Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 01, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
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 | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 104,682,717 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 43,384 | $ 22,895 |
Accounts receivable, net | 1,312 | 302 |
Receivable from Sanofi | 30,557 | |
Inventory | 3,172 | 2,331 |
Asset held for sale | 16,730 | |
Deferred costs from commercial product sales | 500 | 309 |
Prepaid expenses and other current assets | 2,563 | 4,364 |
Total current assets | 50,931 | 77,488 |
Property and equipment-net | 27,920 | 28,927 |
Other assets | 523 | 648 |
Total assets | 79,374 | 107,063 |
Current liabilities: | ||
Accounts payable | 6,541 | 3,263 |
Accrued expenses and other current liabilities | 9,076 | 7,937 |
Facility financing obligation | 57,484 | 71,339 |
Deferred revenue-net | 2,592 | 3,419 |
Deferred payments from collaboration-current | 250 | 1,000 |
Recognized loss on purchase commitments-current | 9,926 | 5,093 |
Total current liabilities | 85,869 | 92,051 |
Note payable to principal stockholder | 79,666 | 49,521 |
Accrued interest-note payable to principal stockholder | 9,281 | |
Senior convertible notes | 27,649 | 27,635 |
Recognized loss on purchase commitments-long term | 99,001 | 95,942 |
Deferred payments from collaboration-long term | 625 | |
Warrant liability | 605 | 7,381 |
Milestone rights liability and other liabilities | 7,202 | 8,845 |
Total liabilities | 300,617 | 290,656 |
Commitments and contingencies (Note 11) | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value-10,000,000 shares authorized; no shares issued or outstanding at June 30, 2017 and December 31, 2016 | ||
Common stock, $0.01 par value-140,000,000 shares authorized, 104,615,982 and 95,680,831 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 1,046 | 957 |
Additional paid-in capital | 2,566,960 | 2,553,039 |
Accumulated other comprehensive loss | (21) | (24) |
Accumulated deficit | (2,789,228) | (2,737,565) |
Total stockholders' deficit | (221,243) | (183,593) |
Total liabilities and stockholders' deficit | $ 79,374 | $ 107,063 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
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 | 140,000,000 | 140,000,000 |
Common stock, shares issued | 104,615,982 | 95,680,831 |
Common stock, shares outstanding | 104,615,982 | 95,680,831 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenues: | ||||
Net revenue-commercial product sales | $ 1,548 | $ 2,745 | ||
Net revenue-collaboration | 63 | 125 | ||
Revenue-other | 552 | 2,302 | ||
Total revenues | 2,163 | 5,172 | ||
Expenses: | ||||
Cost of goods sold | 5,086 | $ 4,045 | 7,635 | $ 9,213 |
Research and development | 3,123 | 4,310 | 6,251 | 9,440 |
Selling, general and administrative | 18,566 | 11,110 | 33,956 | 18,460 |
Property and equipment impairment | 111 | 111 | ||
(Gain) loss on foreign currency translation | 6,848 | (341) | 8,392 | 2,023 |
Total expenses | 33,734 | 19,124 | 56,345 | 39,136 |
Loss from operations | (31,571) | (19,124) | (51,173) | (39,136) |
Other income (expense): | ||||
Change in fair value of warrant liability | 147 | (5,306) | 6,776 | (5,306) |
Interest income | 58 | 26 | 114 | 41 |
Interest expense on notes | (2,422) | (4,181) | (5,128) | (8,401) |
Interest expense on note payable to principal stockholder | (721) | (721) | (1,435) | (1,443) |
Loss on extinguishment of debt | (830) | (830) | ||
Other income | (653) | 13 | (586) | |
Total other expense | (3,768) | (10,835) | (490) | (15,695) |
Loss before benefit for income taxes | (35,339) | (29,959) | (51,663) | (54,831) |
Income tax benefit | 0 | 0 | 0 | 0 |
Net loss | $ (35,339) | $ (29,959) | $ (51,663) | $ (54,831) |
Net loss per share-basic and diluted | $ (0.35) | $ (0.33) | $ (0.53) | $ (0.62) |
Shares used to compute basic and diluted net loss per share | 99,864 | 91,061 | 97,816 | 88,416 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Net loss | $ (35,339) | $ (29,959) | $ (51,663) | $ (54,831) |
Other comprehensive loss: | ||||
Cumulative translation gain (loss) | 3 | (2) | 3 | (1) |
Comprehensive loss | $ (35,336) | $ (29,961) | $ (51,660) | $ (54,832) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (51,663) | $ (54,831) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation, amortization and accretion | 1,787 | 2,058 |
Stock-based compensation expense | 2,516 | 2,628 |
Loss on extinguishment of debt | 830 | |
Gain on disposal of property and equipment | (24) | |
Loss on foreign currency translation | 8,392 | 2,023 |
Interest incurred through borrowings under Sanofi Loan Facility | 2,604 | |
Interest on note payable to principal stockholder | 1,435 | 1,443 |
Warrant issuance cost | 653 | |
Change in fair value of warrant liability | (6,776) | 5,306 |
Other, net | 114 | 717 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (1,010) | 23 |
Receivable from Sanofi | 30,557 | |
Inventory | (841) | (2,866) |
Deferred costs from commercial product sales | (191) | |
Prepaid expenses and other current assets | 1,800 | 2,595 |
Other assets | 125 | (238) |
Accounts payable | 3,357 | (12,532) |
Accrued expenses and other current liabilities | (483) | 2,663 |
Deferred payments from collaboration | (125) | 9,379 |
Deferred revenue-net | (827) | |
Recognized loss on purchase commitments | (500) | (3,892) |
Net cash used in operating activities | (11,527) | (42,267) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property and equipment | (1,144) | |
Net proceeds from sale of asset held for sale | 16,651 | |
Proceeds from sale of property and equipment | 24 | 17 |
Net cash provided by (used in) investing activities | 16,675 | (1,127) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock | 734 | |
Proceeds from direct placement | 50,000 | |
Issuance cost associated with direct placement | (2,678) | |
Borrowings on note payable to principal stockholder | 19,429 | |
Principal payments on facility financing obligation | (4,000) | |
Payment of employment taxes related to vested restricted stock units | (88) | (3) |
Net cash provided by financing activities | 15,341 | 48,053 |
NET INCREASE IN CASH AND CASH EQUIVALENTS | 20,489 | 4,659 |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 22,895 | 59,074 |
CASH AND CASH EQUIVALENTS, END OF PERIOD | 43,384 | 63,733 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ||
Interest paid in cash, net of amounts capitalized | 4,141 | 4,608 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Repayment of facility financing obligation through issuance of common stock | 11,000 | |
Capitalization of interest on note payable to principal stockholder | $ 10,716 | |
Reclassification of deferred payments from collaboration to Sanofi Loan Facility and loss share obligation | 5,003 | |
Reclassification of deferred costs from loss on purchase commitment to deferred costs from collaboration | $ 9,202 |
Description of Business and Sig
Description of Business and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Description of Business and Significant Accounting Policies | 1. Description of Business and Significant Accounting Policies 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, 2016 filed with the SEC on March 16, 2017 (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, 2017 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. Management considers many factors in selecting appropriate financial accounting policies, and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. The more significant estimates reflected in these accompanying condensed consolidated financial statements include revenue recognition, assessing long-lived assets and deferred product costs for impairment, accrued expenses, inventory recoverability, valuation of the facility financing obligation, loss on purchase commitments, warrant liability, milestone rights, 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 On August 11, 2014, the Company executed a license and collaboration agreement (the “Sanofi License Agreement”) with Sanofi-Aventis Deutschland GmbH, which subsequently assigned its rights and obligations under the agreement to Sanofi-Aventis U.S. LLC (“Sanofi”), pursuant to which Sanofi was responsible for global commercial, regulatory and development activities for Afrezza. On January 4, 2016, the Company received written notification from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. The effective date of termination was April 4, 2016, which was when the Company assumed responsibility for worldwide development and commercialization of Afrezza. Under the terms of the transition agreement, Sanofi continued to fulfill orders for Afrezza in the United States until the Company began distributing MannKind-branded Afrezza product to major wholesalers in late July 2016. The Company began recognizing commercial product sales revenue when MannKind-branded Afrezza was dispensed from pharmacies to patients in August 2016. On November 9, 2016, the Company entered into a settlement agreement with Sanofi (the “Settlement Agreement”). Under the terms of the Settlement Agreement, the promissory note between the Company and Aventisub LLC (“Aventisub”), a Sanofi affiliate, was terminated with Aventisub agreeing to fully forgive the outstanding loan balance of $72.0 million. Sanofi also purchased $10.2 million of insulin from the Company in December 2016 under an existing insulin put option and made a cash payment of $30.6 million to the Company in early January 2017 as acceleration and in replacement of all other payments that Sanofi would otherwise have been required to make in the future pursuant to the insulin put option, without the Company being required to deliver any insulin for such payment. The Company was also relieved of its obligation to pay Sanofi $0.5 million in previously uncharged costs pursuant to the Sanofi License Agreement. The Company and Sanofi also agreed to a general release of potential claims against each other. During their initial transition of the commercial responsibilities from Sanofi in the second half of 2016, the Company utilized a contract sales organization to promote Afrezza while the Company focused its internal resources on establishing a channel strategy, entering into distribution agreements and developing co-pay assistance programs, a voucher program, data agreements and payor relationships. In early 2017, the Company recruited its own sales force to promote Afrezza to endocrinologists and certain high-prescribing primary care physicians. In the future, the Company may seek to supplement its sales force through a co-promotion arrangement – an agreement with a third party that has an underutilized primary care sales force, which can be used to promote Afrezza to greater number of primary care physicians. The Company’s current strategy for future commercialization of Afrezza outside of the United States, subject to receipt of the necessary foreign regulatory approvals, is to seek and establish partnerships in foreign jurisdictions where there are appropriate commercial opportunities. The Company has never been profitable or generated positive cash flow from cumulative operations to date. Historically, the Company has reported negative cash flow from operations other than for the nine months ended September 30, 2014, for the year ended December 31, 2014, and for the three months ended March 31, 2015 and 2017 as a result of non-recurring payments from Sanofi. As of June 30, 2017, the Company had an accumulated deficit of $2.8 billion. At June 30, 2017, the Company’s capital resources consisted of cash and cash equivalents of $43.4 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing and sales and marketing of Afrezza and the development of product candidates in the Company’s pipeline. The facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) that resulted in the issuance of 9.75% Senior Convertible Notes due 2019 (“2019 notes”) and the First Amendment to Facility Agreement and Registration Rights Agreement (the “First Amendment”) that resulted in the issuance of an additional tranche of 8.75% Senior Convertible Notes due 2019 (“Tranche B notes”) (see Note 6 — Borrowings) requires the Company to maintain at least $25.0 million in cash and cash equivalents or available borrowings under the loan arrangement, dated as of October 2, 2007, between the Company and The Mann Group LLC (“The Mann Group”) (as amended, restated, or otherwise modified as of the date hereof, “The Mann Group Loan Arrangement”), as of the last day of each fiscal quarter. On June 29, 2017, the Company entered into an Exchange and Third Amendment to Facility Agreement (the “Third Amendment”) with Deerfield which, among other things, amended such financial covenant to provide that, if certain conditions are met, then the obligation to maintain at least $25.0 million in cash as of the end of each quarter will be reduced to $10.0 million as of August 31, 2017, September 30, 2017, October 31, 2017 and December 31, 2017 (see Note 6 — Borrowings). On June 27, 2017, the Company borrowed the remaining $30.1 million principal amount available under The Mann Group Loan Arrangement, of which $19.4 million was received in cash and the remaining amount of $10.7 million representing accrued and unpaid interest as of June 30, 2017 was capitalized into borrowed principal (see Note 5 — Related-Party Arrangements). As a result, no additional funds remain available for borrowing under The Mann Group Loan Arrangement. On March 1, 2017, following stockholder approval, the Company’s board of directors approved a reverse stock split ratio of 1-for-5. On March 1, 2017, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment of the Company’s Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect the 1-for-5 reverse stock split of the Company’s outstanding common stock (the “Reverse Stock Split”) and to reduce the authorized number of shares of the Company’s common stock from 700,000,000 to 140,000,000 shares. The Company’s common stock began trading on the NASDAQ Global Market on a split-adjusted basis when the market opened on March 3, 2017. As a result, all common stock share amounts included in these condensed consolidated financial statements have been retroactively reduced by a factor of five, and all common stock per share amounts have been increased by a factor of five, with the exception of the Company’s common stock par value. On April 18, 2017, the Company entered into an Exchange Agreement with Deerfield resulting in the cash repayment of $4.0 million under the Tranche B notes and the conversion of $1.0 million and $5.0 million of the Tranche B notes and the 2019 notes, respectively, into shares of common stock. On June 29, 2017, the Company entered into the Third Amendment with Deerfield resulting in the conversion of $5.0 million of the 2019 notes into shares of common stock and deferment of the payment of $10.0 million of principal amount of the 2019 notes due July 18, 2017 to August 31, 2017, with an option for the Company to elect to further defer the payment of such principal amount from August 31, 2017 to October 31, 2017 upon the Company’s delivery on August 31, 2017 of a written certification to Deerfield that certain