Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 07, 2015 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | MNKD | |
Entity Registrant Name | MANNKIND CORP | |
Entity Central Index Key | 899,460 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 414,033,866 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - Entity [Domain] - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 107,187 | $ 120,841 |
Receivables from collaboration | 4,748 | 50,436 |
Inventory | 19,816 | 9,670 |
Prepaid expenses and other current assets | 14,076 | 20,206 |
Total current assets | 145,827 | 201,153 |
Property and equipment - net | 193,868 | 192,127 |
Deferred product costs from collaboration | 10,831 | |
Other assets | 2,025 | 1,159 |
Total assets | 352,551 | 394,439 |
Current liabilities: | ||
Accounts payable | 5,190 | 7,394 |
Accrued expenses and other current liabilities | 13,930 | 26,206 |
Facility financing obligation | 73,757 | 72,995 |
Senior convertible notes-current | 64,123 | 99,355 |
Deferred product sales from collaboration | 13,404 | 436 |
Deferred payments from collaboration | 171,850 | 196,967 |
Total current liabilities | 342,254 | 403,353 |
Note payable to principal stockholder | 49,521 | 49,521 |
Sanofi loan facility and loss share obligation | 28,415 | 3,034 |
Senior convertible notes-long term | 35,713 | |
Other liabilities | 12,123 | 12,301 |
Total liabilities | $ 468,026 | $ 468,209 |
Commitments and contingencies | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2015 and December 31, 2014 | ||
Common stock, $0.01 par value - 550,000,000 shares authorized at June 30, 2015 and December 31, 2014; 412,316,619 and 406,059,089 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | $ 4,121 | $ 4,061 |
Additional paid-in capital | 2,434,777 | 2,416,967 |
Accumulated other comprehensive loss | (20) | (14) |
Accumulated deficit | (2,554,353) | (2,494,784) |
Total stockholders' deficit | (115,475) | (73,770) |
Total | $ 352,551 | $ 394,439 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Undesignated preferred stock, par value | $ 0.01 | $ 0.01 |
Undesignated preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Undesignated preferred stock, shares issued | 0 | 0 |
Undesignated preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 550,000,000 | 550,000,000 |
Common stock, shares issued | 412,316,619 | 406,059,089 |
Common stock, shares outstanding | 412,316,619 | 406,059,089 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - Entity [Domain] - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 7,737 | 37,323 | 17,115 | 63,506 |
General and administrative | 10,623 | 32,523 | 21,102 | 47,752 |
Product manufacturing | 5,691 | 7,573 | ||
Total operating expenses | 24,051 | 69,846 | 45,790 | 111,258 |
Loss from operations | (24,051) | (69,846) | (45,790) | (111,258) |
Other income (expense) | (10) | (370) | 1,403 | (6,260) |
Interest expense on note payable to principal stockholder | (721) | (721) | (1,435) | (1,435) |
Interest expense on notes | (4,131) | (2,429) | (13,753) | (6,471) |
Interest income | 3 | 1 | 6 | 2 |
Loss before benefit for income taxes | (28,910) | (73,365) | (59,569) | (125,422) |
Income tax benefit | 0 | 0 | 0 | 0 |
Net loss | $ (28,910) | $ (73,365) | $ (59,569) | $ (125,422) |
Net loss per share - basic and diluted | $ (0.07) | $ (0.19) | $ (0.15) | $ (0.33) |
Shares used to compute basic and diluted net loss per share | 401,018 | 380,770 | 399,972 | 374,810 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Net loss | $ (28,910) | $ (73,365) | $ (59,569) | $ (125,422) |
Other comprehensive loss: | ||||
Cumulative translation (loss) gain | 1 | (6) | ||
Unrealized gain (loss) on investments: | ||||
Unrealized holding gain (loss) during the period | 0 | 0 | 0 | 0 |
Less: reclassification adjustment for gains (losses) included in net loss | 0 | 0 | 0 | 0 |
Net unrealized gain on investments | 0 | 0 | 0 | 0 |
Other comprehensive loss | 1 | (6) | ||
Comprehensive loss | $ (28,909) | $ (73,365) | $ (59,575) | $ (125,422) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (59,569) | $ (125,422) |
Adjustments to reconcile net loss to net cash provided by (used) in operating activities: | ||
Depreciation and accretion | 6,624 | 12,614 |
Stock-based compensation expense | 3,778 | 51,583 |
Loss on disposal of property and equipment | 12 | |
Write off of derivative liability | (363) | |
Other, net | (6) | |
Changes in assets and liabilities: | ||
Inventory | (10,146) | |
Receivables from Collaboration | 45,688 | |
Prepaid expenses and other current assets | 6,130 | 1,789 |
Deferred product costs from collaboration | (10,831) | |
Other assets | (866) | (296) |
Accounts payable | (2,236) | 1,567 |
Accrued expenses and other current liabilities | (7,800) | (3,315) |
Deferred product sales from collaboration | 12,968 | |
Other liabilities | 1,465 | 1,435 |
Net cash used in operating activities | (14,789) | (60,408) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (8,737) | (9,667) |
Net cash used in investing activities | (8,737) | (9,667) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Issuance of common stock and warrants, net of issuance costs | 12,820 | 20,622 |
Proceeds from issuance of Tranche B of the facility financing obligation | 20,000 | |
Milestone payment | (4,220) | |
Other | 40 | |
Proceeds from issuance of common stock pursuant to ATM issuance | 2,050 | |
Payment of employment taxes related to vested restricted stock units | (818) | (123) |
Net cash provided by financing activities | 9,872 | 40,499 |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (13,654) | (29,576) |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 120,841 | 70,790 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 107,187 | 41,214 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ||
Interest paid in cash, net of amounts capitalized | 6,644 | 5,296 |
Issuance of common stock pursuant to conversion of facility financing obligation | 93,500 | |
Non-cash construction in progress and property and equipment | $ 623 | 2,965 |
Reclassification of share-based awards to liability | (19,926) | |
Tranche B Commitment Asset | $ 1,753 |
Description of business and bas
Description of business and basis of presentation | 6 Months Ended |
Jun. 30, 2015 | |
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 (“MannKind,” the “Company,” “we” or “us”), 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. The information included in this quarterly report on Form 10-Q should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2014 filed with the SEC on March 2, 2015 (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 three and six months ended June 30, 2015 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 and deferred product costs for impairment, accrued expenses, 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. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Business — Basis of Presentation At June 30, 2015, the Company’s capital resources consisted of cash and cash equivalents of $107.2 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing of AFREZZA and the development of other product candidates. In addition, the Company had $244.9 million principal amount of outstanding debt as of June 30, 2015, including $100.0 million principal amount of outstanding 5.75% Senior Convertible Notes due 2015 (the “2015 notes”), which have a maturity date of August 15, 2015. See Note 5 – Related-party arrangements, Note 6 – Senior convertible notes, Note 7 – Collaboration arrangement—Sanofi Loan Facility, Note 14 – Facility Agreement, and Note 15 – Subsequent events. In addition, the Company’s facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) (see Note 14 – Facility Agreement) contains a financial covenant that requires the Company’s cash and cash equivalents, which include available borrowings under the Company’s loan arrangement (the “Loan Arrangement”) with The Mann Group LLC (“The Mann Group”), on the last day of each fiscal quarter to not be less than $25.0 million. As of August 10, 2015, pursuant to privately-negotiated exchange agreements with select holders of 2015 notes, the Company issued $27.7 million aggregate principal in 2018 notes. In addition, the Company issued 1.9 million shares of the Company’s common stock in exchange for $8.0 million aggregate principal of 2015 notes. Unless the holders of the remaining outstanding 2015 notes or the holders of the new 2015 notes elect to convert such notes into the Company’s common stock prior to their due date, the Company intends to settle the unconverted notes with either available cash or raise additional funds. However, the Company cannot provide assurance that such additional funds will be available on acceptable terms or at all. The Company cannot be certain that it will achieve its projected cashflows , which raises substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties. Under the Sanofi License Agreement, Sanofi paid the Company an up-front cash payment of $150.0 million in the third quarter of 2014, and $50.0 million in milestone payments in the first quarter of 2015. The foregoing milestone payments were earned as of December 31, 2014. We are also eligible to receive up to $725.0 million in additional milestone payments under the Sanofi License Agreement if certain development, regulatory and sales milestones are achieved. Worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by us and Sanofi that are specifically attributable or related to the development, regulatory