 |
Facility financing obligation & milestone rights issuance costs | -598 | ' | -598 |
Borrowings on notes payable to related party | ' | 11,250 | 387,750 |
Principal payments on notes payable to related party | ' | ' | -70,000 |
Borrowings on notes payable | ' | ' | 3,460 |
Principal payments on notes payable | ' | ' | -1,667 |
Proceeds from senior convertible notes | ' | ' | 207,050 |
Payment of employment taxes related to vested restricted stock units | -2,095 | -887 | -15,122 |
Net cash provided by financing activities | 128,465 | 91,345 | 2,114,244 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 31,963 | -916 | 93,803 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 61,840 | 2,681 | ' |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 93,803 | 1,765 | 93,803 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ' | ' | ' |
Cash paid for income taxes | ' | ' | 26 |
Interest paid in cash, net of amounts capitalized | 7,862 | 7,626 | 67,014 |
Accretion on redeemable convertible preferred stock | ' | ' | -952 |
Issuance of common stock upon conversion of notes payable | ' | ' | 3,331 |
Increase in additional paid-in capital resulting from merger | ' | ' | 171,154 |
Issuance of common stock for notes receivable | ' | ' | 2,758 |
Issuance of put option by stockholder | ' | ' | -2,949 |
Put option redemption by stockholder | ' | ' | 1,921 |
Issuance of Series C convertible preferred stock subscriptions | ' | ' | 50,000 |
Issuance of Series A redeemable convertible preferred stock | ' | ' | 4,296 |
Conversion of Series A redeemable convertible preferred stock | ' | ' | -5,248 |
Non-cash construction in progress and property and equipment | 5,523 | 2,907 | 5,523 |
Capitalization of interest on note payable to related party | ' | 11,876 | 14,219 |
Cancellation of principal on note payable to related party | ' | 77,187 | 212,334 |
Forward purchase contract contribution to APIC | ' | 1,080 | 29,317 |
Reclassification of forward purchase contract to APIC | ' | $13,091 | $28,080 |
Condensed_Consolidated_Stateme3
Condensed Consolidated Statements Of Cash Flows (Parenthetical) | 272 Months Ended |
In Millions, unless otherwise specified | Sep. 30, 2013 |
Series B Preferred Stock | ' |
Conversion of convertible preferred stock amount converted | 15 |
Series C Preferred Stock | ' |
Conversion of convertible preferred stock amount converted | 50 |
Description_of_business_and_ba
Description of business and basis of presentation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Description of business and basis of presentation | ' | ||||||||||||||||
1. Description of business and basis of presentation | |||||||||||||||||
The accompanying unaudited condensed consolidated financial statements of MannKind Corporation and its subsidiaries (the “Company”), have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. These statements should be read in conjunction with the financial statements and notes thereto included in the Company’s latest audited annual financial statements. The audited statements for the year ended December 31, 2012 are included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2012 filed with the SEC on March 18, 2013 (the “Annual Report”). | |||||||||||||||||
In the opinion of management, all adjustments, consisting only of normal, recurring adjustments, considered necessary for a fair presentation of the results of these interim periods have been included. The results of operations for the nine months ended September 30, 2013 may not be indicative of the results that may be expected for the full year. | |||||||||||||||||
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates or assumptions. The more significant estimates reflected in these accompanying financial statements involve assessing long-lived assets for impairment, accrued expenses, including clinical study expenses, valuation of forward purchase contracts, valuation of the facility financing obligation, commitment asset, milestone rights, valuation of stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. | |||||||||||||||||
Business — The Company is a biopharmaceutical company focused on the discovery and development of therapeutic products for diseases such as diabetes. The Company’s lead product candidate, AFREZZA (insulin human [rDNA origin]) inhalation powder, is an ultra rapid-acting insulin therapy that recently completed two additional Phase 3 clinical studies for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. On August 14, 2013, the Company released the results of these Phase 3 clinical studies, both of which met their primary efficacy endpoints and safety objectives. On October 13, 2013, the Company submitted the results of these studies to the U.S. Food and Drug and Administration (“FDA”) as an amendment to its new drug application (“NDA”). The FDA subsequently acknowledged the resubmission and advised the Company that it considers the updated NDA to be a complete class 2 response to the Company’s Completed Response Letter issued in January 2011, and assigned a user fee goal (PDUFA) date of April 15, 2014. | |||||||||||||||||
Basis of Presentation — The Company is considered to be in the development stage as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning, and raising capital. It is costly to develop therapeutic products and conduct clinical studies for these products. From its inception through September 30, 2013, the Company has reported accumulated net losses of $2.2 billion, which include a goodwill impairment charge of $151.4 million and cumulative negative cash flow from operations of $1.7 billion. On December 15, 2013, $115.0 million aggregate principal under the Company’s 3.75% Senior Convertible Notes due 2013 (the “2013 notes”) will become due and payable (see Note 10 — Senior convertible notes). These factors raise 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 these uncertainties. At September 30, 2013, the Company’s capital resources consisted of cash and cash equivalents of $93.8 million. In addition, the Company expects to sell $40.0 million principal amount of the Company’s 9.75% Senior Convertible Notes due 2019 (the “2019 notes”) to Deerfield (as defined below) under a facility agreement in the fourth quarter of 2013 (see Note 11 — Facility financing agreement). The Company is required, with the funds made available by the purchase of these 2019 notes, to repay the 2013 notes. On September 30, 2013, the Company’s ability to borrow additional amounts under a loan arrangement provided by the Company’s principal stockholder, The Mann Group LLC (“The Mann Group”), terminated. In October 2013, however, the loan arrangement was amended to, among other things, extend the maturity date of the loan until January 5, 2020 and extend the date through which the Company can borrow under the loan arrangement to December 31, 2019 (see Note 13 — Subsequent events). As of October 31, 2013, the Company had $30.1 million principal amount of available borrowings under the loan arrangement, although the Company anticipates using a portion of these available borrowings to capitalize into principal, upon mutual agreement of the parties, accrued interest as it becomes due and payable under the loan arrangement (see Note 9 — Related-party arrangements and Note 13 — Subsequent events). Subsequent to September 30, 2013, the Company received $45.0 million in cash proceeds from the exercise of certain public offering warrants prior to their expiration on October 29, 2013. Based upon the Company’s current expectations, including the expectation that Deerfield will purchase $40.0 million principal amount of 2019 notes in the fourth quarter of 2013 in connection with the repayment of the 2013 notes, management believes the Company’s existing capital resources will enable it to continue planned operations into at least the first quarter of 2014. However, the Company cannot provide assurances that Deerfield will fund the third tranche under the Facility Agreement (as defined below), that the Company will be able to access capital through the ATM Agreements (as defined below) on favorable terms, or at all, or that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. | |||||||||||||||||
Capital resources potentially available to the Company include proceeds from the exercise of warrants issued in its February 2012 public offering, the ATM Agreements and issuance of additional 2019 notes to Deerfield, as more fully described below: | |||||||||||||||||
In February 2012, the Company sold in an underwritten public offering 35,937,500 units at an aggregate price to the public of $86.3 million, with each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock. Net proceeds from this offering were approximately $80.6 million, excluding any future proceeds from the exercise of warrants. The warrants are exercisable at $2.40 per share and expire in February 2016. As of September 30, 2013, the Company had received $4.5 million in cash proceeds from the exercise of the February 2012 public offering warrants, with $47.3 million remaining unexercised. | |||||||||||||||||
On March 18, 2013, the Company entered into at-the-market issuance sales agreements (the “ATM Agreements”) with two sales agents, under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $50.0 million under each ATM Agreement (provided that in no event may the Company issue and sell more than $50.0 million of shares of its common stock under both ATM Agreements in the aggregate) from time to time through either of the sales agents. Neither the Company nor either of the sales agents has any obligation to sell shares of the Company’s common stock under the ATM Agreements. Any sales of common stock made under the ATM Agreements will be made in “at the market” offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”). The Company has not yet issued any shares of its common stock under the ATM Agreements. There can be no assurance that the Company will be able to access capital through the ATM Agreements on a timely basis, or at all. | |||||||||||||||||
On July 1, 2013, the Company entered into a 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”), providing for the sale of up to $160.0 million of 2019 notes to Deerfield in four equal tranches of $40.0 million principal amount. In connection with the Facility Agreement, on July 1, 2013 the Company also entered into a Milestone Rights Purchase Agreement (the “Milestone Agreement”) with Deerfield Private Design Fund and Horizon Santé FLML SÁRL (“HS” and together with Deerfield Private Design Fund, the “Milestone Purchasers”), pursuant to which, the Company sold the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones including the first commercial sale of an AFREZZA product and the achievement of specified net sales figures (the “Milestone Rights” see Note 11 – Facility financing agreement). | |||||||||||||||||
On July 1, 2013, Deerfield purchased the first tranche of 2019 notes and the Milestone Rights for an aggregate of $40.0 million. The closing of the second tranche of 2019 notes, which was subject to achievement and reporting of certain results from the Company’s two Phase 3 clinical studies of AFREZZA, occurred on September 5, 2013. There can be no assurance that the conditions required for the purchase of the third or fourth tranches of the 2019 notes will be met or met in a timeframe necessary to support the Company’s liquidity needs. | |||||||||||||||||
The Company will need to raise additional capital through the resources identified above or, through the sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, assets 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 through any such sources or other sources. | |||||||||||||||||
Fair Value of Financial Instruments — The carrying amounts of certain 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 related party cannot be reasonably estimated as the Company would not be able to obtain a similar credit arrangement in the current economic environment. | |||||||||||||||||
Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash. As of September 30, 2013 and December 31, 2012, the Company held $93.8 million and $61.8 million, respectively, of cash and cash equivalents, consisting primarily of money market funds of $91.1 million and $60.8 million, respectively, and the remaining 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). | |||||||||||||||||
The following is a summary of the carrying values and estimated fair values of the 2013 notes, the Company’s 5.75% Senior Convertible Notes due 2015 (the “2015 notes”) and the 2019 notes (in millions). | |||||||||||||||||
September 30, 2013 | December 31, 2012 | ||||||||||||||||
Carrying | Estimated | Carrying | Estimated | ||||||||||||||
value | fair value | value | fair value | ||||||||||||||
2013 notes | $ | 114.9 | $ | 114.8 | $ | 114.4 | $ | 81.9 | |||||||||
2015 notes | $ | 98.2 | $ | 106 | $ | 97.6 | $ | 63.2 | |||||||||
2019 notes | $ | 72.9 | $ | 75.7 | — | — | |||||||||||
The estimated fair value of the 2013 notes was calculated based on quoted prices in an active market (Level 1 in the fair value hierarchy). 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 (Level 3 in the fair value hierarchy). As there is no current 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 there is no current observable market for the 2019 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 (Level 3 in the fair value hierarchy). | |||||||||||||||||
As discussed in Note 11 — Facility financing agreement, in connection with the Facility Agreement, the Company issued 2019 notes and Milestone Rights and recorded a commitment asset on July 1, 2013. The estimated fair value of the 2019 notes was calculated 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 of 12% (Level 3 in the fair value hierarchy). 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 (17.5%) was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The fair value of the commitment asset was estimated using the income approach by estimating the fair value of the future tranches using a market debt rate (12%) commensurate with the risk of the future tranches and the fair value of the cash expected to be received by the Company and assessing the probability of the commitments being funded in the future based on the operational hurdles required for funding being met (Level 3 in the fair value hierarchy). At September 30, 2013, the carrying value of the Milestone Rights and commitment asset approximates their respective estimated fair values. | |||||||||||||||||