conditions have been met (see Note 6 — Borrowings). The Company will need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with another 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. The Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. Reclassifications Correction of an Immaterial Error (In thousands) 2016 as Adjustments 2016 as Common stock $ 4,784 $ (3,827 ) $ 957 Additional paid-in capital $ 2,549,212 $ 3,827 $ 2,553,039 Revenue Recognition Revenue Recognition – Net Revenue – Commercial Product Sales – Given the Company’s limited sales history for Afrezza, the Company cannot reliably estimate expected returns of the product at the time of shipment into the distribution channel. Accordingly, the Company defers recognition of revenue on Afrezza product shipments until the right of return no longer exists, which occurs at the earlier of the time Afrezza is dispensed from pharmacies to patients or expiration of the right of return. Deferred revenue is presented net of deferred product sales discounts which are further described in Gross-to-Net Adjustments For the three and six months ended June 30, 2017, net revenue from commercial product sales consisted of $1.5 million and $2.7 million of net sales of Afrezza dispensed to patients, respectively. As of June 30, 2017 and December 31, 2016, the ending balances for net deferred revenue, were $2.6 million and $3.4 million, on its condensed consolidated balance sheets of which $1.0 million and $0.8 million are gross-to-net revenue adjustments, respectively. The difference, as compared with December 31, 2016, represented deferred revenue from bulk insulin sales of approximately $1.7 million, which is described more fully under the heading Revenue Recognition – Revenue – Other Gross-to-net Adjustments – Wholesaler Distribution Fees – Prompt Pay Discounts – Rebates and Chargebacks – The Company accounts for these rebates and chargebacks by establishing an accrual based on contractual discount rates, expected utilization under each contract and an estimate of the amount of inventory in the distribution channel that will become subject to such rebates and chargebacks based on historical payor data provided by a third-party vendor along with additional data including forecasted participation rates. From that data, as well as input received from the commercial team, an estimated participation rate for each program is determined and applied at the rate for those sales. Any new information regarding changes in the programs’ regulations and guidelines or any changes in the Company’s government price reporting calculations that would impact the amount of the rebates will also be taken into account in determining or modifying the appropriate reserve. The time period between the date the product is sold into the channel and the date such rebates may be paid can be up to approximately six to nine months. As such, continuous monitoring of these estimates will be performed on a periodic basis, and if necessary, adjusted to reflect new facts and circumstances. Rebates and chargebacks are recognized as a reduction of gross revenue in the period the related revenue is recognized. Other Rebates and Discounts – Patient Discount and Co-Pay Assistance Programs – Deferred Costs from Commercial Product Sales Revenue Recognition – Net Revenue – Collaborations – Revenue Recognition — Revenue — Other Cost of Goods Sold Accounts Receivable and Allowances Inventories Recognized Loss on Purchase Commitments Fair Value of Financial Instruments Stock-Based Compensation Warrants Net Loss Per Share of Common Stock The computation of basic and diluted net loss per share for the three and six months ended June 30, 2017 and 2016 excludes the common stock equivalents of the following potentially dilutive securities because their inclusion would be anti-dilutive: Six Months Ended June 30, 2017 2016 Restricted stock units 1,193,100 910,751 Senior convertible notes 814,561 814,561 Warrants 9,740,597 9,740,597 Stock options 7,972,175 5,643,966 19,720,433 17,109,875 Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date The Company will adopt the new guidance for the year beginning January 1, 2018. The Company has the option to either apply the new guidance retrospectively for all prior reporting periods presented (full retrospective) or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (modified retrospective). The Company currently anticipates it will apply the new guidance using the modified retrospective approach with the cumulative effect of initial application recognized as of January 1, 2018. The Company plans to continue analyzing the potential impacts of the application throughout 2017 and, depending on factors that may impact the results, could elect to apply the new guidance on a full retrospective basis. Currently, for commercial sales of Afrezza, the Company has limited sales and returns history, and as such is unable to reliably estimate expected returns of the product at the time of shipment into the distribution channel. Accordingly, the Company defers recognition of revenue on Afrezza product shipments until the right of return no longer exists, which occurs at the earliest of the time Afrezza is dispensed from pharmacies to patients or expiration of the right of return. The Company recognizes revenue based on Afrezza patient prescriptions dispensed, a sell-through model, as estimated by syndicated data provided by a third party. The Company also analyzes additional data points to ensure that such third-party data is reasonable, including data related to inventory movements within the channel and ongoing prescription demand. Upon adoption of the new guidance, the Company expects that it will move from its current sell-through model to a sell-to model for revenue related to commercial sales of Afrezza and will record revenue at the time title and risk of loss passes to its distributors (generally at shipment or delivery to the distributors) along with an estimate of potential returns as variable consideration. The Company also anticipates that its ability to estimate potential returns will improve with an additional six months of sales history that it will have obtained by January 1, 2018. Additionally, the Company has historically entered into collaborative agreements with third-parties under which periodic payments have been received. Revenue recognition for certain payments received have been deferred until the price is fixed and determinable. Further, revenue for certain payments to be received in the future has been prohibited from recognition until received. The Company expects that some of these amounts will be considered variable consideration and may be able to be recognized earlier under the new guidance. The financial impact upon the adoption will be dependent upon a number of factors, including the amount of revenue that has been deferred under the sell-through model for Afrezza, the amount of the revenue deferred under collaborative arrangements and the Company’s estimate of variable consideration at the date of adoption. At this time, the Company has not completed its evaluation of the inputs, assumptions and methodologies that will be used to recognize revenue related to variable consideration under the new guidance. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments Overall (Subtopic 825-10) Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 84 In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting. ASC 718 ASU 2017-09 In July 2017, the FASB issued ASU No. 2017-11, Earnings per Share (Topic 260) and Derivatives and Hedging (Topic 815): Accounting for Certain Financial Instruments with Down Round Provisions. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2017 | |
Inventory | 2. Inventory Inventory consists of the following (in thousands): June 30, 2017 December 31, 2016 Raw materials $ 431 $ — Work-in-process 2,391 2,120 Finished goods 350 211 Total inventory $ 3,172 $ 2,331 Work-in-process and finished goods as of June 30, 2017 and December 31, 2016 include conversion costs but not materials cost because the materials used in its production were previously written off. During the three and six months ended June 30, 2017, the Company recorded a write-down of inventory of approximately $1.5 million for inventory that was forecasted to become obsolete due to expiration which is recorded in costs of goods sold in the accompanying condensed consolidated statements of operations. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2017 | |
Property and Equipment | 3. Property and Equipment Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) June 30, 2017 December 31, 2016 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 34,957 34,957 Machinery and equipment 3-15 62,992 62,992 Furniture, fixtures and office equipment 5-10 3,556 3,556 Computer equipment and software 3 8,531 8,531 Construction in progress — 91 202 128,391 128,502 Less accumulated depreciation (100,471 ) (99,575 ) Total property and equipment, net $ 27,920 $ 28,927 Depreciation expense related to property and equipment for the three and six months ended June 30, 2017 and 2016 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Depreciation expense $ 450 $ 589 $ 896 $ 1,179 Management evaluated certain equipment that was not yet in service and determined that since the equipment was not being used and there was no current estimated date for installation and therefore no future cash flows associated with the equipment, a write-down of construction in progress of approximately $0.1 million was recorded during the three and six months ended June 30, 2017. The Company did not record any impairment charges for the three and six months ended June 30, 2016. On January 6, 2017, the Company and Rexford Industrial Realty, L.P. (“Rexford”) entered into an Agreement of Purchase and Sale and Joint Escrow Instructions (the “Purchase Agreement”), pursuant to which the Company agreed to sell and Rexford agreed to purchase certain parcels of real estate owned by the Company in Valencia, California and certain related improvements, personal property, equipment, supplies and fixtures (collectively, the “Property”) for $17.3 million. The sale and purchase of the Property for $17.3 million pursuant to the terms of the Purchase Agreement, as amended, was completed on February 17, 2017. Net proceeds were $16.7 million after deducting broker’s commission and other fees of approximately $0.6 million paid by the Company. Net proceeds received approximated the carrying value of the asset held for sale. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
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, 2017 December 31, 2016 Salary and related expenses $ 3,729 $ 3,814 Current portion of milestone rights liability 1,643 — Professional fees 968 875 Discounts and allowances for commercial product sales 1,036 754 Sales and marketing services 218 144 Restructuring 362 1,376 Accrued interest 624 619 Other 496 355 Accrued expenses and other current liabilities $ 9,076 $ 7,937 |
Related-Party Arrangements
Related-Party Arrangements | 6 Months Ended |
Jun. 30, 2017 | |
Related-Party Arrangements | 5. Related-Party Arrangements In October 2007, the Company entered into The Mann Group Loan Arrangement, which has been amended from time to time. On October 31, 2013, the promissory note underlying The Mann Group Loan Arrangement was amended to, among other things, extend the maturity date of the loan to January 5, 2020, extend the date through which the Company can borrow under The Mann Group Loan Arrangement to December 31, 2019, increase the aggregate borrowing amount under The Mann Group Loan Arrangement from $350.0 million to $370.0 million and provide that repayments or cancellations of principal under The Mann Group Loan Arrangement will not be available for reborrowing. On June 27, 2017, the Company entered into an agreement with The Mann Group, pursuant to which the parties agreed to, among other things, (i) capitalize $10.7 million of accrued and unpaid interest as of June 30, 2017, resulting in such amount being classified as outstanding principal under The Mann Group Loan Arrangement; (ii) advance to the Company approximately $19.4 million of cash, the remaining amount available for borrowing by the Company under The Mann Group Loan Arrangement after the foregoing capitalization of accrued and unpaid interest; and (iii) defer all interest payable on the outstanding principal until July 1, 2018, unless such payments are otherwise permitted under the subordination agreement with Deerfield, and subject to further deferral pursuant to the terms of the subordination agreement with Deerfield which terms are more fully disclosed below. 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. The Mann Group can require the Company to prepay up to $200.0 million in advances that have been outstanding for at least 12 months, less approximately $105.0 million aggregate principal amount that has been cancelled in connection with two common stock purchase agreements. If The Mann Group exercises this right, the Company will have 90 days after The Mann Group provides written notice, or the number of days to maturity of the note if less than 90 days, to prepay such advances. However, pursuant to a letter agreement entered into in August 2010, The Mann Group has agreed to not require the Company to prepay amounts outstanding under the amended and restated promissory note if the prepayment would require the Company to use its working capital resources. In addition, The Mann Group entered into a subordination agreement with Deerfield pursuant to which The Mann Group agreed with Deerfield not to demand or accept any payment under The Mann Group Loan Arrangement until the Company’s payment obligations to Deerfield under the Facility Agreement have been satisfied in full. Subject to the foregoing, in the event of a default under The Mann Group Loan Arrangement, all unpaid principal and interest either becomes immediately due and payable or may be accelerated at The Mann Group’s option, and the interest rate will increase to the one-year LIBOR calculated on the date of the initial advance or in effect on the date of default, whichever is greater, plus 5% per annum. All borrowings under The Mann Group Loan Arrangement are unsecured. The Mann Group Loan Arrangement contains no financial covenants. As of June 30, 2017 and December 31, 2016, the total principal amount outstanding under The Mann Group Loan Arrangement was $79.7 million and $49.5 million, respectively. As of June 30, 2017, there was no accrued or unpaid interest as a result of all unpaid accrued interest being capitalized pursuant to the June 27, 2017 agreement with The Mann Group. As of December 31, 2016, the Company had accrued and unpaid interest related to the above note of $9.3 million. Interest expense on the Company’s note payable to the Company’s principal stockholder for the three and six months ended June 30, 2017 and 2016 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Interest expense on note payable to principal stockholder $ 721 $ 721 $ 1,435 $ 1,443 In May 2015, the Company entered into a sublease agreement with the Alfred Mann Foundation for Scientific Research (the “Mann Foundation”), a California not-for-profit corporation. The lease was for approximately 12,500 square feet of office space in Valencia, California, which expired in April 2017 and has been renewed on a month-to-month basis at a rate of $20,000 per month, which is expected to expire on August 31, 2017 when the Company moves into its new corporate headquarters (see Note 11). The office space contains the Company’s principal executive offices. Lease payments to the Mann Foundation for the three and six months ended June 30, 2017 and 2016 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Lease payments $ 60 $ 67 $ 122 $ 133 The Company has entered into indemnification agreements with each of its directors and executive officers, in addition to the indemnification provided for in its amended and restated certificate of incorporation and amended and restated bylaws (see Note 11 — Commitments and Contingencies). |