filings, manufacturing, or commercialization of AFREZZA, will be shared 65% by Sanofi and 35% by the Company. In connection with the Sanofi License Agreement, an affiliate of Sanofi provided us with a secured loan facility (the “Sanofi Loan Facility”) of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. Additional funding sources that are, or in certain circumstances may be available to the Company, include approximately $30.1 million principal amount of available borrowings under its Loan Arrangement (see Note 5 – Related-party arrangements) and potential proceeds from the exercise of warrants issued in its February 2012 public offering of approximately $9.8 million., and the Company’s at-the-market issuance sales agreements which allow the Company to sell up to $47.9 million in common stock provided no sales may be made except pursuant to an effective registration statement. In April 2015, the Company sold $2.1 million in common stock under the at-the-market sales agreement. The registration statement under which the shares that may be sold pursuant to the at-the-market issuance sales agreements are registered will expire on August 31, 2015. The Company cannot provide assurances that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company may need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, asset sales or other means, in order to continue the development and commercialization of AFREZZA and other product candidates and to support its other ongoing activities. However, the Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. Fair Value of Financial Instruments — Deferred product costs from collaboration — Recently Issued Accounting Standards — In May 2014, a new standard was issued related to revenue recognition, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The guidance requires a company to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration it expects to be entitled to receive in exchange for those goods or services. In July 2015, the FASB decided to delay the effective date of the new revenue standard by one year. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The standard is effective beginning the first quarter of the Company’s 2018 fiscal year and may be adopted either by restating all years presented in the Company’s financial statements or by recording the impact of adoption as an adjustment to retained earnings at the beginning of fiscal 2018. The Company is assessing the potential impact of the new standard on its consolidated statements of financial position and results of operations and comprehensive income (loss) and has not yet selected a transition method. In August 2014, the FASB issued ASU 2014-15, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern”. The ASU is effective for annual periods ending after December 15, 2016, and interim periods thereafter; early adoption is permitted. The Company is evaluating the impact the adoption of ASU 2014-15 will have on its consolidated financial statements. In April 2015, the FASB issued ASU 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” The guidance requires debt issuance costs to be presented in the balance sheet as a direct deduction from the carrying value of the associated debt, consistent with the presentation of a debt discount. The guidance is effective for annual reporting periods beginning after December 15, 2015 and interim periods thereafter. Early adoption is permitted. The Company does not believe the adoption of the new standard will have a material impact on its consolidated financial statements and disclosures. In July 2015, The FASB has issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendments are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company is evaluating the impact the adoption of ASU 2015-11 will have on its consolidated financial statements. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2015 | |
Inventories | 2. Inventories Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 16,038 $ 4,856 Work-in-process 3,757 4,719 Finished goods 21 95 Total inventories $ 19,816 $ 9,670 |
Property and equipment
Property and equipment | 6 Months Ended |
Jun. 30, 2015 | |
Property and equipment | 3. Property and equipment Property and equipment — net consist of the following (dollar amounts in thousands): Estimated June 30, December 31, Land — $ 5,273 $ 5,273 Buildings 39-40 54,948 54,948 Building improvements 5-40 131,300 114,131 Machinery and equipment 3-15 102,996 80,919 Furniture, fixtures and office equipment 5-10 5,015 5,015 Computer equipment and software 3 10,355 10,465 Leasehold improvements 4 17 17 Construction in progress 7,118 39,580 317,022 310,348 Less accumulated depreciation and amortization (123,154 ) (118,221 ) Property and equipment — net $ 193,868 $ 192,127 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 six months ended June 30, 2015 and 2014 was as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Depreciation and amortization expense $ 2,740 $ 2,449 $ 5,117 $ 4,972 |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 6 Months Ended |
Jun. 30, 2015 | |
Accrued expenses and other current liabilities | 4. Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following (in thousands): June 30, December 31, Salary and related expenses $ 8,455 $ 14,928 Accrued interest 2,396 2,396 Construction in progress 42 1,343 Other 3,037 7,539 Accrued expenses and other current liabilities $ 13,930 $ 26,206 |
Related-party arrangements
Related-party arrangements | 6 Months Ended |
Jun. 30, 2015 | |
Related-party arrangements | 5. Related-party arrangements In October 2007, the Company entered into a $350.0 million loan arrangement with its principal stockholder. The Loan Arrangement has been amended from time to time. On October 31, 2013, the promissory note underlying the Loan Arrangement was amended to, among other things, extend the maturity date of the loan to January 5, 2020, extend the date through which the Company can borrow under the Loan Arrangement to December 31, 2019, increase the aggregate borrowing amount under the Loan Arrangement from $350.0 million to $370.0 million and provide that repayments or cancellations of principal under the Loan Arrangement will not be available for reborrowing. As of June 30, 2015, the total principal amount outstanding under the Loan Arrangement was $49.5 million, and the amount available for future borrowings was $30.1 million. Interest, at a fixed rate of 5.84%, is due and payable quarterly in arrears on the first day of each calendar quarter for the preceding quarter, or at such other time as the Company and The Mann Group mutually agree. All or any portion of accrued and unpaid interest that becomes due and payable may be paid-in-kind and capitalized as additional borrowings at any time and would be classified as non-current upon mutual agreement of both parties. As of June 30, 2015, the Company had accrued $4.9 million of interest in other liabilities related to the Loan Arrangement. The Mann Group can require the Company to prepay up to $200.0 million in advances that have been outstanding for at least 12 months (less approximately $105.0 million aggregate principal amount that has been cancelled in connection with two common stock purchase agreements). If The Mann Group exercises this right, the Company will have 90 days after The Mann Group provides written notice (or the number of days to maturity of the note if less than 90 days) to prepay such advances. However, pursuant to a letter agreement entered into in August 2010, The Mann Group has agreed to not require the Company to prepay amounts outstanding under the amended and restated promissory note if the prepayment would require the Company to use its working capital resources. In addition, The Mann Group entered into a subordination agreement with Deerfield pursuant to which The Mann Group agreed with Deerfield not to demand or accept any payment under the Loan Arrangement until the Company’s payment obligations to Deerfield under the Facility Agreement have been satisfied in full. Subject to the foregoing, in the event of a default under the Loan Arrangement, all unpaid principal and interest either becomes immediately due and payable or may be accelerated at The Mann Group’s option, and the interest rate will increase to the one-year LIBOR 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. During the six months ended June 30, 2015, there were no additional borrowings under or amendments to the Loan Arrangement. |
Senior convertible notes
Senior convertible notes | 6 Months Ended |
Jun. 30, 2015 | |
Senior convertible notes | 6. Senior convertible notes Senior convertible notes consist of the following (in thousands): June 30, December 31, 2015 notes Principal amount $ 100,000 $ 100,000 Unaccreted debt issuance expense (164 ) (645 ) Net carrying amount $ 99,836 $ 99,355 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 $2.4 million as of both June 30, 2015 and December 31, 2014. 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 any outstanding, 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, up 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 of 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 can be net-share 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 accreted to interest expense using the effective interest method over the term of the 2015 notes. The 2015 notes provide that upon an acceleration of certain indebtedness, including the 9.75% Senior Convertible Notes due 2019 (the “2019 notes”) and the 8.75% Senior Convertible Notes due 2019 (the “Tranche B notes”) issued to Deerfield pursuant to the Facility Agreement (see Note 14 – Facility Agreement), the holders may elect to accelerate the Company’s repayment obligations under the notes if such acceleration is not cured, waived, rescinded or annulled. There can be no assurance that the holders would not choose to exercise these rights in the event such events were to occur. Accretion of debt issuance expense in connection with the 2015 notes during the three and six months ended June 30, 2015 and 2014 were as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Accretion expense $ 243 $ 227 $ 481 $ 450 |