The Company concluded its Common Stock Purchase Agreement with The Mann Group entered into in February 2012 (“The Mann Group Common Stock Purchase Agreement”) (see Note 7 — Common and preferred stock) represented a contingent forward purchase contract that met the definition of a derivative instrument in accordance with ASC 815 Derivatives and Hedging (“ASC 815”). Of the 31,250,000 shares issuable pursuant to The Mann Group Common Stock Purchase Agreement, the portion of the derivative instrument representing 14.7 million shares were recorded as equity (“Equity Portion”) as they met the criteria for equity classification under ASC 815-40 Derivatives and Hedging, Contracts in an Entity’s Own Stock. The remaining 16.5 million shares (“Non-Equity Portion”) required classification outside of equity as the Company did not have sufficient available shares at the time of issuance. The Company revalued the Non-Equity Portion of the forward purchase contract at each reporting date and recorded a fair value adjustment within “Other income (expense).” The estimated fair value of The Mann Group Common Stock Purchase Agreement was based on a forward purchase contract valuation (Level 3 in the fair value hierarchy). The fair value of the forward purchase contract was highly sensitive to the discount applied for lack of marketability and the stock price, and changes in this discount and/or the stock price caused the value of the forward purchase contract to change significantly. The Company recognized the change in fair value of $(336,000) in “Other income (expense)” for the three months ended March 31, 2012. The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract was estimated to be equal to the valuation date stock price minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.06% at March 31, 2012. As the shares which would be received upon settlement were unregistered, the Company applied a discount for lack of marketability of 2.57% at issuance and 1.64% at March 31, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock was publicly traded and the fact that there was no contractual restriction on the unregistered shares being registered. As of and for the nine months ended September 30, 2012, the Company recognized the change in fair value of $12.0 million in “Other income.” The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract is estimated to be equal to the valuation date stock price of $2.40 at issuance and $1.69 at May 17, 2012 (the date at which the Company had sufficient available shares) minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.18% at May 17, 2012. As the shares which would be received upon settlement are currently unregistered, the Company applied a discount for lack of marketability of 10.27% at issuance and 1.67% at May 17, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock is publicly traded and the fact that there is no contractual restriction on the unregistered shares being registered. | |||||||||||||||||
The following roll-forward provides a summary of changes in fair value of the Company’s Level 3 forward purchase contract (in thousands): | |||||||||||||||||
Three months | Nine months | ||||||||||||||||
ended | ended | ||||||||||||||||
September 30, 2012 | September 30, 2012 | ||||||||||||||||
Forward | Forward | ||||||||||||||||
Purchase | Purchase | ||||||||||||||||
Contract | Contract | ||||||||||||||||
Beginning Balance | $ | — | $ | — | |||||||||||||
Issuance | — | 1,080 | |||||||||||||||
Adjustments to fair value included in other income | — | 12,011 | |||||||||||||||
Transfers to additional paid-in-capital | — | (13,091 | ) | ||||||||||||||
Ending Balance | $ | — | $ | — | |||||||||||||
Recently Issued Accounting Standards — In February 2013, the FASB issued ASU 2013-02, Comprehensive Income (Topic 220) – Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. These amendments do not change the current requirements for reporting net income or other comprehensive income in the financial statements. These amendments provide for additional disclosure requirements for amounts reclassified out of accumulated other comprehensive income. These amendments are effective prospectively for interim and annual periods beginning after December 15, 2012. Early adoption is permitted. Effective January 1, 2013, the Company adopted the new requirements as set forth in ASU 2013-02 in the disclosure of comprehensive income on the Company’s consolidated financial statements. The adoption of the new requirements did not have a significant impact on the Company’s consolidated financial statements. | |||||||||||||||||
In July 2013, the FASB ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force). The amendments in this ASU provide guidance on the financial statements presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as a liability. The amendments in this ASU do not require new recurring disclosures. The amendments in this ASU are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The Company is evaluating the impact, if any, of the adoption of ASU 2013-11 will have on the Company’s consolidated financial statements. |
Accrued_expenses_and_other_cur
Accrued expenses and other current liabilities | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Accrued expenses and other current liabilities | ' | ||||||||
2. Accrued expenses and other current liabilities | |||||||||
Accrued expenses and other current liabilities are comprised of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Salary and related expenses | $ | 9,414 | $ | 10,074 | |||||
Research and clinical study costs | 3,155 | 5,995 | |||||||
Accrued interest | 3,265 | 4,533 | |||||||
Construction in progress | 226 | 3,878 | |||||||
Other | 5,493 | 1,297 | |||||||
Accrued expenses and other current liabilities | $ | 21,553 | $ | 25,777 | |||||
Accounting_for_stockbased_comp
Accounting for stock-based compensation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Accounting for stock-based compensation | ' | ||||||||||||||||
3. Accounting for stock-based compensation | |||||||||||||||||
Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2013 and 2012 was as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Stock-based compensation | $ | 15,943 | $ | 3,820 | $ | 31,304 | $ | 9,770 | |||||||||
On March 7, 2013, the Company’s board of directors approved a management proposal designed to encourage employee retention, as recommended for approval by the Compensation Committee. The Company granted 5,846,000 performance-based restricted stock units to employees, including executive officers of the Company other than our Chief Executive Officer, with vesting terms subject to the achievement of specified regulatory and business development milestones related to AFREZZA. The performance-based restricted stock units had a grant date fair value of $2.81 per unit. | |||||||||||||||||
On May 23, 2013, the Company’s stockholders approved the 2013 Equity Incentive Plan (the “Plan”). The Plan is the successor to and continuation of the previous active stock-based compensation plans - 2004 Equity Incentive Plan and the 2004 Non-Employee Directors’ Stock Option Plan. The Plan provides for the grant of incentive stock options, nonstatutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, other stock awards, and performance awards that may be settled in cash, stock, or other property. All of the Company’s employees, non-employee directors and consultants are eligible to participate in the Plan and may receive all types of awards; provided that incentive stock options may be granted under the Plan only to employees (including officers) and employees of the Company’s affiliates. | |||||||||||||||||
On May 23, 2013, the Compensation Committee approved a management proposal designed to encourage employee retention. The proposal involved the grant of 5,598,100 performance-based stock options and 1,687,900 performance-based restricted stock units to employees, including executive officers of the Company, with vesting terms subject to the achievement of specified regulatory and business development milestones related to AFREZZA. The performance-based options and performance-based restricted stock units had a grant date per share fair value of $3.05 and $6.85, respectively. | |||||||||||||||||
The Company issued stock awards to employees during the three months ended September 30, 2013 with a four-year vesting schedule. The grant date fair value of the 732,350 restricted stock units and 1,106,000 stock options issued was $5.89 and $4.14, respectively. | |||||||||||||||||
As of September 30, 2013, there was $27.1 million and $21.4 million of unrecognized compensation cost related to restricted stock units and options, respectively, which are expected to be recognized over the remaining weighted average vesting period of 1.5 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 September 30, 2013, there was $107,000 and $3.7 million of unrecognized expenses related to performance restricted stock units and options, respectively, for milestones not considered probable of achievement. |
Net_loss_per_common_share
Net loss per common share | 9 Months Ended |
Sep. 30, 2013 | |
Net loss per common share | ' |
4. Net loss per common share | |
Basic net loss per share excludes dilution for potentially dilutive securities and is computed by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period excluding the shares loaned to Bank of America, N.A. under a share lending arrangement (see Note 7 — Common and preferred stock). As of September 30, 2013, 9,000,000 shares of the Company’s common stock, which were loaned to Bank of America, N.A. pursuant to the terms of a share lending agreement as described in Note 7, were issued and are outstanding, and holders of the borrowed shares have all the rights of a holder of the Company’s common stock. However, because the share borrower must return all borrowed shares to the Company (or, in certain circumstances, the cash value thereof), the borrowed shares are not considered outstanding for the purpose of computing and reporting basic or diluted earnings (loss) per share. 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 and conversion of the facility financing obligation, that are not included in the diluted net loss per share calculation consisted of an aggregate of 133,944,425 shares and 63,833,521 shares as of September 30, 2013 and 2012, respectively, and exclude the 9,000,000 shares loaned under the share lending arrangement. |
State_research_and_development
State research and development credit exchange receivable | 9 Months Ended |
Sep. 30, 2013 | |
State research and development credit exchange receivable | ' |
5. 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. Current estimated amounts receivable under the program were $298,000 and $450,000 at September 30, 2013 and December 31, 2012, respectively. Long-term estimated amounts receivable under the program were $223,000 and $313,000 at September 30, 2013 and December 31, 2012, respectively. |
Property_and_equipment
Property and equipment | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Property and equipment | ' | ||||||||||||||||
6. Property and equipment | |||||||||||||||||
Property and equipment — net consist of the following (dollar amounts in thousands): | |||||||||||||||||
Estimated | September 30, | December 31, | |||||||||||||||
Useful | 2013 | 2012 | |||||||||||||||
Life | |||||||||||||||||
(Years) | |||||||||||||||||
Land | — | $ | 5,273 | $ | 5,273 | ||||||||||||
Buildings | 39-40 | 54,948 | 54,948 | ||||||||||||||
Building improvements | May-40 | 114,245 | 114,245 | ||||||||||||||
Machinery and equipment | 15-Mar | 82,283 | 81,382 | ||||||||||||||
Furniture, fixtures and office equipment | 10-May | 5,164 | 5,239 | ||||||||||||||
Computer equipment and software | 3 | 11,935 | 11,840 | ||||||||||||||
Leasehold improvements | 17 | 17 | |||||||||||||||
Construction in progress | 13,876 | 12,266 | |||||||||||||||
287,741 | 285,210 | ||||||||||||||||
Less accumulated depreciation and amortization | (109,912 | ) | (101,249 | ) | |||||||||||||
Property and equipment — net | $ | 177,829 | $ | 183,961 | |||||||||||||
Leasehold improvements are amortized over four years which is the shorter of the term of the lease or the service lives of the improvements. | |||||||||||||||||
Depreciation and amortization expense related to property and equipment for the three and nine months ended September 30, 2013 and 2012 was as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Depreciation and amortization expense | $ | 2,874 | $ | 3,237 | $ | 8,820 | $ | 9,898 | |||||||||
Common_and_preferred_stock
Common and preferred stock | 9 Months Ended |
Sep. 30, 2013 | |
Common and preferred stock | ' |
7. 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 September 30, 2013 and December 31, 2012, 309,993,285 and 286,035,082 shares of common stock, respectively, were issued and outstanding and no shares of preferred stock were outstanding. Included in the common stock outstanding as of September 30, 2013 and December 31, 2012 are 9,000,000 shares of common stock loaned to Bank of America under a share lending agreement in connection with the offering of $100.0 million aggregate principal amount of 2015 notes (see Note 10 — Senior convertible notes). Bank of America is 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. 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. | |
In February 2012, the Company sold in an underwritten public offering 35,937,500 units at an aggregate price to the public of $86.3 million, with each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock. Net proceeds from this offering were approximately $80.6 million, excluding any future proceeds from the exercise of the warrants. The warrants are exercisable at $2.40 per share and expire in February 2016. Concurrently with this public offering, pursuant to The Mann Group Common Stock Purchase Agreement entered into in February 2012, The Mann Group agreed to purchase $77.2 million worth of restricted shares or 31,250,000 restricted shares of common stock at an aggregate purchase price of $77.2 million, which were issued in June 2012 in exchange for cancellation of principal indebtedness of $77.2 million under the loan arrangement (see Note 9 — Related-party arrangements). For the nine months ended September 30, 2013, the Company received $4.5 million in proceeds from the exercise of the February 2012 public offering warrants, with $47.3 million remaining unexercised. | |