Borrowings
Borrowings | 6 Months Ended |
Jun. 30, 2017 | |
Borrowings | 6. Borrowings Borrowings consist of the following (in thousands): June 30, 2017 December 31, 2016 Facility Financing Obligation (2019 Notes) Principal amount $ 60,000 $ 75,000 Unamortized debt discount (2,516 ) (3,661 ) Net carrying amount $ 57,484 $ 71,339 Senior Convertible Notes (2018 Notes) Principal amount $ 27,690 $ 27,690 Unamortized premium 306 426 Unaccreted debt issuance costs (347 ) (481 ) Net carrying amount $ 27,649 $ 27,635 Note payable to principal stockholder—net carrying amount $ 79,666 $ 49,521 Facility Financing Obligation (2019 Notes) The Company evaluated the transaction and determined that since the principal amount being repaid and exchanged under the Tranche B notes and the principal amount being exchanged under the 2019 notes represents the principal amount that would have otherwise become due and payable in May and July of 2017 under the Tranche B Notes and 2019 notes, respectively, the extinguishment of the May and July 2017 payments was not considered to be a troubled debt restructuring. Accordingly, the Company accounted for the transaction by recording a loss on extinguishment of debt of $0.3 million for the three and six months ended June 30, 2017 which was calculated as the difference between the reacquisition price and the net carrying value of the related debt. The net carrying value of the related debt includes the acceleration of the debt discount and issuance costs amounting to approximately $8,000 as a result of the transaction. The reacquisition price was calculated using the $4.0 million cash repayment and the fair value of the April Exchange Shares on April 18, 2017. The fair value of the April Exchange Shares was determined to be $1.22 per share representing the closing trading price of the Company’s common stock on The NASDAQ Global Market on April 18, 2017. On June 29, 2017, the Company entered into the Third Amendment with Deerfield, pursuant to which the Company agreed to, among other things, (i) exchange $5.0 million principal amount under the 2019 notes for 3,584,230 shares of the Company’s common stock (the “June Exchange Shares”) at an exchange price of $1.395 per share and (ii) amend the Facility Agreement with Deerfield, to (A) defer the payment of $10.0 million in principal amount of the 2019 notes from the original July 18, 2017 due date to August 31, 2017, with an option for the Company to elect to further defer the payment of such principal amount from August 31, 2017 to October 31, 2017 upon the Company’s delivery on August 31, 2017 of a written certification to Deerfield that certain conditions have been met, including that no event of default under the Facility Agreement has occurred, Michael Castagna remains the Company’s Chief Executive Officer, the Company has received the advance from The Mann Group (see Note 5 — Related-Party Arrangements), the Company has at least $10 million in cash and cash equivalents on hand, no material adverse effect on the Company has occurred, the engagement letter between the Company and Greenhill & Co., Inc. (“Greenhill”) has remained in full force and effect and Greenhill has remained actively engaged in exploring capital structure and financial alternatives on behalf of the Company in accordance with such engagement letter (collectively, the “Extension Conditions”), and (B) amend the Company’s financial covenant under the Facility Agreement to provide that, if the Extension Conditions remain satisfied, the obligation under the Facility Agreement to maintain at least $25 million in cash (including available borrowings under The Mann Group Loan Arrangement) as of the end of each quarter will be reduced to $10 million as of August 31, 2017, September 30, 2017, October 31, 2017 and December 31, 2017. The Company evaluated the transaction and determined that since the principal amount being repaid and exchanged under the 2019 notes represents the principal amount that would have otherwise become due and payable under the 2019 notes, the $5.0 million prepayment was not considered to be a troubled debt restructuring. Accordingly, the Company accounted for the transaction by recording a loss on extinguishment of debt of $0.5 million for the three and six months ended June 30, 2017 which was calculated as the difference between the reacquisition price and the net carrying value of the related debt. The net carrying value of the related debt includes the acceleration of the debt discount and issuance costs amounting to approximately $0.3 million as a result of the transaction. The reacquisition price was calculated using the fair value of the June Exchange Shares on June 29, 2017. The fair value of the Exchange Shares was determined to be $1.45 per share representing the closing trading price of the Company’s common stock on The NASDAQ Global Market on June 29, 2017. As of June 30, 2017, there was $45.0 million principal amount of 2019 notes and $15.0 million principal amount of Tranche B notes outstanding. The 2019 notes accrue interest at an annual rate of 9.75% and the Tranche B notes accrue interest at an annual rate of 8.75%. Interest is paid quarterly in arrears on the last day of each March, June, September and December. The Facility Financing Obligation principal repayment schedule is comprised of annual payments which began on July 1, 2016 and end on December 9, 2019. As of June 30, 2017, future payments for the years ending December 31, 2017, 2018, and 2019 are $10.0 million, $20.0 million and $30.0 million, respectively. In connection with the Facility Agreement, on July 1, 2013, the Company entered into a Milestone Rights Purchase Agreement (the “Milestone Agreement”) with Deerfield and Horizon Santé FLML SÁRL (collectively, the “Milestone Purchasers”), which requires the Company to make contingent payments to the Milestone Purchasers, totaling up to $90.0 million, upon the Company achieving specified commercialization milestones (the “Milestone Rights”). As of June 30, 2017 and December 31, 2016, the remaining milestone rights liability balance was $8.9 million. The Company currently estimates that it will reach the next milestone in the second quarter of 2018. Accordingly, $1.6 million in value related to the next milestone payment was recorded in accrued expenses and other current liabilities as of June 30, 2017, resulting in $7.2 million and $8.9 million being recorded in milestone rights liability and other liabilities, which is non-current, in the accompanying condensed consolidated balance sheets as of June 30, 2017 and December 31, 2016, respectively. Accretion of debt issuance cost and debt discount in connection with the Facility Agreement during the three and six months ended June 30, 2017 and 2016, which includes the acceleration of the debt discount and issuance costs related to the transactions disclosed above, are as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Accretion expense—debt issuance cost $ 24 $ 9 $ 32 $ 17 Accretion expense—debt discount $ 686 $ 433 $ 1,133 $ 852 The Facility Agreement includes customary representations, warranties and covenants, including a restriction on the incurrence of additional indebtedness, and a financial covenant which requires the Company’s cash and cash equivalents, which include available borrowings on the note payable to a principal stockholder, on the last day of each fiscal quarter to not be less than $25.0 million, or pursuant to the Third Amendment, $10.0 million as of the last day of each month through October 31, 2017 and as of December 31, 2017 if certain conditions are met. As discussed in Note 1 – Description of Business and Summary of Significant Accounting Policies, the Company will need to raise additional capital to support its current operating plans. Due to the uncertainties related to maintaining sufficient resources to comply with the aforementioned covenant, the 2019 notes and Tranche B notes have been classified as current liabilities in the accompanying condensed consolidated balance sheets as of June 30, 2017 and December 31, 2016. In the event of non-compliance, Deerfield may declare all or any portion of the 2019 notes and/or Tranche B notes to be immediately due and payable. Milestone Rights Security Agreement Embedded Derivatives de minimis Issuance of new 5.75% Convertible Senior Subordinated Exchange Notes Due 2018 in Exchange for 2015 Notes The 2018 notes are convertible, at the option of the holder, at any time on or prior to the close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock at an initial conversion rate of 29 shares per $1,000 principal amount of 2018 notes, which is equal to a conversion price of approximately $34.00 per share, the same conversion price as that of the 2015 notes on the date of exchange. The conversion rate is subject to adjustment under certain circumstances described in an indenture governing the 2018 notes dated August 10, 2015 with US Bank (as successor trustee to Wells Fargo, National Association), including in connection with a make-whole fundamental change. If certain fundamental changes occur, the Company will be obligated to pay a make-whole premium on any 2018 notes converted in connection with such fundamental change by increasing the conversion rate on such 2018 notes. If the Company undergoes certain fundamental changes, except in certain circumstances, each holder of 2018 notes will have the option to require the Company to repurchase all or any portion of that holder’s 2018 notes. The fundamental change repurchase price will be 100% of the principal amount of the 2018 notes to be repurchased plus accrued and unpaid interest, if any. On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. Under the terms of the indenture, the conversion option can be net-share settled and the maximum number of shares that could be required to be delivered under the indenture, including the make-whole shares, is fixed and less than the number of authorized and unissued shares less the maximum number of shares that could be required to be delivered during the term of the 2018 notes under existing commitments. Applying the Company’s sequencing policy, the Company performed an analysis at the time of the offering of the 2018 notes and each reporting date since and has concluded that the number of available authorized shares at the time of the offering and each subsequent reporting date was sufficient to deliver the number of shares that could be required to be delivered during the term of the 2018 notes under existing commitments. The 2018 notes provide that upon an acceleration of certain indebtedness, including the 2019 notes and the Tranche B notes issued to Deerfield pursuant to the Facility Agreement, the holders may elect to accelerate the Company’s repayment obligations under the notes if such acceleration is not cured, waived, rescinded or annulled. There can be no assurance that the holders would not choose to exercise these rights in the event such events were to occur. The Company incurred approximately $0.8 million in issuance costs, which are recorded as an offset to the 2018 notes, in the accompanying condensed consolidated balance sheets. These costs are being accreted to interest expense using the effective interest method over the term of the 2018 notes. Amortization of the premium and accretion of debt issuance costs related to the 2018 notes for the three and six months ended June 30, 2017 and 2016 are as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Amortization of debt premium $ 61 $ 58 $ 120 $ 115 Accretion expense—debt issuance cost $ 68 $ 63 $ 134 $ 126 |
Collaboration Arrangements
Collaboration Arrangements | 6 Months Ended |
Jun. 30, 2017 | |
Collaboration Arrangements | 7. Collaboration Arrangements Receptor Collaboration and License Agreement The Company received $0.4 million in nonrefundable payments in 2016 prior to Receptor exercising the option. On December 30, 2016, following successful completion of the studies, Receptor exercised its option and paid the Company a $1.0 million nonrefundable option exercise and license fee. Under the CLA, the Company may receive the following additional payments: • Nonrefundable milestone payments upon the completion of certain technology transfer activities and the achievement of specified sales targets; • Royalties upon Receptor’s and its sublicensees’ sale of the product; and • Milestones upon total worldwide sales reaching certain agreed upon levels. The Company evaluated the accounting for the payments received in 2016 under the multiple element accounting guidance and determined that the $0.4 million in payments received prior to Receptor exercising its option are separable from the other elements of the agreement and represented payments to offset costs incurred. Therefore, those payments reduced the Company’s research and development expense in 2016. The $1.0 million license fee received in 2016 does not have standalone value from the follow-on transfer of technology. Therefore, the license fee was recorded in deferred payments from collaboration as of December 31, 2016 and will be recognized in net revenue — collaboration over four years. Recognized revenue related to this license agreement amounted to $0.1 million for the three and six months ended June 30, 2017. See Note 1 — Description of Business and Summary of Significant Accounting Policies for additional information on the Company’s accounting for multiple element arrangements. On March 15, 2017, the Company entered into a Manufacturing and Supply Agreement with Receptor pursuant to which the Company will provide certain raw materials to Receptor. On March 16, 2017, the Company agreed to provide certain additional research and formulation consulting services to Receptor. Sanofi License Agreement and Sanofi Supply Agreement During the term of the Sanofi License Agreement, worldwide profits and losses were determined based on the difference between the net sales of Afrezza and the costs and expenses incurred by the Company and Sanofi that were specifically attributable or related to the development, regulatory filings, manufacturing, or commercialization of Afrezza. These profits and losses were shared 65% by Sanofi and 35% by the Company. On January 4, 2016, the Company received a 90-day notification