Collaboration arrangement
Collaboration arrangement | 6 Months Ended |
Jun. 30, 2015 | |
Collaboration arrangement | 7. Collaboration arrangement Sanofi License Agreement and Sanofi Supply Agreement On August 11, 2014, the Company and Sanofi entered into the Sanofi License Agreement, which became effective on September 23, 2014. Under the terms of the Sanofi License Agreement, the Company granted to Sanofi exclusive, worldwide licenses to certain of the Company’s patents, trademarks and know-how for the development and commercialization of AFREZZA. Under the terms of the Sanofi License Agreement, Sanofi has the exclusive right and responsibility to develop AFREZZA worldwide, subject to certain development activities that will be performed by the Company. Sanofi will also be obligated to use commercially reasonable efforts to file for, obtain and maintain marketing approvals for AFREZZA in certain major markets and countries. In addition, Sanofi will have exclusive, worldwide rights to commercialize AFREZZA and will be obligated to use commercially reasonable efforts to market, promote and commercialize AFREZZA in all countries in the world where regulatory approval for AFREZZA has been received. Under the Sanofi License Agreement, Sanofi paid the Company an up-front cash payment of $150.0 million in the third quarter of 2014 and a subsequent payment of $50.0 million in the first quarter of 2015 for the achievement of two manufacturing milestones as of December 31, 2014. If certain development, regulatory and sales milestones are achieved, the Company will also be eligible to receive up to $725.0 million in additional milestone payments, of which $25.0 million relates to a development milestone event, $50.0 million relates to the filing and completion of regulatory approvals and $650.0 million relates to the achievement of certain product sales milestones. In addition, worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by the Company and Sanofi that are specifically attributable or related to the development, improvement, regulatory filings, manufacturing, and commercialization of AFREZZA will be shared 65% by Sanofi and 35% by the Company. In accordance with the terms of the Sanofi License Agreement, profit and loss sharing commenced in the fourth quarter of 2014. Pursuant to the terms of the Sanofi Supply Agreement, the Company will be the exclusive manufacturer and supplier of AFREZZA until the specified conditions are met, upon which a portion of the manufacturing activities may be assumed by Sanofi. The Company analyzed the agreements entered into with Sanofi under the provisions of ASC 605, Revenue Recognition The assessment of multiple element arrangements requires judgment in order to determine the appropriate units of accounting and the points in time that, or periods over which, revenue should be recognized. Under the terms of the Sanofi License Agreement, Sanofi Supply Agreement and the Sanofi Loan Facility the Company determined that the arrangement contained significant deliverables including (i) licenses to develop and commercialize AFREZZA and to use the Company’s trademarks, (ii) development activities, and (iii) manufacture and supply services for AFREZZA. Due to the proprietary nature of the manufacturing services being provided by the Company, the Company determined that all of the significant deliverables should be combined into a single unit of accounting. The Company believes that the manufacturing services are proprietary due to the fact that since the late 1990’s, the Company has developed proprietary knowledge and patented equipment and tools that are used in the manufacturing process of AFREZZA. Due to the complexities of particle formulation and the specialized knowledge and equipment needed to handle the AFREZZA powder, neither Sanofi nor any third-party contract manufacturing organization currently possesses the capability of manufacturing AFREZZA. In order for revenue to be recognized, the seller’s price to the buyer must be fixed and determinable. Given that as of June 30, 2015, the Company did not have the ability to estimate the amount of costs that would potentially be incurred under the loss share provision related to the Sanofi License Agreement and the Sanofi Supply Agreement, the Company believes this requirement for revenue recognition has not been met. As such, the Company did not recognize any revenue pursuant to the Sanofi License Agreement or the Sanofi Supply Agreement for the three or six months ended June 30, 2015. The Company has recorded the $150.0 million up-front payment and $50.0 million from milestone payments as deferred payments from collaboration. In addition, as of June 30, 2015 the Company has recorded $13.4 million in AFREZZA product shipments to Sanofi as deferred product sales from collaboration and recorded $10.8 million as deferred product costs from collaboration. Deferred product costs represent the costs of product manufactured and shipped to Sanofi, not to exceed the amount of deferred product sales, for which recognition of revenue has been deferred. During the three months ended March 31, 2015 and June 30, 2015, the Company’s portion of the loss sharing was $12.4 million and $12.8 million, respectively, which resulted in the reclassification from current deferred payments from collaboration to Sanofi loan facility and loss share obligation. Sanofi Loan Facility On September 23, 2014, the Company entered into the Sanofi Loan Facility, consisting of a senior secured revolving promissory note (the “Note”) and a guaranty and security agreement (the “Security Agreement”) with an affiliate of Sanofi which provides the Company with a secured loan facility of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. In the event of certain future defaults under the Sanofi Loan facility agreement for which the Company is not able to obtain waivers, the lender under the Sanofi Loan Facility may accelerate all of the Company’s repayment obligations, and take control of the Company’s pledged assets, potentially requiring the Company to renegotiate the terms of its indebtedness on terms less favorable to the Company, or to immediately cease operations. Advances under the Sanofi Loan Facility bear interest at a rate of 8.5% per annum and are payable in-kind and compounded quarterly and added to the outstanding principal balance under the Sanofi Loan Facility. The Company is required to make mandatory prepayments on the outstanding loans under the Sanofi Loan Facility from its share of any Profits (as defined in the Sanofi License Agreement) under the Sanofi License Agreement within 30 days of receipt of its share of any such Profits. No advances may be made under the Sanofi Loan Agreement if Deerfield has commenced enforcement proceedings in connection with an event of default under the Facility Agreement. The outstanding principal of all loans under the Sanofi Loan Facility, if not prepaid, will become due and payable on September 23, 2024 unless accelerated pursuant to the terms of the Sanofi Loan Facility. Additionally, if the Company sells its Valencia facility, the Company is required to prepay the loans under the Sanofi Loan Facility in an amount equal to 100% of the net cash proceeds of the sale within five business days of receipt. In order to fund the Company’s portion of the loss sharing during the three months ended June 30, 2015, subsequent to June 30, 2015, the Company borrowed $12.8 million under the Sanofi Loan Facility to finance the portion of the Company’s loss from the quarter ended June 30, 2015. As of August 10, 2015, the total amount owed to Sanofi under the Sanofi Loan Facility was $28.4 million, which includes $0.2 million in paid-in-kind interest. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value of Financial Instruments | 8. Fair Value of Financial Instruments The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1— Quoted prices for identical instruments in active markets. Level 2— Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3— Significant inputs to the valuation model are unobservable. The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement. Cash and cash equivalents 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 June 30, 2015 and December 31, 2014, the Company held $107.2 million and $120.8 million, respectively, of cash and cash equivalents, consisting primarily of money market funds of $104.7 million and $118.5 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, which equals carrying value (Level 1 in the fair value hierarchy). Related-Party Arrangement The fair value of the note payable to our principal stockholder cannot be reasonably estimated as the Company would not be able to obtain a similar credit arrangement in the current economic environment. Senior convertible notes and facility financing obligation The following is a summary of the carrying values and estimated fair values of the 2015 notes and the facility financing obligation (i.e., the 2019 notes and Tranche B notes) (in millions): June 30, 2015 December 31, 2014 Carrying Estimated Carrying Estimated 2015 notes $ 99.8 $ 103.2 $ 99.4 $ 102.9 Facility financing obligation $ 73.8 $ 77.9 $ 73.0 $ 75.1 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. Facility Agreement As discussed in Note 14 — Facility Agreement, in connection with the Facility Agreement, the Company issued 2019 notes and certain rights to receive payments of up to $90.0 million upon the occurrence of specified strategic and sales milestones (the “Milestone Rights”) and subsequently issued Tranche B notes. As there is no current observable market for the 2019 notes or Tranche B notes, the Company determined the estimated fair value using a bond valuation model based on a discounted cash flow methodology. The bond valuation model combined expected cash flows associated with principal repayment and interest based on the contractual terms of the debt agreement discounted to present value using a selected market discount rate. At June 30, 2015 the market discount rate was recalculated at 12.0% for the 2019 notes and the Tranche B notes (Level 3 in the fair value hierarchy). The estimated fair value of the Milestone Rights was calculated using the income approach in which the cash flows associated with the specified contractual payments were adjusted for both the expected timing and the probability of achieving the milestones discounted to present value using a selected market discount rate (Level 3 in the fair value hierarchy). The expected timing and probability of achieving the milestones, starting in 2014, was developed with consideration given to both internal data, such as progress made to date and assessment of criteria required for achievement, and external data, such as market research studies. The discount rate (15.5%) was selected based on an estimation of required rate of returns for similar investment opportunities using available market data. As of June 30, 2015, the fair value of the Milestone Rights is estimated at $43.9 million. Sanofi Loan Facility As discussed in Note 7 — the Sanofi Loan Facility, consists of a senior secured revolving promissory note and a guaranty and security agreement with an affiliate of Sanofi which provides the Company with a secured loan facility of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. As of June 30, 2015, the Company has borrowed $15.6 million, which includes $0.2 million in paid-in-kind interest, under the Sanofi Loan Facility and the estimated fair value was determined to approximate the carrying value based on the consideration of the key elements of the contractual terms of the Sanofi Loan Facility, market-based estimated cost of capital, and time value of money, namely the amount of time to settlement and the estimated discount rate appropriate for the liability (Level 2 in the fair value hierarchy). This analysis was performed using a discounted cash flow model in which time outstanding and discount rate were the primary variables. There were no material re-measurements to fair value during the six months ended June 30, 2015 of financial assets and liabilities that are not measured at fair value on a recurring basis. There were no transfers of assets or liabilities between the fair value measurement levels during the six months ended June 30, 2015. |
Common and preferred stock
Common and preferred stock | 6 Months Ended |
Jun. 30, 2015 | |
Common and preferred stock | 9. Common and preferred stock Included in the common stock outstanding as of June 30, 2015 and December 31, 2014 are 9,000,000 shares of common stock loaned to Bank of America, N.A. under a share lending agreement in connection with the offering of $100.0 million aggregate principal amount of 2015 notes (see Note 6 — 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. |
Accounting for stock-based comp
Accounting for stock-based compensation | 6 Months Ended |
Jun. 30, 2015 | |
Accounting for stock-based compensation | 10. Accounting for stock-based compensation Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2015 and 2014 was as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Stock-based compensation $ 1,775 $ 40,644 $ 3,778 $ 51,583 During the three months ended March 31, 2015, the Company issued stock awards to employees with a four-year vesting schedule. The grant date fair value of the 36,300 restricted stock units and 73,600 stock options issued was $262,086 and $382,720, respectively, with a grant date fair value per share of $7.22 and $5.20, respectively. During the three months ended June 30, 2015, the Company issued stock awards to employees with a four-year vesting schedule. The grant date fair value of the 194,704 restricted stock units and 208,000 stock options issued was $901,480 and $603,802 respectively, with a grant date fair value per share of $4.63 and $2.90, respectively. As of June 30, 2015, there was $7.3 million and $8.6 million of unrecognized compensation cost related to options and restricted stock units, respectively, which are expected to be recognized over the remaining weighted average vesting period of 2.6 years. |
Net loss per common share
Net loss per common share | 6 Months Ended |
Jun. 30, 2015 | |
Net loss per common share | 11. Net loss per common share Basic net loss per share excludes dilution for potentially dilutive securities and is computed by dividing net loss by the weighted average number of common shares outstanding during the period excluding the shares loaned to Bank of America under a share lending arrangement (see Note 9 — Common and preferred stock). As of June 30, 2015, 9,000,000 shares of the Company’s common stock, which were loaned to Bank of America pursuant to the terms of a share lending agreement, were issued and are outstanding, and the holder of the borrowed shares has 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, that are not included in the diluted net loss per share calculation consisted of an aggregate of 40,982,544 shares and 56,844,341 shares as of June 30, 2015 and 2014, respectively, and exclude the 9,000,000 shares loaned under the share lending arrangement. |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and contingencies | 12. Commitments and contingencies Guarantees and Indemnifications — Litigation — Contingencies Contingencies — Commitments — |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2015 | |
Income taxes | 13. Income taxes As required by ASC 740 Income Taxes ASC 740-10-25 Income Taxes Recognition |
Facility Agreement
Facility Agreement | 6 Months Ended |
Jun. 30, 2015 | |
Facility Agreement | 14. Facility Agreement As of June 30, 2015, there were $60.0 million principal amount of 2019 notes and $20.0 million principal amount of Tranche B notes outstanding. The 2019 notes accrue interest at annual rate of 9.75% and the Tranche B notes accrue interest at an annual rate of 8.75%. The Facility Agreement principal repayment schedule is comprised of annual payments beginning on July 1, 2016 and ending December 9, 2019. The repayment dates correspond to the dates on which the 2019 notes or Tranche B notes, as applicable, were issued. In conjunction with the Facility Agreement, the Company entered into a Milestone Rights Agreement with Deerfield which requires the Company to make contingent payments to Deerfield, totaling up to $90.0 million, upon the Company achieving specified commercialization milestones. The Milestone Rights were initially recorded as a short-term liability equal to $3.2 million included in accrued expenses and other current liabilities in the accompanying condensed consolidated balance sheet and a long-term liability equal to $13.1 million included in other liabilities. During the first quarter of 2015, the second milestone triggering event was achieved following the Company’s product launch on February 3, 2015, which resulted in a $5.8 million incremental charge to interest expense due to the increase in carrying value of the liability to the required $10.0 million payment made in February of 2015. In the first quarter of 2015, the Company determined that it was probable that the first commercial sales related milestone would be achieved within the next twelve months. As of June 30, 2015, the short-term portion of the liability had a balance of $1.6 million and the long-term portion of the liability had a balance of $7.3 million. Accretion of debt issuance cost and debt discount in connection with the Facility financing agreement during the three and six months ended June 30, 2015 and 2014 are as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Accretion expense- debt issuance cost $ 9 $ 27 $ 17 $ 309 Accretion expense – debt discount $ 380 $ 516 $ 745 $ 6,883 The Facility Agreement contains a financial covenant that requires the Company’s cash and cash equivalents, which include available borrowings under the Loan Arrangement, on the last day of each fiscal quarter to not be less than $25.0 million. If the Company fails to satisfy this financial covenant, or another event of default occurs under the Facility Agreement, Deerfield may declare all or any portion of the 2019 notes and/or Tranche B notes to be immediately due and payable. |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2015 | |