In October 2012, the Company sold in an underwritten public offering 46,000,000 units at an aggregate price to the public of $92.0 million, with each unit consisting of one share of common stock and a warrant to purchase 0.75 of a share of common stock. Net proceeds from this offering were approximately $86.3 million, excluding any future proceeds from the exercise of warrants. The warrants issued in this offering were exercisable until October 29, 2013 at an exercise price of $2.60 per share. As of September 30, 2013, we had received $44.7 million in proceeds from the exercise of a portion of such warrants with $45.0 million of warrants remaining unexercised. Concurrently with this public offering, pursuant to a Common Stock and Warrant Purchase Agreement with The Mann Group entered into in October 2012 (the “Mann Group Common Stock and Warrant Purchase Agreement”), The Mann Group agreed to purchase for an aggregate purchase price of $107.4 million, 40,000,000 restricted shares of common stock and warrants to purchase 30,000,000 shares of common stock at an exercise price of $2.60 per share (“The Mann Group Warrants”), which were issued in December 2012 in exchange for cancellation of principal indebtedness of $107.4 million under the Company’s revolving loan arrangement with The Mann Group (see Note 9 — Related-party arrangements). In October 2013, the Company received an additional $45.0 million in cash proceeds from the exercise of the October 2012 public offering warrants and $78.0 million of consideration in the form of cancelled principal indebtedness under the Company’s loan arrangement with The Mann Group as payment for the aggregate exercise price of The Mann Group Warrants (see Note 13 – Subsequent events). | |
In connection with both the February and October 2012 public offerings, the Company performed an analysis of the warrants to determine their appropriate classification and concluded that in both instances the warrants should be classified within equity. In connection with The Mann Group Common Stock Purchase Agreement the Company concluded that this agreement represented a contingent forward contract that met the definition of a derivative instrument in accordance with ASC 815 Derivatives and Hedging, and that a portion of the restricted common stock issued should be classified as equity and the remaining portion should be classified as assets or liabilities accounted for at fair value. In connection with The Mann Group Common Stock and Warrant Purchase Agreement, the Company concluded that this agreement represented a contingent forward contract and that the restricted common stock and warrants issued to The Mann Group should be classified as assets or liabilities accounted for at fair value. Both the February and October forward contracts settled during 2012. |
Commitments_and_contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2013 | |
Commitments and contingencies | ' |
8. Commitments and contingencies | |
Guarantees and Indemnifications — In the ordinary course of its business, the Company makes certain indemnities, commitments and guarantees under which it may be required to make payments in relation to certain transactions. The Company, as permitted under Delaware law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal. The Company has not recorded any liability for these indemnities in the accompanying condensed consolidated balance sheets. However, the Company accrues for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable and the amount can be reasonably estimated. | |
Litigation — The Company is subject to legal proceedings and claims which arise in the ordinary course of its business. As of the date hereof, the Company believes that the final disposition of such matters will not have a material adverse effect on the financial position, results of operations or cash flows of the Company. The Company maintains liability insurance coverage to protect the Company’s assets from losses arising out of or involving activities associated with ongoing and normal business operations. In accordance with ASC 450 Contingencies, the Company would record a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. | |
Contingencies — The Company is obligated under a registration rights agreement entered into with Deerfield (the “Registration Rights Agreement”), pursuant to which the Company agreed to register for sale, the shares of common stock issuable upon conversion of the 2019 notes (the “Conversion Shares”) within a specified time period following the issuance of each tranche of 2019 notes. | |
The Company entered into a Milestone Agreement with Deerfield pursuant to which, the Company sold the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones including the first commercial sale of an AFREZZA product and the achievement of specified net sales figures (see Note 11 – Facility financing agreement). |
Relatedparty_arrangements
Related-party arrangements | 9 Months Ended |
Sep. 30, 2013 | |
Related-party arrangements | ' |
9. Related-party arrangements | |
In October 2007, the Company entered into a $350.0 million revolving loan arrangement with Alfred E. Mann, its principal stockholder. In February 2009, as a result of the Company’s principal stockholder being subject to the licensing requirement under the California Finance Lenders Law, the promissory note underlying the loan arrangement was revised to reflect the lender as The Mann Group. Until January 1, 2013, interest on outstanding principal amounts accrued at a fixed rate equal to the one-year LIBOR as reported by the Wall Street Journal on the date of such advance plus 3% per annum. The promissory note underlying the loan arrangement was amended at various dates during 2012. In October 2012, the promissory note was amended to adjust the annual interest rate on all outstanding principal to the one-year LIBOR on December 31, 2012 plus 5%. As a result of these amendments, effective January 1, 2013, the borrowing rate for all borrowings under the promissory note with The Mann Group was set at 5.84%. On October 31, 2013, the promissory note was further 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 loan arrangement to December 31, 2019, increase the aggregate borrowing amount under the loan arrangement from $350.0 million to $370.0 million, provide that repayments or cancellations of principal under the loan arrangement will not be available for reborrowing, and to cancel $78.0 million of principal indebtedness under the loan arrangement as payment for the aggregate exercise price of The Mann Group Warrants. Under guidance of ASC 470-10-45, the note payable to related party is excluded from current liabilities due to the amendment on October 31, 2013 and presented as a non-current liability as of September 30, 2013. In addition, the Company and The Mann Group agreed to capitalize into principal $7.9 million of accrued interest that became due and payable upon cancellation of the $78.0 million of principal indebtedness. As such, the Company included the accrued interest at September 30, 2013 in Other liabilities in the accompanying condensed consolidated balance sheet. | |
As of September 30, 2013, the total principal amount outstanding under the loan arrangement was $119.6 million. As of October 31, 2013, the Company had $30.1 million principal amount of available borrowings under the loan arrangement. Interest 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 at any time upon mutual agreement of both parties. 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 was cancelled in connection with two common stock purchase agreements – a Common Stock Purchase Agreement between the Company and The Mann Group dated August 2010 and the Mann Group Common Stock Purchase Agreement - and subject to the subordination agreement entered into by The Man Group with Deerfield). 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. | |
In the event of a default, 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 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 loan arrangement are unsecured. The loan arrangement contains no financial covenants. There are no warrants associated with the loan arrangement. In connection with the Facility Agreement with Deerfield, The Mann Group entered into a subordination agreement with Deerfield, pursuant to which it agreed to subordinate its right to payments under the loan arrangement and not accept repayment until the 2019 notes have been repaid in full. | |
In February 2012, concurrently with an underwritten public offering (see Note 7 — Common and preferred stock), pursuant to The Mann Group Common Stock Purchase Agreement, The Mann Group agreed to purchase $77.2 million worth of restricted shares or 31,250,000 restricted shares of common stock, which were issued in June 2012 in exchange for cancellation of $77.2 million of principal indebtedness under the revolving loan arrangement. | |
In October 2012, concurrently with an underwritten public offering (see Note 7 — Common and preferred stock), pursuant to The Mann Group Common Stock and Warrant Purchase Agreement, The Mann Group agreed to purchase, for an aggregate purchase price of $107.4 million, 40,000,000 restricted shares of common stock and warrants to purchase 30,000,000 restricted shares of common stock, which were issued in December 2012 in exchange for cancellation of principal indebtedness of $107.4 million under the revolving loan arrangement. Additionally, in accordance with the terms of the loan arrangement, the Company elected to capitalize the accrued and unpaid interest on the cancelled principal amount that became due upon the closing (see Note 7 – Common and preferred stock). During the first, second, and third quarters of 2013, there were no borrowings under or amendments to The Mann Group loan arrangement. The Mann Group exercised the warrants at a price of $2.60 per share in October 2013 in exchange for the cancellation of $78.0 million of principal indebtedness under the Company’s loan arrangement with The Mann Group. | |
The restricted shares sold to The Mann Group in both the June and December 2012 transactions, and the restricted shares issued to The Mann Group upon the exercise of The Mann Group Warrants in October 2013, may not be sold, pledged, assigned or transferred unless (i) the shares have been registered with the Securities and Exchange Commission (“SEC”) or (ii) the restricted shares are exempt from SEC registration requirements and the Company has obtained an opinion from the Company’s counsel that the shares may be sold lawfully without registration. |
Senior_convertible_notes
Senior convertible notes | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Senior convertible notes | ' | ||||||||||||||||
10. Senior convertible notes | |||||||||||||||||
Senior convertible notes consist of the following (in thousands): | |||||||||||||||||
September 30, | December 31, | ||||||||||||||||
2013 | 2012 | ||||||||||||||||
2013 notes | |||||||||||||||||
Principal amount | $ | 115,000 | $ | 115,000 | |||||||||||||
Unaccreted debt issuance expense | (103 | ) | (557 | ) | |||||||||||||
Net carrying amount | 114,897 | 114,443 | |||||||||||||||
2015 notes | |||||||||||||||||
Principal amount | $ | 100,000 | $ | 100,000 | |||||||||||||
Unaccreted debt issuance expense | (1,780 | ) | (2,417 | ) | |||||||||||||
Net carrying amount | 98,220 | 97,583 | |||||||||||||||
Senior convertible notes | $ | 213,117 | $ | 212,026 | |||||||||||||
On August 18, 2010, the Company completed a Rule 144A offering of $100.0 million aggregate principal amount of 2015 notes. The 2015 notes are governed by the terms of an indenture dated as of August 24, 2010 (the “2015 Note Indenture”). The 2015 notes bear interest at the rate of 5.75% per year on the principal amount, payable in cash semi-annually in arrears on February 15 and August 15 of each year, beginning February 15, 2011. In connection with the 2015 notes, the Company had accrued interest of $0.7 million and $2.2 million as of September 30, 2013 and December 31, 2012, respectively. The 2015 notes are general, unsecured, senior obligations of the Company and effectively rank junior in right of payment to all of the Company’s secured debt, to the extent of the value of the assets securing such debt, and to the debt and all other liabilities of the Company’s subsidiaries. The maturity date of the 2015 notes is August 15, 2015 and payment is due in full on that date for unconverted securities. Holders of the 2015 notes may convert, at any time prior to the close of business on the business day immediately preceding the stated maturity date, any outstanding principal into shares of the Company’s common stock at an initial conversion rate of 147.0859 shares per $1,000 principal amount, which is equal to a conversion price of approximately $6.80 per share, subject to adjustment. Except in certain circumstances, if the Company undergoes a fundamental change: (1) the Company will pay a make-whole premium on the 2015 notes converted in connection with a fundamental change by increasing the conversion rate on such 2015 notes, which amount, if any, will be based on the Company’s common stock price and the effective date of the fundamental change, and (2) each holder of 2015 notes will have the option to require the Company to repurchase all or any portion of such holder’s 2015 notes at a repurchase price of 100% of the principal amount of the 2015 notes to be repurchased plus accrued and unpaid interest, if any. The Company may elect to redeem some or all of the 2015 notes if the closing stock price has equaled 150% of the conversion price for at least 20 of the 30 consecutive trading days ending on the trading day before the Company’s redemption notice. The redemption price will equal 100% of the principal amount of the 2015 notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, plus a make-whole payment equal to the sum of the present values of the remaining scheduled interest payments through and including August 15, 2015 (other than interest accrued up to, but excluding, the redemption date). The Company will be obligated to make the make-whole payment on all the 2015 notes called for redemption and converted during the period from the date the Company mailed the notice of redemption to and including the redemption date. The Company may elect to make the make-whole payment in cash or shares of its common stock, subject to certain limitations. Under the terms of the 2015 Note Indenture, the conversion option must be physically settled and the maximum number of shares that could be required to be delivered under the contract, 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 contract period under existing commitments. Applying the Company’s sequencing policy, the Company performed an analysis at the time of the offering of the 2015 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 contract period under existing commitments. | |||||||||||||||||