from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. The effective date of termination was April 4, 2016. On April 5, 2016, the Company assumed responsibility for the worldwide development and commercialization of Afrezza from Sanofi. Under the terms of the transition agreement, Sanofi continued to fulfill orders for Afrezza in the United States until the Company began distributing MannKind-branded Afrezza product to major wholesalers during the week of July 25, 2016. The Company analyzed the agreements entered into with Sanofi at their inception and determined that prior to December 31, 2015, because 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 recorded the $150.0 million up-front payment and the two milestone payments of $25.0 million each as deferred payments from collaboration. In addition, as of December 31, 2015, the Company had recorded $17.5 million in Afrezza product shipments to Sanofi as deferred sales from collaboration and recorded $13.5 million as deferred costs from collaboration. Deferred costs from collaboration represented the costs of product manufactured and shipped to Sanofi, as well as certain direct costs associated with a firm purchase commitment entered into in connection with the collaboration with Sanofi. During the three months ended September 30, 2016, Sanofi provided information to the Company to enable it to reasonably estimate the remaining costs under the Sanofi License Agreement and the Sanofi Supply Agreement. Accordingly, the fixed or determinable fee requirement for revenue recognition was met and there were no future obligations to Sanofi. Therefore, the Company recognized $172.0 million of net revenue — collaboration for the year ended December 31, 2016. The revenue recognized includes the upfront payment of $150.0 million and the two milestone payments of $25.0 million each, net of $64.9 million of net loss share with Sanofi, as well as $17.5 million in sales of Afrezza and $19.4 million from sales of bulk insulin, both to Sanofi. These payments and sales were made pursuant to the contractual terms of the agreements with Sanofi. Sanofi Loan Facility Advances under the Sanofi Loan Facility bore interest at a rate of 8.5% per annum and were payable in-kind and compounded quarterly and added to the outstanding principal balance under the Sanofi Loan Facility. The Company was 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. The Company’s total portion of the loss sharing was $57.7 million for the year ended December 31, 2015, of which $44.5 million was borrowed under the Sanofi Loan Facility as of December 31, 2015. Subsequent to December 31, 2015, the Company borrowed $17.9 million under the Sanofi Loan Facility to finance the portion of the Company’s loss for the quarters ended December 31, 2015 and March 31, 2016. The total amount owed to Sanofi at September 30, 2016 was $71.2 million, which included $5.8 million of paid-in-kind interest. On November 9, 2016, the Company entered into a settlement agreement with Sanofi (the “Settlement Agreement”). Under the terms of the Settlement Agreement, the promissory note between the Company and Aventisub LLC, a Sanofi affiliate, was terminated, with Aventisub agreeing to forgive the full outstanding loan balance of $72.0 million. Sanofi also agreed to purchase $10.2 million of insulin from the Company in December 2016 under an existing insulin put option as well as make a cash payment of $30.6 million to the Company in early January 2017 as acceleration and in replacement of all other payments that Sanofi would otherwise have been required to make in the future pursuant to the insulin put option, without the Company being required to deliver any insulin for such payment. The Company was also relieved of its obligation to pay Sanofi $0.5 million in previously uncharged costs pursuant to the Sanofi License Agreement. The Company and Sanofi also agreed to a general release of potential claims against each other. The settlement was accounted for in the year ended December 31, 2016, except for a $30.6 million cash payment received under the insulin put option agreement which reduced the receivable from Sanofi between December 31, 2016 and June 30, 2017. |
Sale of Intellectual Property
Sale of Intellectual Property | 6 Months Ended |
Jun. 30, 2017 | |
Sale of Intellectual Property | 8. Sale of Intellectual Property On April 12, 2017 the Company entered into an agreement (the “Agreement”) to sell certain oncology assets and patents to Fosun. Fosun is required to pay the Company a one-time nonrefundable payment of $0.6 million (which was received net of taxes in June of 2017), royalties on net sales of products by Fosun and its affiliates and other consideration based on revenues from any licensees. The Company determined that the sale of the assets did not constitute a business and accordingly accounted for the transaction as a sale of assets. The Company evaluated the accounting for the payments received in 2017 under the multiple element accounting guidance and recorded the $0.6 million in payments received in revenue – other in the accompanying condensed consolidated financial statements for the three and six months ended June 30, 2017 as the deliverables under the Agreement were substantially delivered as of June 30, 2017. See Note 1 — Description of Business and Summary of Significant Accounting Policies for additional information on the Company’s accounting for multiple element arrangements. The Company also evaluated the accounting for royalties and other consideration in the Agreement. Since the amount of product that Fosun will ultimately be able to sell upon successfully utilizing this technology is uncertain, no royalty revenue will be recognized until such time when Fosun or its affiliates sell product to a third party and royalties are due to MannKind. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2017 | |
Fair Value of Financial Instruments | 9. 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 that 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 Equivalents Note Payable to Principal Stockholder — Financial Liabilities As of June 30, 2017 Carrying Value Level 1 Level 2 Level 3 Total Financial liabilities: Senior convertible notes $ 27.6 $ — $ — $ 24.2 $ 24.2 Facility financing obligation 57.5 — — 60.0 60.0 Milestone rights 8.9 — — 18.2 18.2 Warrant liability (at recurring fair value) 0.6 — — 0.6 0.6 Total financial liabilities $ 94.6 $ — $ — $ 103.0 $ 103.0 As of December 31, 2016 Carrying Value Level 1 Level 2 Level 3 Total Financial liabilities: Senior convertible notes $ 27.6 $ — $ — $ 22.9 $ 22.9 Facility financing obligation 71.3 — — 74.5 74.5 Milestone rights 8.9 — — 18.4 18.4 Warrant liability (at recurring fair value) 7.4 — — 7.4 7.4 Total financial liabilities $ 115.2 $ — $ — $ 123.2 $ 123.2 On May 12, 2016 we issued certain warrants with a fair value of $12.8 million. As of June 30, 2017 and December 31, 2016, the fair value of the warrant liability was $0.6 million and $7.4 million, respectively. The fair value of the warrants liability as of June 30, 2017 was estimated using a Monte Carlo valuation pricing model with the following underlying assumptions: (a) a risk-free interest rate of 1.4%; (b) an assumed dividend yield of zero percent; (c) an expected term of 0.9 years; and (d) an expected volatility of 112%. The following table provides a roll forward of the fair value of the warrant liability which is the only Level 3 financial instrument that is carried at fair value (in millions): Balance at beginning of period December 31, 2016 $ 7.4 Additions — Changes in fair value (6.8 ) Payments — Fair value, end of period June 30, 2017 $ 0.6 Senior Convertible Notes Facility Agreement Milestone Rights Liability Warrant Liability — Embedded Derivatives de minimis |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 6 Months Ended |
Jun. 30, 2017 | |
Stock-Based Compensation Expense | 10. Stock-Based Compensation Expense In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. • The Company, as of December 31, 2016, had not recognized $11.6 million of excess tax benefits related to windfalls. As a result of adoption, it will now recognize these benefits as deferred tax assets. However, after assessment for realizability, the Company has also recorded a full valuation allowance against the deferred tax assets. This resulted in a zero cumulative effect adjustment to accumulated deficit as a result of the adoption. All shortfalls related to non-qualified options and restricted stock units are now recorded as an income tax expense for the period, offset by a full valuation allowance. • Due to the full valuation allowance for the Company’s deferred tax assets, the excess income tax benefits have never been recorded in additional paid-in-capital. The Company does not contemplate any impact going forward as any amounts to be recorded in the condensed consolidated statements of operations would be fully offset by the valuation allowance nor result in a related classification in cash flows for operating activities. • The Company will continue to recognize forfeitures through estimates consistent with our past practices as opposed to when they occur. • The Company already classifies cash paid to taxing authorities arising from the withholding of shares from employees in cash flows from financing activities. Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2017 and 2016 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Stock-based compensation $ 1,250 $ 1,355 $ 2,516 $ 2,628 During the six months ended June 30, 2017, the Company issued 544,105 restricted units to certain employees which vest over a four-year period. The grant date fair value of the restricted stock units was $0.6 million with a weighted average grant date fair value per share of $1.10. During the six months ended June 30, 2017, the Company granted certain employees stock options to purchase an aggregate of 2,150,537 shares of common stock at a weighted average exercise price of $1.31 per share of which 1,508,159 of these awards vest in four equal tranches upon the achievement of certain product sales targets. The remaining 642,378 options vest over a four year period. The grant date fair value of these awards is $2.0 million with a weighted average grant date fair value of $0.93 per share, as determined using a Black-Scholes option pricing model. As of June 30, 2017, there was $4.2 million, $4.4 million and $3.9 million of unrecognized compensation expense related to restricted stock units, options with performance conditions and options that vest over the vesting period. The Company evaluates stock awards with performance conditions as the probability that the performance conditions will be met and uses that information to estimate the date at which those performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. On a periodic basis and as of June 30, 2017, the Company reviewed the probability of achieving the performance conditions for each of the four vesting tranches of the performance-based stock options that were granted during 2017 and in prior years and determined that it was probable that the Company would achieve the first vesting tranche in December 2017. Therefore, the Company recorded compensation expense related to performance-based stock options of $0.4 million and $0.7 million during the three and six months ended June 30, 2017, respectively. The Company further determined that no compensation costs would be recognized for the second, third and fourth vesting tranches as the probability of achieving those performance conditions has not been determined. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2017 | |
Commitments and Contingencies | 11. Commitments and Contingencies Guarantees and Indemnifications Litigation Following the public announcement of Sanofi’s election to terminate the Sanofi License Agreement and the subsequent decline in the Company’s stock price, two motions were submitted to the district court at Tel Aviv, Economic Department for the certification of a class action against MannKind and certain of its officers and directors. In general, the complaints alleged that MannKind and certain of its officers and directors violated Israeli and U.S. securities laws by making materially false and misleading statements regarding the prospects for Afrezza, thereby artificially inflating the price of its common stock. The plaintiffs are seeking monetary damages. In November 2016, the district court dismissed one of the actions without prejudice. In the remaining action, the district court has been asked to determine whether Israeli or U.S. law is applicable before the case can be certified as a class action but has not yet ruled on this issue. The Company will vigorously defend against the claims advanced. Contingencies Commitments On November 9, 2016, the supply agreement with Amphastar was amended to extend the term over which the Company is required to purchase insulin, without reducing the total amount of insulin to be purchased. Under the amendment, annual minimum quantities of insulin to be purchased for calendar years 2017 through 2023 total an aggregate purchase price of €93.0 million at June 30, 2017. The Insulin Supply Agreement specifies that Amphastar will be deemed to have satisfied its obligations with respect to quantity, if the actual quantity supplied is within plus or minus ten percent (+/- 10%) of the quantity set forth in the applicable purchase order. In addition, the aggregate cancellation fees that the Company would incur in the event that certain insulin quantities are not purchased was lowered from $5.3 million for the period October 1, 2016 through 2018 to $3.4 million over the same period. The Company has not yet purchased any insulin under the amended agreement in 2017. The annual purchase requirements under the contract are as follows: 2017 € 2.7 million 2018 € 8.9 million 2019 € 11.6 million 2020 € 15.5 million 2021 € 15.5 million 2022 € 19.4 million 2023 € 19.4 million Unless earlier terminated, the term of the Insulin Supply Agreement with Amphastar expires on December 31, 2023 and can be renewed for additional, successive two year terms upon 12 months’ written notice given prior to the end of the initial term or any additional two year term. The Company and Amphastar each have normal and customary termination rights, including termination for material breach that is not cured within a specific time frame or in the event of liquidation, bankruptcy or insolvency of the other party. In addition, the Company may terminate the Insulin Supply Agreement upon two years’ prior written notice to Amphastar without cause or upon 30 days’ prior written notice to Amphastar if a controlling regulatory authority withdraws approval for Afrezza, provided, however, in the event of a termination pursuant to either of the latter two scenarios, the provisions of the Insulin Supply Agreement require the Company to pay the full amount of all unpaid purchase commitments due over the initial term within 60 calendar days of the effective date of such termination. At June 30, 2017, the Company has other firm commitments with suppliers for an aggregate of $0.9 million. Office Lease 2017 $ 41,000 2018 457,000 2019 512,000 2020 528,000 2021 544,000 Thereafter 560,000 $ 2,642,000 |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2017 | |