Subsequent events | 15. Subsequent events Issuance of new 5.75% Convertible Senior Subordinated Exchange Notes due 2018 in exchange for 2015 notes On July 28, 2015, the Company entered into privately-negotiated exchange agreements (the “Note Exchange Agreements”) with select holders of 2015 notes, pursuant to which the Company agreed to issue $27.7 million aggregate principal amount of new 5.75% Convertible Senior Subordinated Exchange Notes due 2018 (the “2018 notes”) to such holders in exchange for the delivery to the Company of the same principal amount of 2015 notes. The 2018 notes were issued at the closing of the exchange on August 10, 2015. The 2018 notes will be the Company’s general, unsecured, senior obligations, except that the 2018 notes will be subordinated in right of payment to the outstanding notes issued pursuant to the Facility Agreement and the Company’s borrowings under its secured loan facility with an affiliate of Sanofi-Aventis U.S. LLC. The 2018 notes will rank equally in right of payment with the Company’s other unsecured senior debt, including any 2015 notes that remain outstanding after the completion of the exchange transactions. The 2018 notes will bear interest at the rate of 5.75% per year on the principal amount, payable semiannually in arrears in cash on February 15 and August 15 of each year, beginning February 15, 2016, with interest accruing from August 15, 2015. The 2018 notes will mature on August 15, 2018. The 2018 notes will be convertible, at the option of the holder, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at a conversion rate of 147.0859 shares per $1,000 principal amount of 2018 notes, which is equal to a conversion price of approximately $6.80 per share, the same conversion price as that of the 2015 notes. The conversion rate is subject to adjustment under certain circumstances described in an indenture governing the 2018 notes dated August 10, 2015 with Wells Fargo, National Association (the “2018 Note Indenture”), including in connection with a make-whole fundamental change. If certain fundamental changes occur, the Company will be obligated to pay a fundamental change make-whole premium on any 2018 notes converted in connection with such fundamental change by increasing the conversion rate on such 2018 notes. In such instances, the amount of the fundamental change make-whole premium will be based on the Company’s common stock price and the effective date of the applicable fundamental change. If the Company undergoes certain fundamental changes, except in certain circumstances, each holder of 2018 notes will have the option to require the Company to repurchase all or any portion of that holder’s 2018 notes. The fundamental change repurchase price will be 100% of the principal amount of the 2018 notes to be repurchased plus accrued and unpaid interest, if any. On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. $27.7 million principal amount of 2018 notes were issued in exchange for the cancellation of the same principal amount of 2015 notes after June 30, 2015 but prior to the issuance of our quarterly report on Form 10-Q. As a result, in accordance with ASC 470 we reclassified $27.7 million principal amount of our 2015 notes that were outstanding as of June 30, 2015 from current liabilities to non-current liabilities. Issuance of common stock in exchange for 2015 notes On July 28, 2015 and August 3, 2015, the Company entered into separate, privately-negotiated exchange agreements (the “Stock-for-Note Exchange Agreements”) with other select holders of the 2015 notes pursuant to which the Company agreed to issue shares of its common stock to such holders in exchange for the delivery to the Company of up to $61.8 million aggregate principal amount of 2015 notes. Pursuant to the Stock-for-Note Exchange Agreements, the parties agreed to price the exchange transactions over a 10 trading day period spanning from July 29, 2015 to and including August 11, 2015 (each, an “Exchange Date”). Between July 28, 2015 and August 10, 2015, the Company issued an aggregate of 1.9 million shares of common stock to such holders in exchange for such holders’ delivery to the Company of $8.0 million aggregate principal amount of 2015 notes, resulting in a weighted-average exchange price of $4.40 per share. As of August 10, 2015, $64.3 million aggregate principal amount of 2015 notes remained outstanding. As a result in accordance with ASC 470, we reclassified $8.0 million of our 2015 notes that were outstanding as of the balance sheet date from current liabilities to non-current liabilities. The Company offered and issued the foregoing shares of common stock and the 2018 notes in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. Borrowings under Sanofi Loan Facility On July 28, 2015, we borrowed $12.8 million under the Sanofi Loan Facility to finance the portion of our losses for the three months ended June 30, 2015 (see Note 7 — Collaboration arrangement). |
Description of business and b22
Description of business and basis of presentation (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Business | Business — |
Basis of Presentation | Basis of Presentation At June 30, 2015, the Company’s capital resources consisted of cash and cash equivalents of $107.2 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing of AFREZZA and the development of other product candidates. In addition, the Company had $244.9 million principal amount of outstanding debt as of June 30, 2015, including $100.0 million principal amount of outstanding 5.75% Senior Convertible Notes due 2015 (the “2015 notes”), which have a maturity date of August 15, 2015. See Note 5 – Related-party arrangements, Note 6 – Senior convertible notes, Note 7 – Collaboration arrangement—Sanofi Loan Facility, Note 14 – Facility Agreement, and Note 15 – Subsequent events. In addition, the Company’s facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) (see Note 14 – Facility Agreement) contains a financial covenant that requires the Company’s cash and cash equivalents, which include available borrowings under the Company’s loan arrangement (the “Loan Arrangement”) with The Mann Group LLC (“The Mann Group”), on the last day of each fiscal quarter to not be less than $25.0 million. As of August 10, 2015, pursuant to privately-negotiated exchange agreements with select holders of 2015 notes, the Company issued $27.7 million aggregate principal in 2018 notes. In addition, the Company issued 1.9 million shares of the Company’s common stock in exchange for $8.0 million aggregate principal of 2015 notes. Unless the holders of the remaining outstanding 2015 notes or the holders of the new 2015 notes elect to convert such notes into the Company’s common stock prior to their due date, the Company intends to settle the unconverted notes with either available cash or raise additional funds. However, the Company cannot provide assurance that such additional funds will be available on acceptable terms or at all. The Company cannot be certain that it will achieve its projected cashflows , which raises substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties. Under the Sanofi License Agreement, Sanofi paid the Company an up-front cash payment of $150.0 million in the third quarter of 2014, and $50.0 million in milestone payments in the first quarter of 2015. The foregoing milestone payments were earned as of December 31, 2014. We are also eligible to receive up to $725.0 million in additional milestone payments under the Sanofi License Agreement if certain development, regulatory and sales milestones are achieved. Worldwide profits and losses, which are determined based on the difference between the net sales of AFREZZA and the costs and expenses incurred by us and Sanofi that are specifically attributable or related to the development, regulatory filings, manufacturing, or commercialization of AFREZZA, will be shared 65% by Sanofi and 35% by the Company. In connection with the Sanofi License Agreement, an affiliate of Sanofi provided us with a secured loan facility (the “Sanofi Loan Facility”) of up to $175.0 million to fund the Company’s share of net losses under the Sanofi License Agreement. Additional funding sources that are, or in certain circumstances may be available to the Company, include approximately $30.1 million principal amount of available borrowings under its Loan Arrangement (see Note 5 – Related-party arrangements) and potential proceeds from the exercise of warrants issued in its February 2012 public offering of approximately $9.8 million., and the Company’s at-the-market issuance sales agreements which allow the Company to sell up to $47.9 million in common stock provided no sales may be made except pursuant to an effective registration statement. In April 2015, the Company sold $2.1 million in common stock under the at-the-market sales agreement. The registration statement under which the shares that may be sold pursuant to the at-the-market issuance sales agreements are registered will expire on August 31, 2015. The Company cannot provide assurances that its plans will not change or that changed circumstances will not result in the depletion of its capital resources more rapidly than it currently anticipates. The Company may need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with a pharmaceutical company, the establishment of other funding facilities, licensing arrangements, asset sales or other means, in order to continue the development and commercialization of AFREZZA and other product candidates and to support its other ongoing activities. However, the Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments — |
Deferred product costs from collaboration | Deferred product costs from collaboration — |
Recently Issued Accounting Standards | Recently Issued Accounting Standards — In May 2014, a new standard was issued related to revenue recognition, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The guidance requires a company to recognize revenue to depict the transfer of goods or services to customers in an amount that reflects the consideration it expects to be entitled to receive in exchange for those goods or services. In July 2015, the FASB decided to delay the effective date of the new revenue standard by one year. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The standard is effective beginning the first quarter of the Company’s 2018 fiscal year and may be adopted either by restating all years presented in the Company’s financial statements or by recording the impact of adoption as an adjustment to retained earnings at the beginning of fiscal 2018. The Company is assessing the potential impact of the new standard on its consolidated statements of financial position and results of operations and comprehensive income (loss) and has not yet selected a transition method. In August 2014, the FASB issued ASU 2014-15, which provides guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements. The new standard requires management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements (or within one year after the date on which the financial statements are available to be issued, when applicable). Further, an entity must provide certain disclosures if there is “substantial doubt about the entity’s ability to continue as a going concern”. The ASU is effective for annual periods ending after December 15, 2016, and interim periods thereafter; early adoption is permitted. The Company is evaluating the impact the adoption of ASU 2014-15 will have on its consolidated financial statements. In April 2015, the FASB issued ASU 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” The guidance requires debt issuance costs to be presented in the balance sheet as a direct deduction from the carrying value of the associated debt, consistent with the presentation of a debt discount. The guidance is effective for annual reporting periods beginning after December 15, 2015 and interim periods thereafter. Early adoption is permitted. The Company does not believe the adoption of the new standard will have a material impact on its consolidated financial statements and disclosures. In July 2015, The FASB has issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximately normal profit margin. The amendments do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured using first-in, first-out (FIFO) or average cost. The amendments are effective for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The amendments should be applied prospectively with earlier application permitted as of the beginning of an interim or annual reporting period. The Company is evaluating the impact the adoption of ASU 2015-11 will have on its consolidated financial statements. |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Components of Inventories | Inventories consist of the following (in thousands): June 30, December 31, Raw materials $ 16,038 $ 4,856 Work-in-process 3,757 4,719 Finished goods 21 95 Total inventories $ 19,816 $ 9,670 |
Property and equipment (Tables)
Property and equipment (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Property and Equipment | Property and equipment — net consist of the following (dollar amounts in thousands): Estimated June 30, December 31, Land — $ 5,273 $ 5,273 Buildings 39-40 54,948 54,948 Building improvements 5-40 131,300 114,131 Machinery and equipment 3-15 102,996 80,919 Furniture, fixtures and office equipment 5-10 5,015 5,015 Computer equipment and software 3 10,355 10,465 Leasehold improvements 4 17 17 Construction in progress 7,118 39,580 317,022 310,348 Less accumulated depreciation and amortization (123,154 ) (118,221 ) Property and equipment — net $ 193,868 $ 192,127 |
Depreciation and Amortization Expense Related to Property and Equipment | Depreciation and amortization expense related to property and equipment for the three and six months ended June 30, 2015 and 2014 was as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Depreciation and amortization expense $ 2,740 $ 2,449 $ 5,117 $ 4,972 |
Accrued expenses and other cu25
Accrued expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): June 30, December 31, Salary and related expenses $ 8,455 $ 14,928 Accrued interest 2,396 2,396 Construction in progress 42 1,343 Other 3,037 7,539 Accrued expenses and other current liabilities $ 13,930 $ 26,206 |
Senior convertible notes (Table
Senior convertible notes (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Senior Convertible Notes | Senior convertible notes consist of the following (in thousands): June 30, December 31, 2015 notes Principal amount $ 100,000 $ 100,000 Unaccreted debt issuance expense (164 ) (645 ) Net carrying amount $ 99,836 $ 99,355 |
Accretion of Debt Issuance Expense | Accretion of debt issuance expense in connection with the 2015 notes during the three and six months ended June 30, 2015 and 2014 were as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Accretion expense $ 243 $ 227 $ 481 $ 450 |
Fair Value of Financial Instr27
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Summary of Carrying Values and Estimated Fair Values of Notes and Facility Financing Obligation | The following is a summary of the carrying values and estimated fair values of the 2015 notes and the facility financing obligation (i.e., the 2019 notes and Tranche B notes) (in millions): June 30, 2015 December 31, 2014 Carrying Estimated Carrying Estimated 2015 notes $ 99.8 $ 103.2 $ 99.4 $ 102.9 Facility financing obligation $ 73.8 $ 77.9 $ 73.0 $ 75.1 |
Accounting for stock-based co28
Accounting for stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Stock-Based Compensation Expense | Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2015 and 2014 was as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Stock-based compensation $ 1,775 $ 40,644 $ 3,778 $ 51,583 |
Facility Agreement (Tables)
Facility Agreement (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Accretion of Debt Issuance Cost and Debt Discount | Accretion of debt issuance cost and debt discount in connection with the Facility financing agreement during the three and six months ended June 30, 2015 and 2014 are as follows (in thousands): Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Accretion expense- debt issuance cost $ 9 $ 27 $ 17 $ 309 Accretion expense – debt discount $ 380 $ 516 $ 745 $ 6,883 |
Description of Business and B30
Description of Business and Basis of Presentation - Additional Information (Detail) - USD ($) $ in Thousands, shares in Millions | Aug. 10, 2015 | Aug. 10, 2015 | Aug. 11, 2014 | Apr. 30, 2015 | Mar. 31, 2015 | Sep. 30, 2014 | Jun. 30, 2015 | Dec. 31, 2014 | Sep. 23, 2014 | Jun. 30, 2014 | Dec. 31, 2013 | Aug. 18, 2010 |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Accumulated deficit | $ (2,554,353) | $ (2,494,784) | ||||||||||
Stockholders' deficit | (115,475) | (73,770) | ||||||||||
Cash and cash equivalents | 107,187 | 120,841 | $ 41,214 | $ 70,790 | ||||||||
Principal amount of outstanding debt | 244,900 | |||||||||||
Amount available for future borrowings | 30,100 | |||||||||||
Potential proceeds from the exercise of warrants from February 2012 public offering | 9,800 | |||||||||||
Proceeds from issuance of common stock pursuant to ATM issuance | 2,050 | |||||||||||
License and Collaboration Agreement with Sanofi | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Senior notes, effective interest rate | 8.50% | |||||||||||
Up-front fee | $ 150,000 | |||||||||||
Potential milestone payment | $ 725,000 | $ 725,000 | ||||||||||
Profits and losses sharing percentage | 35.00% | 35.00% | ||||||||||
Maximum secured loan facility | $ 175,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Profits and losses sharing percentage | 65.00% | 65.00% | ||||||||||
Maximum secured loan facility | $ 175,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Manufacturing Milestone Events | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Milestone payments earned | $ 50,000 | |||||||||||
ATM Agreements | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Proceeds from issuance of common stock pursuant to ATM issuance | $ 2,050 | |||||||||||
ATM Agreements | Maximum | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Offering price of common stock under agreement | 47,900 | |||||||||||
Senior convertible notes due August 15, 2015 | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Principal amount of outstanding debt | $ 100,000 | |||||||||||
Senior notes, effective interest rate | 5.75% | |||||||||||
Maturity date | Aug. 15, 2015 | |||||||||||
Principal amount | $ 100,000 | $ 100,000 | $ 100,000 | |||||||||
Senior convertible notes due August 15, 2015 | Subsequent Event | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Number of shares issued up on conversion of debt | 1.9 | 1.9 | ||||||||||
Principal amount of debt converted | $ 8,000 | $ 8,000 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Senior notes, effective interest rate | 9.75% | |||||||||||
Principal amount | $ 60,000 | |||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Senior notes, effective interest rate | 8.75% | |||||||||||