The Company incurred approximately $4.2 million in issuance costs which are recorded as an offset to the 2015 notes in the accompanying condensed consolidated balance sheets. These costs are being amortized to interest expense using the effective interest method over the term of the 2015 notes. | |||||||||||||||||
On December 12, 2006, the Company completed an offering of $115.0 million aggregate principal amount of 2013 notes, including $15.0 million aggregate principal amount of the 2013 notes sold pursuant to the underwriters’ over-allotment option that was exercised in full. The 2013 notes are governed by the terms of an indenture dated as of November 1, 2006 and a First Supplemental Indenture, dated as of December 12, 2006 (the “2013 Note Indenture”). The 2013 notes bear interest at the rate of 3.75% per year on the principal amount, payable in cash semi-annually in arrears on June 15 and December 15 of each year, beginning June 15, 2007. In connection with the 2013 notes, the Company had accrued interest of $1.3 million and $0.2 million as of September 30, 2013 and December 31, 2012, respectively. The 2013 notes are general, unsecured, senior obligations of the Company and effectively rank junior in right of payment to all of the Company’s secured debt, to the extent of the value of the assets securing such debt, and to the debt and all other liabilities of the Company. The maturity date of the 2013 notes is December 15, 2013, and payment is due in full on that date for unconverted securities. The Company intends to use a portion of the net proceeds from the third tranche of 2019 notes expected to be sold under the Facility Agreement to repay the 2013 notes. Holders of the 2013 notes may convert, at any time prior to the close of business on the business day immediately preceding the stated maturity date, any outstanding principal into shares of the Company’s common stock at an initial conversion rate of 44.5002 shares per $1,000 principal amount, which is equal to a conversion price of approximately $22.47 per share, subject to adjustment. Except in certain circumstances, if the Company undergoes a fundamental change: (1) the Company will pay a make-whole premium on the 2013 notes converted in connection with a fundamental change by increasing the conversion rate on such notes, which amount, if any, will be based on the Company’s common stock price and the effective date of the fundamental change, and (2) each holder of 2013 notes will have the option to require the Company to repurchase all or any portion of such holder’s notes at a repurchase price of 100% of the principal amount of the notes to be repurchased plus accrued and unpaid interest, if any. Under the terms of the 2013 Note Indenture, the conversion option must be physically settled and the maximum number of shares that could be required to be delivered under the contract, 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 contract period under existing commitments. Applying the Company’s sequencing policy, the Company performed an analysis at the time of the offering of the 2013 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 contract period under existing commitments. | |||||||||||||||||
The 2013 notes and 2015 notes contain provisions that upon an acceleration of certain indebtedness, which would include the 2019 notes described in Note 11, that 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 $3.7 million in issuance costs which are recorded as an offset to the 2013 notes in the accompanying condensed consolidated balance sheets. These costs are being amortized to interest expense using the effective interest method over the term of the 2013 notes. | |||||||||||||||||
Accretion of debt issuance expense in connection with the offerings of the 2015 notes and the 2013 notes during the three and nine months ended September 30, 2013 were as follows (in thousands). | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Accretion expense | $ | 369 | $ | 348 | $ | 1,091 | $ | 1,031 | |||||||||
Facility_financing_agreement
Facility financing agreement | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Facility financing agreement | ' | ||||||||
11. Facility financing agreement | |||||||||
The components of the facility financing agreement recorded as of September 30, 2013 consist of the following (in thousands): | |||||||||
September 30, | |||||||||
2013 | |||||||||
2019 notes | |||||||||
Principal amount | $ | 80,000 | |||||||
Debt discount-net of amortization | (6,798 | ) | |||||||
Unaccreted debt issuance expense | (269 | ) | |||||||
Net carrying amount of facility financing obligation | $ | 72,933 | |||||||
Milestone rights | |||||||||
Principal amount | $ | 16,276 | |||||||
Debt discount-net of amortization | (51 | ) | |||||||
Unaccreted debt issuance expense | (61 | ) | |||||||
Less current portion of milestone rights included in other current liabilities | (3,150 | ) | |||||||
Net carrying amount included in other liabilities | $ | 13,013 | |||||||
Commitment Asset | |||||||||
Initial commitment asset fair value | $ | 13,393 | |||||||
Less Tranche 2 portion of commitment asset | (3,656 | ) | |||||||
Commitment asset value included in other assets | $ | 9,737 | |||||||
On July 1, 2013, the Company entered into the Facility Agreement with Deerfield providing for the sale of up to $160.0 million of 2019 notes to Deerfield in four equal tranches of $40.0 million principal amount. The 2019 notes accrue interest at a rate of 9.75% per annum until maturity in 2019 or their earlier repayment, repurchase, or conversion. A portion of the principal amount of the 2019 notes may be converted into shares of the Company’s common stock (the “Conversion Shares”) at the noteholder’s option. The conversion price will be determined by the volume weighted average price of the Company’s common stock during the 20 trading days immediately preceding the conversion date. The number of Conversion Shares that may be issued upon conversion of all 2019 notes will be limited to an aggregate of 12.0 million shares or such lesser number of shares as may be determined pursuant to the conversion limitations contained in the 2019 notes if the conversion price at which the 2019 notes are actually converted from time to time is greater than $3.33. | |||||||||
Deerfield purchased the first tranche of 2019 notes (the “Tranche 1 Notes”) and Milestone Rights (as defined below) in the aggregate principal amount of $40.0 million. The closing of the second tranche of 2019 notes (the “Tranche 2 Notes”), which was subject to achievement and reporting of certain results from the Company’s two Phase 3 clinical studies of AFREZZA, occurred on September 5, 2013. Deerfield’s obligation to purchase the third tranche of 2019 notes is subject to the repayment of the 2013 notes with the funds made available by the purchase of these 2019 notes. Deerfield’s obligation to purchase the fourth tranche of 2019 notes is subject to receipt of marketing approval of AFREZZA by the FDA and the prior satisfaction of the conditions for the third tranche closing. In addition to the foregoing conditions, Deerfield’s obligation to purchase 2019 notes at any of the two remaining closings is subject to, at each closing, the Conversion Shares issuable upon conversion of all previously sold 2019 notes being freely tradable pursuant to an effective registration statement filed with the SEC or pursuant to Rule 144 under the Securities Act. | |||||||||
The Company is required to repay 25% of the original principal amount of the 2019 notes sold in each tranche on the third, fourth, fifth and sixth anniversaries of the applicable issue dates of such 2019 notes; provided that the entire outstanding principal amount of all 2019 notes will become due and payable no later than December 31, 2019. The Company had the right to prepay the outstanding principal amount of the Tranche 1 Notes at a price equal to 110% of the outstanding principal thereof plus all accrued and unpaid interest as of the date of prepayment if the conditions for the Tranche 2 Notes had not been satisfied. The Company is required to repay any outstanding 2019 notes in full if the Company completes a major transaction (as defined), which includes, but is not limited to, certain mergers and other change of control transactions involving the Company. | |||||||||
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 related party 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 September 30, 2013. In the event of non-compliance, there can be no assurances that the holders of the 2019 notes will not exercise remedies available to them, which may include, among other things, the issuance of a notice of acceleration. | |||||||||
In connection with the issuance of the Tranche 1 Notes and Milestone Rights on July 1, 2013, the Company recorded $52.9 million in value received, which consisted of $39.5 million in cash from the issuance of the Tranche 1 Notes plus a commitment asset (as described further below) with a fair value equal to $13.4 million. In exchange, the Company issued to Deerfield the Tranche 1 Notes and Milestone Rights with estimated fair values equal to $37.1 million and $16.3 million, respectively. The Tranche 1 Notes, the Milestone Rights and the commitment asset were initially recorded at fair value. | |||||||||
The Tranche 1 Notes are classified as short-term debt and are subsequently accounted for at amortized cost. The effective interest rate on the Tranche 1 Notes is 12.19% and a debt discount of approximately $3.3 million recognized on the Tranche 1 Notes is being amortized to interest expense over the term of the Tranche 1 Notes using the effective interest method. | |||||||||
In accordance with the Facility Agreement, the Company reimbursed Deerfield $500,000 for a portion of documented expenses for attorneys, accountants and other professional advisors, and other out-of-pocket expenses Deerfield incurred in connection with the transaction. These costs were allocated between the 2019 notes and the Milestone Rights based upon their relative fair value resulting in $448,737 being allocated to the 2019 notes and included within the debt discount with the remainder being allocated to the Milestone Rights. In addition, the Company incurred a total of $597,529 in debt issuance costs, of which $536,266 was allocated to the 2019 notes and the remainder to the Milestone Rights using the relative fair value allocation method. A portion of the debt issuance costs, or $259,800, related to the third and fourth tranches of 2019 notes are included in other assets. | |||||||||
The commitment asset represents the right to receive additional funding under the second, third and fourth tranches of the Facility Agreement. The fair value of the commitment asset was estimated using the income approach by estimating the fair value of the future tranches using a market debt rate commensurate with the risk of the future tranches and the fair value of the cash expected to be received by the Company and assessing the probability of the commitments being funded in the future. The commitment asset will not be subsequently remeasured but it will be monitored for impairment until future tranches of 2019 notes are drawn. Upon the drawing of additional tranches of 2019 notes, the portion of the commitment asset related to such tranche will be derecognized resulting in a debt discount being recorded on the additional tranches of 2019 notes issued. If the additional funding under the third and fourth tranches ceases to be probable of occurring, the commitment asset will be impaired and will be written off as an expense in the Statement of Operations. | |||||||||
Upon the issuance of the Tranche 2 Notes, the portion of the commitment asset attributed to the Tranche 2 Notes was derecognized and recorded as a debt discount to the Tranche 2 Notes. Therefore, the Tranche 2 Notes were recorded as short-term debt for the $40.0 million received, less a $3.7 million debt discount. The effective interest rate on the Tranche 2 Notes is 12.45% and the debt discount is being amortized over the term of the Tranche 2 Notes using the effective interest method. | |||||||||
The Company identified and evaluated a number of embedded features in the Facility Agreement to determine if they represented embedded derivatives requiring bifurcation and separate accounting pursuant to ASC 815, Derivatives and Hedging. There were two embedded features that required bifurcation and separate accounting and the Company determined that they should be bundled together as a single, compound embedded derivative, bifurcated from the host contract, and accounted for at fair value, with changes in fair value being recorded in the Statement of Operations. Management determined that the value of these embedded derivatives at July 1, 2013 and at September 30, 2013 was insignificant. | |||||||||
Milestone Agreement | |||||||||
In connection with the Facility Agreement, on July 1, 2013, the Company also entered into the Milestone Agreement with the Milestone Purchasers, pursuant to which, the Company sold the Milestone Purchasers the Milestone Rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones, including the first commercial sale of an AFREZZA product and the achievement of specified net sales figures. The payments due under the Milestone Rights are subject to pro rata reduction in the event of certain funding failures by Deerfield under the Facility Agreement. | |||||||||
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 and terminate if the Company exercises its right to prepay the Tranche 1 Notes. | |||||||||
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. 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. | |||||||||
The Milestone Rights did not meet the definition of a derivative under ASC 815; therefore the Company analogized to the accounting guidance contained in ASC 470-10-35-4, which addresses indexed debt. As each milestone is achieved, the portion of the initial liability pertaining to the specified milestone will be remeasured to equal the amount of the milestone payment. The change in the balance of the liability that occurs upon remeasurement will be recorded as interest expense in the Statement of Operations. Once the milestone payment is made for a specific milestone event, the remeasured liability pertaining to that specific milestone event will be extinguished. The resulting effect is that the payment required to be made upon the occurrence of the milestone event is allocated between a reduction of the initial liability pertaining to that milestone and an expense representing a return on that portion of the liability paid to the Milestone Purchasers for the achievement of that milestone. | |||||||||