Income Taxes | 12. Income Taxes Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and concluded, in accordance with the applicable accounting standards, that net deferred tax assets should be fully reserved. The Company has assessed its position with regards to uncertainty in tax positions and believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material change to its financial position. Therefore, no reserves for uncertain income tax positions have been recorded pursuant to this guidance. Tax years since 2012 remain subject to examination by the major tax jurisdictions in which the Company is subject to tax. The Company adopted ASU 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting |
Restructuring Charges
Restructuring Charges | 6 Months Ended |
Jun. 30, 2017 | |
Restructuring Charges | 13. Restructuring Charges As of June 30, 2017 and December 31, 2016, the Company had a remaining restructuring accrual balance of $0.4 million and $1.4 million, respectively, which is recorded in accrued expenses and other current liabilities in the condensed consolidated balance sheets. The Company expects to substantially pay out the remainder of this obligation by end of first quarter of 2018. A reconciliation of beginning and ending liability balances for the restructuring charges is as follows (in thousands): 2016 2015 Description Restructuring Restructuring Total Accrual—January 1, 2017 $ 209 $ 1,167 $ 1,376 Costs paid or settled (209 ) (805 ) (1,014 ) Accrual—June 30, 2017 $ — $ 362 $ 362 On May 25, 2017, the board of directors (the “Board”) replaced Matthew J. Pfeffer as Chief Executive Officer and Chief Financial Officer of the Company. Pursuant to a severance agreement in effect on that date, Mr. Pfeffer’s estimated current value of payments and benefits upon termination totaled approximately $1.2 million. At the time of the Board action, Mr. Pfeffer was expected to remain employed by the Company in an advisory capacity until July 31, 2017, before transitioning to severance. Subsequently, the Company and Mr. Pfeffer began negotiating a new agreement that would, if and when finalized, supersede the existing severance agreement. Given that the new agreement would override any prior severance agreements and amounts previously due to Mr. Pfeffer and contains special termination benefits that are contingent upon certain factors that cannot be reasonably estimated, the Company recorded no severance accrual for Mr. Pfeffer during the second quarter of 2017. Current salary and benefits continue to be accrued as earned. |
Description of Business and S20
Description of Business and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Business | Business On August 11, 2014, the Company executed a license and collaboration agreement (the “Sanofi License Agreement”) with Sanofi-Aventis Deutschland GmbH, which subsequently assigned its rights and obligations under the agreement to Sanofi-Aventis U.S. LLC (“Sanofi”), pursuant to which Sanofi was responsible for global commercial, regulatory and development activities for Afrezza. On January 4, 2016, the Company received written notification from Sanofi of its election to terminate in its entirety the Sanofi License Agreement. The effective date of termination was April 4, 2016, which was when the Company assumed responsibility for worldwide development and commercialization of Afrezza. Under the terms of the transition agreement, Sanofi continued to fulfill orders for Afrezza in the United States until the Company began distributing MannKind-branded Afrezza product to major wholesalers in late July 2016. The Company began recognizing commercial product sales revenue when MannKind-branded Afrezza was dispensed from pharmacies to patients in August 2016. On November 9, 2016, the Company entered into a settlement agreement with Sanofi (the “Settlement Agreement”). Under the terms of the Settlement Agreement, the promissory note between the Company and Aventisub LLC (“Aventisub”), a Sanofi affiliate, was terminated with Aventisub agreeing to fully forgive the outstanding loan balance of $72.0 million. Sanofi also purchased $10.2 million of insulin from the Company in December 2016 under an existing insulin put option and made a cash payment of $30.6 million to the Company in early January 2017 as acceleration and in replacement of all other payments that Sanofi would otherwise have been required to make in the future pursuant to the insulin put option, without the Company being required to deliver any insulin for such payment. The Company was also relieved of its obligation to pay Sanofi $0.5 million in previously uncharged costs pursuant to the Sanofi License Agreement. The Company and Sanofi also agreed to a general release of potential claims against each other. During their initial transition of the commercial responsibilities from Sanofi in the second half of 2016, the Company utilized a contract sales organization to promote Afrezza while the Company focused its internal resources on establishing a channel strategy, entering into distribution agreements and developing co-pay assistance programs, a voucher program, data agreements and payor relationships. In early 2017, the Company recruited its own sales force to promote Afrezza to endocrinologists and certain high-prescribing primary care physicians. In the future, the Company may seek to supplement its sales force through a co-promotion arrangement – an agreement with a third party that has an underutilized primary care sales force, which can be used to promote Afrezza to greater number of primary care physicians. The Company’s current strategy for future commercialization of Afrezza outside of the United States, subject to receipt of the necessary foreign regulatory approvals, is to seek and establish partnerships in foreign jurisdictions where there are appropriate commercial opportunities. The Company has never been profitable or generated positive cash flow from cumulative operations to date. Historically, the Company has reported negative cash flow from operations other than for the nine months ended September 30, 2014, for the year ended December 31, 2014, and for the three months ended March 31, 2015 and 2017 as a result of non-recurring payments from Sanofi. As of June 30, 2017, the Company had an accumulated deficit of $2.8 billion. At June 30, 2017, the Company’s capital resources consisted of cash and cash equivalents of $43.4 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing and sales and marketing of Afrezza and the development of product candidates in the Company’s pipeline. The facility agreement (the “Facility Agreement”) with Deerfield Private Design Fund II, L.P. (“Deerfield Private Design Fund”) and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) that resulted in the issuance of 9.75% Senior Convertible Notes due 2019 (“2019 notes”) and the First Amendment to Facility Agreement and Registration Rights Agreement (the “First Amendment”) that resulted in the issuance of an additional tranche of 8.75% Senior Convertible Notes due 2019 (“Tranche B notes”) (see Note 6 — Borrowings) requires the Company to maintain at least $25.0 million in cash and cash equivalents or available borrowings under the loan arrangement, dated as of October 2, 2007, between the Company and The Mann Group LLC (“The Mann Group”) (as amended, restated, or otherwise modified as of the date hereof, “The Mann Group Loan Arrangement”), as of the last day of each fiscal quarter. On June 29, 2017, the Company entered into an Exchange and Third Amendment to Facility Agreement (the “Third Amendment”) with Deerfield which, among other things, amended such financial covenant to provide that, if certain conditions are met, then the obligation to maintain at least $25.0 million in cash as of the end of each quarter will be reduced to $10.0 million as of August 31, 2017, September 30, 2017, October 31, 2017 and December 31, 2017 (see Note 6 — Borrowings). On June 27, 2017, the Company borrowed the remaining $30.1 million principal amount available under The Mann Group Loan Arrangement, of which $19.4 million was received in cash and the remaining amount of $10.7 million representing accrued and unpaid interest as of June 30, 2017 was capitalized into borrowed principal (see Note 5 — Related-Party Arrangements). As a result, no additional funds remain available for borrowing under The Mann Group Loan Arrangement. On March 1, 2017, following stockholder approval, the Company’s board of directors approved a reverse stock split ratio of 1-for-5. On March 1, 2017, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment of the Company’s Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect the 1-for-5 reverse stock split of the Company’s outstanding common stock (the “Reverse Stock Split”) and to reduce the authorized number of shares of the Company’s common stock from 700,000,000 to 140,000,000 shares. The Company’s common stock began trading on the NASDAQ Global Market on a split-adjusted basis when the market opened on March 3, 2017. As a result, all common stock share amounts included in these condensed consolidated financial statements have been retroactively reduced by a factor of five, and all common stock per share amounts have been increased by a factor of five, with the exception of the Company’s common stock par value. On April 18, 2017, the Company entered into an Exchange Agreement with Deerfield resulting in the cash repayment of $4.0 million under the Tranche B notes and the conversion of $1.0 million and $5.0 million of the Tranche B notes and the 2019 notes, respectively, into shares of common stock. On June 29, 2017, the Company entered into the Third Amendment with Deerfield resulting in the conversion of $5.0 million of the 2019 notes into shares of common stock and deferment of the payment of $10.0 million of principal amount of the 2019 notes due July 18, 2017 to August 31, 2017, with an option for the Company to elect to further defer the payment of such principal amount from August 31, 2017 to October 31, 2017 upon the Company’s delivery on August 31, 2017 of a written certification to Deerfield that certain conditions have been met (see Note 6 — Borrowings). The Company will need to raise additional capital, whether through a sale of equity or debt securities, a strategic business collaboration with another 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. The Company cannot provide assurances that such additional capital will be available on acceptable terms or at all. These factors raise substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Reclassifications | Reclassifications |
Correction of an Immaterial Error | Correction of an Immaterial Error (In thousands) 2016 as Adjustments 2016 as Common stock $ 4,784 $ (3,827 ) $ 957 Additional paid-in capital $ 2,549,212 $ 3,827 $ 2,553,039 |
Revenue Recognition | Revenue Recognition |
Revenue Recognition - Net Revenue - Commercial Product Sales | Revenue Recognition – Net Revenue – Commercial Product Sales – Given the Company’s limited sales history for Afrezza, the Company cannot reliably estimate expected returns of the product at the time of shipment into the distribution channel. Accordingly, the Company defers recognition of revenue on Afrezza product shipments until the right of return no longer exists, which occurs at the earlier of the time Afrezza is dispensed from pharmacies to patients or expiration of the right of return. Deferred revenue is presented net of deferred product sales discounts which are further described in Gross-to-Net Adjustments For the three and six months ended June 30, 2017, net revenue from commercial product sales consisted of $1.5 million and $2.7 million of net sales of Afrezza dispensed to patients, respectively. As of June 30, 2017 and December 31, 2016, the ending balances for net deferred revenue, were $2.6 million and $3.4 million, on its condensed consolidated balance sheets of which $1.0 million and $0.8 million are gross-to-net revenue adjustments, respectively. The difference, as compared with December 31, 2016, represented deferred revenue from bulk insulin sales of approximately $1.7 million, which is described more fully under the heading Revenue Recognition – Revenue – Other |
Gross-to-net Adjustments | Gross-to-net Adjustments – |
Wholesaler Distribution Fees | Wholesaler Distribution Fees – |
Prompt Pay Discounts | Prompt Pay Discounts – Rebates and Chargebacks – The Company accounts for these rebates and chargebacks by establishing an accrual based on contractual discount rates, expected utilization under each contract and an estimate of the amount of inventory in the distribution channel that will become subject to such rebates and chargebacks based on historical payor data provided by a third-party vendor along with additional data including forecasted participation rates. From that data, as well as input received from the commercial team, an estimated participation rate for each program is determined and applied at the rate for those sales. Any new information regarding changes in the programs’ regulations and guidelines or any changes in the Company’s government price reporting calculations that would impact the amount of the rebates will also be taken into account in determining or modifying the appropriate reserve. The time period between the date the product is sold into the channel and the date such rebates may be paid can be up to approximately six to nine months. As such, continuous monitoring of these estimates will be performed on a periodic basis, and if necessary, adjusted to reflect new facts and circumstances. Rebates and chargebacks are recognized as a reduction of gross revenue in the period the related revenue is recognized. Other Rebates and Discounts – |
Patient Discount and Co-Pay Assistance Programs | Patient Discount and Co-Pay Assistance Programs – |
Deferred costs | Deferred Costs from Commercial Product Sales |
Revenue Recognition- Net Revenue - Collaborations | Revenue Recognition – Net Revenue – Collaborations – |
Recognized Loss on Purchase Commitments | Recognized Loss on Purchase Commitments |
Revenue Recognition - Revenue - Other | Revenue Recognition — Revenue — Other |
Cost of Goods Sold | Cost of Goods Sold |
Accounts Receivable and Allowances | Accounts Receivable and Allowances |
Inventories | Inventories |
Fair Value of Financial Instruments | Fair Value of Financial Instruments |
Stock-Based Compensation | Stock-Based Compensation |
Warrants | Warrants |
Net Income (Loss) Per Share of Common Stock | Net Loss Per Share of Common Stock The computation of basic and diluted net loss per share for the three and six months ended June 30, 2017 and 2016 excludes the common stock equivalents of the following potentially dilutive securities because their inclusion would be anti-dilutive: Six Months Ended June 30, 2017 2016 Restricted stock units 1,193,100 910,751 Senior convertible notes 814,561 814,561 Warrants 9,740,597 9,740,597 Stock options 7,972,175 5,643,966 19,720,433 17,109,875 |