Principal amount | $ 20,000 | |||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Minimum | Facility Agreement | Less portion of commitment asset | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Available amount of credit facility under covenant restrictions | $ 25,000 | |||||||||||
Senior convertible notes due August 15, 2018 | Subsequent Event | ||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | ||||||||||||
Senior notes, effective interest rate | 5.75% | 5.75% | ||||||||||
Maturity date | Aug. 15, 2018 | |||||||||||
Principal amount | $ 27,700 | $ 27,700 |
Components of Inventories (Deta
Components of Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Inventory [Line Items] | ||
Raw materials | $ 16,038 | $ 4,856 |
Work-in-process | 3,757 | 4,719 |
Finished goods | 21 | 95 |
Total inventories | $ 19,816 | $ 9,670 |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 317,022 | $ 310,348 |
Less accumulated depreciation and amortization | (123,154) | (118,221) |
Property and equipment - net | 193,868 | 192,127 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | 5,273 | 5,273 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 54,948 | 54,948 |
Buildings | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 39 years | |
Buildings | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 40 years | |
Building Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 131,300 | 114,131 |
Building Improvements | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Building Improvements | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 40 years | |
Machinery and Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 102,996 | 80,919 |
Machinery and Equipment | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Machinery and Equipment | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 15 years | |
Furniture, fixtures and office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 5,015 | 5,015 |
Furniture, fixtures and office equipment | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 5 years | |
Furniture, fixtures and office equipment | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 10 years | |
Computer Equipment and Software | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Property and equipment - gross | $ 10,355 | 10,465 |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 4 years | |
Property and equipment - gross | $ 17 | 17 |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 7,118 | $ 39,580 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2015 | |
Depreciation and Other Amortization Expenses [Line Items] | |
Amortization period of lease hold improvements | 4 years |
Depreciation and Amortization E
Depreciation and Amortization Expense Related to Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation and amortization expense | $ 2,740 | $ 2,449 | $ 5,117 | $ 4,972 |
Accrued Expenses and Other Cu35
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Accrued Expenses and Other Current Liabilities [Line Items] | ||
Salary and related expenses | $ 8,455 | $ 14,928 |
Accrued interest | 2,396 | 2,396 |
Construction in progress | 42 | 1,343 |
Other | 3,037 | 7,539 |
Accrued expenses and other current liabilities | $ 13,930 | $ 26,206 |
Related-Party Arrangements - Ad
Related-Party Arrangements - Additional Information (Detail) - USD ($) | 1 Months Ended | 6 Months Ended | |
Oct. 31, 2013 | Oct. 31, 2007 | Jun. 30, 2015 | |
Related Party Transaction [Line Items] | |||
Amount available for future borrowings | $ 30,100,000 | ||
Additional borrowings | 0 | ||
Principal stockholder | |||
Related Party Transaction [Line Items] | |||
Loan agreement with related party | $ 370,000,000 | $ 350,000,000 | |
Principal stockholder | Amended Agreement | |||
Related Party Transaction [Line Items] | |||
Maturity date | Jan. 5, 2020 | ||
Principal stockholder | Loan Arrangement | |||
Related Party Transaction [Line Items] | |||
Principal amount outstanding under credit facility | 49,500,000 | ||
Amount available for future borrowings | $ 30,100,000 | ||
Fixed borrowing rate | 5.84% | ||
Interest payable | $ 4,900,000 | ||
Related party transaction prepayment period | 90 days | ||
Aggregate principal amount cancelled | $ 105,000,000 | ||
Principal stockholder | Loan Arrangement | Maximum | |||
Related Party Transaction [Line Items] | |||
Amount prepaid for cancellation of indebtedness | $ 200,000,000 | ||
Principal stockholder | Loan Arrangement | Minimum | |||
Related Party Transaction [Line Items] | |||
Number of months advances outstanding | 12 months | ||
Related Party Debt | Letter Agreement | |||
Related Party Transaction [Line Items] | |||
Description of variable rate interest | The interest rate will increase to the one-year LIBOR calculated on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum. | ||
Related Party Debt | Letter Agreement | LIBOR | |||
Related Party Transaction [Line Items] | |||
Interest rate (LIBOR) | 5.00% |
Summary of Senior Convertible N
Summary of Senior Convertible Notes (Detail) - Entity [Domain] - Senior convertible notes due August 15, 2015 - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 | Aug. 18, 2010 |
Debt Instrument [Line Items] | |||
Principal amount | $ 100,000 | $ 100,000 | $ 100,000 |
Unaccreted debt issuance expense | (164) | (645) | |
Net carrying amount | $ 99,836 | $ 99,355 |
Senior Convertible Notes - Addi
Senior Convertible Notes - Additional Information (Detail) $ / shares in Units, $ in Thousands | Aug. 18, 2010USD ($)d$ / shares | Jun. 30, 2015USD ($) | Dec. 31, 2014USD ($) |
Senior convertible notes due August 15, 2015 | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 100,000 | $ 100,000 | $ 100,000 |
Accrued interest payable | $ 2,400 | $ 2,400 | |
No of convertible shares | 147.0859 | ||
Principal amount per share | $ / shares | $ 1,000 | ||
Conversion price of shares | $ / shares | $ 6.80 | ||
Percentage of repurchase price | 100.00% | ||
Percentage of conversion price equaling stock price | 150.00% | ||
Number of trading days | d | 20 | ||
Consecutive trading days | 30 days | ||
Debt Issuance Cost | $ 4,200 | ||
Senior notes, effective interest rate | 5.75% | ||
Senior convertible notes due December 31, 2019 | Deerfield | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 60,000 | ||
Senior notes, effective interest rate | 9.75% | ||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | |||
Debt Instrument [Line Items] | |||
Principal amount | $ 20,000 | ||
Senior notes, effective interest rate | 8.75% |
Accretion of Debt Issuance Expe
Accretion of Debt Issuance Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Debt Instrument [Line Items] | ||||
Accretion expense | $ 243 | $ 227 | $ 481 | $ 450 |
Collaborative Arrangement - Add
Collaborative Arrangement - Additional Information (Detail) - Entity [Domain] $ in Thousands | Aug. 10, 2015USD ($) | Jul. 28, 2015USD ($) | Sep. 23, 2014USD ($) | Aug. 11, 2014USD ($) | Mar. 31, 2015USD ($)Contract | Sep. 30, 2014USD ($) | Jun. 30, 2015USD ($) |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred cost | $ 10,831 | ||||||
License and Collaboration Agreement with Sanofi | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Up-front fee | $ 150,000 | ||||||
Potential milestone payment | $ 725,000 | $ 725,000 | |||||
Profits and losses sharing percentage | 35.00% | 35.00% | |||||
Maximum secured loan facility | $ 175,000 | ||||||
Senior notes, effective interest rate | 8.50% | ||||||
Prepayment of loan percentage of net cash proceeds sale | 100.00% | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Profits and losses sharing percentage | 65.00% | 65.00% | |||||
Deferred revenue from collaboration product shipments | $ 150,000 | ||||||
Milestone receivable | 50,000 | ||||||
Deferred cost | 10,800 | ||||||
Loss sharing amount reclassified to loan facility and loss share obligation | $ 12,400 | 12,800 | |||||
Maximum secured loan facility | 175,000 | ||||||
Secured loan facility, amount borrowed | 15,600 | ||||||
Paid-in-kind interest | 200 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | Subsequent Event | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Secured loan facility, amount borrowed | $ 12,800 | ||||||
Secured loan facility, amount owed | $ 28,400 | ||||||
Paid-in-kind interest | $ 200 | ||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | AFREZZA product sales | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Deferred revenue from collaboration product shipments | $ 13,400 | ||||||
License and Collaboration Agreement with Sanofi | Manufacturing Milestone Events | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Milestone payments earned | $ 50,000 | ||||||
Number of milestones achieved | Contract | 2 | ||||||
License and Collaboration Agreement with Sanofi | Development Milestone Event | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | $ 25,000 | ||||||
License and Collaboration Agreement with Sanofi | Regulatory Approvals | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | 50,000 | ||||||
License and Collaboration Agreement with Sanofi | Product Sales Milestones | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Potential milestone payment | $ 650,000 |
Fair Value of Financial Instr41
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) | 6 Months Ended | |||||
Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Sep. 23, 2014 | Dec. 31, 2013 | Jul. 01, 2013 | |
Fair Value of Financial Instruments [Line Items] | ||||||