The Company identified and evaluated a number of embedded features in the Milestone Rights to determine if they represented embedded derivatives requiring bifurcation and separate accounting pursuant to ASC 815, Derivatives and Hedging. There were no features in the Milestone Rights that required bifurcation and separate accounting | |||||||||
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 us and MannKind LLC will terminate upon repayment of the 2019 notes in full. Our obligations under the Facility Agreement and the Milestone Agreement are also secured by certain mortgages on the Company’s facilities in Danbury, Connecticut and Valencia, California. | |||||||||
Registration Rights Agreement | |||||||||
In connection with the Facility Agreement and the sale of the 2019 notes pursuant thereto, the Company entered into a Registration Rights Agreement with Deerfield (the “Registration Rights Agreement”), pursuant to which the Company agreed to register for sale, the Conversion Shares within a specified time period following the issuance of each tranche of 2019 notes. | |||||||||
Pursuant to the Registration Rights Agreement, the number of aggregate shares of Common Stock included in the initial mandatory registration statement is 12.0 million shares (subject to adjustment in the event of a stock split, stock combination, reclassification, payment of stock dividends, recapitalization, or other similar transactions). | |||||||||
In the event the Company is unable to meet certain requirements of the Registration Rights Agreement specifically related to the filing of the registration statement within specified periods, using its best efforts to obtain effectiveness of the registration statement, or maintaining the effectiveness of the registration statement, the Company will be required to pay additional damages to Deerfield. The additional damages are calculated as 1% of Deerfield’s original principal amount of the relevant tranche of 2019 notes and shall accrue until the earlier of (i) the date on which the registration failure has been cured and (ii) the date on which the Conversion Shares may be disposed of by Deerfield. | |||||||||
In accordance with the accounting guidance contained in ASC 825-20, the contingent obligation to make future payments, or otherwise transfer consideration, under a registration payment arrangement should be recognized and measured in accordance with ASC 450-20. ASC 450-20 requires an accrual to be recorded for a contingent payment if it is both probable of occurring and the amount of the payment can be reasonably estimated. As of September 30, 2013, the Company determined that it is not probable that it will be obligated to pay additional damages to Deerfield pursuant to the Registration Rights Agreement, and therefore no accrual for such contingent payment has been recorded. | |||||||||
Accretion of debt issuance cost and debt discount in connection with the Deerfield financing during the three and nine months ended September 30, 2013 are as follows (in thousands). | |||||||||
Three months ended | Nine months ended | ||||||||
September 30, | September 30, | ||||||||
2013 | 2013 | ||||||||
Accretion expense- debt issuance cost | $ | 8 | $ | 8 | |||||
Accretion expense- debt discount | $ | 190 | $ | 190 |
Income_taxes
Income taxes | 9 Months Ended |
Sep. 30, 2013 | |
Income taxes | ' |
12. Income taxes | |
As required by ASC 740 Income Taxes (“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 due to its history of operating losses. Accordingly, the net deferred tax assets have been fully reserved. | |
ASC 740-10-25 Income Taxes Recognition clarifies the accounting and disclosure for uncertainty in tax positions, as defined. This guidance seeks to reduce the diversity in practice associated with certain aspects of the recognition and measurement related to accounting for income taxes. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded pursuant to this guidance. Tax years since 1993 remain subject to examination by the major tax jurisdictions in which the Company is subject to tax. |
Subsequent_events
Subsequent events | 9 Months Ended |
Sep. 30, 2013 | |
Subsequent events | ' |
13. Subsequent events | |
In October 2013, the Company received an additional $45.0 million in cash proceeds from the exercise of the October 2012 public offering warrants and $78.0 million of consideration from The Mann Group in the form of cancelled principal indebtedness under the Company’s loan arrangement with The Mann Group as payment for the aggregate exercise price of The Mann Group Warrants. | |
On October 31, 2013, the Company’s loan arrangement with The Mann Group 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 loan arrangement to December 31, 2019, increase the aggregate borrowing amount under the loan arrangement from $350.0 million to $370.0 million, provide that repayments or cancellations of principal under the loan arrangement will not be available for reborrowing, and to cancel $78.0 million of principal indebtedness under the loan arrangement as payment for the aggregate exercise price of The Mann Group Warrants. In addition, the Company and The Mann Group agreed to capitalize into principal $7.9 million of accrued interest that became due and payable upon cancellation of the $78.0 million of principal indebtedness. |
Description_of_business_and_ba1
Description of business and basis of presentation (Policies) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Business | ' | ||||||||||||||||
Business — The Company is a biopharmaceutical company focused on the discovery and development of therapeutic products for diseases such as diabetes. The Company’s lead product candidate, AFREZZA (insulin human [rDNA origin]) inhalation powder, is an ultra rapid-acting insulin therapy that recently completed two additional Phase 3 clinical studies for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. On August 14, 2013, the Company released the results of these Phase 3 clinical studies, both of which met their primary efficacy endpoints and safety objectives. On October 13, 2013, the Company submitted the results of these studies to the U.S. Food and Drug and Administration (“FDA”) as an amendment to its new drug application (“NDA”). The FDA subsequently acknowledged the resubmission and advised the Company that it considers the updated NDA to be a complete class 2 response to the Company’s Completed Response Letter issued in January 2011, and assigned a user fee goal (PDUFA) date of April 15, 2014. | |||||||||||||||||
Basis of Presentation | ' | ||||||||||||||||
Basis of Presentation — The Company is considered to be in the development stage as its primary activities since incorporation have been establishing its facilities, recruiting personnel, conducting research and development, business development, business and financial planning, and raising capital. It is costly to develop therapeutic products and conduct clinical studies for these products. From its inception through September 30, 2013, the Company has reported accumulated net losses of $2.2 billion, which include a goodwill impairment charge of $151.4 million and cumulative negative cash flow from operations of $1.7 billion. On December 15, 2013, $115.0 million aggregate principal under the Company’s 3.75% Senior Convertible Notes due 2013 (the “2013 notes”) will become due and payable (see Note 10 — Senior convertible notes). These factors raise 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 these uncertainties. At September 30, 2013, the Company’s capital resources consisted of cash and cash equivalents of $93.8 million. In addition, the Company expects to sell $40.0 million principal amount of the Company’s 9.75% Senior Convertible Notes due 2019 (the “2019 notes”) to Deerfield (as defined below) under a facility agreement in the fourth quarter of 2013 (see Note 11 — Facility financing agreement). The Company is required, with the funds made available by the purchase of these 2019 notes, to repay the 2013 notes. On September 30, 2013, the Company’s ability to borrow additional amounts under a loan arrangement provided by the Company’s principal stockholder, The Mann Group LLC (“The Mann Group”), terminated. In October 2013, however, the loan arrangement was amended to, among other things, extend the maturity date of the loan until January 5, 2020 and extend the date through which the Company can borrow under the loan arrangement to December 31, 2019 (see Note 13 — Subsequent events). As of October 31, 2013, the Company had $30.1 million principal amount of available borrowings under the loan arrangement, although the Company anticipates using a portion of these available borrowings to capitalize into principal, upon mutual agreement of the parties, accrued interest as it becomes due and payable under the loan arrangement (see Note 9 — Related-party arrangements and Note 13 — Subsequent events). Subsequent to September 30, 2013, the Company received $45.0 million in cash proceeds from the exercise of certain public offering warrants prior to their expiration on October 29, 2013. Based upon the Company’s current expectations, including the expectation that Deerfield will purchase $40.0 million principal amount of 2019 notes in the fourth quarter of 2013 in connection with the repayment of the 2013 notes, management believes the Company’s existing capital resources will enable it to continue planned operations into at least the first quarter of 2014. However, the Company cannot provide assurances that Deerfield will fund the third tranche under the Facility Agreement (as defined below), that the Company will be able to access capital through the ATM Agreements (as defined below) on favorable terms, or at all, or that the Company’s plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. | |||||||||||||||||
Capital resources potentially available to the Company include proceeds from the exercise of warrants issued in its February 2012 public offering, the ATM Agreements and issuance of additional 2019 notes to Deerfield, as more fully described below: | |||||||||||||||||
In February 2012, the Company sold in an underwritten public offering 35,937,500 units at an aggregate price to the public of $86.3 million, with each unit consisting of one share of common stock and a warrant to purchase 0.6 of a share of common stock. Net proceeds from this offering were approximately $80.6 million, excluding any future proceeds from the exercise of warrants. The warrants are exercisable at $2.40 per share and expire in February 2016. As of September 30, 2013, the Company had received $4.5 million in cash proceeds from the exercise of the February 2012 public offering warrants, with $47.3 million remaining unexercised. | |||||||||||||||||
On March 18, 2013, the Company entered into at-the-market issuance sales agreements (the “ATM Agreements”) with two sales agents, under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $50.0 million under each ATM Agreement (provided that in no event may the Company issue and sell more than $50.0 million of shares of its common stock under both ATM Agreements in the aggregate) from time to time through either of the sales agents. Neither the Company nor either of the sales agents has any obligation to sell shares of the Company’s common stock under the ATM Agreements. Any sales of common stock made under the ATM Agreements will be made in “at the market” offerings as defined in Rule 415 of the Securities Act of 1933, as amended (the “Securities Act”). The Company has not yet issued any shares of its common stock under the ATM Agreements. There can be no assurance that the Company will be able to access capital through the ATM Agreements on a timely basis, or at all. | |||||||||||||||||
On July 1, 2013, the Company entered into a 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”), providing for the sale of up to $160.0 million of 2019 notes to Deerfield in four equal tranches of $40.0 million principal amount. In connection with the Facility Agreement, on July 1, 2013 the Company also entered into a Milestone Rights Purchase Agreement (the “Milestone Agreement”) with Deerfield Private Design Fund and Horizon Santé FLML SÁRL (“HS” and together with Deerfield Private Design Fund, the “Milestone Purchasers”), pursuant to which, the Company sold the Milestone Purchasers certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones including the first commercial sale of an AFREZZA product and the achievement of specified net sales figures (the “Milestone Rights” see Note 11 – Facility financing agreement). | |||||||||||||||||
On July 1, 2013, Deerfield purchased the first tranche of 2019 notes and the Milestone Rights for an aggregate of $40.0 million. The closing of the second tranche of 2019 notes, which was subject to achievement and reporting of certain results from the Company’s two Phase 3 clinical studies of AFREZZA, occurred on September 5, 2013. There can be no assurance that the conditions required for the purchase of the third or fourth tranches of the 2019 notes will be met or met in a timeframe necessary to support the Company’s liquidity needs. | |||||||||||||||||
The Company will need to raise additional capital through the resources identified above or, through the sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, assets 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 through any such sources or other sources. | |||||||||||||||||
Fair Value of Financial Instruments | ' | ||||||||||||||||
Fair Value of Financial Instruments — The carrying amounts of certain 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 related party cannot be reasonably estimated as the Company would not be able to obtain a similar credit arrangement in the current economic environment. | |||||||||||||||||
Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase, that are readily convertible into cash. As of September 30, 2013 and December 31, 2012, the Company held $93.8 million and $61.8 million, respectively, of cash and cash equivalents, consisting primarily of money market funds of $91.1 million and $60.8 million, respectively, and the remaining 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). | |||||||||||||||||
The following is a summary of the carrying values and estimated fair values of the 2013 notes, the Company’s 5.75% Senior Convertible Notes due 2015 (the “2015 notes”) and the 2019 notes (in millions). | |||||||||||||||||
September 30, 2013 | December 31, 2012 | ||||||||||||||||
Carrying | Estimated | Carrying | Estimated | ||||||||||||||
value | fair value | value | fair value | ||||||||||||||
2013 notes | $ | 114.9 | $ | 114.8 | $ | 114.4 | $ | 81.9 | |||||||||