Recently Issued Accounting Standards | Recently Issued Accounting Standards In May 2014, the FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date The Company will adopt the new guidance for the year beginning January 1, 2018. The Company has the option to either apply the new guidance retrospectively for all prior reporting periods presented (full retrospective) or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (modified retrospective). The Company currently anticipates it will apply the new guidance using the modified retrospective approach with the cumulative effect of initial application recognized as of January 1, 2018. The Company plans to continue analyzing the potential impacts of the application throughout 2017 and, depending on factors that may impact the results, could elect to apply the new guidance on a full retrospective basis. Currently, for commercial sales of Afrezza, the Company has limited sales and returns history, and as such is unable to reliably estimate expected returns of the product at the time of shipment into the distribution channel. Accordingly, the Company defers recognition of revenue on Afrezza product shipments until the right of return no longer exists, which occurs at the earliest of the time Afrezza is dispensed from pharmacies to patients or expiration of the right of return. The Company recognizes revenue based on Afrezza patient prescriptions dispensed, a sell-through model, as estimated by syndicated data provided by a third party. The Company also analyzes additional data points to ensure that such third-party data is reasonable, including data related to inventory movements within the channel and ongoing prescription demand. Upon adoption of the new guidance, the Company expects that it will move from its current sell-through model to a sell-to model for revenue related to commercial sales of Afrezza and will record revenue at the time title and risk of loss passes to its distributors (generally at shipment or delivery to the distributors) along with an estimate of potential returns as variable consideration. The Company also anticipates that its ability to estimate potential returns will improve with an additional six months of sales history that it will have obtained by January 1, 2018. Additionally, the Company has historically entered into collaborative agreements with third-parties under which periodic payments have been received. Revenue recognition for certain payments received have been deferred until the price is fixed and determinable. Further, revenue for certain payments to be received in the future has been prohibited from recognition until received. The Company expects that some of these amounts will be considered variable consideration and may be able to be recognized earlier under the new guidance. The financial impact upon the adoption will be dependent upon a number of factors, including the amount of revenue that has been deferred under the sell-through model for Afrezza, the amount of the revenue deferred under collaborative arrangements and the Company’s estimate of variable consideration at the date of adoption. At this time, the Company has not completed its evaluation of the inputs, assumptions and methodologies that will be used to recognize revenue related to variable consideration under the new guidance. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments Overall (Subtopic 825-10) Recognition and Measurement of Financial Assets and Financial Liabilities In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 84 In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting. ASC 718 ASU 2017-09 In July 2017, the FASB issued ASU No. 2017-11, Earnings per Share (Topic 260) and Derivatives and Hedging (Topic 815): Accounting for Certain Financial Instruments with Down Round Provisions. |
Description of Business and S21
Description of Business and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Summary of Correction of Error for Prior Period Presented and to Conform to Current Year Presentation | The Company has elected to revise the historical consolidated financial information presented herein to reflect the correction of this error for the prior period presented and to conform to the current year presentation. (In thousands) 2016 as Adjustments 2016 as Common stock $ 4,784 $ (3,827 ) $ 957 Additional paid-in capital $ 2,549,212 $ 3,827 $ 2,553,039 |
Schedule of Potentially Dilutive Common Stock Equivalent Securities | The computation of basic and diluted net loss per share for the three and six months ended June 30, 2017 and 2016 excludes the common stock equivalents of the following potentially dilutive securities because their inclusion would be anti-dilutive: Six Months Ended June 30, 2017 2016 Restricted stock units 1,193,100 910,751 Senior convertible notes 814,561 814,561 Warrants 9,740,597 9,740,597 Stock options 7,972,175 5,643,966 19,720,433 17,109,875 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Components of Inventory | Inventory consists of the following (in thousands): June 30, 2017 December 31, 2016 Raw materials $ 431 $ — Work-in-process 2,391 2,120 Finished goods 350 211 Total inventory $ 3,172 $ 2,331 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Property and Equipment, Net and Depreciation and Amortization Expense Related to Property and Equipment | Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) June 30, 2017 December 31, 2016 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 34,957 34,957 Machinery and equipment 3-15 62,992 62,992 Furniture, fixtures and office equipment 5-10 3,556 3,556 Computer equipment and software 3 8,531 8,531 Construction in progress — 91 202 128,391 128,502 Less accumulated depreciation (100,471 ) (99,575 ) Total property and equipment, net $ 27,920 $ 28,927 Depreciation expense related to property and equipment for the three and six months ended June 30, 2017 and 2016 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Depreciation expense $ 450 $ 589 $ 896 $ 1,179 |
Accrued Expenses and Other Cu24
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following (in thousands): June 30, 2017 December 31, 2016 Salary and related expenses $ 3,729 $ 3,814 Current portion of milestone rights liability 1,643 — Professional fees 968 875 Discounts and allowances for commercial product sales 1,036 754 Sales and marketing services 218 144 Restructuring 362 1,376 Accrued interest 624 619 Other 496 355 Accrued expenses and other current liabilities $ 9,076 $ 7,937 |
Related-Party Arrangements (Tab
Related-Party Arrangements (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Schedule of Interest Expense on Note Payable to Principal Stockholder | Interest expense on the Company’s note payable to the Company’s principal stockholder for the three and six months ended June 30, 2017 and 2016 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Interest expense on note payable to principal stockholder $ 721 $ 721 $ 1,435 $ 1,443 |
Schedule of Lease Payments to the Mann Foundation | Lease payments to the Mann Foundation for the three and six months ended June 30, 2017 and 2016 were as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Lease payments $ 60 $ 67 $ 122 $ 133 |
Borrowings (Tables)
Borrowings (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Summary of Borrowings | Borrowings consist of the following (in thousands): June 30, 2017 December 31, 2016 Facility Financing Obligation (2019 Notes) Principal amount $ 60,000 $ 75,000 Unamortized debt discount (2,516 ) (3,661 ) Net carrying amount $ 57,484 $ 71,339 Senior Convertible Notes (2018 Notes) Principal amount $ 27,690 $ 27,690 Unamortized premium 306 426 Unaccreted debt issuance costs (347 ) (481 ) Net carrying amount $ 27,649 $ 27,635 Note payable to principal stockholder—net carrying amount $ 79,666 $ 49,521 |
Accretion of Debt Issuance Cost and Debt Discount | Accretion of debt issuance cost and debt discount in connection with the Facility Agreement during the three and six months ended June 30, 2017 and 2016, which includes the acceleration of the debt discount and issuance costs related to the transactions disclosed above, are as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Accretion expense—debt issuance cost $ 24 $ 9 $ 32 $ 17 Accretion expense—debt discount $ 686 $ 433 $ 1,133 $ 852 |
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs | Amortization of the premium and accretion of debt issuance costs related to the 2018 notes for the three and six months ended June 30, 2017 and 2016 are as follows: Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Amortization of debt premium $ 61 $ 58 $ 120 $ 115 Accretion expense—debt issuance cost $ 68 $ 63 $ 134 $ 126 |
Fair Value of Financial Instr27
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Fair Value of Financial Instruments | Financial Liabilities As of June 30, 2017 Carrying Value Level 1 Level 2 Level 3 Total Financial liabilities: Senior convertible notes $ 27.6 $ — $ — $ 24.2 $ 24.2 Facility financing obligation 57.5 — — 60.0 60.0 Milestone rights 8.9 — — 18.2 18.2 Warrant liability (at recurring fair value) 0.6 — — 0.6 0.6 Total financial liabilities $ 94.6 $ — $ — $ 103.0 $ 103.0 As of December 31, 2016 Carrying Value Level 1 Level 2 Level 3 Total Financial liabilities: Senior convertible notes $ 27.6 $ — $ — $ 22.9 $ 22.9 Facility financing obligation 71.3 — — 74.5 74.5 Milestone rights 8.9 — — 18.4 18.4 Warrant liability (at recurring fair value) 7.4 — — 7.4 7.4 Total financial liabilities $ 115.2 $ — $ — $ 123.2 $ 123.2 |
Fair Values of Warrant Liability which Include Level 3 Instruments | The following table provides a roll forward of the fair value of the warrant liability which is the only Level 3 financial instrument that is carried at fair value (in millions): Balance at beginning of period December 31, 2016 $ 7.4 Additions — Changes in fair value (6.8 ) Payments — Fair value, end of period June 30, 2017 $ 0.6 |
Stock-Based Compensation Expe28
Stock-Based Compensation Expense (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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, 2017 and 2016 was as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Stock-based compensation $ 1,250 $ 1,355 $ 2,516 $ 2,628 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Annual Purchase Requirements under Contract | The annual purchase requirements under the contract are as follows: 2017 € 2.7 million 2018 € 8.9 million 2019 € 11.6 million 2020 € 15.5 million 2021 € 15.5 million 2022 € 19.4 million 2023 € 19.4 million |
Schedule of Future Minimum Lease Payments | Future minimum lease payments are as follows: 2017 $ 41,000 2018 457,000 2019 512,000 2020 528,000 2021 544,000 Thereafter 560,000 $ 2,642,000 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Reconciliation of Beginning and Ending Liability Balances for Restructuring Charges | A reconciliation of beginning and ending liability balances for the restructuring charges is as follows (in thousands): 2016 2015 Description Restructuring Restructuring Total Accrual—January 1, 2017 $ 209 $ 1,167 $ 1,376 Costs paid or settled (209 ) (805 ) (1,014 ) Accrual—June 30, 2017 $ — $ 362 $ 362 |
Description of Business and S31
Description of Business and Significant Accounting Policies - Additional Information (Detail) | Jun. 29, 2017USD ($) | Apr. 18, 2017USD ($) | Mar. 01, 2017shares | Nov. 09, 2016USD ($) | Jan. 31, 2017USD ($) | Jun. 30, 2017USD ($)Distributorshares | Jun. 30, 2017USD ($)Distributorshares | Dec. 31, 2016USD ($)Distributorshares | Jun. 27, 2017USD ($) | Sep. 30, 2016shares | Jun. 30, 2016USD ($) | Dec. 31, 2015USD ($) | Sep. 23, 2014 |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net revenue from collaboration | $ 63,000 | $ 125,000 | |||||||||||
Gain on extinguishment of debt | (830,000) | (830,000) | |||||||||||
Accumulated deficit | (2,789,228,000) | (2,789,228,000) | $ (2,737,565,000) | ||||||||||
Cash and cash equivalents | $ 43,384,000 | $ 43,384,000 | $ 22,895,000 | $ 63,733,000 | $ 59,074,000 | ||||||||
Stock split of common stock | 0.2 | ||||||||||||
Common stock, shares authorized | shares | 140,000,000 | 140,000,000 | 140,000,000 | 140,000,000 | 700,000,000 | ||||||||
Reverse stock split, description | The Company’s board of directors approved a reverse stock split ratio of 1-for-5. On March 1, 2017, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment of the Company’s Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect the 1-for-5 reverse stock split of the Company’s outstanding common stock (the “Reverse Stock Split”) and to reduce the authorized number of shares of the Company’s common stock from 700,000,000 to 140,000,000 shares. The Company’s common stock began trading on the NASDAQ Global Market on a split-adjusted basis when the market opened on March 3, 2017. As a result, all common stock share amounts included in these condensed consolidated financial statements have been retroactively reduced by a factor of five, and all common stock per share amounts have been increased by a factor of five, with the exception of the Company’s common stock par value. | ||||||||||||
Net deferred revenue | $ 2,592,000 | $ 2,592,000 | $ 3,419,000 | ||||||||||
Net revenue - commercial product sales | $ 1,548,000 | $ 2,745,000 | |||||||||||
Number of wholesale distributors | Distributor | 3 | 3 | |||||||||||
Percentage of product shipments to wholesale distributors | 93.00% | 93.00% | |||||||||||
Deferred revenue from sale of raw insulin | $ 0 | $ 1,700,000 | |||||||||||
Cash discount as incentive for prompt payment | 2.00% | 2.00% | |||||||||||
Number of wholesale distributors accounted for gross accounts receivable | Distributor | 3 | 3 | 3 | ||||||||||
Allowance for doubtful accounts | $ 0 | $ 0 | $ 0 | ||||||||||
Percentage of accounts receivable from major wholesale distributors | 93.00% | 93.00% | 95.00% | ||||||||||
Loss on purchase commitments, number of contracts recognized | 0 | 0 | |||||||||||
License and Collaboration Agreement with Sanofi | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Gain on extinguishment of debt | $ 500,000 | ||||||||||||
Senior notes, effective interest rate | 8.50% | ||||||||||||
Third party logistics | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net deferred revenue | $ 1,000,000 | $ 1,000,000 | $ 800,000 | ||||||||||
Insulin Put | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net revenue from collaboration | 10,200,000 | ||||||||||||
AFREZZA product sales | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Product sales revenue gross to net adjustments | $ 1,100,000 | $ 1,500,000 | |||||||||||
Product sales revenue gross to net adjustments percentage | 41.00% | 36.00% | |||||||||||
Minimum | AFREZZA product sales | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Sales return right following product expiration in months | 6 months | ||||||||||||
Maximum | AFREZZA product sales | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Sales return right following product expiration in months | 12 months | ||||||||||||
Senior convertible notes due December 31, 2019 | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Gain on extinguishment of debt | $ 500,000 | $ 500,000 | |||||||||||
Senior convertible notes due December 31, 2019 | Less portion of commitment asset | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Gain on extinguishment of debt | 300,000 | 300,000 | |||||||||||