Cash and cash equivalents | $ 107,187,000 | $ 41,214,000 | $ 120,841,000 | $ 70,790,000 | ||
Cash equivalents, money market funds | 104,700,000 | $ 118,500,000 | ||||
Transfers of assets between fair value measurement | 0 | 0 | ||||
Transfers of liabilities between fair value measurement | 0 | $ 0 | ||||
License and Collaboration Agreement with Sanofi | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Maximum secured loan facility | $ 175,000,000 | |||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Maximum secured loan facility | 175,000,000 | |||||
Secured loan facility, amount borrowed | 15,600,000 | |||||
Paid-in-kind interest | 200,000 | |||||
Milestone Rights Liability | Deerfield | Maximum | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Contingent liability for milestone payments | $ 90,000,000 | |||||
Fair Value, Inputs, Level 3 | Milestone Rights Liability | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Fair value of Milestone Rights | $ 43,900,000 | |||||
Fair Value, Inputs, Level 3 | Income Approach Valuation Technique | Senior convertible notes due December 31, 2019 | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 12.00% | |||||
Fair Value, Inputs, Level 3 | Income Approach Valuation Technique | Milestone Rights Liability | ||||||
Fair Value of Financial Instruments [Line Items] | ||||||
Market discount rate | 15.50% |
Summary of Carrying Values and
Summary of Carrying Values and Estimated Fair Values of Notes and Facility Financing Obligation (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Senior convertible notes due August 15, 2015 | ||
Convertible Debt [Line Items] | ||
Carrying value | $ 99,836 | $ 99,355 |
Estimated fair value | 103,200 | 102,900 |
Facility financing obligation | ||
Convertible Debt [Line Items] | ||
Carrying value | 73,800 | 73,000 |
Estimated fair value | $ 77,900 | $ 75,100 |
Common and Preferred Stock - Ad
Common and Preferred Stock - Additional Information (Detail) - Entity [Domain] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | ||
Jun. 30, 2015 | Dec. 31, 2014 | Aug. 18, 2010 | |
Class of Stock [Line Items] | |||
Common stock loaned under share lending agreement, shares | 9,000,000 | 9,000,000 | |
Nominal lending fee | $ 0.01 | ||
Senior convertible notes due August 15, 2015 | |||
Class of Stock [Line Items] | |||
Principal amount | $ 100,000 | $ 100,000 | $ 100,000 |
Stock-Based Compensation Expens
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation | $ 1,775 | $ 40,644 | $ 3,778 | $ 51,583 |
Accounting for Stock- Based Com
Accounting for Stock- Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of restricted stock units issued | 194,704 | 36,300 | |
Number of stock options issued | 208,000 | 73,600 | |
Weighted average vesting period for unrecognized compensation cost | 2 years 7 months 6 days | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based payment award , vesting period | 4 years | 4 years | |
Fair value of the stock options granted , value | $ 603,802 | $ 382,720 | |
Weighted average grant date fair value of the stock options granted | $ 2.90 | $ 5.20 | |
Unrecognized compensation cost related to non vested stock options | $ 7,300,000 | $ 7,300,000 | |
Restricted Stock Units (RSUs) | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Fair value of Restricted stock options granted , value | $ 901,480 | $ 262,086 | |
Weighted average grant date fair value of the stock options granted | $ 4.63 | $ 7.22 | |
Unrecognized compensation cost related to non vested stock options | $ 8,600,000 | $ 8,600,000 |
Net Loss per Common Share - Add
Net Loss per Common Share - Additional Information (Detail) - shares | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Net Income Loss Per Common Share [Line Items] | ||
Companies common stock share outstanding | 9,000,000 | |
Antidilutive securities | 40,982,544 | 56,844,341 |
Shares loaned under the share lending arrangement | 9,000,000 | 9,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions, $ in Millions | Jul. 31, 2014EUR (€) | Jul. 01, 2013USD ($) |
Commitments and Contingencies [Line Items] | ||
Purchase commitment amount under Insulin Supply Agreement | € | € 120.1 | |
Deerfield | Milestone Rights Liability | Maximum | ||
Commitments and Contingencies [Line Items] | ||
Contingent liability for milestone payments | $ 90 |
Facility Agreement - Additional
Facility Agreement - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2015 | Mar. 31, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | Jul. 01, 2013 | |
Debt Instrument [Line Items] | |||||||
Short term liability | $ 73,757 | $ 73,757 | $ 72,995 | ||||
Interest expense on notes | 4,131 | $ 2,429 | $ 13,753 | $ 6,471 | |||
Deerfield | |||||||
Debt Instrument [Line Items] | |||||||
Principal repayment schedule, start date | Jul. 1, 2016 | ||||||
Principal repayment schedule, end date | Dec. 9, 2019 | ||||||
Deerfield | Milestone Rights Liability | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Contingent liability for milestone payments | $ 90,000 | ||||||
Deerfield | Senior convertible notes due December 31, 2019 | |||||||
Debt Instrument [Line Items] | |||||||
Debt facility principal amount | $ 60,000 | $ 60,000 | |||||
Senior notes, effective interest rate | 9.75% | 9.75% | |||||
Deerfield | Senior convertible notes due December 31, 2019 | Less portion of commitment asset | |||||||
Debt Instrument [Line Items] | |||||||
Debt facility principal amount | $ 20,000 | $ 20,000 | |||||
Senior notes, effective interest rate | 8.75% | 8.75% | |||||
Deerfield | Senior convertible notes due December 31, 2019 | Less portion of commitment asset | Minimum | Facility Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Available amount of credit facility under covenant restrictions | $ 25,000 | $ 25,000 | |||||
Deerfield | Senior convertible notes due December 31, 2019 | Milestone Rights Liability | |||||||
Debt Instrument [Line Items] | |||||||
Short term liability | 1,600 | 1,600 | 3,200 | ||||
Long term liability | $ 7,300 | $ 7,300 | $ 13,100 | ||||
Interest expense on notes | $ 5,800 | ||||||
Required payment pursuant to the terms of the Milestone Agreement | $ 10,000 |
Accretion of Debt Issuance Cost
Accretion of Debt Issuance Cost and Debt Discount in Connection with Deerfield Financing (Detail) - Deerfield - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Debt Instrument [Line Items] | ||||
Accretion expense- debt issuance cost | $ 9 | $ 27 | $ 17 | $ 309 |
Accretion expense - debt discount | $ 380 | $ 516 | $ 745 | $ 6,883 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Entity [Domain] $ / shares in Units, $ in Thousands, shares in Millions | Aug. 10, 2015USD ($)$ / sharesshares | Aug. 10, 2015USD ($)d$ / sharesshares | Jul. 28, 2015USD ($) | Aug. 18, 2010USD ($)d$ / shares | Jun. 30, 2015USD ($) | Jun. 30, 2014USD ($) | Dec. 31, 2014USD ($) | Sep. 23, 2014 |
Subsequent Event [Line Items] | ||||||||
Aggregate principal amount for conversion | $ 93,500 | |||||||
License and Collaboration Agreement with Sanofi | ||||||||
Subsequent Event [Line Items] | ||||||||
Senior notes, effective interest rate | 8.50% | |||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | ||||||||
Subsequent Event [Line Items] | ||||||||
Secured loan facility, amount borrowed | $ 15,600 | |||||||
Subsequent Event | License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmnH | ||||||||
Subsequent Event [Line Items] | ||||||||
Secured loan facility, amount borrowed | $ 12,800 | |||||||
Senior convertible notes due August 15, 2018 | Subsequent Event | ||||||||
Subsequent Event [Line Items] | ||||||||
Principal amount | $ 27,700 | $ 27,700 | ||||||
Senior notes, effective interest rate | 5.75% | 5.75% | ||||||
Maturity date | Aug. 15, 2018 | |||||||
No of convertible shares | 147.0859 | |||||||
Principal amount per share | $ / shares | $ 1,000 | |||||||
Conversion price of shares | $ / shares | $ 6.80 | $ 6.80 | ||||||
Percentage of repurchase price | 100.00% | |||||||
Debt Instrument, redemption description | On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. | |||||||
Percentage of conversion price equaling stock price | 130.00% | |||||||
Number of trading days | d | 20 | |||||||
Consecutive trading days | 30 days | |||||||
Senior convertible notes due August 15, 2015 | ||||||||
Subsequent Event [Line Items] | ||||||||
Principal amount | $ 100,000 | $ 100,000 | $ 100,000 | |||||
Senior notes, effective interest rate | 5.75% | |||||||
Maturity date | Aug. 15, 2015 | |||||||
No of convertible shares | 147.0859 | |||||||
Principal amount per share | $ / shares | $ 1,000 | |||||||
Conversion price of shares | $ / shares | $ 6.80 | |||||||
Percentage of repurchase price | 100.00% | |||||||
Percentage of conversion price equaling stock price | 150.00% | |||||||
Number of trading days | d | 20 | |||||||
Consecutive trading days | 30 days | |||||||
Long term note payable | $ 27,700 | |||||||
Senior convertible notes due August 15, 2015 | Issuance Of Common Stock In Exchange For 2015 Notes | ||||||||
Subsequent Event [Line Items] | ||||||||
Long term note payable | $ 8,000 | |||||||
Senior convertible notes due August 15, 2015 | Subsequent Event | ||||||||
Subsequent Event [Line Items] | ||||||||
Conversion price of shares | $ / shares | $ 4.40 | $ 4.40 | ||||||
Long term note payable | $ 64,300 | $ 64,300 | ||||||
Aggregate principal amount for conversion | $ 61,800 | |||||||
Number of shares issued up on conversion of debt | shares | 1.9 | 1.9 | ||||||
Principal amount of debt converted | $ 8,000 | $ 8,000 |