2015 notes | $ | 98.2 | $ | 106 | $ | 97.6 | $ | 63.2 | |||||||||
2019 notes | $ | 72.9 | $ | 75.7 | — | — | |||||||||||
The estimated fair value of the 2013 notes was calculated based on quoted prices in an active market (Level 1 in the fair value hierarchy). 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 (Level 3 in the fair value hierarchy). As there is no current 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 there is no current observable market for the 2019 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 (Level 3 in the fair value hierarchy). | |||||||||||||||||
As discussed in Note 11 — Facility financing agreement, in connection with the Facility Agreement, the Company issued 2019 notes and Milestone Rights and recorded a commitment asset on July 1, 2013. The estimated fair value of the 2019 notes was calculated 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 of 12% (Level 3 in the fair value hierarchy). 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 (17.5%) was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. The fair value of the commitment asset was estimated using the income approach by estimating the fair value of the future tranches using a market debt rate (12%) commensurate with the risk of the future tranches and the fair value of the cash expected to be received by the Company and assessing the probability of the commitments being funded in the future based on the operational hurdles required for funding being met (Level 3 in the fair value hierarchy). At September 30, 2013, the carrying value of the Milestone Rights and commitment asset approximates their respective estimated fair values. | |||||||||||||||||
The Company concluded its Common Stock Purchase Agreement with The Mann Group entered into in February 2012 (“The Mann Group Common Stock Purchase Agreement”) (see Note 7 — Common and preferred stock) represented a contingent forward purchase contract that met the definition of a derivative instrument in accordance with ASC 815 Derivatives and Hedging (“ASC 815”). Of the 31,250,000 shares issuable pursuant to The Mann Group Common Stock Purchase Agreement, the portion of the derivative instrument representing 14.7 million shares were recorded as equity (“Equity Portion”) as they met the criteria for equity classification under ASC 815-40 Derivatives and Hedging, Contracts in an Entity’s Own Stock. The remaining 16.5 million shares (“Non-Equity Portion”) required classification outside of equity as the Company did not have sufficient available shares at the time of issuance. The Company revalued the Non-Equity Portion of the forward purchase contract at each reporting date and recorded a fair value adjustment within “Other income (expense).” The estimated fair value of The Mann Group Common Stock Purchase Agreement was based on a forward purchase contract valuation (Level 3 in the fair value hierarchy). The fair value of the forward purchase contract was highly sensitive to the discount applied for lack of marketability and the stock price, and changes in this discount and/or the stock price caused the value of the forward purchase contract to change significantly. The Company recognized the change in fair value of $(336,000) in “Other income (expense)” for the three months ended March 31, 2012. The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract was estimated to be equal to the valuation date stock price minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.06% at March 31, 2012. As the shares which would be received upon settlement were unregistered, the Company applied a discount for lack of marketability of 2.57% at issuance and 1.64% at March 31, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock was publicly traded and the fact that there was no contractual restriction on the unregistered shares being registered. As of and for the nine months ended September 30, 2012, the Company recognized the change in fair value of $12.0 million in “Other income.” The Company revalued the Non-Equity Portion using a forward contract valuation formula, in which the forward contract is estimated to be equal to the valuation date stock price of $2.40 at issuance and $1.69 at May 17, 2012 (the date at which the Company had sufficient available shares) minus the strike price discounted to the valuation date using a risk-free rate of 0.08% at issuance and 0.18% at May 17, 2012. As the shares which would be received upon settlement are currently unregistered, the Company applied a discount for lack of marketability of 10.27% at issuance and 1.67% at May 17, 2012 based on quantitative put models, adjusted to take into account qualitative factors, including the fact that the Company’s stock is publicly traded and the fact that there is no contractual restriction on the unregistered shares being registered. | |||||||||||||||||
The following roll-forward provides a summary of changes in fair value of the Company’s Level 3 forward purchase contract (in thousands): | |||||||||||||||||
Three months | Nine months | ||||||||||||||||
ended | ended | ||||||||||||||||
September 30, 2012 | September 30, 2012 | ||||||||||||||||
Forward | Forward | ||||||||||||||||
Purchase | Purchase | ||||||||||||||||
Contract | Contract | ||||||||||||||||
Beginning Balance | $ | — | $ | — | |||||||||||||
Issuance | — | 1,080 | |||||||||||||||
Adjustments to fair value included in other income | — | 12,011 | |||||||||||||||
Transfers to additional paid-in-capital | — | (13,091 | ) | ||||||||||||||
Ending Balance | $ | — | $ | — | |||||||||||||
Recently Issued Accounting Standards | ' | ||||||||||||||||
Recently Issued Accounting Standards — In February 2013, the FASB issued ASU 2013-02, Comprehensive Income (Topic 220) – Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. These amendments do not change the current requirements for reporting net income or other comprehensive income in the financial statements. These amendments provide for additional disclosure requirements for amounts reclassified out of accumulated other comprehensive income. These amendments are effective prospectively for interim and annual periods beginning after December 15, 2012. Early adoption is permitted. Effective January 1, 2013, the Company adopted the new requirements as set forth in ASU 2013-02 in the disclosure of comprehensive income on the Company’s consolidated financial statements. The adoption of the new requirements did not have a significant impact on the Company’s consolidated financial statements. | |||||||||||||||||
In July 2013, the FASB ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit when a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists (a consensus of the FASB Emerging Issues Task Force). The amendments in this ASU provide guidance on the financial statements presentation of an unrecognized tax benefit when a net operating loss carryforward, a similar tax loss, or a tax credit carryforward exists. An unrecognized tax benefit should be presented in the financial statements as a reduction to a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward with certain exceptions, in which case such an unrecognized tax benefit should be presented in the financial statements as a liability. The amendments in this ASU do not require new recurring disclosures. The amendments in this ASU are effective for fiscal years, and interim periods within those years, beginning after December 15, 2013. The Company is evaluating the impact, if any, of the adoption of ASU 2013-11 will have on the Company’s consolidated financial statements. |
Description_of_business_and_ba2
Description of business and basis of presentation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Summary of Carrying Values and Estimated Fair Values of Senior Convertible Notes | ' | ||||||||||||||||
The following is a summary of the carrying values and estimated fair values of the 2013 notes, the Company’s 5.75% Senior Convertible Notes due 2015 (the “2015 notes”) and the 2019 notes (in millions). | |||||||||||||||||
September 30, 2013 | December 31, 2012 | ||||||||||||||||
Carrying | Estimated | Carrying | Estimated | ||||||||||||||
value | fair value | value | fair value | ||||||||||||||
2013 notes | $ | 114.9 | $ | 114.8 | $ | 114.4 | $ | 81.9 | |||||||||
2015 notes | $ | 98.2 | $ | 106 | $ | 97.6 | $ | 63.2 | |||||||||
2019 notes | $ | 72.9 | $ | 75.7 | — | — | |||||||||||
Changes in Fair Value of Level 3 Forward Purchase Contract | ' | ||||||||||||||||
The following roll-forward provides a summary of changes in fair value of the Company’s Level 3 forward purchase contract (in thousands): | |||||||||||||||||
Three months | Nine months | ||||||||||||||||
ended | ended | ||||||||||||||||
September 30, 2012 | September 30, 2012 | ||||||||||||||||
Forward | Forward | ||||||||||||||||
Purchase | Purchase | ||||||||||||||||
Contract | Contract | ||||||||||||||||
Beginning Balance | $ | — | $ | — | |||||||||||||
Issuance | — | 1,080 | |||||||||||||||
Adjustments to fair value included in other income | — | 12,011 | |||||||||||||||
Transfers to additional paid-in-capital | — | (13,091 | ) | ||||||||||||||
Ending Balance | $ | — | $ | — | |||||||||||||
Accrued_expenses_and_other_cur1
Accrued expenses and other current liabilities (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Accrued Expenses and Other Current Liabilities | ' | ||||||||
Accrued expenses and other current liabilities are comprised of the following (in thousands): | |||||||||
September 30, | December 31, | ||||||||
2013 | 2012 | ||||||||
Salary and related expenses | $ | 9,414 | $ | 10,074 | |||||
Research and clinical study costs | 3,155 | 5,995 | |||||||
Accrued interest | 3,265 | 4,533 | |||||||
Construction in progress | 226 | 3,878 | |||||||
Other | 5,493 | 1,297 | |||||||
Accrued expenses and other current liabilities | $ | 21,553 | $ | 25,777 | |||||
Accounting_for_stockbased_comp1
Accounting for stock-based compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Stock-Based Compensation Expense Recognized in Condensed Consolidated Statements of Operations | ' | ||||||||||||||||
Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2013 and 2012 was as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Stock-based compensation | $ | 15,943 | $ | 3,820 | $ | 31,304 | $ | 9,770 | |||||||||
Property_and_equipment_Tables
Property and equipment (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Property and Equipment | ' | ||||||||||||||||
Property and equipment — net consist of the following (dollar amounts in thousands): | |||||||||||||||||
Estimated | September 30, | December 31, | |||||||||||||||
Useful | 2013 | 2012 | |||||||||||||||
Life | |||||||||||||||||
(Years) | |||||||||||||||||
Land | — | $ | 5,273 | $ | 5,273 | ||||||||||||
Buildings | 39-40 | 54,948 | 54,948 | ||||||||||||||
Building improvements | May-40 | 114,245 | 114,245 | ||||||||||||||
Machinery and equipment | 15-Mar | 82,283 | 81,382 | ||||||||||||||
Furniture, fixtures and office equipment | 10-May | 5,164 | 5,239 | ||||||||||||||
Computer equipment and software | 3 | 11,935 | 11,840 | ||||||||||||||
Leasehold improvements | 17 | 17 | |||||||||||||||
Construction in progress | 13,876 | 12,266 | |||||||||||||||
287,741 | 285,210 | ||||||||||||||||
Less accumulated depreciation and amortization | (109,912 | ) | (101,249 | ) | |||||||||||||
Property and equipment — net | $ | 177,829 | $ | 183,961 | |||||||||||||
Depreciation and Amortization Expense | ' | ||||||||||||||||
Depreciation and amortization expense related to property and equipment for the three and nine months ended September 30, 2013 and 2012 was as follows (in thousands): | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Depreciation and amortization expense | $ | 2,874 | $ | 3,237 | $ | 8,820 | $ | 9,898 | |||||||||
Senior_convertible_notes_Table
Senior convertible notes (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2013 | |||||||||||||||||
Summary of Senior Convertible Notes | ' | ||||||||||||||||
Senior convertible notes consist of the following (in thousands): | |||||||||||||||||
September 30, | December 31, | ||||||||||||||||
2013 | 2012 | ||||||||||||||||
2013 notes | |||||||||||||||||
Principal amount | $ | 115,000 | $ | 115,000 | |||||||||||||
Unaccreted debt issuance expense | (103 | ) | (557 | ) | |||||||||||||
Net carrying amount | 114,897 | 114,443 | |||||||||||||||
2015 notes | |||||||||||||||||
Principal amount | $ | 100,000 | $ | 100,000 | |||||||||||||
Unaccreted debt issuance expense | (1,780 | ) | (2,417 | ) | |||||||||||||
Net carrying amount | 98,220 | 97,583 | |||||||||||||||
Senior convertible notes | $ | 213,117 | $ | 212,026 | |||||||||||||
Accretion of Debt Issuance Expense | ' | ||||||||||||||||
Accretion of debt issuance expense in connection with the offerings of the 2015 notes and the 2013 notes during the three and nine months ended September 30, 2013 were as follows (in thousands). | |||||||||||||||||
Three months ended | Nine months ended | ||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||
Accretion expense | $ | 369 | $ | 348 | $ | 1,091 | $ | 1,031 | |||||||||
Facility_financing_agreement_T
Facility financing agreement (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2013 | |||||||||
Components of Facility Financing Agreement | ' | ||||||||
The components of the facility financing agreement recorded as of September 30, 2013 consist of the following (in thousands): | |||||||||
September 30, | |||||||||
2013 | |||||||||
2019 notes | |||||||||
Principal amount | $ | 80,000 | |||||||
Debt discount-net of amortization | (6,798 | ) | |||||||
Unaccreted debt issuance expense | (269 | ) | |||||||
Net carrying amount of facility financing obligation | $ | 72,933 | |||||||
Milestone rights | |||||||||
Principal amount | $ | 16,276 | |||||||
Debt discount-net of amortization | (51 | ) | |||||||
Unaccreted debt issuance expense | (61 | ) | |||||||
Less current portion of milestone rights included in other current liabilities | (3,150 | ) | |||||||
Net carrying amount included in other liabilities | $ | 13,013 | |||||||
Commitment Asset | |||||||||
Initial commitment asset fair value | $ | 13,393 | |||||||
Less Tranche 2 portion of commitment asset | (3,656 | ) | |||||||
Commitment asset value included in other assets | $ | 9,737 | |||||||
Accretion of Debt Issuance Cost and Debt Discount | ' | ||||||||
Accretion of debt issuance cost and debt discount in connection with the Deerfield financing during the three and nine months ended September 30, 2013 are as follows (in thousands). | |||||||||
Three months ended | Nine months ended | ||||||||
September 30, | September 30, | ||||||||
2013 | 2013 | ||||||||