Allowance for Sales Returns | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Allowance for returns | 200,000 | 200,000 | 0 | ||||||||||
Principal stockholder | Loan Arrangement | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Available amount of credit facility under covenant restrictions | 19,400,000 | 19,400,000 | $ 19,400,000 | ||||||||||
Amount available for future borrowings | 0 | 0 | $ 30,100,000 | ||||||||||
Accrued interest of related party debt | $ 10,700,000 | 10,700,000 | 9,300,000 | ||||||||||
Sanofi-Aventis Deutschland GmbH | License and Collaboration Agreement with Sanofi | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net revenue from collaboration | 172,000,000 | ||||||||||||
Sanofi-Aventis Deutschland GmbH | Insulin Put | License and Collaboration Agreement with Sanofi | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net revenue from collaboration | 19,400,000 | ||||||||||||
Sanofi-Aventis Deutschland GmbH | AFREZZA product sales | License and Collaboration Agreement with Sanofi | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Net revenue from collaboration | $ 17,500,000 | ||||||||||||
Sanofi-Aventis Deutschland GmbH | Put Option | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Payment for insulin put option | $ 30,600,000 | $ 30,600,000 | |||||||||||
Aventisub LLC | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Outstanding loan balance forgive | $ 72,000,000 | ||||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Senior notes, effective interest rate | 9.75% | 9.75% | |||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | Third Amendment [Member] | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Amount available for future borrowings | $ 10,000,000 | ||||||||||||
Conversion of notes to shares of common Stock, value | 5,000,000 | ||||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | Less portion of commitment asset | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Senior notes, effective interest rate | 8.75% | 8.75% | |||||||||||
Cash repayment of senior notes under exchange agreement | $ 4,000,000 | ||||||||||||
Conversion of notes to shares of common Stock, value | 1,000,000 | ||||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | Tranche 1 Notes | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Conversion of notes to shares of common Stock, value | $ 5,000,000 | ||||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | Minimum | Less portion of commitment asset | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Available amount of credit facility under covenant restrictions | $ 25,000,000 | $ 25,000,000 | |||||||||||
Deerfield | Senior convertible notes due December 31, 2019 | Minimum | Less portion of commitment asset | Third Amendment [Member] | |||||||||||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||||||||||
Available amount of credit facility under covenant restrictions | $ 10,000,000 |
Description of Business and S32
Description of Business and Significant Accounting Policies - Summary of Correction of Error for Prior Period Presented and to Conform to Current Year Presentation (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Common stock | $ 1,046 | $ 957 |
Additional paid-in capital | $ 2,566,960 | 2,553,039 |
Previously Presented | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Common stock | 4,784 | |
Additional paid-in capital | 2,549,212 | |
Adjustments | ||
Error Corrections and Prior Period Adjustments Restatement [Line Items] | ||
Common stock | (3,827) | |
Additional paid-in capital | $ 3,827 |
Schedule of Potentially Dilutiv
Schedule of Potentially Dilutive Common Stock Equivalent Securities (Detail) - shares | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 19,720,433 | 17,109,875 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 1,193,100 | 910,751 |
Senior Convertible Notes | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 814,561 | 814,561 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 9,740,597 | 9,740,597 |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,972,175 | 5,643,966 |
Components of Inventory (Detail
Components of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Inventory [Line Items] | ||
Raw materials | $ 431 | |
Work-in-process | 2,391 | $ 2,120 |
Finished goods | 350 | 211 |
Total inventory | $ 3,172 | $ 2,331 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended |
Jun. 30, 2017 | Jun. 30, 2017 | |
Inventory [Line Items] | ||
Inventory write-down | $ 1.5 | $ 1.5 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 128,391 | $ 128,502 |
Less accumulated depreciation | (100,471) | (99,575) |
Total property and equipment, net | 27,920 | 28,927 |
Land | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | 875 | 875 |
Buildings | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 17,389 | 17,389 |
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 | $ 34,957 | 34,957 |
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 | $ 62,992 | 62,992 |
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 | $ 3,556 | 3,556 |
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 | $ 8,531 | 8,531 |
Construction in Progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment - gross | $ 91 | $ 202 |
Depreciation Expense Related to
Depreciation Expense Related to Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation expense | $ 450 | $ 589 | $ 896 | $ 1,179 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | Feb. 17, 2017 | Jan. 06, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 |
Depreciation and Other Amortization Expenses [Line Items] | ||||||
Loss on impairment of property and equipment | $ 111,000 | $ 111,000 | ||||
Cash received from property, plant and equipment | 24,000 | $ 17,000 | ||||
Land, Buildings and Improvements | California | ||||||
Depreciation and Other Amortization Expenses [Line Items] | ||||||
Amount of divestiture of long-lived | $ 17,300,000 | |||||
Cash received from property, plant and equipment | $ 17,300,000 | |||||
Net cash received from property, plant and equipment | 16,700,000 | |||||
Payments for commissions and other fees | $ 600,000 | |||||
Construction in Progress | ||||||
Depreciation and Other Amortization Expenses [Line Items] | ||||||
Loss on impairment of property and equipment | $ 100,000 | $ 0 | $ 100,000 | $ 0 |
Accrued Expenses and Other Cu39
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Accrued Expenses and Other Current Liabilities [Line Items] | ||
Salary and related expenses | $ 3,729 | $ 3,814 |
Current portion of milestone rights liability | 1,643 | |
Professional fees | 968 | 875 |
Discounts and allowances for commercial product sales | 1,036 | 754 |
Sales and marketing services | 218 | 144 |
Restructuring | 362 | 1,376 |
Accrued interest | 624 | 619 |
Other | 496 | 355 |
Accrued expenses and other current liabilities | $ 9,076 | $ 7,937 |
Related-Party Arrangements - Ad
Related-Party Arrangements - Additional Information (Detail) | 1 Months Ended | 6 Months Ended | ||||
May 31, 2015USD ($)ft² | Oct. 31, 2013USD ($) | Oct. 31, 2007USD ($) | Jun. 30, 2017USD ($) | Jun. 27, 2017USD ($) | Dec. 31, 2016USD ($) | |
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] | ||||||
Accrued interest of related party debt | $ 10,700,000 | $ 9,300,000 | ||||
Available amount of credit facility under covenant restrictions | $ 19,400,000 | $ 19,400,000 | ||||
Fixed borrowing rate | 5.84% | |||||
Related party transaction prepayment period | 90 days | |||||
Aggregate principal amount cancelled | $ 105,000,000 | |||||
Principal amount outstanding under credit facility | 79,700,000 | $ 49,500,000 | ||||
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% | |||||
Mann Foundation | Sublease Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Lease expiration date | Aug. 31, 2017 | |||||
Mann Foundation | Sublease Agreement | ||||||
Related Party Transaction [Line Items] | ||||||
Area of office space leased | ft² | 12,500 | |||||
Lease expiration period | 2017-04 | |||||
Amount of leases renewed per month | $ 20,000 |
Schedule of Interest Expense on
Schedule of Interest Expense on Note Payable to Principal Stockholder (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Related Party Transaction [Line Items] | ||||
Interest expense on note payable to principal stockholder | $ 721 | $ 721 | $ 1,435 | $ 1,443 |
Schedule of Lease payments to t
Schedule of Lease payments to the Mann foundation (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Mann Foundation | Sublease Agreement | ||||
Lease and Rental Expense [Line Items] | ||||
Lease payments | $ 60 | $ 67 | $ 122 | $ 133 |
Summary of Borrowings (Detail)
Summary of Borrowings (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||
Note payable to principal stockholder-net carrying amount | $ 79,666 | $ 49,521 |
Senior convertible notes due December 31, 2019 | ||
Debt Instrument [Line Items] | ||
Principal amount | 60,000 | 75,000 |
Unamortized debt discount | (2,516) | (3,661) |
Net carrying amount | 57,484 | 71,339 |
5.75% Senior convertible notes due August 15, 2018 | ||
Debt Instrument [Line Items] | ||
Principal amount | 27,690 | 27,690 |
Unamortized premium | 306 | 426 |
Unaccreted debt issuance costs | (347) | (481) |
Net carrying amount | $ 27,649 | $ 27,635 |
Borrowings - Additional Informa
Borrowings - Additional Information (Detail) | Jun. 29, 2017USD ($)$ / sharesshares | Apr. 18, 2017USD ($)$ / sharesshares | Aug. 10, 2015d$ / shares | Jun. 30, 2017USD ($)$ / shares | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($)$ / shares | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | Jul. 28, 2015USD ($) | Jul. 01, 2013USD ($) |
Debt Instrument [Line Items] | |||||||||||
Loss on extinguishment of debt | $ (830,000) | $ (830,000) | |||||||||
Cash and cash equivalents | 43,384,000 | $ 63,733,000 | 43,384,000 | $ 63,733,000 | $ 22,895,000 | $ 59,074,000 | |||||
Facility Agreement, total principle payment in 2017 | 10,000,000 | 10,000,000 | |||||||||
Facility Agreement, total principle payment in 2018 | 20,000,000 | 20,000,000 | |||||||||
Facility Agreement, total principle payment in 2019 | 30,000,000 | 30,000,000 | |||||||||
Other liabilities | 103,000,000 | 103,000,000 | 123,200,000 | ||||||||
Milestone Rights Liability | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Other liabilities | 18,200,000 | $ 18,200,000 | 18,400,000 | ||||||||
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 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Long term liability | 8,900,000 | $ 8,900,000 | |||||||||
Deerfield | Milestone Rights Liability | Maximum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Contingent liability for milestone payments | $ 90,000,000 | $ 90,000,000 | $ 90,000,000 | ||||||||
Senior convertible notes due December 31, 2019 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Exchange price per share | $ / shares | $ 1.22 | $ 1.45 | $ 1.45 | ||||||||
Loss on extinguishment of debt | $ 500,000 | $ 500,000 | |||||||||
Accretion of debt issuance costs | 300,000 | ||||||||||
Cash repayment | $ 4,000,000 | ||||||||||
Debt extinguishment amount | 5,000,000 | ||||||||||
Debt facility principal amount | 60,000,000 | 60,000,000 | 75,000,000 | ||||||||
Carrying value | 57,484,000 | 57,484,000 | 71,339,000 | ||||||||
Senior convertible notes due December 31, 2019 | Less portion of commitment asset | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Loss on extinguishment of debt | 300,000 | 300,000 | |||||||||
Accretion of debt issuance costs | 8,000,000,000 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Debt facility principal amount | $ 45,000,000 | $ 45,000,000 | |||||||||
Senior notes, effective interest rate | 9.75% | 9.75% | |||||||||
Accrued expenses | $ 1,600,000 | $ 1,600,000 | |||||||||
Other current liabilities | 1,600,000 | 1,600,000 | |||||||||
Other liabilities | 8,900,000 | 8,900,000 | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Facility Agreement Third Amendment [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Cash repayment of senior notes under exchange agreement | $ 10,000,000 | ||||||||||
Conversion of notes to common shares, value | $ 5,000,000 | ||||||||||
Conversion Option, shares | shares | 3,584,230 | ||||||||||
Exchange price per share | $ / shares | $ 1.395 | ||||||||||
Cash | $ 10,000,000 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Minimum | Facility Agreement Third Amendment [Member] | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Cash and cash equivalents | 10,000,000 | ||||||||||
Cash | $ 25,000,000 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Cash repayment of senior notes under exchange agreement | 4,000,000 | ||||||||||
Conversion of notes to common shares, value | $ 1,000,000 | ||||||||||
Debt facility principal amount | $ 15,000,000 | $ 15,000,000 | |||||||||
Senior notes, effective interest rate | 8.75% | 8.75% | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | Facility Agreement | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Available amount of credit facility under covenant restrictions | $ 10,000,000 | $ 10,000,000 | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | Minimum | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Available amount of credit facility under covenant restrictions | 25,000,000 | 25,000,000 | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Less portion of commitment asset | Minimum | Facility Agreement | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Available amount of credit facility under covenant restrictions | 25,000,000 | 25,000,000 | |||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Tranche B Exchange Shares | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Conversion Option, shares | shares | 869,565 | ||||||||||
Exchange price per share | $ / shares | $ 1.15 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Tranche 1 Notes | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Conversion of notes to common shares, value | $ 5,000,000 | ||||||||||
Conversion Option, shares | shares | 4,347,826 | ||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Milestone Rights Liability | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Long term liability | 7,200,000 | 7,200,000 | 8,900,000 | ||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Milestone Rights Liability | Danbury Facility | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Carrying value | 27,900,000 | 27,900,000 | |||||||||
5.75% Senior convertible notes due August 15, 2018 | |||||||||||
Debt Instrument [Line Items] | |||||||||||
Accretion of debt issuance costs | 68,000 | $ 63,000 | 134,000 | $ 126,000 | |||||||
Debt facility principal amount | 27,690,000 | 27,690,000 | 27,690,000 | ||||||||
Senior notes, effective interest rate | 5.75% | ||||||||||
Carrying value | $ 27,649,000 | $ 27,649,000 | $ 27,635,000 | ||||||||
No of convertible shares | 29 | ||||||||||
Principal amount per share | $ / shares | $ 1,000 | ||||||||||
Conversion price of shares | $ / shares | $ 34 | ||||||||||
Percentage of repurchase price | 100.00% | ||||||||||
Debt Instrument, redemption description | On or after the date that is one year following the original issue date of the 2018 notes, the Company will have the right to redeem for cash all or part of the 2018 notes if the last reported sale price of its common stock exceeds 130% of the conversion price then in effect for 20 or more trading days during the 30 consecutive trading day period ending on the trading day immediately prior to the date of the redemption notice. The redemption price will equal the sum of 100% of the principal amount of the 2018 notes to be redeemed, plus accrued and unpaid interest. | ||||||||||
Percentage of conversion price equaling stock price | 130.00% | ||||||||||
Number of trading days | d | 20 | ||||||||||
Consecutive trading days | 30 days | ||||||||||
Debt Issuance Cost | $ 800,000 |
Accretion of Debt Issuance Cost
Accretion of Debt Issuance Cost and Debt Discount in Connection with Facility Financing Agreement (Detail) - Deerfield - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Debt Instrument [Line Items] | ||||
Accretion expense-debt issuance cost | $ 24 | $ 9 | $ 32 | $ 17 |
Accretion expense-debt discount | $ 686 | $ 433 | $ 1,133 | $ 852 |
Schedule of Amortization of Pre
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs (Detail) - 5.75% Senior convertible notes due August 15, 2018 - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Debt Instrument [Line Items] | ||||
Amortization of debt premium | $ 61 | $ 58 | $ 120 | $ 115 |
Accretion expense-debt issuance cost | $ 68 | $ 63 | $ 134 | $ 126 |
Collaboration Arrangements - Ad
Collaboration Arrangements - Additional Information (Detail) - USD ($) | Dec. 30, 2016 | Nov. 09, 2016 | Feb. 10, 2016 | Jan. 04, 2016 | Jan. 31, 2017 | Sep. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Sep. 23, 2014 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | $ 63,000 | $ 125,000 | ||||||||||
Secured loan facility, amount borrowed | 19,429,000 | |||||||||||
Paid-in-kind interest | $ 2,604,000 | |||||||||||
Gain on extinguishment of debt | (830,000) | (830,000) | ||||||||||
Insulin Put | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | $ 10,200,000 | |||||||||||
Sanofi-Aventis Deutschland GmbH | Put Option | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Payment for insulin put option | $ 30,600,000 | $ 30,600,000 | ||||||||||
Aventisub LLC | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Outstanding loan balance forgiven | $ 72,000,000 | |||||||||||
Receptor | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Nonrefundable payments | 400,000 | |||||||||||
Nonrefundable option exercise and license fee | $ 1,000,000 | |||||||||||
Reduction in research and development expense | 400,000 | |||||||||||
Deferred revenue - nonrefundable license fee | 1,000,000 | $ 1,000,000 | ||||||||||
Deferred revenue recognition period | 4 years | |||||||||||
Net revenue from collaboration | 100,000 | $ 100,000 | ||||||||||
License and Collaboration Agreement with Sanofi | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Profits and losses sharing percentage | 35.00% | |||||||||||
Termination date | Apr. 4, 2016 | |||||||||||
Maximum secured loan facility | $ 175,000,000 | |||||||||||
Senior notes, effective interest rate | 8.50% | |||||||||||
Gain on extinguishment of debt | $ 500,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue - nonrefundable license fee | 150,000,000 | $ 150,000,000 | ||||||||||
Net revenue from collaboration | $ 172,000,000 | |||||||||||
Profits and losses sharing percentage | 65.00% | |||||||||||
Milestone receivable | $ 25,000,000 | $ 25,000,000 | ||||||||||
Deferred cost | $ 13,500,000 | |||||||||||
Secured loan facility, amount borrowed | $ 17,900,000 | 44,500,000 | ||||||||||
Secured loan facility, amount owed | $ 71,200,000 | |||||||||||
Paid-in-kind interest | $ 5,800,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | AFREZZA product sales | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Deferred revenue - nonrefundable license fee | 17,500,000 | |||||||||||
Net revenue from collaboration | 17,500,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Up Front Payment [Member] | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | 150,000,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Milestone Payment One | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | 25,000,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Milestone Payment Two | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | 25,000,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Insulin Put | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | 19,400,000 | |||||||||||
License and Collaboration Agreement with Sanofi | Sanofi-Aventis Deutschland GmbH | Operating loss Sharing | ||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||||||
Net revenue from collaboration | $ (64,900,000) | |||||||||||
Company's total portion of loss sharing | $ 57,700,000 |
Sale of Intellectual Property -
Sale of Intellectual Property - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2017 | Jun. 30, 2017 | |
Finite-Lived Intangible Assets [Line Items] | ||
Revenue - other | $ 552,000 | $ 2,302,000 |
Intellectual property | ||
Finite-Lived Intangible Assets [Line Items] | ||
Proceeds from royalties | 600,000 | |
Revenue - other | $ 600,000 | 600,000 |
Royalty revenue | $ 0 |
Fair Value of Financial Instr49
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Millions | 6 Months Ended | ||
Jun. 30, 2017 | Dec. 31, 2016 | May 12, 2016 | |
Fair Value of Financial Instruments [Line Items] | |||
Cash equivalents, money market funds | $ 42.1 | $ 20.5 | |
Warrants issued, fair value | $ 12.8 | ||
Fair value of the liability, percentage decrease | 7.00% | ||
Minimum | |||
Fair Value of Financial Instruments [Line Items] | |||
Probabilities of meeting the milestones, percentage decrease | 5.00% | ||
Fair value of the liability, percentage decrease | 14.00% | ||
Maximum | |||
Fair Value of Financial Instruments [Line Items] | |||
Probabilities of meeting the milestones, percentage decrease | 10.00% | ||
Fair value of the liability, percentage decrease | 26.00% | ||
Milestone Rights Liability | Deerfield | |||
Fair Value of Financial Instruments [Line Items] | |||
Long term liability | $ 8.9 | ||
Milestone Rights Liability | Senior convertible notes due December 31, 2019 | Deerfield | |||
Fair Value of Financial Instruments [Line Items] | |||
Long term liability | 7.2 | 8.9 | |
Warrant Liability | |||
Fair Value of Financial Instruments [Line Items] | |||
Fair value of warrants liability | $ 0.6 | $ 7.4 | |
Valuation technique | Monte Carlo valuation pricing model | ||
Fair value assumption, risk-free rate | 1.40% | ||
Warrant liability fair value assumptions, dividend yield | 0.00% | ||
Warrant liability fair value assumptions, remaining term | 10 months 25 days | ||
Fair value assumption, stock price volatility | 112.00% | ||
Fair Value, Inputs, Level 3 | Milestone Rights Liability | |||
Fair Value of Financial Instruments [Line Items] | |||
Fair value of warrants liability | $ 18.2 | ||
Fair Value, Inputs, Level 3 | Market Approach Valuation Technique | 5.75% Senior convertible notes due August 15, 2018 | Senior Convertible Notes | |||
Fair Value of Financial Instruments [Line Items] | |||
Fair value assumption, risk-free rate | 20.00% | ||
Fair value assumption, stock price volatility | 100.00% | ||
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 | 0.12% | ||
Fair Value, Inputs, Level 3 | Income Approach Valuation Technique | Milestone Rights Liability | |||
Fair Value of Financial Instruments [Line Items] | |||
Market discount rate | 0.00% |
Fair Value of Financial Instr50
Fair Value of Financial Instruments (Detail) - USD ($) $ in Millions | Jun. 30, 2017 | Dec. 31, 2016 |
Financial liabilities: | ||
Financial liabilities fair value | $ 103 | $ 123.2 |
Warrant Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 0.6 | 7.4 |
Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 18.2 | 18.4 |
Senior Convertible Notes | Senior Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 24.2 | 22.9 |
Facility Financing Obligation | ||
Financial liabilities: | ||
Financial liabilities fair value | 60 | 74.5 |
Carrying Value | ||
Financial liabilities: | ||
Financial liabilities fair value | 94.6 | 115.2 |
Carrying Value | Warrant Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 0.6 | 7.4 |
Carrying Value | Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 8.9 | 8.9 |
Carrying Value | Senior Convertible Notes | Senior Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 27.6 | 27.6 |
Carrying Value | Facility Financing Obligation | ||
Financial liabilities: | ||
Financial liabilities fair value | 57.5 | 71.3 |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 103 | 123.2 |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | Warrant Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 0.6 | 7.4 |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 18.2 | 18.4 |
Estimate of Fair Value Measurement | Senior Convertible Notes | Fair Value, Inputs, Level 3 | Senior Convertible Notes | ||
Financial liabilities: | ||
Financial liabilities fair value | 24.2 | 22.9 |
Estimate of Fair Value Measurement | Facility Financing Obligation | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | $ 60 | $ 74.5 |
Fair Value of Warrant Liability
Fair Value of Warrant Liability Carried at Fair Value (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Fair values of financial liabilities, beginning balance | $ 123.2 |
Fair values of financial liabilities, ending balance | 103 |
Warrant Liability | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Fair values of financial liabilities, beginning balance | 7.4 |
Additions | 0 |
Changes in fair value | (6.8) |
Payments | 0 |
Fair values of financial liabilities, ending balance | $ 0.6 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2017USD ($)Tranche$ / sharesshares | Dec. 31, 2016USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Excess tax benefits related to windfalls | $ 11,600,000 | |
Number of restricted stock units issued | shares | 544,105 | |
Weighted average grant date fair value of the stock options granted | $ / shares | $ 0.93 | |
Number of equal tranches | Tranche | 4 | |
Vest in Four Equal Tranches | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate number of shares granted to awards, share-based compensation arrangements | shares | 1,508,159 | |
Vest Over Four Year Period | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Aggregate number of shares granted to awards, share-based compensation arrangements | shares | 642,378 | |
Tranche One | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to options | $ 700,000 | |
Tranche achievement date | 2017-12 | |
Tranche Two | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost, share-based compensation arrangements | $ 0 | |
Tranche Three | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost, share-based compensation arrangements | 0 | |
Tranche Four | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost, share-based compensation arrangements | $ 0 | |
Common Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average grant date fair value of the stock options granted | $ / shares | $ 1.31 | |
Aggregate number of shares granted to awards, share-based compensation arrangements | shares | 2,150,537 | |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Unrecognized compensation expense related to options | $ 4,400,000 | |
Stock Options | Common Stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of stock granted, share-based compensation arrangements | 2,000,000 | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of Restricted stock options granted , value | $ 600,000 | |
Weighted average grant date fair value of the stock options granted | $ / shares | $ 1.10 | |
Unrecognized compensation expense related to non-option | $ 4,200,000 | |
Options vest over vesting period | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to options | $ 3,900,000 |
Stock-Based Compensation Expe53
Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation | $ 1,250 | $ 1,355 | $ 2,516 | $ 2,628 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | May 05, 2017USD ($) | Jun. 30, 2017EUR (€) | Oct. 01, 2018USD ($) | Jun. 30, 2017USD ($) | Jul. 01, 2013USD ($) |
Commitments and Contingencies [Line Items] | |||||
Purchase commitment amount under Insulin Supply Agreement | € | € 93 | ||||
Supply Agreement expiration period | Dec. 31, 2023 | ||||
Supply Agreement renewal period | 2 years | ||||
Scenario Forecast | |||||
Commitments and Contingencies [Line Items] | |||||
Purchase commitment cancellation fees | $ 3,400,000 | ||||
Scenario Forecast | Before Amendment | |||||
Commitments and Contingencies [Line Items] | |||||
Purchase commitment cancellation fees | $ 5,300,000 | ||||
Supply Commitment | |||||
Commitments and Contingencies [Line Items] | |||||
Purchase commitment obligation | $ 900,000 | ||||
Deerfield | Milestone Rights Liability | Maximum | |||||
Commitments and Contingencies [Line Items] | |||||
Contingent liability for milestone payments | $ 90,000,000 | $ 90,000,000 | |||
Russell Ranch Road II LLC [Member] | |||||
Commitments and Contingencies [Line Items] | |||||
Lease monthly rental payments | $ 40,951 | ||||
Percentage of annual increase in lease payment | 3.00% | ||||
Lease expiration period | 65 months | ||||
Lease renewal option | 5 years |
Annual Purchase Requirements un
Annual Purchase Requirements under Contract (Detail) € in Millions | Jun. 30, 2017EUR (€) |
Annual Purchase Requirements under Contract | |
2,017 | € 2.7 |
2,018 | 8.9 |
2,019 | 11.6 |
2,020 | 15.5 |
2,021 | 15.5 |
2,022 | 19.4 |
2,023 | € 19.4 |
Schedule of Future Minimum Leas
Schedule of Future Minimum Lease Payments (Detail) | Jun. 30, 2017USD ($) |
Operating Leased Assets [Line Items] | |
2,017 | $ 41,000 |
2,018 | 457,000 |
2,019 | 512,000 |
2,020 | 528,000 |
2,021 | 544,000 |
Thereafter | 560,000 |
Total | $ 2,642,000 |
Restructuring Charges - Additio
Restructuring Charges - Additional information (Detail) - USD ($) | May 25, 2017 | Jun. 30, 2017 | Jun. 30, 2017 | Dec. 31, 2016 |
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring | $ 362,000 | $ 362,000 | $ 1,376,000 | |
Value of estimated current value of payments and benefits upon termination | 1,014,000 | |||
Severance accrual | 0 | |||
Special Termination Benefits | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Value of estimated current value of payments and benefits upon termination | $ 1,200,000 | |||
Accrued Expenses and Other Current Liabilities | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring | $ 400,000 | $ 400,000 | $ 1,400,000 |
Reconciliation of Beginning and
Reconciliation of Beginning and Ending Liability Balances for Restructuring Charges (Detail) $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($) | |
Restructuring Cost and Reserve [Line Items] | |
Accrual - Beginning balance | $ 1,376 |
Costs paid or settled | (1,014) |
Accrual - Ending balance | 362 |
Twenty Sixteen Restructuring Plan | |
Restructuring Cost and Reserve [Line Items] | |
Accrual - Beginning balance | 209 |
Costs paid or settled | (209) |
Twenty Fifteen Restructuring Plan | |
Restructuring Cost and Reserve [Line Items] | |
Accrual - Beginning balance | 1,167 |
Costs paid or settled | (805) |
Accrual - Ending balance | $ 362 |