Accretion expense- debt issuance cost | $ | 8 | $ | 8 | |||||
Accretion expense- debt discount | $ | 190 | $ | 190 |
Recovered_Sheet1
Description of Business and Basis of Presentation - Additional Information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | 272 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 1 Months Ended | 9 Months Ended | 9 Months Ended | 1 Months Ended | 1 Months Ended | ||||||||||||||||||||||||||
Oct. 31, 2012 | Feb. 29, 2012 | Feb. 28, 2012 | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Jun. 30, 2012 | 17-May-12 | Mar. 31, 2012 | Dec. 31, 2011 | 17-May-12 | Mar. 31, 2012 | Mar. 18, 2013 | Nov. 02, 2013 | Sep. 30, 2013 | 17-May-12 | Mar. 31, 2012 | Sep. 30, 2013 | 17-May-12 | Mar. 31, 2012 | Oct. 31, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 12, 2006 | Sep. 30, 2013 | Nov. 02, 2013 | Sep. 30, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | |
Other Than Equity | Other Than Equity | Maximum | Subsequent Event | Mann Group | Mann Group | Mann Group | Mann Group | Mann Group | Mann Group | Mann Group | Mann Group | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Notes 9.75% Due in 2019 | Notes 9.75% Due in 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Money market funds | Money market funds | ||||||||||||
At Market Sales Agreement | Forward Purchase Contracts | Forward Purchase Contracts | Forward Purchase Contracts | Forward Purchase Contracts | Forward Purchase Contracts | Subsequent Event | Subsequent Event | Subsequent Event | Subsequent Event | Tranche One | Milestone Rights | Deerfield | Deerfield | Deerfield | Deerfield | ||||||||||||||||||||||
Equity Component | Other Than Equity | Other Than Equity | Tranche | Maximum | Tranche One | Milestone Rights | |||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Deficit accumulated during the development stage | ' | ' | ' | $2,242,819,000 | ' | $2,242,819,000 | $2,104,912,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Goodwill impairment | ' | ' | ' | ' | ' | 151,428,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cash flow from operation since inception | ' | ' | ' | -94,681,000 | -91,762,000 | -1,690,942,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Principal amount of convertible senior notes | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 115,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Senior notes, effective interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3.75% | ' | 3.75% | ' | 9.75% | ' | ' | ' | 9.75% | ' | ' | ' | ' | ' |
Senior notes, due date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 15-Dec-13 | ' | ' | 5-Jan-20 | ' | ' | ' | ' | 31-Dec-19 | ' | ' | ' | ' | ' |
Cash and cash equivalents | ' | ' | ' | 93,803,000 | 1,765,000 | 93,803,000 | 61,840,000 | ' | ' | ' | 2,681,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Available borrowings under loan agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Debt facility periodic principal amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' | ' |
Proceeds from exercise warrants | ' | ' | ' | 49,170,000 | ' | 49,170,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 44,700,000 | ' | ' | ' | ' | ' | 45,000,000 | 45,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering, number of shares | ' | 35,937,500 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering, amount | ' | 86,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds from public offering | 86,300,000 | 80,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares purchased by each warrant | ' | 0.6 | 0.6 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants exercise price per share | 2.6 | 2.4 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants, maturity date | ' | '2016-02 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from exercise warrants | ' | 4,500,000 | 4,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants remained unexercised | ' | 47,300,000 | 47,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 45,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate offering price of common stock under agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Debt facility principal amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 115,000,000 | 115,000,000 | 115,000,000 | ' | ' | 80,000,000 | ' | ' | 160,000,000 | ' | 40,000,000 | ' | ' | ' |
Number of equal tranches | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4 | ' | ' | ' | ' | ' |
Proceeds from sale of financial instrument | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 90,000,000 | ' | ' | ' | ' |
Debt facility initial amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' |
Maturity period of cash equivalents | ' | ' | ' | '90 days or less at the time of purchase | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Cash and cash equivalents | ' | ' | ' | 93,800,000 | ' | 93,800,000 | 61,800,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 91,100,000 | 60,800,000 |
Discount rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12.00% | 17.50% | ' | ' | ' | 17.50% | ' | ' |
Market debt rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12.00% | ' | ' | ' | ' | ' | ' |
Capital stock authorized | ' | ' | 31,250,000 | 309,993,285 | ' | 309,993,285 | 286,035,082 | 31,250,000 | ' | ' | ' | ' | ' | ' | ' | 31,250,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Shares that recorded the portion of the derivative instrument representing equity | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 14,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Shares that recorded the portion of the derivative instrument representing outside of equity | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 16,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Change in fair value recognized in other income | ' | ' | ' | ' | $12,000,000 | ' | ' | ' | ' | ($336,000) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Risk Free Interest Rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 0.18% | 0.06% | ' | ' | ' | ' | ' | ' | 0.08% | 0.08% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Discount for lack of marketability | ' | ' | ' | ' | ' | ' | ' | ' | 1.67% | 1.64% | ' | ' | ' | ' | ' | ' | 10.27% | 2.57% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Valuation date stock price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1.69 | ' | ' | ' | ' | ' | ' | ' | $2.40 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Carrying_Values_and
Summary of Carrying Values and Estimated Fair Values of Senior Convertible Notes (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
Senior convertible notes due December 15, 2013 | ' | ' |
Convertible Debt [Line Items] | ' | ' |
Carrying value | $114,897,000 | $114,443,000 |
Estimated fair value | 114,800,000 | 81,900,000 |
Senior convertible notes due August 15 2015 | ' | ' |
Convertible Debt [Line Items] | ' | ' |
Carrying value | 98,220,000 | 97,583,000 |
Estimated fair value | 106,000,000 | 63,200,000 |
Senior convertible notes due December 31 2019 | ' | ' |
Convertible Debt [Line Items] | ' | ' |
Carrying value | 72,933,000 | ' |
Estimated fair value | $75,700,000 | ' |
Changes_in_Fair_Value_of_Level
Changes in Fair Value of Level 3 Forward Purchase Contract (Detail) (Forward Purchase Contracts, USD $) | 3 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2012 | Sep. 30, 2012 |
Forward Purchase Contracts | ' | ' |
Fair Value, Assets and Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ' | ' |
Beginning Balance | ' | ' |
Issuance | ' | 1,080 |
Adjustments to fair value included in other income | ' | 12,011 |
Transfers to additional paid-in-capital | ' | -13,091 |
Ending Balance | ' | ' |
Recovered_Sheet2
Accrued Expenses and Other Current Liabilities (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | ||
Accrued Expenses and Other Current Liabilities [Line Items] | ' | ' |
Salary and related expenses | $9,414 | $10,074 |
Research and clinical study costs | 3,155 | 5,995 |
Accrued interest | 3,265 | 4,533 |
Construction in progress | 226 | 3,878 |
Other | 5,493 | 1,297 |
Accrued expenses and other current liabilities | $21,553 | $25,777 |
StockBased_Compensation_Expens
Stock-Based Compensation Expense Recognized in Condensed Consolidated Statements of Operations (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ' | ' | ' | ' |
Stock-based compensation | $15,943 | $3,820 | $31,304 | $9,770 |
Accounting_for_Stock_Based_Com
Accounting for Stock- Based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 3 Months Ended | 3 Months Ended | ||||
Sep. 30, 2013 | Sep. 30, 2013 | 23-May-13 | 23-May-13 | Mar. 07, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | |
Performance Based Stock Options | Performance Based Restricted Stock Units | Performance Based Restricted Stock Units | Stock Options | Restricted Stock Units (RSUs) | Performance Options | Stock options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Options granted | ' | ' | 5,598,100 | 1,687,900 | 5,846,000 | ' | ' | ' | ' |
Weighted average grant date fair value of the stock options granted | ' | ' | $3.05 | $6.85 | $2.81 | ' | $5.89 | ' | $4.14 |
Share based payment award , vesting period | '4 years | ' | ' | ' | ' | ' | ' | ' | ' |
Fair value of restricted stock units | 732,350 | ' | ' | ' | ' | ' | ' | ' | ' |
Number of restricted stock options | 1,106,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Unrecognized compensation cost related to non-vested stock options | ' | ' | ' | ' | ' | $27,100,000 | $21,400,000 | ' | ' |
Weighted average vesting period for unrecognized compensation cost | ' | '1 year 6 months | ' | ' | ' | ' | ' | ' | ' |
Unrecognized expenses milestones not considered probable of achievement | ' | ' | ' | ' | ' | ' | $3,700,000 | $107,000 | ' |
Net_Loss_per_Common_Share_Addi
Net Loss per Common Share - Additional Information (Detail) | 9 Months Ended | |
Sep. 30, 2013 | Sep. 30, 2012 | |
Net Income Loss Per Common Share [Line Items] | ' | ' |
Companies common stock share outstanding | 9,000,000 | ' |
Antidilutive securities | 133,944,425 | 63,833,521 |
Shares loaned under the share lending arrangement | 9,000,000 | 9,000,000 |
Recovered_Sheet3
State Research and Development Credit Exchange Receivable - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2013 | Dec. 31, 2012 | |
Accounts and Other Receivables [Line Items] | ' | ' |
Percentage of credit exchange receivable | 65.00% | ' |
Prepaid and other current assets under credit exchange program | $298,000 | $450,000 |
Estimated amounts receivable under program | $223,000 | $313,000 |
Property_and_Equipment_Detail
Property and Equipment (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 |
In Thousands, unless otherwise specified | Land | Land | Buildings | Buildings | Buildings | Buildings | Building Improvements | Building Improvements | Building Improvements | Building Improvements | Machinery and Equipment | Machinery and Equipment | Machinery and Equipment | Machinery and Equipment | Furniture, fixtures and office equipment | Furniture, fixtures and office equipment | Furniture, fixtures and office equipment | Furniture, fixtures and office equipment | Computer Equipment and Software | Computer Equipment and Software | Computer Equipment and Software | Leasehold Improvements | Leasehold Improvements | Construction in Progress | Construction in Progress | ||
Minimum | Maximum | Minimum | Maximum | Minimum | Maximum | Minimum | Maximum | Maximum | |||||||||||||||||||
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Estimated Useful Life (Years) | ' | ' | ' | ' | ' | ' | '39 years | '40 years | ' | ' | '5 years | '40 years | ' | ' | '3 years | '15 years | ' | ' | '5 years | '10 years | ' | ' | '3 years | ' | ' | ' | ' |
Property and equipment - gross | $287,741 | $285,210 | $5,273 | $5,273 | $54,948 | $54,948 | ' | ' | $114,245 | $114,245 | ' | ' | $82,283 | $81,382 | ' | ' | $5,164 | $5,239 | ' | ' | $11,935 | $11,840 | ' | $17 | $17 | $13,876 | $12,266 |
Less accumulated depreciation and amortization | -109,912 | -101,249 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Property and equipment - net | $177,829 | $183,961 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Property_and_Equipment_Additio
Property and Equipment - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2013 | |
Depreciation and Other Amortization Expenses [Line Items] | ' |
Amortization period of lease hold improvements | '4 years |
Depreciation_and_Amortization_
Depreciation and Amortization Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Property, Plant and Equipment [Line Items] | ' | ' | ' | ' |
Depreciation and amortization expense | $2,874 | $3,237 | $8,820 | $9,898 |
Common_and_Preferred_Stock_Add
Common and Preferred Stock - Additional Information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | 272 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | ||||||||||
Oct. 31, 2012 | Feb. 29, 2012 | Feb. 28, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Dec. 31, 2012 | Jun. 30, 2012 | Feb. 28, 2012 | Sep. 30, 2013 | Oct. 31, 2012 | Oct. 31, 2013 | Sep. 30, 2013 | Oct. 31, 2012 | Feb. 28, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Aug. 18, 2010 | |
Warrant Liability | Mann Group | Mann Group | Mann Group | Mann Group | Mann Group | Related Party | Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | ||||||||
Subsequent Event | Subsequent Event | Private Placement | |||||||||||||||
Class of Stock [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, shares authorized | ' | ' | ' | 550,000,000 | 550,000,000 | 550,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, par value | ' | ' | ' | $0.01 | $0.01 | $0.01 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Undesignated preferred stock, shares authorized | ' | ' | ' | 10,000,000 | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock, shares issued | ' | ' | ' | 309,993,285 | 309,993,285 | 286,035,082 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Capital stock authorized | ' | ' | 31,250,000 | 309,993,285 | 309,993,285 | 286,035,082 | 31,250,000 | ' | 31,250,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Common stock loaned under share lending agreement, shares | ' | ' | ' | 9,000,000 | 9,000,000 | 9,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Principal amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $100,000,000 | $100,000,000 | $100,000,000 |
Nominal lending fee | ' | ' | ' | $0.01 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of Unit Sold in an Underwritten public offering | ' | ' | 35,937,500 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering | ' | ' | 86,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
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. | ' | ' | ' |
Number of shares of common stock purchased by each warrant | ' | 0.6 | 0.6 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds from offering | ' | ' | 80,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Rate at which warrants are exercisable | 2.6 | 2.4 | ' | ' | ' | ' | ' | 2.4 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrant expiration date | ' | ' | '2016-02 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted Stock Agreed to be Purchased by Lender | ' | ' | 77,200,000 | ' | ' | ' | ' | ' | ' | 107,400,000 | ' | ' | ' | ' | ' | ' | ' |
Proceeds from exercise warrants | ' | 4,500,000 | 4,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrants remained unexercised | ' | 47,300,000 | 47,300,000 | ' | ' | ' | ' | ' | 45,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering | 46,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' |
Net proceeds from public offering | 92,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares in each units issued | 1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrant entitles the holder to purchase a share of common stock | 0.75 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds from public offering | 86,300,000 | 80,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Exercise of warrants for common stock | ' | ' | ' | 49,170,000 | 49,170,000 | ' | ' | ' | 44,700,000 | ' | 45,000,000 | 45,000,000 | ' | ' | ' | ' | ' |
Principal indebtedness cancelled under the loan arrangement as payment for the aggregate exercise price of The Mann Group Warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $78,000,000 | ' | ' | ' | ' | ' | ' |
Commitments_and_Contingencies_
Commitments and Contingencies - Additional Information (Detail) (Deerfield, Milestone Rights, Maximum, USD $) | Sep. 30, 2013 | Jul. 01, 2013 |
In Millions, unless otherwise specified | ||
Deerfield | Milestone Rights | Maximum | ' | ' |
Commitments and Contingencies [Line Items] | ' | ' |
Rights to receive payment | $90 | $90 |
RelatedParty_Arrangements_Addi
Related-Party Arrangements - Additional Information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | 9 Months Ended | 1 Months Ended | 1 Months Ended | 9 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | 1 Months Ended | |||||||||||||
In Millions, except Share data, unless otherwise specified | Oct. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Jun. 30, 2012 | Feb. 29, 2012 | Feb. 28, 2012 | Sep. 30, 2013 | Sep. 30, 2013 | Nov. 02, 2013 | Sep. 30, 2010 | Sep. 30, 2010 | Sep. 30, 2013 | Oct. 31, 2012 | Oct. 31, 2013 | Oct. 31, 2012 | Feb. 28, 2009 | Oct. 31, 2007 | Sep. 30, 2013 | Dec. 31, 2012 | Oct. 31, 2013 | Feb. 28, 2009 | Dec. 31, 2012 | Oct. 31, 2013 |
Maximum | Minimum | Subsequent Event | Letter Agreement | Related Party Debt | Mann Group | Mann Group | Mann Group | Mann Group | Principal stockholder | Principal stockholder | Principal stockholder | Principal stockholder | Principal stockholder | Principal stockholder | Principal stockholder | Principal stockholder | |||||||
Letter Agreement | Subsequent Event | Private Placement | Subsequent Event | Loan Arrangement | Loan Arrangement | Amended Agreement | |||||||||||||||||
Subsequent Event | |||||||||||||||||||||||
Related Party Transaction [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Loan agreement with related party | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $350 | ' | ' | $370 | ' | ' | ' |
Interest rate (LIBOR) | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5.00% | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3.00% | 5.00% | ' |
Description of variable rate interest | ' | ' | ' | ' | ' | ' | ' | ' | ' | 'The interest rate will increase to the one-year LIBOR calculated on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum. | 'One-year LIBOR | ' | ' | ' | ' | 'One-year LIBOR | ' | ' | 'One-year LIBOR | ' | ' | ' | ' |
Borrowing rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5.84% | ' | ' | ' | ' | ' |
Promissory note maturity date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5-Jan-20 |
Principal indebtedness cancelled under the loan arrangement as payment for the aggregate exercise price of The Mann Group Warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 78 | ' | ' | ' | ' | ' | ' | ' | ' | 78 |
Accrued interest that became due and payable upon cancellation of the of principal indebtedness, to be capitalized | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 7.9 |
Principal amount outstanding under credit facility | ' | 119.6 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amount available for future borrowings | ' | ' | ' | ' | ' | ' | ' | ' | 30.1 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Amount prepaid for cancellation of indebtedness | ' | ' | ' | ' | ' | ' | 200 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of months advances outstanding | ' | ' | ' | ' | ' | ' | ' | '12 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Related party transaction prepayment period | ' | '90 days | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate principal amount cancelled | ' | ' | ' | ' | ' | ' | ' | ' | 105 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted Stock Agreed to be Purchased by Lender | ' | ' | ' | ' | ' | $77.20 | ' | ' | ' | ' | ' | ' | $107.40 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Capital stock authorized | ' | 309,993,285 | 286,035,082 | 31,250,000 | ' | 31,250,000 | ' | ' | ' | ' | ' | 31,250,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Underwritten public offering | 46,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Number of shares represented by purchased warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 30,000,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Rate at which warrants are exercisable | 2.6 | ' | ' | ' | 2.4 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Warrant expiration month and year | '2013-10 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Senior_Convertible_
Summary of Senior Convertible Notes (Detail) (USD $) | Sep. 30, 2013 | Dec. 31, 2012 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 12, 2006 | Sep. 30, 2013 | Dec. 31, 2012 | Aug. 18, 2010 |
In Thousands, unless otherwise specified | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | ||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' |
Principal amount | ' | ' | $115,000 | $115,000 | $115,000 | $100,000 | $100,000 | $100,000 |
Unaccreted debt issuance expense | ' | ' | -103 | -557 | ' | -1,780 | -2,417 | ' |
Net carrying amount | ' | ' | 114,897 | 114,443 | ' | 98,220 | 97,583 | ' |
Senior convertible notes | $213,117 | $212,026 | ' | ' | ' | ' | ' | ' |
Senior_Convertible_Notes_Addit
Senior Convertible Notes - Additional Information (Detail) (USD $) | 1 Months Ended | 1 Months Ended | |||||
Aug. 18, 2010 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 12, 2006 | Sep. 30, 2013 | Dec. 31, 2012 | Dec. 12, 2006 | |
Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | Senior convertible notes due August 15 2015 | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | Senior convertible notes due December 15, 2013 | |
Underwriters Overallotment Option | |||||||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Principal amount | $100,000,000 | $100,000,000 | $100,000,000 | $115,000,000 | $115,000,000 | $115,000,000 | $15,000,000 |
Senior notes, effective interest rate | 5.75% | ' | ' | 3.75% | 3.75% | ' | ' |
Accrued interest | ' | 700,000 | 2,200,000 | ' | 1,300,000 | 200,000 | ' |
No of convertible shares | 147.0859 | ' | ' | 44.5002 | ' | ' | ' |
Principal amount per share | $1,000 | ' | ' | $1,000 | ' | ' | ' |
Conversion price of shares | $6.80 | ' | ' | $22.47 | ' | ' | ' |
Percentage of repurchase price | 100.00% | ' | ' | 100.00% | ' | ' | ' |
Percentage of conversion price equaling stock price | 150.00% | ' | ' | ' | ' | ' | ' |
Percentage of redemption price | 100.00% | ' | ' | ' | ' | ' | ' |
Consecutive trading days for which closing stock price is equal to 150% of conversion price | 'At least 20 of the 30 | ' | ' | ' | ' | ' | ' |
Issuance cost | $4,200,000 | ' | ' | $3,700,000 | ' | ' | ' |
Accretion_of_Debt_Issuance_Exp
Accretion of Debt Issuance Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2012 | Sep. 30, 2013 | Sep. 30, 2012 |
Debt Instrument [Line Items] | ' | ' | ' | ' |
Accretion expense | $369 | $348 | $1,091 | $1,031 |
Components_of_Facility_Financi
Components of Facility Financing Agreement (Detail) (USD $) | Sep. 30, 2013 |
In Thousands, unless otherwise specified | |
Securities Financing Transaction [Line Items] | ' |
Net carrying amount of facility financing obligation | $72,933 |
Initial commitment asset fair value | 13,393 |
Commitment asset value included in other assets | 9,737 |
Tranche Two | ' |
Securities Financing Transaction [Line Items] | ' |
Less Tranche 2 portion of commitment asset | -3,656 |
Senior convertible notes due December 31 2019 | ' |
Securities Financing Transaction [Line Items] | ' |
Principal amount | 80,000 |
Debt discount-net of amortization | -6,798 |
Unaccreted debt issuance expense | -269 |
Net carrying amount of facility financing obligation | 72,933 |
Net carrying amount included in other liabilities | 72,933 |
Milestone Rights | ' |
Securities Financing Transaction [Line Items] | ' |
Principal amount | 16,276 |
Debt discount-net of amortization | -51 |
Unaccreted debt issuance expense | -61 |
Less current portion of milestone rights included in other current liabilities | -3,150 |
Net carrying amount included in other liabilities | $13,013 |
Facility_Financing_Agreement_A
Facility Financing Agreement - Additional Information (Detail) (USD $) | 9 Months Ended | 272 Months Ended | 1 Months Ended | 1 Months Ended | 1 Months Ended | 1 Months Ended | ||||||||||||
Share data in Millions, except Per Share data, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Sep. 30, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Sep. 30, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Sep. 30, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 | Jul. 01, 2013 |
Registration Rights Agreement | Facility Agreement | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | Deerfield | |||
Maximum | Tranche One | Milestone Rights | Tranches Three and Four | Maximum | Maximum | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | Senior convertible notes due December 31 2019 | ||||||
Milestone Rights | Milestone Rights | Tranche One | Milestone Rights | Tranche Two | Maximum | Minimum | ||||||||||||
Debt Instrument [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Debt facility principal amount | ' | ' | ' | ' | $80,000,000 | ' | ' | ' | ' | ' | ' | $160,000,000 | ' | $40,000,000 | ' | $40,000,000 | ' | ' |
Debt facility periodic principal amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 40,000,000 | ' | ' | ' | ' | ' | ' |
Interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 9.75% | ' | ' | ' | ' | ' | ' |
Debt facility maturity year | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '2019 | ' | ' | ' | ' | ' | ' |
Shares issued upon conversion | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12 | ' |
Debt facility conversion price | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3.33 |
Repayment as a percentage of original principal amount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 25.00% | ' | 110.00% | ' | ' | ' | ' |
Debt instrument maturity date | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 31-Dec-19 | ' | ' | ' | ' | ' | ' |
Minimum available amount of credit facility under covenant restrictions | ' | ' | ' | 25,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Value received, from Tranche 1 Notes and Milestone Rights | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 52,900,000 | ' | ' | ' | ' | ' | ' |
Proceeds from debt issuance | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 39,500,000 | ' | ' | ' | ' |
Commitment asset at fair value | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 13,400,000 | ' | ' | ' | ' | ' | ' |
Estimated fair values debt issued | ' | ' | ' | ' | 75,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | 37,100,000 | 16,300,000 | ' | ' | ' |
Effective interest rate | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 12.19% | ' | 12.45% | ' | ' |
Debt discount | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,300,000 | ' | 3,700,000 | ' | ' |
Payment for debt issue costs | 598,000 | 598,000 | ' | ' | ' | ' | ' | 500,000 | ' | ' | ' | 448,737 | ' | ' | ' | ' | ' | ' |
Debt issuance costs | ' | ' | ' | ' | ' | ' | ' | 597,529 | 259,800 | ' | ' | 536,266 | ' | ' | ' | ' | ' | ' |
Contingent liability for milestone payments | ' | ' | ' | ' | ' | ' | ' | ' | ' | 90,000,000 | 90,000,000 | ' | ' | ' | ' | ' | ' | ' |
Short term liability | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 3,200,000 | ' | ' | ' |
Long term liability | $72,933,000 | $72,933,000 | ' | ' | $72,933,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | $13,100,000 | ' | ' | ' |
Discount rate | ' | ' | ' | ' | ' | 12.00% | 17.50% | ' | ' | ' | ' | ' | ' | ' | 17.50% | ' | ' | ' |
Risk premium | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5.00% | ' | ' | ' |
Share registration statement shares of common stock to be registered | ' | ' | 12 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Additional damage calculation percentage | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1.00% | ' | ' | ' | ' | ' |
Accretion_of_Debt_Issuance_Cos
Accretion of Debt Issuance Cost and Debt Discount in Connection with Deerfield Financing (Detail) (Deerfield, USD $) | 3 Months Ended | 9 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2013 |
Deerfield | ' | ' |
Debt Instrument [Line Items] | ' | ' |
Accretion expense- debt issuance cost | $8 | $8 |
Accretion expense- debt discount | $190 | $190 |
Subsequent_Event_Additional_In
Subsequent Event - Additional Information (Detail) (USD $) | 9 Months Ended | 272 Months Ended | 1 Months Ended | ||
Sep. 30, 2013 | Sep. 30, 2013 | Sep. 30, 2013 | Oct. 31, 2013 | Oct. 31, 2013 | |
Principal stockholder | Subsequent Event | Subsequent Event | |||
Amended Agreement | Principal stockholder | Principal stockholder | |||
Amended Agreement | |||||
Subsequent Event [Line Items] | ' | ' | ' | ' | ' |
Proceeds from exercise warrants | $49,170,000 | $49,170,000 | ' | $45,000,000 | ' |
Cancelled principal indebtedness | ' | ' | ' | ' | 78,000,000 |
Extended maturity date of loan | ' | ' | ' | ' | 5-Jan-20 |
Loan agreement with related party | ' | ' | 350,000,000 | ' | 370,000,000 |
Accrued interest that became due and payable upon cancellation of the of principal indebtedness, to be capitalized | ' | ' | ' | ' | $7,900,000 |